15.02.2025
07.08.2025
Nintedanib (7, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH
Respiratory system diseases
Interstitial lung disease with systemic sclerosis, 6 to < 18 years of age
0–8
100%
no additional benefit
15.02.2025
07.08.2025
Nintedanib (6, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH
Respiratory system diseases
Clinically significant progressive fibrosing interstitial lung disease, 6 to < 18 years of age
1–35
100%
no additional benefit
01.08.2024
06.02.2025
Dupilumab (10)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
COPD
9,370
71%
Indication of
minor additional benefit
01.12.2022
01.06.2023
Olopatadin / Mometason
Ryaltris®
Berlin-Chemie AG
Respiratory system diseases
Allergic rhinitis
3,807,000–7,356,000
100%
no additional benefit
15.11.2022
12.05.2023
Tezepelumab
Tezspire®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma (AB), ≥ 12 years
42,300–46,700
100%
no additional benefit
15.04.2022
06.10.2022
Dupilumab (6)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Asthma bronchiale, ≥ 6 until ≤ 11 years
150–860
100%
no additional benefit
01.12.2021
19.05.2022
Mepolizumab (4)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic rhinosinusitis with nasal polyps
10,500–12,600
100%
no additional benefit
15.02.2021
05.08.2021
Beclometason / Formoterol / Glycopyrronium
Trimbow®
Chiesi GmbH
Respiratory system diseases
Asthma
0
290,000
100%
no additional benefit
15.08.2020
04.02.2021
Nintedanib (5, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Interstitial pulmonary disease with systemic sclerosis
200–10,700
100%
no additional benefit
15.08.2020
04.02.2021
Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat
Enerzair® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
100,000
100%
no additional benefit
15.08.2020
04.02.2021
Nintedanib (4, Ofev®)
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
01.07.2020
03.09.2020
Indacaterol / Mometason
Atectura® Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Bronchial asthma
1,000,000–1,100,000
100%
no additional benefit
01.12.2019
14.05.2020
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
01.09.2019
20.02.2020
Dupilumab (2)
Dupixent®
Sanofi-Aventis Deutschland GmbH
Respiratory system diseases
Bronchial asthma, ≥ 12 years
17,560–54,300
100%
no additional benefit
15.04.2019
17.10.2019
Nintedanib (3, reassessment >€50m, Ofev®)
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)
15.11.2018
02.05.2019
Fluticasonfuroat / Umeclidinium / Vilanterol (2)
Trelegy 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%
no additional benefit
01.10.2018
22.03.2019
Mepolizumab (2)
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, ≥ 6 to < 18 years
2,200–3,500
100%
no additional benefit
01.03.2018
16.08.2018
Fluticasonfuroat / Umeclidinium / Vilanterol
Trelegy Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
404,000–1,227,000
100%
no additional benefit
15.02.2018
02.08.2018
Benralizumab
Fasenra®
AstraZeneca GmbH
Respiratory system diseases
Bronchial asthma
6,800–80,000
50%
Hint for
minor additional benefit
15.02.2018
02.08.2018
Fluticasonfuroat / Vilanterol-Trifenatat (2, reassessment)
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
0
resolution w/o assessement
15.01.2017
06.07.2017
Reslizumab
Cinqaero®
Teva GmbH
Respiratory system diseases
Bronchial asthma
4,800–12,000
50%
Hint for
minor additional benefit
01.02.2016
21.07.2016
Umeclidinium
Incruse®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,342,000–2,765,000
100%
no additional benefit
01.02.2016
21.07.2016
Mepolizumab
Nucala®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma
16,000–100,000
50%
Hint for
minor additional benefit
15.10.2015
07.04.2016
Aclidiniumbromid (2, reassessment)
Eklira® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,342,800–2,768,200
6%
Indication of
considerable additional benefit
15.08.2015
04.02.2016
Tiotropium / Olodaterol
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
15.03.2015
03.09.2015
Nintedanib (2, Ofev®)
Ofev®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Idiopathic pulmonary fibrosis
0
2,080–19,700
100%
minor additional benefit
Orphan
01.02.2015
16.07.2015
Aclidiniumbromid / Formoterol
Duaklir® Genuair®
AstraZeneca GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,339,200–2,762,500
6%
Indication of
considerable additional benefit
15.07.2014
08.01.2015
Umeclidinium / Vilanterol
Anoro®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,359,600–2,941,700
100%
no additional benefit
15.05.2014
17.07.2014
Olodaterol
Striverdi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
0
100%
no additional benefit
15.11.2013
08.05.2014
Indacaterol / Glycopyrronium
Ultibro Breezhaler®
Novartis Pharma GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
2,359,628–2,949,660
5%
Indication of
minor additional benefit
01.01.2014
20.03.2014
Fluticasonfuroat / Vilanterol-Trifenatat
Relvar® Ellipta®
GlaxoSmithKline GmbH & Co. KG
Respiratory system diseases
Bronchial asthma, COPD
0
100%
no additional benefit
01.10.2012
21.03.2013
Aclidiniumbromid
Eklira® Genuair®
Almirall Hermal GmbH
Respiratory system diseases
Chronic obstructive pulmonary disease (COPD)
0
2,400,000–2,800,000
100%
no additional benefit
15.09.2011
15.03.2012
Pirfenidon
Esbriet®
InterMune Deutschland GmbH
Respiratory system diseases
Idiopathic pulmonary fibrosis
6,000
100%
non-quantifiable additional benefit
Orphan