11 March 2018 - Canada’s Common Drug Review (CDR), which provides recommendations on public payer reimbursement for all non-oncology drugs, including orphan drugs, has been criticised for its negative recommendations on orphan drugs, which some say delay patients access. 

A study newly published in the Orphanet Journal of Rare Diseases sought to analysed the basis on which the CDR makes its recommendations on orphan drugs, and to evaluate the roles that clinical and economic factors play in decision making.

In Canada, there exists no distinct regulatory or reimbursement pathway for orphan drugs. Instead, these products undergo the same review processes as any other drug. When a medicine is submitted for review, CDR examines the clinical and economic evidence, and its expert committee issues a non-binding positive or negative recommendation for listing on publicly funded drug plans. Each Canadian jurisdiction, other than Quebec (which has its own review process), decides whether it will partake in collective product listing negotiations and whether to list the product on its local formulary. Historically, CDR has given positive recommendations to 52% of drugs (for comparison, Australia’s similar process recommends 54%, while the United Kingdom’s recommends 87%).

Read American Journal of Managed Care article