Original Title: Selexipag en hipertensión pulmonar

Authors' recommendations: No studies comparing selexipag with other standard treatments in patients with pulmonary arterial hypertension (WHO Group I) have been found. Indirect evidence suggests that in these patients, selexipag monotherapy as first treatment choice might be less effective and show higher mortality than standard treatments. Moderate-quality evidence from one study suggests that in adult patients with pulmonary arterial hypertension with WHO Functional Class II or III and of idiopathic, inherited origin, or associated to human immunodeficiency virus infection, to the use of drugs or exposure to toxins, to connective tissue disease or with corrected congenital defects, adding selexipag to the PDE 5 inhibitors and ERA combination improves the combined outcome of mortality and complications related to pulmonary hypertension when compared to placebo after one year and a half of follow up. Treatment with selexipag presented more adverse events than placebo, e.g., headache, vasodilatation, jaw pain, diarrhea, nausea, vomiting, pain in the extremities and myalgias. Most clinical practice guidelines consulted do not recommend or mention the use of selexipag due to the lack of evidence. It is only recommended by one guideline, along with other alternatives such as monotherapy or combination therapy with PDE 5 inhibitors and/or ERAs in patients with pulmonary arterial hypertension and WHO Functional Class II-III. Selexipag is included in Argentina’s Unique Reimbursement System while other Latin American countries consulted, do not cover or mention it. Among high-income countries consulted, most reserve its use as add-on to intermediate-risk patients who have progressed to PDE 5 inhibitors and ERA, while Australia explicitly does not cover it. One economic evaluation from a high-income country suggests that selexipag as monotherapy or in combination with PDE 5 inhibitors and/or ERA versus PDE 5 inhibitors and/or ERA is not a cost-effective option based on the thresholds accepted by this country. The direct estimated cost of treatment with selexipag is lower when compared with prostacyclin analogues; but it is higher when compared with PDE-5 inhibitors, ERA, calcium channel blockers and riociguat.

Project Status: Completed

Year Published: 2019

URL for published report: https://www.iecs.org.ar/home-ets/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)