Boehringer Ingelheim’s Ofev (nintedanib) has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of idiopathic pulmonary fibrosis (IPF) in adults with a forced vital capacity (FVC) above 80% predicted.
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients with a FVC value of 50% to 80% predicted, earlier in the course of their disease.
The recommendation follows clinical trial evidence demonstrating that Ofev slows the decline of lung function compared with placebo in patients with IPF with an FVC above 80%, with long-term evidence suggesting that this effect is maintained over time.
IPF is a chronic, progressive lung disease in which scarring occurs, making breathing more difficult and reducing quality of life. The disease course is variable and unpredictable, and over time the lung function of an IPF patient irreversibly declines, with a median survival of two to five years from diagnosis.
NICE estimated that more than 5,200 additional patients could be eligible to receive Ofev in its first year, following the recommendation.
Dr Nazia Chaudhuri, respiratory consultant with expertise in interstitial lung disease, University of Ulster, said: “The expanded recommended use of [Ofev] by NICE represents a major shift in the treatment of IPF.
“This decision will empower clinicians to treat IPF patients earlier in the course of their disease than we were able to before. We know that treatment for IPF with [Ofev] slows the decline in lung function, therefore this is very positive news for a group of patients with a high unmet need.”
Ofev is one of the first medicines to be recommended by NICE that went through part of its new proportionate approach to technology appraisals, aimed at providing patients with access to promising medicines sooner.
Through the new approach, which allows certain treatments to move through streamlined processes, the recommendation for Ofev was completed eight weeks faster than a standard appraisal of this type.
“The proportionate approach is designed to develop a flexible and pragmatic approach to appraisals, learning from our experience and responding to the increased need of guidance for the healthcare system,” said Helen Knight, interim director of medicines evaluation at NICE.