ISPOR EDUCATOR'S TOOL KIT TASK FORCE
Chair:
Tomasz Hermanowski PhD, Warsaw University of Technology,
Warsaw, Poland
Education Chair: Karen Rascati PhD, RPh,
Professor, University of Texas, Pharmacy Admin, Austin, TX, USA
Members:
- Gary Yee PharmD, Professor and Chair, University of
Nebraska Medical Center, Omaha, NE, USA
- Etta Vinik MA, Associate Director Education, Strelitz
Diabetes Institutes, Eastern Virginia Medical School, Norfolk,
VA, USA
- Kirsten Gertsen MSc, Manager Health Economics &
Strategic Pricing, N.V. Organon, Oss, Netherlands
- Olaf Pirk MD, Managing Director, Fricke & Pirk GmbH,
Nuremberg, Germany
- Eva Tsakonas MSc
- Robert Woodward PhD, McKerley Professor of Health
Economics, University of New Hampshire, Durham, NH, USA
- Catherine Brun, Germany
Mission:
The Educator’s Tool Kit Task Force will create and establish
useful teaching resources for the International
Pharmacoeconomics Educator.
The Tool Kit is intended to be international, and will include
written and interactive works from various nations in order to
provide a fully global understanding of the field of
pharmacoeconomics. The Pharmacoeconomics Educator, regardless
of level of familiarity with the topic, will be able to use
this tool in facilitating his or her educational endeavors.
Progress:
The Educator’s Tool Kit will be available by January 2006.
ISPOR EDUCATOR’S TOOL KIT CONTENTS:
Pharmacoeconomics
Resources for Educators:
Developed by the ISPOR Educators Tool Kit Task Force
I. GENERAL BOOKS AND REVIEWS
- Czech M., Orlewska E., Słownik farmakoekonomiczny, Warszawa,
2002, Unimed (Dictionary of Pharmacoeconomics) – second edition,
by Ewa Orlewska, PhD, MD and Marcin Czech PhD, MD, MBA.
This book includes the most important terms and their brief
definitions covering the field of pharmacoeconomics, health
economics, health care management and regulations, health-
related quality of life and outcomes research. It is supplemented
by selected terms concerning clinical trials, macroeconomics,
financial analysis, cost accounting and statistics. All the terms
are listed in alphabetic order (in Polish) with their English
translations given in brackets. English terms are listed in the
alphabetic order at the end of the publication. It is
user-friendly lexicon which may serve as a reference tool for the
practitioners of pharmacoeconomics and outcomes research as well
as for users of pharmacoeconomic analyses.
- Farmakoekonomika. Ekonomiczna ocena programów ochrony zdrowia.
Praca zbiorowa pod redakcją M. Czecha, Warszawa, 2004, Oficyna
Wydawnicza Politechniki Warszawskiej.
Pharmacoeconomics. Economic Assessment of Health Care Programmes.
One of three textbooks currently available on the Polish market.
It was prepared by the group of authors from the Business School,
Warsaw University of Technology, edited by Dr Marcin Czech. Its
aim is to promote and facilitate greater understanding of health
care outcome research and its applications in health care
decision making. It is targeted not only to students of
management, economics, medicine and pharmacy but also to health
care professionals, decision makers and researchers. The
terminology used is compatible with the one used in Polish
Dictionary of Pharmacoeconomics as well as “Polish guidelines for
conducting pharmacoeconomic evaluations”.
- Drummond, M.F., O’Brien, B., Stoddart, G.L., Torrance, Metody
badań ekonomicznych programów ochrony zdrowia, Gdańsk, G.W. 2003,
Via Media . Red.: Jacek Spławiński. Drummond, M.F., O’Brien, B.,
Stoddart, G.L., Torrance, Methods for the Economic Evaluation of
Health Care Programmes. Translation into Polish of well-known
manual for pharmacoeconomics, edited by J. Spławiński.
- T.E.Getzen, przekład M. Jakubiak, T.Żukowski. Ekonomika Zdrowia.
Wydawnictwo Naukowe PWN, Warszawa 2000. Polish edition of Health
Economics by T. E. Getzen, translated by M. Jakubiak and T.
Żukowski
- J. Spławiński, Receptarusz Szpitalny, Oficyna Wydawnicza Unimed,
Jaworzno 1998. J. Spławiński „Hospital Formulary”. Theory and
practice, how to built a formulary for hospitals.
- J. Spławiński, J. Kuźniar, T. Chruściel, W. Bojar. Zasady oceny
skuteczności leków. w; Farmakologia. Podstawy farmakoterapii.
Red.: W. Kostowski i Z.S. Herman. Warszawa, PZWL, 2003. J.
Spławiński, J. Kuźniar, T. Chruściel, W. Bojar “Principles of the
measurement of effectiveness of medicines”, in “Pharmacology.
Foundations of pharmacotherapy”, edited by W. Kostowski and Z.S.
Herman. Principles of the measurements of effectiveness in the
clinical trials (superiority, equivalence and non-inferiority)
are extensively analysed, including some ethical (based on DoH)
and statistical issues.
- E.Orlewska, Polskie wytyczne przeprowadzania badań
farmakoekonomicznych: E.Orlewska “Polish guidelines for
conducting pharmacoeconomic evaluations”,
www.farmakoekonomika.pl
- German: Schöffski Ound von der Schulenburg JM (eds.):
Gesundheitsökonomische Evaluationen, 2nd edition, 2000, Springer,
Heidelberg
Good Introduction in health economics in German language with
several articles dealing with topics below. The reader will find
several helpful hints on how to create a study, how to deal with
pharmacoeconomic data etc.
- Drummond MF (1995). An Introduction to Health Economics. Brookwood Medical Publications, Surrey.
Good compact overview focusing on real “beginners”.
- Drummond MF, Stoddart GL und Torrance GW (1987). Methods for
the Economic Evaluation of Health Care Programmes. Oxford
University Press, Oxford, New York, Toronto.
This book is even a classic one (I think there must be an actual
edition) giving hints in the different chapters on how to
interpret health economic studies, programs, articles, data etc.
The hints are presented as check lists.
- Gisela Kobelt. Health Economics: An Introduction To Economic
Evaluation. (2002) 2nd ed. pp 131.Office of Health Economics,
London, UK.
This books offers a wide range of basic information on health
economics (background, requirements, methodology), supplemented
with real life examples. It is a handy booklet that can be used
bu people wanting to learn about HE, but also by people working
in the field of HE as a book of reference.
- Andrew M Jones. Applied Econometrics For Health Economists - A
Practical Guide. (2001) pp 94. Office of Health Economics,
London, UK.
This booklet assumes basic familiarity with the principles of
statistical inference - estimation and hypothesis testing - and
with the linear regression model. It deals with practical
analysis of qualitative and categorical variables. Examples of
analysis performed with the software package STATA (version 7)
are given including commands and tables.
II. BOOKS AND ARTICLES ON COST
| A. General reviews |
| |
- Gregson N, Sparrowhawk K, Mauskopf J, Paul J. Pricing
medicines: theory and practice, challenges and opportunities.
Nature Reviews | Drug Discovery 2005; 4:121-30.
Summary: This article discusses how pricing strategies are
developed in practice and explains how scientific and
environmental trends provide future pricing challenges and
opportunities.
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| B. Costing methods |
| |
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| C. Cost of illness |
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- Gilks WR, Spiegelhalter DJ, Richardson S (Eds.). Markov Chain
Monte Carlo in Practice. Boca Raton, FL: Chapman & Hall; 1995.
- Vanness DJ, Kim WR. Bayesian estimation, simulation and
uncertainty analysis: the cost-effectiveness of ganciclovir
prophylaxis in liver transplantation. Health Econ.
Sep;11(6):551-66, 2002.
- Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The
health care costs of diabetic peripheral neuropathy in the US.
Diabetes Care. Jun;26(6):1790-5, 2003.
- Shearer A, Scuffham P, Gordois A, Oglesby A. Predicted costs
and outcomes from reduced vibration detection in people with
diabetes in the U.S. Diabetes Care. Aug;26(8):2305-10, 2003.
- Gilmer TP, O'Connor PJ, Rush WA, Crain AL, Whitebird RR, Hanson
AM, Solberg LI. Predictors of health care costs in adults with
diabetes. Diabetes Care. Jan;28(1):59-64, 2005.
- Sidorov J, Shull R, Tomcavage J, Girolami S, Lawton N, Harris
R. Does diabetes disease management save money and improve
outcomes? A report of simultaneous short-term savings and quality
improvement associated with a health maintenance
organization-sponsored disease management program among patients
fulfilling health employer data and information set criteria.
Diabetes Care. Apr;25(4):684-9, 2002.
- Vanness DJ, Kim WR. Empirical modeling, simulation and
uncertainty analysis using Markov Chain Monte Carlo: glanciclovir
prophylaxis in liver transportation. Wisconsin Public Health and
Health Policy Institute website. 2005. Available at: http://www.pophealth.wisc.edu/UWPHI/education/seminars/vanness.pdf.
Accessed July 7, 2005.
- Redekop WK, Stolk EA, KOK E, Lovas K, Kalo Z, Busschbach JJ.
Diabetic foot ulcers and amputations:estimates of health utility
for use in cost-effectiveness analyses of new treatments.
Diabetes Metab; 30(6):549-56, 2004
- Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber
GE, Wagner EH. Incidence, Outcomes, and Cost of Foot Ulcers in
Patients with Diabetes. Diabetes Care; 22:(3)382-387, 1999.
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| D. Indirect costs |
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- Brouwer WB, Koopmanschap MA. The friction-cost method :
replacement for nothing and leisure for free? Pharmacoeconomics.
2005;23(2):105-11.
- Liljas B. How to calculate indirect costs in economic
evaluations. Pharmacoeconomics. 1998 Jan;13(1 Pt 1):1-7.
- Koopmanschap MA, Rutten FF. A practical guide for calculating
indirect costs of disease. Pharmacoeconomics. 1996
Nov;10(5):460-6.
- Health Economics: An Introduction to Economic Evaluation 2nd
Edition
- Gisela Kobelt, ed: Office for Health Economics
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| E. Willingness-to-pay |
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- Hirth RA, Chernew ME, et al. Willingness to pay for a
quality-adjusted life year. Health Economics 2000;20:332-42.
Health benefits are difficult to express in monetary terms, and
there is no consensus on the appropriate dollar value of a QALY
gained on which to base resource allocation decisions. The goal
of this exercise was to find a general value for the WTP to gain
a QALY. The results show that no precise decision rule can be
generated for CEA/CUA from the value-of-life literature. However,
they do suggest that common rules of thumb are too low.
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| F. Discounting/Adjustment |
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- Bootman et al. Principles of Pharmacoeconomics - Third Edition
- Chapter 3.
- Drummond et al. Methods for Economic Evaluation of Health Care Programmes. Second Edition - Chapter 4.
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III.
BOOKS AND ARTICLES ON PATIENT REPORTED OUTCOMES
| A. General reviews |
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- Rapier CM (1996). An Introduction to Outcomes research. Brookwood Medical Publications, Surrey.
Brief Introduction to what outcomes are. Helpful to create ideas
on potential outcomes for a piggy back study.
- Spilker B (ed): Quality of life and pharmacoeconomics in
clinical trials, Lippincott-Raven, Philadelphia, 1996.
Good introduction on nearly all aspects of Qol/Preferences/Utilities
and some aspects of health economic evaluation. Even for the user
with some knowledge the “Spilker” presents new insights.
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| B. Health-related quality of life |
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- PROQOLID: Patient-Reported Outcome and Quality of Life
Instruments Database
Developed by Mapi Research Institute and managed by Mapi Research
Trust (Lyon, France), PROQOLID aims to identify and describe PRO
(Patient Reported Outcomes) and QOL (Quality of Life) instruments
to help you choose appropriate instruments and facilitate your
access to them. www.qolid.org
- IQOD – International Health Related Quality of Life Databases.
ISOQOL- International Society for Quality of Life Research.
www.iqola.org/links.aspx
World Health Organization (WHO) WHO Behavioral Risk Factor
Surveillance Program.
www.cdc.gov/hrqol/resources.htm
- OLGA (The On-Line guide to Quality of Life Assessment)
Dabases with decision-theoretic selection algorithms to assist in
the selection of instruments. Output: detailed descriptions of
instruments and citations to relevant empirical studies.
www.olga-qol.com
- Maurice J. Staquet, Ron D. Hayes, Peter M. Fayers. Quality of
Life Assessment in Clinical Trials. Oxford University Press,
1998.
- Bram Kirshner and Gordon Guyatt. A Methodological Framework for
Assessing Health Indices. J. Chron Dis Vol.38, No.1, pp27-36,
1985.
- Gordon H. Guyatt, Claire Bombadier, Peter X. Tugwell. Measuring
Disease-Specific Quality of Life in Clinical Trials. CMAJ 1986;
13L:889-895.
- David L. Streiner and Geoffrey R. Norman. Health Measurement
Scales. 2nd Edition, Oxford University Press.
- Guyatt, G., Feeny, D., and Patrick, D. Issues in quality of
life measurement in clinical trials. Controlled Clinical Trials
1991; 12:81S-90S.
- Hayes, R. D., Anderson, R., and Revicki, D. A. (1995).
Psychometric evaluation and interpretation of health-related
quality of life data. In The international assessment of
health-related quality of life: theory, translation, measurement
and analysis.
- Nunnally, J. C. (1978). Psychometric theory, (2nd edition), pp.
229-46. Basic Books, New York.
- German: Peterman F (ed.): Lebensqualität und chronische
Krankheit, Dustri, München 1996.
Brief overview on different aspects of QoL. Mainly focused on the
situation in Germany.
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| C. Preferences/utilitiess |
IV. BOOKS AND ARTICLES ON STUDY DESIGN
| A. General reviews |
| B. Modeling |
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1. General modeling issues |
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- Grieve R, Hutton J, Green C. Selecting methods for the
prediction of future events in cost-effectiveness models: a
decision-framework and example from the cardiovascular field.
Health Policy 2003; 64:311-24.
This article illustrates how the development of economic models
can be made more transparent, illustrated by a cost-effectiveness
model of a new drug for primary prevention of cardiovascular
disease. It suggests that the process outlined may be applied to
other disease areas where there are several event prediction
methods to chose from. Such transparence can help decision-makers
understand the scientific basis underpinning models and therefore
make these models more acceptable and useful for health
policy-making.
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2. Decision analysis models |
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- Weinstein M and Fineberg H.: Clinical Decision Analysism WB
Saunders, Phildadelphia 1980.
Although it is a classic book, I think it is one of the best
books on decision analysis giving detailed insights in the theory
dealing with easy examples from practice.
- TreeAge Healthcare User’s Manual [www.treeage.com]
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3. Transition state models (Markov models)) |
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4. Probabilistic models
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| C. Economic evaluation alongside clinical trials (”piggy-back”) |
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- O’Sullivan AK, Thompson D, Drummond MF. Collection of
health-economic data alongside clinical trials: is there a future
for piggyback evaluations? Value in Health 2005;8(1):67-79.
This article discusses step by step the issues surrounding the
conduct of “piggyback evaluations” and presents alternative ways
of addressing problems. Discussed are the issues related to
protocol driven care (in specific blinding, selection of study
population and study sites, choice of comparator, time horizon,
and sample size, identification of resource utilization and cost
measures) and practical issues (such as collection of resource
utilization data and valuation of resource use).
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V.
PHARMACOECONOMICS
RESOURCES FOR EDUCATORS: INTERPRETATION AND APPLICATION OF
PHARMACOECONOMIC DATA
| A. General reviews |
| |
- Barbieri M, Drummond M, Willke R, et al. Variability of
cost-effectiveness estimates for pharmaceuticals in Western
Europe: lessons for inferring generalizability. Value in Health
2005;8(1):10-23
This article discusses the difficulty of generalizing
cost-effectiveness data across countries because of the large,
non systematic variability. The key factor affecting the
variation of results from country to country appears to be
whether resource use is allowed to vary across countries, in
particular for trial based studies. Pooling of resource use data
should therefore be done with caution..
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| B. Reviewing/ critiquing research articles / papers |
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- Sackett et al. Evidence-Based Medicine, Churchill Livingstone,
Edinburgh 2000.
For critical reviewing of pharmoceconomic texts the check lists
are helpful.
- Bootman et al. Principles of Pharmacoeconomics - Third Edition
- Chapter 16.
- Drummond et al. Methods for Economic Evaluation of Health Care Programmes.
Second Edition - Chapter 4.
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