CADTH Pharmaceutical Reviews Update — Issue 30

See Pharmaceutical Reviews Update ― Issue 30 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

• new mandatory status update for pre-NOC submissions
• procedures for Canada's Drug Agency reviews of nationally procured drug products.

Update for Patients and Communities

We recognize the effort that goes into contributing to Canada's Drug Agency reviews of medical procedures, devices, and drugs. Refer to Impact of Patient Involvement to read the latest examples of how insights from patients and caregivers were used in Canada's Drug Agency reviews published between January and March 2022.

Patient groups and clinician groups can offer feedback on draft reimbursement recommendations. We remind groups to use the template to provide feedback and encourage any individuals wishing to provide feedback to add their voice by connecting with relevant patient and clinician groups.

Canada's Drug Agency Program Updates

Canada's Drug Agency Reimbursement Reviews

Mandatory Status Update for Submissions Filed on a Pre-Notice of Compliance (NOC) Basis

Effective for pre-NOC submissions targeting the August 2022 expert committee meetings, sponsors will receive a request from Canada's Drug Agency 20 business days before the target date for the expert committee meeting to confirm the following:

• if there are any revisions to the anticipated date of approval by Health Canada
• if the sponsor is anticipating or discussing revisions to the indication and/or dosing information regarding the drug under review.

This change is being introduced to allow Canada's Drug Agency to finalize the expert committee meeting agenda in situations where the drug under review has not yet been approved by Health Canada. Sponsors will be requested to provide a written response within 3 business days of receipt.

Reminder: Sponsor Comments Must Not Exceed Page Limits

Canada's Drug Agency has recently encountered situations where sponsors are including additional comments on the draft review reports within the section of the template that is reserved for the identification of errors. Canada's Drug Agency reminds sponsors that their combined comments on the draft review report(s) must not exceed the page limitations provided in the template instructions. If the template filed by the sponsor exceeds the page limits, it will not be accepted by Canada's Drug Agency. The sponsor will be asked to refile its comments in accordance with the instructions. This could result in the review timelines being delayed, including the drug being considered at a later meeting of the expert committee. If Canada's Drug Agency is prevented from achieving the performance metric because of such a delay, sponsors will not be eligible for a partial refund.

Procedures for Canada's Drug Agency Review of Nationally Procured Drug Products

Effective immediately, Canada's Drug Agency has replaced the Interim Procedures for Canada's Drug Agency Review of COVID-19 Drugs with the Procedures for Canada's Drug Agency Review of Nationally Procured Drug Products. This change reflects an expansion in the scope of the review process, which may include drugs that are used for conditions other than COVID-19 (e.g., monkeypox). There are no other revisions to the procedures and this process remains distinct from the Canada's Drug Agency reimbursement review process. These reviews are focused on providing implementation advice to support federal, provincial, and territorial governments. Any sponsors with questions about this process should contact Canada's Drug Agency at [email protected].

Canada's Drug Agency Procedures for Non-Sponsored Reviews

Canada's Drug Agency has made a minor revision to the Procedures for Non-Sponsored Reimbursement Reviews to provide a link to the template for industry input. If you have any questions, please feel free to contact Canada's Drug Agency at [email protected]. 

• Canada's Drug Agency Non-Sponsored Reimbursement Review Industry Input Template