Last Updated : July 31, 2019
Details
Project Line:
Reimbursement Review
Project Sub Line:
Pharmaceutical Review Update
Updates for Patients and Communities
Canada's Drug Agency is pleased to announce the membership of its new Patient and Community Advisory Committee. Twelve individuals from across the country have been invited to join the committee as inaugural members.
Committee members are patients or family caregivers and reflect the diversity of people and communities across Canada. Members will advise Canada's Drug Agency on all areas of the agency’s work from the perspective of individuals using the Canadian health care system. Learn more about the committee and its members here.
Consultations on the Canada's Drug Agency Pharmaceutical Review Programs
Canada's Drug Agency is inviting stakeholder comments and feedback on the following proposals:
- Proposal to Enhance the Transparency of the Canada's Drug Agency Review Reports and Recommendations
- Proposal to Revise Category 1 Requirements for Canada's Drug Agency Single Technology Reviews
- CADTH’s Proposed Reassessment Framework.
1. Proposal to Enhance the Transparency of the Canada's Drug Agency Review Reports and Recommendations
Canada's Drug Agency is committed to increasing the transparency of its health technology assessment processes. Canada's Drug Agency would like to invite stakeholder comments on a proposal to further strengthen transparency by requiring that clinical, economic, and other information submitted to the Canada's Drug Agency review processes be made disclosable at the time of publishing its reports and recommendations on its website.
Canada's Drug Agency has formal procedures and guidelines in place to handle information submitted to the Canada's Drug Agency review processes, including non-disclosable information. As a result, Canada's Drug Agency currently spends a substantial amount of time and effort negotiating with the submitter and redacting information deemed to be non-disclosable by the submitter. Redacting means editing a document to delete or mask information that has been deemed as non-disclosable by the submitter. Information that is deemed to be non-disclosable by a submitter is a barrier to transparency. It results in documents being published that contain sometimes significant amounts of relevant information redacted at the request of the submitter. This, in turn, could hamper understanding of the issues outlined in the reports and the rationale for the recommendation.
There are currently numerous initiatives underway by both national and international organizations to enhance transparency in the pharmaceutical, medical devices, and other technology review processes. An example is Health Canada’s recent Public Release of Clinical Information initiative. This is a major initiative that will provide Canadians with access to the clinical information that was submitted and reviewed as part of the regulatory reviews conducted by Health Canada.
Building on best practices, Canada's Drug Agency believes that information contained in its reports and recommendations to support decision-making should be made fully disclosable to ensure that stakeholders and the public can better understand the evidence that supports the outcome of a recommendation made by the Canada's Drug Agency expert review committees.
For complete details, please review the following documents:
2. Proposal to Revise Category 1 Requirements for Canada's Drug Agency Single Technology Reviews
Canada's Drug Agency would like to invite stakeholder comments on a proposal to revise Category 1 requirements to further support single technology reviews through both the Canada's Drug Agency Common Drug Review (CDR) and the Canada's Drug Agency pan-Canadian Oncology Drug Review (pCODR) programs. Proposed additions to Category 1 requirements include a systematic review, complete clinical study reports, a reimbursement status table, and a budget impact analysis.
For complete details, please review the following document:
3. Proposed Canada's Drug Agency Reassessment Framework
There is currently no standardized pan-Canadian process for monitoring and re-evaluating drugs in Canada once they have been funded. Establishing guidelines and processes for the reassessment of drugs is a key objective of the Canada's Drug Agency 2018-2021 Strategic Plan.
Canada's Drug Agency is seeking to establish consistent processes, collectively referred to as a reassessment framework, that would enable the reassessment of drug products to optimize drug reimbursement decisions. Canada's Drug Agency believes that multiple approaches will be required to ensure that the reassessment of drugs is both effective and efficient. Canada's Drug Agency is proposing that reassessments be conducted using the existing well-established drug review pathways, as well as through the establishment of a new targeted reassessment pathway.
For complete details, please review the following documents:
4. How to Submit Your Feedback
To provide feedback on the proposals, please use the feedback template The completed template must be saved in one of the following formats:
- Microsoft Word document (.doc or.docx)
- unlocked PDF document that permits copying and pasting of text.
The completed templates must be uploaded send to [email protected].
Feedback should be presented clearly and succinctly in 11-point font and must be received by Canada's Drug Agency by 5:00 p.m. EDT on Friday, September 13, 2019. For feedback to be considered, you must identify yourself to Canada's Drug Agency. Only one response per organization will be considered. If more than one response is received, only the first will be considered.
If you have any questions about the feedback process, please email us at [email protected]. We thank you in advance for your interest.
Canada's Drug Agency Program Updates
1. Temporary Suspension Following Notice of Deficiency or Notice of Non-compliance
Canada's Drug Agency is providing additional clarity to its drug review processes for submissions filed on a pre-notice of compliance (NOC) basis and may receive a notice of deficiency (NOD) or notice of non-compliance (NON) from Health Canada. Effective immediately, Canada's Drug Agency will allow the review of certain pre-NOC submissions to be temporarily suspended while resolution of the NOD/NON is discussed with Health Canada if it meets the requirements outlined below. The decision to allow for suspension rather than mandatory withdrawal will be made solely at the discretion of Canada's Drug Agency on a case-by-case basis based on the requirements set out in its procedures.
In order to be eligible for suspension rather than withdrawal, applicants must have consented to the information-sharing process between Canada's Drug Agency and Health Canada. Canada's Drug Agency will also consider the following factors when determining if suspension is an option, including but not limited to:
- Health Canada’s rationale for the NOD/NON (e.g., clinical versus quality issues)
- the anticipated timelines for addressing the issues raised by Health Canada.
For drugs that undergo temporary suspension as a result of an NOD/NON, the following information would be required in order for Canada's Drug Agency to lift the suspension:
- a brief summary of the issue and how the manufacturer has or is planning to resolve the issue
- any new clinical data filed with Health Canada to address the issue
- advance notification from the applicant of a minimum of six weeks regarding when the issue is likely to be resolved and a NOC issued by Health Canada.
Depending on the availability of resources, Canada's Drug Agency will resume the review at the stage where it was suspended. The applicant will be advised, in writing, when the review process resumes, along with the anticipated target dates for the remaining steps of the review process.
Should you have any questions or concerns regarding this process change, please contact [email protected] with the specific details.
2. Canada's Drug Agency and INESSS Joint Engagement with Clinicians
In September 2018, Canada's Drug Agency and the Institut national d’excellence en santé et en services sociaux (INESSS) established a pilot project to jointly engage with clinical specialists on selected drug products.
Canada's Drug Agency and INESSS have evaluated the pilot process and found the joint engagement process to be valuable for both organizations. As such, the pilot process is being concluded and joint Canada's Drug Agency-INESSS engagement with clinical specialists has been integrated into the review procedures for the respective agencies. The process will continue to be applied only for selected drugs, as described in the Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review.
Canada's Drug Agency and INESSS thank all the manufacturers for their participation in the pilot process.
3. Updated Pharmacoeconomic Submission Requirements for the Canada's Drug Agency Common Drug Review
To improve transparency in the models submitted by manufacturers and to facilitate improved alignment with the Canada's Drug Agency Guidelines for the Economic Evaluation of Health Technologies: Canada, the economic information requirements for CDR submissions have been updated. The updates are intended to provide clarity for manufacturers regarding what they should be providing to Canada's Drug Agency as part of the pharmacoeconomic submission. The changes that have been made to the economic information requirements are summarized in the table that follows.
Table 1: Summary Table of Changes to Economic Information Requirements
| Text in Previous Canada's Drug Agency Common Drug Review Guidelines | Text in Current Canada's Drug Agency Common Drug Review Guidelines |
|---|---|
| All analyses must be conducted probabilistically. | The base case and all scenario analyses must be conducted probabilistically. |
| Not applicable (new requirement) | Results of the manufacturer’s base case and, if applicable, scenario analysis for the reimbursement-requested population, must be presented in a disaggregated manner before being aggregated. A breakdown by costs (e.g., drug acquisition costs, administration costs, adverse event costs, health state costs) and by quality-adjusted life-years (e.g., benefits generated in each health or event state, benefits generated during the trial period versus the extrapolation period) must be reported based on the probabilistic results. |
| If more than one comparator is included, results should be reported using a sequential analysis that indicates where the drug lies on the cost-effectiveness efficiency frontier. | If more than one comparator is included, the probabilistic analysis should run all comparators simultaneously or be conducted in a way that ensures that the same input parameter values are considered within each simulation. Pairwise analyses assuming different efficacy assumptions for a common comparator are not appropriate. |
4. Updated Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review
The Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review has been updated with the following revisions:
- integration of the Canada's Drug Agency-INESSS process for joint engagement with clinical specialists
- updated pharmacoeconomic requirements.
Applicants who have questions about specific requirements may contact Canada's Drug Agency for guidance on submission preparation by emailing [email protected].
Last Updated : July 31, 2019