Countries in the Asian region are diverse and include some of the world's least and most developed nations, with populations ranging in size from thousands to hundreds of millions (1). Not only are their political, administrative, and economic systems diverse, so too are their healthcare systems, ranging from public- to private-dominated systems, which together address the needs of more than 60 percent of the world's population (Reference Chootipongchaivat, Tritasavit and Luz2). Asian economies spend just over USD$600 per person per year on health, equating on average to 4.5 percent of gross domestic product (GDP), compared with USD$3,200 or 9.5 percent of GDP in Organisation for Economic Co-operation and Development (OECD) countries. In addition, the share of public spending on health is lower in Asia at 57 percent, compared with OECD countries at 72 percent. However, on average between 2000 and 2010, the growth rate in per capita health spending in real terms was 5.6 percent per year in Asia, higher than the 3.6 percent reported across OECD countries. The growth rate in health expenditure for China, Myanmar, and Vietnam was almost twice the average rate for the entire region (1).
The region has experienced years of relative prosperity resulting in an improved life expectancy from reductions in death from communicable, perinatal, nutritional, and maternal conditions. However, health inequalities still exist both between and within countries in the region. In recent years, the greatest economic pressure exerted on healthcare systems in the Asian region has been caused by the shift from acute disease to the looming epidemic of chronic non-communicable disease such as cardiovascular disease, diabetes, and cancer; with tobacco smoking being a major cause of diseases including asthma, chronic obstructive pulmonary disease, and cancer. Concern has been expressed that this economic pressure will only accelerate in the future with the rapid increase in the incidence of chronic conditions (1). These pressures are amplified by the growing demands of an increasingly educated and affluent population for high-quality health care. Health systems in the region need to find the right balance in the provision of services to increase access and reduce health inequalities (Reference Hashim, Chongsuvivatwong and Hong3).
The prioritization of the move toward universal health care (UHC) is viewed as an integral part of getting this balance right, by managing the expectations of the population with the provision of essential health care. The World Health Organization (WHO) definition of UHC embodies three related objectives: (i) equity in access to health services—more people need to be included by coverage decisions and everyone who needs services should get them not only those who can pay for them, (ii) priority services need to be expanded and the quality of health services should be good enough to improve the health of those receiving services, and (iii) out-of-pocket payments need to be reduced so that patients are not at risk of financial harm (4;Reference Ottersen and Norheim5).
Countries that have made the decision to implement UHC to improve access to health care have needed to make decisions around who should be eligible and on what basis. Decisions also needed to be made as to which services should be guaranteed: inpatient or outpatient care and high-cost or low-cost treatments. However, the most important decision of all is how access to health care should be financed, whether through public levies, private contributions, or payments at time of service (Reference Savedoff, de Ferranti and Smith6). While UHC does not require that all possible effective services are provided to everyone, it does require that a wide range of key services, which align with other social goals, are made available to all at reasonable cost (Reference Voorhoeve, Edejer and Kapiriri7).
As such, the topic for the 2017 HTAi Asia Policy Forum (HAPF) was to identify the barriers and challenges of implementing UHC in the Asia region and, in particular, to discuss how HTA and real-world data (RWD) can contribute to the goal of achieving UHC.
METHODS
The fifth HAPF was held from November 2 to 3, 2017, in Beijing, China, with forty-four invited experts in attendance including delegates from public sector HTA agencies, most of whom are embedded within, or funded by, their country's health departments, from eleven countries in the Asia region; delegates from eleven pharmaceutical and medical device companies with interest and experience in Asia; leaders from HTAi; senior public officials from the Chinese National Health and Family Planning Commission; and global and regional representatives from the WHO.
To inform discussions at the Forum, a background paper was developed with the assistance of the Organizing Committee. This paper (background paper) comprised two elements: first, a literature review of UHC in the Asia region, which attempted to identify the requirements for UHC, along with any issues and barriers associated with the development of UHC. Second, the results of two surveys were used to complement this review, to give context to the reality of developing UHC in the region. Representatives attending the HAPF who were nominated by their country's health department completed the first “HTA-agency” survey. This HTA-agency survey was completed by representatives from nine countries: Singapore, China, Taiwan, Republic of Korea, Malaysia, Vietnam, Indonesia, Thailand, and the Philippines.
The purpose of this survey was to identify some of the road blocks, barriers and challenges that countries in the region experience on the road to establish UHC. It should be noted that responses to the survey were provided by individuals, and, therefore, may not accurately reflect the full situation in each agency or country. Representatives from eight of the pharmaceutical and medical device companies attending the HAPF completed the second survey, which was conducted to elucidate issues of concern from an industry perspective. In addition to the results from these surveys, presentations made during the meeting from invited experts formed the basis for breakout session discussions.
The HAPF is designed to promote open and constructive dialogue, without fear or favor. As such, Forum meetings are conducted under the Chatham House Rule in which participants are free to share information obtained during the meeting but the identity or affiliation of the person providing the information cannot be revealed (8). This study provides the authors’ summary of the premeeting surveys and discussions among participants during the 2017 HAPF, and does not represent a consensus statement from those attending the meeting, or represent the views of the organizations they represent.
RESULTS
Results from the Literature
From the literature, it is clear that there is no one path to universal coverage and countries may want to adopt a combination of strategies, taking into account the unique characteristics of their own healthcare systems. However, whilst countries in the region are diverse socially, politically, and economically, they face the same challenges of financing and delivering health care, highlighting the potential for regional collaboration and ability to learn from the experiences of others. The path to UHC requires policy choices and trade-offs to be made, and it is critical to consider the local context when attempting to achieve a balance (Reference Yu9). The challenge for countries progressing toward UHC is to find the right balance between increasing priority services provided in basic packages of care, extending coverage to those individuals previously not covered, while at the same time providing financial protection to people who otherwise may be impoverished by out-of-pocket spending on medical care (Reference Latko, Temporao and Frenk10).
The Asia region has one of the world's highest dependence on out-of-pocket expenditure to finance healthcare systems, with one of the highest number of households driven into poverty by the need to pay for health care at the time of service (1). Direct healthcare costs deters health-seeking behavior, as will indirect costs such as transportation and lost income while waiting for care (1). UHC is viewed as a means of protection against the economic consequences of ill health. The literature widely agrees that reducing reliance on out-of-pocket payments, especially in the first instance for high-priority services, and moving to a system of mandatory pre-payment is a means of addressing the equity, efficiency, and sustainability of health expenditure, and in so doing, achieve UHC (Reference Savedoff, de Ferranti and Smith6).
Funding UHC is a major issue for many of the countries in the region—whether through public levies, private contributions, or payments at time of service (Reference Savedoff, de Ferranti and Smith6). Most countries fund health care from general taxation revenue; however, the inability to raise taxes from large informal workforces to fund health care remains a challenge for many. The most common mechanism used to achieve the service provision trade-off balance is universal health insurance or “risk pooling.” Pooled health spending spreads the financial burden and risk, with individuals being required to contribute based on their ability to pay, whether they need care or not (Reference Savedoff, de Ferranti and Smith6;Reference Voorhoeve, Edejer and Kapiriri7;Reference Abiiro and De Allegri11). Financial risk pooling may be achieved by means of several mechanisms including tax (general or dedicated) revenue channeled through governments to provide subsidized care, contributions to public insurance (usually for formal sector employees), mandatory private insurance, or private co-payments (Reference Savedoff, de Ferranti and Smith6;Reference Abiiro and De Allegri11).
While the UHC challenges are common, experience in overcoming these challenges is varied. Commentators largely agree that the critical ingredients for the success of UHC include political will and commitment, running workable elementary healthcare and preventive services, covering as much of the population as possible, and investing in good healthcare administration (Reference Sen12). As countries in the Asia region commit to implementing UHC, some common challenges are emerging: how to ensure coverage of the informal workers sector; how to design a benefit package that is responsive and appropriate to current health needs, while remaining affordable and fiscally sustainable; and how to ensure the provision of increased coverage translates into improved health outcomes. In addition, how do countries in the region prioritize innovation and evaluate the role of disruptive technologies (Reference Bredenkamp, Evans and Lagrada13)?
When moving toward UHC, decision making regarding what health care to invest in and for which populations requires some form of robust priority-setting criteria. In countries with well-established UHC, such as Australia and the United Kingdom, HTA is a recognized priority-setting tool used to support public reimbursement and coverage decision making. However, in settings with limited HTA capacity, the use of evidence to establish benefit packages is lacking (Reference Chootipongchaivat, Tritasavit and Luz2). The challenge in the Asian region is to define a common benefit package that is appropriate to the burden of disease and represents good value for money while being socially acceptable. In the absence of a clear, rational process for defining and updating the benefit package, discrete and unpredictable “rationing decisions” may occur between client and provider at the point of service (Reference Bredenkamp, Evans and Lagrada13).
The long-term negative consequences of disregarding evidence-based, healthcare priority setting in the development of benefits packages may result in inefficient and inequitable healthcare systems, which are opposite to the goals of UHC (Reference Chootipongchaivat, Tritasavit and Luz2). Without comprehensive and reliable evidence to guide coverage decisions, the benefits package may become ill-defined and too broad (Reference Chootipongchaivat, Tritasavit and Luz2) as demonstrated in Indonesia, where the broad benefit package has few exclusions and, as such, is constrained by the ability to deliver on all fronts (Reference Bredenkamp, Evans and Lagrada13).
An essential tool for effective HTA is evidence, especially real-world evidence, that links interventions with health outcomes, forming the basis for good healthcare decision making. Data are needed for policy makers, clinicians, and patients to make informed healthcare decisions. Data can be used to identify patterns of morbidity and mortality, describe the burden of disease, compare effectiveness of therapies and procedures, determine the cost of care, and to evaluate the delivery of care on patient outcomes (Reference Mues, Liede and Liu14). Access to the right type of data and data linkage remains a worldwide issue, and data needs change over time. In addition, big data need a well-functioning information technology infrastructure, which may be a limiting factor in many countries of the Asia region.
RWD refer to data captured in natural, uncontrolled settings outside of traditional clinical trials and may include primary or secondary data collected through a protocol-specified procedure, patient observation, hospital records, mortality data, claims data, or electronic health records. Registries are an extremely rich source of RWD as they are based on data generated and collected as part of routine clinical care rather than for research purposes (Reference Jarow, LaVange and Woodcock15). The challenges of using RWD in decision making for benefit packages for UHC formed part of the discussions during the Forum; specifically, what are the types of data needed to make informed decisions; does this vary from region-to-region or country-to-country; and what is the importance of obtaining local data compared with regional data or international data?
Results from the Pre-meeting Surveys
In the responses to the pre-meeting survey, seven countries described their healthcare system as having “full UHC” (i.e., some level of healthcare coverage is provided to all citizens), while Vietnam and Indonesia reported having “partial UHC” (i.e., not all citizens have access to healthcare coverage). However, it should be noted that the level of out-of-pocket expenses patients are expected to make when purchasing healthcare services in each of the individual countries was not ascertained and may still be substantial.
The healthcare services provided in the countries surveyed are summarized in Table 1. Of the seven countries with “full UHC,” UHC programs included all forms of health care in five of the countries: Singapore, Philippines, Taiwan, Korea. and Malaysia. All countries include in their UHC program(s) primary, secondary. and tertiary health care; preventative care including screening programs and immunization; mental and oral health care; ophthalmology; and rehabilitation services. Four of the “full UHC” countries provide all medicines, while two of the remaining countries, Malaysia and China, provide essential medicines as defined by WHO package or by a panel of experts. Only Singapore provided medicines defined by a panel of experts. Although Vietnam and Indonesia reported having “partial UHC,” both countries include in their UCH programs all the same elements as the “full UHC” countries. Vietnam reported that most preventive care is funded by government budget and that the benefit package under Social Health Insurance covers almost all available curative care at all levels of healthcare delivery, from primary to central level as well as essential medicines as defined by a panel of experts.
Table 1. Healthcare services included in universal healthcare program(s) by each country surveyed
In the survey, most of the “full UHC” countries described using a range of funding mechanisms to finance health care. Only Korea described the use of a single-payer system, with the government responsible for collecting healthcare fees and healthcare payouts. China uses a system of co-payments operating within a threshold of care, that is, the government and the patient pays for a portion of care until a threshold is reached, with care beyond that threshold self-funded by the patient. The Philippines has a mandate requiring all people to have some form of health coverage in addition to employer insurance, with the government and patient paying a portion of costs in a system of co-payments. Singapore, Taiwan, and Malaysia use a combination of financing mechanisms including employer insurance, public-private partnerships, health coverage mandates, co-payments, and a levy system, where all citizens contribute a proportion of income to subsidize coverage for people with low or no income.
Direct household out-of-pocket health payments in Malaysia are almost exclusively made for the purchase of private health care. Singapore uses healthcare subsidies, some of which may be accessed through non-government healthcare providers, both voluntary private and mandatory government healthcare insurance, in addition to mandatory healthcare savings accounts and compulsory medical insurance. Of the two “partial UHC” countries, Indonesia funds health care through employer insurance and Vietnam by a combination of mechanisms consisting of general tax through the government budget, Social Health Insurance, and household out-of-pocket payments.
Forum attendees from the health or HTA agencies were asked to identify the major impediments and challenges on the road to establishing and implementing UHC in their country. Not surprisingly, the majority of countries (70 percent of respondents) nominated affordability, regardless of the stage of UHC, as the greatest hurdle to be overcome. Of interest was the next two highest ranking factors, with 50 percent of respondents nominating both the lack of political will to implement UHC, and the cultural issue of deference to expert opinion instead of relying on evidence-based assessments.
Both China and Vietnam reported that one of the major impediments to achieving UHC was that HTA is not used to inform decision making; instead, local authorities decide on the scope of the benefit package based on local needs and available resources, resulting in a poorly defined range of services (Reference Bredenkamp, Evans and Lagrada13). In addition, the Philippines, China, and Taiwan noted the lack of a HTA workforce as an obstacle and 30 percent of respondents reported that silo-based decision-making processes are a challenge. Although these challenges may be highly context-specific, varying from country to country and by the stage of UHC development (total or partial), there is value in policy makers across the region to share their experiences and solutions in an environment such as the HAPF.
When asked how healthcare benefits, funding, and prioritization decisions are made in their country, most of the HTA agencies from “full UHC” countries used some form of evidence-based decision making. All healthcare technologies were subject to HTA in Singapore, Malaysia, Thailand, and the Philippines, whereas Taiwan used HTA only for medicines. Singapore, Taiwan, Malaysia, and Thailand used HTA generated in their own countries. Decisions to include or exclude drugs into the Malaysian formulary may be informed by internally produced HTAs, which may apply an implicit cost-effectiveness threshold as a guide, with other factors taken into consideration before a final decision is made.
Four of the seven “full UHC” countries (China, Malaysia, Thailand, and the Philippines) stated that the burden of disease (greatest need, greatest care) was used to prioritize healthcare benefits. Singapore reported that prioritization was based on clinical unmet need in addition to clinical effectiveness, cost effectiveness and affordability. China reported inconsistent use of HTA in decision making, with HTA used only for some technologies. Of interest is that Korea reported that the political agenda and expert opinion played a major role in decision making. Korea reported that preventative care programs, tertiary health care (including procedures, diagnostics, imaging, and pharmaceuticals), and any health technology associated with controversy, were subject to HTA.
Of the two “partial UHC” countries, Vietnam reported that all evidence-based strategies are used at the starting point of an application in decision making for the Basic Health Service Package for primary care, and all proposals to add a new medicine to the current list of reimbursed medicines are required to undergo a HTA. Indonesia reported using only internally generated HTA to make decisions about all types of health care added to their benefits package.
The health or HTA agencies were asked whether policy or funding decision makers in their country had access to RWD. All countries, except for the Philippines, who use international data, reported that they had access to, and used, data obtained from their own country. China and Vietnam reported using additional data obtained from the Asian region and international data, respectively. Thailand was the only country to solely rely on its database of health insurance reimbursements, which has individual medical record and payment level data. Taiwan also used its National Health Insurance claims dataset as a decision-making tool but supplemented this data with government surveys or census data, as did most the remaining “full UHC” countries apart from Singapore. China, Korea, Singapore, and Malaysia all used both primary care data gathered from general practitioners and hospital separation data, whereas the Philippines only make use of the latter.
Of great interest is the number of registries in use throughout the region. China and Singapore access data from registries of chronic diseases (stroke, heart infarction, kidney disease, and cancers). In addition, China has access to a registry of adverse events and registration data for clinical management and research. Malaysia has by far the most extensive network of registries and accesses data from national surveys including the National Health and Morbidity Survey conducted every 2 years, National Eye Survey, and the National Medicine Utilization Survey. The two “partial UHC” countries, Vietnam and Indonesia, both reported using tertiary care data gathered from hospital separation data as their main source of RWD, with Vietnam reporting the use of patient surveys to collect data on patient preferences for a specific health condition and in addition to cost data. Notably, in the pre-meeting survey, China and Taiwan reported that the use of RWD was not a priority.
In the premeeting survey, all eight of the industry respondents agreed that access to RWD is a priority in the region and was best used to develop or support value propositions. RWD were also viewed as useful for informing HTA for reimbursement decisions (87.5 percent of respondents), gauging the market need for a technology (75 percent), demonstrating where a new technology will sit in terms of established models of care (75 percent), understanding the use of a comparator technology (75 percent), and to develop different pricing models (62.5 percent). In addition, one company reported using post-market RWD to meet the needs of regulators and reimbursement agencies, and another reported using RWD for pharmacovigilance.
When thinking about the key challenges or barriers to using RWD, most countries reported the same issues, regardless of the stage of UHC development; however, disconcertingly, both China and Taiwan reported that the use of RWD was not a priority. Singapore, the Philippines, Malaysia, Thailand, China, and Vietnam all reported a lack of capacity to enable information and data sharing. Vietnam, Malaysia, Indonesia, and Thailand all nominated poor quality or lack of accurate cost information for different types of services as a major issue.
Of great interest is that both Korea and Taiwan reported that strict privacy and confidentiality protection makes accessing claims data and linking that data with other registry, trial, or survey data for research purpose extremely difficult. However, these responses appear to be at odds with the experiences reported by industry. As summarized in Figure 1, only a small number of agencies identified each of these issues as a concern, whereas the majority of industry representatives identified all of these areas as issues of concern, especially the lack of infrastructure and the lack of capacity to enable information and data sharing. This different perspective may be driven in part by the lack of industry access to public data in the Asia region, or comparisons are being made to the types of data easily accessible and available in high-income countries.
Figure 1. Industry and health technology assessment (HTA) agency survey responses identifying the challenges and barriers to accessing real-world data.
A range of responses were given by industry representatives when asked how their respective companies overcame these challenges and barriers. Most used a collaborative approach including investing in infrastructure, advocating the use of databases, conducting early assessments and pilot projects, supporting third parties such as universities and think tanks, and capacity building. Most companies were involved in a range of capacity building and development activities in conjunction with HTA agencies to support the development of robust evidence generation infrastructure in the region. The majority of companies were involved in the training and development of skills in HTA and health economics methodology, in addition to patient assistance programs.
DISCUSSION
The HAPF provides a unique opportunity for public sector HTA agencies and private sector industry to hold transparent and wide-ranging discussions, especially in the breakout groups, around themes such as access to data and requirements for public sector funding of technologies. The key objective of the Forum is to provide networking opportunities between industry and government agencies, building relationships and trust. In addition, important relationships and connections have been developed between countries.
All Forum attendees agreed that to improve the health and wealth of a population, UHC is an important and achievable goal for all countries in the region to work toward, several barriers to implementing UHC were consistently identified including affordability, the lack of political will, and the cultural issue of deference to expert opinion instead of using evidence-based assessments.
The use of HTA was identified by attendees as just one priority-setting tool that could be used to achieve UHC. However, with the widespread and increasing use of HTA in the Asian region, driven in part by concerns about affordability and the aim of implementing UHC, concerns were raised around the consistency of HTA methodology used. During discussions throughout the HAPF, it became apparent that there was a great deal of variation in the HTA methodology used in the region. This variation may be technology dependent, with different methodologies, criteria, or quality of evidence used to assess and approve the addition of drugs to benefit packages than that required for the approval of diagnostics or procedures. Representatives from industry were particularly concerned with this inconsistency and would like to work with agencies toward a more transparent process.
Although it was widely agreed that the goal of HTA is to improve timely access to healthcare services, many attendees agreed that HTA is increasingly viewed as being used by government as a cost-containment tool or gatekeeper, rather than a means of delivering appropriate care to the appropriate patient. To overcome these perceptions, it was agreed that agencies in the Asia region should work to develop HTA in parallel to the health system and that a consistent HTA methodology should be developed to enable a transparent prioritization of technologies to be added to benefit packages. Most importantly, the requirements of HTA, particularly the rigidness of the level of effectiveness and cost-effectiveness evidence required for decision making, should be balanced with the ability of the health budget to fund a new health service.
Importantly, attendees agreed that an incremental cost-effectiveness ratio should not be the only decision-making tool; Asian social values and context need to be taken into consideration when making benefit package decisions, with HTA including patient experiences from the region and not just patient outcomes. In addition, participants agreed that, given the complexity and status of the healthcare systems in the Asia region, HTA would be of greater value when used to prioritize and evaluate services of all technologies in a pathway of care, rather than focusing on the assessment of single technologies in isolation. In keeping with this, it was believed that countries in the region should first define their healthcare priorities, identify technologies that address these priorities, and then conduct HTA.
One of the recurring themes throughout the discussions was the issue of increasing transparency and accountability of the HTA process. It was agreed that all stakeholders, including patient groups, clinicians, and industry, would find the online publication of all stages of HTA reports (intent to assess, protocol, and draft assessment) a useful addition, provided that adequate time was given for feedback. As part of this process, it was believed that capacity building and educating patient groups in the region would be critical. In particular, it was agreed that an “Asian-way forward” to engage patients that considers cultural issues needs to be identified and developed.
When discussing the use of RWD in decision making, it quickly became apparent that there is a disconnect between what RWD the HTA agencies and industry have knowledge of, and access to, in the Asia region. In addition, there appears to be a lack of collaboration and trust between agencies and industry in the Asia region, with industry uncertain as to what data HTA agencies in the Asia region require to approve funding for a new health technology. It was acknowledged that countries in the region have a more conservative approach to access to RWD with privacy, legal, ethical, and custodial concerns around public health database linkage. Attendees agreed that there is a need for a code of ethics and common practice among government, agencies, and industry to be developed. In addition, increasing dialogue between HTA/government agencies and industry was viewed as a positive step forward that may lead to the identification of systems or technologies that have been adopted favorably in other countries, or establishment of patient registries.
In conclusion, anecdotally there appears to be an entrenched belief that poor countries must first grow rich before being able to meet the costs of UHC, with the growth in healthcare funding driven by rising national income, making an expanding range of medical interventions available to an ageing population (Reference Savedoff, de Ferranti and Smith6;Reference Sen12). However, the literature suggests that access to UHC can advance people's lives and, importantly, enhance economic and social opportunities, and may facilitate sustained economic growth (Reference Sen12). There is evidence that the health benefit of UHC can be viewed as an efficiency gain for countries, as good health improves educational outcomes and workforce productivity, and over the long-run, promotes economic development and productivity (Reference Bredenkamp, Evans and Lagrada13;Reference Lee, Majeed and Millett16). Discussions before and during the HAPF support this view, that achieving UHC is a valuable goal to work toward, both at the individual and country level, regardless of the country's economic circumstances.
Attendees agreed that Forums such as the HAPF provide a valuable opportunity to partner and share ideas among different stakeholders in a small group setting. The discussions at the 2017 HAPF demonstrate a willingness for public sector HTA agencies and industry to collaborate openly to achieve outcomes of mutual benefit. These include working toward developing a standardized HTA methodology for the prioritization of technologies in the Asia region to support healthcare systems. In addition, Forum attendees agreed to work toward developing a catalogue of the public and private data that are available across countries in the region and developing a policy statement that agencies can use with a common approach to the release of data.
Throughout discussions, it was evident that there was an appetite and desire to effect change, resulting in several direct recommendations and actions, which will form the basis of a solid foundation to build upon for future Forums.
CONFLICTS OF INTEREST
Linda Mundy is the Scientific Secretary for the HTAi Asia Policy Forum and as such is paid for this role by HTAi. Rebecca Trowman is the HTAi Secretariat for all of the HTAi Policy Forums and as such is paid for her role as the Asia Policy Forum Secretariat. Prof Kearney is the Chair of the HTAi Asia Policy Forum Organising Committee and as such is paid for this role by HTAi.
