CADTH Pharmaceutical Reviews Update — Issue 3

Canada's Drug Agency Program Updates

Common Drug Review (CDR)

1. New Template for Requesting Reconsideration

Canada's Drug Agency has created a new standardized template for reconsideration requests on the basis that the Canada's Drug Agency Canadian Drug Expert Committee (CDEC) recommendation is not supported by the evidence that had been submitted or the evidence identified in the Canada's Drug Agency 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).

• Canada's Drug Agency CDR reconsideration template

Canada's Drug Agency is also clarifying that any requests for reconsideration on the basis that Canada's Drug Agency 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.

2. Clarification Regarding Eligible Drugs That Have Become Genericized

As stated in the Procedure and Submissions Guidelines for the Canada's Drug Agency 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 Canada's Drug Agency. However, Canada's Drug Agency has recently encountered a situation where a CDR submission was not filed for a branded drug before the drug became genericized. Canada's Drug Agency would like to take this opportunity to clarify how these scenarios will be addressed.

As these situations are uncommon, when they occur, Canada's Drug Agency will consult with the drug plans to determine if either or both manufacturers of the generic or branded product should file a submission with Canada's Drug Agency. Given that the context and product characteristics for these situations are likely to be unique, Canada's Drug Agency 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, Canada's Drug Agency 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 Canada's Drug Agency may include, but are not limited to, the following:

• One or more generic versions of the drug are approved by Health Canada.
• One or more generic versions of the drug are undergoing review by Health Canada.
• The participating drug plans have indicated they are planning to review the generic drug(s) through their standard processes for reviewing generic drugs.
• Similar products are currently listed by the participating drug plans (e.g., different salts of the active substance).

A CDR submission may be required for a generic product under the following conditions:

• Similar products are not currently listed by the participating drug plans (e.g., different salts of the active substance).
• The manufacturer of the branded product has confirmed that it does not intend to file the product with Canada's Drug Agency and does not intend to seek public reimbursement.
• The generic product was reviewed by Health Canada as a new drug submission or supplemental new drug submission.

Although Canada's Drug Agency 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 Canada's Drug Agency at any time ([email protected]).

3. Clinician Engagement

As previously communicated, Canada's Drug Agency 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.

Other Announcements and Initiatives

1. Canada's Drug Agency Drug Portfolio Information Session

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 the Canada's Drug Agency pharmaceutical reviews portfolio, including the CDR, pCODR, and Canada's Drug Agency Therapeutic Reviews. Updates on other relevant Canada's Drug Agency initiatives will also be provided. The session also includes an open forum where attendees can direct questions to Canada's Drug Agency President and CEO Dr. Brian O’Rourke, and other senior staff at Canada's Drug Agency.

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 Canada's Drug Agency website.

Questions may be sent by email to [email protected].