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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 and Submission Guidelines 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. Manufacturers are limited to one pre-submission meeting per eligible drug submission, and the meeting must occur prior to the submission being received at CADTH. 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.

To request a meeting, manufacturers are must submit the completed Pre-submission Meeting Request Form to meetingrequests@cadth.ca

1.2 Advance Notification Procedure

In February 2018, 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.

For resubmissions, eligibility must be confirmed prior to providing advance notification. For more information on the Advance Notification Procedure, please refer to section 3.2 of the Procedure and Submission Guidelines for the CADTH Common Drug Review.

2. Application Phase

2.1 Filing an Application

Manufacturers must file the application in accordance with the content, format, and organization stipulated in the Procedure and Submission Guidelines for the CADTH Common Drug Review. All applications filed by manufacturers for drugs 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 Procedure and Submission Guidelines for the CADTH Common Drug Review. The screening period for a submission or resubmission is 10 business days, and five business days for a biosimilar submission. Note: The date the submission is received at CADTH is considered day zero for the purposes of calculating timelines Once the submission has been accepted, the Key Milestones for the review are posted on the CADTH website. 

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 used by CADTH in the development of the review protocol and to assist CDEC in their deliberations.

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 requests for advice and drug plan-initiated reviews. All drugs are initiated within 1 to 10 business days of acceptance for review. The initiation dates as well as other key milestones are confirmed only once the submission has been accepted for review. 

4.2 Type of CDR Review Conducted

CADTH conducts either a standard CDR review or a tailored CDR review, depending on the submission type:

  • A standard CDR review consists of the CADTH 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 CADTH 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.

For new combination products, manufacturers must submit a completed New Combination Product Considerations Form to CADTH before filing the submission. CADTH will assess the information and confirm the type of submission (standard or tailored) to be filed by the manufacturer. 

4.3 CDR Clinical and Pharmacoeconomic Review Reports

The CADTH 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 confidential information in the CDR review report(s) prior to the reports being 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, therapeutic advantages and disadvantages 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.

The CDEC meeting schedule is available on the CADTH website.

5.2 Embargoed Recommendation

Confidential Embargoed CDEC Recommendations are distributed to the manufacturer and drug plans 8-10 business days following the CDEC meeting.  For the 10 business day embargo period following distribution, 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

For transparency, the following documents are posted on cadth.ca:

  • Key milestones for reviews
  • CDEC Final Recommendations
  • CDR Clinical and Pharmacoeconomic Review Report(s), as applicable to the type of CDR review conducted
  • Patient Group Input Submissions 

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

Overview of CDR

 

CDR Patient Input Process

Video 1:

 

Video 2: