Some patients with advanced skin cancer will now be able to get routine access to Merck, Sharp & Dohme’s immunotherapy Keytruda on the National Health Service in England and Wales, after cost regulators issued final guidance endorsing its use within a restricted population.

As expected, the National Institute for Health and Care Excellence is recommending Keytruda (pembrolizumab) for some patients with advanced melanoma that is either unresectable or metastatic, but only if the disease has progressed following treatment with Bristol-Myers Squibb’s Yervoy (ipilimumab), or a BRAF or MEK inhibitor in BRAF V600 mutation-positive disease.

The recommendation also depends upon MSD providing the drug to the NHS at the discount agreed in the confidential patient access scheme. Including this discount, the Committee concluded that the most plausible incremental cost effectiveness ratio for the drug compared with best supportive care was likely to be less than £50,000 per QALY gained.

Keytruda was the first drug to be approved through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to promising new treatments yet to receive official marketing approval when there is a clear unmet medical need.

Life Sciences Minister George Freeman said NICE’s approval of the drug “has been a triumph for early access”. But he also said the government wants to go further on this, “which is why we set up the independent Accelerated Access Review which is looking at how we can reduce the time, cost, and risk of drug development, develop a new range of flexible reimbursement models and look at barriers to roll-out of adoption across the NHS”.

Interim findings of the Review are expected this month, with the final report scheduled for April next year.