selpercatinib (Retsevmo)

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

selpercatinib (Retsevmo®) is accepted for restricted use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.

Indication Under Review: monotherapy for the treatment of adults with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

SMC restriction: for use in treatment-naïve patients who have not previously received a RET-inhibitor or any other systemic treatments for their advanced stage of disease.

In a phase I/II study, in treatment-naive patients with RET fusion-positive NSCLC, selpercatinib was associated with an objective response rate (ORR) of 84%. Final study results and comparative study results are awaited.

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.

SMC has previously issued not recommended advice (SMC2371) for selpercatinib for use as monotherapy for the treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. This advice remains valid.

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