2016-2018 Chair Health Policy in Asia-Pacific Isao Kamae, MD, DrPH  University of Tokyo Patient Involvement in Health Technology Assessment in Asia- Tokyo, Japan Introduction, China, Japan, South Korea and Taiwan  Health Technology Assessment and Its Application in Vietnam 2016-2018 Chair-Elect Kun Zhao, PhD, MD, MHSc Regional Health Initiatives China National Health  2nd International PEOR Conference in Andhra Pradesh, India Development Research Center  Beijing, China Workshop in Kolkata, India  Indonesia workshops and publication 2016-2018 Past Chair Surachat Ngorsuraches, PhD Asia Consortium at ISPOR Boston South Dakota State University  Asia Consortium meetings and forums Brookings, ND, USA

Advisory Committee Outcomes Research  Value in Health Regional Issues (ViHRI) Vol 12, May 2017 – focusing on Asia 2017-2019 Chair Bruce Crawford, MPH, MA ISPOR 6th Latin America Conference inVentiv Health  Register at the conference website Tokyo, Japan

2017-2019 Chair-Elect Member-Reported News Chee-Jen Chang, PhD  Stent Price Regulations in India Chang Gung University  HTA Horizons Expanding within the Eurasian Economic Union Taipei, Taiwan  Drug Catalogue Selection in China

 Establishing Cost-effectiveness Threshold for Malaysia 2017-2019 Past Chair  Vivian WY Lee, PharmD New Health Policies in South Korea The Chinese University of Hong  Workshop on Bioterrorism in Iran Kong, Hong Kong, Mainland China  Member-Reported Accomplishments (Prof. Subhash Mandal and Dr. Amit Dang)

Regional Initiatives ׀ ISPOR Asia Consortium ׀ Outcomes Research ׀ Education ׀ Health Technology Assessment ׀ Health Policy in Asia

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017 News Across Asia Co-Editors HEALTH POLICY IN ASIA Patient Involvement in Health Technology Assessment in Asia Dr. Jitendar Sharma, CEO, Andhra Pradesh MedTech Zone, Advisor, Health, Govt. of Andhra Pradesh, and Executive Director, Kalam Institute of Health Technology, New Delhi, India

Introduction The feature of involving patients in health care decision making processes is emerging in Asia. The concept of patient evolvement in health care decision makings stems from the notion of “shared decision making” where Nathorn clinicians and patients make decisions together using the best available evidence which achieve the best health Chaiyakunapruk, outcome. Many global HTA agencies have provided institutionalized structure for patient involvement in assess- PhD, PharmD ment of health technologies during the “values” appraisal process (Figure 1) Professor, School of Figure 1: HTA Process and Patient Involvement Pharmacy, Monash University Malaysia Selangor, Malaysia

Bhagwan Aggarwal, PhD, MBA TEDMED Scholar for So why is shared decision making thought to lead to better health outcomes? If a communication breakdown TED Talks, USA occurs between clinician and patient during treatment, the patient may be unaware of treatment or management

options and outcomes, while the clinician may be unaware of patients’ circumstances and preferences. This would invariably lead to an erroneous or less optimal treatment plan. Thus the optimal decision takes into account evidence-based information about available options, the provider’s knowledge and experience, and the patient’s values and preferences, following the SHARE approach:

The Share Approach Step 1: Seek your patient’s participation Soraya Azmi, MD, Step 2: Help your patient explore and compare treatment options MPH, Managing Step 3: Assess your patient’s values and preferences Step 4: Reach a decision with your patient Director, Azmi Step 5: Evaluate your patient’s decision Burhani Consulting and Veras Research There are limitations towards integrating full shared decision-making in many Asian countries, due to several Petaling Jaya, factors, including information asymmetry, lower education profile of patients, patient participation may open/seek Malaysia options beyond fiscal space of providers, the care continuum pathway is not always assured, a lower risk taking ability of patients for decisions would keep their participation away, general regional development and infrastruc- ture limitations such as internet access. Ultimately, patients can and do have a significant role in health care deci- Managing Editor sion making. They can contribute data for research, take part in framing the decisions to be made, embed the Robert Selby patient perspective in scientific judgements and analysis, contribute values, be involved in the recommendation

process, act as advocates and be involved in decisions, and have a role in governance. Editorial Staff

Nancy Chen

Nancy Sun China Nadia Maldonado Shanlian Hu, MD, MSc, Professor, School of Public Health, Fudan University, Shanghai Health Development Research Center, Shanghai, China

Patient involvement in China through the participation in patient and disease advocacy groups is quite dynamic, and according to the unofficial data source, more than 70 different kinds of disease patient groups have been established in China. Some are registered by the Ministry of Civil Affairs at the national level; some are organized

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017 by hospitals at the local levels. The patient groups or associations are self-organized by patients and their family members. These patient groups have memberships on a voluntary basis, are non-profit and are mutually supporting. The patient association plays a role as a communication platform to help patients in several ways including conducting health education, exchanging their treatment experience, providing psychological comfort to patients, calling on government to focus on their diseases, improving the reimbursement and payment from third-party payer and PAP programs, and serving as a watchdog on key issues such as shortages of drugs.

One example of a major patient association in China Figure 2: Hemophilia Home of China Major Milestones is the Hemophilia Home of China. Major challenges facing patients with Hemophilia in China include lifelong high costs of treatments, insufficient reimbursement of the costs, shortages of medicine sup- plies, discriminating education policies, and lack of understanding or acceptance by family members or society of those with the affliction. The Association has made a large impact on health insurance policy in recent years through its advocacy, including the following milestones (Figure 2):

And apart from these policy impacts, the Association has continued to have a real impact on patients in other ways. Continually growing, there are now 4,665 hemophilia cases and family members have registered at Hemophilia Home of China. The Hemophilia Home has provided direct assistance nationwide (including medical aid, poverty relief, drug donations) for poverty stricken and severe hemophilia cases in 21 provinces and has helped 249 hemophilia cases. In recognition for these achievements, in 2014 China Hemo- philia Home won the World Federation of Hemophilia Outstanding Contribution Award. Patient associations thus play an incredibly important role in health care decision making in China by representing and advocating for the rights of the patient.

Japan Isao Kamae, MD, DrPH, Project Professor of HTA and Public Policy, GraSPP, The University of Tokyo, Tokyo, Japan

Patient involvement in health care decision making has to still be adopted in Japan, and decisions are taken primarily by special government committees such as the Special Committee of Cost-Effectiveness (Chui-I-Kyo). While the Chui-I-Kyo is comprised of different stakeholders and experts such as manufacturers, clinicians and academics, patients are notably missing. However, ways that the public may be engaged in decision making in the future include commenting/voting on the draft on assessment and appealing coverage and pricing decisions vis a vis a new “Appraisal Committee.” Patients certainly can provide useful information for decision makers, including:

 Insights on preferences for health states (for incorporation into societal/ethical factors in appraisal on CE) which could be reflected as QALY estimates  Information about costs borne by the family (i.e. out-of-pocket expenses, time costs, informal care, etc.) which are not included in the CEA guideline  Views on the experience of care (convenience such as oral vs. IV infusion, different dosing schedules, etc.)

And how should patient involvement be incorporated into decision making in Japan? There are several opportunities for engagement. In the context of new HTA activities in Japan, patient organizations are currently not included as stakeholders although it was initially suggested that the appraisal committee have a patient representative. This might be an opportunity for further representation. Addition- ally, even if patient values are used for health states in QALY estimation, these cannot be reviewed by patients’ themselves for validation currently.

That said, some challenges towards implementing patient perspectives include labor and time spent in gathering patient comments, practical difficulty to define selection criteria for 'unbiased' patient representatives, incurring delays in making coverage/pricing decisions, and possible undue influence being placed on those conducting HTAs by the wider range of commenters. To ensure that the process of patient involvement is successful, it will be necessary to train patients to be more effective in their roles, developing a scientific method to reflect patients' view in appraisal of cost-effectiveness, conducting an early engagement of patients through consultation on unmet medical needs and study design, involving patients in implementation of HTA findings, and finally by complying with the WHO/OECD recommendations on 'fair/high' pricing and innovation.

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

South Korea Sukyeong Kim, RPh, MPH, PhD, Coordinating Center for National Health and Clinical Research, National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, Korea

Because of resource limits, we always make choices among various interventions which need to be justifiable to the public they affect. HTA has provided good evidence, traditionally focused on safety, efficacy, and cost-effectiveness with highly quantifiable methods. But decisions also carry the risk of “overreaching” which is why we need to embed HTA in a fair, deliberative process. The HTA process consists of identification, prioritization, assessment, and dissemination, and within these, diffusion and dissemination have been regarded as important points for patient participation by HTA agencies and patient organizations globally.

In Korea, public participation exists in the process of prioritization of National Health Insurance coverage and several trials have been performed based on the accountability for reasonability framework by Daniels and Sabin (2008) which consists of relevance, publicity, ability to be revised, and enforcement. They tried to achieve a social value judgement by garnering public participation for opinions of “average citizens.” Deliberation was important for more informed and robust feedback from participants, consensus building and information exchange among participants. Korea piloted three experiments of lay public participation in 2008, 2010, and 2012. In 2012, the National Health Insurance Service established the “Citizen Committee for Participation” consisting of 30 lay public randomly selected out of 2,650 applicants. The goal was to set priority for 45 medical service items for potential benefit expansion. Committee had deliberative discussions after being briefed on information relayed by scientific evidence from experts. Finally, 23 services items were agreed to be covered among committee members taking special consideration of disease severity and financial burden on patients with the condi- tion. Health Insurance Policy Committee, the final decision making body of Korea National Health Insurance accepted the result and selected 13 items for coverage expansion in 2013.

Korea has a positive list system for NHI pharmaceutical benefit coverage which requires cost effectiveness evidence to be included in submission dossiers. The economic evaluation guidelines recommend social perspectives and health related quality of life is commonly measured by the EQ-5D. The NHI Pharmaceutical Benefits Committee has three members recommended by consumer organizations within the full 22 members. NHI Policy Committee, the final decision making body, has 8 members representing enrollees among 25 members.

The National Evidence-based Healthcare Collaborating Agency (NECA) also has an HTA topic identification process that includes general public suggestions. Recently, a national research program supporting HTA and outcomes researches for local evidence generation is fostering patient and citizen participation referencing organizations such as PCORI in the US and NIHR in the UK.

Taiwan Chung-Lin (Jerry) Yang, MSc, Team Leader of Economic Evaluation Group / Patient Involvement Task Force, Division of Health Technology Assessment, Center for Drug Evaluation, Taipei, Taiwan

Taiwan has made important investments in fostering patient involvement in health care decision making, and has introduced key processes for such participation. During the process of new drug listing outlined on the right, patient feedback is systematically collecting via online survey after expert meetings, and 2 representatives of patient groups are invited to attend the Pharmaceutical Benefit and Reimbursement Standard Meeting and present for 10 minutes (Figure 3).

Figure 3: Patient Involvement in the New Drug Listing Process in Taiwan

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

Health Technology Assessment and Its Application in Vietnam Tuan Quang Kieu, Health Insurance Department, Ministry of Health, Viet Nam

With the aim of achieving universal health coverage in Vietnam, one of the most pressing issues is to improve the per- formance and efficiency of the health care system, especially in terms of financial resource allocation and use. In order to support policymakers in making evidence-informed decisions, health technology assessment (HTA) is considered as an effective tool to improve the efficiency of the health system. However, the foundation of selected health care services (i.e. drugs, medical devices) paid by the National Health Insurance Fund (managed by Vietnam Social Security) is not based on scientific evidence or health technology assessment (HTA) studies such as cost-effectiveness evaluation (CEA), cost benefit analysis (CBA), or cost utility analysis (CUA). While there were some public and private entities starting to adapt for conducting HTA in Vietnam such as Vietnam Health Economics Association (VHEA), Health Economics Research and Consulting Center (HERCC), Health Strategy and Policy Institute (HSPI), and Hanoi Medical University, however HTA development is still quite ad hoc and is lacking direction and management from the Government. Therefore, the Ministry of Health (MoH) has started to pay attention to the development of HTA in recent years. The Ministry of Health has designated the Health Strategy and Policy Institute (HSPI) as the focal point for coordinating HTA activities in Vietnam with the purpose of ensuring a close and effective coordination between policy makers, research institutions and other stakeholders. There were several key activities that have been conducted by stakeholders over past few years:

1. Framework of HTA development plan in Vietnam was developed in 2014 2. Topic selection for HTA has been conducted by MoH from 2014 - 2015 under technical support by international partners such as NICE and HiTAP 3. Several HTA studies and systematic reviews have been conducted in Vietnam recently: For example: (i) Cost effectiveness of Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Hepatitis C in Vietnam; (ii) Cost effectiveness of MRI service in Vietnam; (iii) Cost-effectiveness of trastuzumab in metastatic breast cancer in Vietnam 4. National Health Insurance Policy Consulting Committee (NHIPCM) has been established from 2016 with three taskforces including an HTA group. Those members will be responsible for advising and consulting for NHIPCM in technical review for HTA’s evidence 5. Vietnam has become a member of International HTA organization HTAsiaLink (http://www.htasialink.org/member/ member.php) from the Asia Pacific region and hosted the successful 6th HTAsiaLink Annual Conference in Hanoi from 17 to 20 April, 2017 focusing on the topic “Health Technology Assessment in designing and implementing Benefit Packages for Universal Health Coverage” 6. HTA Guideline is in the first stages of development in Vietnam and it will be completed in October 2017

While some important steps in the development and implementation of an HTA system in Vietnam have been established, some obstacles need to be resolved to see potential improvements of HTA in Vietnam such as capacity building, HTA funding, HTA legislation and official organizational structure, the scope of HTA implementation, decision criteria, quality, timelines, and transparency of HTA implementation, problems in collecting local data, and developing questionnaires to measure outcomes (QALY, DALY).

According to Vietnam Social Security (VSS), while 22% of expenditure on selected medicines reimbursed through the Health Insurance Fund are considered to be for appropriate indications, more than half of the spending (51%) goes to medicines considered inappropriate for specified indications. This reveals that an unnecessary amount of health care expenditure is spent each year on medicines, sometimes without adequate evidence on medicines’ safety, effectiveness as well as value for money. There is a huge opportunity for the Vietnamese government to develop a more effective and efficient benefits package, based on stronger scientific evidence, in addition to local inputs by health care providers.

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

REGIONAL HEALTH INITIATIVES

2nd International Conference on Pharmacoeconomics and Outcomes Research on “Integrating Pharmacists in Health care Decision Making - A Resonate Patient Centric Therapy Initiative” in Andhra Pradesh, India ISPOR India-Andhra Pradesh Chapter held a successful 2nd International Conference on Pharmacoeconomics and Outcomes Research in Tirupati, Andhra Pradesh, India. For summary and photos, visit ISPOR India-Andhra Pradesh Chapter website.

Workshop held in Kolkata, India In partnership with ISPOR India Chapter, the Department of Clinical & Experimental Pharmacol- ogy, Calcutta School of Tropical Medicine, Kolkata, held a 4-day workshop - NWORM2017, 25-28 May, 2017 on themes including Systematic Review and Meta-Analysis, Pharmacoeconomics and Outcomes Research, Qualitative Research, and Applied Psychometrics. For more information, please visit the ISPOR India Chapter website.

A new start for the development of MCDA tool using in Kazakhstan A one-day invitation-only workshop was held on June 1, 2017 in Nazarbayev University of Astana on the topic: “Multi-Criteria Decision Analysis in the National Health System - a Step Towards Innovations” which garnered 40 attendees. The invited participants received a masterclass from Professor Nikos Maniadakis on issues of MCDA application and discussion of the current state of the country's policy on the medicines without patent protection (OPP), and identifying the criteria of the formulary system during the discussion in the evaluation of which MCDA should be applied.

Indonesia workshops and publication ISPOR Indonesia Chapter held two successful In- House Training events and published the 2017 Editions of the books, Social Pharmacy and Phar- makoeconomy. For details, visit ISPOR Indonesia Chapter website.

ASIA CONSORTIUM AT ISPOR BOSTON

ISPOR Asia Consortium held 4 meetings and 2 forums during the recent ISPOR 22nd International Meeting in Boston, MA, USA:

 ISPOR Asia Consortium Business Meeting-Over 45 of attendees representing 14 countries participated, and delegates presented on health policy trends and ongoing ISPOR initiatives including the upcoming ISPOR 8th Asia-Pacific Conference. View the meeting summary here.

 ISPOR Asia Consortium Industry Committee Meeting-There were 30 delegates from Industry and CRO in attendance that shared information on the latest challenges and opportunities facing the Industry and discussed common interests and goals for committee initiatives surrounding RWE, Value-based health care, HTA and Medical Devices. View the meeting summary here.

 ISPOR Global Networks Reception-Over 100 attendees from around the globe met to network, enjoy good food, and take a breather from the busy conference program.

 ISPOR New Professionals Event – Career Advice Across The Globe-This highly popular session featured speakers from Asia-Pacific, Latin America and region, who provided invaluable experience and guidance from their own illustrious careers to over 150 new professionals in attendance.

 Asia Consortium Forum: New Trends Of Health Technology Assessment Development And Value Evidence Requirements For Access And Reimbursement In Asia (China, Japan, South Korea, And Taiwan) - View the presentation slides here.

 Asia Consortium Forum: Patient Involvement in Health Technology Assessment In Asia (China, Japan, South Korea, And Taiwan) - View the presentation slides here.

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

OUTCOMES RESEARCH

Volume 12 (May 2017) Focusing on Asia Value in Health Regional Issues Volume 12 (May 2017) is published and available for ISPOR members: https://www.ispor.org/publications/VIHRI/index.asp

EDITORIAL  Is It Time for Joint Health Technology Assessment in Asia? Opportunities and Challenges Surachat Ngorsuraches, Nathorn Chaiyakunapruk, Jeff Jianfei Guo, and Bong-Min Yang

COMMENTARY  Healthy China 2030: A Vision for Health Care Xiaodong Tan, Xiangxiang Liu, and Haiyan Shao

PATIENT-REPORTED OUTCOMES  The Emerging Role of Patient-Reported Outcomes in Clinical Trials: An Indian Perspective Amit Dang, Raju Kanukula, Chirag Shah, and Veena Shetye  Psychometric Properties of the Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT- QoL) Phantipa Sakthong, Chanadda Chinthammit, Pattarin Sukarnjanaset, Nontapat Sonsa-ardjit, and Wipaporn Munpan  Minimal Clinically Important Differences of the Thai Version of the Leicester Cough Questionnaire for Subacute and Chronic Cough Prapaporn Pornsuriyasak, Poungrat Thungtitigul, Theerasuk Kawamatawong, Surinder S. Birring, and Tipaporn Pongmesa  Translation, Revision, and Validation of the Diabetes Distress Scale for Indonesian Type 2 Diabetic Outpatients with Various Types of Complications Bustanul Arifin S. Farm, Dyah Aryani Perwitasari, Jarir At Thobari, Qi Cao, Paul F.M. Krabbe, Maarten J. Postma  Comparative Study on Health-Related Quality of Life of Farmers and Workers Xiaofang Liu, Shuyan Gu, Shengnan Duan, Yuan Wu, Chiyu Ye, Jing Wang, Hengjin Dong

ECONOMIC EVALUATION  Assessing the Budget Impact and Economic Outcomes of the Introduction of Daclatasvir + Asunaprevir and Sofosbuvir/ Ledipasvir for the Treatment of Chronic Hepatitis C Virus Infection in Japan Thomas Ward, Samantha Webster, Sari Mishina, Phil McEwan, Gail Wygant, and Feng Wang  Cost of Osteoporotic Fractures in Singapore Charmaine Shuyu Ng, Tang Ching Lau, and Yu Ko  Direct Cost for Treating Chronic Kidney Disease at an Outpatient Setting of a Tertiary Hospital: Evidence from a Cross- Sectional Study Rajiv Ahlawat, Pramil Tiwari, and Sanjay D'Cruz  Cost-Effectiveness of Edoxaban vs. Warfarin in Patients with Atrial Fibrillation Based on Results of the ENGAGE AF - TIMI 48 Trial: Taiwanese Perspective Katherine A. Vilain, Ming Chin Yang, Elise Chia Hui Tan, Kaijun Wang, Haiyan Li, Wan Hsuan Hsu, Robert P. Giugliano, David J. Cohen, and Elizabeth A. Magnuson  Cost-Benefit Analysis and Assessment of Quality of Care in Patients with Hemophilia Undergoing Treatment at National Rural Health Mission in Maharashtra, India Priyanka Singh and Kanchan Mukherjee  Economic Burden of Community-Acquired Pneumonia Among Pediatric Patients (Aged 3 Months to < 19 Years) in the Philippines Bernadette A. Tumanan-Mendoza, Victor L. Mendoza, Melchor Victor G. Frias IV, Dolores D. Bonzon

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

OUTCOMES RESEARCH

PREFERENCE-BASED ASSESSMENTS  Mapping Sri Lankan EQ-5D-3L to EQ-5D-5L Value Sets Sanjeewa Kularatna, Gang Chen, Josh Byrnes, and Paul A. Scuffham

SYSTEMATIC REVIEWS  Induction of Type 2 Diabetes Mellitus with Antihypertensive Therapy: Is There Any Role of Alpha Adducin, ACE, and IRS-1 Gene? Sumeet Gupta and Vikas Jhawat

HEALTH POLICY ANALYSIS  Prediction of Change in Prescription Ingredient Costs and Copayment Rates under a Reference Pricing System in South Korea Ji Haeng Heo, Karen L. Rascati, and Eui-Kyung Lee

POLICY PERSPECTIVE  Cost-Utility Analysis of Single-Fraction Versus Multiple-Fraction Radiotherapy in Patients with Painful Bone Metastases: An Iranian Patient's Perspective Study Yahya Bayazidi, Ali Keshtkaran, Enayatollah Homaie Rad, Mansour Ansari, Mehdi Javanbakht, Amir Hashemi Meshkini, Sho- koufeh Nikfar, and Pardis Zaboli

BRIEF REPORT  Exploring Product-Specific Attributes of a Community Cardiac Rehabilitation Program in an Asian Urban City Yu Heng Kwan, Angela Frances Yap, Hung Yong Tay, Cindy Lim, Sui Yung Chan, and Warren Fong  Comparison on Human Resource Requirement between Manual and Automated Dispensing Systems Prapaporn Noparatayaporn, Rungpetch Sakulbumrungsil, Tanita Thaweethamcharoen, and Wunwisa Sangseenil

REVIEWER ACKNOWLEDGEMENT

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Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017

MEMBER-REPORTED NEWS

Stent Price Regulations in India Mohammad Adil, PhD, Research Scholar, School of Pharmaceutical Education and Research, Jamia Hamdard (Hamdard University), New Delhi, India

On February 13, 2017, the National Pharmaceutical Pricing Authority (NPPA) slashed prices of coronary stents by over 75%, capping the ceiling prices of drug eluting stents (DES) and bioresorbable vascular scaffolds (BVS) at ₹ (Indian Rupee) 29,600 (~$461), and bare met- al stents (BMS) at ₹ 7,260 (~$113). Including value-added tax, these stents are expected to cost ₹ 31,080(~$482) and ₹ 7,623(~$118), re- spectively [1]. The specific price ceilings were not arbitrarily estimated, but computed, taking into account average landed cost for the stents plus cost of production and price to distributors with fixed percentages of markups included [2]. However, it does not cover the large trade margins by the hospitals who promote such products. Capping stent prices alone may not serve any purpose if the overall cost of the procedure gets increased as a consequence. The government needs to cap the cost of the overall procedure if it has to make ceiling price fixation on stents meaningful. Moreover, one of the problems with this move is that it does not differentiate between different models of drug-eluting stents. These come in large varieties and have different price points according to their quality and tech- nological innovation [3].

As a consequence to the price capping mandate, two major activities are discernible in India. The first activity included three major companies, Abbott, Medtronic, and Boston Scientific, requesting the NPPA to allow them to withdraw their latest stents from the country, explaining that the current price cap would make it unviable to sell these products in India [4], which NPPA rejected. Second was a phe- nomenon of reverse medical tourism to Nepal [5]. It is now being advocated that India needs greater transparency in costing systems and outcomes-based measurements, and underlining the need of evidence-based policymaking. The Government of India has established the Medical Technology Assessment Board (MTAB) under the Department of Health Research (DHR) similar to that of National Institute of Health and Clinical Excellence (NICE) in the UK or Health Intervention and Technology Assessment Program (HITAP) in Thai- land so that each new drug, medical device, or technology could be subjected to a detailed assessment of clinical effectiveness, safety, and cost-effectiveness. The MTAB to be set as a part of DHR, Ministry of Health and Family Welfare aims to reduce the cost and varia- tions in patient care, expenditure on medical equipment in directly affecting the cost of patient care, overall cost of medical treatment, reduction in out of pocket expenditure of patients and streamline the medical reimbursement procedures for effective implementation of the proposed Universal Coverage Programme [6].

References: 1. National Pharmaceuticals Pricing Authority Order. Government of India, New Delhi: February 13, 2017. Gazette of India Extraordinary. http://www.nppaindia.nic.in/ceiling/press13Feb2017/ so412e-13-02-17.pdf Accessed March 1, 2017. 2. Memorandum: Display of Price Calculation Sheets for Notified Ceiling Price of Coronary Stents on NPPA’s website. Government of India, New Delhi. February 28, 2017. http://www.nppaindia.nic.in/order/ Displayofpriecalculation28022017.pdf Accessed March 1, 2017. 3. https://www.thinkpragati.com/opinion/1323/dont-stunt-stent-market/ 4.http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/nppa-rejects-abbott-medtronics-request-to-withdraw- latest-stents/articleshow/58388550.cms 5.http://www.firstpost.com/india/nepal-cashes-on-as-indias-price-cap-send-stents-disappearing-from-country-3427822.htm 6. http://www.dhr.gov.in/mtab

HTA Horizons Expanding within the Eurasian Economic Union Alima Almadiyeva, MD, PhD, CEO at Kazakh Agency for Health Technology Assessment, Executive Director of Kazakhstan Association of Health Technologies Assessment, Evidence Based Medicine and Pharmacoeconomics Research «KAZSPOR», Astana, Kazakhstan

The International Scientific and Practical Conference on "Development of Health Technology Assessment in the Eurasian Economic Union" was held on April 27-28, 2017 in Astana, Kazakhstan and initiated a new vector of HTA development in Kazakhstan within the framework of the Eurasian Economic Union (EAEU). One hundred and seventy five people from 10 countries took part in the conference, including representatives from the Eurasian Economic Commission, Heads of core-business departments and divisions of the Ministries of Health care of the EAEU countries, representatives of the Health Insurance Funds of the EAEU countries, members of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) as well as representatives of the scientific and expert community, foreign and international organizations, and mass media. The stakeholders expressed their visions and proposals on the prospects of HTA system implementation and harmonization, financing of innovative and costly health technologies taking into account the requirements of the contemporary market. The development of a common market of health technologies (medicines, medical products) within the territory of the EAEU is one of the priorities of health care development of the Eurasian Economic Area countries. The participants also discussed the most sensitive issues of the modern decision-making system in the health care systems of the Com-

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017 monwealth of Independent States (CIS) countries. A one-day training on "Assessment of Health Technologies in the EAEU countries, Trends and Opportunities" and a roundtable on "Issues on long-term clinical and cost-effectiveness of vaccinal prevention,” were held on the second day of the conference, where the participants shared ideas and knowledge in the sphere of HTA and drugs commerce. Alexander Kostyuk, the President of the Kazakhstan Association "KAZSPOR" and ISPOR Kazakhstan Branch observed a significant value of the conference held for the Eurasian Economic Area countries: "Our mutual cooperation in the sphere of medicines circulation will give impetus for further HTA development in the CIS countries. This will support problem solving with the distribution of expenses for health care and reducing the expenses for innovative and costly medicines. For instance, the development of a single concept including the application of fundamental principles and tools for HTA implementation will give an opportunity not only to make adequate decisions for policymakers but also comprehensively evaluate the entire process by both interested parties and, primarily, patients themselves.”

According to the participants of the event, HTA is becoming even more relevant with regard to the integration of processes both within the EAEU and externally as evidenced by participation by experts from the UK, Hungary, Holland and Denmark. Presently professional communities and initiative groups in Kazakhstan, the Russian Federation, Kyrgyzstan, Armenia, and the Republic of Belarus have united to create a Working Group on the development and harmonization of HTA systems in the EAEU countries. The plans of the Working Group include the development of a roadmap for the implementation of HTA systems and guidelines for HTA in the EAEU countries as well as recommendations on its implementation for the local Ministries of the EAEU member states. According to the conference participants’ opinion, this event has given an impetus to the development of HTA in Central Asian countries. Kazakhstan proved its leadership in Central Asian countries for integrating international trends on HTA and drug commerce.

Drug Catalogue Selection in Insurance Schemes will Introduce the Dynamic Adjustment Mechanism in China Fang Zhang, PhD, Associate Professor, Shenyang Pharmaceutical University, Shenyang, China

In May 2017, the Department of Human Resources and Social security issued a notice about seeking public opinion for establishing a dynamic adjusting mechanism during the drug catalogue selection for several insurance schemes including the national basic medical insurance, employment injury insurance and maternity insurance. Presently, the process surrounding evaluation of drug efficiency status for listing is based on a 7 year review and adjustment interval. This notice aims to reform these existing review mechanisms to make them dynamic reporting mechanisms which accurately reflect new drug changes. For example, the National health care medicine insurance list will adjust dynamically as new drugs are approved and reviewed. This notice attracted the attention of drug firms, patients and other groups, and stakeholder concerns and recommendations have centered around the following aspects:

1. Arriving at a balance between supporting clinical needs, innovation and the viability of the medical insurance fund during the dynamic adjustment; 2. Determining what kind of rules and measures should be applied to the newly approved drugs, patented medicine, and non- exclusive varieties listed in the catalogue; 3. Adequately capturing and reflecting the views and needs of different parties, making full use of pharmacoeconomic evaluation, and using objective data to support expert evaluation; 4. Building a negotiations mechanism of medicine list access, determining the effective period of negotiation results, and remaining connected with established health care reimbursement standards; 5. Linking effectively with drug registration approval, production distribution, clinical application and health care reimbursement; and 6. Setting up the elimination mechanism from the drug list.

Establishing a Cost-Effectiveness Threshold for Malaysia Dr. Ku Nurhasni Ku Abd Rahim, Dr. Izzuna Mudla Mohamed Ghazali, and Dr. Junainah Sabirin, Malaysian Health Technology Assessment Section, Medical Development Division, Ministry of Health Malaysia

Universal health coverage requires that all people receive the health care that they need. At the same time, the success and value of universal health coverage depends on its ability to provide safe, efficient and quality services to all people according to their need for care. This is where health technology assessment plays a role in ensuring health technologies provided are safe, effective and cost- effective. In Malaysia, various efforts have been taken to strengthen the value and quality of universal health coverage where evidence based medicine is emphasized. Malaysian Health Technology Assessment Section (MaHTAS) Medical Development Division Ministry of Health has been established since 1995 and provides evidence-based input for policymakers by systematically assessing new health technologies and developing clinical practice guidelines. During recent years, MaHTAS has embarked on the journey of establishing an

Volume 6 Number 1 News Across Asia ISSN 2308-1945 April-July 2017 acceptable cost-effectiveness threshold for Malaysia. This journey begins with a formal meeting among the health economic experts, clinicians and relevant stakeholders to explore the insight of the acceptable value; added with various information and experience from other developed countries. Local studies were also sought to describe the local scenario. Finally, a preliminary threshold of ≤ 1 Gross Domestic Product (GDP) per Capita has been suggested and agreed by the highest Ministry of Health technical committee. This threshold aligns with the acceptable cost-effectiveness threshold by several other countries. Nonetheless, equity issues require further attention and it may determine the applicability of this value to the Malaysian population. Next, guidance and advice from multidisciplinary experts were sought in developing a manual on economic evaluation of health technologies, primarily conducted by (MaHTAS) which will utilize this acceptable threshold as a guide for economic evaluation reports. However, we acknowledged that more health economic and outcomes research are needed to support and strengthen its implementation.

New Health Policies in South Korea Sang-Soo (SS) Lee, PhD, Corporate Affairs Director, Medtronic Korea, Seoul, South Korea

The 19th presidential election was held on May 9, 2017 in South Korea. Moon Jae-In of the Democratic Party won the election with a plurality of the votes at 41.08% and he assumed the office of the President of South Korea with a five-year term immediately upon confirmation of the results on May 10, 2017. During his presidential election campaign, he announced numerous health care policies moving towards the following principles: enhancing social welfare, recovering the public sphere of influence of the health system, expanding national health insurance (NHI) coverage benefits, securing sustainability, redefining the health care delivery system, solving medical polarization, and developing the health care industry (e.g., pharmaceutical and medical device industries) as a economic growth engine for creating quality jobs. The new government is expected to emphasize the public sphere of influence in the health care sector and also expand NHI reimbursement coverage to solve the current sizable non-reimbursement coverage services. He proposed the introduction of dual deputy ministers to the Ministry of Health and Welfare (MOHW), the autonomy and independence of the Korea Centers for Disease Control and Prevention (KCDC), and revision of the NHI payment system for adequate premiums and health care service fees. In addition, President Moon has pledged to establish an independent “Pharmaceutical, Bio, and Medical Device Sub- committee” under the Presidential Committee with objectives of heading toward the 4th industrial revolution. Among extensive and diverse pledges at his presidential election campaign, key health policies for reimbursement coverage expansion expected in the new government are summarized below:  Reimbursement coverage expansion under national health insurance (NHI)  Transition non-reimbursement coverage service into reimbursement coverage  Improvements on dentures, dental implants, hearing aids for the aged and oral medical check-ups  Reimbursement coverage for care-givers  Reimbursement coverage expansion for oriental (non-western) medicines  Ceiling cap for patient co-payment up to 1 million Korean won (approx. 900 US dollars)  Provision of nursing and caregiving integrated services

Workshop on Bioterrorism in Iran Amir Viyanchi, Budget Analyst, Hamedan University of Medical Sciences, Hamedan, Iran

As indicated by the US Centers for Disease Control and Prevention, bioterrorism is the deliberate release of viruses, bacteria, toxins or other harmful agents to cause illness or death in people, animals or plants. Biological agents can be spread through air, water or food. According to Iran’s Food and Drug Administration (IFDANA) a workshop on bioterrorism was held for administration managers, and attended by Dr. Dinarvand, the Ministry Deputy and Head of the FDA. The workshop aimed to familiarize managers and senior di- rectors of the FDA with threats of bioterrorism in the areas of food and pharmaceutical security, and ways to deal with these threats, which was held in the FDA’s Reference Laboratory Hall. It should be noted that this workshop is the third workshop of a series coordi- nated by the Iran FDA.

Member-Reported Accomplishments

ISPOR India West Bengal Chapter President Dr. Subhash Mandal was invited by National Institute of Pharmaceutical Education and Research (NIPER), Kolkata in a " Rare Disease Round Table Conference" held on 22nd April 2017 and made a presentation on "Rare Diseases and Orphan Disease Act.” After the whole day deliberation a committee has been formed including me for drafting a suitable Orphan Disease Act for India.

Dr. Amit Dang, President of ISPOR India-Mumbai Chapter received the “Young Global Leader Award” (2017) from “Global Leaders Foundation” at FICCI, New Delhi, India! For details, visit ISPOR India-Mumbai Chapter website.

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