CADTH Pharmaceutical Reviews Update — Issue 27

See Pharmaceutical Reviews Update ― Issue 27 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

• revised provisional funding algorithm process
• implementation advice for COVID-19 drugs.

Canada's Drug Agency Program Updates

1. Expanded Provisional Funding Algorithm Process

At the request of the participating drug programs, Canada's Drug Agency has expanded the provisional funding algorithm process to include a new rapid algorithm process. This process will be applied when pERC recommendations can be directly inserted into an existing funding algorithm without needing additional advice from clinical specialists. The rapid algorithm process will typically be initiated in situations where the new drug will not alter the current sequence of drugs within an existing funding algorithm (e.g., a follow-on drug within an existing line of therapy or a completely new line with no comparators).

The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to provide details regarding the new rapid algorithm process, as well as additional details regarding the existing provisional funding algorithm process (now referred to as the panel algorithm process). In comparison with the panel algorithm process, the rapid algorithm process will be completed under expedited timelines (e.g., target of 2 months compared with 3 months). Stakeholders will continue to have the opportunity to comment on the draft provisional funding algorithms.

2. Implementation Advice for COVID-19 Drugs

Canada's Drug Agency has been asked to undertake a review of selected drugs indicated for use in the treatment of COVID-19. 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 COVID-19 drugs. The Canada's Drug Agency review will provide a summary and appraisal of key clinical evidence and implementation advice focussed on the specific questions that have been raised by the jurisdictions. Canada's Drug Agency has not been asked to issue a reimbursement recommendation for the public drug programs as part of this process; therefore, Canada's Drug Agency will not be reviewing the cost-effectiveness or potential budget impact of COVID-19 drugs at this time.

Sponsors that elect to participate in the review process will be provided with the opportunity to provide input on the implementation issues, provide key clinical data, and comment on the draft implementation advice report. The review of COVID-19 drugs 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.

Eligibility for review through the Interim Procedures for Canada's Drug Agency Review of COVID-19 Drugs will be determined by Canada's Drug Agency in consultation with Federal, Provincial, and Territorial governments. Sponsors with eligible products will be contacted by Canada's Drug Agency.