Revised Procedures for CDR and pCODR
For all drug applications filed for review through either the Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR) process on or after April 1, 2016, CADTH will no longer accept confidential submitted prices. The submitted price will be disclosed in all applicable CDR and pCODR review reports, as well as CADTH Canadian Drug Expert Committee (CDEC) and CADTH pCODR Expert Review Committee (pERC) recommendation documents posted on the CADTH website.
The following is a list of revised CDR/pCODR documentation/templates (for applications filed on or after April 1, 2016):
- Summary of Revisions to the Procedure for the CADTH Common Drug Review
- Submission Guidelines for the CADTH Common Drug Review
- Application Overview Template
- Commitment to Honour Submitted Price Letter
- pCODR Procedures
- pCODR Submission Guidelines
- pCODR Disclosure of Information Guidelines
Additional New CADTH Updates
Revised Procedure for Providing CADTH Review Team’s Responses
Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, manufacturers will be sent the CDR review team’s responses to their comments eight business days prior to the CDEC meeting. CADTH will forward the CDR review team’s responses to the manufacturer for information only.
Revised Procedure for Voluntary Withdrawal
Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, manufacturers will have until 4:00 p.m. ET three business days prior to the CDEC meeting to voluntarily withdraw from the CDR process.
Revised Procedures for Category 2 Requirements
Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, CADTH will not issue the embargoed CDEC recommendation unless category 2 requirements have been filed. In addition, CADTH will no longer screen category 2 requirements for completeness; however, manufacturers are still required to file copies of category 2 requirements with CADTH.
CADTH to Provide Drug Plans with Copies of CDR Submission or Resubmission Materials
CADTH has begun providing authorized recipients from the CDR-participating drug plans with copies of all category 1 and category 2 requirements prior to the targeted CDEC meeting at which the submission or resubmission is scheduled to be discussed. CADTH will provide copies of the category 1 and category 2 requirements to the CDR-participating drug plans to ensure that they have this information prior to the targeted CDEC meetings.
Manufacturers are still required to provide copies of their CDR submission or resubmission, including all drug plan–specific requirements, to the individual drug plans (i.e., CADTH is not providing the CDR category 1 and category 2 requirements on behalf of the manufacturer).
Password Protection on Confidential File Transfers
CADTH has added password protection when sending confidential files to manufacturers and other authorized recipients. Recipients will now be required to enter a password prior to accessing clinical and pharmacoeconomic review reports, embargoed CDEC recommendations and CDEC Final Recommendations.
Total Email Attachments File Size Threshold
In cases where the current Submission Guidelines for the CADTH Common Drug Review indicate that specific outstanding, updated, or finalized category 1 requirements can be provided to CADTH by email to firstname.lastname@example.org, CADTH has revised the total email attachment(s) file size threshold from 10 MB to 20 MB.
If the total attachments file size for a single email exceeds 20 MB and consists of multiple documents, the documents can be divided among multiple emails as attachments. In cases where a single attachment’s file size exceeds the 20 MB threshold, the document will have to be provided to CADTH on a CD, DVD, or USB flash drive sent to the attention of CADTH’s Central Intake.
Clarification: Requesting Health Canada Clinical Reviewer Report(s) From Health Canada
The filing of Health Canada Clinical Reviewer Report(s) is a category 1 CDR requirement. Should the report(s) not be available at the time of filing category 1 requirements, manufacturers are reminded that it is their responsibility to request, in writing, a copy of the report(s) from the appropriate Health Canada reviewing Bureau or Centre Director and to provide it to CADTH by email to email@example.com as soon as available (i.e., on the day of, or next business day after, receipt from Health Canada).
Please click on the following link for more information and to access the above revised CDR/pCODR documentation/templates.
CADTH Consultation: Proposed Revision to the CADTH Common Drug Review Procedure
CADTH is inviting stakeholder comments and feedback on the following proposed revision to the Procedure for the CADTH Common Drug Review:
Extending the time frame for releasing the embargoed CADTH Canadian Drug Expert Committee (CDEC) recommendation, which is currently five to seven business days, to eight to 10 business days after the CDEC meeting.
Please email your feedback by 5:00 p.m. EST March 24, 2016, to firstname.lastname@example.org.
For more information, please click on the following link.