New Consultation on Additional Improvements to Drug Reimbursement Reviews

Consultation status: Open 
Consultation period: January 6 to February 6, 2025

Canada’s Drug Agency is outlining additional plans to modernize the drug reimbursement review process and is seeking feedback on our proposed approaches.

The consultation document, Proposed Improvements to the Drug Reimbursement Review Process, describes a series of enhancements and new additions to the process we follow to issue drug reimbursement recommendations to public drug plans and cancer agencies (excluding Quebec). This process plays a critical role in the pathway that helps patients access new medicines.

The proposed measures are important procedural improvements that are meant to increase efficiency and transparency and help accelerate patient access to proven new treatments. They have been developed in response to the evolving pharmaceutical environment in Canada, and with insight from patient and clinician groups, industry, and public payers.

Open until February 6, 2025, the consultation covers 6 aspects of our work:

Proportionate review processes

• We aim to expand the scope of our tailored reviews to include select new drugs that are similar to other drugs we have previously reviewed. These drugs are known as pharmaceuticals with anticipated comparable efficacy and/or safety (PACES).

Modernizing our reports

• We will change our clinical and economic report templates to reduce their length, make them easier to read and interpret, and reduce redundancy.

Updating the deliberative process used by our expert committees

• We will publish the deliberative framework that will be used across our expert committees.
• We are investing in our partnership principle by adding a presentation to the expert committee by a person with lived experience, beginning with certain complex reviews.

Accelerated access pathways

• We are detailing the procedures for our expanded rolling review pilot process, which allows any drug application that is filed before Health Canada’s regulatory decision to be eligible for a rolling review.
• We are also modestly expanding the eligibility criteria for time-limited reimbursement recommendations. Drugs that could have been eligible for the time-limited recommendation pathway but were reviewed before the process was introduced may now be resubmitted for a time-limited recommendation.

Improving our engagement with drug sponsors

• By standardizing our meetings with drug sponsors, and in some cases introducing new optional checkpoint meetings, we aim to improve their usefulness and support the timely resolution of challenges that arise during reviews.

Streamlining our application process for drug sponsors

• We are presenting streamlined application requirements for certain drug products. These changes are a first step toward greater alignment with other health technology assessment agencies and increasing the uptake of our prenotice of compliance submission pathway.

Path of Continuous Improvement

Last year, we signalled program improvements that we would add or explore. Since that time, the organization has been engaging with all partners — Health Canada, the life sciences industry, public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA), and patient and clinician groups — to identify additional improvements and new approaches that can reduce review timelines while maintaining our rigorous scientific methods which are known and respected.

During our engagement activities, we received valuable input from our partners that we have considered and implemented, where possible.

We welcome the views of patients, clinicians, drug sponsors, consultants, and other organizations within Canada’s pharmaceutical ecosystem on the 6 areas described in our consultation document. We also described these changes in a preconsultation webinar for patient organizations. The recording is available on our YouTube channel.