|
Nivolumab (14)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
ONCO
|
Squamous cell carcinoma of esophagus, pretreated patients
|
|
Afamelanotid (2, reassessment)
|
Scenesse®
|
Clinuvel (UK) Limited
|
Metabolic diseases
METABOL
ORPHAN
|
erythropoetic Protoporphyria
|
|
Dupilumab (5)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Skin diseases
OTHER
|
Atopic Dermatitis, 6 - 11 years
|
|
Lenvatinib (5, Kisplyx®, reassessment)
|
Kisplyx®
|
Eisai GmbH
|
Oncological diseases
ONCO
|
Renal cell carcinoma (RCC)
|
|
Lumasiran
|
Oxlumo®
|
Alnylam Germany GmbH
|
Metabolic diseases
METABOL
ORPHAN
|
hyperoxaluria
|
|
Ipilimumab (6)
|
Yervoy®
|
Bristol-Myers Squibb Pharma EEIG
|
Oncological diseases
ONCO
|
Non-small cell lung carcinoma (NSCLC), first line, combination with Nivolumab and platin-based chemotherapy
|
|
Nivolumab (13)
|
Opdivo®
|
Bristol-Myers Squibb Pharma EEIG
|
Oncological diseases
ONCO
|
Non-small-cell lung carcinoma (NSCLC), combination with ipilimumab and platin-based chemotherapy, first line
|
|
Perampanel (5)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
CNS
|
Epilepsia, primary focal seizure, ≥ 4 years
|
|
Perampanel (4)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
CNS
|
Epilepsia, primary general seizure, ≥ 7 years
|
|
Sucroferric Oxyhydroxide (2)
|
Velphoro®
|
Fresenius Medical Care Deutschland GmbH
|
Other diseases
OTHER
|
Serumphosphate control in renal insuffiency, ≥ 2 until 18 years
|
|
Olaparib (7)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
Adenocarzinoma of Pankreas, BRCA1/2-Mutation, Maintenance therapy
|
|
Olaparib (6)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
Prostata carcinoma, BRCA1/2-Mutation, Progredience afte hormonal therapy
|
|
Olaparib (5)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
Ovarial carzinoma, tube carcinoma or primary Peritoneal carcinoma, FIGO-Stadium III/ IV, HRD-positive, Maintenance, combination with Bevacizumab
|
|
Guselkumab (2)
|
Tremfya®
|
Janssen-Cilag GmbH
|
Musculoskeletal system diseases
OTHER
|
Psoriasis-Arthritis (PA)
|
|
Nusinersen (2, reassessment >€50m)
|
Spinraza®
|
Biogen GmbH
|
Nervous system diseases
CNS
ORPHAN
|
Spinal Muscelatrophia (SMA)
|
|
Sebelipase alfa (2, reassessment)
|
Kanuma®
|
Alexion Pharma Germany GmbH
|
Metabolic diseases
OTHER
ORPHAN
|
Defieniency of lysosomal acid lipase (LAL)
|
|
Tezacaftor / Ivacaftor (5)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF) combination therapy with Ivacaftor in patients aged 6 to < 12 years (heterozygous with regard to F508del and CF mutation)
|
|
Tezacaftor / Ivacaftor (4)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF) combination therapy with Ivacaftor in patients aged 6 to < 12 years (homozygous with regard to F508del mutation)
|
|
Tafamidis (4, reassessment >€50m)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Other diseases
OTHER
ORPHAN
|
Amyloidosis in cardiomyopathy
|
|
Tafamidis (3, reassessment >€50m)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Other diseases
OTHER
ORPHAN
|
Amyloidosis
|
|
Niraparib (3)
|
Zejula®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
ONCO
|
ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, maintenance therapy)
|
|
Ivacaftor (18)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF) combination therapy with Tezacaftor/Ivacaftor in patients aged 6 to < 12 years (heterozygous with regard to F508del and RF mutation)
|
|
Ivacaftor (17)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF) combination therapy with Tezacaftor/Ivacaftor in patients aged 6 to < 12 years (homozygous F508del mutation)
|
|
Ivacaftor (16)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF) patients from 4 to < 6 months, R117H mutation
|
|
Ivacaftor (15)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
OTHER
ORPHAN
|
cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
|
|
Dapagliflozin (5)
|
Forxiga®
|
AstraZeneca GmbH
|
Cardiovascular diseases
CV
|
chronic heart failure (CHF)
|
|
Acalabrutinib (3)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
Chronic lymphocytic leukemia (CLL)
|
|
Acalabrutinib (2)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
chronic lymphatic Leukemia; combination with Obinutuzumab, first-line
|
|
Acalabrutinib
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
ONCO
|
chronic lymphatic Leukemia (CLL); Monotherapy, first-line
|
|
Amikacin
|
Arikayce®
|
Mykobakterium-avium-Komplex (MAC) Lungeninfektionen
|
Infectious diseases
INFECT
ORPHAN
|
Mycobacterial-avium-complex (MAC) Lung infection)
|
|
Atezolizumab (8)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
ONCO
|
hepatocellular carzinoma (HCC), combination with Bevacizumab
|
|
Crizanlizumab
|
Adakveo®
|
Novartis Pharma GmbH
|
Hematopoietic diseases
CV
ORPHAN
|
Prevention of recurrent vasoocclusive crises in sickle cell anaemia, ≥16 years
|
|
Avapritinib
|
Ayvakyt®
|
Blueprint Medicines (Germany)
|
Oncological diseases
ONCO
ORPHAN
|
Gastrointestinal stromal tumor
|
|
Burosumab (3)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
OTHER
ORPHAN
|
X-chromosomal Hypophosphatemia, ≥ 18 years
|
|
Bempedoinsäure / Ezetimib
|
Nustendi®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
CV
|
Hypercholesterolemia, Dyslipidemia
|
|
Bempedoinsäure
|
Nilemdo®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
CV
|
Hypercholesterolemia, Dyslipidemia
|
|
Semaglutid (2, reassessment)
|
Ozempic®
|
Novo Nordisk Pharma GmbH
|
Metabolic diseases
CV
|
Diabetes mellitus Typw 2 (metabolism)
|
|
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 (14)
|
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 (13)
|
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
|
axiale Spondyloarthritis
|
|
Secukinumab (4)
|
Cosentyx®
|
Novartis Pharma GmbH
|
Musculoskeletal system diseases
OTHER
|
Psoriasis-Arthritis (PA)
|
|
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
|
|
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
|
|
Baricitinib (2)
|
Olumiant®
|
Lilly Deutschland GmbH
|
Skin diseases
OTHER
|
atopic dermatitis (AD)
|
