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 Drug 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
CADTH pCODR applications received prior to October 20, 2020
Templates
The following templates are to be used by sponsors in accordance with the requirements outlined in the Procedures for CADTH Drug 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
Templates for Requirements
- Application overview template
- Declaration letter template
- Executive summary template
- Table of studies template
- Reimbursement status of comparators 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