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Tuesday, 2 September |
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8.00-9.00 |
EXHIBITS, AND RESEARCH PRESENTATION - POSTER VIEWING reception hall, 3rd floor |
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Poster Presentations |
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9.00- 10.30 |
FIRST
PLENARY SESSION
international conference
room 301, 3rd floor |
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9:00- 9:30 |
OPENING REMARKS |
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9:00-9:10 |
WELCOME
Speaker: Isao Kamae MD, DrPH, Research Center for Urban
Safety and Security, and Graduate School of Medicine, Kobe University,
Kobe, Japan |
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9:10-9:20 |
CONFERENCE INTRODUCTIONS
Speakers: Naoki Ikegami
MD, MA, School of Medicine, Keio University, Tokyo, Japan and
Shuzo Nishimura PhD, Faculty of Economics, Kyoto University,
Kyoto, Japan
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9:20-9:30 |
ISPOR PRESIDENT REMARKS
Speaker: Sean Sullivan PhD, University of Washington, Seattle,
Washington, USA
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9.30-10:45 |
FIRST
PLENARY SESSION international
conference room 301, 3rd floor |
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9.30-9:35 |
Role of Pharmacoeconomics and Outcomes
Research in Healthcare Decisions
Moderators: Toshihiko Hasegawa MD,
Director of Health Policy Science, National Institute of Public
Health, Department of Policy Sciences, Saitama-ken, Japan and
Koichi Nobutomo MD, DMSc, Professor of Healthcare Systems,
Graduate School of Medicine, Kyushu University, Fukuoka, Japan
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9.35-9:50 |
Importance of
Healthcare Quality and Outcomes Research in Health Care Reform: A
Policy-maker’s Perspective
Speaker: Honorable David F.
Durenberger, Chairman and CEO, National Institute for Health
Policy; President, Medical Technology Leadership Forum; and US Senator
(1978-1995), Minneapolis, MN, USA
Senator Durenberger will identify the common challenges that all
developed nations face in managing their health care systems and
describe previous attempts at reform. His remarks will conclude with a
discussion of current policy solutions and underscore the important
role that Health Services Research must play in bringing about global
health care reform.
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9:50-10.10
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The Role of Pharmacoeconomic Guidelines
in Drug Selection Healthcare Decisions
Speaker: Sean Sullivan PhD,
Professor, University of Washington, Seattle, WA, USA
Pharmacoeconomic evaluations play an increasingly important role in
resource allocation decisions in a few select countries. In order to
improve relevance and transparency, guidelines have been introduced in
some countries that detail evidentiary requirements for
decision-making, methodologic conduct for research and ethical
responsibilities for analysts and sponsors. Do decision-makers use
economic analyses? Is the evidence for economic impact sufficiently
rigorous and unbiased? Dr. Sullivan will explore these issues and make
recommendations for improving the conduct and use of pharmacoeconomics
for resource allocation.
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10.10-10:30 |
Health Care Reform in Japan
Speaker: Ryoji
Takahara MD, MPH, Director-General, Health Bureau, Ministry of
Health, Labour and Welfare of Japan
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10:30-10:45 |
Break |
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10:45-11:45 |
WORKSHOPS
SESSION I
(4 concurrent sessions) |
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Clinical Studies
room 403 |
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W1 |
PRINCIPLES OF GOOD
PRACTICE FOR EBM AND MODELING IN HEALTH CARE EVALUATION
Kamae I1, Inoue Y2, Koizumi S3,
1Kobe University, Kobe, Japan; 2Yamaguchi University, Yamaguchi,
Japan; 3Saga Medical School Hospital, Saga, Japan
Learning Objectives: Review the standard
criteria for critical appraisal and problem-solving in evidence-based
medicine (EBM), and also understand the guidelines for modeling
studies reported by the ISPOR Task Force; gain a better appreciation
of how outcomes researchers link clinical practice with modeling
studies.
Workshop Description: In recent years,
need for EBM has been growing in clinical practice. EBM community
already established the standard criteria for clinicians in critically
appraising the quality of patient-oriented outcomes research. It is
important for not only clinicians, but also any outcomes researchers
to review what it is and what it means in teams of conducting good
research with scientific soundness. The ISPOR Task Force on good
research practices recently published the consensus of the discussion
with guidelines for modeling studies. The guidelines, of course, are
worth understanding for any health-care researches. The workshop gives
an opportunity to understand the criteria in EBM for good clinical
studies and appreciate a linkage between clinical practice and
outcomes research in the light of focusing on good modeling. A case
study will be presented with the cost-effectiveness analysis in the
Interferon use for hepatitis.
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Pharmacoeconomics
room 402 |
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W2 |
METHODOLOGICAL
ISSUES ON WILLINGNESS-TO-PAY-TAX
Chi C1, Lang HC2,
1Oregon State
University, Corvallis, OR, USA; 2National Yang-Ming University,
Taipei, Taiwan
Learning Objectives: To review key
literature on WTP and WTPT, differentiating between the two, knowing
methods for measuring WTP general and earmarked tax and policy
implications of WTPT methods.
Workshop Description: Willingness-to-pay
(WTP) is a standard method to solicit consumer preferences for
non-market goods, especially in health care services. The finance of
health care in most OECD nations, however, is primarily through either
general tax or earmarked tax, which include premiums, collected by
government. Willingness-to-pay-tax (WTPT), therefore, emerged as an
important research and policy issue in resource allocation and public
finance, which is different from conventional WTP method. The first
part of this workshop reviews key literature on WTP and WTPT. This is
followed by raising and discussing several critical methodological
issues in measuring WTPT, and where it departs from WTP. Special
attention is given to WTPT measurement methods in relation to general
tax and earmarked tax. Because these two types of taxes present
different challenges in measurement, their treatments are discussed
separately. Further, as user charges or cost sharing are increasingly
present in many health care systems, and its underlying methodological
issues are resemblance to WTPT, these issues are also considered here.
On the third part, this paper proposes method for measuring
willingness to pay general tax and earmarked tax. On the fourth part,
given that WTPT solicitation is inevitably leads to resource
allocation decisions and priority settings, the author discusses the
policy implications of WTPT methods. Further, various concerns in
equity related to WTPT are also discussed. Finally, the author
recommends areas of WTPT that calls for further investigation and
development.
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Quality of Life
room 401 |
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W3 |
TRANSLATION AND
VALIDATION OF QUALITY OF LIFE QUESTIONNAIRES
Crawford B1, Conway K2, Abetz L3,
1Mapi
Values, Boston, MA, USA; 2Mapi Research Institute, Lyon, France;
3Mapi
Values, Cheshire, UK
Learning Objectives: To become familiar
with the validation process and quality of life questionnaires.
Workshop Description: International
clinical trials evaluating quality of life require questionnaires that
are culturally adapted into the local language. In addition, whenever
a questionnaire is translated into a new language or used in a new
population, it is recommended that the validation of the questionnaire
be completed by checking the following psychometric properties. This
workshop will review the translation process with an emphasis on
conceptual equivalence and review the validation process, including
validity, reliability and responsiveness. Examples will be provided to
enhance learning. Attendees will be trained to understand translation
processes and standard validation techniques.
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Health Policy
international conference room 301 |
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W4 |
FORMULARY
DEVELOPMENT USING PHARMACOECONOMICS
Neumann P1, Sullivan S2, Foote S3,
1Harvard School of Public Health,
Boston, MA, USA; 2University of Washington, Seattle, WA, US;
3School
of Public Health, University of Minnesots, Minneapolis, MN. USA
Learning Objectives: To learn guidelines
and review formulary development using pharmacoeconomics for the
future.
Workshop Description: Health plans,
pharmacy benefits managers, state Medicaid programs and hospitals in
the U.S. have long used drug formularies, which list the prescription
medications approved for routine use in the organizations. But the
process by which these organizations made formulary decisions has
frequently lacked transparency or scientific rigor. In recent years,
health policy makers have worked to standardize and improve formulary
processes, with the goal of grounding decisions in stronger clinical
and economic evidence. The trend reflects two broader movements in
health care, one towards evidence-based medicine, and the other
towards explicit consideration of cost-effectiveness or "value for
money" arguments. The U.S. has trailed other countries in its adoption
of formulary guidelines but a growing number of health plans and other
organizations have begun to implement new formulary guidelines issued
by the Academy of Managed Care Pharmacy (AMCP). This workshop will
describe the guidelines, review progress to date, and analyze critical
issues for the future. Specifically, we will the following questions:
What information is requested in the AMCP Format? How will the Format
change practices at health plans and pharmaceutical companies? Will
the Format impose an undue burden on health plans and manufacturers?
Do health plans have the expertise to use them? Are formulary
guidelines a smokescreen for cost-containment? Do plans have the clout
to force drug companies to comply? Won’t all drug company submitted
information be "biased?" How will the FDA regulate unsolicited
requests? Are dossiers submitted under the AMCP Format confidential?
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11:45-12:00 |
Break |
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12:00-13:00 |
WORKSHOPS
SESSION II
(4 concurrent sessions) |
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Clinical Studies
room 403 |
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W5 |
J-ARAMIS,
A NEWLY ESTABLISHED LARGE OBSERVATIONAL COHORT OF JAPANESE PATIENTS
WITH RHEUMATOID ARTHRITIS
Yamanaka H1, Singh G2, Tanaka EI1, Nakajima A1, Kamatani N1;
1Tokyo Women's Medical University, Tokyo, Japan;
2Stanford University,
Palo Alto, CA, USA
Learning Objectives: To review and
understand the foundations of the J-ARAMIS program and its relation to
Japanese patients with rheumatoid arthritis.
Workshop Description: Rheumatoid
arthritis (RA) and osteoarthritis are the most common rheumatic
diseases in Japan. Outcome studies in these chronic diseases require
systematic protocol-driven collection of long-term data. Although
there have been a few epidemiological studies in Japan, there is no
system for systematically collecting long-term outcome data in
patients with arthritis. In this workshop, we report the establishment
of the first such system. Methods: The J-ARAMIS program is set up as a
prospective non-interventional observational cohort study of
consecutively enrolled patients with arthritis. Patients are asked to
answer a validated questionnaire (J-HAQ) at clinic visit or complete
it at home and mail it back. The questionnaire includes validated
items on disability, pain, medication use, adverse events, health care
utilization, and satisfaction with care. Finally, a combined database
is made by inclusion of patient-reported data, physician's assessment,
and laboratory data set. Discussion: The first phase of J-ARAMIS was
done in October 2000. Patient questionnaires were administered to 4110
consecutively enrolled patients with rheumatic diseases. A total of
4047 patients answered the questionnaires, for a response rate of
98.5%. Of these, 3763 patients had RA. This cohort is designed to be
followed twice per year and J-ARAMIS database is expected to
accumulate more than 1000 characteristics of these patients for at
least five years. Although the system has just established, J-ARAMIS
is expected to produce useful data for the assessment of RA. These
include the ethnic difference in pharmacogenomics, one of the major
concerns of clinical rheumatology. The near-perfect response rate
indicates that such studies are practical and possible in Japan, and
are likely to yield a high quality of epidemiologic data on rheumatic
diseases in Japan.
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Pharmacoeconomics
room 402 |
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W6 |
INSTITUTIONAL COST
ANALYSIS EMPLOYING MICROSOFT EXCEL: AN EFFICIENT APPROACH FOR
DEVELOPING COUNTRIES |
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Riewpaiboon A,
Mahidol University, Rajathevi, Bangkok, Thailand
Learning Objective: This workshop is
aimed to introduce and exchange experience on the efficiently
institutional cost analysis employing Microsoft Excel.
Workshop Description: Institutional cost
analysis is important for public health planning and efficiency
management. Cost data systems in developing countries are usually not
well organized and not computerized. In this situation, a specific
developed approach is needed to facilitate the analysis. The workshop
will present conventional cost analysis methodology composing of
bottom-up and top-down approaches, economic depreciation cost using
inflation-adjusted current price, simultaneous equation method for
indirect cost allocation, departmental allocation to unit cost by
various techniques. To conduct the analysis efficiently, Microsoft
Excel is employed creating an automatic-updated calculation
instrument. The Excel techniques comprise cell referencing, linking,
transposed linking, copying of linking, copying of formula, and Excel
functions i.e. IF, LOOKUP, YEAR, MINVERSE and MMULT. This cost
analysis instrument acts similar to a software convenient to do
sensitivity analysis and update analysis in following years.
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Quality of Life
room 401 |
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W7 |
RECENT DEVELOPMENT ON THE
MEASUREMENT OF GENERIC QOL IN JAPAN
Nishimura S1, Ikeda S2, Ohkusa Y3,
1Kyoto
University, Kyoto, Japan: 2Keio University, Tokyo, Japan;
3Osaka
University, Osaka, Japan
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Health Policy
International Conference Room 301 |
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W8 |
PHARMACEUTICAL PRICING AND
REIMBURSEMENT POLICIES IN CHINA
Hu S, School of Public Health, Fu Dan University, Shanghai, P.R
China
Learning
Objectives:
To evaluate the present pricing and
reimbursement policies of pharmaceuticals in China and to discuss how
to improve the policy-making on setting rational drug prices and
reimbursement lists.
Workshop
Description:
In China, the share of pharmaceutical
expenditures accounted for 47~56% in national health accounts during
the past decade. The average annual growth rate of pharmaceutical
expenditures was 11.2% higher than that of gross domestic product.
During this workshop the changes of pricing policy, which has
gradually shifted from fixed cost markup to social average pricing and
bulk procurement through price bidding will be presented. As a result
of changes in the pricing policy, some negative impacts have occurred
in the process of pooled purchasing. Although multiple approaches have
been adopted, a significant savings in pharmaceutical expenditure has
not occurred. Alternative drug policy reimbursement plans will be
discussed such as reference-based pricing schemes and price
negotiation with pharmaceutical companies as a future direction to
healthcare cost containment. Workshop participants will be asked to
share experiences with drug reimbursement policies in their country.
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13:00-15:30 |
LUNCH, EXHIBITS, AND RESEARCH PRESENTATION - POSTER
VIEWING reception hall, 3rd
floor |
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Poster Presentations |
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15:30-17.00 |
SPECIAL SESSIONS
(2
concurrent sessions) |
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15:30-17.00 |
THE JAPANESE
HEALTH CARE SYSTEM: STRUCTURE, DYNAMICS, LESSONS room 401
Speaker: Naoki Ikegami MD, MA,
Professor and Chair, Department of Health Policy & Management, School
of Medicine, Keio University, Tokyo, Japan
Japan's health indices are excellent although health expenditures
constitute only 7.6% of the GDP in 2000. The structure and the forces
that drive the system will be explained. The lecture will conclude
with projections about the future and lessons for other countries in
the Asia-Pacific region.
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15:30-17.00 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN ASIA-PACIFIC
international conference room 301
Co-sponsored by:
The Japan Society of Pharmacoepidemiology (JSPE), the International
Society for Pharmacoepidemiology (ISPE), and ISPOR
Organized by: Takashi Fukuda, PhD,
Associate Professor, Department of Pharmacoeconomics, University of
Tokyo,
Tokyo, Japan; Shunya Ikeda, MD, MS, DMSc, Assistant Professor,
Department of Policy and Management, Keio University, Keio, Japan;
Makoto Kobayashi, ME, Manager, CRECON Research and Consulting
Inc., Tokyo, Japan; Kiichiro Tsutani, MD, PhD (chair),
Professor, Department of Pharmacoeconomics, University of Tokyo,
Tokyo, Japan
Moderator: Kiichiro Tsutani MD, PhD,
Professor, Department of Pharmacoeconomics, University of Tokyo,
Tokyo, Japan
For the sound and efficient study of both pharmacoepidemiology and
pharmacoeconomics, high quality datasources are necessary. Datasources
in the Asia-Pacific region are in various stages of development and
use. This Special Session aims: (1) to review the current status of
datasources in Asia-Pacific in these two fields; (2) to identify
problems encountered; and (3) to develop future plans for development.
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15:40-15.55 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN AUSTRALIA
Speaker: Peter Davey MA, Director,
M-TAG, Chatswood , NSW, Australia
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15:55–16:10 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN CHINA
Speaker: S. Hu PhD, Professor, School of
Public of Health, Fudan University, Shanghai, China
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16:10–16:25 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN THE REPUBLIC OF
KOREA
Speakers: Byung Joo Park, MD, PhD,
Professor, Seoul National University College of Medicine, Seoul,
Korea;
Sang-Cheol Bae, MD, PhD, MPH, Head of Rheumatology Division,
Hanyang University, Seoul, Korea
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16:25–16:45 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN JAPAN
Speakers: Takuro Shimbo, MD, DMs,
Associate Professor, General Medicine and Clinical Epidemiology
Graduate School of Medicine, Kyoto University, Kyoto, Japan;
Kiichiro Tsutani, MD, Professor, Department of Pharmacoeconomics,
University of Tokyo, Tokyo, Japan; Takashi Fukuda, PhD, Associate
Professor, Department of Pharmacoeconomics, University of Tokyo,
Tokyo, Japan; Shunya Ikeda MD, MS, DMSc, Assistant Professor,
Department of Policy and Management, Keio University, Keio, Japan;
Makoto Kobayashi, ME, Manager, CRECON Research and Consulting Inc.,
Tokyo, Japan; Masashi Kusunoki
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16:45–17:00 |
DATASOURCES FOR
PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS STUDIES IN TAIWAN
Speaker: Yen-Huei (Tony) Tarn PhD,
Associate Professor, School of Pharmacy, National Defense Medical
Center, Taipai, Taiwan
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17.00-18.00 |
RECEPTION, EXHIBITS, AND RESEARCH PRESENTATIONS - POSTER
VIEWING |
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Poster Presentations |
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17.00-18.00 |
SATELLITE SYMPOSIUM
International Conference Room 301 |
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KOBE MEDICAL
DEVELOPMENT PROJECT IN THE 21ST CENTURY
Moderator: Masayoski Murakami MD,
Director of Clinical Research Coordination, Foundation of Biomedical
Research and Innovation, Kobe, Japan
THE NEED FOR TECHNOLOGY ASSESSMENT IN HEALTH
CARE
Speaker: Peter Neumann ScD,
Associate Professor of Policy & Decision Science, Harvard School of
Public Health, Boston, MA, USA
BUSINESS DEVELOPMENT & TECHNOLOGY ASSESSMENT
Speaker: J. Jaime Caro MD,
Scientific Director, Caro Research, Concord, MA, USA
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18.30-21.00 |
BAY-CRUISING ON THE “CONCERTO”
(Optional) – includes dinner and drinks (see ISPOR registration
desk to purchase tickets – US$36 or
¥ 4500)
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