In a recently published discussion paper, an Advisory Panel (the Panel) convened by the Canadian Agency for Drugs and Technologies in Health (CADTH) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking for feedback on the framework with an online questionnaire. The feedback will inform a stakeholder session in spring 2022 and the Panel’s final report. The Panel’s recommendations will be non-binding and are intended to add to the national conversation in Canada about access to prescription drugs.
In Canada, coverage for prescription drugs exists through an array of public and private drug plans. As we previously reported, CADTH convened the Panel to:
- recommend principles and a framework for developing a pan-Canadian prescription drug list (i.e., a formulary); and
- recommend an initial list of commonly-prescribed drugs and a transparent way to add to that list.
The Panel’s mandate did not include governance structures, financing, patient eligibility, or the interplay between public and private insurance plans.
The Panel has 14 members, providing expertise and experience in health care, in Indigenous and other communities, and in ethics and health policy.
Key points from the discussion paper
Goal and principles: The Panel’s stated goal for the potential pan-Canadian formulary is to include a broad range of safe, effective, evidence-based drugs and related products reflecting the health care needs of Canada’s diverse population. The Panel recommended six guiding principles for the formulary: (i) universal and integrated, (ii) equitable, (iii) effective and high quality, (iv) sustainable, (v) efficient and timely, and (vi) having an inclusive, transparent, and fair process.
Proposed sample formulary: As a starting point for a potential pan-Canadian formulary, the Panel proposed a sample list of prescription drugs and related products. The Panel focused on three therapeutic areas (cardiovascular disease, diabetes, psychiatric illnesses), which were chosen for their high rate of prescription drug use, among other reasons. The Panel then reviewed 277 drugs and 10 related products. The Panel selected 204 for inclusion on the proposed sample list, excluded 29, and flagged 54 for further consideration. In making these decisions, the Panel considered, among other information: a product’s listing status on existing federal, provincial, and territorial formularies; utilization data; availability of a generic or biosimilar; and information about safe use in pregnant and lactating women. Drug cost was not a consideration.
Expanding the formulary: According to the Panel, the next stage in creating a potential pan-Canadian formulary is scaling the process to address other therapeutic areas, including products listed under specialized programs (e.g., cancer and special drug programs). The Panel proposed the following evaluative criteria for new products: (i) alignment with patient and societal values; (ii) clinical benefit; (iii) equitable access; (iv) feasibility of adoption into health systems; (v) value for money; and (vi) additional considerations (e.g., uncertainty of long-term benefits and harms). The Panel also explored alternatives to the “first-in, first-out” process for reviewing new products and indications, including prioritizing the review of innovative products that address unmet needs.
Managing the formulary: The Panel also commented on a range of formulary-management practices, including generic and biosimilar substitution, reference-based reimbursement (e.g., limiting reimbursement to the lowest-priced drug in a category), restricted listing status (e.g., clinical criteria), the number of drug molecules and suppliers within each class or category, aligning the formulary with clinical practice guidelines, and periodic updating through health technology reassessments and therapeutic reviews. To that end, the Panel identified classes of drugs in its proposed sample list that could benefit from therapeutic reviews.
Feedback on the discussion paper
The Panel is seeking input from stakeholders on or before February 25, 2022 via an online questionnaire. CADTH will publish any comments received through this consultation.
- Discussion Paper for Engaging With Stakeholders: Building Toward a Potential Pan-Canadian Formulary, January 2022
- CADTH Stakeholder Engagement form
- Final Report of the Advisory Council on the Implementation of National Pharmacare