CADTH Procedures for Reimbursement Reviews

In order to ensure a smooth and efficient process, it is important that sponsors pay careful attention to CADTH documentation. As documentation posted to the CADTH website is subject to change, please access this content as it is needed instead of downloading and archiving it.

Procedures

The Procedures for CADTH Reimbursement Reviews details the procedures to be followed by all participants involved in a drug reimbursement review, and provides guidance to sponsors in the preparation of their applications. This document must be read in conjunction with any CADTH Pharmaceutical Reviews Update issued after the procedures' date of publication. CADTH has a fee structure that applies to its drug reimbursement review processes, please consult the Fee Schedule for CADTH Pharmaceutical Reviews for complete details. 

Note: For ongoing files that are being reviewed through the previous CADTH Common Drug Review (CDR) and CADTH pan-Canadian Oncology Drug Review (pCODR) processes, the procedure documents and templates listed below are applicable:
 

CADTH CDR applications received prior to October 26, 2020

• Procedures for the CADTH Common Drug Review and Interim Plasma Protein Product Review
  • Reconsideration request template
  • Sponsor comments template
  • Identification of confidential information template

CADTH pCODR applications received prior to October 20, 2020

• Procedures for the CADTH pan-Canadian Oncology Drug Review
  • Non-disclosable information template
  • Verification of non-disclosable information template
  • pCODR procedural review request form
  • Stakeholder Feedback on a pERC Initial Recommendation

Templates

The following templates are to be used by sponsors in accordance with the requirements outlined in the Procedures for CADTH Reimbursement Reviews.

Templates for Pre-submission Phase

• Submission eligibility form
• Resubmission eligibility form
• Pre-submission meeting request form
• Advance notification form
• Proposed place in therapy template
• Tailored review application form
• Request for deviation from pharmacoeconomic requirements form

Templates for Requirements

• Application overview template
• Declaration letter template
• Executive summary template
• Table of studies template
• Reimbursement status of comparators template
• Regulatory and HTA status template
• Patients accessing new drugs template
• Letter for sending NOC to CADTH template
• Implementation plan for a cell or gene therapy
• Tailored review submission template

Templates for Stakeholder Input

• Patient group input template
• Clinician group input template
• Drug program input template
• Sponsor comments on draft reports template
• Stakeholder feedback on draft recommendation
• Reconsideration request template
• Identification of confidential information template
• Procedural review request template
• Stakeholder input on scope of a provisional funding algorithm
• Stakeholder feedback on a draft provisional funding algorithm