Upcoming Improvements to the Reimbursement Review Process

Today, we are communicating a series of improvements that will further our ambition to innovate in the field of health technology assessment (HTA), adapt to changing regulatory and reimbursement environments, and improve the pathway that brings effective drugs to patients across Canada.

During the coming year, we are committed to identifying and implementing improvements to the Drug Reimbursement Review process. These changes are in response to our changing environment, as well as to feedback received from patient groups, clinicians, and industry. We anticipate implementing these changes in the near term and will engage with key stakeholders on next steps.

As a start, we will undertake a lean review of the Reimbursement Review process. The purpose of the lean review will be to identify efficiencies and process improvements that will benefit our patient, clinician, and industry partners, with a goal of reducing overall timelines. In addition, we will pursue other process improvements that will enhance our work.

Examples of process improvements that will be added or explored to streamline all phases of the Reimbursement Review process include:

• adding presubmission pipeline meetings with drug sponsors, effective June 8, 2023. These meetings will foster greater dialogue between us and the pharmaceutical industry, and will provide valuable insight on timetables for regulatory filings, approvals, HTA submissions, and product launches
• developing a budget impact analysis (BIA) template to increase transparency and streamline the conduct of BIAs
• streamlining review requirements for certain drug products
• adding an in-review meeting between us and the sponsor for certain drugs
• introducing a proportionate approach to Reimbursement Reviews based on complexity
• exploring how to advance innovative concepts, such as outcome-based agreements and incorporating new evidence midstream in a review.
• improving committee deliberations to increase transparency and align with international best practices
• for select drugs with broad system implications, introducing implementation advice panels for diagnostics
• for select oncology drugs, delivering provisional funding algorithms in parallel with Reimbursement Reviews
• piloting a new formulary management committee to create a sandbox within which we can trial some of the new processes described above.

In addition to these improvements, we will also work to bring greater transparency and clarity to our processes in a way that offers all stakeholders a better understanding of and visibility into how we work. This will include examining how we better engage with industry, clinicians, and patients with a view toward improvement.

Adjustment to Industry Fees

To enable these changes and continue to deliver our services reliably, we will be making adjustments to the application fee structure for all drug submissions that are filed by industry sponsors.

This year, the fee increase will include an inflationary amount (approximately 6.0%) as well as an additional increase to support the changes in the Drug Reimbursement Review program noted above. The adjusted fee for a standard review will change from $75,900 to $98,670. Please consult the updated Fee Schedule for Pharmaceutical Reviews and our Frequently Asked Questions for more information. The adjusted fees for all submissions will come into effect on July 17, 2023.

We introduced application fees in 2014 (for non-oncology drugs) and 2015 (for oncology drugs) as a way of sharing the costs between government funders and industry. In 2018, we began to make annual adjustments based on the Consumer Price Index and the fees were last adjusted for this purpose in 2022. While our fee structure for a Reimbursement Review has evolved since 2014 to accommodate new review categories, it has not been substantially revised to reflect trends in the pharmaceutical sector.

In addition, effective July 17, 2023, the Scientific Advice service will note an increase in the fee range for projects. The range will enable us to continue to operate the service on a cost-recovery basis. Fees for this program are discussed with requestors when a submission is received, based on the scale of the project. The current fee range is $65,000 to $100,000 and will increase to a new range of $80,000 to $125,000. Please refer to the Fee Schedule for Scientific Advice for detailed information on this service, including the recent expansion to include real-world evidence within the scope of advice available. Note that the Scientific Advice service is an optional offering that is separate from the Drug Reimbursement Review process.

Additional Information

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