Oncological diseases

The xx medicinal products assessed in the field of oncological diseases include products for cell lung carcinoma, multiple myeloma, melanoma and many others. To date, the G-BA has concluded xx resolutions in this therapeutic area and evaluated a total of xx patient populations. When these subpopulations are weighted according to their patient share in the resolution, there is a major additional benefit for xx% of the populations and a considerable additional benefit for a further XX%. A minor additional benefit has been proved in XX% of the subpopulations, with the G-BA identifying a non-quantifiable additional benefit for XX% of the subpopulations.

The G-BA has seen no additional benefit proven for XX% of the subpopulations, with xx% receiving even less benefit than the comparative therapy. According to the G-BA, a total of xx% of the maximum xx million patients do not see any added value from the assessed medicinal product in relation to an appropriate comparative therapy.

All G-BA resolutions concerning malignant diseases

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
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)
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)
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
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
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
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
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
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
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
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)
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
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)
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)
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
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)
Avapritinib (6) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases Gastrointestinal stromal tumours 5–60 100% additional benefit not proven Orphan (turnover limit)
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)
Momelotinib (2) Omjjara® GlaxoSmithKline GmbH & Co. KG Oncological diseases Myelofibrosis 680–2,680 100% additional benefit not proven Orphan (turnover limit)
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
Nirogacestat (1) Ogsiveo® SpringWorks Therapeutics Ireland Limited Oncological diseases Desmoid tumour, advanced 350–630 100% Hint for minor additional benefit Orphan
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
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
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
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
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
Linvoseltamab (1) Lynozyfic® Regeneron GmbH Oncological diseases Multiple myeloma, at least 3 prior treatments, monotherapy 330–340 100% additional benefit not proven
Tisotumab vedotin (1) Tivdak® Genmab Germany GmbH Oncological diseases Cervical cancer, previously treated 381–1,452 100% additional benefit not proven
Daratumumab (15) Darzalex® Janssen-Cilag GmbH Oncological diseases Smouldering multiple myeloma (SMM) 160–325 100% Hint for minor additional benefit Orphan (turnover limit)
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)
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
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
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
Odronextamab (2) Ordspono® Regeneron GmbH Oncological diseases Follicular lymphoma, following ≥ 2 prior treatments 370–840 100% additional benefit not proven
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
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
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
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
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
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
Acalabrutinib (6) Calquence® AstraZeneca GmbH Oncological diseases Mantle cell lymphoma, no prior BTKi treatment, relapsed or refractory, monotherapy 220 100% additional benefit not proven
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
Acalabrutinib (4) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia, first-line treatment, in combination with venetoclax 3,200 100% additional benefit not proven
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
Belzutifan (2) Welireg® MSD Sharp & Dohme GmbH Oncological diseases Von Hippel-Lindau syndrome (VHL)-associated tumours 80–970 100% additional benefit not proven
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
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
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
Blinatumomab (7) Blincyto® Amgen GmbH Oncological diseases Acute lymphoblastic B-cell leukaemia, relapsed/refractory, ≥ 1 month to < 1 year, after ≥ 2 prior therapies or after allogeneic stem cell transplantation 1 100% Hint for non-quantifiable additional benefit Orphan
Daratumumab (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)
Fedratinib (2) Inrebic® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Myelofibrosis 640–1,710 100% Hint for non-quantifiable additional benefit Orphan
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
Isatuximab (3) Sarclisa® Sanofi-Aventis Deutschland GmbH Oncological diseases Multiple myeloma, first-line, stem cell transplantation unsuitable, combination with bortezomib, lenalidomide and dexamethasone 3,450–3,680 100% Hint for minor additional benefit
Pirtobrutinib (1) Jaypirca® Lilly Deutschland GmbH Oncological diseases Mantle cell lymphoma, pre-treated patients 105–150 100% additional benefit not proven
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
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
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
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
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
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
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
Tislelizumab (4) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, after prior therapy 690–1,620 100% additional benefit not proven
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
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
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
Tislelizumab (1) Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, after prior therapy 330–540 100% additional benefit not proven
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
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
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)
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
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
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
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
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
Enfortumab Vedotin (2) Padcev® Astellas Pharma Europe B.V Oncological diseases Urothelial carcinoma, non-resectable or metastatic, first-line, suitable for platinum-containing chemotherapy, combination with pembrolizumab 920–2,280 45% Indication of considerable additional benefit
Pembrolizumab (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
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
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
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
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
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
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
Epcoritamab (2) Tepkinly® AbbVie Deutschland GmbH & Co. KG Oncological diseases Follicular lymphoma, after ≥ 2 prior therapies 370–840 100% additional benefit not proven
Olaparib (12) Lynparza® AstraZeneca GmbH Oncological diseases Primarily advanced or recurrent endometrial cancer with pMMR, combination with durvalumab, maintenance therapy 780–1,430 50% Indication of considerable additional benefit
Durvalumab (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
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
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
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
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
Alectinib (3) Alecensa® Roche Pharma AG Oncological diseases Non-small cell lung cancer, ALK+, high risk of recurrence, adjuvant therapy 330–452 50% Hint for major additional benefit
Gozetotid (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
Fruquintinib (1) Fruzaqla® Takeda GmbH Oncological diseases Colorectal carcinoma, previously treated patients 645–2,180 100% Hint for minor additional benefit
Nivolumab (28) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma, first-line, combination with cisplatin and gemcitabine 435–617 100% additional benefit not proven
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)
Osimertinib (5) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung cancer, EGFR mutations, adjuvant therapy 640–930 50% Hint for major additional benefit
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
Selpercatinib (7) Retsevmo® Lilly Deutschland GmbH Oncological diseases Solid tumors, RET-Fusion+ 59–159 100% additional benefit not proven
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
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
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
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
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
Efbemalenograstim alfa (1) Ryzneuta® Evive Biotech Oncological diseases Febrile neutropenia due to chemotherapy n.d. 100% additional benefit not proven
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)
Decitabin / Cedazuridin (1) Inaqovi® Otsuka Pharma GmbH Oncological diseases Acute myeloid leukaemia, first line 560–840 100% additional benefit not proven
Momelotinib (1) Omjjara® GlaxoSmithKline GmbH & Co. KG Oncological diseases Myelofibrosis 0
210–1,160
50% Hint for minor additional benefit Orphan repealed
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
Quizartinib (1) Vanflyta® Daiichi Sankyo Deutschland GmbH Oncological diseases Acute myeloid leukaemia (AML) 260–820 100% additional benefit not proven
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
Pembrolizumab (33) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Biliary tumours, first-line, combination with gemcitabine and cisplatin 1,480–2,180 100% Indication of minor additional benefit
Pembrolizumab (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
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
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
Avapritinib (3) Ayvakyt® Blueprint Medicines GmbH Oncological diseases Indolent systemic mastocytosis (ISM) 0
715–1,000
100% Indication of minor additional benefit Orphan repealed
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)
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)
Zanubrutinib (5) Brukinsa® BeiGene Germany GmbH Oncological diseases Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab 370–840 100% additional benefit not proven
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
Durvalumab (6) Imfinzi® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, monotherapy 1,900–5,470 100% additional benefit not proven
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)
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)
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
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
Midostaurin (3) Rydapt® Novartis Pharma AG Oncological diseases Systemic Mastocytosis 300–400 100% additional benefit not proven Orphan (turnover limit)
Midostaurin (2) Rydapt® Novartis Pharma AG Oncological diseases Acute myeloic Leukemia, FLT3-Mutation 380–1,040 100% additional benefit not proven Orphan (turnover limit)
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
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
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
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
Teclistamab (1) Tecvayli® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, at least 3 prior therapies 1,210–1,310 100% additional benefit not proven
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
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
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
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
Nivolumab (26) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung cancer, PD-L1 expression ≥ 1 %, neoadjuvant therapy, combination with platinum-based chemotherapy 110–990 100% Hint for non-quantifiable additional benefit
Glofitamab (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
Ivosidenib (2) Tibsovo® Servier Deutschland GmbH Oncological diseases Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy 80–160 100% Hint for non-quantifiable additional benefit Orphan
Ivosidenib (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
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
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
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)
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)
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
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
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
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
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
Cemiplimab (4) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Cervix carcinoma, pretreated 380–1,450 50% Indication of considerable additional benefit
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
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
Durvalumab (3) Imfinzi® AstraZeneca GmbH Oncological diseases Biliary tumors, first-line, combination with gemcitabine and cisplatin 1,800 100% Indication of minor additional benefit
Durvalumab (4) Imfinzi® AstraZeneca GmbH Oncological diseases Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with tremelimumab and platinum-based chemotherapy 14,470–24,660 100% additional benefit not proven
Durvalumab (5) Imfinzi® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with tremelimumab 1,900–5,470 100% additional benefit not proven
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
Tremelimumab (1) Imjudo® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with durvalumab 1,900–5,470 100% additional benefit not proven
Darolutamid (2) Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy 2,590–3,640 100% Indication of considerable additional benefit
Olaparib (11) 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
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
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
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
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
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
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
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
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
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
Zanubrutinib (2) Brukinsa® BeiGene Germany GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line 3,180–3,200 50% Hint for minor additional benefit
Zanubrutinib (3) Brukinsa® BeiGene Germany GmbH Oncological diseases Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody 590–1,760 100% additional benefit not proven
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
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
Relugolix (1) Orgovyx® Accord Healthcare GmbH Oncological diseases Prostate carcinoma (PC), advanced, hormone-sensitive 25,020–44,280 100% additional benefit not proven
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Pembrolizumab (30) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, ≥ 12 to < 18 years 1–4 100% additional benefit not proven
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
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
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
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
Palbociclib (3) Ibrance® Pfizer Pharma GmbH Oncological diseases Breast carcinoma (BC), patient population a1 7,400–34,700 100% additional benefit not proven
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
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
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
Tisagenlecleucel (5) Kymriah® Novartis Pharma GmbH Oncological diseases Follicular lymphoma (FL), pre-treated patients 650–690 100% Hint for non-quantifiable additional benefit Orphan
Axicabtagen-Ciloleucel (3) 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
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
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
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
Nivolumab (22) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy 920–1,580 100% Indication of considerable additional benefit
Nivolumab (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
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
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)
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
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
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
Duvelisib (2) Copiktra® Secura Bio Limited Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies 380–5,170 100% additional benefit not proven
Duvelisib (1) Copiktra® Secura Bio Limited Oncological diseases Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies 550–2,060 100% additional benefit not proven
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
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
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
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
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
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
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
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
Pralsetinib (1) Gavreto® Roche Pharma AG Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+ 170–510 100% additional benefit not proven
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
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
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
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
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
Vandetanib (4) Caprelsa® Sanofi-Aventis Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC) 50–670 100% additional benefit not proven
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)
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
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
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
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)
Blinatumomab (6) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years 7–30 100% Indication of major additional benefit Orphan
Nivolumab (18) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab 350–475 100% additional benefit not proven
Cemiplimab (3) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Basal cell carcinoma (BCC), locally advanced or metastasised 83–155 97% Hint for minor additional benefit
Cemiplimab (2) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 4,130–5,110 100% additional benefit not proven
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
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
Cabozantinib (2) Cometriq® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC) 50–670 100% Hint for non-quantifiable additional benefit Orphan
Nivolumab (17) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Malignant pleural mesothelioma, first-line, combination with ipilimumab 160 50% Indication of considerable additional benefit
Osimertinib (4) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy 0
1,280–1,860
50% Indication of non-quantifiable additional benefit repealed
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
Dostarlimab (1) Jemperli® GlaxoSmithKline GmbH & Co. KG Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy 230–3,360 100% additional benefit not proven
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
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
Bosutinib (4) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 760–890 100% additional benefit not proven
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
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
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
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
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)
Obinutuzumab (4) Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 820–1,480 100% additional benefit not proven Orphan (turnover limit)
Obinutuzumab (5) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL) 790–940 100% additional benefit not proven Orphan (turnover limit)
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
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
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
Nivolumab (15) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adjuvant therapy 3,450–4,350 100% Hint for considerable additional benefit
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
Pembrolizumab (16) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC), CPS ≥ 10, first-line 225–380 100% additional benefit not proven
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
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
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
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
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
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
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
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
Acalabrutinib (3) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment 2,020–7,540 40% Hint for considerable additional benefit
Blinatumomab (5) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+ 5–10 100% Hint for non-quantifiable additional benefit Orphan
Pertuzumab / Trastuzumab (1) Phesgo® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, metastatic or locally recurrent 2,470–4,000 100% additional benefit not proven
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
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
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)
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)
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
Lenvatinib (Kisplyx, 2) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 1,770–3,530 100% additional benefit not proven
Ipilimumab (6) Yervoy® Bristol-Myers Squibb Pharma EEIG Oncological diseases Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy 14,340–16,180 73% Indication of minor additional benefit
Nivolumab (13) Opdivo® Bristol-Myers Squibb Pharma EEIG Oncological diseases Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line 14,340–16,180 73% Indication of minor additional benefit
Olaparib (5) Lynparza® AstraZeneca GmbH Oncological diseases Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy 75–95 100% additional benefit not proven
Olaparib (6) Lynparza® AstraZeneca GmbH Oncological diseases Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment 2,290–3,040 100% Hint for considerable additional benefit
Olaparib (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
Acalabrutinib (2) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line 2,880–3,780 25% Hint for minor additional benefit
Acalabrutinib (1) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); monotherapy, first-line 2,880–3,780 25% Hint for minor additional benefit
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)
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases Hepatocellular carcinoma (HCC), combination with bevacizumab 1,710–4,970 76% Indication of considerable additional benefit
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
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
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)
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
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
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
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
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
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
Encorafenib (2) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Metastatic colorectal carcinoma (CRC) 525–1,235 100% Hint for considerable additional benefit
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
Mogamulizumab (1) Poteligeo® Kyowa Kirin GmbH Oncological diseases Mycosis Fungoides; Sézary Syndrome 310–460 100% Hint for non-quantifiable additional benefit Orphan
Talazoparib (1) Talzenna® Pfizer Pharma GmbH Oncological diseases Breast cancer (BC) BRCA1/2 mutation, HER2- 410–1,830 100% Hint for considerable additional benefit
Ponatinib (2) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Chronic myeloid leukaemia (CML) 500–940 100% Hint for non-quantifiable additional benefit Orphan
Ponatinib (3) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Acute myeloid leukaemia (AML) 25–195 100% Hint for non-quantifiable additional benefit Orphan
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
Brigatinib (2) Alunbrig® Takeda GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients 420–910 50% Hint for considerable additional benefit
Darolutamid (1) Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 1,090–3,800 100% Indication of considerable additional benefit
Venetoclax (4) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab 3,090–3,099 100% additional benefit not proven
Avelumab (3) Bavencio® Merck Serono GmbH Oncological diseases Metastatic Merkel-cell carcinoma (MCC) 370–720 100% additional benefit not proven
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
Gilteritinib (1) Xospata® Astellas Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML), FLT3 mutation 220–580 100% Hint for considerable additional benefit Orphan
Avelumab (2) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with axitinib 3,500 23% Hint for considerable additional benefit
Pembrolizumab (13) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy 4,950–5,370 100% Indication of minor additional benefit
Pembrolizumab (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
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
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
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
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
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases Metastatic gastric cancer, pre-treated patients 590–1,030 100% Indication of minor additional benefit
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
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
Atezolizumab (7) Tecentriq® Roche Pharma AG Oncological diseases Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy 7,280–8,550 100% Hint for minor additional benefit
Elotuzumab (2) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone 0
2,500
100% Hint for considerable additional benefit repealed
Ropeginterferon alfa-2b (1) Besremi® AOP Orphan Pharmaceuticals AG Oncological diseases Polycythemia vera 1,860–19,800 100% additional benefit not proven
Ramucirumab (5) Cyramza® Lilly Deutschland GmbH Oncological diseases Hepatocellular carcinoma (HCC) 500–2,200 100% Proof of minor additional benefit
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)
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)
Cemiplimab (1) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Squamous cell carcinoma (SCC) 450–1,400 100% additional benefit not proven
Olaparib (3) Lynparza® AstraZeneca GmbH Oncological diseases Breast cancer (BC) BRCA1/2 mutations, HER2- 460–710 100% Hint for minor additional benefit
Olaparib (4) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy 0
70–325
100% additional benefit not proven repealed
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)
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
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
Radium-223-dichlorid (2) Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 3,810–4,560 100% additional benefit not proven
Pembrolizumab (10) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel 5,340–5,570 71% Hint for considerable additional benefit
Pembrolizumab (9) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy 8,020–9,120 100% Hint for non-quantifiable additional benefit
Pembrolizumab (8) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Melanoma, adjuvant therapy 2,670–3,400 100% Indication of non-quantifiable additional benefit
Brentuximab Vedotin (4) Adcetris® Takeda GmbH & Co. KG Oncological diseases Hodgkin lymphoma (HL), CD30+, first-line 220–380 100% non-quantifiable additional benefit Orphan
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
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
Blinatumomab (4) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients 40–110 100% non-quantifiable additional benefit Orphan
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
Lenvatinib (3) Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 740–770 100% additional benefit not proven
Ipilimumab (5) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with nivolumab 2,110–2,850 100% Indication of considerable additional benefit
Nivolumab (12) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with ipilimumab 2,110–2,850 100% Indication of considerable additional benefit
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
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
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
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
Atezolizumab (3) Tecentriq® Roche Pharma AG Oncological diseases Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line 220–380 100% additional benefit not proven
Cabozantinib (Cabometyx, 4) Cabometyx® Ipsen Pharma GmbH Oncological diseases Hepatocellular carcinoma (HCC) 1,280–4,900 100% Hint for minor additional benefit
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
Venetoclax (2) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), combination with rituximab 2,000–7,200 37% Indication of minor additional benefit
Venetoclax (3) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 300–700 100% additional benefit not proven
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
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
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
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
Pembrolizumab (6) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Squamous cell carcinoma head and neck 470–3,290 100% additional benefit not proven
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
Trametinib (3) Mekinist® Novartis Pharma GmbH Oncological diseases Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy 1,290–1,590 100% Indication of considerable additional benefit
Dabrafenib (4) Tafinlar® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy 1,290–1,590 100% Indication of considerable additional benefit
Binimetinib (1) Mektovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with encorafenib 1,390 100% additional benefit not proven
Encorafenib (1) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with binimetinib 1,390 100% additional benefit not proven
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
Lenvatinib (2) Lenvima® Eisai GmbH Oncological diseases Hepatocellular carcinoma (HCC) 2,630–4,750 100% additional benefit not proven
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
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
Tisagenlecleucel (1) Kymriah® Novartis Pharma GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 0
440–700
100% non-quantifiable additional benefit Orphan repealed
Tisagenlecleucel (2) Kymriah® Novartis Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 0
50–65
100% non-quantifiable additional benefit Orphan repealed
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
Gemtuzumab Ozogamicin (1) Mylotarg® Pfizer Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML) 560–1,150 100% non-quantifiable additional benefit Orphan
Bosutinib (3) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+ 545–555 100% additional benefit not proven
Osimertinib (3) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 860–2,030 84% Hint for considerable additional benefit
Ipilimumab (4) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, combination with nivolumab 2,500–4,500 85% additional benefit not proven
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
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
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
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
Bosutinib (2) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 0
690–810
100% additional benefit not proven repealed
Sonidegib (1) Odomzo® Sun Pharmaceuticals Germany GmbH Oncological diseases Basal cell carcinoma (BCC) 130–350 100% additional benefit not proven
Ipilimumab (3) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, ≥ 12 to < 18 years 1–5 100% additional benefit not proven
Brentuximab Vedotin (3) Adcetris® Takeda GmbH Oncological diseases Cutaneous T-cell lymphoma, CD30+ 40–130 100% minor additional benefit Orphan
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
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
Abirateronacetat (3) Zytiga® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), high-risk, combination with androgen deprivation therapy 1,500–2,200 100% Indication of considerable additional benefit
Niraparib (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
Tivozanib (1) Fotivda® EUSA Pharma GmbH Oncological diseases Renal cell carcinoma (RCC) 2,953–7,126 100% additional benefit not proven
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
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
Midostaurin (1) Rydapt® Novartis Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM) 0
400–710
80% considerable additional benefit Orphan repealed
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
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
Pembrolizumab (5) Keytruda® MSD SHARP & DOHME GMBH Oncological diseases Urothelial carcinoma (UC) 0
2,300–3,300
61% Indication of considerable additional benefit repealed
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
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
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
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)
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
Ceritinib (3) Zykadia® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, first-line 430–850 100% additional benefit not proven
Inotuzumab ozogamicin (1) Besponsa® Pfizer Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 120–200 100% minor additional benefit Orphan
Nivolumab (9) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma (UC) 1,500–1,900 100% additional benefit not proven
Blinatumomab (2) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 60–170 100% considerable additional benefit Orphan
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
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
Pembrolizumab (4) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Hodgkin lymphoma (HL) 60–180 100% additional benefit not proven
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
Trametinib (2) Mekinist® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation 230–720 100% additional benefit not proven
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
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
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
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
Vandetanib (3) Caprelsa® Genzyme GmbH Oncological diseases Thyroid carcinoma, ≥ 5 years 0
2–8
100% Hint for non-quantifiable additional benefit repealed
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
Nivolumab (6) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Hodgkin lymphoma (HL) 40–90 100% additional benefit not proven
Venetoclax (1) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 0
300–700
100% non-quantifiable additional benefit Orphan repealed
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
Olaratumab (1) Lartruvo® Lilly Deutschland GmbH Oncological diseases Soft tissue sarcoma 0
1,200–1,400
100% considerable additional benefit Orphan repealed
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
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
Crizotinib (4) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+ 210–770 100% additional benefit not proven
Lenvatinib (Kisplyx, 1) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 0
1,200–3,300
100% Hint for minor additional benefit repealed
Idelalisib (3) Zydelig® Gilead Sciences GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), combination with ofatumumab; Chronic lymphocytic leukaemia (CLL), first-line, 17p deletion/TP53 mutation, combination with rituximab 2,020–7,560 0.4% Hint for non-quantifiable additional benefit
Ibrutinib (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)
Pembrolizumab (2) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), after prior chemotherapy 12,500–24,300 40% Indication of considerable additional benefit
Trifluridin / Tipiracil (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
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
Carfilzomib (2) Kyprolis® Amgen GmbH Oncological diseases Multiple myeloma (MM), combination with dexamethasone 0
4,700–7,000
100% minor additional benefit Orphan repealed
Ibrutinib (4) Imbruvica® Janssen-Cilag GmbH Oncological diseases Chronic lymphocytic leukemia (CLL), first-line 2,840 100% additional benefit not proven Orphan (turnover limit)
Crizotinib (3) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 480 71% Hint for considerable additional benefit
Obinutuzumab (2) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL) 0
790–940
100% non-quantifiable additional benefit Orphan repealed
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
Talimogen laherparepvec (1) Imlygic® Amgen GmbH Oncological diseases Melanoma, stage IIIB, IIIC, IVMI1a 375–620 100% additional benefit not proven
Eribulin (3) Halaven® Eisai GmbH Oncological diseases Liposarcoma 30–150 50% Hint for considerable additional benefit
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
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
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
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
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
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
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
Necitumumab (1) Portrazza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 6,300–7,700 100% additional benefit not proven
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
Ramucirumab (2) Cyramza® Lilly Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 2,900–7,300 100% additional benefit not proven
Ramucirumab (3) Cyramza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 5,900–15,400 100% additional benefit not proven
Vismodegib (2) Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 295 95% Hint for minor additional benefit
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)
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
Blinatumomab (1) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 0
60–170
100% non-quantifiable additional benefit Orphan repealed
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
Cobimetinib (1) Cotellic® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation, combination with vemurafenib 1,400 100% Indication of considerable additional benefit
Trametinib (1) Mekinist® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation 1,400 50% Indication of considerable additional benefit
Regorafenib (3) Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 6,900–12,200 100% additional benefit not proven
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)
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
Dabrafenib (2) Tafinlar® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with trametinib 1,400 100% Indication of considerable additional benefit
Pertuzumab (2) Perjeta® Roche Pharma AG Oncological diseases Breast cancer (BC), inflammatory or early with high risk of recurrence, neoadjuvant, combination with trastuzumab and chemotherapy 2,900–4,850 100% additional benefit not proven
Pembrolizumab (1) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma 2,500–4,500 71% Indication of considerable additional benefit
Nivolumab (2) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy 4,200–6,000 87% Indication of considerable additional benefit
Nivolumab (1) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma 2,500–4,500 15% Indication of considerable additional benefit
Lenvatinib (1) Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 0
600–815
100% non-quantifiable additional benefit Orphan repealed
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
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
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
Ruxolitinib (3) Jakavi® Novartis Pharma GmbH Oncological diseases Polycythaemia vera 240–1,470 100% Hint for considerable additional benefit Orphan (turnover limit)
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
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
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
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
Sipuleucel-T (1) Provenge® Dendreon UK Limited Oncological diseases Prostate carcinoma (PC) 11,690–24,480 100% Hint for non-quantifiable additional benefit
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
Regorafenib (2) Stivarga® Bayer Vital GmbH Oncological diseases Gastrointestinal stromal tumor (GIST) 100–700 100% additional benefit not proven
Obinutuzumab (1) Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 0
818–1,477
100% non-quantifiable additional benefit Orphan repealed
Cabozantinib (1) Cometriq® Swedish Orphan Biovitrum GmbH Oncological diseases Thyroid carcinoma (MTC) 0
60–500
100% minor additional benefit Orphan repealed
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
Siltuximab (1) Sylvant® Janssen-Cilag GmbH Oncological diseases Multicentric Castleman Disease (MCD) 130–1,460 100% non-quantifiable additional benefit Orphan
Ruxolitinib (2) Jakavi® Novartis Pharma GmbH Oncological diseases Myelofibrosis (MF) 1,600–5,000 100% Hint for considerable additional benefit Orphan (turnover limit)
Trastuzumab Emtansin (1) Kadcyla® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, pre-treated patients 4,121 72% Indication of considerable additional benefit
Radium-223-dichlorid (1) Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 0
22,700
78% Indication of considerable additional benefit repealed
Ipilimumab (2) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, first-line 500–1,500 100% additional benefit not proven
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
Dabrafenib (1) Tafinlar® GlaxoSmithKline GmbH & Co. KG Oncological diseases Melanoma, BRAF V600 mutation 1,400 100% additional benefit not proven
Regorafenib (1) Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 0
6,600–14,000
100% Hint for minor additional benefit repealed
Vemurafenib (2) Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 1,400 100% Indication of considerable additional benefit
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
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
Vismodegib (1) Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 0
295
95% Hint for minor additional benefit repealed
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
Bosutinib (1) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML) 0
380–500
100% non-quantifiable additional benefit Orphan repealed
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
Vandetanib (2) Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 0
60–1,500
100% Hint for minor additional benefit repealed
Aflibercept (Zaltrap, 1) Zaltrap® Sanofi-Aventis Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 3,500–10,400 100% Indication of minor additional benefit
Abirateronacetat (2) Zytiga® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy 15,000–28,800 100% Indication of considerable additional benefit
Pixantron (1) Pixuvri® CTI Life Sciences Ltd. Oncological diseases B-Cell Non-Hodgkin Lymphoma (NHL) 970 100% additional benefit not proven
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
Decitabin (1) Dacogen® Janssen-Cilag GmbH Oncological diseases Acute myeloid leukaemia (AML) 300–780 100% minor additional benefit Orphan
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
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
Ruxolitinib (1) Jakavi® Novartis Pharma GmbH Oncological diseases Myelofibrosis (MF) 0
1,600
100% minor additional benefit Orphan repealed
Tegafur / Gimeracil / Oteracil (1) Teysuno® Nordic Pharma GmbH Oncological diseases Gastric carcinoma 10,500–12,000 100% additional benefit not proven
Vemurafenib (1) Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 0
1,400
100% Indication of considerable additional benefit repealed
Vandetanib (1) Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 0
130–1,300
100% additional benefit not proven repealed
Ipilimumab (1) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, second-line 3,100 100% Indication of considerable additional benefit
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
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
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