Pharmaceutical Reviews Update — Issue 48

Program Updates

1. Expanding Our Scientific Advice Services for Canada’s Life Sciences Sector

Canada’s Drug Agency is launching a new 1-year learning period in our Scientific Advice program that will expand the type of guidance we offer to drug manufacturers to include those that are seeking advice after a “do not reimburse” recommendation is made for their product.

During the learning period, we will provide advice on plans for new clinical evidence generation intended for drugs that were not recommended for reimbursement and that may be resubmitted to our Reimbursement Review program. To qualify, manufacturers must be planning to generate new clinical evidence that will address gaps identified in our final recommendation. New clinical evidence plans may include real-world evidence.

This new offering will have shorter timelines and a lighter process compared to our standard Scientific Advice and can be customized to meet the needs of the drug sponsor. Applications for this new process can be submitted until June 30, 2025. As part of the process, applicants must consent to the sharing of the advice report and related information within Canada’s Drug Agency. The advice and related information will not be shared with the expert review committee or in a public document.

This development is part of our continued “test and learn” approach to enhancing Canada’s drug reimbursement ecosystem and our efforts to help patients and health systems benefit from innovative products.

For more information, please contact [email protected].

2. Upcoming Feedback Opportunities

Mark your calendar for 2 feedback opportunities that will open next month:

• Thursday, July 11 — Feedback on a discussion paper related to our work on newborn screening and a companion webinar.
• Mid-July — Feedback on a document that outlines the methods involved in conducting evidence appraisals for a product submitted by a drug sponsor for Reimbursement Review.

Subscribe to the Weekly Summary newsletter to be notified of these feedback periods.

3. Leadership of Our Expert and Advisory Committees

We are pleased to share recent and upcoming changes to the leadership of our Canadian Drug Expert Committee (CDEC), pan-Canadian Oncology Drug Review Expert Review Committee (pERC), and Patient and Community Advisory Committee (PCAC).

Dr. Peter Jamieson has been appointed incoming Chair of CDEC and Dr. Catherine Moltzan has been appointed incoming Chair of pERC. Each appointment is for a 3-year term that begins October 1, 2024. Beth Kidd was appointed for a 7-month term as the Acting Chair of the PCAC on March 1, 2024. Read more.

4. New Appropriate Use Advisory Committee  

Appropriate prescribing is critical to ensure that patients have the best health outcomes. It also supports overall drug system sustainability. We are pleased to share that we’ve created a new Appropriate Use Advisory Committee, with Stephen Samis and Dr. Jim Silvius appointed as co-chairs. The committee will support our efforts to improve appropriate prescribing and medication use across Canada. Read more about the new Committee, with more information to come this summer.

If you have questions about activities described in this issue of Pharmaceutical Reviews Update, contact us anytime at [email protected].