CADTH Pharmaceutical Reviews Update — Issue 7

Canada's Drug Agency Program Updates

Common Drug Review

1. Additional Embargo Period Following Revised CDEC Recommendations

Effective immediately, Canada's Drug Agency has revised its procedures for the Canada's Drug Agency Common Drug Review to permit an additional embargo period for Canada's Drug Agency Canadian Drug Expert Committee (CDEC) recommendations that have been substantially revised following a request for reconsideration by a manufacturer or a request for clarification by the participating drug plans. This process will apply in following circumstances:

• An initial embargoed CDEC recommendation stating that a drug not be reimbursed is revised to state that the drug should be reimbursed with or without conditions.
• An initial embargoed CDEC recommendation stating that a drug should be reimbursed with or without conditions is revised to state that the drug should not be reimbursed.

The options available to the manufacturer and the drug plans in this additional embargo period will be the same as those currently described in the Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review.

Canada's Drug Agency has made this revision to ensure that manufacturers and drug plans have a fair opportunity to consider and comment on the revised CDEC recommendation before it is finalized and posted. The Canada's Drug Agency performance metrics will continue to be measured based on the issuance of the initial embargoed CDEC recommendation.