Last Updated : October 11, 2018
CADTH has created a new standardized template for reconsideration requests on the basis that the CADTH Canadian Drug Expert Committee (CDEC) recommendation is not supported by the evidence that had been submitted or the evidence identified in the CADTH Common Drug Review (CDR) report(s). This has been undertaken in an effort to bring greater consistency in the amount and type of information that is being included in these requests. This template should only be completed for reconsideration requests on the basis that the CDEC recommendation is not supported by the evidence that had been submitted or the evidence identified in the CDR report(s).
CADTH is also clarifying that any requests for reconsideration on the basis that CADTH and/or CDEC failed to act fairly and in accordance with its procedures in conducting the review must be documented in a letter that has been signed by a senior company official.
As stated in the Procedure and Submissions Guidelines for the CADTH Common Drug Review, generic drugs are not typically reviewed through the CDR process. This is usually because the branded reference product has previously been reviewed by CADTH. However, CADTH has recently encountered a situation where a CDR submission was not filed for a branded drug before the drug became genericized. CADTH would like to take this opportunity to clarify how these scenarios will be addressed.
As these situations are uncommon, when they occur, CADTH will consult with the drug plans to determine if either or both manufacturers of the generic or branded product should file a submission with CADTH. Given that the context and product characteristics for these situations are likely to be unique, CADTH and the drug plans will provide guidance on a case-by-case basis as to whether a CDR submission is required. Based on the input from the drug plans, CADTH may advise manufacturers of branded or generic products that are eligible for review through the CDR process (e.g., a new drug, a drug with a new indication, or a new combination product) that a CDR submission is not required, and that the drug plans should be contacted.
Circumstances that would likely not require a submission to be filed with CADTH may include, but are not limited to, the following:
A CDR submission may be required for a generic product under the following conditions:
Although CADTH may advise a manufacturer that a submission is not required, it does not preclude the manufacturer from electing to file a submission provided the product meets the eligibility criteria for a new drug, a drug with a new indication, or a new combination product.
As always, manufacturers with questions regarding the CDR process may contact CADTH at any time ([email protected]).
As previously communicated, CADTH is currently seeking to enhance clinician engagement in the CDR process. We anticipate making further announcements in November 2018 regarding the establishment of clinical expert panels in the CDR process.
Event Date: Thursday, November 1, 2018
Time: 1:30 p.m. to 4:00 p.m. EDT
Location: Vantage Venues, Garden Hall, 16th Floor
150 King Street West, Toronto, Ontario
This annual session is an opportunity for all interested stakeholders to get the latest information about priority initiatives and process changes from CADTH’s pharmaceutical reviews portfolio, including the CDR, pCODR, and CADTH Therapeutic Reviews. Updates on other relevant CADTH initiatives will also be provided. The session also includes an open forum where attendees can direct questions to CADTH President and CEO Dr. Brian O’Rourke, and other senior staff at CADTH.
The session will be presented in English and can be attended in person or by webinar. There is no charge to attend but advance registration is required. Registration closes on Thursday, October 25, 2018.
Full details and the registration link are available on the CADTH website.
Questions may be sent by email to [email protected].