following a full submission considered under the orphan equivalent process:
pembrolizumab (Keytruda®) is accepted for use within NHSScotland.
Indication under review: As monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.
Recurrence-free survival was significantly longer in the pembrolizumab group compared with placebo in a phase III study of adult patients with completely resected, stage III melanoma with lymph node involvement.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pembrolizumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.