MORSE Consulting summary of CADTH update.
On July 31, 2019 CADTH released its Pharmaceutical Reviews Update – Issue 9 and MORSE Consulting has prepared a brief summary of the important developments from this CADTH update.
Consultations (Feedback to be provided by September 13, 2019)
CADTH is inviting stakeholder comments and feedback on three proposals for the Pharmaceutical Review Programs.
1) Enhance the Transparency of CADTH’s Review Reports and Recommendations
OBJECTIVE: To strengthen transparency of the CADTH health technology assessment processes.
WHAT ARE THE PROPOSED CHANGES: Requiring that clinical, economic and other information submitted to the CADTH review processes be made disclosable at the time of publishing its reports and recommendations on the CADTH website.
WHY: CADTH believes increasing the transparency will help to:
- provide better accessibility, comprehensiveness, and usefulness of information;
- reduce administrative burden; and
- promote greater confidence in the process.
2) Proposal to Revise Category 1 Requirements for CADTH Single Technology Reviews
OBJECTIVE: Revise category 1 requirements to further support CDR and pCODR programs with a target implementation on April 1, 2020.
WHAT ARE THE PROPOSED CHANGES: There are four proposed new requirements for standard CADTH reviews:
- Systematic Review of the Literature: CADTH is proposing that a systematic literature review by a category 1 requirement for all standard reviews.
- Complete Clinical Study Reports: Routine requests for these reports are almost universally complied with and will be required to validated information in the systematic review.
- Reimbursement Status for Comparators: Reimbursement status of relevant drugs is summarized for consideration by the review teams and expert committees. CADTH will now require the applicant provide this summary and utilize the proposed template.
- Budget Impact Analysis: Currently CADTH conducts a review of pCODR BIAs but for non-oncology drugs this work is provided as implementation support for the pCPA. To promote alignment CADTH will now also be including a review and appraisal of non-oncology BIAs. This includes category 1 requirements for an aggregate pan-Canadian Budget impact report and model.
Note: systematic literature reviews would not be required for CADTH tailored reviews.
WHAT ARE THE POTENTIAL IMPLICATIONS: No changes to application fees or timelines, but new requirements would be required for reviews submitted after April 1, 2020.
3) Proposed CADTH Reassessment Framework
OBJECTIVE: To establish consistent processes that would enable the reassessment of drugs to optimize reimbursement decisions. ANY drug that is currently reimbursed could be eligible for a reassessment.
WHAT ARE THE PROPOSED CHANGES:
Types of reassessments
- Standard: Address questions related to comparative clinical benefit and/or cost-effectiveness of a single drug (replace the existing resubmission process for drugs that are currently reimbursed)
- Conducted in accordance with CADTH’s existing CDR and pCODR processes
- Targeted: Address questions related to changes in contextual factors such as regulatory actions, changes in clinical practice or other forms of information that have introduced implementation questions.
- Conducted in accordance with CADTH’s existing CDR and pCODR processes for requests for advice
- Therapeutic review: Existing process will be used for questions regarding the comparative safety, clinical effectiveness and cost-effectiveness of multiple drugs.
WHAT ARE THE POTENTIAL IMPLICATIONS:
CADTH’s expert committee will apply the existing recommendation framework to the reassessments and have summarized the potential implications:
Updates to the CADTH Procedure and Submission Guidelines
CADTH & INESSS JOINT ENGAGEMENT WITH CLINICIANS
The joint engagement pilot process was valuable for both organizations and the joint engagement with clinical specialists has been integrated into the review procedures for the respective agencies.
UPDATED PHARMACOECONOMIC SUBMISSION REQUIREMENTS FOR CDR
The economic information requirements for CDR submissions have been updated to provide clarity for manufacturers.
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