CADTH Common Drug Review

Executive Summary Template for a Submission

Instructions for Manufacturers

Please read the instructions below and consult the recommended documentation prior to completing the template.
If you have any questions regarding the CADTH Common Drug Review process, please email requests@cadth.ca
with the complete details of your question(s).

Prior to Completing the Template:

Please review the following documents to ensure an understanding of CADTH’s procedures and submission
guidelines:
 CADTH Procedure and Submission Guidelines for the CADTH Common Drug Review
 CADTH Pharmaceutical Review Updates for any applicable information.

Completing the Template:

 The executive summary should provide a high-level summary of the CDR submission. Required headings and
subheadings have been provided in the template; however, additional sections may be added, as needed. The
amount of space used for each section is at the discretion of the applicant.

 All sections of the executive summary template are to be completed.

 Use 11-point Arial font for text outside of tables and 10-point Arial font for text inside of tables.

 The completed template must not exceed five pages, excluding the reference list.

 References must be provided in the following format:

 In text citations must be numbered in ordered of appearance.
 A numbered reference list must be provided in the Citing Medicine format.

 When the template is complete, delete this cover page with the instructions (including the CADTH document
header). Please feel free to add company-specific elements such as a cover page, disclaimers, headers, footers,
etc. as required.

 Save the completed template as a PDF file using the file name structure provided in the CADTH Procedure and
Submission Guidelines for the CADTH Common Drug Review

Submitting the Template to CADTH:

 Incorporate the completed template into the package of category 1 requirements.

 Please consult the CADTH Procedure and Submission Guidelines for the CADTH Common Drug Review for
details on how to file the CDR application package.
CADTH SUBMISSION FOR [BRAND NAME]

Brand name (non-proprietary name) — Executive Summary

1. Brief Description of the Drug

2. Place in Therapy

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CADTH SUBMISSION FOR [BRAND NAME]

3. Summary of Clinical Evidence

3.1 Overview of Studies:

3.2 Efficacy Results:

3.3 Safety Results:

August 2018 Page 3 of 6

CADTH SUBMISSION FOR [BRAND NAME]

4. Summary of Pharmacoeconomic Evidence

(Include disclosable submitted unit price)

August 2018 Page 4 of 6

CADTH SUBMISSION FOR [BRAND NAME]

5. Requested Reimbursement Criteria (include this section if applicable)

5.1 Requested Reimbursement Criteria:

5.2 Rationale for Requested Reimbursement Criteria:

6. Conclusions

August 2018 Page 5 of 6

CADTH SUBMISSION FOR [BRAND NAME]

References

August 2018 Page 6 of 6