Last Updated : October 29, 2020
Our reimbursement review processes are meant to reduce duplication across jurisdictions, maximize the use of limited resources, and enhance the consistency of drug reviews. We undertake reviews of drugs and issues reimbursement recommendations and/or review reports to federal, provincial, and territorial drug programs; cancer agencies; and Canadian Blood Services. It is important to note that our recommendations are non-binding and each drug program makes its own reimbursement decisions based on our recommendation and other factors, including the plan's mandate, jurisdictional priorities, and financial resources. Please refer to the Procedures for Reimbursement Reviews for complete details.
1. Pre-submission Phase
1.1 Pre-submission Meetings
A pre-submission meeting is offered to facilitate the efficient preparation and filing of an application with us. The goal of the meeting is to assist the sponsor in improving the quality, relevance, and clarity of the information filed for review. Pre-submission meetings will be scheduled for a maximum of one hour and sponsors are limited to one meeting per pending application. To request a meeting, sponsors must submit the completed pre-submission meeting request form to us.
1.2 Advance Notification Procedure
Sponsors are required to provide us with a minimum of 30 business days of advance notice for all applications. To fulfill the advance notification requirement, sponsors must complete the advance notification form in its entirety and submit it to us at [email protected].
2. Application Phase
2.1 Application Filing
Sponsors must file the application in accordance with the content, format, and organization stipulated in the Procedures for Reimbursement Reviews. All applications filed by industry sponsors are subject to an application fee.
2.2 Application Screening
We screen applications in the order they are received and in accordance with the requirements and checklists described in the Procedures for Reimbursement Reviews. The screening period for an application is 10 business days.
3. Stakeholder Input
3.1 Patient Group Input
Patient input provides patients' experiences and perspectives of living with a medical condition for which a drug under review is indicated, their experiences with currently available treatments, and their expectations for the drug under review. The call for patient input is posted 29 business days in advance of a sponsor's anticipated date of application filing, as provided in the mandatory notification. A total of 35 business days is provided for preparing and submitting patient input. All patient input received by us for the drug under review is collated and summarized by us. This summary and the patient input received are used by us in the development of the review protocol and to assist the expert committee in its deliberations.
3.2 Clinician Group Input
Clinician group input is used by us in all phases of the review, including the development of the review protocol, appraisal of evidence, and interpretation of the results. The clinician group input summary and individual submissions are included in the committee briefing materials. The call for clinician input regarding a submission, resubmission, or standard reassessment is posted 29 business days in advance of the anticipated filing date. Groups or associations of health care professionals will have a total of 35 business days to prepare and submit their input.
3.3 Drug Program Input
The drug programs provide input on each drug being reviewed through our reimbursement review processes by identifying issues that may impact their ability to implement a recommendation. This input increases the relevance of the recommendations and can potentially avoid the need for an implementation advice panel or targeted reassessment later in the process by ensuring that potential implementation issues were considered during the review.
4. Review Phase
4.1 Initiation of the Review
All applications are assigned to the work schedule on a first-come, first-served basis, as determined by the date they are accepted for review. All drugs are initiated within 1 to 10 business days of acceptance for review. Initiation dates, as well as other key milestones, are confirmed only once the application has been accepted for review.
4.2 Review Reports
Depending on the type of review, we will prepare a clinical report, pharmacoeconomic report, and an ethics report. The sponsor is given the opportunity to review and provide comments on the draft report(s) before they are finalized and distributed to the expert committee. For transparency, we post all our report(s) to our website. Before they are posted, sponsors are responsible for identifying any confidential information contained in the report(s). Samples of these reports can be found as follows:
5. Recommendation Phase
5.1 Expert Committees
The following are our drug expert committees currently provide drug-related recommendations and advice to the drug programs:
- The Canadian Drug Expert Committee (CDEC) is used for drugs that are reviewed through our Common Drug Review process.
- The Canadian Plasma Protein Product Expert Committee (CPEC) is a subcommittee of CDEC that is used for products that are reviewed through the Interim Plasma Protein Product Review Process.
- The pan-Canadian Oncology Drug Review (pCODR) Expert Review committee (pERC) is used for drugs that are reviewed through our pCODR process.
The expert committees may recommend that a drug be reimbursed; that a drug be reimbursed with conditions; or that a drug not be reimbursed. The expert committee meeting schedule is available on the website.
5.2 Draft Recommendation
Draft recommendations are distributed to the sponsor and drug programs 8 to 10 business days after the expert committee meeting. All draft recommendations are posted on the website for stakeholder feedback. Sponsors are responsible for identifying and requesting the redaction of any sponsor-supplied confidential information that has been included in the draft recommendation before this document is posted for stakeholder feedback. The feedback period begins when the draft recommendation is posted on our website. The intent of the feedback period is to allow time for the sponsor, drug programs, and other stakeholders to comment on the draft recommendation and provide feedback before it is finalized and posted. Stakeholders will have 10 business days to review the draft recommendation and provide feedback using our template. During the feedback period, the sponsor and/or the drug programs may make a request for reconsideration.
5.3 Final Recommendation
When a final recommendation is issued, we posts a copy to its website. Before this document is posted, sponsors are responsible for identifying and requesting the redaction of any confidential information that has been included in the recommendation.
6. Implementation Phase
Our recommendations are non-binding to the drug plans. Each drug plan makes its own drug-listing decisions based on the final recommendation and other factors, such as the plan's mandate, priorities, and resources.
After a final recommendation has been issued, we provide the drug programs with implementation support. This can include, but is not limited to, refining reimbursement conditions, developing advice on implementation issues for drugs, and establishing a provisional funding algorithm for selected oncology indications.
Last Updated : October 29, 2020