All G-BA resolutions regarding early benefit assessments (§35a SGB V)

Cabotegravir Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with rilpivirin 100% no additional benefit
Erenumab (2, reassessment) Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis 100% Hint for considerable additional benefit
Risdiplam Evrysdi® Roche Pharma AG Nervous system diseases ORPHAN 5q-associated spinal muscular atrophy (SMA) 42% Hint for non-quantifiable additional benefit
Cabozanitinib (6, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with nivolumab 100% no additional benefit
Nivolumab (16) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with cabozantinib 100% no additional benefit
Rilpivirin (3, Rekambys®) Rekambys® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with cabotegravir 100% no additional benefit
Pemigatinib Pemazyre® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy 100% Hint for non-quantifiable additional benefit
Nivolumab (15) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adjuvant therapy 100% Hint for considerable additional benefit
Natrium-Zirkonium-Cyclosilikat Lokelma® AstraZeneca GmbH Metabolic diseases Hyperkalemia 100% no additional benefit
Remdesivir Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, ≥ 12 years, additional oxygen supply 34% Hint for minor additional benefit
Avatrombopag (2) Doptelet® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Thrombocytopenia in chronic liver disease 100% no additional benefit
Avatrombopag Doptelet® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Immune thrombocytopenia (ITP) 100% no additional benefit
Fostemsavir Rukobia® ViiV Healthcare GmbH Infectious diseases Multidrug-resistant HIV infection 100% no additional benefit
Pembrolizumab (16) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years 46% Hint for considerable additional benefit
Pembrolizumab (15) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC), CPS ≥ 10, first-line 100% no additional benefit
Pembrolizumab (14) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Colorectal carcinoma (CRC) with MSI-H or dMMR, first-line 87% Hint for minor additional benefit
Bedaquilin (3) Sirturo® Janssen-Cilag GmbH Infectious diseases ORPHAN Multidrug-resistant pulmonary tuberculosis, 5 to 11 years 100% Hint for non-quantifiable additional benefit
Imlifidase Idefirix® Hansa Biopharma AB Other diseases ORPHAN Desensitisation in kidney transplantation 100% Hint for non-quantifiable additional benefit
Fedratinib Inrebic® Celgene GmbH Oncological diseases ORPHAN Myelofibrosis (MF) 100% Hint for non-quantifiable additional benefit
Tucatinib Tukysa® Seagen Germany GmbH Oncological diseases Mammary carcinoma, HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine 100% Hint for considerable additional benefit
Selpercatinib Retsevmo® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy 100% no additional benefit
Selpercatinib (2) Retsevmo® Lilly Deutschland GmbH Oncological diseases Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years 100% no additional benefit
Selpercatinib (3) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy 100% no additional benefit
Avelumab (4) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Urothelial carcinoma (UC), first-line 100% Hint for considerable additional benefit
Esketamin (2) Spravato® Janssen-Cilag GmbH Mental illnesses Depression, therapy resistant, combination with SSRI or SNRI 100% no additional benefit
Esketamin Spravato® Janssen-Cilag GmbH Mental illnesses Depression, acute treatment, combination therapy 100% Hint for minor additional benefit
Beclometason / Formoterol / Glycopyrronium Trimbow® Chiesi GmbH Respiratory system diseases Asthma 100% no additional benefit
Baloxavir marboxil (2) Xofluza® Roche Pharma AG Infectious diseases Influenza prophylaxis, ≥ 12 years 58% Indication of considerable additional benefit
Baloxavir marboxil Xofluza® Roche Pharma AG Infectious diseases Influenza, ≥ 12 years 100% no additional benefit
Autologe Anti-CD19-transduzierte CD3-positive Zellen Tecartus® Gilead Sciences GmbH Oncological diseases ORPHAN Mantle cell lymphoma (MCL), pretreated 100% Hint for non-quantifiable additional benefit
Acalabrutinib (3) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment 40% Hint for considerable additional benefit
Blinatumomab (5) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+ 100% Hint for non-quantifiable additional benefit
Pertuzumab / Trastuzumab (3) Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, HER2+, metastatic or locally recurrent 100% no additional benefit
Pertuzumab / Trastuzumab (2) Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant 100% no additional benefit
Pertuzumab / Trastuzumab Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, early stage, HER2+, adjuvant treatment 100% Hint for minor additional benefit
Levofloxacin / Dexamethason Ducressa® Santen GmbH Eye diseases Infections and inflammations associated with cataract surgery 100% no additional benefit
Dolutegravir (3) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV-Infection, children ≥ 4 weeks to < 6 years 100% no additional benefit
Niraparib (4, reassessment) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit
Fenfluramin Fintepla® Zogenix GmbH Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years 100% Hint for considerable additional benefit
Inclisiran Leqvio® Novartis Pharma GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Upadacitinib (3) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriasis arthritis (PA) 69% Hint for considerable additional benefit
Upadacitinib (2) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Ankylosing spondylitis 100% no additional benefit
Carfilzomib (4) Kyprolis® Amgen GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone 100% no additional benefit
Nivolumab (14) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of esophagus, pretreated patients 36% Hint for minor additional benefit
Afamelanotid (2, reassessment) Scenesse® Clinuvel (UK) Limited Metabolic diseases ORPHAN Erythropoietic protoporphyria 100% Hint for non-quantifiable additional benefit
Dupilumab (5) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD), 6 to 11 years 100% Hint for non-quantifiable additional benefit
Lenvatinib (5, reassessment, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 100% no additional benefit
Lumasiran Oxlumo® Alnylam Germany GmbH Metabolic diseases ORPHAN Hyperoxaluria 100% Hint for non-quantifiable additional benefit
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 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 73% Indication of minor additional benefit
Perampanel (5) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years 100% no additional benefit
Perampanel (4) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years 100% no additional benefit
Sucroferric Oxyhydroxide (2) Velphoro® Fresenius Medical Care Deutschland GmbH Genitourinary system diseases Serum phosphate level control in chronic kidney disease, ≥ 2 to 18 years 100% no additional benefit
Olaparib (7) Lynparza® AstraZeneca GmbH Oncological diseases Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy 100% no additional benefit
Olaparib (6) Lynparza® AstraZeneca GmbH Oncological diseases Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment 100% Hint for considerable additional benefit
Olaparib (5) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab 100% no additional benefit
Sebelipase alfa (2, reassessment) Kanuma® Alexion Pharma Germany GmbH Metabolic diseases ORPHAN Lysosomal acid lipase deficiency 100% Hint for non-quantifiable additional benefit
Acalabrutinib (2) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line 25% Hint for minor additional benefit
Acalabrutinib Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); monotherapy, first-line 25% Hint for minor additional benefit
Tezacaftor / Ivacaftor (5) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
Guselkumab (2) Tremfya® Janssen-Cilag GmbH Musculoskeletal system diseases Psoriatic arthritis (PA) 100% no additional benefit
Nusinersen (2, reassessment >€50m) Spinraza® Biogen GmbH Nervous system diseases ORPHAN Spinal muscular atrophy (SMA) 19% Indication of major additional benefit
Tezacaftor / Ivacaftor (4) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del) 100% no additional benefit
Tafamidis (4, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Other diseases ORPHAN Amyloid cardiomyopathy 100% Indication of considerable additional benefit
Tafamidis (3, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Other diseases ORPHAN Amyloid Neuropathy 100% no additional benefit
Niraparib (3) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy 100% no additional benefit
Ivacaftor (18) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation) 100% no additional benefit
Ivacaftor (17) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation) 100% no additional benefit
Ivacaftor (16) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation 100% Hint for non-quantifiable additional benefit
Ivacaftor (15) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations 100% Hint for non-quantifiable additional benefit
Dapagliflozin (5) Forxiga® AstraZeneca GmbH Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for considerable additional benefit
Amikacin (liposomal) Arikayce® liposomal Insmed Germany GmbH Infectious diseases ORPHAN Mycobacterium Avium Complex (MAC) infection 100% Hint for non-quantifiable additional benefit
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases Hepatocellular carcinoma (HCC), combination with bevacizumab 76% Indication of considerable additional benefit
Crizanlizumab Adakveo® Novartis Pharma GmbH Hematopoietic diseases ORPHAN Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years 100% Hint for minor additional benefit
Eszopiclon Lunivia® Hennig Arzneimittel GmbH & Co. KG Nervous system diseases Sleep disorders 100% no additional benefit
Baricitinib (2) Olumiant® Lilly Deutschland GmbH Skin diseases Atopic dermatitis (AD) 100% no additional benefit
Avapritinib Ayvakyt® Blueprint Medicines (Germany) Oncological diseases ORPHAN Gastrointestinal stromal tumor (GIST) 100% Hint for non-quantifiable additional benefit
Burosumab (3) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia (XLH), ≥ 18 years 100% Hint for minor additional benefit
Bempedoinsäure / Ezetimib Nustendi® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Bempedoinsäure Nilemdo® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Semaglutid (2, reassessment) Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Cannabidiol (4, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit
Cannabidiol (3, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit
Filgotinib Jyseleca® Gilead Sciences GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 33% Hint for minor additional benefit
Ibrutinib (7) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab 59% Hint for considerable additional benefit
Durvalumab (2) Imfinzi® AstraZeneca GmbH Oncological diseases Small cell lung cancer (SCLC), first-line, combination with etoposide and either carboplatin or cisplatin 100% Hint for minor additional benefit
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 6 to < 18 years 100% no additional benefit
Belantamab-Mafodotin Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Multiple myeloma (MM), at least 4 prior therapies, monotherapy 100% Hint for non-quantifiable additional benefit
Alpelisib Piqray® Novartis Pharma GmbH Oncological diseases Mammary carcinoma with PIK3CA mutation, pre-treated patients, combination with fulvestrant 41% no additional benefit
Bulevirtid Hepcludex® MYR GmbH Infectious diseases ORPHAN Chronic hepatitis Delta 100% Hint for non-quantifiable additional benefit
Ivacaftor / Tezacaftor / Elexacaftor Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (2) Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit
Ivacaftor (14) Kalydeco® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit
Ivacaftor (13) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit
Entrectinib (2) Rozlytrek® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line 100% no additional benefit
Entrectinib Rozlytrek® Roche Pharma AG Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent. 100% no additional benefit
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases Multidrug-resistant HIV infection 100% no additional benefit
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP), ≥ 6 to < 18 years 100% Hint for minor additional benefit
Secukinumab (5) Cosentyx® Novartis Pharma GmbH Skin diseases Axial spondyloarthritis 100% no additional benefit
Secukinumab (4, reassessment) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Psoriatic arthritis (PA) 35% Indication of minor additional benefit
Glasdegib Daurismo® Pfizer Pharma GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML), combination with cytarabine (LDAC) 100% Hint for considerable additional benefit
Nintedanib (5, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Interstitial pulmonary disease with systemic sclerosis 100% no additional benefit
Trifaroten Selgamis® Galderma Laboratorium GmbH Skin diseases Acne vulgaris, ≥ 12 years 100% no additional benefit
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat Enerzair® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100% no additional benefit
Nintedanib (4, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Progressive fibrosing interstitial lung diseases 100% Indication of minor additional benefit
Ravulizumab (2) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Atypical hemolytic uremic syndrome (aHUS) 100% no additional benefit
Sofosbuvir (3) Sovaldi® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 100% Hint for non-quantifiable additional benefit
Luspatercept (2) Reblozyl® Celgene GmbH Hematopoietic diseases ORPHAN Beta thalassemia 100% Hint for non-quantifiable additional benefit
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases ORPHAN Myelodysplastic syndrome (MDS) 100% Hint for non-quantifiable additional benefit
Ledipasvir / Sofosbuvir (3) Harvoni® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 50% Hint for non-quantifiable additional benefit
Ixekizumab (4) Taltz® Lilly Deutschland GmbH Skin diseases Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg 100% no additional benefit
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Axial spondyloarthritis 100% no additional benefit
Osilodrostat Isturisa® Recordati Rare Diseases Germany GmbH Metabolic diseases ORPHAN Endogenous Cushing syndrome 100% Hint for non-quantifiable additional benefit
Caplacizumab (2) Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases ORPHAN Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Ozanimod Zeposia® Celgene GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 90% Indication of minor additional benefit
Encorafenib (2) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Metastatic colorectal carcinoma (CRC) 100% Hint for considerable additional benefit
Fostamatinib Tavlesse® Grifols Deutschland GmbH Hematopoietic diseases Chronic immune thrombocytopenia 100% no additional benefit
Ivacaftor (12) Kalydeco® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥ 6 months to < 18 years of age 100% Hint for non-quantifiable additional benefit
Tezacaftor / Ivacaftor (3, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del) 100% no additional benefit
Tezacaftor / Ivacaftor (2, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del) 100% no additional benefit
Mogamulizumab Poteligeo® Kyowa Kirin GmbH Oncological diseases ORPHAN Mycosis Fungoides; Sézary Syndrome 100% Hint for non-quantifiable additional benefit
Brentuximab Vedotin (5) Adcetris® Takeda GmbH Oncological diseases ORPHAN Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone 100% Hint for minor additional benefit
Ponatinib (2, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML) 100% Hint for non-quantifiable additional benefit
Ponatinib (3, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Chronic myeloid leukaemia (CML) 100% Hint for non-quantifiable additional benefit
Talazoparib Talzenna® Pfizer Pharma GmbH Oncological diseases Mammary carcinoma, BRCA1/2 mutation, HER2- 100% Hint for considerable additional benefit
Naldemedin Rizmoic® Hexal AG Digestive system diseases Opioid-induced constipation 100% no additional benefit
Apremilast (2) Otezla® Amgen GmbH Other diseases Behçet's disease 100% no additional benefit
Enzalutamid (4, reassessment) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Indication of minor additional benefit
Solriamfetol Sunosi® Jazz Pharmaceuticals Nervous system diseases Narcolepsy 100% no additional benefit
Brigatinib (2) Alunbrig® Takeda GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients 50% Hint for considerable additional benefit
Darolutamid Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 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 100% no additional benefit
Insulin glargin / Lixisenatid (2) Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors 100% no additional benefit
Givosiran Givlaari® Alnylam Germany GmbH Metabolic diseases ORPHAN Acute hepatic porphyria, ≥ 12 years 100% Indication of considerable additional benefit
Avelumab (3, reassessment) Bavencio® Merck Serono GmbH Oncological diseases Metastatic Merkel-cell carcinoma (MCC) 100% no additional benefit
Trifluridin / Tipiracil (3, reassessment) Lonsurf® Servier Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC), pre-treated patients 100% Hint for minor additional benefit
Apalutamid (3, reassessment) Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Indication of minor additional benefit
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases HIV infection, combination with atazanavir or darunavir, 12 to < 18 years 100% no additional benefit
Tisagenlecleucel (3, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% Hint for non-quantifiable additional benefit
Tisagenlecleucel (4, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) 100% Hint for non-quantifiable additional benefit
Indacaterol / Mometason Atectura® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100% no additional benefit
Brolucizumab Beovu® Novartis Pharma GmbH Eye diseases Neovascular age-related macular degeneration 100% no additional benefit
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases Clostridioides difficile infection, children and adolescents 54% Hint for considerable additional benefit
Romosozumab Evenity® UCB Pharma GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal) 100% Indication of minor additional benefit
Riociguat (2, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases ORPHAN Chronic thromboembolic pulmonary hypertension 100% no additional benefit
Riociguat (3, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases ORPHAN Pulmonary arterial hypertension (PAH) 100% no additional benefit
Abemaciclib (3, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 39% Hint for minor additional benefit
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases ORPHAN Amyloid cardiomyopathy 100% Hint for considerable additional benefit repealed
Apalutamid (2) Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy 100% no additional benefit
Ribociclib (3, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 58% Indication of minor additional benefit
Ribociclib (4, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with aromatase inhibitor 100% Hint for minor additional benefit
Polatuzumab Vedotin Polivy® Roche Pharma AG Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab 100% Hint for non-quantifiable additional benefit
Siponimod Mayzent® Novartis Pharma GmbH Nervous system diseases Secondary progressive multiple sclerosis (MS) 100% no additional benefit
Bedaquilin (2) Sirturo® Janssen-Cilag GmbH Infectious diseases ORPHAN Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Daratumumab (5) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 100% Hint for minor additional benefit
Daratumumab (4) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone 100% Hint for non-quantifiable additional benefit
Ramucirumab (6) Cyramza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line 100% no additional benefit
Dulaglutid (2, reassessment) Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 31% Hint for minor additional benefit
Upadacitinib Rinvoq® AbbVie Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 34% Hint for considerable additional benefit
Trastuzumab Emtansin (2) Kadcyla® Roche Pharma AG Oncological diseases Mammary carcinoma, early stage, HER2+, adjuvant treatment 100% Indication of minor additional benefit
Ivacaftor (11) Kalydeco® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), ≥ 6 to < 12 months 100% Hint for non-quantifiable additional benefit
Neratinib Nerlynx® Pierre Fabre Pharma Oncological diseases Mammary carcinoma, HR+, HER2+, adjuvant therapy 100% Hint for minor additional benefit
Gilteritinib XOSPATA® Astellas Pharma GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML), FLT3 mutation 100% Hint for considerable additional benefit
Avelumab (2) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with axitinib 23% Hint for considerable additional benefit
Dupilumab (4) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Chronic rhinosinusitis with nasal polyps 100% Indication of considerable additional benefit
Pembrolizumab (13) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy 100% Indication of minor additional benefit
Pembrolizumab (12) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy 100% Hint for considerable additional benefit
Pembrolizumab (11) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with axitinib 23% Indication of considerable additional benefit
Belimumab (2) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 100% Hint for non-quantifiable additional benefit
Betibeglogene autotemcel Zynteglo® bluebird bio (Germany) GmbH Hematopoietic diseases ORPHAN Beta thalassemia 100% Hint for non-quantifiable additional benefit
Cannabidiol (2) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed
Niraparib (2, reassessment >€50m) Zejula® TESARO Bio Germany GmbH Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit repealed
Cannabidiol Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed
Larotrectinib Vitrakvi® Bayer Vital GmbH Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent. 100% no additional benefit
Atezolizumab (4) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with bevacizumab, paclitaxel and carboplatin; maintenance therapy 100% no additional benefit
Asfotase alfa (2, reassessment >€50m) Strensiq® Alexion Pharma Germany GmbH Metabolic diseases ORPHAN Hypophosphatasia (HPP) 0.8% Hint for non-quantifiable additional benefit
Atezolizumab (6) Tecentriq® Roche Pharma AG Oncological diseases Mammary carcinoma, triple-negative, PD-L1 expression ≥1%. 100% Hint for non-quantifiable additional benefit
Atezolizumab (5) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with nab-paclitaxel and carboplatin; maintenance therapy 100% no additional benefit
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases Metastatic gastric cancer, pre-treated patients 100% Indication of minor additional benefit
Atezolizumab (7) Tecentriq® Roche Pharma AG Oncological diseases Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy 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 100% Hint for considerable additional benefit
Burosumab (2, reassessment) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 100% Hint for non-quantifiable additional benefit
Ropeginterferon alfa-2b Besremi® AOP Orphan Pharmaceuticals AG Oncological diseases Polycythemia vera 100% no additional benefit
Ivacaftor (10) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), 12 ro < 24 months 100% Hint for non-quantifiable additional benefit
Ivacaftor (9, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation 100% Hint for minor additional benefit
Ivacaftor (8, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 2 to 5 years 100% Hint for non-quantifiable additional benefit
Ivacaftor (7, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), various gating mutations, ≥ 6 years 100% Hint for non-quantifiable additional benefit
Ivacaftor (6, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit
Ivacaftor (5, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit
Ivacaftor (4, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), G551D mutation, ≥ 6 years 86% Hint for considerable additional benefit
Ramucirumab (5) Cyramza® Lilly Deutschland GmbH Oncological diseases Hepatocellular carcinoma (HCC) 100% Proof of minor additional benefit
Dupilumab (2) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Bronchial asthma, ≥ 12 years 100% no additional benefit
Dupilumab (3) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD), 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Andexanet alfa Ondexxya® Portola Deutschland GmbH Hematopoietic diseases Antidote for reversal of anticoagulation (factor Xa) 100% no additional benefit
Ibrutinib (5) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab 26% Hint for minor additional benefit
Ibrutinib (6) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Waldenström's disease, combination with rituximab 100% no additional benefit
Volanesorsen Waylivra® Akcea Therapeutics Germany GmbH Metabolic diseases ORPHAN Chylomicronaemia syndrome 100% Hint for non-quantifiable additional benefit
Turoctocog alfa pegol Esperoct® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Dolutegravir / Lamivudin Dovato® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 100% no additional benefit
Ravulizumab Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Paroxysmal hemoglobinuria 100% no additional benefit
Cemiplimab Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Squamous cell carcinoma (SCC) 100% no additional benefit
Olaparib (3) Lynparza® AstraZeneca GmbH Oncological diseases Mammary carcinoma, BRCA1/2 mutations, HER2- 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 100% no additional benefit
Vigabatrin Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, West syndrome, < 7 years 100% no additional benefit
Vigabatrin (2) Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, focal seizures, < 7 years 100% no additional benefit
Pegvaliase Palynziq® BioMarin International Limited Metabolic diseases ORPHAN Phenylketonuria 100% Hint for non-quantifiable additional benefit
Dapagliflozin / Metformin (3, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 50% Hint for minor additional benefit
Dapagliflozin (4, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 41% Hint for minor additional benefit
Pomalidomid (3) Imnovid® Celgene GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone 100% no additional benefit
Empagliflozin / Linagliptin Glyxambi® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Risankizumab Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Plaque psoriasis (PP) 82% Proof of considerable additional benefit
Lorlatinib Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 100% no additional benefit
Fremanezumab Ajovy® Teva GmbH Nervous system diseases Migraine prophylaxis 1.0% Hint for considerable additional benefit
Dacomitinib Vizimpro® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line 100% no additional benefit
Lisdexamfetamindimesilat (2, Elvanse Adult®) Elvanse Adult® Shire Deutschland GmbH Mental illnesses Attention deficit hyperactivity disorder (ADHD), ≥ 18 years 100% no additional benefit
Dapagliflozin (3) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 1 100% Hint for minor additional benefit
Radium-223-dichlorid (2, reassessment) Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 100% no additional benefit
Voretigen Neparvovec Luxturna® Novartis Pharma GmbH Eye diseases ORPHAN Hereditary retinal dystrophy 100% Hint for considerable additional benefit
Glecaprevir / Pibrentasvir (2) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 12 to < 18 years 100% no additional benefit
Nintedanib (3, reassessment >€50m, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases ORPHAN Idiopathic pulmonary fibrosis 100% Hint for considerable additional benefit
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 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 100% Hint for non-quantifiable additional benefit
Pembrolizumab (8) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, adjuvant therapy 100% Indication of non-quantifiable additional benefit
Galcanezumab Emgality® Lilly Deutschland GmbH Nervous system diseases Migraine prophylaxis 1.0% Hint for considerable additional benefit
Brentuximab Vedotin (4) Adcetris® Takeda Pharma GmbH Oncological diseases ORPHAN Hodgkin lymphoma (HL), CD30+, first-line 100% non-quantifiable additional benefit
Emicizumab (2) Hemlibra® Roche Pharma AG Hematopoietic diseases Hemophilia A, without factor VIII inhibitors 100% no additional benefit
Regadenoson (2) Rapiscan® GE Healthcare Buchler GmbH & Co. KG Other diseases Stenosis, Fractional Flow Reserve Measurement (FFR) 100% no additional benefit
Rucaparib Rubraca® Clovis Oncology Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, after at least 2 previous therapies 100% no additional benefit
Rucaparib (2) Rubraca® Clovis Oncology Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy 100% no additional benefit
Blinatumomab (3) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients 100% non-quantifiable additional benefit
Lumacaftor / Ivacaftor (3) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years 100% Hint for non-quantifiable additional benefit
Blinatumomab (4) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years 100% non-quantifiable additional benefit
Lenvatinib (4, reassessment) Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 100% no additional benefit
Ipilimumab (5) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with nivolumab 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 100% Indication of considerable additional benefit
Mexiletin Namuscla® Lupin Europe GmbH Nervous system diseases ORPHAN Myotonia 100% non-quantifiable additional benefit
Apalutamid Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Hint for minor additional benefit repealed
Lanadelumab Takhzyro® Shire Deutschland GmbH, Teil der Takeda Group Other diseases ORPHAN Hereditary angioedema (HAE) 100% considerable additional benefit
Doravirin Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 100% no additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 100% no additional benefit
Glycerolphenylbutyrat (2) Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases ORPHAN Urea cycle disorders (UCD), 0 to < 2 months 100% non-quantifiable additional benefit
Brigatinib Alunbrig® Takeda Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib 100% no additional benefit
Bedaquilin Sirturo® Janssen-Cilag GmbH Infectious diseases ORPHAN Multidrug-resistant pulmonary tuberculosis 100% considerable additional benefit
Melatonin Slenyto® InfectoPharm Arzneimittel und Consilium GmbH Nervous system diseases Sleep disorders 100% Hint for minor additional benefit
Ribociclib (2) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor 100% no additional benefit repealed subgroups
Damoctocog alfa pegol Jivi® Bayer Vital GmbH Hematopoietic diseases Hemophilia A, ≥ 12 years 100% no additional benefit
Pembrolizumab (7, reassessment) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC), CPS ≥ 10, first-line 100% no additional benefit repealed
Fingolimod (5) Gilenya® Novartis Pharma GmbH Nervous system diseases Multiple sclerosis (MS), ≥ 10 to < 18 years 57% Hint for non-quantifiable additional benefit
Atezolizumab (3, reassessment) Tecentriq® Roche Pharma AG Oncological diseases Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line 100% no additional benefit
Cabozantinib (5, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Hepatocellular carcinoma (HCC) 100% Hint for minor additional benefit
Tezacaftor / Ivacaftor Symkevi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, ≥ 12 years 91% considerable additional benefit repealed
Enzalutamid (3) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% no additional benefit repealed
Venetoclax (2) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), combination with rituximab 37% Indication of minor additional benefit
Venetoclax (3, reassessment) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 100% no additional benefit
Insulin degludec (4, reassessment) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Fluticasonfuroat / Umeclidinium / Vilanterol (2) Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD), inadequate control with LAMA and LABA 100% no additional benefit
Tildrakizumab Ilumetri® Almirall Hermal GmbH Skin diseases Plaque psoriasis (PP) 100% no additional benefit
Alirocumab (2, reassessment) Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolemia or mixed dyslipidaemia 100% no additional benefit
Axicabtagen-Ciloleucel (2) Yescarta® Kite, Gilead company Oncological diseases ORPHAN Primary mediastinal large B-cell lymphoma (PMBCL) 100% non-quantifiable additional benefit
Axicabtagen-Ciloleucel Yescarta® Kite, Gilead company Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit
Abemaciclib (2) Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 100% no additional benefit repealed subgroups
Abemaciclib Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with aromatase inhibitor 100% no additional benefit
Semaglutid Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 37% Hint for minor additional benefit repealed
Erenumab Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis 1.0% Hint for considerable additional benefit repealed subgroups
Pembrolizumab (6) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck 100% no additional benefit
Ocriplasmin (2, reassessment) Jetrea® Oxurion NV Eye diseases Vitreomacular traction (VMT) 94% Hint for minor additional benefit
Durvalumab Imfinzi® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), maintenance therapy 100% Hint for considerable additional benefit
Trametinib (3) Mekinist® Novartis Pharma GmbH Oncological diseases Melanoma, in combination with dabrafenib, BRAF V600 mutation, adjuvant therapy 100% Indication of considerable additional benefit
Dabrafenib (4) Tafinlar® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with trametinib, adjuvant therapy 100% Indication of considerable additional benefit
Patisiran Onpattro® Alnylam Germany GmbH Metabolic diseases ORPHAN Amyloidosis 100% considerable additional benefit
Inotersen Tegsedi® Akcea Therapeutics Germany GmbH Metabolic diseases ORPHAN Amyloidosis 100% non-quantifiable additional benefit
Metreleptin Myalepta® Aegerion Pharmaceuticals GmbH Metabolic diseases ORPHAN Lipodystrophy 100% non-quantifiable additional benefit
Binimetinib Mektovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with encorafenib 100% no additional benefit
Encorafenib Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with binimetinib 100% no additional benefit
Palbociclib (2, reassessment) Ibrance® Pfizer Pharma GmbH Oncological diseases Mammary carcinoma 100% no additional benefit
Lenvatinib (3) Lenvima® Eisai GmbH Oncological diseases Hepatocellular carcinoma (HCC) 100% no additional benefit
Daunorubicin / Cytarabin (liposomale Formulierung) Vyxeos® liposomal Jazz Pharmaceuticals Oncological diseases ORPHAN Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia 100% considerable additional benefit
Mepolizumab (2) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, ≥ 6 to < 18 years 100% no additional benefit
Sitagliptin (3, reassessment) Januvia® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2, combination with metformin 100% Hint for minor additional benefit
Tenofoviralafenamid (2, reassessment) Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 100% no additional benefit
Caplacizumab Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases ORPHAN Thrombotic thrombocytopenic purpura (TTP) 100% non-quantifiable additional benefit
Vestronidase alfa Mepsevii® Ultragenyx Germany GmbH Metabolic diseases ORPHAN Mucopolysaccharidosis (MPS VII; Sly syndrome) 100% non-quantifiable additional benefit
Daratumumab (3) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone 100% Hint for considerable additional benefit
Tisagenlecleucel Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit repealed
Tisagenlecleucel (2) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% non-quantifiable additional benefit repealed
Tofacitinib (4) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Psoriatic arthritis (PA) 69% Hint for minor additional benefit
Tofacitinib (3) Xeljanz® Pfizer Pharma GmbH Digestive system diseases Ulcerative colitis 100% no additional benefit
Nivolumab (11) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adjuvant therapy 100% Hint for non-quantifiable additional benefit repealed
Gemtuzumab Ozogamicin Mylotarg® Pfizer Pharma GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML) 100% non-quantifiable additional benefit
Bosutinib (3, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+ 100% no additional benefit
Ingenolmebutat (2, reassessment) Picato® LEO Pharma GmbH Skin diseases Actinic keratosis (AK) 50% Hint for non-quantifiable additional benefit repealed
Brivaracetam (2) Briviact® UCB Pharma GmbH Nervous system diseases Epilepsy, focal seizures, add-on therapy, 4 to < 16 years 100% no additional benefit
Osimertinib (3) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 84% Hint for considerable additional benefit
Ipilimumab (4) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, combination with nivolumab 85% no additional benefit
Nivolumab (10, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab 100% Indication of less benefit
Pertuzumab (3) Perjeta® Roche Pharma AG Oncological diseases Mammary carcinoma, early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy 100% Indication of minor additional benefit
Bictegravir / Emtricitabin / Tenofoviralafenamid Biktarvy® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Velmanase alfa Lamzede® Chiesi GmbH Metabolic diseases ORPHAN Alpha mannosidosis 100% non-quantifiable additional benefit
Olaparib (2, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy 100% Hint for minor additional benefit
Cabozantinib (4, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC) 100% no additional benefit
Dolutegravir / Rilpivirin Juluca® ViiV Healthcare GmbH Infectious diseases HIV infection 100% no additional benefit
Bosutinib (2) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 100% no additional benefit
Darvadstrocel Alofisel® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases ORPHAN Anal fistulas in Crohn's disease 100% non-quantifiable additional benefit
Extrakt aus Cannabis Sativa (2, reassessment) Sativex® Almirall Hermal GmbH Nervous system diseases Multiple sclerosis (MS), spasticity 100% Indication of minor additional benefit
Tofacitinib (2, reassessment) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 100% no additional benefit
Rurioctocog alfa pegol Adynovi® Shire Deutschland GmbH Hematopoietic diseases Hemophilia A, ≥ 12 years 100% no additional benefit
Hydrocortison Alkindi® Diurnal Ltd. Metabolic diseases Adrenal insufficiency, < 18 years 100% no additional benefit
Ertugliflozin / Sitagliptin Steglujan® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Cariprazin Reagila® Recordati Pharma GmbH Mental illnesses Schizophrenia 21% Indication of minor additional benefit
Burosumab Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 100% non-quantifiable additional benefit repealed
Bezlotoxumab Zinplava® MSD Sharp & Dohme GmbH Infectious diseases Prevention of recurrent Clostridium difficile infection 100% Indication of minor additional benefit
Emicizumab Hemlibra® Roche Pharma AG Hematopoietic diseases Hemophilia A 50% Hint for non-quantifiable additional benefit
Patiromer Veltassa® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Hyperkalemia 100% no additional benefit
Glycopyrroniumbromid Sialanar® Proveca Limited Other diseases Sialorrhea 100% Hint for non-quantifiable additional benefit
Evolocumab (2, reassessment) Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 100% no additional benefit
Fluticasonfuroat / Umeclidinium / Vilanterol Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Glycerolphenylbutyrat Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases ORPHAN Urea cycle disorders (UCD), ≥ 2 months 100% non-quantifiable additional benefit
Ixekizumab (2) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Psoriatic arthritis (PA) 35% Hint for minor additional benefit
Insulin glargin / Lixisenatid Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Sonidegib Odomzo® Sun Pharmaceuticals Germany GmbH Oncological diseases Basal cell carcinoma (BCC) 100% no additional benefit
Benralizumab Fasenra® AstraZeneca GmbH Respiratory system diseases Bronchial asthma 50% Hint for minor additional benefit
Letermovir Prevymis® MSD Sharp & Dohme GmbH Infectious diseases ORPHAN Cytomegalovirus infection 100% non-quantifiable additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment) Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma 100% no additional benefit
Ipilimumab (3) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, ≥ 12 to < 18 years 100% no additional benefit
Ocrelizumab Ocrevus® Roche Pharma AG Nervous system diseases Multiple sclerosis (MS) 81% Proof of minor additional benefit
Lumacaftor / Ivacaftor (2) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous F508del mutation in CFTR gene, ≥ 6 years 100% Hint for non-quantifiable additional benefit
Brentuximab Vedotin (3) Adcetris® Takeda Pharma GmbH Oncological diseases ORPHAN Cutaneous T-cell lymphoma, CD30+ 100% minor additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 6 to < 12 years 100% no additional benefit
Allogene, genetisch modifizierte T-Zellen Zalmoxis® Dompé farmaceutici S.p.A Oncological diseases ORPHAN Haematological malignancies, concomitant therapy in haploidentical haematopoietic stem cell transplantation 100% non-quantifiable additional benefit
Alectinib (2) Alecensa® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, first-line 100% Hint for non-quantifiable additional benefit
Dapagliflozin / Metformin (2, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Dapagliflozin (2, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Abirateronacetat (3) Zytiga® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), high-risk, combination with androgen deprivation therapy 100% Indication of considerable additional benefit
Niraparib Zejula® TESARO Bio Germany GmbH Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% non-quantifiable additional benefit repealed
Cladribin Mavenclad® Merck Serono GmbH Nervous system diseases Highly active relapsing multiple sclerosis (MS) 100% no additional benefit
Dupilumab Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD) 100% Indication of considerable additional benefit
Guselkumab Tremfya® Janssen-Cilag GmbH Skin diseases Plaque psoriasis (PP) 45% Proof of considerable additional benefit
Perampanel (3) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, primary generalised seizures, ≥ 12 years 100% no additional benefit
Cenegermin Oxervate® Dompé farmaceutici S.p.A Eye diseases ORPHAN Keratitis 100% non-quantifiable additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (2) Stribild® Gilead Sciences GmbH Infectious diseases HIV infection, 12 to < 18 years 100% no additional benefit
Tivozanib Fotivda® EUSA Pharma GmbH Oncological diseases Renal cell carcinoma (RCC) 100% no additional benefit
Nonacog beta pegol Refixia® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia B, ≥ 12 years 100% no additional benefit
Cabozantinib (3, reassessment, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), after VEGF pre-therapy 100% Indication of minor additional benefit
Telotristatethyl Xermelo® Ipsen Pharma GmbH Oncological diseases ORPHAN Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy 100% non-quantifiable additional benefit
Midostaurin Rydapt® Novartis Pharma GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML); Systemic mastocytosis 100% non-quantifiable additional benefit
Obinutuzumab (3) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL), first-line 100% non-quantifiable additional benefit
Sofosbuvir (2) Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Ribociclib Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, postmenopausal women, combination with aromatase inhibitor 100% no additional benefit repealed
Pembrolizumab (5) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Urothelial carcinoma (UC) 61% Indication of considerable additional benefit repealed subgroups
Elosulfase alfa (2, reassessment) Vimizim® BioMarin Deutschland GmbH Metabolic diseases ORPHAN Mucopolysaccharidosis (type IVA) 100% minor additional benefit
Atezolizumab Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), after prior chemotherapy 40% Indication of considerable additional benefit
Atezolizumab (2) Tecentriq® Roche Pharma AG Oncological diseases Urothelial carcinoma (UC), first-line 61% Hint for minor additional benefit repealed subgroups
Avelumab Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases ORPHAN Merkel-cell carcinoma (MCC) 100% non-quantifiable additional benefit repealed
Dimethylfumarat (2, Skilarence®) Skilarence® Almirall Hermal GmbH Skin diseases Plaque psoriasis (PP) 100% no additional benefit
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid Symtuza® Janssen-Cilag GmbH Infectious diseases HIV infection 100% no additional benefit
Brodalumab Kyntheum® LEO Pharma GmbH Skin diseases Plaque psoriasis (PP) 45% Indication of non-quantifiable additional benefit
Carfilzomib (3, reassessment >€50m) Kyprolis® Amgen GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone 100% Hint for considerable additional benefit
Sarilumab Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 34% Hint for considerable additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 100% no additional benefit
Daratumumab (2, reassessment >€50m) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), monotherapy; multiple myeloma, at least 1 prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 72% Indication of considerable additional benefit
Ledipasvir / Sofosbuvir (2) Harvoni® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, 12 to < 18 years 50% Hint for non-quantifiable additional benefit
Saxagliptin / Metformin (4) Komboglyze® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, combination therapy other than insulin and sulphonylurea 100% no additional benefit
Glecaprevir / Pibrentasvir Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 100% no additional benefit
Ceritinib (3) Zykadia® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, first-line 100% no additional benefit
Inotuzumab Ozogamicin Besponsa® Pfizer Pharma GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% minor additional benefit
Nivolumab (9) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma (UC) 100% no additional benefit
Nusinersen Spinraza® Biogen GmbH Nervous system diseases ORPHAN Spinal muscular atrophy (SMA) 10% major additional benefit repealed
Cerliponase alfa Brineura® BioMarin Deutschland GmbH Metabolic diseases ORPHAN Neuronal ceroid lipofuscinosis type 2 100% non-quantifiable additional benefit
Blinatumomab (2, reassessment) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% considerable additional benefit
Nivolumab (8, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab 100% no additional benefit
Etelcalcetid Parsabiv® Amgen GmbH Metabolic diseases Secondary hyperparathyroidism (HPT) 100% no additional benefit
Nivolumab (7) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma head and neck 77% Hint for considerable additional benefit
Rolapitant Varuby® TESARO Bio Germany GmbH Other diseases Nausea and vomiting due to chemotherapy 100% no additional benefit
Pembrolizumab (4) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Hodgkin lymphoma (HL) 100% no additional benefit
Dabrafenib (3) Tafinlar® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation, combination with trametinib 100% no additional benefit
Trametinib (2) Mekinist® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), BRAF V600 mutation 100% no additional benefit
Tofacitinib Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 100% no additional benefit repealed subgroups
Alectinib Alecensa® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib 81% Hint for minor additional benefit
Osimertinib (2, reassessment) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation 100% Hint for considerable additional benefit
Axitinib (2, reassessment) Inlyta® Pfizer Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy 0.3% Hint for minor additional benefit
Tenofoviralafenamid Vemlidy® Gilead Sciences GmbH Infectious diseases Chronic hepatitis B, ≥ 12 years 100% no additional benefit repealed
Dolutegravir (2) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, 6 to < 12 years 100% no additional benefit
Baricitinib Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 100% no additional benefit
Secukinumab (3, reassessment) Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP) 100% Indication of considerable additional benefit
Ixekizumab Taltz® Lilly Deutschland GmbH Skin diseases Plaque psoriasis (PP) 55% Indication of considerable additional benefit
Pembrolizumab (3) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 100% Indication of considerable additional benefit
Lonoctocog alfa Afstyla® CSL Behring GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Obeticholsäure Ocaliva® Intercept Pharma Deutschland GmbH Digestive system diseases ORPHAN Biliary cirrhosis 100% non-quantifiable additional benefit
Reslizumab Cinqaero® Teva GmbH Respiratory system diseases Bronchial asthma 50% Hint for minor additional benefit
Vandetanib (3) Caprelsa® Genzyme GmbH Oncological diseases Thyroid carcinoma, ≥ 5 years 100% Hint for non-quantifiable additional benefit
Ixazomib Ninlaro® Takeda Pharma GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% non-quantifiable additional benefit
Elbasvir / Grazoprevir Zepatier® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 100% no additional benefit
Nivolumab (6) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Hodgkin lymphoma (HL) 100% no additional benefit
Venetoclax Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases ORPHAN Chronic lymphocytic leukaemia (CLL), monotherapy 100% non-quantifiable additional benefit repealed
Palbociclib Ibrance® Pfizer Pharma GmbH Oncological diseases Mammary carcinoma 100% no additional benefit repealed subgroups
Olaratumab Lartruvo® Lilly Deutschland GmbH Oncological diseases ORPHAN Soft tissue sarcoma 100% considerable additional benefit repealed
Cabozantinib (2, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carcinoma (RCC) 100% Hint for non-quantifiable additional benefit repealed
Macitentan (2, reassessment >€50m) Opsumit® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases ORPHAN Pulmonary arterial hypertension (PAH) 100% no additional benefit
Opicapon Ongentys® Bial-Portela & Ca, S.A. Nervous system diseases Morbus Parkinson 100% no additional benefit
Ceritinib (2, reassessment) Zykadia® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib 81% Hint for considerable additional benefit
Crizotinib (4) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+ 100% no additional benefit
Lenvatinib (2, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 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 0.4% Hint for non-quantifiable additional benefit
Ibrutinib (4) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronic lymphocytic leukaemia (CLL), at least 1 prior therapy, combination with bendamustine and rituximab 50% Hint for considerable additional benefit
Pembrolizumab (2) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), after prior chemotherapy 40% Indication of considerable additional benefit
Trifluridin / Tipiracil Lonsurf® Servier Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC), pre-treated patients 100% Hint for minor additional benefit repealed
Teduglutid (2) Revestive® Shire Deutschland GmbH Digestive system diseases ORPHAN Short bowel syndrome, 1 to < 18 years 100% non-quantifiable additional benefit
Tasimelteon Hetlioz® Vanda Pharmceutical Inc Nervous system diseases ORPHAN Sleep disorders (sleep-wake rhythm), blind adults 100% non-quantifiable additional benefit
Pitolisant Wakix® Bioprojet Pharma SARL Nervous system diseases ORPHAN Narcolepsy 100% non-quantifiable additional benefit
Brentuximab Vedotin (2) Adcetris® Takeda Pharma GmbH Oncological diseases ORPHAN Hodgkin lymphoma (HL), CD30+, increased risk of recurrence or progression after transplantation 100% non-quantifiable additional benefit
Carfilzomib (2) Kyprolis® Amgen GmbH Oncological diseases ORPHAN Multiple myeloma (MM), combination with dexamethasone 100% minor additional benefit repealed
Emtricitabin / Rilpivirin / Tenofoviralafenamid Odefsey® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Sofosbuvir / Velpatasvir Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 28% Hint for considerable additional benefit
Ibrutinib (3) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronic lymphocytic leukemia (CLL), first-line 100% no additional benefit
Sitagliptin / Metformin (2, reassessment) Janumet® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2, monotherapy or combination with sulphonylurea or insulin 100% no additional benefit
Sitagliptin (2, reassessment) Januvia® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2, monotherapy or combination with metformin, sulphonylurea or PPARɣ. 35% Hint for minor additional benefit repealed subgroups
Saxagliptin / Metformin (3, reassessment) Komboglyze® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, monotherapy or combination with insulin 100% no additional benefit
Saxagliptin (2, reassessment) Onglyza® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, combination therapy 100% no additional benefit
Crizotinib (3, reassessment) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 71% Hint for considerable additional benefit
Obinutuzumab (2) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL) 100% non-quantifiable additional benefit
Nivolumab (5) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, combination with ipilimumab 100% no additional benefit repealed subgroups
Selexipag Uptravi® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH) 100% no additional benefit
Eftrenonacog alfa Alprolix® Swedish Orphan Biovitrum GmbH Hematopoietic diseases ORPHAN Hemophilia B 100% non-quantifiable additional benefit
Talimogen laherparepvec Imlygic® Amgen GmbH Oncological diseases Melanoma, stage IIIB, IIIC, IVMI1a 100% no additional benefit
Eribulin (3) Halaven® Eisai GmbH Oncological diseases Liposarcoma 50% Hint for considerable additional benefit
Albutrepenonacog alfa Idelvion® CSL Behring GmbH Hematopoietic diseases ORPHAN Hemophilia B 100% non-quantifiable additional benefit
Migalastat Galafold® Amicus Therapeutics GmbH Metabolic diseases ORPHAN Fabry disease 100% non-quantifiable additional benefit
Elotuzumab Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% Hint for minor additional benefit
Ataluren (2, reassessment) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases ORPHAN Duchenne muscular dystrophy (DMD), ≥ 5 years 100% minor additional benefit
Daratumumab Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), monotherapy, pre-treated patients 100% non-quantifiable additional benefit repealed
Emtricitabin / Tenofoviralafenamid Descovy® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Ospemifen Senshio® Shionogi GmbH Genitourinary system diseases Vulvovaginal atrophy 100% no additional benefit
Ramucirumab (4, reassessment) Cyramza® Lilly Deutschland GmbH Oncological diseases Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel 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 100% no additional benefit
Nivolumab (4) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC) 92% Indication of considerable additional benefit
Nivolumab (3) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, after previous chemotherapy 40% Indication of considerable additional benefit
Osimertinib Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), T790M EGFR mutation 100% no additional benefit repealed subgroups
Necitumumab Portrazza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Ticagrelor (2) Brilique® AstraZeneca GmbH Cardiovascular diseases Prevention of atherothrombotic events in patients with myocardial infarction and high risk for an atherothrombotic event 100% Hint for minor additional benefit
Idelalisib (2, reassessment) Zydelig® Gilead Sciences GmbH Oncological diseases Chronic lymphocytic leukemia (CLL) 24% Hint for non-quantifiable additional benefit
Empagliflozin / Metformin Synjardy® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Empagliflozin (2, reassessment) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 42% Hint for considerable additional benefit
Ramucirumab (3) Cyramza® Lilly Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 100% no additional benefit
Ramucirumab (2) Cyramza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC) 100% no additional benefit
Afamelanotid Scenesse® Clinuvel Ltd. Metabolic diseases ORPHAN Erythropoietic protoporphyria 100% non-quantifiable additional benefit repealed
Brivaracetam Briviact® UCB Pharma GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 16 years 100% no additional benefit
Vismodegib (2, reassessment) Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 95% Hint for minor additional benefit
Umeclidinium Incruse® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Ibrutinib (2, reassessment >€50m) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), Waldenström's disease 12% Indication of considerable additional benefit
Mepolizumab Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma 50% Hint for minor additional benefit
Rilpivirin (2) Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection, 12 to < 18 years 100% no additional benefit
Sacubitril / Valsartan Entresto® Novartis Pharma GmbH Cardiovascular diseases Symptomatic chronic heart failure 68% Hint for considerable additional benefit
Efmoroctocog alfa Elocta® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Crizotinib (2) Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, first-line 100% Hint for considerable additional benefit
Secukinumab (2) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Psoriatic arthritis (PA), Radiographic axial spondyloarthritis (AS)Psoriatic arthritis (PA), Bekhterev's disease 100% no additional benefit repealed subgroups
Blinatumomab Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% non-quantifiable additional benefit repealed
Carfilzomib Kyprolis® Amgen GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone 100% non-quantifiable additional benefit repealed
Cobimetinib Cotellic® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation, combination with vemurafenib 100% Indication of considerable additional benefit
Ivacaftor (3) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), R117H mutation, 2 to 5 years, > 18 years 75% minor additional benefit repealed
Lumacaftor / Ivacaftor Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), > 12 years, homozygous F508del mutation 100% Indication of considerable additional benefit
Aflibercept (6) Eylea® Bayer Vital GmbH Eye diseases Myopic choroidal neovascularisation