Health technology assessment to inform decision making in China: progress, challenges, and sustainability
BMJ 2023; 381 doi: https://doi.org/10.1136/bmj-2021-068910 (Published 15 June 2023) Cite this as: BMJ 2023;381:e068910Read the full collection: Health Technology Assessment in China
- 1School of Public Health, Fudan University, Shanghai 200032, P R China
- 2National Health Commission Key Laboratory of Health Technology Assessment, Fudan University,
- Shanghai 200032, P R China
- 3China National Health Development Research Center, Beijing 100044, P R China
- 4National School of Development, Peking University, Beijing 100871, P R China
- 5 Institute for Global Health and Development, Peking University, Beijing 100871, P R China
- Correspondence to: Y Chen yychen{at}shmu.edu.cn
China has made considerable achievements in social and economic development during the past four decades, yet it is an upper middle income country, albeit the largest, according to World Bank classification.12 Achieving universal health coverage has gained momentum, and the Chinese government has committed to it by providing financial risk protection; access to quality essential health services; and safe, effective, and affordable essential medicines and vaccines for a population of 1.4 billion.34 To attain universal health coverage, decision makers need to ask: What services and technologies should be covered? Who pays for those services and technologies? What cost sharing arrangements should be adopted? They need to find a balance between services that are covered and those that are not, low or high out-of-pocket expenses, generic or brand name pharmaceuticals, a focus on common diseases or rare diseases, generosity or solvency of insurance funds, and so on. Universal health coverage in China also needs to take into account the increasing need to deal with communicable and non-communicable diseases,5 a rapidly ageing population, and fast changing health technologies. Escalating investment in healthcare resources (likely to exceed predicted gross domestic product growth) will be a major challenge.
As a widely used decision making tool, health technology assessment (HTA) is a multidisciplinary activity used to determine the effectiveness or cost effectiveness of a health technology to inform decision making for achieving a high quality healthcare system.6
Since its introduction to China in the 1990s, HTA has had an increasingly important role in healthcare decision making. However, HTA development and its roles in decision making has not been examined in depth. In this article we give an overview of HTA activities in China, summarising the development and current status of HTA, identifying challenges and opportunities for HTA, and discussing how it can be strengthened. Other articles in this BMJ collection, written by experts in various HTA subfields, will consider specific areas in more detail (www.bmj.com/hta-in-china).
Current state of HTA development
Growth of HTA agencies
The 1990s and early 2000s were the formative years of HTA in China. The first wave of HTA development, from 1990 to 2006, was marked by the establishment of academic HTA centres, some HTA pilot projects, and attempts to use HTA findings to inform policy making. The first HTA centre was founded at the Shanghai Medical University (subsequently merged with Fudan University) in 1994, with support from the Ministry of Health and help from international experts. In 2002, the Centre for Pharmacoeconomic Evaluation and Research was established at Fudan University, kick starting pharmacoeconomic research activities in China. This stage was characterised by fragmented HTA activities, initial capacity building, and case based knowledge translation by a partnership of academics, policy makers, and charitable foundations (eg, the China Medical Board).7
In the second stage of development, from 2006 to 2016, more HTA organisations emerged and more activities took place. In 2007, the China National Health Development Research Center, a think tank affiliated with the Ministry of Health, set up a Division of Health Policy Evaluation and Technology Assessment, reflecting the government’s intention to institutionalise HTA in policy making. The Pharmacoeconomics Technical Committee of the Chinese Pharmaceutical Association released, in April 2011, the first set of pharmacoeconomic evaluation guidelines, the China Guidelines for Pharmacoeconomic Evaluations, which provided a methodological framework for doing pharmacoeconomic research.8
Although activities proliferated, HTA was not well positioned for an advisory role9 as it had few institutional linkages with policy making units until the establishment of the National Centre for Medicine and Health Technology Assessment under the National Health Commission (formerly the Ministry of Health) in 2018. There are now dozens of HTA centres and units at different levels of government, universities, professional associations, public hospitals, foundations, and consulting companies. In addition, many HTA allied groups exist in areas such as evidence based medicine and health systems and policy research. The focus of the third stage (2017 to the present) is to explore approaches to inform policy making and to apply HTA evidence to updating the National Reimbursement Drug List.
HTA research output
The number of HTA related publications can be used as a proxy indicator to gauge the level of HTA research activity (fig 1). A bibliometric method was used to track HTA publication trends over 40 years in China. A literature search was done using the following search terms: economic evaluation, HTA focused ethics research, and meta-analysis.
Growth trends of relevant literature between 1980 and 2020. We identified 779 articles on HTA, 10 661 articles on economic evaluation, 271 articles on ethics, and 84 568 articles on meta-analysis. A general upward trend can be discerned in terms of research output, with meta-analysis and economic evaluation accounting for the largest and second largest numbers of publications
The search strategy is (HTA OR health technology assessment OR rapid review) in TITLE, (cost-effectiveness/utility/benefit OR cost OR budget impact OR pharmacoeconomics OR economic) in TITLE, (Ethical OR Ethics) in TITLE, and (Meta OR systematic review) in TITLE; those strategies screened by China [Affiliation] or AD= China. Finally, we collected 96 279 articles by Chinese researchers published in English and in Chinese between 1 January 1980 and 31 December 2020 from six databases (CNKI, WANFANG DATA, SinoMed and CQVIP in Chinese, PubMed, and Web of Science in English).
Impact of HTA on policy making
HTA in China has recently expanded from pure academic research to include policy or decision oriented practice and plays an increasingly important part in informing planning, budgeting, and management for both technology and reimbursement of benefits packages (table 1).
A milestone achievement was the use of HTA evidence to update the national reimbursement drug list for the first time in 2017. This was followed by the inclusion of anti-cancer drugs in the list in 2018 and the decision to use HTA evidence routinely in the review processes in 2019 and 2020 by the National Healthcare Security Administration. Now, the National Healthcare Security Administration typically asks pharmaceutical companies to provide dossiers to support inclusion of their products in the list. Companies are requested to provide evidence showing clinical efficacy, economic evaluation, and potential budget impact. The National Healthcare Security Administration then invites HTA and pharmacoeconomics experts and health insurance fund officials to review these dossiers, and uses such information to negotiate prices and make final inclusion decisions, representing an important switch from “qualitative evaluation by experts” to “quantitative evaluation supported by evidence.” HTA has also been successfully incorporated into policy making procedures.
The National Health Commission has issued guidelines to strengthen the use of HTA since 2016. It has strongly supported the establishment of an HTA system and use of HTA evidence for managing health technology related issues. For instance, commission’s Department of Drug Policy and Essential Medicine has been implementing comprehensive evaluation of drugs in hospitals since 2017; the National Centre for Medicine and Health Technology Assessment has formulated methods and guidelines, and piloted HTA in real world settings. The Department of Clinical Affairs and Clinical Administration regulates use of clinical technologies and has classified them as forbidden, restricted, and general technology since 2018. It has implemented HTA in different stages of clinical technology and piloted hospital based HTA for procedures, devices, and other services in tertiary hospitals. Additional examples include HTA for public health screening programmes and intervention programmes for maternal and child health; and regional health planning for high tech medical equipment, allocation, and performance management and so on. All this shows that the National Health Commission has taken concrete steps to use HTA to inform policy development.10
Table 1 HTA used in different stages of life cycle, by technology
HTA’s future challenges
Lack of policy arrangements for using HTA to support decision making
Although awareness of HTA among policy makers has improved in recent years, gaps remain.
Firstly, insufficient institutionalisation of HTA impedes its further development. Health administration and payers have no well established systems for integrating HTA evidence in advisory, pricing, and reimbursement decision making.
Secondly, standards for guiding the interpretation and implementation of HTA findings by various authorities are lacking. For example, guidelines for conducting and using cost effectiveness studies for reimbursement decision making and critical review of economic evaluations are non-existent.
Thirdly, most HTA studies in China are currently sponsored and funded by manufacturers, giving rise to potential conflict-of-interest concerns. Evidence produced by the pharmaceutical industry could expedite review processes, but transparency and objectivity can be ensured only with HTA conducted by impartial, arm’s length agencies, with public funding required at least for their routine operation, coordination, assessment directly assigned by the government, and appraisals to ensure their objectivity and non-profit nature.
Insufficient HTA staff and expertise
Demand for HTA research has grown rapidly, but there is a notable lack of HTA capacity to do assessments, appraise reports, understand policy implications, and make knowledge translation. Despite an increasing number of HTA centres and a growing workforce, there still is insufficient personnel with requisite skills and experience in governmental institutions, university based centres, consultancy companies, and industry based units. HTA users such as government officials and healthcare professionals are often neglected HTA capacity building targets. While decision makers need to learn more about HTA, HTA practitioners also need to know more about how governments function, the reality of decision making, the timeliness of report preparation, and knowledge translation.
Data availability and accessibility
HTA depends on data availability. In China, difficulties often arise with data infrastructure and access, particularly local data on epidemiology, efficacy, safety, quality of life, resource utilisation, and costs, sometimes resulting in HTA reports lacking in quality and validity.
Lack of standardised methodology and quality control measures
Even when relevant data are available, adoption of appropriate methodology is critical to generating meaningful results to support decision making. While there are global resources that could be used and best practices that are worth learning, China still faces challenges in indigenising methodological approaches to meet national or local needs. For instance, special consideration may be needed when adapting standard HTA methodologies for assessing the efficacy and cost effectiveness of traditional Chinese medicine.
Challenges of integrating evidence into healthcare decision making
HTA evidence typically comprises findings on affordability, potential social and organisational impact, clinical and cost effectiveness considerations, and ethical implications of health technologies. Some HTA practitioners in China have difficulties synthesising multi-level evidence from multiple sources for decision making. Considerable challenges exist in developing an agreed framework by various stakeholders to integrate assessment outcomes in policy making through an evidence informed deliberative process. There are also difficulties in balancing the often divergent interests of stakeholders, including healthcare providers, payers, patients, industry, and regulatory bodies.
Recommendations
Firstly, national level HTA institutionalisation should be prioritised to strengthen the role of HTA in decision making concerning regulation, pricing and reimbursement, planning, and budgeting at hospitals and public health agencies. This includes HTA issue identification and prioritisation, funding of HTA activities, implementation standards for various health technologies, HTA appraisal guidelines, and HTA quality control mechanisms. Public or arm’s length funding of HTA agencies is crucial for safeguarding their independence and the credibility of HTA evidence. It may also help reduce conflict-of-interest concerns among HTA practitioners and users.
Secondly, HTA capacity building is needed to ameliorate inadequate HTA human resources and competency of HTA practitioners. Collaboration and communication among HTA centres at regional, national, and international levels can expedite further development of HTA expertise. Universities in China should be tasked with HTA human resources development and competency building by offering regular degree programmes and short term non-degree training courses for individuals concerned in various HTA activities.
Thirdly, improving the availability of and accessibility to national and local data and developing analytical methodologies appropriate for the nation’s unique healthcare system are essential as part of a mid to long term plan for building a robust HTA system in China. The development of local data infrastructure is critical to generate HTA evidence to support decision making at the sub-national level. Additionally, HTA studies can be conducted more expeditiously if data can be accessed without undue delay. Also, HTA methodologies may need to be modified or indigenised to meet local or special needs.
Finally, to improve the integration of HTA activities with policy making processes, comprehensive value assessment frameworks are needed to meet the requirements of decision making in both national and local settings. Also, making use of global HTA expertise and experience could help strengthen HTA capacity and evidence based decision making processes in China. To this end, exchanges and collaboration between Chinese HTA practitioners and their international counterparts are essential.
Key messages
Health technology assessment (HTA) has an increasingly important role in healthcare decision making in China.
Further development of HTA in China faces potential challenges, including lack of policy arrangements for using HTA to support decision making, insufficient HTA staff and expertise, difficulties with data availability/accessibility, lack of standardised methodology and quality control measures, and challenges of integrating multidimensional assessments into deliberative processes.
We recommend strengthening the institutionalisation of HTA at national level, establishing more HTA agencies with arm’s length funding, using multi-channel resources and inputs, ensuring local data availability, and developing indigenous HTA methodology and evidence informed deliberative processes to enhance HTA in China.
Acknowledgments
We thank John Cairns, Raymond W Pong, and Lizheng Shi for their helpful comments, and Yan Wei, Jian Ming, Yi Yang, Shimeng Liu, and Zhixin Jiang for the literature review, data preparation, and analysis. This work was funded by the National Natural Science Foundation of China (Grant No 72074047).
Footnotes
Contributors and sources: YC’s research focuses on health technology assessment, health economic evaluation, hospital management, and health policy. KZ’s research area includes health technology assessment, health economic evaluation, and health policy. GL’s research focuses on health economics, pharmacoeconomics, global health, and development. WC’s research interests include health economic evaluation, health financing, and health policy. YC, KZ, GL and WC conceived the paper, YC drafted the first manuscript, KZ, GL, and WC reviewed the draft, and all revised and edited the manuscript. YC is the guarantor.
Competing interests: We have read and understood BMJ policy on declaration of interests and have no interests to declare.
Provenance and peer review: Commissioned; externally peer reviewed.
This article is part of a series proposed by China Medical Board and commissioned by The BMJ. The BMJ retained full editorial control over external peer review, editing, and publication of these articles. Article handling fees (including printing, distribution, and open access fees) are funded by the China Medical Board.
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