SOURCE: Canadian Health Policy Institute


January 19, 2016 06:00 ET

Expert Warns That Including Off-Label Drug Indications in HTA Jeopardizes Patient Health and Discourages Innovation

TORONTO, ON--(Marketwired - January 19, 2016) -  An expert has reviewed the health technology assessment (HTA) of a group of drugs for the treatment of vision loss and concluded that the Canadian Agency for Drugs and Technologies in Health (CADTH) recommended reimbursement for "off-label" use of one drug merely to accommodate provincial government cost-containment objectives, despite the potential health risks to patients. 

HTA is used by publicly funded drug plans to guide insurance coverage and reimbursement decisions. In early 2015, provincial governments requested that the CADTH compare the relative cost-effectiveness of 3 drugs: Lucentis, Eylea and Avastin, for the treatment of retinal conditions. Including Avastin in the HTA was controversial because the drug does not have Health Canada safety approval for the indication.

Pharmacoepidemiologist Dr. Nigel Rawson examined the CADTH decision in an article published at Canadian Health Policy the online journal of Canadian Health Policy Institute (CHPI).

Avastin was developed as a systemic treatment for cancer. It was also considered for retinal conditions, but according to Rawson, evidence showed that systemic exposure to Avastin increases the risk of thromboembolic events. Nevertheless, in a practise called "off-label" use, Avastin is prescribed by some clinicians to treat retinal conditions despite the risks because it is less expensive than the other drugs.

Rawson found that CADTH included Avastin because of its off-label use, but excluded some studies from its HTA review that suggested greater relative safety risks with Avastin, predisposing a recommendation that Avastin can be used as the preferred initial anti-VEGF therapy over Lucentis or Eylea.

Based on his review of the decision, Rawson argues that CADTH changed its HTA rules to include a drug that was not approved for the treatment of retinal conditions merely because it was cheaper. He warned that this has negative consequences saying, "including unapproved or off-label indications in the HTA decision process jeopardizes patient health and discourages pharmaceutical innovation."

Get the article
The article, Including off-label drug indications in HTA jeopardizes patient health and discourages innovation, is available online at: or

About CHPI
CHPI is an independent think-tank dedicated to conducting, publishing and communicating evidence-based research on the health system performance and health policy issues that are important to Canadians. 

Contact Information