It is our pleasure to present ISPOR News Across Asia Autumn issue. This issue features a health policy article on Real-World Evidence in China and HEOR and health policy updates from around the region. We also give you important information on ISPOR events and activities relating to Asia Pacific and beyond. We hope you enjoy this issue and warmly invite you to learn more about how ISPOR and ISPOR Asia Consortium are working to improve health care decision making in Asia Pacific and globally.
News Across Asia Co-Editors Alex Fu, Sang Soo Lee, and Fang Zhang
Health Policy Updates
- Producing trustworthy real-world evidence for healthcare practice and policy decisions in China: the initiative to develop an RWE ecosystem and technical guidance
- Health technology assessment in India
- Health policy updates in South Korea
- HTA guideline updates in Thailand
ISPOR Member News
- ISPOR Asia Consortium at ISPOR Europe 2019 Conference
- ISPOR Events in China
- West China Chapter Recognized With the 2019 Outstanding Regional Chapter Award
- Health Economics Workshop in New Zealand
- Second National Workshop on Meta-Analysis and Systematic Review: A Pharmacoeconomic Perspective in Indian Scenario
- Webinar held on ISPOR Chapter Engagement in Local Health Policy Decision-making
- Textbook Publication: Health Technology Assessment in Japan
HEALTH POLICY UPDATES
Producing trustworthy real-world evidence for healthcare practice and policy decisions in China: the initiative to develop an RWE ecosystem and technical guidance
Xin Sun1, Wen Wang1, Jing Tan1, Xiaoxia Peng2, Pei Gao3, Zehuai Wen4, on behalf of ChinaREAL
- Chinese Evidence-based Medicine Center, Cochrane China Center, and ISPOR West China Chapter, West China Hospital, Sichuan University
- Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children’s Hospital, Capital Medical University
- Department of Epidemiology and Biostatistics, School of Public Health, Peking University
- Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine
Since its introduction to China in 2010, real-world evidence (RWE) has increasingly attracted extensive attentions from healthcare practitioners, academic communities, policy makers, and industry partners. The release of key considerations for using RWE by the Center for Drug Evaluation at National Medical Products Administration in May 2019, in particular, represented a formal involvement of governmental authorities in the use of RWE for policy decisions. The proposed use of real-world data for clinical surveillance and assessment of drugs and medical devices also has become an important initiative in the National Heath Commission’s ambition to improve healthcare quality and safety.
Although data usability and accessibility increased with the burgeoning use of information technologies and artificial intelligence in the past decade, significant challenges remain in the production of trustworthy real-world evidence. These not only include issues about data (e.g. data governance, privacy and quality), but also challenges in the appropriate use of data for research purposes. Insufficient research capacities among scientific communities underly ineffective translation of data into trustworthy evidence. Interactions – that are important for the production of RWE – are limited among information experts, clinical research methodologists, and healthcare practitioners. As a result, misunderstanding and misinterpretations continue about real-world data and evidence.
In response to these continuing challenges, China Real World Data and Studies Alliance (ChinaREAL) was created through joint efforts of multiple parties in 2017. The core of the Alliance includes a panel of advisory experts from governmental authorities and academic institutions, and a working group consisting of researchers from leading academic institutions. In addition, efforts have been made to invite data partners across the country to ensure the access to a diversity of data sources. Stakeholders such as industry also have been involved in the activities. Through involving multiple parties, an ecosystem is thus in shape for the production and use of real-world evidence.
One of ChinaREAL’s primary goals is to strengthen the production of high-quality RWE for healthcare practice and policy decisions. It was recognized at its initiation that the technical guidance documents were highly desirable that may profoundly change the pattern for data governance and application, thus improving the quality of ultimate product – research evidence using real world data. Starting October 2017, the Alliance convened a group of experts to brainstorm for the potential topics of the guidance documents and decided the first batch of five topics in May 2018. The first two topics addressed important methodological standards for transforming real-world data into research-oriented databases to lay foundations for data applications; the third and fourth topics dealt with issues about epidemiological designs and statistical considerations in the use of data for assessing treatment outcomes in the context of observational studies; the last topic aimed at methodological issues about pragmatic trials. Instead of developing educational materials, the guidance documents aimed for establishing technical criteria for each of the methodological issues. All the documents were developed in accordance with the rigorous methodological approaches, and the issues specific to healthcare system, data environment, and policy relevance were carefully taken in account when developing recommendations.
Over the course of the guidance development, experts from National Medical Products Administration have gained strong interest and been involved in the development process. These five technical guidance documents were officially released during the Second National Congress on Real World Data and Studies in June 2019, and were electronically available through the website of Chinese Journal of Evidence-based Medicine (http://www.cjebm.com/journal/zgxzyxzz/guokanliulan.html; issue 7 of 2019). We anticipate that the release of the first technical guidance documents would change the current practice of production of real-world evidence in China, and that further efforts are underway to develop more guidance documents that may be specific for certain topics of wide interest.
- Sun X, Tan J, Tang L, et al. Real-world evidence: experience and lessons from China. BMJ 2018;360:j5262
- Sun X, Tan J, Wang W, et al. Developing technical guidance for real-world data and studies to achieve better production and use of real-world evidence in China. Chinese Journal of Evidence-based Medicine. 2019;19(7):755-762
- Wang W, Gao P, Wu J, et al. Technical guidance for developing research databases using existing health and medical data. Chinese Journal of Evidence-based Medicine. 2019;19(7):763-770
- Tan J, Peng X, Shu X, et al. Technical guidance for developing patient registry databases. Chinese Journal of Evidence-based Medicine. 2019;19(7):771-778
- Peng X, Shu X, Tan J, et al. Technical guidance for designing observational studies to assess therapeutic outcomes using real-world data. Chinese Journal of Evidence-based Medicine. 2019;19(7):779-786
- Gao P, Wang Y, Luo J, et al. Technical guidance for statistical analysis to assess therapeutic outcomes using real-world data. Chinese Journal of Evidence-based Medicine. 2019;19(7):787-793
- Wen Z, Li L, Liu Y, et al. Technical guidance for pragmatic randomized controlled trials. Chinese Journal of Evidence-based Medicine. 2019;19(7):794-802
Health Technology Assessment in India
Akriti Chahar, Health Economics & Outcome Research – IQVIA, India
Health Technology Assessment (HTA) programs have been established across the globe in past years, with notable examples including Brazil, Mexico, China, Thailand and South Korea. In India, the Division of Healthcare Technology at the National Health Systems Resource Centre under the Ministry of Health and Family Welfare, Govt. of India (which is also the first South Asian WHO collaborating Centre for priority medical devices and health technology policy) has initiated the HTA process. The first compendium of HTA – an evidence-based approach to technology-related policy making for Indian health care was launched at the 4th International Health Technology Assessment Fellowship in Chennai in August 2014.
HTA is being progressively used as a tool for making decisions in programs covered under the National Health Mission, which is India’s novel approach. While broad health programs that are to be covered and health services that are to be included in such programs are planned based on evidence, social priorities and preferences are also given importance as well. A comprehensive HTA includes the measure of clinical effectiveness, cost effectiveness, legal and social dimensions of technologies and interventions, and these are well-reflected in the Indian decision-making process currently.
Many advancements have been made in the field of HTA. Among them, some major advancement is as below:
- HTA on Dialysis resulted in the launch of the national dialysis program under which people with end stage renal failure could get access to dialysis facilities.
- Along with National Pharmaceutical Pricing Authority (NPPA), HTA on cardiac stents  and Orthopedic  implantation resulted in their inclusion in the national list of essential medicines for cost control on stents.
- National Health Innovation Portal has been launched (www.nhinp.org) on 2nd July 2015 so that innovations, with Technology Readiness Level (TRL) above 7, could be uploaded for assessment through HTA and for ministry’s consideration for uptake. 
In 2017, Government of India has set up formal HTA body, known as Health Technology Assessment in India (HTAIn) under the Department of Health Research (DHR), Ministry of Health and Family welfare, to facilitate the process of transparent and evidence decision making in the field of health. Its primary goal is to inform government health department officials about clinical and cost effectiveness of any intervention to be undertaken in public health programs.
- Compendium of Health Technology Assessments. NHSRC & WHO. Available at: http://nhsrcindia.org/sites/default/files/practice_file/Health%20Technology%20Assessments.pdf
- National Pharmaceutical Pricing Authority REPORT ON PRICING OF STENTS. NPPA, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Available at: http://www.nppaindia.nic.in/wp-content/uploads/2018/08/REPORT-ON-PRICING-OF-STENTS04022016.pdf
- National Pharmaceutical Pricing Authority REPORT ON Orthopedic Implant. NPPA, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers Available at: http://www.nppaindia.nic.in/wp-content/uploads/2018/08/nhsrc_report_on_ortho.pdf
- Available at: http://nhinp.org/index.php/program-database/institutional-framework-for-assessment-of-health-product-innovation
Health Policy Updates in South Korea
Sang-Soo (SS) Lee, PhD, MBA, Healthcare Economics & Government Affairs Director, Medtronic North Asia (Korea & Japan), and Vice President, ISPOR Korea Chapter
- South Korean government’s follow-up measures on national health insurance (NHI) coverage
On September 25, 2019, the Ministry of Health and Welfare (MoHW) held the 19th Health Insurance Policy Deliberation Committee (HIPDC) meeting. MoHW announced their decision to broaden NHI coverage on following fields.
- Expansion of the current criteria for NHI coverage of abdominal and thoracic Magnetic Resonance Imaging (MRI) from the existing four major diseases to patients with gallstones and heart failure who need an in-depth MRI examination
- As a follow-up measure to the enhancement of guaranteeing NHI announced on August 2017, the scope of NHI coverage for the examination of the MRI of the abdominal and thoracic regions will be expanded. In the past, only serious diseases such as cancers were covered by the insurance. Other patients with malignant tumors, benign tumors requiring screening and gallbladder stones with medium or higher degrees were not covered by insurance and paid the full examination fee.
- Starting from November 1, in addition to NHI on patients who are required to have MRI in the abdomen and thoracic lesions, NHI will be applied to patients if the physician determines that a precise diagnosis through MRI is necessary after another prior examination.
- Once abdomen and thoracic MRI are covered by the NHI, patients will pay one third of what they used to pay before.
- NHI reimbursement of self-glucose monitoring devices such as Continuous Glucose Monitoring (CGM), insulin pumps for children (type 1) diabetes
- As a follow-up measure to ‘Protecting Children with Diabetes’ announced by the Office for Government Policy Coordination on November of 2017, the NHI coverage will be newly applied to GGM and insulin pumps.
- Starting from January of 2020, patients will afford for 30% of the lower price between actual purchase price below the base price or base price. Including seven diabetes consumable materials, type 1 diabetes patients will have reduced financial burden up to 4.2million Korean won (KRW) per year based on reimbursement base amount.
- NHI coverage expansion on insulin pumps will ease children patients’ difficulties in insulin injection and their parents’ inconvenience in daily lives.
- Status check and NHI coverage expansion plans of non-covered services and items
Expansion of NHI coverage has been one of the major focuses of “Moon Care” (Korean health reform). Focusing on medical services and items with high necessity and heavy public burden, the Korean government has implemented its major tasks without a glitch over the past two years. However, there remains some points to consider on following sectors.
- There exists a controversy of reimbursement coverage on advanced medical technologies that are expensive but do not have distinct effectiveness. For example, Da Vinci Robot Surgery accounts for non-covered services and items size of $70 million, while robotic surgery’s customary price is about $8,500.
- HIPDC will promote social discussions on methods and possibilities of reimbursement coverage.
- Considering cost-burden of non-covered services and items, the Korean government will plan for reimbursement coverage and lead to appropriate medical treatment through strict application of reimbursement standards and procedure and physician fees. Instead, to further activate medical sectors with higher quality and cost-effectiveness, the government will actively push for raising procedure and physician fees for necessary sectors.
HTA guideline updates in Thailand
Thailand is in the process of updating their HTA guidelines to version 3.0 which will aim to be released in early 2020. Stay tuned for more updates in the coming months.
ISPOR MEMBER NEWS
ISPOR Asia Consortium Activities at ISPOR Europe 2019
ISPOR Asia Consortium will be hosting a business meeting during the ISPOR Europe 2019 Conference on Tuesday, 5 November, 2019, 1:00PM-2:15PM. All interested in HEOR in Asia Pacific and welcomed to join. The meeting will feature updates on health policy and HEOR from 9 jurisdictions in Asia Pacific as well as updates on important ISPOR initiatives in the region including the upcoming ISPOR Asia Pacific 2020 Conference. ISPOR Global Networks will also be organizing a forum entitled “Use of MCDA in HTA, Coverage and Reimbursement Decision-Making: Experience and Insights from EMEA, Latin America and Asia-Pacific” on Tuesday, 05 November 2019, 12:30PM-1:45PM. For more information, please contact firstname.lastname@example.org.
ISPOR Events in China
ISPOR will be hosting and participating in several events in China later this month. Firstly, ISPOR will be hosting HTA and Patient Representative Roundtables in Beijing on Friday October 25, 2019. The HTA roundtable is an invitation-only discussion table for government policymakers, healthcare payers and HTA experts from Asia Pacific to discuss the topics of high cost drugs and curative therapies and HTA development and utilization, with countries presenting key cases of managed entry schemes, negotiation mechanisms, HTA harmonization and HTA in Universal Health Coverage, and patient involvement in healthcare decision-making. The Patient Representative Roundtable is a multi-stakeholder forum featuring discussion on methodologies and practices surrounding patient involvement in HTA decision-making. Reports on these important discussions will be published following the event.
ISPOR will also be participating in the 2nd China Health Technology Assessment (HTA) Conference, Beijing, China, October 26th-27th, 2019 organized by the China National Health Development Research Center. ISPOR Asia Consortium Executive Committee Chair, Dr. Kun Zhao is a leading HTA expert in China and is heavily involved in this initiative. The conference is a neutral forum for researchers, agencies, policymakers, industry, academia, health service providers, patients and other stakeholders within China and abroad to discuss the recent HTA trends and policy reform. ISPOR’s President Nancy Devlin will be delivering a plenary presentation on the topic of value judgements in healthcare. More information will be made available following this event.
West China Chapter Recognized With the 2019 Outstanding Regional Chapter Award
ISPOR West China Chapter has been recognized with the Outstanding Regional Chapter Award, delivering outstanding contribution and leadership in advancing ISPOR’s mission in the region. The ISPOR Outstanding Regional Chapter Award Program was introduced by ISPOR in 2017 to recognize outstanding contribution and leadership of ISPOR Regional Chapters in advancing the Society’s mission in its global regions – Asia Pacific; Latin America; and Europe, Middle East, and Africa. ISPOR also congratulates the ISPOR Russia St. Petersburg and Colombia Regional chapters for being recognized with the award. Additional information about the award can be found here.
The Chapter President, Dr Xin Sun, will be accepting the award during the second plenary session at ISPOR Europe 2019 in Copenhagen, Denmark. An interview with him and other awarded chapter presidents will be featured in the November/December 2019 issue of Value & Outcomes Spotlight.
Health Economics Workshop in New Zealand
ISPOR New Zealand Chapter hosted a workshop on “Perspectives on health economics in New Zealand” on 17 October 2019, 9:00 am-3:30 pm at Massey University, Wellington, New Zealand. Key topics covered will include “Using Real-World Data for Precision Medicine: Where do Patient Preferences play a role?”, patient-centered healthcare, healthcare funding and reimbursement decisions, utility measures and others. For more information please visit the ISPOR New Zealand Chapter website.
Second National Workshop on Meta-Analysis and Systematic Review: A Pharmacoeconomic Perspective in Indian Scenario
The Department of Pharmacy Practice, Chalapathi Institute of Pharmaceutical Sciences, in association with International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Amaravati Regional Chapter conducted 2nd National workshop on meta-analysis and systematic review: A Pharmacoeconomic perspective in Indian scenario on July 19-20, 2019. The workshop covered key topics including methods to collect data, critically appraise and synthesize research studies, study design, and synthesize studies. A total of 250 participants from various institutions attended the conference. For more information please visit the ISPOR India – Amaravati Chapter website.
Webinar held on ISPOR Chapter Engagement in Local Health Policy Decision-making
ISPOR Global Networks recently hosted a webinar on September 30, 2019 that highlighted examples of ISPOR regional chapters supporting and informing healthcare decision-making in their respective countries, such as commenting on policy, formulating guidelines and even establishing government agencies with the support of ISPOR tools and resources. There were speakers representing chapters from all over the globe, and these presentations highlighted the impact ISPOR is making through its chapters and members globally. For more information on this interesting initiative please click here. To access the webinar recording, please click here.
Textbook Publication: Health Technology Assessment in Japan
A textbook was recently published entitled Health Technology Assessment in Japan: Policy, Pharmacoeconomic Methods and Guidelines, Value, and Beyond. This work offers the reader an introduction to the Japanese systems for health technology assessment (HTA) officially introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2016. Policy and guidelines are discussed, with the relevant methods and conditions of cost-effectiveness analysis explained alongside. Numerous instructive examples and exercises, ranging from basic to advanced, impart valuable knowledge and insight on the quantitative methods for economic evaluation, which will appeal to both beginners and experts. For more information please visit here.
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The ISPOR Asia Consortium Consortium is comprised of professionals interested in promoting health economics and outcomes research (HEOR) excellence to improve healthcare decision making in Asia Pacific and globally. The Asia consortium provides a platform for information-sharing and institutional collaboration on HEOR and health policy, facilitating professional networking opportunities through scientific activities and global ISPOR initiatives.
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