CADTH Pharmaceutical Reviews Update — Issue 17

Canada's Drug Agency Program Updates

1. New Procedures for Canada's Drug Agency Drug Reimbursement Reviews

Canada's Drug Agency initiated stakeholder consultations in June 2020 on proposals to align the procedure for its drug reimbursement review processes (i.e., pan-Canadian Oncology Drug Review [pCODR], Common Drug Review [CDR], and Interim Plasma Protein Product Review [PPP]). Individual or joint submissions were received from 80 organizations and companies that represent the pharmaceutical industry, patient and clinician groups, and government and non-profit agencies. All feedback has been documented and reviewed internally for action.

Canada's Drug Agency has carefully considered the feedback received during the consultation and is pleased to announce the new Procedures for Canada's Drug Agency Drug Reimbursement Reviews. These procedures will be effective for all applications targeting the April 2021 expert committee meetings. Applications received on or after the following dates will be processed under the new drug reimbursement review procedures:

• October 26, 2020, for non-oncology drugs
• October 20, 2020, for oncology drugs.

Canada's Drug Agency received many useful and constructive suggestions from stakeholders about its drug reimbursement review processes, and these have been incorporated into the revised procedure wherever feasible; suggestions that will require internal feasibility assessment, substantive changes to the review process, or additional dialogue with stakeholders will be addressed in the future.

Highlights of the new procedures include:

• Communications: Canada's Drug Agency will proceed with consolidating the communications for its drug reimbursement review processes. The new communications are scheduled to begin in late October when the new drug reimbursement review processes are effective.
• Pre-submission procedures: Canada's Drug Agency will proceed with the proposed revisions to the advance notification and pre-submission meeting processes.
• Confidentiality guidelines: Canada's Drug Agency will adopt an interim process, based on the process used for non-oncology applications, for handling confidential information. Canada's Drug Agency remains committed to enhancing transparency and eliminating redactions in its drug reimbursement review processes, and will continue to discuss options with industry to improve transparency over the coming months, anticipating that further changes will be enacted in the future.
• Proposed place in therapy template: Stakeholders noted that the effort required to complete the proposed place in therapy template can be considerable and a challenge for submissions filed on a pre-Notice of Compliance (NOC) basis. Canada's Drug Agency appreciates this perspective and will only require that this form be completed for oncology drug submissions (as it is required in order to inform discussions regarding the need for Canada's Drug Agency to develop a provisional algorithm).   
• Health economics: Canada's Drug Agency will proceed with the proposed revisions to the pharmacoeconomic submission requirements and allow sponsors to file cost-minimization analyses for select drug products.     
• Draft reports: Canada's Drug Agency will proceed with the proposal to allow sponsors to review and provide commentary on the draft review reports. At the request of stakeholders, the template for sponsor commentary has been revised and the identification of any errors with data transcription will no longer count towards the overall page limitations.
• Draft recommendations: Canada's Drug Agency will proceed with the proposal to post all draft recommendations for stakeholder feedback.
• Reconsideration process: Canada's Drug Agency will proceed with the proposal to introduce greater flexibility into the reconsideration process (i.e., requests for major or minor revisions).       
• Procedural review: A new step has been included in the procedural review process to allow Canada's Drug Agency to propose one or more options to resolve the issue and may avoid the need to convene a panel. This change will allow Canada's Drug Agency and the requestor to expedite resolution and avoid potential delays.

Canada's Drug Agency would like to thank all stakeholders that took the time to respond to this consultation. If you have any questions regarding the new Procedures for Canada's Drug Agency Drug Reimbursement Reviews, please feel free to contact Canada's Drug Agency at [email protected].

2. Revised Provisional Algorithm Process

Based on feedback received during the consultation, Canada's Drug Agency has augmented stakeholder input opportunities within the provisional algorithm process. Specifically, the following steps have been added to the new, revised process:

• A call for stakeholder input will now be issued when a new provisional algorithm project is initiated by Canada's Drug Agency. Stakeholders will have the opportunity to review and comment on a summary document outlining the scope, objectives, and rationale for the provisional algorithm.
• Patient and clinician groups will have the opportunity to review and comment on the draft provisional algorithm during a designated stakeholder feedback period.

These additions to the process will supplement existing patient and clinician input processes and will run concurrently with the opportunities for input offered for drug manufacturers whose products may be impacted by the provisional algorithm work.

3. Revised Target Dates for pERC Meetings

Beginning in April 2021, meetings of the pCODR Expert Review Committee (pERC) will target the second Thursday of each month as opposed to the third Thursday of each month. This change will give Canada's Drug Agency and other stakeholders the opportunity to balance resources and timelines by avoiding multiple expert review committees during the same week and allowing staggering of stakeholder feedback periods. This change is reflected in the new pERC and Canadian Drug Expert Committee (CDEC) meeting schedules that are available on the Canada's Drug Agency website.

4. Consultation on Canada's Drug Agency Deliberative Framework and Process

Canada's Drug Agency would like to thank all stakeholders that provided preliminary input on the deliberative framework and process questions that were part of the consultation. This input will be taken into consideration when developing options for forthcoming consultations.

5. Consultation on Health Canada, Canada's Drug Agency, and INESSS Aligned Review Process

In June 2020, Canada's Drug Agency, INESSS, and Health Canada initiated stakeholder consultations on Proposed Enhancements to the Health Canada, Canada's Drug Agency, and INESSS Aligned Review Processes. Individual or joint submissions were received from 18 organizations and companies that represented the pharmaceutical industry, patient groups, and government agencies. Canada's Drug Agency, INESSS, and Health Canada would like to thank all stakeholders that took the time to respond to this consultation. The three agencies will carefully review this feedback and provide an update on next steps in the near future. If you have any questions, please feel free to contact Canada's Drug Agency at [email protected].

6. Clarification Regarding Tumour Group Submissions

Canada's Drug Agency would like to clarify that tumour group submissions for oncology drugs are reserved for exceptional situations where the drug manufacturer is not planning to market a product in Canada for a particular indication and the drug has the potential to address a major unmet therapeutic need. Canada's Drug Agency has encountered several situations where tumour groups are working directly with the drug manufacturer to prepare submissions for products that do not fit these criteria. Canada's Drug Agency processes have been optimized for direct interaction with the drug manufacturer to ensure complete and rapid access to all of the relevant information required to conduct the review; this is meant to ensure the best possible outcome for all stakeholders.

7. Revised Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews

The Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews has been revised to reflect the alignment of milestone 2 for invoicing oncology and non-oncology application fees to the point where the draft reports are sent to the sponsor for comment (which replaces the checkpoint meeting for oncology applications).

8. Canada's Drug Agency webpages for Drug Reimbursement Reviews

Canada's Drug Agency will be updating our drug reimbursement review webpages over the next month, including consolidation of the drug summary tables for oncology and non-oncology drugs. An update will be issued in the near future to notify stakeholders once these changes have been implemented.