NICE issues positive recommendation to expand use of Ofev® (nintedanib) in idiopathic pulmonary fibrosis

NICE issues positive recommendation to expand use of Ofev^® (nintedanib) in idiopathic pulmonary fibrosis

• Patients with life-limiting disease IPF will no longer wait until their lung function drops below 80% predicted forced vital capacity (FVC)[i]
• Early treatment of IPF is important due to poor prognosis, with median survival as low as three years after diagnosis, worse than many cancers[ii]
• Following Boehringer Ingelheim’s submission to review treatment for patients earlier in their disease progression, NICE followed a new proportionate approach to accelerate this appraisal.

Bracknell, UK, 14 December 2022 – Boehringer Ingelheim welcomes the National Institute for Health and Care Excellence (NICE) final draft guidance recommending Ofev^® (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF) in adults with a forced vital capacity (FVC) above 80% predicted. Published today, this positive recommendation means that patients will be eligible for nintedanib treatment earlier in the course of their disease, without having to wait for their lung function to irreversibly decline to FVC 80% predicted.

The appraisal for nintedanib in IPF with FVC over 80% predicted followed a new accelerated process, piloted under NICE’s Proportionate Approach to Technology Appraisals. Nintedanib is already recommended by NICE for use in adult IPF patients with a FVC between 50% and 80% predicted.[iii]

“The expanded recommended use of nintedanib by NICE represents a major shift in the treatment of IPF,” commented Dr Nazia Chaudhuri, Respiratory Consultant with expertise in interstitial lung disease, University of Ulster. “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 nintedanib slows the decline in lung function, therefore this is very positive news for a group of patients with a high unmet need.” 

IPF affects around 32,000 people in the UK and accounts for 1 in 100 deaths.[iv] It causes inflammation and progressive scarring of the lungs, making breathing more difficult and it decreases the amount of oxygen the lungs can supply to the body.[v] The disease course is variable and unpredictable, and over time the lung function of an IPF patient irreversibly declines.[vi] With the new NICE guidance, nintedanib will be the only recommended antifibrotic treatment for adults patients with a FVC above 80% predicted. 

“Action for Pulmonary Fibrosis has campaigned for expanding antifibrotic treatment access, and this announcement by NICE is a decision that many people with idiopathic pulmonary fibrosis and their families have been hoping for,” commented Steve Jones, Chair of Trustees for Action for Pulmonary Fibrosis (APF). “When someone receives the devastating diagnosis of IPF, they can soon be offered an effective treatment earlier in the course of the disease, without having to watch and wait for their lung function to deteriorate to FVC 80% predicted. This is positive news for IPF patients who experience considerable challenges in accessing care and live with an unpredictable, debilitating and relentlessly progressive lung disease.”

“We wholeheartedly welcome NICE’s positive recommendation to expand the use of nintedanib in adults with IPF. Patients will benefit from this decision,” added Dr Christoph Zehendner, Medical Director at Boehringer Ingelheim UK & Ireland. “With this progressive, chronic disease, patients sadly have a reduced life expectancy and it is crucial they receive their diagnosis and effective treatment as soon as possible. NICE has followed a proportionate review process to reach the final appraisal more quickly. We thank them for being responsive to the needs of patients in pursuing new and efficient ways to appraise medicines.”

Nintedanib is an antifibrotic treatment licensed and available for use in the UK and Ireland for the treatment of adults with idiopathic pulmonary fibrosis. It is also indicated in adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).[vii]

Boehringer Ingelheim has a long heritage in respiratory medicine and is committed to supporting patients with pulmonary fibrosis, as well as the patient organisations and clinicians, who together make such a meaningful difference in the lives of people living with IPF.

[i] National Institute for Health and Care Excellence. Nintedanib for treating idiopathic pulmonary fibrosis in people with a forced vital capacity above 80% predicted (part-review of technology appraisal guidance 379) [ID4062]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10975. Accessed: December 2022.

[ii] Vancheri C et al. Idiopathic pulmonary fibrosis: a disease with similarities and links to cancer biology. European Respiratory Journal. 2010 35: 496-504.

[iii] National Institute for Health and Care Excellence. Nintedanib for treating idiopathic pulmonary fibrosis

Technology appraisal guidance [TA379] Published: 27 January 2016. Available at: https://www.nice.org.uk/guidance/ta379. Accessed: December 2022.

[iv] Spencer LG, Loughenbury M, Chaudhuri N, et al. Idiopathic pulmonary fibrosis in the UK: analysis of the British Thoracic Society electronic registry between 2013 and 2019. ERJ Open Res 2021; 7: 00187-2020. Accessed at: https://openres.ersjournals.com/content/7/1/00187-2020

[v] NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Available at: www.nhlbi.nih.gov/health/health-topics/topics/ipf/. Last accessed: December 2022.

[vi] Raghu G., et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med. 2011;183:788–824.

[vii] Ofev^® (nintedanib) Summary of Product Characteristics. Available at www.medicines.org.uk.