NICE has issued final draft guidance which recommends the routine use of nivolumab (Opdivo) as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
For the last two years nivolumab has been available for this indication within the Cancer Drugs Fund (CDF). The data from the CDF and the key clinical trial are still quite immature so it is uncertain if nivolumab increases survival.
NICE had previously been unable to recommend the use of nivolumab in draft guidance. However, following consultation, the appraisal 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 melanoma with lymph node involvement or metastatic disease, subject to the company providing nivolumab according to the commercial arrangement agreed with the NHS.
An appeal period on the final draft guidance has now opened until February 26, 2021, with the final guidance to be published next month.
