|
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
|
