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

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
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, ≥ 2 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), ≥ 2 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
Zolbetuximab (2) Vyloy® Astellas Pharma GmbH Oncological diseases Adenocarcinoma of the stomach or the gastro-oesophageal junction, HER2-negative, first-line treatment, combination with fluoropyrimidine- and platinum-based chemotherapy active procedure Orphan (turnover limit)
Tovorafenib (1) Ojemda® Ipsen Pharma GmbH Oncological diseases Malignant glioma, low-grade with a BRAF fusion or rearrangement or a BRAF V600 mutation, following at least one prior line of treatment, ≥ 6 months active procedure Orphan
Dupilumab (13) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Chronic spontaneous urticaria, aged ≥ 2 years to < 12 years active procedure
Dupilumab (12) Dupixent® Sanofi-Aventis Deutschland GmbH Skin diseases Chronic spontaneous urticaria, aged ≥ 12 years active procedure
Belumosudil (1) Rezurock® Sanofi-Aventis Deutschland GmbH Oncological diseases Chronic graft-versus-host disease (cGvHD), aged ≥ 12 years, weighing ≥ 40 kg active procedure Orphan
Olipudase alfa (2) Xenpozyme® Sanofi-Aventis Deutschland GmbH Metabolic diseases Acid sphingomyelinase deficiency (ASMD) type A/B or type B active procedure Orphan (turnover limit)
Finerenon (3) Kerendia® Bayer Vital GmbH Cardiovascular diseases Chronic heart failure with a left ventricular ejection fraction (LVEF) > 40% active procedure
Depemokimab (2) Exdensur® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic rhinosinusitis with nasal polyps active procedure
Depemokimab (1) Exdensur® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, ≥ 12 years active procedure
Elinzanetant (2) Lynkuet® Bayer Vital GmbH Other diseases Vasomotor symptoms associated with breast cancer active procedure
Elinzanetant (1) Lynkuet® Bayer Vital GmbH Other diseases Vasomotor symptoms associated with the menopause active procedure
Retifanlimab (2) Zynyz® Incyte Biosciences Germany GmbH Oncological diseases Squamous cell carcinoma of the anal canal; first-line treatment active procedure
Retifanlimab (1) Zynyz® Incyte Biosciences Germany GmbH Oncological diseases Merkel cell carcinoma, metastatic or recurrent, monotherapy, first-line treatment active procedure
Belantamab-Mafodotin (4) Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases Multiple myeloma, relapsed or refractory, following at least one prior course of treatment; combination with pomalidomide and dexamethasone active procedure
Belantamab-Mafodotin (3) Blenrep® GlaxoSmithKline GmbH & Co. KG Oncological diseases Multiple myeloma, relapsed or refractory, following at least one prior course of treatment; combination therapy with bortezomib and dexamethasone active procedure
Niraparib / Abirateronacetat (2) Akeega® Janssen-Cilag GmbH Oncological diseases Metastatic, hormone-sensitive prostate cancer; BRCA1/2 mutations; combination with prednis(ol)one and androgen deprivation therapy active procedure
Imlunestrant (1) Inluriyo® Lilly Deutschland GmbH Oncological diseases Breast cancer, ER+, HER2-, with an ESR1 mutation, progressive following prior endocrine therapy active procedure
Inebilizumab (3) Uplizna® Amgen GmbH Nervous system diseases Myasthenia gravis, AChR antibody-positive, MuSK antibody-positive active procedure
Inebilizumab (2) Uplizna® Amgen GmbH Other diseases Immunoglobulin G4-associated disease active procedure
Mepolizumab (6) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases COPD active procedure
Gadopiclenol (2) Elucirem® Guerbet GmbH Oncological diseases Contrast-enhanced magnetic resonance imaging, 0 to < 2 years active procedure
Ivosidenib (4) Tibsovo® Servier Deutschland GmbH Oncological diseases Cholangiocarcinoma with an IDH1 R132 mutation, following at least one prior course of treatment active procedure Orphan (turnover limit)
Ivosidenib (3) Tibsovo® Servier Deutschland GmbH Oncological diseases Acute myeloid leukaemia with the IDH1 R132 mutation, first-line treatment, in combination with azacitidine active procedure Orphan (turnover limit)
Abemaciclib (7) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast cancer, HR+, HER2-, early-stage with a high risk of recurrence, adjuvant therapy, combination with endocrine therapy active procedure
Colchicin (1) Colxi® Apontis Pharma Deutschland GmbH & Co. KG Cardiovascular diseases For the prevention of ischaemic cardiovascular events in patients with atherosclerotic coronary heart disease following a myocardial infarction active procedure
Tirzepatid (2) Mounjaro® Lilly Deutschland GmbH Metabolic diseases Type 2 diabetes mellitus, aged ≥ 10 to ≤ 17 years active procedure
Teprotumumab (1) Tepezza® Amgen GmbH Eye diseases Endocrine orbitopathy active procedure
Donidalorsen (1) Dawnzera® Otsuka Pharma GmbH Other diseases Hereditary angioedema, prophylaxis, ≥ 12 years active procedure