Selexipag (Uptravi®)

Assessment Status Assessment Process Complete
Drug Selexipag
Brand Uptravi®
Indication For the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–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.
Assessment Process
Rapid review commissioned 01/11/2016
Rapid review completed 05/12/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 14/12/2016
Pre-submission consultation with Applicant 13/02/2017
Full submission received from Applicant 13/10/2017
Preliminary review sent to Applicant 23/01/2018
NCPE assessment re-commenced 26/02/2018
Factual accuracy sent to Applicant 19/04/2018
NCPE assessment re-commenced 30/04/2018
NCPE assessment completed 21/05/2018
NCPE assessment outcome The NCPE recommends that selexipag not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.

This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations, anticipated reimbursement date July 2019.