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NICE rejects expanded treatment indication for Roche's Esbriet

Published on 19/09/16 at 12:11pm

NICE has published a final appraisal rejecting the expanded use of Roche’s Esbriet (pirfenidone) for the treatment of early idiopathic pulmonary fibrosis (IPF) in the UK.

Roche said the decision leaves patients with no treatment option to slow the progression of the disease until lung function has been lost, leaving the UK as one of the only countries in Europe where patients do not have access to treatment for early IPF.

Dr James Mawby, medical lead for rare diseases at Roche UK, said the decision “does a great disservice to patients with early IPF because there is still no funded treatment available for them.”

"At Roche we have been calling for a review of the system for evaluating innovative medicines in the UK as it is not set up to respond positively to treatments like pirfenidone,” he continued. “The decision making process used by NICE is not flexible enough when assessing treatments for rare diseases, where it is difficult to prove clinical benefit in different stages of the disease, and it doesn't take into consideration the particular set of circumstances that patients with early IPF face."

IPF affects around 15,000 people in the UK, and without treatment, patients only survive from diagnosis for two to five years on average. The institute recommended Esbriet for treatment of moderate IPF sufferers in 2013; Phase III data showed a 48% relative reduction in risk of death from the disease after one year of treatment compared to placebo.

However, NICE defended its decision, claiming Roche could not offer the drug at a cost-effective level:

"Roche presented new evidence to our committee to propose expanding the use of Esbriet and they also wanted the NHS to pay a higher price for the drug. The NICE committee concluded that pirfenidone was not cost-effective at the higher price. It also concluded that the new evidence was not robust and, and even at the current price paid by the NHS, Esbriet could not be considered cost-effective to a wider group than was already recommended."

Matt Fellows

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