Authors' recommendations: The North of England Specialised Commissioning Group is the lead organisation charged with commissioning targeted therapies for adults with pulmonary hypertension in England. Targeted therapies are currently commissioned for adults with functional class III pulmonary hypertension (marked limitation of physical activity) but not for those in class II (slight limitation on physical activity). European Society of Cardiology guidelines recommend three drugs (ambrisentan, bosentan and sildenafil) as first-line therapies for patients with functional class II pulmonary hypertension. It is unclear from the guidelines how the available research evidence has been used to inform these recommendations. The Scottish Medicines Consortium (SMC) has also approved ambrisentan and sildenafil for patients in this group. There are currently some 80 patients with functional class II PAH being treated at specialist centres in England. Commissioning treatment for these patients with sildenafil would incur costs of at least £500,000 per year. It is likely that there are patients outside the specialist treatment centres who would present for treatment if available but the number of patients involved is uncertain. We identified six systematic reviews of drug therapies for pulmonary hypertension but none of these focuses specifically on patients in functional class II. The most up-to-date systematic review included 24 double-blind, placebo-controlled randomised trials. Only one of these recruited exclusively patients in functional class II. Five other randomised trials included between 30% and 50% of patients in functional class II, the remainder of participants being mainly in class III. We found no fully published economic evaluations of drug therapies for functional class II hypertension. Limited details of manufacturers' submissions to the SMC are available, which makes it difficult to evaluate the strength of the cost-effectiveness evidence supplied by the manufacturers. Overall, few patients with functional class II disease have been included in randomised trials. Based on the published results of trials included in the most up-to-date systematic review, there is no clear evidence of benefit for any of the three dugs recommended by the ESC guidelines when compared to placebo in patients with functional class II disease.

Project Status: Completed

Year Published: 2012

URL for published report: http://www.york.ac.uk/inst/crd/pdf/Pulmonary%20hypertension%20evidence%20briefing.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: University of York

Contact Address: University of York, York, Y01 5DD, United Kingdom. Tel: +44 1904 321040, Fax: +44 1904 321041,

Contact Name: crd@york.ac.uk

Contact Email: crd@york.ac.uk

Copyright: University of York