NICE has launched a public consultation on draft guidance which does not recommend the routine use of nivolumab (Opdivo) as an option after surgery for people with lymph node involvement or metastatic disease melanoma.
For the last 2 years nivolumab has been available for use within the Cancer Drugs Fund (CDF) as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
Between November 30, 2018 and October 29, 2019, 284 people had adjuvant nivolumab. At the end of the data collection period, 72% of patients were still having treatment.
Nivolumab was associated with improved recurrence-free survival compared with ipilimumab. However, the estimate of median overall survival was not available, as the data are still immature.
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 of the data, 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, 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."
According to company estimates, around 1480 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 and will continue until Wednesday, November 25, 2020.
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