Patients with advanced forms of skin cancer should have the option of treatment with Bristol-Myers Squibb’s immunotherapy Opdivo on the NHS in England and Wales after cost regulators issued final guidance endorsing the drug’s use in this setting.

The National Institute for Health and Care Excellence has now published final guidelines recommending Opdivo (nivolumab) as a monotherapy for adult patients with advanced (unresectable or metastatic) melanoma.

The decision came on the back of clinical data showing that the novel immunotherapy significantly extended survival in some patients, as well as calculations that the most plausible incremental cost-effectiveness ratio for the drug was likely to fall under the £30,000 per QALY gained threshold.

The CheckMate-066 trial compared Opdivo to the chemotherapy dacarbazine in patients with treatment-naïve advanced melanoma and showed an objective response rate of 40% versus 14% and a one-year survival rate of 73% vs 42%, respectively, as well as a 58% reduction in the risk of death. 

Opdivo became the first medicine to be cleared for the UK’s Early Access to Medicines Scheme in March last year, and the first PD-L1 inhibitor approved in Europe in June.