NUS INITIATIVE TO. Engaging Stakeholders in Health Technology Assessment for Health Policy. 1 2 July 2013

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1 Engaging Stakeholders in Health Technology Assessment for Health Policy 1 2 July 2013 The Gallery Room, Level 2, Traders Hotel, Singapore NUS INITIATIVE TO IMPROVE HEALTH IN ASIA Better healthcare in Asia through improved research, governance and sustainable financing NUS INITIATIVE TO IMPROVE HEALTH IN ASIA Better healthcare in Asia through improved research, governance and sustainable financing

2 Engaging Stakeholders in Health Technology Assessment for Health Policy

3 2 3 EXECUTIVE SUMMARY Globally, Health Technology Assessment (HTA) is increasingly conducted and used by both the public and private sector in a range of processes that guide policy making such as: regulation, licensing or guidance related to the use of specific health technologies listing decisions for formularies and prioritization of drugs and services for benefits packages determination of value-based prices for contract negotiations and purchasing Such processes affect multiple parties, including the government, industry, providers, patients and members of the public. How best to channel this diverse set of voices into a constructive and transformative dialogue that advances technology-related healthpolicy-making is a challenge that faces HTA practitioners in not just Asia but the world over. The quality, effectiveness and efficiency of HTA can be enhanced by open and consultative processes. Decision makers around the world are adopting a range of measures to constructively engage multiple stakeholders throughout the HTA process. A few key strategies include: ensuring that stakeholder groups are properly represented enabling a flow of input from all groups putting into place formal criteria and process for the lodging and review of appeals communicating HTA evidence and research appropriately across diverse audiences In Asia, a diverse set of health systems and social, political and cultural backgrounds have led to a range of HTA models in different stages of development, and similarly varying scope and practices of stakeholder engagement. Effective engagement can be challenging for a number of reasons, including: INTRODUCTION Health systems in Asia and the rest of the world are under pressure. The double burden of chronic and infectious disease among aging populations coupled with rising user expectations and promises for universal coverage have led to growing fiscal demands on strained public-sector resources. At the same time, rapid technological innovation and an expanding global marketplace for health technology bring new promise as well as untried risks, leading to new interest in evidence-based decision making for resource allocation and strategic planning from policy makers as well as other non-governmental stakeholders. Formal health technology assessment (HTA) is increasingly conducted and used by both the public and private sector, including national and sub-national government bodies but also academic, nonprofit and private research organisations and increasingly, by various players in the healthcare industry, from hospitals introducing new technologies into their facilities to drug companies seeking to market new products and members of the public advocating for their best interests as patients and consumers. The region now faces the challenge of how best to channel this diverse and increasingly active set of voices into a constructive and transformative dialogue that advances technology-related health policy-making. In this white paper, we highlight emerging issues related to stakeholder engagement in HTA processes that guide health policy making, which covers a range of needs such as: regulation, licensing or guidance related to the use of specific technologies listing decisions for formularies and prioritization of drugs and services for benefits packages determination of value-based prices for contract negotiations and purchasing We discuss the background to these issues relevant to the Asia Pacific, drawing on a growing array of regional experiences with building and integrating this capacity into healthcare systems. the cost of time and resources the challenge of balancing conflicts of interest the need for stakeholder education the potential risk of public controversy Meeting these and other challenges to engagement in this context involves bringing together: a strong commitment to clear and transparent processes investment of resources to ensure sound implementation recognition of the need for flexibility and adaptability Strategically investing in appropriate health technologies can improve both health and the quality of life. It is important to appreciate fully the role of the different actors that are involved in this process and provide them with due consideration in HTA processes. This year s NIHA Forum aims to provide a platform to build regional networks and begin a dialogue about key issues in HTA such as stakeholder engagement, to ensure that technological development continues to support population health in Asia, now and in the future.

4 4 5 THE ROLE OF STAKEHOLDERS IN HTA The field [of HTA] is large, diverse, competitive, and highly innovative. This is an area of great promise It is also an area with a number of problems and pitfalls, some familiar, others unique. As many have noted, the field requires, and deserves, its own unique agenda. Health officials and hospital managers in all countries, at all levels of development, need guidance. The World Health Organization defines health technology assessment as the systematic evaluation of properties, effects, and/or impacts of health technology [1], where technology is broadly defined as the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life. Health technologies therefore are not limited to pharmaceuticals, diagnostic technologies and medical equipment but also include therapeutic and preventive care procedures, interventions such as health promotion and workplace health and safety programmes and organisational or support platforms such as electronic medical record keeping. Rather than any one technical approach, HTA is most often characterized by (a) a decision-making focus (b) sensitivity to a particular setting and (c) the use of a rigorous and sound methodology. HTA generally calls for a clearly-articulated decision model aimed at a particular problem, which is then analysed by integrating technical evidence of clinical performance such as efficacy and efficiency studies with context-specific situational analyses, using non-scientific or colloquial evidence such as expert opinion to adapt the findings and resolve gaps or inconsistencies. The specific objectives and methods used vary from horizon scanning to safety and effectiveness assessments economic evaluation - whether cost-benefit analysis, cost-efficiency analysis, cost-minimization analysis, or budget impact analysis and beyond. The HTA process often follows a typical path: topic selection and prioritization, followed by a determination of the appropriate analytic criteria and benchmarks and/or comparators, evidence gathering, Dr Margaret Chan, WHO Director-General evaluation and weighting of the evidence according to the decision criteria, the drawing of conclusions, making recommendations and finally a process of review, dissemination, implementation, all three (sometimes but not always) preceded by an appeal stage. The outcome of any HTA process that guides public policy affects multiple parties with different interests, including the government, industry, providers, patients and members of the public. These stakeholders have very different immediate objectives and longterm goals, resources and operational capacities. For instance, when prioritizing certain procedures FIGURE 1: HTA STAKEHOLDER GROUPS Venture capital groups and other investors Technology manufacturers Government and private sector policy and biomedical research agencies, academic health centres Government and private sector payers Patient and consumer organisations Regulatory agencies and standards setting organisations Hospitals and health care networks, health professional organisations for coverage under a national insurance fund, a local health body may heavily weight the potential for improvements relative to highly-local conditions related to quality of care, whereas a national HTA agency may take a broader social perspective. On the other hand, product development and innovation at pharmaceutical companies or medical technology companies may be driven by access to markets and competitive forces on a global level. In the absence of engagement mechanisms, such groups may pursue their own interests independently or myopically, leading to inefficient policymaking and potentially ineffective policies. The quality, efficiency and effectiveness of HTA can all be enhanced by open and consultative processes. HTA strives for a delicate balance, in that the results need to meet high research standards, but also need to fulfill standards of acceptability, fairness and feasibility of implementation. To accomplish this, HTA needs to be interdisciplinary (in that it covers the clinical, social, economic, legal and ethical implications of the health technology), deliberative [2] (in that it that implies the collection and synthesis of evidence of different kinds and from different sources) and pragmatic (in that objectives, approaches and utilisation are driven by realistic and practical considerations). These features of HTA point to several ways in which inclusive engagement can make results stronger, including [3]: Providing opportunities and incentives for overall quality control and identifying mistakes Broadening the evidence base by allowing novel sources of relevant technical and contextual information to be brought forward (especially information that may be out of the public domain) Ensuring that differing perspectives are fairly and effectively represented by providing a structured platform for exchange [4] Reducing the likelihood of bias and capture by vested interest groups, leading to more balanced recommendations Improving the standard of decision making, by enhancing transparency and accountability Informing guidance with a view to the feasibility and ease of actual implementation Framing the tenor of the underlying relationships among stakeholders as collaborative rather than antagonistic Raising awareness about short and long-term constraints and tradeoffs, as well about multiple stakeholder perspectives Legitimizing final outcomes, especially when decisions are difficult or controversial, increasing the potential for the results to be widely accepted and applied Enhancing the scope of post-decision surveillance and monitoring Building broad-based trust and support for HTA among wider networks, as well as for the resources needed for high-quality HTA capacity. [5] Unless healthcare leaders understand what constitutes good value in healthcare, they will be unable to make efficient cost-cutting decisions, or promote the most effective medicines and health interventions. If health reforms are to be successful, society needs to define what value it wants from the investments made in healthcare. Thus far, value has been defined at a national level by policymakers, functioning without much grassroots involvement. Can the situation change? What is value in healthcare? Engage 2012 London

5 6 7 BUILDING POSITIVE STAKEHOLDER ENGAGEMENT the information they are looking for It is critical to engage stakeholders at the earliest stage in the HTA process. It is very important to understand early on in the evidence generation process Healthcare decision makers around the world are adopting measures to constructively engage stakeholders throughout the HTA process [6]. While different models of HTA have been adopted across countries, there are many common strategies for bringing in key organisations, interest groups, or the broader public - from the initial topic selection, to research contributions, participation in deliberations and finally implementation and review - that have emerged. A widely-known example of a single national agency is the United Kingdom, where the National Institute for Health and Care Excellence (NICE) provides guidance on which technologies should be available on the National Health Service of England and Wales based on whether they provide value for money. In Australia [7], on the other hand, the HTA system is complex and has many interrelationships. Although there is a single HTA Access Point, HTA for reimbursement and surveillance is carried out by multiple bodies including the Medical Services Advisory Committee (MSAC), which provides advice on funding decisions under the national Medicare Scheme as well as the Pharmaceutical Benefits Scheme, and by the Pharmaceutical Benefits Advisory Committee (PBAC) for pharmaceutical products. The Therapeutic Products Authority (TPA) is the country s regulator, and state and local governments may also have their own local systems for providers. Both these cases, despite their differences - offer examples of strategies to build stakeholder engagement, such as the following: Ensuring stakeholder group representation on advisory boards and steering and decision making committees. > In the UK stakeholders are consulted and involved throughout the entire NICE process, [1] Personal Communication, Dr. Amanda Adler, Chair of the NICE Technology Appraisal Committee, UK Multinational Private Sector Company, Asia Pacific and are actively recruited [8] into advisory committees [9]. This includes the independent NICE Technology Appraisal Committee, which is comprised of clinicians, lay members, statisticians, commissioners, health economists and representatives from industry. The Committee interacts with four main groups of stakeholders: invited experts, manufacturer(s), independent academic groups that critique the manufacturer s submission, and, although not technically a stakeholder, NICE itself. The invited experts including clinical experts, patient experts, and commissioners, that is to say, those responsible for paying for a technology the Committee might recommend[1]. In Australia, the 2009 national HTA Review included a Medical Technology Stakeholder Reference Group (MTSRG) to ensure the input of key stakeholders in a public examination of the overall HTA process. Enabling a flow of input from all stakeholder groups during scoping and evidence gathering activities, including applicants. > NICE calls for formal registration of stakeholder groups, which are then routinely consulted online and via meetings. In Australia, stakeholder groups cite PBAC as a good model, which includes opportunities for manufacturers to hold meetings prior to initiating requests for HTA and to provide corrections or amendments as the process continues [10]. Part of the Australian national HTA Review also included a series of intensive and publicly-documented focus groups with over 100 interest groups in major capital cities for discussion and clarification of issues. Solicitation of consultation on guidance as well as publication of responses to consultation requests, before final decisions are taken. > NICE requests feedback on guidance, but also ensures that systematic and transparent responses to stakeholders comments on drafts are published. Similarly, the Australian Pharmaceutical Benefits Advisory Committee allows manufacturers to comment on decisions before publication at specified communication points for applicants in the HTA process, and publicizes the reasons for every negative or restrictive decision. Putting into place formal criteria and process for the lodging and review of appeals. > In Australia, following the HTA review of 2009, new measures to enhance public-private engagement include the establishment of independent review and opportunities for resubmissions in a consistent manner. In the UK, NICE has a standing Appeal Committee including NICE leadership as well as representatives of the National Health Service and industry. Provision of tools and materials to facilitate stakeholder implementation. > Following the issuance of NICE guidance, tools are routinely made available including costing templates or calculators that can be localized, slide sets with key priorities and discussion points and clinical audit support. Other tools may include implementation advice and planning tools, flow charts and checklists [11]. Supporting dedicated skill-development programmes for stakeholders. > NICE s Public Involvement Programme is a dedicated in-house programme for patient, caregiver and public involvement [12]. This programme engages both individual lay people as well as organisations that represent lay people. It identifies opportunities and provides guidance for lay involvement in NICE s work through the provision of information, training and support as well as evaluation of patient, caregiver and public involvement in NICE s activities. In Australia, similar objectives are addressed by the establishment of Australia s Consumer Focus Collaboration under the National Expert Advisory Group on Safety and Quality in Health Care [13]. Proactively forming groups such as citizen juries to serve as representatives of the public or underrepresented special interest groups. > In the UK, the Citizens Council is a panel of 30 members of the public that provides insights into public opinion on controversially moral and ethical issues which are then captured in a Social Value Judgments guidance for NICE s committees [14]. Topics range from health inequalities to patient safety. While the Citizens Councils do not directly participate in NICE s decision making, their reports inform NICE s methodology and decision making process where appropriate [13]. Communicating information about evidence and decision making rationales widely and in formats and language suitable for target audiences, including lay-friendly versions for the broader public. > NICE guidance is developed and disseminated in various versions targeted at key groups (from parliamentarians to local authorities and providers, to the public), including the adaptation of language to meet the needs of individuals with learning disabilities and/ or non-native speakers. In Australia, a key recommendation from the HTA Review (now under implementation) is to improve public disclosure. This includes the introduction of a dedicated website ( au/hta) that presents an overview of the HTA process, hosts the portal for the HTA Access Point and collates data including submission activity, outcome activity and the operations of the expert advisory committees.

6 8 9 PERSPECTIVES FROM ASIA In Asia, various models of HTA have evolved out of the diverse range of health systems and social, political and cultural backgrounds in the region. Capacity building in HTA dates back to the early 1990s and 2000s, initially in the form of pharmaco-economics and outcomes research focused largely on drug development in the Asian marketplace, supported by academic centers and industry researchers [15]. As this capacity has developed further in collaboration with international networks, movement towards a broader and more formal HTA agenda has also taken on new momentum, driven in part by the imperative of universal healthcare insurance coverage in several countries. A number of countries have established national programmes led by specialised agencies that manage the systematic application of HTA, looking towards international models with strong government leadership in HTA [16], such as NICE, the Canadian Agency for Drugs and Technologies in Health (CADTH) and the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)). For instance, In South Korea, HTA is institutionalised within the National Health Insurance (NHI) system, following legislation to regulate the process of determining benefits and to promote the safety and effectiveness related to health technologies [17]. Since 2007, HTA is mandatory for all new drugs, and under review for existing drugs. The National Evidence-Based Collaborating Agency (NECA) and the Health Insurance Review & Assessment Service (HIRA) undertake appraisals, while budget-impact and pricing is undertaken by the National Health Insurance Corporation (NHIC). Together, these bodies work with the Korean Food and Drug Administration, the Committee for New Technology Assessment and the Ministry of Health and Welfare in an integrated process of evidence-based decision making [16]. In Taiwan, HTA has been led by the Center for Drug Evaluation since 2007, to provide evidence for the coverage and reimbursement policies of the Pharmaceutical Affairs Committee under the National Health Insurance (NHI) scheme. In 2013, Taiwan further expanded the scope of HTA nationally by forming an independent National Institute of Health Technology Assessment, Taiwan (NIHTA), both to continue the function of supporting NHI decision making, but also to coordinate wider research and development collaborations in HTA [18]. In Thailand, the Thai Health Intervention and Technology Assessment Program (HITAP) is a well established HTA agency, founded in 2006 [19]. Its founding objectives are to appraise health interventions and technologies efficiently and transparently using qualified research methodology, develop systems and mechanisms to promote the management of health technology as well as appropriate health policy determination and to distribute research findings and educate the public in order to make the best use of the results. While HITAP has no legal authority to make healthcare resource allocation decisions itself, in its role as an advisor to the Ministry of Public Health and other national Thai authorities, HITAP has developed a track record in informing national policy. Other notable examples, such as Japan, Malaysia, Singapore [20], and the Philippines, demonstrate a national HTA capacity that is active and informs policy, albeit via processes that are less formal or fully-integrated into the broader health system. For example, While there is no national program of HTA in Philippines, cost-effectiveness analysis is used to inform the prioritization of new drugs in the Philippines. The Filipino Formulary Executive Committee works closely with the Department of Health and regulators, applying HTA to identifying good value technologies for reimbursement by the country s insurer, PhilHealth [21] The Malaysian Health Technology Assessment (MaHTAS) unit has been in existence since 1995, and provides input into formulation of various national and Ministry of Health policies ranging from immunization and screening to home care programmes, clinical practice guidelines development, government purchasing and public health advertisements [22]. Elsewhere, HTA capacity continues to grow via nascent national initiatives and informal mechanisms or related activities. Examples include Bangladesh, Bhutan, Brunei, Cambodia, China, India, Indonesia, Laos, Maldives, Mongolia, Nepal, Pakistan, Sri Lanka, and Vietnam [23]. The status of China and India are typical in that HTA is seen as desirable but not formally required, and most HTA capacity is located in academia or industry [24]. Neither China nor India have a national HTA program. In China, HTA is recommended but not required for listing a product on either the national or provincial drug reimbursement list. In India, some evidencebased decision making is carried out on a small scale at the central Ministry of Health, but very little at the individual state-level [23], although there exist promising recent examples of local economic evaluation from the academic and research community [25]. While HTA agencies in Asia are relatively new, increasing interest in strengthening capacity has led to growing collaborations. Shortly after their own inception, HITAP (Thailand), CDE (Taiwan) and NECA (Korea) began exploring such opportunities resulting in the formation of the HTAsiaLink network in 2011( HTAsiaLink is a networking platform for regional collaborations in research. It regularly conducts activities bringing together key HTA agencies and experts and distributes a joint newsletter three times a year. Stakeholder engagement policy and practice is similarly diverse, given these differences in systems and backgrounds, and the different stages of development of the HTA process itself. In the case of Thailand, an early systematic review (2007) of the literature on economic evaluation in Thailand found that there were no publications on 15 of the top 20 major health problems in Thailand, indicating a mismatch between research and decision maker priorities in the wider HTA community at the time [26]. In addition, a further study in 2008 showed that existing economic evaluations had little traction among policy actors, from national policymakers to hospital directors and academics, compared to other ethical, institutional and political considerations, suggesting the strong need for HTA assessments to incorporate important societal values when providing guidance on health resource allocation [27]. The founding of HITAP espoused a HTA management policy that actively builds in the views of policy makers and other stakeholders, such as consumers FIGURE 2: STAKEHOLDER ENGAGEMENT IN HITAP HTA phase Approaches Participants Topic selection Conducting HTA research Appraisal of results Dissemination of results and recommendations Consultations Source: Tantivess et al (2009) Consultations (to identify research questions) Technical collaboration Peer review Submission of comments Discussion Publications Presentations Dialogues HITAP, policy makers, healthcare providers, consumer groups, professional associations, etc. HITAP, experts and relevants stakeholders HITAP, experts, private business / Industry, policy makers,consumers / beneficiaries HITAP, funding agencies, the media, consumer groups and other NGOs and insurance beneficiaries, healthcare providers and industry members, from topic selection up to and including dissemination (see Figure 2) [27]. In the first stage, HITAP calls for proposals on health technologies and programmes needing appraisal from Ministry of Public Health departments, the three Thai public insurance plans, the Subcommittee on NLEM (National List of Essential Medicines) Development, the Royal Colleges, specialist associations, public health non-governmental organisations and HITAP funding agencies [28]. In the development of the Thai Universal Coverage health benefit package, for instance 30 topics were nominated by stakeholders for prioritization, out of which 12 were selected for further assessment [29]. When conducting an HTA, clinical specialists and methodologists are invited as researchers, or consultants. During the appraisal period, research findings are open to review, while selected stakeholders are targeted for more detailed discussions. Finally, HTA results and recommendations are publicized using different approaches to get the messages to particular target populations. In South Korea, similarly, there are several channels for stakeholders to participate in the HTA process, including participation in the expert committee for reimbursement decisions, preliminary consultations with industry, an open period for industry and professional organisations to respond and comment during deliberation and a post-deliberation appeal process, which is to be further formalised in the near future.

7 10 11 CHALLENGES TO ENGAGEMENT MEETING CHALLENGES AND LOOKING AHEAD While engagement is critically important, it is often not easy to achieve. Different stakeholder groups pose different challenges, although some common hurdles often arise: Stakeholder engagement takes time and resources. Problems persist even when stakeholder engagement follows a widely emulated and successful model, such as in the case of NICE [6]. Steps such as recruiting and coordinating stakeholders for committees and meetings and soliciting comments and response can add significantly to the timeline of the HTA process, while successful calls for comments and feedback can lead to a large burden in terms of review and response. This can have particular resonance in HTA, when perceived as detracting from the process of quickly ruling on critical drugs or procedures. Problems may also emerge when stakeholders may have unrealistic expectations about engagement outcomes that do not align with existing resources and capacity. Even when the value of HTA is acknowledged, other background factors may impede the willingness of stakeholders to engage. In Thailand, key cited barriers among policy actors included distrust, conflicting philosophies, preexisting loyalties to other organisations, and concerns about political pressure and acceptability [30]. While education and (good) experience with HTA may alleviate distrust, other factors may be more entrenched and difficult to overcome without systemic changes. In practice, balancing stakeholders is not straightforward. Incorporating the perspectives of various groups can be difficult in the face of different interests, perceptions and expectations, some of which may be in conflict. For instance, during HTA processes involving private-sector manufacturers, balancing and respecting the confidentiality of information needs to be managed carefully against the need for transparency and disclosure to the public. Another such challenge involves finding ways to incorporate important but potentially biased stakeholders in a constructive manner, while preventing capture of the overall process. For instance, in South Korea, in spite of the procedures already in place, involving patient and practitioner groups has been a challenge. This is particularly true for disease-related patient groups, who are seen as potentially-biased advocates who may have undue influence on deliberations [31]. At present, on the expert committee, there is no explicit channel for their participation but consumer representatives are taken to be proxies for these interests and supporting petitions may be submitted together with general evidence by a technology manufacturer. Engagement can increase the risk of controversy. When decisions are made behind closed doors among a select group of decision makers, information for a wider audience can be limited and controlled. An open and consultative process introduces risks such as popular outcry and coordination of efforts across powerful lobbies and special interest groups [32]. For instance, in the UK in 2010, NICE rejected the use of Sorafenib (Nexavar), a liver cancer drug, in the National Health Service [33]. NICE s independent advisory committee found that while the drug increased survival by an average further 2.8 months, half of the patients who gained some benefit received less than this amount of additional life. The cost of 27,000 per patient was judged too high to justify the benefits. This decision provoked a strong negative reaction from many, from parliamentarians to patient organisations and the popular press. The Committee [performs its work] in a spirit of transparency.[such] processes help the community address uncertainty and make decisions which better reflect the view of stakeholders. Dr Amanda Adler, Chair of the NICE Technology Appraisal Committee, UK The challenges highlighted above are not simple to resolve, but present experience has given rise to important lessons about how to move forward: Process matters. An important and necessary first step to resolving challenges is to demonstrate a strong commitment to clear and transparent procedures. The impact of the inevitable challenges and frictions inherent in the process of stakeholder engagement can be minimized by setting in place specific and formal mechanisms that acknowledge and anticipate these issues. These include open and transparent rules and procedures for managing stakeholder interactions [34] such as: > recognizing and handling conflicts of interest > moderating disagreement > resolving contradicting evidence > contesting results In the case of Sorafenib (Nexavar) and the UK National Health Service, the manufacturer, Bayer filed an appeal, drawing attention to the important added societal value of pharmaceutical innovation as a benefit. Ultimately, however, the appeal was not upheld. Despite the external pressure, the wide consultation, the rigorous and transparent scientific process and the appeals mechanism allowed NICE to defend the guidance and sustain its overall position as an independent, expert authority [32]. Implementation of the process of HTA also matters. Poorly-managed stakeholder engagement strategies that pay lip service but fail to deliver (for instance, badly-publicized procedures for consultation, insufficient attention to review of submissions, or inaccessible materials) can propagate confusion, generate inefficiencies and lead to unnecessary loss of goodwill that provides fodder for skepticism about HTA in general. Effective HTA requires that researchers and policymakers both work towards bridging the communications gap. Capacity-building needs to focus both on policy-makers ability to interpret and use the evidence from HTA as well as researchers skills and interest in promoting the translation of HTA into practice, such that results are framed effectively and in a manner most relevant to stakeholder needs. The dissemination of HTA evidence and research more broadly also calls for the design and use of communication strategies that are appropriate to other stakeholder groups. No one-size-fits all: flexibility and adaptation are key. > HTA models including aspects related to stakeholder engagement cannot simply be transplanted from one setting to another [35]. Across countries, models of stakeholder engagement need to be as diverse and contextspecific as the health systems they are intended to support, from the levels of involvement to

8 12 13 the forms of recruitment, communication and outreach used and importantly, the degree and allocation of resources spent to facilitate engagement [6]. In countries where the experience of HTA itself is limited, there may need to be a greater emphasis on stakeholder education efforts and capacity building, not only among the public but among policymakers and industry members as well. > Within any particular system, moreover, it is also important to recognise when engagement requires responses outside the letter of existing procedural requirements [36]. For instance, in Thailand, urgent guidance was required to support a decision about the exact formulations to be delivered in a nationwide maternal iodine supplementation policy in HITAP was able to perform a rapid review (including a literature review and preference survey of practitioners) that was shared during the deliberations on short notice, though this topic was not selected through the conventional prioritization channels. Trust and interaction between HITAP and the various stakeholders played a crucial role in generating timely and relevant evidence that ultimately had a large impact on policy. > In addition, over time, even in the most successful cases, experiential learning creates a need for evolution in the modalities of stakeholder engagement. In the experience of NICE, for instance, considerable investments in engagement have been made and are highlyvalued, but questions about the process - such as whether the right stakeholders are involved at appropriate levels or the extent to which these investments themselves represent good value - are openly raised and reflected upon, so that the process itself is subjected to ongoing adaptation and improvement [6]. HTA is a key part of health care system strengthening. Strategic investments in appropriate health technologies improve health and quality of life, and are indispensible for prevention, diagnosis, treatment and management of diseases and disabilities. Ensuring that the right health technologies are prioritized, assessed and made available at an affordable price, are fundamentally linked to achieving healthy outcomes effectively and efficiently. It is therefore important to appreciate fully the role of the different actors that support the development, production and application of technology in a safe, appropriate and efficient manner. Building effective engagement policies and processes is a critical foundation for providing all stakeholders due consideration in the HTA processes, to ensure that technological development continues to support population health in Asia, both now and in the future. ACKNOWLEDGEMENT Dr Joanne Yoong Assistant Professor Saw Swee Hock School of Public Health National University of Singapore Ms Joan Sara Thomas Research Associate Saw Swee Hock School of Public Health, National University of Singapore A/Prof Lim Yee Wei Vice Dean (Research) Saw Swee Hock School of Public Health, National University of Singapore Prof Vrijhoef Hubertus Johannes Maria Saw Swee Hock School of Public Health National University of Singapore A/Prof Audrey Chia NUS Business School National University of Singapore A/Prof Lotte Steuten Department of Health Technology and Services Research University of Twente, Netherlands Dr Kalipso Chalkidou Director NICE International, United Kingdom

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