ipilimumab (Yervoy)

following a full submission considered under the end of life/orphan medicine process.

ipilimumab (Yervoy®) is accepted for use within NHS Scotland.

Indication under review: Treatment of advanced (unresectable or metastatic) melanoma in adults (first-line use).

In a phase III, randomised study median overall survival was extended by 2.1 months in patients treated with ipilimumab plus dacarbazine (an unlicensed dose regimen) compared with dacarbazine alone. Efficacy data for the licensed dose of ipilimumab are limited to two retrospective single-arm observational studies where median overall survival was 11.5 to 14.3 months.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of Ipilimumab.  This advice is contingent upon the continuing availability of the Patient Access Scheme 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.