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.

It is important to read the following documents in conjunction with the CADTH Pharmaceutical Reviews Update, which communicates updates to CADTH procedures and general program developments. To receive new issues of the CADTH Pharmaceutical Reviews Update, please subscribe to the CADTH Weekly Summary email.

Procedures

The Procedures for CADTH Reimbursement Reviewsdetails the process to be followed by all participants involved in a drug reimbursement review, and provides guidance to sponsors in the preparation of their applications.

The Non-Sponsored Reimbursement Review Procedures details the procedures to be followed by all participants involved in a nonsponsored reimbursement review. This review is requested in situations where the sponsor of a potentially eligible drug chooses not to submit through CADTH’s sponsored drug reimbursement review process.

The CADTH Therapeutic Review Framework and Process lists the steps for the evidence-based review of publicly available sources regarding a therapeutic category of drugs or a class of drugs, to support drug listings and policy decisions, as well as to encourage the optimization of drug therapy.

The Procedures for CADTH Streamlined Drug Class Reviews describes the process for a Streamlined Drug Class Review, in which published clinical information is leveraged to provide decision-makers with timely evidence to support drug policy decisions and formulary management

The CADTH Procedures for Medical Imaging Implementation Advice is the process for issuing implementation advice related to medical imaging. It leverages CADTH’s Canadian Medical Imaging Inventory and includes consultation with nuclear medicine and radiology specialists in Canada, to facilitate the introduction of new complex drugs into the health system.

The Procedures for Review of Therapeutic Alternatives During a Drug Supply Shortage are used to provide time-limited advice on therapeutic alternatives when federal, provincial, and territorial governments have indicated that there is a need because of a potential or actual shortage of 1 or more therapies that are standard of care in Canada within a therapeutic area.

Fee Schedule

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 and Frequently Asked Questions about fee adjustments communicated in June 2023.

Position Statement

In April 2023, CADTH published a position statement entitled Confidentiality of Clinical Evidence Informing health technology assessment decision-making,a joint position statement with the Institute for Clinical and Economic Review (ICER) in the US and the National Institute for Health and Care Excellence (NICE) in England. For more information, read CADTH’s announcement.

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

• CADTH pharmaceutical submission SharePoint access request form 
• Submission eligibility form
• Resubmission eligibility form
• Pre-submission meeting request form
• Pre-submission meeting briefing paper template 
• 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
• Checklist for economic requirements  
• Implementation plan for a cell or gene therapy
• Sponsor summary of clinical evidence template 
• Tailored review submission template

Templates for Stakeholder Input

• Patient group input template
• Clinician group input template
• Drug program input template
• Industry input template (non-sponsored reimbursement reviews)
• 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 
• Stakeholder input on implementation advice request
• Stakeholder feedback on draft implementation advice