Revamped Drug Reimbursement Reviews Expected In Canada Soon

Canada’s national health technology assessment agency, the CDA-AMC, is inviting feedback on proposed improvements to its drug reimbursement review procedures, including measures to revise its tailored and complex review processes.

The proposals, published on 6 January, also involve clarifying and enhancing the CDA-AMC’s accelerated access review pathways, streamlining its application requirements for certain drugs, improving its engagement with drug sponsors, modernizing its reports, and updating the deliberative process its expert committees use.

“The proposed measures are important procedural improvements that are meant to increase efficiency and transparency and help accelerate patient access to proven new treatments,” the CDA-AMC said.

They cover a series of enhancements and new additions to the processes the agency follows to issue reimbursement recommendations to public drug plans and cancer treatment agencies (excluding in Quebec).

The proposals are detailed in a consultation document that is out for comment until 6 February.

If all goes to plan, the changes could become effective for applications the CDA-AMC receives in the first half of 2025.

Tailored and Complex Reviews

The CDA-AMC uses a proportionate approach to drug reviews. These involve three levels – tailored, standard and complex – that match the level of resources to the effort required for a robust assessment.

Regarding the tailored review pathway, the agency wants to expand its scope (which at the moment is limited to new combination products and new formulations of existing drugs) to include selected new drugs that are similar to other products previously reviewed by the CDA-AMC.

“This new scope includes simple, low-risk PACES [pharmaceuticals with anticipated comparable efficacy and/or safety],” the agency said, adding that the goal was to accelerate review timelines.

The CDA-AMC plans to trial the new tailored review approach for a period of one to two years and will evaluate if the objectives of the revisions are being achieved.

As for complex reviews, the changes focus on targeted process enhancements, depending on the characteristics of the drug under review.

“For example, a drug that is the first product indicated in a therapeutic area could require the development of novel reimbursement conditions which would benefit from enhanced consultation with clinical specialists,” the agency explained. “Similarly, the therapeutic area could be new to our expert committee and the deliberations would benefit from direct participation by a person with lived experience. With this new approach, the complex process is modular in nature, as opposed to the single complex review process that is currently used.”

The CDA-AMC has proposed eligibility criteria for four complex review scenarios, as well as process enhancements such as improved clinician engagement and additional consultation with methodologists.

In addition, it said that the generation of a standalone ethics review report would “no longer be undertaken for every complex review and will now be initiated only for selected products that may be associated with extensive ethical challenges for our expert committees and/or decision-makers.”

The CDA-AMC expects that the standard review procedure will remain the most commonly used pathway and will apply to all applications that did not meet the criteria for the tailored or complex review processes.

Accelerated Access

The CDA-AMC’s consultation document deals with two accelerated access pathways: the rolling submission pilot process and the time-limited reimbursement procedure.

Regarding rolling submissions, the document provides greater clarity regarding the procedures and eligibility criteria involved with the pathway, which was launched in 2023 for use with COVID-19 products but then expanded last July to include drugs for other diseases.

In a rolling submission, a review is initiated earlier, and evidence is submitted as it becomes available rather than waiting for all the required documentation to be assembled into a single application package. Applications for such reviews must be filed before Health Canada reaches a regulatory decision about the product. The aim is to achieve zero days between regulatory approval of a drug and the CDA-AMC’s reimbursement recommendation to participating public drug plans and cancer treatment agencies.

The consultation document discusses the eligibility criteria for rolling submissions, explains how the application, screening, review and recommendation phases work, and covers target time frames for reviews.

The CDA-AMC said it would evaluate the rolling submission pilot after one to two years to ensure it was having the intended impact.

As for the time-limited reimbursement pathway, the agency wants to “modestly expand” the eligibility criteria for this temporary funding mechanism to include resubmissions of drugs that were previously reviewed by the agency before the pathway was implemented in September 2023.

“The intent of this proposal is to provide fairness to files that may have otherwise met the existing criteria for time-limited recommendations but were reviewed before September 2023,” it said.

A time-limited recommendation is a recommendation to publicly fund a drug or drug regimen for a certain period, on the condition that the sponsor conducts one or more clinical studies to address any uncertainties the CDA-AMC has.

Streamlining Applications

Regarding proposals to streamline the application process for drug sponsors, the consultation document includes a table that lists requirements that the agency proposes can be removed from the reimbursement review process.

These documents include the signed cover letter, the Common Technical Document section 2.7.1 (which refers to the summary of biopharmaceutic studies and associated analytical methods), and editorial articles and a reference list of editorial articles. These have been identified as offering “little value in the review process and their removal will reduce the administrative burden” for sponsors as well as CDA-AMC staff who are required to screen the documents for acceptability, the agency said.

The proposed 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.”

Improving Engagement, The Deliberative Process & Reports

As for improving engagement, the CDA-AMC wants to standardize its meetings with drug sponsors and, in some cases, introduce new optional checkpoint meetings. The aim is to improve the usefulness of the meetings and support the timely resolution of challenges that arise during reviews.

Regarding the deliberative process that the CDA-AMC’s expert committees use, the agency said it wanted to improve the transparency of how these committees reach a conclusion and provide “a new avenue for meaningful patient engagement.”

As such, it has proposed publishing the deliberative framework used, and “investing in our commitment to partnership, by adding a presentation to the expert committee by a person with lived experience, beginning with our complex reviews.”

Concerning review and recommendation reporting by the CDA-AMC, the agency said: “We aim to change our report templates to reduce the length of these documents, make them easier to read and interpret, and reduce redundancy. These changes will enhance the value that our review reports (eg, Clinical Review reports, Pharmacoeconomic Review reports) and recommendation reports bring to decision-makers.”

Next Steps

After the consultation closes on 6 February, the CDA-AMC’s hopes to post its revised procedures on 27 February.

The plan is for the new procedures to become effective for new applications targeting the October 2025 expert committee meetings: ie, for oncology applications received on or after 28 April, and non-oncology applications received on or after 12 May.