CADTH Common Drug Review

Pre-submission Meeting Request Form

Instructions for Manufacturers

  • Please refer to the CADTH Procedure and Submission Guidelines for the CADTH Common Drug Reviewfor further information regarding 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 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 1: All Requests for Pre-submission Meetings
Information Requested / Details
Manufacturer / Insert manufacturer name
Drug name / Insert the brand name and the non-proprietary name
Route of administration / Insert the route of administration (e.g., oral, intravenous, subcutaneous, inhalation)
Dosage form and strength(s) / Provide a list of all the dosage forms and strengths of the drug.
Location of administration/use / Indicate if the drug is used in the community and/or hospital setting.
Indication, as per NOC or anticipated NOC / 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 CADTH.
Anticipated or actual date of NOC or NOC/c / Provide the actual or anticipated date for issuance of the NOC or NOC/c.
Trial information / 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)
Comparator(s) / Provide a list of the other treatment(s) and/or procedure(s) used for the condition.
How is/are the comparator(s) funded / Please indicate if and how the comparator(s) is/are currently funded by theCDR-participating drug plans.
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:
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:

June 2018