CADTH Common Drug ReviewIdentification of Confidential Information TemplateInstructions 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: Ensure that the appropriate section of the template is completed:

Section 1: CADTH reports for a standard CDR review Section 2: CADTH report for a tailored CDR review or request for advice Section 3: CDEC recommendation or record of advice

Please delete all sections that are not applicable Information in the public domain will not be redacted from CADTH documents. Please ensure that information requested for removal is not available in the public domain,

including websites for regulatory authorities (e.g., US FDA, Health Canada, EMA) or heath technology assessment agencies (e.g., NICE, PBAC, SMC, IQWiG)

Outputs of economic models (e.g. ICERs) are not generally considered confidential. Add or remove rows to the tables as required Do not add text to the column for CADTH Responses Use 10-point Arial font. When the template is complete, delete this cover page with the instructions (including the

CADTH document header).

Submitting the Template to CADTH: The completed template should be sent as a Word document to CADTH using Collaborative

Workspaces .

CADTH Common Drug ReviewIdentification of Confidential Information Form

Drug Name

Manufacturer

Date

SECTION 1: STANDARD CDR REVIEWS

CONFIDENTIAL INFORMATION TO BE REMOVED FROM CDR CLINICAL REVIEW REPORTSpecify Exact Wording/Pg.

#Manufacturer’s Rationale for

Removing Information CADTH Response

CONFIDENTIAL INFORMATION TO BE REMOVED FROM CDR PHARMACOECONOMIC REVIEW REPORT

Specify Exact Wording/Pg. #

Manufacturer’s Rationale for Removing Information CADTH Response

SECTION 2: TAILORED CDR REVIEWS AND REQUESTS FOR ADVICE

CONFIDENTIAL INFORMATION TO BE REMOVED FROM THE CDR REVIEW REPORTSpecify Exact Wording/Pg.

#Manufacturer’s Rationale for

Removing Information CADTH Response

__________________________________________________________________________________CADTH Common Drug Review – Confidential

SECTION 3: CDEC FINAL RECOMMENDATION OR RECORD OF ADVICE

CONFIDENTIAL INFORMATION TO BE REMOVEDSpecify Exact Wording/Pg.

#Manufacturer’s Rationale for

Removing Information CADTH Response

ERRORS IDENTIFIED4

Specify Exact Wording/Pg. #

Manufacturer’s Rationale for Removing Information CADTH Response

4 Please limit this section to any errors that are identified in document (e.g., transcription or typographical errors). Note that this does not include any issues with the presentation or interpretation of evidence.

__________________________________________________________________________________CADTH Common Drug Review – Confidential