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

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

Bracknell, UK, 7 June 2021 – The Scottish Medicines Consortium (SMC) has today announced that Ofev^® (nintedanib) has been accepted for use by NHSScotland for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).[i]

Following this positive advice, nintedanib will be made available for NHS use in Scotland, and people living with PF-ILD in Scotland will have access to the first licensed treatment for this devastating, life-limiting disease.[ii] Until now, patients with PF-ILD had no licensed treatments available that effectively modified the course of their disease.

“We are delighted with today’s SMC decision, which offers real hope to people in Scotland living with PF-ILD who for so long have felt powerless with the huge physical and emotional burden of living with this debilitating disease, and while it steadily worsens,” said Steve Jones, Chair of Trustees, Action for Pulmonary Fibrosis. “It is encouraging that they will now have a treatment that can slow its progress.”

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

which is characterised by worsening lung function, breathlessness, physical performance and quality of life and early death.2^,3,[vi] PF-ILD has variable prognoses,2^,3,5 and some can be much worse than many cancers.[vii]^,[viii]

Dr Owen Dempsey, Consultant Respiratory Physician, Aberdeen Royal Infirmary said: “The SMC’s positive announcement regarding nintedanib means that we will soon have available the first licensed treatment for people living with chronic fibrosing interstitial lung diseases with a progressive phenotype.  This will advance the clinical management of patients with this debilitating condition, by providing a treatment in what is currently a complex and challenging disease to manage.”

“Today’s positive recommendation by SMC means that nintedanib will be available through NHSScotland to people living with PF-ILD in Scotland, whose everyday lives can be significantly affected by this progressive disease. We look forward to collaborating with health boards across Scotland to ensure optimal access to nintedanib as part of local PF-ILD service provision,” said Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.  “The next step for Boehringer Ingelheim is to try to ensure that PF-ILD patients in England, Wales, Northern Ireland and Ireland have the same level of access to nintedanib.”

The clinical efficacy and safety of nintedanib for 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 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^,[ix] The 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^,9

Nintedanib was licensed for the treatment of adults with chronic fibrosing interstitial lung diseases with a progressive phenotype in July 2020 across the European Union.