nivolumab (Opdivo)

following a resubmission assessed under the end of life and orphan medicine process:

nivolumab (Opdivo®) is accepted for restricted use within NHS Scotland.

Indication under review: as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.

SMC restriction: patients previously untreated with ipilimumab.

In a phase III randomised double-blind study, treatment with nivolumab extended overall survival compared with a palliative chemotherapy in patients with previously untreated advanced melanoma without a BRAF mutation. In an ongoing open label phase III study, treatment with nivolumab, at the time of primary analysis, extended overall response rate, compared with investigator’s choice of chemotherapy in patients with advanced melanoma previously treated with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) treatment or an anti-CTLA-4 treatment and a BRAF inhibitor.

The base-case economic analysis submitted by the company assumed that patients were treated for a maximum of two years.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nivolumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.