Health Technology Assessment in Taiwan: Reflections of the Last Twenty Years

ABSTRACT This article offers reflections on the development and management of health technology assessment (HTA) in Taiwan, drawing from my experience as a former Minister of Health and Welfare. The article explores my original vision for HTA, progress made, challenges faced, and the lessons learned during my tenure. Key areas discussed include evidence-based decision-making, the need for a balanced decision-making system, challenges in value justification of an independent HTA organization, and recommendations for countries looking to establish their own HTA agencies.


Introduction
Health technology assessment (HTA) has emerged as a crucial tool in health care decision-making, providing evidence-based evaluations of the effectiveness, safety, and cost-effectiveness of medical technologies. 13][4] Drawing on my former role as Minister of Health and Welfare (MOHW) in Taiwan, I offer reflections on the establishment and development of HTA in Taiwan, focusing on my vision, progress made, challenges encountered, and lessons learned.

The HTA System in Taiwan
The current HTA system in Taiwan is a key element in its health care landscape.Taiwan's National Health Insurance (NHI) listing decision process encompasses the Expert Consultation Meeting, which appraises new drugs and makes preliminary listing suggestions.These suggestions are then reviewed by the Pharmaceutical Benefits and Reimbursement Scheme joint committee for final recommendations.The HTA unit initiates this whole process by reviewing dossiers submitted by drug license holders and crafting assessment reports, which serve as the basis for both committee meetings.These reports include crucial information on the technology's comparative effectiveness, financial or budget impact, cost-effectiveness, and ethical considerations.The scope of HTA in Taiwan has expanded over time to include medical devices, diagnostics, and procedures.
Presently, HTA in Taiwan operates as a program, commissioned to the Center for Drug Evaluation (CDE), a government-funded, nonprofit organization.CDE applies for research funds annually from the National Health Insurance Administration (NHIA) and the MOHW to sustain its operations in HTArelated programs.Functioning as an arm's-length body designed to support government operations, it operates closely under the supervision of these administrations.
The primary role of HTA in Taiwan is to facilitate informed policy decisions by systematically evaluating health technologies.It operates with a broad remit, encompassing the assessment of clinical effectiveness, safety, and cost-effectiveness.These evaluations directly impact policy decisions, particularly in the allocation of health care resources.The stakeholders of HTA in Taiwan are diverse, including health care providers, patients, policy makers, researchers, and industry.

Motives for Establishing HTA
Taiwan's HTA initiative was established in 2007 during my role as Deputy Director-General of the Department of Health (now called the Ministry of Health and Welfare). 3Prior to implementing HTA for pharmaceutical listings in the NHI, decisions were made by an expert committee appointed by the National Health Insurance Administration (formerly the Bureau of National Health Insurance). 3,5Back then, financial difficulties constrained Taiwan's NHI reimbursement listing. 6Furthermore, in comparison to other countries, the listing prices were relatively low, which often deterred international pharmaceutical companies from entering Taiwan's market and introducing new medicines. 5,7Ultimately, it could affect the patients' right to access adequate medical treatment.Additionally, there was a need for a transparent mechanism when deciding whether medicines should be reimbursed by the NHI. 8Apart from expert insights and deliberation, it should be supported by impartial, relevant evidence reviewed by a third party.At the time, I anticipated that transparency could be enhanced by leveraging HTA, which would address the lack of scientific evidence in the decision-making process and serve as a new initiative for Taiwan's pharmaceutical policies.

Vision and Realization of HTA
My vision for HTA in Taiwan centered on establishing a robust system that offered evidence-based information to decision-makers (specifically the expert committee making listing recommendations to the Bureau of National Health Insurance) and contributing to a more balanced pricing mechanism.HTA was, at that time, conceived as a comprehensive organization that empowers patients by providing them access to reliable information, complementing the knowledge of health care professionals. 9In addition, the NHI reimbursement process was surrounded by considerable controversy regarding the balance between clinical effectiveness and financial considerations.The introduction of HTA and the utilization of costeffectiveness assessments aimed to mitigate disputes and empower decision-makers with the most optimal treatment options. 10This approach facilitated the allocation of health care resources in the most favorable manner.

Requests Fulfilled and Unfulfilled
Since 2007, HTA in Taiwan has made remarkable strides in providing evidence-based information, countering decision-making based solely on pharmaceutical manufacturers' narratives and expert influence. 5,7owever, determining the basis for value conversion and addressing political pressures, such as lobbying groups, has proved challenging.In retrospect, clearer consensus building on value conversion could have mitigated some of these issues.
Consensus building involves creating common ground among diverse stakeholders, including government officials, health care providers, pharmaceutical companies, patient advocacy groups, and policy makers.Transparent and inclusive discussions are crucial, ensuring all voices are heard and considered.Consensus building seeks to define "fair pricing" and identify truly valuable health care items.To achieve this, we must transition from traditional unilateral decisionmaking to collaborative methods.
Regular, structured dialogs and meetings organized by various stakeholders can facilitate this shift.As a government official, active participation in such meetings is essential.Instead of arbitrary price cuts, the goal is to transform value and ensure rational decisionmaking, fostering understanding among all stakeholders.

Barriers to Establishing an Independent HTA Organization
The intention to establish an independent HTA organization, such as the National Institute of Health Technology Assessment (NIHTA) in Taiwan, encountered both institutional and political barriers. 3Concerns related to trust and accountability arose regardless of whether HTA was situated within or outside of government.Placing it as a separate legal entity outside of the government raised concerns about trust, while positioning it within the government raises doubts about accountability.The decision on where to position the HTA organization elicits diverse opinions, often influenced by government leaders and their level of support and respect for HTA.If leaders are willing to show respect for the current HTA unit, stakeholders may gradually perceive it as a more independent institution.However, when external pressures are directed back to the HTA organization itself, some stakeholders develop a sense of mistrust toward such organizational positioning.

Political Considerations
Political considerations have had a significant impact on HTA, particularly concerning the establishment of an independent HTA organization.Trust and mistrust within the Taiwanese context have played crucial roles in determining the model and structure of HTA and whether it operated as an independent entity or remained embedded within the government.This is evident when assessing the perceived value of HTA, which has relied on the commitment and determination of government officers to advocate for its importance.To address these challenges, I suggest nurturing a new generation that is well-versed in HTA, aiming to cultivate a positive understanding of its inherent value.By positioning these individuals in influential roles, it would help counterbalance the prevailing health care decision-making systems.

Challenges in Converting Value into Prices
One of the significant challenges in HTA implementation is converting the value of a health technology into a price.There are many complexities arising from stakeholders' conflicting interests, such as pharmaceutical manufacturers, insurers, payers, and patient groups.Balancing these interests while ensuring fair pricing is a substantial hurdle.I suggest engaging stakeholders in a transparent and inclusive dialogue, fostering a shared understanding of the value and its financial implications.
Furthermore, I underscore the importance of considering long-term value and the broader societal impact of health technologies.HTA should not solely focus on short-term cost-effectiveness but also on the potential long-term benefits and outcomes.This requires a shift in mindset and the adoption of preventive health care strategies, where investments in technologies that can prevent or mitigate future health issues are prioritized.

Lessons Learned and Recommendations
After the implementation of the HTA initiative over the last 20 years, the most notable changes in the decisionmaking process from my observations are (1) the shift toward evidence-informed decision-making, (2) increased concerns about the financial impact of the technologies, and (3) stakeholder involvement.Some lessons learned and recommendations for countries seeking to establish their own HTA agencies come from my personal lived experience and service in government.Firstly, it is important to stress that the goal of health care management is to prioritize quality and value, rather than focusing on how much money will be spent.Instead of solely focusing on cost-saving measures, decision-makers should view money as a tool to reflect value and prioritize investments that can yield long-term benefits for patients and the health care system.
I also note the need for early education and awareness of HTA concepts among future leaders.By incorporating HTA principles into the education and training of health care professionals and policy makers, countries can develop a cadre of individuals who have a deep understanding and appreciation for evidencebased decision-making.Such a cadre can contribute to the effective implementation and utilization of HTA in health care policy and practice.
To establish an HTA organization, it is crucial to understand political factors and navigate the landscape. 4While the ideal scenario is an independent HTA organization, I acknowledge the challenges in achieving complete independence due to institutional and political considerations.In such cases, collaborative models, such as the one between the HTA unit and the NHIA in Taiwan, can help mitigate political influences and ensure a more balanced and transparent decision-making process.

Conclusion
As described in this article, the initial implementation of the HTA system in Taiwan aimed to introduce a scientific approach to drug pricing, using evidencebased information to systematically determine drug prices for decision-makers.Over the past two decades, Taiwan's HTA system has evolved to encompass the evaluation of medical devices, medical services, and health and welfare policies.
In retrospect, looking back on the development and management of HTA in Taiwan, it is clear that the country has made significant progress in integrating evidencebased decision-making into health care practices through HTA. 2,5,7However, challenges persist, particularly in converting the value into listing and pricing decisions and in addressing political pressures. 5My recommendations highlight the importance of considering long-term value, fostering HTA awareness among future leaders, and understanding the political landscape when establishing an HTA organization.
By reflecting on Taiwan's experiences and lessons learned, other countries can gain valuable insights and guidance in their efforts to establish their own HTA structure.Transparency, trust, and collaboration between HTA agencies, policy makers, and stakeholders are crucial in ensuring the effective use of HTA to promote a more balanced and evidence-informed health care system.Through continuous learning and adaptation, countries can leverage HTA to improve health care outcomes and ensure the sustainability of their health systems.