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NICE green lights Keytruda for second-line lung cancer

Merck & Co's oncology treatment backed in draft guidance for NSCLC

Merck & Co's Keytruda (pembrolizumab) 

The UK cost-effectiveness agency has backed Merck & Co's Keytruda as a second-line treatment for non-small cell lung cancer, reversing its earlier position on the checkpoint inhibitor.

The draft guidance from the National Insitute for Health and Care Excellence (NICE) says that adults with advanced NSCLC who test positive for the PD-L1 biomarker protein and who have received at least one prior treatment with chemotherapy or a targeted anticancer regimen should have routine access to Keytruda (pembrolizumab). 

Last month, NICE said Keytruda's long-term benefits in this setting were unproven and that even with a discount Keytruda costs would overshoot the range typically considered acceptable for routine NHS use.

Since then, Merck (known as MSD outside North America) has "presented newer data and also offered a further discount on the drug", which has a list price of £29,114 per course of treatment, NICE said. The drug should be used and then stopped at two years if a person's disease has not worsened.

It is the first checkpoint inhibitor to be approved by NICE for this use. Opdivo (nivolumab) from Bristol-Myers Squibb was turned down by the agency in draft guidance issued last month, while Roche's recently-approved Tecentriq (atezolizumab) is still in the early stages of review.

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: "People with advanced NSCLC have had limited treatment options so it is great that pembrolizumab will now be routinely available.

"The company put forward a fairly priced proposal that reflected the benefits their drug offered."

Merck said that Keytruda will be immediately made available through the Cancer Drugs Fund (CDF) until the NICE recommendations come into effect in January 2017

Dr Gary Middleton, professor of medical oncology at the University of Birmingham, said: “There has been a lack of new therapies that improve survival without significantly impacting the quality of life of patients, so the NICE recommendation for pembrolizumab is great news.

"Having a new treatment option with a biomarker to help identify the most appropriate patients, means we can start to offer truly personalised care for people with NSCLC," he added.

Around 1,700 people in England with NSCLC are expected to be eligible for treatment with pembrolizumab, said NICE.

Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, welcomed the announcement as a "breakthrough" for patients and their families.

"It is wonderful news, and we hope this paves the way for further positive decisions for lung cancer patients across the UK."

Article by
Phil Taylor

2nd December 2016

From: Regulatory

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