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A consultation on the draft recommendations has now begun until Tuesday 24 November 2020.

NICE yesterday (Thursday 5 November 2020) started a consultation on draft guidance which does not recommend the routine use of nivolumab (Opdivo; Bristol-Myers Squibb) as an option after surgery for some people with melanoma.

For the last 2 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.

However, 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). The cost-effectiveness estimates depend on assumptions about the long-term effect of nivolumab after treatment has stopped.  Because of the remaining uncertainty the committee was cautious when considering the most likely cost-effective estimates. 

Following a review, an independent NICE technology appraisal committee said the most likely cost-effective estimates on the use of nivolumab are above what NICE considers a good use of NHS resources.  

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, yesterday said:

“The data presented to our committee led to a number of uncertainties about the long term benefits of its use, which alongside the pricing of nivolumab, meant they were unable to recommend it for routine commissioning.

“One way for our committee to support this drug for routine commissioning would be for the company to review its value proposition and engage with NICE and NHSE/I on this at the earliest opportunity.

“The decision as it stands will disappoint some people but those already using nivolumab with stage III and IV melanoma and lymph node involvement, who have had surgery to remove the disease, will not be affected. Their treatment will continue until they and their NHS clinician consider it appropriate to stop.

“It is important that NICE committees have the option of using the Cancer Drugs Fund if a treatment could be cost effective but where there is uncertainty in the data being submitted during an appraisal. The Cancer Drugs Fund allows more evidence to be collected while NHS patients have access to the treatment.”

Since the original appraisal, NICE has recommended dabrafenib plus trametinib as an option for people with BRAF mutations and pembrolizumab is currently available through the Cancer Drugs Fund as an option after surgery for some people with melanoma.

According to company estimates around 1,480 people would have been eligible for this treatment if it had been approved for routine use.

A consultation on the draft recommendations has now begun until Tuesday 24 November 2020 at nice.org.uk