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

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)