Common Drug Review
Priority Review Application
Template for Requesting CDR Priority Review
Instructions for Manufacturers
Please read the instructions below and consult the recommended documentation before completing
the template. If you have any questions regarding the CDR application filing process or requirements,
please email requests@cadth.ca with the complete details of your question(s).
Before Completing the Template:
 Please review the following documents to ensure an understanding of the CDR procedures and
submission guidelines:
 Procedure for Common Drug Review (August 2014)
 Submission Guidelines for the CADTH Common Drug Review August 2014)
 CDR Updates (webpage) for any applicable information.
Completing the Template:
 Complete both sections of the application template.

Use 11-point Calibri font for text outside tables and 10-point Calibri font for text inside tables.

Save the completed template as a Word document using the following file name structure:
BrandName_Priority_Review_Application
Submitting the Completed Template to CADTH:

Incorporate the completed priority review template into a complete package of category 1
requirements as directed in Appendix 9 of the Submission Guidelines for the CADTH Common Drug
Review.

Clearly state in the signed cover letter that priority review status has been requested and a
completed priority review application has been provided.
CDR Priority Review Application – Template for Requesting Priority Review
Section 1: Background Information
Name of product
Brand name:
Non-proprietary name:
Manufacturer name(s)
Submission typea
☐ New drug
☐ New indication
☐ New combination product
☐ New combination product (funded components or CADTHdesignated tailored CDR review)
☐ Subsequent entry biologic
NOC status
☐ Post-NOC
☐ Pre-NOC
Date of NOC (issued or anticipated): DD-MM-YYYY
Which of the CDR priority review criteria
does this product satisfy?
☐ Clinical criteria
☐ Economic criteria
Was priority review granted by Health
Canada?b
☐ Not requested
☐ Yes
☐ No
Is this product first-in-class for the
indication(s) to be reviewed?
☐ Yes
☐ No
Indication(s) to be reviewed:
Specific listing criteria if requested:
CDR = CADTH Common Drug Review; NOC = Notice of Compliance.
a
For a resubmission, please indicate the type of submission that was initially filed and reviewed by CDR.
b
Priority review status granted by Health Canada is a consideration for the assessment of a CDR priority review request based
on clinical criteria; however, the request must meet CDR priority review clinical criteria to be eligible for a CDR priority review.
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CDR Priority Review Application – Template for Requesting Priority Review
Section 2: Manufacturer’s Request and Rationale for Priority Review
Request is Based on Clinical Criteriaa ☐ Yes (complete next 3 rows) ☐ No
Is the drug indicated for an immediately life-threatening or other serious disease?
Response:
☐ Yes ☐ No
Rationale:
Is there an unmet medical need that would be addressed by the drug under review?
Response:
☐ Yes ☐ No
Rationale:
Does the drug offer substantial improvement in clinically important outcome measures of efficacy and
effectiveness, when compared with other appropriate comparators b?
Response:
☐ Yes ☐ No
Rationale:
Request is Based on Economic Criteria ☐ Yes (complete next row) ☐ No
Will the projected combined savings for the participating drug plans be an average of at least $7.5 million per
year for the first three years the product is marketed in Canada, when compared with appropriate
comparatorsb?
Response:
☐ Yes ☐ No
Rationale:
a All
b
clinical criteria must be satisfied in order to be eligible for a priority review based on clinical criteria.
An appropriate comparator is typically a drug listed by one or more participating drug plans for the indication under review.
However, the choice of appropriate comparator(s) in a CDR review is made on a case-by-case basis after consideration of all
existing treatment options, including best supportive care.
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