NHS funding for use of Bristol-Myers Squibb’s Opdivo as an adjuvant treatment for resected stage III and IV melanoma is being blocked by the National Institute for Health and Care Excellence.
Earlier this year, the firm released data from the Phase III CheckMate-238 study showing that, at 24 months, nearly two-thirds (63%) of patients treated with Opdivo (nivolumab) had longer recurrent-free survival compared to those treated with Yervoy (ipilimumab; 50%) regardless of BRAF mutation status.
However, in draft guidelines, NICE said clinical effectiveness for overall survival linked with Opdivo in this setting was “very uncertain”, and also noted that there are no trials directly comparing adjuvant Opdivo with routine surveillance, the usual current management for completely resected stage III and IV melanoma.
Cost-effectiveness estimates are also uncertain “because of the uncertainty in the clinical evidence,” it noted, and thus the drug can therefore not be recommended for routine use by the NHS for these patients.
Based on the analyses available it is also not possible to determine whether Opdivo has the potential to be cost-effective, thereby preventing its inclusion within the Cancer Drugs Fund.
The incidence of melanoma in the UK has more than doubled in the last 20 years, where between 2013-2015, around 15,400 people were diagnosed with the condition every year.