15.02.2026
06.08.2026
Zanidatamab (1)
Ziihera®
Jazz Pharmaceuticals Ireland Limited
Oncological diseases
Biliary carcinoma, HER2+ (IHC3+), previously treated
30–160
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2026
06.08.2026
Selumetinib (5)
Koselugo®
Alexion Pharma Germany GmbH
Oncological diseases
Neurofibromatosis type 1 (≥ 1 to < 3 years)
55–95
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.02.2026
16.07.2026
Mirvetuximab-Soravtansin (2)
Elahere®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Ovarian cancer, fallopian tube cancer or primary peritoneal cancer, FRα-positive, platinum-resistant, following 1 to 3 prior treatments
630–1,300
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
15.01.2026
02.07.2026
Tafasitamab (2)
Minjuvi®
Incyte Biosciences Germany GmbH
Oncological diseases
Follicular lymphoma, following ≥ 1 prior line of treatment, in combination with lenalidomide and rituximab
1,050–2,350
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2026
02.07.2026
Toripalimab (2)
Loqtorzi®
LEO Pharma GmbH
Oncological diseases
Squamous cell carcinoma of the oesophagus, first-line treatment, in combination with cisplatin and paclitaxel
2,600
100%
additional benefit not proven
15.01.2026
02.07.2026
Toripalimab (1)
Loqtorzi®
LEO Pharma GmbH
Oncological diseases
Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line treatment, in combination with cisplatin and gemcitabine
70–120
100%
additional benefit not proven
01.01.2026
18.06.2026
Selpercatinib (9)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, RET-fusion+, first-line treatment
155–270
100%
additional benefit not proven
15.12.2025
04.06.2026
Nivolumab (33)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma, PD-L1 expression ≥ 1 %, adjuvant therapy
680–830
100%
Hint for
considerable additional benefit
15.12.2025
04.06.2026
Lisocabtagen maraleucel (4)
Breyanzi®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Mantle cell lymphoma, following ≥ 2 prior treatments
105–150
100%
additional benefit not proven
15.12.2025
04.06.2026
Cemiplimab (6)
Libtayo®
Regeneron GmbH
Oncological diseases
Cutaneous squamous cell carcinoma, following resection and radiotherapy, adjuvant therapy
690–1,420
100%
Indication of
non-quantifiable additional benefit
01.12.2025
21.05.2026
Asciminib (3)
Scemblix®
Novartis Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia, Philadelphia chromosome-positive, chronic phase (Ph+ CML-CP)
7,130–7,330
80%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.12.2025
21.05.2026
Pembrolizumab (41)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Resectable locally advanced squamous cell carcinoma of the head and neck, PD-L1 expression ≥ 1 per cent, neoadjuvant and adjuvant therapy, in combination with radiotherapy with or without concomitant cisplatin therapy
2,550–4,240
86%
Hint for
minor additional benefit
15.11.2025
07.05.2026
Selumetinib (4)
Koselugo®
Alexion Pharma Germany GmbH
Oncological diseases
Neurofibromatosis type 1 (aged 18 years and over)
515–920
100%
Indication of
minor additional benefit
Orphan (turnover limit)
15.11.2025
07.05.2026
Selumetinib (3)
Koselugo®
Alexion Pharma Germany GmbH
Oncological diseases
Neurofibromatosis type 1 (aged ≥ 3 to < 18 years)
515–920
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.11.2025
07.05.2026
Vorasidenib (1)
Voranigo®
Servier Deutschland GmbH
Oncological diseases
Astrocytoma or oligodendroglioma, grade 2, IDH1-R132 or IDH2-R172 mutation, following surgical intervention, aged ≥ 12 years and weighing ≥ 40 kg
380–800
100%
Hint for
non-quantifiable additional benefit
Orphan
01.11.2025
07.05.2026
Avapritinib (4)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Indolent systemic mastocytosis (ISM)
715–1,000
100%
Hint for
minor additional benefit
Orphan (turnover limit)
01.11.2025
16.04.2026
Avapritinib (6)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Gastrointestinal stromal tumours
5–60
100%
additional benefit not proven
Orphan (turnover limit)
01.11.2025
16.04.2026
Avapritinib (5)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Advanced systemic mastocytosis, following at least one prior course of treatment
260–680
100%
additional benefit not proven
Orphan (turnover limit)
01.11.2025
16.04.2026
Momelotinib (2)
Omjjara®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Myelofibrosis
680–2,680
100%
additional benefit not proven
Orphan (turnover limit)
01.11.2025
16.04.2026
Vimseltinib (1)
Romvimza®
Deciphera Pharmaceuticals (Netherlands) B.V.
Oncological diseases
Symptomatic tenosynovial giant cell tumours
160–1,140
100%
Indication of
considerable additional benefit
Orphan
15.10.2025
02.04.2026
Nirogacestat (1)
Ogsiveo®
SpringWorks Therapeutics Ireland Limited
Oncological diseases
Desmoid tumour, advanced
350–630
100%
Hint for
minor additional benefit
Orphan
01.10.2025
19.03.2026
Trastuzumab deruxtecan (7)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction, following trastuzumab-based therapy
360–600
100%
Indication of
minor additional benefit
01.10.2025
19.03.2026
Tislelizumab (9)
Tevimbra®
BeOne Medicines Germany GmbH
Oncological diseases
Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy
5,090–5,780
100%
additional benefit not proven
01.10.2025
19.03.2026
Tislelizumab (8)
Tevimbra®
BeOne Medicines Germany GmbH
Oncological diseases
Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line treatment, in combination with gemcitabine and cisplatin
70–120
100%
additional benefit not proven
01.10.2025
19.03.2026
Tislelizumab (7)
Tevimbra®
BeOne Medicines Germany GmbH
Oncological diseases
Small cell lung cancer, first-line treatment, in combination with etoposide and platinum-based chemotherapy
3,820–8,124
100%
additional benefit not proven
01.10.2025
19.03.2026
Mirdametinib (1)
Ezmekly®
SpringWorks Therapeutics Ireland Limited
Oncological diseases
Plexiform neurofibromas (PN), neurofibromatosis type 1 (NF1); ≥ 2 years
515–920
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2025
19.03.2026
Linvoseltamab (1)
Lynozyfic®
Regeneron GmbH
Oncological diseases
Multiple myeloma, at least 3 prior treatments, monotherapy
330–340
100%
additional benefit not proven
01.09.2025
19.02.2026
Tisotumab vedotin (1)
Tivdak®
Genmab Germany GmbH
Oncological diseases
Cervical cancer, previously treated
381–1,452
100%
additional benefit not proven
15.08.2025
19.02.2026
Daratumumab (15)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Smouldering multiple myeloma (SMM)
160–325
100%
Hint for
minor additional benefit
Orphan (turnover limit)
15.08.2025
19.02.2026
Daratumumab (14)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, unsuitable for stem cell transplantation, in combination with bortezomib, lenalidomide and dexamethasone
3,450–3,680
100%
Hint for
minor additional benefit
Orphan (turnover limit)
15.08.2025
19.02.2026
Isatuximab (4)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma, first-line treatment, suitable for stem cell transplantation, in combination with bortezomib, lenalidomide and dexamethasone
1,750–1,910
100%
additional benefit not proven
15.08.2025
19.02.2026
Darolutamid (3)
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Metastatic, hormone-sensitive prostate cancer, in combination with androgen deprivation therapy
2,590–3,640
100%
additional benefit not proven
15.08.2025
19.02.2026
Inavolisib (1)
Itovebi®
Roche Pharma AG
Oncological diseases
Breast cancer, PIK3CA-mutated, ER+, HER2-, locally advanced or metastatic, recurrence < 12 months after adjuvant endocrine therapy, in combination with palbociclib and fulvestrant
868–3,625
50%
Hint for
considerable additional benefit
01.08.2025
22.01.2026
Odronextamab (2)
Ordspono®
Regeneron GmbH
Oncological diseases
Follicular lymphoma, following ≥ 2 prior treatments
370–840
100%
additional benefit not proven
01.08.2025
22.01.2026
Odronextamab (1)
Ordspono®
Regeneron GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments
960–2,130
100%
additional benefit not proven
01.08.2025
22.01.2026
Durvalumab (11)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Muscle-invasive bladder cancer (MIBC), neoadjuvant/adjuvant therapy following cystectomy, in combination with gemcitabine and cisplatin
4,310–5,730
100%
Indication of
minor additional benefit
01.08.2025
22.01.2026
Durvalumab (10)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-advanced small cell lung cancer, following platinum-based chemoradiotherapy, monotherapy
670–1,750
100%
Indication of
considerable additional benefit
01.08.2025
22.01.2026
Durvalumab (9)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, neoadjuvant/adjuvant therapy, in combination with platinum-based chemotherapy
4,540–4,660
100%
additional benefit not proven
01.07.2025
18.12.2025
Acalabrutinib (7)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia, first-line treatment, in combination with venetoclax and obinutuzumab
3,200
100%
additional benefit not proven
01.07.2025
18.12.2025
Nivolumab (32)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Cancer of the oesophagus or gastro-oesophageal junction, in previously treated patients, as adjuvant therapy
580–910
100%
Hint for
minor additional benefit
01.07.2025
18.12.2025
Acalabrutinib (6)
Calquence®
AstraZeneca GmbH
Oncological diseases
Mantle cell lymphoma, no prior BTKi treatment, relapsed or refractory, monotherapy
220
100%
additional benefit not proven
01.07.2025
18.12.2025
Acalabrutinib (5)
Calquence®
AstraZeneca GmbH
Oncological diseases
Mantle cell lymphoma, autologous stem cell transplant not suitable, first-line treatment, in combination with bendamustine and rituximab
220–460
100%
additional benefit not proven
01.07.2025
18.12.2025
Acalabrutinib (4)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia, first-line treatment, in combination with venetoclax
3,200
100%
additional benefit not proven
15.06.2025
18.12.2025
Nivolumab (29)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Colorectal cancer with MSI-H or dMMR, first-line treatment, in combination with ipilimumab
560–1,800
100%
additional benefit not proven
15.06.2025
04.12.2025
Nivolumab (31)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 1 per cent, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy
3,240–3,680
100%
additional benefit not proven
15.06.2025
04.12.2025
Nivolumab (30)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Unresectable or advanced hepatocellular carcinoma, first-line treatment, in combination with ipilimumab
1,900–5,470
100%
additional benefit not proven
01.06.2025
20.11.2025
Selpercatinib (8)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma, RET-mutated, monotherapy, from 12 years of age
40–170
100%
Indication of
major additional benefit
01.06.2025
20.11.2025
Datopotamab deruxtecan (1)
Datroway®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
HR+, HER2- breast cancer, following at least one prior course of treatment
4,140–14,160
100%
additional benefit not proven
01.06.2025
20.11.2025
Asciminib (2)
Scemblix®
Novartis Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia, Ph+, following ≥ 2 prior treatments
1,500–1,730
50%
Indication of
minor additional benefit
Orphan (turnover limit)
15.05.2025
06.11.2025
Glofitamab (3)
Columvi®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), following ≥ 2 prior treatments
960–2,130
100%
additional benefit not proven
15.05.2025
06.11.2025
Glofitamab (2)
Columvi®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma, relapsed or refractory, in combination with gemcitabine and oxaliplatin; autologous stem cell transplantation is not suitable
2,230–3,550
100%
additional benefit not proven
01.05.2025
16.10.2025
Repotrectinib (2)
Augtyro®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, ROS1-positive
585–1,620
100%
additional benefit not proven
01.05.2025
16.10.2025
Repotrectinib (1)
Augtyro®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Solid tumours, NTRK gene fusion, aged ≥ 12 years
390–770
100%
additional benefit not proven
01.05.2025
16.10.2025
Serplulimab (1)
Hetronifly®
Accord Healthcare GmbH
Oncological diseases
Small cell lung cancer, in combination with carboplatin and etoposide, first-line treatment
3,210–7,719
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2025
16.10.2025
Trastuzumab deruxtecan (6)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast cancer, HR+, HER2-low or -ultralow, following at least one course of endocrine therapy
1,615–6,200
100%
Hint for
minor additional benefit
01.05.2025
16.10.2025
Pembrolizumab (40)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Malignant pleural mesothelioma, non-epithelioid, first-line treatment, in combination with pemetrexed and platinum-based chemotherapy
55–105
100%
additional benefit not proven
15.04.2025
02.10.2025
Lisocabtagen maraleucel (3)
Breyanzi®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Follicular lymphoma, following ≥ 2 prior treatments
370–840
100%
additional benefit not proven
15.04.2025
02.10.2025
Pirtobrutinib (2)
Jaypirca®
Lilly Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), relapsed or refractory, monotherapy
5,390–7,490
9%
Hint for
minor additional benefit
01.04.2025
18.09.2025
Belzutifan (2)
Welireg®
MSD Sharp & Dohme GmbH
Oncological diseases
Von Hippel-Lindau syndrome (VHL)-associated tumours
80–970
100%
additional benefit not proven
01.04.2025
18.09.2025
Belzutifan (1)
Welireg®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma, advanced, after ≥ 2 prior therapies
65–940
50%
Hint for
minor additional benefit
01.03.2025
21.08.2025
Blinatumomab (8)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, high-risk first relapse, Ph-, CD19+, ≥1 month and <1 year
1
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Blinatumomab (9)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, Ph-, CD19+, newly diagnosed
160–270
100%
Hint for
considerable additional benefit
Orphan
01.03.2025
21.08.2025
Blinatumomab (7)
Blincyto®
Amgen GmbH
Oncological diseases
Acute lymphoblastic B-cell leukaemia, relapsed/refractory, ≥ 1 month to < 1 year, after ≥ 2 prior therapies or after allogeneic stem cell transplantation
1
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Daratumumab (13)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Systemic light-chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
220–515
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.03.2025
21.08.2025
Fedratinib (2)
Inrebic®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Myelofibrosis
640–1,710
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2025
07.08.2025
Dostarlimab (3)
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Primarily advanced or recurrent endometrial cancer with pMMR, combination with carboplatin and paclitaxel
990–1,810
100%
additional benefit not proven
15.02.2025
07.08.2025
Isatuximab (3)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, lenalidomide and dexamethasone
3,450–3,680
100%
Hint for
minor additional benefit
15.02.2025
07.08.2025
Pirtobrutinib (1)
Jaypirca®
Lilly Deutschland GmbH
Oncological diseases
Mantle cell lymphoma, pre-treated patients
105–150
100%
additional benefit not proven
15.02.2025
17.07.2025
Lazertinib (1)
Lazcluze®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), combination with amivantamab
1,250–3,025
100%
Hint for
minor additional benefit
01.02.2025
17.07.2025
Amivantamab (4)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 20 insertion mutation, first-line, combination with carboplatin and pemetrexed
70–215
100%
additional benefit not proven
01.02.2025
17.07.2025
Amivantamab (2)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), combination with lazertinib
1,250–3,025
100%
Hint for
minor additional benefit
01.02.2025
17.07.2025
Amivantamab (3)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), pretreated, combination with carboplatin and pemetrexed
985–3,045
100%
additional benefit not proven
15.01.2025
03.07.2025
Osimertinib (7)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR mutations, after platinum-based radiochemotherapy
160–290
100%
additional benefit not proven
01.01.2025
18.06.2025
Erdafitinib (1)
Balversa®
Janssen-Cilag GmbH
Oncological diseases
Urothelial carcinoma, FGFR3 alterations, pretreated with PD-(L)1 inhibitor
169–207
100%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (6)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastro-oesophageal junction, PD-L1 expression ≥ 5, HER2-, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
1,941–3,067
100%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (4)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Non-small cell lung cancer, after prior therapy
690–1,620
100%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (2)
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%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (3)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel
7,780–11,040
100%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (5)
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%
additional benefit not proven
01.01.2025
18.06.2025
Tislelizumab (1)
Tevimbra®
BeiGene Germany GmbH
Oncological diseases
Squamous cell carcinoma of the oesophagus, after prior therapy
330–540
100%
additional benefit not proven
15.12.2024
05.06.2025
Ribociclib (5)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer, HR+, HER2-, early with high risk of recurrence, adjuvant therapy, combination with aromatase inhibitor
3,730–15,960
100%
additional benefit not proven
15.12.2024
05.06.2025
Mirvetuximab-Soravtansin (1)
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
0
630–1,300
100%
Indication of
considerable additional benefit
Orphan
repealed
01.12.2024
15.05.2025
Daratumumab (12)
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%
additional benefit not proven
Orphan (turnover limit)
01.12.2024
15.05.2025
Ciltacabtagen autoleucel (2)
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
15.11.2024
15.05.2025
Pembrolizumab (38)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Cervical carcinoma (stage III to IVA), first-line, combination with radiochemotherapy
750
100%
Indication of
non-quantifiable additional benefit
15.11.2024
15.05.2025
Pembrolizumab (39)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma, first-line, combination with carboplatin and paclitaxel
1,370–3,330
100%
additional benefit not proven
01.11.2024
17.04.2025
Epcoritamab (3)
Tepkinly®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies
920–1,940
100%
additional benefit not proven
01.11.2024
17.04.2025
Zolbetuximab (1)
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
01.10.2024
03.04.2025
Enfortumab Vedotin (2)
Padcev®
Astellas Pharma Europe B.V
Oncological diseases
Urothelial carcinoma, non-resectable or metastatic, first-line, suitable for platinum-containing chemotherapy, combination with pembrolizumab
920–2,280
45%
Indication of
considerable additional benefit
01.10.2024
03.04.2025
Pembrolizumab (36)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma, non-resectable or metastatic, first-line, combination with enfortumab vedotin
1,050–2,601
39%
Indication of
considerable additional benefit
01.10.2024
03.04.2025
Capivasertib (1)
Truqap®
AstraZeneca GmbH
Oncological diseases
Breast cancer, ER+, HER2-, PIK3CA/AKT1/PTEN alteration(s), after prior therapy, combination with fulvestrant
491–26,745
70%
Indication of
considerable additional benefit
01.10.2024
20.03.2025
Encorafenib (3)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with binimetinib
122–476
100%
additional benefit not proven
01.10.2024
20.03.2025
Pembrolizumab (37)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast cancer, triple-negative, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
2,440–2,610
50%
Indication of
minor additional benefit
01.10.2024
20.03.2025
Binimetinib (2)
Mektovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with encorafenib
122–476
100%
additional benefit not proven
01.10.2024
20.03.2025
Atezolizumab (12)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 50%, adjuvant therapy after resection and chemotherapy
700–890
100%
Hint for
considerable additional benefit
01.10.2024
20.03.2025
Atezolizumab (11)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, first-line
1,900–7,570
71%
Indication of
minor additional benefit
15.09.2024
06.03.2025
Epcoritamab (2)
Tepkinly®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Follicular lymphoma, after ≥ 2 prior therapies
370–840
100%
additional benefit not proven
01.09.2024
20.02.2025
Olaparib (12)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Primarily advanced or recurrent endometrial cancer with pMMR, combination with durvalumab, maintenance therapy
780–1,430
50%
Indication of
considerable additional benefit
01.09.2024
20.02.2025
Durvalumab (7)
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%
additional benefit not proven
01.09.2024
20.02.2025
Durvalumab (8)
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
01.09.2024
20.02.2025
RADAMTS13 (1)
Adzynma®
Takeda GmbH
Oncological diseases
ADAMTS13 deficiency in congenital thrombotic thrombocytopenic purpura (cTTP)
120–180
100%
Hint for
non-quantifiable additional benefit
Orphan
01.08.2024
06.02.2025
Osimertinib (6)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, first-line, combination with pemetrexed and platinum-containing chemotherapy
840–2,720
100%
additional benefit not proven
01.08.2024
06.02.2025
Entrectinib (3)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Solid tumors, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology-independent, > 1 month to < 12 years
3
100%
additional benefit not proven
15.07.2024
16.01.2025
Alectinib (3)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer, ALK+, high risk of recurrence, adjuvant therapy
330–452
50%
Hint for
major additional benefit
15.07.2024
16.01.2025
Gozetotid (1)
Locametz®
Novartis Pharma GmbH
Oncological diseases
Detection of PSMA-positive prostate cancer (mCRPC), PSMA-targeted therapy
1,860–2,770
84%
Indication of
considerable additional benefit
15.07.2024
16.01.2025
Fruquintinib (1)
Fruzaqla®
Takeda GmbH
Oncological diseases
Colorectal carcinoma, previously treated patients
645–2,180
100%
Hint for
minor additional benefit
01.07.2024
19.12.2024
Nivolumab (28)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma, first-line, combination with cisplatin and gemcitabine
435–617
100%
additional benefit not proven
01.07.2024
19.12.2024
Axicabtagen-Ciloleucel (7)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory
800–1,130
100%
Hint for
minor additional benefit
Orphan (turnover limit)
01.07.2024
19.12.2024
Osimertinib (5)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR mutations, adjuvant therapy
640–930
50%
Hint for
major additional benefit
01.06.2024
22.11.2024
Futibatinib (1)
Lytgobi®
Taiho Pharma Netherlands
Oncological diseases
Cholangiocarcinoma, with FGFR2 fusion or FGFR2 rearrangement, after at least 1 prior therapy
27–229
100%
additional benefit not proven
15.05.2024
07.11.2024
Selpercatinib (7)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Solid tumors, RET-Fusion+
59–159
100%
additional benefit not proven
15.05.2024
07.11.2024
Selpercatinib (6)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma, RET fusion+, refractory to radioiodine, first-line or after systemic prior therapy, ≥ 12 years of age
6–36
100%
additional benefit not proven
01.05.2024
17.10.2024
Dabrafenib (Finlee, 1)
Finlee®
Novartis Pharma GmbH
Oncological diseases
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with trametinib
7–115
41%
Hint for
considerable additional benefit
Orphan
01.05.2024
17.10.2024
Trametinib (Spexotras, 1)
Spexotras®
Novartis Pharma GmbH
Oncological diseases
Malignant glioma, BRAF V600E mutation, ≥ 1 year, low-grade (LGG) first-line/higher-grade (HGG) after at least 1 prior therapy; combination with dabrafenib
7–115
41%
Hint for
considerable additional benefit
Orphan
01.05.2024
17.10.2024
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%
additional benefit not proven
01.05.2024
17.10.2024
Pembrolizumab (34)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung cancer, adjuvant therapy with high risk of recurrence after resection, after prior chemotherapy
2,690–3,200
100%
additional benefit not proven
01.08.2024
02.10.2024
Efbemalenograstim alfa (1)
Ryzneuta®
Evive Biotech
Oncological diseases
Febrile neutropenia due to chemotherapy
n.d.
100%
additional benefit not proven
01.04.2024
19.09.2024
Idecabtagen vicleucel (3)
Abecma®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma, at least 2 prior therapies
4,900–5,250
100%
additional benefit not proven
Orphan (turnover limit)
01.03.2024
15.08.2024
Decitabin / Cedazuridin (1)
Inaqovi®
Otsuka Pharma GmbH
Oncological diseases
Acute myeloid leukaemia, first line
560–840
100%
additional benefit not proven
15.02.2024
15.08.2024
Momelotinib (1)
Omjjara®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Myelofibrosis
0
210–1,160
50%
Hint for
minor additional benefit
Orphan
repealed
15.02.2024
15.08.2024
Talazoparib (2)
Talzenna®
Pfizer Pharma GmbH
Oncological diseases
Prostate carcinoma, metastasised, castration-resistant, in combination with enzalutamide)
9,400–12,200
75%
additional benefit not proven
01.02.2024
01.08.2024
Quizartinib (1)
Vanflyta®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
260–820
100%
additional benefit not proven
15.01.2024
04.07.2024
Elranatamab (1)
Elrexfio®
Pfizer Pharma GmbH
Oncological diseases
Multiple myeloma, relapsed and refractory, after at least 3 previous therapies
1,250–1,340
100%
additional benefit not proven
01.01.2024
20.06.2024
Pembrolizumab (33)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Biliary tumours, first-line, combination with gemcitabine and cisplatin
1,480–2,180
100%
Indication of
minor additional benefit
01.01.2024
20.06.2024
Pembrolizumab (31)
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%
additional benefit not proven
01.01.2024
20.06.2024
Pembrolizumab (32)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2, first-line, combination with fluoropyrimidine- and platinum-based chemotherapy
285–2,613
100%
additional benefit not proven
01.01.2024
20.06.2024
Dostarlimab (2)
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Primary advanced or recurrent endometrial carcinoma with dMMR/ MSI-H, combination with carboplatin and paclitaxel
790–1,520
50%
Indication of
major additional benefit
01.01.2024
20.06.2024
Avapritinib (3)
Ayvakyt®
Blueprint Medicines GmbH
Oncological diseases
Indolent systemic mastocytosis (ISM)
0
715–1,000
100%
Indication of
minor additional benefit
Orphan
repealed
01.01.2024
20.06.2024
Polatuzumab Vedotin (4)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma, combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
5,640–6,270
100%
additional benefit not proven
Orphan (turnover limit)
01.01.2024
20.06.2024
Polatuzumab Vedotin (3)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma, combination with bendamustine and rituximab
2,550–3,120
100%
additional benefit not proven
Orphan (turnover limit)
15.12.2023
06.06.2024
Zanubrutinib (5)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab
370–840
100%
additional benefit not proven
15.12.2023
06.06.2024
Rucaparib (4)
Rubraca®
Pharmaand Deutschland GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy after first-line therapy
3,250–3,590
100%
additional benefit not proven
15.12.2023
06.06.2024
Durvalumab (6)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, monotherapy
1,900–5,470
100%
additional benefit not proven
01.12.2023
16.05.2024
Tebentafusp (2)
Kimmtrak®
Immunocore Ireland Ltd.
Oncological diseases
Uveal melanoma, HLA-A*02:01-positive
100–130
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Daratumumab (11)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, melphalan and prednisone
3,450–2,680
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Trastuzumab deruxtecan (5)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, HER2(ERBB2) mutation, pre-treated
75–219
100%
additional benefit not proven
15.11.2023
02.05.2024
Niraparib / Abirateronacetat (1)
Akeega®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma, metastastic, castration resistent, BRCA1/2-Mutation, Chemotherapy not indicated, combination with prednis(ol)one
1,030–2,200
50%
Hint for
considerable additional benefit
15.11.2023
02.05.2024
Midostaurin (3)
Rydapt®
Novartis Pharma AG
Oncological diseases
Systemic Mastocytosis
300–400
100%
additional benefit not proven
Orphan (turnover limit)
15.11.2023
02.05.2024
Midostaurin (2)
Rydapt®
Novartis Pharma AG
Oncological diseases
Acute myeloic Leukemia, FLT3-Mutation
380–1,040
100%
additional benefit not proven
Orphan (turnover limit)
01.11.2023
02.05.2024
Elacestrant (1)
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
15.10.2023
04.04.2024
Epcoritamab (1)
Tepkinly®
Abbvie Deutschland GmbH & Co. KG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies)
0
1,050–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.10.2023
21.03.2024
Nivolumab (27)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy).
1,620–2,310
100%
additional benefit not proven
15.09.2023
07.03.2024
Talquetamab (1)
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
01.09.2023
15.02.2024
Teclistamab (1)
Tecvayli®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma, at least 3 prior therapies
1,210–1,310
100%
additional benefit not proven
01.09.2023
15.02.2024
Tisagenlecleucel (6)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukemia, relapsed/refractory, 0 ≤ 25 years).
40–90
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2023
15.02.2024
Tisagenlecleucel (7)
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
15.08.2023
15.02.2024
Sacituzumab govitecan (2)
Trodelvy®
Gilead Sciences GmbH
Oncological diseases
Breast carcinoma, HR+, HER2-, at least 3 prior therapies
2,480–8,240
100%
Indication of
considerable additional benefit
15.08.2023
15.02.2024
Trifluridin / Tipiracil (4)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal cancer, after 2 prior therapies, combination with bevacizumab)
3,530–6,230
100%
Hint for
considerable additional benefit
01.08.2023
01.02.2024
Nivolumab (26)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung cancer, PD-L1 expression ≥ 1 %, neoadjuvant therapy, combination with platinum-based chemotherapy
110–990
100%
Hint for
non-quantifiable additional benefit
01.08.2023
01.02.2024
Glofitamab (1)
Columvi®
Roche Pharma AG
Oncological diseases
B-cell lymphoma, diffuse large cell (DLBCL)
0
1,360–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
15.07.2023
18.01.2024
Ivosidenib (2)
Tibsovo®
Servier Deutschland GmbH
Oncological diseases
Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy
80–160
100%
Hint for
non-quantifiable additional benefit
Orphan
15.07.2023
18.01.2024
Ivosidenib (1)
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
01.07.2023
21.12.2023
Nivolumab (24)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adolescents ≥ 12 to 18 years, monotherapy or combination with ipilimumab).
2–4
100%
additional benefit not proven
01.07.2023
21.12.2023
Nivolumab (25)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy, adolescents ≥ 12 to 18 years, monotherapy
1–4
100%
additional benefit not proven
01.07.2023
21.12.2023
Axicabtagen-Ciloleucel (4)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Follicular lymphoma, after ≥ 3 prior therapies
60–270
100%
additional benefit not proven
Orphan (turnover limit)
01.07.2023
21.12.2023
Axicabtagen-Ciloleucel (6)
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%
additional benefit not proven
Orphan (turnover limit)
01.07.2023
21.12.2023
Axicabtagen-Ciloleucel (5)
Yescarta®
Gilead Sciences GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory
800–1,130
1,600–2,260
50%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
repealed subpopulations
01.07.2023
21.12.2023
Selumetinib (2)
Koselugo®
Alexion Pharma Deutschland GmbH
Oncological diseases
Neurofibromatosis (≥ 3 to < 18 years, type 1)
0
510–740
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.06.2023
16.11.2023
Lisocabtagen maraleucel (2)
Breyanzi®
Bristol-Myers Squibb GmbH
Oncological diseases
Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B; after 1 prior therapy, relapse within 12 months or refractory)
1,675–2,355
50%
Hint for
considerable additional benefit
15.05.2023
02.11.2023
Loncastuximab tesirin (1)
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%
additional benefit not proven
01.05.2023
19.10.2023
Cemiplimab (5)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy
9,540–12,900
100%
additional benefit not proven
01.05.2023
19.10.2023
Cemiplimab (4)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Cervix carcinoma, pretreated
380–1,450
50%
Indication of
considerable additional benefit
15.04.2023
05.10.2023
Tabelecleucel (1)
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
01.04.2023
05.10.2023
Belantamab-Mafodotin (2)
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
repealed
01.04.2023
05.10.2023
Durvalumab (3)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Biliary tumors, first-line, combination with gemcitabine and cisplatin
1,800
100%
Indication of
minor additional benefit
01.04.2023
05.10.2023
Durvalumab (4)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with tremelimumab and platinum-based chemotherapy
14,470–24,660
100%
additional benefit not proven
01.04.2023
05.10.2023
Durvalumab (5)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with tremelimumab
1,900–5,470
100%
additional benefit not proven
01.04.2023
05.10.2023
Tremelimumab (Tremelimumab AstraZeneca, 1)
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%
additional benefit not proven
01.04.2023
05.10.2023
Tremelimumab (1)
Imjudo®
AstraZeneca GmbH
Oncological diseases
Hepatocellular carcinoma, first-line, combination with durvalumab
1,900–5,470
100%
additional benefit not proven
01.04.2023
21.09.2023
Darolutamid (2)
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy
2,590–3,640
100%
Indication of
considerable additional benefit
01.04.2023
21.09.2023
Olaparib (11)
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%
additional benefit not proven
01.04.2023
21.09.2023
Rucaparib (3)
Rubraca®
Zr pharma& GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
1,750–2,270
100%
additional benefit not proven
15.02.2023
17.08.2023
Ciltacabtagen autoleucel (1)
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
repealed
01.02.2023
03.08.2023
Sotorasib (2)
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 prior therapy
480–1,040
44%
Hint for
non-quantifiable additional benefit
01.02.2023
20.07.2023
Trastuzumab deruxtecan (3)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Adenocarcinoma (AC) of the stomach or gastro-oesophageal junction, HER2-positive, after trastuzumab-based therapy
110–170
470–770
100%
additional benefit not proven
repealed subpopulations
01.02.2023
20.07.2023
Trastuzumab deruxtecan (4)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2-low, pre-treated
1,350–4,700
100%
Indication of
considerable additional benefit
01.02.2023
20.07.2023
Ibrutinib (9)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with venetoclax
3,190–3,200
100%
additional benefit not proven
15.01.2023
06.07.2023
Lutetium (177Lu) Vipivotidtetraxetan (1)
Pluvicto®
Novartis Radiopharmaceuticals GmbH
Oncological diseases
Prostate carcinoma (PC), combination with androgen deprivation therapy, PSMA-positive, metastatic, castration-resistant, progression after inhibition of the AR pathway and taxane-based chemotherapy
1,500–2,400
50%
Indication of
considerable additional benefit
15.01.2023
06.07.2023
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
01.01.2023
15.06.2023
Abemaciclib (6)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HR+, HER2-, combination with aromatase inhibitor
7,400–34,790
100%
Hint for
minor additional benefit
15.12.2022
15.06.2023
Zanubrutinib (2)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line
3,180–3,200
50%
Hint for
minor additional benefit
15.12.2022
15.06.2023
Zanubrutinib (3)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody
590–1,760
100%
additional benefit not proven
15.12.2022
15.06.2023
Zanubrutinib (4)
Brukinsa®
BeiGene Germany GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), relapsed and/or refractory
8,800–12,750
23%
Indication of
minor additional benefit
01.11.2022
20.04.2023
Olaparib (9)
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
15.10.2022
06.04.2023
Relugolix (1)
Orgovyx®
Accord Healthcare GmbH
Oncological diseases
Prostate carcinoma (PC), advanced, hormone-sensitive
25,020–44,280
100%
additional benefit not proven
01.09.2022
06.04.2023
Lisocabtagen maraleucel (1)
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%
additional benefit not proven
01.10.2022
16.03.2023
Selinexor (1)
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%
additional benefit not proven
01.10.2022
16.03.2023
Selinexor (2)
Nexpovio®
Stemline Therapeutics B.V.
Oncological diseases
Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
570–1,130
100%
additional benefit not proven
01.10.2022
16.03.2023
Asciminib (1)
Scemblix®
Novartis Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, after ≥ 2 prior therapies
0
840–1,150
100%
Indication of
minor additional benefit
Orphan
repealed
01.10.2022
16.03.2023
Melphalanflufenamid (1)
Pepaxti®
Oncopeptides AB
Oncological diseases
Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone)
1,200–1,300
100%
additional benefit not proven
01.10.2022
16.03.2023
Pertuzumab (4)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy
1,910–3,060
100%
Indication of
minor additional benefit
01.10.2022
16.03.2023
Pertuzumab / Trastuzumab (4)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy
1,910–3,060
100%
Indication of
minor additional benefit
01.10.2022
16.03.2023
Selpercatinib (5)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older
0
40–170
100%
additional benefit not proven
repealed
01.10.2022
16.03.2023
Brexucabtagen-Autoleucel / Autologe Anti-CD19-transduzierte CD3+ Zellen (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
01.09.2022
16.02.2023
Olaparib (8)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy.
540–690
100%
Indication of
minor additional benefit
15.08.2022
02.02.2023
Capmatinib (1)
Tabrecta®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
540–900
100%
additional benefit not proven
01.08.2022
02.02.2023
Trastuzumab deruxtecan (1)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, after 1 prior therapy
3,370–3,750
100%
Indication of
non-quantifiable additional benefit
01.08.2022
02.02.2023
Trastuzumab deruxtecan (2)
Enhertu®
Daiichi Sankyo Deutschland GmbH
Oncological diseases
Breast carcinoma (BC), HER2+, at least 2 previous therapies
1,350–1,640
100%
Indication of
considerable additional benefit
01.08.2022
02.02.2023
Pembrolizumab (28)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab
1,315–1,525
40%
Indication of
considerable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (22)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients
1,518–1,973
100%
Hint for
minor additional benefit
01.08.2022
19.01.2023
Pembrolizumab (23)
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%
additional benefit not proven
01.08.2022
19.01.2023
Pembrolizumab (24)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma with MSI-H or with dMMR, pre-treated
230–3,360
100%
additional benefit not proven
01.08.2022
19.01.2023
Pembrolizumab (25)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Gastric carcinoma with MSI-H or dMMR, pre-treated
80–110
74%
Hint for
non-quantifiable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (26)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Small bowel carcinoma with MSI-H or dMMR, pre-treated
40–380
100%
additional benefit not proven
01.08.2022
19.01.2023
Pembrolizumab (27)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Biliary carcinoma with MSI-H or dMMR, pre-treated
20–150
100%
additional benefit not proven
01.08.2022
19.01.2023
Pembrolizumab (29)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, adjuvant therapy, ≥ 12 years, monotherapy
1,621–2,314
100%
Indication of
non-quantifiable additional benefit
01.08.2022
19.01.2023
Pembrolizumab (30)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma, ≥ 12 to < 18 years
1–4
100%
additional benefit not proven
15.07.2022
05.01.2023
Atezolizumab (10)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy
0
700–790
100%
Hint for
non-quantifiable additional benefit
repealed
01.07.2022
15.12.2022
Mosunetuzumab (1)
Lunsumio®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
650–690
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2022
15.12.2022
Pembrolizumab (21)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
0
2,440–2,520
50%
Hint for
minor additional benefit
repealed
01.07.2022
15.12.2022
Selpercatinib (4)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+, first-line
0
115–310
100%
additional benefit not proven
repealed
01.07.2022
15.12.2022
Palbociclib (3)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast carcinoma (BC), patient population a1
7,400–34,700
100%
additional benefit not proven
01.06.2022
01.12.2022
Enfortumab Vedotin (1)
Padcev®
Astellas Pharma Europe B.V.
Oncological diseases
Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor
410–1,250
47%
Hint for
considerable additional benefit
01.06.2022
01.12.2022
Cabozantinib (Cabometyx, 6)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
125–425
100%
additional benefit not proven
01.06.2022
01.12.2022
Polatuzumab Vedotin (2)
Polivy®
Roche Pharma AG
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
0
5,510–6,130
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.06.2022
01.12.2022
Tisagenlecleucel (5)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Follicular lymphoma (FL), pre-treated patients
650–690
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2022
03.11.2022
Axicabtagen-Ciloleucel (3)
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
repealed
01.05.2022
20.10.2022
Tebentafusp (1)
Kimmtrak®
Immunocore Ireland Ltd.
Oncological diseases
Uveal melanoma, HLA-A*02:01-positive
0
110
100%
Hint for
considerable additional benefit
Orphan
repealed
01.05.2022
20.10.2022
Abemaciclib (5)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy
6,905–9,435
40%
Hint for
minor additional benefit
01.05.2022
20.10.2022
Nivolumab (21)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy
350–460
1,030–1,290
65%
Hint for
non-quantifiable additional benefit
repealed subpopulations
01.05.2022
20.10.2022
Nivolumab (22)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
920–1,580
100%
Indication of
considerable additional benefit
01.05.2022
20.10.2022
Nivolumab (23)
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
01.04.2022
15.09.2022
Avapritinib (2)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Systemic mastocytosis, after at least 1 prior therapy
0
270–680
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.04.2022
15.09.2022
Daratumumab (10)
Darzalex®
Janssen
Oncological diseases
Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
4,700–7,000
100%
Proof of
considerable additional benefit
Orphan (turnover limit)
01.03.2022
01.09.2022
Lorlatinib (2)
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung cancer (NSCLC), ALK+, first-line
390–1,310
100%
additional benefit not proven
01.03.2022
01.09.2022
Tepotinib (1)
Tepmetko®
Merck Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
540–910
100%
additional benefit not proven
15.02.2022
04.08.2022
Sotorasib (1)
Lumykras®
Amgen Europe B.V.
Oncological diseases
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
500–1,080
560–1,210
100%
additional benefit not proven
repealed subpopulations
01.02.2022
21.07.2022
Duvelisib (2)
Copiktra®
Secura Bio Limited
Oncological diseases
Follicular lymphoma (FL), after ≥ 2 prior therapies
380–5,170
100%
additional benefit not proven
01.02.2022
21.07.2022
Duvelisib (1)
Copiktra®
Secura Bio Limited
Oncological diseases
Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
550–2,060
100%
additional benefit not proven
15.01.2022
07.07.2022
Amivantamab (1)
Rybrevant®
Janssen-Cilag GmbH
Oncological diseases
Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy
9–26
100%
additional benefit not proven
15.12.2021
07.07.2022
Lenvatinib (Kisplyx, 3)
Kisplyx®
Eisai GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
2,790–4,180
100%
additional benefit not proven
15.12.2021
07.07.2022
Lenvatinib (4)
Lenvima®
Eisai GmbH
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab
1,130–5,070
100%
Indication of
considerable additional benefit
15.12.2021
07.07.2022
Pembrolizumab (19)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib
1,130–5,070
100%
Indication of
considerable additional benefit
15.12.2021
07.07.2022
Pembrolizumab (20)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib
2,790–4,189
100%
additional benefit not proven
15.12.2021
16.06.2022
Zanubrutinib (1)
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%
additional benefit not proven
01.01.2022
16.06.2022
Idecabtagen vicleucel (1)
Abecma®
Bristol-Myers Squibb GmbH & Co KGaA
Oncological diseases
Multiple myeloma (MM), at least 3 previous therapies
0
1,200–1,300
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.01.2022
16.06.2022
Ripretinib (1)
Qinlock®
Deciphera Pharmaceuticals (Netherlands) B.V.
Oncological diseases
Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies
220–300
100%
Hint for
major additional benefit
Orphan
15.12.2021
16.06.2022
Pralsetinib (1)
Gavreto®
Roche Pharma AG
Oncological diseases
Non-small cell lung cancer (NSCLC), RET fusion+
170–510
100%
additional benefit not proven
01.12.2021
19.05.2022
Abemaciclib (4)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
12,870–59,690
42%
Indication of
minor additional benefit
01.12.2021
19.05.2022
Nivolumab (20)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Adenocarcinoma (AC) of the stomach, gastroesophageal junction or esophagus, CPS ≥ 5, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-based combination chemotherapy
500–3,100
100%
Hint for
considerable additional benefit
01.12.2021
19.05.2022
Sacituzumab govitecan (1)
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
15.11.2021
05.05.2022
Pembrolizumab (17)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy.
535–805
34%
Indication of
considerable additional benefit
15.11.2021
05.05.2022
Pembrolizumab (18)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy
260–270
50%
Hint for
considerable additional benefit
01.10.2021
18.03.2022
Vandetanib (4)
Caprelsa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC)
50–670
100%
additional benefit not proven
01.10.2021
18.03.2022
Daratumumab (9)
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)
15.09.2021
03.03.2022
Tafasitamab (1)
Minjuvi®
Incyte Biosciences Germany GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide
730–1,560
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2021
17.02.2022
Nivolumab (19)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Carcinoma of the esophagus and gastro-esophageal junction, pre-treated patients, adjuvant therapy
0
590–860
100%
Indication of
non-quantifiable additional benefit
repealed
15.08.2021
03.02.2022
Selumetinib (1)
Koselugo®
AstraZeneca GmbH
Oncological diseases
Neurofibromatosis (type 1), ≥ 3 to < 18 years
0
510–740
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.08.2021
03.02.2022
Daratumumab (8)
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)
01.08.2021
20.01.2022
Blinatumomab (6)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
7–30
100%
Indication of
major additional benefit
Orphan
01.08.2021
20.01.2022
Nivolumab (18)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab
350–475
100%
additional benefit not proven
01.08.2021
20.01.2022
Cemiplimab (3)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Basal cell carcinoma (BCC), locally advanced or metastasised
83–155
97%
Hint for
minor additional benefit
01.08.2021
20.01.2022
Cemiplimab (2)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
4,130–5,110
100%
additional benefit not proven
01.08.2021
20.01.2022
Daratumumab (7)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
0
440–1,030
50%
Hint for
minor additional benefit
Orphan (turnover limit)
repealed
01.07.2021
16.12.2021
Brentuximab Vedotin (6)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone
125–127
100%
Hint for
minor additional benefit
Orphan
01.07.2021
16.12.2021
Cabozantinib (2)
Cometriq®
Ipsen Pharma GmbH
Oncological diseases
Thyroid carcinoma (MTC)
50–670
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2021
16.12.2021
Nivolumab (17)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Malignant pleural mesothelioma, first-line, combination with ipilimumab
160
50%
Indication of
considerable additional benefit
01.07.2021
16.12.2021
Osimertinib (4)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy
0
1,280–1,860
50%
Indication of
non-quantifiable additional benefit
repealed
01.07.2021
16.12.2021
Elotuzumab (3)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
2,500
100%
Hint for
considerable additional benefit
15.06.2021
02.12.2021
Dostarlimab (1)
Jemperli®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Endometrial carcinoma (EC), after platinum-based therapy
230–3,360
100%
additional benefit not proven
15.06.2021
02.12.2021
Tagraxofusp (1)
Elzonris®
Stemline Therapeutics B.V.
Oncological diseases
Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line
30–90
100%
Hint for
non-quantifiable additional benefit
Orphan
15.06.2021
02.12.2021
Venetoclax (5)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Acute myeloid leukaemia (AML), combination therapy, first-line
560–840
100%
Hint for
considerable additional benefit
01.06.2021
19.11.2021
Bosutinib (4)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
760–890
100%
additional benefit not proven
01.06.2021
19.11.2021
Enzalutamid (5)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy
2,590–3,640
100%
additional benefit not proven
01.06.2021
19.11.2021
Atezolizumab (9)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line
4,520–5,080
100%
additional benefit not proven
15.05.2021
04.11.2021
Isatuximab (1)
Sarclisa®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone
2,500
100%
Hint for
minor additional benefit
15.05.2021
04.11.2021
Isatuximab (2)
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%
additional benefit not proven
15.05.2021
04.11.2021
Obinutuzumab (6)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
1,300–1,500
100%
additional benefit not proven
Orphan (turnover limit)
15.05.2021
04.11.2021
Obinutuzumab (4)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
820–1,480
100%
additional benefit not proven
Orphan (turnover limit)
15.05.2021
04.11.2021
Obinutuzumab (5)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
790–940
100%
additional benefit not proven
Orphan (turnover limit)
01.05.2021
21.10.2021
Cabozantinib (Cabometyx, 5)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
2,790–4,180
100%
additional benefit not proven
01.05.2021
21.10.2021
Nivolumab (16)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with cabozantinib
2,790–4,180
100%
additional benefit not proven
15.04.2021
07.10.2021
Pemigatinib (1)
Pemazyre®
Incyte Biosciences Germany GmbH
Oncological diseases
Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy
35–300
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2021
16.09.2021
Nivolumab (15)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
3,450–4,350
100%
Hint for
considerable additional benefit
01.04.2021
16.09.2021
Pembrolizumab (14)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years
120–240
46%
Hint for
considerable additional benefit
01.04.2021
16.09.2021
Pembrolizumab (16)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
225–380
100%
additional benefit not proven
01.04.2021
16.09.2021
Pembrolizumab (15)
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
15.03.2021
02.09.2021
Fedratinib (1)
Inrebic®
Celgene GmbH
Oncological diseases
Myelofibrosis (MF)
740–3,590
1,370–5,280
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed subpopulations
15.03.2021
02.09.2021
Tucatinib (1)
Tukysa®
Seagen Germany GmbH
Oncological diseases
Breast cancer (BC) HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine
1,350–1,640
100%
Hint for
considerable additional benefit
15.03.2021
02.09.2021
Selpercatinib (3)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy
2–16
100%
additional benefit not proven
15.03.2021
02.09.2021
Selpercatinib (2)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years
5–80
100%
additional benefit not proven
15.03.2021
02.09.2021
Selpercatinib (1)
Retsevmo®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy
55–200
100%
additional benefit not proven
01.03.2021
19.08.2021
Avelumab (4)
Bavencio®
Merck Serono GmbH und Pfizer Pharma GmbH
Oncological diseases
Urothelial carcinoma (UC), first-line
4,125
100%
Hint for
considerable additional benefit
15.02.2021
05.08.2021
Brexucabtagen-Autoleucel / Autologe Anti-CD19-transduzierte CD3+ Zellen (1)
Tecartus®
Gilead Sciences GmbH
Oncological diseases
Mantle cell lymphoma (MCL), pretreated
105–150
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
05.08.2021
Acalabrutinib (3)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment
2,020–7,540
40%
Hint for
considerable additional benefit
01.02.2021
15.07.2021
Blinatumomab (5)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+
5–10
100%
Hint for
non-quantifiable additional benefit
Orphan
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab (1)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, metastatic or locally recurrent
2,470–4,000
100%
additional benefit not proven
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab (2)
Phesgo®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant
2,690–3,450
100%
additional benefit not proven
01.02.2021
15.07.2021
Pertuzumab / Trastuzumab (3)
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
repealed
01.02.2021
15.07.2021
Niraparib (4)
Zejula®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
700–1,000
100%
additional benefit not proven
Orphan (turnover limit)
15.01.2021
15.07.2021
Carfilzomib (4)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone
4,700–7,000
100%
additional benefit not proven
Orphan (turnover limit)
01.01.2021
01.07.2021
Nivolumab (14)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma of esophagus, pretreated patients
740–2,060
36%
Hint for
minor additional benefit
01.01.2021
01.07.2021
Lenvatinib (Kisplyx, 2)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
1,770–3,530
100%
additional benefit not proven
15.12.2020
03.06.2021
Ipilimumab (6)
Yervoy®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy
14,340–16,180
73%
Indication of
minor additional benefit
15.12.2020
03.06.2021
Nivolumab (13)
Opdivo®
Bristol-Myers Squibb Pharma EEIG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line
14,340–16,180
73%
Indication of
minor additional benefit
01.12.2020
03.06.2021
Olaparib (5)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy
75–95
100%
additional benefit not proven
01.12.2020
03.06.2021
Olaparib (6)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment
2,290–3,040
100%
Hint for
considerable additional benefit
01.12.2020
03.06.2021
Olaparib (7)
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%
additional benefit not proven
repealed
01.12.2020
03.06.2021
Acalabrutinib (2)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line
2,880–3,780
25%
Hint for
minor additional benefit
01.12.2020
03.06.2021
Acalabrutinib (1)
Calquence®
AstraZeneca GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL); monotherapy, first-line
2,880–3,780
25%
Hint for
minor additional benefit
01.12.2020
20.05.2021
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%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Atezolizumab (8)
Tecentriq®
Roche Pharma AG
Oncological diseases
Hepatocellular carcinoma (HCC), combination with bevacizumab
1,710–4,970
76%
Indication of
considerable additional benefit
01.11.2021
21.04.2021
Ixazomib (2)
Ninlaro®
Takeda GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
non-quantifiable additional benefit
Orphan
01.11.2020
15.04.2021
Avapritinib (1)
Ayvakyt®
Blueprint Medicines (Germany) GmbH
Oncological diseases
Gastrointestinal stromal tumor (GIST)
0
1–90
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.10.2020
01.04.2021
Ibrutinib (8)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab
3,090
59%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.10.2020
01.04.2021
Durvalumab (2)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with etoposide and either carboplatin or cisplatin
3,210–6,130
100%
Hint for
minor additional benefit
15.09.2020
04.03.2021
Belantamab-Mafodotin (1)
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
repealed
01.09.2020
18.02.2021
Alpelisib (1)
Piqray®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) with PIK3CA mutation, pre-treated patients, combination with fulvestrant
2,321–21,586
41%
additional benefit not proven
01.09.2020
18.02.2021
Entrectinib (1)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line
462–1,274
100%
additional benefit not proven
01.09.2020
18.02.2021
Entrectinib (2)
Rozlytrek®
Roche Pharma AG
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
390–770
100%
additional benefit not proven
15.08.2020
18.02.2021
Glasdegib (1)
Daurismo®
PFIZER PHARMA GmbH
Oncological diseases
Acute myeloid leukaemia (AML), combination with cytarabine (LDAC)
780–840
100%
Hint for
considerable additional benefit
Orphan
01.07.2020
17.12.2020
Encorafenib (2)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Metastatic colorectal carcinoma (CRC)
525–1,235
100%
Hint for
considerable additional benefit
15.06.2020
03.12.2020
Brentuximab Vedotin (5)
Adcetris®
Takeda GmbH
Oncological diseases
Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone
0
125–127
100%
Hint for
minor additional benefit
Orphan
repealed
15.06.2020
03.12.2020
Mogamulizumab (1)
Poteligeo®
Kyowa Kirin GmbH
Oncological diseases
Mycosis Fungoides; Sézary Syndrome
310–460
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2020
20.11.2020
Talazoparib (1)
Talzenna®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutation, HER2-
410–1,830
100%
Hint for
considerable additional benefit
01.06.2020
20.11.2020
Ponatinib (2)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
500–940
100%
Hint for
non-quantifiable additional benefit
Orphan
01.06.2020
20.11.2020
Ponatinib (3)
Iclusig®
Incyte Biosciences Germany GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
25–195
100%
Hint for
non-quantifiable additional benefit
Orphan
15.05.2020
05.11.2020
Enzalutamid (4)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
minor additional benefit
01.05.2020
15.10.2020
Brigatinib (2)
Alunbrig®
Takeda GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients
420–910
50%
Hint for
considerable additional benefit
01.05.2020
15.10.2020
Darolutamid (1)
Nubeqa®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
considerable additional benefit
15.04.2020
15.10.2020
Venetoclax (4)
Venclyxto®
AbbVie Deutschland GmbH & Co. KG
Oncological diseases
Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab
3,090–3,099
100%
additional benefit not proven
01.04.2020
01.10.2020
Avelumab (3)
Bavencio®
Merck Serono GmbH
Oncological diseases
Metastatic Merkel-cell carcinoma (MCC)
370–720
100%
additional benefit not proven
01.04.2020
01.10.2020
Trifluridin / Tipiracil (3)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
6,900–12,200
100%
Hint for
minor additional benefit
01.04.2020
01.10.2020
Apalutamid (3)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
1,090–3,800
100%
Indication of
minor additional benefit
15.03.2020
17.09.2020
Tisagenlecleucel (3)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
50–65
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
15.03.2020
17.09.2020
Tisagenlecleucel (4)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
450–720
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
15.03.2020
03.09.2020
Abemaciclib (3)
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
repealed subpopulations
01.03.2020
20.08.2020
Apalutamid (2)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy
2,590–3,640
100%
additional benefit not proven
01.03.2020
20.08.2020
Ribociclib (4)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with fulvestrant
13,140–59,690
58%
Indication of
minor additional benefit
01.03.2020
20.08.2020
Ribociclib (3)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, combination with aromatase inhibitor
7,400–34,790
100%
Hint for
minor additional benefit
15.02.2020
20.08.2020
Polatuzumab Vedotin (1)
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
repealed
15.02.2020
20.08.2020
Daratumumab (5)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone
0
3,479–3,670
100%
Hint for
minor additional benefit
Orphan (turnover limit)
repealed
15.02.2020
20.08.2020
Daratumumab (6)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone
1,800–1,900
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2020
20.08.2020
Ramucirumab (6)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
780–1,810
100%
additional benefit not proven
15.01.2020
02.07.2020
Trastuzumab Emtansin (2)
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) early stage, HER2+, adjuvant treatment
1,980
100%
Indication of
minor additional benefit
01.12.2019
14.05.2020
Neratinib (1)
Nerlynx®
Pierre Fabre Pharma
Oncological diseases
Breast cancer (BC) HR+, HER2+, adjuvant therapy
2,330–4,560
100%
Hint for
minor additional benefit
01.12.2019
14.05.2020
Gilteritinib (1)
Xospata®
Astellas Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML), FLT3 mutation
220–580
100%
Hint for
considerable additional benefit
Orphan
01.12.2019
14.05.2020
Avelumab (2)
Bavencio®
Merck Serono GmbH / Pfizer Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
3,500
23%
Hint for
considerable additional benefit
01.12.2019
14.05.2020
Pembrolizumab (13)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy
4,950–5,370
100%
Indication of
minor additional benefit
01.12.2019
14.05.2020
Pembrolizumab (11)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy
4,955–5,370
100%
Hint for
considerable additional benefit
01.12.2019
14.05.2020
Pembrolizumab (12)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with axitinib
3,500
23%
Indication of
considerable additional benefit
15.10.2019
02.04.2020
Niraparib (2)
Zejula®
TESARO Bio Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
0
1,900–2,400
100%
additional benefit not proven
Orphan (turnover limit)
repealed
15.10.2019
02.04.2020
Larotrectinib (1)
Vitrakvi®
Bayer Vital GmbH
Oncological diseases
Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent
390–770
100%
additional benefit not proven
01.10.2019
02.04.2020
Atezolizumab (5)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with bevacizumab, paclitaxel and carboplatin; maintenance therapy
8,990–9,590
100%
additional benefit not proven
15.10.2019
02.04.2020
Trifluridin / Tipiracil (2)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Metastatic gastric cancer, pre-treated patients
590–1,030
100%
Indication of
minor additional benefit
01.10.2019
02.04.2020
Atezolizumab (4)
Tecentriq®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), triple-negative, PD-L1 expression ≥1%
920–1,110
100%
Hint for
non-quantifiable additional benefit
01.10.2019
02.04.2020
Atezolizumab (6)
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%
additional benefit not proven
15.10.2019
02.04.2020
Atezolizumab (7)
Tecentriq®
Roche Pharma AG
Oncological diseases
Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy
7,280–8,550
100%
Hint for
minor additional benefit
01.10.2019
02.04.2020
Elotuzumab (2)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
0
2,500
100%
Hint for
considerable additional benefit
repealed
15.09.2019
05.03.2020
Ropeginterferon alfa-2b (1)
Besremi®
AOP Orphan Pharmaceuticals AG
Oncological diseases
Polycythemia vera
1,860–19,800
100%
additional benefit not proven
01.09.2019
20.02.2020
Ramucirumab (5)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
500–2,200
100%
Proof of
minor additional benefit
01.09.2019
20.02.2020
Ibrutinib (6)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab
3,090
26%
Hint for
minor additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ibrutinib (7)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Waldenström's disease, combination with rituximab
590–1,180
100%
additional benefit not proven
Orphan (turnover limit)
01.08.2019
06.02.2020
Cemiplimab (1)
Libtayo®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Squamous cell carcinoma (SCC)
450–1,400
100%
additional benefit not proven
15.07.2019
16.01.2020
Olaparib (3)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Breast cancer (BC) BRCA1/2 mutations, HER2-
460–710
100%
Hint for
minor additional benefit
15.07.2019
16.01.2020
Olaparib (4)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
0
70–325
100%
additional benefit not proven
repealed
15.06.2019
05.12.2019
Pomalidomid (3)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone
3,060–3,450
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2019
22.11.2019
Lorlatinib (1)
Lorviqua®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
200–1,310
100%
additional benefit not proven
01.05.2019
17.10.2019
Dacomitinib (1)
Vizimpro®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line
890–2,210
100%
additional benefit not proven
15.04.2019
17.10.2019
Radium-223-dichlorid (2)
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
3,810–4,560
100%
additional benefit not proven
01.04.2019
19.09.2019
Pembrolizumab (10)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel
5,340–5,570
71%
Hint for
considerable additional benefit
01.04.2019
19.09.2019
Pembrolizumab (9)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy
8,020–9,120
100%
Hint for
non-quantifiable additional benefit
01.04.2019
19.09.2019
Pembrolizumab (8)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Melanoma, adjuvant therapy
2,670–3,400
100%
Indication of
non-quantifiable additional benefit
15.03.2019
05.09.2019
Brentuximab Vedotin (4)
Adcetris®
Takeda GmbH & Co. KG
Oncological diseases
Hodgkin lymphoma (HL), CD30+, first-line
220–380
100%
non-quantifiable additional benefit
Orphan
01.03.2019
15.08.2019
Rucaparib (1)
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%
additional benefit not proven
repealed
01.03.2019
15.08.2019
Rucaparib (2)
Rubraca®
Clovis Oncology Germany GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy
0
1,900–2,400
100%
additional benefit not proven
repealed
15.02.2019
15.08.2019
Blinatumomab (4)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients
40–110
100%
non-quantifiable additional benefit
Orphan
15.02.2019
15.08.2019
Blinatumomab (3)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years
30–80
100%
non-quantifiable additional benefit
Orphan
15.02.2019
15.08.2019
Lenvatinib (3)
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
740–770
100%
additional benefit not proven
15.02.2019
15.08.2019
Ipilimumab (5)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with nivolumab
2,110–2,850
100%
Indication of
considerable additional benefit
15.02.2019
15.08.2019
Nivolumab (12)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC), first-line, combination with ipilimumab
2,110–2,850
100%
Indication of
considerable additional benefit
01.02.2019
01.08.2019
Apalutamid (1)
Erleada®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
0
810–1,180
100%
Hint for
minor additional benefit
repealed
15.01.2019
04.07.2019
Brigatinib (1)
Alunbrig®
Takeda GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
160–1,060
100%
additional benefit not proven
15.01.2019
04.07.2019
Ribociclib (2)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor
9,450–45,780
21,940–106,310
100%
additional benefit not proven
repealed subpopulations
01.01.2019
20.06.2019
Pembrolizumab (7)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Urothelial carcinoma (UC), CPS ≥ 10, first-line
0
240–420
100%
additional benefit not proven
repealed
01.01.2019
20.06.2019
Atezolizumab (3)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line
220–380
100%
additional benefit not proven
15.12.2018
06.06.2019
Cabozantinib (Cabometyx, 4)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
1,280–4,900
100%
Hint for
minor additional benefit
01.12.2018
16.05.2019
Enzalutamid (3)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), non-metastatic, high-risk
0
810–1,180
100%
additional benefit not proven
repealed
01.12.2018
16.05.2019
Venetoclax (2)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with rituximab
2,000–7,200
37%
Indication of
minor additional benefit
01.12.2018
16.05.2019
Venetoclax (3)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
300–700
100%
additional benefit not proven
01.11.2018
02.05.2019
Axicabtagen-Ciloleucel (2)
Yescarta®
Kite, a Gilead Company
Oncological diseases
Primary mediastinal large B-cell lymphoma (PMBCL)
0
5–9
100%
non-quantifiable additional benefit
Orphan
repealed
01.11.2018
02.05.2019
Axicabtagen-Ciloleucel (1)
Yescarta®
Kite, a Gilead Company
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
440–700
100%
non-quantifiable additional benefit
Orphan
repealed
01.11.2018
02.05.2019
Abemaciclib (2)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with fulvestrant
14,560–70,550
100%
additional benefit not proven
01.11.2018
02.05.2019
Abemaciclib (1)
Verzenios®
Lilly Deutschland GmbH
Oncological diseases
Breast cancer (BC), HR+, HER2-, combination with aromatase inhibitor
14,560–70,550
100%
additional benefit not proven
15.10.2018
04.04.2019
Pembrolizumab (6)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Squamous cell carcinoma head and neck
470–3,290
100%
additional benefit not proven
15.10.2018
04.04.2019
Durvalumab (1)
Imfinzi®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), maintenance therapy
1,600–1,800
100%
Hint for
considerable additional benefit
01.10.2018
22.03.2019
Trametinib (3)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy
1,290–1,590
100%
Indication of
considerable additional benefit
01.10.2018
22.03.2019
Dabrafenib (4)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy
1,290–1,590
100%
Indication of
considerable additional benefit
01.10.2018
22.03.2019
Binimetinib (1)
Mektovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with encorafenib
1,390
100%
additional benefit not proven
01.10.2018
22.03.2019
Encorafenib (1)
Braftovi®
Pierre Fabre Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with binimetinib
1,390
100%
additional benefit not proven
01.10.2018
22.03.2019
Palbociclib (2)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC), patient population b1 and b2
6,190–30,000
100%
additional benefit not proven
01.10.2018
22.03.2019
Lenvatinib (2)
Lenvima®
Eisai GmbH
Oncological diseases
Hepatocellular carcinoma (HCC)
2,630–4,750
100%
additional benefit not proven
01.10.2018
22.03.2019
Daunorubicin / Cytarabin (1)
Vyxeos®
Jazz Pharmaceuticals
Oncological diseases
Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia
310–510
100%
considerable additional benefit
Orphan
01.10.2018
22.03.2019
Daratumumab (4)
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)
repealed
15.09.2018
07.03.2019
Tisagenlecleucel (1)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
Diffuse large B-cell lymphoma (DLBCL)
0
440–700
100%
non-quantifiable additional benefit
Orphan
repealed
15.09.2018
07.03.2019
Tisagenlecleucel (2)
Kymriah®
Novartis Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
50–65
100%
non-quantifiable additional benefit
Orphan
repealed
01.09.2018
21.02.2019
Nivolumab (11)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, adjuvant therapy
0
2,980–3,780
100%
Hint for
non-quantifiable additional benefit
repealed
01.09.2018
21.02.2019
Gemtuzumab Ozogamicin (1)
Mylotarg®
Pfizer Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
560–1,150
100%
non-quantifiable additional benefit
Orphan
01.09.2018
21.02.2019
Bosutinib (3)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+
545–555
100%
additional benefit not proven
15.07.2018
17.01.2019
Osimertinib (3)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
860–2,030
84%
Hint for
considerable additional benefit
01.07.2018
20.12.2018
Ipilimumab (4)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with nivolumab
2,500–4,500
85%
additional benefit not proven
15.06.2018
20.12.2018
Nivolumab (10)
Opdivo®
Bristol-Myers-Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
270–810
100%
Indication of
less benefit
01.07.2018
20.12.2018
Pertuzumab (3)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy
0
3,020
100%
Indication of
minor additional benefit
repealed
15.06.2018
06.12.2018
Olaparib (2)
Lynparza®
AstraZeneca GmbH
Oncological diseases
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy
1,900–2,400
100%
Hint for
minor additional benefit
15.06.2018
06.12.2018
Cabozantinib (Cabometyx, 3)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC)
2,240–2,570
100%
additional benefit not proven
01.06.2018
22.11.2018
Bosutinib (2)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML), Ph+, first-line
0
690–810
100%
additional benefit not proven
repealed
15.02.2018
02.08.2018
Sonidegib (1)
Odomzo®
Sun Pharmaceuticals Germany GmbH
Oncological diseases
Basal cell carcinoma (BCC)
130–350
100%
additional benefit not proven
15.02.2018
02.08.2018
Ipilimumab (3)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, ≥ 12 to < 18 years
1–5
100%
additional benefit not proven
15.01.2018
05.07.2018
Brentuximab Vedotin (3)
Adcetris®
Takeda GmbH
Oncological diseases
Cutaneous T-cell lymphoma, CD30+
40–130
100%
minor additional benefit
Orphan
15.01.2018
05.07.2018
Allogene, genetisch modifizierte T-Zellen (1)
Zalmoxis®
Dompé farmaceutici S.p.A.
Oncological diseases
Haematological malignancies, concomitant therapy in haploidentical haematopoietic stem cell transplantation
100–140
100%
non-quantifiable additional benefit
Orphan
01.01.2018
21.06.2018
Alectinib (2)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
350–850
100%
Hint for
non-quantifiable additional benefit
15.12.2017
07.06.2018
Abirateronacetat (3)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), high-risk, combination with androgen deprivation therapy
1,500–2,200
100%
Indication of
considerable additional benefit
15.12.2017
07.06.2018
Niraparib (1)
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
repealed
01.11.2017
19.04.2018
Tivozanib (1)
Fotivda®
EUSA Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
2,953–7,126
100%
additional benefit not proven
15.10.2017
05.04.2018
Cabozantinib (Cabometyx, 2)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC), after VEGF pre-therapy
1,200–3,300
100%
Indication of
minor additional benefit
15.10.2017
05.04.2018
Telotristatethyl (1)
Xermelo®
Ipsen Pharma GmbH
Oncological diseases
Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy
300–1,000
100%
non-quantifiable additional benefit
Orphan
15.10.2017
05.04.2018
Midostaurin (1)
Rydapt®
Novartis Pharma GmbH
Oncological diseases
Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM)
0
400–710
80%
considerable additional benefit
Orphan
repealed
15.10.2017
05.04.2018
Obinutuzumab (3)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL), first-line
0
1,300–1,500
100%
non-quantifiable additional benefit
Orphan
repealed
15.09.2017
16.03.2018
Ribociclib (1)
Kisqali®
Novartis Pharma GmbH
Oncological diseases
Breast cancer (BC) HR+, HER2-, postmenopausal women, combination with aromatase inhibitor
0
7,180–34,790
100%
additional benefit not proven
repealed
15.09.2017
16.03.2018
Pembrolizumab (5)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Urothelial carcinoma (UC)
0
2,300–3,300
61%
Indication of
considerable additional benefit
repealed
01.10.2017
16.03.2018
Atezolizumab (1)
Tecentriq®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
18,800–34,600
40%
Indication of
considerable additional benefit
01.10.2017
16.03.2018
Atezolizumab (2)
Tecentriq®
Roche Pharma AG
Oncological diseases
Urothelial carcinoma (UC), first-line
1,500–1,900
2,300–3,300
61%
Hint for
minor additional benefit
repealed subpopulations
01.10.2017
16.03.2018
Avelumab (1)
Bavencio®
Merck Serono GmbH/Pfizer Pharma GmbH
Oncological diseases
Merkel-cell carcinoma (MCC)
0
160–410
100%
non-quantifiable additional benefit
Orphan
repealed
15.08.2017
15.02.2018
Carfilzomib (3)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.08.2017
15.02.2018
Daratumumab (3)
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)
repealed subpopulations
01.08.2017
01.02.2018
Ceritinib (3)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
430–850
100%
additional benefit not proven
15.07.2017
18.01.2018
Inotuzumab ozogamicin (1)
Besponsa®
Pfizer Pharma GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
120–200
100%
minor additional benefit
Orphan
01.07.2017
21.12.2017
Nivolumab (9)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Urothelial carcinoma (UC)
1,500–1,900
100%
additional benefit not proven
15.06.2017
07.12.2017
Blinatumomab (2)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
60–170
100%
considerable additional benefit
Orphan
15.06.2017
07.12.2017
Nivolumab (8)
Opdivo®
Bristol-Myers-Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
0
500–1,500
100%
additional benefit not proven
repealed
01.06.2017
17.11.2017
Nivolumab (7)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Squamous cell carcinoma head and neck
970–6,850
77%
Hint for
considerable additional benefit
01.06.2017
17.11.2017
Pembrolizumab (4)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Hodgkin lymphoma (HL)
60–180
100%
additional benefit not proven
01.05.2017
19.10.2017
Dabrafenib (3)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation, combination with trametinib
230–820
100%
additional benefit not proven
01.05.2017
19.10.2017
Trametinib (2)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation
230–720
100%
additional benefit not proven
01.05.2017
19.10.2017
Alectinib (1)
Alecensa®
Roche Pharma AG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
200–1,310
81%
Hint for
minor additional benefit
01.05.2017
19.10.2017
Osimertinib (2)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
560–2,730
100%
Hint for
considerable additional benefit
01.04.2017
21.09.2017
Axitinib (2)
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
15.02.2017
03.08.2017
Pembrolizumab (3)
Keytruda®
MSD SHARP & DOHME GMBH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), first-line
4,000
100%
Indication of
considerable additional benefit
15.01.2017
06.07.2017
Vandetanib (3)
Caprelsa®
Genzyme GmbH
Oncological diseases
Thyroid carcinoma, ≥ 5 years
0
2–8
100%
Hint for
non-quantifiable additional benefit
repealed
15.01.2017
06.07.2017
Ixazomib (1)
Ninlaro®
Takeda 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
repealed
01.01.2017
15.06.2017
Nivolumab (6)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Hodgkin lymphoma (HL)
40–90
100%
additional benefit not proven
01.01.2017
15.06.2017
Venetoclax (1)
Venclyxto®
AbbVie Deutschland GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), monotherapy
0
300–700
100%
non-quantifiable additional benefit
Orphan
repealed
01.12.2016
18.05.2017
Palbociclib (1)
Ibrance®
Pfizer Pharma GmbH
Oncological diseases
Breast cancer (BC)
7,380–35,760
14,560–70,550
100%
additional benefit not proven
repealed subpopulations
01.12.2016
18.05.2017
Olaratumab (1)
Lartruvo®
Lilly Deutschland GmbH
Oncological diseases
Soft tissue sarcoma
0
1,200–1,400
100%
considerable additional benefit
Orphan
repealed
01.11.2016
20.04.2017
Cabozantinib (Cabometyx, 1)
Cabometyx®
Ipsen Pharma GmbH
Oncological diseases
Renal cell carcinoma (RCC)
0
1,200–3,300
100%
Hint for
non-quantifiable additional benefit
repealed
01.10.2016
16.03.2017
Ceritinib (2)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
200–1,310
81%
Hint for
considerable additional benefit
01.10.2016
16.03.2017
Crizotinib (4)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ROS1+
210–770
100%
additional benefit not proven
01.10.2016
16.03.2017
Lenvatinib (Kisplyx, 1)
Kisplyx®
Eisai GmbH
Oncological diseases
Renal cell carcinoma (RCC)
0
1,200–3,300
100%
Hint for
minor additional benefit
repealed
01.10.2016
16.03.2017
Idelalisib (3)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), combination with ofatumumab; Chronic lymphocytic leukaemia (CLL), first-line, 17p deletion/TP53 mutation, combination with rituximab
2,020–7,560
0.4%
Hint for
non-quantifiable additional benefit
01.10.2016
16.03.2017
Ibrutinib (5)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), at least 1 prior therapy, combination with bendamustine and rituximab
1,500–5,600
50%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.08.2016
02.02.2017
Pembrolizumab (2)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
12,500–24,300
40%
Indication of
considerable additional benefit
15.08.2016
02.02.2017
Trifluridin / Tipiracil (1)
Lonsurf®
Servier Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC), pre-treated patients
0
6,900–12,200
100%
Hint for
minor additional benefit
repealed
01.08.2016
19.01.2017
Brentuximab Vedotin (2)
Adcetris®
Takeda GmbH
Oncological diseases
Hodgkin lymphoma (HL), CD30+, increased risk of recurrence or progression after transplantation
40–60
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Carfilzomib (2)
Kyprolis®
Amgen GmbH
Oncological diseases
Multiple myeloma (MM), combination with dexamethasone
0
4,700–7,000
100%
minor additional benefit
Orphan
repealed
01.07.2016
15.12.2016
Ibrutinib (4)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL), first-line
2,840
100%
additional benefit not proven
Orphan (turnover limit)
01.07.2016
15.12.2016
Crizotinib (3)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
480
71%
Hint for
considerable additional benefit
01.07.2016
15.12.2016
Obinutuzumab (2)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Follicular lymphoma (FL)
0
790–940
100%
non-quantifiable additional benefit
Orphan
repealed
15.06.2016
15.12.2016
Nivolumab (5)
Opdivo®
Bristol-Myers-Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, combination with ipilimumab
2,230–3,690
2,500–4,500
100%
additional benefit not proven
repealed subpopulations
15.06.2016
15.12.2016
Talimogen laherparepvec (1)
Imlygic®
Amgen GmbH
Oncological diseases
Melanoma, stage IIIB, IIIC, IVMI1a
375–620
100%
additional benefit not proven
01.06.2016
01.12.2016
Eribulin (3)
Halaven®
Eisai GmbH
Oncological diseases
Liposarcoma
30–150
50%
Hint for
considerable additional benefit
01.06.2016
01.12.2016
Elotuzumab (1)
Empliciti®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone
4,700–7,000
100%
Hint for
minor additional benefit
01.06.2016
01.12.2016
Daratumumab (1)
Darzalex®
Janssen-Cilag GmbH
Oncological diseases
Multiple myeloma (MM), monotherapy, pre-treated patients
0
2,300
100%
non-quantifiable additional benefit
Orphan
repealed
01.05.2016
20.10.2016
Ramucirumab (4)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel
5,900–7,900
50%
Hint for
minor additional benefit
01.05.2016
20.10.2016
Afatinib (3)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology
6,720–12,420
100%
additional benefit not proven
01.05.2016
20.10.2016
Nivolumab (3)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Renal cell carcinoma (RCC)
1,200–3,300
92%
Indication of
considerable additional benefit
01.05.2016
20.10.2016
Nivolumab (4)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, after previous chemotherapy
11,830–21,830
40%
Indication of
considerable additional benefit
15.03.2016
15.09.2016
Osimertinib (1)
Tagrisso®
AstraZeneca GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation
245–1,465
475–2,830
100%
additional benefit not proven
repealed subpopulations
01.04.2016
15.09.2016
Necitumumab (1)
Portrazza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
6,300–7,700
100%
additional benefit not proven
01.04.2016
15.09.2016
Idelalisib (2)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukemia (CLL)
2,000–7,500
2,200–7,800
24%
Hint for
non-quantifiable additional benefit
repealed subpopulations
01.03.2016
01.09.2016
Ramucirumab (2)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
2,900–7,300
100%
additional benefit not proven
01.03.2016
01.09.2016
Ramucirumab (3)
Cyramza®
Lilly Deutschland GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
5,900–15,400
100%
additional benefit not proven
15.02.2016
04.08.2016
Vismodegib (2)
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
295
95%
Hint for
minor additional benefit
01.02.2016
21.07.2016
Ibrutinib (3)
Imbruvica®
Janssen-Cilag GmbH
Oncological diseases
Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), Waldenström's disease
3,780–11,100
12%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.01.2016
16.06.2016
Crizotinib (2)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, first-line
0
300–900
100%
Hint for
considerable additional benefit
repealed
15.12.2015
02.06.2016
Blinatumomab (1)
Blincyto®
Amgen GmbH
Oncological diseases
B-cell acute lymphoblastic leukaemia (ALL)
0
60–170
100%
non-quantifiable additional benefit
Orphan
repealed
15.12.2015
02.06.2016
Carfilzomib (1)
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
repealed
15.12.2015
02.06.2016
Cobimetinib (1)
Cotellic®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation, combination with vemurafenib
1,400
100%
Indication of
considerable additional benefit
01.10.2015
17.03.2016
Trametinib (1)
Mekinist®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
50%
Indication of
considerable additional benefit
01.10.2015
17.03.2016
Regorafenib (3)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
6,900–12,200
100%
additional benefit not proven
01.10.2015
17.03.2016
Pomalidomid (2)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
2,300
50%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.10.2015
17.03.2016
Panobinostat (1)
Farydak®
Novartis Pharma GmbH
Oncological diseases
Multiple myeloma (MM), at least 1 prior therapy, combination with pomalidomide and dexamethasone
2,300
100%
non-quantifiable additional benefit
Orphan
01.10.2015
17.03.2016
Dabrafenib (2)
Tafinlar®
Novartis Pharma GmbH
Oncological diseases
Melanoma, BRAF V600 mutation, combination with trametinib
1,400
100%
Indication of
considerable additional benefit
01.09.2015
18.02.2016
Pertuzumab (2)
Perjeta®
Roche Pharma AG
Oncological diseases
Breast cancer (BC), inflammatory or early with high risk of recurrence, neoadjuvant, combination with trastuzumab and chemotherapy
2,900–4,850
100%
additional benefit not proven
15.08.2015
04.02.2016
Pembrolizumab (1)
Keytruda®
MSD Sharp & Dohme GmbH
Oncological diseases
Melanoma
2,500–4,500
71%
Indication of
considerable additional benefit
15.08.2015
04.02.2016
Nivolumab (2)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy
4,200–6,000
87%
Indication of
considerable additional benefit
15.07.2015
07.01.2016
Nivolumab (1)
Opdivo®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma
2,500–4,500
15%
Indication of
considerable additional benefit
01.07.2015
17.12.2015
Lenvatinib (1)
Lenvima®
Eisai GmbH
Oncological diseases
Thyroid carcinoma (DTC)
0
600–815
100%
non-quantifiable additional benefit
Orphan
repealed
01.07.2015
17.12.2015
Ceritinib (1)
Zykadia®
Novartis Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib
0
120–560
100%
additional benefit not proven
repealed
01.06.2015
27.11.2015
Olaparib (1)
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
repealed
15.05.2015
05.11.2015
Afatinib (2)
Giotrif®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients
3,670–8,590
42%
Indication of
major additional benefit
15.04.2015
15.10.2015
Ruxolitinib (3)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Polycythaemia vera
240–1,470
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.02.2015
16.07.2015
Ramucirumab (1)
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
repealed
01.01.2015
18.06.2015
Nintedanib (1)
Vargatef®
Boehringer Ingelheim Pharma GmbH & Co. KG
Oncological diseases
Non-small cell lung carcinoma (NSCLC)
3,700–15,100
100%
Indication of
minor additional benefit
01.01.2015
18.06.2015
Enzalutamid (2)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
15,000–28,800
100%
Indication of
considerable additional benefit
01.11.2014
16.04.2015
Ibrutinib (1)
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
repealed
01.10.2014
19.03.2015
Sipuleucel-T (1)
Provenge®
Dendreon UK Limited
Oncological diseases
Prostate carcinoma (PC)
11,690–24,480
100%
Hint for
non-quantifiable additional benefit
01.10.2014
19.03.2015
Idelalisib (1)
Zydelig®
Gilead Sciences GmbH
Oncological diseases
Chronic lymphocytic leukaemia (CLL), Follicular lymphoma (FL)
1,800–7,050
3,000–11,100
20%
Hint for
non-quantifiable additional benefit
repealed subpopulations
01.09.2014
19.02.2015
Regorafenib (2)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Gastrointestinal stromal tumor (GIST)
100–700
100%
additional benefit not proven
15.08.2014
05.02.2015
Obinutuzumab (1)
Gazyvaro®
Roche Pharma AG
Oncological diseases
Chronic lymphocytic leukemia (CLL)
0
818–1,477
100%
non-quantifiable additional benefit
Orphan
repealed
01.08.2014
22.01.2015
Cabozantinib (1)
Cometriq®
Swedish Orphan Biovitrum GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
60–500
100%
minor additional benefit
Orphan
repealed
01.08.2014
22.01.2015
Eribulin (2)
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC), after at least 2 chemotherapies; mammary carcinoma, after at least 1 chemotherapy
5,101–7,601
75%
Hint for
considerable additional benefit
15.06.2014
04.12.2014
Siltuximab (1)
Sylvant®
Janssen-Cilag GmbH
Oncological diseases
Multicentric Castleman Disease (MCD)
130–1,460
100%
non-quantifiable additional benefit
Orphan
15.05.2014
06.11.2014
Ruxolitinib (2)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
1,600–5,000
100%
Hint for
considerable additional benefit
Orphan (turnover limit)
01.01.2014
19.06.2014
Trastuzumab Emtansin (1)
Kadcyla®
Roche Pharma AG
Oncological diseases
Breast cancer (BC) HER2+, pre-treated patients
4,121
72%
Indication of
considerable additional benefit
01.01.2014
19.06.2014
Radium-223-dichlorid (1)
Xofigo®
Bayer Vital GmbH
Oncological diseases
Prostate carcinoma (PC)
0
22,700
78%
Indication of
considerable additional benefit
repealed
15.12.2013
05.06.2014
Ipilimumab (2)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, first-line
500–1,500
100%
additional benefit not proven
15.11.2013
08.05.2014
Afatinib (1)
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
repealed
01.10.2013
03.04.2014
Dabrafenib (1)
Tafinlar®
GlaxoSmithKline GmbH & Co. KG
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
100%
additional benefit not proven
01.10.2013
20.03.2014
Regorafenib (1)
Stivarga®
Bayer Vital GmbH
Oncological diseases
Colorectal carcinoma (CRC)
0
6,600–14,000
100%
Hint for
minor additional benefit
repealed
15.09.2013
06.03.2014
Vemurafenib (2)
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
1,400
100%
Indication of
considerable additional benefit
01.09.2013
20.02.2014
Pomalidomid (1)
Imnovid®
Celgene GmbH
Oncological diseases
Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone
0
1,900
100%
considerable additional benefit
Orphan
repealed
01.09.2013
20.02.2014
Enzalutamid (1)
Xtandi®
Astellas Pharma GmbH
Oncological diseases
Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy
6,300
100%
Indication of
considerable additional benefit
15.08.2013
06.02.2014
Vismodegib (1)
Erivedge®
Roche Pharma AG
Oncological diseases
Basal cell carcinoma (BCC)
0
295
95%
Hint for
minor additional benefit
repealed
01.08.2013
23.01.2014
Ponatinib (1)
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
repealed
01.05.2013
17.10.2013
Bosutinib (1)
Bosulif®
Pfizer Pharma GmbH
Oncological diseases
Chronic myeloid leukaemia (CML)
0
380–500
100%
non-quantifiable additional benefit
Orphan
repealed
01.04.2013
01.10.2013
Pertuzumab (1)
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
15.03.2013
05.09.2013
Vandetanib (2)
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
60–1,500
100%
Hint for
minor additional benefit
repealed
01.03.2013
15.08.2013
Aflibercept (Zaltrap, 1)
Zaltrap®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Colorectal carcinoma (CRC)
3,500–10,400
100%
Indication of
minor additional benefit
15.01.2013
04.07.2013
Abirateronacetat (2)
Zytiga®
Janssen-Cilag GmbH
Oncological diseases
Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy
15,000–28,800
100%
Indication of
considerable additional benefit
01.12.2012
16.05.2013
Pixantron (1)
Pixuvri®
CTI Life Sciences Ltd.
Oncological diseases
B-Cell Non-Hodgkin Lymphoma (NHL)
970
100%
additional benefit not proven
01.12.2012
16.05.2013
Brentuximab Vedotin (1)
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
01.11.2012
02.05.2013
Decitabin (1)
Dacogen®
Janssen-Cilag GmbH
Oncological diseases
Acute myeloid leukaemia (AML)
300–780
100%
minor additional benefit
Orphan
15.11.2012
02.05.2013
Crizotinib (1)
Xalkori®
Pfizer Pharma GmbH
Oncological diseases
Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated
0
480
71%
Hint for
considerable additional benefit
repealed
01.10.2012
21.03.2013
Axitinib (1)
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
repealed
15.09.2012
07.03.2013
Ruxolitinib (1)
Jakavi®
Novartis Pharma GmbH
Oncological diseases
Myelofibrosis (MF)
0
1,600
100%
minor additional benefit
Orphan
repealed
01.07.2012
20.12.2012
Tegafur / Gimeracil / Oteracil (1)
Teysuno®
Nordic Pharma GmbH
Oncological diseases
Gastric carcinoma
10,500–12,000
100%
additional benefit not proven
15.03.2012
06.09.2012
Vemurafenib (1)
Zelboraf®
Roche Pharma AG
Oncological diseases
Melanoma, BRAF V600 mutation
0
1,400
100%
Indication of
considerable additional benefit
repealed
15.03.2012
06.09.2012
Vandetanib (1)
Caprelsa®
AstraZeneca GmbH
Oncological diseases
Thyroid carcinoma (MTC)
0
130–1,300
100%
additional benefit not proven
repealed
01.08.2011
02.08.2012
Ipilimumab (1)
Yervoy®
Bristol-Myers Squibb GmbH & Co. KGaA
Oncological diseases
Melanoma, second-line
3,100
100%
Indication of
considerable additional benefit
01.05.2011
19.04.2012
Eribulin (1)
Halaven®
Eisai GmbH
Oncological diseases
Breast cancer (BC) after at least 2 chemotherapies
0
5,630–7,310
80%
Hint for
minor additional benefit
repealed
15.04.2011
29.03.2012
Cabazitaxel (1)
Jevtana®
Sanofi-Aventis Deutschland GmbH
Oncological diseases
Prostate carcinoma (PC), docetaxel pre-treatment, combination with prednisone or prednisolone
5,670–6,930
85%
Indication of
minor additional benefit
01.10.2011
29.03.2012
Abirateronacetat (1)
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