On September 28, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 128) describing the following changes.
- Revised Procedure for Advance Notification of Pending CDR Submissions and Resubmissions
CADTH has received numerous inquiries regarding challenges interpreting and complying with the existing 120-day advance notification process. As a result of these issues, CADTH reduced the advance notification requirement in June 2017 from 120 calendar days to 30 business days for drugs undergoing Health Canada review through an expedited review pathway.
Due to overall lack of accuracy with the advance notification data, including frequent and substantial changes to the anticipated filing dates, CADTH will be revising the minimum mandatory advance notification period for CDR submissions and resubmissions to 30 business days. All manufacturers are still encouraged to provide CADTH with as much notice as possible as CADTH’s preferred advance notification period remains 120 calendar days to facilitate resource planning, including clinical expert recruitment, and budgeting for the CDR program.
This revision will be effective for submissions and resubmissions filed on or after January 2, 2018. Manufacturers who are planning to file a CDR application before January 2, 2018 and who have already provided CADTH with 120 calendar days advance notification should contact CADTH at email@example.com if they are considering making a change to the anticipated filing date. Based on the availability of resources, CADTH will determine if changes can be accommodated. Please note this process change applies only to the CDR program; the pCODR advance notification process remains unchanged. Information on the pCODR process can be found here.
Please consult the following document for complete details of the revised procedure for advance notification:
- CADTH to Schedule CDEC Meetings in December and August
As part of ongoing initiatives to align the best practices of the CDR and pCODR programs, CADTH will be scheduling CDEC meetings in December and August on an ongoing basis. The CDEC meeting schedule has been updated as a result of this change.
- Mandatory Disclosure of Requested Reimbursement Criteria
As communicated in CDR Update – Issue 118 and CDR Update – Issue 122, information regarding a pending CDR submission or resubmission will be posted on the CADTH website at the time the call for patient input is posted (i.e., 20 business days before the anticipated filing date, so that patient advocacy groups have as much notice as possible about a pending review). This information will include the brand name (if available and not confidential until approved) and the non-proprietary name of the drug, submission type, notice of compliance (NOC) status at the time of filing, a brief description of the therapeutic area, requested reimbursement criteria, submission target date, stakeholder input deadline, and the name of the manufacturer.
Effective for all submissions and resubmissions received on or after January 2, 2018, CADTH will begin posting the requested reimbursement criteria provided by the applicant for all CDR submissions and resubmissions. Disclosure of the requested reimbursement will be mandatory to ensure that stakeholders, including patient groups, have all of the information required to fully understand the scope of the CDR review. Confidentially submitted requested reimbursement criteria will not be accepted by CADTH.
The posted information will be based on the details provided in the Pre-submission Information Requirements Form. It is the responsibility of the applicant to ensure that CADTH is notified of any changes to the information provided in the Pre-submission Information Requirements Form.
- Reminder: CADTH Drug Portfolio Information Sessions
The CADTH Drug Portfolio Information Sessions will be held on October 3, 2017. These sessions provide an opportunity to receive an update on CADTH’s drug portfolio, including CDR, pCODR, and therapeutic review initiatives. Updates on other relevant CADTH initiatives will also be provided. Registration has been extended to end of day Friday, September 29, 2017. If you have not already registered and plan on attending in person or via webinar, please register using one of the links below:
- Patient Groups, Policy-Makers, and Health Care Professionals
- Pharmaceutical Industry and Consultants
For further information, please refer to the CADTH website.