Patients with lung cancer are to be barred from routine NHS access to MSD's immunotherapy Keytruda in England and Wales after cost regulators concluded that it could not be considered a cost-effective use of resources.

In draft guidelines, the National Institute for Health and Care Excellence turned down the drug for patients with advanced non-small cell lung cancer (NSCLC) with specific mutations on the basis that there is currently no robust data on its long-term benefits.

The company's submission assumed that patients stopped using Keytruda (pembrolizumab) at two years if their disease had not progressed, but the Institute's appraisal committee felt that in clinical practice "it was very unlikely" that those benefiting from treatment would stop taking it, and therefore it could not be considered value for money.

"Even when making assumptions about the value of using pembrolizumab beyond two years, our lowest estimates showed it would be over the range of what we normally consider cost-effective," explained Professor Carole Longson, director of the centre for health technology evaluation at NICE. According to the Institute's calculations, the most plausible ICER for Keytruda would exceed £50,000 per QALY gained.

MSD said it is disappointed with the draft decision. "We are working with both NICE and NHS England to ensure we can find a solution to get back on track and make sure this much needed treatment option is made available to people with previously treated advanced NSCLC as quickly as possible," noted Louise Houson, UK Managing Director, MSD. "This is particularly important as these patients have a very poor prognosis, with limited time."

Around 1,700 people with NSCLC are expected to be eligible for treatment with the drug next year. Its list price is £29,114 for an average course of treatment, but that doesn't take into account the confidential discount being offered to the NHS.

The drug had been available to patients before its European approval in August via the UK's Early Access to Medicines Scheme.