Pharmaceutical Reviews Update — Issue 50

Program Updates

1. Communicating When Manufacturers Decline to File Submissions for Eligible Drugs

When a sponsor declines to file a submission with Canada’s Drug Agency for a drug that is eligible for review through our Reimbursement Review program, we follow a process to inform interested parties of the nonsubmission. Section 2.6 of Procedures for Reimbursement Reviews outlines the scenarios for which we will publish a notice that a submission was not filed on our website. The notice we publish includes the drug’s brand and generic names, indication(s), and the not filed status.

To enhance transparency around products that are not filed for Reimbursement Review, and in response to feedback, we will begin including these products in our Weekly Summary newsletter, effective immediately. This newsletter is distributed every Thursday, and you can subscribe on our website. This update was previously shared in the August 1, 2024, issue of the Weekly Summary.

2. Communicating Compliance With Reimbursement Review Performance Metrics

In 2014, we introduced a performance metric for our drug reimbursement reviews indicating that a draft recommendation will be issued to the sponsor and drug programs within 180 calendar days from the date the file was accepted for review. This performance metric is described in Table 3 of our Fee Schedule for Pharmaceutical Reviews.

To improve the transparency of our reimbursement review process, we will now publish the status of this performance metric on the web page of each drug under review. If the performance metric was not applicable due to delays that were outside of the control of our organization, we will also include this information.

A new “Performance Metric” field will be added to each drug web page. The following status indicators will communicate compliance with the performance metric (if applicable):

• Achieved
• Not achieved
• Not applicable due to external delays — Temporary suspension and/or submission of new information by sponsor
• Not applicable due to external delays — Substantial deviation between the proposed and approved indications
• Not applicable due to external delays — Application held awaiting decision by Health Canada
• Not applicable due to external delays — Application delayed at sponsor’s request
• Not applicable due to external delays — Deferral of recommendation by expert committee
• Not applicable due to external delay(s)
• Not applicable — Predated performance metrics

This update will be applied retroactively in the coming months and will be included on all applicable drug web pages. Sponsors may contact [email protected]  with any questions.

3. New Templates and Forms for Provisional Funding Algorithms

In May 2024, we published revised procedures for Provisional Funding Algorithms that are effective for applications received on or after September 3, 2024. We have now revised our Place in Therapy Form that can be used for new applications.

We have also updated our input and feedback forms, which should be used after September 3. The forms linked here are samples provided for information, they should not be used before September 3. The new input form will be available for use in October 2024, and the new feedback form will be available for use in February 2025.

Questions about Provisional Funding Algorithms or the documents described should be sent to [email protected].

4. Scientific Advice Opportunities for the Life Sciences Industry

We are reminding drug sponsors that they can apply for Scientific Advice from Canada’s Drug Agency at different points in time, including but not limited to:

• Before a pivotal trial: Advice on pivotal trial(s) prior to finalization of protocol(s), which may include questions related to real-world evidence (RWE) plans.
• After a pivotal trial: Advice on RWE plans before regulatory approval, which may include questions related to the pivotal trial (e.g., population, comparators, outcomes) and potential gaps in evidence.
• After a drug product receives a “do not reimburse” recommendation from Canada’s Drug Agency: May include questions related to RWE or trials being planned to address gaps identified in the recommendation. This is part of a 1-year learning period pilot program ending June 30, 2025, that was announced in June 2024.

Questions related to health economic evaluation plans may be included at any time point. We invite drug sponsors to contact us anytime at [email protected] to discuss potential applications that fall outside these eligibility criteria.