NICE has today (Friday 12 February 2021) issued final draft guidance which recommends the routine use of nivolumab (Opdivo; Bristol-Myers Squibb) as an option after surgery for some people with melanoma.
For the last two years nivolumab was recommended for use within the Cancer Drugs Fund as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
This allowed for patients to access the drug while data on its effectiveness was collected to address significant clinical uncertainty and before it could be considered for routine commissioning.
The data from the Cancer Drugs Fund and the key clinical trial are still quite immature so it is uncertain if nivolumab increases the length of time people live, or by how much (overall survival).
NICE had previously been unable to recommend the use of nivolumab in draft guidance.
Following consultation, the committee was persuaded that some of its preferred assumptions for estimating long-term survival of people who had been treated with nivolumab had been too conservative. New analyses presented by the company showed that the most likely estimates of cost-effectiveness were within the range NICE considers a cost-effective use of NHS resources.
The committee has now recommended the routine use of nivolumab as an option after surgery for some people with melanoma, subject to the company providing nivolumab according to the commercial arrangement agreed with the NHS.
An appeal period has now opened until 26 February 2021.