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

Start Resolution Procedure (no.) Brand name Pharm. company Therapeutic area Indication Additional benefit (best subpopulation)
Epcoritamab Tepkinly® Abbvie Deutschland GmbH & Co. KG Oncological diseases Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies) 100% Hint for non-quantifiable additional benefit (Orphan)
Sirolimus Hyftor® Plusultra pharma GmbH Skin diseases Facial angiofibroma in tuberous sclerosis, ≥ 6 years. 100% Hint for non-quantifiable additional benefit (Orphan)
Pegunigalsidase alfa Elfabrio® Chiesi GmbH Metabolic diseases Morbus Fabry 100% no additional benefit
Nivolumab (27) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy). 100% no additional benefit
Talquetamab Talvey® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, at least 3 prior therapies 100% Hint for non-quantifiable additional benefit (Orphan)
Risdiplam (2) Evrysdi® Roche Pharma AG Nervous system diseases Spinal muscular atrophy, < 2 months 100% no additional benefit
Lonapegsomatropin Skytrofa® Ascendis Pharma Endocrinology GmbH Metabolic diseases Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years. 100% Hint for non-quantifiable additional benefit (Orphan)
Teclistamab Tecvayli® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, at least 3 prior therapies 100% no additional benefit
Vosoritid (2, reassessement >€30m) Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 2 years 100% Indication of non-quantifiable additional benefit (Orphan (turnover limit))
Tisagenlecleucel (7, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukemia, relapsed/refractory, 0 ≤ 25 years). 100% Hint for non-quantifiable additional benefit (Orphan)
Tisagenlecleucel (6, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases Diffuse large B-cell lymphoma, relapsed or refractory, ≥ 2 prior therapies). 100% Hint for non-quantifiable additional benefit (Orphan)
Nonacog beta pegol (2) Refixia® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia B, < 12 years 100% no additional benefit
Sacituzumab govitecan (2) Trodelvy® Gilead Sciences GmbH Oncological diseases Breast carcinoma, HR+, HER2-, at least 3 prior therapies. 100% Indication of considerable additional benefit
Migalastat (3, reassessment >€30m) Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease, ≥ 12 years 100% no additional benefit (Orphan (turnover limit))
Trifluridin / Tipiracil (4) Lonsurf® Servier Deutschland GmbH Oncological diseases Colorectal cancer, after 2 prior therapies, combination with bevacizumab) 100% Hint for considerable additional benefit
Bedaquilin (4, reassessment) Sirturo® Janssen-Cilag GmbH Infectious diseases Multidrug-resistant pulmonary tuberculosis. 100% Hint for considerable additional benefit (Orphan)
Nivolumab (26) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung cancer, PD-L1 expression ≥ 1 %, neoadjuvant therapy, combination with platinum-based chemotherapy 100% Hint for non-quantifiable additional benefit
Glofitamab Columvi® Roche Pharma AG Oncological diseases B-cell lymphoma, diffuse large cell (DLBCL) 100% Hint for non-quantifiable additional benefit (Orphan)
Mavacamten Camzyos® Bristol-Myers Squibb GmbH & Co. KGaA Cardiovascular diseases Symptomatic hypertrophic obstructive cardiomyopathy (NYHA Klasse II–III) 100% Hint for considerable additional benefit
Eftrenonacog alfa (2, reassessment >€30m) Alprolix® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Hemophilia B 100% no additional benefit (Orphan (turnover limit))
Empagliflozin (5) Jardiance® Boehringer Ingelheim Pharma GmbH Genitourinary system diseases Chronic renal insufficiency 100% no additional benefit
Dalbavancin (2) Xydalba® Advanz Pharma Germany GmbH Infectious diseases Acute bacterial skin and soft tissue infections (ABSSSI), ≥ 3 months 100% additional benefit considered proven
Cipaglucosidase alfa Pombiliti® Amicus Therapeutics GmbH Metabolic diseases Pompe's disease, combination with miglustat 100% Hint for minor additional benefit
Lumacaftor / Ivacaftor (5) Orkambi® Vertex Pharmaceuticals Metabolic diseases Cystic fibrosis, homozygous F508del mutation in CFTR gene, 1 to < 2 years) 100% Hint for non-quantifiable additional benefit
Ivosidenib (2) Tibsovo® Servier Deutschland GmbH Oncological diseases Cholangiocarcinoma with IDH1-R132 mutation, after at least 1 prior therapy 100% Hint for non-quantifiable additional benefit (Orphan)
Ivosidenib Tibsovo® Servier Deutschland GmbH Oncological diseases Acute myeloid leukemia with IDH1-R132 mutation, first-line, combination with azacitidine 100% Indication of major additional benefit (Orphan)
Mirikizumab Omvoh® Lilly Deutschland GmbH Digestive system diseases Ulcerative colitis, pre-treated 100% no additional benefit
Dimethylfumarat (3) Tecfidera® Biogen GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older)) 100% no additional benefit
Nivolumab (25) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adolescents ≥ 12 to 18 years, monotherapy or combination with ipilimumab). 100% no additional benefit
Nivolumab (24) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adjuvant therapy, adolescents ≥ 12 to 18 years, monotherapy 100% no additional benefit
Axicabtagen-Ciloleucel (6) Yescarta® Gilead Sciences GmbH Oncological diseases Follicular lymphoma, after ≥ 3 prior therapies 100% no additional benefit (Orphan (turnover limit))
Axicabtagen-Ciloleucel (4, reassessment >€30m) Yescarta® Gilead Sciences GmbH Oncological diseases Diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies 100% no additional benefit (Orphan (turnover limit))
Axicabtagen-Ciloleucel (5) Yescarta® Gilead Sciences GmbH Oncological diseases Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory 50% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Riociguat (4) Adempas® MSD SHARP & DOHME GMBH Cardiovascular diseases Pulmonary arterial hypertension, < 18 years of age 100% no additional benefit
Bimekizumab (4) Bimzelx® UCB Pharma GmbH Skin diseases Psoriatic arthritis, monotherapy or in combination with methotrexate 100% no additional benefit
Bimekizumab (3) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis 100% no additional benefit
Bimekizumab (2) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Axial spondyloarthritis, non-radiographic 100% no additional benefit
Selumetinib (2, reassessment) Koselugo® AstraZeneca GmbH Oncological diseases Neurofibromatosis (≥ 3 to < 18 years, type 1) 100% Hint for non-quantifiable additional benefit (Orphan)
Sacubitril / Valsartan (2) Entresto® Novartis Pharma GmbH Cardiovascular diseases Chronic heart failure with left ventricular dysfunction, ≥ 1 year) 100% no additional benefit
Secukinumab (9) Cosentyx® Novartis Pharma GmbH Skin diseases Hidradenitis suppurativa (Acne inversa) 100% no additional benefit
Ravulizumab (5) Ultomiris® Alexion Pharma Germany GmbH Nervous system diseases Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive 100% no additional benefit
Lisocabtagen maraleucel (2) Breyanzi® Bristol-Myers Squibb GmbH Oncological diseases Diffuse large B-cell lymphoma, highly malignant B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B; after 1 prior therapy, relapse within 12 months or refractory). 50% Hint for considerable additional benefit
Setmelanotid (2) Imcivree® Rhythm Pharmaceuticals Inc. Metabolic diseases Obesity and control of hunger, Bardet-Biedl syndrome, ≥ 6 years 100% Hint for non-quantifiable additional benefit (Orphan)
Loncastuximab tesirin Zynlonta® Swedish Orphan Biovitrum GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma (HGBL), ≥ 2 prior therapies) 100% no additional benefit
Luspatercept (5, reassessment >€30m) Reblozyl® Bristol-Myers Squibb GmbH & Co. KGaA Hematopoietic diseases Β-thalassaemia, transfusion-dependent anaemia 100% no additional benefit (Orphan (turnover limit))
Luspatercept (4, reassessment >€30m) Reblozyl® Bristol-Myers Squibb GmbH & Co. KGaA Hematopoietic diseases Myelodysplastic syndrome with transfusion-dependent anaemia, pre-treated 100% no additional benefit (Orphan (turnover limit))
Tixagevimab / Cilgavimab (2) Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, Preexposition prophylaxis, ≥ 12 years 100% no additional benefit
Cemiplimab (5) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1 %, combination with platinum-based chemotherapy 100% no additional benefit
Cemiplimab (4) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Cervix carcinoma, pretreated 50% Indication of considerable additional benefit
Etranacogen Dezaparvovec Hemgenix® CSL Behring GmbH Hematopoietic diseases Hemophilia B 100% Hint for non-quantifiable additional benefit (Orphan)
Upadacitinib (7) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Morbus Crohn, pretreated 100% no additional benefit
Lasmiditan Rayvow® Lilly Deutschland GmbH Nervous system diseases Migraine acute therapy 100% no additional benefit
Tabelecleucel Ebvallo® Pierre Fabre Pharma GmbH Oncological diseases Relapsed or refractory Epstein-Barr virus positive posttransplant lymphoproliferative disease (EBV+ PTLD), pretreated, 2 years and older. 100% Hint for non-quantifiable additional benefit (Orphan)
Deucravacitinib Sotyktu® Bristol-Myers Squibb GmbH & Co. KGaA Skin diseases Moderate to severe plaque psoriasis 100% no additional benefit
Belantamab-Mafodotin (2, reassessment) Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases Multiple myeloma, at least 4 prior therapies, monotherapy 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Durvalumab (5) Imfinzi® AstraZeneca GmbH Oncological diseases Biliary tumors, first-line, combination with gemcitabine and cisplatin 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 100% no additional benefit
Durvalumab (3) Imfinzi® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with tremelimumab 100% no additional benefit
Tremelimumab Tremelimumab AstraZeneca® AstraZeneca GmbH Oncological diseases Non-small cell lung cancer, EGFR/ALK-negative, first-line, combination with durvalumab and platinum-based chemotherapy 100% no additional benefit
Tremelimumab (2, Imjudo®) Imjudo® AstraZeneca GmbH Oncological diseases Hepatocellular carcinoma, first-line, combination with durvalumab 100% no additional benefit
Dupilumab (9) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Prurigo nodularis 100% Hint for non-quantifiable additional benefit
Darolutamid (2) Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy 100% Indication of considerable additional benefit
Olaparib (11, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy 100% no additional benefit
Pitolisant (3) Wakix® Bioprojet Deutschland GmbH Nervous system diseases Narcolepsy, with or without cataplexy (children and adolescents, 6-17 years) 100% Hint for non-quantifiable additional benefit (Orphan)
Dulaglutid (3) Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2, ≥ 10 years 100% no additional benefit
Luspatercept (3) Reblozyl® Bristol-Myers Squibb GmbH & Co. KGaA Hematopoietic diseases Β-thalassaemia, non-transfusion-dependent anaemia 100% Indication of minor additional benefit (Orphan (turnover limit))
Rucaparib (3, reassessment) Rubraca® zr pharma& GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy 100% no additional benefit
Dupilumab (8) Dupixent® Sanofi-Aventis Deutschland GmbH Digestive system diseases Eosinophilic oesophagitis, ≥ 12 years, min. 40 kg 100% no additional benefit
Dupilumab (7) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis, 6 months to 5 years 50% Hint for non-quantifiable additional benefit
Esketamin (3, reassessment) Spravato® Janssen-Cilag GmbH Mental illnesses Depression, therapy resistent, in combination with SSRI or SNRI 100% Hint for considerable additional benefit
Voclosporin Lupkynis® Otsuka Pharma GmbH Musculoskeletal system diseases Lupusnephritis 100% no additional benefit
Emicizumab (3) Hemlibra® Roche Pharma AG Hematopoietic diseases Moderate haemophilia A, without factor VIII inhibitors, with severe bleeding phenotype 100% no additional benefit
Finerenon (2) Kerendia® Bayer Vital GmbH Genitourinary system diseases Chronic kidney disease in type 2 diabetes, stages 1 and 2 with albuminuria 100% Hint for non-quantifiable additional benefit
Finerenon Kerendia® Bayer Vital GmbH Genitourinary system diseases Chronic kidney disease in type 2 diabetes, stages 3 and 4 with albuminuria 100% no additional benefit
Dolutegravir / Abacavir / Lamivudin (2) Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 14 kg to < 12 years 100% no additional benefit
Dapagliflozin (8) Forxiga® AstraZeneca GmbH Cardiovascular diseases Chronic heart failure with left ventricular ejection fraction LVEF > 40 % 100% Hint for minor additional benefit
Ciltacabtagene Autoleucel Carvykti® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, at least 3 previous therapies 100% Hint for non-quantifiable additional benefit (Orphan)
Fenfluramin (2) Fintepla® Zogenix GmbH Nervous system diseases Lennox-Gastaut syndrome, add-on therapy, ≥ 2 years 100% Hint for considerable additional benefit (Orphan)
Sotorasib (2, reassessment) Lumykras® Amgen Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 prior therapy 44% Hint for non-quantifiable additional benefit
Trastuzumab-Deruxtecan (4) Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Adenocarcinoma (AC) of the stomach or gastro-oesophageal junction, HER2-positive, after trastuzumab-based therapy 100% no additional benefit
Trastuzumab-Deruxtecan (3) Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Breast carcinoma (BC), HER2-low, pre-treated 100% Indication of considerable additional benefit
Ibrutinib (8) Imbruvica® Janssen-Cilag GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line, combination with venetoclax 100% no additional benefit
Spesolimab Spevigo® Boehringer Ingelheim Pharma GmbH & Co. KG Skin diseases Generalised pustular psoriasis, acute treatment 100% no additional benefit
Lutetium (177Lu) Vipivotidtetraxetan Pluvicto® Novartis Radiopharmaceuticals GmbH Oncological diseases Prostate carcinoma (PC), combination with androgen deprivation therapy, PSMA-positive, metastatic, castration-resistant, progression after inhibition of the AR pathway and taxane-based chemotherapy 50% Indication of considerable additional benefit
Maralixibat Livmarli® Mirum Pharmaceuticals Germany GmbH Digestive system diseases Alagille-Syndrome, ≥ 2 months 100% Hint for non-quantifiable additional benefit (Orphan)
Olaparib (10) Lynparza® AstraZeneca GmbH Oncological diseases Prostate carcinoma (PC), metastatic, castration-resistant, chemotherapy not clinically indicated, combination with abiraterone and/or prednisone 25% Hint for considerable additional benefit
Risankizumab (3) Skyrizi® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Morbus Crohn, pre-treated 40% Hint for minor additional benefit
Bictegravir / Emtricitabin / Tenofoviralafenamid (2) Biktarvy® Gilead Sciences GmbH Infectious diseases HIV-Infection, 2 until < 18 years 100% no additional benefit
Sutimlimab Enjaymo® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases Cold agglutinin disease (CAD) 100% Hint for minor additional benefit (Orphan)
Abemaciclib (6, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast carcinoma (BC), HR+, HER2-, combination with aromatase inhibitor 100% Hint for minor additional benefit
Latanoprost / Netarsudil Roclanda® Santen GmbH Eye diseases Reduction of increased intraocular pressure in open-angle glaucoma or ocular hypertension 100% no additional benefit
Zanubrutinib (4) Brukinsa® BeiGene Germany GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line 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 100% no additional benefit
Zanubrutinib (2) Brukinsa® BeiGene Germany GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), relapsed and/or refractory 23% Indication of minor additional benefit
Olopatadin / Mometason Ryaltris® Berlin-Chemie AG Respiratory system diseases Allergic rhinitis 100% no additional benefit
Maribavir Livtencity® Takeda GmbH Infectious diseases Cytomegalovirus infection (CMI), refractory to therapy 100% Hint for minor additional benefit (Orphan)
Tezepelumab Tezspire® AstraZeneca GmbH Respiratory system diseases Bronchial asthma (AB), ≥ 12 years 100% no additional benefit
Tralokinumab (2) Adtralza® LEO Pharma GmbH Skin diseases Atopic dermatitis (AD), 12 to < 18 years 100% no additional benefit
Daridorexant Quviviq® Idorsia Pharmaceuticals Germany GmbH Mental illnesses Sleep disorders (mental illnesses) 100% no additional benefit
Dalbavancin Xydalba® Advanz Pharma Germany GmbH Infectious diseases Acute bacterial skin and skin structure infections (ABSSSI) resolution w/o assessement
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 2 to < 6 years 100% no additional benefit
Olaparib (9, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma (OC), fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab 100% Hint for considerable additional benefit
Ravulizumab (4) Ultomiris® Alexion Pharma Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 100% no additional benefit
Tixagevimab / Cilgavimab Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre 33% Hint for minor additional benefit
Faricimab (2) Vabysmo® Roche Pharma AG Eye diseases Neovascular age-related macular degeneration (AMD) 100% no additional benefit
Remdesivir (4) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg) 100% no additional benefit
Remdesivir (3) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years 100% no additional benefit
Vutrisiran Amvuttra® Alnylam Germany GmbH Metabolic diseases Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2) 100% Indication of minor additional benefit (Orphan)
Relugolix Orgovyx® Accord Healthcare GmbH Oncological diseases Prostate carcinoma (PC), advanced, hormone-sensitive 100% no additional benefit
Lonafarnib Zokinvy® EigerBio Europe Ltd Other diseases Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over 100% Hint for non-quantifiable additional benefit (Orphan)
Faricimab Vabysmo® Roche Pharma AG Eye diseases Diabetic macular edema (DME) 100% no additional benefit
Difelikefalin Kapruvia® Fresenius Medical Care Nephrologica Deutschland GmbH Skin diseases Pruritus in chronic kidney disease (CKD), haemodialysis patients 100% no additional benefit
Lisocabtagen maraleucel Breyanzi® Bristol-Myers Squibb GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies 100% no additional benefit
Selinexor (2) Nexpovio® Stemline Therapeutics B.V. Oncological diseases Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone 100% no additional benefit
Selinexor Nexpovio® Stemline Therapeutics B.V. Oncological diseases Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone 100% no additional benefit
Asciminib Scemblix® Novartis Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, after ≥ 2 prior therapies 100% Indication of minor additional benefit (Orphan)
Melphalanflufenamid Pepaxti® Oncopeptides AB Oncological diseases Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone) 100% no additional benefit
Olipudase alfa Xenpozyme® Sanofi-Aventis Deutschland Metabolic diseases Acid sphingomyelinase deficiency (ASMD) type A/B or type B 100% Hint for non-quantifiable additional benefit (Orphan)
Pertuzumab (4, reassessment) Perjeta® Roche Pharma AG Oncological diseases Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy 100% Indication of minor additional benefit
Pertuzumab / Trastuzumab (4, reassessment) Phesgo® Roche Pharma AG Oncological diseases Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy 100% Indication of minor additional benefit
Selpercatinib (5) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older 100% no additional benefit
Brexucabtagene-Autoleucel (2) Tecartus® Gilead Sciences GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), aged > 26 100% Hint for non-quantifiable additional benefit (Orphan)
Valoctocogene roxaparvovec Roctavian® BioMarin International Ltd. Hematopoietic diseases Hemophilia A 100% Hint for non-quantifiable additional benefit (Orphan)
Burosumab (6) Crysvita® Kyowa Kirin GmbH Metabolic diseases FGF23-related hypophosphatemia in tumour-induced osteomalacia 100% no additional benefit (Orphan (turnover limit))
Efgartigimod alfa Vyvgart® Argenx Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 100% Hint for considerable additional benefit (Orphan)
Eptinezumab Vyepti® Lundbeck GmbH Nervous system diseases Migraine prophylaxis 100% no additional benefit
Olaparib (8) Lynparza® AstraZeneca GmbH Oncological diseases Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy. 100% Indication of minor additional benefit
Upadacitinib (6) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis (UC), pre-treated 100% no additional benefit
Upadacitinib (5) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Axial spondyloarthritis (AS), non-radiographic 100% no additional benefit
Birkenrindenextrakt Filsuvez® Amryt Pharma GmbH Other diseases Wound treatment in epidermolysis bullosa (from 6 months) 100% Hint for minor additional benefit (Orphan)
Ceftolozan / Tazobactam (7) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications, < 18 years of age 100% additional benefit considered proven
Capmatinib Tabrecta® Novartis Pharma GmbH Oncological diseases Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients 100% no additional benefit
Eladocagene Exuparvovec Upstaza® PTC Therapeutics International Limited Metabolic diseases Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months 100% Hint for non-quantifiable additional benefit (Orphan)
Trastuzumab-Deruxtecan (2) Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Breast carcinoma (BC), HER2+, after 1 prior therapy 100% Indication of non-quantifiable additional benefit
Trastuzumab-Deruxtecan Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Breast carcinoma (BC), HER2+, at least 2 previous therapies 100% Indication of considerable additional benefit
Pembrolizumab (30) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab 40% Indication of considerable additional benefit
Pembrolizumab (29) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients 100% Hint for minor additional benefit
Pembrolizumab (28) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy. 100% no additional benefit
Pembrolizumab (27) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Endometrial carcinoma with MSI-H or with dMMR, pre-treated 100% no additional benefit
Pembrolizumab (26) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Gastric carcinoma with MSI-H or dMMR, pre-treated 74% Hint for non-quantifiable additional benefit
Pembrolizumab (25) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Small bowel carcinoma with MSI-H or dMMR, pre-treated 100% no additional benefit
Pembrolizumab (24) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Biliary carcinoma with MSI-H or dMMR, pre-treated 100% no additional benefit
Pembrolizumab (23) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, adjuvant therapy, ≥ 12 years, monotherapy 100% Indication of non-quantifiable additional benefit
Pembrolizumab (22) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, ≥ 12 to < 18 years 100% no additional benefit
Glycopyrronium Axhidrox® Dr. August Wolff GmbH & Co. KG Arzneimittel Other diseases Severe primary axillary hyperhidrosis 100% no additional benefit
Inebilizumab Uplizna® Horizon Therapeutics GmbH Nervous system diseases Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive 100% no additional benefit
Eravacyclin Xerava® PAION Deutschland GmbH Infectious diseases Reserve antibiotics: Complicated intra-abdominal infections (cIAI) 100% additional benefit considered proven
Secukinumab (8) Cosentyx® Novartis Pharma GmbH Skin diseases Juvenile psoriatic arthritis (PA), ≥ 6 years 100% no additional benefit
Secukinumab (7) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Enthesitis-related arthritis (ERA) 100% no additional benefit
Atezolizumab (10) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy. 100% Hint for non-quantifiable additional benefit
Mosunetuzumab Lunsumio® Roche Pharma AG Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies 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 50% Hint for minor additional benefit
Selpercatinib (4) Retsevmo® Lilly Deutschland GmbH Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+, first-line 100% no additional benefit
Palbociclib (3, reassessment) Ibrance® Pfizer Pharma GmbH Oncological diseases Breast carcinoma (BC), patient population a1 100% no additional benefit
Nirmatrelvir / Ritonavir Paxlovid® Pfizer Pharma GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression 100% Hint for considerable additional benefit
Cerliponase alfa (2, reassessment) Brineura® BioMarin Deutschland GmbH Metabolic diseases Neuronal ceroid lipofuscinosis (NCL) type 2 100% Hint for major additional benefit (Orphan)
Enfortumab Vedotin Padcev® Astellas Pharma Europe B.V Oncological diseases Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor 47% Hint for considerable additional benefit
Setmelanotid Imcivree® Rhythm Pharmaceuticals Inc. Metabolic diseases Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years. 100% Hint for non-quantifiable additional benefit (Orphan)
Cabozantinib (8, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients 100% no additional benefit
Polatuzumab Vedotin (2) Polivy® Roche Pharma AG Oncological diseases Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) 100% Hint for non-quantifiable additional benefit (Orphan)
Tisagenlecleucel (5) Kymriah® Novartis Pharma GmbH Oncological diseases Follicular lymphoma (FL), pre-treated patients 100% Hint for non-quantifiable additional benefit (Orphan)
Axicabtagen-Ciloleucel (3, reassessment) Yescarta® Gilead Sciences GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Voxelotor Oxbryta® Global Blood Therapeutics Germany GmbH Hematopoietic diseases Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years. 100% Hint for non-quantifiable additional benefit (Orphan)
Sotrovimab Xevudy® GlaxoSmithKline GmbH & Co. KG Infectious diseases COVID-19, ≥ 12 years 33% Hint for considerable additional benefit
Imipenem / Cilastatin / Relebactam (2) Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 100% additional benefit considered proven
Ceftolozan / Tazobactam (6) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications 100% additional benefit considered proven
Ceftazidim / Avibactam (2) Zavicefta® Pfizer Pharma GmbH Infectious diseases Bacterial infections, multiple indications 100% additional benefit considered proven
Tebentafusp Kimmtrak® Immunocore Ireland Ltd. Oncological diseases Uveal melanoma, HLA-A*02:01-positive 100% Hint for considerable additional benefit (Orphan)
Brolucizumab (2) Beovu® Novartis Pharma GmbH Eye diseases Diabetic macular edema 100% no additional benefit
Abemaciclib (5) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast cancer (BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy 40% Hint for minor additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil (2) Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 100% no additional benefit
Doravirin (2) Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years 100% no additional benefit
Nivolumab (23) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy 65% Hint for non-quantifiable additional benefit
Nivolumab (22) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy 100% Indication of considerable additional benefit
Nivolumab (21) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma (SCC) of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with ipilimumab 100% Hint for considerable additional benefit
Casirivimab / Imdevimab (2) Ronapreve® Roche Pharma AG Infectious diseases Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years 33% Hint for minor additional benefit
Casirivimab / Imdevimab Ronapreve® Roche Pharma AG Infectious diseases COVID-19-Infection, ≥ 12 years 33% Hint for considerable additional benefit
Dupilumab (6) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Asthma bronchiale, ≥ 6 until ≤ 11 years 100% no additional benefit
Glucarpidase Voraxaze® SERB GmbH Other diseases Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults. 100% Hint for non-quantifiable additional benefit (Orphan)
Anifrolumab Saphnelo® AstraZeneca GmbH Musculoskeletal system diseases Systemic lupus erythematosus (SLE) 100% no additional benefit
Avapritinib (2) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases Systemic mastocytosis, after at least 1 prior therapy 100% Hint for non-quantifiable additional benefit (Orphan)
Somatrogon Ngenla® Pfizer Pharma GmbH Metabolic diseases Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age 100% Hint for non-quantifiable additional benefit (Orphan)
Dolutegravir (4, reassessment) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, age 6 to < 18 years resolution w/o assessement
Voretigen Neparvovec (2, reassessment) Luxturna® Novartis Pharma GmbH Eye diseases Hereditary retinal dystrophy 100% Hint for considerable additional benefit (Orphan)
Pegcetacoplan Aspaveli® Swedish Orphan Biovitrum GmbH Hematopoietic diseases Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients 100% Hint for non-quantifiable additional benefit (Orphan)
Idebenon (2, reassessment) Raxone® Chiesi GmbH Eye diseases Leber's hereditary optic neuropathy (LHOP) 100% Hint for non-quantifiable additional benefit (Orphan)
Empagliflozin (4) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Cardiovascular diseases Chronic heart failure (CHF) with preserved ejection fraction 100% Hint for minor additional benefit
Daratumumab (9, reassessment) Darzalex® Janssen-Cilag Oncological diseases Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 100% Proof of considerable additional benefit (Orphan (turnover limit))
Brivaracetam (3) Briviact® UCB Pharma GmbH Nervous system diseases Focal seizures in epilepsy, additional therapy, 2 to < 4 years 100% no additional benefit
Lorlatinib (2) Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung cancer (NSCLC), ALK+, first-line 100% no additional benefit
Tepotinib Tepmetko® Merck Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients 100% no additional benefit
Vedolizumab (2) Entyvio® Takeda GmbH Digestive system diseases Antibiotic-refractory pouchitis, pre-treated patients 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (10) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (9) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (8) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (7) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (6) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation) 100% Indication of considerable additional benefit (Orphan (turnover limit))
Ivacaftor (26) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (25) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (24) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor). 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (23) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor (22) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutation) 100% Indication of considerable additional benefit (Orphan (turnover limit))
Avacopan Tavneos® Vifor Pharma Deutschland GmbH Musculoskeletal system diseases Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide 100% Hint for minor additional benefit (Orphan)
Sotorasib Lumykras® Amgen Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies 100% no additional benefit repealed subpopulations
Sofosbuvir / Velpatasvir (3) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 3 to < 6 years of age 100% no additional benefit
Calcifediol Rayaldee® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Secondary hyperparathyroidism in chronic renal failure 100% no additional benefit
Isofluran Sedaconda® Sedana Medical AB Other diseases Sedation of mechanically ventilated patients during intensive care therapy (ICT) 100% no additional benefit
Burosumab (5, reassessment >€50m) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia, ≥ 18 years of age 100% no additional benefit (Orphan (turnover limit))
Burosumab (4, reassessment >€50m) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia, ≥ 1 to < 18 years of age 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Duvelisib (2) Copiktra® Secura Bio Limited Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies 100% no additional benefit
Duvelisib Copiktra® Secura Bio Limited Oncological diseases Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies 100% no additional benefit
Abrocitinib Cibinqo® Pfizer Pharma GmbH Skin diseases Atopic Dermatitis (AD) 100% Hint for considerable additional benefit
Amivantamab Rybrevant® Janssen-Cilag GmbH Oncological diseases Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy 100% no additional benefit
Remdesivir (2) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression 100% Hint for minor additional benefit
Lenvatinib (7, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab 100% no additional benefit
Lenvatinib (6) Lenvima® Eisai GmbH Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab 100% Indication of considerable additional benefit
Pembrolizumab (20) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib 100% Indication of considerable additional benefit
Pembrolizumab (19) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib 100% no additional benefit
Zanubrutinib Brukinsa® BeiGene Germany GmbH Oncological diseases Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy 100% no additional benefit
Idecabtagen vicleucel Abecma® Bristol-Myers Squibb GmbH & Co KGaA Oncological diseases Multiple myeloma (MM), at least 3 previous therapies 100% Hint for non-quantifiable additional benefit (Orphan)
Evolocumab (3) Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age 100% no additional benefit
Ripretinib Qinlock® Deciphera Pharmaceuticals (Netherlands) B.V. Oncological diseases Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies 100% Hint for major additional benefit (Orphan)
Pralsetinib Gavreto® Roche Registration GmbH Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+ 100% no additional benefit
Tofacitinib (7) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis (AS) 100% no additional benefit
Ozanimod (2) Zeposia® Bristol-Myers Squibb GmbH & Co. KGaA Digestive system diseases Ulcerative colitis (UC), pre-treated patients 100% no additional benefit
Dapagliflozin (7) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus Type 2, ≥ 10 years 100% no additional benefit
Ponesimod (2) Ponvory® Janssen-Cilag GmbH Nervous system diseases Relaps multiple sclerosis (MS) 50% Indication of minor additional benefit
Abemaciclib (4, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast cancer (BC), HR+, HER2-, combination with fulvestrant 42% Indication of minor additional benefit
Filgotinib (2) Jyseleca® Galapagos Biopharma Germany GmbH Digestive system diseases Ulcerative colitis (UC), pretreated patients 100% no additional benefit
Mepolizumab (5) Nucala® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Eosinophilic granulomatosis with polyangiitis 100% no additional benefit
Mepolizumab (4) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic rhinosinusitis with nasal polyps 100% no additional benefit
Mepolizumab (3) Nucala® GlaxoSmithKline GmbH & Co. KG Hematopoietic diseases Hypereosinophilic syndrome 100% Hint for considerable additional benefit
Ertugliflozin Steglatro® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus (DM) type 2 100% no additional benefit
Nivolumab (20) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Adenocarcinoma (AC) of the stomach, gastroesophageal junction or esophagus, CPS ≥ 5, HER2-negative, first-line, combination with fluoropyrimidine- and platinum-based combination chemotherapy 100% Hint for considerable additional benefit
Risankizumab (2) Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriatic arthritis (PA), monotherapy or combination with methotrexate 100% no additional benefit
Sacituzumab Govitecan Trodelvy® Gilead Sciences GmbH Oncological diseases Breast cancer (BC) triple-negative, after 2 previous therapies 100% Indication of major additional benefit
Lusutrombopag Mulpleo® Shionogi GmbH Hematopoietic diseases Thrombocytopenia in chronic liver disease 100% no additional benefit
Cefiderocol (2) Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens 100% additional benefit considered proven
Delamanid (2) Deltyba® Otsuka Novel Products Infectious diseases Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg 100% Hint for non-quantifiable additional benefit (Orphan)
Elbasvir / Grazoprevir (2) Zepatier® MSD Sharp & Dohme B.V. Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 100% no additional benefit
Pembrolizumab (18) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy. 34% Indication of considerable additional benefit
Pembrolizumab (17) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Breast cancer (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy 50% Hint for considerable additional benefit
Icosapent-Ethyl Vazkepa® Amarin Pharmaceuticals Ireland Limited Metabolic diseases Dyslipidemia, pre-treated patients 100% no additional benefit
Ixazomib (2, reassessment) Ninlaro® Takeda GmbH Oncological diseases Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% Hint for non-quantifiable additional benefit (Orphan)
Pitolisant (2, Ozawade®) Ozawade® Bioprojet Deutschland GmbH Nervous system diseases Daytime sleepiness in obstructive sleep apnea, after previous therapy 100% no additional benefit
Sofosbuvir / Velpatasvir / Voxilaprevir (2) Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 100% no additional benefit
Albutrepenonacog alfa (2, reassessment >€50m) Idelvion® CSL Behring GmbH Hematopoietic diseases Hemophilia B, congenital factor IX deficiency 100% no additional benefit (Orphan (turnover limit))
Erdnussprotein als entfettetes Pulver von Arachis hypogaea L., semen (Erdnüsse) Palforzia® Aimmune Therapeutics Germany GmbH Other diseases Peanut allergy, ≥ 4 years 100% no additional benefit
Solriamfetol (2) Sunosi® Jazz Pharmaceuticals Ireland Nervous system diseases Daytime sleepiness in obstructive sleep apnoea, after previous therapy 100% no additional benefit
Vandetanib (4, reassessment) Caprelsa® Sanofi-Aventis Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC) 100% no additional benefit
Vosoritid Voxzogo® BioMarin International Limited Other diseases Achondroplasia, ≥ 2 years 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Daratumumab (8, reassessment) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 100% Hint for considerable additional benefit (Orphan (turnover limit))
Lumacaftor / Ivacaftor (4, reassessment) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, ≥ 2 to ≤ 5 years 100% Hint for non-quantifiable additional benefit
Ravulizumab (3) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Paroxysmal hemoglobinuria, pediatric patients 100% no additional benefit
Tofacitinib (6) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Polyarticular juvenile idiopathic arthritis, RF+ or RF polyarthritis and dilated oligoarthritis, and juvenile psoriatic arthritis, ≥ 2 years 100% no additional benefit
Roxadustat Evrenzo® Astellas Pharma GmbH Hematopoietic diseases Symptomatic anemia in chronic kidney disease (CKD) 100% no additional benefit
Bimekizumab Bimzelx® UCB Pharma GmbH Skin diseases Plaque psoriasis (PP) 100% Indication of minor additional benefit
Vericiguat Verquvo® Bayer Vital GmbH Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for minor additional benefit
Odevixibat Bylvay® Albireo Pharma AB Digestive system diseases Cholestasis, ≥ 6 months 100% Hint for minor additional benefit (Orphan)
Tafasitamab Minjuvi® Incyte Biosciences Germany Oncological diseases Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide 100% Hint for non-quantifiable additional benefit (Orphan)
Misoprostol Angusta® Norgine GmbH Other diseases Labor induction 100% no additional benefit
Nivolumab (19) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Carcinoma of the esophagus and gastro-esophageal junction, pre-treated patients, adjuvant therapy 100% Indication of non-quantifiable additional benefit
Migalastat (2) Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease, 12 to < 16 years 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Tofacitinib (5, reassessment) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate 100% no additional benefit
Tirbanibulin Klisyri® Almirall Hermal GmbH Skin diseases Actinic keratosis (AK), Olsen grade I 100% no additional benefit
Relugolix / Estradiol / Norethisteronacetat Ryeqo® Gedeon Richter Pharma GmbH Genitourinary system diseases Uterine myoma 50% Hint for considerable additional benefit
Dapagliflozin (6) Forxiga® AstraZeneca GmbH Genitourinary system diseases Chronic kidney disease (CKD) 50% Hint for considerable additional benefit
Upadacitinib (4) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Atopic dermatitis (AD), ≥ 12 years 33% Indication of considerable additional benefit
Selumetinib Koselugo® AstraZeneca GmbH Oncological diseases Neurofibromatosis (type 1), ≥ 3 to < 18 years 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Daratumumab (7) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason 38% Hint for minor additional benefit (Orphan (turnover limit))
Imipenem / Cilastatin / Relebactam Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Pneumonia, Bacteriemia resolution w/o assessement
Ceftolozan / Tazobactam (5) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) resolution w/o assessement
Teriflunomid (2) Aubagio® Sanofi-Aventis Deutschland GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS), 10 to 17 years 100% no additional benefit
Blinatumomab (6) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years 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 100% no additional benefit
Cemiplimab (3) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Basal cell carcinoma (BCC), locally advanced or metastasised 97% Hint for minor additional benefit
Cemiplimab (2) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line 100% no additional benefit
Daratumumab (6) Darzalex® Janssen-Cilag GmbH Oncological diseases Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone 50% Hint for minor additional benefit (Orphan (turnover limit))
Ceftazidim / Avibactam Zavicefta® Pfizer Pharma GmbH Infectious diseases Complicated intra-abdominal infections, complicated urinary tract infections, nosocomial pneumonias, infections caused by aerobic gram-negative pathogens resolution w/o assessement
Satralizumab Enspryng® Roche Pharma AG Nervous system diseases Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years 100% Hint for minor additional benefit (Orphan)
Empagliflozin (3) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for minor additional benefit
Tralokinumab Adtralza® LEO Pharma A/S Skin diseases Atopic dermatitis (AD) 100% no additional benefit
Angiotensin-II-Acetat Giapreza® La Jolla Pharmaceutical II B.V. Cardiovascular diseases Hypotension 100% no additional benefit
Brentuximab Vedotin (6, reassessment) Adcetris® Takeda GmbH Oncological diseases Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone 100% Hint for minor additional benefit (Orphan)
Cabozantinib (7, reassessment) Cometriq® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC) 100% Hint for non-quantifiable additional benefit (Orphan)
Glecaprevir / Pibrentasvir (3) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 3 to < 12 years 100% no additional benefit
Nivolumab (17) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Malignant pleural mesothelioma, first-line, combination with ipilimumab 50% Indication of considerable additional benefit
Osimertinib (4) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy 50% Indication of non-quantifiable additional benefit
Elotuzumab (3, reassessment) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone 100% Hint for considerable additional benefit
Dostarlimab Jemperli® GlaxoSmithKline GmbH & Co. KG Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy 100% no additional benefit
Tagraxofusp Elzonris® Stemline Therapeutics B.V. Oncological diseases Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line 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 100% Hint for considerable additional benefit
Berotralstat Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 100% no additional benefit
Ponesimod Ponvory® Janssen-Cilag GmbH Nervous system diseases Relapsing multiple sclerosis (MS) 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (5) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation). 100% no additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (4) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (3) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)). 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (21) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (20) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (19) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and gating mutation (incl. R117H)) 100% no additional benefit (Orphan (turnover limit))
Bosutinib (4, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line 100% no additional benefit
Enzalutamid (5) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy 100% no additional benefit
Cenobamat Ontozry® Angelini Pharma Deutschland GmbH Nervous system diseases Epilepsy, focal seizures, after at least 2 previous therapies 100% no additional benefit
Atezolizumab (9) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line 100% no additional benefit
Isatuximab (2) Sarclisa® Sanofi-Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone 100% Hint for minor additional benefit
Isatuximab Sarclisa® Sanofi-Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), after at least 1 prior therapy, combination with carfilzomib and dexamethasone 100% no additional benefit
Lanadelumab (2, reassessment >€50m) Takhzyro® Takeda GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 100% no additional benefit (Orphan (turnover limit))
Onasemnogen-​Abeparvovec Zolgensma® Novartis Gene Therapies EU Limited Nervous system diseases 5q-associated spinal muscular atrophy (SMA) 100% no additional benefit (Orphan (turnover limit))
Obinutuzumab (6, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL), first-line 100% no additional benefit (Orphan (turnover limit))
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 100% no additional benefit (Orphan (turnover limit))
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL) 100% no additional benefit (Orphan (turnover limit))
Cannabidiol (5) Epidyolex® GW Pharmaceuticals plc Other diseases Seizures in Tuberous Sclerosis, ≥ 2 years 100% Hint for non-quantifiable additional benefit (Orphan)
Atidarsagen autotemcel OTL-200 Libmeldy® Orchard Therapeutics GmbH Metabolic diseases Metachromatic leukodystrophy with biallelic mutation in the ARSA gene 50% Hint for major additional benefit (Orphan)
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 5q-associated spinal muscular atrophy (SMA) 42% Hint for non-quantifiable additional benefit (Orphan)
Cabozantinib (6, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with nivolumab 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
Cefiderocol Fetcroja® Shionogi GmbH Infectious diseases Infections caused by aerobic gram-negative pathogens resolution w/o assessement
Pemigatinib Pemazyre® Incyte Biosciences Germany GmbH Oncological diseases Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy 100% Hint for non-quantifiable additional benefit (Orphan)
Nivolumab (15, reassessment) 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, reassessment) 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 Multidrug-resistant pulmonary tuberculosis, 5 to 11 years 100% Hint for non-quantifiable additional benefit (Orphan)
Imlifidase Idefirix® Hansa Biopharma AB Other diseases Desensitisation in kidney transplantation 100% Hint for non-quantifiable additional benefit (Orphan)
Fedratinib Inrebic® Celgene GmbH Oncological diseases Myelofibrosis (MF) 100% Hint for non-quantifiable additional benefit (Orphan)
Tucatinib Tukysa® Seagen Germany GmbH Oncological diseases Breast cancer (BC) HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine 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 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 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
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 repealed
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 Mantle cell lymphoma (MCL), pretreated 100% Hint for non-quantifiable additional benefit (Orphan)
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 B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+ 100% Hint for non-quantifiable additional benefit (Orphan)
Pertuzumab / Trastuzumab (3) Phesgo® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, metastatic or locally recurrent 100% no additional benefit
Pertuzumab / Trastuzumab (2) Phesgo® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant 100% no additional benefit
Pertuzumab / Trastuzumab Phesgo® Roche Pharma AG Oncological diseases Breast cancer (BC) early stage, HER2+, adjuvant treatment 100% Hint for minor additional benefit repealed
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 Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit (Orphan (turnover limit))
Fenfluramin Fintepla® Zogenix GmbH Nervous system diseases Dravet syndrome, ≥ 2 years 100% Hint for considerable additional benefit (Orphan)
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 Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone 100% no additional benefit (Orphan (turnover limit))
Nivolumab (14) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of esophagus, pretreated patients 36% Hint for minor additional benefit
Afamelanotid (2, reassessment) Scenesse® Clinuvel (UK) Limited Metabolic diseases Erythropoietic protoporphyria 100% Hint for non-quantifiable additional benefit (Orphan)
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 Hyperoxaluria 100% Hint for non-quantifiable additional benefit (Orphan)
Ipilimumab (6) Yervoy® Bristol-Myers Squibb Pharma EEIG Oncological diseases Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy 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 repealed
Sebelipase alfa (2, reassessment) Kanuma® Alexion Pharma Germany GmbH Metabolic diseases Lysosomal acid lipase deficiency 100% Hint for non-quantifiable additional benefit (Orphan)
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 Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit (Orphan (turnover limit))
Guselkumab (2) Tremfya® Janssen-Cilag GmbH Skin diseases Psoriatic arthritis (PA) 100% no additional benefit
Nusinersen (2, reassessment >€50m) Spinraza® Biogen GmbH Nervous system diseases Spinal muscular atrophy (SMA) 19% Indication of major additional benefit (Orphan (turnover limit))
Tezacaftor / Ivacaftor (4) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del) 100% no additional benefit (Orphan (turnover limit))
Tafamidis (4, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid cardiomyopathy 100% Indication of considerable additional benefit (Orphan (turnover limit))
Tafamidis (3, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid Neuropathy 100% no additional benefit (Orphan (turnover limit))
Niraparib (3) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (18) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (17) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation) 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (16) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor (15) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Dapagliflozin (5) Forxiga® AstraZeneca GmbH Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for considerable additional benefit
Crizanlizumab Adakveo® Novartis Pharma GmbH Hematopoietic diseases Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years 100% Hint for minor additional benefit repealed (Orphan)
Amikacin (liposomal) Arikayce® liposomal Insmed Germany GmbH Infectious diseases Mycobacterium Avium Complex (MAC) infection 100% Hint for non-quantifiable additional benefit (Orphan)
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases Hepatocellular carcinoma (HCC), combination with bevacizumab 76% Indication of considerable 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 Gastrointestinal stromal tumor (GIST) 100% Hint for non-quantifiable additional benefit (Orphan)
Burosumab (3) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia (XLH), ≥ 18 years 100% Hint for minor additional benefit repealed (Orphan)
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 Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit (Orphan)
Cannabidiol (3, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit (Orphan)
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 Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab 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 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 Multiple myeloma (MM), at least 4 prior therapies, monotherapy 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Alpelisib Piqray® Novartis Pharma GmbH Oncological diseases Breast cancer (BC) with PIK3CA mutation, pre-treated patients, combination with fulvestrant 41% no additional benefit
Bulevirtid Hepcludex® MYR GmbH Infectious diseases Chronic hepatitis Delta 100% Hint for non-quantifiable additional benefit (Orphan)
Ivacaftor / Tezacaftor / Elexacaftor Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit (Orphan (turnover limit))
Ivacaftor / Tezacaftor / Elexacaftor (2) Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit (Orphan (turnover limit))
Ivacaftor (14) Kalydeco® Vertex Pharmaceuticals Ltd Metabolic diseases Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit (Orphan (turnover limit))
Ivacaftor (13) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit (Orphan (turnover limit))
Entrectinib (2) Rozlytrek® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line 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 Musculoskeletal system diseases Axial spondyloarthritis 100% no additional benefit
Secukinumab (4, reassessment) Cosentyx® Novartis Pharma GmbH Skin diseases Psoriatic arthritis (PA) 35% Indication of minor additional benefit
Glasdegib Daurismo® Pfizer Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML), combination with cytarabine (LDAC) 100% Hint for considerable additional benefit (Orphan)
Nintedanib (5, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Interstitial pulmonary disease with systemic sclerosis 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 Beta thalassemia 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases Myelodysplastic syndrome (MDS) 100% Hint for non-quantifiable additional benefit repealed (Orphan)
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 Endogenous Cushing syndrome 100% Hint for non-quantifiable additional benefit (Orphan)
Ozanimod Zeposia® Celgene GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 90% Indication of minor additional benefit
Caplacizumab (2) Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years 100% Hint for non-quantifiable additional benefit (Orphan)
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 Cystic fibrosis (CF), patients ≥ 6 months to < 18 years 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Tezacaftor / Ivacaftor (3, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del) 100% no additional benefit (Orphan (turnover limit))
Tezacaftor / Ivacaftor (2, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del) 100% no additional benefit (Orphan (turnover limit))
Brentuximab Vedotin (5) Adcetris® Takeda GmbH Oncological diseases Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone 100% Hint for minor additional benefit repealed (Orphan)
Mogamulizumab Poteligeo® Kyowa Kirin GmbH Oncological diseases Mycosis Fungoides; Sézary Syndrome 100% Hint for non-quantifiable additional benefit (Orphan)
Talazoparib Talzenna® Pfizer Pharma GmbH Oncological diseases Breast cancer (BC) BRCA1/2 mutation, HER2- 100% Hint for considerable additional benefit
Ponatinib (3, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Chronic myeloid leukaemia (CML) 100% Hint for non-quantifiable additional benefit (Orphan)
Ponatinib (2, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases Acute myeloid leukaemia (AML) 100% Hint for non-quantifiable additional benefit (Orphan)
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 Acute hepatic porphyria, ≥ 12 years 100% Indication of considerable additional benefit (Orphan)
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 B-cell acute lymphoblastic leukaemia (ALL) 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Tisagenlecleucel (4, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 100% Hint for non-quantifiable additional benefit repealed (Orphan)
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 Chronic thromboembolic pulmonary hypertension 100% no additional benefit (Orphan (turnover limit))
Riociguat (3, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH) 100% no additional benefit (Orphan (turnover limit))
Abemaciclib (3, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 39% Hint for minor additional benefit repealed subpopulations
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid cardiomyopathy 100% Hint for considerable additional benefit repealed (Orphan)
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 Breast cancer (BC) HR+, HER2-, combination with fulvestrant 58% Indication of minor additional benefit
Ribociclib (4, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases Breast cancer (BC) HR+, HER2-, combination with aromatase inhibitor 100% Hint for minor additional benefit
Polatuzumab Vedotin Polivy® Roche Pharma AG Oncological diseases Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab 100% Hint for non-quantifiable additional benefit (Orphan)
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 Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years 100% Hint for non-quantifiable additional benefit (Orphan)
Daratumumab (5) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 100% Hint for minor additional benefit repealed (Orphan (turnover limit))
Daratumumab (4) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone 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 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 Breast cancer (BC) early stage, HER2+, adjuvant treatment 100% Indication of minor additional benefit
Ivacaftor (11) Kalydeco® Vertex Pharmaceuticals Metabolic diseases Cystic fibrosis (CF), ≥ 6 to < 12 months 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Neratinib Nerlynx® Pierre Fabre Pharma Oncological diseases Breast cancer (BC) HR+, HER2+, adjuvant therapy 100% Hint for minor additional benefit
Gilteritinib XOSPATA® Astellas Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML), FLT3 mutation 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 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 Beta thalassemia 100% Hint for non-quantifiable additional benefit (Orphan)
Cannabidiol (2) Epidyolex® GW Pharmaceuticals plc Nervous system diseases Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed (Orphan)
Niraparib (2, reassessment >€50m) Zejula® TESARO Bio Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit repealed (Orphan (turnover limit))
Cannabidiol Epidyolex® GW Pharmaceuticals plc Nervous system diseases Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed (Orphan)
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
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases Metastatic gastric cancer, pre-treated patients 100% Indication of minor additional benefit
Asfotase alfa (2, reassessment >€50m) Strensiq® Alexion Pharma Germany GmbH Metabolic diseases Hypophosphatasia (HPP) 0.8% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Atezolizumab (6) Tecentriq® Roche Pharma AG Oncological diseases Breast cancer (BC), triple-negative, PD-L1 expression ≥1% 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
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 repealed
Burosumab (2, reassessment) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 100% Hint for non-quantifiable additional benefit repealed (Orphan)
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 Cystic fibrosis (CF), 12 ro < 24 months 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor (9, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation 100% Hint for minor additional benefit (Orphan (turnover limit))
Ivacaftor (8, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), patients from 2 to 5 years 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor (7, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), various gating mutations, ≥ 6 years 100% Hint for non-quantifiable additional benefit (Orphan (turnover limit))
Ivacaftor (6, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (5, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit (Orphan (turnover limit))
Ivacaftor (4, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), G551D mutation, ≥ 6 years 86% Hint for considerable additional benefit (Orphan (turnover limit))
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 Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab 26% Hint for minor additional benefit (Orphan (turnover limit))
Ibrutinib (6) Imbruvica® Janssen-Cilag GmbH Oncological diseases Waldenström's disease, combination with rituximab 100% no additional benefit (Orphan (turnover limit))
Volanesorsen Waylivra® Akcea Therapeutics Germany GmbH Metabolic diseases Chylomicronaemia syndrome 100% Hint for non-quantifiable additional benefit (Orphan)
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 Breast cancer (BC) 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 repealed
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 Phenylketonuria 100% Hint for non-quantifiable additional benefit (Orphan)
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 Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone 100% no additional benefit (Orphan (turnover limit))
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 repealed
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 Hereditary retinal dystrophy 100% Hint for considerable additional benefit repealed (Orphan)
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 Idiopathic pulmonary fibrosis 100% Hint for considerable additional benefit (Orphan (turnover limit))
Pembrolizumab (10) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel 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 Hodgkin lymphoma (HL), CD30+, first-line 100% non-quantifiable additional benefit (Orphan)
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 repealed
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 repealed
Rucaparib (2) Rubraca® Clovis Oncology Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy 100% no additional benefit repealed
Blinatumomab (3) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients 100% non-quantifiable additional benefit (Orphan)
Lumacaftor / Ivacaftor (3) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years 100% Hint for non-quantifiable additional benefit repealed
Blinatumomab (4) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years 100% non-quantifiable additional benefit (Orphan)
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 Myotonia 100% non-quantifiable additional benefit (Orphan)
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 Hereditary angioedema (HAE) 100% considerable additional benefit repealed (Orphan)
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 Urea cycle disorders (UCD), 0 to < 2 months 100% non-quantifiable additional benefit (Orphan)
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 Multidrug-resistant pulmonary tuberculosis 100% considerable additional benefit repealed (Orphan)
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 Breast cancer (BC) HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor 100% no additional benefit repealed subpopulations
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 Cystic fibrosis (CF), F508del mutation, ≥ 12 years 91% considerable additional benefit repealed (Orphan)
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 Primary mediastinal large B-cell lymphoma (PMBCL) 100% non-quantifiable additional benefit repealed (Orphan)
Axicabtagen-Ciloleucel Yescarta® Kite, Gilead company Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit repealed (Orphan)
Abemaciclib (2) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast cancer (BC), HR+, HER2-, combination with fulvestrant 100% no additional benefit repealed subpopulations
Abemaciclib Verzenios® Lilly Deutschland GmbH Oncological diseases Breast cancer (BC), HR+, HER2-, combination with aromatase inhibitor 100% no additional benefit repealed subpopulations
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 subpopulations
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 Amyloidosis 100% considerable additional benefit (Orphan)
Inotersen Tegsedi® Akcea Therapeutics Germany GmbH Metabolic diseases Amyloidosis 100% non-quantifiable additional benefit (Orphan)
Metreleptin Myalepta® Aegerion Pharmaceuticals GmbH Metabolic diseases Lipodystrophy 100% non-quantifiable additional benefit (Orphan)
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 Breast cancer (BC), patient population b1 and b2 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 Therapy-related acute myeloid leukaemia (AML); acute myeloid leukaemia (AML) with multilinear dysplasia 100% considerable additional benefit (Orphan)
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 Thrombotic thrombocytopenic purpura (TTP) 100% non-quantifiable additional benefit (Orphan)
Vestronidase alfa Mepsevii® Ultragenyx Germany GmbH Metabolic diseases Mucopolysaccharidosis (MPS VII; Sly syndrome) 100% non-quantifiable additional benefit (Orphan)
Daratumumab (3) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone 100% Hint for considerable additional benefit (Orphan (turnover limit))
Tisagenlecleucel Kymriah® Novartis Pharma GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit repealed (Orphan)
Tisagenlecleucel (2) Kymriah® Novartis Pharma GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 100% non-quantifiable additional benefit repealed (Orphan)
Tofacitinib (4) Xeljanz® Pfizer Pharma GmbH Skin 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 Acute myeloid leukaemia (AML) 100% non-quantifiable additional benefit (Orphan)
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 Breast cancer (BC), early with high risk of recurrence, adjuvant, combination with trastuzumab and chemotherapy 100% Indication of minor additional benefit repealed
Bictegravir / Emtricitabin / Tenofoviralafenamid Biktarvy® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Velmanase alfa Lamzede® Chiesi GmbH Metabolic diseases Alpha mannosidosis 100% non-quantifiable additional benefit (Orphan)
Olaparib (2, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy 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 repealed
Darvadstrocel Alofisel® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases Anal fistulas in Crohn's disease 100% non-quantifiable additional benefit (Orphan)
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 repealed
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 X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 100% non-quantifiable additional benefit repealed (Orphan)
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 Urea cycle disorders (UCD), ≥ 2 months 100% non-quantifiable additional benefit (Orphan)
Ixekizumab (2) Taltz® Lilly Deutschland GmbH Skin 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 Cytomegalovirus infection 100% non-quantifiable additional benefit (Orphan)
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment) Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma resolution w/o assessement
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 Cutaneous T-cell lymphoma, CD30+ 100% minor additional benefit (Orphan)
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 Haematological malignancies, concomitant therapy in haploidentical haematopoietic stem cell transplantation 100% non-quantifiable additional benefit (Orphan)
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 Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% non-quantifiable additional benefit repealed (Orphan)
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 Keratitis 100% non-quantifiable additional benefit (Orphan)
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 Carcinoid tumor, neuroendocrine tumors, combination with SAA therapy 100% non-quantifiable additional benefit (Orphan)
Midostaurin Rydapt® Novartis Pharma GmbH Oncological diseases Acute myeloid leukaemia (AML); Systemic mastocytosis (ASM) 80% considerable additional benefit (Orphan)
Obinutuzumab (3) Gazyvaro® Roche Pharma AG Oncological diseases Follicular lymphoma (FL), first-line 100% non-quantifiable additional benefit repealed (Orphan)
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 Breast cancer (BC) 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 subpopulations
Elosulfase alfa (2, reassessment) Vimizim® BioMarin Deutschland GmbH Metabolic diseases Mucopolysaccharidosis (type IVA) 100% minor additional benefit (Orphan)
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 subpopulations
Avelumab Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Merkel-cell carcinoma (MCC) 100% non-quantifiable additional benefit repealed (Orphan)
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 Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone 100% Hint for considerable additional benefit (Orphan (turnover limit))
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 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 repealed subpopulations (Orphan (turnover limit))
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 B-cell acute lymphoblastic leukaemia (ALL) 100% minor additional benefit (Orphan)
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 Spinal muscular atrophy (SMA) 10% major additional benefit repealed (Orphan)
Cerliponase alfa Brineura® BioMarin Deutschland GmbH Metabolic diseases Neuronal ceroid lipofuscinosis type 2 100% non-quantifiable additional benefit repealed (Orphan)
Blinatumomab (2, reassessment) Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 100% considerable additional benefit (Orphan)
Nivolumab (8, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab 100% no additional benefit repealed
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
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 Biliary cirrhosis 100% non-quantifiable additional benefit (Orphan)
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 Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% non-quantifiable additional benefit repealed (Orphan)
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 Chronic lymphocytic leukaemia (CLL), monotherapy 100% non-quantifiable additional benefit repealed (Orphan)
Palbociclib Ibrance® Pfizer Pharma GmbH Oncological diseases Breast cancer (BC) 100% no additional benefit repealed subpopulations
Olaratumab Lartruvo® Lilly Deutschland GmbH Oncological diseases Soft tissue sarcoma 100% considerable additional benefit repealed (Orphan)
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 Pulmonary arterial hypertension (PAH) 100% no additional benefit (Orphan (turnover limit))
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 Chronic lymphocytic leukaemia (CLL), at least 1 prior therapy, combination with bendamustine and rituximab 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 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 Short bowel syndrome, 1 to < 18 years 100% non-quantifiable additional benefit (Orphan)
Tasimelteon Hetlioz® Vanda Pharmceutical Inc Nervous system diseases Sleep disorders (sleep-wake rhythm), blind adults 100% non-quantifiable additional benefit (Orphan)
Pitolisant Wakix® Bioprojet Pharma SARL Nervous system diseases Narcolepsy 100% non-quantifiable additional benefit (Orphan)
Brentuximab Vedotin (2) Adcetris® Takeda Pharma GmbH Oncological diseases Hodgkin lymphoma (HL), CD30+, increased risk of recurrence or progression after transplantation 100% non-quantifiable additional benefit (Orphan)
Carfilzomib (2) Kyprolis® Amgen GmbH Oncological diseases Multiple myeloma (MM), combination with dexamethasone 100% minor additional benefit repealed (Orphan)
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 Chronic lymphocytic leukemia (CLL), first-line 100% no additional benefit (Orphan (turnover limit))
Sitagliptin / Metformin (2, reassessment) Janumet® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2, monotherapy or combination with sulphonylurea or insulin 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 subpopulations
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 Follicular lymphoma (FL) 100% non-quantifiable additional benefit repealed (Orphan)
Nivolumab (5) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, combination with ipilimumab 100% no additional benefit repealed subpopulations
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 Hemophilia B 100% non-quantifiable additional benefit repealed (Orphan)
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 Hemophilia B 100% non-quantifiable additional benefit repealed (Orphan)
Migalastat Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease 100% non-quantifiable additional benefit (Orphan)
Elotuzumab Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% Hint for minor additional benefit
Ataluren (2, reassessment) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 100% minor additional benefit (Orphan)
Daratumumab Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma (MM), monotherapy, pre-treated patients 100% non-quantifiable additional benefit repealed (Orphan)
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 subpopulations
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 repealed
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 Erythropoietic protoporphyria 100% non-quantifiable additional benefit repealed (Orphan)
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 Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), Waldenström's disease 12% Indication of considerable additional benefit (Orphan (turnover limit))
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 subpopulations
Blinatumomab Blincyto® Amgen GmbH Oncological diseases B-cell acute lymphoblastic leukaemia (ALL) 100% non-quantifiable additional benefit repealed (Orphan)
Carfilzomib Kyprolis® Amgen GmbH Oncological diseases Multiple myeloma (MM), at least 1 prior therapy, combination with dexamethasone or lenalidomide and dexamethasone 100% non-quantifiable additional benefit repealed (Orphan)
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 Cystic fibrosis (CF), R117H mutation, 2 to 5 years, > 18 years 75% minor additional benefit repealed (Orphan)
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 100% no additional benefit
Fingolimod (4) Gilenya® Novartis Pharma GmbH Nervous system diseases Highly active relapsing-remitting multiple sclerosis (MS), after inadequate pre-treatment 100% no additional benefit
Alirocumab Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolemia or mixed dyslipidaemia 100% no additional benefit repealed subpopulations
Isavuconazol Cresemba® Basilea Pharmaceutica International Ltd. Infectious diseases Aspergillosis, mucormycosis 100% non-quantifiable additional benefit (Orphan)
Aclidiniumbromid (2, reassessment) Eklira® Genuair® AstraZeneca GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 5% Indication of considerable additional benefit
Trametinib Mekinist® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation 50% Indication of considerable additional benefit
Sebelipase alfa Kanuma® Synageva BioPharma Limited Metabolic diseases Lysosomal acid lipase deficiency 100% non-quantifiable additional benefit repealed (Orphan)
Regorafenib (3, reassessment) Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 100% no additional benefit
Pomalidomid (2, reassessment >€50m) Imnovid® Celgene GmbH Oncological diseases Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone 50% Hint for considerable additional benefit (Orphan (turnover limit))
Panobinostat Farydak® Novartis Pharma GmbH Oncological diseases Multiple myeloma (MM), at least 1 prior therapy, combination with pomalidomide and dexamethasone 100% non-quantifiable additional benefit (Orphan)
Idebenon Raxone® Santhera Pharmaceuticals Eye diseases Leber hereditary optic neuropathy 100% non-quantifiable additional benefit repealed (Orphan)
Dabrafenib (2) Tafinlar® Novartis Pharma GmbH Oncological diseases Melanoma, BRAF V600 mutation, combination with trametinib 100% Indication of considerable additional benefit
Asfotase alfa Strensiq® Alexion Europe SAS Metabolic diseases Hypophosphatasia (HPP) 100% non-quantifiable additional benefit repealed (Orphan)
Evolocumab Repatha® Amgen GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 100% no additional benefit repealed subpopulations
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 100% no additional benefit
Insulin degludec / Liraglutid (2) Xultophy® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2, combination with oral antidiabetics 100% no additional benefit
Tiotropium / Olodaterol Spiolto® Respimat® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 92% Indication of minor additional benefit
Pembrolizumab Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma 71% Indication of considerable additional benefit
Netupitant / Palonosetron Akynzeo® RIEMSER Pharma GmbH Other diseases Nausea and vomiting due to chemotherapy 100% no additional benefit
Nivolumab (2) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy 87% Indication of considerable additional benefit
Gaxilose LacTest™ VENTER PHARMA S.L. Metabolic diseases Diagnosis of hypolactasia 100% no additional benefit
Edoxaban Lixiana® Daiichi Sankyo Deutschland GmbH Cardiovascular diseases Prophylaxis of thromboembolic events 81% Indication of minor additional benefit
Nivolumab Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma 15% Indication of considerable additional benefit
Belatacept (2, reassessment) Nulojix® Bristol-Myers Squibb GmbH & Co. KGaA Genitourinary system diseases Prophylaxis of graft rejection (GvHD) after kidney transplantation 100% Indication of considerable additional benefit
Lenvatinib Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 100% non-quantifiable additional benefit repealed (Orphan)
Ceritinib Zykadia® Novartis Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib 100% no additional benefit repealed
Lomitapid (2, reassessment) Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases Hypercholesterolemia 100% no additional benefit
Secukinumab Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP) 8% Indication of considerable additional benefit repealed subpopulations
Olaparib Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, platinum-sensitive, maintenance therapy 100% non-quantifiable additional benefit repealed (Orphan)
Ivermectin Soolantra® Galderma Laboratorium GmbH Skin diseases Inflammatory lesions of rosacea 100% no additional benefit
Afatinib (2, reassessment) Giotrif® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients 42% Indication of major additional benefit
Safinamid Xadago® Zambon S.p.A. Nervous system diseases Morbus Parkinson 100% no additional benefit
Vortioxetin Brintellix® Lundbeck GmbH Mental illnesses Major depression 100% no additional benefit
Insulin degludec / Liraglutid Xultophy® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Ruxolitinib (3) Jakavi® Novartis Pharma GmbH Oncological diseases Polycythaemia vera 100% Hint for considerable additional benefit (Orphan (turnover limit))
Fingolimod (3, reassessment) Gilenya® Novartis Pharma GmbH Nervous system diseases Rapidly progressing relapsing-remitting multiple sclerosis (MS) 21% Indication of considerable additional benefit repealed subpopulations
Eliglustat Cerdelga® Genzyme GmbH Metabolic diseases Sphingolipidoses (Gaucher disease type 1) 100% non-quantifiable additional benefit (Orphan)
Aflibercept (5) Eylea® Bayer Vital GmbH Eye diseases Macular edema following retinal branch vein occlusion 100% no additional benefit
Nintedanib (2, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Idiopathic pulmonary fibrosis 100% minor additional benefit repealed (Orphan)
Insulin degludec (3) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 1 and type 2, ≥ 1 to < 18 years 100% no additional benefit
Apremilast Otezla® Celgene GmbH Skin diseases Plaque psoriasis (PP); Psoriatic arthritis (PA) 100% no additional benefit
Ombitasvir / Paritaprevir / Ritonavir Viekirax® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 9% Indication of considerable additional benefit
Ramucirumab Cyramza® Lilly Deutschland GmbH Oncological diseases Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel 100% minor additional benefit repealed (Orphan)
Dasabuvir Exviera® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C 24% Indication of considerable additional benefit
Dulaglutid Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 30% Hint for minor additional benefit repealed
Aclidiniumbromid / Formoterol Duaklir® Genuair® AstraZeneca GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 5% Indication of considerable additional benefit
Pasireotid (2) Signifor® Novartis Pharma GmbH Metabolic diseases Acromegaly 100% minor additional benefit (Orphan)
Nintedanib Vargatef® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases Non-small cell lung carcinoma (NSCLC) 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 100% Indication of considerable additional benefit
Tafluprost / Timolol Taptiqom® Santen GmbH Eye diseases Reduction of intraocular pressure in patients with glaucoma/hypertension 100% no additional benefit
Ataluren Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 100% minor additional benefit repealed (Orphan)
Vildagliptin (2, reassessment) Galvus® Novartis Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Ledipasvir / Sofosbuvir Harvoni® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 79% Hint for considerable additional benefit
Alipogentiparvovec Glybera® Chiesi GmbH Metabolic diseases Familial lipoprotein lipase deficiency 100% non-quantifiable additional benefit (Orphan)
Simoctocog alfa Nuwiq® Octapharma GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Lurasidon Latuda® Takeda Pharma GmbH Mental illnesses Schizophrenia 100% no additional benefit
Ibrutinib Imbruvica® Janssen-Cilag GmbH Oncological diseases Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL) 100% non-quantifiable additional benefit repealed (Orphan)
Albiglutid Eperzan® GlaxoSmithKline GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 35% Indication of minor additional benefit
Dolutegravir / Abacavir / Lamivudin Triumeq® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 9% Indication of considerable additional benefit
Sucroferric Oxyhydroxide Velphoro® Fresenius Medical Care Deutschland GmbH Genitourinary system diseases Serum phosphate level control in chronic kidney disease 100% no additional benefit
Sipuleucel-T Provenge® Dendreon UK Limited Oncological diseases Prostate carcinoma (PC) 100% Hint for non-quantifiable additional benefit
Idelalisib Zydelig® Gilead Sciences GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), Follicular lymphoma (FL) 20% Hint for non-quantifiable additional benefit repealed subpopulations
Aflibercept (4) Eylea® Bayer Vital GmbH Eye diseases Diabetic macular edema 100% no additional benefit
Teduglutid Revestive® NPS Pharma Germany GmbH Digestive system diseases Short bowel syndrome 100% minor additional benefit (Orphan)
Daclatasvir Daklinza® Bristol-Myers Squibb GmbH & Co. KGaA Infectious diseases Chronic hepatitis C 1.4% Hint for considerable additional benefit
Regorafenib (2) Stivarga® Bayer Vital GmbH Oncological diseases Gastrointestinal stromal tumor (GIST) 100% no additional benefit
Propranolol Hemangiol® Pierre Fabre Dermatologie Other diseases Infantile hemangioma 33% Indication of major additional benefit
Nalmefen Selincro® Lundbeck GmbH Mental illnesses Reduction of alcohol consumption in alcohol dependence 100% no additional benefit
Ivacaftor (2) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases Cystic fibrosis (CF), various mutations, ≥ 6 years 100% minor additional benefit repealed (Orphan)
Apixaban (3) Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases Treatment and prophylaxis of venous thrombosis and pulmonary embolism 47% Indication of minor additional benefit
Obinutuzumab Gazyvaro® Roche Pharma AG Oncological diseases Chronic lymphocytic leukemia (CLL) 100% non-quantifiable additional benefit repealed (Orphan)
Empagliflozin Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Canagliflozin / Metformin Vokanamet® Janssen-Cilag GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Cabozantinib Cometriq® Swedish Orphan Biovitrum GmbH Oncological diseases Thyroid carcinoma (MTC) 100% minor additional benefit repealed (Orphan)
Eribulin (2, reassessment) Halaven® Eisai GmbH Oncological diseases Breast cancer (BC), after at least 2 chemotherapies; mammary carcinoma, after at least 1 chemotherapy 75% Hint for considerable additional benefit
Umeclidinium / Vilanterol Anoro® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Vedolizumab Entyvio® Takeda Pharma Vertrieb GmbH & Co. KG Digestive system diseases Ulcerative colitis, Crohn's disease 100% no additional benefit
Fingolimod (2) Gilenya® Novartis Pharma GmbH Nervous system diseases Multiple sclerosis (MS), pre-treated 100% no additional benefit repealed
Siltuximab Sylvant® Janssen-Cilag GmbH Oncological diseases Multicentric Castleman Disease (MCD) 100% non-quantifiable additional benefit (Orphan)
Insulin degludec (2) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2, combination with GLP-1 agonists 100% no additional benefit repealed
Simeprevir Olysio® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 91% Indication of considerable additional benefit
Elosulfase alfa Vimizim® BioMarin Deutschland GmbH Metabolic diseases Mucopolysaccharidosis (type IVA) 100% minor additional benefit repealed (Orphan)
Mirabegron Betmiga® Astellas Pharma GmbH Genitourinary system diseases Imperative desire to urinate 100% no additional benefit
Lebende Larven von Lucilia sericata BioBag® BioMonde GmbH Other diseases Chronic or hard to heal wounds 100% no additional benefit
Perampanel (2, reassessment) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 100% no additional benefit
Cholsäure Orphacol® Laboratoires CTRS Metabolic diseases Bile acid synthesis disorder 100% non-quantifiable additional benefit (Orphan)
Ruxolitinib (2, reassessment >€50m) Jakavi® Novartis Pharma GmbH Oncological diseases Myelofibrosis (MF) 100% Hint for considerable additional benefit (Orphan (turnover limit))
Dimethylfumarat Tecfidera® Biogen GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 100% no additional benefit
Insulin degludec Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 1 and type 2 100% no additional benefit repealed subpopulations
Riociguat Adempas® Bayer Vital GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTPH) 100% minor additional benefit repealed (Orphan)
Cobicistat Tybost® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Canagliflozin Invokana® Janssen-Cilag GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Dapagliflozin / Metformin Xigduo® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Dolutegravir Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 11% Proof of considerable additional benefit
Olodaterol Striverdi® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 100% no additional benefit
Sofosbuvir Sovaldi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C 4% Indication of considerable additional benefit
Macitentan Opsumit® Actelion Pharmaceuticals Deutschland GmbH Cardiovascular diseases Pulmonary arterial hypertension (PAH) 100% minor additional benefit repealed (Orphan)
Retigabin (3, reassessment) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 100% no additional benefit
Turoctocog alfa NovoEight® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Trastuzumab Emtansin Kadcyla® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, pre-treated patients 72% Indication of considerable additional benefit
Radium-223-dichlorid Xofigo® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC) 78% Indication of considerable additional benefit repealed
Emtricitabin / Rilpivirin / Tenofovirdisoproxil (2) Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Lomitapid Lojuxta® Aegerion Pharmaceuticals GmbH Metabolic diseases Hypercholesterolemia 100% no additional benefit repealed
Ipilimumab (2) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, first-line 100% no additional benefit
Afatinib Giotrif® Boehringer Ingelheim Pharma GmbH & Co. KG Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, EGFR-TKI-naive patients 44% Indication of considerable additional benefit repealed
Indacaterol / Glycopyrronium Ultibro Breezhaler® Novartis Pharma GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 5% Indication of minor additional benefit
Dabrafenib Tafinlar® GlaxoSmithKline GmbH & Co. KG Oncological diseases Melanoma, BRAF V600 mutation 100% no additional benefit
Teriflunomid Aubagio® sanofi-aventis groupe / Genzyme GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 100% no additional benefit
Regorafenib Stivarga® Bayer Vital GmbH Oncological diseases Colorectal carcinoma (CRC) 100% Hint for minor additional benefit repealed
Aflibercept (3) Eylea® Bayer Vital GmbH Eye diseases Macular edema following retinal vein occlusion 100% no additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat Relvar® Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, COPD 100% no additional benefit
Vemurafenib (2, reassessment) Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 100% Indication of considerable additional benefit
Pomalidomid Imnovid® Celgene GmbH Oncological diseases Multiple myeloma (MM), at least 2 prior therapies, combination with dexamethasone 100% considerable additional benefit repealed (Orphan)
Enzalutamid Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy 100% Indication of considerable additional benefit
Vismodegib Erivedge® Roche Pharma AG Oncological diseases Basal cell carcinoma (BCC) 95% Hint for minor additional benefit repealed
Ponatinib Iclusig® ARIAD Pharmaceuticals (Germany) GmbH Oncological diseases Chronic myeloid leukaemia (CML); acute lymphoblastic leukaemia (ALL), Ph+ or T315I mutation 100% non-quantifiable additional benefit repealed (Orphan)
Nepafenac Nevanac® Alcon Pharma GmbH Eye diseases Postoperative pain after eye surgery 100% no additional benefit
Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil Stribild® Gilead Sciences GmbH Infectious diseases HIV infection 100% no additional benefit
Lisdexamfetamindimesilat Elvanse® Shire Deutschland GmbH Mental illnesses Attention deficit hyperactivity disorder (ADHD), ≥ 6 to < 18 100% no additional benefit
Ocriplasmin Jetrea® ThromboGenics NV / Alcon Pharma GmbH Eye diseases Vitreomacular traction (VMT) 95% Hint for considerable additional benefit repealed
Linaclotid Constella® Almirall Hermal GmbH Digestive system diseases Irritable bowel syndrome (IBS) 100% no additional benefit
Bosutinib Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML) 100% non-quantifiable additional benefit repealed (Orphan)
Vildagliptin Galvus® Novartis Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed subpopulations
Vildagliptin / Metformin Eucreas® Novartis Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Sitagliptin / Metformin Janumet® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2 78% Hint for minor additional benefit repealed
Sitagliptin Januvia® MSD Sharp & Dohme GmbH Metabolic diseases Diabetes mellitus type 2 64% Hint for minor additional benefit repealed
Saxagliptin / Metformin (2) Komboglyze® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, combination with sulphonylurea 100% no additional benefit
Saxagliptin Onglyza® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2, combination therapy 49% Hint for minor additional benefit repealed
Pertuzumab Perjeta® Roche Pharma AG Oncological diseases Breast cancer (BC) HER2+, combination with trastuzumab and docetaxel 33% Hint for considerable additional benefit
Colestilan BindRen® Mitsubishi Pharma Deutschland GmbH Other diseases Hyperphosphatemia 100% no additional benefit
Vandetanib (2, reassessment) Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 100% Hint for minor additional benefit repealed
Lixisenatid Lyxumia® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Aflibercept (2, Zaltrap®) Zaltrap® Sanofi-Aventis Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC) 100% Indication of minor additional benefit
Ingenolmebutat Picato® LEO Pharma GmbH Skin diseases Actinic keratosis (AK) 100% no additional benefit repealed
Fidaxomicin Dificlir® Astellas Pharma GmbH Infectious diseases Clostridium difficile infections 41% Proof of considerable additional benefit
Abirateronacetat (2) Zytiga® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), after androgen deprivation therapy, no indication for chemotherapy 100% Indication of considerable additional benefit
Apixaban (2) Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases Prophylaxis of strokes and systemic embolisms 100% Indication of minor additional benefit
Dapagliflozin Forxiga® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Aflibercept Eylea® Bayer Vital GmbH Eye diseases Neovascular age-related macular degeneration 100% no additional benefit
Pixantron Pixuvri® CTI Life Sciences Ltd. Oncological diseases B-Cell Non-Hodgkin Lymphoma (NHL) 100% no additional benefit
Linagliptin (3) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Brentuximab Vedotin Adcetris® Takeda Pharma Vertrieb GmbH & Co. KG Oncological diseases Hodgkin lymphoma (HL), CD30+; Systemic anaplastic large cell lymphoma 100% non-quantifiable additional benefit (Orphan)
Saxagliptin / Metformin Komboglyze® Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 85% Hint for minor additional benefit repealed
Decitabin Dacogen® Janssen-Cilag GmbH Oncological diseases Acute myeloid leukaemia (AML) 100% minor additional benefit (Orphan)
Crizotinib Xalkori® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 71% Hint for considerable additional benefit repealed
Axitinib Inlyta® Pfizer Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), after failure of sunitinib or a cytokine theryapy 0.7% Indication of minor additional benefit repealed
Aclidiniumbromid Eklira® Genuair® Almirall Hermal GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 100% no additional benefit repealed
Ruxolitinib Jakavi® Novartis Pharma GmbH Oncological diseases Myelofibrosis (MF) 100% minor additional benefit repealed (Orphan)
Perampanel Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 100% no additional benefit repealed
Linagliptin (2, reassessment) Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Ivacaftor Kalydeco® Vertex Pharmaceuticals GmbH Metabolic diseases Cystic fibrosis (CF), G551D mutation, ≥ 6 years 84% considerable additional benefit repealed (Orphan)
Tegafur / Gimeracil / Oteracil Teysuno® Nordic Pharma GmbH Oncological diseases Gastric carcinoma 100% no additional benefit
Pasireotid Signifor® Novartis Pharma GmbH Metabolic diseases Pituitary dysfunction 100% minor additional benefit (Orphan)
Vemurafenib Zelboraf® Roche Pharma AG Oncological diseases Melanoma, BRAF V600 mutation 100% Indication of considerable additional benefit repealed
Vandetanib Caprelsa® AstraZeneca GmbH Oncological diseases Thyroid carcinoma (MTC) 100% no additional benefit repealed
Ipilimumab Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, second-line 100% Indication of considerable additional benefit
Belimumab Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 100% Indication of considerable additional benefit
Fampridin Fampyra® Biogen GmbH Nervous system diseases Multiple sclerosis (MS) 100% no additional benefit
Belatacept Nulojix® Bristol-Myers Squibb GmbH & Co. KGaA Genitourinary system diseases Prophylaxis of graft rejection (GvHD) after kidney transplantation 100% Indication of minor additional benefit repealed
Emtricitabin / Rilpivirin / Tenofovirdisoproxil Eviplera® Gilead Sciences GmbH Infectious diseases HIV infection, pre-treated patients 100% Proof of minor additional benefit
Rilpivirin Edurant® Janssen-Cilag GmbH Infectious diseases HIV infection 100% Proof of minor additional benefit
Extrakt aus Cannabis Sativa Sativex® Almirall Hermal GmbH Nervous system diseases Multiple sclerosis (MS), spasticity 100% Hint for minor additional benefit repealed
Tafamidis Vyndaqel® Pfizer Pharma GmbH Metabolic diseases Amyloid Neuropathy 100% minor additional benefit repealed (Orphan)
Apixaban Eliquis® Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH Cardiovascular diseases Prophylaxis of venous thromboembolism 58% Indication of minor additional benefit
Aliskiren / Amlodipin Rasilamlo® Novartis Pharma GmbH Cardiovascular diseases Essential hypertension, add-on therapy 100% no additional benefit
Retigabin Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 100% no additional benefit repealed
Eribulin Halaven® Eisai GmbH Oncological diseases Breast cancer (BC) after at least 2 chemotherapies 80% Hint for minor additional benefit repealed
Collagenase aus Clostridium histolyticum Xiapex® Pfizer Pharma GmbH Musculoskeletal system diseases Dupuytren's contracture 100% no additional benefit
Telaprevir Incivo® Janssen-Cilag GmbH Infectious diseases Chronic hepatitis C 100% Indication of non-quantifiable additional benefit
Regadenoson Rapiscan® Rapidscan Pharma Solutions EU Ltd. Other diseases Myocardial perfusion imaging 100% no additional benefit
Fingolimod Gilenya® Novartis Pharma GmbH Nervous system diseases Rapidly progressing relapsing-remitting multiple sclerosis (MS) 18% Hint for minor additional benefit repealed
Cabazitaxel Jevtana® Sanofi-Aventis Deutschland GmbH Oncological diseases Prostate carcinoma (PC), docetaxel pre-treatment, combination with prednisone or prednisolone 85% Indication of minor additional benefit
Linagliptin Trajenta® Boehringer Ingelheim International GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit repealed
Abirateronacetat Zytiga® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), progression during or after docetaxel-containing chemotherapy, combination with prednisone or prednisolone 85% Indication of considerable additional benefit
Azilsartan Medoxomil Edarbi® Takeda Pharma GmbH Cardiovascular diseases Arterial hypertension 100% no additional benefit
Pirfenidon Esbriet® InterMune Deutschland GmbH Respiratory system diseases Idiopathic pulmonary fibrosis 100% non-quantifiable additional benefit (Orphan)
Boceprevir Victrelis® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 100% Indication of non-quantifiable additional benefit
Bromfenac Yellox® Bausch & Lomb / Dr. Mann Pharma Eye diseases Postoperative inflammation of the eye 100% no additional benefit
Ticagrelor Brilique® AstraZeneca GmbH Cardiovascular diseases Prevention of atherothrombotic events in acute coronary syndrome 82% Proof of considerable additional benefit
Pitavastatin Livazo® Merckle Recordati GmbH Metabolic diseases Primary hypercholesterolaemia, mixed dyslipidaemia 100% no additional benefit