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New HTA Decisions in England
March 2021
Drug name
OPDIVO® (nivolumab)
Company
Bristol-Myers Squibb
Decision date
12/02/2021
Therapeutic area
Cancer
Therapeutic sub area
Metastases
Decision
Recommended
Indication
Nivolumab is recommended, within its marketing authorisation, as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.
Decision Detail
It is recommended only if the company provides nivolumab according to the commercial arrangement (there is a commercial arrangement for nivolumab).
Summary
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease (NICE technology appraisal guidance 558). The clinical evidence for nivolumab was presented for CheckMate 238, an ongoing multinational randomised double-blind trial comparing adjuvant nivolumab with adjuvant ipilimumab in patients who have had complete resection of stage 3B, 3C, or 4 melanoma. Through the Cancer Drugs Fund, systemic anti-cancer therapy data were collected from people having adjuvant nivolumab for resected stage 3 and 4 melanoma. The committee concluded that nivolumab improves recurrence-free survival compared with ipilimumab. However, it is not known if nivolumab increases the length of time people live, or by how much, because the survival data are still immature. Adjuvant ipilimumab is an immunotherapy that is not used in the NHS. There are no trials directly comparing nivolumab with standard care in the NHS, but an indirect comparison suggests that people taking nivolumab are likely to live longer before the cancer comes back than with routine surveillance. There are still not enough data from the Cancer Drugs Fund and the trial to be certain by how much nivolumab increases the length of time people live. Because of the uncertainty the cost-effectiveness estimates vary. When the committee took into account all the confidential patient access schemes for subsequent treatments and the committee's preferences of the censoring of overall survival and the same hazard of death for routine surveillance and adjuvant nivolumab after 3 to 5 years, then most of the resulting ICERs were less than £30,000 per QALY gained. The most likely estimates are within what NICE considers a cost-effective use of NHS resources, therefore, nivolumab is recommended.