Procedures for Reimbursement Reviews

Procedures for Reimbursement Reviews 

To ensure a smooth and efficient process, it is important that sponsors pay careful attention to CDA-AMC documentation. As documentation posted to the CDA-AMC 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. 

Fee Schedule 

CDA-AMC has a fee structure that applies to its drug reimbursement review processes, please consult the Fee Schedule for Pharmaceutical Reviews for complete details  

Templates 

The following templates are to be used by sponsors throughout the reimbursement review process:  

Templates for Presubmission Phase 

Pharmaceutical submission SharePoint access request form  

Eligibility inquiry form 

Pre-submission meeting request form 

Pre-submission meeting briefing paper template  

Advance notification form 

Proposed place in therapy template

Evidence presentation meeting briefing paper template

Pipeline meeting briefing paper template

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 

Letter for sending finalized indication template 

Checklist for economic requirements   

Implementation plan for a cell or gene therapy 

Sponsor summary of clinical evidence template  

PACES tailored review submission template 

Product variation tailored review submission template 

Templates for Input 

Patient group input template 

Clinician group input template 

Drug program input template 

Industry input template (non-sponsored reimbursement reviews) 

Input on implementation advice request 

Input on scope of a provisional funding algorithm 

Templates for Feedback on Reports or Recommendations 

Sponsor comments on draft reports template 

Feedback on draft recommendation 

Reconsideration request template 

Feedback on a draft provisional funding algorithm  

Feedback on draft implementation advice 

Other Templates 

Identification of confidential information template 

Procedural review request template

Log of model changes to sponsor