Last week, CADTH shared its new Procedure and Submission Guidelines for the CADTH Common Drug Review document which combines the previously separate procedure and submission guidelines into a single document. Manufacturers are encouraged to follow the new guidelines immediately, however new submission requirements will be only be enforced for submissions received on or after July 27, 2018.
Most updates appearing the in the document have been announced by CADTH since the previous procedure and guidelines documents were published in August 2014. Key changes include:
- Data that becomes available from ongoing studies, or which is published after a submission is accepted for review should now be provided to CADTH.
- New pharmacoeconomic requirements come into force, consistent with the 4th Edition of CADTH’s Guidelines for the Economic Evaluation of Health Technologies, published in 2017.
- No longer required: Literature search strategy, CONSORT Diagrams, Health Canada Reviewers’ Report and CIDP.
- A new template consolidates previous templates for Disclosure of Studies, Commitment to Honour Submitted Price and the Unrestricted Sharing of Information Letter.
- Target date for providing Category 2 requirements moves up to 20 business days following the submission being accepted for review (instead of 20 days prior to target CDEC meeting).
For more details, please see CDR Update – Issue 138.
CADTH also published its new Therapeutic Review Framework and Process which now provides a pathway for CDEC to revise previously issued CDEC and CEDAC recommendations.
As part of the new process, CDEC will consider whether previously issued CDEC recommendations should be revised according to the results of the therapeutic review. Patient groups and manufacturers affected by potential revisions to a recommendation will be notified and provided an opportunity to comment on draft revisions. Manufacturers will be allowed to file a request for reconsideration if a new recommendation is issued for one its products.
Implications of CDR Guidelines Changes
- Manufacturers can expect a reduced burden when it comes to completing forms and letters, as duplication has been reduced and templates are now consolidated.
- However, two new requirements may prove challenging for some manufacturers planning submissions this summer:
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- Revisions to the pharmacoeconomic components – including a mandatory cost-utility analysis as the base case – may not be surprising, as they were foreshadowed in CADTH’s March 2017 update to the Guidelines for the Economic Evaluation of Health Technologies, but as of July 27, deviations from this new requirement, unless pre-cleared with CADTH staff, will result in submissions not being accepted for review.
- Advanced schedule for Category 2 requirements will require earlier planning and perhaps reallocation of resources to complete budget impact analyses that will lay the groundwork for future pCPA negotiations.
Implications of New Therapeutic Review Framework & Process
This change has the potential to create significant uncertainty for manufacturers in the post-public reimbursement lifecycle for a drug, as product listing agreement renegotiations will likely be instigated in absence of a new CDR review for a product.
To prepare, manufacturers must keep apprised of therapeutic reviews underway and on the horizon to take advantage of opportunities to contribute stakeholder feedback both in the therapeutic review process and to the revised embargoed recommendations. Additionally, even as the ink dries on recent pCPA negotiations, manufacturers must continually revisit and renew their post-launch reimbursement strategy. This includes considering the potential outcomes of therapeutic reviews and the corresponding potential revisions to existing CDEC recommendations so they may adequately assess risk levels, and prepare accordingly.
To discuss how the new process could affect your product launches and reimbursement strategy contact us at info@pdci.ca.