Respiratory system diseases

The therapeutic area of respiratory diseases includes diseases such as asthma, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF). In this area, the G-BA has assessed xx medicinal products in xx procedures. The G-BA has found a major additional benefit for xx% and a considerable additional benefit for XX% of the subpopulations weighted according to patient shares in the respective resolution and in relation to the comparative therapy. The G-BA has identified a minor additional benefit for XX% and a non-quantifiable additional benefit for another XX%. No additional benefit was shown for XX% of the subpopulations and less benefit has been identified for a further xx% in relation to the comparative therapy. According to resolutions by the G-BA, xx% of the maximum of the xx million patients treatable with the evaluated medicinal products do not benefit from these medicinal products.

All G-BA resolutions concerning respiratory system diseaeses

Tezepelumab (2) Tezspire® AstraZeneca GmbH Respiratory system diseases Chronic rhinosinusitis with nasal polyps 10,500–12,600 100% Hint for non-quantifiable additional benefit
Nintedanib (Ofev, 6) Ofev® Boehringer Ingelheim Pharma GmbH Respiratory system diseases Interstitial lung disease with systemic sclerosis, 6 to < 18 years of age 0–8 100% additional benefit not proven
Nintedanib (Ofev, 5) Ofev® Boehringer Ingelheim Pharma GmbH Respiratory system diseases Clinically significant progressive fibrosing interstitial lung disease, 6 to < 18 years of age 1–35 100% additional benefit not proven
Dupilumab (10) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases COPD 9,370 71% Indication of minor additional benefit
Olopatadin / Mometason (1) Ryaltris® Berlin-Chemie AG Respiratory system diseases Allergic rhinitis 3,807,000–7,356,000 100% additional benefit not proven
Tezepelumab (1) Tezspire® AstraZeneca GmbH Respiratory system diseases Bronchial asthma (AB), ≥ 12 years 42,300–46,700 100% additional benefit not proven
Dupilumab (6) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Asthma bronchiale, ≥ 6 until ≤ 11 years 150–860 100% additional benefit not proven
Mepolizumab (3) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic rhinosinusitis with nasal polyps 10,500–12,600 100% additional benefit not proven
Beclometason / Formoterol / Glycopyrronium (1) Trimbow® Chiesi GmbH Respiratory system diseases Asthma 0
290,000
100% additional benefit not proven repealed
Nintedanib (Ofev, 3) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Interstitial pulmonary disease with systemic sclerosis 200–10,700 100% additional benefit not proven
Nintedanib (Ofev, 4) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Progressive fibrosing interstitial lung diseases 4,500–11,400 100% Indication of minor additional benefit
Indacaterol / Mometason (1) Atectura Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 1,000,000–1,100,000 100% additional benefit not proven
Dupilumab (4) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Chronic rhinosinusitis with nasal polyps 10,500–12,600 100% Indication of considerable additional benefit
Dupilumab (2) Dupixent® Sanofi-Aventis Deutschland GmbH Respiratory system diseases Bronchial asthma, ≥ 12 years 17,560–54,300 100% additional benefit not proven
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat (1) Enerzair Breezhaler® Novartis Pharma GmbH Respiratory system diseases Bronchial asthma 100,000 100% additional benefit not proven
Nintedanib (Ofev, 2) Ofev® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Idiopathic pulmonary fibrosis 1,800–18,900 100% Hint for considerable additional benefit Orphan (turnover limit)
Fluticasonfuroat / Umeclidinium / Vilanterol (Trelegy Ellipta, Elebrato Ellipta, 1) Trelegy Ellipta, Elebrato Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD), inadequate control with LAMA and LABA 524,000–1,217,000 100% additional benefit not proven
Mepolizumab (2) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, ≥ 6 to < 18 years 2,200–3,500 100% additional benefit not proven
Fluticasonfuroat / Umeclidinium / Vilanterol (1) Trelegy Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 404,000–1,227,000 100% additional benefit not proven
Benralizumab (1) Fasenra® AstraZeneca GmbH Respiratory system diseases Bronchial asthma 6,800–80,000 50% Hint for minor additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat (2) Relvar Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma n.d. 100% additional benefit not proven
Reslizumab (1) Cinqaero® Teva GmbH Respiratory system diseases Bronchial asthma 4,800–12,000 50% Hint for minor additional benefit
Umeclidinium (1) Incruse® GlaxoSmithKline GmbH & Co KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,342,000–2,765,000 100% additional benefit not proven
Mepolizumab (1) Nucala® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma 16,000–100,000 50% Hint for minor additional benefit
Aclidiniumbromid (2) Eklira Genuair, Bretaris Genuair® AstraZeneca GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,342,800–2,768,200 6% Indication of considerable additional benefit
Tiotropium / Olodaterol (1) Spiolto Respimat® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,342,000–2,780,000 92% Indication of minor additional benefit
Nintedanib (Ofev, 1) Ofev® Boehringer Ingelheim Pharma GmbH & Co KG Respiratory system diseases Idiopathic pulmonary fibrosis 0
2,080–19,700
100% minor additional benefit Orphan repealed
Aclidiniumbromid / Formoterol (1) Duaklir Genuair, Brimica Genuair® AstraZeneca GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,339,200–2,762,500 6% Indication of considerable additional benefit
Umeclidinium / Vilanterol (1) Anoro, Laventair® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,359,600–2,941,700 100% additional benefit not proven
Olodaterol (1) Striverdi Respimat® Boehringer Ingelheim Pharma GmbH & Co. KG Respiratory system diseases Chronic obstructive pulmonary disease (COPD) n.d. 100% additional benefit not proven
Indacaterol / Glycopyrronium (1) Ultibro Breezhaler, Xoterna Breezhaler® Novartis Pharma GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 2,359,628–2,949,660 5% Indication of minor additional benefit
Fluticasonfuroat / Vilanterol-Trifenatat (1) Relvar Ellipta® GlaxoSmithKline GmbH & Co. KG Respiratory system diseases Bronchial asthma, COPD n.d. 100% additional benefit not proven
Aclidiniumbromid (1) Eklira Genuair, Bretaris Genuair® Almirall Hermal GmbH Respiratory system diseases Chronic obstructive pulmonary disease (COPD) 0
2,400,000–2,800,000
100% additional benefit not proven repealed
Pirfenidon (1) Esbriet® InterMune Deutschland GmbH Respiratory system diseases Idiopathic pulmonary fibrosis 6,000 100% non-quantifiable additional benefit Orphan