Around the World in HTAs: Canada – Autonomous yet Collaborative

Canada has a universal single-payer healthcare system made up of provincial and territorial systems. These are guided by the Canada Health Act alongside other federal regulations and institutions. Provinces and territories receive substantial federal health funding so long as they comply with the requirements of the Canada Health Act, but these systems fund themselves to some degree and have historically operated independently.

The Canada Health Act ensures that ‘all medically necessary services’ are provided at no cost to citizens, regardless of which province or territory they live in, ensuring some consistency between systems. Each system may interpret ‘medically necessary’ according to their needs and priorities, resulting in some variability between systems. Notably, prescription and over-the counter medicines are not covered by the Canada Health Act. Each province and territory has its own prescription medicines plan, and eligibility and formularies can differ dramatically.

The provinces and territories guard their independence – from the federal government and from each other – but several pan-Canadian institutions are central to regulatory and health technology assessment processes in Canada. Health Canada is the regulatory agency that assesses the safety and efficacy of new treatments. Once this process has begun, drugs can then be submitted to Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) for health technology assessment (HTA).

The evolution of HTA in Canada

All provinces except Quebec collaborated in the establishment of the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) in 1989, one of the first HTA bodies in the world. This evolved into the Canadian Agency for Drugs and Technology in Health (CADTH) in 2006. CADTH administered the pan-Canadian Oncology Drug Review (pERC) and the Common Drug Review (CDR) for the assessment of cancer drugs and all other drugs, respectively. CADTH’s mandate expanded in 2023 to include improving the appropriate prescribing and use of medications; data collection including real-world evidence on drug and treatment data; and improving coordination between provincial drug plans. Along with this new mandate, CADTH adopted a new name: Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC).

CDA-AMC’s methodological guidelines focus on five ‘domains of value’: clinical value, unmet clinical need, distinct social and ethical considerations, economic considerations (value for money), and impacts on health systems, especially economic feasibility (budget impact) and organizational feasibility (the feasibility of adopting the new treatment or treatment pathway). The CDA-AMC adopts a deliberative approach, with no explicit weights or thresholds for the different dimensions. This implicit approach – especially in terms of the absence of an explicit cost-effectiveness threshold – contrasts with that used by England’s National Institute for Health and Care Excellence (NICE). CDA-AMC’s processes also differ from NICE’s in terms of committees’ explicit consideration of feasibility (especially infrastructure needs and affordability) as a central dimension of overall value.

Review process

Currently, CDA-AMC has three permanent expert committees: the Common Drug Expert Committee (CDEC), the pan-Canadian Oncology Review Expert Review Committee (pERC), and the Health Technology Expert Review Committee (HTERP); there is also a pilot or interim expert committee: the Formulary Management Expert Committee (FMEC). The permanent committees have similar structures; typically, they comprise around 15 individuals with a mix of clinical, economic, and ethical expertise. Importantly, each committee also includes 1-2 patient representatives. [Authors’ note: Dear reader, rest assured that we find the alphabet soup of Canadian HTA as confusing as you, particularly with respect to how CDA-AMC decided that “pan-Canadian Oncology Review Expert Review Committee” should be shortened to “pERC”.]

Recommendations from these committees can take the form of an outright positive (i.e., recommended for reimbursement), outright negative, or conditional positive (typically suggesting a reduction in the price of the product). Recently, a mechanism has been put in place for a ‘time-limited recommendation’ (TLR) similar to ‘coverage with evidence generation’ assessment pathways seen in other HTA systems. Notably, this process is driven by the sponsor and must be chosen prior to submission – it is not possible for the expert committees to suggest this as an outcome of a submission originally started under the standard assessment pathway. There is a corresponding ‘Temporary Access Process’ to facilitate price negotiations for time-limited recommendations.

CDA-AMC recommendations are non-binding, and each province and territory makes their own decision in the context of their individual health and fiscal priorities. (Arguably, these factors could be extended to include political priorities.) There is no requirement to follow CDA-AMC’s recommendation (positive or negative) or to align with the decisions of other provinces and territories.

Beyond CDA-AMC

Quebec introduced a parallel HTA system in 2000 with the establishment of the Agence d’évaluation des technologies et des modes d’intervention en santé (Agency for the Assessment of Health Technologies and Methods of Intervention). This was merged with the Conseil du Médicament (Drug Advice Agency) in 2011 to form the Institut national d’excellence en santé et en services sociaux (National Institute of Excellence in Health and Social Services; INESSS). Like CDA-AMC, INESSS’s mandate is to promote clinical excellence and the efficient use of resources in the health and social services sectors.

Alongside these parallel HTA processes, the provinces and territories excluding Quebec established the pan-Canadian Pricing Alliance (pCPA) in 2010 with the goal of achieving greater value for publicly-funded drugs plans by combining the negotiating power of individual drug plans. With the addition of Quebec in 2015, pCPA changed its name to the pan-Canadian Pharmaceutical Alliance.

In addition to these provincially-coordinated bodies, the Patented Medicines Prices Review Board (PMPRB) operates as a quasi-judicial federal regulator of prices for patented drugs across Canada. This price regulation is based on a comparison of the prices of patented medicines sold in Canada with a basket of reference prices for the same formulations in 11 comparator countries (the ‘PMPRB11’). Canadian prices greater than the median price of the PMPRB11 can be deemed to be excessive and may lead to federal litigation against the offending companies.

Looking back, looking forward

The history of HTA in Canada has been one of evolving structures and greater cooperation among provinces and territories.

From CCOHTA in the 1990s to today’s CDA-AMC, HTA processes in Canada have evolved to include greater patient involvement in decision-making and to adopt innovations from other HTA processes, including time-limited recommendations to facilitate timely patient access to promising treatments. A common criticism of CDA-AMC’s assessment processes is that it limits access to new treatments and may be overly slow; while there is little empirical evidence to support these criticisms, TLRs might be a means of addressing them.

CDA-AMC is also participating in a joint ‘Health Economics Methods Advisory’ alongside NICE (UK) and ICER (USA). This initiative, which includes OHE’s Deputy Chief Executive is intended to identify areas where novel methods could improve the quality of decision-making and ensure alignment in methods.

Alongside international cooperation around methods, we also see increasing cooperation between provinces and territories, especially in the pan-Canadian Pharmaceutical Alliance, which pools the purchasing power of all the Canadian provinces and territories, including Quebec. As HTA continues to evolve, and the evaluation of novel technologies such as gene therapies introduces complexity, we might expect to see ever-greater cooperation and coordination between CDA-AMC and INESS.

The future of a national, universal Canadian Pharmacare plan, and CDA-AMC’s role in such a plan, remains to be seen. In the first phase of this proposed plan, the federal government is negotiating with the provinces and territories to fund contraception and diabetes medicines. In future phases, CDA-AMC may be required to develop, “a list of essential drugs and related products to inform the development of a national formulary, a national bulk purchasing strategy to help further reduce drug prices, and a pan-Canadian strategy on the appropriate use of prescription medications.” The final shape of a national Pharmacare, and CDA-AMC’s role within this plan, are likely to be the most important areas of change in the Canadian system in the coming years.