selpercatinib (Retsevmo)

following a full submission assessed under the orphan equivalent medicine process:

selpercatinib (Retsevmo®) is accepted for restricted use within NHSScotland.

Indication under review: as monotherapy for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).

SMC restriction: patients who require systemic therapy who have not previously received systemic therapy.
In an open-label, single-arm, phase I/II study in adult patients with RET fusion-positive thyroid cancer, 89% of patients who received selpercatinib achieved an objective response.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

SMC has previously issued advice (SMC2370) for selpercatinib for the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with lenvatinib and/or sorafenib. This advice remains valid.