WORKSHOP PROPOSALS

8Workshop Session I 12:00-13:00 Monday 6 March 2006
8Workshop Session II 14:30-15:30 Monday 6 March 2006
8Workshop Session III 12:00-13:00 Tuesday 7 March 2006
8Workshop Session IV 14:30-15:30 Tuesday 7 March 2006

WORKSHOP SESSION I - 12:00-13:00 Monday, 6 March 2006

Health Policy

W1 DRUG PRICING AND REIMBURSEMENT ISSUES USING HEALTH ECONOMICS AND OUTCOMES RESEARCH IN DRUG REIMBURSEMENT – WHICH WAY FORWARD FOR THE ASIAN REGION

Discussion Leaders: Peter Davey BA(Ec), MA(Ec), Director, M-TAG Pty Ltd, Chatswood, Australia Meaghan Lynch BSc, MSc, Economist, M-TAG, A Unit of IMS Health, Chatswood, NSW, Australia;  Oh-Serk Hahn, Executive Director, Korea Heath Isurance Review Agency, South Korea; Lee Pak Wai, Chief Pharmacist, Hong Kong Hospital Authority, Hong Kong, P.R. China.

Workshop Purpose: To discuss drug pricing and reimbursement issues using health economics and outcomes research in drug reimbursement in Asia
Workshop Description: Since it was first formally integrated into drug policy in 1993, pharmacoeconomics has developed as an important policy tool to improve efficiency in health spending in Western countries. The Asian region is now at the cusp of applying pharmacoeconomics principles in drug policy development. The Republic of Korea will be the region's first country to establish pharmacoeconomic guidelines and mandatory requirements. Several other countries in the region have recognised the benefits of pharmacoeconomics and have discussed their introduction, but have yet to develop formal pharmacoeconomic guidelines. The Korean experience, global trends, and above all, burgeoning drug costs could well advance the adoption of formal pharmacoeconomic requirements in the region. Alternatively, failure of the approach in Korea, government inertia and disinclination to move beyond draconian cost containment measures may exclude or delay pharmacoeconomics from playing a meaningful role in drug policy development. The authors have examined the experience in the use of pharmacoeconomics in countries where this is established policy. We suggest a formula for sensible adoption of pharmacoeconomics in the Asian region. The formula addresses the concepts and needs for both the guidelines requirements and management and maintenance of the working system. Guideline scope, level of prescriptiveness and complexity are key concepts. Operational issues include appropriate resourcing by industry and government, as well as the impact on the funding process and communication and consultation requirements.

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W2 USE OF PHARMACOECONOMICS IN SELECTION OF NATIONAL ESSENTIAL MEDICINES

Discussion Leaders: Lin Yan PhD, Center for Drug Reevaluation, State Food and Drug Administration, Beijing, China;
Jie Ming Zhou MD, Deputy Chief, Center for Drug Reevaluation, State Food and Drug Administration, Beijing, China;
Gang Cheng PhD
, Chief, Center for Drug Reevaluation, State Food and Drug Administration, Beijing, China;
Li Ya Cao Master
, Director, Center for Drug Reevaluation, State Food and Drug Administration, Beijing, China

Workshop Purpose: To discuss the issues hindering the use of pharmacoeconomics in the selection of national essential medicines (EM) and propose the resolution scheme.
Workshop Description: EM are those that satisfy the priority health care needs of the population. This concept was initially proposed by the WHO and has now been adopted by 156 Member States as a key component of National Drug Policy. In China, the first-edition list of EM was published in 1994, and has been revised every two years. Since EM is an important means to allocate limited health resources, PE property of medicines must be considered as important as safety and efficacy, but the economic evaluations of medicines have not currently been used routinely in EM selection processes. The issues hindering the use of PE are as follows: 1.) Quality: A survey which assessed the PE literature published in Chinese academic journals showed that the quality of these studies was not satisfactory and results were difficult to adopt. Due to lack of PE guidelines in China, common standards about key points of PE study are deficient. 2.) Reliability: Sponsors of PE studies often bring reliability problems. Researches funded by pharmaceutical companies are more likely to report favorable outcomes than those by other sources, and 3.) Applicability: Many factors influence the applicability of PE studies. Firstly, regional limitations, differences in health care costs between city and countryside; east area and west area; and coast cities and inland towns. Secondly, the extensive use of assumptions and the extrapolation of benefits in PE study. Thirdly, different prices for the same drug. Additionally, selection of EM emphasized affordability, but good cost-effectiveness doesn't equal good affordability. In order to promote PE use in EM selection, it's necessary to improve the quality of PE information, develop clear guidelines and strengthen education on PE evaluations in Chinas health care sector.

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W3 HEALTH TECHNOLOGY ASSESSMENT - ISSUES ON ITS USE BY EUROPEAN DECISION MAKERS WITH ADDITIONAL INSIGHTS INTO THE GERMAN HEALTH CARE SYSTEM-LESSONS FOR ASIA

Discussion Leaders: JM von der Schulenburg PhD, Professor, University of Hanover, Hanover, Germany; Wolfgang Greiner PhD, Professor, University of Bielefeld, Bielefeld, Germany; Thomas Mittendorf MSc, University of Hanover, Hanover, Germany

Workshop Purpose: The aim of the workshop is to present and discuss recent developments in the understanding and use of health economic studies by European decision-makers.
Workshop Description: The workshop will introduce the audience to Health Technology Assessment (HTA) in Europe. Furthermore the formal process currently undertaken by German authorities will be presented. Nowadays, health economic models are standard instruments in the evaluation of cost-effectiveness ratios of novel pharmaceutical products. Little information is published on how decision makers in health care and administration use such data structured via HTA. In a second step, results from two studies on the knowledge of health economics and the use of such data by decision-makers undertaken in eight European countries will be discussed. The first study was undertaken in 2000, the second in 2004. Since identical variables were being evaluated, a structured look on the developments in this important issue within policy decision making can be analyzed. Participants will get a detailed look at the use of health economic information by decision-makers in several European countries. The example of Germany as one of the most important markets will add some hints for pharmaceutical companies on how the preparation of health economic data should be organized for the European market.

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Outcomes Research Methods

W4 ADAPTING MODELS TO ASIA

Discussion Leaders: Bruce Crawford MA, MPH, Senior Project Director, Mapi Values, Boston, MA, USA; Takashi Fukuda PhD, Associate Professor, University of Tokyo, Tokyo, Japan; Eui Kyung Lee PhD, Director, Korea Institute for Health and Social Affairs (KIHASA), Seoul, South Korea

Workshop Purpose: Economic models are frequently developed in the US or Europe, but these results cannot be readily applied to Asia. This workshop will review principles of modeling, international modeling, and methods for adapting existing models to the local setting. Examples will be provided from recent models and at the conclusion, attendees should be able to understand how to evaluate and structure a model for adaptation.
Workshop Description: This session is directed at individuals who are responsible for the design and conduct of economic evaluations. Individuals who need to interpret study results will also benefit from this workshop. The increase in economic evaluations to provide evidence of product value has spurred the interest and necessity of model development. However, most economic models are developed in the US or Europe and provided to local researchers. These models are not readily applicable to the local setting, and therefore the models must be reconstructed or adapted to the local setting. This is partly caused by the difference in health care settings and practice patterns in Asia. This workshop will review the principles of modeling, international modeling (use of a core model for adaptation), and several strategies for adapting models to the local setting. Parameters used in the models will also be discussed including QOL measurement.

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W5 ASIA-PACIFIC ISSUES IN MEASURING HEALTH-RELATED QUALITY OF LIFE

Discussion Leaders:
  Wolfgang Greiner MBA, Professor, Bielefeld University, Bielefeld, Germany; Rosalind Rabin, Executive Officer, EuroQoL Group, Rotterdam, The Netherlands

Workshop Purpose: This workshop will consider uses of EQ-5D (a generic measure of health-related quality of life) in the Asian-Pacific Region with particular reference to issues related to adaptation and translation. Researchers will discuss their experience of using a generic measure developed outside the Region and that has distinct European/North America origins. The principal workshop objective is to define the type of adaptation and testing that is considered most useful to users in the Region.
Workshop Description: Many of the most widely used generic measures of health-related quality of life have been developed by European or North American researchers. EQ-5D is one such measure and was developed by the EuroQoL Group (an international network of researchers) and it has been translated into many of the languages relevant for the Asian-Pacific Region. The workshop will include summary presentations by researchers from China, Korea, Singapore and Taiwan who have used EQ-5D. These studies include measurement of population health, valuation of EQ-5D health states and use in economic evaluation. Researchers will comment on both the application and their experience in using EQ-5D. Translation procedures will be examined interactively with workshop participants. After completion of the workshop, participants should be entirely familiar with procedures for the translation and adaptation of EQ-5D as a specific example of a more general question that applies to most measures used for measuring health outcomes.

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WORKSHOP SESSION II - 14:30-15:30 Monday, 6 March 2006

Health Policy

W7 OUTCOMES RESEARCH FOR THE ASIAN MARKET: APPLICATIONS AND COMMUNICATIONS

Discussion Leaders:
Bruce Crawford MA, MPH, Director, Patient-Report Outcomes and Regulatory Consulting, Mapi Values, Boston, MA, USA; LillianYu-Jen Wang MSc, Health Economics and Market Access Manager, Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan; Michael Stanley BA, Director, Adelphi Targis, Tokyo, Japan

Workshop Purpose: To understand the practical application of outcomes research by industry, be able to explain outcomes studies to other internal customers and understand how results may be influential and provide a framework for developing communication strategies (beyond publications) to further disseminate health economic and outcomes research.
Workshop Description: This session is directed at individuals who are responsible for the implementation and use of outcomes studies. Individuals who need to perform or interpret study results will also benefit from this workshop. Outcomes research can provide compelling data to help support the development, reimbursement, and uptake of health care technologies. This workshop will discuss the various applications of health economics and patient-reported outcomes research for internal decision-making, reimbursement, and marketing. Examples will be provided to illustrate “real world” applications of data with discussions on educating the end-user on how to use the data. This workshop will also discuss how to collect local data in the “real world” setting, timing of data collection with respect to product launch, how to prepare/augment the submission dossier with data availability, how to interpret the outcomes studies and support marketing and other media for “noise making” such as using generalist as well as specialist journals, monographs, roundtables, symposia, interactive software, and web pages.

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W8 PAYOR ORIENTED EVIDENCE GUIDELINES

Discussion Leader:
Joseph Singer MD, Co-Chair VBR POEM Working Group, HealthCore Inc, Wilmington, DE, USA

Workshop Purpose: This will be the second panel discussion for the Value-Based Reimbursement Special Interest Group of ISPOR, discussing the nature and scope of outcomes research that payors are requesting to make formulary placement and reimbursement desicions. The first panel was held in Florence and the EU perspectives were discussed. This panel will discuss the Asian and Pacific perspectives. The May 20, 2006 panel in Philadelphia will discuss North American payor perspectives.
Workshop Description: Healthcare payors are now requiring expanded dossiers for new products to be considered for formulary placement and reimbursement consideration. Their previous expectations often have been limited to efficacy and unit cost information. Current expectations have been expanded to include more detailed pharmacoeconomic data, predictive modeling, an expanded scope and scale of valuing new products in a "real world" setting and outcomes data reflecting the effectiveness of new products in a "real world" setting. This panel will discuss the perspectives of payors in the Asian and Pacific region regarding the scope, scale and forms of outcomes research that they need to see for the entry of new products into their markets.

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Outcomes Research Methods

W9 INTERPRETATION OF COST-EFFECTIVENESS RESULTS IN ASIA

Discussion Leaders:
Bruno Jolain MD, Director Health Economics Intercontinental Region, Sanofi-Synthelabo, Gentilly Cedex, France; Bong-Min Yang PhD, Professor of Economics and Dean, School of Public Health, Seoul National University, Seoul, South Korea; Nathorn Chaiyakunapruk PharmD, PhD, Assistant Professor, Department of Pharmacy Practice, Naresuan University, Pitsanuloak, Thailand

Workshop Purpose: To review the criteria used to interpret cost-effectiveness results in Western countries, to discuss the experiences of researchers having presented cost-effectiveness results in Asia, and to discuss how to improve the criteria to help interpretation in Asia.
Workshop Description: Cost-benefit analysis (CBA) provides a clear decision rule: undertake an intervention if the monetary value of benefits exceeds the costs. But as we know, health benefits are difficult to measure in monetary terms, and most economic evaluations of health care interventions are cost-utility (CUA) or cost-effectiveness (CEA) approaches. Analysts have suggested setting a threshold value for the cost per QALY, or per life-year saved, that represents the willingness of society to pay for such benefits. Different thresholds exist in countries with a long tradition of performing economic evaluations of health technologies. What should be done in Asian countries that have a more recent history of performing economic evaluations? The workshop will start with an introductory overview of the question, including a review of the criteria used in Western countries (BJ), followed by a presentation by two Asian experts (Prof. Yang and Prof. Chaiyahunapruk) of their experience to present and interpret results in their country, and then by a discussion with the audience.

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W10 MEASURING TREATMENT ADHERENCE USING PAID CLAIMS RECORDS AND APPLICATION OF LATENT CLASSIFICATION ANALYSIS (LCA) IN PATIENTS WITH SCHIZOPHRENIA

Discussion Leaders:
Lizheng Shi PhD, Assistant Professor, Tenure Track, Tulane University, New Orleans, LA, USA; Jeonghoon Ahn PhD, Assistant Professor, University of Southern California, Los Angeles, CA, USA

Workshop Purpose: The participants of this workshop will gain an understanding of definition and analysis of treatment adherence (i.e., compliance and persistence) using different methods (e.g., paid claims records). We will briefly present a case study to introduce the latent classification analysis which assigns antipsychotic adherence casemix memberships among patients with schizophrenia.
Workshop Description: Poor outcomes have been associated with non-adherence to medication treatment, which may precipitate relapse and can result in significant increases in total costs of care. Researchers generally suggest that treatment adherence reflects both treatment compliance and persistence. The ISPOR Medication Persistence Compliance Special Interest Group has recommended the working definitions for compliance and persistence. “The unit of measure for compliance is administered doses per defined period of time (i.e., a proportion of prescribed doses taken at the prescribed time interval). Medication persistence is the accumulation of time from initiation to discontinuation of therapy.” As a latent variable, treatment adherence needs to take into account the information on both treatment compliance and persistence. LCA is a versatile methodology, assuming a latent index which can be used to distinguish latent classes. We apply the LCA to identify non-adherence, partial adherence, and adherence casemix classes by multiple observable indicators for compliance and persistence in the California Medicaid (Medi-Cal) patients treated with antipsychotic agents. While the concept of adherence casemix is emerging as an aid to understand population characteristics, we need to be cautious to the pitfalls to ensure better use of adherence casemix in the clinical care for patients with schizophrenia.

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WORKSHOP SESSION III - 12:00-13:00  Tuesday, 7 March 2006

Health Policy

W11 ISSUES IN DRUG PRICING, REIMBURSEMENT, AND ACCESS IN THE ASIA-PACIFIC REGION

Discussion Leaders:
Stuart O. Schweitzer PhD, Professor of Health Services, UCLA School of Public Health, Lawrenceville, NJ, USA; Yingyao Chen PhD, Professor of Hospital Management, Fudan University School of Public Health, Shanghai, PR China

Workshop Purpose: Three issues define national policies toward pharmaceuticals: The prices paid to pharmaceutical manufacturers, the extent of patient or third-party payment for drugs, and access to new products.
Workshop Description: The price paid for pharmaceuticals is determined by health authorities, either public or private. Often a formula is used to set these prices based upon the price paid in other countries. This is called “reference pricing”. The price can be set according to either of two objectives. A “Health Policy” perspective will attempt to minimize expenditures so as to contain total health care costs. A “Health Industry Policy” will also consider the effect of drug prices on the pharmaceutical research climate in the country The second issue is the question of who pays for drugs. Some health systems impose very high user fees, or cost-sharing on patients, while in other countries the cost of drugs is more heavily subsidized by the insurance program. In some countries, most notably the US, cost-sharing is part of a broader attempt to bring economic incentives into the pharmaceutical marketplace. In these programs patients face lower prices for drugs that are determined to be a particularly good value to the health plan, while consumer prices are considerably higher for products that are thought to be less cost-effective. Lastly, we consider whether patients have access to the latest pharmaceutical products, or whether the health system is slow in approving new drugs. Slowness of approval is usually an attempt to contain the cost of pharmaceuticals. We compare these pharmaceutical policies for four countries in the Asia-Pacific Region: China, Japan, Korea, and the US.

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W12 INTERPRETING REAL WORLD PHARMACOECONOMIC INTERVENTIONS – DIFFICULTIES ARISING FROM UNFORESEEN ACCESS EFFECTS

Discussion Leader:
JJeonghoon Ahn PhD, Assistant Professor, University of Southern California, Los Angeles, CA, USA

Workshop Purpose: TThe participants of this workshop will gain an understanding of difficulties in interpreting the impact of pharmacoeconomic policy changes. Special emphasis will be on the issue of unforeseen access effects, which may generate either overuse of formulary expanded items or underuse of formulary restricted items. Potential solutions will be sought with the audience.
Workshop Description: Many pharmacoeconomic studies are used to establish cost-effective formulary in the real world. Even in the simple cases of formulary expansion or restriction, unforeseen access effects may distort the expected economic outcomes and may cast doubt on the usefulness of pharmacoeconomic interventions. This workshop will use an example of unforeseen access effect in California Medicaid. Open access (lifting the requirement of prior authorization) of 2nd generation antipsychotics in October 1997 showed sharp increases in cost outcomes however, these increases are difficult to interpret since many patients who did not use any service came back to the Medicaid system as a result of open access. In other words, open access has changed the characteristics of the average patient using services and the average cost of treating patients well. The advantages and disadvantages of time trend analysis and other solutions such as matching methods, which can help interpret the correct impact of pharmacoeconomic intervenention in the case of unforeseen access effects, will be discussed with the audience. Finally, alternative possibilities of the unforeseen access effect will be discussed with the audience, for example, closed access (employing prior authorization requirement) of Proton Pump Inhibitors may restrict access to PPI's even for the necessary patients.


W13  Withdrawn

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Outcomes Research Methods

W14: PHARMACOECONOMICS: EVALUATING FREE SOFTWARE ON THE INTERNET FOR COST EFFECTIVENESS ANALYSIS, DECISION ANALYSIS AND NUMBER NEEDED TO TREAT CALCULATIONS

Discussion Leader:
William McGhan, PharmD, PhD, Professor of Pharmacy & Health Policy University of the Sciences, Philadelphia, PA, USA

Workshop Purpose: The purpose of this workshop is to demonstrate and evaluate calculators and freeware on the Internet that could be useful for individual patient assessment and population-based calculations by clinicians and government agency personnel in Asia. These interactive tools allow a range of tasks from basic cost-effectiveness analysis, decision-making, and Number Needed to Treat (NNT) calculations.
Workshop Description: Innovative calculators and freeware are becoming more widely available on the internet that can be useful at various levels from government agencies to individual patient care.
Pharmacoeconomic software and Internet offerings allow data and results to be examined from different policy perspectives: 1) patients, 2) practitioners, 3) hospitals, and 4) government. Software options can also allow the assessment of health interventions or services from different quantitative perspectives: 1) cost of illness, 2) cost minimization, 3) cost benefit, 4) cost effectiveness, and 5) cost utility. Calculators, spreadsheets, and software approaches will be demonstrated and reviewed. Internet and software applications can assist in analyzing data, presenting findings, or educating providers and patients. Creative software is becoming increasingly available that facilitates pharmacoeconomic evaluations and incorporation of cost- effectiveness into therapy decisions and treatment protocol implementation. Questions that should be asked in evaluating tools include: how much of the engine is validated with rigorous clinical trial data, have the tools been peer reviewed and field-tested, is the information well- referenced? Pros and cons of diverse analytical, implementation, hardware, and software approaches will be examined and critiqued.

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W15 RETROSPECTIVE DATABASES IN THE UNITED STATES, EUROPE AND ASIA

Discussion Leaders:
Diana Brixner PhD, Associate Professor, University of Utah College of Pharmacy, Salt Lake City, UT, USA; Gary M Oderda PharmD, MPH, Professor, University of Utah College of Pharmacy, Salt Lake City, UT, USA

Workshop Purpose: This workshop has two goals: 1) To describe and compare restrospective databases in the United States, Europe and Asia that are used for outcomes research, and 2) to describe the challenges of conducting retrospective outcomes research using and combining multi-national data bases.
Workshop Description: Choice of the appropriate databases depends on the research question being asked. For example, EMR databases are ideal to answer questions that require specific patient-level information such as BMI, blood pressure, lab tests, etc. Although EMRs include drug orders, they are not appropriate to examine compliance or persistence since data on prescription fills is not available. Commercial claims databases in the United States have access to data on millions of patients and include medical and prescriptions claims. These databases are ideal for examining prescription drug use, since drug claims are available. Medical claims ICD-9 codes that can be used to determine diagnoses. Faculty members will be added from Europe and Asia to describe available databases for outcomes research in those areas. In addition to a description of available databases, faculty will briefly present representative data from studies completed using the databases of interest. Faculty will also address the challenges of using data from multiple countries in a single research project. An interactive opportunity will be provided through posing various research questions and exploring the best database options within the major markets.

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WORKSHOP SESSION IV - 14:30-15:30 Tuesday, 7 March 2006

Health Policy

W16 ECOMONIC BENEFITS OF WORKSITE PROMOTION & DISEASE PREVENTION IN THE US: LESSIONS FOR ASIA

Discussion Leaders:
Louis Yen PhD, Research Scientist and Director, International Research and Development, Health Management Research Center, The University of Michigan, Ann Arbor, MI, USA; Dee W Edington PhD, Director and Professor, The University of Michigan, Ann Arbor, MI, USA

Workshop Purpose: Through the review of the programming experiences, evaluation methods, and research findings from various worksite health promotion and disease prevention studies conducted in the United States, the presentation will discuss what lessons the Asian decision- makers and health practitioners can learn.
Workshop Description: In the United States, the overall health expenditures totaled over 1.5 trillion and accounted for over 14% of gross domestic product (GDP), this is significantly higher than that of any industrialized country. Employers, the major payor of the health care costs in the U.S., have increasingly faced the challenges to pay their employees’ health care and have almost reached the limitation of their affordability. The worksite health promotion and disease prevention programs have been positioned as the only positive solution to solve the crisis of the increases in health care costs in the U.S. During the workshop, the relationships between health care costs and productivity to personal health, change in health risks, and participation in health promotion and disease prevention programs will be discussed throughout. Those relationships should have a similar impact among the Asian countries, although among them the governments, in general are the main payor of the health care costs. To individual workers, better health and the participation in the health promotion and disease prevention programs will enhance personal health and improve their vitality and quality of life. To employers, a healthy workforce and the providing of the programs will improve their productivity and reducing their health care payments due to employees’ unhealthy behaviors. To the main health care payors in Asian countries—the government, a healthy workforce and promotion of these programs will result in improved population health and financial savings in national health care costs. Therefore, there are incentives for both government and employers to develop and implement health promotion and disease prevention programs and for individuals to participate in those programs to improve their health and quality of life, reduce their morbidity, and out-out-package expenses for personal health. Workshop participants will be asked to share experiences and practices about the implementation of those programs and their battles with the increasing in health care expenditure within their country.

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W17 HOW ARE PHARMACEUTICAL PRICES AND ACCESS SET IN COUNTRIES IN THE ASIA-PACIFIC REGION: COMPARING “HEALTH POLICY” AND “HEALTH INDUSTRY POLICY”

Discussion Leader:
Marco R. Di Tommaso PhD, Professor, University of Ferrara, Ferrara, Italy

Workshop Purpose: Comparing “Health Policy” and “Health Industry Policy”
Workshop Description: Health Policy is commonly used to determine cost of and access to new health services. Health Policy attempts to minimize the cost of health services, while maintaining an acceptable level of health in the community. A new perspective suggests that treating the health system as an “industry” leads to a different set of policies toward health prices and access. The difference is that Health Industry Policy recognizes that a strong health industry stimulates high-tech industrial growth throughout an economy, while a policy that merely tries to minimize health expenditures not only reduces the incentive to invest in R&D in new health technologies, but retards overall expansion of high-tech industrial growth. Policies toward the pharmaceutical sector in countries of the Asia Pacific Region will be compared, to identify which countries are merely trying to minimize health expenditures, and which are taking advantage of these economic spillovers between pharmaceuticals and other high tech sectors.

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W19 CURRENT DEVELOPMENTS AND ISSUES ABOUT DRUG SAFETY

Discussion Leaders:
Jeff Jianfei Guo PhD, Assistant Professor, University of Cincinnati, Cincinnati, OH, USA; Yong Hua Jing MS, Research Assistant, University of Cincinnati, Cincinnati, OH, USA; Wenmin Du PhD, Deputy Director, Shanghai Adverse Drug Reaction Monitoring Center, Shanghai, China

Workshop Purpose: To review and discuss current developments and issues about risk management and drug safety.
Workshop Description: More than a dozen of high profile pharmaceuticals, such as, Vioxx (rofecoxib), Seldane (terfenadine), Rezulin (troglitazone), and Propusid (cisapride), were withdrawn from marketing in the past decade. Pharmaceutical regulators are increasingly calling for risk-benefit assessment for both new and existing pharmaceutical products. The risk management for pharmaceutical products is a multidisciplinary method to document, monitor, and evaluate adverse drug events (ADE), and plan interventions. It applies to the life of a drug from investigation new drug (IND), new drug application (NDA), post-marketing, and event removal from marketing. The US risk management guideline includes Premarketing Risk Assessment, Development and Use of Risk Minimization Action Plans (RiskMAP), and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. The commonly used research methods for risk management include case report/case series, case-control study, cohort study, meta-analysis, and causal analysis of randomized clinical trials. In this workshop, we will review the recently released United States Food & Drug Administration (FDA) Risk Management Guidance, the European Medicines Agency (EMeA) Guideline on Risk Management Systems for Medicinal Products for Human Use, as well as the current issues about risk management and drug safety in Asian countries or regions. We will use several cases to illustrate the concepts and methods of risk management. Finally, we will discuss what we can learn from past experiences, and what common issues and differences about pharmacovigilance and drug safety between Western and Asian countries and regions.

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W20 EQ-5D AND OTHER GENERIC MEASURES OF HEALTH

Discussion Leaders:
Frank De Charro, Executive Director, EuroQoL Group, Centre for Health Policy and Law, Rotterdam, The Netherlands; Paul Kind, Principal Investigator, Outcomes Research Group, York, United Kingdom

Workshop Purpose: This workshop provides an overview of the design and development of EQ-5D, a widely used generic measure of health-related quality of life. The workshop will be led by founder members of the EuroQoL Group who will describe the current status of EQ-5D, including information on application studies as well as on future plans.
Workshop Description: Health-related quality of life (HrQoL) measurement is essential for a variety of applications that include the evaluation of healthcare as well as monitoring outcomes in patients and populations. EQ-5D is a generic measure of HrQoL that has become one of the most widely used instruments for measuring health outcomes. Based on 5 key dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression, EQ-5D defines a system of 243 health states. The relative value of these states can be determined by collecting social preferences from the general population or from specific patient or population subgroups. These weights enable EQ-5D data to be summarised into a single index of health status that can be used to measure health outcomes. EQ-5D was designed as a low-burden/high-yield measure and attendees will be given direct experience by self-completion in the workshop. Participants will be encouraged to discuss their own potential applications of this measure. After completion of the workshop participants can expect to have full information and knowledge regarding the current status of EQ-5D as well as an understanding of future development plans. Workshop participants will be encouraged to consider participation with the research activities of the EuroQoL Group.
 

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