The immune checkpoint inhibitor Keytruda (pembrolizumab) had received European Union approval last December as first-line therapy for patients with non-small cell lung cancer who have PD-L1 expression in at least 50 percent of the tumor cells, and who have no EGFR or ALK mutations.

But following a recent decision from the U.K.’s National Institute for Health and Care Excellence (NICE), patients in England and Wales are unlikely to access it.

NICE’s draft guidelines turning down Keytruda suggest that while the drug offers an “extension-to-life benefit” compared to platinum-based chemotherapy, the incremental cost-effectiveness ratio for the drug compared with standard of care was not identified.

The agency also claims that the drug does not meet the criteria for inclusion in the Cancer Drugs Fund (CDF). Keytruda has a list price of £2,360 per 100 mg vial, which means that the Quality Adjusted Life Year (QALY) was likely to exceed the usual threshold for cost-effectiveness of £50,000, even with a confidential discount made by Merck.

Merck (known as MSD outside North America) described NICE’s decision as disappointing, and is currently working with NICE and the NHS (National Health Service) England to overturn the decision. “This is a much needed medicine as there are very few treatments available for these patients which increase the survival rate without significantly affecting quality of life,” Louise Houson, who was recently appointed Merck’s UK managing director, said in a news release.

In December, Merck was able to overturn NICE’s rejection of Keytruda as second-line therapy for NSCLC patients whose tumors are positive for PD-L1, and who have received at least one prior chemotherapy treatment or a targeted anti-cancer drug. The company is confident it will again find a way around the problem, making Keytruda available for the 1,500 eligible patients in England.

Keytruda is a monoclonal antibody that increases the immune system’s ability to recognize and fight tumor cells. It blocks a protein called PD-1 (programmed cell death protein 1) and associated proteins PD-L1 and PD-L2, and activates tumor-killing immune cells, known as T-lymphocytes. The therapy is approved by the U.S. Food and Drug Administration for the treatment of inoperable or metastatic melanoma, and for metastatic, PD-L1-positive NSCLC tumors.

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