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

Indacaterol / Mometason Atectura® Breezhaler® Novartis Pharma GmbH Respiratory diseases OTHER Asthma
Ravulizumab (2) Ultomiris Alexion Pharma Germany GmbH Hematopoietic diseases OTHER Atypical hemolytic-uremic syndrome (aHUS)
Sofosbuvir (3) Sovaldi® Gilead Sciences Ireland UC Infectious diseases INFECT Chronic hepatitis C infection
Luspatercept (2) Reblozyl® Celgene GmbH Hematopoietic diseases OTHER ORPHAN β-thalassemia
Luspatercept Reblozyl® Celgene GmbH Hematopoietic diseases OTHER ORPHAN Anemia due to myelodysplastic syndromes (MDS)
Ledipasvir / Sofosbuvir (3) Harvoni® Gilead Sciences Ireland UC Infectious diseases INFECT Chronic hepatitis C infection, <12 years
Ixekizumab (4) Taltz® Lilly Deutschland GmbH Skin diseases OTHER Plaque psoriasis, children ≥6–<18 years
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Diseases of the musculoskeletal diseases OTHER Axial spondyloarthritis
Osilodrostat Isturisa Recordati Rare Diseases Germany GmbH Metabolic diseases METABOL ORPHAN endogenous Cushing-syndrome
Encorafenib (2) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases ONCO Metastatic colorectal carcinoma (mCRC)
Fostamatinib Tavlesse® Grifols Deutschland GmbH Hematopoietic diseases CV Chronic immune thrombocytopenia (ITP)
Onasemnogen-Abeparvovec Zolgensma® AveXis Metabolic diseases METABOL ORPHAN Spinal Muscle atrophia (SMA)
Ivacaftor (12) Kalydeco® Vertex Pharmaceuticals Metabolic diseases METABOL ORPHAN Cystic fibrosis (CF)
Tezacaftor / Ivacaftor (3) Symkevi® Vertex Pharmaceuticals Metabolic diseases METABOL ORPHAN Cystic fibrosis (CF)
Tezacaftor / Ivacaftor (2) Symkevi® Vertex Pharmaceuticals Metabolic diseases METABOL ORPHAN Cystic Fibrosis (CF)
Caplacizumab (2) Cablivi® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases CV ORPHAN thrombotic thrombocytopenic purpura (aTTP)
Ozanimod Zeposia® Celgene GmbH Diseases of the nervous system CNS Multiple Sclerosis (MS)
Mogamulizumab POTELIGEO® Kyowa Kirin GmbH Oncological diseases ONCO ORPHAN Mycosis Fungoides; Sézary Syndrome
Naldemedin Rizmoic® Hexal AG Diseases of the digestive system CNS Constipation
Apremilast (2) Otezla® Amgen GmbH Other OTHER Behçet's disease
Enzalutamid (4, reassessment) Xtandi® Astellas Pharma GmbH Oncological diseases ONCO Prostate carcinoma (CRPC)
Solriamfetol Sunosi® Jazz Pharmaceuticals Diseases of the nervous system CNS Narcolepsy
Ponatinib (2, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ONCO ORPHAN Acute lymphatic leukemia (ALL)
Ponatinib (3, reassessment) Iclusig® Incyte Biosciences Germany GmbH Oncological diseases ONCO ORPHAN Chronic myelogenous leukemia (CML)
Talazoparib Talzenna® Pfizer Pharma GmbH Oncological diseases ONCO Breast cancer
Brigatinib (2) Alunbrig® Takeda GmbH Oncological diseases ONCO non-small cell lung carcinoma (ALK+ NSCLC)
Darolutamid Nubeqa® Bayer Vital GmbH Oncological diseases ONCO Prostate carcinoma
Venetoclax (4) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases ONCO Chronic lymphocytic leukemia (CLL)
Insulin glargin / Lixisenatid (2) Suliqua® Sanofi-Aventis Deutschland GmbH Metabolic diseases CV Diabetes mellitus type 2
Givosiran Givlaari® Alnylam Germany GmbH Metabolic diseases METABOL ORPHAN Acute hepatic porphyria
Avelumab (3, reassessment) Bavencio® Merck Serono GmbH Oncological diseases ONCO Merkel cell carcinoma
Trifluridin / Tipiracil (3, reassessment) Lonsurf® Servier Deutschland GmbH Oncological diseases ONCO Colorectal carcinoma, pretreated patients
Apalutamid (3) Erleada® Janssen-Cilag GmbH Oncological diseases ONCO Prostate carcinoma (mHSPC)
Cobicistat (2) Tybost® Gilead Sciences GmbH Infectious diseases INFECT HIV infection
Brolucizumab Beovu® Novartis Pharma GmbH Eye diseases OTHER Macular degeneration
Fidaxomicin (2) Dificlir® Astellas Pharma GmbH Infectious diseases INFECT Clostriudium difficile associated diarrhea (CDAD)
Romosozumab Evenity® UCB Pharma GmbH Diseases of the musculoskeletal diseases OTHER Osteoporosis, postmenopausal women
Tisagenlecleucel (3, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ONCO ORPHAN Acute lymphoblastic leukemia (ALL)
Tisagenlecleucel (4, reassessment) Kymriah® Novartis Pharma GmbH Oncological diseases ONCO ORPHAN Diffuse large B-cell lymphoma (DLBCL)
Riociguat (2, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases CV ORPHAN Hypertension
Riociguat (3, reassessment >€50m) Adempas® MSD Sharp & Dohme GmbH Cardiovascular diseases CV ORPHAN Hypertension
Abemaciclib (3, reassessment) Verzenios® Lilly Deutschland GmbH Oncological diseases ONCO Breast cancer
Ceftolozan / Tazobactam Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases INFECT Acute pyelonephritis
Ceftolozan / Tazobactam (2) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases INFECT Complicated urinary tract infections
Ceftolozan / Tazobactam (3) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases INFECT Complicated intraabdominal infections
Ceftolozan / Tazobactam (4) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases INFECT Nosocomial pneumonia
Tafamidis (2) Vyndaqel® Pfizer Pharma GmbH Other OTHER ORPHAN Amyloidosis
Apalutamid (2) Erleada® Janssen-Cilag GmbH Oncological diseases ONCO Prostate carcinoma
Ribociclib (3, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases ONCO Breast cancer
Ribociclib (4, reassessment) Kisqali® Novartis Pharma GmbH Oncological diseases ONCO Breast cancer
Polatuzumab Vedotin Polivy® Roche Pharma AG Oncological diseases ONCO ORPHAN Diffuse large B-cell lymphoma (DLBCL)
Siponimod Mayzent® Novartis Pharma GmbH Diseases of the nervous system CNS Multiple sclerosis (MS)
Bedaquilin (2) Sirturo® Janssen-Cilag GmbH Infectious diseases INFECT ORPHAN Tuberculosis
Daratumumab (5) Darzalex® Janssen-Cilag GmbH Oncological diseases ONCO ORPHAN Multiple Myeloma (MM)
Daratumumab (4) Darzalex® Janssen-Cilag GmbH Oncological diseases ONCO ORPHAN Multiple myeloma (MM)
Ramucirumab (6) Cyramza® Lilly Deutschland GmbH Oncological diseases ONCO Non-small cell lung carcinoma (NSCLC)
Brentuximab Vedotin (5) Adcetris® Takeda GmbH Oncological diseases ONCO ORPHAN Non-Hodgkin lymphoma