ARTICLE
7 July 2025

CDA Opens Public Consultation On Pharmacare National Formulary – Deadline July 18, 2025

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On June 19, 2025, the Essential Prescription Drugs and Related Products Advisory Panel of Canada's Drug Agency ("CDA") opened a public consultation...
Canada Food, Drugs, Healthcare, Life Sciences

On June 19, 2025, the Essential Prescription Drugs and Related Products Advisory Panel of Canada's Drug Agency ("CDA") opened a public consultation to gather feedback on a proposed process for preparing a list of essential prescription drugs and related products. Stakeholders are invited to provide feedback using the on-line feedback form during the 1-month consultation period, with submissions due by July 18, 2025, at 5 p.m. ET.

The public consultation is required by the federal Pharmacare Act (S.C. 2024, c. 24) which established a universal single-payer, first dollar public prescription drug insurance program in Canada. As previously reported, the Pharmacare Act became law on October 10, 2024, and initially covers prescription contraceptives and diabetes treatments for eligible patients.

The public consultation seeks input on three key questions:

  • Suggestions that could enhance the process for including and excluding products on the proposed list of essential prescription drugs and related products;
  • Specific suggestions to support the process for updating the proposed list over time; and
  • The identification of commonly prescribed drugs and related product that are not already on the proposed list, such as high-use prescription drugs in Canada that are listed on most public drug plans.

The CDA has published an Initial Recommendation paper in connection with the public consultation which provides more detail on the CDA's proposed approach to the development of a national formulary. There are several notable take-aways:

  • The CDA has identified a proposed initial list of 513 prescription drugs for inclusion on a national formulary, plus a list of 142 products that are specifically excluded. The lists are set out in Appendix 2 of the Initial Recommendation.
  • The proposed initial list was prepared using the CLEAN Meds list as a starting point, informed by WHO-EML, and includes a range of evidence-based drugs commonly prescribed based on select utilization data, including that the drug has been adopted by at least seven Canadian public drug plans or cancer agencies.
  • Drug cost was not taken into account in compiling the proposed initial list.
  • Drugs having major safety issues, are dormant, received a negative HTA recommendation, are no longer standard of care, or are in a new drug class and not recommended as first-line treatment, were excluded.
  • Coverage for drugs funded by a public or private plan that do not appear on the proposed initial list will not be impacted. It is assumed there will be no loss of existing access.
  • Drugs and related products for rare diseases are out of scope. The federal government is working separately with provinces and territories to develop a common drug list for rare diseases under the National Strategy for Drugs for Rare Diseases.

According to the Initial Recommendation, the proposed initial list is a starting point and is not intended to be comprehensive. The methodology adopted following the public consultation will provide a roadmap to guide future updates to the list, which may expand and evolve over time. Moreover, implementation of a national formulary is intended to follow a phased approach, where core drugs meeting basic medication needs and oral cancer drugs will be prioritized in Phase 1. Additional drugs will be added in subsequent phases.

The CDA's public consultation seeks input from the pharmaceutical industry, people with lived and living experience, healthcare professionals, Indigenous health leaders, and public and private drug plan representatives. Feedback from stakeholders will be used to inform the CDA advisory panel's final report, which is expected to be published in the fall of 2025. A separate CDA public consultation regarding a national bulk purchasing strategy is expected to commence in early to mid July 2025.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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