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

Vorasidenib Voranigo® Servier Deutschland GmbH Oncological diseases Astrocytoma or oligodendroglioma, grade 2, IDH1-R132 or IDH2-R172 mutation, after surgical intervention, ≥ 12 years ≥ 40 kg Active procedure Orphan
Tezepelumab (2) Tezspire® AstraZeneca GmbH Respiratory system diseases Chronic rhinosinusitis with nasal polyps Active procedure
Selumetinib (4) Koselugo® Alexion Pharma Germany GmbH Oncological diseases Neurofibromatosis type 1 (≥ 18 years) Active procedure Orphan (turnover limit)
Selumetinib (3, reassessment) Koselugo® Alexion Pharma Germany GmbH Oncological diseases Neurofibromatosis type 1 (≥ 3 to < 18 years) Active procedure Orphan (turnover limit)
Diflunisal Attrogy® Purpose Pharma International AB Metabolic diseases Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2) Active procedure
Avapritinib (6, reassessment >€30m) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases Indolent systemic mastocytosis (ISM) Active procedure Orphan (turnover limit)
Avapritinib (5, reassessment >€30m) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases Gastrointestinal stromal tumours Active procedure Orphan (turnover limit)
Avapritinib (4, reassessment >€30m) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases Advanced systemic mastocytosis, after at least 1 prior therapy Active procedure Orphan (turnover limit)
Donanemab Kisunla® Lilly Deutschland GmbH Nervous system diseases Early Alzheimer's disease Active procedure
Momelotinib (2, reassessment >€30m) Omjjara® GlaxoSmithKline GmbH & Co. KG Oncological diseases Myelofibrosis Active procedure Orphan (turnover limit)
Vimseltinib Romvimza® Deciphera Pharmaceuticals (Germany) GmbH Oncological diseases Symptomatic tenosynovial giant cell tumours) Active procedure Orphan
Nirogacestat Ogsiveo® SpringWorks Therapeutics Oncological diseases Desmoid tumour, advanced Active procedure Orphan
Sebetralstat Ekterly® KalVista Pharmaceuticals Other diseases Hereditary angioedema, acute treatment, ≥ 12 years of age Active procedure
Tislelizumab (7) Tevimbra® BeiGene Germany GmbH Oncological diseases Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line, combination with gemcitabine and cisplatin Active procedure
Mirdametinib Ezmekly® SpringWorks Therapeutics Oncological diseases Plexiform neurofibromas (PN), neurofibromatosis type 1 (NF1); ≥ 2 years Active procedure
Linvoseltamab Lynozyfic® Regeneron GmbH Oncological diseases Multiple myeloma, at least 3 prior therapies, monotherapy Active procedure
Concizumab (3) Alhemo® Novo Nordisk GmbH Hematopoietic diseases Haemophilia A, ≥ 12 years, without factor VIII inhibitors Active procedure
Ixekizumab (7) Taltz® Lilly Deutschland GmbH Skin diseases Juvenile psoriatic arthritis, ≥ 6 years Active procedure
Ixekizumab (5) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Enthesitis-associated arthritis, ≥ 6 years Active procedure
Tislelizumab (9) Tevimbra® BeiGene Germany GmbH Oncological diseases Small cell lung carcinoma, first-line, combination with etoposide and platinum chemotherapy Active procedure
Tislelizumab (8) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with platinum-based chemotherapy Active procedure
Trastuzumab deruxtecan (7, reassessment) Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Adenocarcinoma of the stomach or gastro-oesophageal junction, HER2+, after trastuzumab-based therapy Active procedure
Resmetirom Rezdiffra® Madrigal Pharmaceuticals Digestive system diseases Metabolic dysfunction-associated steatohepatitis (MASH), non-cirrhotic Active procedure
Concizumab (4) Alhemo® Novo Nordisk GmbH Hematopoietic diseases Haemophilia B, ≥ 12 years, without factor IX inhibitors Active procedure
Avacopan (2, reassessment) Tavneos® Fresenius Medical Care Nephrologica Deutschland Musculoskeletal system diseases Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide Active procedure Orphan (turnover limit)
Daratumumab (14) Darzalex® Janssen-Cilag GmbH Oncological diseases Multiple myeloma, stem cell transplantation unsuitable, combination with bortezomib, lenalidomide and dexamethasone Active procedure Orphan (turnover limit)
Daratumumab (13) Darzalex® Janssen-Cilag GmbH Oncological diseases Smouldering multiple myeloma (SMM) Active procedure Orphan (turnover limit)
Beremagen geperpavec Vyjuvek® Krystal Biotech Skin diseases Wound treatment for dystrophic epidermolysis bullosa, all age groups Active procedure Orphan
Darolutamid (3) Nubeqa® Bayer Vital GmbH Oncological diseases Prostate carcinoma, metastasised, hormone-sensitive, combination with androgen deprivation therapy Active procedure
Lecanemab Leqembi® Eisai GmbH Nervous system diseases Early Alzheimer's disease Active procedure
Bulevirtid (4, reassessment >€30m) Hepcludex® Gilead Sciences GmbH Infectious diseases Hepatitis delta virus (HDV) infection, HDV RNA-positive, ≥ 3 years, ≥ 10 kg bw Active procedure Orphan (turnover limit)
Tisotumab vedotin Tivdak® Genmab Germany GmbH Oncological diseases Cervical carcinoma, pre-treated Active procedure
Isatuximab (4) Sarclisa® Sanofi-Aventis Deutschland GmbH Oncological diseases Multiple myeloma, first-line, stem cell transplantation suitable, combination with bortezomib, lenalidomide and dexamethasone Active procedure
Inavolisib Itovebi® Roche Pharma AG Oncological diseases Breast cancer, PIK3CA-mutated, ER+, HER2-, locally advanced or metastatic, recurrence < 12 months after adjuvant endocrine therapy, combination with palbociclib and fulvestrant Active procedure
Deutivacaftor / Tezacaftor / Vanzacaftor Alyftrek® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases Cystic fibrosis, at least one non-class I mutation, ≥ 6 years of age Active procedure Orphan
Durvalumab (11) Imfinzi® AstraZeneca GmbH Oncological diseases Small cell lung cancer, non-advanced stage, after platinum-based radiochemotherapy, monotherapy Active procedure
Durvalumab (10) Imfinzi® AstraZeneca GmbH Oncological diseases Muscle-invasive bladder cancer (MIBC), neoadjuvant/adjuvant therapy after cystectomy, combination with gemcitabine and cisplatin Active procedure
Durvalumab (9) Imfinzi® AstraZeneca GmbH Oncological diseases Non-small cell lung cancer, EGFR/ALK-negative, neoadjuvant/adjuvant therapy, combination with platinum-based chemotherapy Active procedure
Efgartigimod alfa (3) Vyvgart® Argenx Germany GmbH Nervous system diseases Chronic inflammatory demyelinating polyneuropathy, pre-treated patients Active procedure Orphan (turnover limit)
Odronextamab (2) Ordspono® Regeneron GmbH Oncological diseases Diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies Active procedure
Odronextamab Ordspono® Regeneron GmbH Oncological diseases Follicular lymphoma, after ≥ 2 prior therapies Active procedure
Vutrisiran (2) Amvuttra® Alnylam Germany GmbH Metabolic diseases Wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) Active procedure Orphan
Givinostat Duvyzat® ITF Pharma GmbH Musculoskeletal system diseases Duchenne muscular dystrophy, ≥ 6 years, combination with a corticosteroid Active procedure Orphan
Remdesivir (5) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no need for additional oxygen supply, ≥ 4 weeks, ≥ 3 kg to 40 kg Active procedure
Sepiapterin Sephience® PTC Therapeutics International Limited Metabolic diseases Hyperphenylalaninaemia in phenylketonuria Active procedure Orphan
Acalabrutinib (7) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia, first-line, combination with venetoclax Active procedure
Acalabrutinib (6) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukaemia, first-line, combination with venetoclax and obinutuzumab Active procedure
Acalabrutinib (5) Calquence® AstraZeneca GmbH Oncological diseases Mantle cell lymphoma, no previous BTKi therapy, relapsed or refractory, monotherapy Active procedure
Acalabrutinib (4) Calquence® AstraZeneca GmbH Oncological diseases Mantle cell lymphoma, not suitable for ASCT, first-line, combination with bendamustine and rituximab Active procedure
Andexanet alfa (2, reassessment) Ondexxya® AstraZeneca GmbH Hematopoietic diseases Repeal of drug anticoagulation Active procedure
Nivolumab (32, reassessment) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Carcinoma of the oesophagus or gastro-oesophageal junction, pre-treated patients, adjuvant therapy Active procedure
Omaveloxolon (2, reassessment) Skyclarys® Biogen GmbH Nervous system diseases Friedreich's ataxia, ≥ 16 years Active procedure Orphan (turnover limit)
Nivolumab (30) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Non-resectable or advanced hepatocellular carcinoma, first-line, combination with ipilimumab Active procedure