In July 2019, CADTH announced a new round of public consultations on its Pharmaceutical Review Programs. CADTH’s proposed changes would affect how it manages, reviews and reconsiders information submitted by pharmaceutical manufacturers through its Common Drug Review. Stakeholders were invited to submit feedback on three consultations:
- Proposal to Enhance the Transparency of CADTH’s Review Reports and Recommendations
- Proposal to Revise Category 1 Requirements for CADTH Single Technology Reviews
- CADTH’s Proposed Reassessment Framework
PDCI Market Access carefully reviewed the proposed scope of changes and subsequently submitted feedback and guidance to CADTH. While we support the proposed changes in principle, we offered CADTH important caution and feedback about some elements of their proposed changes. Highlights from PDCI’s feedback include:
1. Response to Proposal to Enhance Transparency of CADTH’s Review Reports and Recommendations: A key justification for the transparency initiative is to generate greater confidence in CADTH’s CDR process. PDCI’s feedback included a recommendation to enhance clarity through full disclosure of CADTH generated reports and verbatim written and verbal inputs of clinician and expert panels, including full unredacted clinical and economic guidance. CADTH should align with Health Canada with regards to disclosing information found in Confidential Regulatory Documentation and a process for redaction of confidential data from CADTH reports and supporting documentation may still be appropriate.
2. Response to Proposal to Revise Category 1 Requirements for CADTH Single Technology Reviews
- Systematic Reviews: It will be important for CADTH to provide clear guidelines and standards for systematic reviews. Search strategies, study exclusions, and findings used by the manufacturer may be subject to CADTH critique. It will be important to ensure that both the manufacturer and CADTH align on a systematic review protocol.
- Budget Impact Analysis: A pan-Canadian Budget Impact Analysis (BIA) provides a perspective of public expenditures across the country. There are numerous differences between provincial plans that make a national BIA challenging, including different costs, dispensing fees, markup, and comparator market shares. A summarized BIA of all provinces may be desirable, but requires traceable and distinct assumptions for all CADTH participating plans to ensure consistency with individual BIAs.
3. Response to CADTH’s Proposed Reassessment Framework: Some of the listed potential triggers for reassessment may fall beyond the mandate of CADTH. For example, expiration of reimbursement agreements and potential high or uncertain budget impact are issues that should be negotiated with the public drug plans and should not require additional HTA assessment.
The full response submitted by PDCI to CADTH can be found here.
Please contact John-Paul Dowson, Director of Reimbursement Strategy at PDCI at email@example.com for any questions or further information.