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BMS’s Opdivo rejected by NICE for melanoma
In the last 20 years the number of patients in the UK diagnosed with melanoma has more than doubled, with 15,400 diagnoses annually between 2013 and 2015.
In early 2018, BMS released Phase III CheckMate-238 study data that evidenced that, regardless of BRAF mutation status, 63% of patients treated with Opdivo (nivolumab) had longer recurrent-free survival at 24 months versus 50% for patients treated with Yervoy (ipilimumab).
Despite these results, NICE is blocking NHS funding for use of Opdivo as an adjuvant treatment for resected stage III and IV melanoma, because clinical effectiveness for overall survival linked with Opdivo in this setting was in their words “very uncertain”, and there are no trials directly comparing adjuvant Opdivo with routine surveillance, the usual current management for completely resected stage III and IV melanoma. NICE also said that Opdivo cannot be recommended for routine use by the NHS for these patients or included in the Cancer Drugs Fund because cost-effectiveness estimates are uncertain “because of the uncertainty in the clinical evidence.”
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