CADTH Pharmaceutical Reviews Update — Issue 34

See Pharmaceutical Reviews Update — Issue 34 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

• new application process for reimbursement reviews  

• new application requirement for RIS file for economic references 

• revised process and updated template for ethics review.

Canada's Drug Agency Program Updates 

1.  New Application Process

Effective February 16, 2023, Canada's Drug Agency will be replacing its previous secure file submission portal, Collaborative Workspaces, with the Pharmaceutical Submissions Microsoft SharePoint site, as the platform for sponsors to securely exchange files with Canada's Drug Agency throughout the reimbursement review process.​ This new system is a more user-friendly and reliable interface for sponsors and adds an increased level of security with Microsoft Authenticator multifactor authentication.

The new system will be implemented in the following phases:

• February 16, 2023: All new applications must be filed using the new application tool.

• Beginning of March: The transition of all ongoing active files to the new system will take place on a rolling basis, starting with the most recently received submissions. Canada's Drug Agency will reach out to sponsors individually to initiate the transition of active projects.

Sponsors can refer to the instructions for the new application process for details. If you have questions regarding the new process, please email [email protected] and our support team will be in contact to provide technical support.

2.  New Application Requirement: RIS File for Economic References

Canada's Drug Agency currently requires the sponsor to provide an RIS file with all references used in the sponsor summary of clinical evidence. Effective for all applications filed on or after April 3, 2023, Canada's Drug Agency will require an RIS file with all references that are used in the following documents:

• pharmacoeconomic evaluation technical report

• budget impact analysis technical report.

CADTH’s preference is for a single RIS file for both of the previously noted reports, but separate RIS files for the pharmacoeconomic evaluation technical report and budget impact analysis technical report would be accepted. This new requirement has been incorporated into an updated version of the Procedures for Canada's Drug Agency Reimbursement Reviews.

3.  Revised Process and Updated Template for Ethics Review

The Procedures for Canada's Drug Agency Reimbursement Review have been updated to introduce efficiencies in the ethics review process for complex drugs. Effective immediately, when there are multiple products with a similar mechanism of action and with indications in the same or a similar therapeutic area (e.g., CAR T-cell therapies for blood cancers), Canada's Drug Agency will use a summary report to identify relevant ethical considerations as opposed to conducting de novo reviews of ethical considerations for each application. The summary report will consist of an overview of ethical considerations summarized from the normative and empirical literature on CAR T-cell therapies and informed by prior completed Canada's Drug Agency reports of similar therapies. The report may be augmented with novel or emerging ethical considerations that are specific to the therapy, its target population, the disease state, or the evidence used to evaluate its safety, efficacy, or value. In addition to this revision, Canada's Drug Agency has posted an updated sample of the ethics review template.  

4.  Clarification of Biosimilar Eligibility 

Canada's Drug Agency has received inquiries from stakeholders regarding the eligibility of biosimilars for review through the reimbursement process. Additional text has been added to the Procedures for Canada's Drug Agency Reimbursement Reviews to clarify that biosimilars are not typically reviewed through the Canada's Drug Agency reimbursement review processes. Applications are only required in exceptional circumstances where a biosimilar meets other eligibility criteria (e.g., a new indication that is not approved for the reference product or a new formulation that is eligible for review). Each of those scenarios is approached on a case-by-case basis and a decision is made in consultation with the participating drug programs. Sponsors that have questions regarding whether or not a biosimilar is eligible for review by Canada's Drug Agency are asked to complete an eligibility request form and submit it to [email protected].