Last Updated : September 30, 2020
CADTH initiated stakeholder consultations in June 2020 on proposals to align the procedure for its drug reimbursement review processes (i.e., pan-Canadian Oncology Drug Review [pCODR], Common Drug Review [CDR], and Interim Plasma Protein Product Review [PPP]). Individual or joint submissions were received from 80 organizations and companies that represent the pharmaceutical industry, patient and clinician groups, and government and non-profit agencies. All feedback has been documented and reviewed internally for action.
CADTH has carefully considered the feedback received during the consultation and is pleased to announce the new Procedures for CADTH Drug Reimbursement Reviews. These procedures will be effective for all applications targeting the April 2021 expert committee meetings. Applications received on or after the following dates will be processed under the new drug reimbursement review procedures:
CADTH received many useful and constructive suggestions from stakeholders about its drug reimbursement review processes, and these have been incorporated into the revised procedure wherever feasible; suggestions that will require internal feasibility assessment, substantive changes to the review process, or additional dialogue with stakeholders will be addressed in the future.
Highlights of the new procedures include:
CADTH would like to thank all stakeholders that took the time to respond to this consultation. If you have any questions regarding the new Procedures for CADTH Drug Reimbursement Reviews, please feel free to contact CADTH at firstname.lastname@example.org.
Based on feedback received during the consultation, CADTH has augmented stakeholder input opportunities within the provisional algorithm process. Specifically, the following steps have been added to the new, revised process:
These additions to the process will supplement existing patient and clinician input processes and will run concurrently with the opportunities for input offered for drug manufacturers whose products may be impacted by the provisional algorithm work.
Beginning in April 2021, meetings of the pCODR Expert Review Committee (pERC) will target the second Thursday of each month as opposed to the third Thursday of each month. This change will give CADTH and other stakeholders the opportunity to balance resources and timelines by avoiding multiple expert review committees during the same week and allowing staggering of stakeholder feedback periods. This change is reflected in the new pERC and Canadian Drug Expert Committee (CDEC) meeting schedules that are available on the CADTH website.
CADTH would like to thank all stakeholders that provided preliminary input on the deliberative framework and process questions that were part of the consultation. This input will be taken into consideration when developing options for forthcoming consultations.
In June 2020, CADTH, INESSS, and Health Canada initiated stakeholder consultations on Proposed Enhancements to the Health Canada, CADTH, and INESSS Aligned Review Processes. Individual or joint submissions were received from 18 organizations and companies that represented the pharmaceutical industry, patient groups, and government agencies. CADTH, INESSS, and Health Canada would like to thank all stakeholders that took the time to respond to this consultation. The three agencies will carefully review this feedback and provide an update on next steps in the near future. If you have any questions, please feel free to contact CADTH at email@example.com.
CADTH would like to clarify that tumour group submissions for oncology drugs are reserved for exceptional situations where the drug manufacturer is not planning to market a product in Canada for a particular indication and the drug has the potential to address a major unmet therapeutic need. CADTH has encountered several situations where tumour groups are working directly with the drug manufacturer to prepare submissions for products that do not fit these criteria. CADTH processes have been optimized for direct interaction with the drug manufacturer to ensure complete and rapid access to all of the relevant information required to conduct the review; this is meant to ensure the best possible outcome for all stakeholders.
The Fee Schedule for CADTH Pharmaceutical Reviews has been revised to reflect the alignment of milestone 2 for invoicing oncology and non-oncology application fees to the point where the draft reports are sent to the sponsor for comment (which replaces the checkpoint meeting for oncology applications).
CADTH will be updating our drug reimbursement review webpages over the next month, including consolidation of the drug summary tables for oncology and non-oncology drugs. An update will be issued in the near future to notify stakeholders once these changes have been implemented.