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