CADTH Pharmaceutical Reviews Update — Issue 41

Canada's Drug Agency Program Updates       
 

1.  Procedures for Time-Limited Reimbursement Recommendations

Canada's Drug Agency is pleased to announce the introduction of time-limited reimbursement recommendations. For complete details, read our news announcement and consult the Procedures for Time-Limited Reimbursement Recommendations. These procedures are effective immediately for all eligible applications.

Canada's Drug Agency thanks all stakeholders who participated in our public consultations between March 30 and May 1, 2023, on a proposal to introduce time-limited reimbursement recommendations. We received responses from 31 organizations, spanning the pharmaceutical industry, patient and clinician groups, consulting companies, and public drug programs. Canada's Drug Agency carefully considered the constructive feedback from stakeholders about the proposed processes and incorporated suggestions wherever feasible.  

If you have questions about the new Procedures for Time-Limited Reimbursement Recommendations, please contact [email protected].  

2.  New Canada's Drug Agency Pilot Process for Rolling Reviews

As communicated in Issue 40 on July 27, 2023, Canada's Drug Agency is now accepting Reimbursement Review applications for the review of COVID-19 drugs. To expedite the review of applications for COVID-19 drugs that are currently funded through the national procurement process, Canada's Drug Agency is launching a “rolling review” pilot process. Under the pilot process, Canada's Drug Agency encourages sponsors to submit the required clinical and economic documentation as soon as it is available rather than assembling all required materials into a single application package. This will allow Canada's Drug Agency to initiate the review process earlier than the current process in which all application materials must be filed prior to initiating the review.   

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

The scope of the pilot process is limited to applications for a drug currently being funded through the national procurement process for the indication under review. All other drugs, including new COVID-19 therapies or new indications that are not subject to national procurement, are required to file applications according to the existing Procedures for Canada's Drug Agency Reimbursement Reviews. Sponsors with products that are eligible for review through the pilot process will be contacted by Canada's Drug Agency to further discuss details and timelines.

Canada's Drug Agency will examine the learnings from this pilot process and engage with industry partners to determine if there is interest in adopting rolling reviews for other products in the future.  

3.  Revisions to the Therapeutic Review Framework and Process

A Canada's Drug Agency Therapeutic Review is a review that compares the clinical effectiveness and cost-effectiveness of drugs in a therapeutic category or drug class.  

Canada's Drug Agency has revised the Therapeutic Review Framework and Process to reflect recent process changes that increase efficiency and transparency. The Canada's Drug Agency Formulary Management Expert Committee (Interim) is now the committee that assesses Therapeutic Reviews and makes recommendations on the optimal use of oncology and non-oncology drugs and, if appropriate, updated Reimbursement Review recommendations. Additionally, the previously named “Science Report” has been split into 2 reports and renamed Clinical Summary Report and Economic Summary Report, to align with streamlined procedures.

Canada's Drug Agency is currently conducting a Therapeutic Review of Optimal Pharmacotherapy for Transplant-Ineligible Multiple Myeloma.  

4.  Requests for Deviation from Pharmacoeconomic Requirements

4.1  New Application Requirement

Effective for all applications received on or after November 1, 2023, all sponsors that file a request for deviation will be required to include a copy of the decision letter from Canada's Drug Agency within the General Information section of the application. This change will offer important efficiencies for Canada's Drug Agency by streamlining the application screening process. Sponsors are required to include a copy of the letter about the decision from Canada's Drug Agency regarding whether the deviation has been accepted. If the sponsor has not filed a request for deviation, we request that they include a placeholder document stating that no request was filed. The Procedures for Canada's Drug Agency Reimbursement Reviews, including the checklists and application folder structures, have been updated to include this new requirement.  

4.2  Revised Application Overview

Canada's Drug Agency has made a minor revision to the application overview template in the section regarding requests for deviation. The sponsor is now required to indicate if the request was accepted, partially accepted, or not accepted by Canada's Drug Agency.  

4.3  Reminder About Timing of Requests for Deviation

Canada's Drug Agency has recently received requests for deviation during the screening period or embedded within the application materials. Sponsors are reminded that deviations from any of the requirements within the economic evaluation section must be discussed with, and accepted by, Canada's Drug Agency before filing the application. Failure to seek advanced approval of the deviation may result in an extension of the screening timelines.  

5.  Expert Committee Meetings: Drugs and Topics Under Review

Starting in October 2023, the first Canada's Drug Agency Weekly Summary newsletter of each month will include information about the drug products under review at upcoming meetings of the Canada's Drug Agency Canadian Drug Expert Committee, Canada's Drug Agency pan-Canadian Oncology Drug Review Expert Review Committee, and Canada's Drug Agency Formulary Management Expert Committee (Interim). It will also include the topic(s) under discussion by the Canada's Drug Agency Health Technology Expert Review Panel, which delivers guidance on medical devices, diagnostic tests, and clinical interventions. This information will first be included in the October 5th newsletter.

Canada's Drug Agency is consolidating this information monthly to support greater transparency and to help all interested parties follow products and topics through the review process. Visit the Subscribe page on our website to subscribe to the Canada's Drug Agency Weekly Summary.

6.  Reminder: Source Documentation for Sponsor Summary of Clinical Evidence Template

Sponsors are reminded that all source documentation for clinical data reported in the sponsor summary of clinical evidence must be clearly labelled and provided within the application materials. Canada's Drug Agency has recently encountered situations in which the data cuts reported in the sponsor summary of clinical evidence are different from those reported in the source documentation. This inconsistency can lead to delays in the review process. Sponsors are strongly encouraged to carefully review the application to ensure all source documentation has been included.

7.  Updated Schedule for Presubmission, Pipeline, and Reconsideration Meeting Dates

Canada's Drug Agency has updated the schedule for presubmission, pipeline, and reconsideration meeting dates to the end of 2024.  

8.  Reconsideration Meeting Attendance

Effective immediately, Canada's Drug Agency will invite members of the jurisdictional advisory committees (i.e., Formulary Working Group for non-cancer applications and Provincial Advisory Group for cancer applications) to observe the reconsideration meetings with the sponsor. The attendance of the advisory committee member(s) will be optional. Section 9.5.6b of the Procedures for Canada's Drug Agency Reimbursement Reviews has been updated to communicate this process revision.