CADTH Pharmaceutical Reviews Update — Issue 29

See Pharmaceutical Reviews Update ― Issue 29 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include: 

• procedures for review of therapeutic alternatives during a drug supply shortage
• procedures for non-sponsored reimbursement reviews.

Canada's Drug Agency Program Updates

1. Procedures for Review of Therapeutic Alternatives During a Drug Supply Shortage 

Canada's Drug Agency has been asked to undertake reviews of selected drugs that are anticipated to have a potential drug supply shortage. The purpose of these reviews is to provide implementation advice to the provincial and territorial ministries of health through an implementation advice report. 

To address these requests in a transparent manner, Canada's Drug Agency has established a new process for the review of therapeutic alternatives during a drug supply shortage. The Canada's Drug Agency review will provide a summary and appraisal of key clinical evidence and implementation advice focused on the specific questions that have been raised by the jurisdictions. Given the expedited nature, and that the report is time-limited for the period of the drug supply shortage, economic analysis will not be conducted.  

Review in the event of an anticipated drug supply shortage is being conducted through the Canada's Drug Agency health technology assessment program and will not have an application fee for the sponsor at this time.  

Review through the Procedures for Review of Therapeutic Alternatives During a Drug Supply Shortage will be determined by Canada's Drug Agency in consultation with federal, provincial, and territorial governments.  

2. Procedures for Non-Sponsored Reimbursement Reviews 

Canada's Drug Agency initiated stakeholder consultations in March 2022 on a proposal for a new review process that will provide the public drug programs with reimbursement recommendations in selected situations where there is no sponsor to file an application. Canada's Drug Agency has carefully considered the feedback received during the consultation and is pleased to announce the new Procedures for Non-sponsored Reimbursement Reviews. 

Canada's Drug Agency would like to thank all stakeholders who took the time to respond to this consultation. If you have any questions regarding the new Procedures for Non-sponsored Reimbursement Reviews, please feel free to contact Canada's Drug Agency at  [email protected]. 

3. Minor Revisions to Application Template

Canada's Drug Agency has made a minor addition to the Letter for Sending NOC or NOC/c to Canada's Drug Agency template to ensure there is clarity regarding any potential revisions to the sponsor’s requested reimbursement criteria as a result of revisions to the indication. This change will increase efficiency by limiting the need for additional correspondence between Canada's Drug Agency and the sponsor for submissions filed on a pre-Notice of Compliance (NOC) basis.