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Concrete Steps Toward National Pharmacare in Canada
Judith Glennie
JL Glennie Consulting Inc.
@DrJudithGlennie
C

reation of a National Pharmacare program has been a focus of the Federal Liberal government since their election in 2015. Various committees, reports, and government budget announcements have reiterated a commitment to National Pharmacare, although a specific path forward had yet to be articulated—until recently.

Over the past few months, the government has started to advance some of the recommendations in the final report of the Advisory Council on the Implementation of National Pharmacare. (See October 2019 Global Forum.) Movement has occurred on the proposed Canadian Drug Agency, the national strategy for drugs for rare diseases, and the creation of an essential medicines list, as key developments on the path toward National Pharmacare in Canada.

Canadian Drug Agency (CDA)

The concept of creating a Canadian Drug Agency (CDA) was first introduced in the March 2019 federal budget. At the time, it was positioned as a new federal agency, distinct from Health Canada and designed to improve access to and prices of prescription drugs. Specifically, it was envisioned to be responsible for:

  • evaluating the comparative effectiveness of new prescription drugs (as opposed to the safety, efficacy, and quality assessment undertaken by Health Canada);
  • negotiating prices with manufacturers on behalf of public drug plans;
  • recommending which drugs provide the best value for money for Canadians;
  • providing impartial and independent advice on drug evaluation and price negotiation; and
  • consulting with provinces and territories on developing a national formulary (for the purposes of a National Pharmacare program).

Of note, many functions envisioned for the CDA have been and continue to be provided by organizations that already exist at a pan-Canadian and/or regional level in the form of the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d’excellence en santé et en services sociaux (INESSS) for value assessments, and the pan-Canadian Pharmaceutical Alliance (pCPA) for national drug price negotiations. It is not known what role these organizations will have if the CDA comes to fruition.

In April 2021, Health Canada announced the appointment of the head of the Canadian Drug Agency Transition Office, officially launching the federal government’s foray into the creation of the CDA. The mandate of the office is to develop a vision and mandate for the CDA, advance work on pharmacare-related initiatives, and provide dedicated leadership and resources to support federal-provincial-territorial discussions. It will also engage provinces, territories, and stakeholders in discussions on the creation of a new agency.

The Transition Office recently started its work to develop a national formulary (see Advisory Panel for Pan-Canadian Prescription Drug List below) envisioned as a comprehensive, evidence-based list of prescribed drugs that will support consistent patient access to treatments across the country.

One of the key challenges of moving ahead with the CDA is that the existing component parts (particularly CADTH and pCPA) were developed by and have formal reporting relationships to provincial and territorial governments. The degree to which these jurisdictions might be willing to cede control over the governance of these bodies remains to be seen. In addition, if the CDA is intended to be national in scope, it is not clear what the implications are for INESSS and its activities in Quebec.

National Strategy for High-Cost Drugs for Rare Diseases

As reported in the March 2021 Global Forum, Health Canada launched a consultation in early 2021 on the development of a National Strategy for High-Cost Drugs for Rare Diseases. A July 2021 report from those consultations summarized the input from this national public and stakeholder engagement process.

A sampling of some of the key themes and ideas articulated by stakeholders is outlined below.

Themes
Ideas
Improving access to rare-disease treatments and making it consistent across Canada
  • A single national framework for rare disease treatments would make access fairer and was the most important element for a national strategy.
  • A national strategy should not remove access from those who already have access through public programs.
  • Desire for a transparent coordinating body, better alignment across the system, and a greater say in all aspects of the strategy for patients and clinicians.
Getting the best possible evidence for decisions on drugs for rare diseases
  • People overwhelmingly ranked innovative approaches to approval and coverage (i.e., pay for performance, early access, and managed access) as the most important option for building a better evidence base.
Balancing spending on drugs for rare diseases and keeping Canadian healthcare sustainable overall
  • Most people felt that better cost-sharing and pooling of risks was the best approach.
  • Some felt that the federal government could reinsure drug plans, by paying costs for drugs over a specified dollar threshold.
Next steps important to participants
  • Working closely with provinces, territories, Indigenous partners, and stakeholders to develop a coordinated strategy that gets patients the effective treatments they need.
  • Establishing common definitions of “rare diseases” and “high-cost drugs” and better guidelines for what constitute “benefits” and “improvements” for assessing rare disease treatments.
  • Researching best practices in other jurisdictions including France, Germany, the UK, and Australia.
  • Ensuring Canada’s regulatory approach, drug pricing landscape, and research and innovation capacity are conducive for rare disease drugs.
  • Considering how to support patients more holistically, including screening, testing, and diagnostics.
Improving access to rare-disease treatments and making it consistent across Canada
  • A single national framework for rare disease treatments would make access fairer and was the most important element for a national strategy.
  • A national strategy should not remove access from those who already have access through public programs.
  • Desire for a transparent coordinating body, better alignment across the system, and a greater say in all aspects of the strategy for patients and clinicians.
Getting the best possible evidence for decisions on drugs for rare diseases
  • People overwhelmingly ranked innovative approaches to approval and coverage (i.e., pay for performance, early access, and managed access) as the most important option for building a better evidence base.
Balancing spending on drugs for rare diseases and keeping Canadian healthcare sustainable overall
  • Most people felt that better cost-sharing and pooling of risks was the best approach.
  • Some felt that the federal government could reinsure drug plans, by paying costs for drugs over a specified dollar threshold.
Next steps important to participants
  • Working closely with provinces, territories, Indigenous partners, and stakeholders to develop a coordinated strategy that gets patients the effective treatments they need.
  • Establishing common definitions of “rare diseases” and “high-cost drugs” and better guidelines for what constitute “benefits” and “improvements” for assessing rare disease treatments.
  • Researching best practices in other jurisdictions including France, Germany, the UK, and Australia.
  • Ensuring Canada’s regulatory approach, drug pricing landscape, and research and innovation capacity are conducive for rare disease drugs.
  • Considering how to support patients more holistically, including screening, testing, and diagnostics.
Health Canada will continue discussions with stakeholders through the summer of 2021 in parallel with discussions and collaboration with provinces and territories, pharmaceutical management system partners, and Indigenous partners. Further public consultation to inform a comprehensive model for the national strategy will take place in fall 2021, with the goal of launching the national strategy for drugs for rare diseases in 2022.

Advisory Panel for Pan-Canadian Prescription Drug List

CADTH recently announced that they had convened an Advisory Panel on behalf of Health Canada to recommend a framework for developing a potential pan-Canadian prescription drug list, or formulary. Creating an initial list of essential medicines was a key pillar for implementation of National Pharmacare per the recommendations of the Advisory Council noted above, with the goal of expanding that list toward a fully comprehensive formulary by 2027.

The mandate of the Advisory Panel is to:

  • recommend principles and a framework for developing a pan-Canadian prescription drug list;
  • recommend an initial list of commonly prescribed drugs and a transparent way to add to that list; and
  • consult with key stakeholders and health system partners, including federal, provincial, and territorial governments; patients and clinicians; industry; and others.

The plan is for the Advisory Panel to complete its recommendations by the end of April 2022. Their report will be submitted to HC, shared with provincial/territorial governments, and made available publicly. Stakeholders will have the opportunity to provide input and feedback on the panel’s proposed recommendations via webinars to be held between late October and early December 2021.

The Advisory Panel’s membership comprises two co-chairs and 12 members. Members include those with expertise and experience as healthcare providers (nursing, pharmacy, and medicine), persons with lived experience, and individuals with backgrounds in ethics and health policy. While some members have rare disease experience, it is worth noting that there is no oncology-specific expertise on the panel and no one who specializes in private drug plans. There was no public call for applicants to be part of this panel (as is CADTH’s usual process); instead, CADTH selected members with advice and guidance from its federal, provincial, and territorial funders.

While Health Canada’s creation of this Advisory Panel signals the federal government’s continuing interest in National Pharmacare, it is still very unclear what specific form such a program might take. Will the list created by the panel a) serve as a formulary to be managed by the federal government; b) serve as the bare minimum of what drug plans need to offer their clients (private or public); c) serve as the basis of a plan targeted to people who have no access to public and/or private drug plans; or d) be the basis of some other type of program that has yet to be defined? Many details remain undefined when it comes to a National Pharmacare program for Canada.

Conclusions

Many of the pieces envisioned within the 2019 recommendations of the Advisory Council on the Implementation of National Pharmacare have started to move ahead within the past year. Rare disease strategy consultations, leadership to further develop the concept of a Canadian Drug Agency, and creation of a panel to develop an essential medicines list align with the reaffirmed commitment to National Pharmacare in the April 2021 Federal Budget.

There remains much uncertainty in terms of the exact form and structure of these component parts, let alone an overall National Pharmacare program. It is also uncertain whether or how the federal government will start to better align its pharmaceutical policy efforts with its investments in innovation as signaled in that same 2021 Budget.

The recent announcement of further delays in implementing the Patented Medicines Regulations and final Patented Medicine Prices Review Board Guidelines may signal a willingness to listen to stakeholders on the importance of such alignment and congruence. This will be especially important if a National Pharmacare program is to be successful within a vibrant therapeutic product innovation ecosystem.

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