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

Start Resolution Procedure (no.) Brand name Pharm. company Therapeutic area Indication
Olopatadin/Mometason Ryaltris® Berlin-Chemie AG Respiratory system diseases Allergic rhinitis (diseases of the respiratory system)
Maribavir Livtencity® Takeda GmbH Infectious diseases ORPHAN Cytomegalovirus infection (CMI), refractory to therapy
Tezepelumab Tezspire® AstraZeneca GmbH Respiratory system diseases Bronchial asthma (AB), ≥ 12 years
Tralokinumab (2) Adtralza® LEO Pharma GmbH Skin diseases Atopic dermatitis (AD), 12 to < 18 years
Axicabtagen-Ciloleucel (5) Yescarta® Gilead Sciences GmbH Oncological diseases ORPHAN Follicular lymphoma (FL), after ≥ 3 prior therapies
Axicabtagen-Ciloleucel (4) Yescarta® Gilead Sciences GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL) and highly malignant B-cell lymphoma, relapsed within 12 months after first-line therapy or refractory
Daridorexant Quviviq® Idorsia Pharmaceuticals Germany GmbH Mental illnesses Sleep disorders (mental illnesses)
Ravulizumab (4) Ultomiris® Alexion Pharma Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+
Olaparib (9, reassessment) Lynparza® AstraZeneca GmbH Oncological diseases Ovarian carcinoma (OC), fallopian tube carcinoma or primary peritoneal carcinoma, FIGO stages III and IV, HRD-positive, maintenance therapy, combination with bevacizumab
Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (3) Genvoya® Gilead Sciences GmbH Infectious diseases HIV infection, 2 to < 6 years
Tixagevimab / Cilgavimab Evusheld® AstraZeneca GmbH Infectious diseases COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre
Faricimab (2) Vabysmo® Roche Pharma AG Eye diseases Neovascular age-related macular degeneration (AMD)
Remdesivir (4) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg)
Remdesivir (3) Veklury® Gilead Sciences GmbH Infectious diseases COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years
Vutrisiran Amvuttra® Alnylam Germany GmbH Metabolic diseases ORPHAN Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2))
Relugolix Orgovyx® Accord Healthcare GmbH Oncological diseases Prostate carcinoma (PC), advanced, hormone-sensitive
Lonafarnib Zokinvy® EigerBio Europe Ltd Other diseases ORPHAN Hutchinson-Gilford progeria syndrome or progeroid laminopathy, 12 months and over
Faricimab Vabysmo® Roche Pharma AG Eye diseases Diabetic macular edema (DME)
Lisocabtagen maraleucel Breyanzi® Bristol-Myers Squibb GmbH Oncological diseases ORPHAN Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma and follicular lymphoma (PMBCL) grade 3B, after ≥ 2 prior therapies
Brexucabtagene-Autoleucel (2) Tecartus® Gilead Sciences GmbH Oncological diseases ORPHAN B-cell acute lymphoblastic leukaemia (ALL), aged > 26
Pertuzumab / Trastuzumab (4, reassessment) Phesgo® Roche Pharma AG Oncological diseases Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy
Selpercatinib (5) Retsevmo® Lilly Deutschland GmbH Oncological diseases Thyroid carcinoma (MTC), RET-mutated, monotherapy, 12 years and older
Melphalanflufenamid Pepaxti® Oncopeptides AB Oncological diseases Multiple myeloma (MM) after at least 3 previous therapies, combination with dexamethasone)
Asciminib Scemblix® Novartis Pharma GmbH Oncological diseases ORPHAN Chronic myeloid leukaemia (CLL), Ph+, after ≥ 2 prior therapies
Olipudase alfa Xenpozyme® Sanofi-Aventis Deutschland Metabolic diseases ORPHAN Acid sphingomyelinase deficiency (ASDM) type A/B or type B
Difelikefalin Kapruvia® Fresenius Medical Care Nephrologica Deutschland GmbH Skin diseases Pruritus in chronic kidney disease (CKD), haemodialysis patients
Selinexor Nexpovio® Stemline Therapeutics B.V. Oncological diseases Multiple myeloma (MM) at least 4 prior therapies, combination with dexamethasone
Selinexor (2) Nexpovio® Stemline Therapeutics B.V. Oncological diseases Multiple myeloma (MM) at least 1 prior therapy, combination with bortezomib and dexamethasone
Pertuzumab (4, reassessment) Perjeta® Roche Pharma AG Oncological diseases Breast carcinoma (BC), early with high risk of recurrence, adjuvant therapy, combination with trastuzumab and chemotherapy
Valoctocogene roxaparvovec Roctavian® BioMarin International Ltd. Hematopoietic diseases ORPHAN Hemophilia A
Burosumab (6) Crysvita® Kyowa Kirin GmbH Metabolic diseases ORPHAN FGF23-related hypophosphatemia in tumour-induced osteomalacia
Efgartigimod alfa Vyvgart® Argenx Germany GmbH Nervous system diseases ORPHAN Myasthenia gravis, AChR antibody+
Eptinezumab Vyepti® Lundbeck GmbH Nervous system diseases Migraine prophylaxis
Olaparib (8) Lynparza® AstraZeneca GmbH Oncological diseases Breast carcinoma (BC), HER2, BRCA1/2 mutation, pre-treated, high risk of recurrence, adjuvant, monotherapy or combination with chemotherapy.
Upadacitinib (6) Rinvoq® AbbVie Deutschland GmbH & Co. KG Digestive system diseases Ulcerative colitis (UC), pre-treated
Upadacitinib (5) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Axial spondyloarthritis (AS), non-radiographic
Birkenrindenextrakt Filsuvez® Amryt Pharma GmbH Other diseases ORPHAN Wound treatment in epidermolysis bullosa (from 6 months))
Ceftolozan / Tazobactam (7) Zerbaxa® MSD Sharp & Dohme GmbH Infectious diseases Bacterial infections, multiple indications, < 18 years of age
Capmatinib Tabrecta® Novartis Pharma GmbH Oncological diseases Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
Eladocagene Exuparvovec Upstaza® PTC Therapeutics International Limited Metabolic diseases ORPHAN Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months
Trastuzumab Deruxtecan (2) Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Breast carcinoma (BC), HER2+, after 1 prior therapy
Trastuzumab Deruxtecan Enhertu® Daiichi Sankyo Deutschland GmbH Oncological diseases Breast carcinoma (BC), HER2+, at least 2 previous therapies
Pembrolizumab (30) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Renal cell carcinoma (RCC), adjuvant, monotherapy, pre-treated patients
Pembrolizumab (29) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Colorectal cancer (CRC)) with MSI-H or with dMMR, after fluoropyrimidine-based combination therapy.
Pembrolizumab (28) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Endometrial carcinoma with MSI-H or with dMMR , pre-treated
Pembrolizumab (27) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Gastric carcinoma with MSI-H or dMMR, pre-treated
Pembrolizumab (26) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Small bowel carcinoma with MSI-H or dMMR, pre-treated
Pembrolizumab (25) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Biliary carcinoma with MSI-H or dMMR, pre-treated
Pembrolizumab (24) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Cervical carcinoma, PD-L1 expression ≥ 1 (CPS), combination with or without bevacizumab
Pembrolizumab (23) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, adjuvant therapy, ≥ 12 years, monotherapy
Pembrolizumab (22) Keytruda® MSD Sharp & Dohme GmbH Oncological diseases Melanoma, ≥ 12 to < 18 years
Glycopyrronium Axhidrox® Dr. August Wolff GmbH & Co. KG Arzneimittel Other diseases Severe primary axillary hyperhidrosis
Inebilizumab Uplizna® Horizon Therapeutics GmbH Nervous system diseases Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
Eravacyclin Xerava® PAION Deutschland GmbH Infectious diseases Reserve antibiotics: Complicated intra-abdominal infections (cIAI)
Atezolizumab (10) Tecentriq® Roche Pharma AG Oncological diseases Non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50 % of TC, EGFR/ALK negative, adjuvant therapy after resection and chemotherapy.
Secukinumab (7) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Enthesitis-associated arthritis (EAA)
Secukinumab (8) Cosentyx® Novartis Pharma GmbH Skin diseases Juvenile psoriatic arthritis (PA), ≥ 6 years
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