Following Nivolumab, NICE Rejects Pembrolizumab for Use in Patients With NSCLC

A draft guidance issued by the National Institute for Health and Care Excellence (NICE) rejected use of Merck Sharpe & Dohme (MSD)’s programmed death-1 inhibitor pembrolizumab (Keytruda) in patients diagnosed with non-small cell lung cancer (NSCLC), citing lack of robust information on long-term benefits of the treatment. The National Health Service (NHS) is bound to use NICE guidance as soon as it is published.

MSD’s submission to NICE assumed that patients would stop taking the drug at 2 years following treatment initiation if their disease had not progressed—an assumption that NICE disagrees with. This, the appraisal committee pointed out, would make the drug cost-ineffective.

“Even when making assumptions about the value of using pembrolizumab beyond 2 years, our lowest estimates showed it would be over the range of what we normally consider cost-effective,” according to professor Carole Longson, director of the center for health technology evaluation at NICE. Their calculations project that the incremental cost-effectiveness ratio for pembrolizumab would exceed £50,000 per quality-adjusted life years (QALY) gained. QALY calculations consider both, the length of years added to a patient’s survival and the person’s quality of life during those years.

The company is disappointed with the decision, as was Bristol-Myers Squib, whose nivolumab (Opdivo) received similar treatment from NICE at the end of last year. “This initial consultation document from NICE is very disappointing and 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. This is particularly important as these patients have a very poor prognosis, with limited time,” said Louise Houson, UK managing director, MSD.

Going by the listed price of pembrolizumab in the United Kingdom, an average course of treatment would be about £29,114 ($37,382). Currently, the drug is approved for treatment of patients with NSCLC whose disease has progressed on chemotherapy. Also, not being cost-effective also means that pembrolizumab cannot be included in the list of drugs provided under the Cancer Drugs Fund, which was recently revived.

MSD had made pembrolizumab available for use as a second-line agent in 140 patients diagnosed with NSCLC, prior to its European approval, via UK’s Early Access to Medicines Scheme. With the new decision by NICE, patients can no longer access the drug.