Challenges,choices, and Canada

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was established by the Federal, Provincial, and Territorial Ministers of Health in 1989 for a 3-year trial period. In 1993 CCOHTA was made a permanent organization and in 1999 the Deputy Ministers of Health renewed CCOHTA's mandate and increased its funding. CCOHTA's role is to coordinate health technology assessment (HTA) priorities across jurisdictions, foster and undertake assessment activity, and function as a clearinghouse for technology assessment results while increasing healthcare system stakeholder awareness of HTA findings. The coordinated and collaborated approach adopted by CCOHTA minimizes duplication with other national and provincial organizations and contributes to the ability of the Canadian healthcare system to continue to deliver high-quality health care to its constituents.     

"The future should not take us by surprise": preparation of an early warning system in Denmark

OBJECTIVES: To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue. METHODS: On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study. RESULTS: Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred. CONCLUSIONS: The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.     

The personal costs of caring for a child with a disability: a review of the literature

This article presents a review of the literature published from 1989 to 2005 for articles that examined the economic burden incurred by families as a result of caring for a child with disabilities. The review was performed according to a comprehensive economic conceptual model developed by the authors and to the guidelines set out by Canadian Coordinating Office for Health Technology Assessment. The analysis indicated that the burden incurred by these families can be substantial, especially among families who care for a child with a severe disability. However, the variability and the quality of methods is such that the return on investment in knowledge of costs in this area is not as high as it could have been had methodological procedures been more standardized. A comprehensive and systematic approach is suggested for future research.     

Use of economic evaluation guidelines: 2 years' experience in Canada

Considerable effort has been expended in recent years in the development of methodology guidelines for economic evaluation of pharmaceutical products, driven in part by the desire to improve the rigour and quality of economic evaluations and to help decision making. Canada was one of the first countries to develop such guidelines and to encourage their use. This paper examines the extent to which the economic evaluations that were submitted to the Canadian Coordinating Office for Health Technology Assessment in the last two years adhered to Canadian guidelines. The analytic technique employed by twelve studies as well as the comparator used, the perspective taken, the outcome measure selected, the cost items that were taken into consideration and the extent of sensitivity analyses that were performed are reviewed in this paper. It can be concluded that although studies have been of variable quality, the majority of them were well presented, complete and transparent, due in part to the guidelines. Except for the perspective of the analysis, guidelines were, in many respects, adhered to and did not restrict investigators to specific methodologies or specific techniques. They were also instrumental in ensuring a minimum set of standards. © 1998 John Wiley & Sons, Ltd.     

Impact of the 1997 Canadian Guidelines on the Conduct of Canadian-Based Economic Evaluations in the Published Literature

ObjectiveTo assess the impact of the 1997 Canadian guidelines on the methods and presentation of economic evaluations conducted from a Canadian perspective in the published literature.MethodsA systematic literature review was conducted to identify health technology economic evaluations conducted from a Canadian perspective published in peer-reviewed journals between 2001 and 2006. To investigate the impact of the 1997 Canadian Coordinating Office of Health Technology Assessment guidelines, each included study was assessed against 17 of the 25 recommendations.ResultsOf the 153 included studies, a base set of 9 methodological standards, as outlined by the 1997 guidelines, were followed by over 50% of the studies including: indications, outcomes for cost utility analysis, outcomes for cost benefit analysis, discounting future cost and outcomes, cost identification and valuation, evaluating uncertainty and disclosing funding relationships. Main divergences from the guidelines were found for analytic technique (38%), study perspective (23%), source of preferences (8%), equity (7%), and cost measurement (24%).ConclusionThe current assessment has shown that the 1997 Canadian guidelines have set a minimum methodological standard within the community of “doers” conducting economic analyses from a Canadian perspective. Although there was divergence from some of the recommendations, the majority were reflected as changes in the 2006 Canadian guidelines.     

Developing a system for evaluating a national health promotion programme

According to Canadian government policy, all federal governmentprogrammes must be evaluated periodically. To facilitate evaluations,it is required than an "evaluation framework" be developed forall new or substantially revised programmes. A framework was developed for the Canadian federal Health PromotionDirectorate following the approval of a revised programme bythe government in 1982. Completed in 1984, it identified fivekey issues and eight key questions that were likely to be addressedin the evaluation of the programme in 1987, numerous indicatorsto measure the answers to these questions, methods that mightbe used to obtain the required data and five recommendationsfor implementing the framework. Subsequently, the Health Promotion Directorate implemented theserecommendations by establishing systems for monitoring projectsand for carrying out evaluation studies, and by designing andcarrying out national surveys. This paper describes the process of developing and implementingthe health promotion evaluation framework. It concludes withan attempt to draw lessons from the experience that may be helpfulin further work in Canada and perhaps in other countries.     

The Canadian health care system: an overview

Although health care is a provincial responsibility in Canada, universal hospital insurance was fully adopted by 1961; universal medical insurance followed 10 years later. Each province enacted universal insurance after the federal government offered to pay 50% of provincial hospital and medical care costs. Hospital insurance had wide public and provider support but universal medical care insurance was opposed by organized medicine. The federal government soon realized that it had no control over total expenditures and no mechanisms for controlling costs. In 1977 it enacted Bill C-37 which limited total federal contributions and made those contributions independent of provincial health care expenditures so that increased costs had to be met by the provinces. Since private health care insurance for universal benefits is prohibited by the federal terms of reference for health insurance, the provinces must raise the money by taxes and (in some provinces) premiums. Although prohibited by the terms of reference of the universal program, some provinces have adopted hospital user fees and are allowing their physicians to bill patients in excess of provincial fee schedules. The 1980s have seen increased confrontations between the federal and provincial governments and between the provinces and their providers. The issues are cost containment and control of the system. The provinces have two broad options. The first is more private funding through private insurance and user fees. The proposed new Canada Health Act will probably prohibit such charges. A second option involves greater control and management of the system by the provinces; this has already occurred in Quebec. Greater control is vigorously opposed by physicians and hospitals. The Canadian solution to health insurance problems in the past has been moderation. Extreme moves in either direction would represent a break with tradition, but they may prove to be unavoidable.     

Are the best available clinical effectiveness data used in economic evaluations of drug therapies?

OBJECTIVES: Use of evidence on clinical effectiveness that is of poor quality or is biased in favour of the therapy under study is a concern in economic evaluations and may contribute to a mistrust of pharmacoeconomic studies. This study aimed to determine whether the authors of economic evaluations use the best available evidence for clinical effectiveness. METHODS: One hundred economic evaluations of drug therapies (published in 2001-2003) were sampled randomly from the National Health Service Economic Evaluation Database, and the source of clinical evidence was identified. For each therapy, alternative, high quality sources of clinical effectiveness data were sought by searching the Database of Abstracts of Reviews of Effects and Health Technology Assessment databases. The magnitude and direction of the effect size in the different sources of evidence were compared. RESULTS: Relevant systematic reviews were found for only 32 of the 100 economic evaluations in the sample. In three cases these reviews had been identified by the authors of the economic evaluations and two of these cases were used in the evaluation. Comparisons were possible in 21 cases. The clinical effects reported in all 21 comparisons were similar in direction but differed in magnitude. Compared to the systematic reviews, the authors of economic evaluations used evidence that was more favourable in five cases, less favourable in four cases, and similar in 12 cases. Six of the economic evaluations and corresponding systematic reviews did not present measures of effectiveness in a manner that allowed comparison. CONCLUSIONS: Authors of economic evaluations have not made sufficient use of the evidence available from systematic reviews of clinical effectiveness. The central role of economic evaluations in health policy makes it essential that improvements in economic methods are accompanied by a structured search for the highest quality information on clinical effectiveness.     

The Economics of Hypercholesterolemia and Lipid-Lowering Therapy: A Brief Historical Tour

The first formal economic evaluation of a lipid-lowering intervention was conducted almost 20 years ago. The field exploded in the mid-1980s following the publication of findings from the Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT), in which the bile-acid sequestrant, cholestyramine, was reported to reduce the incidence of coronary artery disease in adults with significant elevations in cholesterol. Almost all of the early pharmacoeconomic studies that followed focused on this agent. Later in the decade, the introduction of lovastatin, the first 3-hydroxy-3 methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (or "statin"), revolutionized the treatment of hypercholesterolemia, as it was significantly more effective than earlier agents (as were the other statins that followed it). Pharmacoeconomic studies of the statins generally have reported that, despite their higher cost, they are significantly more cost-effective than bile acid sequestrants. Recent long-term clinical trials, such as the West of Scotland Coronary Prevention Study (WOSCOPS) and the Scandinavian Simvastatin Survival Study (4S), have provided firm evidence of the benefits of the statins in both the primary and secondary prevention of coronary artery disease. Formal economic evaluations were incorporated into most of these end-point studies-in contrast to morbidity and mortality trials of earlier lipid-lowering agents-and results from these evaluations are just now becoming available. The availability of primary economic data derived directly from large-scale, long-term clinical trials raises important questions about the future role of modeling in this area.     

PCV5 Pharmaceutical Costs of Patient Non-Adherence to Lipid-Lowering Drug Therapy

The "statin" market is highly competitive, with primary differences being lipid-lowering ability and acquisition cost. Health care decision makers must be able to demonstrate and compare the clinical and economic value of each statin. To date, the best available data for such comparisons come from the long-term studies 4S, CARE, and WOSCOPS.
OBJECTIVE: Lipobay, a potent new statin, was recently introduced in Europe and will be introduced in the United States as Baycol this year. Our objective was to model the clinical and economic results of 4S to compare the cost-efficiency of Lipobay to other statins.
METHODS: Our research was based on the following assumptions: lipid-lowering ability and acquisition cost are the only distinctions among statins; a positive linear relationship exists between reduced lipids and reduced cardiovascular costs; all statins, based on efficacy and cost, can be incorporated into this relationship. Using these assumptions, we extracted numeric data points for cardiac hospitalization cost in 4S and developed a linear equation, incorporating efficacy and drug cost, to estimate total cost for each statin. Our cost-efficiency measurement consisted of an index calculated by dividing estimated annual per patient total cost or drug cost in Deutchmarks by unit reduction in LDL. This measurement is interpreted as the cost per unit reduction in LDL. Drugs whose total and drug cost indices had negative or zero slopes when graphed and low indices were considered cost-efficient.
RESULTS: Lipobay presented a negative slope for the total cost indices and a zero slope for drug cost indices. When comparing actual cost indices for all drugs, Lipobay was generally within mid-range (total cost: DM98–DM149; drug cost: DM14).
CONCLUSION: Lipobay is cost-efficient when compared to other statins, particularly when considering drug cost and efficacy.     

Advancing Indigenous primary health care policy in Alberta,Canada

For Indigenous people worldwide, accessing Primary Health Care (PHC) services responsive to socio-cultural realities is challenging, with institutional inequities in healthcare and jurisdictional barriers encumbering patients, providers, and decision-makers. In the Canadian province of Alberta, appropriate Indigenous health promotion, disease prevention, and primary care health services are needed, though policy reform is hindered by complex networks and competing interests between: federal/provincial funders; reserve/urban contexts; medical/allied health professional priorities; and three Treaty territories each structuring fiduciary responsibilities of the Canadian government.In 2015, the Truth and Reconciliation Commission (TRC) of Canada released a final report from over six years spent considering impacts of the country's history of Indian residential schools, which for more than a century forcibly removed thousands of children from their families and communities. The TRC directed 94 calls to action to all levels of society, including health systems, to address an historical legacy of cultural assimilationism against Indigenous peoples. To address TRC calls that Indigenous health disparities be recognized as resulting from previous government policies, and to integrate Indigenous leadership and perspectives into health systems, PHC decision-makers, practitioners, and scholars in the province of Alberta brought together stakeholders from across Canada. The gathering detailed here explored Indigenous PHC models from other Canadian provinces to collaboratively build relationships for policy reform and identify opportunities for PHC innovations within Alberta.     

Canada's national initiative to advance access to electronic journals

This paper describes a national experiment in the licensing of full text information in journals, primarily in the fields of science, technology and medicine. It discusses the initiative of the federal government of Canada through the creation of the Canada Foundation for Innovation as a new funding agency, with an objective of improving research and creativity in Canadian science. The successful efforts initiated by the Canadian Association of Research Libraries/Association des bibliothèques de recherche du Canada to create a funding opportunity to develop the 'information infrastructure' for Canadian researchers and the resulting Canadian National Site Licensing Project (CNSLP) progress is discussed. The evolution of a project governance structure to maintain the support of the 64 participating institutions is reviewed and the need to develop an appropriate exit strategy at the conclusion of the federal funding is also considered.     

A tale of three cities--where RHIOS meet the NHIN

Regional health information exchanges in California, Indiana, and Massachusetts have been collaborating on a prototype for a nationwide health information network, first under the auspices of the Markle Foundation's Connecting for Health program and now under contract to the Department of Health and Human Services' Office of the National Coordinator for Health Information Technology. Since mid-2004, this collaboration has evolved from a collection of regional efforts to a standards-driven cooperative and now to one of four prototype national networks fostered by federal efforts. This development reflects a maturing market for interoperability and integration in healthcare information technology, starting with RHIOs, and suggests one response to the industry's need for the type of plug-and-play information exchange available in other industries. The authors share their experiences and their views of how RHIOs and a Nationwide Health Information Network will further develop to make interoperable electronic health records a reality in coming years. The content of this article is solely the responsibility of the authors and does not necessarily represent the official view of the Office of the National Coordinator for Health Information Technology.     

Health policy versus industrial policy in the pharmaceutical sector: the case of Canada

This paper analyses the trade-off between health policy and industrial policy objectives in the field of pharmaceuticals in the Canadian policy setting. In Canada pharmaceutical regulation is organized in two tiers. The federal government is responsible for the conduct of industrial policy for the pharmaceutical sector, including the patenting of new molecular entities, the registration and approval of pharmaceutical products, and the pricing of new products. At the province level, policy-makers are responsible for the reimbursement of the cost of medicines; the methodologies implemented for this purpose may be geared towards meeting the objective of cost containment within tight health budgets rather than addressing industrial policy objectives and, thereby, supporting the pharmaceutical industry. The reimbursement methodologies implemented may also be related with the strength of pharmaceutical presence in each province. The paper provides evidence from two such provinces, British Columbia and Ontario, and contrasts pharmaceutical policy-making at the provincial level with that at the federal level.     

From sandbox to pandemic: Agile reform of Canadian drug regulation

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.     

Analysis of the National Institutes of Health Medicare coverage assessment

The National Institutes of Health (NIH) is periodically asked to conduct assessments of new medical technologies to assist in coverage decisions made at the Office of Health Technology Assessment (OHTA) for the Health Care Financing Administration coverage policy. Analysis of NIH assessments indicates that even though most NIH assessments rely only on expert opinion, OHTA agreed with NIH recommendations in over 90%.     

Health promotion in Canada: 1986 to 2006

The evolution of health promotion in Canada between 1986 and 2006 is characterized by three major eras: Health Promotion in the Limelight, 1986-1992, Health Promotion Behind the Scenes, 1993-2003, and Health Promotion Restaged, 2003-2006. These eras are illustrated using the Canadian Heart Health Initiative as an example. The first era, backed by strong federal government leadership and support, was a progressive time of developing concepts, collaborations and infrastructure for health promotion across the country. Despite significant progress, by the end of this era, health promotion was neither sufficiently developed nor funded to make it a cornerstone of the health system. In addition, the emphasis was heavily biased towards changing individual behaviour. In the second era, health promotion continued to develop in pockets across the country and debates within the field intensified. However, these events went largely unnoticed and massive overall cuts at federal and provincial levels of government made acute care a much higher priority than health promotion. The third era, mostly shaped by fears linked to public health threats, saw a restaging of health promotion through efforts to strengthen public health infrastructure. Nevertheless, at the end of this era, the necessary intersectoral partnerships (such as in health, housing, education, food, income) remained scarce, and little progress was made to decrease health inequalities. The Canadian Heart Health Initiative was implemented over the same time period as the three eras. Its legacy includes collegial relationships across various levels of government and with non-government organizations, a culture that values pan-Canadian initiatives, and support for integration of research, evaluation, surveillance, policy and practice. It remains to be seen how quickly it will be possible to advance the vision of health promotion conceived during the Limelight Era in Canada.     

Comparison of outpatient coverage in Canada: Assistive and medical devices

Outpatient technologies are important for maintaining health and overall quality of life, yet the degree of access and coverage of these technologies remains variable within and across jurisdictions. In Canada, assistive technologies are not included in universal health coverage, and are not subject to the Canada Health Act's criteria and conditions that provinces and territories must fulfill to receive the full federal cash contribution under the Canada Health Transfer. As such, the thirteen Canadian provincial and territorial governments make separate decisions on programs and coverage. Drawing on the WHO Universal Coverage Cube we compare who gets access, the types of technologies that can be accessed, and the level of coverage (total costs covered) in Canada. Overall, each Canadian jurisdiction had at least one publicly supported program. All relied on a ‘health assessment’ of an individual's need to determine eligibility. Income and eligibility for social assistance was used as eligibility criteria in 6 of the 13 jurisdictions. Mobility aids as well as audio, visual, and communication aids were included in all jurisdictions. While some programs offered full financial support for some technologies, forms of cost sharing were common. The results are discussed in the context of international experiences, demographic changes, and health system trends to highlight areas for policy learning.     

Health care technology in Canada (with special reference to Quebec)

In Canada, all citizens are insured for health services. Health care is a provincial responsibility. The federal role is limited to health care financing, health protection including regulation of pharmaceuticals, and environmental health. The health care system represents a balance among government direction, consumer choice, and provider autonomy. Canada has largely controlled the costs of health care by funding and management mechanisms, the most important of which is the global budget formula used to fund hospitals. This paper discusses the Canadian health care system, with particular emphasis on the province of Quebec. In 1988, the provincial government of Quebec established the first Canadian body dedicated to technology assessment. Since then, a national coordinating office and several other provincial bodies have developed. The work of these and other evaluation efforts has had a growing influence on technology management decisions, particularly those dealing with procurement of capital-intensive technologies. Expanding this influence into the realm of technology use, especially for low-cost, high-volume technologies, remains a challenge.