Virtual Program

Slide presentations from this conference and past conferences are also available (subject to speaker approval) at the ISPOR Presentations Database

* Program subject to change

Monday, 14 September9:00 - 10:30PLENARY SESSIONKEYNOTE ADDRESSSpeaker

Kwang Hyub Han, MD, PhD

National Evidence-based Healthcare Collaborating Agency, Seoul, Korea, Republic of (South)

Dr. Kwang Hyub Han is the president of National Evidence-based Healthcare Collaborating Agency (NECA), the leading Health Technology Assessment (HTA) agency in Korea. Based on his 30 year experience as a clinical expert, his major goal is to build in ways to promote e vi dence based practice in healthcare. Before joining NECA, Dr. Han was a professor of Internal Medicine at Yonsei University College of Medicine and served as the Director of Yonsei Liver Center in Severance Hospital from 2015 to 2019. He was graduated from Yonsei University College of Medicine in 1979 and was a research associate in Baylor College of Medicine in the US (1990~1992 ). As a world renowned scholar on liver disease, Dr. Han was appointed as the first Korean president of the International Association for the Stu dy of the Liver in 2019. He served as the first chairman of the Asia Pacific Primary Liver Cancer Expert Association (2013~2015) and has represented Korea as a member of the committee responsible for publishing WHO guidelines regarding Hepatitis B in 2014. Both as a prominent academian and clinician, Dr . Han served as the president of Korean Association for the Study of the Liver (2014~2015). Dr. Han started his government funded research as the Director of Liver Cirrhosis Clinical Research Center (2009~2014) designated by the Ministry of Health and Welfare and has made significant contributions to the development of government funded health clinical research. Dr. Han is a current member of the Korean Academy of Science and Technology and National Academy of Medicine in Korea.

COVID-19 IN ASIA PACIFIC- LESSONS LEARNED AND THE PATH FORWARD

A novel Coronavirus that surfaced in late December 2019 and caused COVID-19 pandemic has shocked the world with unprecedented health and economic crisis and triggered uncertainties surrounding almost every aspect of human life worldwide. However, the pace and level of responses to the coronavirus crisis varied in different countries leading to different results. In light of the ongoing developments with COVID-19 situation, this special session brings together health experts across the Asia Pacific region to provide the latest updates and share the anti-COVID-19 strategies in different countries bringing regional insights on how to slow the spread of the virus, reduce its impact on public health, and minimize economic and social disruption. The session will cover multiple perspectives on the short- and long-term effects of the COVID-19 outbreak and how the pandemic shapes the future of healthcare in the region.

Moderators

Shawn Vasoo, MBBS, MRCP, D (ABIM) (Infectious Diseases)

National Centre for Infectious Diseases, Tan Tock Seng Hospital, -, Singapore

Dr Shawn Vasoo is Clinical Director and Senior Consultant at the National Centre for Infectious Diseases (NCID), Singapore. He graduated from the National University of Singapore in 2001, and completed his residency training in Internal Medicine and his fellowship in Infectious Diseases at Rush University Medical Center in Chicago and following that, a Clincal Microbiology Fellowship and Orthopaedic ID fellowship at the Mayo Clinic in Rochester, Minnesota. He also leads the Infectious Diseases Research Laboratory at NCID. He oversees clinical and outbreak preparedness activities at NCID, which is a ~330 bed facility in Singapore purpose-built for outbreaks, which has cared for over 7000 patients with confirmed COVID-19 since the start of the pandemic, and also chairs the COVID-19 therapeutic workgroup in Singapore.

Speakers

Wang-jun Lee, MD, PhD

Myongii Hospital, Seoul, Korea, Republic of (South)

Dr. Lee is one of the most influential person in the Korean healthcare sector. He is chairman and CEO of Myong-Ji Medical Foundation, and running two more acute hospitals and 3 LTC facilities. Also, he is CEO of Korea’s most influential healthcare news & publishing company, ‘The Korean Doctors' Weekly’, founded in 1992. He is one of the leading NGO activists in the medical aid area for migrant workers in Korea, now serves as vice chairman of the Migrant Health Association in Korea. As an Executive Chairman of international affairs of the Korean Hospital Association, he is in charge of general secretary of the Korea Healthcare Congress, which is the top healthcare related annual congress in Asia. He is also a CEO and Chairman of very venturous biotech company 'CancerROP' that is listed in KOSDAQ market, along with a cell therapy company 'MJ CellBio' Dr. Lee graduated from Seoul National University, College of Medicine. He achieved board of surgery in Seoul National Univ. Hospital. He was awarded a Ph.D. degree from the same Univ.

Kenji Shibuya, MD, DrPH

King’s College, London, United Kingdom

Professor Kenji Shibuya is currently Director, University Institute for Population Health at King’s College London. His expertise ranges across important topics in global and population health. Dr. Shibuya has been an advisor to both central and local governments, and most recently he was appointed as Special Advisor to the Director-General of the World Health Organization on health metrics and systems and a member of the Scientific Advisory Committee of Coalition for Epidemic Preparedness Innovations, a new vaccine fund. He spearheaded the future strategic directions of the Japanese global health policy agenda at the Hokkaido Toyako G8 Summit in 2008 on health system strengthening and Ise-Shima G7 Summit in 2016 on global health secirity. He obtained his MD at the University of Tokyo and earned a doctorate of public health in international health economics at Harvard University.

Fan Wu, MD, PhD

Shanghai Medical College of Fudan University, Shanghai, China

Fan Wu, MD, PhD, chief physician, doctoral supervisor, the national expert with special allowance of the State Council. She is now the deputy dean of Shanghai Medical College, Fudan University; the president of Shanghai Preventive Medicine Association; the Director of WHO Collaborating Center for Healthy City. She also serves as an expert of Shanghai municipal leading group for control and prevention of COVID-19, a member of the committee of Shanghai science and technology research group, and a member of China-WHO Joint Mission on COVID-19. She has successively served as the founding director of National Center for Non-Communicable Disease Control and Prevention, China CDC; the director-general of Shanghai Municipal Center for Disease Control and Prevention (at the time the director-general of Shanghai Institutes of Preventive Medicine); the deputy director-general of Shanghai Municipal Health Commission, etc. She has led to establish the national network for NCD control and prevention, set up the national NCD surveillance system and injury surveillance system, as well as to refine the surveillance system in Shanghai regarding on infectious disease, NCD and nutrition. She led the shanghai CDC team to successfully deal with influenza H1N1, avian influenza H7N9 and other public health emergencies, and successfully implement public health security for mass gathering, such as 2010 Shanghai World Expo. She played an important role on consultation of controlling COVID-19 at national and municipal level.

10:30 - 11:00ISPOR NETWORKING SESSIONImmediately following the morning plenary sessions, continue the conversation with key thought leaders in HEOR. Hear from their perspectives, as well as networking with your peers in a lively, interactive discussion session. Be prepared to share your thoughts and questions, as we want YOU as part of the dialogue.

Day 1 Topic: COVID-19 in Asia Pacific: A discussion on the way forward

Moderators: Robert Selby and Clarissa Cooblall, ISPOR

Panelists: Isao Kamae, DrPH, MD, University of Tokyo, Japan; Paul Scuffham, PhD, Griffith University, Australia; Hwee Lin Wee, PhD, National University of Singapore; Richard J. Willke, PhD, ISPOR; Lucinda Orsini, DPM, MPH, ISPOR

This 30-minute session brings together an esteemed panel of thought leaders in the region to talk about how COVID-19 is impacting the Asia Pacific and HEOR’s role in this new environment. How must healthcare and decision-making adapt in the new post-COVID landscape? What is the future of HEOR in the post-COVID era? These are just some of the questions we will be debating. Join us for this interactive session.

11:00 - 12:00Breakout Session 1Use of Real World Endpoints to Drive Next Generation Healthcare – Viewpoints of Regulators, Payors, Clinicians and Patients in Asia Pacific Region

ISSUE: The evidence used for approvals and reimbursement of new medicines is fast expanding beyond clinical trials to include real-word data (RWD) and real world-derived endpoints. The panellists will debate 1) pros and cons of using RWD in regulatory and HTA decision-making, 2) endpoints relevant to support such decision-making and 3) how the collection of RWD can be improved to provide high quality evidence from different end-user perspectives (Prof. Gau for regulators, Prof. Wu for HTA/payors, and Prof. Kang for clinicians and patients). Prof. Lim will open the discussion and moderate the debate.

OVERVIEW: There are many challenges with using RWD to drive next generation health and improve outcomes for patients. These include translating endpoints from oncology trials to the real-world and finding high-quality real-world databases for research. Currently, overall survival (OS) is widely accepted by regulators and payors; however, it is becoming increasingly difficult to capture due to the availability of more effective therapies, thereby resulting in delays to accessing new medicines. Novel surrogate real-world endpoints are being developed, but their acceptability is limited and varies by end-user. Additionally, developing high-quality real-world databases that include these endpoints is challenging. For instance, EMRs are increasingly being used as a source for real-world data, but creation of such databases is time consuming and costly due to the curation required. Data privacy concerns are also creating barriers to accessing this information for research. Policy changes, such as standardization of data capture, could enable better use of this data for research, but increases the workload on physicians. The panellists will debate the acceptability of RWD and surrogate real-world endpoints for decision-making and describe the policy changes that are needed to move this field forward.

Moderators

John CW Lim, MD, MSc, SM

Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore; Consortium for Clinical Research & Innovation Singapore, Singapore, Singapore

Panelists

Churn-Shiouh Gau, Ph.D

National Taiwan University, Taipei, TPQ, Taiwan

Jin-Hyoung Kang, M.D. Ph.D

Seoul St. Mary’s Hospital The Catholic University of Korea, Seoul, Korea, Republic of (South)

Jipan Xie, MD, PhD

Analysis Group, Inc., Los Angeles, CA, USA

Digital Surgery in Korea- Access and Reimbursement, and Key Considerations

ISSUE

: With the advancement of technology and improved surgical technique, minimally invasive surgery was introduced, which enabled smaller incisions, less pain, shorter hospital stays and faster recovery. In addition, further technological advancement brought about robotic surgery, which offered better visualization, dexterity and access to hard to reach areas for surgeons, potentially enabling better outcomes for the patients. Most recently, the healthcare sector saw the emergence of digital surgery, which comprises 3 areas: 1) robotics and advanced instruments, 2) advanced imaging, 3) machine learning and big data. As these are new in healthcare, there are no established mechanisms to appropriately evaluate their value, and access and reimbursement mechanisms. Therefore, it would be critical to gather key stakeholders and discuss the current developments of digital surgery and ways to evaluate its value.

OVERVIEW

: Digital surgery is a newly emerging concept, beyond robotic surgery. With the advancement of artificial intelligence and technology, software elements such as advanced imaging and machine learning and big data have been added to the existing hardware components (i.e. robotics equipment and advanced instruments). To make up for the current lack of any established mechanisms that can appropriately evaluate the value and access and reimbursement mechanisms of digital surgery, three panelists from hospital, government and industry have been invited to this discussion.

Each panel will share their view and experience on the value digital surgery can bring, the unique nature of digital surgery, the considerations for value evaluation system, and discuss next steps to have a more orchestrated and efficient way to serve the shared goal of improved patients outcomes and sustainability in healthcare system.

Moderators

Wonjoo Jung, MSc

Johnson & Johnson, Singapore, 01, Singapore

Panelists

Woo Jin Hyung, MD, PhD

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of (South)

Joo Youn Kim, DVM, PhD

National Evidence-based Healthcare Collaborating Agency, Seoul, Korea, Republic of (South)

Jae Yoo, MBA

Korea Medical Devices Industry Association, Seoul, Korea, Republic of (South)

Value Assessment Frameworks Beyond QALY Metric- Is It Time for Countries in Asia?

ISSUE: Leading experts and key stakeholders in the health economics and outcomes research community in European countries and North America have discussed value assessment frameworks beyond QALY metric. However, they were rarely considered or discussed among countries in Asia. Panelists will discuss their views on various value assessment frameworks and how these frameworks fit with the healthcare decision context in Asian countries from academic, payer, and industry perspectives.

OVERVIEW

: Despite the wide use of cost-effectiveness analysis (CEA) with quality-adjusted life years (QALYs) for assessing value of drugs, its use remains controversial. Since the QALY metric is a single-dimensional and generic health measure, the value assessments using CEA with QALYs therefore fails to capture other important elements of value. In addition, the QALY generally neither addresses the heterogeneity of patient preferences nor engages patients, who are increasingly taking on an active role in healthcare systems across the globe. Recently, new non-QALY based value assessments have been proposed in European countries and the US. This issue panel will first provide a broad overview of the value assessment frameworks beyond QALY metric. The panelists will comment on strengths, weaknesses, and limitations of these value assessment frameworks, based on the healthcare context of countries in Asia. The panelists will also discuss what the countries need, e.g., knowledge and infrastructure, in order to apply the frameworks. Finally, the panelists will suggest the next steps for value assessment frameworks beyond QALY metric for countries in Asia. The target audiences of this issue panel are researchers, payers or policy makers, and pharmaceutical industry. The moderator and each panelist will have approximately five and 15 minutes for their presentations, respectively. The audiences will have 10 minutes to discuss and debate on the issues of value assessment frameworks beyond QALY metric.

Moderators

Nathorn Chaiyakunapruk, PharmD, PhD

University of Utah, Salt Lake City, UT, USA

Panelists

Eun-Young Bae, PhD

Gyeongsang National University, Jinju, NJ, Korea, Republic of (South)

Christoph Glaetzer, Dipl. Kfm

Janssen, Pharmaceutical Companies of Johnson&Johnson, Raritan, NJ, USA

Surachat Ngorsuraches, PhD

Auburn University, Harrison School of Pharmacy, Auburn, AL, USA

12:00 - 12:30BREAK12:30 - 14:00Educational SymposiumAccess to Personalized Medicine- Challenges from Single Arm Studies

Recent scientific advancements in human genome research have led to increasing drug discovery on personalized medicine. Single arm trials (SAT) are often used as study designs during drug development in hematology and oncology because of first in class and lack of existing comparators. However, SAT is not only facing challenges from regulatory review and approval due to methodology and evidence accepted by drug review authorities, it is also experiencing issues from health technology assessment (HTA) perspective for considerations of access and reimbursement.

Panel experts from Asia and the US will highlight opportunities and challenges of SAT in personalized medicine and share their experience and raise considerations of new methodology. The objective of this panel is to continue exploring a better framework how SAT should be considered from access perspective for the ultimate goal of improving patient care to innovative medical technology.

SponsorAmgen Inc.Moderators

Delphine Courmier, PhD, MBA

AMGEN, Thousand Oaks, CA, USA

Speakers

Bor-Sheng Ko, M.D. Ph.D.

National Taiwan University Hospital, New Taipei City, TPE, Taiwan

Jeremy Rassen, ScD

Aetion, Inc., New York, NY, USA

Dr. Jeremy A. Rassen, ScD, is co-founder and chief scientific officer at Aetion, Inc., a company that provides software to evaluate the effectiveness, safety, and value of medical treatments. At Aetion, Dr. Rassen leads the scientific effort around designing methodology for obtaining and communicating medical evidence from real-world data. Dr. Rassen was formerly an assistant professor of Medicine at the Brigham and Women's Hospital and Harvard Medical School, where he focused on methodology for improved validity and reach of pharmacoepidemiology and comparative effectiveness research, including research into propensity score and instrumental variable methods. Before coming to the Brigham and Women’s Hospital, Dr. Rassen worked in Silicon Valley in numerous computer and software companies, including Hewlett-Packard and Epiphany, Inc. His focus was on high-performance software for the creation and analysis of large marketing databases. Dr. Rassen received his Bachelor’s degree from Harvard College and his Doctorate degree in Epidemiology from the Harvard School of Public Health.

Jing Wu, PhD

Tianjin University, Tianjin, 12, China

14:00 - 14:30BREAK14:30 - 15:30Breakout Session 2The Diversity of HTA Systems in Asia Pacific- Exploring the Implications for Patient Access to New Medical Technologies

ISSUE

: Healthcare systems in the Asia Pacific region are extremely diverse. As such, the degree of HTA implementation and the level of complexity of HTA systems reflects this variation. While some countries, such as Japan are only at the beginning of their HTA journey, other countries, such as South Korea are at a mature stage of evolution. With such diversity comes opportunity. The Asia Pacific region is in a unique position to embed best practice alongside novel approaches in the assessment of medical technologies.

OVERVIEW

: This panel will explore and discuss medical technology HTA in the Asia Pacific region with important considerations given to:

the differences in newly formed and mature HTA organisations and how they can learn from each to achieve timely patient access to new medical technologies;
how the medical technology industry can navigate and respond to a rapidly changing HTA environment and the implications of doing this successfully;
the importance of collaboration to help solve issues of capacity and skills shortages in both HTA organisations and industry alike;
continued education on the value of implementing different HTA guidelines when assessing devices compared to drugs and how this can be achieved;
moving toward alternative patient access schemes, such as managed entry arrangements or coverage with evidence development in circumstances where patient access is deemed important but normal HTA methods are not appropriate.

After short presentations (15 minutes) from each panelist, the remainder of the time will be dedicated to audience Q&A, which will be carefully managed by the moderator.

This panel will provide an opportunity to discuss the practical challenges experienced by HTA organisations and industry in assessing new and novel technologies. This panel should be of interest to all HTA stakeholders that are engaged or interested in timely patient access to medical technologies.

Moderators

Jeonghoon Ahn, PhD

Ewha Womans University, Seoul, Korea, Republic of (South)

Dr. Jeonghoon Ahn is a full professor (since March 2020) at the Ewha Womans University (Seoul, Korea) and an adjunct fellow at the National Evidence-based healthcare Collaborating Agency (NECA), Seoul, 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 many international professional organizations such as ISPOR, HTAi, INAHTA, and HTAsiaLink. He is the Chair of the ISPOR Asia Consortium (2020-2022) and was a president of ISPOR Korea Chapter (2012-2014). Dr. Ahn was elected as a board director of the Health Technology Assessment International (HTAi) (2014-2016) and a board director for the International Network of Agencies for Health Technology Assessment (INAHTA) for three times (2012-2016). He also contributed to form a regional Health Technology Assessment agency network, the HTAsiaLink (www.htasialink.org), along with other experts in the region.

Panelists

Takashi Fukuda, PhD

National Institute of Public Health, Wako, Japan

Yoko Ishiguro, Masters in Public Policy

Medtronic, Tokyo, Japan

Chaemin Shin, PhD

National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, Korea, Republic of (South)

Are Standard Methods for Health Economic Evaluation Applicable for Gene Replacement Therapies?

ISSUE: Several limitations and challenges have been identified when conducting economic evaluations of gene replacement therapies (GRT) using standard approaches, such as recommended by HTA organisations using cost-effectiveness analysis as a key driver of decisions. These include in particular: 1) assessment of clinical effectiveness and safety based on small clinical trials, often single-arm; 2) valuation of health outcomes for children, who are often targeted by GRT; 3) time horizon and extrapolation, as there is substantial uncertainty long-term effects, positive or negative; 4) possible development of new payment models specific to GRT. The panel will provide a forum to discuss potential solutions for key methodological issues in health economic evaluation of gene replacement therapies.

OVERVIEW: The moderator will initiate the debate by providing an overview of the gene replacement therapies pipeline and the evidence in development. He will introduce four questions on which the panellists will debate. 1) Under which conditions are single-arm studies acceptable and sufficient for decision-making? 2) Should generic utility instruments like EQ-5D be used for the valuation of health outcomes in severe paediatric diseases? 3) Are analyses over a lifetime horizon feasible and appropriate despite substantial uncertainty around the long-term efficacy and safety? Extrapolation approaches will be discussed. 4) Are the difficulties of economic evaluations for GRT alleviated with the use of new payment models? The panellists, Mondher Toumi, Ataru Igarashi, and Omar Dabbous, will succinctly present their position on these questions, providing academic and industry perspectives. Time will be reserved for debate between panellists, focusing about points of divergence in opinion, with participation of the audience.

Moderators

Samuel Aballea, PhD

Creativ-Ceutical, Rotterdam, 75, Netherlands

Panelists

Omar Dabbous, MD, MPH

AveXis, Inc., Bannockburn, IL, USA

Ataru Igarashi, PhD

Yokohama City University, Yokohama, Japan

Mondher Toumi, MD, MSc, PhD

Aix-Marseille University, Marseille, France

The Role of Multi-Level Insurance Plans- An Increasing Central Driving Force for Health Policy Dynamics in China

PURPOSE

: The objective of this workshop is to discuss how public healthcare insurance, private insurance, and manufacturers can work together to provide multi-level insurance plans and establish early access for innovative drugs in China. Perspectives from a public insurance expert, private insurer and manufacturer will be shared.

DESCRIPTION

: With the current annual National Reimbursement Drug List (NRDL) negotiations, public coverage of healthcare in China has improved substantially. While the public coverage aims for broader and essential access, private insurers are keen to provide supplementary coverage. This approach seeks to increase the affordability for innovative therapies in collaboration with manufacturers. Private insurers are piloting various programs which include reimbursing additional specialty drugs that are currently not on the NRDL and leveraging new technology platforms, such as Wechat and Alipay, to achieve better customer reach, provide healthcare pathway guidance, and offer drug utilization recommendations and financial support.

During the workshop, panelists and the participants will discuss how these multi-level insurance plans and manufacturer efforts will expand access to address public demand, innovation, and payer / consumer value drivers.

Discussion Leader

Mingqiang Li, PhD.

Taikang Insurance Group, Beijing, NY, China

Wahseng Lim, PhD. MBA

Takeda China, Beijing, NY, China

Gordon G Liu, PhD.

National School of Development, Peking University, Beijing, China

Monica Martin De Bustamante, AB, BE

CBPartners, New York City, NY, USA

15:30 - 16:00BREAK16:00 - 16:15HEOR NEWS DESKJoin the Value & Outcomes Spotlight Editors-in-Chief at the “News Desk” for a daily recap of conference highlights and activities.

Zeba M. Khan, RPh, PhD and Laura T. Pizzi, PharmD, MPH will review the hot topics of the day, conduct interviews with key presenters, and preview upcoming events for the next day.

Add the “News Desk” to your daily conference agenda and tune in to see how health economics and outcomes research is informing healthcare decisions around the world.

Tuesday, 15 September8:30 - 10:00PLENARY SESSIONADVANCING PRECISION MEDICINES IN ASIA PACIFIC- PROGRESS, OPPORTUNITIES, AND CHALLENGES

Precision medicine is a customized therapeutic strategy that enables more accurate diagnosis, individually targeted disease prevention and treatment strategies, and better health outcomes. Given its revolutionary technological capabilities, precision medicine holds enormous potential to make treatments both more clinically- and cost-effective. Although precision medicine is still in its infancy, significant efforts—such as the European Union’s Horizon 2020 Program and the White House Precision Medicine Initiative in the United States—have been made in the field and resulted in its rapid advancement over the last decade. Asia Pacific is now becoming the fastest growing precision medicine market in the world. Realizing the promise of precision medicine, the growing burden of genetic disorders and chronic disease, and the rising prevalence of cancer and aging populations, some countries in the Asia Pacific region, such as Japan, China, Singapore, and South Korea, are taking proactive steps to accelerate innovation by establishing their precision medicine initiatives. This session will bring together experts to explore opportunities and challenges precision medicine is bringing to health systems and discuss the role of HEOR in this field.

Moderators

Elina Hypponen, PhD, MPH, MSc

Australian Centre for Precision Health, University of South Australia Cancer Research Institute, Adelaide, Australia

Professor Elina Hyppönen is the Director of the Australian Centre for Precision Health at the University of South Australia Cancer Research Institute. She also holds appointments as a Senior Principal Research Fellow at the South Australian Health and Medical Research Institute (SAHMRI) and as an Adjunct Professor in Epidemiology at the University of Tampere, Finland. Professor Hyppönen has an interdisciplinary academic background, with academic qualifications in epidemiology, medical statistics, nutrition and public health. Professor Hyppönen has a H-factor of 70, having been cited over 19,000 times in the past five years only. She has authored more than 160 high-profile refereed publications and several book chapters. She leads the Nutritional and Genetic Epidemiology group which has a focus on using genetic tools to inform on dietary and lifestyle guidelines for optimal health. She has a long-term research interest in life-course and intergenerational epidemiology, and an extensive track record in gene and risk factor discovery. Her current interests are related to implementing phenomewide analyses and systems epidemiology approaches to establish effective strategies for disease prediction and prevention.

Speakers

Yeul Hong Kim, MD, PhD

Korea University College of Medicine, K-MASTER Cancer Precision Medicine Diagnosis and Treatment Enterprise, Seoul, Korea, Republic of (South)

Yeul Hong Kim, MD, PhD is Professor of Medical Oncology at the Korea University College of Medicine as well as Director of the Korea University Cancer Institute. He is certified in internal medicine and medical oncology by the Korean Association of Internal Medicine. Dr. Kim is primarily interested in the chemotherapy of stomach cancer, colon cancer and other gastrointestinal cancers including pancreatic cancer and biliary cancer. He is actively involved in the Cancer Genomic research for lung and gastrointestinal cancers using microarray, proteomics, and NGS analysis. He is a pioneer in Korea in the area of liquid biopsy using circulating tumor DNA isolated from cancer patient’s blood. He is President of Asian Oncology Society. Currently he is Director of the Korean Precision Medicine Enterprise, which is funded from Korea Ministry of Health and Welfare. He has published 176 papers in SCI or SCIE listed peer-reviewed medical journals including Nature Genetics, Lancet, Journal of Clinical Oncology, Clinical Cancer Research, etc..

Kazuhiko Yamamoto, MD, PhD

RIKEN Center for Integrative Medical Sciences, Yokohama, Japan

Kazuhiko Yamamoto graduated from the University of Tokyo School of Medicine in 1977. After finishing his training and residency in internal medicine and rheumatology, he conducted basic research in the laboratory of Prof T. Tada in Tokyo and Prof G. Haemmerling in Heidelberg. In 1985, he started his own research projects and also served as clinical rheumatologist in the University of Tokyo Hospital. He then moved to St. Marianna University School of Medicine as an associate professor and to Medical Institute of Bioregulation, Kyushu University as a professor. In 1997, he was promoted to be the professor and chairman of Department of Allergy and Rheumatology, the University of Tokyo Graduate School of Medicine. In 2017, he reached the mandatory retirement age of the University of Tokyo and moved to RIKEN Center for Integrative Medical Sciences as a deputy director. In 2020, he become the director. He is also an emeritus professor of the University of Tokyo. Dr. Yamamoto’s research interests include genetic and functional genetic analyses of rheumatoid arthritis and other autoimmune diseases as well as the characterization of newly identified regulatory T cells. He is now planning to establish a research system of human immunology in the research center.

Teo Yik Ying, PhD

National University of Singapore, Singapore, Singapore

Prof Yik-Ying Teo, or commonly known as YY, is the second Dean of the Saw Swee Hock School of Public Health at the National University of Singapore. Trained as a mathematician at Imperial College and completed his MSc and DPhil at Oxford in statistical genetics, YY returned to Singapore in 2010 after working for four years as a Lecturer in Oxford and concurrently a researcher at the Wellcome Trust Centre for Human Genetics. Prior to his Deanship, he was the Founding Director for the Centre for Health Services and Policy Research, and also the Director for the Center for Infectious Disease Epidemiology and Research. He is presently a member on the Council of Scientists for the International Human Frontier Science Program, as well as a member governing board member of the Regional Centre for Tropical Medicine and Public Health Network for Southeast Asia.

Xiaotian Zhang, MD, PhD

Peking University Cancer Hospital & School of Oncology, Beijing, China

Dr. Zhang has been working in the Department of Gastrointestinal (GI) Oncology, Peking University Cancer Hospital since 2000, focusing on diagnosis, medical treatment and research of GI cancer, especially the clinical and translational research of gastric cancer and nutrition support. She participated in draft writing of several national guidelines in China, including the Standards for Diagnosis and Treatment of Gastric Cancer (Issued by the National Health Commission of the People’s Republic of China), Clinical Practice Guideline for Gastric Cancer(Issued by Chinese Society of Clinical Oncology, CSCO), Experts Consensus on Nutrition Support for Cancer Patients(Issued by CSCO), etc. She participated in over a dozen of international and domestic multi-center clinical trials. As the local PI, She is now leading implementation of several phase II and III clinical trials on first- and second-line treatment of gastric cancer. She took charge of a large-sample multi-center phase III randomized trial (PACC of advanced gastric cancer) and two large-scale domestic multi-center phase III randomized trials (RESOLVE and RESOLVE2 for locally advanced gastric cancer). She is also listed in the team of a key project of Beijing “Study on optimization of surgery and post-operation adjuvant therapy scheme for elderly gastric cancer patients”. These clinical trials will greatly contribute to improve individualized treatment for gastric cancer patients in China and are expected to upgrade the concept and mode of comprehensive treatment for locally advance gastric cancer based on solid evidence.

10:00 - 10:30ISPOR NETWORKING SESSIONImmediately following the morning plenary sessions, continue the conversation with key thought leaders in HEOR. Hear from their perspectives, as well as networking with your peers in a lively, interactive discussion session. Be prepared to share your thoughts and questions, as we want YOU as part of the dialogue.

Day 2 Topic: HEOR within the Next-Generation Healthcare Paradigm: Perspectives within the ISPOR Community

Moderators: Robert Selby and Clarissa Cooblall, ISPOR

Panelists Shanlian Hu, MD, MSc, Fudan University, Shanghai, China , Vivian WY Lee, BSc, PharmD, Chinese University of Hong Kong; Trudy Sullivan, PhD, University of Otago, New Zealand; Jitendar Sharma, PhD, Andrha Pradesh Medtech Zone, India; Richard J. Willke, PhD, ISPOR; Lucinda Orsini, DPM, MPH, ISPOR

This 30-minute session brings together an esteemed panel of thought leaders in the region to talk about how the wave of technological innovation is transforming healthcare for all stakeholders. What are the greatest challenges that new modes of healthcare such as precision medicine and digital health posing to health systems? What are the key opportunities? And how can HEOR help fill the gap? These are just some of the questions we will be debating. Join us for this interactive session.

10:30 - 11:30Breakout Session 3Real-World Utilization of Biosimilar Medicines- Learnings for Asia-Pacific

PURPOSE: Balancing improvement in population health while maintaining a sustainable healthcare budget is increasingly challenging worldwide. Biosimilars which have already been introduced in several regions and will become available in Asia Pacific can contribute to addressing unmet medical needs while supporting healthcare budget management. This workshop will present an overview of global access and adoption landscape for biosimilars, analyze barriers, and discuss solutions from distinct perspectives covering clinical, economic and humanistic aspects.

DESCRIPTION: Payers in Asia-Pacific are under scrutiny to control healthcare expenditure and to enhance the sustainability of healthcare systems. Pressure on healthcare budget will likely continue to increase due to numerous factors including aging populations and innovative therapies. Moreover, some countries in the region are experiencing limited access to medicines, especially biologic drugs, due to budget constraints. Biosimilars have the potential to expand access¹ to life-saving therapies and to reduce healthcare costs. Despite this seemingly positive outlook, adoption of biosimilars in the region remain suboptimal notwithstanding the recent market entry of a growing number of biosimilars. Recent improvement in biosimilar uptake in Europe and the US can serve as a benchmark for stakeholders in Asia Pacific and demonstrate how various healthcare systems have successfully managed biosimilar uptake.

The panelists will bring insights from their respective regions, Europe, the US and APAC and share real-world successes as well as remaining gaps and challenges from the payer, physician and patient perspectives to optimize a sustainable use of biosimilars to benefit patients and healthcare systems. The panel will also address frequent concerns around biosimilars such as product quality and regulatory processes as well as real-world clinical effectiveness and safety that are needed to foster confidence in biosimilar adoption.

^1. IQVIA (2018). The Impact of Biosimilar Competition in Europe.

Discussion Leader

Leah Christl, PhD

Amgen Inc., Washington, DC, USA

Colin Ge, PhD

IQVIA, Plymouth Meeting, PA, USA

Ka-on Lam, MBBS, FRCR, FHKCR, FHKAM

The University of Hong Kong, Hong Kong, Hong Kong

Arnold Vulto, PhD, PharmD, FCP

The Erasmus University Medical Center, Rotterdam, Netherlands

Health Technology Assessment in Multi-Payer Health Care Systems- Challenges and Lessons Learned in Asia

PURPOSE

: The purpose of the workshop is to explore the challenges of conducting and using HTA in health care systems with multiple payers. Potential solutions will be discussed, using examples from a range of health care settings.

DESCRIPTION

: Naoko Ronquest (12 mins) will discuss the findings of a literature review conducted for the ISPOR HTA Council Working Group on Challenges of HTA in Pluralistic Healthcare Systems. Potential challenges include; developing a critical mass (budget and expertise) for conducting HTA; contextualizing study findings to suit individual payers’ needs; sharing experiences on the use of HTA for decision-making in different environments;. Yingyao Chen (12 mins) will share experiences of HTA informing decision makers at national and provincial levels from China. In particular, how various decision makers at provincial level has consumed HTA findings and make a decision, including challenges and potential solution to harmonize the system. Devarshi Bhattacharyya (12 mins) will discuss the challenges in India from government and industry perspectives.

Application of HTA for local decision making will be discussed. Nathorn Chaiyakunapruk (24 mins) will share experiences from Thailand where HTA is conducted at national level to serve 3 differing health insurance schemes and describe the revolution on how this national assessment was established. In addition, he will moderate the workshop and orchestrate the discussion. In addition to responding to several polling questions, workshop participants will be encouraged to share their experiences of HTA in pluralistic systems, from a payer, manufacturer or researcher perspective.

Discussion Leader

Devarshi Bhattacharyya, BDS, MSc, MPH

Eli Lilly and Company, Bengaluru, KA, India

Nathorn Chaiyakunapruk, PharmD, PhD

University of Utah, Salt Lake City, UT, USA

Yingyao Chen, PhD

Fudan University, Shanghai, China

Naoko Ronquest, PhD

RTI Heatlh Solutions, Durham, NC, USA

Tumour-Agnostic Therapies- Valuable Additions to the Oncology Arsenal in Asia, or Just Not Cost-Effective?

ISSUE: Regulatory approval of various oncology therapies defined by a common biomarker of response, regardless of histological origin – also known as “tumour-agnostic therapies” – has been hailed as a new era of precision medicine. Tumour-agnostic therapies that have been made available on the market include pembrolizumab for high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumours, and larotrectinib and entrectinib for neurotrophic receptor tyrosine kinase gene fusion (NTRK) tumour types. In APAC, Japan is the first country to approve a tumour-agnostic therapy (entrectinib). Ongoing HTA evaluations of tumour-agnostic therapies in the West suggest unique challenges faced by this group of treatments which may require non-traditional HTA approaches that account for clinical and economic uncertainties posed by basket trial designs, the lack of comparator data and use of biomarker-based endpoints, amongst other difficulties. The increasing availability of tumour-agnostic therapies will raise pertinent questions on how APAC systems should respond. Is a QALY-based value framework appropriate for assessing tumour-agnostic therapies? Should multiple HTA evaluations be conducted for multiple tumour sites? While few APAC countries have adopted non-traditional HTA processes and pathways (e.g. managed access schemes/funds, coverage with evidence development), is it now time for APAC to embrace adaptive HTA processes to pave the way for access to tumour-agnostic therapies?

OVERVIEW: Schezn Lim will introduce the topic and moderate the debate on the methodological and practical challenges for HTA of tumour-agnostic therapies in APAC. Hang Le will provide the industry perspective, Sukyeong Kim and Ataru Igarashi will provide the HTA perspective from two countries with different HTA systems. After the panellist presentations, the audience will be asked to vote on whether tumour-agnostic therapies are valuable additions to the oncology arsenal in Asia. The floor will then be opened for questions.

Moderators

Schezn LIM, BSc (Pharm) MSc PGCert (Health Economics)

Costello Medical Singapore Pte Ltd, SINGAPORE, Singapore

Panelists

Le Hang, PhD

Roche Pharma International, Singapore, Singapore

Ataru Igarashi, PhD

Yokohama City University, Yokohama, Japan

Sukyeong Kim, PhD, RPh, MPH

National Evidence-based Health Care Collaborating Agency (NECA), Seoul, South Korea

11:30 - 12:00BREAK12:00 - 13:30Educational SymposiumFrom Hype to Reality- Personalizing the Value Assessment of Personalized Medicine in APAC

Personalized medicine/ precision medicine (PM) is considered as the future of healthcare as it offers patients individualized treatment experience with promising clinical benefits. Particularly in oncology where cancer is known as a disease of genome, PM has the potential to provide tailored treatment with the best clinical outcomes. Recent advances in science have led to the development of innovative products that will accelerate the realization of PM. However, some of these technologies pose significant challenges to the existing approach of HTA. Two prime examples of these technologies are Next Generation Sequencing (NGS) or Comprehensive Genomic Profiling (CGP) which can test multiple genes at the same time, and help predict patient responses across multiple targeted therapies in multiple cancer indications, and tumor-agnostic therapies which is informed by genomic alterations regardless of tumor location. Tumor-agnostic therapies such as entrectinib for neutrophic receptor tyrosine kinase gene fusion (NTRK) or pembrolizumab for high microsatellite instability (MSI-H) as well as large panel gene testing like NGS or CGP have been made available in many countries including in the APAC region. However, employing traditional HTA approaches in the assessment of these new technologies may not fully capture their values. Not accounting for heterogeneity of treatment effects across patients and not sufficiently acknowledging elements of personalized medicine may result in restricted and delayed patient access, and may unintentionally set back countries' drive toward personalized medicine.

SponsorIQVIAModerators

Yang Xie, PhD.

IQVIA, Shanghai, China

Speakers

Louis P. Garrison, PhD

University of Washington, Seattle, WA, USA

Lou Garrison, PhD, is professor emeritus in The Comparative Health Outcomes, Policy, and Economics Institute in the School of Pharmacy at the University of Washington, where he joined the faculty in 2004. For the first 13 years of his career, Dr. Garrison worked in non-profit health policy at Battelle and then the Project HOPE Center for Health Affairs, where he was the Director from 1989-1992. Following this, he worked as an economist in the pharmaceutical industry for 12 years. From 2002-2004, he was vice president and head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, based in Basel, Switzerland. Dr. Garrison received a BA in Economics from Indiana University, and a PhD in Economics from Stanford University. He has more than 150 publications in peer-reviewed journals. His research interests include national and international health policy issues related to personalized medicine, benefit-risk analysis, and other topics, as well as the economic evaluation of pharmaceuticals, diagnostics, and other technologies. Dr. Garrison was elected as ISPOR President for July 2016-June 2017, following other leadership roles since 2005. He recently co-chaired the ISPOR Special Task Force on US Value Frameworks. He was selected in 2017 by PharmaVOICE as being among “100 of the Most Inspiring People” in the industry. He recently received the PhRMA Foundation and Personalized Medicine Coalition 2018 Value Assessment Challenge First-Prize Award as lead author on a paper on “A Strategy to Support the Efficient Development and Use of Innovations in Personalized and Precision Medicine.”

George Papadopoulos, BSc(Hons), GradDipEpi

Lucid Health Consulting Pty. Ltd., NSW, Australia

Jasmine Pwu, PhD

Ministry of Health and Welfare, Taipei, Taiwan

Vanessa Schaub, PhD

F.Hoffmann-La Roche, Switzerland

13:30 - 14:00BREAK14:00 - 15:00Breakout Session 4The 3rd Version of the Korean Economic Evaluation Guidelines

PURPOSE: The Korean Government announced in December 2006 that only medications offering good value for money, will be reimbursed in the Korean National Health Insurance (NHI) programme (the Positive List System, or PLS). With the introduction of the PLS, the Health Insurance Review and Assessment Service (HIRA) published the first version of the Korean pharmacoeconomic evaluation guidelines in 2006. The 2^nd version was announced in 2011 and the 3^rd version is scheduled to be announced in 2020. The purpose of this workshop is to share the overview of the 3^rd version of the Korean economic evaluation guidelines.

DESCRIPTION: Professor Lee will lead the discussion as a moderator, and Professor EY Bae will provide overview of the direction of the revision. Professor An will overview the major statistical considerations in the revision. Professor Hong will review the health-related quality of life (HRQoL) data submitted to HIRA and discuss HRQoL-related issues raised in the revision.

Profesor SJ Bae will outline issues raised in the areas of modeling and uncertainty analysis.

Discussion Leader

Hyonggin An, Ph.D.

Korea University, college of medicine, Seoul, Korea, Republic of (South)

Eun Young Bae, PHD

Gyong-Sang National University, South Korea, Jinju, Gyeongnam province, Korea, Republic of (South)

SeungJin Bae, SC.D.

Ewha Womans University, College of Pharmacy, Seoul, Korea, Republic of (South)

Jihyung Hong, PhD

Gachon University, Seongnam, Korea, Republic of (South)

Tae Jin Lee, PhD

Seoul National University, Seoul, Korea, Republic of (South)

Measuring Health Outcomes- Understanding the Variation in EQ-5D-5L Values across the Asian Region

PURPOSE: Although several EQ-5D-5L valuation studies have been conducted in the Asian region, including China, Hong Kong, Indonesia, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand, and Vietnam, published value sets differ across health jurisdictions. Accounting for these variations is complicated by several factors that include underlying differences in healthcare governance, finance and organization. Variability attributable to the valuation methods used is imperfectly understood. The use of EQ-VT (a standardized method for eliciting health state valuations) has helped to improve data quality; differences in data analysis strategies and the details of modelling methods may nevertheless still contribute to variations between value sets.

This workshop is intended to improve our understanding of how EQ-5D values differs across the Asian region and to explore their implications for future valuation studies. Findings based on the analysis of primary data collected in Asian 5L valuation studies will form the basis of the workshop. PIs of 5L valuation studies whose data have been shared with the workshop leaders, will be invited to participate.

DESCRIPTION: The workshop will begin with an introduction to the current state of play in EQ-5D-5L valuation in the Asian region. Key elements of the EQ-VT procedure will be described, for example the use of the lead-time form of TTO to value states worse than dead. The robustness of data across valuation studies will demonstrated using pre-defined criteria. Internal consistency between DCE and TTO methods will be compared. A panel-led discussion will explore potential explanations for the observed differences in regional EQ-5D-5L value sets. The implications of this variation in values for health policy will be exemplified. Recommendations for the future conduct of valuation studies will be proposed

The workshop will conclude with an interactive Q&A session during which audience will have the opportunity to discuss with members of the panel and valuation study PIs.

Discussion Leader

Ling-Hsiang Chuang, PhD

GongJing Healthcare, Nanjing, China

Paul Kind, PhD

University of Leeds, Leeds, United Kingdom

Nan Luo, PhD

National University of Singapore, Singapore, Singapore

Spotlight SessionHTA Harmonization in Asia Pacific- Just a Dream or a Future Reality? A Joint ISPOR – HTAsiaLink session

Health technology assessment (HTA) is increasingly being accepted by decision-makers as an essential tool to formulate and implement evidence-informed health policy in the Asia Pacific region. Recognizing the wide variety of healthcare systems and HTA processes in the region and the importance of considering the local context when assessing health technologies, by leveraging inherent strengths in each system, HTA harmonization will bring many benefits, such as reducing cost, saving resources, having access to pooled expertise, and improving efficiency of regulatory and reimbursement processes, among others. There has been notable success with these efforts in Europe. However, in the face of challenges including social-cultural differences, differences in decision processes, legal conditions, and views on the medico-economic value of health interventions, is HTA harmonization still feasible for the region? As global organizations comprised of experts with different perspectives and backgrounds, ISPOR and HTAsiaLink are well-positioned to support the global health pursuit toward adopting universal best practices. This session will examine the key opportunities and barriers to harmonization of HTA across Asia Pacific, with a view toward future development and solutions.

Moderators

Oshima Sachin, PhD

Department of Health Research, New Delhi, DL, India

Speakers

Budi Hidayat, SKM, MPPM, PhD

University of Indonesia, Depok, Indonesia

Andrew Wilson

Pharmaceutical Benefits Advisory Committee (PBAC), Canberra, NJ, Australia

Kun Zhao, MD, MHSci, PhD

China National Health Development Research Center, Beijing, China

15:00 - 15:30BREAK15:30 - 15:45HEOR NEWS DESKJoin the Value & Outcomes Spotlight Editors-in-Chief at the “News Desk” for a daily recap of conference highlights and activities.

Zeba M. Khan, RPh, PhD and Laura T. Pizzi, PharmD, MPH will review the hot topics of the day, conduct interviews with key presenters, and preview upcoming events for the next day.

Add the “News Desk” to your daily conference agenda and tune in to see how health economics and outcomes research is informing healthcare decisions around the world.

Wednesday, 16 September8:30 - 10:00PLENARY SESSIONINNOVATIVE APPROACHES TO PRICING, VALUE ASSESSMENT, AND PATIENT ACCESS TO HIGH-COST INTERVENTIONS

High-cost innovative healthcare technologies often bring substantial health benefit or even cures to patients, but they can carry massive price tags and are developing more rapidly than health systems can react. The high cost is often cited as a major barrier to patient access for these treatments, such as cancer drugs and non-cancer drugs for rare diseases, prosthetics, and other lifesaving devices. How should we consider different stakeholder perspectives, address their concerns, and balance their needs regarding the value of high-cost interventions while making these technologies more affordable and accessible to patients? A few ideas to address this—eg, more centralized procurement, risk-sharing or performance-based schemes, or other special methods for setting prices and assessing value—have been heavily debated, but stakeholders are far from consensus. This plenary will present and discuss some novel models to overcome access barriers in Asia Pacific while sharing global experiences outside the region.

Moderators

Diane Munch, MA

Pfizer, Inc., New York, NY, USA

Diane has been working for the Pharmaceutical Industry for more than 18 years. She has held various Pricing roles at Pfizer and before at Rhone Poulainc Paris. Diane is responsible for leading Pfizer’s biopharmaceutical global pricing function and providing strategic guidance, analysis and a standardized process on pricing matters spanning across business units.

Speakers

Jeonghoon Ahn, PhD

Ewha Womans University, Seoul, Korea, Republic of (South)

Sarah Fitt, BPharm

Pharmaceutical Management Agency (PHARMAC), Wellington, NY, New Zealand

Sarah was appointed Chief Executive of PHARMAC in January 2018, having been PHARMAC’s Director of Operations since 2013. Under Sarah’s leadership, PHARMAC has continued to expand the number and range of funded medicines available to New Zealanders as well as widening access to currently funded medicines. She has also overseen the management of funding medicines in all New Zealand public hospitals and is laying the groundwork for PHARMAC to manage hospital medical devices. Leading a crown entity that is transparent and has high public confidence is important to Sarah. She is driving an improvement programme to make PHARMAC’s decisions clearer and faster. She is also committed to reducing inequities of access to funded medicines and a new identity was launched in late 2018, Te Pātaka Whaioranga, to show PHARMAC’s commitment to Te Tiriti O Waitangi. Before joining PHARMAC, Sarah spent 12 years as Chief Pharmacist at Auckland Hospital where she led a large comprehensive pharmacy service. Sarah graduated in pharmacy from the University of London. She worked as a clinical pharmacist in the NHS specialising in HIV, intensive care and hepatology.

Shanlian Hu, MD, MSc

Fudan University, Shanghai, China

Netnapis Suchonwanich

Health Intervention and Technology Assessment Program (HITAP), Bangkok, Thailand

Mrs. Netnapis Suchonwanich is Former Deputy Secretary-General of National Health Security Office in Thailand, graduated her Bachelor degree in Pharmacy and Master degree in IT Management. She played a key role in Universal Coverage Scheme in Thailand since 2002. During the times, she was the pioneer in health insurance information systems development at National Health Security Office and developed many core applications needed for UHC such as Beneficiaries enrollment system, Provider registration, Medicines and medical devices administration, Financial and accounting system, Electronic claim system with automatic financial tracking process. In 2009, she started to collaborate with Government Pharmaceutical Organization for establishment the central procurement with Vendor managed inventory program for high costly medicines, vaccines listed in national priority program finally extended to National Antidotes program in the year 2011. From the experiences in universal health care administration, she has been nominated as member for National Essential Drug Subcommittee and chairs for price negotiation working group for competitive medicines submitted to be Essential medicines in Thailand. Currently, she has participated as a Temporary Advisor to the World Health Organization (WHO) in developing the Guideline on Country Pharmaceutical Pricing Policy.

Day 3 Topic: New Pathways for Patient Access – Engaging with all Healthcare Stakeholders – A Group Discussion

Moderators: Robert Selby and Clarissa Cooblall, ISPOR

Panelists: Ratna Devi, MBA, MBBS, DakshamA Health, India; Bruce Crawford, MA, MPH, Syneos Health, Japan; Hong Li, PhD, MPH, Amgen, Hong Kong; Viva Ma, PhD, MPH, MBA, Becton Dickinson, Singapore; Richard J. Willke, PhD, ISPOR; Lucinda Orsini, DPM, MPH, ISPOR

This 30-minute session brings together an esteemed panel of thought leaders in the region to talk about stakeholder roles in exploring different approaches to overcoming access barriers. Where can the role of the patient voice be strengthened in patient access efforts? What are the future directions for broader stakeholder dialogue and engagement in healthcare? These are just some of the questions we will be debating. Join us for this interactive session.

10:30 - 11:30Breakout Session 5The Potential Role and Impact of Machine Learning in Health Economics and Outcomes Research

PURPOSE: The availability of data to support health economics and outcomes research (HEOR) is increasing at an exponential rate. In the age of big data, cutting-edge machine learning algorithms, which have been tremendously successful in transportation and retail industry (e.g., Uber and Amazon) can play a promising role in HEOR. The objective of this workshop is to introduce the basics and key concepts in machine learning (ML), how machine learning can influence the field of HEOR, what are some of the potential pitfalls of machine learning and applications from health economics outcomes research that utilize machine learning.

DESCRIPTION: In this workshop, we will introduce the current landscape in HEOR through the lens of the state-of-the-art modern machine learning techniques. In particular, we will start with reviewing basics and key concepts of modern machine learning techniques for descriptive, predictive, prescriptive analytics. We will proceed with discussing how ML differs from statistical learning and modeling and provide an overview of selected ML algorithms such as deep neural networks, and random forests. We will then illustrate state-of-the-art applications of ML to HEOR– this will include use of ML for augmenting health economic modeling for cost-effectiveness analysis, developing ML-driven Apps or online tools for running complex models in real time, and synthetic data generation using ML. We will conclude by discussing potential pitfalls of ML in health outcomes research and promising future research directions. This workshop will be primarily geared towards the interested audience from the pharmaceutical industry concerned with health economic evaluation.

Discussion Leader

Turgay Ayer, PhD.

Georgia Institute of Technology, Atlanta, GA, USA

Jag Chhatwal, PhD

Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

Selin Merdan, Ph.D.

Value Analytics Labs, Boston, MA, USA

Funding High-Cost Innovations in Asia- Is the Current HTA System Adequate?

ISSUE

: Innovative new therapies (particularly in oncology and rare diseases) tend to be associated with a high cost of treatment, and often less robust evidence compared with other therapeutic areas at time of launch. Asia is currently facing issues that more developed HTA markets such as UK, Australia and Canada have previously faced. An increasing number of Asian countries (South Korea, Taiwan and most recently Japan) have moved, or are moving towards the use of HTA and pharmacoeconomic evaluation to inform drug pricing and/or funding decisions.

Developed HTA markets have so far piloted and/or adopted different solutions, including the use of innovative pricing schemes, risk-share arrangements (RSAs), managed entry schemes. Some Asian countries (e.g. S. Korea, Australia) have already started adopting RSAs.

OVERVIEW

: The panel will discuss current situation and issues of funding high-cost innovations in Asia, what is working well and what is not, what can be learned from other countries and what cannot be learned due to the diversity of healthcare / funding systems; is there a one-size fit all solution? The panel will focus on the Asian perspective considering both predominantly public / universal coverage and private / out-of-pocket countries to ensure the discussion is representative and targeted to a broad audience.

Joe Caputo will moderate the panel and provide the perspective of HTA-developed countries of UK & Australia. Joe will also prompt and ask key questions to panellists aimed to provide an Asian perspective focused on Japan (Professor Isao Kamae) and Korea (Professor Jeonghoon Ahn), alongside an Industry perspective (Marius Van Den Berg).

Moderators

Joe Caputo, BSc (Hons)

Vista Health Pte Ltd., Singapore, Singapore

Panelists

Jeonghoon Ahn, PhD

Ewha Womans University, Seoul, Korea, Republic of (South)

Isao Kamae, MD, DrPH

The University of Tokyo, Tokyo, Japan

Marius Van Den Berg, DBA

Illumina Singapore Pte Ltd, Singapore, Singapore

Current Status and Future Access to Innovative Cancer Treatments in Korea, Taiwan and New Zealand- A Perspective of Patient Advocacy Groups?

ISSUE

: Since 2014, six PD-(L)1 inhibitors - atezolizumab, avelumab, cemiplimab, durvalumab, nivolumab and pembrolizumab - have been approved for various tumour types by regulatory agencies across the world. Unprecedented overall survival (OS) gains and improvements in various aspects of patients’ lives have been consistently demonstrated in clinical trial and real-world settings. Various types of patient access or assistance programs were launched to improve affordability and access, however, in most Asia Pacific countries, PD(L)1 inhibitors have been reimbursed for only a few of the approved indications. This means the majority of patients cannot access them through national formularies in places such as Korea, Taiwan and New Zealand. In contrast, patients of different tumour types across Europe with similar healthcare systems have broader and quicker access to PD-(L)1 inhibitors.

OVERVIEW

: Using PD-(L)1 inhibitors as a case study, this panel will explore the current reimbursement listing landscape of innovate cancer treatments focusing on the perspectives of patient advocacy groups, including their current roles in reimbursement processes and the potential for better engagement in processes.

The discussion will be underpinned by desktop research comparing the listing status and landscape of PD-(L)1 inhibitors and mapping current reimbursement listing processes in selected countries. A survey will be carried out among PAGs who have actively involved with cancer patient activities in Korea, Taiwan and New Zealand to understand their involvement in reimbursement listing decisions. From the analysis of this research, focus group discussions will be conducted to share the findings and explore how patient engagement in reimbursement decision-making can be improved to support access to innovative treatments such as PD-(L)1 inhibitors on national reimbursement listings.

The moderator will introduce the topic and panelists in the first five minutes. Each panelist will then take 15 minutes to present their perspectives. Finally, there will be 10 minutes of Q&A and discussion.

Moderators

Ann Single, BBus MA

Patient Voice Initiative, Ashgrove, QLD, Australia

Panelists

Philip Hope, Dip. Bus. Hons. CFRM MFINZ

Lung Foundation New Zealand, Auckland, QLD, New Zealand

Jin Young Paik, NA

Korea Kidney Cancer Association, Seoul, QLD, Korea, Republic of (South)

Jane Tsai, NA

Formosa Cancer Foundation Taiwan, Taipei, QLD, Taiwan

11:30 - 12:00BREAK12:00 - 13:30Educational SymposiumGene Therapy- Valuation of Novel Therapies

Gene therapy is an innovative approach designed to address the genetic root cause of monogenic diseases. The lack of standardized evaluation methodologies for gene therapies provide challenges for medical and health technology assessment and require innovative solutions. This symposium will examine the fundamentals of gene therapy and provide an overview of its clinical application to treat rare diseases, such as spinal muscular atrophy. It will also introduce value-based assessments of gene therapies, including the current and proposed methods of evaluation, assessment of payment models, value-based principles and managing the affordability challenges that could be posed by novel treatments, such as gene therapies.

MED-CON--00001-GLO

SponsorAveXis, Inc.Speaker

Michael Drummond, MCom, DPhil

Bocconi University, York, YOR, United Kingdom

Michael Drummond, BSc, MCom, DPhil is professor of Health Economics and former Director of the Centre for Health Economics at the University of York. His particular field of interest is in the economic evaluation of health care treatments and programmes. He has undertaken evaluations in a wide range of medical fields including care of the elderly, neonatal intensive care, immunization programmes, services for people with AIDS, eye health care and pharmaceuticals. He is the author of two major textbooks and more than 650 scientific papers, and has acted as a consultant to the World Health Organization and the European Union. He has been President of the International Society of Technology Assessment in Health Care, and the International Society for Pharmacoeconomics and Outcomes Research. In October 2010 he was made a member of the National Academy of Medicine in the USA. He has advised several governments on the assessment of health technologies and chaired one of the Guideline Review Panels for the National Institute for Health and Care Excellence (NICE) in the UK. He is currently Co-Editor-in-Chief of Value in Health and has been awarded 3 honorary doctorates, from City University (London), Erasmus University (Rotterdam) and the University of Lisbon.

Sean Sullivan, PhD, MSc, RPh

University of Washington, Seattle, WA, USA

13:30 - 14:00BREAK14:00 - 15:00Breakout Session 6ICER Threshold for Innovative Medicines – Harmonization with Novel Payment Model (NPM)

ISSUE: National insurers in HTA countries provide reimbursement when clinical benefits and cost-effectiveness are proven in the assessment process. Since pipelines are becoming filled with more biologics that carry higher market prices than chemical drugs, there is a strong necessity to find practical solutions and learn from other countries on how to manage this challenge through a Novel Payment Model (NPM) that is harmonized with the Incremental Cost-Effectiveness Ratio (ICER). To expedite the access of innovative new drugs and make processes more patient-centric not only in Korea but also other HTA countries in the Asia Pacific, now is the time to revisit use of ICER thresholds and other indicators through novel payment models.

OVERVIEW: Local and global experiences to implement ICER threshold in reimbursement decision of innovative new medicine will be provided with panel presentations to identify barriers and appropriate solutions for patient access and recognizing fair value of innovative medicines.

Dong churl Suh will encourage all participants to exchange opinions about implications and provide recommendations in relation to positioning ICER threshold in reimbursement decision in Asia Pacific and future direction for harmonizing with NPM.

Kevin Haninger introduces the concept of Novel Payment Model and what is happening in other HTA countries including Canada, Australia, and UK, in terms of how they balance ICER threshold with other measures in reimbursement decision including implementation of Novel Payment Model.

Eunsuk Kim clarifies the barriers in local HTA system in industry perspective identified from local analysis of ICER threshold logs. She will address the rationale of flexible ICER threshold necessary for evaluating innovative medicines based on the analysis.

Soomi So shares the lessons from HIRA’s experience in HTA accumulated over 12 years in payor perspective. Specially, she will share the direction of HIRA to handle high cost innovative medicine and plan for implementation of NPM.

Brian Godman will discuss applicability of the Novel Payment Model from patients and national healthcare system perspectives

Moderators

Dong-Chul Suh, PhD

ChungAng University, Seoul, Korea, Republic of (South)

Panelists

Brian Godman, PhD

Karolinska Institutet, Stockholm, Sweden

Kevin Haninger, PhD

Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC, USA

Eun-Sook KIM, PhD

MSD Korea, Seoul, Korea, Republic of (South)

Soomi So, PhD

Health Insurance Review and Assessment Service (HIRA), Gangwon-do, Korea, Republic of (South)

Follow-the-Leader No More- Should Asia’s Developing HTA Systems Advance with Real-World Data/Evidence Use, or Wait to Learn from Established HTA Bodies?

ISSUE: Despite the increasing number of RWD/RWE studies being conducted and the growing potential of converting RWD to RWE, RWE has not been used extensively to inform decision-making in developed HTA systems. Given the rapid development of HTA systems and the accelerating evolution of RWE in Asia, examination is required of whether developing HTA systems can forge ahead with RWE use.

OVERVIEW: This panel will describe the current use of RWD/RWE in HTA processes and the learnings from established HTA systems, evaluate the current availability, accessibility, and quality of RWD/RWE in Asia, and determine if and how developing HTA systems in Asia can lead the way with RWD/RWE use.

Ma Qian will introduce the issues and then moderate the panel discussion. The panellists will present their viewpoints from different perspectives. Pilar Pinilla Domínguez will discuss the considerations and challenges of incorporating RWE into decision-making from NICE’s perspective and some of NICE’s future plans for RWE use. Assistant Professor Hwee-Lin Wee will discuss the practical challenges faced by stakeholders and share recommendations on when to use RWE, how to collect and how to use RWD/RWE based on the REALISE Working Group Guidance which has been developed by the HTAsiaLink network. Dr Hu Hao will discuss industry’s approach to and capacity for RWE, outline improvements required in RWD collection and analysis, and consider whether the potential costs of RWE can outweigh the potential gains of it.

The panel is targeted at policymakers from the government, HTA practitioners, industry, RWE experts and other stakeholders who are interested in the development of RWE and the future role of RWE in developing HTA processes. Panellists will speak for 15 minutes each, and audience questions are encouraged throughout. The panel will close with a 15-minute Q&A and a short summary.

Moderators

Qian Ma, Double Bachelor Degrees

Costello Medical, Singapore, Singapore

Panelists

Hao Hu, PhD

Gilead Sciences, Hong Kong, 92, Hong Kong

Pilar Pinilla, MSc

National Institute for Health and Care Excellence, London, United Kingdom

Hwee-Lin Wee, PhD

Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore

The Opportunity Cost of Using Financially Driven Tools in Reimbursement Decisions for Pharmaceuticals

ISSUE

: Financially driven decision tools are rigorous, time-consuming and onerous. Over time, the complexity of processes and information requirements for pharmaceuticals have grown as efforts are made to increase the precision of models, despite the inability to remove all uncertainties. Similar decision processes are rarely used in other aspects of health funding (or other areas of government expenditure). This may lead to disproportionate and potentially biased focus on driving efficiency from one area of the system.

Do such approaches, therefore, represent the most effective or efficient process for governments to provide patients with reimbursed access to innovative pharmaceuticals?

OVERVIEW

: Governments improving universal healthcare must balance availability with finite resources. For emerging markets, lacking in health infrastructure, pharmaceuticals can represent a high proportion of expenditure compared to developed systems. In considering how to evolve decision making processes, countries are increasingly relying upon financially driven approaches to make reimbursement decisions about pharmaceuticals. These include cost-effectiveness analysis, budget impact and more recently “opportunity cost”.

Whilst financially driven decision approaches offer the opportunity for short term budget control, the application raises questions about equity of patient access and consistency across health funding. This panel will consider the impacts upon various stakeholders and explore potential alternatives that accommodate constraining factors. The panel will discuss the changing nature of health technologies and how their adoption is affected by current decision making processes.

Short introduction from moderator (10 minutes):

Discussion of pharmaceutical costs in health systems of different maturity/coverage.
Trends in decision-making approaches for reimbursement decision making.

Guided Q&A with opportunity for audience interaction (50 minutes):

Richard Vines will provide patient perspectives. Jasmine Pwu will represent payer perspectives. Christoph Glaetzer will offer the pharmaceutical industry perspective.

Moderators

Adrian Towse, MA, MPhil

Office of Health Economics, London, United Kingdom

Professor Adrian Towse is director emeritus and senior research fellow of the Office of Health Economics in the UK. Adrian’s current research includes incentives for new drugs and vaccines to tackle Antimicrobial Resistance, the use of 'risk-sharing' arrangements between healthcare payers and pharmaceutical companies, including value-based pricing approaches; the economics of pharmacogenetics for healthcare payers and the pharmaceutical industry; economic issues that affect both R&D for and access to treatments for diseases prevalent in the developing world; the economics of medical negligence; and measuring productivity in healthcare. A visiting professor at the London School of Economics and a senior researcher at the Nuffield Department of Population Health at the University of Oxford, Adrian also has been a visiting professor at the University of York. For ten years, he served as the non-executive director of the Oxford Radcliffe Hospitals NHS Trust, one of the UK’s largest hospitals. Adrian was president of ISPOR, for the 2014-15 term. Adrian joined the OHE in 1993 and served as director for 25 years. He holds an MA (Hons) in Politics, Philosophy and Economics from Keble College, Oxford; an MPhil in Management Studies from Nuffield College, Oxford, and the Oxford Centre for Management Studies; and is a member of the Chartered Institute of Management Accountants.

Panelists

Christoph Glaetzer, Dipl. Kfm

Janssen, Pharmaceutical Companies of Johnson&Johnson, Raritan, NJ, USA

Jasmine Pwu, PhD

Ministry of Health and Welfare, Taipei, Taiwan

Richard Vines, TBA

Rare Cancers Australia, Bowral, NSW, Australia

15:00 - 15:30BREAK15:30 - 15:45HEOR NEWS DESKJoin the Value & Outcomes Spotlight Editors-in-Chief at the “News Desk” for a daily recap of conference highlights and activities.

Zeba M. Khan, RPh, PhD and Laura T. Pizzi, PharmD, MPH will review the hot topics of the day, conduct interviews with key presenters, and preview upcoming events for the next day.

Add the “News Desk” to your daily conference agenda and tune in to see how health economics and outcomes research is informing healthcare decisions around the world.

Virtual ISPOR Asia Pacific 2020

14-16 September 2020

Virtual Program

The Professional Society for
Health Economics and Outcomes Research