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News

NICE draft decision on nerandomilast

August 27, 2026

NICE has issued draft guidance saying nerandomilast should not currently be used routinely on the NHS in England for people with IPF or PPF. The decision is not final, and APF will respond formally to the consultation and continue making the case for greater treatment choice.

The National Institute for Health and Care Excellence (NICE), the organisation that decides which treatments should be routinely available on the NHS in England, has issued draft guidance saying that nerandomilast should not currently be used routinely for adults living with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

We know this will be deeply disappointing for people who have been waiting and hoping for another treatment option.

But this is not NICE’s final decision.

The guidance is now open for consultation. NICE’s committee will meet again to look at further evidence and the responses it receives before making its final recommendation. NICE is clear that its recommendation may change after consultation.

Action for Pulmonary Fibrosis (APF) will respond formally and will continue working to make sure the experiences and priorities of people living with pulmonary fibrosis are heard throughout the next stage.

What has NICE said?

Nerandomilast is a new treatment for adults with IPF and PPF. It was licensed for use in the UK in July 2026, becoming the first new medicine licensed for pulmonary fibrosis in more than a decade.

A medicine being licensed means it has been approved for use in the UK. NICE then has a separate role in deciding whether it should be routinely funded and available through the NHS in England.

NICE’s draft decision does not mean that nerandomilast does not work.

The clinical trials considered by NICE showed that nerandomilast slowed the decline in lung function compared with a placebo in people with both IPF and PPF.

However, NICE says there is still uncertainty about how nerandomilast compares with the treatments already available and whether the benefits justify the cost to the NHS.

This is why NICE has not recommended it at this stage.

Why treatment choice matters

People living with pulmonary fibrosis currently have very limited treatment choices.

Existing antifibrotic medicines can slow the progression of pulmonary fibrosis for some people, but they do not stop or reverse the disease. They are also not suitable or tolerable for everyone.

For many people, the side effects can have a major impact on everyday life.

Our State of the Nation 2026 report, based on the experiences of more than 1,200 people affected by pulmonary fibrosis, found that 75% of people taking antifibrotic treatment reported experiencing multiple side effects.

APF has consistently told NICE that treatment choice and side effects matter. A medicine can only benefit someone if they are able to take it and continue taking it.

NICE’s own draft guidance recognises this. It acknowledges that side effects from current treatments can have a significant impact on quality of life and can lead people to reduce their dose, stop treatment or decide not to start treatment.

NICE also says there is a high unmet need for more treatments that are both effective and well tolerated. Its committee found that nerandomilast may have an important advantage over nintedanib when it comes to some side effects.

APF will respond to the consultation

APF has worked throughout this process to make sure the voices of people affected by pulmonary fibrosis are heard.

We made a detailed submission to NICE using evidence from our State of the Nation research and our wider work with the pulmonary fibrosis community. We nominated APF’s Director of Policy, Research and Involvement, Bradley Price, to contribute expert evidence to the appraisal.

We highlighted the impact of pulmonary fibrosis itself, the burden of side effects from existing treatments and the urgent need for greater treatment choice.

We will now respond formally to NICE’s draft decision.

We believe the final decision must give enough weight to the real-life impact of current treatments, the importance of having more treatment choices and the difference that better tolerability can make to someone’s ability to stay on treatment and live their life.

Bradley Price, Director of Policy, Research and Involvement at Action for Pulmonary Fibrosis, said:

“This is a deeply disappointing draft decision, but it is not the end of the process.

“People living with pulmonary fibrosis have waited more than a decade for another treatment option. NICE itself recognises the high unmet need for more effective and well-tolerated treatments, and the profound impact that side effects from existing medicines can have on people’s lives.

“We will respond formally to this consultation and continue to make the strongest possible case for greater treatment choice. The experiences of people living with pulmonary fibrosis must be given the weight they deserve in the final decision.

“We will keep working with NICE, clinicians, people affected by pulmonary fibrosis and other partners throughout the next stage of the appraisal.”

What happens next?

NICE is consulting on its draft recommendation.

Once the consultation has finished, the committee will consider the responses and any further evidence before preparing its final recommendation.

We will continue to keep the pulmonary fibrosis community updated as the appraisal progresses.

APF

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info@actionpf.org

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