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CADTH Pharmaceutical Reviews Update — Issue 7

Last updated: April 17, 2019
Product Line: Pharmaceutical Review Update
Issue: 7
Result type: Report

CADTH Program Updates

Common Drug Review

1. Additional Embargo Period Following Revised CDEC Recommendations

Effective immediately, CADTH has revised its procedures for the CADTH Common Drug Review to permit an additional embargo period for CADTH 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 CADTH Common Drug Review.

CADTH 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. CADTH’s performance metrics will continue to be measured based on the issuance of the initial embargoed CDEC recommendation.