Pharmaceutical Reviews Update — Issue 54

Program Updates

1. Update: Consultation on Our Methods Guide

Canada's Drug Agency (CDA-AMC) had a targeted consultation on our methods guide with interested and impacted parties in the summer of 2024. This was followed by a public consultation period from November 2024 through January 2025. During the public consultation period, individual or joint submissions were received from 26 individuals, organizations, and companies that represent patient groups, clinicians, government agencies, the pharmaceutical industry, health technology assessment organizations, and health economics and outcomes research consultants.

The feedback received on the methods guide is currently being reviewed and we are ensuring alignment with our Guidelines for the Economic Evaluation of Health Technologies: Canada and Procedures for Reimbursement Reviews. The final methods guide will be published in March 2025.

 2. New: Reimbursement Review Procedures

 2.1. Process Improvements Following Consultation

We initiated consultations with interested parties in January 2025 on proposals to improve our reimbursement review processes. Individual or joint submissions were received from 55 organizations and companies that represent the pharmaceutical industry, patient and clinician groups, and government agencies. All feedback has been documented and reviewed internally for action. We have carefully considered the feedback received during the consultation and have now published the updated Procedures for Reimbursement Reviews.

These procedures will be effective for all oncology applications received on or after April 28, 2025, and non-oncology applications received on or after May 12, 2025 (i.e., standard and complex reviews targeting the October 2025 expert committee meetings). The effective start dates are the same for the new tailored review applications, though these will not routinely target the full expert committee meetings and the target timelines for completion will be accelerated in comparison with standard and complex reviews. 

Highlights of the new procedures include:  

• New proportionate review processes: We have introduced new eligibility criteria and review approaches for complex drug submissions and introduced the new Pharmaceuticals with Anticipated Comparable Efficacy and Safety (PACES) tailored review process.
• Deliberative process: We will be launching the deliberative framework and process that will be used across our expert committees. This will include the participation of a person with lived experience, beginning with select complex reviews.
• Review and recommendation reporting: We will be launching new report templates to reduce the length of these documents, make them easier to read and interpret, and reduce redundancy.
• Accelerated access pathways: We have detailed the procedures for our expanded rolling drug reimbursement review pilot process and expanded the eligibility criteria for time-limited reimbursement recommendations to include resubmissions of drugs that were previously reviewed by CDA-AMC before the implementation of the time-limited reimbursement recommendation process.
• Sponsor engagement: We have implemented the new approach to presubmission meetings and introduced the new evidence presentation meeting and in-review meetings. These revisions will improve the overall usefulness of meetings between CDA-AMC and industry and support the timely resolution of challenges that arise during reviews.
• Application requirements for sponsor submissions: We have removed several application requirements to help streamline the application process for sponsors.
• Clinical expert suggestions: The advance notification form has been updated to give the sponsor the opportunity to provide us with a list of suggested clinical experts (and their contact information). 

On March 6, 2025, join us for a webinar with Peter Dyrda (Director, Pharmaceutical Reviews) and Michelle Gibbens (Director, Engagement) that will summarize elements of the feedback we received and highlight key changes to Procedures for Reimbursement Reviews. 

We thank the organizations and individuals who participated in our consultation. If you have any questions, please contact us.

2.2. Consolidation of Pharmaceutical Review Procedures

We have consolidated our procedural documents for pharmaceutical reviews into a single document. This new consolidated document replaces the following individual documents:  

• Procedures for Time-Limited Reimbursement Recommendations
• Non-Sponsored Reimbursement Review Procedures  
• Therapeutic Review Framework and Process  
• Procedures for Streamlined Drug Class Reviews  
• Procedures for Implementation Advice for Health Technologies.

2.3. New Application Fee for PACES Tailored Review

Applications that are eligible for review through the new PACES process will be assigned a schedule B application fee. The schedule B fee will be set at 90% of the schedule A fee. We will apply the schedule B fee for a 2-year period after which we will conduct an evaluation and determine if revisions are required. We will post an updated Fee Schedule for Pharmaceutical Reviews in March 2025. Any sponsors with questions about the PACES application fee may contact us for more information.

2.4. Consolidation of Inquiry Forms  

We have launched the new consolidated eligibility inquiry form, which is effective immediately. This single form will be used to screen for the following: 

• general eligibility inquiries (i.e., for sponsors seeking guidance on whether a product is eligible for the reimbursement review process)
• eligibility for the complex review process (new)
• eligibility for the tailored review process (updated)
• eligibility for a time-limited reimbursement recommendation
• eligibility for a resubmission or reassessment
• requests for deviation from the pharmacoeconomic requirements (updated)
• eligibility for the rolling submission pilot process (new)
• eligibility for a testing procedure assessment (new)
• inquiries regarding application splitting and/or multiple application fees (new).

3. New Contact Process for Inquiries

Effective the week of March 6, 2025, we are implementing a new online inquiry form on our website’s Contact Us page. Instead of emailing inquiries to [email protected], users will be directed to complete and submit the online form.

This new contact form will help us:

• collect relevant information from every inquiry
• reduce spam and keep our communication more secure
• efficiently direct inquiries to the appropriate team(s)
• efficiently track inquiries.

We ask that all users transition to the online form after it is posted on our website on March 6, 2025.