CADTH Pharmaceutical Reviews Update — Issue 10

Consultations on CADTH’s Pharmaceutical Review Programs

1. Extension of the Consultation Feedback Period

At the request of stakeholders, CADTH has extended the deadline for feedback from September 13, 2019, to September 27, 2019, for the following 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.

CADTH Program Updates

1. Updated Procedure for Implementation Panels

CADTH has revised its procedures for implementation panels to allow representatives from l‘Institut national d'excellence en santé et services sociaux (INESSS) and/or INESSS’s expert review committee members to attend the implementation panel meetings.

2. CADTH and Canadian Blood Services Pilot Process

CADTH and Canadian Blood Services will be announcing a new pilot process for the review of selected plasma-related drugs in the near future. The pilot process will build upon the strengths of both agencies to provide stakeholders with an objective, transparent, evidence-informed review process for plasma-related products.

3. Updated and Aligned Terminology

CADTH has updated the language in its procedures to align key terminology in our drug review processes. The term “sponsor” will now replace “applicant” and “submitter” in the Common Drug Review and pan-Canadian Oncology Drug Review procedures, respectively.

4. Updated Procedure and Submission Guidelines for the CADTH Common Drug Review

The Procedure and Submission Guidelines for the CADTH Common Drug Review has been updated with the following revisions:

• revised terminology with “sponsor” replacing “applicant”
• updated procedure for implementation panels
• clarified pharmacoeconomic requirements.

Sponsors who have questions about specific requirements may contact CADTH for guidance on submission preparation by emailing [email protected].