24 August 2016 - CADTH is not convinced that Egrifta should be reimbursed in Canada.
The CADTH Canadian Drug Expert Committee has recommended that tesamorelin should not be reimbursed for the treatment of excess visceral adipose tissue (VAT) in treatment-experienced adult HIV-infected patients with lipodystrophy.
Three randomized placebo-controlled clinical trials suggested that tesamorelin can reduce the amount of VAT in treatment-experienced adult HIV-infected patients with lipodystrophy. However, the change in VAT is a surrogate outcome and there is inconsistent evidence that the reduction in VAT observed in tesamorelin-treated patients improves patient-reported outcomes such as body image. In addition, there is no evidence that tesamorelin treatment reduces the risk of cardiovascular events.
There is insufficient evidence regarding the long-term safety of tesamorelin therapy, which is of concern because tesamorelin may be used for extended periods due to the re- accumulation of VAT that occurs upon cessation of tesamorelin therapy.