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

Imlifidase (2) Idefirix® Hansa Biopharma AB Genitourinary system diseases Desensitisation in kidney transplantation active procedure Orphan
Vorasidenib (2) Voranigo® Servier Deutschland GmbH Oncological diseases Astrocytoma or oligodendroglioma, grade 2, with an IDH1-R132 or IDH2-R172 mutation, following surgical intervention, aged ≥ 12 years and weighing ≥ 40 kg active procedure
Inclisiran (3) Leqvio® Novartis Pharma GmbH Metabolic diseases Primary hypercholesterolaemia or mixed dyslipidaemia active procedure
Sparsentan (2) Filspari® Vifor Pharma Deutschland GmbH Genitourinary system diseases Immunoglobulin A nephropathy, primary active procedure Orphan (turnover limit)
Upadacitinib (10) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years active procedure
Upadacitinib (9) Rinvoq® AbbVie Deutschland GmbH & Co. KG Skin diseases Non-segmental vitiligo active procedure
Darunavir / Cobicistat / Emtricitabin / Tenofoviralafenamid (2) Symtuza® Johnson & Johnson Infectious diseases HIV infection, aged ≥ 6 years to < 12 years active procedure
Sugemalimab (2) Cejemly® Gentili Pharma GmbH Oncological diseases Stage III non-small cell lung cancer, EGFR-, ALK- and ROS1-negative, PD-L1 ≥ 1 per cent, which has not progressed following platinum-based chemoradiotherapy active procedure
Sugemalimab (1) Cejemly® Gentili Pharma GmbH Oncological diseases Non-small cell lung cancer, first-line treatment, in combination with platinum-based chemotherapy active procedure
Rilzabrutinib (1) Wayrilz® Sanofi-Aventis Deutschland GmbH Hematopoietic diseases Immune thrombocytopenia (ITP), refractory active procedure Orphan
Trofinetid (1) Daybu® Acadia Pharmaceuticals (Germany) GmbH Mental illnesses Rett syndrome, ≥ 5 years active procedure Orphan
Sacituzumab govitecan (4) Trodelvy® Gilead Sciences GmbH Oncological diseases Triple-negative breast cancer, first-line treatment, PD-L1 expression ≥ 10 (CPS), in combination with pembrolizumab active procedure
Tolebrutinib (1) Cenrifki® Sanofi-Aventis Deutschland GmbH Nervous system diseases Secondary progressive multiple sclerosis active procedure
Berotralstat (2) Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema, prophylaxis, 2 to < 12 years active procedure
Nogapendekin alfa inbakicept (1) Anktiva® ImmunityBio, Inc. Oncological diseases BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), in combination with Bacillus Calmette-Guérin (BCG) active procedure
Extrakt aus Cannabisblüten (1) Exilby® Vertanical GmbH Musculoskeletal system diseases Chronic lower back pain with a radicular (neuropathic) component active procedure
Mavorixafor (1) Xolremdi® Norgine GmbH Other diseases WHIM syndrome (Warts-Hypogammaglobulinaemia-Immunodeficiency-Myelocathexis syndrome) active procedure Orphan
Pirtobrutinib (3) Jaypirca® Lilly Deutschland GmbH Oncological diseases Chronic lymphocytic leukaemia (CLL), monotherapy active procedure
Datopotamab deruxtecan (2) Datroway® Daiichi Sankyo Deutschland GmbH Oncological diseases Triple-negative breast cancer, first-line treatment active procedure
Inclisiran (2) Leqvio® Novartis Pharma GmbH Metabolic diseases Primary hypercholesterolaemia, aged ≥ 12 years to < 18 years active procedure
Doxecitin / Doxribtimin (1) Kygevvi® UCB Pharma GmbH Other diseases Thymidine kinase 2 deficiency active procedure Orphan
Nerandomilast (2) Jascayd® Boehringer Ingelheim Pharma GmbH und Co. KG Respiratory system diseases Idiopathic pulmonary fibrosis active procedure
Nerandomilast (1) Jascayd® Boehringer Ingelheim Pharma GmbH und Co. KG Respiratory system diseases Progressive pulmonary fibrosis active procedure
Plozasiran (1) Redemplo® Arrowhead Pharmaceuticals Ireland Limited Metabolic diseases Familial chylomicronemia syndrome (FCS) active procedure Orphan
Serplulimab (5) Hetronifly® Accord Healthcare GmbH Oncological diseases Small-cell lung cancer, in combination with carboplatin and etoposide, first-line treatment active procedure
Serplulimab (4) Hetronifly® Accord Healthcare GmbH Oncological diseases Non-small cell lung cancer, squamous cell, first-line treatment, combination with carboplatin and nab-paclitaxel active procedure
Pegvaliase (2) Palynziq® BioMarin Deutschland GmbH Metabolic diseases Phenylketonuria; 12 to < 16 years active procedure Orphan
Enfortumab Vedotin (3) Padcev® Astellas Pharma GmbH Oncological diseases Muscle-invasive bladder cancer, neoadjuvant/adjuvant therapy following cystectomy, in combination with pembrolizumab active procedure
Sacituzumab govitecan (3) Trodelvy® Gilead Sciences GmbH Oncological diseases Triple-negative breast cancer, first-line treatment active procedure
Glecaprevir / Pibrentasvir (4) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Acute hepatitis C virus infection, ≥ 3 years active procedure
Onasemnogen abeparvovec (1) Itvisma® Novartis Pharma GmbH Nervous system diseases 5q-associated spinal muscular atrophy with ≥ 4 copies of the SMN2 gene and SMA type 2, type 3, type 4 or of undefined type, aged ≥ 2 years active procedure
Risankizumab (5) Skyrizi® AbbVie Deutschland GmbH & Co. KG Skin diseases Moderate to severe plaque psoriasis; 6 to < 18 years active procedure
Serplulimab (3) Hetronifly® Accord Healthcare GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 with CPS ≥ 5, first-line treatment, in combination with fluoropyrimidine- and platinum-based chemotherapy active procedure
Serplulimab (2) Hetronifly® Accord Healthcare GmbH Oncological diseases Non-small cell lung cancer, non-squamous, EGFR-, ALK- and ROS-negative, first-line treatment, combination with carboplatin and pemetrexed active procedure
Durvalumab (12) Imfinzi® AstraZeneca GmbH Oncological diseases Adenocarcinoma of the stomach or the gastro-oesophageal junction; neoadjuvant and adjuvant combination with FLOT chemotherapy followed by adjuvant monotherapy active procedure
Decitabin / Cedazuridin (2) Inaqovi® Otsuka Pharma GmbH Oncological diseases Acute myeloid leukaemia, first-line treatment, combination with venetoclax active procedure
Encorafenib (4) Braftovi® Pierre Fabre Pharma GmbH Oncological diseases Colorectal cancer with a BRAF V600E mutation; first-line treatment; combination with cetuximab and FOLFOX active procedure
Benralizumab (3) Fasenra® AstraZeneca GmbH Hematopoietic diseases Hypereosinophilic syndrome, aged ≥ 12 years, weighing ≥ 35 kg active procedure
Epcoritamab (4) Tepkinly® AbbVie Deutschland GmbH Oncological diseases Follicular lymphoma, relapsed or refractory, in combination with lenalidomide and rituximab active procedure
Zuranolon (1) Zurzuvae® Biogen GmbH Mental illnesses Postnatal depression active procedure
Atidarsagen autotemcel OTL-200 (2) Libmeldy® Orchard Therapeutics GmbH Metabolic diseases Metachromatic leukodystrophy with a biallelic mutation in the ARSA gene active procedure Orphan
Deutivacaftor / Tezacaftor / Vanzacaftor (2) Alyftrek® Vertex Pharmaceuticals (Ireland) Limited Metabolic diseases Cystic fibrosis, at least one non-Class I mutation, aged ≥ 6 years active procedure Orphan (turnover limit)
Leniolisib (1) Joenja® Pharming Group BV Hematopoietic diseases Activated phosphoinositide-3-kinase delta syndrome, aged ≥ 12 years, weighing ≥ 45 kg active procedure Orphan
Burosumab (7) Crysvita® Kyowa Kirin GmbH Metabolic diseases X-linked hypophosphataemia; ≥ 1 month to < 1 year active procedure Orphan (turnover limit)
Lurbinectedin (1) Zepzelca® Pharma Mar S.A. Oncological diseases Small-cell lung cancer, extensive-stage, maintenance therapy, in combination with atezolizumab active procedure Orphan
Venetoclax (7) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Chronic lymphocytic leukaemia, first-line treatment, combination of acalabrutinib with or without obinutuzumab active procedure
Venetoclax (6) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Chronic lymphocytic leukaemia, first-line treatment, combination with ibrutinib active procedure
Tarlatamab (1) Imdylltra® Amgen GmbH Oncological diseases Advanced small-cell lung cancer, previously treated active procedure Orphan
Atogepant (2) Aquipta® AbbVie Deutschland GmbH & Co. KG Nervous system diseases Acute treatment of migraine active procedure
Ganaxolon (1) Ztalmy® Immedica Pharma Germany GmbH Nervous system diseases CDKL5 deficiency, adjunctive therapy, 2 to < 18 years active procedure Orphan
Dorocubicel / nicht-expandierte allogene CD34- Zellen aus der Nabelschnur (1) Zemcelpro® Cordex Biologics International Ltd Oncological diseases Haematological malignancies, allogeneic haematopoietic stem cell transplantation indicated, no donor available active procedure
Vamorolon (2) Agamree® Santhera Pharmaceuticals GmbH Musculoskeletal system diseases Duchenne muscular dystrophy, aged ≥ 2 to < 4 years active procedure Orphan
Selpercatinib (12) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma, RET fusion-positive, refractory to radioactive iodine, aged ≥ 2 years to < 12 years active procedure
Selpercatinib (11) Retsevmo® Lilly Deutschland GmbH Oncological diseases Solid tumours, RET-fusion-positive, aged ≥ 2 to < 18 years active procedure
Selpercatinib (10) Retsevmo® Lilly Deutschland GmbH Oncological diseases RET-mutated medullary thyroid carcinoma (MTC), aged ≥ 2 years to < 12 years active procedure
Mexiletin (2) Namuscla® Lupin Europe GmbH Nervous system diseases Myotonia, 6 to ≤ 17 years, ≥ 20 kg active procedure Orphan
Deucravacitinib (2) Sotyktu® Bristol-Myers Squibb GmbH & Co. KGaA Skin diseases Psoriatic arthritis, as monotherapy or in combination with methotrexate active procedure
Nivolumab / Relatlimab (1) Opdualag® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, PD-L1 expression < 1 per cent, advanced, first-line treatment, ≥ 12 years active procedure
Remibrutinib (1) Rhapsido® Novartis Pharma GmbH Skin diseases Chronic spontaneous urticaria active procedure
Clascoteron (1) Winlevi® InfectoPharm Arzneimittel und Consilium GmbH Skin diseases Acne vulgaris; ≥ 12 years active procedure
Marstacimab (4) Hympavzi® Pfizer Pharma GmbH Hematopoietic diseases Haemophilia B, aged ≥ 12 years, with factor IX inhibitors active procedure
Marstacimab (3) Hympavzi® Pfizer Pharma GmbH Hematopoietic diseases Haemophilia A, aged ≥ 12 years, with factor VIII inhibitors active procedure
Blinatumomab (14) Blincyto® Amgen GmbH Oncological diseases Acute lymphocytic B-cell leukaemia, Ph-, CD19+, newly diagnosed, adults active procedure Orphan (turnover limit)
Blinatumomab (13) Blincyto® Amgen GmbH Oncological diseases Acute lymphocytic B-cell leukaemia, Ph-, CD19+, high-risk first relapse, children aged ≥1 month active procedure Orphan (turnover limit)
Blinatumomab (12) Blincyto® Amgen GmbH Oncological diseases Acute lymphocytic B-cell leukaemia, Ph-, CD19+, MRD-positive, adults active procedure Orphan (turnover limit)
Blinatumomab (11) Blincyto® Amgen GmbH Oncological diseases Acute lymphocytic B-cell leukaemia, Ph-, CD19+, relapsed/refractory, following ≥ 2 prior treatments or following allogeneic haematopoietic stem cell transplantation, children aged ≥ 1 month active procedure Orphan (turnover limit)
Blinatumomab (10) Blincyto® Amgen GmbH Oncological diseases Acute lymphocytic B-cell leukaemia, CD19+, relapsed or refractory, adults active procedure Orphan (turnover limit)
Inotuzumab ozogamicin (2) Besponsa® Pfizer Pharma GmbH Oncological diseases Acute lymphoblastic B-cell leukaemia, relapsed/refractory, following allogeneic haematopoietic stem cell transplantation or following a very high-risk relapse or following ≥ 2 prior treatments, CD22+, paediatric patients aged ≥ 1 year active procedure Orphan
Aficamten (1) Myqorzo® Cytokinetics Germany GmbH Cardiovascular diseases Hypertrophic obstructive cardiomyopathy active procedure
Asciminib (4) Scemblix® Novartis Pharma GmbH Oncological diseases Chronic myeloid leukaemia, Ph+, CML-CP with T315I mutation, previously treated active procedure Orphan (turnover limit)
Pretomanid (1) Dovprela® Viatris Germany GmbH Infectious diseases Tuberculosis active procedure Orphan
Clesrovimab (1) Enflonsia® MSD Sharp & Dohme GmbH Infectious diseases Secondary prevention of RSV infections in children during their first RSV season active procedure