selinexor (Nexpovio)

Following a full submission under the orphan equivalent medicine process:

selinexor (Nexpovio®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

SMC restriction: restricted for use in patients with lenalidomide-refractory multiple myeloma, and where an anti-CD38 monoclonal antibody is not appropriate.
In a randomised, open-label, phase III study, the addition of selinexor to bortezomib plus dexamethasone resulted in statistically significant improvements in progression-free survival.

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.