Pharmaceutical Reviews Update — Issue 49

Program Updates

1. Working Toward Target Zero: Expanding Our Rolling Review Pilot Process

Canada’s Drug Agency is taking a new step to improve the timeliness of patient access to new drugs. The action supports our ambitious Target Zero campaign — an initiative that aims to achieve zero days between Health Canada’s regulatory approval of a drug and our reimbursement recommendation to participating public drug plans. 

Effective immediately, we are expanding our pilot process for rolling drug reimbursement reviews. As a result, we can now initiate a rolling reimbursement review for any drug application that is filed before Health Canada’s regulatory decision (on a pre-Notice of Compliance basis) if the sponsor consents to information sharing between our organization and Health Canada.

The review timelines will be determined on a case-by-case basis and will depend on the complexity of the economic submission and the timeline for filing the information, with an overall goal of reaching Target Zero. 

Rolling Review Pilot Process 

In September 2023, we launched a rolling review pilot process limited to COVID-19 drugs. This process allows drug sponsors to submit the required clinical and economic evidence to us as soon as it is available rather than assembling all required documentation into a single application package. As a result, we can initiate the review earlier than our standard process in which all application materials must be filed before the review is initiated. 

The pilot process is modelled on the innovative approaches Health Canada adopted to expedite the regulatory review of COVID-19 therapies during the pandemic. The overall objective of the rolling review pilot process is to allow Canada’s Drug Agency to deliver a reimbursement recommendation earlier than would be possible if the sponsor waited until all documentation was ready to initiate the review process. 

Since we launched the initial pilot process last fall, the pharmaceutical industry has expressed interest in expanding our process to include drugs beyond those used to treat COVID-19. 

Target Zero Goal  

A key factor that influences the timing of our drug reimbursement recommendations is when we can start our work on a review. The start date is determined by the timing of a manufacturer’s submission to Canada’s Drug Agency and whether the submission is filed before or after Health Canada has issued a Notice of Compliance. To support improved timeliness, we accept drug submissions up to 180 days before Health Canada’s anticipated regulatory decision.  

Through ongoing consultations with the pharmaceutical industry, we heard that expanding the rolling review procedure to include a broader range of drugs could spur greater uptake of our pre-Notice of Compliance submission process. As a result of these discussions, we are pleased to expand our pilot process and to work collaboratively toward our goal of targeting zero days between regulatory and reimbursement decisions. 

Get In Touch  

Drug sponsors that would like to learn more about the rolling review pilot process or any aspect of our submission procedures are invited to contact us at [email protected].  

2. Now Available: Updated Budget Impact Analysis Tool and New User Guide 

We have updated the first version of our budget impact analysis tool and published a companion user guide. The user guide outlines how to use the tool, restrictions with the tool’s current form, and when a more bespoke de novo tool may be warranted.

The expectation is that this tool will be usable for most epidemiological budget impact analyses; however, certain reviews and decision problems will have unique nuances that it cannot address. This tool is not a requirement for drug reimbursement reviews submitted to Canada’s Drug Agency.  

Visit our website to access to the tool and user guide