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.2On average,13-40% of patients with ILD might develop a progressive fibrosing phenotype.3Patients 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
Notes to Editor:
About Ofev® (nintedanib)
Nintedanib is an anti-fibrotic medicine licensed and available for use in the UK and Ireland for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 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).10
About the INBUILD® trial
INBUILD® is 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 reduced the rate of decline in FVC over 52 weeks (mL/year) by 57%* compared with placebo regardless of the underlying disease.6 The adjusted annual rate of decline was -80.8 mL/year with nintedanib compared to -187.8 mL/year with placebo (difference: 107.0 mL/year [95% CI: 65.4 to 148.5]; p<0.001), in the overall population.6 The trial also demonstrated a similar treatment effect for nintedanib in patients with PF-ILD as with IPF regardless of the underlying cause of the disease.6,11The safety profile observed in INBUILD® was similar to that seen in nintedanib trials in IPF, with diarrhoea, vomiting and nausea being the most common adverse events in the nintedanib group.6,11
* 57% (between-group difference as a percentage of placebo) is calculated from the trial results showing that in the overall population, the adjusted rate of decline in the FVC was −80.8 ml per year with nintedanib and −187.8 ml per year with placebo, for a between-group difference of 107.0 ml per year (95% confidence interval [CI], 65.4 to 148.5; P<0.001).
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[i]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
7 Office for National Statistics. 2019. Cancer survival in England: adult, stage at diagnosis and childhood - patients followed up to 2018. Available at: www.ons.gov.uk/peoplepopulationandcomFmunity/healthandsocialcare/conditi.... Last accessed June 2021
8 Su R et al. 2011. An analysis of connective tissue disease-associated interstitial lung disease at a US Tertiary Care Center: better survival in patients with systemic sclerosis. J Rheumatol.;38(4):693-701
9 SMC advice on nintedanib. Available at: https://www.scottishmedicines.org.uk/medicines-advice/?active-tab=0&node-id=6990&keywords=ofev&filter-3561=&filter-3567=&filter-3803=&from=&to=&total-results-0=2&total-results-1=0
10 EMA. SmPC. Ofev 100mg and 150mg soft capsules. Accessed October 2021. Available at: https://www.medicines.org.uk/emc/product/7705 Accessed June 2021.
11 Richeldi L et al. 2014. Efficacy and safety of nintedanib in Idiopathic Pulmonary Fibrosis. New England Journal of Medicine. 370. 2071-2082
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