We are pleased to announce that process and operational changes have been made to transition Cancer Drug Implementation Advisory Committee (CDIAC) functions to CADTH effective July 1, 2019. These changes will further enhance the transparency of the CADTH pan-Canadian Oncology Drug Review (pCODR) review process and better support public payers with informed decision-making. The new changes will apply to all new pre-submission information forms received by the CADTH pCODR program on or after July 1, 2019.
In March 2019, CADTH solicited stakeholder feedback on integrating key functions of the CDIAC into the pCODR process. We would like to thank all stakeholders who responded to the consultation. Feedback was received from five patient groups, one individual patient, one clinician, six pharmaceutical companies, two industry association groups, and two public payors — all of whom emphasized their support for increased transparency and stakeholder engagement, while maintaining the current review timeline.
The objectives of transitioning the functions of CDIAC to pCODR are to:
- enhance the transparency of the pan-Canadian cancer drug review process
- allow for greater stakeholder input into the development of a provisional algorithm for each new cancer drug or indication to indicate how the new therapy could be used compared to existing funded treatments; and to indicate the impact on the sequence of use for other existing funded therapies to better support jurisdictional decision-making for drug reimbursement
- streamline and reduce the duplication of administrative processes.
Highlights of changes include:
- the expansion of Provincial Advisory Group membership and responsibilities
- confirmation that submitters must provide the pre-submission information using the online form at least 120 calendar days before the anticipated date of filing the complete pCODR submission or resubmission
- for each submission or resubmission, a pre-submission meeting will be scheduled by teleconference, pending the completion of the online Pre-submission Information Requirements Form; submitters may request an in-person pre-submission meeting with the pCODR program, but this will be limited to one meeting in a six-month period in order to ensure fair access to CADTH staff and relevant experts involved in the pCODR review process
- requirements for relevant comparators in the Canadian context will include those that, at a minimum, received an initial or final pCODR Expert Review Committee (pERC) recommendation
- an ad hoc clinical panel may be established and/or an online survey may be distributed to the clinical leads affiliated with provincial cancer agencies with experience in the diagnosis and management of the condition for which the drug under review is indicated to support the development of a provisional algorithm; some key factors for establishing an ad hoc clinical panel may relate to implementation issues or delivery of care considerations
- for greater clarity, inclusion of a provisional algorithm is intended to support jurisdictional decision-making and does not presuppose the outcome of a reimbursement recommendation by pERC and does not in any way bind participating jurisdictions to fund the new therapy or follow the provisional algorithm
- administrate changes to the pCODR program templates to provide additional clarity and guidance to all stakeholders; the updated templates for new submissions to the pCODR program follow:
- Online pCODR Pre-submission Information Form – Submission and Resubmission (must be registered with pCODR to view form)
- Template for Summary Table Listing Submitted Non-Disclosable Information
- Template for pCODR Structured Summary of Economic Information for Disclosure
- Patient Input Template for CADTH CDR and pCODR Programs
- Stakeholder Feedback on a pCODR Expert Review Committee Initial Recommendation.
For a complete description of the changes, we encourage all stakeholders to review our updated:
- pCODR Procedures
- pCODR Pre-Submission, Submission, and Resubmission Guidelines
- pan-Canadian Oncology Drug Review Disclosure of Information Guidelines.
Please also take a moment to review the FAQs on the new process requirements relating to filing a pre-submission and submission to the CADTH pCODR program. CADTH will review this new process in one year from the implementation date and will consult with stakeholders as part of the evaluation.