• Progress on HTA and Pharmacoeconomics in Asia

    In many countries, health care and pharmaceutical regulators have decades of experience employing health technology assessment (HTA) to better inform decisions on reimbursement policies and pricing negotiations. More recently, a number of Asian countries have started down the same path.

    HTA introduces the concept of economic value into the evaluation of new health care technologies – that is, drugs, devices, or procedures used in treating health conditions. HTA allows a country’s health care regulators to negotiate the best value for money, while ensuring accessibility of high-quality care. It goes beyond relying solely on a clinical evaluation of efficacy and safety to provide methodologies for quantifying the economic value of a technology as well.

    By the time HTA began to be introduced in Asia in the late 1990s, many European countries, Canada, and Australia already had years of experience with institutionalizing it. In 2006, South Korea became the first Asian country to introduce a formal HTA process for listing new drugs for reimbursement.

    Since then, other Asian countries have started to adapt others’ experience to their own country-specific situations. As we noted in our 2019 paper, “The Development of Health Technology Assessment in Asia: Current Status and Future Trends,” each country’s starting point, mechanisms, and systems are unique. However, collectively their experiences in implementing HTA provide useful insights into the fundamental principles underlying HTA, as well as common challenges many of them have faced.

    The experiences of South Korea, Japan, and China illustrate countries at three different stages of implementation.

    SOUTH KOREA: Building on successful experience
    The first national HTA program in Asia, established in 2006
    Before HTA
    HTA developments
    If drugs were approved for use by the Ministry of Food and Drug Safety, no additional data were required before they were added to the official list of reimbursable drugs

    New drugs will not be eligible for reimbursement unless pharmacoeconomic factors are considered along with clinical benefits:

    • Cost effectiveness assessed against a comparator
    • Budget impact analysis
    • Public health considerations
    • Reimbursement status of the same drug in other countries
    Pricing for listed drugs was not negotiated, but based on predetermined formulae Value-based pricing is negotiated with manufacturers before drugs are listed
    JAPAN: Taking the first steps
    3-year pilot led to national program in 2019
    Before HTA
    HTA developments
    Manufacturers rarely provided cost-effectiveness data

    In the pilot program for 7 drugs and 6 devices, formal HTA elements were introduced:

    • Cost effectiveness
    • Budget impact analysis
    • Flexible considerations for rare diseases, cancers, etc.
    • Reimbursement and price status of the same drug in other countries

    Drug prices were set by comparison with similar drugs available in Japan or other markets

    If no comparator was available, cost-plus pricing was used to cover manufacturers’ drug development costs

    For drugs and devices in the pilot program, incremental cost-effectiveness ratio (ICER) and quality-adjusted life-year (QALY) thresholds were employed to adjust prices based on demonstrated cost effectiveness
    CHINA: Laying the groundwork
    HTA concepts beginning to be incorporated into pricing and reimbursement decisions
    Before HTA
    HTA developments
    HTA research projects and activities were conducted only at local academic institutions, and were not used as a policy tool China Guidelines for Pharmacoeconomic Evaluations provides a framework for HTA
    Price and reimbursement decisions were based almost solely on qualitative expert consensus Both clinical and economic evaluations (value-based negotiations) are required before new drugs are placed on the National Reimbursement Drug List
    The use of HTA was fragmented The China Health Policy and Technology Assessment Network was formed to develop HTA capacity and expertise

    Keys for success

    Although South Korea, Japan, and China are at different points along the path to full HTA implementation, they all face similar challenges in moving their programs forward. International collaborations and networks with experts and with countries farther along the path to implementation can provide crucial guidance and support for establishing frameworks, particularly during the initial phases of HTA implementation.

    The experiences of these countries show that successful HTA programs are based on several key principles.

    Establish a coherent and comprehensive framework

    It is critical to develop clear and standardized guidelines that contain:

    • Objectives
    • Assessment criteria and processes
    • Formal measures for the impact of HTA on health care delivery, clinical outcomes, quality of life, etc.
    • Quality standards
    • Best practices

    In South Korea, “a lack of clear guidelines … initially led to dissatisfaction among manufacturers and healthcare providers, requiring corrective measures.”

    –“The Development of Health Technology Assessment in Asia”

    Build accountability into the program

    Accountability is based on:

    • Ensuring that stakeholders perceive the process as fair
    • Having transparency in decision making
    • Documenting how evaluation results will be used in reimbursement decisions and price negotiations

    “To ensure the transparency of the HTA appraisal process, all stakeholders should be involved at each step of implementation, from manufacturers to healthcare providers and patients.”

    –“The Development of Health Technology Assessment in Asia”

    Develop in-country expertise

    A shortage of experts who have a deep understanding of the HTA framework and methodologies can hamper HTA’s implementation and institutionalization.

    “One of the biggest remaining challenges [in South Korea] is the development of professional staff with the necessary pharmacoeconomic expertise.”

    –“The Development of Health Technology Assessment in Asia”

    Raise awareness among all stakeholders

    A successful nationwide implementation of HTA depends in large part on promoting a thorough understanding of it among stakeholders who are unfamiliar or inexperienced with HTA processes and benefits.

    “In research conducted in China, “60% of policy makers were unable to understand HTA studies, and only 3.5% reported [being able] to fully understand the concept of HTA.” development of professional staff with the necessary pharmacoeconomic expertise.”

    –“The Development of Health Technology Assessment in Asia”

    Coordinate activities of different stakeholders

    HTA research that is scattered among governmental, academic, and industry centers impedes full integration of HTA into policymaking, reimbursement, and pricing processes.

    For example, in China “[t]he use of HTA is fragmented, and there is currently no single HTA agency operating at the national level that supervises and coordinates all HTA activities.”

    –“The Development of Health Technology Assessment in Asia”

  • New pharmacoeconomics guidelines help China move forward

    In recent years, China has issued a series of guidelines intended to strengthen the implementation of HTA, starting with the publication of the China Guidelines for Pharmacoeconomic Evaluations in 2015. Updated guidelines were released in late 2019, codifying standards for pharmacoeconomic research in China.

    The updated guidelines serve as a methodological guide for implementing pharmacoeconomic research and provide a set of standards for research quality assessment, which will improve the value of such research for health care decision making.

    Analysis Group was invited to participate in preparing the update, drawing on our extensive experience with pharmacoeconomic evaluation and HTA in different countries. Managing Principal Eric Q. Wu served on the expert panel contributing to HTA development. Peking University’s Professor Gordon Liu, a leading expert on health and development economics and health policy reform, was also a key member of our team. The Analysis Group team was the first to make China’s guidelines available in English translation.

  • Eric Q. Wu, Managing Principal
    Hongbo Yang, Managing Principal

    Portions adapted from “The Development of Health Technology Assessment in Asia: Current Status and Future Trends,” by Gordon Liu, Eric Q. Wu, Jeonghoon Ahn, Isao Kamae, Jipan Xie, and Hongbo Yang, published in
    Value in Health Regional Issues, 2020; 21(c):39-44