selexipag (Uptravi)

following a resubmission assessed under the orphan equivalent process:

selexipag (Uptravi®) is accepted for restricted use within NHSScotland.

Indication under review: For the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II to III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.

SMC restriction: combination therapy in a sub-population of patients with PAH specifically those in WHO FC III who are insufficiently controlled with an ERA and a PDE-5 inhibitor and who would be considered for treatment with inhaled iloprost.

In a phase III study of patients with PAH, selexipag was statistically significantly better than placebo as measured by a composite primary outcome of death or a complication related to PAH.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of selexipag. 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 the views from a Patient and Clinician Engagement (PACE) meeting.