UPDATED: Breaking News - NICE approve Nintedanib for use in PF-ILD, which includes SSc Interstitial Lung Disease

SRUK are pleased to announce that NICE have approved the use of Nintedanib in treating progressive fibrosing interstitial lung disease (PF-ILD)!

BREAKING NEWS

SRUK are pleased to announce that NICE have approved the use of Nintedanib in treating progressive fibrosing interstitial lung disease (PF-ILD). Your views on the realities of living with this condition helped SRUK to contribute to the success of the appraisal process.

Interstitial lung disease (ILD) is a leading cause of mortality for people with scleroderma, responsible for approximately 35% of deaths. Nintedanib reduces the fibrosis which causes ILD, benefiting many people through slowing decline in their lung function, thereby improving both quality and duration of life.

NICE approve Nintedanib for Use in PF-ILD, Which Includes SSc Interstitial Lung Disease

Lung Fibrosis in Scleroderma

Scleroderma causes inflammation and scarring in the walls of the small air sacks within the lungs, which is the leading cause of mortality, responsible for approximately 35% of deaths in people living with scleroderma. A way to stop that fibrosis is essential to improve the quality of life, and mortality rates in people with scleroderma associated lung fibrosis.

What is Nintedanib?

Nintedanib is an oral medication which is currently used to treat idiopathic pulmonary fibrosis and scleroderma associated interstitial lung disease. These are fibrosing conditions where the tissue in the lungs becomes thick and stiff, impacting a person’s ability to breathe over time.

The licencing of any drug is complex, and occurs in stages. Ongoing clinical trials at different stages have supported different approvals for use of Nintedanib in various fibrosing lung conditions, as these usually have to be approved separately, rather than collectively.

TIMELINE

2014, May - (published) INPULSIS trial – Assessing the efficacy and safety of Nintedanib on idiopathic pulmonary fibrosis
2014, October – FDA approval for treatment of idiopathic pulmonary fibrosis (IPF) in the USA
2016 – Approved by NICE for the treatment of idiopathic pulmonary fibrosis (IPF)
2019 – SENSCIS trial – assessing the safety and tolerability of Nintedanib in people with SSc-ILD (phase 3, double blind). Showed that Nintedanib is able to effectively slow fibrosis, therefore slow the loss of lung function. Tested in 288 people
2019, September – FDA approval for treatment of SSc associated interstitial lung disease (SSc-ILD) in the USA
2020, February - Approved by the European Commission for use in SSc associated interstitial lung disease (SSc-ILD)
2020, March (published) INBUILD trial – Assessing the effect of Nintedanib on various interstitial lung diseases that were progressive and caused fibrosis. Randomized, double blind.
2021, October– NICE recommend Nintedanib for use in treatment of chronic fibrosing interstitial lung diseases with progressive phenotype (PF-ILD) which includes SSc-ILD

SRUK Involvement

Before a treatment can be used by the NHS, it requires market authorisation via the National Institute of Health and Clinical Excellence (NICE). NICE engage with a range of stakeholders during their approval processes including patient organisations such as SRUK as they run a consultation to establish the effectiveness of a treatment, and its cost-effectiveness in relation to existing therapies. Part of this work involves measuring the level of need in the relevant patient communities in order to put forward a stronger application to gain approval. SRUK and our community were part of this progress for the latest round of approval for Nintedanib, use in treating progressive fibrosing interstitial lung diseases (PF-ILD).

We surveyed individuals for their thoughts on their current treatments – were they effective, was the regime easy, did people feel they were improving on their current course of treatment? We saw, and fed back to NICE, that the lung aspects of an individual’s scleroderma impacted more significantly on their daily life than other scleroderma aspects. Patients expressed frustration and guilt at:

Not being able to work Not being able to do housework.
Constraining their family activities, hobbies, or simply not being able to play with their kids.
Not being able to walk for long distances.
The mental health toll on both themselves and their families.

One patient said “Everyone has to slow down for me.”

Half of those who responded to our survey felt that the treatments they were currently on did not benefit the lung aspects of their condition. The reported that “the medication I receive doesn’t seem to be slowing the progression of this disease” and “I still struggle with each breath.”

There was an enthusiastic response from those SRUK surveyed when they were asked whether they would want access to an anti-fibrotic treatment for their PF-ILD. 97% of those surveyed felt that it could benefit them compared to their current treatments. SRUK then stated our full support for the approval of Nintedanib in treating PF-ILD.

Technology Appraisal Committee Meeting

Following submission of SRUK feedback, we were invited to attend the Technology Appraisal Committee Meeting in early July to assess the suitability of Nintedanib for use in treating PF-ILD. This was a complex, and highly detailed meeting which discussed health economics, clinical trial data and trial methodology.

Approval

Following the Technology Appraisal, we are delighted to say that Nintedanib was approved in October 2021 for the treatment of progressive-fibrosing interstitial lung diseases, which was officially announced on the 17th November.If you would like to read more about Nintedanib, SRUK have written previously on the subject here: