Nintedanib (Ofev, 5) – Ofev®
Clinically significant progressive fibrosing interstitial lung disease, 6 to < 18 years of age
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 12.02.2025 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Nintedanib |
| Brand name | Ofev® |
| Pharm. company | Boehringer Ingelheim Pharma GmbH |
| G-BA Procedure ID | D-1156 |
| ATC code | L01EX09 Other protein kinase inhibitors (L01EX) |
| ICD-10 codes (AIS) | J68.4Chronic respiratory conditions due to chemicals, gases, fumes and vapors, J70.1Fibrosis of lung following radiation, J70.3Chronic drug-induced interstitial lung disorders, J84.10, J84.80, J84.90 |
| Alpha-ID codes (AIS) | I111403Interstitial lung disease, I125488Interstitial lung disease due to surfactant protein C deficiency, I14551Chronic pulmonary fibrosis, I18927Pulmonary fibrosis due to radiation, I5278Chronic drug-induced interstitial lung disease, I86077Chronic pulmonary fibrosis due to inhalation of vapor |
| Therapeutic area | Respiratory system diseases Interstitial lung disease (ILD) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Ofev is used in children and adolescents aged 6 to 17 years for the treatment of clinically significant progressive fibrosing interstitial lung disease (ILD). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged 6 to 17 years with clinically significant progressive fibrosing interstitial lung diseases (ILDs) | Best Supportive Care |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (InPedILD) |
|---|---|
|
Study design
(best subpopulation) |
Evidence transfer |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the InPedILD study. This was a randomised, double-blind, parallel-group study comparing nintedanib with placebo, both administered in addition to standard therapy at the discretion of the doctor.
- To assess the additional benefit, the pharmaceutical manufacturer also draws on the INBUILD study involving adults, in addition to the InPedILD study, as part of an evidence transfer. The INBUILD study is a placebo-controlled, randomised, parallel-group study of nintedanib, which investigated adult patients with chronic, progressive fibrosing interstitial lung diseases.
Children and adolescents aged 6 to 17 years with clinically significant progressive fibrosing interstitial lung diseases (ILDs)
- For children and adolescents aged 6 to 17 years with clinically significant progressive fibrosing interstitial lung diseases (ILDs), additional benefit of nintedanib is not proven.
- mortality
- No deaths occurred during the course of the study.
- Morbidity – Acute exacerbation or death
- The pharmaceutical manufacturer provides analyses of the composite endpoint of acute exacerbations or death.
- For the endpoint of acute exacerbation or death, there is no statistically significant difference between the treatment groups.
- Morbidity – exercise capacity assessed using the 6-minute walk test (6MWT)
- In the study, the 6MWT was performed at baseline (week 0) and at weeks 24 and 52.
- Overall, therefore, the analyses submitted by the pU for the endpoint of exercise capacity, assessed using the 6MWT, are not suitable for the benefit assessment.
- Morbidity – Forced Vital Capacity (FVC)
- FVC is a prognostic indicator in pulmonary function testing and is therefore a surrogate parameter.
- The FVC is therefore not used for the present benefit assessment.
- Health-related quality of life – Paediatric Quality of Life Inventory (PedsQL)
- To assess health-related quality of life, the pharmaceutical manufacturer has provided data from the generic instrument, the Paediatric Quality of Life Inventory (PedsQL), which is used to measure the quality of life of children and adolescents.
- For the endpoint of health-related quality of life, as assessed using the PedsQL, there is no statistically significant difference between the treatment groups.
- Side effects – severe adverse events (SUEs) and discontinuation due to adverse events (UEs)
- For the endpoints SUEs and discontinuation due to AEs, there is no statistically significant difference between the treatment groups in either case.
- Side effects – liver and biliary disorders (SUEs), gastrointestinal disorders (UEs), diarrhoea (UEs)
- For the endpoints liver and biliary disorders (SUEs), gastrointestinal disorders (UEs) and diarrhoea (UEs), there was no statistically significant difference between the treatment groups in any case.
- Overall assessment
- For children and adolescents aged 6 to 17 years with clinically significant progressive fibrosing interstitial lung diseases, results from the InPedILD study comparing nintedanib with placebo, in each case in addition to standard therapy, are available for the benefit assessment.
- In the mortality category, no events occurred during the study. In the morbidity endpoint category, there was no statistically significant difference for the endpoint ‘acute exacerbation or death’. No suitable data are available for the endpoint ‘exercise capacity assessed using the 6-minute walk test (6MWT)’. For the category of health-related quality of life assessed using the PedsQL, there was no statistically significant difference between the treatment groups. In the category of side effects, there were also no statistically significant advantages or disadvantages.
- In summary, additional benefit is not proven for children and adolescents aged 6 to 17 years with clinically significant, progressive fibrosing interstitial lung diseases compared with the appropriate comparator therapy, best supportive care.
Courtesy translation only, please refer to the German original.
Associated procedures
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