NICE blocks immunotherapy drug nivolumab (Opdivo) for kidney cancer

Decision comes despite nivolumab being accepted for the Early Access to Medicines Scheme (EAMS) based upon some impressive Phase III clinical trial results.

There is some hope, however, that nivolumab might enter the new Cancer Drugs Fund (CDF), which becomes operational this month. This will be on the proviso that the manufacturer, Bristol-Myers Squibb, is able to prove the cost-effectiveness of nivolumab during the 24 months that the drug will be funded by the CDF. This decision will be made at a second NICE appraisal meeting to be held early next month, after which NICE will release its final appraisal decision in October. It is well known that a clinical response to cancer drugs is individual, and some patients respond better than others; the Kidney Cancer Support Network (KCSN) believe that clinicians need to have a choice of drugs to be able to effectively treat kidney cancer patients. NICE’s decision leaves clinicians with a very limited choice, and is denying patients access to a new and innovative class of drug with proven long-term benefits in about one third of cases. This decision also has a profound effect on the way England treats cancer patients, leaving people with kidney cancer at a significant disadvantage and more likely to die prematurely compared to the rest of Europe and America. KCSN calls upon NICE to review its procedures for the appraisal of drugs for rare and less common cancers. The current appraisal system is unsuitable for small patient populations, and has been shown to be unfair to different groups of patients, denying rare cancer patients access to life-prolonging treatments during the most difficult time for both them and their families. “Not only is today’s news deeply distressing for kidney cancer patients and their families, it demonstrates the current frustrating and fragmented approach to reviewing cancer medicines in the UK,” said Rose Woodward from the KCSN. “Despite the fact NICE has recognised the benefits of nivolumab for skin cancer patients, and despite hearing first-hand the difference nivolumab is making to kidney cancer patients here and in other countries, NICE is set to block access. An urgent review of this decision is needed and I sincerely hope everyone involved will work hard to reverse this decision and get this drug to the kidney cancer patients who need it.”