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.TO TOP
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. TO TOP
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. TO TOP
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. TO TOP
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.
TO TOP
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.
TO TOP
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.
TO TOP
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.
TO TOP
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. TO TOP
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.
TO TOP
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
TO TOP
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.
TO TOP
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.
TO TOP
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. TO TOP
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. TO TOP
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. TO TOP
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.
TO TOP
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