Institutionalizing Health Technology Assessment and Priority Setting in South Korea’s Universal Health Coverage Journey

ABSTRACT This study charts the chronological developments of the three institutions that were established in South Korea for priority setting in health. In 2007, the Evidence-based Medicine Team and the Center for New Health Technology Assessment (CnHTA) were established and nested in the Health Insurance Review and Assessment Service (HIRA). In December 2008, the National Evidence-based Healthcare Collaborating Agency (NECA) was launched, to which the CnHTA was transferred in 2010. Since then, non-drug technologies have been reviewed by NECA and drugs have been reviewed by HIRA. Political debates about how to embrace expensive but important health technologies that were not on the benefits list led to the creation of the Participatory Priority Setting Committee (PPSC) in 2012. The PPSC, led by the general public, has played a key role in advancing the path toward universal health coverage by revitalizing the list of essential, yet previously overlooked, medical technologies. PPSC offers these technologies a second chance at coverage. HIRA and NECA served to strengthen evidence-based and efficiency-based decision-making in the health system via CnHTA, and PPSC served to strengthen social value–based decision making via priority setting in Korea. The reassessment by PPSC may be relevant in countries where the economy is growing and citizens want to rapidly expand the benefits list.


Introduction
As a country progresses toward universal health coverage (UHC), through the growth of national health programs and their expansion of benefits and population coverage, priority-setting institutions can be established to help address questions of how to expand the coverage of benefits.In South Korea, public coverage of health services had been low compared to other high-income countries, and the benefit expansion trajectory toward UHC was not smooth (Table 1). 1 South Korea established its social health insurance in 1977 via the Medical Insurance Act when insurance coverage of both population and services was low.Initially, Korea's social health insurance covered only government officers, teachers, and employees of large corporations with more than 500 employees.However, by 1989, its health insurance expanded to include all citizens including farmers and small businesses, effectively achieving universal population coverage.Amidst challenges to address population coverage, service or benefits coverage was not comprehensive, such that "medically necessary" services were not covered.One example of the limitations in the benefits is illustrated in the drug benefit.In the years before 1995, patients with chronic conditions requiring daily medication were only covered for up to 6 months per condition per year.But starting in 1995, the benefits for this drug coverage were increased by 1 month over six years, ultimately covering all 12 months of coverage for daily medication and with no cap on months of this drug coverage.
In this path toward UHC, the twin challenges of fairness and budget constraints-and two corresponding goals of equity and sustainability-emerged.These two challenges provided the rationale for institutionalizing HTA in making benefits list decisions explicit and cost-effective by conducting effectiveness and costeffectiveness assessments. 2South Korea's path toward the adoption of HTA is thus comparable to the United Kingdom's, which pioneered the use of explicit processes to ensure fairness of the benefits covered.It also used evidence to selectively cover benefits to meet the budget constraint and its corresponding institutionalization of the National Institute of Clinical Excellence (NICE) in 1999. 35][6] Since its enactment, there have been very few studies to date that have explored the history and political economy of the institutionalization of HTA in South Korea.Park and Lee commented on the importance of effectiveness to exclude technologies lacking evidence in accordance with the evidence-based medicine discourse. 7Kim argued for the need for HTA independence from budget conditions of National Health Insurance (NHI). 5To address this gap in the literature, this article begins by summarizing the current institutional processes and division of labor.Following this summary, there is a review of the history, key achievements, and results of the three HTA institutions.Furthermore, we explore the political economy surrounding priority setting as South Korea moves toward UHC, especially in expanding and developing the benefits list, while addressing these two twin challenges of fairness and budget constraints.

Data and Methods
We reviewed official documents from five government agencies-the Ministry of Food and Drug Safety (MFDS), Health Insurance Review and Assessment Service (HIRA), National Evidence-based Healthcare Collaborating Agency (NECA), National Health Insurance Services (NHIS), and Ministry of Health and Welfare (MOHW) as well as academic publications, supplemented by lived experiences and reflections of the authors.
For the analysis, we used the stakeholder framework for health policy implementation by Campos and Reich, political leaders, bureaucracies, interest groups, financial decision makers, and beneficiaries to examine South Korea's institutional development history for benefits list expansion. 8Donors were not relevant for the study period and thus were excluded from the framework for this article.Institutional development and current arrangements for health benefit coverage decision making were reviewed by document analysis.Recent benefit coverage decision results were also reviewed.Members from academic and government agencies responsible for the decisions also participated in the content analysis for this article as coauthors of this study.

Current Process Flow for Listing Health Technologies in the Benefits List
South Korea currently has three tracks for making decisions on the inclusion of technologies in the benefits list: (1) a main track for new technologies, (2) a rapid conditional approval track for specific innovative therapies that will later undergo a full review, and (3) a rapid conditional approval track for old technologies.
The primary track for adopting a new health technology in the benefits list of the National Health Insurance is described in Figure 1.MFDS reviews new applications for approval, registration, and certification of medicine, medical devices, and diagnostics with a focus on safety and efficacy.Once the applied technology passes the MFDS review, HIRA reviews any duplication in the current technology list.If the technology is identified as a new health technology, NECA reviews safety and effectiveness, unless the applied technology is a pharmaceutical product.Based on NECA's results of the safety and effectiveness evaluation of the new nonpharmaceutical technology, HIRA assesses uniqueness and cost-effectiveness if listed in the benefits list and sets the reimbursement price.For pharmaceutical products, NHIS conducts price negotiations with the applicant.MOHW determines whether to include the technology in the benefits list and announces the decision.
In addition, a second track for HTA decisions, known as the "conditional fast track," is available.This track is designated for selected health technologies that lack sufficient evidence for widespread use.The conditional track allows for the coverage of new health technologies on the condition that they must undergo a reassessment after sufficiently accumulating data within a three-year period.Established to facilitate the early introduction of innovative technologies with low usage instances, this track targets technologies that possess limited evidence due to their rarity or the required maturation time to gather sufficient proof.Consequently, this conditional track allows temporary use for a limited period, allowing for the collection of sufficient postmarket, real-world evidence, thereby avoiding delays in the technology's coverage decision.
To speed up reviews across the previously mentioned tracks, medical device licensing, insurance coverage decision making, and HTA can occur simultaneously (Table 2).If the usage of a medical device is aligned with the health technology (or procedure) to be evaluated for HTA, the use of the new health technology can be expedited by reducing the required time for entry into  Implementation of integrated review and assessment system for innovative medical device the health care system by up to ten months compared to the previous process.The New Health Technology Assessment One-Stop Service System or Unified Operation of Medical Device Approval is a simultaneous review system of medical device approval and health technology assessment by MFDS, HIRA, and NECA to expedite decision making.
In parallel to the primary and second tracks, there is the third conditional or preliminary approval pathway for older technologies.This third track, established during the presidency of Park Geun-hye, aimed to rapidly expand the list of existing technologies previously excluded from the benefits list.These were medically necessary technologies initially not included due to the lack of opportunities for reassessment.With this conditional track, technologies could be included in the benefits list in a reduced period due to a streamlined review process.This approach addressed challenges posed by standard reassessment procedures, which had previously kept technologies off the list for extended periods.Often, technologies were initially deemed not suitable for coverage due to budget constraints linked to low health insurance premiums and contributions.This situation resulted in Korea being recognized as a high-income nation with notably low coverage on its benefits list.However, most technologies temporarily covered by this conditional approval were eventually integrated into the permanent benefits list in subsequent years.
This third track evolved from the successful experience of the Participatory Priority Setting Committee (PPSC) established in 2012.It initially provided a prioritized list as a recommendation for revision of the benefits list when it was launched.PPSC consists of 30 members of the lay public, who use information provided by experts.In 2014, PPSC shifted its functional contributions from addressing the specific items for list inclusion to adopting the general policy guidance of the HTA process nested in HIRA, NECA, and MOHW (Table 3).PPSC was established to embrace social value for benefit coverage decisions and revisions, designed using the UK NICE Citizen Council as an international benchmark. 9Rapid inclusion of the wide range of remaining uninsured but medically necessary services became possible through the third track even without PPSC gathering for each set of technologies since PPSC moved to deal general policy guidance from specific items.

History of Institutionalization of HTA and Priority Setting in South Korea
The current HTA process described above had its origins in 2007 with the Evidence-based Medicine Team at the Center for New HTA, which was established as a nested institution in HIRA (Figure 2). 2 Since 2007, tracks for new drugs versus other new health (nondrug) technologies were separated by different committees in HIRA.
With the global UHC movement beginning around 2008, the domestic movement to expand benefit coverage eventually led to the launch of the NECA in December 2008, specializing in HTA research.The Center for New HTA, previously nested in HIRA, was transferred to NECA in 2010.This transfer meant that NECA was now also responsible for reviewing non-drug technologies. 10,11n 2008, during discussions on how to include expensive yet crucial older health technologies not on the benefits list, there was also political debate on the need for an institution similar to NECA. 12 This led to the establishment of the PPSC, led by the lay public, in 2012.As one of the new institutions moving South Korea toward UHC, PPSC played a key role by providing a second opportunity for new coverage decisions for existing but excluded technologies. 9This practical approach toward UHC by the newly introduced reassessment procedures was aligned across the three agencies HIRA, NECA, and MOHW in 2013 (Table 3).

Political Economy of Institutionalization of HTA and Priority Setting
The historical path of the introduction and institutionalization of HTA and priority setting in South Korea was closely linked to its path in moving toward UHC.Two motivations, each with its own challenges and related goals, drove the introduction of HTA-fairness (or equity) and budget constraint (or sustainability).The challenge of fairness was addressed by ensuring an equal explicit benefits list across insurers in the 1990s.This challenge was brought about in part by a group of welfare state movement activists known as the "single payer movement for benefit expansion," originating in 1993.This civil movement advocated for the merger of multiple insurers into a single payer.The national government eventually decided to merge multiple insurers into a single payer with an amendment of the NHI Law in 2000 to standardize, equalize, and improve the benefits list across all enrollees, who were formerly insured by different insurers. 13This civil movement group comprised scholars, labor union movement groups, farmers, and socially disadvantaged groups.United in their goals, they sought a better benefits list, promoting UHC by advocating for a single payer system to achieve a more equitable and comprehensive benefits list.There was no separate request to establish an HTA agency or priority-setting institution; instead they focused on expanding the benefits list and raising more public insurance contributions to cover these services.
A political leader who adopted the vision of welfarist activism toward UHC was President Kim Dae-Joong, who led the eventual merger of fragmented insurers into a single payer in 2000.This initiative triggered government efforts to establish consistent processes for making coverage decisions regarding health technologies.With the benefits list expansion beginning in 2005, there was extensive debate over several years due to inconsistencies in expert consensus-based recommendations across various expert or professional societies.This challenge motivated a request for a new decision-making mechanism based on evidence-based medicine by diverse stakeholders.The legal framework for HTA was established by amendment of the Medical Service Act in October 2006.
The second motivation for South Korea's introduction of HTA was sustainability-specifically how to expand the benefit package carefully during a period of increasing budgets.Between 1977 and 2005, there had been little consideration in the health insurance system of cost containment pressures.When insurers   began to expand the benefits list thanks to financially positive balance sheets, the budget constraint began to emerge amidst a wish list of expanding benefits by realizing the gap between available resources and needed resources to cover all wish lists.In other words, it became apparent to the single payer insurer, NHIS, that there was a pressing need to prioritize the candidate technologies list under a generous budget constraint.Thus, South Korea's HTA agency policy reforms happened despite, or arguably because of, more fiscal room than before, creating momentum for benefits list expansion.
In 2006, Korea decided to launch an HTA agency, initially nested in HIRA and eventually launched in 2007.Initially, pharmaceuticals were not subject to HTA even though pharmaceutical expenditure comprised 25.8% of total health expenditure in 2006. 14By excluding pharmaceuticals from being subjected to strict HTA decisions, pharmaceutical products had more generous coverage compared to other health technologies.This situation persisted until significant expansion reforms began in 2013 and 2017 when new presidents began to expand the benefits list as part of their public election campaign promises.Thanks to two presidential policies during the Park and Moon administrations to expand the benefits list, the list included more comprehensive coverage of nonpharmaceutical technologies than before.External experience and knowledge also influenced the introduction of HTA, such as the NICE Citizen Council of UK as a mechanism for lay public participation in HTA.Academic research also influenced debates by bureaucrats amidst institutionalization attempts; for example, the accountability for reasonableness framework developed by Norman Daniels and James E. Sabin as a form of procedural justice to ensure rational choice in priority setting. 15Industries or beneficiaries generally did not take an active role in the establishment of these institutions, though beneficiaries-through PPSC-ensured that the HTA system represented public opinions.Civil movement groups, led by some professional experts rather than directly by lay citizens, also actively participated in the UHC movement.However, they held ambivalent perspectives and did not clearly support PPSC, where the lay public played a more active role.
Financial and policy decision makers initially relied more on the HTA agency than the PPSC.When political debates continued, policy makers began to rely on the PPSC when it showed the potential of procedural justice by embracing social values complementing classic HTA. 12 Industry did not show its active voice and followed technical requirements passively when the HTA and priority-setting agencies such as NECA and PPSC were established.Eventually, the experts participating in the HTA agency began to insist on more social value judgment integration by involving more of the lay public in the HTA decision-making process. 16olitical leaders, especially the presidents of Korea, have significantly influenced the expansion of the benefits list through various initiatives.President Roh Moo-Hyun was instrumental in the institutionalization of HTA in 2007 by benefits list expansion efforts, which uncovered the resource constraints between available resources versus necessary resources to cover all needs even in a positive financial phase.President Park Geun-hye leveraged the established HTA agency in her policy implementation for adding new technologies into the benefits list in 2013; for example, she introduced PPSC and the conditional preliminary approval third track within HTA to rapidly include a preexisting, medically necessary list of uninsured services.In 2018, President Moon Jae-In made functional use of PPSC to better understand social values by asking several rounds from the PPSC in his first year of presidency regarding willingness to pay when he began to expand the benefits list.
The importance of well-functioning priority setting has been better understood over time with regard to fairness and sustainability.

Agenda of the PPSC, 2012-2022
There was heavy public criticism when the new benefit expansion began through the new priority-setting processes established in HIRA and NECA in 2005 through to 2013.Paradoxically, the lay public and health policy experts did not welcome the list of newly expanded benefits.Different groups favored different priority lists by refusing to support the announced list of new benefits because of a lack of institutionalized priority setting.This criticism was voiced each year, especially on the day after the public announcement of newly expanded benefits by the government.The PPSC changed the atmosphere and tone of public debate, because all committee members were from the lay public, like the NICE Citizen Council.For the first few years, the priority-setting committee worked directly as if it were a health technology reassessment institution by deciding whether to cover every excluded but arguably medically necessary health technology.In the first two years, PPSC addressed approximately 80 technologies, effectively decreasing public criticism.After those two years, the committee evolved to not only assess technologies but also to shape the direction of benefit policy.
Since the PPSC's launch in 2012, there have been 16 convenings over a decade covering diverse topics (Table 3), with the PPSC meeting up to three times per year.For the first PPSC, 45 excluded but postmarket health technologies were reviewed in 2012.Scientific evidence was provided to PPSC by the relevant professional academic societies for each technology.After hearing evidence from the professional societies on the first day of meeting, PPSC deliberated on the second day until a consensus or majority vote after saturation of diverse opinions of the 30 committee members who were selected based on the latest census demographic distribution.The high-priority technologies were newly listed in the updated benefits list.The budget impact of this update was more than a trillion Korean won (1 billion USD)-more than 1% of the annual budget  of NHIS at the time.After this PPSC-based decision to revise and expand the benefits list, ongoing political debate waned.Since the first and second PPSC in 2012 and 2013, PPSC evolved to address both specific technologies and more general policy debate topics such as social value and acceptable payment limits of highly expensive new drugs in 2022.

Discussion
This article is limited by the availability of documents.Where these were not available, we relied on the recollected and imperfect memories and experiences of the authors.The authors tried to reduce this bias by consulting other experts regarding other key events affecting institutional changes.
Benefits list decisions, including technology pricing in fee-for-service-based health insurance systems, require an HTA function regardless of the specific label of HTA itself.PPSC had a unique and different role compared to typical HTA in other high-income countries.Korea had an extensive list of arguably medically necessary but uncovered health technologies that merited rapid inclusion, especially considering that the nation had one of the lowest public finance-based coverage among OECD countries.Though HTA is usually designed to determine the provision of new health technologies, PPSC prioritized health technologies that were not new but arguably medically necessary health technologies that were currently not covered.In this regard, PPSC played the role of health technology reassessment (HTR), although its function was opposite to that in other countries that used HTR to delist old and inefficient technologies by reassessment. 17oth HTA and HTR, including PPSC, serve the purpose of strategic utilization of public resources for improved population health aligned with UHC.In most parts of the world, HTA and HTR primarily serve the purpose of cost containment, focusing on the quality and efficiency of health technology.However, PPSC leans more toward cost-increasing measures that aim to address unmet needs in the benefits list while also considering a rational supply considering the nation's economy.PPSC may not be suitable for other high-income countries that typically do not face unmet needs of this magnitude.Conversely, many low-and middle-income nations share similar needs to include previously uninsured medically necessary health technologies due to resource scarcity, aiming for an expanded benefits list as they experience steady or rapid economic growth.This approach, combined with conditional approval, which enabled rapid coverage of uninsured items by generating a temporary, preliminary list, could serve as a valuable model for the growing economies among low-and middle-income nations as they work to rapidly expand their benefits list.
Recently, Korea has shifted its focus to the budget constraint challenge for HTA.It has become apparent that HTA needs to address the sustainability goal, given that 16% of GDP is anticipated to be spent on health in 2030 at current trends.Value-based health care may divert HTA into every practice or accountable care organization for their own decentralized benefit decision possibilities.Devolving decisions to individual practices seems to diverge from the traditional approach of HTA, which emphasizes a more standardized and centralized format.
To summarize, in South Korea, HIRA and NECA served to strengthen evidence-based and efficiency-based decision making in the health system via HTA, while PPSC served to strengthen social value-based decision making via participatory priority setting.Conditional approval using temporary lists, along with priority setting by the lay public through PPSC, serves as a key lesson to low-and middle-income countries with rapidly growing economies and citizens eager to quickly expand their benefits list.

Disclosure Statement
No potential conflict of interest was reported by the author (s).

Funding
The guest editors of this special issue reported funding from the Bill and Melinda Gates Foundation [OPP1202541].

Figure 1 .
Figure 1.The process of approval and assessment of nonpharmaceutical health technology in National Health Insurance and health technology assessment agencies.
Used as basic data to strengthen coverage of treatment services for obesity 14th (Saturday) December 4, 2021 Priority of items to strengthen coverage in the dental field Used as basic data to strengthen coverage in the dental field 15th (Saturday) September 24, 2022 Social value and acceptable payment limits of ultraexpensive new drugs Used as basic data to strengthen coverage of ultraexpensive new drugs 16th (Saturday) October 29, 2022 How to improve the life-sustaining treatment decision system and introduce physician-assisted death Used as basic data to improve the life-sustaining treatment decision system

Figure 2 .
Figure 2. History of institutionalization of HTA and priority setting in South Korea.

Table 1 .
The evolution of population coverage, scope of service coverage, and depth of coverage toward universal health coverage in South Korea.

Table 2 .
Summary of the series of the health technology assessment optimization policy.
Simultaneous review of new health technology assessment and health care coverage determination November 2020 Implementation of conversion of Unified Operation of Medical Device Approval and HTA October 2022 Time required for innovative health technology assessment is reduced from 250 days to 120 days October 2022
Used as basic data for the first comprehensiveNational Health Insurance plan 12th (Sunday) December 13, 2020 Necessity and strategy for public health care Used as basic data for expanding public health care 13th (Saturday) November 6, 2021 Necessity and measures to strengthen coverage of treatment services for obesity

Table 4 .
List of technologies that passed the New Health Technology Assessment (nHTA) in 2022 (based on application year).

Table 5 .
List of technologies that did not pass the New Health Technology Assessment (nHTA) in 2022 (based on application year, excluding withdrawal or return).Subcutaneous or intramuscular injection (jet injection; for other patient groups: intramuscular injection, dental anesthesia, or intradermal injection) 5 E.M. routine (PBMC) 6 In patients with meniscal defect, applying implantation of polyurethane scaffold on partial meniscal treatment 7 Liquid-based cytology system using centrifuge automation technology 8 Cranial nerve restoration combining repeated nerve blocks with stimulation of auditory and non-auditory nerves via the trigeminal and facial cranial nerves by hypodermic needle 9 Single nucleotide polymorphism (SNP) markers analysis in hematopoietic stem cell transplantation (next-generation sequencing) vasoreactivity in hands and feet by cyclic cooling and warming 21 Autologous bone marrow stem cell treatment in patients with diabetes with critical limb ischemia 22 18F-dopa positron emission tomography/positron emission tomography-computed tomography (PET/PET-CT; to distinguish Parkinson's disease from essential tremor) 23 Transuretheral water vapor ablation of prostate (prostate volume less than 30 cc, more than 80 cc) Center for New Health Technology Assessment, National Evidence-based Healthcare Collaborating Agency.Assessment Status.Retrieved September 13, 2023, from https://nhta.neca.re.kr/nhta/application/nhtaU0509L.ecg