So far, xx procedures concerning xx different medicinal products have been finalised by the G-BA following an early benefit assessment. The decisions entered into force after being published in the Federal Gazette (Bundesanzeiger). On the procedure level, i.e. without taking individual subpopulations into account and using the highest benefit as the basis, the following results can be obtained: According to the G-BA approximately xx% of the medicinal products were able to show a major additional benefit and further xx% a considerable additional benefit. xx% of the assessed products offered a minor additional benefit and xx% a non-quantifiable additional benefit. The G-BA found no additional benefit for xx% of the innovative medicinal products and for xx% less benefit than the appropriate comparative therapy.

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)
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)
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
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
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
Repotrectinib (2) Augtyro® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Solid tumours, NTRK gene fusion, ≥ 12 years 390–770 100% no additional benefit
Repotrectinib Augtyro® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung cancer, ROS1-positive 585–1,620 100% no additional benefit
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
Eplontersen Wainzua® AstraZeneca GmbH Metabolic diseases Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2) 360 100% no additional benefit
Concizumab (2) Alhemo® Novo Nordisk GmbH Hematopoietic diseases Haemophilia B, ≥ 12 years, with factor IX inhibitors 2–12 57% Hint for considerable additional benefit
Concizumab Alhemo® Novo Nordisk GmbH Hematopoietic diseases Haemophilia A, ≥ 12 years, with factor VIII inhibitors 80–125 100% no additional benefit
Bevacizumab Lytenava® Outlook Therapeutics Limited Eye diseases Neovascular age-related macular degeneration 85,500–504,400 100% no additional benefit
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
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
Belzutifan (2) Welireg® MSD Sharp & Dohme GmbH Oncological diseases Von Hippel-Lindau syndrome (VHL)-associated tumours 80–970 100% no additional benefit
Belzutifan Welireg® MSD Sharp & Dohme GmbH Oncological diseases Renal cell carcinoma, advanced, after ≥ 2 prior therapies 65–940 50% Hint for minor additional benefit
Acoramidis Beyonttra® Bayer Vital GmbH Metabolic diseases Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy 1,760–2,120 100% no additional benefit
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
Mirikizumab (2) Omvoh® Lilly Deutschland GmbH Digestive system diseases Crohn's disease, pre-treated 12,600–78,300 100% no additional benefit
Fosdenopterin Nulibry® Sentynl Therapeutics Nervous system diseases Molybdenum cofactor deficiency type A 2 100% Hint for non-quantifiable additional benefit Orphan
Atogepant Aquipta® AbbVie Deutschland GmbH & Co. KG Nervous system diseases Migraine prophylaxis 1,386,900–1,726,200 100% no additional benefit
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
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
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
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)
Fedratinib (2, reassessment) Inrebic® Bristol-Myers Squibb GmbH Oncological diseases Myelofibrosis 640–1,710 100% Hint for non-quantifiable additional benefit Orphan
Garadacimab Andembry® CSL Behring GmbH Other diseases Hereditary angioedema, prophylaxis, ≥ 12 years 140–440 100% Hint for considerable additional benefit
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
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
Vibegron Obgemsa® Pierre Fabre Pharma GmbH Genitourinary system diseases Overactive bladder 587,900–1,270,000 100% no additional benefit
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
Nemolizumab (2) Nemluvio® Galderma Laboratorium GmbH Skin diseases Atopic dermatitis, ≥ 12 years 57,300–62,600 100% no additional benefit
Nemolizumab Nemluvio® Galderma Laboratorium GmbH Skin diseases Prurigo nodularis 3,500–5,500 100% no additional benefit
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
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
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
Sarilumab (2) Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Polymyalgia rheumatica 10,300–14,200 100% no additional benefit
Sipavibart Kavigale® AstraZeneca GmbH Infectious diseases COVID-19, pre-exposure prophylaxis, ≥ 12 years 0 100% no additional benefit
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
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
Pirtobrutinib Jaypirca® Lilly Deutschland GmbH Oncological diseases Mantle cell lymphoma, pre-treated patients 105–150 100% no additional benefit
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
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
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
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
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
Marstacimab Hympavzi® Pfizer Pharma GmbH Hematopoietic diseases Severe haemophilia B, ≥ 12 years, without factor IX inhibitors 300–310 100% no additional benefit
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
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
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
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
Osimertinib (7) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung cancer, EGFR mutations, after platinum-based radiochemotherapy 160–290 100% no additional benefit
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
Erdafitinib Balversa® Janssen-Cilag GmbH Oncological diseases Urothelial carcinoma, FGFR3 alterations, pretreated with PD-(L)1 inhibitor 169–207 100% no additional benefit
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
Tislelizumab (5) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, after prior therapy 690–1,620 100% no additional benefit
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
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
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
Tislelizumab Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, after prior therapy 330–540 100% no additional benefit
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
Linzagolix (2) Yselty® Theramex Ireland Limited Genitourinary system diseases Endometriosis 8,100–13,900 100% no additional benefit
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
Benralizumab (2) Fasenra® AstraZeneca GmbH Musculoskeletal system diseases Eosinophilic granulomatosis with polyangiitis 90–1,360 100% no additional benefit
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)
Dupilumab (11) Dupixent® Sanofi-Aventis Deutschland GmbH Digestive system diseases Eosinophilic oesophagitis, ≥ 1 year to < 12 years 530–590 100% no additional benefit
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)
Apremilast (3) Otezla® Amgen GmbH Skin diseases Moderate to severe plaque psoriasis; 6 to < 18 years of age 360–430 100% no additional benefit
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
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
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
Artesunat Artesunate Amivas® Amivas Ireland Ltd Infectious diseases Severe malaria, from birth 87 100% non-quantifiable additional benefit Orphan
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
Meropenem / Vaborbactam Vaborem® Berlin-Chemie AG Infectious diseases Acterial infections, several therapeutic indications 1,294–1,405 100% additional benefit considered proven
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
Delgocitinib Anzupgo® LEO Pharma GmbH Skin diseases Moderate to severe chronic hand eczema 160,000–200,000 100% no additional benefit
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
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
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
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
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
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
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
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
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
Polihexanid Akantior® SIFI S.p.A. Eye diseases Acanthamoebic keratitis; ≥ 12 years of age 70–410 100% Hint for non-quantifiable additional benefit Orphan
Isavuconazol (2) Cresemba® Pfizer Pharma GmbH Infectious diseases Mucormycosis, ≥ 1 to ≤ 17 years 8 100% Hint for non-quantifiable additional benefit Orphan
Isavuconazol (3) Cresemba® Pfizer Pharma GmbH Infectious diseases Aspergillosis, ≥ 1 to ≤ 17 years 40–215 100% Hint for non-quantifiable additional benefit Orphan
Epcoritamab (2) Tepkinly® AbbVie Deutschland GmbH & Co. KG Oncological diseases Follicular lymphoma, after ≥ 2 prior therapies 370–840 100% no additional benefit
Crovalimab Piasky® Roche Pharma AG Hematopoietic diseases Paroxysmal nocturnal haemoglobinuria, ≥ 12 years, ≥ 40 kg 260–749 100% no additional benefit
Sotatercept Winrevair® MSD Sharp & Dohme GmbH Cardiovascular diseases Pulmonary arterial hypertension 580–7,850 100% Hint for minor additional benefit Orphan
Linzagolix Yselty® Theramex Ireland Limited Genitourinary system diseases Uterine fibroid 20,160–100,800 100% no additional benefit
Faricimab (3) Vabysmo® Roche Pharma AG Eye diseases Macular oedema due to retinal vein occlusion 59,200–96,400 100% no additional benefit
Insulin icodec (2) Awiqli® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 855,000–1,184,000 100% no additional benefit
Insulin icodec Awiqli® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 1 161,750 100% no additional benefit
Risankizumab (4) Skyrizi® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis, pre-treated 29,100 100% no additional benefit
Aztreonam / Avibactam Emblaveo® Pfizer Pharma GmbH Infectious diseases Bacterial infections, several therapeutic indications 2,600–6,600 100% additional benefit considered proven
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
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
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
rADAMTS13 Adzynma® Takeda GmbH Hematopoietic diseases ADAMTS13 deficiency in congenital thrombotic thrombocytopenic purpura (cTTP) 120–180 100% Hint for non-quantifiable additional benefit Orphan
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
Sparsentan Filspari® Vifor Pharma Deutschland GmbH Genitourinary system diseases Immunoglobulin A - Nephropathy, primary 900–13,000 100% Hint for minor additional benefit Orphan
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
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
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
Dupilumab (10) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases COPD 9,370 71% Indication of minor additional benefit
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
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
Fruquintinib Fruzaqla® Takeda GmbH Oncological diseases Colorectal carcinoma, previously treated patients 645–2,180 100% Hint for minor additional benefit
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
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)
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
Iptacopan Fabhalta® Novartis Pharma GmbH Hematopoietic diseases Paroxysmal nocturnal hemoglobinuria 290–945 100% Hint for non-quantifiable additional benefit Orphan
Tofersen Qalsody® Biogen GmbH Nervous system diseases Amyotrophic lateral sclerosis (ALS) 90–170 100% Hint for non-quantifiable additional benefit Orphan
Cefepim / Enmetazobactam Exblifep® Advanz Pharma Germany GmbH Infectious diseases Bacterial infections, several areas of application 1,000–2,600 100% additional benefit considered proven
Pegcetacoplan (2) Aspaveli® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Paroxysmal nocturnal hemoglobinuria, untreated patients 100–425 100% Hint for non-quantifiable additional benefit Orphan
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
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
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
Bimekizumab (5) Bimzelx® UCB Pharma GmbH Skin diseases Hidradenitis suppurativa (acne inversa)) 2,800–6,400 100% no additional benefit
Selpercatinib (7) Retsevmo® Lilly Deutschland GmbH Oncological diseases Solid tumors, RET-Fusion+ 59–159 100% no additional benefit
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
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
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
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)
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
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
Abrocitinib (2) Cibinqo® Pfizer Pharma GmbH Skin diseases Atopic dermatitis, ≥ 12 to < 18 years 5,300–10,600 100% no additional benefit
Efbemalenograstim alfa Ryzneuta® Evive Biotech Oncological diseases Febrile neutropenia due to chemotherapy 0 100% no additional benefit
Efanesoctocog alfa Altuvoct® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia A 0 100% no additional benefit Orphan
Etrasimod Velsipity® Pfizer Pharma GmbH Digestive system diseases Ulcerative colitis, ≥ 16 years 29,100 100% no additional benefit
Abaloparatid Eladynos® Theramex Germany GmbH Musculoskeletal system diseases Osteoporosis, postmenopausal women 484,000 100% no additional benefit
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)
Gadopiclenol Elucirem® Guerbet GmbH Other diseases Contrast-enhanced magnetic resonance imaging, ≥ 2 years 2,900,000–3,300,000 100% no additional benefit
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)
Omaveloxolon Skyclarys® Biogen GmbH Nervous system diseases Friedreich's ataxia, ≥ 16 years 970 100% Hint for non-quantifiable additional benefit Orphan
Zilucoplan Zilbrysq® UCB Pharma GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 6,300–19,000 100% no additional benefit
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
Enalapril Aqumeldi® Proveca Pharma Limited Cardiovascular diseases Heart failure, < 18 years 0
3,070
100% no additional benefit
Decitabin / Cedazuridin Inaqovi® Otsuka Pharma GmbH Oncological diseases Acute myeloid leukaemia, first line 560–840 100% no additional benefit
Daridorexant (2, reassessment) Quviviq® Idorsia Pharmaceuticals Germany GmbH Mental illnesses Sleep disorders 8,300–218,500 100% no additional benefit
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
Momelotinib Omjjara® GlaxoSmithKline GmbH & Co. KG Oncological diseases Myelofibrosis 210–1,160 50% Hint for minor additional benefit Orphan
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
Rezafungin Rezzayo® Mundipharma Infectious diseases Invasive candida infections 31,800–34,600 100% Hint for non-quantifiable additional benefit Orphan
Patiromer (2) Veltassa® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Hyperkalaemia, ≥ 12 to < 18 years 370–790 100% no additional benefit
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
Ublituximab Briumvi® Neuraxpharm Arzneimittel GmbH Nervous system diseases Relapsing-remitting multiple sclerosis 70,300–274,900 63% Indication of minor additional benefit
Quizartinib Vanflyta® Daiichi Sankyo Deutschland GmbH Oncological diseases Acute myeloid leukaemia (AML) 260–820 100% no additional benefit
Pegzilarginase Loargys® Immedica Pharma Germany GmbH Metabolic diseases Hyperargininemia (ARG1-D), ≥ 2 years 50 100% Hint for non-quantifiable additional benefit Orphan
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
Vamorolon Agamree® Santhera Pharmaceuticals GmbH Musculoskeletal system diseases Duchenne muscular dystrophy, ≥ 4 years 740–3,670 100% Hint for non-quantifiable additional benefit Orphan
Evinacumab (2) Evkeeza® Ultragenyx Germany GmbH Metabolic diseases Homozygous familial hypercholesterolemia, ≥ 12 years of age 73–80 100% no additional benefit
Evinacumab Evkeeza® Ultragenyx Germany GmbH Metabolic diseases Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age 5–6 100% no additional benefit
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
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
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
Palopegteriparatid Yorvipath® Ascendis Pharma Endocrinology GmbH Metabolic diseases Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy 18,300–20,800 100% no additional benefit Orphan
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
Empagliflozin (6) Jardiance® Boehringer Ingelheim Pharma GmbH Metabolic diseases Diabetes Mellitus Type 2, ≥ 10 years 300–385 100% no additional benefit
Avapritinib (3) Ayvakyt® Blueprint Medicines GmbH Oncological diseases Indolent systemic mastocytosis (ISM) 715–1,000 100% Indication of minor additional benefit Orphan
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)
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)
Zanubrutinib (5) Brukinsa® BeiGene Germany GmbH Oncological diseases Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab 370–840 100% no additional benefit
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
Durvalumab (6) Imfinzi® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, monotherapy 1,900–5,470 100% no additional benefit
Alirocumab (3) Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolaemia, ≥ 8 years to 17 years 958–1,178 100% no additional benefit
Lebrikizumab Ebglyss® Almirall Hermal GmbH Skin diseases Atopic dermatitis, ≥ 12 years 57,300–62,600 100% no additional benefit
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)
Letermovir (2) Prevymis® MSD Sharp & Dohme GmbH Infectious diseases CMV disease, prophylaxis after kidney transplantation 320 100% no additional benefit Orphan (turnover limit)
Lanadelumab (3) Takhzyro® Takeda GmbH Other diseases Hereditary angioedema, prophylaxis, 2 to < 12 years 1–30 100% no additional benefit Orphan (turnover limit)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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
Tirzepatid Mounjaro® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 1,461,000–2,021,000 23% Hint for minor additional benefit
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
Midostaurin (3, reassessment >€30m) Rydapt® Novartis Pharma AG Oncological diseases Systemic Mastocytosis 300–400 100% no additional benefit Orphan (turnover limit)
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)
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
Baricitinib (5) Olumiant® Lilly Deutschland GmbH Skin diseases Juvenile Psoriatic Arthritis, ≥ 2 years 140–240 100% no additional benefit
Baricitinib (4) Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Enthesitis-associated arthritis, ≥ 2 years 330–390 100% no additional benefit
Baricitinib (3) Olumiant® Lilly Deutschland GmbH Skin diseases Atopic dermatitis, ≥ 2 until < 17 years 17,700–28,600 100% no additional benefit
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
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
Brolucizumab (3, reassessment) Beovu® Novartis Pharma GmbH Eye diseases Neovascular age-related macular degeneration 85,200–681,400 100% no additional benefit
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
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
Pegunigalsidase alfa Elfabrio® Chiesi GmbH Metabolic diseases Morbus Fabry 60–1,260 100% no additional benefit
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
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
Risdiplam (2) Evrysdi® Roche Pharma AG Nervous system diseases Spinal muscular atrophy, < 2 months 56–95 100% no additional benefit
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
Teclistamab Tecvayli® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, at least 3 prior therapies 1,210–1,310 100% no additional benefit
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)
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
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
Nonacog beta pegol (2) Refixia® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia B, < 12 years 100–110 100% no additional benefit
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
Migalastat (3, reassessment >€30m) Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease, ≥ 12 years 20–460 100% no additional benefit Orphan (turnover limit)
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
Bedaquilin (4, reassessment) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis 70–100 100% Hint for considerable additional benefit Orphan
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
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
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
Eftrenonacog alfa (2, reassessment >€30m) Alprolix® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia B 560–720 100% no additional benefit Orphan (turnover limit)
Empagliflozin (5) Jardiance® Boehringer Ingelheim Pharma GmbH Genitourinary system diseases Chronic renal insufficiency 2,259,300–2,478,100 100% no additional benefit
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
Cipaglucosidase alfa Pombiliti® Amicus Therapeutics GmbH Metabolic diseases Pompe's disease, combination with miglustat 170–1,760 100% Hint for minor additional benefit
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
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
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
Mirikizumab Omvoh® Lilly Deutschland GmbH Digestive system diseases Ulcerative colitis, pre-treated 5,300–25,000 100% no additional benefit
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
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
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
Axicabtagen-Ciloleucel (6) Yescarta® Gilead Sciences GmbH Oncological diseases Follicular lymphoma, after ≥ 3 prior therapies 60–270 100% no additional benefit Orphan (turnover limit)
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)
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)
Riociguat (4) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases Pulmonary arterial hypertension, < 18 years of age 5–35 100% no additional benefit
Bimekizumab (4) Bimzelx® UCB Pharma GmbH Skin diseases Psoriatic arthritis, monotherapy or in combination with methotrexate 30,300 100% no additional benefit
Bimekizumab (3) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis 16,800 100% no additional benefit
Bimekizumab (2) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Axial spondyloarthritis, non-radiographic 19,500 100% no additional benefit
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
Sacubitril / Valsartan (2) Entresto® Novartis Pharma GmbH Cardiovascular diseases Chronic heart failure with left ventricular dysfunction, ≥ 1 year) 170–860 100% no additional benefit
Secukinumab (9) Cosentyx® Novartis Pharma GmbH Skin diseases Hidradenitis suppurativa (Acne inversa) 4,800–6,400 100% no additional benefit
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
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
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
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
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)
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)
Tixagevimab / Cilgavimab (2) Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, Preexposition prophylaxis, ≥ 12 years 0 100% no additional benefit
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
Cemiplimab (4) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Cervix carcinoma, pretreated 380–1,450 50% Indication of considerable additional benefit
Etranacogen Dezaparvovec Hemgenix® CSL Behring GmbH Hematopoietic diseases Hemophilia B 231–358 100% Hint for non-quantifiable additional benefit Orphan
Upadacitinib (7) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Morbus Crohn, pretreated 18,900–35,350 100% no additional benefit
Lasmiditan Rayvow® Lilly Deutschland GmbH Nervous system diseases Migraine acute therapy 2,750,000 100% no additional benefit
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
Deucravacitinib Sotyktu® Bristol-Myers Squibb GmbH & Co. KGaA Skin diseases Moderate to severe plaque psoriasis 26,900–27,900 100% no additional benefit
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
Durvalumab (5) Imfinzi® AstraZeneca GmbH Oncological diseases Biliary tumors, first-line, combination with gemcitabine and cisplatin 1,800 100% Indication of minor additional benefit
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
Durvalumab (3) Imfinzi® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with tremelimumab 1,900–5,470 100% no additional benefit
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
Tremelimumab (2, Imjudo®) Imjudo® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with durvalumab 1,900–5,470 100% no additional benefit
Dupilumab (9) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Prurigo nodularis 3,500–4,800 100% Hint for non-quantifiable additional benefit
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
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
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
Dulaglutid (3) Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2, ≥ 10 years 640–710 100% no additional benefit
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)
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
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
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
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
Voclosporin Lupkynis® Otsuka Pharma GmbH Musculoskeletal system diseases Lupusnephritis 1,090–13,050 100% no additional benefit
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
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
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
Dolutegravir / Abacavir / Lamivudin (2) Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 14 kg to < 12 years 86 100% no additional benefit
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
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
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
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
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
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
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
Spesolimab Spevigo® Boehringer Ingelheim Pharma GmbH & Co. KG Skin diseases Generalised pustular psoriasis, acute treatment 170–400 100% no additional benefit
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
Maralixibat Livmarli® Mirum Pharmaceuticals Germany GmbH Digestive system diseases Alagille-Syndrome, ≥ 2 months 139–377 100% Hint for non-quantifiable additional benefit Orphan
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
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
Bictegravir / Emtricitabin / Tenofoviralafenamid (2) Biktarvy® Gilead Sciences GmbH Infectious diseases HIV-Infection, 2 until < 18 years 184 100% no additional benefit
Sutimlimab Enjaymo® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases Cold agglutinin disease (CAD) 370–1,510 100% Hint for minor additional benefit Orphan
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
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
Zanubrutinib (4) Brukinsa® BeiGene Germany GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line 3,180–3,200 50% Hint for minor additional benefit
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
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
Olopatadin / Mometason Ryaltris® Berlin-Chemie AG Respiratory system diseases Allergic rhinitis 3,807,000–7,356,000 100% no additional benefit
Maribavir Livtencity® Takeda GmbH Infectious diseases Cytomegalovirus infection (CMI), refractory to therapy 90–130 100% Hint for minor additional benefit Orphan
Tezepelumab Tezspire® AstraZeneca GmbH Respiratory system diseases Bronchial asthma (AB), ≥ 12 years 42,300–46,700 100% no additional benefit
Tralokinumab (2) Adtralza® LEO Pharma GmbH Skin diseases Atopic dermatitis (AD), 12 to < 18 years 5,300–10,600 100% no additional benefit
Daridorexant Quviviq® Idorsia Pharmaceuticals Germany GmbH Mental illnesses Sleep disorders (mental illnesses) 0
1,900–79,000
100% no additional benefit
Dalbavancin Xydalba® Advanz Pharma Germany GmbH Infectious diseases Acute bacterial skin and skin structure infections (ABSSSI) 0 resolution w/o assessement
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 2 to < 6 years 16 100% no additional benefit
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
Ravulizumab (4) Ultomiris® Alexion Pharma Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 800–1,200 100% no additional benefit
Tixagevimab / Cilgavimab Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre 0 100% Hint for minor additional benefit
Faricimab (2) Vabysmo® Roche Pharma AG Eye diseases Neovascular age-related macular degeneration (AMD) 85,200–681,400 100% no additional benefit
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
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
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
Relugolix Orgovyx® Accord Healthcare GmbH Oncological diseases Prostate carcinoma (PC), advanced, hormone-sensitive 25,020–44,280 100% no additional benefit
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
Faricimab Vabysmo® Roche Pharma AG Eye diseases Diabetic macular edema (DME) 190,000–241,000 100% no additional benefit
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
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
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
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
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
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
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
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
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
Selpercatinib (5) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older 40–170 100% no additional benefit
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
Valoctocogene roxaparvovec Roctavian® BioMarin International Ltd. Hematopoietic diseases Hemophilia A 690–800 100% Hint for non-quantifiable additional benefit Orphan
Burosumab (6) Crysvita® Kyowa Kirin GmbH Metabolic diseases FGF23-related hypophosphatemia in tumour-induced osteomalacia 60–140 100% no additional benefit Orphan (turnover limit)
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
Eptinezumab Vyepti® Lundbeck GmbH Nervous system diseases Migraine prophylaxis 1,614,300–1,645,200 100% no additional benefit
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
Upadacitinib (6) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis (UC), pre-treated 5,300–25,000 100% no additional benefit
Upadacitinib (5) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Axial spondyloarthritis (AS), non-radiographic 19,500 100% no additional benefit
Birkenrindenextrakt Filsuvez® Amryt Pharma GmbH Other diseases Wound treatment in epidermolysis bullosa (from 6 months) 270–860 100% Hint for minor additional benefit Orphan
Ceftolozan / Tazobactam (7) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications, < 18 years of age 40 100% additional benefit considered proven
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
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
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
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
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
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
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
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
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
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
Pembrolizumab (24) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Biliary carcinoma with MSI-H or dMMR, pre-treated 20–150 100% no additional benefit
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
Pembrolizumab (22) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, ≥ 12 to < 18 years 1–4 100% no additional benefit
Glycopyrronium Axhidrox® Dr. August Wolff GmbH & Co. KG Arzneimittel Other diseases Severe primary axillary hyperhidrosis 73,000–704,000 100% no additional benefit
Inebilizumab Uplizna® Horizon Therapeutics GmbH Nervous system diseases Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive 460–980 100% no additional benefit
Eravacyclin Xerava® PAION Deutschland GmbH Infectious diseases Reserve antibiotics: Complicated intra-abdominal infections (cIAI) 2,600–6,600 100% additional benefit considered proven
Secukinumab (8) Cosentyx® Novartis Pharma GmbH Skin diseases Juvenile psoriatic arthritis (PA), ≥ 6 years 120–180 100% no additional benefit
Secukinumab (7) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Enthesitis-related arthritis (ERA) 240–290 100% no additional benefit
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
Mosunetuzumab Lunsumio® Roche Pharma AG Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies 650–690 100% Hint for non-quantifiable additional benefit Orphan
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
Selpercatinib (4) Retsevmo® Lilly Deutschland GmbH Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+, first-line 115–310 100% no additional benefit
Palbociclib (3, reassessment) Ibrance® Pfizer Pharma GmbH Oncological diseases Breast carcinoma (BC), patient population a1 7,400–34,700 100% no additional benefit
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
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
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
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
Cabozantinib (8, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients 125–425 100% no additional benefit
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
Tisagenlecleucel (5) Kymriah® Novartis Pharma GmbH Oncological diseases Follicular lymphoma (FL), pre-treated patients 650–690 100% Hint for non-quantifiable additional benefit Orphan
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
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
Sotrovimab Xevudy® GlaxoSmithKline GmbH & Co. KG Infectious diseases COVID-19, ≥ 12 years 0 100% Hint for considerable additional benefit
Imipenem / Cilastatin / Relebactam (2) Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 2,598–6,600 100% additional benefit considered proven
Ceftolozan / Tazobactam (6) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 2,600–6,600 100% additional benefit considered proven
Ceftazidim / Avibactam Zavicefta® Pfizer Pharma GmbH Infectious diseases Bacterial infections, multiple indications 2,600–6,600 100% additional benefit considered proven
Tebentafusp Kimmtrak® Immunocore Ireland Ltd. Oncological diseases Uveal melanoma, HLA-A*02:01-positive 0
110
100% Hint for considerable additional benefit Orphan
Brolucizumab (2) Beovu® Novartis Pharma GmbH Eye diseases Diabetic macular edema 190,000–241,000 100% no additional benefit
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
Doravirin / Lamivudin / Tenofovirdisoproxil (2) Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 10–20 100% no additional benefit
Doravirin (2) Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 130–140 100% no additional benefit
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
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
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
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
Casirivimab / Imdevimab Ronapreve® Roche Pharma AG Infectious diseases COVID-19-Infection, ≥ 12 years 0 100% Hint for considerable additional benefit
Dupilumab (6) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Asthma bronchiale, ≥ 6 until ≤ 11 years 150–860 100% no additional benefit
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
Anifrolumab Saphnelo® AstraZeneca GmbH Musculoskeletal system diseases Systemic lupus erythematosus (SLE) 4,600–18,500 100% no additional benefit
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
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
Dolutegravir (4, reassessment) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, age 6 to < 18 years 0 resolution w/o assessement
Voretigen Neparvovec (2, reassessment) Luxturna® Novartis Pharma GmbH Eye diseases Hereditary retinal dystrophy 100–530 100% Hint for considerable additional benefit Orphan
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
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
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
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)
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
Lorlatinib (2) Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung cancer (NSCLC), ALK+, first-line 390–1,310 100% no additional benefit
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
Vedolizumab (2) Entyvio® Takeda GmbH Digestive system diseases Antibiotic-refractory pouchitis, pre-treated patients 20–40 100% no additional benefit
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
Sofosbuvir / Velpatasvir (3) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 3 to < 6 years of age 1–12 100% no additional benefit
Calcifediol Rayaldee® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Secondary hyperparathyroidism in chronic renal failure 146,700–184,300 100% no additional benefit
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
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)
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)
Duvelisib (2) Copiktra® Secura Bio Limited Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies 380–5,170 100% no additional benefit
Duvelisib Copiktra® Secura Bio Limited Oncological diseases Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies 550–2,060 100% no additional benefit
Abrocitinib Cibinqo® Pfizer Pharma GmbH Skin diseases Atopic Dermatitis (AD) 52,000 100% Hint for considerable additional benefit
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
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
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
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
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
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
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
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
Evolocumab (3) Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age 768–950 100% no additional benefit
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
Pralsetinib Gavreto® Roche Pharma AG Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+ 170–510 100% no additional benefit
Tofacitinib (7) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis (AS) 16,800 100% no additional benefit
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
Dapagliflozin (7) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus Type 2, ≥ 10 years 650–710 100% no additional benefit
Ponesimod (2) Ponvory® Janssen-Cilag GmbH Nervous system diseases Relaps multiple sclerosis (MS) 186,000–200,000 50% Indication of minor additional benefit
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
Filgotinib (2) Jyseleca® Galapagos Biopharma Germany GmbH Digestive system diseases Ulcerative colitis (UC), pretreated patients 5,300–25,000 100% no additional benefit
Mepolizumab (5) Nucala® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Eosinophilic granulomatosis with polyangiitis 80–1,130 100% no additional benefit
Mepolizumab (4) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic rhinosinusitis with nasal polyps 10,500–12,600 100% no additional benefit
Mepolizumab (3) Nucala® GlaxoSmithKline GmbH & Co. KG Hematopoietic diseases Hypereosinophilic syndrome 100–400 100% Hint for considerable additional benefit
Ertugliflozin Steglatro® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus (DM) type 2 1,451,000–2,021,000 100% no additional benefit
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
Risankizumab (2) Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriatic arthritis (PA), monotherapy or combination with methotrexate 29,100 100% no additional benefit
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
Lusutrombopag Mulpleo® Shionogi GmbH Hematopoietic diseases Thrombocytopenia in chronic liver disease 1,790–24,130 100% no additional benefit
Cefiderocol (2) Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens 2,600–6,600 100% additional benefit considered proven
Delamanid Deltyba® Otsuka Novel Products Infectious diseases Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg 80–114 100% Hint for non-quantifiable additional benefit Orphan
Elbasvir / Grazoprevir (2) Zepatier® MSD Sharp & Dohme B.V. Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 0 100% no additional benefit
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
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
Icosapent-Ethyl Vazkepa® Amarin Pharmaceuticals Ireland Limited Metabolic diseases Dyslipidemia, pre-treated patients 844,000–878,000 100% no additional benefit
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
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
Sofosbuvir / Velpatasvir / Voxilaprevir (2) Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 24–39 100% no additional benefit
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)
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
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
Vandetanib (4, reassessment) Caprelsa® Sanofi-Aventis Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC) 50–670 100% no additional benefit
Vosoritid Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 2 years 0
340–480
100% Hint for non-quantifiable additional benefit Orphan
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)
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
Ravulizumab (3) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Paroxysmal hemoglobinuria, pediatric patients 0–49 100% no additional benefit
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
Roxadustat Evrenzo® Astellas Pharma GmbH Hematopoietic diseases Symptomatic anemia in chronic kidney disease (CKD) 151,000–195,000 100% no additional benefit
Bimekizumab Bimzelx® UCB Pharma GmbH Skin diseases Plaque psoriasis (PP) 35,900–121,500 100% Indication of minor additional benefit
Vericiguat Verquvo® Bayer Vital GmbH Cardiovascular diseases Chronic heart failure (CHF) 74,600–530,000 100% Hint for minor additional benefit
Odevixibat Bylvay® Albireo Pharma AB Digestive system diseases Cholestasis, ≥ 6 months 40–110 100% Hint for minor additional benefit Orphan
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
Misoprostol Angusta® Norgine GmbH Other diseases Labor induction 76,500–90,000 100% no additional benefit
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
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
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
Tirbanibulin Klisyri® Almirall Hermal GmbH Skin diseases Actinic keratosis (AK), Olsen grade I 700,000–1,380,000 100% no additional benefit
Relugolix / Estradiol / Norethisteronacetat Ryeqo® Gedeon Richter Pharma GmbH Genitourinary system diseases Uterine myoma 20,160–100,840 50% Hint for considerable additional benefit
Dapagliflozin (6) Forxiga® AstraZeneca GmbH Genitourinary system diseases Chronic kidney disease (CKD) 2,520,200–3,409,200 50% Hint for considerable additional benefit
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
Selumetinib Koselugo® AstraZeneca GmbH Oncological diseases Neurofibromatosis (type 1), ≥ 3 to < 18 years 0
510–740
100% Hint for non-quantifiable additional benefit Orphan
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)
Imipenem / Cilastatin / Relebactam Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Pneumonia, Bacteriemia 0 resolution w/o assessement
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
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
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
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
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
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
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)
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
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
Tralokinumab Adtralza® LEO Pharma A/S Skin diseases Atopic dermatitis (AD) 52,000 100% no additional benefit
Angiotensin-II-Acetat Giapreza® La Jolla Pharmaceutical II B.V. Cardiovascular diseases Hypotension 3,980–37,625 100% no additional benefit
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
Cabozantinib (7, reassessment) Cometriq® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC) 50–670 100% Hint for non-quantifiable additional benefit Orphan
Glecaprevir / Pibrentasvir (3) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 3 to < 12 years 146–238 100% no additional benefit
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
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
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
Dostarlimab Jemperli® GlaxoSmithKline GmbH & Co. KG Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy 230–3,360 100% no additional benefit
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
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
Berotralstat Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 140–430 100% no additional benefit
Ponesimod Ponvory® Janssen-Cilag GmbH Nervous system diseases Relapsing multiple sclerosis (MS) 21,000–23,000 100% no additional benefit
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)
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)
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)
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)
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)
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)
Bosutinib (4, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 760–890 100% no additional benefit
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
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
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
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
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
Lanadelumab (2, reassessment >€50m) Takhzyro® Takeda GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 140–430 100% no additional benefit Orphan (turnover limit)
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)
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)
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 820–1,480 100% no additional benefit Orphan (turnover limit)
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL) 790–940 100% no additional benefit Orphan (turnover limit)
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
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
Cabotegravir Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with rilpivirin 59,900 100% no additional benefit
Erenumab (2, reassessment) Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis 1,540,100–1,568,800 100% Hint for considerable additional benefit
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
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
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
Rilpivirin (3, Rekambys®) Rekambys® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with cabotegravir 59,900 100% no additional benefit
Cefiderocol Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens 0 resolution w/o assessement
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
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
Natrium-Zirkonium-Cyclosilikat Lokelma® AstraZeneca GmbH Metabolic diseases Hyperkalemia 77,700–308,500 100% no additional benefit
Remdesivir Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, ≥ 12 years, additional oxygen supply 45,000–79,000 34% Hint for minor additional benefit
Avatrombopag (2) Doptelet® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Thrombocytopenia in chronic liver disease 1,790–24,130 100% no additional benefit
Avatrombopag Doptelet® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Immune thrombocytopenia (ITP) 4,260–10,830 100% no additional benefit
Fostemsavir Rukobia® ViiV Healthcare GmbH Infectious diseases Multidrug-resistant HIV infection 80–240 100% no additional benefit
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
Pembrolizumab (15, reassessment) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC), CPS ≥ 10, first-line 225–380 100% no additional benefit
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
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
Imlifidase Idefirix® Hansa Biopharma AB Other diseases Desensitisation in kidney transplantation 3–69 100% Hint for non-quantifiable additional benefit Orphan
Fedratinib Inrebic® Celgene GmbH Oncological diseases Myelofibrosis (MF) 740–3,590
1,370–5,280
100% Hint for non-quantifiable additional benefit Orphan
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
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
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
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
Avelumab (4) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Urothelial carcinoma (UC), first-line 4,125 100% Hint for considerable additional benefit
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
Esketamin Spravato® Janssen-Cilag GmbH Mental illnesses Depression, acute treatment, combination therapy 49,100–69,200 100% Hint for minor additional benefit
Beclometason / Formoterol / Glycopyrronium Trimbow® Chiesi GmbH Respiratory system diseases Asthma 0
290,000
100% no additional benefit
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
Baloxavir marboxil Xofluza® Roche Pharma AG Infectious diseases Influenza, ≥ 12 years 1,871,000–3,303,000 100% no additional benefit
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
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
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
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
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
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
Levofloxacin / Dexamethason Ducressa® Santen GmbH Eye diseases Infections and inflammations associated with cataract surgery 454,000–811,000 100% no additional benefit
Dolutegravir (3) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV-Infection, children ≥ 4 weeks to < 6 years 29 100% no additional benefit
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)
Fenfluramin Fintepla® Zogenix GmbH Nervous system diseases Dravet syndrome, ≥ 2 years 450–2,450 100% Hint for considerable additional benefit Orphan
Inclisiran Leqvio® Novartis Pharma GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 284,750–410,900 100% no additional benefit
Upadacitinib (3) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriasis arthritis (PA) 29,100 69% Hint for considerable additional benefit
Upadacitinib (2) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Ankylosing spondylitis 7,800–16,800 100% no additional benefit
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)
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
Afamelanotid (2, reassessment) Scenesse® Clinuvel (UK) Limited Metabolic diseases Erythropoietic protoporphyria 540–1,090 100% Hint for non-quantifiable additional benefit Orphan
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
Lenvatinib (5, reassessment, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 1,770–3,530 100% no additional benefit
Lumasiran Oxlumo® Alnylam Germany GmbH Metabolic diseases Hyperoxaluria 50–880 100% Hint for non-quantifiable additional benefit Orphan
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
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
Perampanel (5) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years 2,950–6,700 100% no additional benefit
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
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
Olaparib (7) Lynparza® AstraZeneca GmbH Oncological diseases Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy 75–95 100% no additional benefit
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
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
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
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
Acalabrutinib Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); monotherapy, first-line 2,880–3,780 25% Hint for minor additional benefit
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)
Guselkumab (2) Tremfya® Janssen-Cilag GmbH Skin diseases Psoriatic arthritis (PA) 29,100 100% no additional benefit
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)
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)
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)
Tafamidis (3, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid Neuropathy 230 100% no additional benefit Orphan (turnover limit)
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)
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)
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)
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)
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)
Dapagliflozin (5) Forxiga® AstraZeneca GmbH Cardiovascular diseases Chronic heart failure (CHF) 2,061,700–2,273,000 100% Hint for considerable additional benefit
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
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
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases Hepatocellular carcinoma (HCC), combination with bevacizumab 1,710–4,970 76% Indication of considerable additional benefit
Eszopiclon Lunivia® Hennig Arzneimittel GmbH & Co. KG Nervous system diseases Sleep disorders 0 100% no additional benefit
Baricitinib (2) Olumiant® Lilly Deutschland GmbH Skin diseases Atopic dermatitis (AD) 52,000 100% no additional benefit
Avapritinib Ayvakyt® Blueprint Medicines (Germany) Oncological diseases Gastrointestinal stromal tumor (GIST) 1–90 100% Hint for non-quantifiable additional benefit Orphan
Burosumab (3) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia (XLH), ≥ 18 years 0
410–810
100% Hint for minor additional benefit Orphan
Bempedoinsäure / Ezetimib Nustendi® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 284,750–286,750 100% no additional benefit
Bempedoinsäure Nilemdo® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 284,750–286,750 100% no additional benefit
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
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
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
Filgotinib Jyseleca® Gilead Sciences GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 89,710–193,750 33% Hint for minor additional benefit
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)
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
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 6 to < 18 years 120 100% no additional benefit
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
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
Bulevirtid Hepcludex® MYR GmbH Infectious diseases Chronic hepatitis Delta 300–4,800 100% Hint for non-quantifiable additional benefit Orphan
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)
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)
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)
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)
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
Entrectinib Rozlytrek® Roche Pharma AG Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent 390–770 100% no additional benefit
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases Multidrug-resistant HIV infection 50–110 100% no additional benefit
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP), ≥ 6 to < 18 years 270–2,035 100% Hint for minor additional benefit
Secukinumab (5) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Axial spondyloarthritis 19,500 100% no additional benefit
Secukinumab (4, reassessment) Cosentyx® Novartis Pharma GmbH Skin diseases Psoriatic arthritis (PA) 29,100 35% Indication of minor additional benefit
Glasdegib Daurismo® Pfizer Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML), combination with cytarabine (LDAC) 780–840 100% Hint for considerable additional benefit Orphan
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
Trifaroten Selgamis® Galderma Laboratorium GmbH Skin diseases Acne vulgaris, ≥ 12 years 887,500–1,950,700 100% no additional benefit
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat Enerzair® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100,000 100% no additional benefit
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
Ravulizumab (2) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Atypical hemolytic uremic syndrome (aHUS) 210–700 100% no additional benefit
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
Luspatercept (2) Reblozyl® Celgene GmbH Hematopoietic diseases Beta thalassemia 0
170–300
100% Hint for non-quantifiable additional benefit Orphan
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases Myelodysplastic syndrome (MDS) 0
840–1,870
100% Hint for non-quantifiable additional benefit Orphan
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
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
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Axial spondyloarthritis 36,300 100% no additional benefit
Osilodrostat Isturisa® Recordati Rare Diseases Germany GmbH Metabolic diseases Endogenous Cushing syndrome 1,130–1,550 100% Hint for non-quantifiable additional benefit Orphan
Ozanimod Zeposia® Celgene GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 149,500–166,000 90% Indication of minor additional benefit
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
Encorafenib (2) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Metastatic colorectal carcinoma (CRC) 525–1,235 100% Hint for considerable additional benefit
Fostamatinib Tavlesse® Grifols Deutschland GmbH Hematopoietic diseases Chronic immune thrombocytopenia 4,200–9,700 100% no additional benefit
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)
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)
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)
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
Mogamulizumab Poteligeo® Kyowa Kirin GmbH Oncological diseases Mycosis Fungoides; Sézary Syndrome 310–460 100% Hint for non-quantifiable additional benefit Orphan
Talazoparib Talzenna® Pfizer Pharma GmbH Oncological diseases Breast cancer (BC) BRCA1/2 mutation, HER2- 410–1,830 100% Hint for considerable additional benefit
Ponatinib (3, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Chronic myeloid leukaemia (CML) 500–940 100% Hint for non-quantifiable additional benefit Orphan
Ponatinib (2, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Acute myeloid leukaemia (AML) 25–195 100% Hint for non-quantifiable additional benefit Orphan
Naldemedin Rizmoic® Hexal AG Digestive system diseases Opioid-induced constipation 65,000 100% no additional benefit
Apremilast (2) Otezla® Amgen GmbH Other diseases Behçet's disease 750–2,200 100% no additional benefit
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
Solriamfetol Sunosi® Jazz Pharmaceuticals Nervous system diseases Narcolepsy 16,200–19,500 100% no additional benefit
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
Darolutamid Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 1,090–3,800 100% Indication of considerable additional benefit
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
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
Givosiran Givlaari® Alnylam Germany GmbH Metabolic diseases Acute hepatic porphyria, ≥ 12 years 1,000–1,700 100% Indication of considerable additional benefit Orphan
Avelumab (3, reassessment) Bavencio® Merck Serono GmbH Oncological diseases Metastatic Merkel-cell carcinoma (MCC) 370–720 100% no additional benefit
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
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
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases HIV infection, combination with atazanavir or darunavir, 12 to < 18 years 130 100% no additional benefit
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
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
Indacaterol / Mometason Atectura® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 1,000,000–1,100,000 100% no additional benefit
Brolucizumab Beovu® Novartis Pharma GmbH Eye diseases Neovascular age-related macular degeneration 0
85,200–681,400
100% no additional benefit
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases Clostridioides difficile infection, children and adolescents 350 54% Hint for considerable additional benefit
Romosozumab Evenity® UCB Pharma GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal) 475,000 100% Indication of minor additional benefit
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)
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)
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
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid cardiomyopathy 0
1,630–1,730
100% Hint for considerable additional benefit Orphan
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
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
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
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
Siponimod Mayzent® Novartis Pharma GmbH Nervous system diseases Secondary progressive multiple sclerosis (MS) 13,200–28,900 100% no additional benefit
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
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)
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)
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
Dulaglutid (2, reassessment) Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 2,108,000 31% Hint for minor additional benefit
Upadacitinib Rinvoq® AbbVie Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 88,709–188,210 34% Hint for considerable additional benefit
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
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)
Neratinib Nerlynx® Pierre Fabre Pharma Oncological diseases Breast cancer (BC) HR+, HER2+, adjuvant therapy 2,330–4,560 100% Hint for minor additional benefit
Gilteritinib XOSPATA® Astellas Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML), FLT3 mutation 220–580 100% Hint for considerable additional benefit Orphan
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
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
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
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
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
Belimumab (2) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 30–550 100% Hint for non-quantifiable additional benefit
Betibeglogene autotemcel Zynteglo® bluebird bio (Germany) GmbH Hematopoietic diseases Beta thalassemia 50 100% Hint for non-quantifiable additional benefit Orphan
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
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)
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
Larotrectinib Vitrakvi® Bayer Vital GmbH Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent 390–770 100% no additional benefit
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
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases Metastatic gastric cancer, pre-treated patients 590–1,030 100% Indication of minor additional benefit
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)
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
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
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
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
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
Ropeginterferon alfa-2b Besremi® AOP Orphan Pharmaceuticals AG Oncological diseases Polycythemia vera 1,860–19,800 100% no additional benefit
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)
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)
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)
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)
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)
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)
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)
Ramucirumab (5) Cyramza® Lilly Deutschland GmbH Oncological diseases Hepatocellular carcinoma (HCC) 500–2,200 100% Proof of minor additional benefit
Dupilumab (2) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Bronchial asthma, ≥ 12 years 17,560–54,300 100% no additional benefit
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
Andexanet alfa Ondexxya® Portola Deutschland GmbH Hematopoietic diseases Antidote for reversal of anticoagulation (factor Xa) 4,200–27,600 100% no additional benefit
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)
Ibrutinib (6) Imbruvica® Janssen-Cilag GmbH Oncological diseases Waldenström's disease, combination with rituximab 590–1,180 100% no additional benefit Orphan (turnover limit)
Volanesorsen Waylivra® Akcea Therapeutics Germany GmbH Metabolic diseases Chylomicronaemia syndrome 60–120 100% Hint for non-quantifiable additional benefit Orphan
Turoctocog alfa pegol Esperoct® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia A 2,840–3,190 100% no additional benefit
Dolutegravir / Lamivudin Dovato® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 52,060–61,380 100% no additional benefit
Ravulizumab Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Paroxysmal hemoglobinuria 260–700 100% no additional benefit
Cemiplimab Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Squamous cell carcinoma (SCC) 450–1,400 100% no additional benefit
Olaparib (3) Lynparza® AstraZeneca GmbH Oncological diseases Breast cancer (BC) BRCA1/2 mutations, HER2- 460–710 100% Hint for minor additional benefit
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
Vigabatrin Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, West syndrome, < 7 years 0
1,000–2,400
100% no additional benefit
Vigabatrin (2) Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, focal seizures, < 7 years 0
7,300–14,500
100% no additional benefit
Pegvaliase Palynziq® BioMarin International Limited Metabolic diseases Phenylketonuria 435 100% Hint for non-quantifiable additional benefit Orphan
Dapagliflozin / Metformin (3, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 1,139,000 50% Hint for minor additional benefit
Dapagliflozin (4, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 2,108,000 41% Hint for minor additional benefit
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)
Empagliflozin / Linagliptin Glyxambi® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 326,100–341,100 100% no additional benefit
Risankizumab Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Plaque psoriasis (PP) 35,900–121,500 82% Proof of considerable additional benefit
Lorlatinib Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 200–1,310 100% no additional benefit
Fremanezumab Ajovy® Teva GmbH Nervous system diseases Migraine prophylaxis 1,443,400–1,471,000 1.0% Hint for considerable additional benefit
Dacomitinib Vizimpro® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line 890–2,210 100% no additional benefit
Lisdexamfetamindimesilat (2, Elvanse Adult®) Elvanse Adult® Shire Deutschland GmbH Mental illnesses Attention deficit hyperactivity disorder (ADHD), ≥ 18 years 73,000 100% no additional benefit
Dapagliflozin (3) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 1 0
19,200
100% Hint for minor additional benefit
Radium-223-dichlorid (2, reassessment) Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 3,810–4,560 100% no additional benefit
Voretigen Neparvovec Luxturna® Novartis Pharma GmbH Eye diseases Hereditary retinal dystrophy 0
100–530
100% Hint for considerable additional benefit Orphan
Glecaprevir / Pibrentasvir (2) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 12 to < 18 years 540 100% no additional benefit
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)
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
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
Pembrolizumab (8) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, adjuvant therapy 2,670–3,400 100% Indication of non-quantifiable additional benefit
Galcanezumab Emgality® Lilly Deutschland GmbH Nervous system diseases Migraine prophylaxis 1,443,400–1,471,000 1.0% Hint for considerable additional benefit
Brentuximab Vedotin (4) Adcetris® Takeda Pharma GmbH Oncological diseases Hodgkin lymphoma (HL), CD30+, first-line 220–380 100% non-quantifiable additional benefit Orphan
Emicizumab (2) Hemlibra® Roche Pharma AG Hematopoietic diseases Hemophilia A, without factor VIII inhibitors 2,000 100% no additional benefit
Regadenoson (2) Rapiscan® GE Healthcare Buchler GmbH & Co. KG Other diseases Stenosis, Fractional Flow Reserve Measurement (FFR) 0
780,000
100% no additional benefit
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
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
Blinatumomab (3) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients 40–110 100% non-quantifiable additional benefit Orphan
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
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
Lenvatinib (4, reassessment) Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 740–770 100% no additional benefit
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
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
Mexiletin Namuscla® Lupin Europe GmbH Nervous system diseases Myotonia 530–650 100% non-quantifiable additional benefit Orphan
Apalutamid Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 0
810–1,180
100% Hint for minor additional benefit
Lanadelumab Takhzyro® Shire Deutschland GmbH, Teil der Takeda Group Other diseases Hereditary angioedema (HAE) 0
140–430
100% considerable additional benefit Orphan
Doravirin Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 57,800–73,700 100% no additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 48,800–68,000 100% no additional benefit
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
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
Bedaquilin Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis 0
70–100
100% considerable additional benefit Orphan
Melatonin Slenyto® InfectoPharm Arzneimittel und Consilium GmbH Nervous system diseases Sleep disorders 0
8,000–86,000
100% Hint for minor additional benefit
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
Damoctocog alfa pegol Jivi® Bayer Vital GmbH Hematopoietic diseases Hemophilia A, ≥ 12 years 2,840–3,190 100% no additional benefit
Pembrolizumab (7, reassessment) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC), CPS ≥ 10, first-line 0
240–420
100% no additional benefit
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
Atezolizumab (3, reassessment) Tecentriq® Roche Pharma AG Oncological diseases Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line 220–380 100% no additional benefit
Cabozantinib (5, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Hepatocellular carcinoma (HCC) 1,280–4,900 100% Hint for minor additional benefit
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
Enzalutamid (3) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 0
810–1,180
100% no additional benefit
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
Venetoclax (3, reassessment) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 300–700 100% no additional benefit
Insulin degludec (4, reassessment) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 776,100–991,100 100% no additional benefit
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
Tildrakizumab Ilumetri® Almirall Hermal GmbH Skin diseases Plaque psoriasis (PP) 157,100–234,400 100% no additional benefit
Alirocumab (2, reassessment) Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolemia or mixed dyslipidaemia 271,750 100% no additional benefit
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
Axicabtagen-Ciloleucel Yescarta® Kite, Gilead company Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 0
440–700
100% non-quantifiable additional benefit Orphan
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
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
Semaglutid Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 1,969,100–2,184,100 37% Hint for minor additional benefit
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
Pembrolizumab (6) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck 470–3,290 100% no additional benefit
Ocriplasmin (2, reassessment) Jetrea® Oxurion NV Eye diseases Vitreomacular traction (VMT) 1,160–16,500 94% Hint for minor additional benefit
Durvalumab Imfinzi® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), maintenance therapy 1,600–1,800 100% Hint for considerable additional benefit
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
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
Patisiran Onpattro® Alnylam Germany GmbH Metabolic diseases Amyloidosis 0
350
100% considerable additional benefit Orphan
Inotersen Tegsedi® Akcea Therapeutics Germany GmbH Metabolic diseases Amyloidosis 350 100% non-quantifiable additional benefit Orphan
Metreleptin Myalepta® Aegerion Pharmaceuticals GmbH Metabolic diseases Lipodystrophy 90–180 100% non-quantifiable additional benefit Orphan
Binimetinib Mektovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with encorafenib 1,390 100% no additional benefit
Encorafenib Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with binimetinib 1,390 100% no additional benefit
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
Lenvatinib (3) Lenvima® Eisai GmbH Oncological diseases Hepatocellular carcinoma (HCC) 2,630–4,750 100% no additional benefit
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
Mepolizumab (2) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, ≥ 6 to < 18 years 2,200–3,500 100% no additional benefit
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
Tenofoviralafenamid (2, reassessment) Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 12,400–38,100 100% no additional benefit
Caplacizumab Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases Thrombotic thrombocytopenic purpura (TTP) 150 100% non-quantifiable additional benefit Orphan
Vestronidase alfa Mepsevii® Ultragenyx Germany GmbH Metabolic diseases Mucopolysaccharidosis (MPS VII; Sly syndrome) 2–7 100% non-quantifiable additional benefit Orphan
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)
Tisagenlecleucel Kymriah® Novartis Pharma GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 0
440–700
100% non-quantifiable additional benefit Orphan
Tisagenlecleucel (2) Kymriah® Novartis Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 0
50–65
100% non-quantifiable additional benefit Orphan
Tofacitinib (4) Xeljanz® Pfizer Pharma GmbH Skin diseases Psoriatic arthritis (PA) 25,900 69% Hint for minor additional benefit
Tofacitinib (3) Xeljanz® Pfizer Pharma GmbH Digestive system diseases Ulcerative colitis 5,300–25,000 100% no additional benefit
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
Gemtuzumab Ozogamicin Mylotarg® Pfizer Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML) 560–1,150 100% non-quantifiable additional benefit Orphan
Bosutinib (3, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+ 545–555 100% no additional benefit
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
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
Osimertinib (3) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 860–2,030 84% Hint for considerable additional benefit
Ipilimumab (4) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, combination with nivolumab 2,500–4,500 85% no additional benefit
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
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
Bictegravir / Emtricitabin / Tenofoviralafenamid Biktarvy® Gilead Sciences GmbH Infectious diseases HIV infection 66,800 100% no additional benefit
Velmanase alfa Lamzede® Chiesi GmbH Metabolic diseases Alpha mannosidosis 70–140 100% non-quantifiable additional benefit Orphan
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
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
Dolutegravir / Rilpivirin Juluca® ViiV Healthcare GmbH Infectious diseases HIV infection 53,000 100% no additional benefit
Bosutinib (2) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 0
690–810
100% no additional benefit
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
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
Tofacitinib (2, reassessment) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 0
29,490–63,815
100% no additional benefit
Rurioctocog alfa pegol Adynovi® Shire Deutschland GmbH Hematopoietic diseases Hemophilia A, ≥ 12 years 2,840–3,190 100% no additional benefit
Hydrocortison Alkindi® Diurnal Ltd. Metabolic diseases Adrenal insufficiency, < 18 years 780–1,180 100% no additional benefit
Ertugliflozin / Sitagliptin Steglujan® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2 326,100–341,100 100% no additional benefit
Cariprazin Reagila® Recordati Pharma GmbH Mental illnesses Schizophrenia 224,000–299,000 21% Indication of minor additional benefit
Burosumab Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 0
200–500
100% non-quantifiable additional benefit Orphan
Bezlotoxumab Zinplava® MSD Sharp & Dohme GmbH Infectious diseases Prevention of recurrent Clostridium difficile infection 6,800–37,600 100% Indication of minor additional benefit
Emicizumab Hemlibra® Roche Pharma AG Hematopoietic diseases Hemophilia A 100 50% Hint for non-quantifiable additional benefit
Patiromer Veltassa® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Hyperkalemia 61,700 100% no additional benefit
Glycopyrroniumbromid Sialanar® Proveca Limited Other diseases Sialorrhea 2,800–3,100 100% Hint for non-quantifiable additional benefit
Evolocumab (2, reassessment) Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 271,500 100% no additional benefit
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
Glycerolphenylbutyrat Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases Urea cycle disorders (UCD), ≥ 2 months 100–250 100% non-quantifiable additional benefit Orphan
Ixekizumab (2) Taltz® Lilly Deutschland GmbH Skin diseases Psoriatic arthritis (PA) 29,100 35% Hint for minor additional benefit
Insulin glargin / Lixisenatid Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 461,400–472,500 100% no additional benefit
Sonidegib Odomzo® Sun Pharmaceuticals Germany GmbH Oncological diseases Basal cell carcinoma (BCC) 130–350 100% no additional benefit
Benralizumab Fasenra® AstraZeneca GmbH Respiratory system diseases Bronchial asthma 6,800–80,000 50% Hint for minor additional benefit
Letermovir Prevymis® MSD Sharp & Dohme GmbH Infectious diseases Cytomegalovirus infection 0
1,000–1,800
100% non-quantifiable additional benefit Orphan
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment) Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma 0 resolution w/o assessement
Ipilimumab (3) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, ≥ 12 to < 18 years 1–5 100% no additional benefit
Ocrelizumab Ocrevus® Roche Pharma AG Nervous system diseases Multiple sclerosis (MS) 165,300–182,200 81% Proof of minor additional benefit
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
Brentuximab Vedotin (3) Adcetris® Takeda Pharma GmbH Oncological diseases Cutaneous T-cell lymphoma, CD30+ 40–130 100% minor additional benefit Orphan
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 6 to < 12 years 100 100% no additional benefit
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
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
Dapagliflozin / Metformin (2, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 0
468,700
100% no additional benefit
Dapagliflozin (2, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 0
468,700
100% no additional benefit
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
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
Cladribin Mavenclad® Merck Serono GmbH Nervous system diseases Highly active relapsing multiple sclerosis (MS) 40,300–41,000 100% no additional benefit
Dupilumab Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD) 52,000 100% Indication of considerable additional benefit
Guselkumab Tremfya® Janssen-Cilag GmbH Skin diseases Plaque psoriasis (PP) 52,200–234,400 45% Proof of considerable additional benefit
Perampanel (3) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, primary generalised seizures, ≥ 12 years 15,600–50,700 100% no additional benefit
Cenegermin Oxervate® Dompé farmaceutici S.p.A Eye diseases Keratitis 1,730–3,170 100% non-quantifiable additional benefit Orphan
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) Stribild® Gilead Sciences GmbH Infectious diseases HIV infection, 12 to < 18 years 100 100% no additional benefit
Tivozanib Fotivda® EUSA Pharma GmbH Oncological diseases Renal cell carcinoma (RCC) 2,953–7,126 100% no additional benefit
Nonacog beta pegol Refixia® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia B, ≥ 12 years 500–570 100% no additional benefit
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
Telotristatethyl Xermelo® Ipsen Pharma GmbH Oncological diseases Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy 300–1,000 100% non-quantifiable additional benefit Orphan
Midostaurin Rydapt® Novartis Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM) 0
400–710
80% considerable additional benefit Orphan
Obinutuzumab (3) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL), first-line 0
1,300–1,500
100% non-quantifiable additional benefit Orphan
Sofosbuvir (2) Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, 12 to < 18 years 1,025 100% Hint for non-quantifiable additional benefit
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
Pembrolizumab (5) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC) 0
2,300–3,300
61% Indication of considerable additional benefit
Elosulfase alfa (2, reassessment) Vimizim® BioMarin Deutschland GmbH Metabolic diseases Mucopolysaccharidosis (type IVA) 20–100 100% minor additional benefit Orphan
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
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
Avelumab Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Merkel-cell carcinoma (MCC) 0
160–410
100% non-quantifiable additional benefit Orphan
Dimethylfumarat (2, Skilarence®) Skilarence® Almirall Hermal GmbH Skin diseases Plaque psoriasis (PP) 52,200–234,100 100% no additional benefit
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid Symtuza® Janssen-Cilag GmbH Infectious diseases HIV infection 62,050 100% no additional benefit
Brodalumab Kyntheum® LEO Pharma GmbH Skin diseases Plaque psoriasis (PP) 52,200–234,400 45% Indication of non-quantifiable additional benefit
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)
Sarilumab Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 87,300–184,470 34% Hint for considerable additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 104,600 100% no additional benefit
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)
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
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
Glecaprevir / Pibrentasvir Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 104,600 100% no additional benefit
Ceritinib (3) Zykadia® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, first-line 430–850 100% no additional benefit
Inotuzumab Ozogamicin Besponsa® Pfizer Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 120–200 100% minor additional benefit Orphan
Nivolumab (9) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma (UC) 1,500–1,900 100% no additional benefit
Nusinersen Spinraza® Biogen GmbH Nervous system diseases Spinal muscular atrophy (SMA) 0
840–1,060
10% major additional benefit Orphan
Cerliponase alfa Brineura® BioMarin Deutschland GmbH Metabolic diseases Neuronal ceroid lipofuscinosis type 2 0
20–40
100% non-quantifiable additional benefit Orphan
Blinatumomab (2, reassessment) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 60–170 100% considerable additional benefit Orphan
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
Etelcalcetid Parsabiv® Amgen GmbH Metabolic diseases Secondary hyperparathyroidism (HPT) 21,896–26,360 100% no additional benefit
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
Rolapitant Varuby® TESARO Bio Germany GmbH Other diseases Nausea and vomiting due to chemotherapy 157,700–279,700 100% no additional benefit
Pembrolizumab (4) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Hodgkin lymphoma (HL) 60–180 100% no additional benefit
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
Trametinib (2) Mekinist® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation 230–720 100% no additional benefit
Tofacitinib Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 0
87,300–184,470
100% no additional benefit
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
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
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
Tenofoviralafenamid Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 0
12,400–38,100
100% no additional benefit
Dolutegravir (2) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, 6 to < 12 years 110 100% no additional benefit
Baricitinib Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 87,300–184,470 100% no additional benefit
Secukinumab (3, reassessment) Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP) 19,800–137,300 100% Indication of considerable additional benefit
Ixekizumab Taltz® Lilly Deutschland GmbH Skin diseases Plaque psoriasis (PP) 52,200–234,400 55% Indication of considerable additional benefit
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
Lonoctocog alfa Afstyla® CSL Behring GmbH Hematopoietic diseases Hemophilia A 3,190–3,590 100% no additional benefit
Obeticholsäure Ocaliva® Intercept Pharma Deutschland GmbH Digestive system diseases Biliary cirrhosis 0
1,050–7,350
100% non-quantifiable additional benefit Orphan
Reslizumab Cinqaero® Teva GmbH Respiratory system diseases Bronchial asthma 4,800–12,000 50% Hint for minor additional benefit
Vandetanib (3) Caprelsa® Genzyme GmbH Oncological diseases Thyroid carcinoma, ≥ 5 years 2–8 100% Hint for non-quantifiable additional benefit
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
Elbasvir / Grazoprevir Zepatier® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 64,800 100% no additional benefit
Nivolumab (6) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Hodgkin lymphoma (HL) 40–90 100% no additional benefit
Venetoclax Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 0
300–700
100% non-quantifiable additional benefit Orphan
Palbociclib Ibrance® Pfizer Pharma GmbH Oncological diseases Breast cancer (BC) 1,190–5,760
14,560–70,550
100% no additional benefit
Olaratumab Lartruvo® Lilly Deutschland GmbH Oncological diseases Soft tissue sarcoma 0
1,200–1,400
100% considerable additional benefit Orphan
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
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)
Opicapon Ongentys® Bial-Portela & Ca, S.A. Nervous system diseases Morbus Parkinson 45,200–61,100 100% no additional benefit
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
Crizotinib (4) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+ 210–770 100% no additional benefit
Lenvatinib (2, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 0
1,200–3,300
100% Hint for minor additional benefit
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
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)
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
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
Teduglutid (2) Revestive® Shire Deutschland GmbH Digestive system diseases Short bowel syndrome, 1 to < 18 years 230–500 100% non-quantifiable additional benefit Orphan
Tasimelteon Hetlioz® Vanda Pharmceutical Inc Nervous system diseases Sleep disorders (sleep-wake rhythm), blind adults 7,000 100% non-quantifiable additional benefit Orphan
Pitolisant Wakix® Bioprojet Pharma SARL Nervous system diseases Narcolepsy 15,000–30,000 100% non-quantifiable additional benefit Orphan
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
Carfilzomib (2) Kyprolis® Amgen GmbH Oncological diseases Multiple myeloma (MM), combination with dexamethasone 0
4,700–7,000
100% minor additional benefit Orphan
Emtricitabin / Rilpivirin / Tenofoviralafenamid Odefsey® Gilead Sciences GmbH Infectious diseases HIV infection 56,800–59,300 100% no additional benefit
Sofosbuvir / Velpatasvir Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 100,000 28% Hint for considerable additional benefit
Ibrutinib (3) Imbruvica® Janssen-Cilag GmbH Oncological diseases Chronic lymphocytic leukemia (CLL), first-line 2,840 100% no additional benefit Orphan (turnover limit)
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
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
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
Saxagliptin (2, reassessment) Onglyza® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, combination therapy 1,182,900–1,382,900 100% no additional benefit
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
Obinutuzumab (2) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL) 0
790–940
100% non-quantifiable additional benefit Orphan
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
Selexipag Uptravi® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH) 580–7,850 100% no additional benefit
Eftrenonacog alfa Alprolix® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia B 0
580–660
100% non-quantifiable additional benefit Orphan
Talimogen laherparepvec Imlygic® Amgen GmbH Oncological diseases Melanoma, stage IIIB, IIIC, IVMI1a 375–620 100% no additional benefit
Eribulin (3) Halaven® Eisai GmbH Oncological diseases Liposarcoma 30–150 50% Hint for considerable additional benefit
Albutrepenonacog alfa Idelvion® CSL Behring GmbH Hematopoietic diseases Hemophilia B 0
580–660
100% non-quantifiable additional benefit Orphan
Migalastat Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease 0
20–490
100% non-quantifiable additional benefit Orphan
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
Ataluren (2, reassessment) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 30–40 100% minor additional benefit Orphan
Daratumumab Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), monotherapy, pre-treated patients 0
2,300
100% non-quantifiable additional benefit Orphan
Emtricitabin / Tenofoviralafenamid Descovy® Gilead Sciences GmbH Infectious diseases HIV infection 63,000 100% no additional benefit
Ospemifen Senshio® Shionogi GmbH Genitourinary system diseases Vulvovaginal atrophy 133,400–151,800 100% no additional benefit
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
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
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
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
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
Necitumumab Portrazza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 6,300–7,700 100% no additional benefit
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
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
Empagliflozin / Metformin Synjardy® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 615,299–615,301 100% no additional benefit
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
Ramucirumab (3) Cyramza® Lilly Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 2,900–7,300 100% no additional benefit
Ramucirumab (2) Cyramza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 5,900–15,400 100% no additional benefit
Afamelanotid Scenesse® Clinuvel Ltd. Metabolic diseases Erythropoietic protoporphyria 0
540–1,090
100% non-quantifiable additional benefit Orphan
Brivaracetam Briviact® UCB Pharma GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 16 years 86,000–200,000 100% no additional benefit
Vismodegib (2, reassessment) Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 295 95% Hint for minor additional benefit
Umeclidinium Incruse® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,342,000–2,765,000 100% no additional benefit
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)
Mepolizumab Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma 16,000–100,000 50% Hint for minor additional benefit
Rilpivirin (2) Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection, 12 to < 18 years 10 100% no additional benefit
Sacubitril / Valsartan Entresto® Novartis Pharma GmbH Cardiovascular diseases Symptomatic chronic heart failure 550,000–1,350,000 68% Hint for considerable additional benefit
Efmoroctocog alfa Elocta® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia A 3,190–3,590 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection 56,800 100% no additional benefit
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
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
Blinatumomab Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 0
60–170
100% non-quantifiable additional benefit Orphan
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
Cobimetinib Cotellic® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation, combination with vemurafenib 1,400 100% Indication of considerable additional benefit
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
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
Aflibercept (6) Eylea® Bayer Vital GmbH Eye diseases Myopic choroidal neovascularisation 27,500–80,000 100% no additional benefit
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
Alirocumab Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolemia or mixed dyslipidaemia 1,500
273,250
100% no additional benefit
Isavuconazol Cresemba® Basilea Pharmaceutica International Ltd. Infectious diseases Aspergillosis, mucormycosis 1,293–5,342 100% non-quantifiable additional benefit Orphan
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
Trametinib Mekinist® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation 1,400 50% Indication of considerable additional benefit
Sebelipase alfa Kanuma® Synageva BioPharma Limited Metabolic diseases Lysosomal acid lipase deficiency 0
31–843
100% non-quantifiable additional benefit Orphan
Regorafenib (3, reassessment) Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 6,900–12,200 100% no additional benefit
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)
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
Idebenon Raxone® Santhera Pharmaceuticals Eye diseases Leber hereditary optic neuropathy 0
1,500–3,000
100% non-quantifiable additional benefit Orphan
Dabrafenib (2) Tafinlar® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with trametinib 1,400 100% Indication of considerable additional benefit
Asfotase alfa Strensiq® Alexion Europe SAS Metabolic diseases Hypophosphatasia (HPP) 0
1,000
100% non-quantifiable additional benefit Orphan
Evolocumab Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 1,810–1,819
273,310–273,319
100% no additional benefit
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
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
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
Pembrolizumab Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma 2,500–4,500 71% Indication of considerable additional benefit
Netupitant / Palonosetron Akynzeo® RIEMSER Pharma GmbH Other diseases Nausea and vomiting due to chemotherapy 157,700–279,700 100% no additional benefit
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
Gaxilose LacTest™ VENTER PHARMA S.L. Metabolic diseases Diagnosis of hypolactasia 180,000–230,000 100% no additional benefit
Edoxaban Lixiana® Daiichi Sankyo Deutschland GmbH Cardiovascular diseases Prophylaxis of thromboembolic events 1,167,000–1,334,000 81% Indication of minor additional benefit
Nivolumab Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma 2,500–4,500 15% Indication of considerable additional benefit
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
Lenvatinib Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 0
600–815
100% non-quantifiable additional benefit Orphan
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
Lomitapid (2, reassessment) Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases Hypercholesterolemia 60–69 100% no additional benefit
Secukinumab Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP) 32,400–97,100
52,200–234,400
8% Indication of considerable additional benefit
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
Ivermectin Soolantra® Galderma Laboratorium GmbH Skin diseases Inflammatory lesions of rosacea 0
309,000–703,000
100% no additional benefit
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
Safinamid Xadago® Zambon S.p.A. Nervous system diseases Morbus Parkinson 45,200–61,100 100% no additional benefit
Vortioxetin Brintellix® Lundbeck GmbH Mental illnesses Major depression 3,369,000–3,669,000 100% no additional benefit
Insulin degludec / Liraglutid Xultophy® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 752,000–903,000 100% no additional benefit
Ruxolitinib (3) Jakavi® Novartis Pharma GmbH Oncological diseases Polycythaemia vera 240–1,470 100% Hint for considerable additional benefit Orphan (turnover limit)
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
Eliglustat Cerdelga® Genzyme GmbH Metabolic diseases Sphingolipidoses (Gaucher disease type 1) 150–500 100% non-quantifiable additional benefit Orphan
Aflibercept (5) Eylea® Bayer Vital GmbH Eye diseases Macular edema following retinal branch vein occlusion 23,100–60,000 100% no additional benefit
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
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
Apremilast Otezla® Celgene GmbH Skin diseases Plaque psoriasis (PP); Psoriatic arthritis (PA) 50,800–140,500 100% no additional benefit
Ombitasvir / Paritaprevir / Ritonavir Viekirax® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 54,800 9% Indication of considerable additional benefit
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
Dasabuvir Exviera® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 61,700 24% Indication of considerable additional benefit
Dulaglutid Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 0
1,705,500–1,905,500
31% Hint for minor additional benefit
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
Pasireotid (2) Signifor® Novartis Pharma GmbH Metabolic diseases Acromegaly 265–1,133 100% minor additional benefit Orphan
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
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
Tafluprost / Timolol Taptiqom® Santen GmbH Eye diseases Reduction of intraocular pressure in patients with glaucoma/hypertension 95,600 100% no additional benefit
Ataluren Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 0
82–110
100% minor additional benefit Orphan
Vildagliptin (2, reassessment) Galvus® Novartis Pharma GmbH Metabolic diseases Diabetes mellitus type 2 35,900 100% no additional benefit
Ledipasvir / Sofosbuvir Harvoni® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 74,100 79% Hint for considerable additional benefit
Alipogentiparvovec Glybera® Chiesi GmbH Metabolic diseases Familial lipoprotein lipase deficiency 17–35 100% non-quantifiable additional benefit Orphan
Simoctocog alfa Nuwiq® Octapharma GmbH Hematopoietic diseases Hemophilia A 3,190–3,585 100% no additional benefit
Lurasidon Latuda® Takeda Pharma GmbH Mental illnesses Schizophrenia 250,000 100% no additional benefit
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
Albiglutid Eperzan® GlaxoSmithKline GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 1,705,400–1,905,400 35% Indication of minor additional benefit
Dolutegravir / Abacavir / Lamivudin Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 54,398 9% Indication of considerable additional benefit
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
Sipuleucel-T Provenge® Dendreon UK Limited Oncological diseases Prostate carcinoma (PC) 11,690–24,480 100% Hint for non-quantifiable additional benefit
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
Aflibercept (4) Eylea® Bayer Vital GmbH Eye diseases Diabetic macular edema 128,350–132,360 100% no additional benefit
Teduglutid Revestive® NPS Pharma Germany GmbH Digestive system diseases Short bowel syndrome 1,100–2,400 100% minor additional benefit Orphan
Daclatasvir Daklinza® Bristol-Myers Squibb GmbH & Co. KGaA Infectious diseases Chronic hepatitis C 70,500 1.4% Hint for considerable additional benefit
Regorafenib (2) Stivarga® Bayer Vital GmbH Oncological diseases Gastrointestinal stromal tumor (GIST) 100–700 100% no additional benefit
Propranolol Hemangiol® Pierre Fabre Dermatologie Other diseases Infantile hemangioma 1,668–6,999 33% Indication of major additional benefit
Nalmefen Selincro® Lundbeck GmbH Mental illnesses Reduction of alcohol consumption in alcohol dependence 220,000–248,000 100% no additional benefit
Ivacaftor (2) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases Cystic fibrosis (CF), various mutations, ≥ 6 years 0
10–11
100% minor additional benefit Orphan
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
Obinutuzumab Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 0
818–1,477
100% non-quantifiable additional benefit Orphan
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
Canagliflozin / Metformin Vokanamet® Janssen-Cilag GmbH Metabolic diseases Diabetes mellitus type 2 615,300 100% no additional benefit
Cabozantinib Cometriq® Swedish Orphan Biovitrum GmbH Oncological diseases Thyroid carcinoma (MTC) 0
60–500
100% minor additional benefit Orphan
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
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
Vedolizumab Entyvio® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases Ulcerative colitis, Crohn's disease 16,100 100% no additional benefit
Fingolimod (2) Gilenya® Novartis Pharma GmbH Nervous system diseases Multiple sclerosis (MS), pre-treated 0
8,240–8,390
100% no additional benefit
Siltuximab Sylvant® Janssen-Cilag GmbH Oncological diseases Multicentric Castleman Disease (MCD) 130–1,460 100% non-quantifiable additional benefit Orphan
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
Simeprevir Olysio® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 64,800 91% Indication of considerable additional benefit
Elosulfase alfa Vimizim® BioMarin Deutschland GmbH Metabolic diseases Mucopolysaccharidosis (type IVA) 0
15–95
100% minor additional benefit Orphan
Mirabegron Betmiga® Astellas Pharma GmbH Genitourinary system diseases Imperative desire to urinate 7,422,000 100% no additional benefit
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
Perampanel (2, reassessment) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 70,600–106,800 100% no additional benefit
Cholsäure Orphacol® Laboratoires CTRS Metabolic diseases Bile acid synthesis disorder 10–25 100% non-quantifiable additional benefit Orphan
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)
Dimethylfumarat Tecfidera® Biogen GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 85,000–105,000 100% no additional benefit
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
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
Cobicistat Tybost® Gilead Sciences GmbH Infectious diseases HIV infection 57,400 100% no additional benefit
Canagliflozin Invokana® Janssen-Cilag GmbH Metabolic diseases Diabetes mellitus type 2 1,253,400–1,453,400 100% no additional benefit
Dapagliflozin / Metformin Xigduo® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 0
615,300
100% no additional benefit
Dolutegravir Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 57,399 11% Proof of considerable additional benefit
Olodaterol Striverdi® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 0 100% no additional benefit
Sofosbuvir Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 99,841 4% Indication of considerable additional benefit
Macitentan Opsumit® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH) 0
580–7,850
100% minor additional benefit Orphan
Retigabin (3, reassessment) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 26,800–53,600 100% no additional benefit
Turoctocog alfa NovoEight® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia A 3,190–3,585 100% no additional benefit
Trastuzumab Emtansin Kadcyla® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, pre-treated patients 4,121 72% Indication of considerable additional benefit
Radium-223-dichlorid Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 0
22,700
78% Indication of considerable additional benefit
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2) Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection 46,000 100% no additional benefit
Lomitapid Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases Hypercholesterolemia 0
61–71
100% no additional benefit
Ipilimumab (2) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, first-line 500–1,500 100% no additional benefit
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
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
Dabrafenib Tafinlar® GlaxoSmithKline GmbH & Co. KG Oncological diseases Melanoma, BRAF V600 mutation 1,400 100% no additional benefit
Teriflunomid Aubagio® sanofi-aventis groupe / Genzyme GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 85,000–105,000 100% no additional benefit
Regorafenib Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 0
6,600–14,000
100% Hint for minor additional benefit
Aflibercept (3) Eylea® Bayer Vital GmbH Eye diseases Macular edema following retinal vein occlusion 19,600–21,200 100% no additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, COPD 0 100% no additional benefit
Vemurafenib (2, reassessment) Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 1,400 100% Indication of considerable additional benefit
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
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
Vismodegib Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 0
295
95% Hint for minor additional benefit
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
Nepafenac Nevanac® Alcon Pharma GmbH Eye diseases Postoperative pain after eye surgery 850,000–1,000,000 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil Stribild® Gilead Sciences GmbH Infectious diseases HIV infection 49,800 100% no additional benefit
Lisdexamfetamindimesilat Elvanse® Shire Deutschland GmbH Mental illnesses Attention deficit hyperactivity disorder (ADHD), ≥ 6 to < 18 29,600–59,600 100% no additional benefit
Ocriplasmin Jetrea® ThromboGenics NV / Alcon Pharma GmbH Eye diseases Vitreomacular traction (VMT) 0
9,970–39,300
95% Hint for considerable additional benefit
Linaclotid Constella® Almirall Hermal GmbH Digestive system diseases Irritable bowel syndrome (IBS) 394,000–838,000 100% no additional benefit
Bosutinib Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML) 0
380–500
100% non-quantifiable additional benefit Orphan
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
Vildagliptin / Metformin Eucreas® Novartis Pharma GmbH Metabolic diseases Diabetes mellitus type 2 792,050–811,850 100% no additional benefit
Sitagliptin / Metformin Janumet® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2 0
792,050–810,850
78% Hint for minor additional benefit
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
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
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
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
Colestilan BindRen® Mitsubishi Pharma Deutschland GmbH Other diseases Hyperphosphatemia 44,500–57,000 100% no additional benefit
Vandetanib (2, reassessment) Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 0
60–1,500
100% Hint for minor additional benefit
Lixisenatid Lyxumia® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 903,000 100% no additional benefit
Aflibercept (2, Zaltrap®) Zaltrap® Sanofi-Aventis Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 3,500–10,400 100% Indication of minor additional benefit
Ingenolmebutat Picato® LEO Pharma GmbH Skin diseases Actinic keratosis (AK) 0
1,112,000–3,253,000
100% no additional benefit
Fidaxomicin Dificlir® Astellas Pharma GmbH Infectious diseases Clostridium difficile infections 33,300 41% Proof of considerable additional benefit
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
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
Dapagliflozin Forxiga® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 0
896,100
100% no additional benefit
Aflibercept Eylea® Bayer Vital GmbH Eye diseases Neovascular age-related macular degeneration 305,000 100% no additional benefit
Pixantron Pixuvri® CTI Life Sciences Ltd. Oncological diseases B-Cell Non-Hodgkin Lymphoma (NHL) 970 100% no additional benefit
Linagliptin (3) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 450,000–650,000 100% no additional benefit
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
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
Decitabin Dacogen® Janssen-Cilag GmbH Oncological diseases Acute myeloid leukaemia (AML) 300–780 100% minor additional benefit Orphan
Crizotinib Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 0
480
71% Hint for considerable additional benefit
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
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
Ruxolitinib Jakavi® Novartis Pharma GmbH Oncological diseases Myelofibrosis (MF) 0
1,600
100% minor additional benefit Orphan
Perampanel Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 0
70,600–106,800
100% no additional benefit
Linagliptin (2, reassessment) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 1,219,500 100% no additional benefit
Ivacaftor Kalydeco® Vertex Pharmaceuticals GmbH Metabolic diseases Cystic fibrosis (CF), G551D mutation, ≥ 6 years 0
170
84% considerable additional benefit Orphan
Tegafur / Gimeracil / Oteracil Teysuno® Nordic Pharma GmbH Oncological diseases Gastric carcinoma 10,500–12,000 100% no additional benefit
Pasireotid Signifor® Novartis Pharma GmbH Metabolic diseases Pituitary dysfunction 160–360 100% minor additional benefit Orphan
Vemurafenib Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 0
1,400
100% Indication of considerable additional benefit
Vandetanib Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 0
130–1,300
100% no additional benefit
Ipilimumab Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, second-line 3,100 100% Indication of considerable additional benefit
Belimumab Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 7,000 100% Indication of considerable additional benefit
Fampridin Fampyra® Biogen GmbH Nervous system diseases Multiple sclerosis (MS) 43,100–49,900 100% no additional benefit
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
Emtricitabin / Rilpivirin / Tenofovirdisoproxil Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection, non-pretreated patients 1,260 100% Proof of minor additional benefit
Rilpivirin Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection 1,260 100% Proof of minor additional benefit
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
Tafamidis Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid Neuropathy 0
40–104
100% minor additional benefit Orphan
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
Aliskiren / Amlodipin Rasilamlo® Novartis Pharma GmbH Cardiovascular diseases Essential hypertension, add-on therapy 156,600–565,900 100% no additional benefit
Retigabin Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 0
85,000–175,000
100% no additional benefit
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
Collagenase aus Clostridium histolyticum Xiapex® Pfizer Pharma GmbH Musculoskeletal system diseases Dupuytren's contracture 35,000 100% no additional benefit
Telaprevir Incivo® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 46,000 100% Indication of non-quantifiable additional benefit
Regadenoson Rapiscan® Rapidscan Pharma Solutions EU Ltd. Other diseases Myocardial perfusion imaging 41,000 100% no additional benefit
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
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
Linagliptin Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 0
1,219,500
100% no additional benefit
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
Azilsartan Medoxomil Edarbi® Takeda Pharma GmbH Cardiovascular diseases Arterial hypertension 0 100% no additional benefit
Pirfenidon Esbriet® InterMune Deutschland GmbH Respiratory system diseases Idiopathic pulmonary fibrosis 6,000 100% non-quantifiable additional benefit Orphan
Boceprevir Victrelis® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 46,000 100% Indication of non-quantifiable additional benefit
Bromfenac Yellox® Bausch & Lomb / Dr. Mann Pharma Eye diseases Postoperative inflammation of the eye 850,000–1,000,000 100% no additional benefit
Ticagrelor Brilique® AstraZeneca GmbH Cardiovascular diseases Prevention of atherothrombotic events in acute coronary syndrome 220,000–269,000 82% Proof of considerable additional benefit
Pitavastatin Livazo® Merckle Recordati GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 0 100% no additional benefit