The treatment of venous leg ulcers and optimal use of Apligraf™

Leg ulcers affect approximately 1% of the population. Most are of venous origin, often chronic and recurrent. The hignest proportion of leg ulcers occurs in the elderly. Their treatments are varied, and convincing data on their effectiveness are few. Evidence on the effectiveness of compressions therapy is still recent. Studies on cost-effectiveness are practically non-existent.

Apligraf™, a product of tissue-engineering, is a bilayered human skin substitute classified as a medical device. Approved in Canada in 1997, it is indicated in the treatment of venous leg ulcers, and since August 2000, for the treatment of diabetic ulcers.

The Canadian distributor, Novartis, submitted a request to the Conseil consultative de pharmacologie du Québec for Apligraf™ to appear on the list of exceptional medications. The request was not considered since the product is not a medication, and the currect trend is to reduce the number of these inscriptions.

The Ministère de la Santé et des Services sociaux gave the Conseil d’évaluation des technologies de la santé (CÉTS) in 1998, which became the Agence d’évaluation des technologies et des modes d’intervention en santé (AÉTMIS) in June 2000, the mandate of studying the clinical and economic value of Apligraf™.

The objective of this report is to specify under what conditions the use of Apligraf™ would be optimal for the treatment of venous leg ulcers that are resistant to compression therapy. These conditions are defined as a temporary measure, while awaiting the results of a multicentre randomised controlled trial that will either confirm or invalidate current estimates, most likely in the summer of 2001.