Musculoskeletal system diseases

The therapeutic area diseases of the musculoskeletal system is currently comprised of xx medicinal products with xx procedures regarding conditions such as arthritis, systemic lupus erythematosus (SLE) or rheumatoid arthritis. In its resolutions, the G-BA has divided the patients into xx subpopulations. If these are weighted according to their patient share in the resolution, xx% of the subpopulations have seen a major additional benefit, XX% have seen a considerable additional benefit and a further XX% of the subpopulations have seen a minor additional benefit in relation to the comparative therapy. While XX% of the subpopulations have been able to record a non-quantifiable additional benefit in relation to the comparative therapy, XX% of the subpopulations have shown no additional benefit. This corresponds to xx% of all xx million patients suitable for treatment with the assessed medicinal products.

All G-BA resolutions concerning musculoskeletal diseaeses

Ixekizumab (6) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Enthesitis-associated arthritis, ≥ 6 years 240–290 100% additional benefit not proven
Avacopan (2) Tavneos® Fresenius Medical Care Nephrologica Deutschland Musculoskeletal system diseases Granulomatosis with polyangiitis or microscopic polyangiitis, in combination with rituximab or cyclophosphamide 2,330–2,850 100% additional benefit not proven Orphan (turnover limit)
Givinostat (1) Duvyzat® ITF Pharma GmbH Musculoskeletal system diseases Duchenne muscular dystrophy, ≥ 6 years, in combination with a corticosteroid 270–400 100% Hint for non-quantifiable additional benefit Orphan
Upadacitinib (8) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Giant cell arteritis 13,100–15,900 20% Hint for minor additional benefit
Sarilumab (2) Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years 1,370–1,480 100% additional benefit not proven
Sarilumab (3) Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Polymyalgia rheumatica 10,300–14,200 100% additional benefit not proven
Benralizumab (2) Fasenra® AstraZeneca GmbH Musculoskeletal system diseases Eosinophilic granulomatosis with polyangiitis 90–1,360 100% additional benefit not proven
Abaloparatid (1) Eladynos® Theramex Germany GmbH Musculoskeletal system diseases Osteoporosis, postmenopausal women 484,000 100% additional benefit not proven
Vamorolon (1) Agamree® Santhera Pharmaceuticals GmbH Musculoskeletal system diseases Duchenne muscular dystrophy, ≥ 4 years 740–3,670 100% Hint for non-quantifiable additional benefit Orphan
Baricitinib (3) Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Polyarticular juvenile idiopathic Arthritis, RF+ or RF− polyarticular and expanded oligoarticular, ≥ 2 years 1,370–1,410 100% additional benefit not proven
Baricitinib (5) Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Enthesitis-associated arthritis, ≥ 2 years 330–390 100% additional benefit not proven
Bimekizumab (3) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis 16,800 100% additional benefit not proven
Bimekizumab (4) Bimzelx® UCB Pharma GmbH Musculoskeletal system diseases Axial spondyloarthritis, non-radiographic 19,500 100% additional benefit not proven
Voclosporin (1) Lupkynis® Otsuka Pharma GmbH Musculoskeletal system diseases Lupusnephritis 1,090–13,050 100% additional benefit not proven
Upadacitinib (6) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Axial spondyloarthritis (AS), non-radiographic 19,500 100% additional benefit not proven
Secukinumab (7) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Enthesitis-related arthritis (ERA) 240–290 100% additional benefit not proven
Anifrolumab (1) Saphnelo® AstraZeneca GmbH Musculoskeletal system diseases Systemic lupus erythematosus (SLE) 4,600–18,500 100% additional benefit not proven
Avacopan (1) Tavneos® Vifor Pharma Deutschland GmbH Musculoskeletal system diseases Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide 0
2,180–2,280
100% Hint for minor additional benefit Orphan repealed
Tofacitinib (7) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Ankylosing spondylitis (AS) 16,800 100% additional benefit not proven
Mepolizumab (4) Nucala® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Eosinophilic granulomatosis with polyangiitis 80–1,130 100% additional benefit not proven
Tofacitinib (6) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Polyarticular juvenile idiopathic arthritis, RF+ or RF polyarthritis and dilated oligoarthritis, and juvenile psoriatic arthritis, ≥ 2 years 1,450 100% additional benefit not proven
Tofacitinib (5) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA), pretreated patients, monotherapy or combination with methotrexate 27,100–93,500 100% additional benefit not proven
Upadacitinib (3) Rinvoq® AbbVie Deutschland GmbH & Co. KG Musculoskeletal system diseases Ankylosing spondylitis 7,800–16,800 100% additional benefit not proven
Filgotinib (1) Jyseleca® Gilead Sciences GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 89,710–193,750 33% Hint for minor additional benefit
Secukinumab (6) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Axial spondyloarthritis 19,500 100% additional benefit not proven
Ixekizumab (3) Taltz® Lilly Deutschland GmbH Musculoskeletal system diseases Axial spondyloarthritis 36,300 100% additional benefit not proven
Romosozumab (1) Evenity® UCB Pharma GmbH Musculoskeletal system diseases Osteoporosis (postmenopausal) 475,000 100% Indication of minor additional benefit
Upadacitinib (1) Rinvoq® AbbVie Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 88,709–188,210 34% Hint for considerable additional benefit
Belimumab (2) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 30–550 100% Hint for non-quantifiable additional benefit
Tofacitinib (2) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 0
29,490–63,815
100% additional benefit not proven repealed
Sarilumab (1) Kevzara® Sanofi-Aventis Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 87,300–184,470 34% Hint for considerable additional benefit
Tofacitinib (1) Xeljanz® Pfizer Pharma GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 0
87,300–184,470
100% additional benefit not proven repealed
Baricitinib (1) Olumiant® Lilly Deutschland GmbH Musculoskeletal system diseases Rheumatoid arthritis (RA) 87,300–184,470 100% additional benefit not proven
Ataluren (2) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 0
30–40
100% minor additional benefit Orphan repealed
Secukinumab (2) Cosentyx® Novartis Pharma GmbH Musculoskeletal system diseases Psoriatic arthritis (PA), Radiographic axial spondyloarthritis (AS)Psoriatic arthritis (PA), Bekhterev's disease 40,400–141,600 100% additional benefit not proven
Ataluren (1) Translarna® PTC Therapeutics International Limited Musculoskeletal system diseases Duchenne muscular dystrophy (DMD), ≥ 5 years 0
82–110
100% minor additional benefit Orphan repealed
Belimumab (1) Benlysta® GlaxoSmithKline GmbH & Co. KG Musculoskeletal system diseases Systemic lupus erythematosus 7,000 100% Indication of considerable additional benefit
Collagenase aus Clostridium histolyticum (1) Xiapex® Pfizer Pharma GmbH Musculoskeletal system diseases Dupuytren's contracture 35,000 100% additional benefit not proven