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

Start Resolution Procedure (no.) Brand name Pharm. company Therapeutic area Indication
Mosunetuzumab Lunsumio® Roche Pharma AG Oncological diseases ORPHAN Follicular lymphoma (FL), after ≥ 2 prior therapies
Pembrolizumab (21) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy
Selpercatinib (4) Retsevmo® Lilly Deutschland GmbH Oncological diseases Non-small cell lung cancer (NSCLC), RET fusion+, first-line
Palbociclib (3, reassessment) Ibrance® Pfizer Pharma GmbH Oncological diseases Breast carcinoma (BC) , patient population a1
Nirmatrelvir / Ritonavir Paxlovid® Pfizer Pharma GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression
Cerliponase alfa (2, reassessment) Brineura® BioMarin Deutschland GmbH Metabolic diseases ORPHAN Neuronal ceroid lipofuscinosis (NCL) type 2
Enfortumab Vedotin Padcev® Astellas Pharma Europe B.V Oncological diseases Urothelial carcinoma (UC) pre-treated with platinum-based chemotherapy and PD-(L)1 inhibitor
Setmelanotide Imcivree® Rhythm Pharmaceuticals Inc. Metabolic diseases ORPHAN Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years.
Cabozantinib (8) Cabometyx® Ipsen Pharma GmbH Oncological diseases Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
Polatuzumab Vedotin (2) Polivy® Roche Pharma AG Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP)
Tisagenlecleucel (5) Kymriah® Novartis Pharma GmbH Oncological diseases ORPHAN Follicular lymphoma (FL), pre-treated patients
Axicabtagen-Ciloleucel (3, reassessment) Yescarta® Gilead Sciences GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma, after at least 2 prior therapies
Voxelotor Oxbryta® Global Blood Therapeutics Germany GmbH Hematopoietic diseases ORPHAN Haemolytic anaemia in sickle cell disease, monotherapy or combination with hydroxycarbamide, ≥ 12 years.
Sotrovimab Xevudy® GlaxoSmithKline GmbH & Co. KG Infectious diseases COVID-19, ≥ 12 years
Tebentafusp Kimmtrak® Immunocore Ireland Ltd. Oncological diseases ORPHAN Uveales Melanom, HLA-A*02:01-positive
Brolucizumab (2) Beovu® Novartis Pharma GmbH Eye diseases Diabetic macular edema
Abemaciclib (5) Verzenios® Lilly Deutschland GmbH Oncological diseases Breast carcinoma(BC), HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy
Imipenem / Cilastatin / Relebactam Recarbrio® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications
Ceftolozan / Tazobactam (6) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications
Ceftazidim / Avibactam Zavicefta® Pfizer Pharma GmbH Infectious diseases Bacterial infections, multiple indications
Doravirin / Lamivudin / Tenofovirdisoproxil (2) Delstrigo® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years
Doravirin (2) Pifeltro® MSD Sharp & Dohme GmbH Infectious diseases HIV infection, 12 to < 18 years
Nivolumab (23) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Urothelial carcinoma (UC) PD-L1 expression ≥ 1 %, adjuvant therapy
Nivolumab (22) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy
Nivolumab (21) Opdivo® Bristol-Myers Squibb GmbH & Co. KGaA Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression ≥ 1, first-line, combination with ipilimumab
Casirivimab / Imdevimab Ronapreve® Roche Pharma AG Infectious diseases COVID-19-Infection, ≥ 12 years
Dupilumab (6) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Asthma bronchiale, ≥ 6 until ≤ 11 years
Glucarpidase Voraxaze® SERB GmbH Other diseases ORPHAN Reduction of toxic MTX plasma concentrations; children ≥ 28 days and adults.
Casirivimab / Imdevimab (2) Ronapreve® Roche Pharma AG Infectious diseases Post-exposure prophylaxis of COVID-19 infection, ≥ 12 years
Avapritinib (2) Ayvakyt® Blueprint Medicines (Germany) GmbH Oncological diseases ORPHAN Leukaemia, myeloid, acute (AML); mastocytosis; after at least 1 previous therapy
Anifrolumab Saphnelo® AstraZeneca GmbH Musculoskeletal system diseases Systemic lupus erythematosus (SLE)
Somatrogon Ngenla® Pfizer Pharma GmbH Metabolic diseases ORPHAN Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age
Dolutegravir (4, reassessment) Tivicay® ViiV Healthcare GmbH Infectious diseases HIV infection, age 6 to < 18 years
Voretigen Neparvovec (2, reassessment) Luxturna® Novartis Pharma GmbH Eye diseases ORPHAN Hereditary retinal dystrophy
Pegcetacoplan Aspaveli® Swedish Orphan Biovitrum GmbH Hematopoietic diseases ORPHAN Paroxysmal nocturnal haemoglobinuria (PNH), pre-treated patients
Idebenon (2, reassessment) Raxone® Chiesi GmbH Eye diseases ORPHAN Leber's hereditary optic neuropathy (LHOP)
Empagliflozin (4) Jardiance® Boehringer Ingelheim Pharma GmbH & Co. KG Cardiovascular diseases Chronic heart failure (CHF) with preserved ejection fraction
Daratumumab (9, reassessment) Darzalex® Janssen-Cilag Oncological diseases ORPHAN Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone
Brivaracetam (3) Briviact® UCB Pharma GmbH Nervous system diseases Focal seizures in epilepsy, additional therapy, 2 to < 4 years
Lorlatinib (2) Lorviqua® Pfizer Pharma GmbH Oncological diseases Non-small cell lung cancer (NSCLC), ALK+, first-line
Tepotinib Tepmetko® Merck Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
Vedolizumab (2) Entyvio® Takeda GmbH Digestive system diseases Antibiotic-refractory pouchitis, pre-treated patients
Ivacaftor / Tezacaftor / Elexacaftor (10) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
Ivacaftor / Tezacaftor / Elexacaftor (9) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
Ivacaftor / Tezacaftor / Elexacaftor (8) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH ORPHAN Treatment of patients with CF from 6 to 11 years of age who are are heterozygous for the F508del mutation in the CFTR gene and have an RF mutation on the second allele (patients with F508del/RF mutation). (patients with F508del/RF mutation).
Ivacaftor / Tezacaftor / Elexacaftor (7) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
Ivacaftor / Tezacaftor / Elexacaftor (6) Kaftrio® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
Ivacaftor (26) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutations)
Ivacaftor (25) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (hmoozygous for F508del mutations)
Ivacaftor (24) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del mutation)
Ivacaftor (23) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor/tezacaftor/elexacaftor
Ivacaftor (22) Kalydeco® Vertex Pharmaceuticals (Germany) GmbH Metabolic diseases ORPHAN Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor/tezacaftor/elexacaftor
Avacopan Tavneos® Vifor Pharma Deutschland GmbH Hematopoietic diseases ORPHAN Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide
Sotorasib Lumykras® Amgen Europe B.V. Oncological diseases Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
Sofosbuvir / Velpatasvir (3) Epclusa® Gilead Sciences GmbH Infectious diseases Chronic hepatitis C, ≥ 3 to < 6 years of age
Calcifediol Rayaldee® Fresenius Medical Care Nephrologica Deutschland GmbH Metabolic diseases Secondary hyperparathyroidism in chronic renal failure
Isofluran Sedaconda® Sedana Medical AB Other diseases Sedation of mechanically ventilated patients during intensive care therapy (ICT)
Burosumab (5, reassessment >€50m) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia, ≥ 18 years of age
Burosumab (4, reassessment >€50m) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN X-linked hypophosphatemia, ≥ 1 to < 18 years of age
Duvelisib (2) Copiktra® Secura Bio Limited Oncological diseases Follicular lymphoma (FL), after ≥ 2 prior therapies
Duvelisib Copiktra® Secura Bio Limited Oncological diseases Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies
Abrocitinib Cibinqo® Pfizer Pharma GmbH Skin diseases Atopic Dermatitis (AD)
Amivantamab Rybrevant® Janssen-Cilag GmbH Oncological diseases Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy
Remdesivir (2) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no need for supplementary oxygen, increased risk of severe progression
Lenvatinib (7) Kisplyx® Eisai GmbH Oncological diseases Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab
Lenvatinib (6) Lenvima® Eisai GmbH Oncological diseases Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab
Pembrolizumab (20) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib
Pembrolizumab (19) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib