01.05.2025
16.10.2025
Ivacaftor / Tezacaftor / Elexacaftor (17)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, ≥ 2 years, non-class I mutation (no F508del mutation and no gating mutation)
375
64%
Hint for
major additional benefit
Orphan (turnover limit)
01.05.2025
16.10.2025
Ivacaftor / Tezacaftor / Elexacaftor (16)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, ≥ 2 years, non-class I mutation (one gating mutation and no F508del mutation)
100
100%
no additional benefit
Orphan (turnover limit)
01.05.2025
16.10.2025
Trastuzumab deruxtecan (6)
Enhertu®
Daiichi Sankyo GmbH
Oncological diseases
Breast cancer, HR+, HER2-low or -ultralow, after at least 1 endocrine therapy
1,615–6,200
100%
Hint for
minor additional benefit
01.05.2025
16.10.2025
Tiratricol
Emcitate®
Rare Thyroid Therapeutics International AB
Metabolic diseases
Peripheral thyrotoxicosis in monocarboxylate transporter deficiency 8
40–110
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2025
16.10.2025
Serplulimab
Hetronifly®
Accord Healthcare GmbH
Oncological diseases
Small cell lung carcinoma, in combination with carboplatin and etoposide, first-line
3,210–7,719
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2025
16.10.2025
Repotrectinib (2)
Augtyro®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Solid tumours, NTRK gene fusion, ≥ 12 years
390–770
100%
no additional benefit
01.05.2025
16.10.2025
Repotrectinib
Augtyro®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, ROS1-positive
585–1,620
100%
no additional benefit
01.05.2025
16.10.2025
Pembrolizumab (40)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Malignant pleural mesothelioma, non-epithelioid, first-line, combination with pemetrexed and platinum chemotherapy
55–105
100%
no additional benefit
01.05.2025
16.10.2025
Eplontersen
Wainzua®
AstraZeneca GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
360
100%
no additional benefit
01.05.2025
16.10.2025
Concizumab (2)
Alhemo®
Novo Nordisk GmbH
Hematopoietic diseases
Haemophilia B, ≥ 12 years, with factor IX inhibitors
2–12
57%
Hint for
considerable additional benefit
01.05.2025
16.10.2025
Concizumab
Alhemo®
Novo Nordisk GmbH
Hematopoietic diseases
Haemophilia A, ≥ 12 years, with factor VIII inhibitors
80–125
100%
no additional benefit
01.05.2025
16.10.2025
Bevacizumab
Lytenava®
Outlook Therapeutics Limited
Eye diseases
Neovascular age-related macular degeneration
85,500–504,400
100%
no additional benefit
15.04.2025
02.10.2025
Lisocabtagen maraleucel (3)
Breyanzi®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Follicular lymphoma, after ≥ 2 prior therapies
370–840
100%
no additional benefit
Orphan
15.04.2025
02.10.2025
Pirtobrutinib (2)
Jaypirca®
Lilly Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), relapsed or refractory, monotherapy
5,390–6,050
10%
Hint for
minor additional benefit
01.04.2025
18.09.2025
Belzutifan (2)
Welireg®
MSD Sharp & Dohme GmbH
Oncological diseases
Von Hippel-Lindau syndrome (VHL)-associated tumours
80–970
100%
no additional benefit
01.04.2025
18.09.2025
Belzutifan
Welireg®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma, advanced, after ≥ 2 prior therapies
65–940
50%
Hint for
minor additional benefit
01.04.2025
18.09.2025
Acoramidis
Beyonttra®
Bayer Vital GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
1,760–2,120
100%
no additional benefit
15.03.2025
04.09.2025
Seladelpar
Lyvdelzi®
Gilead Sciences GmbH
Digestive system diseases
Primary biliary cholangitis (combination with ursodeoxycholic acid)
6,000–13,000
100%
Indication of
minor additional benefit
Orphan
15.03.2025
04.09.2025
Mirikizumab (2)
Omvoh®
Lilly Deutschland GmbH
Digestive system diseases
Crohn's disease, pre-treated
12,600–78,300
100%
no additional benefit
15.03.2025
04.09.2025
Fosdenopterin
Nulibry®
Sentynl Therapeutics
Nervous system diseases
Molybdenum cofactor deficiency type A
2
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Atogepant
Aquipta®
AbbVie Deutschland GmbH & Co. KG
Nervous system diseases
Migraine prophylaxis
1,386,900–1,726,200
100%
no additional benefit
01.03.2025
21.08.2025
Blinatumomab (9)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, high-risk first relapse, Ph-, CD19+, ≥1 month and <1 year
1
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Blinatumomab (8)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, Ph-, CD19+, newly diagnosed
160–270
100%
Hint for
considerable additional benefit
Orphan
01.03.2025
21.08.2025
Blinatumomab (7)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, relapsed/refractory, ≥ 1 month to < 1 year, after ≥ 2 prior therapies or after allogeneic stem cell transplantation
1
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Daratumumab (12, reassessment)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Systemic light-chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
220–515
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.03.2025
21.08.2025
Fedratinib (2, reassessment)
Inrebic®
Bristol-Myers Squibb GmbH
Oncological diseases
Myelofibrosis
640–1,710
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Garadacimab
Andembry®
CSL Behring GmbH
Other diseases
Hereditary angioedema, prophylaxis, ≥ 12 years
140–440
100%
Hint for
considerable additional benefit
01.03.2025
21.08.2025
Nirsevimab (3)
Beyfortus®
Sanofi-Aventis Deutschland GmbH
Infectious diseases
Prevention of RSV infections, children during their 1st RSV season, which are not addressed in the therapeutic indication for RSV antibodies
541,000–555,000
100%
Indication of
considerable additional benefit
01.03.2025
21.08.2025
Setmelanotid (3)
Imcivree®
Rhythm Pharmaceuticals Inc
Metabolic diseases
Obesity and control of hunger, POMC, PCSK1, LEPR deficiency or Bardet-Biedl syndrome, ≥ 2 to < 6 years of age
24–67
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Vibegron
Obgemsa®
Pierre Fabre Pharma GmbH
Genitourinary system diseases
Overactive bladder
587,900–1,270,000
100%
no additional benefit
15.02.2025
07.08.2025
Cabotegravir (2)
Vocabria®
ViiV Healthcare GmbH
Infectious diseases
HIV-1 infection, treatment-experienced adolescents, combination with rilpivirine, 12 to 17 years of age
65
100%
no additional benefit
15.02.2025
07.08.2025
Nemolizumab (2)
Nemluvio®
Galderma Laboratorium GmbH
Skin diseases
Atopic dermatitis, ≥ 12 years
57,300–62,600
100%
no additional benefit
15.02.2025
07.08.2025
Nemolizumab
Nemluvio®
Galderma Laboratorium GmbH
Skin diseases
Prurigo nodularis
3,500–5,500
100%
no additional benefit
15.02.2025
07.08.2025
Nintedanib (7, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH
Respiratory system diseases
Interstitial lung disease with systemic sclerosis, 6 to < 18 years of age
0–8
100%
no additional benefit
15.02.2025
07.08.2025
Nintedanib (6, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH
Respiratory system diseases
Clinically significant progressive fibrosing interstitial lung disease, 6 to < 18 years of age
1–35
100%
no additional benefit
15.02.2025
07.08.2025
Sarilumab (3)
Kevzara®
Sanofi-Aventis Deutschland GmbH
Musculoskeletal system diseases
Polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years
1,370–1,480
100%
no additional benefit
15.02.2025
07.08.2025
Sarilumab (2)
Kevzara®
Sanofi-Aventis Deutschland GmbH
Musculoskeletal system diseases
Polymyalgia rheumatica
10,300–14,200
100%
no additional benefit
15.02.2025
07.08.2025
Sipavibart
Kavigale®
AstraZeneca GmbH
Infectious diseases
COVID-19, pre-exposure prophylaxis, ≥ 12 years
0
100%
no additional benefit
15.02.2025
07.08.2025
Dostarlimab (3)
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Primarily advanced or recurrent endometrial cancer with pMMR, combination with carboplatin and paclitaxel
990–1,810
100%
no additional benefit
15.02.2025
07.08.2025
Isatuximab (3)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, lenalidomide and dexamethasone
3,450–3,680
100%
Hint for
minor additional benefit
15.02.2025
07.08.2025
Pirtobrutinib
Jaypirca®
Lilly Deutschland GmbH
Oncological diseases
Mantle cell lymphoma, pre-treated patients
105–150
100%
no additional benefit
15.02.2025
17.07.2025
Lazertinib
Lazcluze®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), combination with amivantamab
1,250–3,025
100%
Hint for
minor additional benefit
01.02.2025
17.07.2025
Amivantamab (4)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 20 insertion mutation, first-line, combination with carboplatin and pemetrexed
70–215
100%
no additional benefit
01.02.2025
17.07.2025
Amivantamab (3)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), combination with lazertinib
1,250–3,025
100%
Hint for
minor additional benefit
01.02.2025
17.07.2025
Amivantamab (2)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), pretreated, combination with carboplatin and pemetrexed
985–3,045
100%
no additional benefit
01.02.2025
17.07.2025
Marstacimab (2)
Hympavzi®
Pfizer Pharma GmbH
Hematopoietic diseases
Severe haemophilia A, ≥ 12 years, without factor VIII inhibitors
1,900–2,000
100%
no additional benefit
01.02.2025
17.07.2025
Marstacimab
Hympavzi®
Pfizer Pharma GmbH
Hematopoietic diseases
Severe haemophilia B, ≥ 12 years, without factor IX inhibitors
300–310
100%
no additional benefit
01.02.2025
17.07.2025
Natriumthiosulfat
Pedmarqsi®
Norgine GmbH
Oncological diseases
Prevention of ototoxicity due to cisplatin chemotherapy, solid tumours, 1 month to < 18 years
38–228
16%
Indication of
non-quantifiable additional benefit
15.01.2025
03.07.2025
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse) (2)
Palforzia®
Stallergenes GmbH
Other diseases
Peanut allergy, ≥ 1 to < 4 years
9,960–22,700
100%
Hint for
non-quantifiable additional benefit
15.01.2025
03.07.2025
Exagamglogen autotemcel (2)
Casgevy®
Vertex Pharmaceuticals (Germany) GmbH
Hematopoietic diseases
Sickle cell disease with recurrent vaso-occlusive crises; ≥ 12 years; no HLA-matched related stem cell donation available
130–1,230
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2025
03.07.2025
Exagamglogen autotemcel
Casgevy®
Vertex Pharmaceuticals (Germany) GmbH
Hematopoietic diseases
Β-thalassaemia, transfusion-dependent, ≥ 12 years, no HLA-compatible related stem cell donation available
20–150
100%
Indication of
non-quantifiable additional benefit
Orphan
15.01.2025
03.07.2025
Osimertinib (7)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR mutations, after platinum-based radiochemotherapy
160–290
100%
no additional benefit
01.01.2025
18.06.2025
Eliglustat (2)
Cerdelga®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Gaucher disease type 1, ≥ 6 to < 18 years, ≥ 15 kg bw
10–30
100%
Hint for
non-quantifiable additional benefit
Orphan
01.01.2025
18.06.2025
Erdafitinib
Balversa®
Janssen-Cilag GmbH
Oncological diseases
Urothelial carcinoma, FGFR3 alterations, pretreated with PD-(L)1 inhibitor
169–207
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab (6)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastro-oesophageal junction, PD-L1 expression ≥ 5, HER2-, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
1,941–3,067
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab (5)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Non-small cell lung cancer, after prior therapy
690–1,620
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab (4)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Non-small cell lung cancer, non-squamous, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-containing chemotherapy
3,460–4,600
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab (3)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel
7,780–11,040
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab (2)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Squamous cell carcinoma of the oesophagus, PD-L1 expression TAP score ≥ 5%, first-line, combination with platinum-based chemotherapy
1,530–2,050
100%
no additional benefit
01.01.2025
18.06.2025
Tislelizumab
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Squamous cell carcinoma of the oesophagus, after prior therapy
330–540
100%
no additional benefit
15.12.2024
05.06.2025
Ribociclib (5)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer, HR+, HER2-, early with high risk of recurrence, adjuvant therapy, combination with aromatase inhibitor
3,730–15,960
100%
no additional benefit
15.12.2024
05.06.2025
Linzagolix (2)
Yselty®
Theramex Ireland Limited
Genitourinary system diseases
Endometriosis
8,100–13,900
100%
no additional benefit
15.12.2024
05.06.2025
Mirvetuximab Soravtansin
Elahere®
AbbVie Deutschland GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FRα-positive, platinum-resistant, after 1 to 3 prior therapies
630–1,300
100%
Indication of
considerable additional benefit
Orphan
01.12.2024
15.05.2025
Benralizumab (2)
Fasenra®
AstraZeneca GmbH
Musculoskeletal system diseases
Eosinophilic granulomatosis with polyangiitis
90–1,360
100%
no additional benefit
01.12.2024
15.05.2025
Daratumumab (11)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, first-line, stem cell transplantation suitable, combination with bortezomib, lenalidomide and dexamethasone
1,750–1,910
100%
no additional benefit
Orphan (turnover limit)
01.12.2024
15.05.2025
Dupilumab (11)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Digestive system diseases
Eosinophilic oesophagitis, ≥ 1 year to < 12 years
530–590
100%
no additional benefit
01.12.2024
15.05.2025
Ciltacabtagen autoleucel (2, reassessment >€30m)
Carvykti®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, after at least 1 prior therapy, refractory to lenalidomide
2,280–3,640
62%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.11.2024
15.05.2025
Apremilast (3)
Otezla®
Amgen GmbH
Skin diseases
Moderate to severe plaque psoriasis; 6 to < 18 years of age
360–430
100%
no additional benefit
15.11.2024
15.05.2025
Ceftazidim / Avibactam (2)
Zavicefta®
Pfizer Pharma GmbH
Infectious diseases
Bacterial infections, several therapeutic indications, from birth to < 3 years
10–27
100%
additional benefit considered proven
15.11.2024
15.05.2025
Pembrolizumab (39)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Cervical carcinoma (stage III to IVA), first-line, combination with radiochemotherapy
750
100%
Indication of
non-quantifiable additional benefit
15.11.2024
15.05.2025
Pembrolizumab (38)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma, first-line, combination with carboplatin and paclitaxel
1,370–3,330
100%
no additional benefit
01.11.2024
17.04.2025
Artesunat
Artesunate Amivas®
Amivas Ireland Ltd
Infectious diseases
Severe malaria, from birth
87
100%
non-quantifiable additional benefit
Orphan
01.11.2024
17.04.2025
Epcoritamab (3, reassessment)
Tepkinly®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies
920–1,940
100%
no additional benefit
01.11.2024
17.04.2025
Meropenem / Vaborbactam
Vaborem®
Berlin-Chemie AG
Infectious diseases
Acterial infections, several therapeutic indications
1,294–1,405
100%
additional benefit considered proven
01.11.2024
17.04.2025
Zolbetuximab
Vyloy®
Astellas Pharma GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastro-oesophageal junction, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-containing chemotherapy
250–1,310
100%
Indication of
minor additional benefit
Orphan
15.10.2024
03.04.2025
Delgocitinib
Anzupgo®
LEO Pharma GmbH
Skin diseases
Moderate to severe chronic hand eczema
160,000–200,000
100%
no additional benefit
15.10.2024
03.04.2025
Elafibranor
Iqirvo®
Ipsen Pharma GmbH
Digestive system diseases
Primary biliary cholangitis (combination with ursodeoxycholic acid)
6,000–13,000
100%
Hint for
minor additional benefit
Orphan
01.10.2024
03.04.2025
Enfortumab Vedotin (2)
Padcev®
Astellas Pharma Europe B.V
Oncological diseases
Urothelial carcinoma, non-resectable or metastatic, first-line, suitable for platinum-containing chemotherapy, combination with pembrolizumab
920–2,280
45%
Indication of
considerable additional benefit
01.10.2024
03.04.2025
Pembrolizumab (37)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma, non-resectable or metastatic, first-line, combination with enfortumab vedotin
1,050–2,601
39%
Indication of
considerable additional benefit
01.10.2024
03.04.2025
Capivasertib
Truqap®
AstraZeneca GmbH
Oncological diseases
Breast cancer, ER+, HER2-, PIK3CA/AKT1/PTEN alteration(s), after prior therapy, combination with fulvestrant
491–26,745
70%
Indication of
considerable additional benefit
01.10.2024
20.03.2025
Encorafenib (3)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with binimetinib
122–476
100%
no additional benefit
01.10.2024
20.03.2025
Pembrolizumab (36, reassessment)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast cancer, triple-negative, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
2,440–2,610
50%
Indication of
minor additional benefit
01.10.2024
20.03.2025
Binimetinib (2)
Mektovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with encorafenib
122–476
100%
no additional benefit
01.10.2024
20.03.2025
Atezolizumab (12, reassessment)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 50%, adjuvant therapy after resection and chemotherapy
700–890
100%
Hint for
considerable additional benefit
01.10.2024
20.03.2025
Atezolizumab (11)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, first-line
1,900–7,570
71%
Indication of
minor additional benefit
01.10.2024
20.03.2025
Polihexanid
Akantior®
SIFI S.p.A.
Eye diseases
Acanthamoebic keratitis; ≥ 12 years of age
70–410
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2024
20.03.2025
Isavuconazol (2)
Cresemba®
Pfizer Pharma GmbH
Infectious diseases
Mucormycosis, ≥ 1 to ≤ 17 years
8
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2024
20.03.2025
Isavuconazol (3)
Cresemba®
Pfizer Pharma GmbH
Infectious diseases
Aspergillosis, ≥ 1 to ≤ 17 years
40–215
100%
Hint for
non-quantifiable additional benefit
Orphan
15.09.2024
06.03.2025
Epcoritamab (2)
Tepkinly®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Follicular lymphoma, after ≥ 2 prior therapies
370–840
100%
no additional benefit
15.09.2024
06.03.2025
Crovalimab
Piasky®
Roche Pharma AG
Hematopoietic diseases
Paroxysmal nocturnal haemoglobinuria, ≥ 12 years, ≥ 40 kg
260–749
100%
no additional benefit
15.09.2024
06.03.2025
Sotatercept
Winrevair®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Pulmonary arterial hypertension
580–7,850
100%
Hint for
minor additional benefit
Orphan
15.09.2024
06.03.2025
Linzagolix
Yselty®
Theramex Ireland Limited
Genitourinary system diseases
Uterine fibroid
20,160–100,800
100%
no additional benefit
01.09.2024
20.02.2025
Faricimab (3)
Vabysmo®
Roche Pharma AG
Eye diseases
Macular oedema due to retinal vein occlusion
59,200–96,400
100%
no additional benefit
01.09.2024
20.02.2025
Insulin icodec (2)
Awiqli®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
855,000–1,184,000
100%
no additional benefit
01.09.2024
20.02.2025
Insulin icodec
Awiqli®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1
161,750
100%
no additional benefit
01.09.2024
20.02.2025
Risankizumab (4)
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Ulcerative colitis, pre-treated
29,100
100%
no additional benefit
01.09.2024
20.02.2025
Aztreonam / Avibactam
Emblaveo®
Pfizer Pharma GmbH
Infectious diseases
Bacterial infections, several therapeutic indications
2,600–6,600
100%
additional benefit considered proven
01.09.2024
20.02.2025
Olaparib (12)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Primarily advanced or recurrent endometrial cancer with pMMR, combination with durvalumab, maintenance therapy
780–1,430
50%
Indication of
considerable additional benefit
01.09.2024
20.02.2025
Durvalumab (8)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Primarily advanced or relapsed endometrial cancer, first-line therapy, combination with carboplatin and paclitaxel; maintenance therapy
380–1,520
100%
no additional benefit
01.09.2024
20.02.2025
Durvalumab (7)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Primarily advanced or recurrent endometrial cancer, combination with carboplatin and paclitaxel; maintenance therapy, combination with olaparib
990–1,810
50%
Indication of
considerable additional benefit
10.09.2024
20.02.2025
rADAMTS13
Adzynma®
Takeda GmbH
Hematopoietic diseases
ADAMTS13 deficiency in congenital thrombotic thrombocytopenic purpura (cTTP)
120–180
100%
Hint for
non-quantifiable additional benefit
Orphan
15.08.2024
20.02.2025
Nirsevimab (2)
Beyfortus®
Sanofi-Aventis Deutschland GmbH
Infectious diseases
Secondary prophylaxis of RSV infections, children during their 2nd RSV season, ≥ 24 months of life
9,535
100%
no additional benefit
01.08.2024
06.02.2025
Sparsentan
Filspari®
Vifor Pharma Deutschland GmbH
Genitourinary system diseases
Immunoglobulin A - Nephropathy, primary
900–13,000
100%
Hint for
minor additional benefit
Orphan
01.08.2024
06.02.2025
Osimertinib (6)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, first-line, combination with pemetrexed and platinum-containing chemotherapy
840–2,720
100%
no additional benefit
01.08.2024
06.02.2025
Maralixibat (2)
Livmarli®
Mirum Pharmaceuticals International B.V.
Digestive system diseases
Progressive familial intrahepatic cholestasis (PFIC), ≥ 3 months
80–180
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2024
06.02.2025
Entrectinib (3)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Solid tumors, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology-independent, > 1 month to < 12 years
3
100%
no additional benefit
01.08.2024
06.02.2025
Dupilumab (10)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
COPD
9,370
71%
Indication of
minor additional benefit
15.07.2024
16.01.2025
Alectinib (3)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, ALK+, high risk of recurrence, adjuvant therapy
330–452
50%
Hint for
major additional benefit
15.07.2024
16.01.2025
Gozetotid
Locametz®
Novartis Pharma GmbH
Oncological diseases
Detection of PSMA-positive prostate cancer (mCRPC), PSMA-targeted therapy
1,860–2,770
84%
Indication of
considerable additional benefit
15.07.2024
16.01.2025
Fruquintinib
Fruzaqla®
Takeda GmbH
Oncological diseases
Colorectal carcinoma, previously treated patients
645–2,180
100%
Hint for
minor additional benefit
01.07.2024
19.12.2024
Nivolumab (28)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma, first-line, combination with cisplatin and gemcitabine
435–617
100%
no additional benefit
01.07.2024
19.12.2024
Axicabtagen-Ciloleucel (7, reassessment)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory
800–1,130
100%
Hint for
minor additional benefit
Orphan (turnover limit)
01.07.2024
19.12.2024
Osimertinib (5, reassessment)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR mutations, adjuvant therapy
640–930
50%
Hint for
major additional benefit
01.07.2024
19.12.2024
Iptacopan
Fabhalta®
Novartis Pharma GmbH
Hematopoietic diseases
Paroxysmal nocturnal hemoglobinuria
290–945
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2024
19.12.2024
Tofersen
Qalsody®
Biogen GmbH
Nervous system diseases
Amyotrophic lateral sclerosis (ALS)
90–170
100%
Hint for
non-quantifiable additional benefit
Orphan
15.06.2024
05.12.2024
Cefepim / Enmetazobactam
Exblifep®
Advanz Pharma Germany GmbH
Infectious diseases
Bacterial infections, several areas of application
1,000–2,600
100%
additional benefit considered proven
01.06.2024
22.11.2024
Pegcetacoplan (2)
Aspaveli®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Paroxysmal nocturnal hemoglobinuria, untreated patients
100–425
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2024
22.11.2024
Vadadustat
Vafseo®
MEDICE Arzneimittel Pütter GmbH & Co. KG
Hematopoietic diseases
Symptomatic anemia in chronic kidney disease (CKD)
60,800–71,400
100%
no additional benefit
01.06.2024
22.11.2024
Futibatinib
Lytgobi®
Taiho Pharma Netherlands
Oncological diseases
Cholangiocarcinoma, with FGFR2 fusion or FGFR2 rearrangement, after at least 1 prior therapy
27–229
100%
no additional benefit
01.06.2024
22.11.2024
Danicopan
Voydeya®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Paroxysmal hemoglobinuria in residual hemolytic anemia, add-on therapy to ravulizumab or eculizumab)
70–350
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2024
22.11.2024
Bimekizumab (5)
Bimzelx®
UCB Pharma GmbH
Skin diseases
Hidradenitis suppurativa (acne inversa))
2,800–6,400
100%
no additional benefit
15.05.2024
07.11.2024
Selpercatinib (7)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Solid tumors, RET-Fusion+
59–159
100%
no additional benefit
15.05.2024
07.11.2024
Selpercatinib (6)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma, RET fusion+, refractory to radioiodine, first-line or after systemic prior therapy, ≥ 12 years of age
6–36
100%
no additional benefit
01.05.2024
17.10.2024
Dabrafenib (5, Finlee®)
Finlee®
Novartis Pharma GmbH
Oncological diseases
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with trametinib
7–115
41%
Hint for
considerable additional benefit
Orphan
01.05.2024
17.10.2024
Trametinib (4, Spexotras®)
Spexotras®
Novartis Pharma GmbH
Oncological diseases
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with dabrafenib
7–115
41%
Hint for
considerable additional benefit
Orphan
01.05.2024
17.10.2024
Luspatercept (6)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Myelodysplastic syndromes with transfusion-dependent anemia, not pretreated, and without ring sideroblasts, pretreated
4,960–7,080
80%
Hint for
minor additional benefit
Orphan (turnover limit)
01.05.2024
17.10.2024
Pembrolizumab (35)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with platinum-based chemotherapy
5,090–6,780
100%
no additional benefit
01.05.2024
17.10.2024
Pembrolizumab (34)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung cancer, adjuvant therapy with high risk of recurrence after resection, after prior chemotherapy
2,690–3,200
100%
no additional benefit
01.05.2024
17.10.2024
Abrocitinib (2)
Cibinqo®
Pfizer Pharma GmbH
Skin diseases
Atopic dermatitis, ≥ 12 to < 18 years
5,300–10,600
100%
no additional benefit
01.08.2024
02.10.2024
Efbemalenograstim alfa
Ryzneuta®
Evive Biotech
Oncological diseases
Febrile neutropenia due to chemotherapy
0
100%
no additional benefit
15.07.2024
02.10.2024
Efanesoctocog alfa
Altuvoct®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia A
0
100%
no additional benefit
Orphan
15.04.2024
02.10.2024
Etrasimod
Velsipity®
Pfizer Pharma GmbH
Digestive system diseases
Ulcerative colitis, ≥ 16 years
29,100
100%
no additional benefit
15.04.2024
02.10.2024
Abaloparatid
Eladynos®
Theramex Germany GmbH
Musculoskeletal system diseases
Osteoporosis, postmenopausal women
484,000
100%
no additional benefit
01.04.2024
19.09.2024
Efgartigimod alfa (2, reassessment >€30m)
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+
6,300–19,000
100%
no additional benefit
Orphan (turnover limit)
01.04.2024
19.09.2024
Gadopiclenol
Elucirem®
Guerbet GmbH
Other diseases
Contrast-enhanced magnetic resonance imaging, ≥ 2 years
2,900,000–3,300,000
100%
no additional benefit
01.04.2024
19.09.2024
Idecabtagen vicleucel (3)
Abecma®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma, at least 2 prior therapies
4,900–5,250
100%
no additional benefit
Orphan (turnover limit)
15.03.2024
19.09.2024
Omaveloxolon
Skyclarys®
Biogen GmbH
Nervous system diseases
Friedreich's ataxia, ≥ 16 years
970
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2024
15.08.2024
Zilucoplan
Zilbrysq®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
6,300–19,000
100%
no additional benefit
01.03.2024
15.08.2024
Rozanolixizumab
Rystiggo®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+, MuSK antibodies+
6,470–19,300
98%
Hint for
considerable additional benefit
Orphan
01.03.2024
15.08.2024
Enalapril
Aqumeldi®
Proveca Pharma Limited
Cardiovascular diseases
Heart failure, < 18 years
0
3,070
100%
no additional benefit
01.03.2024
15.08.2024
Decitabin / Cedazuridin
Inaqovi®
Otsuka Pharma GmbH
Oncological diseases
Acute myeloid leukaemia, first line
560–840
100%
no additional benefit
01.03.2024
15.08.2024
Daridorexant (2, reassessment)
Quviviq®
Idorsia Pharmaceuticals Germany GmbH
Mental illnesses
Sleep disorders
8,300–218,500
100%
no additional benefit
01.03.2024
15.08.2024
Nirsevimab
Beyfortus®
Sanofi-Aventis Deutschland GmbH
Infectious diseases
Secondary prophylaxis of RSV infections, children during their 1st RSV season
52,450–66,450
100%
no additional benefit
15.02.2024
15.08.2024
Momelotinib
Omjjara®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Myelofibrosis
210–1,160
50%
Hint for
minor additional benefit
Orphan
15.02.2024
15.08.2024
Talazoparib (2)
Talzenna®
Pfizer Pharma GmbH
Oncological diseases
Prostate carcinoma, metastasised, castration-resistant, in combination with enzalutamide)
9,400–12,200
75%
no additional benefit
01.02.2024
01.08.2024
Rezafungin
Rezzayo®
Mundipharma
Infectious diseases
Invasive candida infections
31,800–34,600
100%
Hint for
non-quantifiable additional benefit
Orphan
01.02.2024
01.08.2024
Patiromer (2)
Veltassa®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Hyperkalaemia, ≥ 12 to < 18 years
370–790
100%
no additional benefit
01.02.2024
01.08.2024
Fezolinetant
Veoza®
Astellas Pharma GmbH
Other diseases
Severe vasomotor symptoms (VMS) associated with the menopause
2,589,650–3,015,900
80%
Hint for
minor additional benefit
01.02.2024
01.08.2024
Ublituximab
Briumvi®
Neuraxpharm Arzneimittel GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis
70,300–274,900
63%
Indication of
minor additional benefit
01.02.2024
01.08.2024
Quizartinib
Vanflyta®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
260–820
100%
no additional benefit
15.01.2024
04.07.2024
Pegzilarginase
Loargys®
Immedica Pharma Germany GmbH
Metabolic diseases
Hyperargininemia (ARG1-D), ≥ 2 years
50
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2024
04.07.2024
Elranatamab
Elrexfio®
Pfizer Pharma GmbH
Oncological diseases
Multiple myeloma, relapsed and refractory, after at least 3 previous therapies
1,250–1,340
100%
no additional benefit
15.01.2024
04.07.2024
Vamorolon
Agamree®
Santhera Pharmaceuticals GmbH
Musculoskeletal system diseases
Duchenne muscular dystrophy, ≥ 4 years
740–3,670
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2024
04.07.2024
Evinacumab (2)
Evkeeza®
Ultragenyx Germany GmbH
Metabolic diseases
Homozygous familial hypercholesterolemia, ≥ 12 years of age
73–80
100%
no additional benefit
15.01.2024
04.07.2024
Evinacumab
Evkeeza®
Ultragenyx Germany GmbH
Metabolic diseases
Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age
5–6
100%
no additional benefit
01.01.2024
20.06.2024
Pembrolizumab (33)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Biliary tumours, first-line, combination with gemcitabine and cisplatin
1,480–2,180
100%
Indication of
minor additional benefit
01.01.2024
20.06.2024
Pembrolizumab (32)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2+, first-line, combination with trastuzumab, fluoropyrimidine- and platinum-based chemotherapy
70–710
100%
no additional benefit
01.01.2024
20.06.2024
Pembrolizumab (31)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2, first-line, combination with fluoropyrimidine- and platinum-based chemotherapy
285–2,613
100%
no additional benefit
01.01.2024
20.06.2024
Palopegteriparatid
Yorvipath®
Ascendis Pharma Endocrinology GmbH
Metabolic diseases
Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy
18,300–20,800
100%
no additional benefit
Orphan
01.01.2024
20.06.2024
Dostarlimab (2)
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Primary advanced or recurrent endometrial carcinoma with dMMR/ MSI-H, combination with carboplatin and paclitaxel
790–1,520
50%
Indication of
major additional benefit
01.01.2024
20.06.2024
Empagliflozin (6)
Jardiance®
Boehringer Ingelheim Pharma GmbH
Metabolic diseases
Diabetes Mellitus Type 2, ≥ 10 years
300–385
100%
no additional benefit
01.01.2024
20.06.2024
Avapritinib (3)
Ayvakyt®
Blueprint Medicines GmbH
Oncological diseases
Indolent systemic mastocytosis (ISM)
715–1,000
100%
Indication of
minor additional benefit
Orphan
01.01.2024
20.06.2024
Polatuzumab (3, reassessment >€30m)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma, combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
0
5,640–6,270
100%
no additional benefit
Orphan (turnover limit)
01.01.2024
20.06.2024
Polatuzumab (4, reassessment >€30m)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma, combination with bendamustine and rituximab
2,550–3,120
100%
no additional benefit
Orphan (turnover limit)
15.12.2023
06.06.2024
Zanubrutinib (5)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab
370–840
100%
no additional benefit
15.12.2023
06.06.2024
Rucaparib (4)
Rubraca®
pharmaand Deutschland GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy after first-line therapy
3,250–3,590
100%
no additional benefit
15.12.2023
06.06.2024
Durvalumab (6)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, monotherapy
1,900–5,470
100%
no additional benefit
15.12.2023
06.06.2024
Alirocumab (3)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolaemia, ≥ 8 years to 17 years
958–1,178
100%
no additional benefit
15.12.2023
06.06.2024
Lebrikizumab
Ebglyss®
Almirall Hermal GmbH
Skin diseases
Atopic dermatitis, ≥ 12 years
57,300–62,600
100%
no additional benefit
15.12.2023
06.06.2024
Letermovir (3, reassessment >€30m)
Prevymis®
MSD Sharp & Dohme GmbH
Infectious diseases
CMV reactivation/disease, prophylaxis after stem cell transplantation
1,400–1,800
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.12.2023
06.06.2024
Letermovir (2)
Prevymis®
MSD Sharp & Dohme GmbH
Infectious diseases
CMV disease, prophylaxis after kidney transplantation
320
100%
no additional benefit
Orphan (turnover limit)
15.12.2023
06.06.2024
Lanadelumab (3)
Takhzyro®
Takeda GmbH
Other diseases
Hereditary angioedema, prophylaxis, 2 to < 12 years
1–30
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (15)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, from 2 to ≤ 5 years of age (heterozygous for F508del and MF mutation)
160
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (14)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, 2 to ≤ 5 years (homozygous for F508del mutation)
250
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (13)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
13
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (12)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and RF mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
20
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (11)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and other or unknown mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
33
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Cannabidiol (8, reassessment >€30m)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
500–2,900
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Cannabidiol (7, reassessment >€30m)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
1,700–22,700
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Cannabidiol (6, reassessment >€30m)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Other diseases
Seizures associated with tuberous sclerosis, ≥ 2 years
200–2,700
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Tebentafusp (2, reassessment >€30m)
Kimmtrak®
Immunocore Ireland Ltd.
Oncological diseases
Uveal melanoma, HLA-A*02:01-positive
100–130
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Patisiran (2, reassessment >€30m)
Onpattro®
Alnylam Germany GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
360
100%
Indication of
less benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Daratumumab (10, reassessment)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, melphalan and prednisone
3,450–2,680
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Relugolix / Estradiol / Norethisteronacetat (2)
Ryeqo®
Gedeon Richter Pharma GmbH
Genitourinary system diseases
Endometriosis, after medical or surgical treatment
8,200–13,900
100%
no additional benefit
01.12.2023
16.05.2024
Vosoritid (3)
Voxzogo®
BioMarin International Limited
Other diseases
Achondroplasia, ≥ 4 months to < 2 years
35–49
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Trastuzumab-Deruxtecan (5)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, HER2(ERBB2) mutation, pre-treated
75–219
100%
no additional benefit
15.11.2023
02.05.2024
Tirzepatid
Mounjaro®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
1,461,000–2,021,000
23%
Hint for
minor additional benefit
15.11.2023
02.05.2024
Niraparib / Abirateronacetat
Akeega®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma, metastastic, castration resistent, BRCA1/2-Mutation, Chemotherapy not indicated, combination with prednis(ol)one
1,030–2,200
50%
Hint for
considerable additional benefit
15.11.2023
02.05.2024
Midostaurin (3, reassessment >€30m)
Rydapt®
Novartis Pharma AG
Oncological diseases
Systemic Mastocytosis
300–400
100%
no additional benefit
Orphan (turnover limit)
15.11.2023
02.05.2024
Midostaurin (2, reassessment >€30m)
Rydapt®
Novartis Pharma AG
Oncological diseases
Acute myeloic Leukemia, FLT3-Mutation
380–1,040
100%
no additional benefit
Orphan (turnover limit)
15.11.2023
02.05.2024
Baricitinib (6)
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Polyarticular juvenile idiopathic Arthritis, RF+ or RF− polyarticular and expanded oligoarticular, ≥ 2 years
1,370–1,410
100%
no additional benefit
15.11.2023
02.05.2024
Baricitinib (5)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Juvenile Psoriatic Arthritis, ≥ 2 years
140–240
100%
no additional benefit
15.11.2023
02.05.2024
Baricitinib (4)
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Enthesitis-associated arthritis, ≥ 2 years
330–390
100%
no additional benefit
15.11.2023
02.05.2024
Baricitinib (3)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Atopic dermatitis, ≥ 2 until < 17 years
17,700–28,600
100%
no additional benefit
01.11.2023
02.05.2024
Elacestrant
Orserdu®
Stemline Therapeutics B.V.
Oncological diseases
Breast carcinoma, ER+, HER2-, with ESR1 mutation, after min. 1 previous therapy
1,527–16,070
39%
Indication of
considerable additional benefit
01.11.2023
02.05.2024
Somapacitan
Sogroya®
Novo Nordisk Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 years
9,150–11,600
100%
Hint for
non-quantifiable additional benefit
Orphan
01.11.2023
02.05.2024
Brolucizumab (3, reassessment)
Beovu®
Novartis Pharma GmbH
Eye diseases
Neovascular age-related macular degeneration
85,200–681,400
100%
no additional benefit
15.10.2023
04.04.2024
Epcoritamab
Tepkinly®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies)
1,050–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2023
21.03.2024
Sirolimus
Hyftor®
Plusultra pharma GmbH
Skin diseases
Facial angiofibroma in tuberous sclerosis, ≥ 6 years.
1,500–5,000
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2023
21.03.2024
Pegunigalsidase alfa
Elfabrio®
Chiesi GmbH
Metabolic diseases
Morbus Fabry
60–1,260
100%
no additional benefit
01.10.2023
21.03.2024
Nivolumab (27)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy).
1,620–2,310
100%
no additional benefit
15.09.2023
07.03.2024
Talquetamab
Talvey®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 prior therapies
1,210–1,310
100%
Hint for
non-quantifiable additional benefit
Orphan
15.09.2023
07.03.2024
Risdiplam (2)
Evrysdi®
Roche Pharma AG
Nervous system diseases
Spinal muscular atrophy, < 2 months
56–95
100%
no additional benefit
15.09.2023
07.03.2024
Lonapegsomatropin
Skytrofa®
Ascendis Pharma Endocrinology GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years.
5,710–6,550
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2023
15.02.2024
Teclistamab
Tecvayli®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 prior therapies
1,210–1,310
100%
no additional benefit
01.09.2023
15.02.2024
Vosoritid (2, reassessement >€30m)
Voxzogo®
BioMarin International Limited
Other diseases
Achondroplasia, ≥ 2 years
330–460
100%
Indication of
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2023
15.02.2024
Tisagenlecleucel (7, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukemia, relapsed/refractory, 0 ≤ 25 years).
40–90
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2023
15.02.2024
Tisagenlecleucel (6, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma, relapsed or refractory, ≥ 2 prior therapies)
530–1,200
100%
Hint for
non-quantifiable additional benefit
Orphan
30.08.2023
15.02.2024
Nonacog beta pegol (2)
Refixia®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia B, < 12 years
100–110
100%
no additional benefit
15.08.2023
15.02.2024
Sacituzumab govitecan (2)
Trodelvy®
Gilead Sciences GmbH
Oncological diseases
Breast carcinoma, HR+, HER2-, at least 3 prior therapies
2,480–8,240
100%
Indication of
considerable additional benefit
15.08.2023
15.02.2024
Migalastat (3, reassessment >€30m)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, ≥ 12 years
20–460
100%
no additional benefit
Orphan (turnover limit)
15.08.2023
15.02.2024
Trifluridin / Tipiracil (4)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal cancer, after 2 prior therapies, combination with bevacizumab)
3,530–6,230
100%
Hint for
considerable additional benefit
01.08.2023
01.02.2024
Bedaquilin (4, reassessment)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis
70–100
100%
Hint for
considerable additional benefit
Orphan
01.08.2023
01.02.2024
Nivolumab (26)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 1 %, neoadjuvant therapy, combination with platinum-based chemotherapy
110–990
100%
Hint for
non-quantifiable additional benefit
01.08.2023
01.02.2024
Glofitamab
Columvi®
Roche Pharma AG
Oncological diseases
B-cell lymphoma, diffuse large cell (DLBCL)
1,360–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2023
01.02.2024
Mavacamten
Camzyos®
Bristol-Myers Squibb GmbH & Co. KGaA
Cardiovascular diseases
Symptomatic hypertrophic obstructive cardiomyopathy (NYHA Klasse II–III)
18,900–19,500
100%
Hint for
considerable additional benefit
01.08.2023
01.02.2024
Eftrenonacog alfa (2, reassessment >€30m)
Alprolix®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia B
560–720
100%
no additional benefit
Orphan (turnover limit)
01.08.2023
01.02.2024
Empagliflozin (5)
Jardiance®
Boehringer Ingelheim Pharma GmbH
Genitourinary system diseases
Chronic renal insufficiency
2,259,300–2,478,100
100%
no additional benefit
01.08.2023
01.02.2024
Dalbavancin (2)
Xydalba®
Advanz Pharma Germany GmbH
Infectious diseases
Acute bacterial skin and soft tissue infections (ABSSSI), ≥ 3 months
190–9,800
100%
additional benefit considered proven
01.08.2023
01.02.2024
Cipaglucosidase alfa
Pombiliti®
Amicus Therapeutics GmbH
Metabolic diseases
Pompe's disease, combination with miglustat
170–1,760
100%
Hint for
minor additional benefit
15.07.2023
18.01.2024
Lumacaftor / Ivacaftor (5)
Orkambi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis, homozygous F508del mutation in CFTR gene, 1 to < 2 years)
50
100%
Hint for
non-quantifiable additional benefit
15.07.2023
18.01.2024
Ivosidenib (2)
Tibsovo®
Servier Deutschland GmbH
Oncological diseases
Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy
80–160
100%
Hint for
non-quantifiable additional benefit
Orphan
15.07.2023
18.01.2024
Ivosidenib
Tibsovo®
Servier Deutschland GmbH
Oncological diseases
Acute myeloid leukemia with IDH1-R132 mutation, first-line, combination with azacitidine
45–125
100%
Indication of
major additional benefit
Orphan
15.07.2023
18.01.2024
Mirikizumab
Omvoh®
Lilly Deutschland GmbH
Digestive system diseases
Ulcerative colitis, pre-treated
5,300–25,000
100%
no additional benefit
15.07.2023
18.01.2024
Dimethylfumarat (3)
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older))
350–1,200
100%
no additional benefit
01.07.2023
21.12.2023
Nivolumab (25)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adolescents ≥ 12 to 18 years, monotherapy or combination with ipilimumab).
2–4
100%
no additional benefit
01.07.2023
21.12.2023
Nivolumab (24)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy, adolescents ≥ 12 to 18 years, monotherapy
1–4
100%
no additional benefit
01.08.2023
21.12.2023
Axicabtagen-Ciloleucel (6)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Follicular lymphoma, after ≥ 3 prior therapies
60–270
100%
no additional benefit
Orphan (turnover limit)
01.07.2023
21.12.2023
Axicabtagen-Ciloleucel (4, reassessment >€30m)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
680–1,200
100%
no additional benefit
Orphan (turnover limit)
01.07.2023
21.12.2023
Axicabtagen-Ciloleucel (5)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory
800–1,130
1,600–2,260
50%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.07.2023
21.12.2023
Riociguat (4)
Adempas®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Pulmonary arterial hypertension, < 18 years of age
5–35
100%
no additional benefit
01.07.2023
21.12.2023
Bimekizumab (4)
Bimzelx®
UCB Pharma GmbH
Skin diseases
Psoriatic arthritis, monotherapy or in combination with methotrexate
30,300
100%
no additional benefit
01.07.2023
21.12.2023
Bimekizumab (3)
Bimzelx®
UCB Pharma GmbH
Musculoskeletal system diseases
Ankylosing spondylitis
16,800
100%
no additional benefit
01.07.2023
21.12.2023
Bimekizumab (2)
Bimzelx®
UCB Pharma GmbH
Musculoskeletal system diseases
Axial spondyloarthritis, non-radiographic
19,500
100%
no additional benefit
01.07.2023
21.12.2023
Selumetinib (2, reassessment)
Koselugo®
AstraZeneca GmbH
Oncological diseases
Neurofibromatosis (≥ 3 to < 18 years, type 1)
510–740
100%
Hint for
non-quantifiable additional benefit
Orphan
15.06.2023
07.12.2023
Sacubitril / Valsartan (2)
Entresto®
Novartis Pharma GmbH
Cardiovascular diseases
Chronic heart failure with left ventricular dysfunction, ≥ 1 year)
170–860
100%
no additional benefit
15.06.2023
07.12.2023
Secukinumab (9)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Hidradenitis suppurativa (Acne inversa)
4,800–6,400
100%
no additional benefit
15.06.2023
07.12.2023
Ravulizumab (5)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
460–1,170
100%
no additional benefit
01.06.2023
16.11.2023
Lisocabtagen maraleucel (2)
Breyanzi®
Bristol-Myers Squibb GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B; after 1 prior therapy, relapse within 12 months or refractory)
1,675–2,355
50%
Hint for
considerable additional benefit
15.05.2023
02.11.2023
Setmelanotid (2)
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, Bardet-Biedl syndrome, ≥ 6 years
300–1,100
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2023
02.11.2023
Loncastuximab tesirin
Zynlonta®
Swedish Orphan Biovitrum GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma (HGBL), ≥ 2 prior therapies)
1,360–1,900
100%
no additional benefit
15.05.2023
02.11.2023
Luspatercept (5, reassessment >€30m)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Β-thalassaemia, transfusion-dependent anaemia
250–330
100%
no additional benefit
Orphan (turnover limit)
15.05.2023
02.11.2023
Luspatercept (4, reassessment >€30m)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Myelodysplastic syndrome with transfusion-dependent anaemia, pre-treated
790–1,860
100%
no additional benefit
Orphan (turnover limit)
15.05.2023
02.11.2023
Tixagevimab / Cilgavimab (2)
Evusheld®
AstraZeneca GmbH
Infectious diseases
COVID-19, Preexposition prophylaxis, ≥ 12 years
0
100%
no additional benefit
01.05.2023
19.10.2023
Cemiplimab (5)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy
9,540–12,900
100%
no additional benefit
01.05.2023
19.10.2023
Cemiplimab (4)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Cervix carcinoma, pretreated
380–1,450
50%
Indication of
considerable additional benefit
01.05.2023
19.10.2023
Etranacogen Dezaparvovec
Hemgenix®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B
231–358
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2023
19.10.2023
Upadacitinib (7)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Morbus Crohn, pretreated
18,900–35,350
100%
no additional benefit
01.05.2023
05.10.2023
Lasmiditan
Rayvow®
Lilly Deutschland GmbH
Nervous system diseases
Migraine acute therapy
2,750,000
100%
no additional benefit
15.04.2023
05.10.2023
Tabelecleucel
Ebvallo®
Pierre Fabre Pharma GmbH
Oncological diseases
Relapsed or refractory Epstein-Barr virus positive posttransplant lymphoproliferative disease (EBV+ PTLD), pretreated, 2 years and older
7–30
100%
Hint for
non-quantifiable additional benefit
Orphan
15.04.2023
05.10.2023
Deucravacitinib
Sotyktu®
Bristol-Myers Squibb GmbH & Co. KGaA
Skin diseases
Moderate to severe plaque psoriasis
26,900–27,900
100%
no additional benefit
01.04.2023
05.10.2023
Belantamab-Mafodotin (2, reassessment)
Blenrep®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Multiple myeloma, at least 4 prior therapies, monotherapy
0
570–1,130
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2023
05.10.2023
Durvalumab (5)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Biliary tumors, first-line, combination with gemcitabine and cisplatin
1,800
100%
Indication of
minor additional benefit
01.04.2023
05.10.2023
Durvalumab (4)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with tremelimumab and platinum-based chemotherapy
14,470–24,660
100%
no additional benefit
01.04.2023
05.10.2023
Durvalumab (3)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with tremelimumab
1,900–5,470
100%
no additional benefit
01.04.2023
05.10.2023
Tremelimumab
Tremelimumab AstraZeneca®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with durvalumab and platinum-based chemotherapy
14,470–24,660
100%
no additional benefit
01.04.2023
05.10.2023
Tremelimumab (2, Imjudo®)
Imjudo®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with durvalumab
1,900–5,470
100%
no additional benefit
01.04.2023
05.10.2023
Dupilumab (9)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Prurigo nodularis
3,500–4,800
100%
Hint for
non-quantifiable additional benefit
01.04.2023
21.09.2023
Darolutamid (2)
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy
2,590–3,640
100%
Indication of
considerable additional benefit
01.04.2023
21.09.2023
Olaparib (11, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
520–630
100%
no additional benefit
01.04.2023
21.09.2023
Pitolisant (3)
Wakix®
Bioprojet Deutschland GmbH
Nervous system diseases
Narcolepsy, with or without cataplexy (children and adolescents, 6-17 years)
120–650
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2023
21.09.2023
Dulaglutid (3)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, ≥ 10 years
640–710
100%
no additional benefit
01.04.2023
21.09.2023
Luspatercept (3)
Reblozyl®
Bristol-Myers Squibb GmbH & Co. KGaA
Hematopoietic diseases
Β-thalassaemia, non-transfusion-dependent anaemia
470–560
100%
Indication of
minor additional benefit
Orphan (turnover limit)
01.04.2023
21.09.2023
Rucaparib (3, reassessment)
Rubraca®
zr pharma& GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
1,750–2,270
100%
no additional benefit
01.04.2023
21.09.2023
Dupilumab (8)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Digestive system diseases
Eosinophilic oesophagitis, ≥ 12 years, min. 40 kg
3,900–4,400
100%
no additional benefit
01.04.2023
21.09.2023
Dupilumab (7)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis, 6 months to 5 years
2,700–3,900
50%
Hint for
non-quantifiable additional benefit
15.03.2023
21.09.2023
Esketamin (3, reassessment)
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, therapy resistent, in combination with SSRI or SNRI
317,000–505,000
100%
Hint for
considerable additional benefit
01.03.2023
17.08.2023
Voclosporin
Lupkynis®
Otsuka Pharma GmbH
Musculoskeletal system diseases
Lupusnephritis
1,090–13,050
100%
no additional benefit
01.03.2023
17.08.2023
Emicizumab (3)
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Moderate haemophilia A, without factor VIII inhibitors, with severe bleeding phenotype
220–240
100%
no additional benefit
01.03.2023
17.08.2023
Finerenon (2)
Kerendia®
Bayer Vital GmbH
Genitourinary system diseases
Chronic kidney disease in type 2 diabetes, stages 1 and 2 with albuminuria
436,400–493,750
100%
Hint for
non-quantifiable additional benefit
01.03.2023
17.08.2023
Finerenon
Kerendia®
Bayer Vital GmbH
Genitourinary system diseases
Chronic kidney disease in type 2 diabetes, stages 3 and 4 with albuminuria
304,500–322,500
100%
no additional benefit
01.03.2023
17.08.2023
Dolutegravir / Abacavir / Lamivudin (2)
Triumeq®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 14 kg to < 12 years
86
100%
no additional benefit
01.03.2023
17.08.2023
Dapagliflozin (8)
Forxiga®
AstraZeneca GmbH
Cardiovascular diseases
Chronic heart failure with left ventricular ejection fraction LVEF > 40 %
1,270,000–1,400,000
100%
Hint for
minor additional benefit
15.02.2023
17.08.2023
Ciltacabtagene Autoleucel
Carvykti®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 previous therapies
0
1,210–1,310
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2023
03.08.2023
Fenfluramin (2)
Fintepla®
Zogenix GmbH
Nervous system diseases
Lennox-Gastaut syndrome, add-on therapy, ≥ 2 years
2,100–22,700
100%
Hint for
considerable additional benefit
Orphan
01.02.2023
03.08.2023
Sotorasib (2, reassessment)
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 prior therapy
480–1,040
44%
Hint for
non-quantifiable additional benefit
01.02.2023
20.07.2023
Trastuzumab-Deruxtecan (4)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Adenocarcinoma (AC) of the stomach or gastro-oesophageal junction, HER2-positive, after trastuzumab-based therapy
470–770
100%
no additional benefit
01.02.2023
20.07.2023
Trastuzumab-Deruxtecan (3)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2-low, pre-treated
1,350–4,700
100%
Indication of
considerable additional benefit
01.02.2023
20.07.2023
Ibrutinib (8)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with venetoclax
3,190–3,200
100%
no additional benefit
01.02.2023
20.07.2023
Spesolimab
Spevigo®
Boehringer Ingelheim Pharma GmbH & Co. KG
Skin diseases
Generalised pustular psoriasis, acute treatment
170–400
100%
no additional benefit
15.01.2023
06.07.2023
Lutetium (177Lu) Vipivotidtetraxetan
Pluvicto®
Novartis Radiopharmaceuticals GmbH
Oncological diseases
Prostate carcinoma (PC), combination with androgen deprivation therapy, PSMA-positive, metastatic, castration-resistant, progression after inhibition of the AR pathway and taxane-based chemotherapy
1,500–2,400
50%
Indication of
considerable additional benefit
15.01.2023
06.07.2023
Maralixibat
Livmarli®
Mirum Pharmaceuticals Germany GmbH
Digestive system diseases
Alagille-Syndrome, ≥ 2 months
139–377
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2023
06.07.2023
Olaparib (10)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Prostate carcinoma (PC), metastatic, castration-resistant, chemotherapy not clinically indicated, combination with abiraterone and/or prednisone
9,400–12,200
25%
Hint for
considerable additional benefit
02.01.2023
15.06.2023
Risankizumab (3)
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Morbus Crohn, pre-treated
18,800–35,250
40%
Hint for
minor additional benefit
02.01.2023
15.06.2023
Bictegravir / Emtricitabin / Tenofoviralafenamid (2)
Biktarvy®
Gilead Sciences GmbH
Infectious diseases
HIV-Infection, 2 until < 18 years
184
100%
no additional benefit
02.01.2023
15.06.2023
Sutimlimab
Enjaymo®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Cold agglutinin disease (CAD)
370–1,510
100%
Hint for
minor additional benefit
Orphan
02.01.2023
15.06.2023
Abemaciclib (6, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HR+, HER2-, combination with aromatase inhibitor
7,400–34,790
100%
Hint for
minor additional benefit
15.12.2022
15.06.2023
Latanoprost / Netarsudil
Roclanda®
Santen GmbH
Eye diseases
Reduction of increased intraocular pressure in open-angle glaucoma or ocular hypertension
87,800
100%
no additional benefit
15.12.2022
15.06.2023
Zanubrutinib (4)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line
3,180–3,200
50%
Hint for
minor additional benefit
15.12.2022
15.06.2023
Zanubrutinib (3)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody
590–1,760
100%
no additional benefit
15.12.2022
15.06.2023
Zanubrutinib (2)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), relapsed and/or refractory
8,800–12,750
23%
Indication of
minor additional benefit
01.12.2022
01.06.2023
Olopatadin / Mometason
Ryaltris®
Berlin-Chemie AG
Respiratory system diseases
Allergic rhinitis
3,807,000–7,356,000
100%
no additional benefit
01.12.2022
01.06.2023
Maribavir
Livtencity®
Takeda GmbH
Infectious diseases
Cytomegalovirus infection (CMI), refractory to therapy
90–130
100%
Hint for
minor additional benefit
Orphan
15.11.2022
12.05.2023
Tezepelumab
Tezspire®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma (AB), ≥ 12 years
42,300–46,700
100%
no additional benefit
15.11.2022
12.05.2023
Tralokinumab (2)
Adtralza®
LEO Pharma GmbH
Skin diseases
Atopic dermatitis (AD), 12 to < 18 years
5,300–10,600
100%
no additional benefit
15.11.2022
12.05.2023
Daridorexant
Quviviq®
Idorsia Pharmaceuticals Germany GmbH
Mental illnesses
Sleep disorders (mental illnesses)
0
1,900–79,000
100%
no additional benefit
09.02.2023
20.04.2023
Dalbavancin
Xydalba®
Advanz Pharma Germany GmbH
Infectious diseases
Acute bacterial skin and skin structure infections (ABSSSI)
0
resolution w/o assessement
01.11.2022
20.04.2023
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3)
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 2 to < 6 years
16
100%
no additional benefit
01.11.2022
20.04.2023
Olaparib (9, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma (OC), fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
1,030–1,250
100%
Hint for
considerable additional benefit
01.11.2022
20.04.2023
Ravulizumab (4)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
800–1,200
100%
no additional benefit
15.10.2022
20.04.2023
Tixagevimab / Cilgavimab
Evusheld®
AstraZeneca GmbH
Infectious diseases
COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre
0
100%
Hint for
minor additional benefit
15.10.2022
06.04.2023
Faricimab (2)
Vabysmo®
Roche Pharma AG
Eye diseases
Neovascular age-related macular degeneration (AMD)
85,200–681,400
100%
no additional benefit
15.10.2022
06.04.2023
Remdesivir (4)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg)
2,600–14,200
100%
no additional benefit
15.10.2022
06.04.2023
Remdesivir (3)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years
350–1,060
100%
no additional benefit
15.10.2022
06.04.2023
Vutrisiran
Amvuttra®
Alnylam Germany GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2)
360
100%
Indication of
minor additional benefit
Orphan
15.10.2022
06.04.2023
Relugolix
Orgovyx®
Accord Healthcare GmbH
Oncological diseases
Prostate carcinoma (PC), advanced, hormone-sensitive
25,020–44,280
100%
no additional benefit
15.10.2022
06.04.2023
Lonafarnib
Zokinvy®
EigerBio Europe Ltd
Other diseases
Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over
5–6
100%
Hint for
non-quantifiable additional benefit
Orphan
15.10.2022
06.04.2023
Faricimab
Vabysmo®
Roche Pharma AG
Eye diseases
Diabetic macular edema (DME)
190,000–241,000
100%
no additional benefit
01.10.2022
06.04.2023
Difelikefalin
Kapruvia®
Fresenius Medical Care Nephrologica Deutschland GmbH
Skin diseases
Pruritus in chronic kidney disease (CKD), haemodialysis patients
3,500–22,000
100%
no additional benefit
01.09.2022
06.04.2023
Lisocabtagen maraleucel
Breyanzi®
Bristol-Myers Squibb GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies
1,420–1,980
100%
no additional benefit
01.10.2022
16.03.2023
Selinexor (2)
Nexpovio®
Stemline Therapeutics B.V.
Oncological diseases
Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone
4,700–7,000
100%
no additional benefit
01.10.2022
16.03.2023
Selinexor
Nexpovio®
Stemline Therapeutics B.V.
Oncological diseases
Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
570–1,130
100%
no additional benefit
01.10.2022
16.03.2023
Asciminib
Scemblix®
Novartis Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, after ≥ 2 prior therapies
840–1,150
100%
Indication of
minor additional benefit
Orphan
01.10.2022
16.03.2023
Melphalanflufenamid
Pepaxti®
Oncopeptides AB
Oncological diseases
Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone)
1,200–1,300
100%
no additional benefit
01.10.2022
16.03.2023
Olipudase alfa
Xenpozyme®
Sanofi-Aventis Deutschland
Metabolic diseases
Acid sphingomyelinase deficiency (ASMD) type A/B or type B
70–80
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2022
16.03.2023
Pertuzumab (4, reassessment)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy
1,910–3,060
100%
Indication of
minor additional benefit
01.10.2022
16.03.2023
Pertuzumab / Trastuzumab (4, reassessment)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy
1,910–3,060
100%
Indication of
minor additional benefit
01.10.2022
16.03.2023
Selpercatinib (5)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older
40–170
100%
no additional benefit
01.10.2022
16.03.2023
Brexucabtagene-Autoleucel (2)
Tecartus®
Gilead Sciences GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), aged > 26
81–200
100%
Hint for
non-quantifiable additional benefit
Orphan
15.09.2022
16.03.2023
Valoctocogene roxaparvovec
Roctavian®
BioMarin International Ltd.
Hematopoietic diseases
Hemophilia A
690–800
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2022
16.02.2023
Burosumab (6)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
FGF23-related hypophosphatemia in tumour-induced osteomalacia
60–140
100%
no additional benefit
Orphan (turnover limit)
01.09.2022
16.02.2023
Efgartigimod alfa
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
0
14,000–16,800
100%
Hint for
considerable additional benefit
Orphan
01.09.2022
16.02.2023
Eptinezumab
Vyepti®
Lundbeck GmbH
Nervous system diseases
Migraine prophylaxis
1,614,300–1,645,200
100%
no additional benefit
01.09.2022
16.02.2023
Olaparib (8)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy.
540–690
100%
Indication of
minor additional benefit
01.09.2022
16.02.2023
Upadacitinib (6)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Digestive system diseases
Ulcerative colitis (UC), pre-treated
5,300–25,000
100%
no additional benefit
01.09.2022
16.02.2023
Upadacitinib (5)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Musculoskeletal system diseases
Axial spondyloarthritis (AS), non-radiographic
19,500
100%
no additional benefit
01.09.2022
16.02.2023
Birkenrindenextrakt
Filsuvez®
Amryt Pharma GmbH
Other diseases
Wound treatment in epidermolysis bullosa (from 6 months)
270–860
100%
Hint for
minor additional benefit
Orphan
15.08.2022
02.02.2023
Ceftolozan / Tazobactam (7)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications, < 18 years of age
40
100%
additional benefit considered proven
15.08.2022
02.02.2023
Capmatinib
Tabrecta®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
540–900
100%
no additional benefit
15.08.2022
02.02.2023
Eladocagene Exuparvovec
Upstaza®
PTC Therapeutics International Limited
Metabolic diseases
Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months
4–30
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2022
02.02.2023
Trastuzumab-Deruxtecan (2)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, after 1 prior therapy
3,370–3,750
100%
Indication of
non-quantifiable additional benefit
01.08.2022
02.02.2023
Trastuzumab-Deruxtecan
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, at least 2 previous therapies
1,350–1,640
100%
Indication of
considerable additional benefit
01.08.2022
02.02.2023
Pembrolizumab (30)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab
1,315–1,525
40%
Indication of
considerable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (29)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients
1,518–1,973
100%
Hint for
minor additional benefit
01.08.2022
19.01.2023
Pembrolizumab (28)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy.
350–1,470
100%
no additional benefit
01.08.2022
19.01.2023
Pembrolizumab (27)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma with MSI-H or with dMMR, pre-treated
230–3,360
100%
no additional benefit
01.08.2022
19.01.2023
Pembrolizumab (26)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Gastric carcinoma with MSI-H or dMMR, pre-treated
80–110
74%
Hint for
non-quantifiable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (25)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Small bowel carcinoma with MSI-H or dMMR, pre-treated
40–380
100%
no additional benefit
01.08.2022
19.01.2023
Pembrolizumab (24)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Biliary carcinoma with MSI-H or dMMR, pre-treated
20–150
100%
no additional benefit
01.08.2022
19.01.2023
Pembrolizumab (23)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, adjuvant therapy, ≥ 12 years, monotherapy
1,621–2,314
100%
Indication of
non-quantifiable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (22)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, ≥ 12 to < 18 years
1–4
100%
no additional benefit
01.08.2022
19.01.2023
Glycopyrronium
Axhidrox®
Dr. August Wolff GmbH & Co. KG Arzneimittel
Other diseases
Severe primary axillary hyperhidrosis
73,000–704,000
100%
no additional benefit
01.08.2022
19.01.2023
Inebilizumab
Uplizna®
Horizon Therapeutics GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
460–980
100%
no additional benefit
01.08.2022
19.01.2023
Eravacyclin
Xerava®
PAION Deutschland GmbH
Infectious diseases
Reserve antibiotics: Complicated intra-abdominal infections (cIAI)
2,600–6,600
100%
additional benefit considered proven
15.07.2022
05.01.2023
Secukinumab (8)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Juvenile psoriatic arthritis (PA), ≥ 6 years
120–180
100%
no additional benefit
15.07.2022
05.01.2023
Secukinumab (7)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Enthesitis-related arthritis (ERA)
240–290
100%
no additional benefit
15.07.2022
05.01.2023
Atezolizumab (10)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy.
700–790
100%
Hint for
non-quantifiable additional benefit
01.07.2022
15.12.2022
Mosunetuzumab
Lunsumio®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
650–690
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2022
15.12.2022
Pembrolizumab (21)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
0
2,440–2,520
50%
Hint for
minor additional benefit
01.07.2022
15.12.2022
Selpercatinib (4)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+, first-line
115–310
100%
no additional benefit
01.07.2022
15.12.2022
Palbociclib (3, reassessment)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast carcinoma (BC), patient population a1
7,400–34,700
100%
no additional benefit
01.07.2022
15.12.2022
Nirmatrelvir / Ritonavir
Paxlovid®
Pfizer Pharma GmbH
Infectious diseases
COVID-19, no need for supplementary oxygen, increased risk of severe progression
218,000–1,307,000
100%
Hint for
considerable additional benefit
01.07.2022
15.12.2022
Cerliponase alfa (2, reassessment)
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis (NCL) type 2
40–50
100%
Hint for
major additional benefit
Orphan
01.06.2022
01.12.2022
Enfortumab Vedotin
Padcev®
Astellas Pharma Europe B.V
Oncological diseases
Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor
410–1,250
47%
Hint for
considerable additional benefit
01.06.2022
01.12.2022
Setmelanotid
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years
140–280
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2022
01.12.2022
Cabozantinib (8, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
125–425
100%
no additional benefit
01.06.2022
01.12.2022
Polatuzumab Vedotin (2)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
0
5,510–6,130
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2022
01.12.2022
Tisagenlecleucel (5)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Follicular lymphoma (FL), pre-treated patients
650–690
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2022
03.11.2022
Axicabtagen-Ciloleucel (3, reassessment)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
0
455–729
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2022
03.11.2022
Voxelotor
Oxbryta®
Global Blood Therapeutics Germany GmbH
Hematopoietic diseases
Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years
1,590–2,580
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2022
03.11.2022
Sotrovimab
Xevudy®
GlaxoSmithKline GmbH & Co. KG
Infectious diseases
COVID-19, ≥ 12 years
0
100%
Hint for
considerable additional benefit
01.05.2022
03.11.2022
Imipenem / Cilastatin / Relebactam (2)
Recarbrio®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications
2,598–6,600
100%
additional benefit considered proven
01.05.2022
03.11.2022
Ceftolozan / Tazobactam (6)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Bacterial infections, multiple indications
2,600–6,600
100%
additional benefit considered proven
01.05.2022
03.11.2022
Ceftazidim / Avibactam
Zavicefta®
Pfizer Pharma GmbH
Infectious diseases
Bacterial infections, multiple indications
2,600–6,600
100%
additional benefit considered proven
01.05.2022
20.10.2022
Tebentafusp
Kimmtrak®
Immunocore Ireland Ltd.
Oncological diseases
Uveal melanoma, HLA-A*02:01-positive
0
110
100%
Hint for
considerable additional benefit
Orphan
01.05.2022
20.10.2022
Brolucizumab (2)
Beovu®
Novartis Pharma GmbH
Eye diseases
Diabetic macular edema
190,000–241,000
100%
no additional benefit
01.05.2022
20.10.2022
Abemaciclib (5)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy
6,905–9,435
40%
Hint for
minor additional benefit
01.05.2022
20.10.2022
Doravirin / Lamivudin / Tenofovirdisoproxil (2)
Delstrigo®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection, 12 to < 18 years
10–20
100%
no additional benefit
01.05.2022
20.10.2022
Doravirin (2)
Pifeltro®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection, 12 to < 18 years
130–140
100%
no additional benefit
01.05.2022
20.10.2022
Nivolumab (23)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy
1,030–1,290
65%
Hint for
non-quantifiable additional benefit
01.05.2022
20.10.2022
Nivolumab (22)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
920–1,580
100%
Indication of
considerable additional benefit
01.05.2022
20.10.2022
Nivolumab (21)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma (SCC) of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with ipilimumab
920–1,560
100%
Hint for
considerable additional benefit
15.04.2022
06.10.2022
Casirivimab / Imdevimab (2)
Ronapreve®
Roche Pharma AG
Infectious diseases
Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years
0
100%
Hint for
minor additional benefit
15.04.2022
06.10.2022
Casirivimab / Imdevimab
Ronapreve®
Roche Pharma AG
Infectious diseases
COVID-19-Infection, ≥ 12 years
0
100%
Hint for
considerable additional benefit
15.04.2022
06.10.2022
Dupilumab (6)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Asthma bronchiale, ≥ 6 until ≤ 11 years
150–860
100%
no additional benefit
15.04.2022
06.10.2022
Glucarpidase
Voraxaze®
SERB GmbH
Other diseases
Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults.
90–440
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
06.10.2022
Anifrolumab
Saphnelo®
AstraZeneca GmbH
Musculoskeletal system diseases
Systemic lupus erythematosus (SLE)
4,600–18,500
100%
no additional benefit
01.04.2022
15.09.2022
Avapritinib (2)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Systemic mastocytosis, after at least 1 prior therapy
270–680
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
15.09.2022
Somatrogon
Ngenla®
Pfizer Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age
5,710–6,550
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
15.09.2022
Dolutegravir (4, reassessment)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, age 6 to < 18 years
0
resolution w/o assessement
01.04.2022
15.09.2022
Voretigen Neparvovec (2, reassessment)
Luxturna®
Novartis Pharma GmbH
Eye diseases
Hereditary retinal dystrophy
100–530
100%
Hint for
considerable additional benefit
Orphan
01.04.2022
15.09.2022
Pegcetacoplan
Aspaveli®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients
190–520
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
15.09.2022
Idebenon (2, reassessment)
Raxone®
Chiesi GmbH
Eye diseases
Leber's hereditary optic neuropathy (LHOP)
1,400–3,000
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
15.09.2022
Empagliflozin (4)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Cardiovascular diseases
Chronic heart failure (CHF) with preserved ejection fraction
1,270,000–1,400,000
100%
Hint for
minor additional benefit
01.04.2022
15.09.2022
Daratumumab (9, reassessment)
Darzalex®
Janssen-Cilag
Oncological diseases
Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
4,700–7,000
100%
Proof of
considerable additional benefit
Orphan (turnover limit)
01.03.2022
01.09.2022
Brivaracetam (3)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Focal seizures in epilepsy, additional therapy, 2 to < 4 years
300–1,800
100%
no additional benefit
01.03.2022
01.09.2022
Lorlatinib (2)
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), ALK+, first-line
390–1,310
100%
no additional benefit
01.03.2022
01.09.2022
Tepotinib
Tepmetko®
Merck Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
540–910
100%
no additional benefit
01.03.2022
01.09.2022
Vedolizumab (2)
Entyvio®
Takeda GmbH
Digestive system diseases
Antibiotic-refractory pouchitis, pre-treated patients
20–40
100%
no additional benefit
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (10)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
56
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (9)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
21
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (8)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor)
28
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (7)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
470
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (6)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
233
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (26)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
56
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (25)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
21
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (24)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor).
28
100%
no additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (23)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
470
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (22)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
230
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Avacopan
Tavneos®
Vifor Pharma Deutschland GmbH
Musculoskeletal system diseases
Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide
2,180–2,280
100%
Hint for
minor additional benefit
Orphan
15.02.2022
04.08.2022
Sotorasib
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
80–170
560–1,210
100%
no additional benefit
15.02.2022
04.08.2022
Sofosbuvir / Velpatasvir (3)
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, ≥ 3 to < 6 years of age
1–12
100%
no additional benefit
01.02.2022
21.07.2022
Calcifediol
Rayaldee®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Secondary hyperparathyroidism in chronic renal failure
146,700–184,300
100%
no additional benefit
01.02.2022
21.07.2022
Isofluran
Sedaconda®
Sedana Medical AB
Other diseases
Sedation of mechanically ventilated patients during intensive care therapy (ICT)
146,000–219,000
100%
no additional benefit
01.02.2022
21.07.2022
Burosumab (5, reassessment >€50m)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 18 years of age
410–810
100%
no additional benefit
Orphan (turnover limit)
01.02.2022
21.07.2022
Burosumab (4, reassessment >€50m)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 1 to < 18 years of age
200–550
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.02.2022
21.07.2022
Duvelisib (2)
Copiktra®
Secura Bio Limited
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
380–5,170
100%
no additional benefit
01.02.2022
21.07.2022
Duvelisib
Copiktra®
Secura Bio Limited
Oncological diseases
Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
550–2,060
100%
no additional benefit
15.01.2022
07.07.2022
Abrocitinib
Cibinqo®
Pfizer Pharma GmbH
Skin diseases
Atopic Dermatitis (AD)
52,000
100%
Hint for
considerable additional benefit
15.01.2022
07.07.2022
Amivantamab
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy
9–26
100%
no additional benefit
15.01.2022
07.07.2022
Remdesivir (2)
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, no need for supplementary oxygen, increased risk of severe progression
218,000–1,307,000
100%
Hint for
minor additional benefit
15.12.2021
07.07.2022
Lenvatinib (7, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
2,790–4,180
100%
no additional benefit
15.12.2021
07.07.2022
Lenvatinib (6)
Lenvima®
Eisai GmbH
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab
1,130–5,070
100%
Indication of
considerable additional benefit
15.12.2021
07.07.2022
Pembrolizumab (20)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib
1,130–5,070
100%
Indication of
considerable additional benefit
15.12.2021
07.07.2022
Pembrolizumab (19)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib
2,790–4,189
100%
no additional benefit
15.12.2021
16.06.2022
Zanubrutinib
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy
450–1,050
100%
no additional benefit
01.01.2022
16.06.2022
Idecabtagen vicleucel
Abecma®
Bristol-Myers Squibb GmbH & Co KGaA
Oncological diseases
Multiple myeloma (MM), at least 3 previous therapies
1,200–1,300
100%
Hint for
non-quantifiable additional benefit
Orphan
01.01.2022
16.06.2022
Evolocumab (3)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age
768–950
100%
no additional benefit
01.01.2022
16.06.2022
Ripretinib
Qinlock®
Deciphera Pharmaceuticals (Netherlands) B.V.
Oncological diseases
Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies
220–300
100%
Hint for
major additional benefit
Orphan
15.12.2021
16.06.2022
Pralsetinib
Gavreto®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+
170–510
100%
no additional benefit
15.12.2021
16.06.2022
Tofacitinib (7)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Ankylosing spondylitis (AS)
16,800
100%
no additional benefit
15.12.2021
16.06.2022
Ozanimod (2)
Zeposia®
Bristol-Myers Squibb GmbH & Co. KGaA
Digestive system diseases
Ulcerative colitis (UC), pre-treated patients
5,300–25,000
100%
no additional benefit
15.12.2021
16.06.2022
Dapagliflozin (7)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus Type 2, ≥ 10 years
650–710
100%
no additional benefit
01.12.2021
19.05.2022
Ponesimod (2)
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relaps multiple sclerosis (MS)
186,000–200,000
50%
Indication of
minor additional benefit
01.12.2021
19.05.2022
Abemaciclib (4, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
12,870–59,690
42%
Indication of
minor additional benefit
01.12.2021
19.05.2022
Filgotinib (2)
Jyseleca®
Galapagos Biopharma Germany GmbH
Digestive system diseases
Ulcerative colitis (UC), pretreated patients
5,300–25,000
100%
no additional benefit
01.12.2021
19.05.2022
Mepolizumab (5)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Eosinophilic granulomatosis with polyangiitis
80–1,130
100%
no additional benefit
01.12.2021
19.05.2022
Mepolizumab (4)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic rhinosinusitis with nasal polyps
10,500–12,600
100%
no additional benefit
01.12.2021
19.05.2022
Mepolizumab (3)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Hematopoietic diseases
Hypereosinophilic syndrome
100–400
100%
Hint for
considerable additional benefit
01.12.2021
19.05.2022
Ertugliflozin
Steglatro®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus (DM) type 2
1,451,000–2,021,000
100%
no additional benefit
01.12.2021
19.05.2022
Nivolumab (20)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Adenocarcinoma (AC) of the stomach, gastroesophageal junction or esophagus, CPS ≥ 5, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-based combination chemotherapy
500–3,100
100%
Hint for
considerable additional benefit
01.12.2021
19.05.2022
Risankizumab (2)
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Psoriatic arthritis (PA), monotherapy or combination with methotrexate
29,100
100%
no additional benefit
01.12.2021
19.05.2022
Sacituzumab Govitecan
Trodelvy®
Gilead Sciences GmbH
Oncological diseases
Breast cancer (BC) triple-negative, after 2 previous therapies
1,150–2,370
100%
Indication of
major additional benefit
01.12.2021
19.05.2022
Lusutrombopag
Mulpleo®
Shionogi GmbH
Hematopoietic diseases
Thrombocytopenia in chronic liver disease
1,790–24,130
100%
no additional benefit
15.11.2021
05.05.2022
Cefiderocol (2)
Fetcroja®
Shionogi GmbH
Infectious diseases
Infections caused by aerobic gram-negative pathogens
2,600–6,600
100%
additional benefit considered proven
15.11.2021
05.05.2022
Delamanid
Deltyba®
Otsuka Novel Products
Infectious diseases
Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg
80–114
100%
Hint for
non-quantifiable additional benefit
Orphan
15.11.2021
05.05.2022
Elbasvir / Grazoprevir (2)
Zepatier®
MSD Sharp & Dohme B.V.
Infectious diseases
Chronic hepatitis C (HCV), 12 to < 18 years
0
100%
no additional benefit
15.11.2021
05.05.2022
Pembrolizumab (18)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy.
535–805
34%
Indication of
considerable additional benefit
15.11.2021
05.05.2022
Pembrolizumab (17)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy
260–270
50%
Hint for
considerable additional benefit
01.09.2021
05.05.2022
Icosapent-Ethyl
Vazkepa®
Amarin Pharmaceuticals Ireland Limited
Metabolic diseases
Dyslipidemia, pre-treated patients
844,000–878,000
100%
no additional benefit
01.11.2021
21.04.2022
Ixazomib (2, reassessment)
Ninlaro®
Takeda GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
non-quantifiable additional benefit
Orphan
01.11.2021
21.04.2022
Pitolisant (2, Ozawade®)
Ozawade®
Bioprojet Deutschland GmbH
Nervous system diseases
Daytime sleepiness in obstructive sleep apnea, after previous therapy
200,000–400,000
100%
no additional benefit
15.10.2021
07.04.2022
Sofosbuvir / Velpatasvir / Voxilaprevir (2)
Vosevi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C (HCV), 12 to < 18 years
24–39
100%
no additional benefit
15.10.2021
07.04.2022
Albutrepenonacog alfa (2, reassessment >€50m)
Idelvion®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B, congenital factor IX deficiency
560–720
100%
no additional benefit
Orphan (turnover limit)
15.10.2021
07.04.2022
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse)
Palforzia®
Aimmune Therapeutics Germany GmbH
Other diseases
Peanut allergy, ≥ 4 years
43,900–97,200
100%
no additional benefit
01.10.2021
18.03.2022
Solriamfetol (2)
Sunosi®
Jazz Pharmaceuticals Ireland
Nervous system diseases
Daytime sleepiness in obstructive sleep apnoea, after previous therapy
200,000–400,000
100%
no additional benefit
01.10.2021
18.03.2022
Vandetanib (4, reassessment)
Caprelsa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC)
50–670
100%
no additional benefit
01.10.2021
18.03.2022
Vosoritid
Voxzogo®
BioMarin International Limited
Other diseases
Achondroplasia, ≥ 2 years
0
340–480
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2021
18.03.2022
Daratumumab (8, reassessment)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
3,470–3,670
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.10.2021
18.03.2022
Lumacaftor / Ivacaftor (4, reassessment)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, ≥ 2 to ≤ 5 years
290
100%
Hint for
non-quantifiable additional benefit
01.10.2021
18.03.2022
Ravulizumab (3)
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Paroxysmal hemoglobinuria, pediatric patients
0–49
100%
no additional benefit
15.09.2021
03.03.2022
Tofacitinib (6)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Polyarticular juvenile idiopathic arthritis, RF+ or RF polyarthritis and dilated oligoarthritis, and juvenile psoriatic arthritis, ≥ 2 years
1,450
100%
no additional benefit
15.09.2021
03.03.2022
Roxadustat
Evrenzo®
Astellas Pharma GmbH
Hematopoietic diseases
Symptomatic anemia in chronic kidney disease (CKD)
151,000–195,000
100%
no additional benefit
15.09.2021
03.03.2022
Bimekizumab
Bimzelx®
UCB Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
35,900–121,500
100%
Indication of
minor additional benefit
15.09.2021
03.03.2022
Vericiguat
Verquvo®
Bayer Vital GmbH
Cardiovascular diseases
Chronic heart failure (CHF)
74,600–530,000
100%
Hint for
minor additional benefit
15.09.2021
03.03.2022
Odevixibat
Bylvay®
Albireo Pharma AB
Digestive system diseases
Cholestasis, ≥ 6 months
40–110
100%
Hint for
minor additional benefit
Orphan
15.09.2021
03.03.2022
Tafasitamab
Minjuvi®
Incyte Biosciences Germany
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide
730–1,560
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2021
17.02.2022
Misoprostol
Angusta®
Norgine GmbH
Other diseases
Labor induction
76,500–90,000
100%
no additional benefit
01.09.2021
17.02.2022
Nivolumab (19)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Carcinoma of the esophagus and gastro-esophageal junction, pre-treated patients, adjuvant therapy
590–860
100%
Indication of
non-quantifiable additional benefit
01.09.2021
17.02.2022
Migalastat (2)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, 12 to < 16 years
0
1–19
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2021
17.02.2022
Tofacitinib (5, reassessment)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate
27,100–93,500
100%
no additional benefit
01.09.2021
17.02.2022
Tirbanibulin
Klisyri®
Almirall Hermal GmbH
Skin diseases
Actinic keratosis (AK), Olsen grade I
700,000–1,380,000
100%
no additional benefit
01.09.2021
17.02.2022
Relugolix / Estradiol / Norethisteronacetat
Ryeqo®
Gedeon Richter Pharma GmbH
Genitourinary system diseases
Uterine myoma
20,160–100,840
50%
Hint for
considerable additional benefit
01.09.2021
17.02.2022
Dapagliflozin (6)
Forxiga®
AstraZeneca GmbH
Genitourinary system diseases
Chronic kidney disease (CKD)
2,520,200–3,409,200
50%
Hint for
considerable additional benefit
01.09.2021
17.02.2022
Upadacitinib (4)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Atopic dermatitis (AD), ≥ 12 years
57,300–62,850
33%
Indication of
considerable additional benefit
15.08.2021
03.02.2022
Selumetinib
Koselugo®
AstraZeneca GmbH
Oncological diseases
Neurofibromatosis (type 1), ≥ 3 to < 18 years
0
510–740
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2021
03.02.2022
Daratumumab (7)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason
3,190–3,600
38%
Hint for
minor additional benefit
Orphan (turnover limit)
23.11.2020
20.01.2022
Imipenem / Cilastatin / Relebactam
Recarbrio®
MSD Sharp & Dohme GmbH
Infectious diseases
Pneumonia, Bacteriemia
0
resolution w/o assessement
20.08.2020
20.01.2022
Ceftolozan / Tazobactam (5)
Zerbaxa®
MSD Sharp & Dohme GmbH
Infectious diseases
Complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP)
0
resolution w/o assessement
01.08.2021
20.01.2022
Teriflunomid (2)
Aubagio®
Sanofi-Aventis Deutschland GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
350–1,200
100%
no additional benefit
01.08.2021
20.01.2022
Blinatumomab (6)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
7–30
100%
Indication of
major additional benefit
Orphan
01.08.2021
20.01.2022
Nivolumab (18)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab
350–475
100%
no additional benefit
01.08.2021
20.01.2022
Cemiplimab (3)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Basal cell carcinoma (BCC), locally advanced or metastasised
83–155
97%
Hint for
minor additional benefit
01.08.2021
20.01.2022
Cemiplimab (2)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
4,130–5,110
100%
no additional benefit
01.08.2021
20.01.2022
Daratumumab (6)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
440–1,030
50%
Hint for
minor additional benefit
Orphan (turnover limit)
15.07.2021
06.01.2022
Satralizumab
Enspryng®
Roche Pharma AG
Nervous system diseases
Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years
460–5,050
100%
Hint for
minor additional benefit
Orphan
15.07.2021
06.01.2022
Empagliflozin (3)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Cardiovascular diseases
Chronic heart failure (CHF)
2,061,700–2,273,000
100%
Hint for
minor additional benefit
15.07.2021
06.01.2022
Tralokinumab
Adtralza®
LEO Pharma A/S
Skin diseases
Atopic dermatitis (AD)
52,000
100%
no additional benefit
15.07.2021
06.01.2022
Angiotensin-II-Acetat
Giapreza®
La Jolla Pharmaceutical II B.V.
Cardiovascular diseases
Hypotension
3,980–37,625
100%
no additional benefit
01.07.2021
16.12.2021
Brentuximab Vedotin (6, reassessment)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone
125–127
100%
Hint for
minor additional benefit
Orphan
01.07.2021
16.12.2021
Cabozantinib (7, reassessment)
Cometriq®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC)
50–670
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2021
16.12.2021
Glecaprevir / Pibrentasvir (3)
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
146–238
100%
no additional benefit
01.07.2021
16.12.2021
Nivolumab (17)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Malignant pleural mesothelioma, first-line, combination with ipilimumab
160
50%
Indication of
considerable additional benefit
01.07.2021
16.12.2021
Osimertinib (4)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy
1,280–1,860
50%
Indication of
non-quantifiable additional benefit
01.07.2021
16.12.2021
Elotuzumab (3, reassessment)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
2,500
100%
Hint for
considerable additional benefit
15.06.2021
02.12.2021
Dostarlimab
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy
230–3,360
100%
no additional benefit
15.06.2021
02.12.2021
Tagraxofusp
Elzonris®
Stemline Therapeutics B.V.
Oncological diseases
Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line
30–90
100%
Hint for
non-quantifiable additional benefit
Orphan
15.06.2021
02.12.2021
Venetoclax (5)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Acute myeloid leukaemia (AML), combination therapy, first-line
560–840
100%
Hint for
considerable additional benefit
15.06.2021
02.12.2021
Berotralstat
Orladeyo®
BioCryst Pharma Deutschland GmbH
Other diseases
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
140–430
100%
no additional benefit
15.06.2021
02.12.2021
Ponesimod
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relapsing multiple sclerosis (MS)
21,000–23,000
100%
no additional benefit
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (5)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation).
310
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (4)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
173
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (3)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)).
133
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (21)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation)
310
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (20)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
173
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (19)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and gating mutation (incl. R117H))
133
100%
no additional benefit
Orphan (turnover limit)
01.06.2021
19.11.2021
Bosutinib (4, reassessment)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
760–890
100%
no additional benefit
01.06.2021
19.11.2021
Enzalutamid (5)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy
2,590–3,640
100%
no additional benefit
01.06.2021
19.11.2021
Cenobamat
Ontozry®
Angelini Pharma Deutschland GmbH
Nervous system diseases
Epilepsy, focal seizures, after at least 2 previous therapies
52,910–167,470
100%
no additional benefit
01.06.2021
19.11.2021
Atezolizumab (9)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line
4,520–5,080
100%
no additional benefit
15.05.2021
04.11.2021
Isatuximab (2)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone
2,500
100%
Hint for
minor additional benefit
15.05.2021
04.11.2021
Isatuximab
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma (MM), after at least 1 prior therapy, combination with carfilzomib and dexamethasone
4,700–7,000
100%
no additional benefit
15.05.2021
04.11.2021
Lanadelumab (2, reassessment >€50m)
Takhzyro®
Takeda GmbH
Other diseases
Hereditary angioedema (HAE), prophylaxis, ≥ 12 years
140–430
100%
no additional benefit
Orphan (turnover limit)
15.05.2021
04.11.2021
Onasemnogen-Abeparvovec
Zolgensma®
Novartis Gene Therapies EU Limited
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
46–67
100%
no additional benefit
Orphan (turnover limit)
15.05.2021
04.11.2021
Obinutuzumab (6, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
1,300–1,500
100%
no additional benefit
Orphan (turnover limit)
15.05.2021
04.11.2021
Obinutuzumab (5, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
820–1,480
100%
no additional benefit
Orphan (turnover limit)
15.05.2021
04.11.2021
Obinutuzumab (4, reassessment >€50m)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
790–940
100%
no additional benefit
Orphan (turnover limit)
15.05.2021
04.11.2021
Cannabidiol (5)
Epidyolex®
GW Pharmaceuticals plc
Other diseases
Seizures in Tuberous Sclerosis, ≥ 2 years
0
500–2,700
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2021
04.11.2021
Atidarsagen autotemcel OTL-200
Libmeldy®
Orchard Therapeutics GmbH
Metabolic diseases
Metachromatic leukodystrophy with biallelic mutation in the ARSA gene
2–4
67%
Hint for
major additional benefit
Orphan
01.05.2021
21.10.2021
Cabotegravir
Vocabria®
ViiV Healthcare GmbH
Infectious diseases
HIV-1 infection, pre-treated, combination with rilpivirin
59,900
100%
no additional benefit
01.05.2021
21.10.2021
Erenumab (2, reassessment)
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
1,540,100–1,568,800
100%
Hint for
considerable additional benefit
01.05.2021
21.10.2021
Risdiplam
Evrysdi®
Roche Pharma AG
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
992–2,142
42%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2021
21.10.2021
Cabozantinib (6, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
2,790–4,180
100%
no additional benefit
01.05.2021
21.10.2021
Nivolumab (16)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with cabozantinib
2,790–4,180
100%
no additional benefit
01.05.2021
21.10.2021
Rilpivirin (3, Rekambys®)
Rekambys®
ViiV Healthcare GmbH
Infectious diseases
HIV-1 infection, pre-treated, combination with cabotegravir
59,900
100%
no additional benefit
16.07.2020
21.10.2021
Cefiderocol
Fetcroja®
Shionogi GmbH
Infectious diseases
Infections caused by aerobic gram-negative pathogens
0
resolution w/o assessement
15.04.2021
07.10.2021
Pemigatinib
Pemazyre®
Incyte Biosciences Germany GmbH
Oncological diseases
Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy
35–300
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2021
16.09.2021
Nivolumab (15, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
3,450–4,350
100%
Hint for
considerable additional benefit
01.04.2021
16.09.2021
Natrium-Zirkonium-Cyclosilikat
Lokelma®
AstraZeneca GmbH
Metabolic diseases
Hyperkalemia
77,700–308,500
100%
no additional benefit
01.04.2021
16.09.2021
Remdesivir
Veklury®
Gilead Sciences GmbH
Infectious diseases
COVID-19, ≥ 12 years, additional oxygen supply
45,000–79,000
34%
Hint for
minor additional benefit
01.04.2021
16.09.2021
Avatrombopag (2)
Doptelet®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Thrombocytopenia in chronic liver disease
1,790–24,130
100%
no additional benefit
01.04.2021
16.09.2021
Avatrombopag
Doptelet®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Immune thrombocytopenia (ITP)
4,260–10,830
100%
no additional benefit
01.04.2021
16.09.2021
Fostemsavir
Rukobia®
ViiV Healthcare GmbH
Infectious diseases
Multidrug-resistant HIV infection
80–240
100%
no additional benefit
01.04.2021
16.09.2021
Pembrolizumab (16)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years
120–240
46%
Hint for
considerable additional benefit
01.04.2021
16.09.2021
Pembrolizumab (15, reassessment)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
225–380
100%
no additional benefit
01.04.2021
16.09.2021
Pembrolizumab (14)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Colorectal carcinoma (CRC) with MSI-H or dMMR, first-line
370–955
87%
Hint for
minor additional benefit
01.04.2021
16.09.2021
Bedaquilin (3)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis, 5 to 11 years
1
100%
Hint for
non-quantifiable additional benefit
Orphan
15.03.2021
02.09.2021
Imlifidase
Idefirix®
Hansa Biopharma AB
Other diseases
Desensitisation in kidney transplantation
3–69
100%
Hint for
non-quantifiable additional benefit
Orphan
15.03.2021
02.09.2021
Fedratinib
Inrebic®
Celgene GmbH
Oncological diseases
Myelofibrosis (MF)
740–3,590
1,370–5,280
100%
Hint for
non-quantifiable additional benefit
Orphan
15.03.2021
02.09.2021
Tucatinib
Tukysa®
Seagen Germany GmbH
Oncological diseases
Breast cancer (BC) HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine
1,350–1,640
100%
Hint for
considerable additional benefit
15.03.2021
02.09.2021
Selpercatinib (3)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy
2–16
100%
no additional benefit
15.03.2021
02.09.2021
Selpercatinib (2)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years
5–80
100%
no additional benefit
15.03.2021
02.09.2021
Selpercatinib
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy
55–200
100%
no additional benefit
01.03.2021
19.08.2021
Avelumab (4)
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Urothelial carcinoma (UC), first-line
4,125
100%
Hint for
considerable additional benefit
01.03.2021
19.08.2021
Esketamin (2)
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, therapy resistant, combination with SSRI or SNRI
0
932,000–974,000
100%
no additional benefit
01.03.2021
19.08.2021
Esketamin
Spravato®
Janssen-Cilag GmbH
Mental illnesses
Depression, acute treatment, combination therapy
49,100–69,200
100%
Hint for
minor additional benefit
15.02.2021
05.08.2021
Beclometason / Formoterol / Glycopyrronium
Trimbow®
Chiesi GmbH
Respiratory system diseases
Asthma
0
290,000
100%
no additional benefit
15.02.2021
05.08.2021
Baloxavir marboxil (2)
Xofluza®
Roche Pharma AG
Infectious diseases
Influenza prophylaxis, ≥ 12 years
1,909,000–3,965,000
58%
Indication of
considerable additional benefit
15.02.2021
05.08.2021
Baloxavir marboxil
Xofluza®
Roche Pharma AG
Infectious diseases
Influenza, ≥ 12 years
1,871,000–3,303,000
100%
no additional benefit
15.02.2021
05.08.2021
Autologe Anti-CD19-transduzierte CD3-positive Zellen
Tecartus®
Gilead Sciences GmbH
Oncological diseases
Mantle cell lymphoma (MCL), pretreated
105–150
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
05.08.2021
Acalabrutinib (3)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment
2,020–7,540
40%
Hint for
considerable additional benefit
01.02.2021
15.07.2021
Blinatumomab (5)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+
5–10
100%
Hint for
non-quantifiable additional benefit
Orphan
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab (3)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, metastatic or locally recurrent
2,470–4,000
100%
no additional benefit
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab (2)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant
2,690–3,450
100%
no additional benefit
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) early stage, HER2+, adjuvant treatment
0
1,970–3,200
100%
Hint for
minor additional benefit
01.02.2021
15.07.2021
Levofloxacin / Dexamethason
Ducressa®
Santen GmbH
Eye diseases
Infections and inflammations associated with cataract surgery
454,000–811,000
100%
no additional benefit
01.02.2021
15.07.2021
Dolutegravir (3)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV-Infection, children ≥ 4 weeks to < 6 years
29
100%
no additional benefit
01.02.2021
15.07.2021
Niraparib (4, reassessment)
Zejula®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
700–1,000
100%
no additional benefit
Orphan (turnover limit)
01.02.2021
15.07.2021
Fenfluramin
Fintepla®
Zogenix GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years
450–2,450
100%
Hint for
considerable additional benefit
Orphan
01.02.2021
15.07.2021
Inclisiran
Leqvio®
Novartis Pharma GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–410,900
100%
no additional benefit
01.02.2021
15.07.2021
Upadacitinib (3)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Psoriasis arthritis (PA)
29,100
69%
Hint for
considerable additional benefit
01.02.2021
15.07.2021
Upadacitinib (2)
Rinvoq®
AbbVie Deutschland GmbH & Co. KG
Musculoskeletal system diseases
Ankylosing spondylitis
7,800–16,800
100%
no additional benefit
15.01.2021
15.07.2021
Carfilzomib (4)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone
4,700–7,000
100%
no additional benefit
Orphan (turnover limit)
01.01.2021
01.07.2021
Nivolumab (14)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of esophagus, pretreated patients
740–2,060
36%
Hint for
minor additional benefit
01.01.2021
01.07.2021
Afamelanotid (2, reassessment)
Scenesse®
Clinuvel (UK) Limited
Metabolic diseases
Erythropoietic protoporphyria
540–1,090
100%
Hint for
non-quantifiable additional benefit
Orphan
01.01.2021
01.07.2021
Dupilumab (5)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD), 6 to 11 years
9,700–14,100
100%
Hint for
non-quantifiable additional benefit
01.01.2021
01.07.2021
Lenvatinib (5, reassessment, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
1,770–3,530
100%
no additional benefit
01.01.2021
01.07.2021
Lumasiran
Oxlumo®
Alnylam Germany GmbH
Metabolic diseases
Hyperoxaluria
50–880
100%
Hint for
non-quantifiable additional benefit
Orphan
15.12.2020
03.06.2021
Ipilimumab (6)
Yervoy®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy
14,340–16,180
73%
Indication of
minor additional benefit
15.12.2020
03.06.2021
Nivolumab (13)
Opdivo®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line
14,340–16,180
73%
Indication of
minor additional benefit
15.12.2020
03.06.2021
Perampanel (5)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years
2,950–6,700
100%
no additional benefit
15.12.2020
03.06.2021
Perampanel (4)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years
195–663
100%
no additional benefit
15.12.2020
03.06.2021
Sucroferric Oxyhydroxide (2)
Velphoro®
Fresenius Medical Care Deutschland GmbH
Genitourinary system diseases
Serum phosphate level control in chronic kidney disease, ≥ 2 to 18 years
390–470
100%
no additional benefit
01.12.2020
03.06.2021
Olaparib (7)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy
75–95
100%
no additional benefit
01.12.2020
03.06.2021
Olaparib (6)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment
2,290–3,040
100%
Hint for
considerable additional benefit
01.12.2020
03.06.2021
Olaparib (5)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
0
1,030
100%
no additional benefit
01.12.2020
03.06.2021
Sebelipase alfa (2, reassessment)
Kanuma®
Alexion Pharma Germany GmbH
Metabolic diseases
Lysosomal acid lipase deficiency
35–70
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
03.06.2021
Acalabrutinib (2)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line
2,880–3,780
25%
Hint for
minor additional benefit
01.12.2020
03.06.2021
Acalabrutinib
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); monotherapy, first-line
2,880–3,780
25%
Hint for
minor additional benefit
01.12.2020
20.05.2021
Tezacaftor / Ivacaftor (5)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation)
50
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Guselkumab (2)
Tremfya®
Janssen-Cilag GmbH
Skin diseases
Psoriatic arthritis (PA)
29,100
100%
no additional benefit
01.12.2020
20.05.2021
Nusinersen (2, reassessment >€50m)
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
1,013–1,203
19%
Indication of
major additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Tezacaftor / Ivacaftor (4)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del)
470
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Tafamidis (4, reassessment >€50m)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
1,760–1,810
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Tafamidis (3, reassessment >€50m)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
230
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Niraparib (3)
Zejula®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy
2,010–2,810
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (18)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation)
50
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (17)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation)
470
100%
no additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (16)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation
1
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (15)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
1
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Dapagliflozin (5)
Forxiga®
AstraZeneca GmbH
Cardiovascular diseases
Chronic heart failure (CHF)
2,061,700–2,273,000
100%
Hint for
considerable additional benefit
01.12.2020
20.05.2021
Crizanlizumab
Adakveo®
Novartis Pharma GmbH
Hematopoietic diseases
Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years
0
390–1,690
100%
Hint for
minor additional benefit
Orphan
01.12.2020
20.05.2021
Amikacin (liposomal)
Arikayce® liposomal
Insmed Germany GmbH
Infectious diseases
Mycobacterium avium complex (MAC) lung infections
350–760
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
20.05.2021
Atezolizumab (8)
Tecentriq®
Roche Pharma AG
Oncological diseases
Hepatocellular carcinoma (HCC), combination with bevacizumab
1,710–4,970
76%
Indication of
considerable additional benefit
15.02.2021
06.05.2021
Eszopiclon
Lunivia®
Hennig Arzneimittel GmbH & Co. KG
Nervous system diseases
Sleep disorders
0
100%
no additional benefit
15.11.2020
06.05.2021
Baricitinib (2)
Olumiant®
Lilly Deutschland GmbH
Skin diseases
Atopic dermatitis (AD)
52,000
100%
no additional benefit
01.11.2020
15.04.2021
Avapritinib
Ayvakyt®
Blueprint Medicines (Germany)
Oncological diseases
Gastrointestinal stromal tumor (GIST)
1–90
100%
Hint for
non-quantifiable additional benefit
Orphan
01.11.2020
15.04.2021
Burosumab (3)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 18 years
0
410–810
100%
Hint for
minor additional benefit
Orphan
01.11.2020
15.04.2021
Bempedoinsäure / Ezetimib
Nustendi®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–286,750
100%
no additional benefit
01.11.2020
15.04.2021
Bempedoinsäure
Nilemdo®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–286,750
100%
no additional benefit
01.11.2020
15.04.2021
Semaglutid (2, reassessment)
Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
0
2,107,999–2,108,001
100%
no additional benefit
15.10.2020
15.04.2021
Cannabidiol (4, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
0
2,600–22,700
100%
Hint for
considerable additional benefit
Orphan
15.10.2020
15.04.2021
Cannabidiol (3, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
0
1,100–3,100
100%
Hint for
considerable additional benefit
Orphan
15.10.2020
15.04.2021
Filgotinib
Jyseleca®
Gilead Sciences GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
89,710–193,750
33%
Hint for
minor additional benefit
01.10.2020
01.04.2021
Ibrutinib (7)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab
3,090
59%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.10.2020
01.04.2021
Durvalumab (2)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with etoposide and either carboplatin or cisplatin
3,210–6,130
100%
Hint for
minor additional benefit
01.10.2020
01.04.2021
Sofosbuvir / Velpatasvir (2)
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, ≥ 6 to < 18 years
120
100%
no additional benefit
15.09.2020
04.03.2021
Belantamab-Mafodotin
Blenrep®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Multiple myeloma (MM), at least 4 prior therapies, monotherapy
0
570–1,130
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2020
18.02.2021
Alpelisib
Piqray®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) with PIK3CA mutation, pre-treated patients, combination with fulvestrant
2,321–21,586
41%
no additional benefit
01.09.2020
18.02.2021
Bulevirtid
Hepcludex®
MYR GmbH
Infectious diseases
Chronic hepatitis Delta
300–4,800
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2020
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor
Kaftrio®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation)
2,400
100%
Indication of
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor (2)
Kaftrio®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation)
1,000
100%
Hint for
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor (14)
Kalydeco®
Vertex Pharmaceuticals Ltd
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation)
1,000
100%
Hint for
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor (13)
Kalydeco®
Vertex Pharmaceuticals Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation)
2,400
100%
Indication of
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Entrectinib (2)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line
462–1,274
100%
no additional benefit
01.09.2020
18.02.2021
Entrectinib
Rozlytrek®
Roche Pharma AG
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
390–770
100%
no additional benefit
01.09.2020
18.02.2021
Ibalizumab
Trogarzo®
Theratechnologies Europe limited
Infectious diseases
Multidrug-resistant HIV infection
50–110
100%
no additional benefit
01.09.2020
18.02.2021
Secukinumab (6)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP), ≥ 6 to < 18 years
270–2,035
100%
Hint for
minor additional benefit
01.09.2020
18.02.2021
Secukinumab (5)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Axial spondyloarthritis
19,500
100%
no additional benefit
01.09.2020
18.02.2021
Secukinumab (4, reassessment)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Psoriatic arthritis (PA)
29,100
35%
Indication of
minor additional benefit
15.08.2020
18.02.2021
Glasdegib
Daurismo®
Pfizer Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML), combination with cytarabine (LDAC)
780–840
100%
Hint for
considerable additional benefit
Orphan
15.08.2020
04.02.2021
Nintedanib (5, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Interstitial pulmonary disease with systemic sclerosis
200–10,700
100%
no additional benefit
15.08.2020
04.02.2021
Trifaroten
Selgamis®
Galderma Laboratorium GmbH
Skin diseases
Acne vulgaris, ≥ 12 years
887,500–1,950,700
100%
no additional benefit
15.08.2020
04.02.2021
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat
Enerzair® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
100,000
100%
no additional benefit
15.08.2020
04.02.2021
Nintedanib (4, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Progressive fibrosing interstitial lung diseases
4,500–11,400
100%
Indication of
minor additional benefit
01.08.2020
21.01.2021
Ravulizumab (2)
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Atypical hemolytic uremic syndrome (aHUS)
210–700
100%
no additional benefit
01.08.2020
21.01.2021
Sofosbuvir (3)
Sovaldi®
Gilead Sciences Ireland UC
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
30–50
100%
Hint for
non-quantifiable additional benefit
01.08.2020
21.01.2021
Luspatercept (2)
Reblozyl®
Celgene GmbH
Hematopoietic diseases
Beta thalassemia
0
170–300
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2020
21.01.2021
Luspatercept
Reblozyl®
Celgene GmbH
Hematopoietic diseases
Myelodysplastic syndrome (MDS)
0
840–1,870
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2020
21.01.2021
Ledipasvir / Sofosbuvir (3)
Harvoni®
Gilead Sciences Ireland UC
Infectious diseases
Chronic hepatitis C, 3 to < 12 years
100–170
50%
Hint for
non-quantifiable additional benefit
01.08.2020
21.01.2021
Ixekizumab (4)
Taltz®
Lilly Deutschland GmbH
Skin diseases
Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg
270–2,035
100%
no additional benefit
01.08.2020
21.01.2021
Ixekizumab (3)
Taltz®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Axial spondyloarthritis
36,300
100%
no additional benefit
15.07.2020
07.01.2021
Osilodrostat
Isturisa®
Recordati Rare Diseases Germany GmbH
Metabolic diseases
Endogenous Cushing syndrome
1,130–1,550
100%
Hint for
non-quantifiable additional benefit
Orphan
15.07.2020
07.01.2021
Ozanimod
Zeposia®
Celgene GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
149,500–166,000
90%
Indication of
minor additional benefit
15.07.2020
07.01.2021
Caplacizumab (2)
Cablivi®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years
2–3
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2020
17.12.2020
Encorafenib (2)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Metastatic colorectal carcinoma (CRC)
525–1,235
100%
Hint for
considerable additional benefit
01.07.2020
17.12.2020
Fostamatinib
Tavlesse®
Grifols Deutschland GmbH
Hematopoietic diseases
Chronic immune thrombocytopenia
4,200–9,700
100%
no additional benefit
01.07.2020
17.12.2020
Ivacaftor (12)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 6 months to < 18 years
26
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.07.2020
17.12.2020
Tezacaftor / Ivacaftor (3, reassessment >€50m)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del)
2,400
100%
no additional benefit
Orphan (turnover limit)
01.07.2020
17.12.2020
Tezacaftor / Ivacaftor (2, reassessment >€50m)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del)
200–300
100%
no additional benefit
Orphan (turnover limit)
15.06.2020
03.12.2020
Brentuximab Vedotin (5)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone
0
125–127
100%
Hint for
minor additional benefit
Orphan
15.06.2020
03.12.2020
Mogamulizumab
Poteligeo®
Kyowa Kirin GmbH
Oncological diseases
Mycosis Fungoides; Sézary Syndrome
310–460
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2020
20.11.2020
Talazoparib
Talzenna®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutation, HER2-
410–1,830
100%
Hint for
considerable additional benefit
01.06.2020
20.11.2020
Ponatinib (3, reassessment)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
500–940
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2020
20.11.2020
Ponatinib (2, reassessment)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
25–195
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2020
05.11.2020
Naldemedin
Rizmoic®
Hexal AG
Digestive system diseases
Opioid-induced constipation
65,000
100%
no additional benefit
15.05.2020
05.11.2020
Apremilast (2)
Otezla®
Amgen GmbH
Other diseases
Behçet's disease
750–2,200
100%
no additional benefit
15.05.2020
05.11.2020
Enzalutamid (4, reassessment)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
minor additional benefit
15.05.2020
05.11.2020
Solriamfetol
Sunosi®
Jazz Pharmaceuticals
Nervous system diseases
Narcolepsy
16,200–19,500
100%
no additional benefit
01.05.2020
15.10.2020
Brigatinib (2)
Alunbrig®
Takeda GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients
420–910
50%
Hint for
considerable additional benefit
01.05.2020
15.10.2020
Darolutamid
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
considerable additional benefit
15.04.2020
15.10.2020
Venetoclax (4)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab
3,090–3,099
100%
no additional benefit
15.04.2020
15.10.2020
Insulin glargin / Lixisenatid (2)
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors
532,000
100%
no additional benefit
15.04.2020
15.10.2020
Givosiran
Givlaari®
Alnylam Germany GmbH
Metabolic diseases
Acute hepatic porphyria, ≥ 12 years
1,000–1,700
100%
Indication of
considerable additional benefit
Orphan
01.04.2020
01.10.2020
Avelumab (3, reassessment)
Bavencio®
Merck Serono GmbH
Oncological diseases
Metastatic Merkel-cell carcinoma (MCC)
370–720
100%
no additional benefit
01.04.2020
01.10.2020
Trifluridin / Tipiracil (3, reassessment)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
6,900–12,200
100%
Hint for
minor additional benefit
01.04.2020
01.10.2020
Apalutamid (3, reassessment)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
minor additional benefit
01.04.2020
01.10.2020
Cobicistat (2)
Tybost®
Gilead Sciences GmbH
Infectious diseases
HIV infection, combination with atazanavir or darunavir, 12 to < 18 years
130
100%
no additional benefit
15.03.2020
17.09.2020
Tisagenlecleucel (3, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
50–65
100%
Hint for
non-quantifiable additional benefit
Orphan
15.03.2020
17.09.2020
Tisagenlecleucel (4, reassessment)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
450–720
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2020
03.09.2020
Indacaterol / Mometason
Atectura® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
1,000,000–1,100,000
100%
no additional benefit
15.03.2020
03.09.2020
Brolucizumab
Beovu®
Novartis Pharma GmbH
Eye diseases
Neovascular age-related macular degeneration
0
85,200–681,400
100%
no additional benefit
15.03.2020
03.09.2020
Fidaxomicin (2)
Dificlir®
Astellas Pharma GmbH
Infectious diseases
Clostridioides difficile infection, children and adolescents
350
54%
Hint for
considerable additional benefit
15.03.2020
03.09.2020
Romosozumab
Evenity®
UCB Pharma GmbH
Musculoskeletal system diseases
Osteoporosis (postmenopausal)
475,000
100%
Indication of
minor additional benefit
15.03.2020
03.09.2020
Riociguat (2, reassessment >€50m)
Adempas®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Chronic thromboembolic pulmonary hypertension
920–5,460
100%
no additional benefit
Orphan (turnover limit)
15.03.2020
03.09.2020
Riociguat (3, reassessment >€50m)
Adempas®
MSD Sharp & Dohme GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
580–7,850
100%
no additional benefit
Orphan (turnover limit)
15.03.2020
03.09.2020
Abemaciclib (3, reassessment)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Mammary carcinoma, HR+, HER2-, combination with fulvestrant
906–4,118
13,776–63,808
39%
Hint for
minor additional benefit
01.03.2020
20.08.2020
Tafamidis (2)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
0
1,630–1,730
100%
Hint for
considerable additional benefit
Orphan
01.03.2020
20.08.2020
Apalutamid (2)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy
2,590–3,640
100%
no additional benefit
01.03.2020
20.08.2020
Ribociclib (3, reassessment)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with fulvestrant
13,140–59,690
58%
Indication of
minor additional benefit
01.03.2020
20.08.2020
Ribociclib (4, reassessment)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with aromatase inhibitor
7,400–34,790
100%
Hint for
minor additional benefit
15.02.2020
20.08.2020
Polatuzumab Vedotin
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab
0
730–1,560
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2020
20.08.2020
Siponimod
Mayzent®
Novartis Pharma GmbH
Nervous system diseases
Secondary progressive multiple sclerosis (MS)
13,200–28,900
100%
no additional benefit
15.02.2020
20.08.2020
Bedaquilin (2)
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years
9–13
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2020
20.08.2020
Daratumumab (5)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
0
3,479–3,670
100%
Hint for
minor additional benefit
Orphan (turnover limit)
15.02.2020
20.08.2020
Daratumumab (4)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone
1,800–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2020
20.08.2020
Ramucirumab (6)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
780–1,810
100%
no additional benefit
01.02.2020
16.07.2020
Dulaglutid (2, reassessment)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
2,108,000
31%
Hint for
minor additional benefit
01.02.2020
16.07.2020
Upadacitinib
Rinvoq®
AbbVie Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
88,709–188,210
34%
Hint for
considerable additional benefit
15.01.2020
02.07.2020
Trastuzumab Emtansin (2)
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) early stage, HER2+, adjuvant treatment
1,980
100%
Indication of
minor additional benefit
15.12.2019
04.06.2020
Ivacaftor (11)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), ≥ 6 to < 12 months
2
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2019
14.05.2020
Neratinib
Nerlynx®
Pierre Fabre Pharma
Oncological diseases
Breast cancer (BC) HR+, HER2+, adjuvant therapy
2,330–4,560
100%
Hint for
minor additional benefit
01.12.2019
14.05.2020
Gilteritinib
XOSPATA®
Astellas Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML), FLT3 mutation
220–580
100%
Hint for
considerable additional benefit
Orphan
01.12.2019
14.05.2020
Avelumab (2)
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
3,500
23%
Hint for
considerable additional benefit
01.12.2019
14.05.2020
Dupilumab (4)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Chronic rhinosinusitis with nasal polyps
10,500–12,600
100%
Indication of
considerable additional benefit
01.12.2019
14.05.2020
Pembrolizumab (13)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy
4,950–5,370
100%
Indication of
minor additional benefit
01.12.2019
14.05.2020
Pembrolizumab (12)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy
4,955–5,370
100%
Hint for
considerable additional benefit
01.12.2019
14.05.2020
Pembrolizumab (11)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
3,500
23%
Indication of
considerable additional benefit
15.11.2019
14.05.2020
Belimumab (2)
Benlysta®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Systemic lupus erythematosus
30–550
100%
Hint for
non-quantifiable additional benefit
15.11.2019
14.05.2020
Betibeglogene autotemcel
Zynteglo®
bluebird bio (Germany) GmbH
Hematopoietic diseases
Beta thalassemia
50
100%
Hint for
non-quantifiable additional benefit
Orphan
15.10.2019
02.04.2020
Cannabidiol (2)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
0
1,100–3,100
100%
Hint for
non-quantifiable additional benefit
Orphan
15.10.2019
02.04.2020
Niraparib (2, reassessment >€50m)
Zejula®
TESARO Bio Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
0
1,900–2,400
100%
no additional benefit
Orphan (turnover limit)
15.10.2019
02.04.2020
Cannabidiol
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
0
2,600–22,700
100%
Hint for
non-quantifiable additional benefit
Orphan
15.10.2019
02.04.2020
Larotrectinib
Vitrakvi®
Bayer Vital GmbH
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
390–770
100%
no additional benefit
01.10.2019
02.04.2020
Atezolizumab (4)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with bevacizumab, paclitaxel and carboplatin; maintenance therapy
8,990–9,590
100%
no additional benefit
15.10.2019
02.04.2020
Trifluridin / Tipiracil (2)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Metastatic gastric cancer, pre-treated patients
590–1,030
100%
Indication of
minor additional benefit
15.10.2019
02.04.2020
Asfotase alfa (2, reassessment >€50m)
Strensiq®
Alexion Pharma Germany GmbH
Metabolic diseases
Hypophosphatasia (HPP)
1,074
0.8%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.10.2019
02.04.2020
Atezolizumab (6)
Tecentriq®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥1%
920–1,110
100%
Hint for
non-quantifiable additional benefit
01.10.2019
02.04.2020
Atezolizumab (5)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with nab-paclitaxel and carboplatin; maintenance therapy
8,020–9,110
100%
no additional benefit
15.10.2019
02.04.2020
Atezolizumab (7)
Tecentriq®
Roche Pharma AG
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy
7,280–8,550
100%
Hint for
minor additional benefit
01.10.2019
02.04.2020
Elotuzumab (2)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
0
2,500
100%
Hint for
considerable additional benefit
01.10.2019
02.04.2020
Burosumab (2, reassessment)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
0
200–500
100%
Hint for
non-quantifiable additional benefit
Orphan
15.09.2019
05.03.2020
Ropeginterferon alfa-2b
Besremi®
AOP Orphan Pharmaceuticals AG
Oncological diseases
Polycythemia vera
1,860–19,800
100%
no additional benefit
01.09.2019
20.02.2020
Ivacaftor (10)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), 12 ro < 24 months
5
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (9, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation
35–44
100%
Hint for
minor additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (8, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 2 to 5 years
15
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (7, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), various gating mutations, ≥ 6 years
10–11
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (6, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor
200–300
100%
no additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (5, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor
2,400
100%
no additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (4, reassessment >€50m)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
210
86%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ramucirumab (5)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
500–2,200
100%
Proof of
minor additional benefit
01.09.2019
20.02.2020
Dupilumab (2)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Bronchial asthma, ≥ 12 years
17,560–54,300
100%
no additional benefit
01.09.2019
20.02.2020
Dupilumab (3)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD), 12 to < 18 years
5,300–10,600
100%
Hint for
non-quantifiable additional benefit
01.09.2019
20.02.2020
Andexanet alfa
Ondexxya®
Portola Deutschland GmbH
Hematopoietic diseases
Antidote for reversal of anticoagulation (factor Xa)
4,200–27,600
100%
no additional benefit
01.09.2019
20.02.2020
Ibrutinib (5)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab
3,090
26%
Hint for
minor additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ibrutinib (6)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Waldenström's disease, combination with rituximab
590–1,180
100%
no additional benefit
Orphan (turnover limit)
15.08.2019
20.02.2020
Volanesorsen
Waylivra®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Chylomicronaemia syndrome
60–120
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2019
06.02.2020
Turoctocog alfa pegol
Esperoct®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia A
2,840–3,190
100%
no additional benefit
01.08.2019
06.02.2020
Dolutegravir / Lamivudin
Dovato®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
52,060–61,380
100%
no additional benefit
01.08.2019
06.02.2020
Ravulizumab
Ultomiris®
Alexion Pharma Germany GmbH
Hematopoietic diseases
Paroxysmal hemoglobinuria
260–700
100%
no additional benefit
01.08.2019
06.02.2020
Cemiplimab
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Squamous cell carcinoma (SCC)
450–1,400
100%
no additional benefit
15.07.2019
16.01.2020
Olaparib (3)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutations, HER2-
460–710
100%
Hint for
minor additional benefit
15.07.2019
16.01.2020
Olaparib (4)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
0
70–325
100%
no additional benefit
01.07.2019
19.12.2019
Vigabatrin
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, West syndrome, < 7 years
0
1,000–2,400
100%
no additional benefit
01.07.2019
19.12.2019
Vigabatrin (2)
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, focal seizures, < 7 years
0
7,300–14,500
100%
no additional benefit
01.07.2019
19.12.2019
Pegvaliase
Palynziq®
BioMarin International Limited
Metabolic diseases
Phenylketonuria
435
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2019
19.12.2019
Dapagliflozin / Metformin (3, reassessment)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
1,139,000
50%
Hint for
minor additional benefit
01.07.2019
19.12.2019
Dapagliflozin (4, reassessment)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
2,108,000
41%
Hint for
minor additional benefit
15.06.2019
05.12.2019
Pomalidomid (3)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone
3,060–3,450
100%
no additional benefit
Orphan (turnover limit)
01.06.2019
22.11.2019
Empagliflozin / Linagliptin
Glyxambi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
326,100–341,100
100%
no additional benefit
01.06.2019
22.11.2019
Risankizumab
Skyrizi®
AbbVie Deutschland GmbH & Co. KG
Skin diseases
Plaque psoriasis (PP)
35,900–121,500
82%
Proof of
considerable additional benefit
01.06.2019
22.11.2019
Lorlatinib
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
200–1,310
100%
no additional benefit
15.05.2019
07.11.2019
Fremanezumab
Ajovy®
Teva GmbH
Nervous system diseases
Migraine prophylaxis
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
01.05.2019
17.10.2019
Dacomitinib
Vizimpro®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
890–2,210
100%
no additional benefit
01.05.2019
17.10.2019
Lisdexamfetamindimesilat (2, Elvanse Adult®)
Elvanse Adult®
Shire Deutschland GmbH
Mental illnesses
Attention deficit hyperactivity disorder (ADHD), ≥ 18 years
73,000
100%
no additional benefit
01.05.2019
17.10.2019
Dapagliflozin (3)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 1
0
19,200
100%
Hint for
minor additional benefit
15.04.2019
17.10.2019
Radium-223-dichlorid (2, reassessment)
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
3,810–4,560
100%
no additional benefit
15.04.2019
17.10.2019
Voretigen Neparvovec
Luxturna®
Novartis Pharma GmbH
Eye diseases
Hereditary retinal dystrophy
0
100–530
100%
Hint for
considerable additional benefit
Orphan
15.04.2019
17.10.2019
Glecaprevir / Pibrentasvir (2)
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
540
100%
no additional benefit
15.04.2019
17.10.2019
Nintedanib (3, reassessment >€50m, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Idiopathic pulmonary fibrosis
1,800–18,900
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.04.2019
19.09.2019
Pembrolizumab (10)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel
5,340–5,570
71%
Hint for
considerable additional benefit
01.04.2019
19.09.2019
Pembrolizumab (9)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy
8,020–9,120
100%
Hint for
non-quantifiable additional benefit
01.04.2019
19.09.2019
Pembrolizumab (8)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, adjuvant therapy
2,670–3,400
100%
Indication of
non-quantifiable additional benefit
01.04.2019
19.09.2019
Galcanezumab
Emgality®
Lilly Deutschland GmbH
Nervous system diseases
Migraine prophylaxis
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
15.03.2019
05.09.2019
Brentuximab Vedotin (4)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Hodgkin lymphoma (HL), CD30+, first-line
220–380
100%
non-quantifiable additional benefit
Orphan
15.03.2019
05.09.2019
Emicizumab (2)
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Hemophilia A, without factor VIII inhibitors
2,000
100%
no additional benefit
01.03.2019
19.08.2019
Regadenoson (2)
Rapiscan®
GE Healthcare Buchler GmbH & Co. KG
Other diseases
Stenosis, Fractional Flow Reserve Measurement (FFR)
0
780,000
100%
no additional benefit
01.03.2019
15.08.2019
Rucaparib
Rubraca®
Clovis Oncology Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, after at least 2 previous therapies
0
95
100%
no additional benefit
01.03.2019
15.08.2019
Rucaparib (2)
Rubraca®
Clovis Oncology Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
0
1,900–2,400
100%
no additional benefit
15.02.2019
15.08.2019
Blinatumomab (3)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients
40–110
100%
non-quantifiable additional benefit
Orphan
15.02.2019
15.08.2019
Lumacaftor / Ivacaftor (3)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years
0
280
100%
Hint for
non-quantifiable additional benefit
15.02.2019
15.08.2019
Blinatumomab (4)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years
30–80
100%
non-quantifiable additional benefit
Orphan
15.02.2019
15.08.2019
Lenvatinib (4, reassessment)
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
740–770
100%
no additional benefit
15.02.2019
15.08.2019
Ipilimumab (5)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
2,110–2,850
100%
Indication of
considerable additional benefit
15.02.2019
15.08.2019
Nivolumab (12)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with ipilimumab
2,110–2,850
100%
Indication of
considerable additional benefit
01.02.2019
01.08.2019
Mexiletin
Namuscla®
Lupin Europe GmbH
Nervous system diseases
Myotonia
530–650
100%
non-quantifiable additional benefit
Orphan
01.02.2019
01.08.2019
Apalutamid
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
0
810–1,180
100%
Hint for
minor additional benefit
01.02.2019
01.08.2019
Lanadelumab
Takhzyro®
Shire Deutschland GmbH, Teil der Takeda Group
Other diseases
Hereditary angioedema (HAE)
0
140–430
100%
considerable additional benefit
Orphan
15.01.2019
04.07.2019
Doravirin
Pifeltro®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection
57,800–73,700
100%
no additional benefit
15.01.2019
04.07.2019
Doravirin / Lamivudin / Tenofovirdisoproxil
Delstrigo®
MSD Sharp & Dohme GmbH
Infectious diseases
HIV infection
48,800–68,000
100%
no additional benefit
15.01.2019
04.07.2019
Glycerolphenylbutyrat (2)
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), 0 to < 2 months
10–18
100%
non-quantifiable additional benefit
Orphan
15.01.2019
04.07.2019
Brigatinib
Alunbrig®
Takeda Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
160–1,060
100%
no additional benefit
15.01.2019
04.07.2019
Bedaquilin
Sirturo®
Janssen-Cilag GmbH
Infectious diseases
Multidrug-resistant pulmonary tuberculosis
0
70–100
100%
considerable additional benefit
Orphan
15.01.2019
04.07.2019
Melatonin
Slenyto®
InfectoPharm Arzneimittel und Consilium GmbH
Nervous system diseases
Sleep disorders
0
8,000–86,000
100%
Hint for
minor additional benefit
15.01.2019
04.07.2019
Ribociclib (2)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor
9,450–45,780
21,940–106,310
100%
no additional benefit
01.01.2019
20.06.2019
Damoctocog alfa pegol
Jivi®
Bayer Vital GmbH
Hematopoietic diseases
Hemophilia A, ≥ 12 years
2,840–3,190
100%
no additional benefit
01.01.2019
20.06.2019
Pembrolizumab (7, reassessment)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
0
240–420
100%
no additional benefit
01.01.2019
20.06.2019
Fingolimod (5)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), ≥ 10 to < 18 years
190–840
57%
Hint for
non-quantifiable additional benefit
01.01.2019
20.06.2019
Atezolizumab (3, reassessment)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line
220–380
100%
no additional benefit
15.12.2018
06.06.2019
Cabozantinib (5, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
1,280–4,900
100%
Hint for
minor additional benefit
01.12.2018
16.05.2019
Tezacaftor / Ivacaftor
Symkevi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, ≥ 12 years
0
2,600–2,700
91%
considerable additional benefit
Orphan
01.12.2018
16.05.2019
Enzalutamid (3)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
0
810–1,180
100%
no additional benefit
01.12.2018
16.05.2019
Venetoclax (2)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with rituximab
2,000–7,200
37%
Indication of
minor additional benefit
01.12.2018
16.05.2019
Venetoclax (3, reassessment)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
300–700
100%
no additional benefit
01.12.2018
16.05.2019
Insulin degludec (4, reassessment)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
776,100–991,100
100%
no additional benefit
15.11.2018
02.05.2019
Fluticasonfuroat / Umeclidinium / Vilanterol (2)
Trelegy Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD), inadequate control with LAMA and LABA
524,000–1,217,000
100%
no additional benefit
15.11.2018
02.05.2019
Tildrakizumab
Ilumetri®
Almirall Hermal GmbH
Skin diseases
Plaque psoriasis (PP)
157,100–234,400
100%
no additional benefit
01.11.2018
02.05.2019
Alirocumab (2, reassessment)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
271,750
100%
no additional benefit
01.11.2018
02.05.2019
Axicabtagen-Ciloleucel (2)
Yescarta®
Kite, Gilead company
Oncological diseases
Primary mediastinal large B-cell lymphoma (PMBCL)
0
5–9
100%
non-quantifiable additional benefit
Orphan
01.11.2018
02.05.2019
Axicabtagen-Ciloleucel
Yescarta®
Kite, Gilead company
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
440–700
100%
non-quantifiable additional benefit
Orphan
01.11.2018
02.05.2019
Abemaciclib (2)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
1,190–5,760
14,560–70,550
100%
no additional benefit
01.11.2018
02.05.2019
Abemaciclib
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with aromatase inhibitor
7,380–35,760
14,560–70,550
100%
no additional benefit
01.11.2018
02.05.2019
Semaglutid
Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
1,969,100–2,184,100
37%
Hint for
minor additional benefit
01.11.2018
02.05.2019
Erenumab
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
14,000–15,000
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
15.10.2018
04.04.2019
Pembrolizumab (6)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Squamous cell carcinoma head and neck
470–3,290
100%
no additional benefit
15.10.2018
04.04.2019
Ocriplasmin (2, reassessment)
Jetrea®
Oxurion NV
Eye diseases
Vitreomacular traction (VMT)
1,160–16,500
94%
Hint for
minor additional benefit
15.10.2018
04.04.2019
Durvalumab
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), maintenance therapy
1,600–1,800
100%
Hint for
considerable additional benefit
01.10.2018
22.03.2019
Trametinib (3)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy
1,290–1,590
100%
Indication of
considerable additional benefit
01.10.2018
22.03.2019
Dabrafenib (4)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy
1,290–1,590
100%
Indication of
considerable additional benefit
01.10.2018
22.03.2019
Patisiran
Onpattro®
Alnylam Germany GmbH
Metabolic diseases
Amyloidosis
0
350
100%
considerable additional benefit
Orphan
01.10.2018
22.03.2019
Inotersen
Tegsedi®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Amyloidosis
350
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Metreleptin
Myalepta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Lipodystrophy
90–180
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Binimetinib
Mektovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with encorafenib
1,390
100%
no additional benefit
01.10.2018
22.03.2019
Encorafenib
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with binimetinib
1,390
100%
no additional benefit
01.10.2018
22.03.2019
Palbociclib (2, reassessment)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC), patient population b1 and b2
6,190–30,000
100%
no additional benefit
01.10.2018
22.03.2019
Lenvatinib (3)
Lenvima®
Eisai GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
2,630–4,750
100%
no additional benefit
01.10.2018
22.03.2019
Daunorubicin / Cytarabin (liposomale Formulierung)
Vyxeos® liposomal
Jazz Pharmaceuticals
Oncological diseases
Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia
310–510
100%
considerable additional benefit
Orphan
01.10.2018
22.03.2019
Mepolizumab (2)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, ≥ 6 to < 18 years
2,200–3,500
100%
no additional benefit
01.10.2018
22.03.2019
Sitagliptin (3, reassessment)
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin
781,600
100%
Hint for
minor additional benefit
01.10.2018
22.03.2019
Tenofoviralafenamid (2, reassessment)
Vemlidy®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis B, ≥ 12 years
12,400–38,100
100%
no additional benefit
01.10.2018
22.03.2019
Caplacizumab
Cablivi®
Sanofi-Aventis Deutschland GmbH
Hematopoietic diseases
Thrombotic thrombocytopenic purpura (TTP)
150
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Vestronidase alfa
Mepsevii®
Ultragenyx Germany GmbH
Metabolic diseases
Mucopolysaccharidosis (MPS VII; Sly syndrome)
2–7
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Daratumumab (3)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone
0
3,380–3,900
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.09.2018
07.03.2019
Tisagenlecleucel
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
440–700
100%
non-quantifiable additional benefit
Orphan
15.09.2018
07.03.2019
Tisagenlecleucel (2)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
50–65
100%
non-quantifiable additional benefit
Orphan
01.09.2018
21.02.2019
Tofacitinib (4)
Xeljanz®
Pfizer Pharma GmbH
Skin diseases
Psoriatic arthritis (PA)
25,900
69%
Hint for
minor additional benefit
01.09.2018
21.02.2019
Tofacitinib (3)
Xeljanz®
Pfizer Pharma GmbH
Digestive system diseases
Ulcerative colitis
5,300–25,000
100%
no additional benefit
01.09.2018
21.02.2019
Nivolumab (11)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
0
2,980–3,780
100%
Hint for
non-quantifiable additional benefit
01.09.2018
21.02.2019
Gemtuzumab Ozogamicin
Mylotarg®
Pfizer Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
560–1,150
100%
non-quantifiable additional benefit
Orphan
01.09.2018
21.02.2019
Bosutinib (3, reassessment)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+
545–555
100%
no additional benefit
01.09.2018
21.02.2019
Ingenolmebutat (2, reassessment)
Picato®
LEO Pharma GmbH
Skin diseases
Actinic keratosis (AK)
0
990,000–1,114,000
50%
Hint for
non-quantifiable additional benefit
01.08.2018
17.01.2019
Brivaracetam (2)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, add-on therapy, 4 to < 16 years
5,000–10,000
100%
no additional benefit
15.07.2018
17.01.2019
Osimertinib (3)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
860–2,030
84%
Hint for
considerable additional benefit
01.07.2018
20.12.2018
Ipilimumab (4)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with nivolumab
2,500–4,500
85%
no additional benefit
15.06.2018
20.12.2018
Nivolumab (10, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
270–810
100%
Indication of
less benefit
01.07.2018
20.12.2018
Pertuzumab (3)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy
0
3,020
100%
Indication of
minor additional benefit
01.07.2018
20.12.2018
Bictegravir / Emtricitabin / Tenofoviralafenamid
Biktarvy®
Gilead Sciences GmbH
Infectious diseases
HIV infection
66,800
100%
no additional benefit
01.07.2018
20.12.2018
Velmanase alfa
Lamzede®
Chiesi GmbH
Metabolic diseases
Alpha mannosidosis
70–140
100%
non-quantifiable additional benefit
Orphan
15.06.2018
06.12.2018
Olaparib (2, reassessment)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy
1,900–2,400
100%
Hint for
minor additional benefit
15.06.2018
06.12.2018
Cabozantinib (4, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC)
2,240–2,570
100%
no additional benefit
15.06.2018
06.12.2018
Dolutegravir / Rilpivirin
Juluca®
ViiV Healthcare GmbH
Infectious diseases
HIV infection
53,000
100%
no additional benefit
01.06.2018
22.11.2018
Bosutinib (2)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
0
690–810
100%
no additional benefit
01.06.2018
22.11.2018
Darvadstrocel
Alofisel®
Takeda Pharma Vertrieb GmbH & Co. KG
Digestive system diseases
Anal fistulas in Crohn's disease
90–230
100%
non-quantifiable additional benefit
Orphan
01.05.2018
01.11.2018
Extrakt aus Cannabis Sativa (2, reassessment)
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
13,400–38,500
100%
Indication of
minor additional benefit
01.05.2018
01.11.2018
Tofacitinib (2, reassessment)
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
0
29,490–63,815
100%
no additional benefit
15.05.2018
01.11.2018
Rurioctocog alfa pegol
Adynovi®
Shire Deutschland GmbH
Hematopoietic diseases
Hemophilia A, ≥ 12 years
2,840–3,190
100%
no additional benefit
15.05.2018
01.11.2018
Hydrocortison
Alkindi®
Diurnal Ltd.
Metabolic diseases
Adrenal insufficiency, < 18 years
780–1,180
100%
no additional benefit
15.05.2018
01.11.2018
Ertugliflozin / Sitagliptin
Steglujan®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
326,100–341,100
100%
no additional benefit
15.04.2018
04.10.2018
Cariprazin
Reagila®
Recordati Pharma GmbH
Mental illnesses
Schizophrenia
224,000–299,000
21%
Indication of
minor additional benefit
15.04.2018
04.10.2018
Burosumab
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
0
200–500
100%
non-quantifiable additional benefit
Orphan
01.04.2018
20.09.2018
Bezlotoxumab
Zinplava®
MSD Sharp & Dohme GmbH
Infectious diseases
Prevention of recurrent Clostridium difficile infection
6,800–37,600
100%
Indication of
minor additional benefit
01.04.2018
20.09.2018
Emicizumab
Hemlibra®
Roche Pharma AG
Hematopoietic diseases
Hemophilia A
100
50%
Hint for
non-quantifiable additional benefit
01.04.2018
20.09.2018
Patiromer
Veltassa®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Hyperkalemia
61,700
100%
no additional benefit
01.04.2018
20.09.2018
Glycopyrroniumbromid
Sialanar®
Proveca Limited
Other diseases
Sialorrhea
2,800–3,100
100%
Hint for
non-quantifiable additional benefit
15.03.2018
06.09.2018
Evolocumab (2, reassessment)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
271,500
100%
no additional benefit
01.03.2018
16.08.2018
Fluticasonfuroat / Umeclidinium / Vilanterol
Trelegy Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
404,000–1,227,000
100%
no additional benefit
01.03.2018
16.08.2018
Glycerolphenylbutyrat
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), ≥ 2 months
100–250
100%
non-quantifiable additional benefit
Orphan
01.03.2018
16.08.2018
Ixekizumab (2)
Taltz®
Lilly Deutschland GmbH
Skin diseases
Psoriatic arthritis (PA)
29,100
35%
Hint for
minor additional benefit
01.03.2018
16.08.2018
Insulin glargin / Lixisenatid
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
461,400–472,500
100%
no additional benefit
15.02.2018
02.08.2018
Sonidegib
Odomzo®
Sun Pharmaceuticals Germany GmbH
Oncological diseases
Basal cell carcinoma (BCC)
130–350
100%
no additional benefit
15.02.2018
02.08.2018
Benralizumab
Fasenra®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma
6,800–80,000
50%
Hint for
minor additional benefit
15.02.2018
02.08.2018
Letermovir
Prevymis®
MSD Sharp & Dohme GmbH
Infectious diseases
Cytomegalovirus infection
0
1,000–1,800
100%
non-quantifiable additional benefit
Orphan
15.02.2018
02.08.2018
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment)
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
0
resolution w/o assessement
15.02.2018
02.08.2018
Ipilimumab (3)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, ≥ 12 to < 18 years
1–5
100%
no additional benefit
01.02.2018
02.08.2018
Ocrelizumab
Ocrevus®
Roche Pharma AG
Nervous system diseases
Multiple sclerosis (MS)
165,300–182,200
81%
Proof of
minor additional benefit
01.02.2018
02.08.2018
Lumacaftor / Ivacaftor (2)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in CFTR gene, ≥ 6 years
500
100%
Hint for
non-quantifiable additional benefit
15.01.2018
05.07.2018
Brentuximab Vedotin (3)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Cutaneous T-cell lymphoma, CD30+
40–130
100%
minor additional benefit
Orphan
15.01.2018
05.07.2018
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2)
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 6 to < 12 years
100
100%
no additional benefit
15.01.2018
05.07.2018
Allogene, genetisch modifizierte T-Zellen
Zalmoxis®
Dompé farmaceutici S.p.A
Oncological diseases
Haematological malignancies, concomitant therapy in haploidentical haematopoietic stem cell transplantation
100–140
100%
non-quantifiable additional benefit
Orphan
01.01.2018
21.06.2018
Alectinib (2)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
350–850
100%
Hint for
non-quantifiable additional benefit
01.01.2018
21.06.2018
Dapagliflozin / Metformin (2, reassessment)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
468,700
100%
no additional benefit
01.01.2018
21.06.2018
Dapagliflozin (2, reassessment)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
468,700
100%
no additional benefit
15.12.2017
07.06.2018
Abirateronacetat (3)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), high-risk, combination with androgen deprivation therapy
1,500–2,200
100%
Indication of
considerable additional benefit
15.12.2017
07.06.2018
Niraparib
Zejula®
TESARO Bio Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
0
1,900–2,400
100%
non-quantifiable additional benefit
Orphan
01.12.2017
17.05.2018
Cladribin
Mavenclad®
Merck Serono GmbH
Nervous system diseases
Highly active relapsing multiple sclerosis (MS)
40,300–41,000
100%
no additional benefit
01.12.2017
17.05.2018
Dupilumab
Dupixent®
Sanofi-Aventis Deutschland GmbH
Skin diseases
Atopic dermatitis (AD)
52,000
100%
Indication of
considerable additional benefit
01.12.2017
17.05.2018
Guselkumab
Tremfya®
Janssen-Cilag GmbH
Skin diseases
Plaque psoriasis (PP)
52,200–234,400
45%
Proof of
considerable additional benefit
01.12.2017
17.05.2018
Perampanel (3)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years
15,600–50,700
100%
no additional benefit
15.11.2017
03.05.2018
Cenegermin
Oxervate®
Dompé farmaceutici S.p.A
Eye diseases
Keratitis
1,730–3,170
100%
non-quantifiable additional benefit
Orphan
15.11.2017
03.05.2018
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2)
Stribild®
Gilead Sciences GmbH
Infectious diseases
HIV infection, 12 to < 18 years
100
100%
no additional benefit
01.11.2017
19.04.2018
Tivozanib
Fotivda®
EUSA Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
2,953–7,126
100%
no additional benefit
01.11.2017
19.04.2018
Nonacog beta pegol
Refixia®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia B, ≥ 12 years
500–570
100%
no additional benefit
15.10.2017
05.04.2018
Cabozantinib (3, reassessment, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after VEGF pre-therapy
1,200–3,300
100%
Indication of
minor additional benefit
15.10.2017
05.04.2018
Telotristatethyl
Xermelo®
Ipsen Pharma GmbH
Oncological diseases
Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy
300–1,000
100%
non-quantifiable additional benefit
Orphan
15.10.2017
05.04.2018
Midostaurin
Rydapt®
Novartis Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM)
0
400–710
80%
considerable additional benefit
Orphan
15.10.2017
05.04.2018
Obinutuzumab (3)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
0
1,300–1,500
100%
non-quantifiable additional benefit
Orphan
15.10.2017
05.04.2018
Sofosbuvir (2)
Sovaldi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
1,025
100%
Hint for
non-quantifiable additional benefit
15.09.2017
16.03.2018
Ribociclib
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal women, combination with aromatase inhibitor
0
7,180–34,790
100%
no additional benefit
15.09.2017
16.03.2018
Pembrolizumab (5)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC)
0
2,300–3,300
61%
Indication of
considerable additional benefit
15.09.2017
16.03.2018
Elosulfase alfa (2, reassessment)
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
20–100
100%
minor additional benefit
Orphan
01.10.2017
16.03.2018
Atezolizumab
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
18,800–34,600
40%
Indication of
considerable additional benefit
01.10.2017
16.03.2018
Atezolizumab (2)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), first-line
1,500–1,900
2,300–3,300
61%
Hint for
minor additional benefit
01.10.2017
16.03.2018
Avelumab
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Merkel-cell carcinoma (MCC)
0
160–410
100%
non-quantifiable additional benefit
Orphan
01.10.2017
16.03.2018
Dimethylfumarat (2, Skilarence®)
Skilarence®
Almirall Hermal GmbH
Skin diseases
Plaque psoriasis (PP)
52,200–234,100
100%
no additional benefit
01.10.2017
16.03.2018
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid
Symtuza®
Janssen-Cilag GmbH
Infectious diseases
HIV infection
62,050
100%
no additional benefit
01.09.2017
01.03.2018
Brodalumab
Kyntheum®
LEO Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
52,200–234,400
45%
Indication of
non-quantifiable additional benefit
15.08.2017
15.02.2018
Carfilzomib (3, reassessment >€50m)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.08.2017
15.02.2018
Sarilumab
Kevzara®
Sanofi-Aventis Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
87,300–184,470
34%
Hint for
considerable additional benefit
15.08.2017
15.02.2018
Sofosbuvir / Velpatasvir / Voxilaprevir
Vosevi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
104,600
100%
no additional benefit
15.08.2017
15.02.2018
Daratumumab (2, reassessment >€50m)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), monotherapy; multiple myeloma, at least 1 prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
2,300
7,000–9,300
72%
Indication of
considerable additional benefit
Orphan (turnover limit)
15.08.2017
15.02.2018
Ledipasvir / Sofosbuvir (2)
Harvoni®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C, 12 to < 18 years
5,300
50%
Hint for
non-quantifiable additional benefit
01.08.2017
01.02.2018
Saxagliptin / Metformin (4)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy other than insulin and sulphonylurea
77,400
100%
no additional benefit
01.08.2017
01.02.2018
Glecaprevir / Pibrentasvir
Maviret®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
104,600
100%
no additional benefit
01.08.2017
01.02.2018
Ceritinib (3)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
430–850
100%
no additional benefit
15.07.2017
18.01.2018
Inotuzumab Ozogamicin
Besponsa®
Pfizer Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
120–200
100%
minor additional benefit
Orphan
01.07.2017
21.12.2017
Nivolumab (9)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC)
1,500–1,900
100%
no additional benefit
01.07.2017
21.12.2017
Nusinersen
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
0
840–1,060
10%
major additional benefit
Orphan
01.07.2017
21.12.2017
Cerliponase alfa
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis type 2
0
20–40
100%
non-quantifiable additional benefit
Orphan
15.06.2017
07.12.2017
Blinatumomab (2, reassessment)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
60–170
100%
considerable additional benefit
Orphan
15.06.2017
07.12.2017
Nivolumab (8, reassessment)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
0
500–1,500
100%
no additional benefit
01.06.2017
17.11.2017
Etelcalcetid
Parsabiv®
Amgen GmbH
Metabolic diseases
Secondary hyperparathyroidism (HPT)
21,896–26,360
100%
no additional benefit
01.06.2017
17.11.2017
Nivolumab (7)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma head and neck
970–6,850
77%
Hint for
considerable additional benefit
01.06.2017
17.11.2017
Rolapitant
Varuby®
TESARO Bio Germany GmbH
Other diseases
Nausea and vomiting due to chemotherapy
157,700–279,700
100%
no additional benefit
01.06.2017
17.11.2017
Pembrolizumab (4)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL)
60–180
100%
no additional benefit
01.05.2017
19.10.2017
Dabrafenib (3)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation, combination with trametinib
230–820
100%
no additional benefit
01.05.2017
19.10.2017
Trametinib (2)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation
230–720
100%
no additional benefit
01.05.2017
19.10.2017
Tofacitinib
Xeljanz®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
0
87,300–184,470
100%
no additional benefit
01.05.2017
19.10.2017
Alectinib
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
200–1,310
81%
Hint for
minor additional benefit
01.05.2017
19.10.2017
Osimertinib (2, reassessment)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
560–2,730
100%
Hint for
considerable additional benefit
01.04.2017
21.09.2017
Axitinib (2, reassessment)
Inlyta®
Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy
483–2,406
0.3%
Hint for
minor additional benefit
01.04.2017
21.09.2017
Tenofoviralafenamid
Vemlidy®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis B, ≥ 12 years
0
12,400–38,100
100%
no additional benefit
01.04.2017
21.09.2017
Dolutegravir (2)
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, 6 to < 12 years
110
100%
no additional benefit
01.04.2017
21.09.2017
Baricitinib
Olumiant®
Lilly Deutschland GmbH
Musculoskeletal system diseases
Rheumatoid arthritis (RA)
87,300–184,470
100%
no additional benefit
01.03.2017
17.08.2017
Secukinumab (3, reassessment)
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
19,800–137,300
100%
Indication of
considerable additional benefit
01.03.2017
17.08.2017
Ixekizumab
Taltz®
Lilly Deutschland GmbH
Skin diseases
Plaque psoriasis (PP)
52,200–234,400
55%
Indication of
considerable additional benefit
15.02.2017
03.08.2017
Pembrolizumab (3)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
4,000
100%
Indication of
considerable additional benefit
01.02.2017
20.07.2017
Lonoctocog alfa
Afstyla®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia A
3,190–3,590
100%
no additional benefit
15.01.2017
06.07.2017
Obeticholsäure
Ocaliva®
Intercept Pharma Deutschland GmbH
Digestive system diseases
Biliary cirrhosis
0
1,050–7,350
100%
non-quantifiable additional benefit
Orphan
15.01.2017
06.07.2017
Reslizumab
Cinqaero®
Teva GmbH
Respiratory system diseases
Bronchial asthma
4,800–12,000
50%
Hint for
minor additional benefit
15.01.2017
06.07.2017
Vandetanib (3)
Caprelsa®
Genzyme GmbH
Oncological diseases
Thyroid carcinoma, ≥ 5 years
2–8
100%
Hint for
non-quantifiable additional benefit
15.01.2017
06.07.2017
Ixazomib
Ninlaro®
Takeda Pharma GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
0
4,700–7,000
100%
non-quantifiable additional benefit
Orphan
15.12.2016
15.06.2017
Elbasvir / Grazoprevir
Zepatier®
MSD Sharp & Dohme GmbH
Infectious diseases
Chronic hepatitis C
64,800
100%
no additional benefit
01.01.2017
15.06.2017
Nivolumab (6)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Hodgkin lymphoma (HL)
40–90
100%
no additional benefit
01.01.2017
15.06.2017
Venetoclax
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
0
300–700
100%
non-quantifiable additional benefit
Orphan
01.12.2016
18.05.2017
Palbociclib
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC)
1,190–5,760
14,560–70,550
100%
no additional benefit
01.12.2016
18.05.2017
Olaratumab
Lartruvo®
Lilly Deutschland GmbH
Oncological diseases
Soft tissue sarcoma
0
1,200–1,400
100%
considerable additional benefit
Orphan
01.11.2016
20.04.2017
Cabozantinib (2, Cabometyx®)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
0
1,200–3,300
100%
Hint for
non-quantifiable additional benefit
15.10.2016
06.04.2017
Macitentan (2, reassessment >€50m)
Opsumit®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
580–7,850
100%
no additional benefit
Orphan (turnover limit)
01.10.2016
16.03.2017
Opicapon
Ongentys®
Bial-Portela & Ca, S.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
no additional benefit
01.10.2016
16.03.2017
Ceritinib (2, reassessment)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
200–1,310
81%
Hint for
considerable additional benefit
01.10.2016
16.03.2017
Crizotinib (4)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+
210–770
100%
no additional benefit
01.10.2016
16.03.2017
Lenvatinib (2, Kisplyx®)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
0
1,200–3,300
100%
Hint for
minor additional benefit
01.10.2016
16.03.2017
Idelalisib (3)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with ofatumumab; Chronic lymphocytic leukaemia (CLL), first-line, 17p deletion/TP53 mutation, combination with rituximab
2,020–7,560
0.4%
Hint for
non-quantifiable additional benefit
01.10.2016
16.03.2017
Ibrutinib (4)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 prior therapy, combination with bendamustine and rituximab
1,500–5,600
50%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.08.2016
02.02.2017
Pembrolizumab (2)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
12,500–24,300
40%
Indication of
considerable additional benefit
15.08.2016
02.02.2017
Trifluridin / Tipiracil
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
0
6,900–12,200
100%
Hint for
minor additional benefit
01.08.2016
19.01.2017
Teduglutid (2)
Revestive®
Shire Deutschland GmbH
Digestive system diseases
Short bowel syndrome, 1 to < 18 years
230–500
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Tasimelteon
Hetlioz®
Vanda Pharmceutical Inc
Nervous system diseases
Sleep disorders (sleep-wake rhythm), blind adults
7,000
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Pitolisant
Wakix®
Bioprojet Pharma SARL
Nervous system diseases
Narcolepsy
15,000–30,000
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Brentuximab Vedotin (2)
Adcetris®
Takeda Pharma GmbH
Oncological diseases
Hodgkin lymphoma (HL), CD30+, increased risk of recurrence or progression after transplantation
40–60
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Carfilzomib (2)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), combination with dexamethasone
0
4,700–7,000
100%
minor additional benefit
Orphan
15.07.2016
05.01.2017
Emtricitabin / Rilpivirin / Tenofoviralafenamid
Odefsey®
Gilead Sciences GmbH
Infectious diseases
HIV infection
56,800–59,300
100%
no additional benefit
15.07.2016
05.01.2017
Sofosbuvir / Velpatasvir
Epclusa®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
100,000
28%
Hint for
considerable additional benefit
01.07.2016
15.12.2016
Ibrutinib (3)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL), first-line
2,840
100%
no additional benefit
Orphan (turnover limit)
01.07.2016
15.12.2016
Sitagliptin / Metformin (2, reassessment)
Janumet®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with sulphonylurea or insulin
792,050–810,850
100%
no additional benefit
01.07.2016
15.12.2016
Sitagliptin (2, reassessment)
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with metformin, sulphonylurea or PPARɣ
1,070,800–1,270,800
1,705,400–1,905,400
35%
Hint for
minor additional benefit
01.07.2016
15.12.2016
Saxagliptin / Metformin (3, reassessment)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with insulin
729,650–748,450
100%
no additional benefit
01.07.2016
15.12.2016
Saxagliptin (2, reassessment)
Onglyza®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
1,182,900–1,382,900
100%
no additional benefit
01.07.2016
15.12.2016
Crizotinib (3, reassessment)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
480
71%
Hint for
considerable additional benefit
01.07.2016
15.12.2016
Obinutuzumab (2)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
0
790–940
100%
non-quantifiable additional benefit
Orphan
15.06.2016
15.12.2016
Nivolumab (5)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with ipilimumab
2,230–3,690
2,500–4,500
100%
no additional benefit
15.06.2016
15.12.2016
Selexipag
Uptravi®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
580–7,850
100%
no additional benefit
15.06.2016
15.12.2016
Eftrenonacog alfa
Alprolix®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia B
0
580–660
100%
non-quantifiable additional benefit
Orphan
15.06.2016
15.12.2016
Talimogen laherparepvec
Imlygic®
Amgen GmbH
Oncological diseases
Melanoma, stage IIIB, IIIC, IVMI1a
375–620
100%
no additional benefit
01.06.2016
01.12.2016
Eribulin (3)
Halaven®
Eisai GmbH
Oncological diseases
Liposarcoma
30–150
50%
Hint for
considerable additional benefit
01.06.2016
01.12.2016
Albutrepenonacog alfa
Idelvion®
CSL Behring GmbH
Hematopoietic diseases
Hemophilia B
0
580–660
100%
non-quantifiable additional benefit
Orphan
01.06.2016
01.12.2016
Migalastat
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease
0
20–490
100%
non-quantifiable additional benefit
Orphan
01.06.2016
01.12.2016
Elotuzumab
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
minor additional benefit
01.06.2016
01.12.2016
Ataluren (2, reassessment)
Translarna®
PTC Therapeutics International Limited
Musculoskeletal system diseases
Duchenne muscular dystrophy (DMD), ≥ 5 years
30–40
100%
minor additional benefit
Orphan
01.06.2016
01.12.2016
Daratumumab
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), monotherapy, pre-treated patients
0
2,300
100%
non-quantifiable additional benefit
Orphan
15.05.2016
03.11.2016
Emtricitabin / Tenofoviralafenamid
Descovy®
Gilead Sciences GmbH
Infectious diseases
HIV infection
63,000
100%
no additional benefit
01.05.2016
20.10.2016
Ospemifen
Senshio®
Shionogi GmbH
Genitourinary system diseases
Vulvovaginal atrophy
133,400–151,800
100%
no additional benefit
01.05.2016
20.10.2016
Ramucirumab (4, reassessment)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel
5,900–7,900
50%
Hint for
minor additional benefit
01.05.2016
20.10.2016
Afatinib (3)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology
6,720–12,420
100%
no additional benefit
01.05.2016
20.10.2016
Nivolumab (4)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC)
1,200–3,300
92%
Indication of
considerable additional benefit
01.05.2016
20.10.2016
Nivolumab (3)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, after previous chemotherapy
11,830–21,830
40%
Indication of
considerable additional benefit
15.03.2016
15.09.2016
Osimertinib
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
245–1,465
475–2,830
100%
no additional benefit
01.04.2016
15.09.2016
Necitumumab
Portrazza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
6,300–7,700
100%
no additional benefit
01.04.2016
15.09.2016
Ticagrelor (2)
Brilique®
AstraZeneca GmbH
Cardiovascular diseases
Prevention of atherothrombotic events in patients with myocardial infarction and high risk for an atherothrombotic event
105,000
100%
Hint for
minor additional benefit
01.04.2016
15.09.2016
Idelalisib (2, reassessment)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL)
0
2,200–7,800
24%
Hint for
non-quantifiable additional benefit
01.03.2016
01.09.2016
Empagliflozin / Metformin
Synjardy®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
615,299–615,301
100%
no additional benefit
01.03.2016
01.09.2016
Empagliflozin (2, reassessment)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
1,253,400–1,453,400
42%
Hint for
considerable additional benefit
01.03.2016
01.09.2016
Ramucirumab (3)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
2,900–7,300
100%
no additional benefit
01.03.2016
01.09.2016
Ramucirumab (2)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
5,900–15,400
100%
no additional benefit
15.02.2016
04.08.2016
Afamelanotid
Scenesse®
Clinuvel Ltd.
Metabolic diseases
Erythropoietic protoporphyria
0
540–1,090
100%
non-quantifiable additional benefit
Orphan
15.02.2016
04.08.2016
Brivaracetam
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 16 years
86,000–200,000
100%
no additional benefit
15.02.2016
04.08.2016
Vismodegib (2, reassessment)
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
295
95%
Hint for
minor additional benefit
01.02.2016
21.07.2016
Umeclidinium
Incruse®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,342,000–2,765,000
100%
no additional benefit
01.02.2016
21.07.2016
Ibrutinib (2, reassessment >€50m)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), Waldenström's disease
3,780–11,100
12%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.02.2016
21.07.2016
Mepolizumab
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
16,000–100,000
50%
Hint for
minor additional benefit
01.01.2016
16.06.2016
Rilpivirin (2)
Edurant®
Janssen-Cilag GmbH
Infectious diseases
HIV infection, 12 to < 18 years
10
100%
no additional benefit
01.01.2016
16.06.2016
Sacubitril / Valsartan
Entresto®
Novartis Pharma GmbH
Cardiovascular diseases
Symptomatic chronic heart failure
550,000–1,350,000
68%
Hint for
considerable additional benefit
01.01.2016
16.06.2016
Efmoroctocog alfa
Elocta®
Swedish Orphan Biovitrum GmbH
Hematopoietic diseases
Hemophilia A
3,190–3,590
100%
no additional benefit
01.01.2016
16.06.2016
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid
Genvoya®
Gilead Sciences GmbH
Infectious diseases
HIV infection
56,800
100%
no additional benefit
01.01.2016
16.06.2016
Crizotinib (2)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
300–900
100%
Hint for
considerable additional benefit
15.12.2015
02.06.2016
Secukinumab (2)
Cosentyx®
Novartis Pharma GmbH
Musculoskeletal system diseases
Psoriatic arthritis (PA), Radiographic axial spondyloarthritis (AS)Psoriatic arthritis (PA), Bekhterev's disease
22,000–98,200
40,400–141,600
100%
no additional benefit
15.12.2015
02.06.2016
Blinatumomab
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
60–170
100%
non-quantifiable additional benefit
Orphan
15.12.2015
02.06.2016
Carfilzomib
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone
0
4,700–7,000
100%
non-quantifiable additional benefit
Orphan
15.12.2015
02.06.2016
Cobimetinib
Cotellic®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation, combination with vemurafenib
1,400
100%
Indication of
considerable additional benefit
15.12.2015
02.06.2016
Ivacaftor (3)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), R117H mutation, 2 to 5 years, > 18 years
0
59
75%
minor additional benefit
Orphan
15.12.2015
02.06.2016
Lumacaftor / Ivacaftor
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), > 12 years, homozygous F508del mutation
2,600
100%
Indication of
considerable additional benefit
01.12.2015
19.05.2016
Aflibercept (6)
Eylea®
Bayer Vital GmbH
Eye diseases
Myopic choroidal neovascularisation
27,500–80,000
100%
no additional benefit
01.12.2015
19.05.2016
Fingolimod (4)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Highly active relapsing-remitting multiple sclerosis (MS), after inadequate pre-treatment
14,000–16,000
100%
no additional benefit
15.11.2015
04.05.2016
Alirocumab
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
1,500
273,250
100%
no additional benefit
15.11.2015
04.05.2016
Isavuconazol
Cresemba®
Basilea Pharmaceutica International Ltd.
Infectious diseases
Aspergillosis, mucormycosis
1,293–5,342
100%
non-quantifiable additional benefit
Orphan
15.10.2015
07.04.2016
Aclidiniumbromid (2, reassessment)
Eklira® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,342,800–2,768,200
6%
Indication of
considerable additional benefit
01.10.2015
17.03.2016
Trametinib
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
50%
Indication of
considerable additional benefit
01.10.2015
17.03.2016
Sebelipase alfa
Kanuma®
Synageva BioPharma Limited
Metabolic diseases
Lysosomal acid lipase deficiency
0
31–843
100%
non-quantifiable additional benefit
Orphan
01.10.2015
17.03.2016
Regorafenib (3, reassessment)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
6,900–12,200
100%
no additional benefit
01.10.2015
17.03.2016
Pomalidomid (2, reassessment >€50m)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
2,300
50%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.10.2015
17.03.2016
Panobinostat
Farydak®
Novartis Pharma GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with pomalidomide and dexamethasone
2,300
100%
non-quantifiable additional benefit
Orphan
01.10.2015
17.03.2016
Idebenon
Raxone®
Santhera Pharmaceuticals
Eye diseases
Leber hereditary optic neuropathy
0
1,500–3,000
100%
non-quantifiable additional benefit
Orphan
01.10.2015
17.03.2016
Dabrafenib (2)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib
1,400
100%
Indication of
considerable additional benefit
01.10.2015
17.03.2016
Asfotase alfa
Strensiq®
Alexion Europe SAS
Metabolic diseases
Hypophosphatasia (HPP)
0
1,000
100%
non-quantifiable additional benefit
Orphan
15.09.2015
09.03.2016
Evolocumab
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
1,810–1,819
273,310–273,319
100%
no additional benefit
01.09.2015
18.02.2016
Pertuzumab (2)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), inflammatory or early with high risk of recurrence, neoadjuvant, combination with trastuzumab and chemotherapy
2,900–4,850
100%
no additional benefit
15.08.2015
04.02.2016
Insulin degludec / Liraglutid (2)
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with oral antidiabetics
78,500–170,000
100%
no additional benefit
15.08.2015
04.02.2016
Tiotropium / Olodaterol
Spiolto® Respimat®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,342,000–2,780,000
92%
Indication of
minor additional benefit
15.08.2015
04.02.2016
Pembrolizumab
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma
2,500–4,500
71%
Indication of
considerable additional benefit
15.08.2015
04.02.2016
Netupitant / Palonosetron
Akynzeo®
RIEMSER Pharma GmbH
Other diseases
Nausea and vomiting due to chemotherapy
157,700–279,700
100%
no additional benefit
15.08.2015
04.02.2016
Nivolumab (2)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy
4,200–6,000
87%
Indication of
considerable additional benefit
15.08.2015
04.02.2016
Gaxilose
LacTest™
VENTER PHARMA S.L.
Metabolic diseases
Diagnosis of hypolactasia
180,000–230,000
100%
no additional benefit
01.08.2015
21.01.2016
Edoxaban
Lixiana®
Daiichi Sankyo Deutschland GmbH
Cardiovascular diseases
Prophylaxis of thromboembolic events
1,167,000–1,334,000
81%
Indication of
minor additional benefit
15.07.2015
07.01.2016
Nivolumab
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma
2,500–4,500
15%
Indication of
considerable additional benefit
15.07.2015
07.01.2016
Belatacept (2, reassessment)
Nulojix®
Bristol-Myers Squibb GmbH & Co. KGaA
Genitourinary system diseases
Prophylaxis of graft rejection (GvHD) after kidney transplantation
2,950–3,380
100%
Indication of
considerable additional benefit
01.07.2015
17.12.2015
Lenvatinib
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
0
600–815
100%
non-quantifiable additional benefit
Orphan
01.07.2015
17.12.2015
Ceritinib
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
0
120–560
100%
no additional benefit
15.06.2015
27.11.2015
Lomitapid (2, reassessment)
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
60–69
100%
no additional benefit
01.06.2015
27.11.2015
Secukinumab
Cosentyx®
Novartis Pharma GmbH
Skin diseases
Plaque psoriasis (PP)
32,400–97,100
52,200–234,400
8%
Indication of
considerable additional benefit
01.06.2015
27.11.2015
Olaparib
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy
0
200–600
100%
non-quantifiable additional benefit
Orphan
01.06.2015
27.11.2015
Ivermectin
Soolantra®
Galderma Laboratorium GmbH
Skin diseases
Inflammatory lesions of rosacea
0
309,000–703,000
100%
no additional benefit
15.05.2015
05.11.2015
Afatinib (2, reassessment)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients
3,670–8,590
42%
Indication of
major additional benefit
15.05.2015
05.11.2015
Safinamid
Xadago®
Zambon S.p.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
no additional benefit
01.05.2015
15.10.2015
Vortioxetin
Brintellix®
Lundbeck GmbH
Mental illnesses
Major depression
3,369,000–3,669,000
100%
no additional benefit
01.05.2015
15.10.2015
Insulin degludec / Liraglutid
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
752,000–903,000
100%
no additional benefit
15.04.2015
15.10.2015
Ruxolitinib (3)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Polycythaemia vera
240–1,470
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.04.2015
01.10.2015
Fingolimod (3, reassessment)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
4,600–12,300
17,100–24,800
21%
Indication of
considerable additional benefit
01.04.2015
01.10.2015
Eliglustat
Cerdelga®
Genzyme GmbH
Metabolic diseases
Sphingolipidoses (Gaucher disease type 1)
150–500
100%
non-quantifiable additional benefit
Orphan
15.03.2015
03.09.2015
Aflibercept (5)
Eylea®
Bayer Vital GmbH
Eye diseases
Macular edema following retinal branch vein occlusion
23,100–60,000
100%
no additional benefit
15.03.2015
03.09.2015
Nintedanib (2, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Idiopathic pulmonary fibrosis
0
2,080–19,700
100%
minor additional benefit
Orphan
01.03.2015
20.08.2015
Insulin degludec (3)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2, ≥ 1 to < 18 years
20,200
100%
no additional benefit
15.02.2015
05.08.2015
Apremilast
Otezla®
Celgene GmbH
Skin diseases
Plaque psoriasis (PP); Psoriatic arthritis (PA)
50,800–140,500
100%
no additional benefit
01.02.2015
16.07.2015
Ombitasvir / Paritaprevir / Ritonavir
Viekirax®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
54,800
9%
Indication of
considerable additional benefit
01.02.2015
16.07.2015
Ramucirumab
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel
0
5,900–7,900
100%
minor additional benefit
Orphan
01.02.2015
16.07.2015
Dasabuvir
Exviera®
AbbVie Deutschland GmbH & Co. KG
Infectious diseases
Chronic hepatitis C
61,700
24%
Indication of
considerable additional benefit
01.02.2015
16.07.2015
Dulaglutid
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,705,500–1,905,500
31%
Hint for
minor additional benefit
01.02.2015
16.07.2015
Aclidiniumbromid / Formoterol
Duaklir® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,339,200–2,762,500
6%
Indication of
considerable additional benefit
01.01.2015
18.06.2015
Pasireotid (2)
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Acromegaly
265–1,133
100%
minor additional benefit
Orphan
01.01.2015
18.06.2015
Nintedanib
Vargatef®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
3,700–15,100
100%
Indication of
minor additional benefit
01.01.2015
18.06.2015
Enzalutamid (2)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
15,000–28,800
100%
Indication of
considerable additional benefit
01.01.2015
18.06.2015
Tafluprost / Timolol
Taptiqom®
Santen GmbH
Eye diseases
Reduction of intraocular pressure in patients with glaucoma/hypertension
95,600
100%
no additional benefit
01.12.2014
21.05.2015
Ataluren
Translarna®
PTC Therapeutics International Limited
Musculoskeletal system diseases
Duchenne muscular dystrophy (DMD), ≥ 5 years
0
82–110
100%
minor additional benefit
Orphan
01.12.2014
21.05.2015
Vildagliptin (2, reassessment)
Galvus®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
35,900
100%
no additional benefit
01.12.2014
21.05.2015
Ledipasvir / Sofosbuvir
Harvoni®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
74,100
79%
Hint for
considerable additional benefit
01.11.2014
21.05.2015
Alipogentiparvovec
Glybera®
Chiesi GmbH
Metabolic diseases
Familial lipoprotein lipase deficiency
17–35
100%
non-quantifiable additional benefit
Orphan
15.11.2014
07.05.2015
Simoctocog alfa
Nuwiq®
Octapharma GmbH
Hematopoietic diseases
Hemophilia A
3,190–3,585
100%
no additional benefit
01.11.2014
16.04.2015
Lurasidon
Latuda®
Takeda Pharma GmbH
Mental illnesses
Schizophrenia
250,000
100%
no additional benefit
01.11.2014
16.04.2015
Ibrutinib
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL)
0
2,900–8,750
100%
non-quantifiable additional benefit
Orphan
01.10.2014
19.03.2015
Albiglutid
Eperzan®
GlaxoSmithKline GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
1,705,400–1,905,400
35%
Indication of
minor additional benefit
01.10.2014
19.03.2015
Dolutegravir / Abacavir / Lamivudin
Triumeq®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
54,398
9%
Indication of
considerable additional benefit
01.10.2014
19.03.2015
Sucroferric Oxyhydroxide
Velphoro®
Fresenius Medical Care Deutschland GmbH
Genitourinary system diseases
Serum phosphate level control in chronic kidney disease
56,600–71,500
100%
no additional benefit
01.10.2014
19.03.2015
Sipuleucel-T
Provenge®
Dendreon UK Limited
Oncological diseases
Prostate carcinoma (PC)
11,690–24,480
100%
Hint for
non-quantifiable additional benefit
01.10.2014
19.03.2015
Idelalisib
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), Follicular lymphoma (FL)
800–3,300
3,000–11,100
20%
Hint for
non-quantifiable additional benefit
15.09.2014
05.03.2015
Aflibercept (4)
Eylea®
Bayer Vital GmbH
Eye diseases
Diabetic macular edema
128,350–132,360
100%
no additional benefit
01.09.2014
19.02.2015
Teduglutid
Revestive®
NPS Pharma Germany GmbH
Digestive system diseases
Short bowel syndrome
1,100–2,400
100%
minor additional benefit
Orphan
01.09.2014
19.02.2015
Daclatasvir
Daklinza®
Bristol-Myers Squibb GmbH & Co. KGaA
Infectious diseases
Chronic hepatitis C
70,500
1.4%
Hint for
considerable additional benefit
01.09.2014
19.02.2015
Regorafenib (2)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Gastrointestinal stromal tumor (GIST)
100–700
100%
no additional benefit
01.09.2014
19.02.2015
Propranolol
Hemangiol®
Pierre Fabre Dermatologie
Other diseases
Infantile hemangioma
1,668–6,999
33%
Indication of
major additional benefit
01.09.2014
19.02.2015
Nalmefen
Selincro®
Lundbeck GmbH
Mental illnesses
Reduction of alcohol consumption in alcohol dependence
220,000–248,000
100%
no additional benefit
01.09.2014
19.02.2015
Ivacaftor (2)
Kalydeco®
Vertex Pharmaceuticals Limited
Metabolic diseases
Cystic fibrosis (CF), various mutations, ≥ 6 years
0
10–11
100%
minor additional benefit
Orphan
01.09.2014
19.02.2015
Apixaban (3)
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Treatment and prophylaxis of venous thrombosis and pulmonary embolism
241,000
47%
Indication of
minor additional benefit
15.08.2014
05.02.2015
Obinutuzumab
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
0
818–1,477
100%
non-quantifiable additional benefit
Orphan
15.08.2014
05.02.2015
Empagliflozin
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
0
1,253,400–1,453,400
100%
no additional benefit
15.08.2014
05.02.2015
Canagliflozin / Metformin
Vokanamet®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
615,300
100%
no additional benefit
01.08.2014
22.01.2015
Cabozantinib
Cometriq®
Swedish Orphan Biovitrum GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
60–500
100%
minor additional benefit
Orphan
01.08.2014
22.01.2015
Eribulin (2, reassessment)
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC), after at least 2 chemotherapies; mammary carcinoma, after at least 1 chemotherapy
5,101–7,601
75%
Hint for
considerable additional benefit
15.07.2014
08.01.2015
Umeclidinium / Vilanterol
Anoro®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,359,600–2,941,700
100%
no additional benefit
15.07.2014
08.01.2015
Vedolizumab
Entyvio®
Takeda Pharma Vertrieb GmbH & Co. KG
Digestive system diseases
Ulcerative colitis, Crohn's disease
16,100
100%
no additional benefit
01.07.2014
18.12.2014
Fingolimod (2)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), pre-treated
0
8,240–8,390
100%
no additional benefit
15.06.2014
04.12.2014
Siltuximab
Sylvant®
Janssen-Cilag GmbH
Oncological diseases
Multicentric Castleman Disease (MCD)
130–1,460
100%
non-quantifiable additional benefit
Orphan
15.06.2014
04.12.2014
Insulin degludec (2)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with GLP-1 agonists
0
170,100
100%
no additional benefit
01.06.2014
20.11.2014
Simeprevir
Olysio®
Janssen-Cilag GmbH
Infectious diseases
Chronic hepatitis C
64,800
91%
Indication of
considerable additional benefit
01.06.2014
20.11.2014
Elosulfase alfa
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
0
15–95
100%
minor additional benefit
Orphan
01.06.2014
20.11.2014
Mirabegron
Betmiga®
Astellas Pharma GmbH
Genitourinary system diseases
Imperative desire to urinate
7,422,000
100%
no additional benefit
01.06.2014
20.11.2014
Lebende Larven von Lucilia sericata
BioBag®
BioMonde GmbH
Other diseases
Chronic or hard to heal wounds
500,000–1,000,000
100%
no additional benefit
15.05.2014
06.11.2014
Perampanel (2, reassessment)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
70,600–106,800
100%
no additional benefit
15.05.2014
06.11.2014
Cholsäure
Orphacol®
Laboratoires CTRS
Metabolic diseases
Bile acid synthesis disorder
10–25
100%
non-quantifiable additional benefit
Orphan
15.05.2014
06.11.2014
Ruxolitinib (2, reassessment >€50m)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
1,600–5,000
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.05.2014
16.10.2014
Dimethylfumarat
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
no additional benefit
01.05.2014
16.10.2014
Insulin degludec
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2
161,750
1,095,950
100%
no additional benefit
01.05.2014
16.10.2014
Riociguat
Adempas®
Bayer Vital GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH)
0
1,500–13,310
100%
minor additional benefit
Orphan
01.04.2014
18.09.2014
Cobicistat
Tybost®
Gilead Sciences GmbH
Infectious diseases
HIV infection
57,400
100%
no additional benefit
15.03.2014
04.09.2014
Canagliflozin
Invokana®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
1,253,400–1,453,400
100%
no additional benefit
15.02.2014
07.08.2014
Dapagliflozin / Metformin
Xigduo®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
615,300
100%
no additional benefit
15.02.2014
07.08.2014
Dolutegravir
Tivicay®
ViiV Healthcare GmbH
Infectious diseases
HIV infection, ≥ 12 years
57,399
11%
Proof of
considerable additional benefit
15.05.2014
17.07.2014
Olodaterol
Striverdi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
0
100%
no additional benefit
01.02.2014
17.07.2014
Sofosbuvir
Sovaldi®
Gilead Sciences GmbH
Infectious diseases
Chronic hepatitis C
99,841
4%
Indication of
considerable additional benefit
01.02.2014
17.07.2014
Macitentan
Opsumit®
Actelion Pharmaceuticals Deutschland GmbH
Cardiovascular diseases
Pulmonary arterial hypertension (PAH)
0
580–7,850
100%
minor additional benefit
Orphan
15.01.2014
03.07.2014
Retigabin (3, reassessment)
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
26,800–53,600
100%
no additional benefit
15.01.2014
03.07.2014
Turoctocog alfa
NovoEight®
Novo Nordisk Pharma GmbH
Hematopoietic diseases
Hemophilia A
3,190–3,585
100%
no additional benefit
01.01.2014
19.06.2014
Trastuzumab Emtansin
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, pre-treated patients
4,121
72%
Indication of
considerable additional benefit
01.01.2014
19.06.2014
Radium-223-dichlorid
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
0
22,700
78%
Indication of
considerable additional benefit
01.01.2014
19.06.2014
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2)
Eviplera®
Gilead Sciences GmbH
Infectious diseases
HIV infection
46,000
100%
no additional benefit
15.12.2013
05.06.2014
Lomitapid
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
0
61–71
100%
no additional benefit
15.12.2013
05.06.2014
Ipilimumab (2)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, first-line
500–1,500
100%
no additional benefit
15.11.2013
08.05.2014
Afatinib
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients
0
640–4,980
45%
Indication of
considerable additional benefit
15.11.2013
08.05.2014
Indacaterol / Glycopyrronium
Ultibro Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,359,628–2,949,660
5%
Indication of
minor additional benefit
01.10.2013
03.04.2014
Dabrafenib
Tafinlar®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
100%
no additional benefit
01.10.2013
20.03.2014
Teriflunomid
Aubagio®
sanofi-aventis groupe / Genzyme GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
no additional benefit
01.10.2013
20.03.2014
Regorafenib
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
0
6,600–14,000
100%
Hint for
minor additional benefit
01.10.2013
20.03.2014
Aflibercept (3)
Eylea®
Bayer Vital GmbH
Eye diseases
Macular edema following retinal vein occlusion
19,600–21,200
100%
no additional benefit
01.01.2014
20.03.2014
Fluticasonfuroat / Vilanterol-Trifenatat
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, COPD
0
100%
no additional benefit
15.09.2013
06.03.2014
Vemurafenib (2, reassessment)
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
100%
Indication of
considerable additional benefit
01.09.2013
20.02.2014
Pomalidomid
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
0
1,900
100%
considerable additional benefit
Orphan
01.09.2013
20.02.2014
Enzalutamid
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy
6,300
100%
Indication of
considerable additional benefit
15.08.2013
06.02.2014
Vismodegib
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
0
295
95%
Hint for
minor additional benefit
01.08.2013
23.01.2014
Ponatinib
Iclusig®
ARIAD Pharmaceuticals (Germany) GmbH
Oncological diseases
Chronic myeloid leukaemia (CML); acute lymphoblastic leukaemia (ALL), Ph+ or T315I mutation
0
525–1,135
100%
non-quantifiable additional benefit
Orphan
01.07.2013
19.12.2013
Nepafenac
Nevanac®
Alcon Pharma GmbH
Eye diseases
Postoperative pain after eye surgery
850,000–1,000,000
100%
no additional benefit
15.06.2013
05.12.2013
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil
Stribild®
Gilead Sciences GmbH
Infectious diseases
HIV infection
49,800
100%
no additional benefit
01.06.2013
14.11.2013
Lisdexamfetamindimesilat
Elvanse®
Shire Deutschland GmbH
Mental illnesses
Attention deficit hyperactivity disorder (ADHD), ≥ 6 to < 18
29,600–59,600
100%
no additional benefit
01.05.2013
17.10.2013
Ocriplasmin
Jetrea®
ThromboGenics NV / Alcon Pharma GmbH
Eye diseases
Vitreomacular traction (VMT)
0
9,970–39,300
95%
Hint for
considerable additional benefit
01.05.2013
17.10.2013
Linaclotid
Constella®
Almirall Hermal GmbH
Digestive system diseases
Irritable bowel syndrome (IBS)
394,000–838,000
100%
no additional benefit
01.05.2013
17.10.2013
Bosutinib
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
0
380–500
100%
non-quantifiable additional benefit
Orphan
01.04.2013
01.10.2013
Vildagliptin
Galvus®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
1,669,500–1,869,500
1,705,400–1,905,400
100%
no additional benefit
01.04.2013
01.10.2013
Vildagliptin / Metformin
Eucreas®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
792,050–811,850
100%
no additional benefit
01.04.2013
01.10.2013
Sitagliptin / Metformin
Janumet®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
0
792,050–810,850
78%
Hint for
minor additional benefit
01.04.2013
01.10.2013
Sitagliptin
Januvia®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,705,400–1,905,400
64%
Hint for
minor additional benefit
01.04.2013
01.10.2013
Saxagliptin / Metformin (2)
Komboglyze®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with sulphonylurea
62,400
100%
no additional benefit
01.04.2013
01.10.2013
Saxagliptin
Onglyza®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
0
1,182,900–1,382,900
50%
Hint for
minor additional benefit
01.04.2013
01.10.2013
Pertuzumab
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, combination with trastuzumab and docetaxel
3,300–5,118
33%
Hint for
considerable additional benefit
01.04.2013
01.10.2013
Colestilan
BindRen®
Mitsubishi Pharma Deutschland GmbH
Other diseases
Hyperphosphatemia
44,500–57,000
100%
no additional benefit
15.03.2013
05.09.2013
Vandetanib (2, reassessment)
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
60–1,500
100%
Hint for
minor additional benefit
15.03.2013
05.09.2013
Lixisenatid
Lyxumia®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
903,000
100%
no additional benefit
01.03.2013
15.08.2013
Aflibercept (2, Zaltrap®)
Zaltrap®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
3,500–10,400
100%
Indication of
minor additional benefit
15.01.2013
04.07.2013
Ingenolmebutat
Picato®
LEO Pharma GmbH
Skin diseases
Actinic keratosis (AK)
0
1,112,000–3,253,000
100%
no additional benefit
15.01.2013
04.07.2013
Fidaxomicin
Dificlir®
Astellas Pharma GmbH
Infectious diseases
Clostridium difficile infections
33,300
41%
Proof of
considerable additional benefit
15.01.2013
04.07.2013
Abirateronacetat (2)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
15,000–28,800
100%
Indication of
considerable additional benefit
01.01.2013
20.06.2013
Apixaban (2)
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Prophylaxis of strokes and systemic embolisms
926,000–1,093,000
100%
Indication of
minor additional benefit
15.12.2012
06.06.2013
Dapagliflozin
Forxiga®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
896,100
100%
no additional benefit
15.12.2012
06.06.2013
Aflibercept
Eylea®
Bayer Vital GmbH
Eye diseases
Neovascular age-related macular degeneration
305,000
100%
no additional benefit
01.12.2012
16.05.2013
Pixantron
Pixuvri®
CTI Life Sciences Ltd.
Oncological diseases
B-Cell Non-Hodgkin Lymphoma (NHL)
970
100%
no additional benefit
01.12.2012
16.05.2013
Linagliptin (3)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
450,000–650,000
100%
no additional benefit
01.12.2012
16.05.2013
Brentuximab Vedotin
Adcetris®
Takeda Pharma Vertrieb GmbH & Co. KG
Oncological diseases
Hodgkin lymphoma (HL), CD30+; Systemic anaplastic large cell lymphoma
75–420
100%
non-quantifiable additional benefit
Orphan
15.11.2012
02.05.2013
Saxagliptin / Metformin
Komboglyze®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
729,650–748,450
85%
Hint for
minor additional benefit
01.11.2012
02.05.2013
Decitabin
Dacogen®
Janssen-Cilag GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
300–780
100%
minor additional benefit
Orphan
15.11.2012
02.05.2013
Crizotinib
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
0
480
71%
Hint for
considerable additional benefit
01.10.2012
21.03.2013
Axitinib
Inlyta®
Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy
0
920
0.7%
Indication of
minor additional benefit
01.10.2012
21.03.2013
Aclidiniumbromid
Eklira® Genuair®
Almirall Hermal GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
0
2,400,000–2,800,000
100%
no additional benefit
15.09.2012
07.03.2013
Ruxolitinib
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
0
1,600
100%
minor additional benefit
Orphan
15.09.2012
07.03.2013
Perampanel
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
0
70,600–106,800
100%
no additional benefit
01.09.2012
21.02.2013
Linagliptin (2, reassessment)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
1,219,500
100%
no additional benefit
15.08.2012
07.02.2013
Ivacaftor
Kalydeco®
Vertex Pharmaceuticals GmbH
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
0
170
84%
considerable additional benefit
Orphan
01.07.2012
20.12.2012
Tegafur / Gimeracil / Oteracil
Teysuno®
Nordic Pharma GmbH
Oncological diseases
Gastric carcinoma
10,500–12,000
100%
no additional benefit
15.06.2012
06.12.2012
Pasireotid
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Pituitary dysfunction
160–360
100%
minor additional benefit
Orphan
15.03.2012
06.09.2012
Vemurafenib
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
0
1,400
100%
Indication of
considerable additional benefit
15.03.2012
06.09.2012
Vandetanib
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
130–1,300
100%
no additional benefit
01.08.2011
02.08.2012
Ipilimumab
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, second-line
3,100
100%
Indication of
considerable additional benefit
27.07.2011
02.08.2012
Belimumab
Benlysta®
GlaxoSmithKline GmbH & Co. KG
Musculoskeletal system diseases
Systemic lupus erythematosus
7,000
100%
Indication of
considerable additional benefit
29.07.2011
02.08.2012
Fampridin
Fampyra®
Biogen GmbH
Nervous system diseases
Multiple sclerosis (MS)
43,100–49,900
100%
no additional benefit
15.07.2011
05.07.2012
Belatacept
Nulojix®
Bristol-Myers Squibb GmbH & Co. KGaA
Genitourinary system diseases
Prophylaxis of graft rejection (GvHD) after kidney transplantation
0
2,945–3,385
100%
Indication of
minor additional benefit
15.01.2012
05.07.2012
Emtricitabin / Rilpivirin / Tenofovirdisoproxil
Eviplera®
Gilead Sciences GmbH
Infectious diseases
HIV infection, non-pretreated patients
1,260
100%
Proof of
minor additional benefit
15.01.2012
05.07.2012
Rilpivirin
Edurant®
Janssen-Cilag GmbH
Infectious diseases
HIV infection
1,260
100%
Proof of
minor additional benefit
01.07.2011
21.06.2012
Extrakt aus Cannabis Sativa
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
0
13,400–38,500
100%
Hint for
minor additional benefit
15.12.2011
07.06.2012
Tafamidis
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
0
40–104
100%
minor additional benefit
Orphan
15.06.2011
07.06.2012
Apixaban
Eliquis®
Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH
Cardiovascular diseases
Prophylaxis of venous thromboembolism
390,000
58%
Indication of
minor additional benefit
15.05.2011
03.05.2012
Aliskiren / Amlodipin
Rasilamlo®
Novartis Pharma GmbH
Cardiovascular diseases
Essential hypertension, add-on therapy
156,600–565,900
100%
no additional benefit
15.05.2011
03.05.2012
Retigabin
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
0
85,000–175,000
100%
no additional benefit
01.05.2011
19.04.2012
Eribulin
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC) after at least 2 chemotherapies
0
5,630–7,310
80%
Hint for
minor additional benefit
01.05.2011
19.04.2012
Collagenase aus Clostridium histolyticum
Xiapex®
Pfizer Pharma GmbH
Musculoskeletal system diseases
Dupuytren's contracture
35,000
100%
no additional benefit
15.10.2011
29.03.2012
Telaprevir
Incivo®
Janssen-Cilag GmbH
Infectious diseases
Chronic hepatitis C
46,000
100%
Indication of
non-quantifiable additional benefit
15.04.2011
29.03.2012
Regadenoson
Rapiscan®
Rapidscan Pharma Solutions EU Ltd.
Other diseases
Myocardial perfusion imaging
41,000
100%
no additional benefit
15.04.2011
29.03.2012
Fingolimod
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
0
9,500–7,500
18%
Hint for
minor additional benefit
15.04.2011
29.03.2012
Cabazitaxel
Jevtana®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Prostate carcinoma (PC), docetaxel pre-treatment, combination with prednisone or prednisolone
5,670–6,930
85%
Indication of
minor additional benefit
01.10.2011
29.03.2012
Linagliptin
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,219,500
100%
no additional benefit
01.10.2011
29.03.2012
Abirateronacetat
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy, combination with prednisone or prednisolone
5,670–6,930
85%
Indication of
considerable additional benefit
15.01.2012
15.03.2012
Azilsartan Medoxomil
Edarbi®
Takeda Pharma GmbH
Cardiovascular diseases
Arterial hypertension
0
100%
no additional benefit
15.09.2011
15.03.2012
Pirfenidon
Esbriet®
InterMune Deutschland GmbH
Respiratory system diseases
Idiopathic pulmonary fibrosis
6,000
100%
non-quantifiable additional benefit
Orphan
01.09.2011
01.03.2012
Boceprevir
Victrelis®
MSD Sharp & Dohme GmbH
Infectious diseases
Chronic hepatitis C
46,000
100%
Indication of
non-quantifiable additional benefit
01.08.2011
19.01.2012
Bromfenac
Yellox®
Bausch & Lomb / Dr. Mann Pharma
Eye diseases
Postoperative inflammation of the eye
850,000–1,000,000
100%
no additional benefit
01.01.2011
15.12.2011
Ticagrelor
Brilique®
AstraZeneca GmbH
Cardiovascular diseases
Prevention of atherothrombotic events in acute coronary syndrome
220,000–269,000
82%
Proof of
considerable additional benefit
01.06.2011
18.08.2011
Pitavastatin
Livazo®
Merckle Recordati GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
0
100%
no additional benefit