The National Institute for Clinical and Healthcare Excellence (NICE) has released its draft appraisal consultation document (ACD), rejecting the use of nivolumab (Opdivo) as an adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
The committee noted that there were no trials that directly compared adjuvant nivolumab with routine surveillance, which meant that there was uncertainty about the clinical effectiveness in this regard. Evidence was presented from an ongoing trial, which added to the uncertainty, especially on overall survival.
The uncertainty in clinical effectiveness contributed to the uncertainty surrounding nivolumab’s cost effectiveness, which the committee stated as the reason why it could not recommend nivolumab for use within the Cancer Drugs Fund.
The new cancer drugs fund began operating in July 2016, whereby all decisions relating to access to cancer drugs was placed solely within NICE’s remit. Medicines approved within this scheme will have interim funding available for up to two years, during which time further evidence is collected on the drug’s efficacy. The current CDF budget sits at £340 million.
A drug will be recommended for use within the CDF if it meets the following criteria:
- Potential to meet the value for money criteria
- Pharmaceutical company agrees to the terms of the CDF
- There is an established process in place to collect the data NICE requires to make its final decision at the end of the two-year period
The full ACD can be read here.