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

Cannabidiol (4, reassessment) Epidyolex GW Pharmaceuticals plc Nervous system diseases
ORPHAN
Lennox-Gastaut-Syndrome, ≥ 2 years, combination with Clobazam
Cannabidiol (3, reassessment) Epidyolex GW Pharmaceuticals plc Nervous system diseases
CNS ORPHAN
Dravet-Syndrome, ≥ 2 years, combination with Clobazam
Filgotinib Jyseleca Gilead Sciences GmbH Musculoskeletal system diseases
OTHER
Rheumatoid arthritis (muscle-skeleton-system)
Alpelisib Piqray® Novartis Pharma GmbH Oncological diseases
ONCO
breast cancer
Bulevirtid Hepcludex® MYR GmbH Infectious diseases
INFECT ORPHAN
Chronic Hepatitis-D-Virus (HDV)-Infection, HDV-RNA-positive
Ivacaftor / Tezacaftor / Elexacaftor Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor in patients > 12 years (homoocygotic bzgl. F508del und MF-Mutation))
Ivacaftor / Tezacaftor / Elexacaftor (2) Kaftrio® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor in patients > 12 years (heterocygotic bzgl. F508del und MF-Mutation))
Ivacaftor (13) Kalydeco® Vertex Pharmaceuticals Ltd Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor/Tezacaftor/Elexacaftor in patients >12 yearse (heterocygotic or F508del- and MF-Mutation)
Ivacaftor (12) Kalydeco® Vertex Pharmaceuticals Limited Metabolic diseases
OTHER ORPHAN
Cystic Fibrosis, combination with Ivacaftor/Tezacaftor/Elexacaftor in patients > 12 years (homocygotic or F508del-Mutation
Entrectinib (2) Rozlytrek® Roche Pharma AG Oncological diseases
ONCO
NSCLC, ROS1-positive, advanced, first line
Entrectinib Rozlytrek® Roche Pharma AG Oncological diseases
ONCO
Solide Tumors, Neurotrophic Tyrosin-Receptor-Kinase (NTRK)-Genfusion, tissue-independent
Ibalizumab Trogarzo® Theratechnologies Europe limited Infectious diseases
INFECT
HIV-Infection
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
Plaque-Psoriasis, > 6 years
Secukinumab (5) Cosentyx® Novartis Pharma GmbH Skin diseases
OTHER
Psoriasis-Arthritis
Secukinumab (4) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases
OTHER
Spondyloarthritis
Nintedanib (5, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER ORPHAN
interstitial pulmonary disease with systemic sclerosis
Trifaroten Selgamis® Galderma Laboratorium GmbH Skin diseases
OTHER
Acne vulgaris
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat Enerzair Breezhaler Novartis Pharma GmbH Respiratory system diseases
OTHER
Asthma bronchiale
Nintedanib (4, Ofev®) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases
OTHER ORPHAN
chronic fibrotic interstitial progressive pulmonary disease
Glasdegib Daurismo® PFIZER PHARMA GmbH Oncological diseases
ONCO ORPHAN
acute myeloic leucemia (AML)
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 Musculoskeletal system 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 Nervous system diseases
CNS
Multiple Sclerosis (MS)
Mogamulizumab POTELIGEO® Kyowa Kirin GmbH Oncological diseases
ONCO ORPHAN
Mycosis Fungoides; Sézary Syndrome
Naldemedin Rizmoic® Hexal AG Digestive system diseases
CNS
Constipation
Apremilast (2) Otezla® Amgen GmbH Other diseases
OTHER
Behçet's disease
Enzalutamid (4, reassessment) Xtandi® Astellas Pharma GmbH Oncological diseases
ONCO
Prostate carcinoma (CRPC)
Solriamfetol Sunosi® Jazz Pharmaceuticals Nervous system diseases
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
Ibrutinib (7) Imbruvica® Janssen-Cilag GmbH Oncological diseases
ONCO ORPHAN
CLL, first line, combination with Rituximab
Durvalumab (2) Imfinzi® AstraZeneca GmbH Oncological diseases
ONCO
NSCLC, first line, combination with Etoposid and either Carboplatin nor Cisplatin
Sofosbuvir / Velpatasvir (2) Epclusa® Gilead Sciences GmbH Infectious diseases
INFECT
chronic hepatitis C, ≥ 6 and < 18 years
Belantamab-Mafodotin Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases
ONCO ORPHAN
Multiples Myeloma, at least 4 prior reatments, monotherapy
Brentuximab Vedotin (5) Adcetris® Takeda GmbH Oncological diseases
ONCO ORPHAN
Non-Hodgkin lymphoma