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New HTA Decisions in France
March 2021
Drug name
OFEV® (nintedanib)
Company
Boehringer Ingelheim France
Decision date
16/12/2020
Therapeutic area
Respiratory conditions
Therapeutic sub area
Respiratory conditions: general and other
Official notice date
22/01/2021
Reimbursement %
30
Decision (SMR)
Moderate
Decision (ASMR)
Minor improvement (IV)
Indication
OFEV® is indicated in adults for the treatment of progressive fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF), and for the treatment of diffuse systemic sclerosis-associated interstitial lung disease (SSC-ILD).
Decision Type
Extension of indication
Summary
The committee considered the actual benefit of OFEV® to be 'moderate' in the indication of the Marketing Authorization. OFEV® provides a minor improvement in actual benefit (ASMR IV) in the treatment of progressive fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF)*, and in the treatment of diffuse systemic sclerosis-associated interstitial lung disease (SSC-ILD)** considering: • the demonstration in a randomised, double-blind phase III study of the superiority of OFEV® compared to placebo but with a moderate amount of effect on an intermediate but clinically relevant primary endpoint (difference between the 2 groups of 107 ml / year*, 40.95 ml / year** on the annual rate of decline in forced vital capacity); • its satisfactory tolerance marked mainly by diarrhoea and experience of its use in other diffuse interstitial lung disease; • the medical need in this rare disease in the absence of a therapeutic alternative with Marketing Authorisation; but considering the absence of: • robust data in terms of survival of treated patients; • robust data in terms of quality of life in these diseases which have a strong impact on it; • long-term data in diseases which admittedly progress slowly; The committee proposed 30% reimbursement.