Tue 20 Sep
9:00 - 10:15
Opening Plenary
Welcome
Speaker
Paul Scuffham, PhD
Griffith University, Queensland, Australia
Value or Volume: Is the Asia Pacific Region Transforming into Value-Based Health Care?
Amid the global COVID-19 outbreak, many countries are trying to provide equitable, good quality, and cost-effective healthcare services. Value-based health care (VBHC), which aims to improve healthcare services by increasing outcomes with lowered costs, bas been in the spotlight against volume-based healthcare delivery systems such as fee-for-service payment models. The Asia Pacific region is no exception in this global trend of VBHC and the concept of VBHC is rapidly spreading and various demonstrations (e.g., value-based payment, value-based pricing, or value-based procurement, etc.) are being undertaken and more discussion to adopt this value-based approach is underway. There has been divergent operation of VBHC across the Asia Pacific region such as the VBHC arrangements limited to specific technologies (e.g., pharmaceuticals, medical devices, and diagnostics) or comprehensive healthcare delivery transformation to embrace VBHC throughout the healthcare system. In addition, there are some countries that still focus on volume-based payment rather than value as their main theme in payment models.
This session will address the snapshot of VBHC operation across the Asia Pacific region and discuss about the health policy aligned with VBHC in the areas of reimbursement, pricing, and payment models, as well as opportunities and challenges to implement VBHC to help build sustainable and resilient healthcare systems.
Moderators
Kathleen Carberry, RN, MPH
Dell Medical School, The University of Texas, Austin, TX, USA
Kathy serves as the Outcomes Program Officer at the Value Institute for Health and Care at the University of Texas at Austin, where she holds faculty appointments at Dell Medical School and McCombs School of Business. Kathy is responsible for developing and teaching graduate courses and executive programs focused on how to measure health outcomes and create relationship-centered solutions that improve outcomes and meet people’s unmet health needs. She works with a variety of clinical partners to design and implement value-based care delivery models. Kathy has been a registered nurse for over 20 years.
Speakers
Daphne Khoo, MD
Ministry of Health, Singapore, Singapore
Dr. Daphne Khoo is currently the Deputy Director of Medical Services (DDMS) (Healthcare
Performance Group - HPG) as well as the founding Executive Director of the Agency for Care
Effectiveness (ACE).
As DDMS (HPG) she leads the Ministry of Health’s teams which oversee Patient Safety, Clinical
Outcomes, Value Driven Care, Population Health Indicators, Healthcare System Indicators and the
National Improvement Unit. ACE is Singapore’s national Healthcare Technology Agency which
conducts clinical and cost effective evaluation of drugs and device classes prior to coverage
decisions by the Ministry of Health (MOH). ACE also issues MOH’s Appropriate Care Guides which
guide clinical practice nationally.
Dr. Khoo received her Endocrinology training at the Singapore General Hospital and the Cleveland
Clinic, USA. She spent earlier years of her career in clinical and translational research, as well as
in the private sector. As Chief Medical Officer, Fortis Healthcare, she had responsibilities in 11
countries including India and Vietnam. She is a Past President of the Endocrine and Metabolic
Society, Singapore, ASEAN Federation of Endocrine Societies as well as the Association of
Women Doctors, Singapore.
Sun Min Kim, MD, PhD
Health Insurance Review & Assessment Service (HIRA), republic, South Korea
Dr. Sun Min Kim is a President of the Health Insurance Review and Assessment Service (HIRA) that conducts claims review, healthcare service quality assessment and benefit listing with value based healthcare and pharmaceuticals.
Dr. Kim recently finished a role of OECD chair for Working Party on Health Care Quality and Outcome (HCQO). She worked as Senior Technical Officer of WHO and WHO Advisory Committee member for Global Report on Patient Safety and Health Care Quality.
She was trained as a doctor of family medicine and occupational and environmental medicine (OEM) at the Seoul National University Hospital and obtained a Doctor of Philosophy (Preventive Medicine) from Seoul National University.
Kylie Woolcock
Australian Healthcare and Hospitals Association (AHHA), Deakin West, ACT, WA, Australia
Kylie Woolcock is CEO, Australian Healthcare and Hospitals Association.
She has worked in the health sector for over 20 years, starting her career as a pharmacist, before moving her focus into health workforce development and service implementation. She has extensive experience in the for-purpose sector, bringing the diverse views of stakeholders together with the evidence base to influence and effect change. She has worked with a range of health professions, service providers and governments; from the perspectives of education, policy, professional practice, service provision and regulation; and from a local region, national and international focus. She has postgraduate qualifications in health economics, artificial intelligence, training and management. She is Visiting Fellow, Queensland University of Technology and a Board Director, All.Can Australia.
10:15 - 10:30
Break
10:30 - 11:30
Educational Symposium
Recognizing Cultural Diversity in Patient-Centered Outcomes for Healthcare Decision Making
Across multiple international clinical trials, different effect sizes have been seen in Asian patients compared to their Western country counterparts, especially for endpoints that are self-reported. This leads to challenges in value development and evidence generation, ultimately limiting patient access to potentially highly efficacious products in Asian countries. Previous evidence has showed that this difference could be due to PK/PD or genetic differences in Asian patients. However, another highly impactful variable that is not well understood is the role of cultural diversity.
What are the cultural differences that exist and what is their impact?
What are the perspectives of the HTA stakeholders in Asia?
What are the methodologies that could be implemented to recognize these differences in clinical trials and real-world studies?
Sponsor
EMD Serono
Moderators
Ember Lu, PharmD, MS
EMD Serono, Billerica, MA, USA
Ember Lu is an Global Evidence & Value Development associate director at EMD Serono supporting a late phase oncology product. She is an experienced health economics and outcomes research professional with a PharmD background. Prior to joining EMD Serono, Ember supported products across different therapeutic areas including respiratory, nephrology, and oncology, at a large pharmaceutical company.
Speakers
Arinesalingam Gnanasakthy, MSc, MBA
RTI Health Solutions, Research Triangle Park, NC, USA
Ari Gnanasakthy is a Principal Scientist at RTI Health Solutions. Prior to his appointment seven years ago at RTI-HS Ari was an Executive Director at Novartis Pharmaceuticals, and headed the Patient Reported Outcomes Center of Excellence. He has been in the pharmaceutical industry for almost 35 years. Within Novartis he has been in various functions including Biostatistics, Health Economics, Pricing, and Outcomes Research. Ari has extensively published in topics related PROs.
Andrea Latour, MSc
PRMA Consulting, Singapore, 01, Singapore
Andrea is the Senior Director of APAC in PRMA Consulting and a market access expert based in Singapore. He has considerable experience in both Pharma and Consulting. In his role he is primarily responsible for managing project teams delivering market access and health economics assignments in the Asia-Pacific region, particularly related to access of high cost and high value technologies across different country archetypes.
Jipan Xie, MD, PhD
XL Source Inc, Los Angeles, CA, USA
Dr. Xie is a health economist with extensive experience in health economics and outcomes research (HEOR). Her expertise includes economic evaluations, health technology assessments (HTAs) in both US and global markets, and real-world evidence. Dr. Xie has worked in a variety of disease areas, including oncology, mental health, other chronic diseases, and infectious diseases. Her work has been widely published in leading clinical, economic, and managed care journals such as Circulation, Stroke, PharmacoEconomics, Value in Health, and The American Journal of Managed Care. Dr. Xie has extensive experience in emerging markets, particularly in China. Her work in this area includes outcomes research using electronic medial record (EMR) data, claims and surveys, and economic evaluations. She coedited a special issue on health care in China for PharmacoEconomics.
11:30 - 11:45
Break
11:45 - 12:45
Concurrent Breakout Session 1
The EQ-5D-Y (Youth) in the Asia-Pacific: What Is It, How to Get It, and How to Use It?
Level: Foundational
PURPOSE:
A child-friendly version of EQ-5D (EQ-5D-Y) has been in demand for quite some years, but only recently progress in the development has accelerated. The EQ-5D-Y is an internationally developed health-related quality of life measure, designed for use in both clinical research and health economics. The aim is to share experiences of using EQ-5D-Y in the Asia-Pacific region and helping researchers and users to incorporate the instrument into their studies.
DESCRIPTION:
The workshop has four prerecorded pitches, each followed by answering questions from the chat, to maximize interaction. Prerecorded pitches will be subtitled in Chinese and English.
Pitch 1) What is EQ-5D-Y? The pitch will be started with a 4-minute animation explaining how to use EQ-5D-Y, followed by an update of the latest developments in different Asian Pacific regions. Pitch 2) How to obtain EQ-5D-Y instrument? For most research the EQ-5D-Y is free of charge. Nevertheless, researchers may have difficulty finding its official version. A short animation will teach audience how to obtain the latest and thus the most valid version of the instrument. We then discuss what to do if there is not yet a version available for an Asian-Pacific child population. Pitch 3) Which mode of administration to use? For instance, there are different self-complete versions: paper/PDA/tablet/laptop; proxy versions and interview protocols: face-to-face telephone. A video with examples will be presented and the considerations for choosing different modes of administration will be discussed. Pitch 4) How to value children’s health states? A summary ‘score’ or ‘value’ can be derived from a formula that attaches values (weights) to EQ-5D-Y health states. These sophisticated EQ-5D-Y values are a major feature of the EQ-5D instruments, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of healthcare interventions. A video will explain how the summary value is calculated.
Discussion Leaders
Nan Luo, PhD
National University of Singapore, Singapore, Singapore
Dr Nan Luo is an Associate Professor in Saw Swee Hock School of Public Health at the National University of Singapore. Dr Luo’s main research interest is measurement of patient-reported outcomes (PRO) including health-related quality of life (HRQoL) and health preferences.
Discussants
Jan Van Busschbach, PhD
Erasmus University Medical Center, Rotterdam, Netherlands
Prof. Dr. Jan Busschbach is the chair of the section Medical Psychology at the Erasmus Medical Centre. He is a member of the committee who advices on reimbursement dossier submitted to the Dutch National Health Insurance (APC). As former chair of the EuroQol Group, he is involved many quality of life studies, and studies about the application of arguments next to cost-effectiveness in reimbursement discussions.
Zhihao Yang, PhD
Jinan University, Guiyang, China
Zhihao Yang is an Associate Professor from Guizhou Medical University, China who has extensieve experience in conducting health preference and patient reported outcome studies. He is an EuroQol member.
Wenjing Zhou, MSc
Erasmus Medical Centre, Rotterdam, ZH, Netherlands
Wenjing Zhou is a pediatric physician at Shanghai Renji Hospital, China. She is now undertaking PhD programme at Erasmus University Rotterdam. Her research is focusing on the Health-related Quality of Life in children and adolescents.
Real-World Data-Based Health Economic Framework for Drug Value Re-Assessment to Support Clinical and Policy Decisions Using Glucose-Lowering Agents as an Example
Level: Intermediate
PURPOSE:
Real-world cost-effectiveness analyses (CEAs) that provide good estimates of health costs and outcomes associated with pharmaceuticals among patients in actual practice are particularly valuable for re-assessing values of pharmaceuticals from the post-marketing perspective. This workshop will focus on building a real-world CEA for pharmaceuticals using glucose-lowering agents in diabetes as an example. Participants will learn how to conduct real-world data (RWD)-based CEAs through applying science-based health economic theories, adopting advanced methodologies, and utilizing large-scale, multidimensional, individual-level, and longitudinal RWD, which all together ensure the validity and applicability of findings to local settings.
DESCRIPTION:
Attendees will obtain a working knowledge of RWD-based CEAs for pharmaceuticals. The workshop will present a series of studies as a research framework to build RWD-based CEAs, including how to 1) identify a study cohort of comparable treatment groups for generating reliable real-world evidence on comparative treatment effectiveness/safety, 2) estimate country/setting-specific health cost and utility parameters for better reflecting patient characteristics in target clinical settings, and 3) conduct cohort study-based and model-based simulation studies for analyzing the long-term health and economic outcomes. Dr. Ou will chair the session, and present the challenges for conducting RWD-based CEAs and introduce a framework for RWD-based CEAs (5 min.), Ms. Yang will show how to estimate treatment effectiveness/safety with rigorous methods and real-world population data (10 min.), Dr. Kuo will present how to assess country-specific health cost and utility estimates using RWD with adjustment for potential confounders (15 min.), and Mr. Peng will demonstrate how these real-world parameters can be input into study-based or risk equation-based modeling CEAs, and how these results can be provided for clinical and policy implications (15 min.). Audience participation will include a hypothetical case study for RWD-based CEAs (15 min.). This workshop will be valuable to researchers, clinicians, and industry analysts who are interested in RWD-based CEAs.
Discussion Leaders
Huang-Tz Ou, PhD
National Cheng Kung University, Tainan, Taiwan
Dr. Ou has been involved in numerous comparative effectiveness, safety and cost-effectiveness studies in Taiwan. She leads the effort to the growth and development of Health Outcomes and Economic research in Taiwan, and builds a strong collaborative research in international community. Her research portfolio in the past 10 years showcases her great interest to advance real-world cost-effectiveness analyses with strong commitment to inform clinicians and policy-makers of cost-effective treatments through innovative and quality research. Her long-term goals are to promote personalized medicine and facilitate health policy decisions through robust evidence on clinical, economic and humanistic outcomes of pharmaceuticals, and ultimately support the substantiality of the Taiwan’s National Health Insurance program.
Discussants
Shihchen Kuo, PhD
Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan, Tainan City, Taiwan
Dr. Shihchen Kuo is an Assistant Research Scientist at the University of Michigan Medical School. He is a pharmacist-epidemiologist, health services researcher, and decision-analytic modeler. His research is focused on using health economics and outcomes research (HEOR), computer simulation modeling, and decision-analytic science to help inform clinical care and health policy decision-making. He has been working with the Michigan diabetes modeling group and collaborating with multidisciplinary researchers in the U.S. and around the world to conduct HEOR for diabetes prevention and control.
Zi-Yang Peng, MS
Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Mr. Zi-Yang Peng is a junior researcher at National Cheng Kung University in Taiwan. His research is mainly focused on the health economic and outcome research using large-scale health insurance database, TreeAge software for generating high value evidence to support clinical and policy decision-making. He collaborated with multiple talented researchers in this field who have experienced on conducting the real-world based cost-effectiveness analysis to re-assess the drugs’ value.
Chun-Ting Yang, MS
Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, TNN, Taiwan
Ms. Chun-Ting Yang is a PhD candidate at the National Cheng Kung University in Taiwan. She is a pharmacist and researcher in the fields of pharmacoepidemiology, health economics and outcomes research, and the science of decision making.
In the last 5 years, she worked on several population-based real-world studies that assessed the comparative effectiveness, safety, and cost-effectiveness of disease treatments. Also, she has extensive experiences on collaborating with multidisciplinary teams for real-world evidence generation to inform clinical decisions and health policy formulations.
Health Equity Research in HEOR (Health Economics and Outcomes Research): The State of Play in the Asia Pacific Region
Level: Foundational
ISSUE:
Health equity concerns are receiving increasing attention globally in recent years, following the COVID-19 pandemic and subsequent, widening socioeconomic disparities. Although "health equity” and “health gaps” are frequently discussed in the global policy dialogue, its implications, relevant interventions and impacts differ substantially across the country. While there has been significant progress in research methodology for integrating equity considerations in Health Economics and Outcomes Research (HEOR) in the last decade, such advanced research is mostly increasing in other regions. In the Asia-Pacific region, learning and application of equity-informative HEOR methodology have been initiated in some countries. However, its application is generally still limited, despite growing interests across the region. Therefore, the goal of this workshop is to share the state of play of health equity research in the region, and discuss the opportunities, challenges and a way forward, which is coordinated by the network of researchers in the region who undertake equity-informative HEOR. OVERVIEW:
The moderator and panelists will provide a short presentation from each country to share experience on equity-informative HEOR (e.g., India, the Philippines, Thailand and Japan). Presentations about India and Thailand will be delivered from the HTA body’s perspective (i.e., JIPMER and HITAP); a presentation about the Philippines will be provided from the academia or the ministry of health (TBC); and a presentation about Japan will be delivered from the academia’s perspective. Following the presentations from different perspectives, a moderated discussion will address the opportunities and challenges in initiating and advancing equity-informative HEOR in the region, primarily in terms of learning/training, methodological advancement, advocacy, networking and data-generation. Discussions will also acknowledge some different approaches and steps for equity-informative HEOR in each context. Session participants will be also encouraged to contribute to the discussion, in exploring a way forward to initiate and advance equity-informative HEOR in the region.
Moderators
Kyoko Shimamoto, PhD
Keio University, Tokyo, Japan
She is an international public health specialist and health economist. Her research focuses on health equity, Social Determinants of Health, health economics and health economic evaluations, targeting the vulnerable population groups. She currently works in the academia and previously worked in the field of policy and program with NGOs, bilateral and multilateral agencies in Africa, Asia and South America. She holds a PhD in Public Health and a Master of Public Health (University of California in Los Angeles) and a Master of Science in Health Policy, Planning and Financing (University of London).
Panelists
Diana Beatriz Bayani, BA, MSc
Saw Swee Hock School of Public Health, University of Singapore, Singapore, Singapore
Dana Bayani is currently a PhD candidate at the Saw Swee Hock School of Public Health, National University of Singapore. Her research involves exploring the use of real-world data for HTA and value-based payments, and modelling for oncology drug evaluations. Before moving to Singapore, she led the HTA Study Group, the predecessor of the HTA Unit in the Philippine Department of Health (DOH), which produces evidence to inform coverage decisions of drugs, national health insurance benefit packages and programmes. She has experience in HTA policy research, economic evaluations, cost-of-illness studies, and health financing policy research and has served as consultant for private, public, and non-profit sectors locally and overseas. Dana is trained in epidemiology, health economics, and policy with a masters degree from the London School of Economics and Political Science and the London School of Hygiene and Tropical Medicine.
Sitanshu Kar, MD, MBA
JIPMER, Puducherry, India
Sarin Kc, MSc
Ministry of Public Health, Nonthaburi, Thailand
Sarin is a health policy researcher at the Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health, Thailand. He supports the use of evidence for policymaking. His recent work includes the economic evaluation of biologic agents for juvenile rheumatoid arthritis, RWD for reimbursement decisions, infectious disease modelling, digital health, cross-border travel, and strengthening the capacity to produce and consume evidence, among others. Prior to joining HITAP, Sarin worked as a research analyst at the Ministry of Health and Population, Nepal, and the London School of Economics and Political Science (LSE), UK.
Riku Ota, MSc
Novo Nordisk, Tokyo, 13, Japan
Riku Ota is a motivated young professional with progressive experience in the pharmaceutical industry. His career background started in the clinical development of new health technology. His strong passion then brought him to work with market access and Health Economics Outcome Research (HEOR) to secure broader healthcare access for patients by demonstrating the value of new health technology. He is currently working at Novo Nordisk Pharma Ltd. as a HEOR Manager since May 2022, and he recently joined Health Equity Special Interest Group (SIG) in Asia-Pacific.
Are International Trials Good Enough to Support the Reimbursement of a New Technology in Asia? When and How?
ISSUE:
An increasing number of Asian countries are implementing an HTA model for pricing and reimbursement decisions of new technologies. So far, several challenges emerged in evidence generation such as representation of Asian patients in multinational trials. Previous evidence in personalized medicine (e.g., PD-1/PD-L1) have showed that being Asian might be a potential prognostic factor or treatment effect modifier, contributing to differences in clinical and safety outcomes of technologies. Correspondingly, several Asian HTA bodies show a- priory preference on Asian trial data where available reflecting local populations, or international trials with a significant Asian representation. However, trials cannot always be conducted locally, and the quality and availability of local real-world evidence can be a concern for payers. Furthermore, limiting to the Asian subpopulation from international trials might produce uncertain results due to small sample size. Given this dilemma, what are the perspectives of different stakeholders, local payers in Asia, and manufacturers? When and how, international trials can meet the HTA requirements in Asia?
OVERVIEW:
Understanding when and how Asian representation in clinical trials is needed while managing the evidentiary requirements of multiple market access activities of new technologies is a challenge. The moderator will introduce the topic (5min). Panelists will then present their perspective (15min each); Dr Louise Goh will discuss why HTA bodies show preference on Asian trials or international trials with considerable number of Asian patients. Dr Hernandez will present the challenges (trial design, costs, data quality) faced by manufacturers in terms of ensuring wider (Asian) representation when technology submissions are prepared for several countries. Dr Sarri will discuss the methodological considerations on how to reliably identify if Asian background can affect treatment effect estimates through literature reviews. 10min discussion will follow. Stakeholders (industry, researchers, payers) will benefit.
Panelist
Louise Goh, PhD
Agency for Care Effectiveness (ACE), Ministry of Health, Singapore, Singapore
Louise is a Lead Specialist at the Agency for Care Effectiveness (Singapore). She is involved in managing the Utilisation Review and Outcomes Evaluation team which tracks utilisation and outcomes related to health technologies to assess the impact of funding decisions. Louise obtained her Doctor of Philosophy in Public Health and was an academic at Curtin University prior to joining ACE.
Luis G. Hernandez, PhD MPH MSc
Takeda Pharmaceuticals America, Inc., Westford, MA, USA
Luis Hernandez, PhD MPH MSc, is the Head of Global Health Economics, in the Global Oncology Patient Value, Policy, and Access, at Takeda, where he is responsible for generating health economics evidence to demonstrate the value of innovative and transformative medicines to accelerate access for patients across the world, sustainable pricing, and develop valuable partnerships to shape the environment. Dr. Hernandez has extensive experience in health economics and outcomes research, evidence generation planning, market access, and cross functional team leadership and management.
Prior to joining Takeda, Dr. Hernandez spent 13 years at Evidera (a business within Pharmaceutical Product Development, LLC, [PPD] a leading global contract research organization [CRO]) where he spearheaded health economics evidence generation and dissemination to support the optimal value proposition for pipeline, launch, and lifecycle assets. During his tenure, Dr. Hernandez held several leadership roles including Senior Director and Senior Scientist heading Evidera’s health economics modeling and simulation in Waltham, Massachusetts, USA.
Between 2009 and 2010, Dr. Hernandez was a full time professor of Probability, Statistics, Discrete Event Simulation, and Decision Analysis for undergraduate and graduate students at Universidad de los Andes (Bogota, Colombia) for the Industrial Engineering Department and the Executive MBA program.
Dr. Hernandez holds a PhD in Health Economics from the University of Groningen (the Netherlands), a Master’s in Public Health from Tufts University (Boston, Massachusetts, USA), and Master’s and Bachelor’s degrees in Industrial Engineering from Universidad de los Andes (Bogota, Colombia).
Grammati Sarri, PhD
Comparative Effectiveness Research Special Interest Group, London, United Kingdom
Chair-Elect ISPE Comparative Effectiveness Special Interest Group
Active Member of ISPOR RWE SIG
Moderator in previous Issue Panels
US ISPOR 2022_Is the Global Real-World Data Supply-Chain Broken? Choosing Between RWD Quality Versus Locality in Supporting Single Arm Submissions [Issue Panel IP16, May 18]
HTAi 2019_Integrating Patient Experience In Complex Pharmacological Solutions: Are The HTA Bodies Ready?
selected Webinars
ISPE Sponsored_ "Building Trust in Reliably Synthesizing Evidence from Non-Randomized Studies and RCTs in Healthcare Decision Making; a proposed ISPE Framework" October 2021
HTAi issue panel 2021 (panelist)_ Bridging Evidence Gaps in HTA: Building Confidence In Analytical Methods for Combining Results from Randomized and Non-Randomized Studies
HTAi issue panel 2020
Expert Workshop (2021): New RWE frameworks, new analytical methods but not yet much HTA acceptance; what is next?
Relevant Publications
sarri et al (2022) ISPE-Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID-19: Opportunities and Trade-Offs
3. Kongnakorn T, Sarri G, Freitag A, Marczell K, Kazmierska P, Masters E, Pawar V, Zhang X. Modeling Challenges in Cost-Effectiveness Analysis of First-Line Immuno-Oncology Therapies in Non-small Cell Lung Cancer: A Systematic Literature Review. Pharmacoeconomics. 2022 Feb;40(2):183-201. doi: 10.1007/s40273-021-01089-4.
Sarri G et al. The Role of Patient Experience in the Value Assessment of Complex Technologies – Do HTA Bodies Need to Reconsider How Value is Assessed? Health Policy 2021.
Sarri G et al. Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making. BMJ Evid Based Med. 2020 Dec 9:bmjebm-2020-111493.
D'Andrea E, ... Sarri G. How well can we assess the validity of non-randomised studies of medications? A systematic review of assessment tools. BMJ Open. 2021 Mar 24;11(3):e043961. doi: 10.1136/bmjopen-2020-043961.
11. Sarri G et al. PNS221 Healthcare Decision-Making Using Real-World Evidence: Many Opportunities, Little Guidance. Results from a Systematic Review of Guidance. Value in Health 2020.
13. Freitag A and Sarri G. PNS156 Are Surrogate Outcomes Enough for the Reimbursement of Health Technologies? An Umbrella Literature Review. Value in Health 2020.
Real World Evidence in Network Meta-analysis: Is it Now a “Must Have” in Technology Appraisals?, July 2018
New EU HTA Directive Set to Revolutionize HTA in Europe – How Will it Affect You?, May 2018
12:45 - 13:00
Break
13:00 - 14:00
Concurrent Breakout Session 2
How Can We Incentivize Medical Technology Innovation through Premium Reimbursement in Asia Pacific: A Case Study Discussion?
ISSUE:
Innovative products often come with a hefty price tag as the research and development process requires a huge amount of investment and resources. How can we motivate potential innovators of healthcare technologies to innovate and manufacture products that help to advance health? Can we incentivize innovation through premium reimbursement? If yes, how? If no, why?
OVERVIEW:
Objectives: Understand the importance of incentivizing medical technology innovation with premium reimbursement; Understand the methodologies, with case studies, to guide the framework of differentiated reimbursement Dr Ma will kick off the session by sharing the importance of incentivizing innovation and how reimbursement remains an important lever. [10 minutes] Prof Xiao will discuss the key considerations and challenges in evaluating innovative health technologies, especially those unique to Asia Pacific. She will share an example where incremental technical/functional benefits of a device led to clinical/economic/operational improvement. [10 minutes] A/Prof Igarashi will discuss the various methodologies used in evaluating innovative products and share a case study on how innovative medical devices can be evaluated. [10 minutes] Prof Ahn will share examples on how innovative medical devices are evaluated under the new health technology assessment and medical device reimbursement process in Korea and discuss how other countries can learn from these examples. [10 minutes] Dr Ma will engage the panelists in a discussion around how evaluation should recognize incremental innovation that leads to improvements other than clinical outcomes. The session will end with recommendations to policy makers and a call for action to develop a guiding framework for evaluating and according differentiated reimbursement for innovative technologies. [20 minutes]
Moderators
Viva Ma, PhD, MPH, MBA
Becton Dickinson Holdings Pte Ltd, Singapore, 05, Singapore
Dr. Ma is the Director of Strategic Access, Greater Asia, in Becton Dickinson, one of the largest global medical device companies. Dr. Ma has dedicated her career to improving the affordability and patient access to innovative diagnostic and therapeutic technologies around the world. Prior to BD, she worked in Johnson & Johnson and Edwards Lifesciences in several corporate functions including health economics, market access, reimbursement and supply chain. As an Executive Committee member for the International Society for Pharmacoeconomics Outcomes Research (ISPOR) Singapore, she is a catalyst in building the health economics and outcomes research capacity for the Asia Pacific region. Through her leadership role in HTAi Asia Policy Forum and AmCham Singapore, she is actively driving value-based healthcare, as well as cross-sector dialogue and partnerships in the healthcare eco-system. Dr. Ma holds a MPH and a MBA degree from the Johns Hopkins University, a PhD degree from the University of Wyoming, and a Postdoctoral Certificate from Yale University School of Medicine.
Panelists
Jeonghoon Ahn, PhD
Ewha Womans University, Seoul, Korea, Republic of (South)
Jeonghoon Ahn is a full professor at the Ewha Womans University and an adjunct fellow of the National Evidence-based healthcare Collaborating Agency (NECA), Korea. He is an expert on health technology assessment (HTA) and health economics. He worked 7 years in NECA and served in various decision making and advisory committees of public agencies such as the Health Insurance Review and Assessment Services (HIRA) and the Korean Centers for Disease Control (KCDC). Professor Ahn has graduated the Seoul National University Department of International Economics for undergraduate and master program. He also received a PhD in Economics from the University of Southern California (USC) and was an assistant professor of pharmaceutical economics and Policy at the USC. Dr. Ahn has served on international professional organizations such as ISPOR, HTAi, INAHTA, and HTAsiaLink. He cofounded a regional Health Technology Assessment agency network, the HTAsiaLink.
Ataru Igarashi, PhD
The University of Tokyo, Tokyo, Japan
Yue Xiao, PhD
China National Health Development Research Center, Beijing, China
Is International Reference Pricing and HTA Driven Reimbursement Compatible?
ISSUE:
Is international reference pricing and HTA driven reimbursement compatible?
OVERVIEW:
Submitting the reimbursed prices of other jurisdictions is mandatory when seeking drug reimbursement in an increasing number of APAC countries like Korea, Singapore, Taiwan, Thailand, and Vietnam. In general, countries typically refer to other markets with similar economic development. For example, Korea and Taiwan refer to advanced economies that include countries like Australia, Canada, and UK that set the price of drugs using health technology assessments (HTA), as well as countries that do not utilize HTA like the USA. Reasons for using international reference pricing (IRP) include: ensuring that payers get a fair deal when procuring new health technologies and providing countries with HTA capacity/capability issue with a reference point in price negotiations. However, results of CEA or CUA performed in one country is not easily transferred to another due to differences in health resource utilisation, quality of life tariffs, National fiscal policy etc. Moreover, public listed prices may not reflect the effective price due to commercial in confidence agreements (e.g., risk sharing, outcomes-based pricing), patient co-payments, different markups across the supply chain, which makes it the use of price referencing somewhat unreliable. This issue panel will discuss the role of IRP in jurisdictions with mandatory HTA requirements for new pharmaceuticals and/or device. The first panellist will give an overview of the pros and cons from an academic perspective with multiple examples. The second panellist will give an industry perspective on IRP and with examples on how risks are dealt with and opportunities relating to IRP. The last panellist will present a payer/decision maker perspective.
Moderators
Hansoo Kim, PhD
Griffith University, Nathan, QLD, Australia
Dr Hansoo Kim is a senior research fellow at the Centre for Applied Health Economics at Griffith University in Australia. His primary research interests are pharmacoeconomics and cost-effectiveness modelling. He worked in the pharmaceutical industry for companies such as Pfizer, GSK and BMS for more than 15 years before crossing over into academia. Dr Kim is a past president (2018-2019) of the ISPOR Australian Chapter.
Panelists
Raoh-Fang Jasmine Pwu, PhD
Ministry of Health and Welfare, Taipei, Taiwan
Raoh-Fang (Jasmine) Pwu, PhD, is the Director, National Hepatitis C Program Office, Ministry of Health and Welfare in Taiwan. She also is adjunct Assistant Professor at the Taipei Medical University.
Trained as an epidemiologist at College of Public Health, National Taiwan University, Dr Pwu has gained expertise in research designs and analysis of large/claims database early in her career. Along the research path she found economic evaluations in healthcare quite interesting and became determined to pursue a career in this field. She is one of the first researchers to excel in modeling cost-effectiveness of medicines and public health interventions in Taiwan. She gives lectures and advises students on analytic-decision models and their applications. Since completing her master thesis, she has over 20 years of experience in research and application in health economics and outcomes research (HEOR) studies.
Dr Pwu and several of her college colleagues founded a consulting company specializing in clinical/epidemiological research design and data analysis in 1999. However, when the Taiwan government asked her to develop a health technology assessment (HTA) system in Taiwan in 2007, she began working for the Division of HTA, Center for Drug Evaluation. She became the second Director of the HTA Division since 2009. In this role, she and her team have developed a strong HTA system and research.
Dr Pwu is an enthusiastic collaborator. Therefore, she welcomes any chance to serve the Society. She served on the INAHTA Board from 2010-2012. She and her HTA colleagues from Thailand and Korea created HTAsiaLink in 2010 and she served as their President from 2014 to 2016. Dr Pwu has been an ISPOR member since 2001 and served as the Board of Director for 3 years (2018-2021).
Joshua Siow, BSc
Simon-Kucher & Partners, Singapore, 01, Singapore
Joshua Siow is a Director at Simon-Kucher & Partners, specializing in Pricing and Market Access with a focus on Asia Specific.
At Simon-Kucher, Joshua works across all stages of the product lifecycle to advise client on topics including drug pricing and reimbursement strategy, international price referencing and launch sequencing, and innovative contracting.
Jonathan Tan, MBA
Novartis Pharma, Singapore, Singapore
Jonathan has focused his career on re-imagining access to medicines for patients - through fundamentals like health economics to deliver value, and the development of innovative funding models to unlock funding and drive better outcomes for patients. Jonathan currently serves as Head of Market Access for Innovative Medicines in GSK’s emerging markets.
Determining the Potential Payoff at City and District Levels From Up-Front Investments in New Technologies for Dengue Prevention in Two Endemic Countries (Thailand and Indonesia): Combining Surveillance, Screening and Interviewing
Level: Intermediate
PURPOSE: Recent randomized trials of two new technologies (Wolbachia and Takeda's vaccine) established that each would cut dengue by ~75% without adverse effects. However, deployment would require substantial up-front investment, particularly at the city and district levels. Most existing studies overlook the many non-hospitalized cases, which impose substantial economic costs from healthcare utilization and lost productivity, thereby understating costs.
DESCRIPTION: Workshop attendees will obtain a working knowledge of approaches to provide needed data accurately, quickly, and efficiently. Prof. Shepard will lead the session and introduce the topic, describing the new technologies and limitations of existing studies. For example, dengue and other illnesses, including COVID-19, reduce presenteeism--patients' ability to maintain usual activities for income, household tasks, and schooling (10 min). Prof. Kongsin and colleagues piloted a study assessing presenteeism losses in Umphang District, Tak Province, Thailand. The pilot enrolled 22 laboratory-confirmed dengue patients, aged 7-78, from April-July, 2021 with interviews every 1-4 weeks for up to 6 months until symptoms ended. Enrollees reflected the diverse ages of dengue patients (14% under age 18, 72% aged 19-59, and 14% age 60+) and their distinct settings (27% inpatient and 73% outpatient). With participant incentives and well-trained staff, all enrollees completed every planned interview (15 min). Dr. Wilastonegoro will describe a five-step protocol for Semarang City, Indonesia (population 1.7 million): (1) Using data from the surveillance system to select a small but representative sample of public and private health centers and hospitals. (2) Promptly screening their clinically diagnosed patients for laboratory confirmation. (3) Inviting NS1-positive patients to enroll in an observational study. (4) Interviewing consenting patients every 1-4 weeks about health care utilization, absenteeism, and presenteeism. (5) Linking interviews with surveillance and screening data to weight to the city level (15 min). Audience participation in this interactive workshop will explore wider applicability and adaptation (20 min).
Discussion Leaders
Donald Shepard, PhD, MPP, FASTMH
Brandeis University, Waltham, MA, USA
Professor Shepard is a professor at the Heller School for Social Policy and Management, Brandeis University, and leader of its Cost and Value Group. In 2016 he was elected as Fellow of the American Society of Tropical Medicine and Hygiene as recognition of lifetime achievements in tropical medicine. He holds three degrees from Harvard University (BA, MPP, and PhD).
Discussants
Sukhontha Kongsin, PhD
Mahidol University, Bangkok, Thailand
Dr. Kongsin is Associate Professor, head of the Research Center on Health Economics and Evaluaion, and Deputy Dean for Finance and Budgeting in the Faculty of Public Health, Mahidol University. She is the Thailand Principal Investigator on a study supported by Takeda Vaccines on the economics of dengue in Thailand. She is internationally recognized for her research on the economics of dengue and HIV/AIDS in Thailand.
Nandyan Wilastonegoro, MD, MScIH
Gadjah Mada University, Yogyakarta, Indonesia
Dr. Nandyan Wilastonegoro earned his MD degree at Univeritas Gadjah Mada (Yogyakarta Indonesia) and MScIH with a focus on health economics in Charite Medical University, Berlin, Germany. For the past decade, he has been a lecturer and senior researcher in public health and dengue at Univeritas Gadjah Mada. He served as its Principal Investigator on studies on the economics of Wolbachia to control dengue funded by the Bill & Melinda Gates Foundation.
Target Trial Emulation in Health Economics and Outcomes Research: Opportunities and Challenges
Level: Foundational
PURPOSE: We will provide an overview of challenges of real-world evidence (RWE) for the use in health technology assessment (HTA). We discuss the risk of different potential biases in RWE and the concept of target trial emulation to account for these biases. Three speakers will describe the concept of the target trial emulation, provide examples and challenges of applications of the target trial concept to real-world data and their acceptance in HTA agencies.
DESCRIPTION:
Health Economics and Outcomes Research is generating evidence of the value of an intervention for clinical, payer, or public health decisions using best available data. More and more real-world data are available and can be analyzed to guide such decisions. The focus of this workshop is on discussing how to gain unbiased causal RWE. We concentrate on the target trial emulation concept which provides a counterfactual framework guiding the analysis of observational data. We provide an overview, discuss case examples, and discuss potentials and challenges of the target rial concept. This workshop has four parts: 1. Felicitas Kühne will provide an overview of the target trial concept and how that concept accounts for potential biases occurring in RWE. 2. A speaker that is still to be determined will discuss potentials, expectations, and challenges following of the target trial concept in registry planning and analyses. 3. Uwe Siebert will present case examples of target trial emulations and challenges in the HTA process. 4. We will actively engage participants in the discussion and use polling to collect the audience’s view on discussed issues.
Discussion Leaders
Felicitas Kuehne, MSc
UMIT-University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria
Felicitas Kuehne is a senior scientist in decision-analytic modeling and epidemiology at UMIT TIROL. She is leading the Program on Causal Inference in Science and is the Coordinator of the HTADS course “Causal Inference for Assessing Effectiveness in Real World Data and Clinical Trials”. She conducts decision-analytic as well as epidemiological studies in several disease areas and teaches epidemiology classes.
Her research interests include evaluating public health intervention by applying evidence-based quantitative methods from epidemiology, comparative effectiveness research, health services and outcomes research, economic evaluation, and decision sciences. Her current substantive research focuses on identifying synergies of causal inference and decision science.
Discussants
Isao Kamae, MD, PhD, MSc, MSc
The University of Tokyo, Tokyo, 13, Japan
Felicitas Kuehne, MSc
UMIT-University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria
Felicitas Kuehne is a senior scientist in decision-analytic modeling and epidemiology at UMIT TIROL. She is leading the Program on Causal Inference in Science and is the Coordinator of the HTADS course “Causal Inference for Assessing Effectiveness in Real World Data and Clinical Trials”. She conducts decision-analytic as well as epidemiological studies in several disease areas and teaches epidemiology classes.
Her research interests include evaluating public health intervention by applying evidence-based quantitative methods from epidemiology, comparative effectiveness research, health services and outcomes research, economic evaluation, and decision sciences. Her current substantive research focuses on identifying synergies of causal inference and decision science.
Uwe Siebert, MD, MPH, MSc, ScD
Harvard T.H. Chan School of Public Health / UMIT - University for Health Sciences, Medical Informatics and Technology / ONCOTYROL - Center for Personalized Cancer Medicine, Boston (Harvard); Tirol (UMIT), MA, USA
Uwe Siebert, MD, MPH, MSc, ScD is Professor of Public Health, Medical Decision Making & HTA, Chair of the Dept. of Public Health, Health Services Research and HTA, and Director of HTADS Continuing Education (www.htads.org) at UMIT TIROL, and Adj. Professor of Epidemiology and Health Policy & Mgmt at the Harvard Chan School of Public Health. He is Past-President of the Society for Medical Decision Making (SMDM), member of several Boards of Directors, and he advices several HTA/government agencies. He has authored more than 400 publications and is Editor of the European Journal of Epidemiology.
Wed 21 Sep
10:15 - 11:15
Concurrent Breakout Session 3
Current and Future Trends in Value Assessment of Innovative Medtech in APAC – How Do They Fair Compared to Pharmaceuticals and Beyond APAC?
ISSUE: Healthcare systems across APAC are rapidly evolving due to economic pressures and demographic shifts. While the booming APAC MedTech market is expected to account for a third of global sales by 2025, there are significant discrepancies and variability across the region on how to assess the value of MedTech. Conversations about current and future trends in MedTech Health Technology Assessments (HTA) are important if we aim to improve patient outcomes and maintain healthcare sustainability by achieving value for money in healthcare spending. Joe Caputo will moderate and guide the discussion based on audience-selected topics of interest; while Jenifer Levinson, Chris Foteff and Dr Tamura Makoto will speak to global, Australian, and Japanese experiences of innovative MedTech HTA.
OVERVIEW: MedTech accounts for a significant proportion of healthcare spending, yet its assessment approaches and access policies are often out of the spotlight and at times lagging pharmaceuticals. In this panel, the current and future trends in MedTech HTA in APAC will be explored: How are MedTech assessment approaches evolving? What are the methodological differences in assessment approaches between MedTech and pharmaceuticals? How is value demonstrated in current assessment frameworks, and is there room for broader criteria to fully capture benefits conferred by innovative MedTech? How can industry engage with stakeholders to generate and present alternative evidence approaches that support value? This session hopes to advance the dialogue on MedTech assessment approaches and support the development of evidence generation for MedTech as part of the shift towards value-based healthcare. The panel will begin with an overview (15 minutes) of the above topics, followed by an interactive discussion (30 minutes) with the use of audience polling and Q&A to identify discussion points for input from the panellists and audiences alike.
Moderators
Joe Caputo, AAAA
Vista Health, Singapore, 01, Singapore
Joe’s background and experience spans industry and consulting roles across multiple continents. He worked for 14 years with GlaxoSmithKline where his roles included drug development, sales & marketing and UK & global health outcomes. As a Principal at IMS Health, Joe moved to Singapore in 2012 to set up and manage the Real-World Evidence & HEOR team for the Asia-Pacific region, before founding Vista Health in 2016. An expert in RWE & HEOR strategy development, HTA, market access, patient level data analysis and value communications, Joe is currently the President of ISPOR Singapore Chapter.
Joe is also the former Associate Director for ESSEC Business School Institute of Health Economics and Management Asia-Pacific, and guest lecturer at ESSEC; he is a frequent speaker at international conferences, having attended many client and subject matter meetings as an industry expert; In 2012 he was invited to present an overview of HTA to the China FDA and in 2017 presented on HTA methodology to VSS and MOH in Vietnam.
Panelists
Chris Foteff, MClinEpid
MedTech Strategic Assessment Services, Charlestown, NSW, Australia
Principal Consultant and Managing Director at MedTech Strategic Assessment Services, Australia.
Chris Foteff has 28 years of experience in health services, clinical research, Health Economics Outcomes Research and market access in both the public and private sector. He has experience in Health Technology Assessment (HTA), critical appraisal, evidence synthesis and health economic modelling across jurisdictions including Australia, New Zealand, China, India, Japan, Korea, Singapore, Taiwan, etc.
Before founding MedTech Strategic Assessment Services, Chris was the Deputy Director/ Senior Lead Specialist for medical devices at the Agency for Care Effectiveness, MOH, Singapore. Prior to that, Chris worked in the private sector for 19 years in clinical research and health economics roles, as a consultant with Contract Research Organizations, and in health economics roles for Cochlear Limited and Medtronic ANZ Ltd. Chris also worked for NSW Health for 9 years in several senior roles earlier in his career.
Chris obtained his Master’s Degree in Clinical Epidemiology from the Centre for Clinical Epidemiology & Biostatistics, The University of Newcastle, with concentrations in clinical epidemiology and pharmacoepidemiology.
Jenifer Levinson, BA
Boston Scientific, Washington, DC, USA
Ms. Levinson currently serves as VP, Global Health Economics and Market Access (HEMA) for Boston Scientific. In this role, Jenny leads a team of health economists, data analysts, and reimbursement experts who demonstrate the economic value of our products and optimize the policy and reimbursement environment to ensure appropriate patient access to our therapies. Prior to joining Boston Scientific in 2021, Jenny held a series of leadership roles in the medical technology, pharmaceutical and biotechnology industries and consulting.
Makoto Tamura, PhD
Healthcare System Planning Institute, Tokyo, Japan
Makoto Tamura, Ph.D.
Founder and CEO, Healthcare System Planning Institute
1984-1995 Meiji Mutual Life Insurance
1995-2004 Assistant professor at the University of Tokyo and Professor at the International University of Health and Welfare
2004-2017 Vice president of Government affairs at Guidant, Boston Scientific and Abbott. 2011-2017 Expert member of Chuikyo (government reimbursement advisory council)
2017- Healthcare System Planning Institute, Director of AMDD Medical Technology Policy Research Institute, and research professor at International Univ of Health and Welfare.
Ph.D of health science from the University of Tokyo. Master of Management, from Northwestern University.
ICER Thresholds Across Asia - What They Are, How Are They Determined and Used? What Are the Implications of This for Patient Access?
ISSUE: ICER thresholds are used as a cut-off point by many HTA’s to assess value for money and whether or not a new medicine should be reimbursed. Whilst there are strengths and limitations using thresholds, there remains outstanding knowledge gaps in how ICER thresholds should be estimated and applied now and into the future
OVERVIEW: ICER thresholds in the Asia Pacific region vary in terms of: whether they are used, the threshold dollar value, and how these thresholds are estimated, including based on GDP, willingness to pay or unclear methods.
There are advantages and disadvantages of using ICER thresholds for decision-making. Several disadvantages are possible to overcome by allowing flexibility/modification in the threshold over time or for different disease, patient, or other factors. The derivation of an ICER value is also impacted by the evaluation framework and approaches required by the HTA agency and the data used to conduct the CEA. Which elements of value can be incorporated, what perspective is taken, what time horizon and discounting are accepted in the CEA, and how certain are the results. These factors should also be considered when estimating and applying ICER thresholds to reimbursement decisions. It is expected that ICER thresholds will continue to be used but there are opportunities to evolve their determination and application to achieve the best balance between efficiency and patient access. Differences in the determination and application of ICER thresholds across the Asia Pacific region will be discussed. Panelists will be encouraged to offer their thoughts on what can be done to improve this for positive impact on decision-making and patient access to innovative technologies. Each speaker will present for approximately 10-15 minutes, with around 20 minutes for debate and questions. Speakers from different geographies have been chosen to represent variety of HTA approaches and maturity.
Moderators
Colman Taylor, PhD
Health Technology Analysts, Surry Hills, NSW, Australia
Dr Colman Taylor joined HTANALYSTS in May 2014 and was part of a management buy-out in July 2016. During his time with HTANALYSTS, Colman has provided strategic oversight for over 500 projects in Australia and the Asia Pacific, working with a diverse variety of companies from local start-ups to international pharmaceutical, digital health and medical technology companies. During his career, Colman has contributed to over 100 reimbursement submissions and economic modelling projects, respectively, as well as multiple cost and burden of illness studies, clinical guidelines, market access strategy projects and late phase studies.
Colman has a strong background in academia and currently holds positions with The George Institute for Global Health (Post-Doctoral Research Fellow) and The University of NSW (Conjoint Senior Lecturer). Colman completed his PhD studies at the George Institute – examining the cost and benefit of helicopter emergency medical services. He has been a lead author or co-author on >50 peer reviewed publications (including The Lancet and NEJM), >50 conference proceedings and has provided several invited speaker presentations. He is also an active reviewer for several international and local journals and has been granted over $15m in peer-reviewed funding through bodies such as the NHMRC.
Panelists
Jonathan Karnon, PhD
Flinders University, Adelaide, SA, Australia
Jonathan is professor of health economics at Flinders University, South Australia. He has been undertaking applied economic evaluations of health care technologies and services for over 20 years. He has particular expertise in the use of cost-effectiveness models and was a member of the most recent ISPOR taskforce on good modelling practice, chairing the discrete event simulation working group. In Australia, he has sat on the Economic Sub-Committee of the Pharmaceuticals Benefits Advisory Committee since 2009.
Bor-Sheng Ko, MD, PhD
Department of Hematological Oncology, National Taiwan University Cancer Center, New Taipei City, TPE, Taiwan
Evolving Dynamics of Reimbursement and Post Listing Accessibility of High-Priced Innovative Medicines
Level: Experienced
PURPOSE:
This workshop will focus on the recent efforts and initiatives on the accessibility of patients to high-priced innovative medicines from multiple perspectives. The participants will gain a comprehensive understanding of the evolving dynamics of reimbursement assessment and access challenges post listing with a focus on China and complemented with international experiences.
DESCRIPTION:
Patient access to the life-saving and life-changing innovative medicines is challenging in many countries because of the limitation on the affordability and availability. Receiving national reimbursement subsidization is a big step forward to improve the affordability; however, following the listing, there still exist subsequent processes and barriers associated with the last mile of patient access to the treatment. The panel will discuss: 1) evolving dynamics of value assessment of high-priced innovative medicines; 2) efforts of improving the efficiency of reimbursement decisions with experiences from China; 3) the unique challenges of the last mile logistics of access post the reimbursement listing with case study from China; 4) the role industry is playing in improving patient access with collaborating with multiple stakeholders. The unique contribution of this workshop is covering both reimbursement assessment process as well as the post-listing accessibility issues. Dr Fei-Li Zhao will moderate the workshop and provide an overview of the accessibility issues of high-priced innovative medicines. Professor Kun Zhao will present recent development and her experience of assessing the value of high-cost innovative medicines from the standpoint of public payers. Professor Jiuhong Wu will use real world examples to elaborate the challenges and potential areas to improve for the post-listing accessibility. Professor Boxiong Tang will provide an industry perspective to address the topics. Discussions will start from China’s experiences, as well as other countries. We will engage all participants, especially those from Asian countries, to share their own country’s experiences and challenges through a round-table discussion.
Discussion Leaders
Fei-Li Zhao, PharmD, MS, PhD
BeiGene, Castle Hill, NSW, Australia
Fei-Li Zhao, PhD, MS
Dr Fei-Li Zhao is HEOR APAC lead at BeiGene and has over 15 years of experience in health economics and outcomes research (HEOR) and health technology assessment (HTA) across industry and academia including providing consulting support to the government HTA agency. She holds a Conjoint Senior Lecturer role at the University of Newcastle.
Discussants
Boxiong Tang, MD, PhD
BeiGene USA, Emeryville, CA, USA
Dr. Tang has over 23 years experiences in medicine, public health, and health economics and outcomes research.
Currently, he is the Executive Director, Head of Health Economics and Outcomes Research (HEOR) at Beigene ex-China Medical Affairs, responsible for developing HEOR function and implementing health outcomes research strategies globally. He established HEOR function to support the product launches and reimbursement globally.
Before joining Beigene, he served as a Sr. Director of Global HEOR, and Growth Markets at Teva Pharmaceutical. Dr. Tang has established the newly created Growth Markets Market Access and HEOR team within Teva.
Previous, Dr. Tang was a Senior Director of Health Outcomes Research at Pfizer Emerging Markets supporting Asia region. His responsibilities includes developing and implementing research strategies in clinical development (specialized in health economics assessment and patient reported outcomes, product value dossiers), and post market products (real world and large database creation and analysis). Dr. Tang is specialized in therapeutic areas of oncology, hematology, and immunology (biologics), and women’s health.
Prior to Pfizer, Dr. Tang was the director of Health Economics and Clinical Outcomes Research in Johnson & Johnson and GlaxoSmithKline, where he was responsible for health outcomes research in biologics and oncology.
He was also an adjuvant professor of China Fudan University and faculty of Zhejiang University Medical School. Meanwhile, Dr. Tang was the Chair of the HTA (Industry) Committee, Asia Consortium of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and a member of Asia Consortium Executive Committee.
Dr. Tang’s training includes a MD in Preventive Medicine, a PhD in Health Services Research, and a MPH in Health Planning and International Health.
Dr. Tang serves as the chair of Industry Committee of International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Asia Consortium. He has published more than 30 manuscripts in peer review journals, 100+ abstracts and numerous speeches and presentations in major scientific congresses including ISPOR. He is knowledgeable in the development of Health Technology Assessment around the world. In addition, he served at Scientific Committees of International Health Economics Association (iHEA), Society for Medical Decision Making (SMDM), and a Peer Reviewer of America Journal of Managed Care.
Jiuhong Wu, PhD, PharmD
Beijing Health Economics Association, Beijing, China
Resume of Wu Jiuhong
Professor Wu Jiuhong, PhD supervisor, chief pharmacist, state Council government special paste expert. Director of Department of Pharmacy, 306 Hospital (2000-2014); Adjunct Associate Professor, University of North Carolina at Chapel Hill (2000.9-2002.9); Doctoral Supervisor, Academy of Military Medical Sciences (2005-); Director of Chinese Pharmaceutical Association, Vice Chairman of Pharmaceutical Economics Committee; Chairman of Pharmacoeconomics Committee, Beijing Society of Health Economics; Secretary General of Pharmaceutical Economics and Policy Committee, Chinese Society of Health Economics; President-elect of ISPOR Beijing Branch, International Society for Pharmaceutical Economics and Outcomes Research. Won the eighth "Wu Yang Award"; Provincial and ministerial level "first prize" 1, "second prize" 4; She was elected one of the first "Top Ten Outstanding Young Men of TCM in China". She has presided over 8 projects of National Natural Science Foundation of China, "Outstanding Talents" Fund of the Army, and returnee start-up Fund of the Ministry of Education. Published 260 papers (SCI nearly 50). She is the chief editor of three monographs, including the textbook "Pharmacoeconomics" published by Higher Education Press. Deputy editor of "China Pharmacoeconomic Evaluation Guide 2020 edition" and other monographs. She is the deputy editor of The Editorial board of 17 journals including Chinese Journal of Pharmacy and the Journal of Drug Evaluation. She is an evaluation and consulting expert of the State Food and Drug Administration, National Health Insurance Administration, National Health Commission, National Development and Reform Commission and other departments.
Kun Zhao, MD, MHSci, PhD
Tsinghua University, Beijing, China
11:15 - 11:30
Break
11:30 - 12:30
Concurrent Breakout Session 4
Risk-Sharing Arrangement: The Role of Real-World Evidence and Budget Impact Analysis
Level: Experienced
PURPOSE:
This workshop will have an overview of the development and implementation of risk sharing arrangement (RSA) and provide in-depth presentation and discussion on the role of real-world evidence (RWE) and budget impact analysis (BIA) in supporting the development and execution of RSA. The participants will gain a comprehensive understanding of the RSA practice and unique perspectives of the application of RWE and BIA in supporting RSA.
DESCRIPTION:
RSA between pharmaceutical companies and payers are increasingly practiced as an additional approach to address the value and sustainability of healthcare funding. It allows the patients to have earlier access to the medicines, particularly innovative medicines, by speeding up the reimbursement process in the context of uncertainty about the clinical and economics evidence. Broadly speaking, RSA can be subdivided into either financial-based models or outcome/performance-based models. Both RWE and BIA become critical components to support the design and execution of the RSA. With Prof Jiu-Hong Wu chairing and moderating, Prof Shanlian Hu will first present an overview of the international efforts and recent development of RSA. Prof Shu Chuen Li and Dr Fei-Li Zhao will focus on discussing how to use the RWE and BIA to support the RSA from different perspectives with presenting case studies. The panel will highlight the challenges and discuss the possible solutions, particularly in the context of Asian countries. We will engage all participants, especially those from Asian countries, to share their own country’s experiences and challenges through a round-table discussion, and to leverage the results from discussion to contribution to the improvement of efficiency of RSA practice in Asia.
Discussion Leaders
Jiuhong Wu, PhD, PharmD
Beijing Health Economics Association, Beijing, China
Resume of Wu Jiuhong
Professor Wu Jiuhong, PhD supervisor, chief pharmacist, state Council government special paste expert. Director of Department of Pharmacy, 306 Hospital (2000-2014); Adjunct Associate Professor, University of North Carolina at Chapel Hill (2000.9-2002.9); Doctoral Supervisor, Academy of Military Medical Sciences (2005-); Director of Chinese Pharmaceutical Association, Vice Chairman of Pharmaceutical Economics Committee; Chairman of Pharmacoeconomics Committee, Beijing Society of Health Economics; Secretary General of Pharmaceutical Economics and Policy Committee, Chinese Society of Health Economics; President-elect of ISPOR Beijing Branch, International Society for Pharmaceutical Economics and Outcomes Research. Won the eighth "Wu Yang Award"; Provincial and ministerial level "first prize" 1, "second prize" 4; She was elected one of the first "Top Ten Outstanding Young Men of TCM in China". She has presided over 8 projects of National Natural Science Foundation of China, "Outstanding Talents" Fund of the Army, and returnee start-up Fund of the Ministry of Education. Published 260 papers (SCI nearly 50). She is the chief editor of three monographs, including the textbook "Pharmacoeconomics" published by Higher Education Press. Deputy editor of "China Pharmacoeconomic Evaluation Guide 2020 edition" and other monographs. She is the deputy editor of The Editorial board of 17 journals including Chinese Journal of Pharmacy and the Journal of Drug Evaluation. She is an evaluation and consulting expert of the State Food and Drug Administration, National Health Insurance Administration, National Health Commission, National Development and Reform Commission and other departments.
Discussants
Shanlian Hu, MD,PhD
Fudan University, Shanghai, China
Shu Chuen Li, MApplSc, MBA, PhD
University of Newcastle, Callaghan, NSW, Australia
Fei-Li Zhao, PharmD, MS, PhD
BeiGene, Castle Hill, NSW, Australia
Fei-Li Zhao, PhD, MS
Dr Fei-Li Zhao is HEOR APAC lead at BeiGene and has over 15 years of experience in health economics and outcomes research (HEOR) and health technology assessment (HTA) across industry and academia including providing consulting support to the government HTA agency. She holds a Conjoint Senior Lecturer role at the University of Newcastle.
Real-World Data and Real-World Evidence in Support of Drug Development: Will China Soon be Leading the Way?
ISSUE: Similar to the US, China is exploring use of RWE in support of drug development and regulatory decisions. In parallel the data landscape is fast evolving with emerging local RWD sources providing rich data. This session focuses on recent developments in utilising RWE across the product lifecycle and potential challenges and opportunities of China RWD sources. Stakeholders from different organizations will share their perspective and experiences. Dr Lu Ban (Evidera) will provide an up-to-date overview of the regulatory context and the need for RWE generation (15 minutes). Dr Haijun Cao (HLT) will discuss opportunities and challenges of RWD in China and guidance for study success (15 minutes). Dr Sunil Garg (Astellas) will provide an industry perspective on the need and challenges in generating RWE in China and potential mitigation strategies (15 minutes).
OVERVIEW: RWE plays an increasingly significant role in life-cycle management of therapeutic interventions including regulatory and pricing and reimbursement decision making. The Centre for Drug Evaluation (CDE) encourages exploration of RWE to provide supporting evidence for label expansion and effectiveness and safety of products post launch in China. In addition, real-world studies are being undertaken to describe incidence and prevalence of disease, treatment pathway, healthcare resource utilization and clinical and economic burden. RWE is also used to inform payers on National Reimbursement Drug List (NRDL) listing, budget impact analysis, or new round negotiations to limit price cuts in NRDL. In parallel RWE research opportunities are driven by the expanding data landscape. However appropriate data collection, curation, standardization, and validation are required. Advanced analytic techniques including machine learning and AI technology play a crucial role in managing large unstructured data sets. Executing RWE studies requires understanding of unique study approval landscape in China for efficiently delivery of RWE generation programs.
Moderators
Amanda Pulfer, BA (Hons)
Evidera, London, United Kingdom
Amanda Pulfer, BA, is Executive Director, Integrated Solutions, within the Real-World Evidence (RWE) team at Evidera with a particular focus on RWE generation in the Asia Pacific region. Amanda has 18 years’ experience in RWE Consulting supporting life sciences organisations with the design and delivery of RWE generation plans using secondary data and de novo data collection. Prior to consulting, Amanda worked in biopharma for more than 10 years responsible for life-cycle management of brands through launch to maturity.
Panelists
Lu Ban, PhD
Evidera, Beijing, China
Haijun Cao, MD, PhD
Happy Life Technology, Shanghai, China
Vice President，Happy Life Technology
Bachelor of Medicine,Fudan University;
Ph.D in epidemiology, University of California, Los Angeles
over 15 years of experience in real world research, pharmacoeconomics, health outcome research, clinical development and medical affairs.
Neuroscience clinical research in GlaxoSmithKline R & D China, supporting 3 neuroscience products phase III and phase I clinical studies in China
Medical director in Eli Lilly China. led the real-world research and pharmacoeconomics team to support real world evidence and outcome research evidence generation to support Lilly product from development and reimbursement and commercialization
In October 2020, joined Happy Life Technology and led the innovative medical and real world evidence team to provide solutions of the real world and pharmacoeconomic evidence for pharmaceutical enterprises and medical device companies.
Sunil Garg, PhD
Astellas Pharma Singapore Pte. Ltd, SINGAPORE, 01, Singapore
Sunil Garg, PhD
Astellas Pharma, Singapore
Sunil Garg is Head of Evidence Generation Operations, Medical Affairs, for the International Market and Greater China region at Astellas Pharma, Singapore. He is responsible for supporting the data generation activities across the company product portfolio in the region covering Medical Affairs & HEOR interventional and non-intervention studies including collaborative research and investigator-sponsored research.
With a deep passion for evidence-based medicine and drug development, he has contributed to and led
numerous clinical trials across therapy areas. With over 19 years in clinical research including over a decade managing China, he held several leadership positions both in pharma as well as CROs.
Can We Do Better for Health Technology Assessors & Patients? How to Overcome “Mistrust” in Digital Technology for Asia Pacific
ISSUE:
Digital health technologies (DHTs) offer potential value to personalized care for cancer patients. However, reimbursement, funding, and adoption of DHTs depend on the healthcare system priorities, infrastructure, and level of trust in DHT by payers/funders, HCPs, and patients. Several value aspects determine trust. We focus on the value assessment. While in high-income countries, the payer level of trust is often determined by applying sophisticated value frameworks from pharmaceuticals to assess the DHTs’ value. In low-middle income countries (LMCIs), the diversity in the socio-economic status and healthcare systems imposes challenges to applying these frameworks similarly. This provides opportunities for developing new fit-for-purpose frameworks for these healthcare systems. The session discusses trust- and value drivers of DHTs for HTA, funders, and patients in Asia-pacific countries. Case studies will elucidate their different perspectives. We aim to get feedback from the Asia Pacific ISPOR community on the relevant value drivers and acceptable level of evidence to invest in trustworthy DHTs.
OVERVIEW:
An interactive session will address the following questions:
What drives funding and adoption of DHTs in LMICs from a public and private perspective accounting for DHT use acceleration during the COVID-19-pandemic, the rapidness of emerging new technologies, and the IoT status? What is the patients’ role in the value assessment and funding of DHTs? What are the biggest hurdles for healthcare systems to fund DHTs? How can we measure patient-relevant outcomes and cost in LMICs? What is the role of RWE? Participants from public and private payers, HTA agencies, policymakers, medical technology manufacturers, patient advocacy representatives, and healthcare providers will benefit from attending this session. They will better understand the critical aspects of the value assessment of DHTs in LMCIs. The collected feedback will inform the development of a value framework to inform reimbursement and funding decision-making in LMCIs.
Moderators
Kenneth Kwing Chin Lee, MPhil, PhD
Monash University Malaysia, Petaling Jaya, Malaysia
Professor Lee is Professor of Health Economics at School of Pharmacy, Taylor’s University, Malaysia. He was previously Professor of Pharmacy at Monash University Malaysia. Before he moved to Malaysia, he was Professor and Associate Director of External Affairs of the Chinese University of Hong Kong School of Pharmacy.
He obtained his undergraduate degree in pharmacy from the University of Washington in Seattle, USA, and his subsequent higher qualifications from the Chinese University of Hong Kong (CUHK) and the University of Oxford, UK.
He is widely recognized as one of the pioneers in pharmacoeconomics and outcomes research in Asia, and was the founding president of the Hong Kong Chapter of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) established in 1999.
Professor Lee served in the ISPOR Board of Directors 2016 - 2018. He was the elected Chair of ISPOR Asia Consortium 2014-2016. He has published extensively in international peer-reviewed journals. He has been Editor-in-Chief of Journal of Medical Economics (UK) since 2006 and recently invited as Associate Editor (Pharmaceutical Medicine and Outcomes Research) by Frontiers in Pharmacology 2020-2024.
Panelists
Shu Chuen Li, MApplSc, MBA, PhD
University of Newcastle, Callaghan, NSW, Australia
Izzuna Mudla Mohamed Ghazali, MBBS, MPH, MPH
Malaysian Health Technology Assessment Section (MaHTAS), Putrajaya, Malaysia
Dr. Izzuna Mudla Mohamed Ghazali is the Deputy Director of the Medical Development Division, and Head of Malaysian Health Technology Assessment Section (MaHTAS), the HTA agency in Malaysia. Dr Izzuna is a Public Health Physician and has been with MaHTAS since 15 years ago. Other than HTA, her experience includes setting up horizon scanning system for Malaysia and development and implementation of clinical practice guidelines. She is currently the Chair of ISPOR HTA Roundtable Asia Pacific, Vice President of HTAsiaLink and the Regional Coordinator for AsiaScan of International Health TechScan (i-HTS).
Gurmit Sandhu, BPharm (Hons), MBA, MPH
Gurmit Sandhu Consulting GmbH, Basel, BS, Switzerland
Gurmit Sandhu, B Pharm (Hons), MPH, MBM was a Global Brand Director, Novartis AG where he led the global commercial strategy, for a new molecule, from clinical development to launch in more than 25 countries. Subsequently, he was a Patient Engagement Specialist in the Medicines Life Cycle. He was a member of the ISPOR EU Patient Council & co -authored the Patient Engagement section, ISPOR Code of Ethics 2017. In 2019, he enrolled in a Master of Science Medical Informatics degree, where he trained including in coding for AI technologies, applications of AI including Digital Biomarkers in healthcare. In parallel, he works as an AI Practitioner in Healthcare while completing his master’s thesis.
Early Treatment in Cancer – What Is the Real Value?
ISSUE: What is the value of treatment in early-stage (ES) cancer? Does it differ from that in advanced cancer, and does it vary across stakeholders? What impact does this have on timely access to treatments, and what can be done to improve reimbursement assessment?
OVERVIEW: Early detection and treatment can have a profound impact for patients, with the potential of cure in some cases. Whilst treatment of ES cancer can provide an opportunity for meaningful and durable clinical benefit, HTA can be quite challenging – due to the time it takes to measure overall survival, clinical studies usually rely on surrogate endpoints; moreover, the patient population tends to be larger, making the financial impact of the reimbursement decision more meaningful. These considerations often result in delayed access to innovative treatments, resulting in patients missing out on interventions that could change the course of their disease.
In addition, treatment of ES cancer can provide benefits that are not routinely used by decision-makers in subsidy decisions; for example, attributes such as value of hope, real option value, value of cure, ability to return to work, impact on carers and their family. During this session, panellists will share their view on the value of treatment in ES cancer, linkage between early clinical data to projected OS benefit, and their view on the broader perspective of value capturing the human impact, societal impact, clinical impact, and economic impact. Differences in perspectives will be debated, and participants will be encouraged to offer their thoughts on what can be done to ensure that the benefits of ES treatments are appropriately valued alongside with ways to address uncertainty in decision-making, and ultimately, to improve patient access. Each speaker will present for 10 minutes, with around 20 minutes for debate and questions.
Moderators
Colman Taylor, PhD
Health Technology Analysts, Surry Hills, NSW, Australia
Dr Colman Taylor joined HTANALYSTS in May 2014 and was part of a management buy-out in July 2016. During his time with HTANALYSTS, Colman has provided strategic oversight for over 500 projects in Australia and the Asia Pacific, working with a diverse variety of companies from local start-ups to international pharmaceutical, digital health and medical technology companies. During his career, Colman has contributed to over 100 reimbursement submissions and economic modelling projects, respectively, as well as multiple cost and burden of illness studies, clinical guidelines, market access strategy projects and late phase studies.
Colman has a strong background in academia and currently holds positions with The George Institute for Global Health (Post-Doctoral Research Fellow) and The University of NSW (Conjoint Senior Lecturer). Colman completed his PhD studies at the George Institute – examining the cost and benefit of helicopter emergency medical services. He has been a lead author or co-author on >50 peer reviewed publications (including The Lancet and NEJM), >50 conference proceedings and has provided several invited speaker presentations. He is also an active reviewer for several international and local journals and has been granted over $15m in peer-reviewed funding through bodies such as the NHMRC.
Panelists
Kara Alikpala
ICanServe Foundation, Pasig City, Philippines
Frances Boyle, AM, MBBS, PhD, FRACP
Patricia Ritchie Centre for Cancer Care & Research, North Sydney, NSW, Australia
Prof Fran Boyle is a medical oncologist in Sydney Australia involved in breast cancer research and treatment. She is the current President of COSA and is involved in advocacy for improved access to new therapies.
Dong Suh, PhD
Chung-Ang University, Seoul, Korea, Republic of (South)
12:30 - 12:45
Break
12:45 - 14:00
Closing Plenary
Digital Health Innovations: Improving Patient Outcomes and Equity in the Asia Pacific Region
Innovations in digital health technologies have become increasingly available for patients, providers, and health systems. There is a raft of technologies that could be considered digital health technologies, for example: apps aimed directly at patients and consumers; apps aimed at patients with the interaction with their clinicians; systems aimed at clinicians for example, decision support systems, and digital tools that can be implemented at a system level, such as electronic medical records. These technologies offer significant promise for improving patient outcomes and reducing inequities; however, these potential benefits need to be balanced against potential downsides. This session will consider how these innovative technologies can be considered within a health technology assessment framework, or other evaluation frameworks to measure how they improve patient health outcomes and equity.
Moderators
Kerryn Butler-Henderson, PhD, MPH, MBA
RMIT University, Melbourne, VIC, Australia
Professor Kerryn Butler-Henderson is the Director of RMIT Digital Health Hub at RMIT University. She is a well-respected digital health academic, with more than twenty years’ experience working in health and higher education. She is known for her passion and dedication to the promotion and advocacy of the specialist digital health workforce. Kerryn is a Fellow of the Australasian Institute of Digital Health, Deputy Editor on the BMJ Health and Care Informatics journal, and was recognised for her expertise as a Future50 Health IT Leader by HIMSS.
Speakers
Raymond Francis Sarmiento, MD
University of the Philippines Manila, Manila, Metro Manila, Philippines
Raymond is a physician-scientist and currently the Director of the National Telehealth Center, National Institutes of Health, University of the Philippines Manila. He is also a Clinical Assistant Professor of the UP College of Medicine's Medical Informatics Unit and chair of the Health Informatics for Development Working Group of the International Medical Informatics Association. He is the current chair of HL7 Philippines (2022-present) and is the immediate past president of the Philippine Medical Informatics Society (2017-2021). He is the Philippines’ representative to the WHO Working Group on Regulatory Considerations on Artificial Intelligence for Healthcare and is a member of the Philippines’ Health Technology Assessment Council.
Kohta Satake, MD, MBA, MPH
CureApp, Tokyo, Japan
Kohta Satake, MD, MBA, MPH
Pulmonologist, Japanese Red Cross Medical Center
Chairman of SIG Digital Therapeutics and Digital Therapy, JTTA
(Japanese Telemedicine and Telecare Association)
Councilor, Japan Society for Tobacco Control
Co-founder and CEO, CureApp, Inc.
Kohta Satake is co-founder and CEO of CureApp Inc., No.1 digital therapeutics company in Japan. He is a physician specialized in respiratory medicine and smoking cessation, in Japanese Red Cross Medical Center.
The digital therapeutic for nicotine addiction treatment (CureApp SC) was approved and covered by public health insurance in December of the same year as the first case digital therapeutic product.
Guangjun Yu, MD, PhD
Shanghai Children's Hospital, Shanghai, China
Dr. GuangJun Yu is Deputy Dean of Medical School, Chinese University of Hong Kong, Shenzhen, President of the Second Affiliated Hospital of The Chinese University of Hong Kong, Shenzhen, and Director of Medical Information Institute of Shanghai Jiaotong University China Hospital Development Institute. Dr. Yu served as President of the Shanghai Children’s Hospital from April 2012 to August 2022. Under his leadership, Shanghai Children's Hospital has built a smart hospital 5R model and it became one of the best smart hospitals as well as one of the earliest internet hospitals in China. Prior to this position, Dr. Yu was Director of Medical Affair Department in Shanghai Hospital Development Center where he led the Shanghai Hospital Link Project, a medical information sharing system that connects 23 public hospitals in Shanghai.
Dr. Yu held many leadership roles in professional societies including Chairman of Shanghai Medical Association Internet Medical Branch, Vice Chairman of China Hospital Association Medical Information Committee, Vice Chairman of Big Data Quality Committee of China Health Information Society, Vice Chairman of Internet Medical Committee of China Medical Information Society.
Dr. Yu received his PhD in social medicine and health management from Fudan University, and his medical degree as well as master’s degree in pediatrics and clinical epidemiology from Shanghai Medical College of Fudan University. He published two books “Medical Big Data” and “Step into Mobile Health Era”.
