Procedures for Reimbursement Reviews

In order to ensure a smooth and efficient process, it is important that sponsors pay careful attention to our documentation. As documentation posted to the 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 Pharmaceutical Reviews Update, which communicates updates to procedures and general program developments. To receive new issues of the Pharmaceutical Reviews Update, please subscribe to the Weekly Summary email.

Procedures

The Procedures for Reimbursement Reviews details 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 Procedures for Time-Limited Reimbursement Recommendations details the process for issuing time-limited recommendations. These are recommendations to publicly fund a drug or drug regimen for a certain period of time, based on the condition the drug sponsor will conduct ongoing clinical studies to address uncertainty in the evidence. Consult our Frequently Asked Questions for more information

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 our sponsored drug reimbursement review process.

The 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 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 Procedures for Implementation Advice for Health Technologies describes the process for issuing implementation advice for various health technologies, including drugs, medical devices, and diagnostics. Our implementation advice is intended to address relevant implementation considerations or timely policy decisions. Implementation advice is most appropriate when there are limitations or gaps with available evidence and/or there is a need for additional consultation with subject matter experts to gather consensus regarding implementation issues (e.g., place of drug in therapy, implementation criteria where none exist, therapeutic alternatives during a drug shortage, alternate diagnostic agents). 

Fee Schedule

There is a fee structure that applies to its drug reimbursement review processes, please consult the Fee Schedule for Pharmaceutical Reviews for complete details and Frequently Asked Questions about fee adjustments communicated in June 2023.

Templates

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

Templates for Pre-submission Phase

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 the 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