CADTH’s Pharmaceutical Reviews Updates are used to communicate new CDR and pCODR drug review process updates to the public. PDCI has outlined below the key highlights from the most recent update. For more information, please consult the CADTH website.

1. New Procedures for CADTH Drug Reimbursement Reviews

In June 2020, CADTH initiated stakeholder feedback on the consultation to align the procedures for its CDR and pCODR review process. CADTH carefully considered feedback received and released it’s new Procedures for CADTH Drug Reimbursement Reviews. These procedures will be effective for all applications targeting the April 2021 expert committee meetings. All applications received on or after the following dates will be process under new drug reimbursement review: 

• October 26, 2020, for non-oncology drugs.
• October 20, 2020, for oncology drugs.

Highlights of the new procedures include:

• Communications: a single email newsletter that is issued once per week.
• Pre-submission procedures: drug plans will be notified of the pending application.
• Confidentiality guidelines: aligned definitions of confidential material.
• Proposed place in therapy template: required for oncology drug submissions.
• Health economics: conditions for submitting a cost minimization analysis (CMA).
• Draft reports: opportunity for drug manufacturers to comment on scientific reports.
• Draft recommendations: posting of draft recommendations for stakeholder feedback.
• Reconsideration process: stratified into three categories to introduce additional flexibility.
• Procedural review: a new step introduced to allow CADTH to propose options.

       2. Revised Provisional Algorithm Process

Based on consultation feedback CADTH as added the following to the provisional algorithm process:

• A call for stakeholder input will now be issued when a new provisional algorithm project is initiated by CADTH. Stakeholders will have the opportunity to review and comment on a summary document outlining the scope, objectives, and rationale for the provisional algorithm.
• Patient and clinician groups will have the opportunity to review and comment on the draft provisional algorithm during a designated stakeholder feedback period.

       3. Revised Target Dates for pERC Meetings

Beginning in April 2021, meetings of the pCODR Expert Review Committee (pERC) will target the second Thursday of each month as opposed to the third Thursday of each month.

This change is reflected in the new pERC and Canadian Drug Expert Committee (CDEC) meeting schedules.        

4. Consultation on CADTH Deliberative Framework and Process

Preliminary input on the deliberative framework and process questions will be taken into consideration when developing options for forthcoming consultations.

5. Consultation on Health Canada, CADTH, and INESSS Aligned Review Process

In June 2020, CADTH, INESSS, and Health Canada initiated stakeholder consultations on the Proposed Enhancements to the Health Canada, CADTH, and INESSS Aligned Review Processes. The three agencies will review this feedback and provide an update on next steps in the near future.

6. Clarification Regarding Tumour Group Submissions

CADTH would like to clarify that tumour group submissions for oncology drugs are reserved for exceptional situations where the drug manufacturer is not planning to market a product in Canada for a particular indication and the drug has the potential to address a major unmet therapeutic need.
 

7. Revised Fee Schedule for CADTH Pharmaceutical Reviews

The Fee Schedule for CADTH Pharmaceutical Reviews has been revised to reflect the alignment of milestone 2 for invoicing oncology and non-oncology application fees to the point where the draft reports are sent to the sponsor for comment (which replaces the checkpoint meeting for oncology applications).

8. CADTH webpages for Drug Reimbursement Reviews

CADTH will be updating their drug reimbursement review webpages over the next month, including consolidation of the drug summary tables for oncology and non-oncology drugs.

Contact Ara Salazar, Director of Market Access, to learn more about how these changes may affect your upcoming submissions