In the next step towards National Pharmacare, on June 30, 2022, the Canadian Agency for Drugs and Technologies in Health’s (“CADTH”) pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the “Advisory Panel”) released its final report entitled Building Toward a Potential Pan-Canadian Formulary (the “Report”). The Report outlines the principles and features of a potential pan-Canadian formulary and proposes a three-stage approach to its creation and maintenance. As proof of concept for the proposed framework, the Advisory Panel selected a small sample list of products to illustrate the application of the principles.
The Report was submitted to Health Canada and shared with provincial and territorial governments.
The Advisory Panel’s work is part of a larger conversation on a potential national prescription drug insurance program. In a June 2019 report, the Advisory Council on the Implementation of National Pharmacare, an external body convened by Health Canada, recommended a universal, single-payer, public system of prescription drug coverage in Canada. In March 2022, the Liberal Party of Canada and New Democratic Party agreed to work toward a universal national pharmacare program, including passing related legislation by the end of 2023.
Background on the Advisory Panel
The Advisory Panel was created by CADTH in July 2021, at the request of Health Canada, to provide non-binding recommendations on a framework for a potential pan-Canadian formulary. The Advisory Panel’s scope of work included:
- developing principles that could guide the development of the potential formulary;
- creating a proposed sample list of commonly prescribed drugs in a subset of therapeutic areas and selecting related products, as a test case for the potential formulary;
- establishing criteria and a transparent process for expanding the proposed sample list to other therapeutic areas, and guiding the addition of new products and the maintenance of the list over time; and
- engaging with interested parties to solicit broad perspectives to inform the panel’s recommendations.
As previously reported, the Advisory Panel published a discussion paper in January 2022 and invited stakeholders to provide comments on the proposed framework. A compilation of the stakeholder feedback received during the consultation period is available on the CADTH website [PDF].
Highlights from the Advisory Panel’s Report
Guiding principles: The Advisory Panel proposed that the potential formulary adhere to six principles, namely, that it be: (1) universal and integrated; (2) equitable; (3) effective, safe, and high quality; (4) sustainable; (5) efficient and timely; and (6) inclusive, transparent, with fair process.
Features: The Advisory Panel recommended that the potential formulary:
- be a dynamic and living system and involve multiple perspectives;
- be aligned with, if not integrated into, other elements of the health system;
- be equitable and support a distinction-based approach that promotes self-determination;
- incorporate evidence that considers diverse populations, perspectives, and experiences;
- be aligned with current evidence;
- be sustainable; and
- adopt systems and process efficiencies, including by providing simplified points of access for products related to listed drugs and exploring a hybrid submission review model.
Staged approach: The Advisory Panel proposed a three-stage approach to the creation of the potential formulary: (1) creating a proposed sample list of commonly prescribed drugs and related products; (2) expanding to other therapeutic areas; and (3) adding new products and maintaining the potential formulary.
Sample list: As proof of concept for the proposed framework, the Advisory Panel selected a sample list of 204 prescription drugs and related products in three therapeutic areas: cardiovascular diseases, diabetes, and psychiatric illnesses. A further 54 drugs and related products were flagged for further consideration and 29 were excluded from the proposed sample list. The list can be found at Table 5 on page 69 and following of the Report.
The six proposed principles listed above were integrated into the assessment criteria used to create the sample list.
Future Scope & Next Steps
While out of scope of the current mandate, the Advisory Panel felt that further clarity on the following elements could result in the recommendations being refined and enhanced:
- assessment of current drug plan processes or expectations about the impact of the potential formulary on existing drug plan coverage;
- identification of governance structures to implement the potential formulary;
- consideration of financing issues;
- review of the terms for coverage (e.g., copayments or deductibles) and patient eligibility, including status (e.g., international workers or refugee status);
- consideration of the interplay between public and private insurance plans; and
- consideration of other ongoing pharmaceutical initiatives (e.g., Health Canada’s Drugs for Rare Diseases Strategy).
The Advisory Panel’s recommendations are non-binding, but the federal government will likely use the Report to inform their discussions about a potential pan-Canadian formulary.