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selexipag (Uptravi)

Advice

following a full submission assessed under the orphan equivalent process:

selexipag (Uptravi®) is not recommended for use within NHS Scotland.

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.

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.

The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Drug Details

Drug Name: selexipag (Uptravi)
SMC Drug ID: 1235/17
Manufacturer: Actelion Pharmaceuticals UK Ltd
Indication: 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.
BNF Category:
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 10 July 2017

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