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pCODR Update 53 (Introducing a Common CADTH Recommendation Framework and Establishing a Minimum Period of 120 Calendar Days for Advance Notification of Anticipated Submissions and Resubmissions for CADTH CDR and pCODR)

Published on: March 24, 2016
Result type: News

CADTH would like to thank all stakeholders who responded to our recent consultations.

Regarding the proposed recommendation framework for the CADTH Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) programs, CADTH received feedback from two industry association groups, nine drug manufacturers, three patient advocacy groups, a consulting firm, a health economist, committee members, and public drug plans.

Feedback was also received on proposed revisions to the CADTH CDR and pCODR procedures that would establish a set minimum advanced notification period from five patient advocacy groups, eight pharmaceutical companies, two industry association groups, and one consulting firm.

1. Recommendation Framework for CADTH Common Drug Review and pan-Canadian Oncology Drug Review Programs

In collaboration with the participating jurisdictions and with input from stakeholders, CADTH is pleased to announce that we have established a single recommendation framework to support our drug expert committees (the CADTH Canadian Drug Expert Committee [CDEC] and the CADTH pCODR Expert Review Committee [pERC]) in making recommendations to the participating jurisdictions to guide their reimbursement decisions.

To learn more about the new recommendation framework for the CADTH Drug Review programs, please consult the following documents:

2. Establishing a Minimum Period of 120 Calendar Days for Advance Notification of Anticipated Submissions and Resubmissions

CADTH will be implementing changes to the CDR Procedures and pCODR Procedures that will require all manufacturers/submitters to provide a minimum 120 calendar days advance notification for anticipated submissions and resubmissions. This requirement will apply to all CADTH Pre-submission Information Requirements Form received on May 1, 2016 and onwards, and would pertain to all submissions and resubmissions filed on or after September 1, 2016. This procedural revision has been made to improve forecasting of the quantity and type of CDR and pCODR applications to be filed. This, in turn, will help with better resource planning, including clinical expert recruitment, and budgeting for both programs. In addition, this revision will ensure that CADTH has reasonable time to work with the manufacturer/submitter to prepare them for the submission process.

For more detail about this new requirement, please see our update on Procedures for the CADTH Common Drug Review and pan-Canadian Oncology Drug Review: Establishing a Minimum Period of 120 Calendar Days for Advance Notification of Anticipated Submissions and Resubmissions

Should you have any questions regarding the above information, please contact us at requests@cadth.ca.