nivolumab (Opdivo)

following a full submission assessed under the end of life and ultra-orphan medicine process:

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

Indication under review: As monotherapy, for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.

SMC restriction: treatment with nivolumab is subject to a two year clinical stopping rule.

A phase III randomised study demonstrated significantly improved overall survival in patients receiving nivolumab compared with investigator choice of treatment (taxane, folic acid antagonist or epidermal growth factor receptor monoclonal antibody) in adults with SCCHN who had progressed within six months after platinum-based therapy.

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.