Common Drug Review
Pre-submission Meeting
Request Form
Please refer to section 3.1 of the Procedure for the CADTH Common Drug Review for further information
regarding CDR pre-submission meetings.
Section 1 of this form is to be complete for all pre-submission meeting requests (i.e., standard and early
pre-submission meetings).
Section 1: All Requests for Pre-submission Meetings
Background Information
Requested
Details
Manufacturer
Drug name
Route of administration
Insert manufacturer name
Insert the brand name and the non-proprietary name
Insert the route of administration (e.g., oral, intravenous, subcutaneous,
inhalation)
Provide a list of all the dosage forms and strengths of the drug.
Dosage form and
strength(s)
Location of
administration/use
Indication, as per NOC or
anticipated NOC
Anticipated or actual date
of NOC or NOC/c
Trial information
Comparator(s)
How is/are the
comparator(s) funded
Indicate if the drug is used in the community and/or hospital setting.
Provide the exact wording of the indication(s) approved by Health Canada or
the anticipated indication(s) as filed with Health Canada, to be reviewed by
CDR.
Provide the actual or anticipated date for issuance of the NOC or NOC/c.
Provide a brief high-level overview of pivotal trials (i.e., study design, sample
size, population description, intervention & comparator details, primary and
key secondary endpoints)
Provide a list of the other treatment(s) and/or procedure(s) used for the
condition.
Please indicate if and how the comparator(s) is/are currently funded by the
CDR-participating drug plans.
Section 2 of this form is to be completed only if an early pre-submission meeting 6 to 12 months in
advance of filing is being requested.
Section 2: Additional Information for an Early Pre-submission Meeting
Is the drug indicated for a relatively small patient population?
Response: ☐ Yes ☐ No
Supporting information:
Are the clinical data limited to surrogate end points?
Response: ☐ Yes ☐ No
Supporting information:
Revised April 2015
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Common Drug Review
Pre-submission Meeting
Request Form
Is the natural history of the disease poorly characterized?
Response: ☐ Yes ☐ No
Supporting information:
Are there a limited number of clinical trials and do they have small sample sizes?
Response: ☐ Yes ☐ No
Supporting information:
Does the treatment have a high cost relative to appropriate comparator(s)?
Response: ☐ Yes ☐ No
Supporting information:
Do you have questions regarding the appropriate type of economic analysis to submit?
Response: ☐ Yes ☐ No
Supporting information:
Overall rationale for requesting an early pre-submission meeting:
Revised April 2015
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