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CDR Update — Issue 136

Last Updated: May 31, 2018
Result type: Reports
Product Line: CDR Update Newsletter
Issue: 136

1. CDEC Meeting Schedule

CADTH has updated the format of the Canadian Drug Expert Committee (CDEC) meeting schedule to provide additional information and target dates to assist manufacturers who are planning to file a CADTH Common Drug Review (CDR) submission or resubmission. The updated schedule provides the CDEC meeting dates until December 2019.

2. Advance Notification Form

CADTH has updated the advance notification form to include a statement that information provided as part of the advance notification process may be shared with the federal, provincial, and territorial governments, including their agencies and departments, as well as the pan-Canadian Pharmaceutical Alliance (pCPA). Effective immediately, applicants providing advance notice to CADTH of a pending CDR submission or resubmission are required to use the updated form.

3. Addition of Patient Groups who Provide Input to Key Milestone Table

Effective for CDR submissions or resubmissions received on or after July 2, 2018, CADTH will include the names of the patient groups who provided input within the key milestone table on the CADTH website. The information will be posted for the drug under review after the call for patient input is closed and in advance of when the original patient input is posted on the CADTH website.

4. Participation of Drug Plans in Pre-submission Meetings

Effectively immediately, representatives from the CDR-participating drug plans may attend pre-submission meetings.  

5. Updated Submission Guidelines and Procedure for the CADTH Common Drug Review Documents

CADTH is currently finalizing updates to the Submission Guidelines and the Procedure for the CADTH Common Drug Review which will be posted in June 2018. Highlights of this updated document are summarized below.

Sections

Description

Category 1 requirements

The following category 1 requirements will no longer be needed for submissions and resubmissions:

  • Letter for finalized category 1 requirements
  • Literature search strategy
  • CONSORT diagrams
  • Health Canada reviewers report (although CADTH may continue to request copies of these reports from manufacturers as additional information).

A new consolidated letter template will be created to replace the following:

  • Letter confirming disclosure of all known unpublished studies
  • Commitment to honour submitted price letter
  • Unrestricted sharing of information letter.

Requirements for the signed cover letter will be reduced to limit duplication of information in the submission package.

Category 2 requirements

To align with CADTH’s pan-Canadian Oncology Drug Review (pCODR) process, the Certified Product Information Document (CPID) will no longer be a category 2 requirement for CDR submissions and resubmissions. Manufacturers may still be required to provide the CPID to individual drug plans when seeking reimbursement and should conform with the requirements of individual jurisdictions.

Target date for filing category 2 requirements will now be ≤ 20 business days from the date the submission or resubmission was accepted for review.

A signed cover letter will no longer be required when filing category 2 requirements.

Embargo period

Due to limited usage and to align CADTH’s CDR and pCODR processes, CDR will no longer accept resubmissions at a reduced price during the embargo period.

Reassessment

Revisions to the therapeutic review process will be implemented to incorporate the reassessment of existing CDEC recommendations that have been issued through CADTH’s CDR process.