NICE is recommending InterMune’s Esbriet for certain people who have the chronic lung condition idiopathic pulmonary fibrosis.

Esbriet (pirfenidone), taken as a pill, aims to slow down the irreversible damage in the lungs caused by idiopathic pulmonary fibrosis; a progressive disease, in which breathing becomes increasingly difficult because of scarring to the lung tissues.

In its final guidance, NICE recommends pirfenidone for people with idiopathic pulmonary fibrosis who have a forced vital capacity (FVC) between 50% and 80% predicted - FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

The Institute’s positive recommendation comes after InterMune submitted additional evidence to demonstrate the drug’s potential benefits and revised the terms of its patient access scheme, details of which are being kept under wraps – NICE has been originally minded not to back the drug.

In fact the watchdog says that Esbriet had “a modest but measurable effect on slowing the decline in lung function”, but added that it was uncertain whether this benefit persisted over time because the clinical trials were short in duration.

In an unusual move this original rejection prompted a response by the ABPI – who never normally comments on a specific NICE appraisal – and said the provisional rejection by NICE “reiterates that medicine evaluation processes need to take into greater account levels of unmet need, which includes considering whether there are other treatments available”.

Both InterMune and the UK lobby group should now be satisfied that the drug will be made available to patients, and at a cost effective price for the NHS.

NICE estimates that around 6,800 people in England and Wales with idiopathic pulmonary fibrosis could be eligible for treatment in line with its recommendations.

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said: “Our independent experts have recommended pirfenidone as an option to consider for certain people who have idiopathic pulmonary fibrosis in England and Wales, and so we are pleased to recommend the drug in our final guidance.

“Our guidance replaces decision-making at local levels across the NHS and so we hope it will ensure that patients who are clinically suitable for the medication will have access to it.”

The annual cost of treatment with the drug is just over £26,100 0 but this does not include the agreed upon discount, which is confidential.

NICE’s guidance advises doctors that patients should stop taking the pirfenidone if their disease continues to worsen (i.e. if their FVC declines by 10% or more predicted over a twelve-month period).

Also, people who are currently taking the drug for their idiopathic pulmonary fibrosis but who do not fulfil the treatment criteria, should have the option to continue until they and their doctors consider it appropriate to stop.

The drug will be available for patients on the NHS by July this year under the watchful eye of the ‘Innovation Scorecard’, which ensures NICE-approved medicines are placed onto local formularies across England within three months of guidance.