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

Start Resolution Procedure (no.) Brand name Pharm. company Therapeutic area Indication Additional benefit (best subpopulation)
Avapritinib (2) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases ORPHAN Leukaemia, myeloid, acute (AML); mastocytosis; after at least 1 previous therapy 100% Hint for non-quantifiable additional benefit
Somatrogon Ngenla® Pfizer Pharma GmbH Metabolic diseases ORPHAN Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age 100% Hint for non-quantifiable additional benefit
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 ORPHAN Hereditary retinal dystrophy 100% Hint for considerable additional benefit
Pegcetacoplan Aspaveli® Swedish Orphan Biovitrum GmbH Hematopoietic diseases ORPHAN Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients 100% Hint for non-quantifiable additional benefit
Idebenon (2, reassessment) Raxone® Chiesi GmbH Eye diseases ORPHAN Leber's hereditary optic neuropathy (LHOP) 100% Hint for non-quantifiable additional benefit
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 ORPHAN Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 100% Proof of considerable additional benefit
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 ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (9) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (8) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor) 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (7) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (6) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation) 100% Indication of considerable additional benefit
Ivacaftor (26) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit
Ivacaftor (25) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit
Ivacaftor (24) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor). 100% no additional benefit
Ivacaftor (23) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit
Ivacaftor (22) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN 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
Avacopan Tavneos® Vifor Pharma Deutschland GmbH Musculoskeletal system diseases ORPHAN Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide 100% Hint for minor additional benefit
Sotorasib Lumykras® Amgen Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies 100% no additional benefit
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 ORPHAN X-linked hypophosphatemia, ≥ 18 years of age 100% no additional benefit
Burosumab (4, reassessment >€50m) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia, ≥ 1 to < 18 years of age 100% Hint for non-quantifiable additional benefit
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 ORPHAN Multiple myeloma (MM), at least 3 previous therapies 100% Hint for non-quantifiable additional benefit
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 ORPHAN Gastrointestinal stromal tumours (GIST), ≥ 3 prior therapies 100% Hint for major additional benefit
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 Mammary carcinoma (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
Lusutrombopag Mulpleo® Shionogi GmbH Hematopoietic diseases Thrombocytopenia in chronic liver disease 100% no additional benefit
Sacituzumab Govitecan Trodelvy® Gilead Sciences GmbH Oncological diseases Mammary carcinoma (BC), triple-negative, after 2 previous therapies 100% Indication of major additional benefit
Risankizumab (2) Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriatic arthritis (PA), monotherapy or combination with methotrexate 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 ORPHAN Multidrug-resistant pulmonary tuberculosis (TBC), ≥ 10 kg 100% Hint for non-quantifiable additional benefit
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 Mammary carcinoma (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 ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with lenalidomide and dexamethasone 100% Hint for non-quantifiable additional benefit
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 ORPHAN Hemophilia B, congenital factor IX deficiency 100% no additional benefit
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
Vandetanib (4, reassessment) Caprelsa® Sanofi-Aventis Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC) 100% no additional benefit
Vosoritid Voxzogo® BioMarin International Limited Other diseases ORPHAN Achondroplasia, ≥ 2 years 100% Hint for non-quantifiable additional benefit
Daratumumab (8, reassessment) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 100% Hint for considerable additional benefit
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
Solriamfetol (2) Sunosi® Jazz Pharmaceuticals Ireland Nervous system diseases Daytime sleepiness in obstructive sleep apnoea, after previous therapy 100% no additional benefit
Vericiguat Verquvo® Bayer Vital GmbH Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for minor additional benefit
Bimekizumab Bimzelx® UCB Pharma GmbH Skin diseases Plaque psoriasis (PP) 100% Indication of minor additional benefit
Roxadustat Evrenzo® Astellas Pharma GmbH Hematopoietic diseases Symptomatic anemia in chronic kidney disease (CKD) 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
Tafasitamab Minjuvi® Incyte Biosciences Germany Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide 100% Hint for non-quantifiable additional benefit
Odevixibat Bylvay® Albireo Pharma AB Digestive system diseases ORPHAN Cholestasis, ≥ 6 months 100% Hint for minor additional benefit
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 ORPHAN Fabry disease, 12 to < 16 years 100% Hint for non-quantifiable additional benefit
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 ORPHAN Neurofibromatosis (type 1), ≥ 3 to < 18 years 100% Hint for non-quantifiable additional benefit
Daratumumab (7) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason 38% Hint for minor additional benefit
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 ORPHAN B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years 100% Indication of major additional benefit
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 ORPHAN Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone 50% Hint for minor additional benefit
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
Imipenem / Cilastatin / Relebactam Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Pneumonia, Bacteriemia resolution w/o assessement
Satralizumab Enspryng® Roche Pharma AG Nervous system diseases ORPHAN Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years 100% Hint for minor additional benefit
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 ORPHAN Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone 100% Hint for minor additional benefit
Cabozantinib (7, reassessment) Cometriq® Ipsen Pharma GmbH Oncological diseases ORPHAN Thyroid carcinoma (MTC) 100% Hint for non-quantifiable additional benefit
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 ORPHAN Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line 100% Hint for non-quantifiable additional benefit
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 ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation). 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (4) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (3) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)). 100% no additional benefit
Ivacaftor (21) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN 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
Ivacaftor (20) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
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
Ivacaftor (19) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN 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
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 ORPHAN Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 100% no additional benefit
Onasemnogen-​Abeparvovec Zolgensma® Novartis Gene Therapies EU Limited Nervous system diseases ORPHAN 5q-associated spinal muscular atrophy (SMA) 100% no additional benefit
Obinutuzumab (6, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL), first-line 100% no additional benefit
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Chronic lymphocytic leukemia (CLL) 100% no additional benefit
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL) 100% no additional benefit
Cannabidiol (5) Epidyolex® GW Pharmaceuticals plc Other diseases ORPHAN Seizures in Tuberous Sclerosis, ≥ 2 years 100% Hint for non-quantifiable additional benefit
Atidarsagen autotemcel OTL-200 Libmeldy® Orchard Therapeutics GmbH Metabolic diseases ORPHAN Metachromatic leukodystrophy with biallelic mutation in the ARSA gene 50% Hint for major additional benefit
Cabotegravir Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pre-treated, combination with rilpivirin 100% no additional benefit
Erenumab (2, reassessment) Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis 100% Hint for considerable additional benefit
Risdiplam Evrysdi® Roche Pharma AG Nervous system diseases ORPHAN 5q-associated spinal muscular atrophy (SMA) 42% Hint for non-quantifiable additional benefit
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 ORPHAN Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy 100% Hint for non-quantifiable additional benefit
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 ORPHAN Multidrug-resistant pulmonary tuberculosis, 5 to 11 years 100% Hint for non-quantifiable additional benefit
Imlifidase Idefirix® Hansa Biopharma AB Other diseases ORPHAN Desensitisation in kidney transplantation 100% Hint for non-quantifiable additional benefit
Fedratinib Inrebic® Celgene GmbH Oncological diseases ORPHAN Myelofibrosis (MF) 100% Hint for non-quantifiable additional benefit
Tucatinib Tukysa® Seagen Germany GmbH Oncological diseases Mammary carcinoma, HER2+, at least 2 previous therapies, combination with trastuzumab and capecitabine 100% Hint for considerable additional benefit
Selpercatinib Retsevmo® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), RET fusion+, after platinum-based chemotherapy and/or immunotherapy 100% no additional benefit
Selpercatinib (2) Retsevmo® Lilly Deutschland GmbH Oncological diseases Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years 100% no additional benefit
Selpercatinib (3) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy 100% no additional benefit
Avelumab (4) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Urothelial carcinoma (UC), first-line 100% Hint for considerable additional benefit
Esketamin (2) Spravato® Janssen-Cilag GmbH Mental illnesses Depression, therapy resistant, combination with SSRI or SNRI 100% no additional benefit
Esketamin Spravato® Janssen-Cilag GmbH Mental illnesses Depression, acute treatment, combination therapy 100% Hint for minor additional benefit
Beclometason / Formoterol / Glycopyrronium Trimbow® Chiesi GmbH Respiratory system diseases Asthma 100% no additional benefit
Baloxavir marboxil (2) Xofluza® Roche Pharma AG Infectious diseases Influenza prophylaxis, ≥ 12 years 58% Indication of considerable additional benefit
Baloxavir marboxil Xofluza® Roche Pharma AG Infectious diseases Influenza, ≥ 12 years 100% no additional benefit
Autologe Anti-CD19-transduzierte CD3-positive Zellen Tecartus® Gilead Sciences GmbH Oncological diseases ORPHAN Mantle cell lymphoma (MCL), pretreated 100% Hint for non-quantifiable additional benefit
Acalabrutinib (3) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), at least 1 pretreatment 40% Hint for considerable additional benefit
Blinatumomab (5) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia, relapsed or refractory, Ph+ CD19+ 100% Hint for non-quantifiable additional benefit
Pertuzumab / Trastuzumab (3) Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, HER2+, metastatic or locally recurrent 100% no additional benefit
Pertuzumab / Trastuzumab (2) Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant 100% no additional benefit
Pertuzumab / Trastuzumab Phesgo® Roche Pharma AG Oncological diseases Mammary carcinoma, early stage, HER2+, adjuvant treatment 100% Hint for minor additional benefit
Levofloxacin / Dexamethason Ducressa® Santen GmbH Eye diseases Infections and inflammations associated with cataract surgery 100% no additional benefit
Dolutegravir (3) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV-Infection, children ≥ 4 weeks to < 6 years 100% no additional benefit
Niraparib (4, reassessment) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit
Fenfluramin Fintepla® Zogenix GmbH Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years 100% Hint for considerable additional benefit
Inclisiran Leqvio® Novartis Pharma GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Upadacitinib (3) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Psoriasis arthritis (PA) 69% Hint for considerable additional benefit
Upadacitinib (2) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Ankylosing spondylitis 100% no additional benefit
Carfilzomib (4) Kyprolis® Amgen GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with daratumumab and dexamethasone 100% no additional benefit
Nivolumab (14) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of esophagus, pretreated patients 36% Hint for minor additional benefit
Afamelanotid (2, reassessment) Scenesse® Clinuvel (UK) Limited Metabolic diseases ORPHAN Erythropoietic protoporphyria 100% Hint for non-quantifiable additional benefit
Dupilumab (5) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD), 6 to 11 years 100% Hint for non-quantifiable additional benefit
Lenvatinib (5, reassessment, Kisplyx®) Kisplyx® Eisai GmbH Oncological diseases Renal cell carcinoma (RCC) 100% no additional benefit
Lumasiran Oxlumo® Alnylam Germany GmbH Metabolic diseases ORPHAN Hyperoxaluria 100% Hint for non-quantifiable additional benefit
Ipilimumab (6) Yervoy® Bristol-Myers Squibb Pharma EEIG Oncological diseases Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy 73% Indication of minor additional benefit
Nivolumab (13) Opdivo® Bristol-Myers Squibb Pharma EEIG Oncological diseases Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line 73% Indication of minor additional benefit
Perampanel (5) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years 100% no additional benefit
Perampanel (4) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years 100% no additional benefit
Sucroferric Oxyhydroxide (2) Velphoro® Fresenius Medical Care Deutschland GmbH Genitourinary system diseases Serum phosphate level control in chronic kidney disease, ≥ 2 to 18 years 100% no additional benefit
Olaparib (7) Lynparza® AstraZeneca GmbH Oncological diseases Pancreatic adenocarcinoma (AC), BRCA1/2 mutations, maintenance therapy 100% no additional benefit
Olaparib (6) Lynparza® AstraZeneca GmbH Oncological diseases Prostate carcinoma (PC), BRCA1/2 mutations, progression after hormonal treatment 100% Hint for considerable additional benefit
Olaparib (5) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab 100% no additional benefit
Sebelipase alfa (2, reassessment) Kanuma® Alexion Pharma Germany GmbH Metabolic diseases ORPHAN Lysosomal acid lipase deficiency 100% Hint for non-quantifiable additional benefit
Acalabrutinib (2) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, first-line 25% Hint for minor additional benefit
Acalabrutinib Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL); monotherapy, first-line 25% Hint for minor additional benefit
Tezacaftor / Ivacaftor (5) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
Guselkumab (2) Tremfya® Janssen-Cilag GmbH Skin diseases Psoriatic arthritis (PA) 100% no additional benefit
Nusinersen (2, reassessment >€50m) Spinraza® Biogen GmbH Nervous system diseases ORPHAN Spinal muscular atrophy (SMA) 19% Indication of major additional benefit
Tezacaftor / Ivacaftor (4) Symkevi® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del) 100% no additional benefit
Tafamidis (4, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases ORPHAN Amyloid cardiomyopathy 100% Indication of considerable additional benefit
Tafamidis (3, reassessment >€50m) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases ORPHAN Amyloid Neuropathy 100% no additional benefit
Niraparib (3) Zejula® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy 100% no additional benefit
Ivacaftor (18) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation) 100% no additional benefit
Ivacaftor (17) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation) 100% no additional benefit
Ivacaftor (16) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation 100% Hint for non-quantifiable additional benefit
Ivacaftor (15) Kalydeco® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations 100% Hint for non-quantifiable additional benefit
Dapagliflozin (5) Forxiga® AstraZeneca GmbH Cardiovascular diseases Chronic heart failure (CHF) 100% Hint for considerable additional benefit
Amikacin (liposomal) Arikayce® liposomal Insmed Germany GmbH Infectious diseases ORPHAN Mycobacterium Avium Complex (MAC) infection 100% Hint for non-quantifiable additional benefit
Atezolizumab (8) Tecentriq® Roche Pharma AG Oncological diseases Hepatocellular carcinoma (HCC), combination with bevacizumab 76% Indication of considerable additional benefit
Crizanlizumab Adakveo® Novartis Pharma GmbH Hematopoietic diseases ORPHAN Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years 100% Hint for minor additional benefit
Eszopiclon Lunivia® Hennig Arzneimittel GmbH & Co. KG Nervous system diseases Sleep disorders 100% no additional benefit
Baricitinib (2) Olumiant® Lilly Deutschland GmbH Skin diseases Atopic dermatitis (AD) 100% no additional benefit
Avapritinib Ayvakyt® Blueprint Medicines (Germany) Oncological diseases ORPHAN Gastrointestinal stromal tumor (GIST) 100% Hint for non-quantifiable additional benefit
Burosumab (3) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia (XLH), ≥ 18 years 100% Hint for minor additional benefit repealed
Bempedoinsäure / Ezetimib Nustendi® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Bempedoinsäure Nilemdo® Daiichi Sankyo Deutschland GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia 100% no additional benefit
Semaglutid (2, reassessment) Ozempic® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Cannabidiol (4, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit
Cannabidiol (3, reassessment) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for considerable additional benefit
Filgotinib Jyseleca® Gilead Sciences GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 33% Hint for minor additional benefit
Ibrutinib (7) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronic lymphocytic leukaemia (CLL), first-line, combination with rituximab 59% Hint for considerable additional benefit
Durvalumab (2) Imfinzi® AstraZeneca GmbH Oncological diseases Small cell lung cancer (SCLC), first-line, combination with etoposide and either carboplatin or cisplatin 100% Hint for minor additional benefit
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 6 to < 18 years 100% no additional benefit
Belantamab-Mafodotin Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases ORPHAN Multiple myeloma (MM), at least 4 prior therapies, monotherapy 100% Hint for non-quantifiable additional benefit
Alpelisib Piqray® Novartis Pharma GmbH Oncological diseases Mammary carcinoma with PIK3CA mutation, pre-treated patients, combination with fulvestrant 41% no additional benefit
Bulevirtid Hepcludex® MYR GmbH Infectious diseases ORPHAN Chronic hepatitis Delta 100% Hint for non-quantifiable additional benefit
Ivacaftor / Tezacaftor / Elexacaftor Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (2) Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit
Ivacaftor (14) Kalydeco® Vertex Pharmaceuticals Ltd Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation) 100% Hint for major additional benefit
Ivacaftor (13) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation) 100% Indication of major additional benefit
Entrectinib (2) Rozlytrek® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), ROS1+, advanced, first-line 100% no additional benefit
Entrectinib Rozlytrek® Roche Pharma AG Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent 100% no additional benefit
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases Multidrug-resistant HIV infection 100% no additional benefit
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Skin diseases Plaque psoriasis (PP), ≥ 6 to < 18 years 100% Hint for minor additional benefit
Secukinumab (5) Cosentyx® Novartis Pharma GmbH 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 ORPHAN Acute myeloid leukaemia (AML), combination with cytarabine (LDAC) 100% Hint for considerable additional benefit
Nintedanib (5, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Interstitial pulmonary disease with systemic sclerosis 100% no additional benefit
Trifaroten Selgamis® Galderma Laboratorium GmbH Skin diseases Acne vulgaris, ≥ 12 years 100% no additional benefit
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat Enerzair® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100% no additional benefit
Nintedanib (4, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Progressive fibrosing interstitial lung diseases 100% Indication of minor additional benefit
Ravulizumab (2) Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Atypical hemolytic uremic syndrome (aHUS) 100% no additional benefit
Sofosbuvir (3) Sovaldi® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 100% Hint for non-quantifiable additional benefit
Luspatercept (2) Reblozyl® Celgene GmbH Hematopoietic diseases ORPHAN Beta thalassemia 100% Hint for non-quantifiable additional benefit
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases ORPHAN Myelodysplastic syndrome (MDS) 100% Hint for non-quantifiable additional benefit
Ledipasvir / Sofosbuvir (3) Harvoni® Gilead Sciences Ireland UC Infectious diseases Chronic hepatitis C, 3 to < 12 years 50% Hint for non-quantifiable additional benefit
Ixekizumab (4) Taltz® Lilly Deutschland GmbH Skin diseases Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg 100% no additional benefit
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Axial spondyloarthritis 100% no additional benefit
Osilodrostat Isturisa® Recordati Rare Diseases Germany GmbH Metabolic diseases ORPHAN Endogenous Cushing syndrome 100% Hint for non-quantifiable additional benefit
Caplacizumab (2) Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases ORPHAN Thrombotic thrombocytopenic purpura (aTTP)Thrombotic thrombocytopenic purpura (TTP), 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Ozanimod Zeposia® Celgene GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 90% Indication of minor additional benefit
Brentuximab Vedotin (5) Adcetris® Takeda GmbH Oncological diseases ORPHAN Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin and prednisone 100% Hint for minor additional benefit repealed
Encorafenib (2) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Metastatic colorectal carcinoma (CRC) 100% Hint for considerable additional benefit
Fostamatinib Tavlesse® Grifols Deutschland GmbH Hematopoietic diseases Chronic immune thrombocytopenia 100% no additional benefit
Ivacaftor (12) Kalydeco® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥ 6 months to < 18 years 100% Hint for non-quantifiable additional benefit
Tezacaftor / Ivacaftor (3, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del) 100% no additional benefit
Tezacaftor / Ivacaftor (2, reassessment >€50m) Symkevi® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del) 100% no additional benefit
Mogamulizumab Poteligeo® Kyowa Kirin GmbH Oncological diseases ORPHAN Mycosis Fungoides; Sézary Syndrome 100% Hint for non-quantifiable additional benefit
Ponatinib (2, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML) 100% Hint for non-quantifiable additional benefit
Ponatinib (3, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Chronic myeloid leukaemia (CML) 100% Hint for non-quantifiable additional benefit
Talazoparib Talzenna® Pfizer Pharma GmbH Oncological diseases Mammary carcinoma, BRCA1/2 mutation, HER2- 100% Hint for considerable additional benefit
Naldemedin Rizmoic® Hexal AG Digestive system diseases Opioid-induced constipation 100% no additional benefit
Apremilast (2) Otezla® Amgen GmbH Other diseases Behçet's disease 100% no additional benefit
Enzalutamid (4, reassessment) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Indication of minor additional benefit
Solriamfetol Sunosi® Jazz Pharmaceuticals Nervous system diseases Narcolepsy 100% no additional benefit
Brigatinib (2) Alunbrig® Takeda GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, ALK inhibitor-naive patients 50% Hint for considerable additional benefit
Darolutamid Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Indication of considerable additional benefit
Venetoclax (4) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab 100% no additional benefit
Insulin glargin / Lixisenatid (2) Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors 100% no additional benefit
Givosiran Givlaari® Alnylam Germany GmbH Metabolic diseases ORPHAN Acute hepatic porphyria, ≥ 12 years 100% Indication of considerable additional benefit
Avelumab (3, reassessment) Bavencio® Merck Serono GmbH Oncological diseases Metastatic Merkel-cell carcinoma (MCC) 100% no additional benefit
Trifluridin / Tipiracil (3, reassessment) Lonsurf® Servier Deutschland GmbH Oncological diseases Colorectal carcinoma (CRC), pre-treated patients 100% Hint for minor additional benefit
Apalutamid (3, reassessment) Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Indication of minor additional benefit
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases HIV infection, combination with atazanavir or darunavir, 12 to < 18 years 100% no additional benefit
Tisagenlecleucel (3, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL) 100% Hint for non-quantifiable additional benefit
Tisagenlecleucel (4, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) 100% Hint for non-quantifiable additional benefit
Indacaterol / Mometason Atectura® Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100% no additional benefit
Brolucizumab Beovu® Novartis Pharma GmbH Eye diseases Neovascular age-related macular degeneration 100% no additional benefit
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases Clostridioides difficile infection, children and adolescents 54% Hint for considerable additional benefit
Romosozumab Evenity® UCB Pharma GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal) 100% Indication of minor additional benefit
Riociguat (2, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases ORPHAN Chronic thromboembolic pulmonary hypertension 100% no additional benefit
Riociguat (3, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases ORPHAN Pulmonary arterial hypertension (PAH) 100% no additional benefit
Abemaciclib (3, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 39% Hint for minor additional benefit repealed subpopulations
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Metabolic diseases ORPHAN Amyloid cardiomyopathy 100% Hint for considerable additional benefit repealed
Apalutamid (2) Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), hormone-sensitive, combination with androgen deprivation therapy 100% no additional benefit
Ribociclib (3, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 58% Indication of minor additional benefit
Ribociclib (4, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with aromatase inhibitor 100% Hint for minor additional benefit
Polatuzumab Vedotin Polivy® Roche Pharma AG Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab 100% Hint for non-quantifiable additional benefit
Siponimod Mayzent® Novartis Pharma GmbH Nervous system diseases Secondary progressive multiple sclerosis (MS) 100% no additional benefit
Bedaquilin (2) Sirturo® Janssen-Cilag GmbH Infectious diseases ORPHAN Multidrug-resistant pulmonary tuberculosis, 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Daratumumab (5) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 100% Hint for minor additional benefit repealed
Daratumumab (4) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone 100% Hint for non-quantifiable additional benefit
Ramucirumab (6) Cyramza® Lilly Deutschland GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line 100% no additional benefit
Dulaglutid (2, reassessment) Trulicity® Lilly Deutschland GmbH Metabolic diseases Diabetes mellitus type 2 31% Hint for minor additional benefit
Upadacitinib Rinvoq® AbbVie Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 34% Hint for considerable additional benefit
Trastuzumab Emtansin (2) Kadcyla® Roche Pharma AG Oncological diseases Mammary carcinoma, early stage, HER2+, adjuvant treatment 100% Indication of minor additional benefit
Ivacaftor (11) Kalydeco® Vertex Pharmaceuticals Metabolic diseases ORPHAN Cystic fibrosis (CF), ≥ 6 to < 12 months 100% Hint for non-quantifiable additional benefit
Neratinib Nerlynx® Pierre Fabre Pharma Oncological diseases Mammary carcinoma, HR+, HER2+, adjuvant therapy 100% Hint for minor additional benefit
Gilteritinib XOSPATA® Astellas Pharma GmbH Oncological diseases ORPHAN Acute myeloid leukaemia (AML), FLT3 mutation 100% Hint for considerable additional benefit
Avelumab (2) Bavencio® Merck Serono GmbH / Pfizer Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with axitinib 23% Hint for considerable additional benefit
Dupilumab (4) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Chronic rhinosinusitis with nasal polyps 100% Indication of considerable additional benefit
Pembrolizumab (13) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy 100% Indication of minor additional benefit
Pembrolizumab (12) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy 100% Hint for considerable additional benefit
Pembrolizumab (11) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Renal cell carcinoma (RCC), first-line, combination with axitinib 23% Indication of considerable additional benefit
Belimumab (2) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 100% Hint for non-quantifiable additional benefit
Betibeglogene autotemcel Zynteglo® bluebird bio (Germany) GmbH Hematopoietic diseases ORPHAN Beta thalassemia 100% Hint for non-quantifiable additional benefit
Cannabidiol (2) Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Dravet syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed
Niraparib (2, reassessment >€50m) Zejula® TESARO Bio Germany GmbH Oncological diseases ORPHAN Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma 100% no additional benefit repealed
Cannabidiol Epidyolex® GW Pharmaceuticals plc Nervous system diseases ORPHAN Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam 100% Hint for non-quantifiable additional benefit repealed
Larotrectinib Vitrakvi® Bayer Vital GmbH Oncological diseases Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent 100% no additional benefit
Atezolizumab (4) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with bevacizumab, paclitaxel and carboplatin; maintenance therapy 100% no additional benefit
Asfotase alfa (2, reassessment >€50m) Strensiq® Alexion Pharma Germany GmbH Metabolic diseases ORPHAN Hypophosphatasia (HPP) 0.8% Hint for non-quantifiable additional benefit
Atezolizumab (6) Tecentriq® Roche Pharma AG Oncological diseases Mammary carcinoma, triple-negative, PD-L1 expression ≥1% 100% Hint for non-quantifiable additional benefit
Atezolizumab (5) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous, 1st line, combination with nab-paclitaxel and carboplatin; maintenance therapy 100% no additional benefit
Trifluridin / Tipiracil (2) Lonsurf® Servier Deutschland GmbH Oncological diseases Metastatic gastric cancer, pre-treated patients 100% Indication of minor additional benefit
Atezolizumab (7) Tecentriq® Roche Pharma AG Oncological diseases Small cell lung cancer (SCLC), first-line, combination with carboplatin and etoposide; maintenance therapy 100% Hint for minor additional benefit
Elotuzumab (2) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Multiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone 100% Hint for considerable additional benefit repealed
Burosumab (2, reassessment) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years 100% Hint for non-quantifiable additional benefit repealed
Ropeginterferon alfa-2b Besremi® AOP Orphan Pharmaceuticals AG Oncological diseases Polycythemia vera 100% no additional benefit
Ivacaftor (10) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), 12 ro < 24 months 100% Hint for non-quantifiable additional benefit
Ivacaftor (9, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation 100% Hint for minor additional benefit
Ivacaftor (8, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), patients from 2 to 5 years 100% Hint for non-quantifiable additional benefit
Ivacaftor (7, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), various gating mutations, ≥ 6 years 100% Hint for non-quantifiable additional benefit
Ivacaftor (6, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit
Ivacaftor (5, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor 100% no additional benefit
Ivacaftor (4, reassessment >€50m) Kalydeco® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), G551D mutation, ≥ 6 years 86% Hint for considerable additional benefit
Ramucirumab (5) Cyramza® Lilly Deutschland GmbH Oncological diseases Hepatocellular carcinoma (HCC) 100% Proof of minor additional benefit
Dupilumab (2) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Bronchial asthma, ≥ 12 years 100% no additional benefit
Dupilumab (3) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Atopic dermatitis (AD), 12 to < 18 years 100% Hint for non-quantifiable additional benefit
Andexanet alfa Ondexxya® Portola Deutschland GmbH Hematopoietic diseases Antidote for reversal of anticoagulation (factor Xa) 100% no additional benefit
Ibrutinib (5) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Chronische lymphatische Leukämie (CLL), Erstlinie, Kombination mit Obinutuzumab 26% Hint for minor additional benefit
Ibrutinib (6) Imbruvica® Janssen-Cilag GmbH Oncological diseases ORPHAN Waldenström's disease, combination with rituximab 100% no additional benefit
Volanesorsen Waylivra® Akcea Therapeutics Germany GmbH Metabolic diseases ORPHAN Chylomicronaemia syndrome 100% Hint for non-quantifiable additional benefit
Turoctocog alfa pegol Esperoct® Novo Nordisk Pharma GmbH Hematopoietic diseases Hemophilia A 100% no additional benefit
Dolutegravir / Lamivudin Dovato® ViiV Healthcare GmbH Infectious diseases HIV infection, ≥ 12 years 100% no additional benefit
Ravulizumab Ultomiris® Alexion Pharma Germany GmbH Hematopoietic diseases Paroxysmal hemoglobinuria 100% no additional benefit
Cemiplimab Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Squamous cell carcinoma (SCC) 100% no additional benefit
Olaparib (3) Lynparza® AstraZeneca GmbH Oncological diseases Mammary carcinoma, BRCA1/2 mutations, HER2- 100% Hint for minor additional benefit
Olaparib (4) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy 100% no additional benefit
Vigabatrin Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, West syndrome, < 7 years 100% no additional benefit
Vigabatrin (2) Kigabeq® Desitin GmbH Nervous system diseases Epilepsy, focal seizures, < 7 years 100% no additional benefit
Pegvaliase Palynziq® BioMarin International Limited Metabolic diseases ORPHAN Phenylketonuria 100% Hint for non-quantifiable additional benefit
Dapagliflozin / Metformin (3, reassessment) Xigduo® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 50% Hint for minor additional benefit
Dapagliflozin (4, reassessment) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 2 41% Hint for minor additional benefit
Pomalidomid (3) Imnovid® Celgene GmbH Oncological diseases ORPHAN Multiple myeloma (MM), at least 1 prior therapy, combination with bortezomib and dexamethasone 100% no additional benefit
Empagliflozin / Linagliptin Glyxambi® Boehringer Ingelheim Pharma GmbH & Co. KG Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Risankizumab Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Plaque psoriasis (PP) 82% Proof of considerable additional benefit
Lorlatinib Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated 100% no additional benefit
Fremanezumab Ajovy® Teva GmbH Nervous system diseases Migraine prophylaxis 1.0% Hint for considerable additional benefit
Dacomitinib Vizimpro® Pfizer Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutation, first-line 100% no additional benefit
Lisdexamfetamindimesilat (2, Elvanse Adult®) Elvanse Adult® Shire Deutschland GmbH Mental illnesses Attention deficit hyperactivity disorder (ADHD), ≥ 18 years 100% no additional benefit
Dapagliflozin (3) Forxiga® AstraZeneca GmbH Metabolic diseases Diabetes mellitus type 1 100% Hint for minor additional benefit 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 ORPHAN Hereditary retinal dystrophy 100% Hint for considerable additional benefit repealed
Glecaprevir / Pibrentasvir (2) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 12 to < 18 years 100% no additional benefit
Nintedanib (3, reassessment >€50m, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases ORPHAN Idiopathic pulmonary fibrosis 100% Hint for considerable additional benefit
Pembrolizumab (10) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel 71% Hint for considerable additional benefit
Pembrolizumab (9) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy 100% Hint for non-quantifiable additional benefit
Pembrolizumab (8) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, adjuvant therapy 100% Indication of non-quantifiable additional benefit
Galcanezumab Emgality® Lilly Deutschland GmbH Nervous system diseases Migraine prophylaxis 1.0% Hint for considerable additional benefit
Brentuximab Vedotin (4) Adcetris® Takeda Pharma GmbH Oncological diseases ORPHAN Hodgkin lymphoma (HL), CD30+, first-line 100% non-quantifiable additional benefit
Emicizumab (2) Hemlibra® Roche Pharma AG Hematopoietic diseases Hemophilia A, without factor VIII inhibitors 100% no additional benefit
Regadenoson (2) Rapiscan® GE Healthcare Buchler GmbH & Co. KG Other diseases Stenosis, Fractional Flow Reserve Measurement (FFR) 100% no additional benefit
Rucaparib Rubraca® Clovis Oncology Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, after at least 2 previous therapies 100% no additional benefit
Rucaparib (2) Rubraca® Clovis Oncology Germany GmbH Oncological diseases Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy 100% no additional benefit
Blinatumomab (3) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), MRD-positive patients 100% non-quantifiable additional benefit
Lumacaftor / Ivacaftor (3) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years 100% Hint for non-quantifiable additional benefit repealed
Blinatumomab (4) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), ≥ 1 to <18 years 100% non-quantifiable additional benefit
Lenvatinib (4, reassessment) Lenvima® Eisai GmbH Oncological diseases Thyroid carcinoma (DTC) 100% no additional benefit
Ipilimumab (5) Yervoy® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with nivolumab 100% Indication of considerable additional benefit
Nivolumab (12) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC), first-line, combination with ipilimumab 100% Indication of considerable additional benefit
Mexiletin Namuscla® Lupin Europe GmbH Nervous system diseases ORPHAN Myotonia 100% non-quantifiable additional benefit
Apalutamid Erleada® Janssen-Cilag GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% Hint for minor additional benefit repealed
Lanadelumab Takhzyro® Shire Deutschland GmbH, Teil der Takeda Group Other diseases ORPHAN Hereditary angioedema (HAE) 100% considerable additional benefit repealed
Doravirin Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 100% no additional benefit
Doravirin / Lamivudin / Tenofovirdisoproxil Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection 100% no additional benefit
Glycerolphenylbutyrat (2) Ravicti® Swedish Orphan Biovitrum GmbH Metabolic diseases ORPHAN Urea cycle disorders (UCD), 0 to < 2 months 100% non-quantifiable additional benefit
Brigatinib Alunbrig® Takeda Pharma GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), ALK+, pre-treated with crizotinib 100% no additional benefit
Bedaquilin Sirturo® Janssen-Cilag GmbH Infectious diseases ORPHAN Multidrug-resistant pulmonary tuberculosis 100% considerable additional benefit
Melatonin Slenyto® InfectoPharm Arzneimittel und Consilium GmbH Nervous system diseases Sleep disorders 100% Hint for minor additional benefit
Ribociclib (2) Kisqali® Novartis Pharma GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, postmenopausal, premenopausal and perimenopausal women, combination with fulvestrant, combination with aromatase inhibitor 100% no additional benefit repealed 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 ORPHAN Cystic fibrosis (CF), F508del mutation, ≥ 12 years 91% considerable additional benefit repealed
Enzalutamid (3) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), non-metastatic, high-risk 100% no additional benefit repealed
Venetoclax (2) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), combination with rituximab 37% Indication of minor additional benefit
Venetoclax (3, reassessment) Venclyxto® AbbVie Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy 100% no additional benefit
Insulin degludec (4, reassessment) Tresiba® Novo Nordisk Pharma GmbH Metabolic diseases Diabetes mellitus type 2 100% no additional benefit
Fluticasonfuroat / Umeclidinium / Vilanterol (2) Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD), inadequate control with LAMA and LABA 100% no additional benefit
Tildrakizumab Ilumetri® Almirall Hermal GmbH Skin diseases Plaque psoriasis (PP) 100% no additional benefit
Alirocumab (2, reassessment) Praluent® Sanofi-Aventis Deutschland GmbH Metabolic diseases Hypercholesterolemia or mixed dyslipidaemia 100% no additional benefit
Axicabtagen-Ciloleucel (2) Yescarta® Kite, Gilead company Oncological diseases ORPHAN Primary mediastinal large B-cell lymphoma (PMBCL) 100% non-quantifiable additional benefit
Axicabtagen-Ciloleucel Yescarta® Kite, Gilead company Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) 100% non-quantifiable additional benefit
Abemaciclib (2) Verzenios® Lilly Deutschland GmbH Oncological diseases Mammary carcinoma, HR+, HER2-, combination with fulvestrant 100% no additional benefit repealed subpopulations