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

Satralizumab Enspryng® Roche Pharma AG Nervous system diseases Neuromyelitis Optica Spectrum Disorder (NMOSD), ≥12 years
Empagliflozin (3) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Cardiovascular diseases Chronic heart failure (CHF)
Tralokinumab Adtralza® Leo Pharma A/S Skin diseases Atopic Dermatitis (AD)
Angiotensin-II-Acetat Giapreza® La Jolla Pharmaceutical II B.V. Cardiovascular diseases Hypotension
Brentuximab Vedotin (6) Adcetris® Takeda GmbH Oncological diseases ORPHAN Systemic anaplastic large cell lymphoma; first-line; combination with cyclophosphamide, doxorubicin, and prednisone.
Cabozantinib (7) Cometriq® Ipsen Pharma GmbH Oncological diseases ORPHAN Thyroid Carcinoma (MTC)
Glecaprevir / Pibrentasvir (3) Maviret® AbbVie Deutschland GmbH & Co. KG Infectious diseases Chronic hepatitis C (CHC), 3 to < 12 years of age
Nivolumab (17) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Malignant pleural mesothelioma, first-line, combination with ipilimumab
Osimertinib (4) Tagrisso® AstraZeneca GmbH Oncological diseases NSCLC, EGFR Mutation, adjuvant therapy
Elotuzumab (3) Empliciti® Bristol-Myers Squibb GmbH & Co. KGaA Digestive system diseases Multiple Myeloma (MM), at least 2 preteatments, combination with Pomalidomid and Dexamethason
Venetoclax (5) Venclyxto® AbbVie Deutschland GmbH & Co. KG Oncological diseases Acute myeloid leukemia (AML), combination therapy, first-line
Dostarlimab Jemperli® GlaxoSmithKline GmbH & Co. KG Oncological diseases Endometrial carcinoma (EC), after prior platinum-based therapy.
Tagraxofusp Elzonris® Stemline Therapeutics B.V. Oncological diseases ORPHAN Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), first line
Berotralstat Orladeyo® BioCryst Pharma Deutschland GmbH Other diseases Hereditary angioedema, prophylaxis (HAE), ≥ 12 years of age
Ponesimod Ponvory® Janssen-Cilag GmbH Nervous system diseases Relapsing Multiple Sclerosis (MS)
Ivacaftor / Tezacaftor / Elexacaftor (5) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), patients <12 years (heterozygous for F508del and other/unknown mutations)
Ivacaftor / Tezacaftor / Elexacaftor (4) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥12 years (heterozygous for F508del and other mutations)
Ivacaftor / Tezacaftor / Elexacaftor (3) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), patients ≥12 years (heterozygous for F508del and Gating mutations (incl. R117H))
Ivacaftor (21) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis, patients ≥12 years (heterozygous for F508del and other mutation)
Ivacaftor (20) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination with Ivacaftor/Tezacaftor/Elexacaftor in patients ≥12 years (heterozygous for F508del and RF mutation)
Bosutinib (4, reassessment) Bosulif® Pfizer Pharma GmbH Oncological diseases Chronic myeloid Leukemia (CML), Ph+, first line
Enzalutamid (5) Xtandi® Astellas Pharma GmbH Oncological diseases Prostata carcinoma (mPC), metastatic, hormonsensitive
Cenobamat Ontozry® Angelini Pharma Deutschland GmbH Nervous system diseases Epilepsy, focal seizures, pretreated
Atezolizumab (9) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung carcinoma (NSCLC), EGFR/ALK-, first-line
Ivacaftor (19) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), patients <12 years (heterozygous for F508del and Gating mutation (incl. R117H))
Isatuximab (2) Sarclisa® Sanofi-​Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), pretreated, combination with Pomalidomid and Dexamethason
Isatuximab Sarclisa® Sanofi-​Aventis Deutschland GmbH Oncological diseases Multiple myeloma (MM), pretreated
Lanadelumab (2, reassessment >€50m) Takhzyro® Takeda GmbH Other diseases ORPHAN Hereditary angioedema, prophylaxis, ≥ 12 years
Onasemnogen-​Abeparvovec Zolgensma® Novartis Gene Therapies EU Limited Nervous system diseases ORPHAN 5q-​associated spinal musular atrpohy (SMA)
Obinutuzumab (6, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL), first line
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Chronic lymphocytic leukemia (CLL)
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL)
Cannabidiol (5) Epidyolex® GW Pharmaceuticals plc Other diseases ORPHAN Seizures in relation to tuberous sclerosis
Cabotegravir Vocabria® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pretreated, combination with Rilpivirin
Erenumab (2, reassessment) Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis
Risdiplam Evrysdi® Roche Pharma AG Musculoskeletal system diseases ORPHAN 5q-assoziated spinal Muskelatrophia (SMA)
Cabozanitinib (6, Cabometyx®) Cabometyx® Ipsen Pharma GmbH Oncological diseases Renal cell carcinoma (RCC), first line, combination with Nivolumab
Nivolumab (16) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Renal cell carcinoma (RCC) , first line, combination with Cabozantinib
Rilpivirin (3, Rekambys®) Rekambys® ViiV Healthcare GmbH Infectious diseases HIV-1 infection, pretreated, combination with Cabotegravir
Atidarsagen autotemcel OTL-200 Libmeldy® Orchard Therapeutics GmbH Metabolic diseases ORPHAN Metachromatic leucodystrophia
Pemigatinib Pemazyre® Incyte Biosciences Germany GmbH Oncological diseases ORPHAN Cholangiocarcinoma, pretreated
Nivolumab (15) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Melanoma, adjuvant therapy
Natrium-Zirkonium-Cyclosilikat Lokelma® AstraZeneca GmbH Metabolic diseases Hyperkalemia
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 Immune thrombocytopenia
Fostemsavir Rukobia® ViiV Healthcare GmbH Infectious diseases HIV infection, multi-resistant
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 Urothelial carcinoma (UC), 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 Multi-resistant pulmonary tuberculosis
Imlifidase Idefirix® Hansa Biopharma AB Other diseases ORPHAN Desensitization after kidney transplantation
Fedratinib Inrebic® Celgene GmbH Oncological diseases ORPHAN Myelofibrosis (MF)
Tucatinib Tukysa® Seagen Germany GmbH Oncological diseases Mamma carcinoma (BC), pretreated, combination with Trastuzumab and Capecitabin
Selpercatinib Retsevmo® Lilly Deutschland GmbH Oncological diseases Medullary thyroid carcinoma (MTC), pretreated
Selpercatinib (2) Retsevmo® Lilly Deutschland GmbH Oncological diseases Medullary thyroid carcinoma (MTC), pretreated, > 12 years
Selpercatinib (3) Retsevmo® Lilly Deutschland GmbH Oncological diseases Medullary thyroid carcinoma (MTC), pretreated with Sorafenib and/or Lenvatinib
Avelumab (4) Bavencio® Merck Serono GmbH und Pfizer Pharma GmbH Oncological diseases Urothelial 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 treatment, combination therapy
Beclometason / Formoterol / Glycopyrronium Trimbow® Chiesi GmbH Respiratory system diseases Asthma
Baloxavir marboxil (2) Xofluza® Roche Pharma AG Infectious diseases Influenza prophylaxis
Baloxavir marboxil Xofluza® Roche Pharma AG Infectious diseases Influenza
Autologe Anti-CD19-transduzierte CD3-positive Zellen Tecartus® Gilead Sciences GmbH Oncological diseases ORPHAN Mantle cell lymphoma (MCL), pretreated
Acalabrutinib (3) Calquence® AstraZeneca GmbH Oncological diseases Chronic lymphocytic leukemia (CLL), pretreated