NEW YORK – The UK's National Institute for Health and Care Excellence on Tuesday recommended Bristol Myers Squibb's immunotherapy combination Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for metastatic colorectal cancer patients who have high microsatellite instability (MSI-high) or mismatch repair deficiency (dMMR).
In a final draft guidance, NICE recommended the combination for use within the National Health Service (NHS) England based on results from the Phase III CheckMate 8HW trial and the Phase II CheckMate 142 trial. In CheckMate 8HW, Opdivo plus Yervoy demonstrated a 12-month progression-free survival rate of 78.7 percent compared with 20.6 percent for the chemotherapy arm. CheckMate 142 was used to assess median overall survival, which had not been reached for patients on Opdivo-Yervoy at a median follow-up of 64.2 months. The five-year survival rate for those on the combination was 67 percent.
The NICE committee also conducted an indirect comparison of Opdivo-Yervoy to Merck's immunotherapy Keytruda (pembrolizumab), which is the standard treatment in this setting, using results from the KEYNOTE-177 trial. The analysis suggested that advanced colorectal cancer patients on Opdivo-Yervoy had better outcomes.
NICE initially declined to recommend the Opdivo-Yervoy combination in February, citing uncertainties about whether the combo improved outcomes compared to Keytruda or chemo and questions about BMS's cost-effectiveness modeling. After BMS submitted additional data for further analysis, the committee reversed its decision.
The list price is £2,633 ($3,514) for a 240 mg vial of Opdivo and £3,750 for a 50 mg vial of Yervoy, but BMS is providing them to the NHS at a confidential discount. In its evaluation of the incremental cost-effectiveness ratio (ICER) for the treatment, NICE noted there were uncertainties due to the lack of mature overall survival data and limitations of the indirect comparisons to chemo and Keytruda. Based on the available data, the committee estimated that the ICER for Opdivo-Yervoy was below the preferred threshold of £25,000 per quality-adjusted life year (QALY) gained.
NICE estimated that about 700 patients per year will be eligible for first-line Opdivo-Yervoy treatment within NHS England.
The combination was approved earlier this month in the US in this same setting and in Europe in December 2024.