NICE issues positive recommendation for treatment with Ofev® (nintedanib) for adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD)

NICE issues positive recommendation for treatment with Ofev^® (nintedanib) for adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD)

Bracknell, UK, 18 October 2021 – The National Institute for Health and Care Excellence (NICE) has today announced that Ofev^® (nintedanib) is recommended 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]

This positive Final Appraisal Document (FAD) from NICE makes nintedanib the first and only reimbursed treatment in England and Wales for PF-ILD.¹

“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." said Steve Jones, Chair of Trustees, Action for Pulmonary Fibrosis.

Interstitial lung disease (ILD) describes a diverse collection of more than 200 lung disorders.² On average,13-40% of patients with ILD might develop a progressive fibrosing phenotype.³ Patients with PF-ILD typically have progressive, self-perpetuating scarring (fibrosing) of interstitial lung tissue,^3,5

which is characterised by worsening lung function, breathlessness, decrease in exercise capacity and poorer quality of life, and early death. ^3,4,6 PF-ILD has a variable prognosis, ^3,4,5 and can be much worse than many cancers.^7,8

“The approval of nintedanib for patients in England and Wales represents a major shift in the treatment of PF-ILD,” said Dr Nazia Chaudhuri, Consultant Respiratory Physician, Manchester University NHS Foundation Trust. “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.“

Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland, said, “We welcome NICE’s positive FAD recommendation, which means that nintedanib will now be made available in England and Wales for people living with PF-ILD. Boehringer Ingelheim remains committed to supporting clinicians and the people who live with PF-ILD, which is a very debilitating condition.”

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 

Nintedanib was licensed for the treatment of adults with chronic fibrosing interstitial lung diseases with a progressive phenotype in July 2020 in the UK and across the European Union. In June 2021, the Scottish Medicines Consortium (SMC) announced that nintedanib had been accepted for use by NHSScotland for the treatment of adult patients with PF-ILD.⁹