CADTH Pharmaceutical Reviews Update — Issue 20

Update for Patients and Communities

Canada's Drug Agency has three expert committees that provide recommendations to publicly funded drug programs, health ministries, and health authorities on the appropriate use of drugs, medical devices, and clinical interventions. All of the committees use a deliberative process to discuss the value of these technologies and provide recommendations on how they should be used effectively in Canada.

On February 4, 2021, Canada's Drug Agency is hosting a webinar to explain what deliberative processes are and why they are important when making recommendations that impact many people. Everyone is welcome to attend. To register, see How Canada's Drug Agency Expert Committees Deliberate.

Canada's Drug Agency has also worked with a few patient groups to support consultation on the deliberative appraisal process at Canada's Drug Agency. Patient and community groups are invited to register for Consultation for Patients on the Deliberative Appraisal Process at Canada's Drug Agency to be held online on February 11, 2021. Insights from the discussion will be shared publicly. Canada's Drug Agency will also follow its usual consultation process for any proposed changes to our programs.

Canada's Drug Agency Program Updates

1. Provisional Funding Algorithms for Oncology Drugs

Canada's Drug Agency is pleased announce that Dr. Marianne Taylor has been appointed to chair the implementation advice panels for oncology drugs. Dr. Taylor is a practising medical oncologist who serves on the Canada's Drug Agency pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC). She has held leadership positions at BC Cancer and is the staff medical oncologist for the Drug Funding Sustainability Initiative at the Canadian Association of Provincial Cancer Agencies (CAPCA). Dr. Taylor will be joined by additional clinical specialists selected for each project based on their expertise in the diagnosis and management of the condition for which the provisional algorithm is required.

2. Clarifications for Pharmacoeconomic Requirements

Canada's Drug Agency has received several inquiries regarding the requirement for all references to be provided for the economic evaluation and budget impact analysis. To address these queries, a clarification to this requirement has been made in the Procedures for Canada's Drug Agency Reimbursement Reviews to note that supporting documentation (e.g., articles and reports) is required when it has been used to inform the methods, assumptions, and inputs in the economic evaluation and the budget impact analysis reports.

3. Uploading Advance Notification and Pre-submission Meeting Request Forms

As noted in the Proposed Alignment of Canada's Drug Agency Drug Reimbursement Review Processes, Canada's Drug Agency will be aligning the collaborative space portals for all reimbursement reviews. This work is currently ongoing as we are investigating options for the single portal. Canada's Drug Agency has introduced some interim changes to align the functionality of the existing oncology and non-oncology portals. Effective immediately, sponsors are asked to upload advance notification forms and pre-submission meeting request forms to the Canada's Drug Agency collaborative space.

• Advance notification forms should no longer be emailed to [email protected]
• Pre-submission request forms should no longer be emailed to [email protected].

These changes have been introduced to ensure that sponsors have a secure portal for sending all required documents to Canada's Drug Agency.

4. Reminder: Clinician Group Input Forms and Conflict of Interest

Canada's Drug Agency would like to remind stakeholders that clinician group input must be provided using the clinician group input template and that the completed form must include conflict of interest disclosures. Canada's Drug Agency continues to receive input from clinicians who have not completed the proper form or provided conflict of interest declarations. In each instance, Canada's Drug Agency has had to contact individuals and groups to obtain the necessary declaration. Clinician input is an important part of our reimbursement review process; however, Canada's Drug Agency would like to remind all stakeholders that we cannot accept input that is submitted without the required conflict of interest disclosures.

Stakeholders are also reminded that input must be submitted by groups of clinicians and not by individuals. We have recently received clinician input from individuals, including situations where the same clinicians are also included on input received from a clinician group. As previously communicated, Canada's Drug Agency will only accept input from clinician groups for the following reasons:

• to ensure that the input we receive is reflective of the broader clinical community
• to reduce the administrative burden for health care professionals who wish to provide input
• to reduce duplication of effort and ensure that Canada's Drug Agency is able to maximize the resources available for conducting reimbursement reviews.