|
Nivolumab (15)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Melanoma, adjuvant Therapy
|
|
Natrium-Zirkonium-Cyclosilikat
|
Lokelma®
|
AstraZeneca GmbH
|
Metabolic diseases
|
Hyperkalaemia
|
|
Remdesivir
|
Veklury®
|
Gilead Sciences GmbH
|
Infectious diseases
|
COVID-19, ≥ 12 years, additional oxygen supply
|
|
Avatrombopag (2)
|
Doptelet®
|
Swedish Orphan Biovitrum GmbH
|
Hematopoietic diseases
|
Thrombocytopenia in chronic liver disease
|
|
Avatrombopag
|
Doptelet®
|
Swedish Orphan Biovitrum GmbH
|
Hematopoietic diseases
|
Immunothrombocytopenia
|
|
Fostemsavir
|
Rukobia®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
Multiresistent HIV-Infection
|
|
Pembrolizumab (16)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Hodgkin-Lymphoma (HL), pretreated patients, ≥ 3 years
|
|
Pembrolizumab (15)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Urothel carcinoma (UC), CPS ≥ 10, first-line
|
|
Pembrolizumab (14)
|
Keytruda®
|
MSD Sharp & Dohme GmbH
|
Oncological diseases
|
Colorectal carcinoma with MSI-H or dMMR, first line
|
|
Bedaquilin (3)
|
Sirturo®
|
Janssen-Cilag GmbH
|
Infectious diseases
ORPHAN
|
Multiresistent pulmonary tuberkulosis, 5 - 11 years
|
|
Imlifidase
|
Idefirix®
|
Hansa Biopharma AB
|
Other diseases
ORPHAN
|
Desensibilisation after kidney transplantation
|
|
Fedratinib
|
Inrebic®
|
Celgene GmbH
|
Oncological diseases
ORPHAN
|
Myelofibrosis (MF)
|
|
Tucatinib
|
Tukysa®
|
Seagen Germany GmbH
|
Oncological diseases
|
Mamma carcinoma (BC), HER2+, ad least 2 pretreatments, Combination with Trastuzumab and Capecitabin)
|
|
Tezacaftor / Ivacaftor (5)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic Fibrosis (CF), combination with Ivacaftor in patients > 6 < 12 years (heterozygot or F508del- and CF-Mutation))
|
|
Avelumab (4)
|
Bavencio®
|
Merck Serono GmbH und Pfizer Pharma GmbH
|
Oncological diseases
|
Urothal carcinoma (UC), first line
|
|
Esketamin (2)
|
Spravato®
|
Janssen-Cilag GmbH
|
Mental illnesses
|
Depression, therapy resistent, in combination with SSRI or SNRI
|
|
Esketamin
|
Spravato®
|
Janssen-Cilag GmbH
|
Mental illnesses
|
Depression, acute short-term treatment, combination
|
|
Beclometason / Formoterol / Glycopyrronium
|
Trimbow®
|
Chiesi GmbH
|
Respiratory system diseases
|
Asthma
|
|
Baloxavir marboxil (2)
|
Xofluza®
|
Roche Pharma AG
|
Infectious diseases
|
Influenca, Postexposition-Prophylaxis, ≥ 12 years
|
|
Baloxavir marboxil
|
Xofluza®
|
Roche Pharma AG
|
Infectious diseases
|
Influenca, ≥ 12 years
|
|
Eszopiclon
|
Lunivia®
|
Hennig Arzneimittel GmbH & Co. KG
|
Nervous system diseases
|
Sleep disorder
|
|
Autologe Anti-CD19-transduzierte CD3-positive Zellen
|
Tecartus®
|
Gilead Sciences GmbH
|
Oncological diseases
ORPHAN
|
Mantle cell lymphoma (MCL), pretreated patients
|
|
Blinatumomab (5)
|
Blincyto®
|
Amgen GmbH
|
Oncological diseases
ORPHAN
|
Acute lymphatic B-cell-Leukemia (ALL), refractory or relaps, CD19-positive
|
|
Pertuzumab / Trastuzumab (3)
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mamma carinoma, HER2+, metastatic or local rezidive (inoperable), first linie, combination with Docetaxe
|
|
Pertuzumab / Trastuzumab (2)
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mamma carcinoma (MM), HER2+, local advanced or inflammatoriy or earyl with high risk of relaps, neoadjuvanceoadjuvanz
|
|
Pertuzumab / Trastuzumab
|
Phesgo®
|
Roche Pharma AG
|
Oncological diseases
|
Mamma carcinoma (MM) HER2+, early with high risk of relaps, adjuvance
|
|
Levofloxacin / Dexamethason
|
Ducressa®
|
Santen GmbH
|
Eye diseases
|
Infection and inflammation in context of cataract operations
|
|
Dolutegravir (3)
|
Tivicay®
|
ViiV Healthcare GmbH
|
Infectious diseases
|
HIV-Infection, children ≥ 4 weeks < 6 years
|
|
Niraparib (4, reassessment)
|
Zejula®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
ORPHAN
|
Ovarial carcinoma, tube or peritoneal carcinoma
|
|
Fenfluramin
|
Fintepla®
|
Zogenix GmbH
|
Nervous system diseases
ORPHAN
|
Dravet-Syndrom, ≥ 2 years
|
|
Inclisiran
|
Leqvio®
|
Novartis Pharma GmbH
|
Metabolic diseases
|
Primary hypercholesteremia or mixed dyslipemdia (Metabolic disease)
|
|
Upadacitinib (3)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. K
|
Skin diseases
|
Psoriasis-arthritis (PA) (skin disease)
|
|
Upadacitinib (2)
|
Rinvoq®
|
AbbVie Deutschland GmbH & Co. KG
|
Musculoskeletal system diseases
|
Ancylosix Spondylitis (Musculo-Skeletal-Systems)
|
|
Carfilzomib (4)
|
Kyprolis®
|
Amgen GmbH
| |
Multiples Myelom (MM), at least 1 pretreatment, Combination with Daratumumab and Dexamethason
|
|
Nivolumab (14)
|
Opdivo®
|
Bristol-Myers Squibb GmbH & Co. KGaA
|
Oncological diseases
|
Squamous cell carcinoma of esophagus, pretreated patients
|
|
Afamelanotid (2, reassessment)
|
Scenesse®
|
Clinuvel (UK) Limited
|
Metabolic diseases
ORPHAN
|
Erythropoetic Protoporphyria
|
|
Dupilumab (5)
|
Dupixent®
|
Sanofi-Aventis Deutschland GmbH
|
Skin diseases
|
Atopic Dermatitis, 6 - 11 years
|
|
Lenvatinib (5, Kisplyx®, reassessment)
|
Kisplyx®
|
Eisai GmbH
|
Oncological diseases
|
Renal cell carcinoma (RCC)
|
|
Lumasiran
|
Oxlumo®
|
Alnylam Germany GmbH
|
Metabolic diseases
ORPHAN
|
Hyperoxaluria
|
|
Ipilimumab (6)
|
Yervoy®
|
Bristol-Myers Squibb Pharma EEIG
|
Oncological diseases
|
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
|
Non-small-cell lung carcinoma (NSCLC), combination with ipilimumab and platin-based chemotherapy, first line
|
|
Perampanel (5)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
|
Epilepsia, primary focal seizure, ≥ 4 years
|
|
Perampanel (4)
|
Fycompa®
|
Eisai GmbH
|
Nervous system diseases
|
Epilepsia, primary general seizure, ≥ 7 years
|
|
Sucroferric Oxyhydroxide (2)
|
Velphoro®
|
Fresenius Medical Care Deutschland GmbH
|
Other diseases
|
Serumphosphate control in renal insuffiency, ≥ 2 until 18 years
|
|
Olaparib (7)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Adenocarzinoma of Pankreas, BRCA1/2-Mutation, Maintenance therapy
|
|
Olaparib (6)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
Prostata carcinoma, BRCA1/2-Mutation, Progredience afte hormonal therapy
|
|
Olaparib (5)
|
Lynparza®
|
AstraZeneca GmbH
|
Oncological diseases
|
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
|
Psoriasis-Arthritis (PA)
|
|
Nusinersen (2, reassessment >€50m)
|
Spinraza®
|
Biogen GmbH
|
Nervous system diseases
ORPHAN
|
Spinal Muscelatrophia (SMA)
|
|
Sebelipase alfa (2, reassessment)
|
Kanuma®
|
Alexion Pharma Germany GmbH
|
Metabolic diseases
ORPHAN
|
Defieniency of lysosomal acid lipase (LAL)
|
|
Tezacaftor / Ivacaftor (4)
|
Symkevi®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
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
ORPHAN
|
Amyloidosis in cardiomyopathy
|
|
Tafamidis (3, reassessment >€50m)
|
Vyndaqel®
|
Pfizer Pharma GmbH
|
Other diseases
ORPHAN
|
Amyloidosis with polyneuropathy
|
|
Niraparib (3)
|
Zejula®
|
GlaxoSmithKline GmbH & Co. KG
|
Oncological diseases
|
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
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
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
ORPHAN
|
Cystic fibrosis (CF) patients from 4 to < 6 months, R117H mutation
|
|
Ivacaftor (15)
|
Kalydeco®
|
Vertex Pharmaceuticals (Ireland) Limited
|
Metabolic diseases
ORPHAN
|
Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
|
|
Dapagliflozin (5)
|
Forxiga®
|
AstraZeneca GmbH
|
Cardiovascular diseases
|
Chronic heart failure (CHF)
|
|
Acalabrutinib (3)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphocytic leukemia (CLL)
|
|
Acalabrutinib (2)
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphatic Leukemia; combination with Obinutuzumab, first-line
|
|
Acalabrutinib
|
Calquence®
|
AstraZeneca GmbH
|
Oncological diseases
|
Chronic lymphatic Leukemia (CLL); Monotherapy, first-line
|
|
Amikacinsulfat (liposomal)
|
Arikayce®
|
Mykobakterium-avium-Komplex (MAC) Lungeninfektionen
|
Infectious diseases
ORPHAN
|
Mycobacterial-avium-complex (MAC) Lung infection)
|
|
Atezolizumab (8)
|
Tecentriq®
|
Roche Pharma AG
|
Oncological diseases
|
Hepatocellular carzinoma (HCC), combination with Bevacizumab
|
|
Crizanlizumab
|
Adakveo®
|
Novartis Pharma GmbH
|
Hematopoietic diseases
ORPHAN
|
Prevention of recurrent vasoocclusive crises (VOC) in sickle cell anaemia, ≥16 years
|
|
Avapritinib
|
Ayvakyt®
|
Blueprint Medicines (Germany)
|
Oncological diseases
ORPHAN
|
Gastrointestinal stromal tumor
|
|
Burosumab (3)
|
Crysvita®
|
Kyowa Kirin GmbH
|
Metabolic diseases
ORPHAN
|
X-chromosomal Hypophosphatemia, ≥ 18 years
|
|
Bempedoinsäure / Ezetimib
|
Nustendi®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
|
Hypercholesterolemia, Dyslipidemia
|
|
Bempedoinsäure
|
Nilemdo®
|
Daiichi Sankyo Deutschland GmbH
|
Metabolic diseases
|
Hypercholesterolemia, Dyslipidemia
|
|
Semaglutid (2, reassessment)
|
Ozempic®
|
Novo Nordisk Pharma GmbH
|
Metabolic diseases
|
Diabetes mellitus Typ 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
ORPHAN
|
Dravet-Syndrome, ≥ 2 years, combination with Clobazam
|
|
Filgotinib
|
Jyseleca®
|
Gilead Sciences GmbH
|
Musculoskeletal system diseases
|
Rheumatoid arthritis (muscle-skeleton-system)
|
|
Selpercatinib
|
Retsevmo®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
MTC, RET-Fusion+, pretreatment with Sorafenib and/or Lenvatinib
|
|
Selpercatinib (2)
|
Retsevmo®
|
Lilly Deutschland GmbH
| |
MTC, RET-mutation, pretreatment with Cabozantinib and/or Vandetanib , ≤ 12 years
|
|
Selpercatinib (3)
|
Retsevmo®
|
Lilly Deutschland GmbH
|
Oncological diseases
|
MTC, RET-mutation, pretreatment with Cabozantinib and/or Vandetanib Vortherapie, ≤ 12 years
|
|
Baricitinib (2)
|
Olumiant®
|
Lilly Deutschland GmbH
|
Skin diseases
|
Atopic dermatitis (AD)
|
