nivolumab (Opdivo)

following a full submission assessed under the end of life and orphan equivalent process:

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

Indication under review: in combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults.

SMC restriction: for the first-line treatment of advanced melanoma

In a randomised, double-blind, phase III study of adults with previously untreated advanced melanoma nivolumab in combination with ipilimumab was associated with a clinically important and statistically significant improvement in progression-free survival when compared with a single-agent immunotherapy. Overall survival data are immature.

The base-case economic analysis submitted by the company assumed that responding patients were treated for a maximum of 18 months.

SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of nivolumab and 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 the views from a Patient and Clinician Engagement (PACE) meeting.