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Process in Brief

Through the CADTH Common Drug Review (CDR) process, CADTH undertakes the review of drugs, and issues formulary listing recommendations to all federal, provincial, and territorial drug plans that participate in the CDR process (hereafter referred to as the "drug plans"). The review process has a targeted performance metric of 180 calendar days from the time that an application is accepted for review to the date of issuing the embargoed Canadian Drug Expert Committee (CDEC) recommendation. Simplified descriptions of the main phases of the CDR process are subsequently provided. Please refer to the Procedure for the CADTH Common Drug Review for complete details.

1. Pre-submission Phase

1.1 Pre-submission Meetings

To facilitate the efficient preparation and filing of submissions for review under the CDR process, manufacturers may request a pre-submission meeting with CADTH to introduce the drug and discuss submission requirements. CADTH offers two types of pre-submission meetings:

  • Standard pre-submission meeting: up to 6 months in advance of filing any drug submission
  • Early pre-submission meetings: 6 to12 months in advance of filing a submission for a high-cost drug that is indicated for a poorly characterized disease with a small patient population.

1.2 Advance Notification Procedure

In September 2017, CADTH announced a revised procedure for advance notification for pending CDR submissions and resubmissions. Please consult the following document for details: Advance notification process for pending CDR submissions.

2. Application Phase

2.1 Filing an Application

Manufacturers must file the application in accordance with the content, format, and organization stipulated in the Submission Guidelines for the CADTH Common Drug Review. All applications filed by manufacturers for drugs that receive a Health Canada Notice of Compliance (NOC) on or after September 1, 2014, are subject to an application fee.

2.2 Application Screening

CADTH screens applications in the order they are received and in accordance with the requirements and checklists described in the Submission Guidelines for the CADTH Common Drug Review. An initial screening of a submission is completed by CADTH within 10 business days. If the filed requirements for a submission are deficient, CADTH sends a notice to the manufacturer advising what information needs to be included or revised in order to meet the requirements. Once the application has been accepted for review, CADTH posts a status report, with key targeted time frames for the review, on cadth.ca.

3. Patient 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 20 business days in advance of the manufacturer'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 CADTH for the drug under review is collated and summarized by CADTH staff. This summary, as well as the patient input received, are provided to the CDR review team to use in the development of the review protocol and to CDEC to inform their deliberations. For transparency, all patient input received, as well as the summary report prepared by CADTH, will be posted on cadth.ca in the future.

4. Review Phase

4.1 Initiation of a CDR Review

All applications are assigned to the CDR work schedule on a first-come, first-served basis, as determined by the date they are accepted for review — with the exception of those that are granted priority review status, requests for advice, and drug plan-initiated reviews. When the review of an application is initiated, CADTH establishes a review team based on the nature of the application content; and in consideration of the proposed team members' qualifications, expertise, and compliance with the conflict of interest guidelines.

4.2 Type of CDR Review Conducted

The CDR review team conducts either a standard CDR review or a tailored CDR review, depending on the type of application filed by a manufacturer.

  • A standard CDR review consists of the CDR review team conducting a systematic review of clinical evidence provided by the manufacturer, along with studies identified through its independent, systematic literature search, and an appraisal of the manufacturer-provided pharmacoeconomic evaluation.
  • A tailored CDR review consists of the CDR review team conducting an appraisal of the clinical evidence and pharmacoeconomic evaluation filed by the manufacturer using a CADTH-provided review template that is specific to the type of drug product to be reviewed.

4.3 CDR Clinical and Pharmacoeconomic Review Reports

The CDR review team prepares CDR Clinical and Pharmacoeconomic Review Report(s) in accordance with the appropriate review template (e.g., standard CDR review or tailored CDR review). Manufacturers are given the opportunity to review and provide comments on the draft CDR review report(s) before they are finalized and distributed to CDEC. For transparency, CADTH posts all CDR review report(s) on the CADTH website. Manufacturers are responsible for the identification of any confidential information in the CDR review report(s) and for requesting any redactions before these reports are posted.

5. Recommendation Phase

5.1 CDEC

CDEC is an advisory body to CADTH that makes drug-related recommendations and provides drug-related advice through the CADTH CDR and therapeutic review processes. CDEC's recommendations and advice are provided to CADTH to inform the drug plans and a range of stakeholders. CDEC members' deliberations take into account patient group input; clinical studies demonstrating the safety, efficacy, and effectiveness of the drug compared with alternatives; therapeutic advantages and disadvantages relative to current accepted therapy; and cost and cost-effectiveness relative to current accepted therapy. Following deliberation of the available evidence, CDEC may recommend one of these options for a drug under review: that a drug be reimbursed; that a drug be reimbursed with clinical criteria and/or conditions; or that a drug not be reimbursed.

5.2 Embargoed Recommendation

During the 10-day embargo period, the distribution of the CDEC recommendation is limited to the manufacturer and the drug plans. The intent of the embargo period is to allow time for the manufacturer and CDR-participating jurisdictions to consider the embargoed CDEC recommendation before it is made public. During the embargo period, the following may occur with respect to the embargoed CDEC recommendation: the drug plans may submit a request for clarification, and/or the manufacturer may make a request for reconsideration or file a resubmission based on a reduced price.

5.3 CDEC Final Recommendation

When a CDEC Final Recommendation is issued, CADTH sends the recommendation to the drug plans and the manufacturer, and posts a copy on cadth.ca. CDEC recommendations are non-binding to the drug plans. Each drug plan makes its own drug-listing decisions based on the CDEC Final Recommendation in addition to other factors, including the plan's mandate, priorities, and resources.

6. Transparency of the CADTH Common Drug Review Process

The following documents are posted on cadth.ca:

  • CDR Submission Status reports
  • CDEC Final Recommendations
  • CDR Clinical and Pharmacoeconomic Review Report(s), as applicable to the type of CDR review conducted
  • Patient input received from patient groups (or individual patients/caregivers from the pilot program), as well as the summary report prepared by CADTH, will be posted in the future.

Additional brief information videos regarding CDR are available, as follows:

Overview of CDR

 

CDR Patient Input Process

Video 1:

 

Video 2: