Health Technology Strategy 1.0

Prepared by:
Health Technology Assessment Task Group,
on behalf of:
Federal/Provincial/Territorial Advisory Committee on Information and Emerging Technologies
June 2004

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Table of Contents

• Why a Pan-Canadian Strategy?
• Summary of recommendations
• National Health Technology Agency
• The Forum
• The Exchange
• Field Evaluations and Infostructure
• Acronyms

Why a Pan-Canadian Strategy?

Technological change is a major cost escalator in Canada's health systems accounting for an estimated one quarter of health expenditure growth.¹ Technological change and heightened public expectations are primary sources of escalating costs, which threaten the financial sustainability of Canada's health systems. Much of this expenditure growth is driven by changing technology and consumer demand. The pace of health technology² development is outpacing the health systems' ability to effectively operationalize it. Health technology and its management are therefore leading priorities for policy makers and academic researchers.

Notwithstanding, technological innovation also holds the promise of new treatments, ways to improve patient care, and better tools for managing and improving the overall quality of the health systems. Furthermore, health technology innovation is a driver of economic benefits to Canada. To realize these clinical and economic benefits, health technology needs to be managed better.

There are many common health technology management issues facing F/P/T (Federal/Provincial/Territorial) jurisdictions so a voluntary, pan-Canadian, coordinated approach to formulating specific policy advice to be made available to all jurisdictions is required. This strategy proposes a means for developing shared policy advice to aid health technology investment decisions in all jurisdictions. This policy advice needs to be clear, concise, and timely.

At the February 2003 First Ministers Meeting (FMM), Canada's federal, provincial, and territorial Health Ministers were directed to address this issue.

FMM 2003 Accord Directive: Health Ministers are directed to develop, by September 2004, a comprehensive strategy for technology assessment which assesses the impact of new technology and provides advice on how to maximize its effective utilization in the future.

Reporting to the Conference of F/P/T Deputy Ministers of Health (CDM), the responsibility to develop this strategy fell to the Advisory Committee on Information and Emerging Technologies (ACIET), which in turn created the Health Technology Assessment Task Group (Task Group).

Health Technology Strategy 1.0. The Task Group coined the term Health Technology Strategy 1.0, or HTS 1.0 for short, to give a name to the first version of this comprehensive strategy. In years to come subsequent versions of this strategy will be created to address new health system realities created by rapidly evolving health technologies.

The CDM interpreted "comprehensive strategy" and "assessment" in the FMM 2003 Accord to include management of technologies across the entire spectrum of the technology lifecycle, from innovation through to obsolescence.

The Task Group identified some Canadian initiatives already aligned to the comprehensiveness of the strategy:

• Health Innovation Canada seeks to make the health system an economic driver for innovation, not simply a cost centre.
• Canada Health Infoway Inc. is moving aggressively in the area of electronic health record (EHR) deployment and telehealth leading to the development of a Canadian health "infostructure". This infostructure should be leveraged to optimize the management of health technologies.
• Through quality and measurement initiatives such as the Canada Health Council, the Health Quality Councils in Alberta and Saskatchewan, Statistics Canada and the Canadian Institute for Health Information, there is an increasing focus on the measurement of the quality outcomes of Canada's health systems. Management of health technology should be tightly linked to desired outcomes.

Deficiencies in Traditional HTA. Health technology assessment, or HTA, is a term widely understood in international academic circles to mean the secondary research activity of collecting primary research data about a given health technology and normalizing it for policy input. HTAs are expected to provide unbiased information to policy-makers on a technology's:

1. clinical effectiveness,
2. impact to providers,
3. service improvements to patients, and
4. economic impact.

Many concerns related to current HTA products and services were raised by the CDM:

• HTA reports take too long to develop delaying important policy decisions impacting patient care;
• HTA reports often report that insufficient primary research exists to cull together a complete report;
• HTA reports use technical language that is difficult for policy-makers to understand;
• The number of people completing HTA reports is inadequate compared to the amount of technology diffusing into the health systems; and
• HTAs do not effectively address policy issues common to all F/P/T jurisdictions.

Moving Beyond Traditional HTA. HTS 1.0 proposes moving beyond the traditional notion of HTA. Policy development is wide ranging; it occurs both horizontally across the technology life cycle:

• Economic development policy to stimulate new health technology innovation;
• Regulatory and clinical evaluation policy to ensure safety and efficacy;
• Social and economic policy to evaluate broader system impacts;
• Funding policy to determine fiscal viability;
• Operational policy to manage the ongoing use and ultimate decommissioning of a technology;

and vertically through the health systems' major stakeholders:

• Patient and providers;
• Facility and regional administrators, and
• Government policy-makers.

Traditional HTA focuses on providing evidence to support policy decisions to operationalize a technology. A wider spectrum of evidence is required commensurate with the true broad nature of policy development.

Also, policy development processes vary both across jurisdictions as well as across technologies. Québec's process for developing health technology policy is different from Ontario's. The processes for developing drug policies are different than those for PET (Positron Emission Tomography) scanners. Traditional HTA pulls together research evidence including clinical effectiveness, service improvements to patients, impact to providers, and economic impact. Unfortunately, the wide range of policy development processes means a "one size fits all" traditional HTA fails to fully meet the needs of many policy-makers. For those working in HTA circles, this is referred to as "the gap" between policy-makers and HTA researchers, namely the inability of HTA to provide a full contextual application of research to different health systems.

HTAs are only one starting point for policy development. The decision to fund and operationalize a technology on a wide-scale in a jurisdiction requires a more comprehensive analysis - a health technology policy analysis (HTPA) - that addresses all the policy questions.

New Approach to Evidence-based Decisions. HTS 1.0 proposes creating a Health Technology Policy Sharing Forum (Forum) as a mechanism for finding areas of common health technology policy interest, either bilaterally between jurisdictions or on a pan Canadian basis. HTS 1.0 further proposes creating a Health Technology Analysis Exchange (Exchange) to coordinate providing research evidence and policy advice (when requested) to specific decision points determined by the Forum.

Both the Forum and the Exchange span the full technology life cycle, from innovation to obsolescence. The various jurisdictional policy processes are depicted by the flow charts. The boxes are policy analysis activities, including evidence gathering and policy analysis. The diamonds are policy decision points. The Forum (blue) identifies the decision points of common interest. The Exchange (red) operates as a distributed network of content developers (e.g. AETMIS, CCOHTA, AHFMR) that provides evidence and analysis to the evidence gathering and policy analysis activities.

The Forum shares policy information, sets collaborative policy direction, where appropriate, and decides which elements of policy analysis the Exchange should do. The Exchange, therefore, does not decide what policy analysis should be done regarding a technology and only provides policy analysis on request.

Benefits to Jurisdictions. The major benefits to jurisdictions of this new approach are that:

• Jurisdictions do not need to change their existing policy processes;
• Jurisdictions will be aware of each other's policy priorities and timing thus preventing the "whipsawing effect" when one jurisdiction announces deployment of a technology to the surprise of the others;
• Jurisdictions will be able to share best practices in their policy development processes thus providing an educational opportunity for all jurisdictions to improve;
• Jurisdictions, large and small, can actively participate;
• Jurisdictions gate their participation in the Forum and Exchange based on their level of interest or perceived benefit.

HTS 1.0 also proposes a coordinated approach to manage Field Evaluations of new technologies. Field Evaluation studies are seen as a key mechanism to gather primary research data on a technology. Depending on the study, evidence can be gathered regarding such issues as clinical efficacy, determining appropriate use, understanding the operational impact on a facility or a region, or developing economic models for broader implementation.

No single jurisdiction has the evidence and policy development capacity to match all the technologies entering Canada's health systems. Therefore, all jurisdictions must work collaboratively to achieve what cannot be done alone.

Patients and Providers. Ultimately, all policy decisions must resonate with patients and providers in order to improve care. HTS 1.0 does not displace existing consultation mechanisms used by jurisdictions to communicate with these key stakeholders. HTS 1.0 does provide two additional mechanisms to enhance their participation in the HTPA decision process. First, the Exchange provides unprecedented transparency to the HTPA process. Second, because the Exchange will coordinate a national Field Evaluation system, feedback generated by patients and providers regarding their experiences in the Field Evaluations can be incorporated into the HTPA processes in all jurisdictions. This information sharing is made available to other patients and providers, health system administrators, and government policy makers.

Other Success Factors. For the Exchange and Forum to be effective, each jurisdiction will need corresponding structures to provide the necessary information to these new bodies, and to act on the results of their work. Each jurisdiction needs structures to:

• Support the work of its representatives on the Forum and the Exchange;
• Contextualize the products of health technology policy analysis to its environment; and
• Facilitate the uptake and utilization of health technology policy analysis within its health care system.

The implementation of HTS 1.0 must build upon exiting investments and structures and should not create unnecessary parallel structures.

HTS 1.0 is a massive change management challenge. In addition to national and provincial/territorial structures, two key processes are needed to ensure its successful implementation:

• Consultation and communication; and
• Partnerships with practitioners.

Processes are needed at the national and jurisdictional level to consult and communicate with the wide range of stakeholders that will be affected by HTS 1.0 and have influence over its implementation. A process of continuous dialogue between the stakeholders and decision makers is necessary to:

• Raise the level of awareness of health technology issues;
• Educate stakeholders in health technology policy analysis;
• Gather the necessary information for good decisions; and
• Secure their support for the ultimate decisions.

Summary of recommendations

National Health Technology Agency

1. That CCOHTA evolve beyond HTA to become the national health technology agency as described herein.

The Forum

1. That a Health Technology Policy Sharing Forum (Forum) be created for jurisdictions to identify areas of common policy interest, share information, and collaborate where beneficial.
2. That the Forum identify policy levers to manage the implementation, the appropriate use, and the decommissioning of health technologies.
3. That opportunities for health innovation be identified by the Forum to support the health technology innovation agenda.

The Exchange

1. That a Health Technology Analysis Exchange (Exchange) be created to coordinate the gathering of evidence and policy advice regarding health technologies to support the needs of jurisdictions and their stakeholders.
2. That the Exchange use an open, inclusive and flexible model that builds on current capacity and grows as the pan-Canadian capacity builds.
3. That evidence generated through the Exchange use methodologies that foster consistency.
4. That the Exchange liaise with granting and research organizations to support health technology innovation, evidence gathering, and policy needs and priorities.
5. That CCOHTA coordinate and support the Exchange.

Field Evaluation and Infostructure

1. That a coordinated Field Evaluation system be established to collect primary research data on new and experimental technologies where data needed for decision-making is insufficient.
2. That Canada's health information resources and infostructure be developed and leveraged to guide innovation, health quality, and diffusion of health technology.
3. That common health quality indicators be used to track the performance of Field Evaluations wherever possible.

National Health Technology Agency

A National Health Technology Agency. The Task Group recommends that CCOHTA evolve its role and mandate to become the National Health Technology Agency. An upcoming organizational review will assess what, if any changes need to be made to support this role.

As HTA is currently in the CCOHTA name, a name change is also suggested to reflect the move away from traditional HTA to a broader, yet more granular evidence and policy advice model.

The Forum

The Task Group concluded that better opportunities should exist for inter?jurisdictional policy sharing to allow opportunities for jurisdictions to voluntarily develop similar policies for appropriate technologies before policy decisions are made.

Health technology policy development occurs in many ways with many health system stakeholders. Providers and patients are the foundational stakeholders. Through Field Evaluations and other consultations, they provide valuable policy recommendations on the effectiveness and acceptability of new technologies. Facility and regional administrators provide valuable policy recommendations regarding the systemic impacts of a technology in a particular geography or setting. Governments develop macro-level health policy decisions.

The Forum must be attuned to and facilitate the integration of the needs of all of these stakeholders.

A policy-sharing forum will:

• Consist of government representatives;
• Provide a mechanism to share HTPA processes;
• Ensure that HTPA capacity is developed to meet areas of specific policy concern of the Conference of F/P/T Deputy Ministers of Health;
• Support coordinated, targeted innovation in health technology;
• Identify areas of common interest requiring evidence and policy analysis;
• Identify jurisdictions that will take the lead on developing evidence and policy analysis (with the results being published to all through the Exchange);
• Encourage granting and research organizations to support health technology innovation, assessment, and policy needs and priorities;
• Share best practices in the development of policies with respect to the adoption, management and replacement of health technologies; and
• Monitor the implementation of the HTS 1.0 and determine the need for changes.

Reengineering, Inappropriate Use, and Obsolescence. During the Task Group's consultations, feedback was received regarding the need for policy that relates to the implementation of technologies (organizational re engineering impacts), excessive or inappropriate use of some technologies, the need to effectively decommission displaced technologies, and the need to aggressively foster Canada's health technology innovation agenda. These issues would be focus areas for the Forum.

Innovation. HTS 1.0 recognizes that health technology policy has its genesis in health technology innovation policy. Necessity is the mother of innovation and innovation is a key stimulant to investment in the development of new technologies. Health technology has often been viewed as a pressure rather than an enabler to overcome system-wide deficiencies and improve patient outcomes. The health systems across Canada are warehouses of innovation and should be used as a platform for the development of homegrown health technologies.

The Forum is a mechanism to focus innovative development in those areas of concern to the health system. The Exchange described in the next section provides a mechanism to tap into this warehouse and extract innovations when they materialize.

Health Innovation Canada is a pre existing national effort to encourage innovations in health technology. This effort fosters the notion of Canada's responsibility as a steward of health technology. We will spend over a trillion dollars in the next decade on health care; a responsible steward would take action to ensure that national health technology assets are built rather than just expensed.

Health systems must embrace these opportunities to promote innovation to improve outcomes and the systems' efficiencies.

Forum Implementation. The Forum will require senior policy maker representation from each F/P/T jurisdiction and across the technology life cycle, from innovation through obsolescence. The Task Group has not identified an existing structure that covers this policy waterfront.

The Exchange

It is becoming increasingly obvious that HTA, which is an evidence-based analysis of efficacy/effectiveness and cost effectiveness, represents only a starting point for health technology policy analysis. For this reason, there needs to be a closer alignment between technology assessment and policy decision makers to perform a Health Technology Policy Analysis, or HTPA³. Ontario, Québec and Alberta have already developed HTPA models that align these two essential components that result in policy relevant evidence-based analyses.

In Ontario, a government appointed Health Technology Advisory Committee (OHTAC) prioritizes technologies to be assessed by the Medical Advisory Secretariat of the Ministry of Health and Long-Term Care. Based on a critical appraisal of the Medical Advisory Secretariat's technology assessment report and policy analysis, OHTAC advises the Ministry on the introduction and diffusion of the technology. In Québec, there is an alignment between the provincial HTA agency, Agence d'évaluation des technologies et des modes d'intervention en santé, or AETMIS and the Ministry of Health. A similar relationship has developed between the HTA agency in Alberta (the Alberta Heritage Foundation for Medical Research, or AHFMR) and the Ministry of Health and Wellness. These changes have produced a new dynamic and approach to policy-relevant evidence based decision making for new health technologies that could expand to include existing health technologies. This successful approach forms an important foundation on which to build this national health technology strategy.

Health Information Technology Exchange. Rapidly changing expectations for health technology analysis have resulted in some fragmentation as each province moves ahead at its own pace to bolster their response to new technologies. Key to this is the requirement that effective and cost-effective technologies are introduced to improve patient outcomes through equal access. HTS 1.0 makes recommendations to facilitate sharing of this new evidence and policy analysis through a collaborative and coordinated arrangement, the Health Technology Analysis Exchange (Exchange). The Exchange will also allow jurisdictions that have not developed similar strategies to share in the knowledge gained from these experiences.

Exchange Contributors. Exchange Contributors are organizations that supply content to the Exchange. Because this new model recognizes that policy advice development occurs across both a wide spectrum (innovation through obsolescence) and across multiple stakeholders (providers, administrators, government policy analysts), the Exchange will accept evidence and policy analysis from a larger input base than traditional HTA.

As a starting point, the Exchange Contributors should consist of representatives of the existing HTA organizations: CCOHTA, AETMIS, AHFMR, Health Canada, the Medical Advisory Secretariat of the Ontario Ministry of Health and Long-Term Care, as well as HTA researchers that were identified in some of the other jurisdictions.

The Task Group envisions the list of Exchange Contributors going well beyond these agencies to include more health technology research sources from all jurisdictions. Contributors could include academic research units in universities or private organizations doing health technology economics analyses or administrative organizations doing post market evaluations of operationalized technologies. Because HTS 1.0 puts emphasis on the creation of smaller, more discrete units of evidence and policy analysis, jurisdictions currently without HTA capacity can now participate in the Exchange without requiring the larger critical mass required to support the development of full-scale, traditional HTA products. Because a contributor could be as small as one researcher, through the Exchange, all jurisdictions can leverage their existing academic research capacity and join as Exchange Contributors. For example, a researcher assessing a telehealth technology implementation in Nunavut can publish her research findings to the Exchange along side the results of a wide-scale Field Evaluation of PET scanners from Ontario.

An open, inclusive and flexible model is recommended that builds on current capacity and grows as pan-Canadian capacity builds. The Exchange will be transparent and available to all jurisdictions, whether they have dedicated health technology units or not. It is not the objective of the Exchange to do all of the policy analysis but to coordinate and leverage all appropriate resources and share information across the country.

The Work of the Exchange. The Exchange will be the workhorse of the system, and will build on CCOHTA's existing business functions and capacity to coordinate activity, build analytical capacity, and support jurisdictions in conducting the health technology policy analysis required by decision-makers throughout the health systems. Specifically, it will build or build upon existing activities to:

• Support a systematic, collaborative approach to scan the technology horizon, identify the priority needs of the health systems, and provide information to the Forum to discuss which collaborative technology reviews need to be undertaken;
• Provide communication mechanisms to accept relevant evidence and policy analysis information from Exchange Contributors across the technology diffusion continuum (innovation through obsolescence);
• Support dissemination of health technology policy analysis results in formats appropriate for their target audiences;
• Support harmonization of health technology policy analysis methodologies and report preparation protocols;
• Support ongoing methodological development and a culture of continuous improvement;
• Provide, on request, health technology policy analysis on issues of jurisdictional and/or pan-Canadian interest;
• Coordinate a pan-Canadian Field Evaluation program;
• Assist jurisdictions to identify health technology human resource issues;
• Operate a national clearinghouse that collects and distributes information pertaining to assessments of technologies;
• Facilitate information exchanges between health technology policy analysis agencies (domestic and international), decision-makers and organizations that manage the innovation and research agendas across Canada; and
• On request, develops and supports education opportunities for decision-makers in the use of health technology policy analysis.

In addition to the process of health technology policy analysis described above, policy-makers need access to consulting services to provide advice on how to implement new technologies. These consulting services will be provided by or accessed through the Exchange. They will be contracted on a case-by-case basis and could provide collaborative support in situations where multiple jurisdictions are tackling similar technology questions.

Because of the broad mandate and the range of activities that the Exchange is being asked to undertake, it will need to be responsive to policy needs. To provide the Forum with horizon scanning information and advice on priorities, the Exchange will need to periodically consult and/or assemble representatives from all jurisdictions (e.g. Health Plan Medical Directors). Vehicles for jurisdictional consultation are also essential to ensure equitable participation by all jurisdictions, while not burdening those jurisdictions with limited resources.

The results of health technology policy analysis initiatives will be available to all jurisdictions. However, in order to remain flexible and responsive, it is expected that each technology assessment and field evaluation project may involve a different combination of jurisdictions depending on their interest, resources and the requirements of the work. These groups of agencies and jurisdictions will be constantly changing to suit the needs of the work and the resources available to do it.

The Exchange as a Network. This flexible model has many of the characteristics of a network. Exchange Contributors will use this network to the extent that they perceive benefit. Networks are a relatively new but increasingly utilized structure for bringing stakeholders together to achieve share information and gain efficiencies. According to some estimates, only 30% of networks survive, so attention needs to be given to the key success factors. The following elements of successful networks have been identified in research and should be incorporated into the models for the Forum and the Exchange:

• Network participation has to be voluntary;
• The governance and operations of the network must be transparent;
• The Network must be able to articulate a common vision and goal;
• Sufficient resources must be committed to support the network; and
• Time is needed to build trust and develop the relationships and processes to make the network effective.

The Current Role of CCOHTA. The Canadian Coordinating Office for Health Technology Assessment⁴ (CCOHTA) is an independent, not-for-profit organization funded by Canadian federal, provincial and territorial governments. CCOHTA's mission is to encourage the appropriate use of health technology by influencing decision makers through the collection, analysis, creation and dissemination of information concerning the effectiveness and cost of technology and its impact on health. As a pan-Canadian organization, CCOHTA facilitates information exchange, resource pooling and the coordination of priorities for health technology assessments. In September 2002, CCOHTA's mandate was expanded to include responsibility for the Common Drug Review (CDR). In April 2004, CCOHTA's mandate was further expanded to include responsibility for the Canadian Optimum Medication Prescribing and Utilization Service (COMPUS).

$45 Million Funding for HTA. The Parliament of Canada announced in the 2003-2004 federal budget that additional funding would be provided to CCOHTA:

"With the development of new diagnostic and treatment technologies, there is increasing need for reliable, evidence-based information to ensure that these technologies are used in clinically beneficial, cost-effective ways. This budget provides $45 million over the next five years to develop a Canadian Strategy for Technology Assessment. This funding will be provided to the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), a non-profit organization supported by federal-provincial-territorial Ministers of Health. CCOHTA encourages the appropriate use of health technology through the collection, analysis, creation and dissemination of information concerning the effectiveness and cost of technology and its impact on health."

- Federal Budget for 2003-2004

Field Evaluations and Infostructure

The Task Group considered the lack of sufficient evidence of effectiveness and cost-effectiveness for many new non-drug related health technologies. This has led to multi-million dollar multi-year investments in new technologies for which there is inadequate evidence on which to make these kinds of investments. For this reason, a recommendation is made to increase Canada's capacity for pan-Canadian Field Evaluations of new health technologies that look promising but for which there is inadequate evidence to justify large investments. These field evaluations could take the form of randomized controlled trials, observational or registry studies. The front-end investment for field evaluation could offset inappropriate larger investments downstream and sets a higher quality bar for the health systems across Canada.

Field Evaluations. Field evaluations are mechanisms for collecting primary research information on a new or experimental technology to test a technology's effectiveness within a real environment and where data is insufficient for fully informed, evidence-based, decision making. They can be used strategically to manage the diffusion of a technology into a health system. A field evaluation includes:

• A set of research questions;
• A defined time frame;
• A defined budget; and
• A defined population of patients.

Infostructure. The development of Canada's health infostructure will support health technology innovation, assessment and diffusion. In particular, the increased availability of encounter level and clinical outcome data (e.g. derived from electronic health record) will strengthen the health technology policy analysis products. As these systems develop, it is important to ensure that the data for technology assessment and policy is being captured and is available for analysis. Both the Forum and the Exchange have a role in this through their linkages and their own activities.

Information technology and information systems are frequently an integral element of some new health technologies. In some cases, the new technology itself incorporates information technology to achieve what it is designed to achieve. In other cases, information systems are needed to effectively manage the introduction or utilization of the new technology. In all cases, analysis of the infostructure elements and impacts must be part of a comprehensive health technology policy analysis.

Acronyms

ACIET

Advisory Committee on Information and Emerging Technologies

AETMIS

Agence d'évaluation des technologies et des modes d'intervention en santé (Québec)

AHFMR

Alberta Heritage Foundation for Medical Research (Alberta)

CCOHTA

Canadian Coordinating Office for Health Technology Assessment

CDM

Conference of F/P/T Deputy Ministers of Health

CDR

Common Drug Review

CIHI

Canadian Institute for Health Information

COMPUS

Canadian Optimum Medication Prescribing and Utilization Services

EHR

Electronic Health Record

FMM

First Ministers' Meeting

F/P/T

Federal/Provincial/Territorial

HTA

Health Technology Assessment

HTPA

Health Technology Policy Analysis

HTS 1.0

Health Technology Strategy 1.0 (this document)

PET

Positron Emission Tomography

References

¹ "Understanding Health Care Cost Drivers and Escalators" - Conference Board of Canada, Report March 2004.

² Health Technology includes any technology that may be used to promote health; prevent, diagnose, or treat disease; or aid in rehabilitation or long term care.

³ It must be emphasized that HTPA is a process, whereas HTA is a product. An HTPA process is specific to a jurisdiction. HTA products are generic advice applicable to all jurisdictions, worldwide.

⁴ As HTA is current in the CCOHTA name, a name change is also recommended to reflect the move away from traditional HTA to a broader, yet more granular evidence and policy advice model.