pembrolizumab (Keytruda)

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

pembrolizumab (Keytruda®) is accepted for restricted use within NHS Scotland.

Indication under review: As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.

SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
In a phase II study, pembrolizumab was associated with a clinically meaningful overall response rate in adults with classical Hodgkin lymphoma who had failed autologous stem cell transplant and brentuximab vedotin, or who were transplant-ineligible and had failed brentuximab vedotin.

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 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.