Currently active benefit assessment procedures persuant to art. 35a SGB V

Sofosbuvir / Velpatasvir / Voxilaprevir (2) Vosevi® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C (HCV) , 12 to < 18 years of age
Albutrepenonacog alfa (2) Idelvion® CSL Behring GmbH Hematopoietic diseases ORPHAN Hemophilia B, congenital factor IX deficiency
AR101 Palforzia® Aimmune Therapeutics Germany GmbH Other diseases Peanut allergy, ≥ 4 years
Vandetanib (4, reassessment) Caprelsa® Sanofi-Aventis Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), ≥ 5 to < 18 years
Vosoritid Voxzogo® BioMarin International Limited Other diseases ORPHAN Achondroplasia, ≥ 2 years
Daratumumab (8) 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
Lumacaftor / Ivacaftor (4, reassessment) Orkambi® Vertex Pharmaceuticals (Europe) Limited Metabolic diseases ORPHAN Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, ≥ 2 to ≤ 5 years
Ravulizumab (3) Ultomiris® Alexion Pharma Germany GmbHAlexion Pharma Germany GmbH Hematopoietic diseases ORPHAN Paroxysmal hemoglobinuria, pediatric patients
Solriamfetol (2) Sunosi® Jazz Pharmaceuticals Ireland Nervous system diseases Daytime sleepiness in obstructive sleep apnoea, after previous therapy
Vericiguat Verquvo® Bayer Vital GmbH Cardiovascular diseases Chronic heart failure (CHF)
Bimekizumab Bimzelx® UCB Pharma GmbH Skin diseases Plaque psoriasis (PP)
Roxadustat Evrenzo® Astellas Pharma GmbH Hematopoietic diseases Symptomatic anemia in chronic kidney disease (CKD)
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
Tafasitamab Minjuvi® Incyte Biosciences Germany Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), combination with lenalidomide
Odevixibat Bylvay® Albireo Pharma AB Digestive system diseases ORPHAN Cholestasis, ≥ 6 months
Misoprostol Angusta® Norgine GmbH Other diseases Labor induction
Nivolumab (19) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Carcinoma of the esophagus and gastro-esophageal junction, pre-treated patients, adjuvant therapy
Migalastat (2) Galafold® Amicus Therapeutics GmbH Metabolic diseases Fabry disease, 12 to < 16 years
Icosapent-Ethyl Vazkepa® Amarin Pharmaceuticals Ireland Limited Metabolic diseases Dyslipidemia, pre-treated patients
Tofacitinib (5, reassessment) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate
Tirbanibulin Klisyri® Almirall Hermal GmbH Skin diseases Actinic keratosis (AK), Olsen grade I
Relugolix / Estradiol / Norethisteronacetat Ryeqo® Gedeon Richter Pharma GmbH Genitourinary system diseases Uterine myoma
Dapagliflozin (6) Forxiga® AstraZeneca GmbH Genitourinary system diseases Chronic kidney disease (CKD)
Upadacitinib (4) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Atopic dermatitis (AD), ≥ 12 years
Selumetinib Koselugo® AstraZeneca GmbH Oncological diseases ORPHAN Neurofibromatosis (type 1), ≥ 3 to < 18 years
Teriflunomid (2) Aubagio Sanofi-Aventis Deutschland GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
Blinatumomab (6) Blincyto® Amgen GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years
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
Cemiplimab (3) Libtayo® Sanofi-Aventis Deutschland GmbH Oncological diseases Basal cell carcinoma (BCC), locally advanced or metastasised
Cemiplimab (2) Libtayo® https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/721/#:~:text=Sanofi-Aventis%20Deutschland%20GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), first-line
Daratumumab (7) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone
Daratumumab (6) Darzalex® Janssen-Cilag GmbH Oncological diseases ORPHAN Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason
Satralizumab Enspryng® Roche Pharma AG Nervous system diseases Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years
Empagliflozin (3) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Cardiovascular diseases Chronic heart failure (CHF)
Tralokinumab Adtralza® Leo Pharma A/S Skin diseases Atopic dermatitis (AD)
Angiotensin-II-Acetat Giapreza® La Jolla Pharmaceutical II B.V. Cardiovascular diseases Hypotension
Brentuximab Vedotin (6) Adcetris® Takeda GmbH Oncological diseases ORPHAN Systemic anaplastic large cell lymphoma; sALCL; first-line; combination with cyclophosphamide, doxorubicin and prednisone
Cabozantinib (7) Cometriq® Ipsen Pharma GmbH Oncological diseases ORPHAN Thyroid carcinoma (MTC)
Glecaprevir / Pibrentasvir (3) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C, 3 to < 12 years
Nivolumab (17) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Malignant pleural mesothelioma, first-line, combination with ipilimumab
Osimertinib (4) Tagrisso® AstraZeneca GmbH Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR mutations, adjuvant therapy
Elotuzumab (3) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Digestive system diseases Multiple Myeloma (MM), at least 2 preteatments, combination with Pomalidomid and DexamethasonMultiple myeloma (MM), at least 2 previous therapies, combination with pomalidomide and dexamethasone
Venetoclax (5) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Acute myeloid leukaemia (AML), combination therapy, first-line
Dostarlimab Jemperli® GlaxoSmithKline GmbH & Co. KG Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy
Tagraxofusp Elzonris® Stemline Therapeutics B.V. Oncological diseases ORPHAN Blastic plasmacytoid dendritic cell neoplasm (BPDCN), first-line
Berotralstat Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema (HAE), prophylaxis, ≥ 12 years of age
Ponesimod Ponvory® Janssen-Cilag GmbH Nervous system diseases Relapsing multiple sclerosis (MS)
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).
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)
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)).
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)
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)
Bosutinib (4, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid leukaemia (CML), Ph+, first-line
Enzalutamid (5) Xtandi® Astellas Pharma GmbH Oncological diseases Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy
Cenobamat Ontozry® Angelini Pharma Deutschland GmbH Nervous system diseases Epilepsy, focal seizures, after at least 2 previous therapies
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
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))
Isatuximab (2) Sarclisa® Sanofi-​Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone
Isatuximab Sarclisa® Sanofi-​Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), after at least 1 prior therapy, combination with carfilzomib and dexamethasone
Lanadelumab (2, reassessment >€50m) Takhzyro® Takeda GmbH Other diseases ORPHAN Hereditary angioedema (HAE), prophylaxis, ≥ 12 years of age
Onasemnogen-​Abeparvovec Zolgensma® Novartis Gene Therapies EU Limited Nervous system diseases ORPHAN 5q-associated spinal muscular atrophy (SMA)
Obinutuzumab (6, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL), first-line
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Chronic lymphocytic leukemia (CLL)
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL)
Cannabidiol (5) Epidyolex® GW Pharmaceuticals plc Other diseases ORPHAN Seizures in Tuberous Sclerosis, ≥ 2 years
Atidarsagen autotemcel OTL-200 Libmeldy® Orchard Therapeutics GmbH Metabolic diseases ORPHAN Metachromatic leukodystrophy with biallelic mutation in the ARSA gene