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New Public Governance in health care: Health Technology Assessment for Canadian pharmaceuticals.

Introduction

A vexing issue of contemporary governance is coordinating complex policy initiatives across fragmented jurisdictions (Peters 2015). Health care is an intricate policy area; and, of all the OECD states, Canada has the most decentralized and fragmented system (Requejo 2010). Thus, health care decision-makers in Canada cannot easily address key issues, including choices about high-cost technologies.

To address these difficulties, a discourse of New Public Governance (NPG) has emerged (Osborne 2010; Levi-Faur 2012). This approach focuses on coordinating policy not only vertically (from overarching centres of governance to geographically-specific points of service provision) but also horizontally (across geographic jurisdictions or policy areas). In this article, we argue that attempts to reform Canadian health care should consider NPG's strategy of horizontal linkages, specifically for pharmaceutical health technology assessment (HTA). We examine how strategic horizontal relationships have already evolved, why they developed, and the promises and limitations of these relationships.

We begin by introducing NPG and contrast it with current approaches to health care governance. Then we discuss fragmentation in Canadian health care. We explain why robust provincial pharmaceutical HTA capacity is required for efficient and equitable health care, and how provinces without this capacity are disadvantaged. We then examine how and why HTA for newly licensed medications developed through horizontal coordination, and evaluate the advantages and limitations of this system.

We conclude by identifying conditions under which horizontal governance in pharmaceutical HTA succeeded and where it failed, and suggest that they are generalizable. In summary, while there are likely limits to the application of NPG principles in health policy, there are many opportunities to apply these principles to HTA and health care generally.

New Public Governance and the challenge to New Public Management as an organizational model for health care

Soon after adopting public health insurance, provincial commissions were warning of an "approaching crisis" of increasing health services use, increasing salaries and wages of health care personnel, and absent evaluation standards and methods (for example, Nova Scotia 1972). New Public Management (NPM) became increasingly popular throughout the 1990s and strongly influenced regionalization reforms in most provinces (Fierlbeck 2011; Barker and Church 2017). NPM maintained a vertical relationship of accountability, with community health boards firmly controlled by regional health authorities, which reported in turn to provincial Departments of Health. Informed by business-oriented critiques of "big government," NPM used private sector tools to achieve effectiveness and efficiency in public bureaucracies. These included markets or quasimarkets, business plans, continuous monitoring of performance, contracting out, self-regulation, and responsiveness to consumers (Klijn 2012). NPM emphasized operational autonomy from government while affirming clear lines of accountability. In health care, this principle often took the form of regional health authorities responsible for supplying services within fixed budgets.

Yet, as Marchildon (2015: 236) observes, "regionalization has failed to achieve its original objectives." Private sector practices were often ill-suited to government operations (Savoie 1995; Aucoin 1995; Pollitt, van Thiel, and Homburg 2007). In response, NPG began to emerge as an analytical perspective which, like NPM, challenged the centrality of government in managing policy.

Unlike NPM, NPG asserted that collaboration, coordination, and integration were as important to policy as competition, and that partnerships with nongovernmental actors should include both private and public stakeholders connected through integrated networks. "Collaboration," or the process of actors working to a common end, is different from "coordination," where actors (who may not be working closely) search for efficiency. Integration fuses discrete entities into a single administratively-coherent body. These activities are complementary, while posing different challenges.

NPG governance attempts to sustain "co-ordination and coherence among a wide variety of actors with different purposes and objectives" (Pierre 2002: 3). NPG approaches emphasize "[putting] people back into governance by focusing on the ways in which governance is constructed differently by many actors working against the background of diverse traditions" (Rhodes 2012). NPG replaced the NPM's state hierarchy versus private markets dyad, and it identified informal policy networks as essential mechanisms of governance.

A policy network is "a horizontal articulation of interdependent, but operationally autonomous, actors from the public and/or private sector who interact ... through ongoing negotiations ... within a regulative, normative, cognitive, and imaginary framework; facilitate self-regulation in the shadow of hierarchy; and contribute to the production of public regulation in the broad sense of the term" (Torfing 2012: 101; see also Sorensen and Torfing 2007). Proponents argue that networks can address "wicked problems" where there is conflict about the problem itself, where specialized knowledge is required, and where stakeholders hold vested interests (Klijn and Koppenjan 2004). Therefore, in contrast to the NPM's top-down/bottom-up ("steering versus rowing") schematic, NPG emphasizes mutual interdependence among network participants.

Network actors are autonomous and self-regulating: "because their participation is voluntary and they are free to leave the network, they cannot be forced to think or act in a certain way" (Torfing 2012: 101). The concept of network governance evolved within the European tradition of corporatism and corporate pluralism (see, for example, Coleman 1988, chapter 4). However, as Osborne (2006: 382) observes, NPG is now "rooted firmly" in network theory, drawing from the work of Ouchi (1979) and Powell (1990). Thus, Ferlie and Andresani define the NPG (or simply "governance") paradigm as "centred on very different notions of inclusion of a range of different stakeholders in public management, a greater use of networks (rather than markets or hierarchies) and greater partnership between public, private, and civic actors rather than 'pure' government control" (2006: 391).

Normatively, NPG theories address the "collective problems associated with governance" (Peters 2012: 21), especially situations involving the mutual interdependence of autonomous jurisdictions, where solutions require negotiation (Torfing 2012: 101, 104). Governance becomes "softer" and decentralized and relies on recursive negotiation of goals and shared best practices, evaluation, and public accountability (Sabel and Zeitlin 2010). It is a participatory rather than representative form of governance; at times it champions technical expertise (Papadopoulis 2012).

However, the NPG critique of NPM was also functional. The functional critique was that many jurisdictions lacked both the policy capacity and flexibility to address the complex challenges in contemporary societies. Stakeholder networks can mobilize the expertise to solve difficult problems. As Klijn argues, states "have become more dependent on societal actors to achieve their goals because of the increasing complexity of the challenges they face ... It is only through collaborative action that societal policy problems can be resolved" (2008: 506).

Pharmaceutical HTA is an important test case for these competing organizational theories because the relevant knowledge is dispersed across a network of diverse actors who are not linked through either governmental office or a market. This fragments both knowledge and capacity for action. We next describe how such fragmentation has played out in Canadian health care.

Fragmentation in Canadian health care

Provincial health care governance is experiencing increasing stress. All health systems face challenges, but some have adapted better than others. In the Commonwealth Fund's 2017 survey, Canada scored ninth out of eleven comparator states, scoring badly on access to care and health outcomes. Although Canadians believe that their health care system is inclusive, Canada scored ninth on equity (Schneider et al. 2017). As the 2015 Report of the Advisory Panel on Healthcare Innovation (Naylor Report) warned, "absent federal action and investment, and absent political resolve ... Canadian healthcare systems are headed for a continued slow decline in performance relative to peers" (p. 4).

Part of the explanation for Canada's poor performance is that Canada's constitution devolves jurisdiction over health care to provinces more completely than any other federal state. The Canadian system is more decentralized than the functional federalism of Germany or Austria (Lang 2015; Matzke and Stoger 2015) or the "marble cake" federalism of Australian health care (Duckett 2015). Decentralization degrades Canadian performance because provinces have inadequate policy capacity (Denis 2015; Forest et al. 2015) and inadequate resources to provide timely access to health care. For example, Nova Scotia has consistently had the longest orthopedic surgical wait times of all provinces: only 56% of Nova Scotians are operated on within the wait time benchmark for hip replacements (compared to the national average of 79%) and 38% meet the benchmark for knee replacements (compared to 73%; CIHI 2017)).

For several years, the governance of Canadian provinces has been guided by NPM, with its promise of greater responsiveness and accountability. Provincial Ministries of Health sought to contain costs by setting clear budgets and defining performance measures. By allowing regional managers flexibility to provide services within fixed budgets, provincial health care systems would innovate and respond sensitively to local demand (the classic distinction between "steering" and "rowing"). Nonetheless, vertical regionalization within health care failed. Some jurisdictions, including Alberta, Nova Scotia, and Saskatchewan, reverted back to single health authorities. As Marchildon (2015) notes, this restructuring (like the regionalization that occurred before it) was undertaken with minimal evidence. And yet, the Canadian health care reform debate remains focused on regionalization/deregionalization within provinces, and Canadians continue to debate whether to disperse or consolidate authority along a vertical axis.

Applying NPG concepts at the provincial level is challenging, even though the problem that NPG proposes to solve is evident in provincial health care governance. Canadian line departments have "lost their place under the sun": departmental policy-making is ineffective because the challenges are too complex and too interwoven at the interdepartmental level (Savoie 2015: 210; Lahey and Fierlbeck 2016). The difficulties of addressing public policies across cognate line departments include risk avoidance, turf protection, and the dilution of accountability (Peters 2015). Instead of implementing networked governance, provincial governments typically tighten control in response to problems.

Similarly, relations between federal and provincial governments are rarely congenial, even though the federal government sporadically generates good will with the provinces by increasing funding. But starting in 1948 with the National Health Grants (and later with public health insurance legislation), Ottawa recognized that many provinces could not ensure their inhabitants received effective health care. Since the expiration of the 2003 and 2004 health accords, there have been two responses to the lack of capacity within provinces. Both positions recognize policy capacity in Canada "varies across jurisdictions," and that Canada needs "to build a shared knowledge-base and learn from it" (Advisory Panel on Healthcare Innovation 2015:10, 20).

The first (and dominant) position holds that Ottawa must rebuild Canada's public health care system (for example, Marchildon 2013). Moreover, "a recent public opinion survey conducted by The Strategic Counsel for Health Canada concluded that most Canadians still 'support the federal government taking a stronger leadership role in health care in a range of areas'" (ibid: 185). Proposals include strengthening the Canada Health Act (1985) and establishing "federal leadership" through bodies such as the Healthcare Innovation Agency. As the Naylor Report noted, this agency would "seek to advance the twin goals of removing structural barriers to innovation in Canadian healthcare, and supporting spread and scale-up of proven models and modalities of care" (p. 34). Naylor and his colleagues see Canadian health care being driven by "an overarching vision" (p. 17) led by Ottawa.

The second position is that the provinces must lead the process because they are the governments responsible for financing care. The federal government should collaborate with and facilitate coordination between provinces, but not lead the process. Healthcare CAN (an umbrella body of healthcare organizations), for example, called for a Canadian Health Innovation Network "to allow for coordination across existing priorities and resources in the health and life sciences" (2014: 3). Other organizations involve stakeholders from jurisdictions across the country. Such organizations include the Canadian Institute for Health Information (CIHI) and the Strategy for Patient-Oriented Research (SPOR) network, which are research networks; as well as the Canadian Agency for Drugs and Technologies (CADTH), the Drug Safety and Effectiveness Network (DSEN), the Canadian Partnership Against Cancer (CPAC), Canada Blood Services, and the new Canadian Immunization Research Network (CIRN). This second approach fits the NPG rubric. It depends upon a voluntary "bottom-up" engagement by participants; its objective is a continual iterative process rather than a static institutional endpoint; and it seeks flexibility for those choosing to participate. Nonetheless, the debate about how to develop Canadian health care capacity has only been programmatic, where it has occurred at all. There has been little attempt to theorize these horizontal relationships or understand how and when they work.

In summary, many Canadian jurisdictions lack the financial and policy capacity to nurture high-performing health systems. HTA is a case study for evaluating the utility of NPG theories. HTA provides an evidence-based framework to make health care technology choices. An NPG approach to the collaborative development of national HTA capacity capitalizes upon pan-Canadian expertise, while permitting flexibility and responsiveness within individual jurisdictions. In the next section we investigate how HTA has evolved from a governance point of view.

Pharmaceutical HTA in Canada

HTA "[informs] health policy decision-making through provision of analyses of efficacy, safety, costs, ethics, and legal issues, related to the acquisition and use of health technologies" (McGregor and Brophy 2005: 263). Because modern health care deploys complex and expensive technologies, a sophisticated and robust HTA framework is essential for effective and sustainable health care. According to the World Health Organization (http://www.who.int/medical_devices/assessment/en/ accessed November 9, 2017), HTA is the systematic evaluation of properties, effects, and impacts of health technology. The main purposes of HTA are to generate evidence and to inform policy- and decision-making. As such, HTA requires a multidisciplinary approach that incorporates economic, social, organizational, and ethical issues alongside unbiased evaluation of the effects of a health technology, intervention, or process of care. A high-quality HTA process includes a systematic evidence review, epidemiologic analyses, economic evaluation, and a structured dissemination. It may also include an assessment of ethical and societal implications.

Formal pharmaceutical FITA in Canada began in the 1980s, when several provincial agencies such as the British Columbia Office of Health Technology Assessment published advisory reports. Several health authorities also developed HTA units (McGregor and Brophy 2005). Before 2003, various provinces had review processes that were perceived to be "financially draining and [wasting] resources by repeating review processes" (Spitz 2013). In the early 1990s, the Federal/Provincial/Territorial governments established the Canadian Coordinating Office of Health Technology Assessment (CCOHTA) (Sanders 2002). In 2006, CCOHTA became the Canadian Agency for Drugs and Technology in Health (CADTH). Provinces (excepting Quebec) jointly established the Common Drug Review (CDR) under CADTH's auspices to evaluate the comparative clinical effectiveness and cost-effectiveness of newly approved outpatient medications.

Before 2003, prescription drug coverage varied widely across Canada (Anis, Guh, and Wang 2001). CADTH's recommendations help inform provinces and territories about the value of outpatient medications and help guide public insurers' formularies reimbursement decisions. In 2010, a pan-Canadian Oncology Drug Review (pCODR) was established and, in 2011, the Canadian Institutes for Health Research and Health Canada established the Drug Safety and Effectiveness Network (DSEN), including the Canadian Network for Observational Drug Effect Studies (CNODES), to facilitate ex-post drug safety analyses (Suissa et al. 2012). CADTH's Common Drug Review (CDR) recommendations are not always followed (Allen et al. 2016) because there are other factors that affect the formulary, such as local needs or values. It is important to note that HTA is conducted at the pan-Canadian level separately for medical technologies and for medications and that most of the CDR recommendations concern out-patient medications.

CDR and pCODR have similar review processes: the manufacturer submits a dossier which is assigned to clinical and pharmacoeconomic reviewers from CADTH. They evaluate the product on cost, clinical outcomes, quality of life, and therapeutic advantages over other available products. The manufacturer can respond to the review. Then it is presented to the Canadian Expert Drug Advisory Committee (CEDAC) or pCODR Expert Advisory Committee (pERC), the advisory groups for the CDR and pCODR, respectively. Then the CDR provides a national recommendation. Manufacturers can challenge negative recommendations. Provinces and territories make drug reimbursement decisions for their formularies. Recent drug listing decisions show moderate to substantial agreement with CEDAC recommendations (Allen et al. 2016).

But high-quality HTA is beyond the capacity of many Canadian provinces. Compared to most other federal systems, Canadian HTA bodies make independent decisions (although in Spain, as in Canada, HTA organizations are decentralized within the country's autonomous regions). Most (but not all) provinces have some HTA capacity, although it varies substantially. Some provinces have bodies that are mandated to do HTA; others do some HTA in addition to other functions. Most HTA agencies are provincial, although some have emerged to service health authorities or large university-affiliated hospitals (Gagnon 2014). Martin et al. (2016) review local HTA initiatives across Canada.

Useful insights into the policy problems highlighted by NPG can be gleaned by considering the HTA process for new medications dispensed in Canada. There are at least two reasons why medications can undergo greater HTA scrutiny: 1) medications account for 15% to 20% of health care spending; and 2) the evidence base for new medications is typically more robust than for other technologies. The potential gains through the coordination of information, the standardization of processes, and better communication between experts often outweigh the protection of provinces' autonomy over the evaluation of drugs, devices, and processes. Nevertheless, there is substantial fragmentation of Canadian HTA processes for new medications.

Evidence of this fragmentation can be seen in the variation among Canadian formularies (Gamble et al. 2011). Responsibilities for regulating, pricing, evaluating, and reimbursing medications are distributed between the federal and provincial/territorial governments. Regulation and pricing are primarily federal responsibilities, but reimbursement on publicly-paid drug formularies is largely a provincial/territorial responsibility (either provincially for outpatient medications or in hospitals for inpatient medications). Economic evaluation is shared between levels of government. The federal government is responsible for regulating medications through Health Canada. The Patented Medicines Prices Review Board, a federal body answerable to the Minister of Health, sets maximum prices for brand-names drugs (Zhang, Martin, and Naylor 2017). For Canadians who meet provincial eligibility standards, medications dispensed from community pharmacies are covered by the 13 provincial/territorial and four federal public Pharmacare programs. Over half of medications are reimbursed under private insurance plans or purchased out-of-pocket directly by consumers. Other special interest groups can also influence reimbursement for medications. Martin et al. (2016: 179) argue that as HTA becomes more important, "more could be achieved through effective collaboration or networking to combine efforts and experiences across the nation. A more effective approach to share local HTA information and avoid wasteful duplication of effort and to provide this information to decision makers is necessary."

Coordination of Pharmaceutical HTA

In response to these problems, Canada has been able to establish a voluntary, partially cooperative system for coordinating and streamlining HTA. Purchasing decisions for new technologies in Canada are highly decentralized to physicians. To coordinate HTA across Canada, the Federal, Provincial, and Territorial Ministers of Health established the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) in 1989. At that time, Ottawa contributed 20% of the costs, while the provinces supplied the rest on a per capita basis. Thus Ontario, which already had more HTA capacity than most other provinces, contributed 32% of the budget (McDaid 2003: 209). Quebec negotiated a reduced per capita contribution and the smaller provinces, with the most to gain, paid the least (ibid.). Thus some provinces got better deals to join, and this flexibility facilitated national participation.

Throughout, the effort "to quantify impact and the resulting cost saving was an important contributing factor in increased funding" (McDaid 2003: 212). Throughout the 1990s and 2000s, provinces were attuned to the need "to manage the stresses created by the ever increasing availability of expensive new technologies (procedures, drugs, devices) in the context of relatively fixed resources" (McGregor and Brophy 2005: 264). Economic incentives also promoted further intergovernmental cooperation, this time on the pricing of pharmaceuticals. A survey of five provincial HTA organizations between 2001 and 2007 showed that only 19% of HTA reports included a full economic evaluation (Tarride et al. 2008). Therefore these provinces did not have a strong basis for purchasing cost-effective drugs. This decentralized provision of pharmaceuticals resulted in "whipsawing," a beggar-thy-neighbour practice in which drug makers played jurisdictions off against each other. Smaller provinces were often disadvantaged by the process. Provinces with large markets got better prices while smaller jurisdictions were pressured to pay the list price (Husereau and Cameron 2011).

Thus, the smaller and poorer provinces stood to gain more from HTA, but in a Catch-22, these provinces were the least able to afford HTA capacity. As Husereau and Cameron (2011) explain, HTA-based price negotiation requires "significant intellectual capital in the form of highly trained and experienced policy scientists with discipline-specific training in clinical epidemiology, health services research, information science, health informatics, political science, ethics and health economics, as well as structures required to support them" (p. 25). But many provinces cannot afford this technical infrastructure. Hence these pricing strategies threatened to increase the disparity between provinces in the prices paid for drugs. As pharmaceutical expenditures increased, the lack of interaction between regulators, payers, and HTA bodies was seen as a source of "health system inefficiencies" by all parties (Tsoi et al. 2015: 78).

This has led to new methods of acquiring medications in Canada that link HTA to purchasing decisions. National collaboration on pharmaceutical pricing has been difficult to achieve. Although the Harper administration was uninterested in health care policy, provincial HTA coordination was facilitated politically by provinces' determination to establish greater ties. Under the Council of the Federation, the provinces discussed collective health policies, one outcome being the establishment of the Pan-Canadian Pricing Alliance (pCPA) in 2010. The goals of the pCPA are lower drug costs and consistent pricing across provinces, increased drug treatment options, and more consistent drug coverage across Canada (Miiliken et al. 2015). Within a year, the pCPA had negotiated ten contracts, with 17 negotiations in progress (Husereau et al. 2014: 889). However, this activity has focused exclusively on pharmaceutical products. Non-drug technology (such as medical devices) poses additional challenges to cooperation. As Menon (2015: E20) writes, "the question remains whether a more centralized approach to evidence review of new nondrug technologies is needed, or even desired."

By 2015, the pCPA had negotiated 74 agreements on brand-name drug purchasing and 14 agreements on generic drugs, generating $490 million annual savings (Council of the Federation n.d.). A permanent office (renamed the pan-Canadian Pharmaceutical Alliance) was established in Ontario with dedicated staff. Quebec joined in October 2015 and the federal government in February 2016. This buy-in from Quebec and Ottawa reflected the effectiveness of this horizontal process, in which the pCPA incorporated cross-national HTA into voluntary national purchasing. By May 2016, this relationship was institutionalized when CADTH agreed to include the pCPA office in the CDR and pCODR processes.

How effective has a national HTA framework been in achieving its goals?

On many counts, Canada's HTA processes have succeeded. They have been cited as an international leader in HTA (McDaid 2003; Hailey 2007; Battista et al. 2009). Some duplication across jurisdictions has been eliminated (Lehoux et al. 2004). While earlier criticisms of the drug review process identified the need to improve economic evaluations (Tarride et al. 2008), Canada's HTA framework has increasingly focused on value for money. While the CDR and pCODR cannot negotiate directly with pharmaceutical companies to obtain competitive pricing (as in Australia), HTA data are used increasingly in national price negotiations (Morgan et al. 2013). The institutionalization of national HTA was solidified in 2016 by the inclusion of the pCPA in CDR and pCODR reviews, allowing the pCPA to access confidential information on drugs reviewed therein. The framework has balanced national and regional approaches (Hailey 2007) and the coordination of HTA in Canada has "substantially increasefd] awareness of HTA in Canada, both in policy-making and within medical communities" (McDaid 2003: 207). Finally, the coordination of HTA in Canada has advanced the standardization of national methodologies and guidelines so that results can be compared more effectively (McDaid 2003; Menon and Stafinski 2009).

Nevertheless, there are limitations in Canada's HTA framework. First, there are structural deficiencies in how HTA information is generated and used. For example, while the pCODR process focuses on both in-hospital and community-based cancer medications, CDR recommendations apply primarily to medications dispensed in the community setting (McDonald et al. 2015). Thus, the CDR does not affect hospital costs. Moreover, HTA addresses only therapeutic products that are newly introduced to the market rather than those already in use. While not precluded, there is no HTA process to review products already in use.

There are also notable tensions within the HTA framework. Canada's decentralized HTA institutions exemplify the conditions identified by advocates of NPG. Fragmented decision-making can produce high costs and inefficient outcomes. Canada has partially mitigated these risks through a voluntary and flexible system of communication and coordination. However, managing tensions does not mean eliminating them. There remains a conflict between the desire for greater standardization across jurisdictions and responsiveness to local needs.

But actual policies must reflect local conditions. For example, decisions about the medications available for cancers may depend on the number of patients and the budget impact. Similarly, McDaid (2003) has described the "conflicts of interest between national and provincial agendas, and disagreements on the level of funding" in the early development of CCOHTA (p. 208). These disputes have become less visible because of the infusion of capital given to CADTH, following recommendations from the Romanow Committee and the Senate Standing Committee on Social Affairs, Science, and Technology (Menon 2015). One can achieve harmony between actors with competing interests, but it is expensive.

There are deeper criticisms of Canada's HTA framework. Provincial and federal governments have worked to reduce duplication of HTA processes. Because Canada spends more per capita on pharmaceuticals "than any comparable country with a universal healthcare system" (Morgan et al. 2016), the motivation for governments to cooperate is high. Nevertheless, HTA is a blunt tool for cost containment. As Sackett et al. (1996) have explained, evidence can also lead physicians to use more expensive yet more cost-effective treatments, leading to a justified increase in treatment costs.

Moreover, HTA could be more frequently used to improve equity of access (Cookson and Maynard 2000). All Canadian provinces are committed to equity, hence they should evaluate whether health care resources are being equitably deployed. In cases in which an economic evaluation shows that a treatment is saving costs or is cost-effective, reimbursement is not questioned. However, at the margins of benefits and costs, equity considerations increase in importance because the opportunity costs become higher. High-quality HTA is critical here. However, governments are often less than enthusiastic in discussing whether marginally effective therapies should be approved, because these discussions can lead to controversies about rationing.

HTA should also be used to impose accountability upon decisionmakers. Archie Cochrane's observation that "allocations of funds and facilities are nearly always based on the opinions of senior consultants" (1972: 5) still rings true, especially where smaller jurisdictions lack policy capacity to challenge powerful clinicians. "Without appropriate HTA processes in place," state Martin et al., "decisions may be driven more by political motivation than by an objective assessment" (2016: 177). For example, a group of cardiologists may convince a Ministry of Health to procure left ventricular assist devices (LVADs). The benefits of expensive technologies ought to be weighed against alternative uses (for example, spending on mental health). The problem is not with the technologies per se, but rather that there is little public accountability for health care spending, and no transparency about the values that guide resource allocation. An HTA framework which examined the tradeoffs between expensive technologies and other health services (one LVAD is worth how many mental health beds?) would facilitate greater accountability. Yet most governments resist transparency. CEDAC meetings, for example, are confidential and issue only summary recommendations. This opacity seems unnecessary, because any trade secrets can be redacted. Likewise, a 2011 study found that eight provinces examined provided no public criteria explaining how decisions were made about formularies, "whether because true criteria do not exist, or because they are secret" (Attaran, Cartagena, and Taylor 2011: 6).

Finally, patient involvement in HTA processes has been limited (Hoch et al. 2014). While there has been a concern that patient participation may bias deliberations (Menon 2015), engaging users strengthens, validates, and legitimizes technology evaluation. Specifically, it "improves the likelihood that they will assist with knowledge transfer, uptake and implementation of the recommendations" (Martin et al. 2016: 177) and, done well, it promotes trust by end-users (Rocchi, Chabot, and Glennie 2015: 291). CADTH now routinely solicits feedback from patients through "e-alerts" (Berglas et al. 2016).

How does NPG help explain the success of Canadian HTA?

HTA processes in Canada have produced efficiency gains in the assessment, greater transparency and equity, and greater efficiency for medications and device use. This was largely achieved by provincial and federal governments working collaboratively to develop a national HTA framework. These processes of horizontal collaboration are recommended by NPG. The HTA example indicates that NPG approaches work particularly well in the following circumstances:

1. Engagement is discretionary/, and the terms of participation are flexible. Engagement can be difficult if the parties worry that they may lose their autonomy, particularly when jurisdictions vary widely in policy and financial capacity. Smaller entities may worry that participation may oblige them to commit scarce resources. Larger participants may already have capacity and might wish to reserve the ability to pursue their own directions. Similarly, flexibility is important when local and regional needs vary.

2. Participants perceive clear, immediate, and tangible gains from cooperation. Canada has pursued HTA to save costs. HTA has justified its cost by reducing duplication of research and informing bargaining over pharmaceuticals. Moreover, an integrated HTA strategy can contain political demands for marginally beneficial but expensive technologies. Unfortunately, discussions of NPG sometimes conflate the strategic and normative goals of NPG strategies. A process focused on cost savings may not necessarily generate greater accountability, transparency, or public engagement.

3. There already is already a foundation for cooperation. Common values and interests may be insufficient to build strong horizontal relationships. A gradual development of collaborative institutional capacity, established protocols, trust, and growth of social capital may also be needed. CADTH, for example, evolved out of CCOHTA; while the pCODR benefited from the early experiences of the CDR in evaluating oncological therapies (Rocchi, Chabot and Glennie 2015). Conversely, it is hard to begin collaborating de novo even if the parties perceive it to be in their interests. Likewise, toxic relationships cannot be scaled up.

4. There is adequate funding. While collaboration "works well on a voluntary basis, when different parties share similar values, interests, and methods" (Lehoux et al. 2004: 335), collaborative enterprises also fall prey to disputes over resources. Money cannot dissipate all friction, but it helps in two ways. First, it can turn a perceived zero-sum relationship into a positive-sum one: While a party might benefit less than others, it may nevertheless participate if it benefits in absolute terms. Second, funding that supports a stable hub will facilitate project administration and shield participants from those administrative costs. Moreover, without a permanent secretariat, collaborative ventures depend on a "lead" government driving a project forward and maintaining it, making the collaboration vulnerable to changes in that government's priorities. Mutual cooperation works best when it is institutionalized and well-funded. When collaborations among jurisdictions have been denied adequate administrative capacities because they were assumed to be "self-organizing," they have functioned poorly (Schout, Jordan and Twena 2010).

Conclusion

This study investigated how well, and under what circumstances, NPG strategies work in HTA. The NPG paradigm challenged the vertical topdown/bottom-up thinking of both command-and-control models and systems based upon NPM. NPG holds that vertical accountability can and should be superseded by more collaborative, horizontal linkages between ecosystem stakeholders. NPG strategies are directly applicable to Canadian HTA: participation is voluntary, minimal rules define the price of membership in the system, and participants choose how extensively to utilize the process.

We examined HTA in pharmaceuticals, a health care domain in which NPG concepts apply well in terms of both the problematic and the operationalization. Against those who hold that collaborative systems across jurisdictions are unworkable, we found that Canada's HTA framework delivered real benefits. And against those who maintain that collaborative systems can deepen into a more democratic and accountable form of governance, we have found that the HTA model has worked best when clear technical or economic advantages were attainable, but that it has not yet delivered much inclusion or transparency.

Public policy is beset by growing complexity, a blurring of jurisdictions, greater reliance upon technical knowledge, speedier change, demands for wider engagement by citizens and end users, and expectations for greater accountability. Complex policies require policy and fiscal capacities that many provinces do not enjoy. These deficits are keenly experienced in health care. There has been limited discussion of governance systems to meet these challenges. NPG theory, at its heart, argues that difficult governance challenges can be addressed through strategies that emphasize discretionary, flexible participation horizontally across autonomous jurisdictions.

This approach has been criticized as naively optimistic by rational-choice theorists, who assume an unwillingness to cooperate under any but the most advantageous circumstances. We found that, contrary to skeptics, NPG-style governance has contributed to the development and integration of Canadian HTA. At the provincial level, the theoretical approach to health care governance has been largely limited to how health services and planning should be regionalized or centralized. Nationally, the debate has focused on whether the federal government should lead more in health care, or whether provinces ought to retain control of health care.

Despite the limitations of the applicability of the NPG model, there is room for greater application of its principles of collaborative and cooperative governance both in health care generally, and in HTA specifically. For example, HTA could usefully develop into a more recursive system, in which HTA users react to assessments and negotiate solutions (Lehoux, Battista, and Lance 2000). It could address the tension between generalizable results and local relevance by more closely connecting central and peripheral agencies (McGregor and Brophy 2005). It could reach out to grass roots care providers rather than simply serving governmental policymakers (McDaid 2003). And it could move toward a system of postmarket drug evaluation by coordinating stakeholders to more efficiently collect data, establish core data sets, apply common definitions, combine data sources, and embed research data into routine clinical work and patients' lives (Shuren and Califf 2016).

Many other health care issues could benefit through HTA institutions, including the evaluation of therapeutic effectiveness, health equity, and the efficiency of service delivery, regulation, and policy. Whether provincial governments are willing to open discussion on these difficult issues is uncertain, but the horizontal HTA institutions that have been established give Canada a forum for addressing them.

Many NPG concepts only work some of the time, and only in specific situations. Nevertheless, the instances where these principles are helpful make it worthwhile to think about applying NPG ideas more deeply and broadly. An understanding of the conceptual promise of NPG, along with a solid empirical evidence base documenting its utility, may be a fruitful start to rethinking health care governance in Canada.

Katherine Fierlbeck is Professor of Political Science and Community Health and Epidemiology, Dalhousie University. William Gardner is the Children's Hospital of Eastern Ontario Senior Research Chair in Child and Adolescent Psychiatry and Professor of Epidemiology and Public Health, University of Ottawa. Adrian Levy is Professor of Community Health and Epidemiology, Dalhousie University.

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Author:Fierlbeck, Catherine; Gardner, William; Levy, Adrian
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Date:Mar 1, 2018
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