CADTH Pharmaceutical Reviews Update — Issue 13

Updates for Patients and Communities​

We’ve surprised a few patient groups recently with our belated thank you letters. Our letters highlight in detail how the group’s input was used in our review protocol, clinical report, economic report, and expert committee deliberations. We identify ideas that were especially helpful and offer suggestions for future input. Thank you for your contributions. Canada's Drug Agency is always grateful for the patient input we receive.

If you or your organization has any feedback to Canada's Drug Agency, from your experiences of providing patient input to us, we’d be happy to learn more.  Please email or call the Patient Engagement team ([email protected]) any time.  

Canada's Drug Agency Program Updates

1. Clarification of Economic Requirements

Canada's Drug Agency has updated the description of the economic and pricing requirements for drugs reviewed through the Common Drug Review (CDR), pan-Canadian Oncology Drug Review (pCODR), and Interim Plasma Protein Product Review processes. These revisions have been made to provide greater clarity on the following:

• When an economic model includes survival data, sponsors should ensure that they have presented relevant parametric distributions. This is required to allow Canada's Drug Agency to easily model alternative distributions and to visually inspect the model fit for survival data.
• The time horizon for the budget impact analysis includes a baseline year (one-year period prior to the proposed listing date), followed by a three-year forecast period from the proposed listing date, and that cost breakdown should also include dispensing fees and mark-ups.
• Sponsors are reminded that confidentially submitted prices are not accepted by Canada's Drug Agency in submissions or resubmissions through the single drug review processes. This includes prices for drug under review as well as relevant comparators and companion diagnostic tests (if applicable). Prices will be disclosed in all Canada's Drug Agency reports and recommendations.
• Text within the category 2 requirements for Common Drug Review submissions was also updated to clarify that the budget impact information submitted should be aligned with the budget impact information submitted as part of category 1 requirements.

2. New Consolidated Procedural Documents for the Canada's Drug Agency pCODR Process

Canada's Drug Agency has drafted a new Procedures for the Canada's Drug Agency pan-Canadian Oncology Drug Review document that consolidates the following separate documents for the Pan-Canadian Oncology Drug Review (pCODR) process:

• pCODR Procedures;
• pCODR Disclosure of Information Guidelines;
• pCODR Pre-Submission, Submission and Resubmission Guidelines;
• pCODR Procedural Review Guidelines;
• pCODR Expert Review Committee Deliberative Framework.

Highlights of the changes within the updated document include the following:

• Sections the document have been consolidated to simplify the layout and limit repetition of key information within the document (e.g., procedures and guidelines are now laid in accordance with key steps in the review process as opposed to the type of application being filed).
• Key terminology and the economic guidelines have updated as described in Canada's Drug Agency Pharmaceutical Reviews Update − 12 and section 1 above.
• The description of the process for checkpoint meetings has been revised in accordance with the previous announcements (i.e., meetings will now occur via teleconference). In addition, the procedures have been updated to specify that there is no longer a limit of four sponsor attendees for these meetings.
• The document has been updated to reflect the Canada's Drug Agency new process for the submission and review of cell and gene therapies.
• Canada's Drug Agency has revised the description of the procedural review process to reflect the changes in the Canada's Drug Agency strategic advisory committee.
• The disclosure of information guidelines have been updated to reflect the new Canada's Drug Agency Economic Report template. Effectively immediately, sponsors are no longer required to provide the Template for pCODR Structured Summary of Economic Information for Disclosure when filing a submission or resubmission.
• The checklists for submission and resubmission requirements have been updated to provide greater detail.
• The following letters have been discontinued as standalone documents: 1) Letter Authorizing Unrestricted Sharing of Information; 2) Signed declaration that all unpublished studies have been disclosed. These have been consolidated into a single declaration letter.
• The guidelines have been revised to specify that the Letter of Authorization allowing Health Canada to Share Information with pCODR is not a requirement for a submission filed on a pre-NOC basis. This letter was discontinued and replaced with a new Health Canada consent form at the time the new aligned review process was launched with Health Canada, Canada's Drug Agency, and INESSS.

To simplify the application process for the sponsors, Canada's Drug Agency will be making the templates for pCODR category 1 requirements available on the Canada's Drug Agency website (many are currently accessible only through the Collaborative Spaces portal).

3. Updated Procedural Documents for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review Processes

The Procedures for the Canada's Drug Agency Common Drug Review and Interim Plasma Protein Product Review have been updated to provide greater clarity on new economic requirements as described in section 1 above. Sponsors are reminded that there are currently no changes to the current category 2 requirements for CDR submissions as a result of the new category 1 requirement for a pan-Canadian budget impact analysis.