CADTH Pharmaceutical Reviews Update — Issue 38

See Pharmaceutical Reviews Update ― Issue 38 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

• new Canada's Drug Agency Formulary Management Expert Committee  
• new industry pipeline meetings
• updated reconsideration template and sponsor summary of clinical evidence template
• revised reimbursement review procedures
• revised fee schedule for Canada's Drug Agency pharmaceutical reviews.

Canada's Drug Agency Pharmaceutical Program Updates

1.  CADTH’s New Pilot Expert Committee to Support Decision-Making Across the Drug Life Cycle

CADTH, Canada’s drug and health technology agency, announces the creation and inaugural membership of a new Formulary Management Expert Committee as a 1-year pilot program.

The objectives of this pilot project are twofold. The first is to respond to the need of public payers for evidence and recommendations that will help them maximize the value of drugs across their lifespan. The second is to create a controlled test-and-learn environment where Canada's Drug Agency can introduce innovative approaches to reviews, methods, deliberative processes, stakeholder inputs, and the communication of outputs.

The Formulary Management Expert Committee will make recommendations on the optimal use and, if appropriate, reimbursement of both oncology and non-oncology drugs across their life cycle to Canada’s publicly funded drug programs and cancer agencies (excluding Quebec). The committee will assess various types of evaluations that may be requested by participating public payers including: non-sponsored single drug reviews, therapeutic reviews, and streamlined drug class reviews.

Canada's Drug Agency will also convene a small advisory board that will provide feedback on the pilot program throughout the process, made up of external stakeholders from various perspectives (e.g., patients, industry). Details about the advisory board will be shared in the coming weeks.

The Canada's Drug Agency Non-Sponsored Reimbursement Review Procedures have been updated to reflect that recommendations for these reviews will be issued by the Formulary Management Expert Committee.  

2.  New Industry Pipeline Meetings

Effective June 8, 2023, Canada's Drug Agency will offer sponsors the opportunity to participate in pipeline meetings with Canada's Drug Agency staff. Pipeline meetings will provide an opportunity for sponsors to present an overview of their forthcoming pharmaceutical and diagnostic products and pose questions to Canada's Drug Agency on procedural and process initiatives. Pipeline meetings are intended to be mutually beneficial for industry and Canada's Drug Agency; sponsors will benefit through early advice on questions regarding the preparation of their applications and Canada's Drug Agency will benefit through earlier notification and dialogue on new treatments.  

Please consult section 4.2 of the Procedures for Canada's Drug Agency Reimbursement Reviews for complete details regarding industry pipeline meetings. The following templates have been updated to accommodate requests for industry pipeline meetings:  

• presubmission meeting request form
• presubmission meeting briefing paper.  

3.  Updated Application Templates

3.1  Sponsor Summary of Clinical Evidence Template Updates

The procedures and instructions within the sponsor summary of clinical evidence template have been updated as follows:

• Sponsors should refer to the Guidance for Reporting Real-World Evidence when including real-world evidence in a reimbursement review application. For additional details, please refer to this announcement.  
• Instructions for reporting efficacy results in the systematic review section now specify types of data that should be reported, including absolute differences in effects. In the absence of this information, the Canada's Drug Agency review team may not be able to fully assess the clinical importance of the estimated effect for a given outcome.

3.2  Reconsideration Request Template

Canada's Drug Agency has updated the reconsideration request template to assist sponsors in preparing their requests for reconsideration. Canada's Drug Agency has consulted its expert review committees and has added additional instructions to help sponsors communicate their request for reconsideration clearly and concisely.  

4.  Additional Procedural Updates

The following additional changes are reflected in the updated version of the Procedures for Canada's Drug Agency Reimbursement Reviews and applicable application templates.

• A list of efficacy outcomes to be included in the clinical review will be sent with the list of studies currently sent to the sponsor for informational purposes. This will take effect for applications received starting April 26, 2023, for oncology drugs and April 5, 2023, for non-oncology drugs.
• Canada's Drug Agency communicated instructions for industry regarding how to invite Canada's Drug Agency observers to Health Canada meetings (refer to Canada's Drug Agency Pharmaceutical Reviews Update — Issue 35). The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to reflect these instructions.  
• Canada's Drug Agency has revised the Pre-submission Meeting Briefing Paper to include new questions that are focused on the potential implications of introducing a new drug on medical imaging resources in Canada. This information will be used to better inform implementation considerations for new drugs.  

5.  Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews

Canada's Drug Agency has updated the Fee Schedule for Canada's Drug Agency Pharmaceutical Reviews. The adjusted fees for all applications will come into effect on July 17, 2023. The fee increase includes an inflationary amount as well as an additional increase to support the Reimbursement Review program. Please consult Upcoming Improvements to the Canada's Drug Agency Reimbursement Review Process for more information.