The National Institute for Health and Care Excellence is supporting NHS use of a novel immunotherapy for skin cancer shown to double two-year survival in some patients.
Bristol-Myers Squibb’s Opdivo (nivolumab) has been recommended as a monotherapy for adult patients with advanced (unresectable or metastatic) melanoma, after the Institute concluded that the most plausible incremental cost-effectiveness ratio for the drug was likely to be less than £30,000 per QALY gained.
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. Phase III data show its potential to boost response rates and overall survival versus standard care in both first-line and previously-treated settings, offering new hope to a group of patients facing an average survival rate of just six months.
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.
NICE’s independent committee decided that a consultation on the draft recommendations was not needed for this appraisal, skipping straight to a final appraisal determination (FAD) instead, because the treatment has been endorsed in line with its license.
Paul Workman, chief executive of The Institute of Cancer Research, London, welcomed the decision. “Patients with advanced melanoma currently have few treatment options, so it’s positive that NICE has approved this at the first time of asking. It’s vital that we get novel and exciting cancer treatments to patients as quickly as possible, and avoid the tortuous back and forths we have seen with other recent appraisals.”
The company will be particularly relieved given that Opdivo was recently turned down by NICE in draft guidelines as a treatment for lung cancer.