NICE recommends Ofev for the treatment of PF-ILD

NICE issues draft recommendation for Forxiga to treat kidney disease

The National Institute for Health and Care Excellence (NICE) has recommended Ofev® (nintedanib) for use in England and Wales for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).[i]

The positive Final Appraisal Document (FAD) from NICE makes nintedanib the first and only reimbursed treatment in England and Wales for PF-ILD.[1] Interstitial lung disease (ILD) describes a diverse collection of more than 200 lung disorders.[2]

The clinical efficacy and safety of nintedanib for the treatment of PF-ILD is supported by data from the INBUILD® trial, the first phase III, international, randomised, double-blind placebo-controlled trial to evaluate patients with a broad range of chronic fibrosing ILDs with a progressive disease behaviour. The INBUILD® trial found that nintedanib met the primary endpoint, significantly slowing disease progression, defined as an absolute decline in forced vital capacity (FVC) over 52 weeks in patients with PF-ILD vs placebo.[6] 

Steve Jones, Chair of Trustees, Action for Pulmonary Fibrosis said: “This is a landmark moment for patients with PF-ILD. Action for Pulmonary Fibrosis is delighted that a treatment option is now available for people living with this condition, which can be devastating for the people who live with it daily, as well as their families and carers. This is the news our patient community have been long waiting for.”

Dr Nazia Chaudhuri, Consultant Respiratory Physician, Manchester University NHS Foundation Trust said: “The approval of nintedanib for patients in England and Wales represents a major shift in the treatment of PF-ILD. PF-ILD is complex and challenging to treat, and at present we are only able to manage its symptoms. For the first time we now have a treatment we can use, which will be welcomed by clinicians trying to treat PF-ILD and their patients.”

[1] NICE Final Appraisal Document (FAD) for nintedanib. Available at Project information | Nintedanib for treating progressive fibrosing interstitial lung disease excluding idiopathic pulmonary fibrosis [ID1599] | Guidance | NICE

[2] Cottin V et al. 2018 Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev. 27:180076

[3] Olson A et al. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther; 38(2):854–867

[4] Kolb M and Vašáková M. 2019. The natural history of progressive fibrosing interstitial lung diseases. Respiratory Research. 20:57

[5] Wong, AW. et al. 2020. Progression of fibrosing interstitial lung disease. Respiratory research. 21(1). 32

[6] Flaherty KR et al. 2019. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med; 381:1718-1727