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CONNECTIONSCONNECTIONSUNITING SCIENCE AND PRACTICEF O R M E R L Y I S P O R N E W S

IN THIS ISSUEHealthcare Databases with Longitudinal Patient Data in EuropeBernd Brüggenjürgen, MD MPH, Institute for Social Medicine, Epidemiology and HealthEconomics, Humboldt-University Berlin, Charité and Alpha Care GmbH, Management andResearch in Health Care Systems, Celle (German Member of AEGISnet)

continued on page 3

1 Healthcare Databases with LongitudinalPatient Data in Europe

2 Letter From the Editor

6 Patients’ Willingness to Pay for PharmacistManaged Warfarin Therapy at CommunityTherapies

9 Number Needed to Treat (NNT): Is it a UsefulBenchmark for the Efficiency of Therapies?

10 Fireside Chat

11 Pharmacoeconomic Fellowship Survey

11 Article Reviews

12 ISPOR 2002 Winter Leadership MeetingSummary

13 PRAP Employer Registration Form

14 News Briefs From Around the World

16 Using Pharmacoeconomics and Outcomes Research Innovatively

20 ISPOR 5th Annual European Congress Information

21 ISPOR 7th Annual International MeetingSummary of Events

23 ISPOR 7th Annual International MeetingRegistration Form

REGISTER NOWFOR THE 7TH ANNUAL INTERNATIONAL MEETING!

APRIL 15, 2002 VOL. 8, NO.2 � INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH

This article is a summary of the presenta-tion given at the 2nd Plenary Session duringthe ISPOR 4th Annual European Congress,November 11-13, 2001 in Cannes, France.Information is based on Internet search,interviews with database experts and pub-lished information material.

Introduction

About 2600 years ago Hippokrates describedthe progress of Appolonius’ status as follows:“There was exacerbation of the fever, thebowels passed practically nothing of the foodtaken, no sleep... About the fourteenth dayacute fever, copious thin stools, wandering,cold extremities, speechlessness. Thirty-fourth day: Death.”

With the medical understanding 2600 yearsago these kind of documentation were oldversions of time-oriented, longitudinal med-ical records. They were not yet used to reflectcausal interdependencies, but described different states of disease and helpful foreducating students.

Although medical notes since Hippokratesare usually recorded on paper, this way ofdocumentation nowadays has disadvantagesas medical knowledge is exploding and it isincreasingly no longer feasible to link all dif-ferent sources of information per individual.The same is true for analysing patient baseddata. With the advent of large computeriseddata management tools, even the scrutiny ofpaper based sources could be entered intodatabases and being available for scientificresearch. However, more convenient and

efficient are those approaches, where theoriginal data materials originate from elec-tronically recorded primary sources.

The following overview of longitudinal patientdata is restricted towards easily, (i.e. also quasi-commercially) available data. It is alsorestricted to data, which are originally stem-ming from patient based documentations,which are in their complexity different fromdiseases register data. Different from the US,databases based on patient records are availablewith easy access only within ambulatory care.

Range of Applications for

Longitudinal Patient Data (LPD)

Anonymized patient data are a rich sourcefor scientific analysis of disease pattern aswell as identifying health care system influ-ences. They are both useful for scientific

organisations and medical industry.

Disease EpidemiologyLPD could be used for describing pattern ofdisease epidemiology with regard to inci-dence and prevalence of disease and mor-bidity or multimorbidity of selected patientgroups. This would be specially useful fortrial planning and/or feasibility analysis.

PharmacoepidemiologyLPD is a major source for identifying anddescribing side effects of patient treatmentregimens. A wide range of publications dorefer to the pharmacoepidemiologic aspectsof the third-generation pill. They help inidentifying prescribed therapies and could

ISP R

Dear ISPOR Members:

The mission of this publication is to “bridge the gap” betweenthe conduct of pharmacoeconomics and outcomes research andthe use of it in making health care decisions worldwide. Thepublication has expanded it content to include: a feature article,news brief from around the world, using pharmacoeconomicand outcomes reach innovatively, a summary of key articles, letter from the editor, firesidechat from the president, summary of ISPOR Board actions, summary of meeting events,meeting announcements and registration, advertisements, as well as cartoons. It has becomemore than just an organizational newsletter to communicate the organization’s activities. Tobetter reflect its content, the Editorial Board explored renaming the publication. TheEditorial Board considered approximately 30 new names. We narrowed the list down tothe top five and presented them to the ISPOR Board for consideration. And the winner isISPOR CONNECTIONS.

In keeping with our mission, the Editorial Board is interested in identifying individualsoutside of the United States who would like to actively participate on the ISPOR CONNECTIONS Editorial Board. The international perspective is critical to ensure fairbalance worldwide on issues related the pharmacoeconomics and outcomes research. Asa member of the Editorial Board, you will participate in bi-monthly conference calls,identify individuals to write feature articles, and/or support an existing or new column.Become the correspondent for your country by joining the ISPOR CONNECTIONSEditorial Board.

Even if you’re not interested in becoming an Editorial Board member, we’re very interestedin publishing summaries of country-specific government guidelines, polices, etc, related topharmacoeconomics and outcomes research. If your country has recently introduced orchanged their position on pharmacoeconomics and outcomes research, our publicationwould certainly benefit from your expertise. This is a great opportunity for pharmacoeco-nomic fellows, residents, and students. Your practice insight is of great value and interest toyour fellow members.

I like to take this opportunity to introduce our new Managing Editor at the ISPOR Office,Stephen Priori. Stephen has done an outstanding job in making this a smooth transition andensuring no interruptions to the publication. Thank you and welcome aboard.

Finally, please remember that your constructive comments are always welcome. If you espe-cially like something in these pages, or have suggestions on how to improve the publication,be sure to send us an e-mail at [email protected].

Respectfully,

Steve E. Marx PharmD, MS, Editor-in-Chief

ISPOR 2001-2002 Board of DirectorsPRESIDENT – Eva Lydick PhD, [email protected]

PRESIDENT-ELECT – Peter Davey MD, FRCP,University of Dundee and MEMO,[email protected]

PAST PRESIDENT – Jon C. Clouse MS, IngenixPharmaceutical Services, [email protected]

DIRECTORS – Michael Drummond PhD, Universityof York, [email protected]; A. Mark Fendrick MD,University of Michigan Medical Center, [email protected]; Brenda Motheral RPh, PhD,Express Scripts, [email protected]; Joan Rovira PhD, The World Bank,[email protected]; Kent H. Summers PhD, Eli Lilly & Company, [email protected]

TREASURER – Jean Paul Gagnon PhD, AventisPharmaceuticals, [email protected]

EXECUTIVE DIRECTOR – Marilyn Dix Smith RPh,PhD, ISPOR, [email protected]

ISPOR CONNECTIONS Editor & Editorial BoardEDITOR – Steven E. Marx PharmD, MS, AbbottLaboratories, [email protected]

EDITORIAL BOARD – Bonnie M. Korenblat DonatoPhD, Bristol Myers Squibb; Helma Monteban, Pfizer;Peter Wong RPH, MS, MBA. PhD, Good SamaritanHospital

ISPOR CONNECTIONS Publishing, Subscription,and Advertising Office:ISPOR CONNECTIONS (ISSN 1538-5108) (USPS019121) is published bi-monthly by the InternationalSociety for Pharmacoeconomics and OutcomesResearch, 3100 Princeton Pike, Building 3, Suite D,Lawrenceville, NJ 08648. Phone: 609-219-0773 Fax: 609-219-0774 Website: www.ispor.org.

Managing Editor: Stephen L. Priori, email:[email protected]; Advertising Manager: Nadia Naamanemail: [email protected].

Direct advertising, photocopy permission, and reprintrequests, to Managing Editor. Periodicals Postage paid atTrenton, New Jersey and additional offices.

Annual membership dues include $30 for regular mem-bers and $15 for student members for a 1-year subscrip-tion to ISPOR CONNECTIONS.POSTMASTER: Send address changes to ISPORCONNECTIONS, 3100 Princeton Pike, Building 3,Suite D, Lawrenceville, NJ 08648.

Letter From the Editor

Copyright © 2002 International Society of Pharmacoeconomics and Outcomes Research (ISPOR)All rights reserved under International and Pan-American Copyright Conventions. Published in the United States of America by the International Society for Pharmacoeconomics and Outcomes Research.No part of this publication may be used or reproduced in any manner whatsoever or by any means – graphic, electronic, ormechanical, including photocopying, taping, or information storage and retrieval systems without express written permission ofthe International Society for Pharmacoeconomics and Outcomes Research.ISPOR and ISPOR CONNECTIONS are trademarks of the International Society for Pharmacoeconomics and Outcomes Research.Inquiries should be addressed to: International Society for Pharmacoeconomics and Outcomes Research, 3100 Princeton Pike, Building 3, Suite D, Lawrenceville, NJ 08648 USA

2 April 15, 2002 ISPOR CONNECTIONS

continued from cover...help in tracking diseases with all potentialmono- and combination-therapy used inreal life. With the monitoring of adverseevents they are also useful for pharmacovigi-lance purposes.

Disease Management ResearchLPD could be a basis for outlining guide-lines and potentially increase the acceptanceof realistic guidelines. They help identifyingpatient behaviour, could be used as a proxy for compliance and serve as a bench-marking for comparing alternative treatmentpathways.

Pharmacoeconomics / PricingWith the real life aspect of LPDs they reflecta valuable source of identifying resource con-sumption of drugs and processes performed.Some databases do even reflect charges forcertain services.

Market ResearchLPD help market researcher in detailingspreading effects, switching behaviour andtime of uptake by prescriber. LPD shed alsolight on usage by specialists or hospitals.

Accessible Longitudinal

Patient Databases

Computerised database, available in a num-ber of different countries, are a potentiallyimportant source of observational data. Thisinformation could be used either alone or inconjunction with information from clinicaltrials. Beyond mere scientific research ques-tions LPD could increasingly meet pharma-ceutical companies‘ information needs.

Features of Longitudinal PatientDatabasesPopulation characteristics could be obtainedfor a wide range of diseases or subpopula-tions of interest. However, information withregard to severity of disease is usually notdirectly available, but has to be generated viaaccompanying analyses, such as an approxi-mation via drug use or symptom assessment. With regard to resource use the availabilityof information depends on the selected data-

base. In most databases frequency of consul-tation and prescriptions are well documented.Most databases provide good overview onrelevant comparators and—in addition—atleast some treatment outcomes can be iden-tified. However, information from treatmentapproaches and resources consumed in hos-pitals is scarce or not available.

Some databases allow follow-up of singlecases as long as confidentiality is guaranteedand the purpose for acquiring data is of sci-entific research nature.

European DatabasesThe table given on page 5 provides anoverview with regard to computerised data-bases being available in Europe. Databasesincluded with good documented evidencewere the General Practitioner ResearchDatabase (GPRD) in the UK; theMEdicines MOnitoring Unit (MEMO)database in Tayside, Scotland; the IMSMediplus databases in UK, France,Germany and Austria; the Cegedim ThalesDatabase in France; the Health SearchDatabase in Italy; and the General PracticeDatabase (IPCI) in The Netherlands.

Issues working with

Longitudinal Patient Data

The underlying structure of patient datacould be as follows. It could be either time-oriented, source oriented or problem-oriented.This has to be born in mind in any datapreparation for further analysis of the med-ical record data. LPD would be also different

with regard to the classifications used, whichis especially important in comparing differ-ent European databases.

For identifying correct patient groups it isnecessary to have a clear definition of the targetdisease, which should be performed ideallywith database experts. Table 1 below showsan example from the GPRD database ofpotential codes referring to schizophrenia.These have to be defined in accordance withdatabase experts.

A major issue with regard to most applica-tions mentioned above is the longitudinalnature of the data. Complex analytic pro-grams have to be written in order to identifycomparable patients with drugs being usedover similar periods with certain events following in the same time period. This isfurthermore complicated by the wide granu-larity of the data and the complexity of data,which have to be taken into account both forspecific and general analyses.

Finally it has to be mentioned that LPDcould not easily be used for identifyingabsolute prevalence figures. This is due tothe fact that the underlying denominator isnot known. Figure 1 provides results fromthe Mediplus in Germany. The listing of theleading diagnoses is an approximation of theprevalence of disease in Germany only (e.g.diagnoses are coded predominantly for reim-bursement reasons and not for all patientswho are visiting a doctor in the ambulatorycare setting).

Table 1: Potential GPRD codes referring to schizophrenia

Acute Schizophrenic Episode Paranoid Schizo.- Chronic Schizophrenia – Chronic Type

Atypical Schizophrenia Paranoid Schizo.-Chr.+Acute Ex Schizophrenia – Unspecified

Catatonia – Unspecified Paranoid Schizo.-In Remission Schizophrenia Atypical

Catatonic Schizophrenia Paranoid Schizophrenia Schizophrenia Chronic

Chronic Paranoid Psychosis Paranoid States Schizophrenia Nos

Hebephrenic Schizophrenia Paraphrenia Schizophrenia Paranoid

Movements Catatonic Paraphrenia Schizophrenia Paraphrenic

Other Paranoid States Residual Schizophrenia Schizophrenic Disorders

Other Schizophrenia Nos Schizo-Affective Disorder Schizophrenic Episode

Paranoid Illness Schizoaffective Psychosis Schizophrenic Psychosis

Paranoid Psychosis Nos Schizo-Affective Schizophrenia Simple Paranoid State

ISPOR CONNECTIONS April 15, 2002 3

The following list provides a few examplesfor database-based articles:• Why are patients prescribed proton

inhibitors? Retrospective analysis of linkbetween morbidity and prescribing in theGeneral Practice Research Database(Bashford JNR, Norwood J et al. 1998)

• The most common indications for antibi-otic prescribing: a study using the generalpractice research database (GPRD)(Chapman SR and Frischer M 1999)

• Population-based study of risk of venousthromboembolism associated with variousoral contraceptives (Farmer RDT,Lawrenson RA et al. 1997)

• The treatment of depression in UK general practice: selective serotonin reuptake inhibitors and tricyclic antide-pressants compared (Lawrenson R, TyrerFCT et al. 1999)

• Drug utilization patterns for flu or flu-likeillness in primary care in the UK (MeierCR, Napalkov PN et al. 1999)

• Preferential prescribing of type of com-bined oral contraceptive pill by generalpractitioners to teenagers (Rowlands S,Devalia H et al. 1999)

• Duration of antidepressant therapy andrisk of depression relapse (SturkenboomMCJM, Martha I et al. 1999)

• Risk of VTE in users of postcoital contra-ceptive pills (Vasilakis C, Hick Susan J etal. 1999)

Recommendations for Use of

Longitudinal Patient Databases

To use LPDs effectively pharmaceuticalcompanies or research organisations have toconsider the following issues in particular:• Characteristics of each database have to be

understood• Adequate time and research personnel has

to be allocated• Pharmacoepidemiological skills will

ensure quality of research• Explicit statement of information needs

has to be submitted to data provider• Study design should be developed togeth-

er with data provider• Expertise in working with databases based

on patient records needed

Only through experience of using LPDcompanies will be able to determine whetherthese resources could support their outcomesand pharmacoeconomics research work. Asound approach of making best use of theavailable data is to establish a close coopera-tion-working group consisting from bothdatabase experts and application expertssuch as outcomes researcher, pharmacoecon-omists or drug safety experts. This approachwill definitely require some investment withregard to time and personnel, before gettinganswers. However, if done properly newinsight is provided to some of the increasingand sometimes burning informationrequests within the pharmaceutical orhealthcare industry. �

References1. Bashford JNR, Norwood J, and Chapman SR,

Why are patients prescribed proton inhibitors?Retrospective analysis of link between morbidityand prescribing in the General Practice ResearchDatabase, British Medical Journal 1998;317: 452-456.

2. Chapman SR and Frischer M, The most commonindications for antibiotic prescribing: a study usingthe general practice research database (GPRD),Pharmacoepidemiology and Drug Safety1999;8:S85.

3. Farmer RDT, Lawrenson RA, Thompson CR,Kennedy JG, and Hambleton IR, Population-basedstudy of risk of venous thromboembolism associat-ed with various oral contraceptives, The Lancet1997;349.

4. Lawrenson R, Tyrer FCT, Farmer RDT, andNewson RB, The treatment of depression in UKgeneral practice: selective serotonin reuptakeinhibitors and tricyclic antidepressants compared,Pharmacoepidemiology and Drug Safety 1999;8:S132.

5. Meier CR, Napalkov PN, Wegmüller Y, andJefferson T, Drug utilization patterns for flu or flu-like illness in primary care in the UK,Pharmacoepidemiology and Drug Safety 1999;8:S96.

6. Rowlands S, Devalia H, and Lawrenson R,Preferential prescribing of type of combined oralcontraceptive pill by general practitioners toteenagers, Pharmacoepidemiology and Drug Safety1999;8:S113.

7. Sturkenboom MCJM, Martha I, Lee K, vanLinden P, van der Lei J, and Quik R, Duration ofantidepressant therapy and risk of depressionrelapse, Pharmacoepidemiology and Drug Safety1999;8:S171.

8. Vasilakis C, Hick Susan J, and Jick H, Risk of VTE in users of postcoital contraceptive pills,Pharmacoepidemiology and Drug Safety 1999; 8:S83.


Figure 1: Leading diagnoses in Germany. Example from the Mediplus database (Source: Mediplus Pro 400,N = 878.743 patients with at least one diagnosis in 1999)

0% 5% 10% 15%

M54 Dorsalia

I10 Essential Hypertension

J40 Brronchitis non specified

5 Acute Upper Respiratory Infection

Z26 Viral Disease Immunisation

K29 Gastritis and Duodenitis

E78 Lipidaemias

R69 Unknown/Unspecified

125 Chr. isch Heart Disease

15.1%

15.0%

14.7%

9.2%

7.3%

6.6%

6.4%

6.3%

5.7%

GPRD UK: MEMO IMS IMS Cegedim IMS Health Search IPCI IMS Mediplus Mediplus Thales Mediplus Database Mediplus

Geographic Coverage UK Tayside, UK Germany France France Italy Netherlands AustriaScotland

Size 8 million ~0.5 million ~3 million ~1,5 million (3yr) 1 million ~1,1 million ~0,4 million ~0,4 million(total 5,98 million)

Loss of patients 5-15% 1% Unknown ~10% unknown unknownfor follow-up

Average longitudinal 8-9 > 6 yr. up to 10 yr. ~12 yr. ~1/3 for more 4 yr. ~4-5 yr. unknownpatient record (up to13) yr. (.5 Million) than 5years

Level of data GP GP GP GP GP GP GP GP individual collection gynecologists physician

pediatricians

Point of data capture alongside at sites via GP alongside alongside alongside alongside alongside alongside consultation primary care computer primary care medical primary care medical medical primary care

consultation system consultation consultation consultation consultation consultation

Site Characteristics size no size size, size, size, size, size, size,geography geograhy, geograhy region, geograhy, geography, region geograhy,fundholding practice practice practice practice practice practice

setting setting setting setting setting

Number of Sites > 1.600 district GPs/ > 2000 > 2000 600 400 ~3500 and ~200 110hospitals 800 target 1000 target expanding

Doctors characteristics none age, aex, age, sex, number, type age, sex, number, type age, sex,education, education of employee, year qualified of employee, year qualifiedyear qualified sex, education sex,education

Inauguration of 1987 1980 hospital 1991 1989 1991 1996 1998 1995 1996database 1989 Rx

Coding system OXMIS / ICD9 / READ ICD-9/10 proprietary ICD-9 ICD IX/X ICPC ICD 10for diagnoses READ READ (free text) clasification,

transcoded ICD-10

Coding procedures READ at site GPs and IMS IMS CEGEDIM IMS ICD via MIEUR I IMS(READ to (free text) (free text) (Inst.Medical ICD 10) Informatics at

Erasmus University)

Coding System for BNF script tex, bridged to ATC ATC ATC ATC ATC Nordic, ATCDrug Utilisation BNF ATC and NFC (EPhMRA) (EPhMRA) KNMP

Drug Utilisation Rx, date, Rx, date, Rx, date, Rx, date, Rx, date, Rx, date, Rx, date, Rx, date, Rx, date,features prescriber, dosage, dosage, prescriber, prescriber, prescriber, prescriber, prescriber, dosage

dosage, switch switch dosage, dosage dosage, dosage, dosage,duration switch switch duration duration

Scope of main patient details, patient details, patient details, patient details, clinical patient details, medical clinical patient details,data set Rx issued, Rx details, Rx issued/ Rx issued, patient details, Rx issued, diagnosis, patient details, Rx issued,

symptoms, tests, diagnoses, stop, diagnoses, diagnoses, diagnoses, diagnoses, clinical diagnoses, diagnoses,referrals, secondary care, lab-tests, laboratory tests, referrals, laboratory tests, patient referrals, laboratory outcome on referrals, referrals, referrals, outcome on hospitalisations, details, outcome on tests,referral, medical notes notes sickleave, referral, sickleave, sickleave referrals? referral, referralsdiagnosis, billing data Socioprof. status, sickleavecomments (EBM number) Risk factors

Linkage of diagnosis no to some yes yes no yes yes yes noto prescription extent (according to (substitution

example given) of drugs possible)

Frequency of 6 weekly as required sent daily, monthly 2 weekly monthly online monthlydata collection created

monthly

Quality Assurance yes data / data / data / quality data / data data /documentation documentation documentation assurance, documentation checks documentation checks checks checks data checks checks

completenesscheck

External Validation some some no no certification no some noof data of quality indicated

checks

Table of Database



INTRODUCTION

Pharmacist-managed warfarin therapy(PMWT)a is one of many PharmaceuticalCare (PC)b activities that has yielded significant benefits such as reduction in hos-pitalizations, emergency room visits andthromboembolic events due to side effects ofinappropriate dosing and monitoring. 1,2,3,4

These benefits can be translated into eco-nomic gain for patients, payers and society.However, a majority of previous studies ofPMWT activities employed less than opti-mal economic evaluation techniques.5,6 Indocumenting the value of PMWT activities,pharmacists have focused mainly on costsavings. This approach does not take intoconsideration patient feelings, pain, and suf-fering. Seldom have patients who receivedPC been asked their perceived willingness topay (WTP) value for such services.

Use of WTP (contingent valuation) to assessthe benefits of PC is at the infancy stage. Themajority of previous studies assessed WTP ofselected services for the purpose of deter-mining charges and the potential demand ofeach service.7 These marketing studies arenot theoretically consistent with welfare eco-nomics since they are based on positive consumer theory.8 Two studies, Lee andSchommer9 and Reutzel and Furmaga10, surveyed the patient’s WTP value for phar-maceutical care of warfarin monitoring services. Although these studies documentthe patient’s perceptions of the benefits ofpharmacist-managed warfarin clinic, theyhave limitations and biases especially in notusing a hypothetical market that describesthe goods or services in question. In addition,perceived benefit has not been measured in

community pharmacy patients.

Previous literature on PMWT in clinics sup-ports the claim that pharmacists improvepatients’ quality of life by reducing sideeffects/complications of warfarin. Mostlythis service was in hospital-based clinicsbecause it required a laboratory to assessProthrombin Time (PT)c and theInternational Normalized Ratio (INR)d tests.PT & INR can now be assessed instantlyanywhere with less wait but comparable tothe hospital laboratory test results (normally45-120 minutes).11 This point-of-care test-ing device furnishes the enabling technologyfor a community pharmacist to manage war-farin therapy. However, the success of pharmacist managed warfarin therapy hasnever been proven in community pharma-cies. This provides a hypothetical market forcontingent valuation (CV) study.12

This study determined the benefits ofPMWT at community pharmacies as meas-ured by the CV method. Benefits of PMWTin clinic settings are reduction in hospitaliza-tions, emergency room visits, and throm-boembolic events due to side effects of inappropriate dosing and monitoring. Thesebenefits have not been measured using CVmethods nor from a community pharmacypatient’s perspective, a) those with chronicdiseases and b) those on warfarin therapy.

METHOD

A self-administered 24 question CV surveywas mailed to 2800 patients’ home. It wasfollowed by a postcard reminder in 14 daysand another mailing of the original survey

14 days after the postcard. The survey sce-nario presented first, facts about warfarintherapy and continued with the descriptionof a new pharmacist warfarin monitoringservice at retail drug stores. Second, a menuof health care services and cost ranges werelisted. Third, the scenario placed the respon-dent in the hypothetical situation thathe/she was just placed on warfarin therapy.The respondent was asked to determine theWTP value based on the chance of havingunwanted side effects/complications andprobability of successfully reducing them bythe PMWT service. The question wasrepeated with varying outcome chances andprobabilities. Each respondent was alsoasked to select a health plan from twooptions, one with PMWT with additionalinsurance premiums and one withoutPMWT with no additional insurance premi-ums. In addition, respondents were askedwhether each health plan should makePMWT available to enrollees.

Patients were selected from a chain commu-nity pharmacy or rural health plan prescrip-tion files. They were divided into warfarinclinic (ex post) and non-warfarin clinic (exante) groups. A payment card method withgraphic illustration13 of probabilities wasused to elicit WTP values in form of out-of-pocket (OOP) expense and additional insurance premium (INS) for PMWT. Twoprobabilities for success were determinedfrom the range of incremental benefits ofhospitalization reduction (28%; range from7.8% to 64.7%) and blood clot event reduc-tion (26%; range from 5.6% to 80%) fromprevious studies.2,5,6 These probabilities werechosen because they were the mid range ofsuccess of reported studies. To assess whetherrespondents were able to assign different values for different health gains, two otherprobabilities were presented for hospitaliza-tion reduction (8%, 40%) and blood clotreduction (3%, 35%). Thus, a total of sixprobabilities were assessed.

Patients’ Willingness to Pay for Pharmacist Managed WarfarinTherapy at Community Pharmacies Peter K. Wong, PhD1, Raymond Jang, PhD1, Judith T. Barr, ScD2, Jean Paul Gagnon, PhD3,Haynes Goddard, PhD4, and Alex C. Lin, PhD1, 1University of Cincinnati, College of Pharmacy,Cincinnati, OH, 2Northeastern University, National Education and Research Center for OutcomeAssessment, Boston, MA, 3Aventis Pharmaceuticals Inc., Bridgewater, NJ, 4University ofCincinnati, Department of Economics, Cincinnati, OH

a The oral anticoagulant, warfarin, is efficacious in preventing potentially life-threatening thromboembolic events. However, because of a narrow therapeutic window, complexity of the homeostaticsystem and multiple variables involved in many steps of the clotting process, warfarin has been associated with frequent complications. Optimal dosing and careful monitoring of such a therapy iswarranted to achieve positive outcomes.

b Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life. These outcomes are 1) cure of disease, 2) elimination or reduction of a patient’s symptomatology, 3) arresting or slowing of a disease process, and 4) preventing a disease or symptomatology.


Descriptive statistics in the form of means,medians, standard deviations, skewness, andkurtosis, were used to summarize by studygroups, i.e., ex post versus ex ante; warfarinnaïveg versus warfarin treated. Age, sex, edu-cation and income levels, insurance coverage,employment, warfarin therapy, PMWT andnumber of chronic diseases were comparedamong three groups of respondents by sitesand by study groups.

Most WTP data are positively skewed and itis common to see a large number of zerodollar WTP values. The natural log trans-formation of the dependent variables wasemployed to normalize the error distributionin the regression analysis and to account formeasurement error.

There were six dependent variables assessedfor each of the out-of-pocket and insuranceWTP. For the regression analysis, only twodependent variables from each paymentgroups (i.e., OOP and INS) were used andthe other four dependent variables were usedfor sensitivity analysis in the CBA (notreported here).

To assess mean difference of WTP valuesbetween study groups, independent samplet-tests were used. Although the t-test is veryrobust for normality as long as equal varianceis assumed, an additional non-parametricstatistic the Mann-Whitney U test was utilizedto test group medians.

The regressions used ordinary least squares(OLS). Each of four dependent variables(WTP value for 28% blood clot reductionand 26% reduction in hospitalization forOOP and INS) were regressed against theindependent variables: age, sex, number ofchronic conditions, years of education,annual household income, prior experiencewith warfarin therapy, health plan selectionand attitude toward PMWT. Regressionmodels were developed using the OLS log

transformed dependent variables. Due to aneight months difference between data collec-tion at the first two sites and the rural healthplan, a dichotomous variable coded (1,0)was used to test whether the two groups havedifferent WTP due to time difference.Dummy variables were established for vari-ables such as: incomes, sex, PMWT clinic,warfarin treatment, PMWT attitude, andchoice of health plan selection.

RESULTS

Five hundred and thirty patients (393usable) responded to the CV survey. Forty-seven percent were female. The average agewas 64.85 years old (range 27 to 93 ± S. D.12.53). Overall WTP values for PMWT inthe form OOP or INS were significantlygreater than zero. The monthly mean OOPWTP amounts for 28% blood clot eventreduction and 26% hospitalization reduc-tion were $17.19 ± 15.57 and $19.26 ±17.56 respectively. The monthly mean INSWTP for the same probabilities were $11.97± 13.66 and $12.66 ± 14.63 respectively.

Mean WTP values were compared betweenex post and ex ante groups. No significantdifferences were detected in the form ofOOP (p = 0.676 for blood clot reduction, p = 0.637 for hospitalization reduction) orINS (p = 0.843 for blood clot reduction, p = 0.479 for hospitalization reduction).There was no significant difference in meanWTP values for patients that had prior warfarin therapy versus patients that werewarfarin naive. The Mann-Whitney U statis-tics also confirmed there were no significantdifferences.

Regression analyses identified that annualhousehold income, selection of health planwith PMWT and attitude towards the healthplan’s inclusion of PMWT were significantpositive predictors for OOP scheme and onlyannual household income and selection ofhealth plan with PMWT for INS scheme.

Twenty individuals had no opinion onwhether the health plan should providePMWT as part of the health benefit cover-age. Forty individuals did not select a healthplan at all. Ninety-three (25%) individualsdid not make consistent choices. Eighty-sixindividuals believed the health plan shouldprovide PMWT. However, when askedwhether they were willing to pay for PMWT,they opted to choose a health plan withoutPMWT. The results demonstrated there wasinconsistency between WTP (INS) andopinion of respondents towards PMWT.

DISCUSSION

Using the well documented clinic PMWTfunction as a vehicle, we demonstrated thatCV was a viable economic tool for measur-ing the benefit of PC in community phar-macies. This study also confirmed the CVmethod as a tool to assess the benefit valuefor PC, previously successfully performed byMetge.14 Respondents in our study were will-ing to pay for the PMWT service. Therewere some zero values but overall consumersrecognized and understood the benefit thatpharmacists provide to society. This was doc-umented through positive WTP amounts.The majority of respondents were rationalconsumers. Their choices were consistentwith their attitude and belief. However, it isclear that some consumers were not toorational in making choices as demonstratedby their behavior in this hypothetical market.Blumenschein et al. assessed the consistencyof WTP for a hypothetical market comparedto real purchases.15 One group of studentswas asked to provide a WTP value to pur-chase a pair of sunglasses and the othergroup was offered the opportunity to pur-chase the sunglasses at the same price.Students who would hypothetically purchasethe sunglasses significantly exceeded thenumber of students that actually purchased.We posed a similar question. Respondentswere placed in a situation in which that theywere to choose a health plan exactly as in a

c PT is a coagulation test. It provides an indication of how well warfarin is working as anticoagulant.d International Normalized Ratio (INR) is now considered the standard of practice for monitoring warfarin therapy. The current recommendation for monitoring most indications of warfarin

therapy is an INR of 2.0 to 3.0. The INR takes into account the sensitivity of the thromboplastin used in determining the PT for each specific laboratory. e Chance – In this manuscript, the term chance is used to describe the likelihood of getting unwanted side effects/complications.f Probability – The term probability was used to describe the likelihood of successfully avoiding unwanted side effects/complications due to the PMWT intervention.g Warfarin naïve means patients never treated with warfarin before.


real life situation. There was a 24% inconsis-tency between the choice and the WTPamount. In the attitude survey questions,22% of the respondents believed the healthplan should provide PMWT but they werenot willing to pay for it. This suggests thefree rider phenomena.16

Respondents were able to differentiate thesize of health gains and assigned appropriatevalues. A payment gradient was detectedwith increase in probabilities of success forboth out-of-pocket and insurance values. Ithas been documented that the payment cardmethod is prone to range bias. In our pilotstudy, the range was tested and was revised.Despite the effort, there was significantrange bias, but only in OOP WTP amounts,not in INS WTP amounts.

The regression models demonstrated thatWTP is hinged on the ability to pay. Theincome effect played a significant role. Thedesire (i.e., attitude) to have PMWT andhealth plan choice also determined the sizeof WTP amount.

CONCLUSION

Community pharmacy patients were able toassign positive WTP values to different sizesof PMWT health gains. Range bias andinconsistency of choice were detected fromthis sampled population. Several limitationsneed to be mentioned to put the studyresults into proper perspective. First,response rate, although the intent was tohave a final sample size of approximately600, the overall survey response rate was

19%. This rate is lower than the acceptedtraditional survey response rate of 35-40%.Second, the original intent was to coverwider geographical areas, but the majority ofthe respondents came from the health planand the chain drug store. It is especially truewith the advanced age in our sample that isnot a typical representation. Therefore, theresults can only be inferred to the regionalchain drug store or to eastern United Statehealth plan enrollees. Third, there was limit-ed information content in the survey instru-ment. Although sufficient information wasprovided for decision-making, respondentscannot be considered as totally informedconsumers. Besides reducing potential forhospitalizations and blood clot events, thereare more benefits from having PMWT serv-ices such as reducing emergency room andclinic visits. In constructing the WTP instru-ment, consideration was given to the amountof information given and the respondents’abilities to comprehend the information andmake a sensible and quantifiable answer.Therefore, a decision was made to omit theemergency room and clinic information.

Overall, this study confirmed that CVmethod is a viable tool to measure the bene-fit value for PMWT. �

References1. Chenella FC, Klotz TA, Gill MA, Kern JW, et al.

Comparison of physician and pharmacist manage-ment of anticoagulation therapy of inpatients.AJHP. 1983;40:1642-45.

2. Garabedian-Ruffalo SM, Gray DR, Sax MJ, &Ruffalo RL. Retrospective evaluation of a pharma-cist-managed warfarin anticoagulation clinic. AJHP.1985;42:304-8.

3. Bussey HI, Chiquette E & Amato MG. Workshop:Anticoagulation clinic care versus routine medicalcare: A review and intern report. J Thrombosis &Thrombolysis.1996;2:315-19.

4. Chiquette E, Amato MG & Bussey HI.Comparison of an anticoagulation clinic with usualmedical care. Arch Intern Med. 1998;158:1641-47.

5. Gray DR, Garabedian-Ruffalo SM & Chretien SD.Cost-justification of a clinical pharmacist-managedanticoagulation clinic. Drug Intelligence andClinical Pharmacy. 1985;19:575-80.

6. Wilt VM, Gums JG, Ahmed OI, & Moore LM.Outcomes analysis of a pharmacist-managed anti-coagulation service. Pharmacotherapy. 1995;15:732-39.

7. Blumenschein K & Johannesson M. Use of con-tingent valuation to place a monetary value onpharmacy services: An overview and review of theliterature. Clinical Therapeutics. 1999;21:1402-17.

8. Gafni A. Willingness to pay: What’s in a name.Pharmacoeconomics. 1998;14:465-70.

9. Lee YP & Schommer JC. Evaluation of an antico-agulation clinic: Focusing on avoidance of hospitalreadmission and patient’s perception of quality.ASHP Mid-Year Meeting. Poster Presentation.1995; Las Vegas, Nevada.

10. Reutzel TJ & Furmaga E. Willingness to pay forpharmacist services in a veteran’s administrationhospital. J Research Pharm Econ. 1993;5;89-113.

11. Pierce MT, Crain L, Smith J & Metha V. Point-of-care versus laboratory measurement of the inter-national normalized ratio. AJHP. 2000;57: 2271-4.

12. Mitchell RC & Carson RT. Using surveys to valuepublic goods: The contingent valuation method.Washington DC: Resources for the Future, 1989.

13. Appel LJ, Steinberg EP, Powe NR, Anderson GF,et al. Risk reduction from low osmolarity contrastmedia. What do patients think it is worth?Medical Care. 1990;28:324-34.

14. Metge CJ. Determining the economic value ofpharmacist services: A study of the reliability andvalidity of contingent valuation methods.Doctoral Dissertation. Baltimore: University ofMaryland, 1996.

15. Blumenschein K, Johannesson M, Blomquist GC,et al. Experimental and results on expressed cer-tainty and hypothetical bias in contingent valua-tion. Southern Economic J. 1998;65:169-77.

16. Schneider F & Pommerehne WW. Free riding andcollective action: An experiment in public micro-economics. Quarterly J Econ. 1981;97:6

Dilbert

DILBERT reprinted by permission of United Feature Syndicate, Inc.


The NNT was introduced in 1988 as an “easilyunderstood yardstick to describe the harm aswell as the benefit of therapy and other clinical maneuvers”[1]. It is defined as thenumber of patients who must be treated inorder to prevent one adverse event, and isequivalent to the reciprocal of the absoluterisk reduction1.

Although presented as a tool to facilitateclinical decision-making at the individualpatient level, use of the NNT in publichealth decision-making was already hintedat in this first publication. Indeed, it is suggested that by comparing the NNT fordifferent conditions it should be possible todetermine which efforts on the part of theclinician (and patient) will achieve the great-est net benefit [1]. The NNT has since beenportrayed as a first approximation to morecomplex measures such as cost-utility ratios— which are considered the ultimate goal ofEvidence Based Medicine [2] — and NNT-based league tables have been presented [3].However, for any measure to be a usefuldecision-making tool, it needs to be compar-ative, easy to understand, and standardized;ease of calculation is a bonus. Although theNNT clearly seems to meet the first two criteria, and appears easy to calculate, it hasmajor shortcomings in terms of standardiza-tion, which relate to the time horizon, thereference risk, the choice of comparator andthe outcome considered.

The originators of the measure recognizedthe potential time-dependency of the NNTand its implications for rankings based ontrials of different length. They therefore

proposed that the NNT be converted to acommon duration using a linear conversion2.

As the authors acknowledged, this can onlybe done when the benefit and harm areknown to be constant over time [1]. Yet, thiscondition will only be met (i) if the relativerisk reduction is constant over time and (ii)

if events occur at a con-stant rate. An alternativesuggestion has been to cal-culate the NNT as the

reciprocal of the hazard difference; therationale being that as long as the hazard difference is constant over time, the resultingNNT does not depend on the duration offollow-up [4]. Such an NNT must be inter-preted differently: it represents the amountof person-time of treatment required to prevent one event. But more importantly,the assumption of a constant hazard differ-ence is applicable only to chronic diseaseswith a relatively high mortality and few yearsof follow-up. In all other cases, the need fora standardized follow-up time remains.Others have proposed to estimate a time-dependent NNT function which expressesthe number of patients who need to be treat-ed for one additional patient to “survive” toa given time point3[5].

Although appealing because no assumptionshave to be made regarding the underlyingtime course of events, an important draw-back of this approach is the loss of simplicity— supposedly one of the major advantagesof the NNT.

The NNT is also dependent on the riskobserved in the control group, frequentlyreferred to as the reference risk. It has there-fore been proposed to calculate a patient-specific NNT using a linear conversion4,

assuming that the relative risk reduction isconstant over the reference risk [6].

Although the hypothesis that the relative riskreduction applies well across populations hasnot been confirmed empirically very often, itis at the root of much of current clinicalresearch.

Surprisingly, the need for standardization ofthe comparator is not addressed in the liter-ature, other than acknowledgment that “tobe fully specified, the NNT must alwaysspecify the comparator”[7]. Yet, simply statingthe comparator does not solve the problemof different comparators. As with cost-effec-tiveness analyses, if the comparator is not the same, then the results are not directlycomparable either.

Finally, there are several unresolved issuesrelated to the selection of the event or out-come of interest. The target audience for theanalysis will influence the most appropriateoutcome for the NNT. From the clinician’spoint of view, the NNT that is meaningfulfor Alzheimer’s disease for example, may beabout one person improving on a cognitiverating scale (e.g., MMSE) [8]. From a policymaker point of view, on the other hand, theNNT to avoid one person-year of full timecare might be more informative [9]. It hasalso been stated that other aspects of therapy,such as monetary cost and inconvenience,can be added to the main outcome measureif pertinent data are available, but “themeans of doing so are beyond the resourcesof most clinicians” [1]. It is unclear to us,however, how the clinician is supposed toincorporate these additional aspects into theNNT measure other than treating them asinputs to an informal clinical judgmentprocess.

In summary, several serious shortcomings ofthe NNT have been noted and none of theproposed modifications fully resolve them,

Number Needed to Treat (NNT): Is it a Useful Benchmark for the Efficiency of Therapies? J.J. Caro , Caro Research Institute, Concord, MA, USA and McGill University, Montreal,Quebec, Canada and K.F. Huybrechts, McGill University, Montreal, Quebec, Canada

1 1

(Riskcontrol - Risktreatment) (Riskcontrol X relative risk reduction)

Follow - Upactual

Follow - UpstandardNNT X

1

Streatment (t) - Scontrol (t)

Risktrial

Risktarget patientNNT X

table 2

table 1

table 3

table 4


yet greatly increase its complexity.Consequently, in its current form, the NNTcannot adequately fulfill its role as the “currency” of Evidence Based Medicine: itcreates the erroneous impression of simplicityand comparability and public health deci-sions based on it will lead us astray. If themedical community insists on continuing touse the NNT for decision-making purposes,we strongly recommend estimating an“adjusted” NNT through the use of com-puter simulation models — NNT models— that allow for the required standardiza-tion. But, even then, the NNT should never

become the only measure considered; itshould at most be one of several outcomespresented as a result of formal cost-conse-quence analyses. �

References1, Laupacis A, Sackett DL, Roberts RS. An assessment

of clinically useful measures of the consequences oftreatment. NEJM 1988;318:1728-33.

2. Riegelman R, Schroth WS. Adjusting the numberneeded to treat: Incorporating adjustments for theutility and timing of benefits and harms. MedDecis Making 1993;13:247-52.

3. Website of the NHS Research and Development:Centre for Evidence Based Medicine.

4. Implications of trial results: the potentially misleadingnotions of number needed to treat and average dura-

tion of life gained. Lancet 2000;356:1757-9.

5. Altman DG, Andersen PK. Calculating the num-ber needed to treat for trials where the outcome istime to an event. BMJ 1999;319:1492-95.

6. Cook RJ, Sackett DL. The number needed to treat:a clinically useful measure of treatment effect. BMJ1995;310:452-4.

7. McQuay HJ, Moore RA. Using numerical resultsfrom systematic reviews in clinical practice. AnnIntern Med 1997;126:712-20.

8. Livingston G, Katona C. How useful arecholinesterase inhibitors in the treatment ofAlzheimer’s disease? A number needed to treatanalysis. Int J Geriat Psychiatry 2000;15:203-7.

9. Caro JJ, Getsios D, Migliaccio-Walle K.Assessment of health economics in Alzheimer’s dis-ease (AHEAD) based on need for full-time care.Neurology 2001;57:964-71.

ISPOR President’s Fireside ChatEva Lydick PhD, 2001-2002 ISPOR President

When I first joined the pharmaceutical industry as an epidemiologist many years ago, Inaively thought I was being hired because com-panies, having introduced population-wideinterventions, wished to monitor their effects.Not only was that not true then, but it is nottrue today. Pharmaceutical therapy owes a greatdebt to the regulatory agencies, which have enforced the rigorous collection of information on safety and efficacy prior to wide scaleimplementation. However, unless extraordinary circumstances exist,there is little effort to monitor which new interventions, and programsactually deliver the value promised from the early results of small-scalestudies in selected populations, under well-controlled conditions.The exception is monitoring for risk; post-marketing surveillance isalmost synonymous with safety. However, conducting clinical trials ofpharmaceuticals should not relieve us of the responsibilities of evaluat-ing their effects, both beneficial and adverse, on population basis.

In fact, even if a choice exists between real observational studies andmodels, the preference appears to be to develop a model. Perhaps themodeling approach is more often chosen because there is more con-trol over the results, but that is precisely why models will always beviewed with suspicion. Or maybe models are just sexier than siftingthrough mounds of messy data. Models are valuable to bridge fromwhat we can determine empirically to situations that we cannotdirectly measure. Where results can be directly measured, the emphasisshould be on doing so, not relying on models.

We are faced with a serious credibility issues among decision-makersand consumers. Today the value of pharmaceuticals is questioned byincreasing segments of the population, some of these questions validand some perhaps raised to forward other agendas. However we haveprecious little data to support arguments around the value delivered.That is not to say there is no evidence, but demonstration of theimpact of interventions has taken a back seat to building models and

creating perception through advertising. This is the issue I had hopedto address during my tenure as President of ISPOR. Increasing theappreciation for the ‘O’ in ISPOR, and encouraging rigorous analysisof outcomes research based on evidence rather than assumptions.

I would like to see us move to the situation where we rely on modelsto provide insights into areas where no data exist, but once a decisionhas been made to adopt a particular intervention, to argue with con-viction that, along with adoption, we need a program of assessment.It is in the best long-term interest for all – the industry, contractresearch organizations, academics, decision makers, healthcareproviders and, most importantly, the patient – to ask that real data beprovided as evidence, whenever it is possible to do so. No matter howsophisticated a model, it does not relieve us of the obligation todemonstrate by formal study that we have indeed added an interven-tion where benefit significantly outweighs risk and through efficientuse of resources. I hope ISPOR never loses sight of the real objective,which is to improve the health of patients through the most efficientuse of health care funds. We cannot do this unless we have credibili-ty borne out by real data. �

ISPOR CONNECTIONSCall for Editorial Board Members

We are increasing the number of ISPOR CONNECTIONS Editorial Boa rd members. If you are interested, send your resumé to [email protected]. We encourage ISPOR members fromCanada, Europe, and Asia to participate. A multi-national perspective iscritical to ensure fair balance worldwide on issues related to pharma-coeconomics and outcomes research.

As a member of the ISPOR CONNECTIONS Editorial Board you will beexpected to participate in bimonthly conference calls, identify individualsto write feature articles, or support an existing or new column.

If you are interested in participating on the ISPOR CONNECTIONSEditorial Board, please email, send, or fax your resumé to:Steve E. Marx PharmD, MS, Editor, ISPOR CONNECTIONSInternational Society for PharmacoEconomics and Outcomes Research3100 Princeton Pike, Building 3 Suite D, Lawrenceville, NJ 08648 Phone: (609) 219-0773 Fax: (609) 219-0774 [email protected]


The Pharmacoeconomic Fellowship ProgramSurvey conducted December 2001 was aninitiative of the ISPOR Fellowship TaskForce. Even though more than a decade ofpharmacoeconomic fellowship programshave been in existence, the effectiveness ofthese programs has not been determined.1

The objectives of this survey are: a) to deter-mine the current structure, process, and out-comes of existing fellowship programs, b) to determine to what extent do these fellowship programs accomplish their role ofaugmenting pharmacoeconomic skills andabilities of the recipients, and c) to determinewhether pharmacoeconomic fellowship programs are following published guidelinessuch as the American College of ClinicalPharmacy (ACCP) guidelines.2

The Taskforce developed a set of three ques-tionnaires, one for fellows currently enrolledin a fellowship program, one for former fellows who completed a fellowship program,and one for fellowship preceptors. The surveywas conducted via the ISPOR website.Fellows and preceptors involved in a phar-macoeconomic fellowship program were

identified collecting information from dif-ferent sources including the ACCP andISPOR directories of pharmacoeconomicfellowships.3,4 In addition, participants wererecruited through the ISPOR website, aswell as through the ISPOR membership.Survey responses were collected at theISPOR website. All collected data are keptconfidential in the study file. A total of 34current fellows, 68 former fellows, and 49preceptors completed the web-based survey.Survey results will be presented as a posterentitled “Evaluating the Structure ofPharmacoeconomic Fellowship Programs” atthe upcoming 7th Annual InternationalMeeting in Arlington, VA on May 21 (PosterSession II, 8:00AM-7:00PM). In addition,survey outcomes will be discussed at theworkshop entitled “Paving a Road toSuccess: How to Obtain an OutcomesResearch Fellowship within the Pharma-ceutical Industry” on May 21 (WorkshopSession III, 2:45-3:45PM).

We would like to express our gratitude to thenumerous pharmacoeconomic fellows andpreceptors who completed the questionnaires.

If you would like to receive additional infor-mation concerning the survey, please contactVittorio Maio at [email protected].

Acknowledgements: We would like to thankthe following people for their assistance andsupport: Marilyn Dix Smith and the ISPORstaff, Nelda Johnson, and the ISPORFellowship Task Force members (ZebaKhan, Sandeep Duttagupta, Sujit S.Sansgiry, QuynhChau Doan, KristaYokoyama, Jennifer Sung, Amishi Shah,Amy Phillips). �

References1. Maio V, Girts TK, Lofland JH, Nash DB.

Pharmacoeconomic fellowships: the need for out-come measures. Pharmacoeconomics. 2001;19:795-802

2. Lee J, Lawrence BJ, Sullivan SD, et al. Guidelinesfor pharmacoeconomic research fellowship.Pharmacotherapy 1999;19:1105-9

3. American College of Clinical Pharmacy. Directoryof Residencies and Fellowships. Available from:URL: http://www.accp.com/resandfel/ [Accessed2001 Sept 19]

4. International Society for Pharmacoeconomics andOutcomes Research. ISPOR directory of fellow-ships in pharmacoeconomics, health economics,outcomes research or related field study. Availablefrom: URL: http://www.ispor.org.fellowships.html[Accessed 2001 Sept 19]

Pharmacoeconomic Fellowship Survey Vittorio Maio, PharmD and Jennifer H. Lofland, PharmD, MPH; Office of Health Policy and Clinical Outcomes, Thomas JeffersonUniversity, Philadelphia, USA

Health Spending Projections For 2001-2011: The Latest OutlookHeffler S, et al., Health Affairs 21 (2) 207-218.This article describes a 10-year projection of national health carespending in the United States. The forecast is based on econometricand actuarial models of the health care sector. They expect healthspending to grow faster than nominal gross domestic product (GPD),so that in 10 years it will constitute about 17% of GPD. Two impor-tant changes occurred in the past year, the recession and legislativechanges. Lower than projected spending growth in the private sectoroff set higher than projected growth in the public sector. Prescriptiondrug spending is projected to rise, while hospital and physician shares are expected to slowly decline. However, the general pattern ofhealth spending growth remains consistent with their previous yearprediction.

In Search of Value: An International Comparison of Cost Access, and Outcomes.Anderson G., Health Affairs 16 (6) 163-171.This article compares health indicators related to cost, access and out-comes between 29 countries. The author used data from theOrganization for Economic Cooperation and Development from1990 and 1996. Some comparisons involved all 29 countries, whileothers comparisons only involved 7 countries: Canada, France,Germany, Italy, Japan, United Kingdom, and United States. The arti-cle compared: percent of GDP spent on health, per capita spending,scanners and magnetic resonance imagers per million persons, inpa-tient hospital data: beds per 1,000 population, average length of stay,percent population admitted, and staffing ratios, percent spending byhospital, physician and drugs, percent eligible for publicly mandatedcoverage, and infant mortality and life expectancy. The data allowspolicy makers to compare their countries progress relative to that ofother countries.

Article Reviews


ISPOR 2002 Winter Leadership MeetingMarch 2, 2002 • Westin Philadelphia Hotel, Philadelphia, PA, USA

On March 2nd, the 2001-2002 ISPOR Committee, Task Force, Council, and SpecialInterest Group Chairs and Members of the Board of Directors met in Philadelphia todiscuss their respective group activities and plans for the future.

The participants were: Renée Goldberg Arnold PharmD, Pharmacon International, Inc (Awards Committee Chair);Jennifer Casillas, ISPOR (staff liaison Student Network); Pamela Chavis MD, Medical College of Virginia (Chair,Clinical Practice Special Interest Group); C. Denise Clemmons, University of Illinois/Chicago (Student Network/CouncilChair); Jon Clouse RPh, MS, Ingenix Pharmaceutical Services (Past President); Peter Davey MD, FRCP, University ofDundee (President-elect); Jean Paul Gagnon PhD, Aventis Pharmaceuticals Inc.(Treasurer); Gregory Hess MD, MBA,Consultant (Institutional Council); Zeba Khan PhD, Glaxo Wellcome Inc (Student Network Advisor); Paul Kind Mphil,University of York (Co-chair, Quality of Life Special Interest Group); Sachin Kulkarni, University of the Sciences inPhiladelphia; Barbara Edelman Lewis PhD, MHA, Focus Managed Research (Managed Care_PBM Co-chair); Bryan Luce PhD, MBA, MEDTAP International (Communications Chair); Eva Lydick PhD, AstraZeneca (President);William McGhan PharmD, PhD, University of the Sciences in Philadelphia (Past President); Wallace Marsh PhD, NovaSoutheastern University (Curriculum Development Task Force Chair); Josephine Mauskopf PhD, RTI Health Solutions(Value in Health Acting Editor-in-Chief ); Louis Morris PhD, Louis A. Morris & Associates (Good Practice Standards-Prospective Studies Task Force Chair); Nadia Naaman, ISPOR, staff liaison Awards Committee); Peter Neumann ScD,Harvard School of Public Health (Annual Meeting Chair); Frank Palumbo PhD, JD, University of Maryland (Code ofEthics Task Force Chair); Stephen Priori, ISPOR (staff liaison Value in Health and ISPOR CONNECTIONS); Karen Rascati RPh, PhD, University of Texas (Education Committee Chair); Joan Rovira PhD, The World Bank (Boardof Directors); Samira Shrivastav, ISPOR (staff liaison Annual Meeting and European Congress); Dean Smith PhD,University of Michigan (Lifetime Achievement Award Chair); Marilyn Dix Smith RPh, PhD, ISPOR (Board ofDirectors); Kent Summers RPh, PhD, Eli Lilly & Company (Board of Directors)

The Leadership Meeting background information and suggested actions can be found at the ISPOR website at:http://www.ispor.org/leadermtg2002.htm

left to right: Peter Neumann,Josephine Mauskopf, andPresident-elect Peter Davey

Renee Goldberg Arnold and Dean Smith below left to right:President-elect Peter Davey,

Josephine Mauskopf, andMarilyn Dix Smith

PRAP EMPLOYER REGISTRATION FORM We would like to participate in the ISPOR Professional Recruitment Assistance Program (PRAP) at the ISPOR 7th AnnualInternational Meeting to be held May 19-22, 2002, at the Hyatt Regency Crystal City, Arlington, VA (Washington, DC Area)

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The ISPOR Professional Recruitment Assistance Program(PRAP) will again be at the ISPOR 7th Annual Inter-national Meeting to be held May 19-22, 2002, at theHyatt Regency Crystal City, Arlington, VA (Washington,DC Area).

The PRAP Center continues to provide participants with a CONFIDENTIAL, EFFICIENT and PROFESSIONAL servicethat pairs individuals seeking positions with employerswho have available positions. The PRAP Center offers:• Listings of available positions• Listings of qualified candidates• A mailbox system for applicants and employers• Private rooms for interviewing

INSTRUCTIONS FOR EMPLOYERS: Register now and get a1/4 page announcement printed in the Final Programfree of charge if the POSITION DESCRIPTION IS RECEIVEDBY April 19, 2002. Position descriptions received after

April 19 will only be advertised in the PRAP Book at themeeting. To participate, complete the PRAP "EmployerRegistration Form" below or at the ISPOR website atwww.ispor.org under Employment and send or fax thecompleted form to 609-219-0774. Email position descrip-tion (up to 1 page and a 1/4 page formatted advertise-ment, employer contact person and interviewer name [email protected] The fee for this service is USD $1000 forthe first position and USD $500 for each additional position advertised by the same employer. For moreinformation call Nadia Naaman at 609-219-0773 ext 11 or email: [email protected]

INSTRUCTIONS FOR APPLICANTS: Bring at least 10 copies ofyour CV or resume to the meeting and register for PRAPat the PRAP Center. This service is free for ISPOR membersand conference registrants. If you are not an ISPORmember or registrant, the cost is USD $50 for full-timestudents and USD $145 for non-students.

ISPOR PROFESSIONAL RECRUITMENTASSISTANCE PROGRAM


ISPOR SEVENTH ANNUAL INTERNATIONAL MEETINGMAY 19 -22 , 2002 � H YATT REGENCY CRYSTAL C I TY � ARL INGTON, VA , USA

Are you an employer in search of the right candidate to fill a position in

Pharmacoeconomics and Outcomes Research? Or are you a candidate looking for a position in these disciplines?


EUROPEBelgium The Belgian Social Affairs Minister, Frank

Vandenbroucke, has officially inaugurated the new drug

reimbursement committee (CRM). The minister has

promised that henceforth, if decisions on reimburse-

ment applications are not made within the 180 days

stipulated in EC rules, reimbursement status as request-

ed by the company will automatically be granted.

(SCRIP 2715:6) Denmark Allowing the sale of OTC

medicines in Danish supermarkets and other outlets has

not led to a marked increase in consumption. Sales of

non-prescription medicines in November and

December 2001 in Denmark increased by only 2.4%

measured in average defined daily dose (DDD) to

DKr177.5 million ($20.8 million) compared with the

same periods in 2000, according to statistics from the

Danish Medicines Agency (DMA). (SCRIP 2725:7) �

Public spending on pharmaceutical products in

Denmark increased by 12.5% to DKr5.7 billion ($669

million) in 2001. (SCRIP 2721:7) � At an estimated

DKr30 billion ($3.6 billion), Danish exports of phar-

maceutical products reached record levels in 2001, mak-

ing them the number one export item. (SCRIP 2721:7)

France A total of 174 pharmaceutical companies

signed agreements with the French contract negotiating

committee, the CEPS, by the end of 2001, according to

a notice in the Journal Officiel. These agreements,

under the “sectoral accord” negotiated by industry and

the CEPS, set the prices of ach company’s products as

well as commitments on various issues, which, if they

are not honored, can lead to price reductions or repay-

ments. (SCRIP 2728:7) � Pharmaceutical company

policies aimed at hindering parallel trade in the EC are

coming under increasing pressure, with and association

representing the major French wholesaling groups plan-

ning to complain to the French competition authorities

about product supply quotas operated by a number of

multinational pharmaceutical companies. (SCRIP

2725:2) � The head of the biotech industry association,

France Biotech, has proposed that the EC stimulate

investment in new enterprises by creating a special taxstatus for biotech companies that are on the cutting

edge of new technology. (SCRIP 2720:4)

Germany The German pharmaceutical wholesaling

industry reported a 7.8% increase in sales to

EURO18.7 billion last year. According to Phagro, theGerman association of pharmaceutical wholesalers, sales

of pharmacy-only products grew by 8.2% in the same

period. (SCRIP 2725:6) � The German regulatorybody, BFARM, has set up an expert committee to devel-

op guidelines for the use of pediatric medicines in

Germany. The committee will collect existing data on

the dosing of medicines used by children and adoles-

cents, as well as help improve the regulations for clinicaltesting of new medicine for this age group. (SCRIP

2725:6)

Greece The Greek authorities have prepared draft legis-

lation which would cap the amount pharmaceuticalcompanies can spend on promotional activities, with

maximum levels of expenditure being based on sales in

the previous year. (SCRIP 2726:7) � The Greek

Supreme Court has suspended the pharmaceutical price

bulletin following an application by the pharmaceutical

industry association, SFEE. (SCRIP 2721:6)

Italy The Confusion in Italy caused by the decentraliza-

tion of responsibility for healthcare funding is growing

as more regions take steps to curb their escalating phar-

maceutical bills by imposing varying patient co-pay-

ments and delisting some “non-essential” products.

(SCRIP 2731:2) � The Italian health ministry has

taken the surprise step of announcing that pharmaceu-

tical prices are too high and will have to be cut. Data

from an assessment being conducted by the ministry’s

medicines evaluation and pharmacovigilance unit show

that Italian prices are 5% above the average European

price, according to health minister Professor Girolamo

Sirchia. (SCRIP 2717:3)

Portugal In the run-up to the general elections in

Portugal on march 17th, the Portugese pharmaceutical

industry association, Apifarma, is calling for changes to

national medicines policy on issues including prescrib-

ing by generic name and the reimbursement system.

(SCRIP 2729:5)

Sweden The Swedish Association of the

Pharmaceutical Industry (LIF) and about 130 Swedish

pharmaceutical companies have developed a medicines

portal, which will update pharmacy dispensing systems,

provide drug information to doctors and patients, and

be used for regulatory submissions. (SCRIP 2730:8) �

Sales of pharmaceutical products in Sweden rose by

6.7% to SKr21.6 billion ($2 billion) in 2001, statistics

from the Swedish Association of the Pharmaceutical

Industry (LIF) show. This represents a decline in growth

rates from the 9.8% seen in 2000. (SCRIP 2729:9)

UK The UK Prescription Pricing Authority says that the

6.3% growth in prescription volume in England in the

last calendar year was “unexpectedly high” compared

with previous years (4.1% in 2000). (SCRIP 2731:6) �

Roche’s advanced breast cancer treatment, Herceptin

(trastuzumab), which has long been subject to postcode

prescribing in the UK, has received backing from theNational Institute for Clinical Excellence for use in the

NHS. NICE estimates the uptake of its guidance will

cost the health service BP 17 million per year, withabout 2,000 women receiving the product. (SCRIP

2730:2) � Metaformin should be the first choice treat-

ment for type 2 diabetics, according to a draft version of

the clinical guidelines on glycaemic control for the dis-

ease, which was funded by the UK National Institutefor Clinical Excellence. (SCRIP 2726:5) � A number

of UK primary care organizations and the British

Generic Manufactures Association have criticized tacticsused by pharmaceutical companies to hinder or delay he

launch of generic versions of their blockbuster products.

(SCRIP 2724:4) � The UK Department for

International Development is sponsoring a BP 16 mil-

lion five-year program to develop new microbicides tooffer protection against HIV infection. (SCRIP

2723:18) � The UK Department of Health is holding

discussions with wholesalers and pharmacists about

abandoning the zero discount scheme in the drug tariff.

(SCRIP 2723:2) � The NHS Alliance, which repre-

sents primary care organizations (PCOs) in the UK, has

called on the Department of Health to increase GP’s

prescribing budgets by at least 12% next year. (SCRIP

2719:2) � The UK Department of Health and five

companies marketing two multiple sclerosis treatments,

beta-interferon and glatiramer, have reached a unique

agreement to make the products available to eligible

patients on the NHS. The deal involves price cuts for

these products of 6-26%. (SCRIP 2718:2) � The UK

Department of Health is funding a network of cancer

research centers to increase the number of clinical trials

in cancer and the number of patients entering them. To

date only 10% of eligible patients enter cancer trials,

according to government estimates. (SCRIP 2717:4) �

The UK government is funding a network of genetic

research centers to help put the UK at the leading edge

of genetic technology and ensure better treatments for

patients. The UK is second only to the US in research

in biotechnology and genetics. (SCRIP 2715:3)

WORLDEC Pharmaceutical companies will see their fees to the

European Medicines Evaluation Agency (EMEA)

increase by a minimum of 6% next year if a budget

drawn up by the agency’s management board is

approved by the European Parliament and the EC

Council of Ministers. (SCRIP 2730:6) � The World

Bank plans to allocate loans worth up to $190 million

to Armenia, one of the poorest countries in the

Commonwealth of Independent States (CIS), in 2002-

04. This includes an estimated $15 million loan for

improving healthcare sector and medical services.

(SCRIP 2729:9) � Nine members of the Committee

for Proprietary Medicinal Products (CPMP) have taken

the unusual step of calling for a change in the institu-

tional governance of the European Medicines

Evaluation Agency (EMEA). (SCRIP 2729:3) � The

EC Commission’s plans for encouraging pediatric clini-

cal trials are likely to lead to a heated debate, with theR&D industry coming out in favor of added exclusivi-

ty for products, and the generics industry against.

(SCRIP 2727:3) � The European Medicines

Evaluation Agency has announced that its scientific

advisory committee, the CPMP, has begun assessing therisk-benefit profile of GlaxoSmithKline’s smoking cessa-

tion agent, Zyban (bupropion). (SCRIP 2725:5) �

Public support for cheaper medicines in Europe is grow-ing, but it remains to be seen whether generics compa-

nies can take advantage of the improved political cli-

mate to secure changes to the EC’s pharmaceutical leg-

islation, which favor their interests. (SCRIP 2724:7) �

Deregulation and other moves in the OTC distributionchannels in the EC are expected to result in significant

changes to the shape and structure of the distribution

system over the next few years. (SCRIP 2722:2) � Aspart of the program to improve access to essential med-

icines, the World Health Organization’s Executive

Board has approved a resolution advocating differential

pricing and continued monitoring of the impact of

intellectual property laws and agreements on medicines

News Briefs From Around the WorldPrepared by Stephen L. Priori, Director, Publications


access. (SCRIP 2716:19) � The Ministries of

Healthcare and Finance in Kazakhstan are developing

draft legislation that would seriously restrict or even ban

pharmaceutical imports to the country. The govern-

ment may also introduce a law encouraging companies

to buy locally produced goods and services even though

they may be up to 20% more expensive than similar

imported ones. (SCRIP 2715:8)

Russia Pharmaceutical imports to Russia increased by

44% to $1.7 billion, the same imports value as in 1997

when the highest ever level of imports was registered.

(SCRIP 2731:8) � Foreign companies operating in

Russia say that higher prices for their products follow-

ing the introduction of VAT may slow down the sales

growth seen last year but will not reverse it. (SCRIP

2725:8) � In the third quarter of last year, the output

of many Russian pharmaceutical manufactures fell,

while imports rose by 36%, reducing the market share

of domestically produced pharmaceuticals to 32% from

42% in 2000 and 1999 respectively. (SCRIP 2718:6) �

In the first nine months of last year, pharmaceutical

imports to Russia increased by 36% to $1.1 billion

compared with the 2000 period. Imports in the third

quarter worth $366 million exceeded the corresponding

figure for the previous year by 28%, but were 5% down

on the second quarter, according to the Pharmexpert

market research center in Moscow. (SCRIP 2716: 7) �

Russia’s Prime Minister, Mihail Kasyanov, has signed a

decree granting a 6.5% increase in state pensions starting

from February 1st to compensate for the growth of prices,

principally those of pharmaceuticals. (SCRIP 2716: 7)

THE AMERICASCanada Canada’s provincial and territorial premiers

have agreed to start a common review process for new

drugs, including a common assessment of their cost

effectiveness to guide their decisions on paying for

them. They have also agreed to direct their health min-

isters to streamline the approval process for generic

drugs by December 2002. (SCRIP 2718:16)

LATIN AMERICAArgentina The Argentinian government has yet to

finalize and implement measures to deal with theimpact of the economic crisis on healthcare and medi-

cine provision in the country. (SCRIP 2728:19)

Brazil Brazilian Health Minister Jose Serra announceda 46% price cut for Abbott Laboratories’ antiretroviral,

Kaletra (lopinavir plus ritonavir), in Brazil. (SCRIP

2720:18) � Employment levels fell and marketing

budgets were cut in the Brazilian pharmaceutical indus-

try in 2001, according to local industry reports. Theindustry has attributed the cutbacks partly to medicine

price controls and the devaluation of the local currency,

the real. (SCRIP 2002:18) � Brazilian drug prices havebeen granted an average increase of 4.32% for this year,

below the 7% called for by the pharmaceutical industry.

The increase was approved by the government’s medi-

cines committee at the end of January, and was to be

introduced at the beginning of February. (SCRIP2720:18) � Savings in Brazil from the use of generic

products in the treatment of hypertension, diabetes,

high cholesterol, gout, prostate cancer and glaucoma

have been between 37% and 65% over the past two

years, reports the national healthcare monitoring

agency, Anvisa. (SCRIP 2719:21)

US The US National Association of Chain Drug Stores

is to issue a prescription benefit card for low-income

seniors that would link up the discount schemes being

offered by pharmaceutical companies. The Pharmacy-

CareOneCard is intended to remove some of the con-

fusion caused by multiple cards, as patients would only

have to present on card to the pharmacist. (SCRIP

2731:16) � The US FDA has released details of its

agreements with the pharmaceutical and biotechnology

industries over new performance goals and procedures it

will adopt if Congress reauthorizes the Prescription

Drug User Fee Act (PDUFA). (SCRIP 2730:17) � The

revenues and profitability of US pharmacy benefit man-

agers (PBMs) has increased significantly in the past 12

months, fuelled by a growth in membership, increasing

use by members and higher drug prices. (SCRIP

2728:17) � US pharmaceutical companies spent $2.5

billion on direct-to-consumer (DTC) advertising in

2000, an increase of 34% over 1999, according to data

from IMS Health and Competitive Media Reporting.

Since 1996, expenditures on these ads have increased by

an average of 33% a year, rising from 9.2% of total pro-

motional spending in 1996 to 15.7% in 2000. (SCRIP

2723:17) � Novartis has announced that it is adding

three ophthalmic drugs to its US CareCard program,

which offers discounts of 25% off the wholesale prices

of prescription medications to elderly, low-income,

patients. (SCRIP 2721:17) � President Bush has asked

the US Congress for a $123 million net increase in the

FDA’s budget, raising the total to $1.73 billion for the

fiscal year ending September 30th, 2003. (SCRIP

2719:16) � President Bush has proposed spending an

additional $77 billion over the next 10 years to provide

prescription drug coverage for low-income elderly and

disabled beneficiaries of the Medicare program who do

not qualify for Medicaid. (SCRIP 2717:13) � Pfizer is

to offer its drugs to low-income elderly US patients for

a co-payment of $15 for a 30-day supply of its branded

prescription products, less than a quarter of the average

retail price of $69.54. (SCRIP 2714:13) � Spending on

prescription drugs in the US rose by 17.3% to $121.8

billion in 2000, leading the growth among the various

components of healthcare in the year. It was the sixthconsecutive year of double-digit growth for prescription

drugs, although slightly less than the 19.2% increase

seen in 1999. (SCRIP 2714:14)

AUSTRALASIAAustralia Government spending on prescription medi-

cines under the Australian Pharmaceutical BenefitsScheme rose by 19.6% to Aus$3,937.9 million ($2 bil-

lion) in the year ended September 30th, 2001. PBS

prescriptions by volume increased by 6.3% to 149.1

million. (SCRIP 2727:17)

China Total commercial sales of pharmaceuticals inChina are forecast to have risen by between 6.3-9.3% in

calendar 2001 to Yuan 150-170 billion ($18-20 bil-

lion). Synthetic chemical products, sales of which grewby 15% in the first half, are expected to account for at

least two-thirds of the total sales figure. (SCRIP

2720:22)

India Most Indian manufactures of HIV/AIDS drugs

have decided to cut their prices after the government

granted an excise duty exemption for nine AIDS drugs

in its recent budget for 2002-03. (SCRIP 2731:18) �

Pfizer has joined forces with the Bombay College of

Pharmacy, India’s premier institute for pharmaceutical

sciences education, to set up an academy for clinical

excellence (ACE) in the country. (SCRIP 2725:23) �

The Indian cabinet has approved the long-awaited

Pharmaceutical Policy – 2002. As expected, it contains

measures to reduce the number of drugs covered by

price controls, and it also aims to boost innovation and

exports, and improve the quality. (SCRIP 2720:20)

Japan The impact on individual companies of this

April’s regular reimbursement price revision in Japan is

becoming clearer, as firms learn how their own products

will be affected. (SCRIP 2729:20) � Vitamin A and D

products will be hardest hit in this April’s general reim-

bursement price revision for prescription pharmaceuti-

cals in Japan, with an average 12.3% reduction. The

second-highest average price cut by product category is

10.4%, for anti-ulcer drugs, according to preliminary

details released by the Ministry of Health, Labor, and

Welfare (MHLW). (SCRIP 2725:20) � Three new

chemical entities developed by Japanese pharmaceutical

companies and now in clinical trials are expected to

generate peak annual worldwide sales of more than $1

billion each. (SCRIP 2723:21) � The Japanese govern-

ment has decided to push ahead with an increase in

patient co-payments for medical care, including phar-

maceuticals, from 20% to 30% from April 1st, 2003.

The move is likely to further hit the country’s already

stagnant prescription market. (SCRIP 2721:18)

New Zealand New Zealand Health Minister Annette

King has approved a national strategy which will see the

medicines purchasing agency, Pharmac, become the sole

central negotiating agent for purchases of pharmaceuti-

cals by hospitals. (SCRIP 2726:20) � The New

Zealand medicines funding agency, Pharmac, is consid-

ering removing the limit on the available budget for

subsidies for beta-interferon for the treatment of multi-

ple sclerosis, and removing the existing waiting list for

the product. (SCRIP 2723:20) � In an ongoing debate

in New Zealand over funding for the oral anticancer,

Glivec (imatinib), Novartis has said it will continue to

supply the product free of charge to 30 patients withchronic myeloid leukaemia until May 1st while the

medicines purchasing agency, Pharmac, decides

whether to subsidize it. (SCRIP 2718:17)

South Korea Pfizer had the highest sales among sub-

sidiaries of multinational pharmaceutical companies inSouth Korea in calendar 2001, recording a 41.7%

growth in revenues to WON170 billion ($128.8 mil-

lion). The fastest-growing foreign concern was Roche,whose sales jumped by 95.8% to WON116.7 billion,

helped by the local roll out of the obesity product,

Xenical (orlistat). (SCRIP 2725:23)

Taiwan Taiwan’s Development Center for

Biotechnology (DCB) has entered into a multi-milliondollar research agreement to optimize and develop a

proprietary small molecule developed by Dynamis

Therapeutics for diabetic complications and other dis-

orders. (SCRIP 2719:21) �


DISEASE RELATED RESEARCH

Cardiovascular Disease

• Blumenthal JA, Babyak M, Wei J, O'ConnorC, Waugh R, Eisenstein E, Mark D, SherwoodA, Woodley PS, Irwin RJ, Reed G. Usefulnessof psychosocial treatment of mental stress-induced myocardial ischemia in men. Am JCardiol. 2002;89:164-8.

• Brown RE, Henderson RA, Koster D, HuttonJ, Simoons ML. Cost effectiveness of eptifi-batide in acute coronary syndromes. An eco-nomic analysis of Western European patientsenrolled in the PURSUIT trial. Eur Heart J.2002;23:50-8.

• Coombs JH, Cornish L, Hiller P, Smith DG.Compliance and refill pattern behavior withHMG-CoA reductase inhibitors after acutemyocardial infarction. Managed Care Interface.2002;15:54-8,60.

• Coyne KS, Davis D, Frech F, Hill MN. Health-related quality of life in patients treated forhypertension: a review of the literature from1990 to 2000. Clin Ther. 2002;24:142-69.

• Eisenstein EL, Shaw LK, Nelson CL, AnstromKJ, Hakim Z, Mark DB. Obesity and long-term clinical and economic outcomes in coronary artery disease patients. Obes Res.2002;10:83-91.

• Huse DM, Cummins G, Taylor DC, RussellMW. Outpatient treatment of venous throm-boembolism with low-molecular-weightheparin: an economic evaluation. Am JManaged Care. 2002;8;S10-S6.

• Nuijten MJ, Berto P, Kosa J, Nadipelli V,Cimminiello C, Spreafico A. Cost-effectivenessof enoxaparin as thromboprophylaxis in acutelyill medical patients from the Italian NHS perspective. Recenti Prog Med. 2002;93:80-91.

• Omar MA, Wilson JP. FDA adverse eventreports on statin-associated rhabdomyolysis.Ann Pharmacother. 2002;36:288-95.

• Reddy P, Dunn AB, White CM, Tsikouris JP,Giri S, Kluger J. An economic analysis of amiodarone versus placebo for the prevention of atrial fibrillation after open heart surgery.Pharmacotherapy. 2002;22:75-80.

• Russell MW, Taylor DC, Cummins G, HuseDM. Use of managed care claims data in therisk assessment of venous thromboembolism inoutpatients. Am J Manag Care. 2002;8;3S-9S.

• Whyte JL, Lapuerta P, L'Italien GJ, FranklinSS. The challenge of controlling systolic bloodpressure: data from the National Health andNutrition Examination Survey NHANES III,

1988-1994. J Clin Hypertens Greenwich.2002;4:76.

Diabetes

• Calabrese AT, Coley KC, DaPos SV, SwansonD, Rao RH. Evaluation of prescribing practices:risk of lactic acidosis with metformin therapy.Arch Intern Med. 2002;162:434-7.

• Caro JJ, Ward AJ, O'Brien JA. Lifetime costs ofcomplications resulting from type 2 diabetes inthe u.s. Diabetes Care. 2002;25:476-81.

• Egede LE, Zheng D, Simpson K. Comorbiddepression is associated with increased healthcare use and expenditures in individuals withdiabetes. Diabetes Care. 2002;25:464-70.

• Maclean JR, Fick DM, Hoffman WK, KingCT, Lough ER, Waller JL. Comparison of 2systems for clinical practice profiling in diabeticcare: medical records versus claims and adminis-trative data. Am J Manag Care. 2002;8:175-9.

• Ramsey S, Summers KH, Leong SA, BirnbaumHG, Kemner JE, Greenberg P. Productivity andmedical costs of diabetes in a large employerpopulation. Diabetes Care. 2002;25:23-9.

Gastro-intestinal

• Christie AH, Culbert P, Guest JF. EconomicImpact of Low Dose Polyethylene Glycol 3350Plus Electrolytes Compared with Lactulose inthe Management of Idiopathic Constipation inthe UK. Pharmacoeconomics. 2002;20:49-60.

• Marshall JK, Cawdron R, Yamamura DL,Ganguli S, Lad R, O'Brien BJ. Use and misuseof cost-effectiveness terminology in the gas-troenterology literature: a systematic review. Am J Gastroenterol. 2002;97:172-9. Review.

Gerontology

• Doraiswamy PM, Khan ZM, Donahue RM,Richard NE. The Spectrum of Quality-of-LifeImpairments in Recurrent Geriatric Depression.J Gerontol A Biol Sci Med Sci. 2002;57:M134-137.

• Moisan J, Gaudet M, Gregoire JP, Bouchard R.Non-Compliance with Drug Treatment andReading Difficulties with Regard to PrescriptionLabeling among Seniors. Gerontology.2002;48:44-51.

Infectious Disease

• Cantrell R, Young AF, Martin BC. Antibioticprescribing in ambulatory care settings foradults with colds, upper respiratory tract infec-tions, and bronchitis. Clin Ther. 2002;24:170-82.

• Dandekar PK, Quintiliani R, Nightingale CH,Nicolau DP. Extended-spectrum beta-

Using Pharmacoeconomics and Outcomes Research InnovativelyRecently Published Work by ISPOR members

This column includes books, articles,

and abstracts recently published by

ISPOR members. This column was

prepared from a survey of biomedical

and healthcare literature using

Medline as well as citations submitted

by ISPOR members.

To ensure that your published work in

pharmacoeconomic or outcomes

research is reported here, please keep

your contact information up to date

with the Society. You may also submit

reprints directly for inclusion in future

columns or email your citations to

[email protected].

Any questions or comments concern-

ing this review can be directed to

Stephen Priori at the following e-mail

address: [email protected].


lactamases ESBL. Conn Med. 2002;66:13-5.

• Gupta AK. Topical metronidazole for rosacea.Skin Therapy Lett. 2002;7:1-6.

• Kew O, Morris-Glasgow V, Landaverde M,Burns C, Shaw J, Garib Z, Andre J, BlackmanE, Freeman CJ, Jorba J, Sutter R, Tambini G,Venczel L, Pedreira C, Laender F, Shimizu H,Yoneyama T, Miyamura T, van Der Avoort H,Oberste MS, Kilpatrick D, Cochi S, PallanschM, de Quadros C. Outbreak of Poliomyelitisin Hispaniola Associated with CirculatingType 1 Vaccine-Derived Poliovirus. Science.2002

• Li JZ, Willke RJ, Rittenhouse BE, Glick HA.Approaches to analysis of length of hospitalstay related to antibiotic therapy in a random-ized clinical trial: linezolid versus vancomycinfor treatment of known or suspected methicillin-resistant Staphylococcus species infections.Pharmacotherapy. 2002;22:Pt 2:45S-54S.

• Reed SD, Laxminarayan R, Black DJ, SullivanSD. Economic issues and antibiotic resistancein the community. Ann Pharmacother.2002;36:148-54.

• Schackman BR, Goldie SJ, Freedberg KA,Losina E, Brazier J, Weinstein MC.Comparison of health state utilities using com-munity and patient preference weights derivedfrom a survey of patients with HIV/AIDS.Med Decis Making. 2002;22:27-38.

• Shaw JW, Joish VN, Coons SJ.Onychomycosis: health-related quality of lifeconsiderations. Pharmacoeconomics.2002;20:23-36.

Neonatology

• McDonnell J, Goverde AJ, Rutten FF,Vermeiden JP. Multivariate Markov chainanalysis of the probability of pregnancy ininfertile couples undergoing assisted reproduc-tion. Hum Reprod. 2002;17:103-6.

• Van Weering HG, Schats R, McDonnell J,Vink JM, Vermeiden JP, Hompes PG. Theimpact of the embryo transfer catheter on thepregnancy rate in IVF. Hum Reprod.2002;17:666-70.

Neurology & Mental Health

• Caro JJ, Getsios D. Pharmacoeconomic evi-dence and considerations for triptan treatmentof migraine. Expert Opin Pharmacother.2002;3:237-48.

• Das Gupta R, Guest JF. Annual cost of bipolardisorder to UK society. Br J Psychiatry.2002;180:227-233.

• Ellis JM, Reddy P. Effects of Panax ginseng onquality of life. Ann Pharmacother.2002;36:375-9.

• Hill JW, Futterman R, Duttagupta S, MasteyV, Lloyd JR, Fillit H. Alzheimer's disease and

related dementias increase costs of comorbidi-ties in managed Medicare. Neurology.2002;58:62-70.

• Mayo KW, Osterhaus JT. Health outcomesevaluations: estimating the impact of almotrip-tan in managed care settings. Am J ManagCare. 2002;8:S85-93. Review.

• Nuijten MJ, Hutton J. Cost-effectivenessanalysis of interferon beta in multiple sclerosis:a Markov process analysis. Value Health.2002;5:44-54.

• Polsky D, Onesirosan P, Bauer MS, Glick HA.Duration of therapy and health care costs offluoxetine, paroxetine, and sertraline in 6health plans. J Clin Psychiatry. 2002;63:156-64.

• Sculpher M, Millson D, Meddis D, Poole L.Cost-effectiveness analysis of stratified versusstepped care strategies for acute treatment ofmigraine: the disability in strategies for careDISC Study. Pharmacoeconomics.2002;20:91-100.

• Swift RH, Harrigan EP, Cappelleri JC, KramerD, Chandler LP. Validation of the behaviouralactivity rating scale BARS: a novel measure ofactivity in agitated patients. J Psychiatr Res.2002;36:87-95.

• Wang JT, Barr CE, Torigoe Y, Wang E,Rowland CR, Goldfarb SD. Cost savings inmigraine associated with less chest pain onnew triptan therapy. Am J Manage Care.2002;8:S102-7.

• Zhao Z. A retrospective economic evaluationof olanzapine versus risperidone in the treat-ment of schizophrenia. Manag Care Interface.2002;15:75-81.

Oncology

• Crott R, Neymark N. Health Economics Unitachievements. Eur J Cancer. 2002;38:S147-50.

• Delea TE, Vera-Llonch M, Edelsberg JS,McGarry L, Anton S, Ulcickas-Yood M, OsterG. The incidence and cost of hospitalizationfor 5-FU toxicity among Medicare beneficiarieswith metastatic colorectal cancer. ValueHealth. 2002;5:35-43.

• Lindgren P, Jonsson B, Redaelli A, Radice D.Cost-effectiveness analysis of exemestane compared with megestrol in advanced breastcancer: a model for europe and australia.Pharmacoeconomics. 2002;20:101-8.

• Ramsey SD, Moinpour CM, Lovato LC,Crowley JJ, Grevstad P, Presant CA, RivkinSE, Kelly K, Gandara DR. Economic analysisof vinorelbine plus Cisplatin versus Paclitaxelplus Carboplatin for advanced non-small-celllung cancer. J Natl Cancer Inst. 2002;94:291-7.

• Rubio-Terres C, Luis Tisaire J, Kobina S,Moyano A. Cost-minimisation analysis of

three regimens of chemotherapy docetaxel-cisplatin, paclitaxel-cisplatin, paclitaxel-carboplatin for advanced non-small-cell lungcancer. Lung Cancer. 2002;35:81-9.

• Sylvester R, Van Glabbeke M, Collette L,Suciu S, Baron B, Legrand C, Gorlia T,Collins G, Coens C, Declerck L, Therasse P.Statistical methodology of phase III cancerclinical trials: advances and future perspectives.Eur J Cancer. 2002;38:S162-8.

• Van D, Lima BS, Snodin D. Alternatives models in carcinogenicity testing--a Europeanperspective. Toxicol Pathol. 2002;30:157-9.

Respiratory Disorders

• Birnbaum HG, Berger WE, Greenberg PE,Holland M, Auerbach R, Atkins KM, WankeLA. Direct and indirect costs of asthma to anemployer. J Allergy Clin Immunol.2002;109:264-70.

• Chou TY, Wu KY, Shieh CC, Wang JY. Theclinical efficacy of in vitro allergen-specific IgEantibody test in the diagnosis of allergic chil-dren with asthma. Acta Paediatr Taiwan.2002;43:35-9.

• Ward MM, Javitz HS, Smith WM, WhanMA. Lost income and work limitations in persons with chronic respiratory disorders. J Clin Epidemiol. 2002;55:260-8.

Skeletal/Arthritis

• Blalock SJ, DeVellis BM, Patterson CC,Campbell MK, Orenstein DR, Dooley MA.Effects of an osteoporosis prevention programincorporating tailored educational materials.Am J Health Promot. 2002;16:146-56.

• Cheng JC, Guo X, Law LP, Lee KM, ChowDH, Rosier R. How does recombinant humanbone morphogenetic protein-4 enhance poste-rior spinal fusion? Spine. 2002;27:467-74.

• Gabriel SE, Tugwell P, Drummond M.Progress towards an OMERACT-ILAR guide-line for economic evaluations in rheumatology.Ann Rheum Dis. 2002;61:370-3.

• Kim TH, Lee HS, Ji JD, Jun JB, Jung S, BaeSC, Yoo DH, Kim SY. Undifferentiatedspondyloarthropathy in Korea: focusing onperipheral arthritis. J Korean Med Sci.2002;17:71-4.

• Oh YB, Ahn JY, Lee HS, Kim TH, Jun JB,Jung SS, Bae SC, Kim SY, Yoo DH.Association Between FcgammaR IIa and IIIaPolymorphism and Clinical Manifestations inKorean Patients with Adult-Onset Still'sDisease. J Korean Med Sci. 2002;17:75-80.

Surgery/Trauma

• Hackam DJ, Potoka D, Meza M, Pollock A,Gardner M, Abrams P, Upperman J, Schall L,Ford H. Utility of radiographic hepatic injury

www.ispor.org18 April 15, 2002 ISPOR CONNECTIONS

grade in predicting outcome for children afterblunt abdominal trauma. J Pediatr Surg. 2002;37:386-9.

• Potoka DA, Schall LC, Ford HR. Risk factorsfor splenectomy in children with blunt splenictrauma. J Pediatr Surg. 2002;37:294-9.

• Schall LC, Potoka DA, Ford HR. A newmethod for estimating probability of survivalin pediatric patients using revised TRISSmethodology based on age-adjusted weights. J Trauma. 2002;52:235-41.

TOPICS OF GENERAL INTEREST

Methodology

• Klepser DG. Pitfalls associated with commonlyused methods for pharmacoeconomic analyses.Pharmacotherapy. 2002;22:S35-38.

• Leader S, Jacobson P, Marcin J, Vardis R,Sorrentino M, Murray D. A method for iden-tifying the financial burden of hospitalizedinfants on families. Value Health. 2002;5:55-9.

• Mason J, Axon AT, Forman D, Duffett S,Drummond M, Crocombe W, Feltbower R,Mason S, Brown J, Moayyedi P. The cost-effectiveness of population Helicobacter pyloriscreening and treatment: a Markov modelusing economic data from a randomized

controlled trial. Aliment Pharmacol Ther.2002;16:559-568.

Health Services

• Blewett CJ, Hollenbeak CS, Cilley RE, DillonPW. Economic implications of current surgicalmanagement of gastroesophageal reflux disease.J Pediatr Surg. 2002;37:427-30.

• Guest JF, Das Gupta R. Health-RelatedQuality of Life in a UK-Based Population ofMen with Erectile Dysfunction.Pharmacoeconomics. 2002;20:109-17.

• Kolawole OA, Pedersen CA, Schneider PJ,Smeenk DA. Perspectives on the attributes andcharacteristics of pharmacy executives. Am JHealth Syst Pharm. 2002;59:278-81.

• Lemons J, Fanaroff A, Stewart EJ, BentkoverJD, Murray G, Diefendorf A. NewbornHearing Screening: Costs of Establishing aProgram. J Perinatol. 2002;22:120-24.

• Lloyd KB, Krueger KP, Moore RT, WaltersNB, Eichner SF, Fanning K. Impact of a work-place health and wellness pharmaceutical careservice on the weight and obesity classificationof employees. J Am Pharm Assoc Wash.2002;42:118-20.

• McKeithan EK, Shepherd MD.Pharmaceutical products declared by US residents on returning to the United States

from Mexico. Clin Ther. 1996;18:1242-51.

• O'Neal BC, Schneider PJ, Pedersen CA,Mirtallo JM. Compliance with safe practicesfor preparing parental nutrition formulations.Am J Health Syst Pharm. 2002;59:264-9.

• McDermott JH, Christensen DB. Provision of pharmaceutical care services in NorthCarolina: a 1999 survey. J Am Pharm AssocWash. 2002;42:26-35.

• Pang F. Design, analysis and presentation ofmultinational economic studies: the need forguidance. Pharmacoeconomics. 2002;20:75-90.

• Perneger TV, Martin DP, Bovier PA.Physicians' attitudes toward health carerationing. Med Decis Making. 2002;22:65-70.

• Phillips KA, Chen JL. Impact of the U.S.panel on cost-effectiveness in health and medicine. Am J Prev Med. 2002;22:98-105.

• Roe CM, McNamara AM, Motheral BR.Gender- and age-related prescription drug usepatterns. Ann Pharmacother. 2002;36:30-9.

• Strassels SA, Chen C, Carr DB. Postoperativeanalgesia: economics, resource use, and patientsatisfaction in an urban teaching hospital.Anesth Analg. 2002;94:130-7, table of contents. �

Visit the ISPOR Website at www.ispor.orgThe ISPOR website has never been better. Its drop-down menus provide easy navigation throughout the site.It is clear, precise and current. Following are some of its helpful features:

> ISPOR FUTURE MEETINGS: In the Future Meetings section(under Meetings), abstract submission deadlines and early registration deadlines are displayed through 2005.(http://www.ispor.org/meetings/future/index.htm)

> MEMBER-TO-MEMBER COMMUNICATIONS: In the MembersArea section (under Member Email Address), ISPOR memberscan request the email address of another ISPOR member(http://www.ispor.org/lookup.asp)

> CONTRIBUTED PODIUM AND POSTER PRESENTATIONS:Presentations at ISPOR Annual International Meetings orEuropean Congress can be posted at the ISPOR website(Example: Go to http://www.ispor.org/meetings/cannes1101/index_new.html, go to Contributed PosterPresentations - Session 1, scroll down to PIN 15 and activatethe hyperlink on presentation title)

> UPCOMING FEATURES: Online surveys to benchmark pharmacoeconomics and outcomes research activities; onlineISPOR Meeting / European Congress Evaluations for your easy access and convenience

We, at ISPOR, strive to give our valued ISPOR members faster and improved services to meet all their growing needs.Thousands of people a day are finding www.ispor.org a valuable site to visit. We invite you to add it to your own list of favorite sites.


RESEARCH SCIENTIST

DURHAM, NC Play major role in conducting research & product dvlpmt activities, as well as supportingbusiness dvlpmt. Perform data mgmt by SAS or Stata software. Conduct literature research.Dvlp research protocols. Organize & presentresearch findings at group & co. meetings. Build up predication models for mgmt of chronicdisease. Build up efficacy models for the long-termoutcomes research to drug treatment. Dvlp screening models for safety mgmt of drugtreatments. Must have Master's in Pharmacy or related & min. 6 mos exp. $59,500/yr. Send resume to: 1822 East NC Hwy 54, Ste. 350Durham, NC 27713.

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Senior Managing Scientist, Health PracticeExponent is a leading independent consulting firm providing solutionsto complex engineering and scientific problems. We are currentlyseeking a Senior Managing Scientist for our Alexandria, VA office.

This individual will function independently in designing and perform-ing health economic and outcomes research studies; preparing studydocuments, including proposals and reports, with little guidance; publishing and presenting study findings, and; working well with other personnel in the Health Practice as well as other practices. Thisperson will carry out marketing and business development activities;have substantial interaction with clients; assist in staff mentoring,and; perform appropriate QMS activities.

This position requires a Master’s degree (doctoral degree preferred)and a minimum of four years of experience in health economics,outcomes research, or related fields. Also required are good writing,public speaking, and presentation skills and previous relevant publications/presentations. Experience in the private sector and with marketing/business development is preferred.

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For confidential consideration, please contact:Human Resources, Req. #1080TREXPONENT149 Commonwealth Drive, Menlo Park, CA 94025Fax: 650-328-3049 [email protected] www.exponent.com

20

ISPOR 5th Annual European Congress3-5 November, 2002de Doelen Congress CenterRotterdam, The Netherlands

Pre-Meeting Short CoursesSATURDAY, 2 NOVEMBER 2002 (9:00-17:00)• Pharmacoeconomic Evaluations: Methods and Applications for

Decision Making

SUNDAY, 3 NOVEMBER 2002 (8:00-12:00)• Combining Ethical and Economic Considerations in Health Policy

• Adapting Quality of Life Measurement for Disease Specific Outcomes

• Cost Calculations and Modeling in International Trials

• Bootstrapping: Fundamentals and Applications

• Bayesian Methods in Economic Evaluations

• Computer-Assisted Decision Analysis Applications

ISPOR 5th Annual European Congress3-5 NOVEMBER 2002 • DE DOELEN CONGRESS CENTER ROTTERDAM, THE NETHERLANDS

Program Chair: Frans Rutten PhD, Professor of Health Economics, iMTA,Erasmus University, Rotterdam, The Netherlands

Program Committee: Ron Herrings PhD, University of Utrecht, Utrecht,The Netherlands; Peter Spoorendonk MSc, Ministry of Health, TheHague, The Netherlands

Contributed Research Review Committee Co-Chairs: Carin Uyl-de Groot PhD, iMTA, Erasmus University, Rotterdam, TheNetherlands; Maureen Rutten-van Mölken PhD, iMTA, ErasmusUniversity, Rotterdam, The Netherlands

Contributed Workshop Review Committee Chair: Maiwenn Al PhD, iMTA,Erasmus University, Rotterdam, The Netherlands

Congress Day 1SUNDAY, 3 NOVEMBER – 12:00-19:00

EXHIBITS AND CONTRIBUTED POSTER PRESENTATIONS

WELCOMESpeaker: Peter Davey MD, FRCP, 2002-2003 ISPOR President and Head ofPharmacoeconomics, University of Dundee, Dundee, Scotland, UK

INTRODUCTION AND CONGRESS OBJECTIVESSpeaker: Frans Rutten PhD, Congress Chair and Professor of HealthEconomics, iMTA, Erasmus University, Rotterdam, The Netherlands

FIRST PLENARY SESSION: “THE SOCIETAL BENEFITS AND COSTS OF THE4TH HURDLE: THE EUROPEAN EXPERIENCE”The Government’s PerspectiveSpeaker: European Commission Representative

The Pharmaceutical Industry’s PerspectiveSpeaker: Mark Ratcliffe PhD, Director, European Health OutcomesResearch, Eli Lilly & Co Ltd, Windlesham, United Kingdom

Evidence of the Impact on the Pharmaceutical IndustrySpeaker: C. Daniel Mullins PhD, Associate Professor, University ofMaryland, School of Pharmacy, Baltimore, MD, USA

ISPOR FORUMS• QUALITY OF LIFE FORUM: “SUMMARY MEASURES OF POPULATION

HEALTH STATUS – WHO CARES?”

• MEDICAL DEVICE & DIAGNOSTICS FORUM

• CENTRAL & EASTERN EUROPEAN FORUM

EXHIBITS, POSTER PRESENTATIONS & RECEPTION

Congress Day 2MONDAY, 4 NOVEMBER – 8:00-19:00

SECOND PLENARY SESSION: “INTEGRATING ECONOMIC ARGUMENTS IN HEALTH POLICY”Risk-Sharing Between Payer and ProducerSpeaker: Adrian Towse MA, Mphil, Director, Office of Health Economics, London, United Kingdom

Cost-Effectiveness and GuidanceSpeaker: Martin Buxton PhD, Professor, Health Economics Research, Brunel University, Uxbridge, United Kingdom

Reconciliation of Economic Arguments and Clinical PracticeSpeaker: Jan Busschbach PhD, Senior Researcher, iMTA ErasmusUniversity, Rotterdam, The Netherlands

CONTRIBUTED PODIUM SESSIONS

EXHIBITS AND POSTER PRESENTATIONS

ISSUES PANELS• The Burden of the Reimbursement Hurdle

• Criteria for Reimbursement Decisions

• Measuring Indirect Costs: Relevant to Decision-Makers?

• Bayesian Statistics: Barriers to Acceptance by Decision-Makers

CONTRIBUTED WORKSHOPS

EXHIBITS, POSTER PRESENTATIONS AND RECEPTION

Congress Day 3TUESDAY, 5 NOVEMBER – 7:00-16:00

ISPOR GROUP BREAKFASTS (BY INVITATION)

THIRD PLENARY SESSION: “THE FALSE PROMISES OF PHARMACEUTICAL TRIALS”Empirical Evidence on ComplianceSpeaker: John Urquhart MD, Professor of Pharmacoepidemiology,Maastricht University, Maastricht, The Netherlands

Empirical Evidence on PersistenceSpeaker: Jacques LeLorier MD, PhD, FRCP, Chief, Pharmaco-epidemiology & Pharmacoeconomy Research Unit, University ofMontreal, Montreal, Quebec, Canada

The Influence of Side-Effects on EffectivenessSpeaker: Ron Herings PhD, University of Utrecht, Utrecht, The Netherlands


EXHIBITS AND POSTER PRESENTATIONS

ISSUES PANELS• From Efficacy to Effectiveness

• Discounting and Actual Time Preference in Society

• Re-Assessment of Reimbursement Status Using Outcomes Research

• Why Should Physicians be Interested in Economic Evaluations?


21

I S P O R S E V E N T H A N N U A L I N T E R N AT I O N A L M E E T I N GM AY 1 9 - 2 2 , 2 0 0 2 � H YAT T R E G E N C Y C R Y S TA L C I T Y � A R L I N G T O N , VA , U S A

Saturday, May 18, 20029:00AM-5:00PM• Pharmacoeconomics

Sunday, May 19, 20028:00AM-12:00PM• Meta-Analysis and Systematic Literature Review – Introduction• Introduction to Patient Reported Outcomes (PRO) Assessment: Designing a

PRO Strategy• Statistics for Non-Statisticians

• Decision Analysis – Introduction• Introduction to Bayesian Approaches to Health Economics and Outcomes

Research• Introduction to Pharmacoepidemiology

1:00PM-5:00PM• Decision-Analysis – Advanced Applications• Prospective Economic Trials• Quality of Life – Advanced• Advanced Retrospective Database Analysis• Statistical Considerations in Pharmacoeconomic Evaluations – Advanced• Elements of Pharmaceutical Pricing

PATIENT-REPORTED OUTCOMES ‘PRO’ SYMPOSIUMCONCEPTUAL AND METHODOLOGICAL ISSUESHyatt Regency Crystal City, Arlington, Virginia, USAPrior to the ISPOR 7th Annual International MeetingSunday, May 19, 2002 6:30 – 8:30 pmFollowed by a ReceptionCo-Sponsored by: FDA, ISPOR and PhRMA Health Outcomes CommitteeThis program was developed in cooperation with the Patient-Reported Outcomes Harmonization Group

Background:Data to evaluate the efficacy or effectiveness of treatment can come from a variety of sources, including laboratory tests, clinician evaluation, and the patients themselves. In theoutcomes research community, the term “patient-reported outcomes (PRO)” is used to refer to a host of outcomes that can be provided only by the patient. Examples of theseoutcomes include symptom severity, perception of daily functioning, feelings of well being, global impressions of the impact of treatment on daily life, satisfaction with treatment,and health-related quality of life. The role that PROs can and should play in evaluating the efficacy of pharmaceuticals and medical devices and the means by which these outcomes are communicated to clinicians and consumers are subjects of much discussion and debate.

Over the past 2 years, representatives from ISPOR, PhRMA HOC, ISOQOL and ERIQA (now collectively called the Patient-Reported Outcomes (PRO) Harmonization Group) havebeen participating in discussions with the FDA about the use of health-related quality of life (HRQL) and, more recently, patient reported outcomes (PRO) in pharmaceuticalresearch and communications. An overview of PRO Harmonization Group initiatives, meetings, presentations are at the PRO Harmonization Group website at www.pro-harmonization-group.com. This symposium will highlight activities of the PRO Harmonization Group, and provide an overview of discussions related to conceptualand methodological issues with specific examples.

PROGRAM6:30 – 6:35 PM INTRODUCTION

Kati Copley-Merriman MS, MBA, Director of Outcomes Research, Pfizer Pharmaceutical Group, Ann Arbor, MI, USA and Chair, PhRMA Health Outcomes Committee

6:35 – 6:40 PM OVERVIEW OF THE PRO HARMONIZATION GROUP EFFORTSSpeaker & Moderator: Jean Paul Gagnon PhD, Director, Public Policy, Aventis Pharmaceuticals, Bridgewater, NJ, USA

6:40 – 6:55 PM PRO’ CONCEPTUAL ISSUESSpeaker: Margaret Rothman PhD, Executive Director, Health Economics Johnson and Johnson Pharmaceutical Research andDevelopment, Raritan, NJ, USA

6:55 – 7:10 PM PRO’ METHODOLOGICAL ISSUESSpeaker: Nancy Santanello MD, MS, Executive Director, Epidemiology, Merck Research Laboratories, West Point, PA, USA

7:10 – 7:40 PM SPECIFIC FDA ISSUES

7:10 – 7:25 PM INSTRUMENT DEVELOPMENT: WHAT ARE THE STANDARDS?Speaker: Donald Patrick PhD, MSPH, Professor, University of Washington, Seattle, WA, USA

7:25 – 7:40 PM INTERPRETING CHANGES THAT ARE NOT CONSISTENT BETWEEN OUTCOMESSpeaker: Joyce Cramer BS, Associate Research Scientist, Yale University School of Medicine, West Haven, CT, USA

7:40 – 8:00 PM FDA PERSPECTIVE OF ‘PRO’Speaker: Laurie Beth Burke RPh, MPH, Chief, Regulatory Review Branch, FDA, CDER, DDMAC, Rockville, MD, USA

8:00 – 8:30 PM PANEL AND AUDIENCE DISCUSSION

8:30 – 9:30 PM ANNOUNCEMENTS AND RECEPTIONKati Copley-Merriman MS, MBA, Director of Outcomes Research, Pfizer Pharmaceutical Group

Congratulations!The tests were negative,everything is perfectly

alright!

My whole life is affected!

I cannot bendover or exercise

I cannot sleep

I cannot eat and drink

whatever I like

PRE-MEETING SHORT COURSES

MEETING DAY 1MONDAY, MAY 20TH – 7:00AM-8:00PM

EARLY BIRD FORUM

AMCP FORMAT FOR FORMULARY SUBMISSIONS:Who is using them, Who will be evaluating them, andWhat regulatory concerns do they raise

Moderator/Speaker: Dell Mather PharmD, Senior Director,Pharmacotherapy Assessment & Policy, PrimeTherapeutics, Inc, St. Paul, MN, USA

Who is Using ThemSpeaker: Peter M. Penna PharmD, President, PM PennaLLC, Seattle, WA, USA and AMCP Officer

Regulatory ConcernsSpeaker: Laurie Beth Burke RPh, MPH, Chief, RegulatoryReview Branch, FDA, CDER, DDMAC, Rockville, MD, USA

WELCOMESpeaker: Peter Neumann ScD, ISPOR Annual MeetingProgram Chair and Assistant Professor of Policy &Decision Sciences, Harvard School of Public Health,Boston, MA, USA

PRESIDENTIAL ADDRESSSpeaker: Eva Lydick PhD, 2001-2002 ISPOR President &Director, Outcomes Research, AstraZeneca, Wilmington,DE, USA

FIRST PLENARY SESSION: “NEW FRONTIERS FOROUTCOMES RESEARCHERS”Moderator: Sandy Schwartz MD, Professor of Medicineand Health Management and Economics, University ofPennsylvania, School of Medicine and Wharton School,Philadelphia, PA, USASpeaker: Jerome Avorn MD, Associate Professor, HarvardMedical School, Boston, MA, USAPanelist: Deborah Zarin MD, Director, TechnologyAssessment Program, Agency for Healthcare Researchand Quality, US Department of Health & Human Services,Rockville, MD, USAPanelist: Edwin Hedblom PharmD, Chief PharmacyOfficer – AARP Pharmacy Division, UnitedHealth Group,Minnetonka, MN, USA

EXHIBITS & POSTER PRESENTATIONS


ISSUES PANELS• How Does Genomics Change Portfolio Management?

Chair: Kevin Schulman MD, MBA, Director, Center forClinical & Genetic Economics, Duke University, Durham,NC, USA

• Standards of Evidence: What is Appropriate?Chair: Bryan Luce PhD, MBA, Senior Research Leader& CEO, MEDTAP International, Bethesda, MD, USA

• Should Meta-Analysis Only Include Clinical Trial Data?Chair: Adrian Towse MA, Mphil, Director, Office ofHealth Economics, London, United Kingdom

• Who Will Develop New Drugs for Tuberculosis or Malaria?Chair: Doris Rouse PhD, Director, Global Health, RTIInternational, Research Triangle Park, NC, USA


ISPOR FORUMS• HEALTH SCIENCE FORUM• STUDENT FORUM

Careers in Pharmacoeconomics and Health Outcomes Research

EXHIBITS, POSTER PRESENTATIONS &

RECEPTION

MEETING DAY 2TUESDAY, MAY 21ST – 7:00AM-7:00PM

BREAKFAST WITH THE EXPERTS

• N.I.C.E.Adrew H. Briggs Dphil, Health Economics ResearchCentre, Institute of Health Sciences, Oxford University,Oxford, United Kingdom

• Outcomes Research in the Pharmaceutical IndustryMarc Berger MD, Vice President, Outcomes Research & Management, Merck & Company, Inc., West Point,PA, USA

• Quality of Life ResearchPennifer Erickson PhD, Cofounder, O.L.G.A, StateCollege, PA, USA

• Theoretical Issues in Cost-Effectiveness AnalysisMilton Weinstein PhD, Professor, Health Policy &Management, Harvard School of Public Health, Boston,MA, USA

EXHIBITS & POSTER PRESENTATIONS

CONTRIBUTED PODIUM PRESENTATIONS

SECOND PLENARY SESSION: “THE RISE OF RISKMANAGEMENT”Moderator: Peter Neumann ScD, ISPOR Annual MeetingProgram Chair and Assistant Professor of Policy &Decision Sciences, Harvard School of Public Health,Boston, MA, USA

Speaker: John D. Graham PhD, Administrator, Office ofManagement and Budget, Washington, DC, USA

Speaker: Janet Woodcock MD, Director, Center for DrugEvaluation & Research, Rockville, MD, USA

ISSUES PANELS• Is $50,000/QALY High Enough for a US Benchmark?

Chair: A. Mark Fendrick MD, Associate Professor,University of Michigan Medical Center, Ann Arbor,MI, USA

• What’s Next for Outcomes Research in Asia?Chair: Hong Li PhD, Associate Director, Bristol-MyersSquibb, Wallingford, CT, USA

• Medication Compliance: How Can It Be Included inPharmacoeconomic Studies?Chair: Joyce Cramer BS, Associate Research Scientist,Yale University School of Medicine, West Haven, CT, USA

• Using Health Economic and Other Outcomes Informationto Develop Sound Prescription Drug Plans: Practical ofImprobable in the US?

Chair: Joanna Siegel ScD, Director, Research Initiativein Clinical Economics, Agency for Healthcare Research &Quality, Rockville, MD, USA


ISPOR FORUMS• MEDICAL DEVICE & DIAGNOSTICS FORUM

“USING MEDICAL DEVICE AND DIAGNOSTICS OUT-COMES RESEARCH TO SUPPORT HEALTH POLICY &REIMBURSEMENT DECISIONS”

• QUALITY OF LIFE FORUM“SUMMARY MEASURES OF POPULATION HEALTH STATUS – WHO CARES?”

• CLINICAL PRACTICE FORUM“USING COST-EFFECTIVENESS & OUTCOMES RESEARCHTO INCREASE A PATIENT'S ACCESS TO NEW DRUGS:CASE STUDY IN DIABETIC COMPLICATIONS”

ISPOR BUSINESS MEETING

MEETING DAY 3WEDNESDAY, MAY 22ND – 8:30AM-12NOON

BREAKFAST WITH THE EXPERTS

• Cost-Effectiveness Analysis in the Developing WorldJoan Rovira PhD, Health, Nutrition and Population, TheWorld Bank, Washington, DC, USA

• Pharmaceutical Costs, Expenditures and PolicyImplicationsC. Daniel Mullins PhD, Associate Professor, Universityof Maryland, School of Pharmacy, Baltimore, MD, USA

• Issues in Modeling in Cost-Effectiveness AnalysisJ. Jaime Caro MD, Scientific Director, Caro Research,Concord, MA, USA

• Economic Evaluation Alongside Clinical TrialsHenry Glick, Division of General Internal Medicine,University of Pennsylvania, Philadelphia, PA, USA


THIRD PLENARY SESSION: “THE RISE OF CON-SUMERISM”

Moderator: Louis A. Morris PhD, ISPOR Annual MeetingPlenary Session Chair and President, Louis A. Morris &Associates, Dix Hills, NY, USA

Speaker: Linda F. Golodner, Executive Director, NationalConsumer League, Washington, DC, USA

Speaker: Karen Donelan ScD, Senior Vice President,Medrock, Cambridge, MA, USA

Speaker: Charles Inlander, President, People’s MedicalSociety, Fogelsville, PA, USA

Discussant: Newell McElwee PharmD, MSPH, SeniorDirector/Team Leader, Global Outcomes Research, Pfizer,Inc., New York, NY, USA

ADJOURNMENT

General Chair: Peter Neumann ScD, Assistant Professor of Policy & Decision Sciences, Harvard School of Public Health, Boston, MA, USA

Plenary Sessions Chair: Louis A. Morris PhD, President, Louis A. Morris & Associates, Dix Hills, NY, USA

Issues Panels Chair & Contributed Workshop Review Committee Chair: Josephine Mauskopf PhD, MEDTAP International, Durham, NC, USA

Contributed Research Review Committee Chair: Kathryn Phillips PhD, Associate Professor of Health Economics and Health Services Research, University of California-San Francisco, CA, USA


22

NAME DEGREES

POSITION ORGANIZATION

MAILING ADDRESS

CITY STATE ZIP COUNTRY

TELEPHONE FAX EMAIL

ISPOR SHORT COURSE REGISTRATION

ALL DAY SESSION SATURDAY, MAY 18, 9:00AM – 5:00PM�� Pharmacoeconomics for the Healthcare Decision Maker

�� Reg. Fee Before May 1, 2002 US$ 350 �� Student Fee Before May 1, 2002 US$ 175�� Reg. Fee After May 1, 2002 US$ 400 �� Student Fee After May 1, 2002 US$ 200

(Check one course from the AM session and/or one course from the PM session)MORNING SESSIONS SUNDAY, MAY 19, 8:00AM – 12:00PM�� Meta-Analysis and Systematic Literature Review – Introduction

�� Introduction to Patient Reported Outcomes (PRO) Assessment:Designing a PRO Strategy

�� Statistics for Non-Statisticians

�� Decision Analysis – Introduction

�� Introduction to Bayesian Approaches to Health Economics andOutcomes Research

�� Introduction to Pharmacoepidemiology

AFTERNOON SESSIONS SUNDAY, MAY 19, 1:00PM – 5:00PM�� Decision Analysis - Advanced Applications

�� Elements of Pharmaceutical Pricing

�� Prospective Economic Trials

�� Quality-of-Life – Advanced

�� Advanced Retrospective Database Analyses

�� Statistical Considerations in Pharmacoeconomic Evaluations – Advanced

�� Registration Fee Before May 1, 2002 US$ 150 [ x no. of courses= ]

�� Registration Fee After May 1, 2002 US$ 200 [ x no. of courses= ]

�� Student Fee Before May 1, 2002 US$ 75 [ x no. of courses= ]

�� Student Fee After May 1, 2002 US$ 100 [ x no. of courses= ]

TOTAL: $__________

Please enclose a check payable in US dollars to: International Society for Pharmacoeconomics and Outcomes Research or ISPOR and send to the ISPOR address given below or charge to: �� VISA �� MasterCard �� American Express

NAME: AUTHORIZED SIGNATURE:

ACCOUNT NUMBER: EXPIRATION DATE:

Payment must be made in US dollars. Payment may be made by check or travelers check. VISA, MasterCard, or American Express will be charged in US dollars. Signature,account number, and expiration date must be included. Non-US checks written in US$ must be written on banks with a US counterpart. Phone charges will NOT be accepted.If payment is being made by your company, please make sure your name is indicated on the check stub or correspondence.

If ISPOR cannot verify your current membership, you will be charged the non-member registration rate.

*One-Day Registration does not include membership benefits. When you register as a non-member, you receive ISPOR membership and a one-year, hard copy subscription to VALUE IN HEALTH-The Journal of the International Society forPharmacoeconomics and Outcomes Research. Cancellation fee before May 1, 2002 is US $100. No refunds given after May 1, 2002.

SEND REGISTRATION FORM (OR FAX, IF USING CREDIT CARD) TO:International Society for Pharmacoeconomics and Outcomes Research

3100 Princeton Pike, Building 3, Suite D, Lawrenceville, NJ 08648 USA Tel: 1-609-219-0773 Fax: 1-609-219-0774 Email: [email protected] Internet: www.ispor.org

CONFERENCE REGISTRATION ISPOR Member Non-Member*

StandardRegistration Before May 1, 2002 �� US$ 600 �� US$ 745Registration After May 1, 2002 �� US$ 700 �� US$ 845

Clinical Practitioners (PBM, HMO, Hospital)

Registration Before May 1, 2002 �� US$ 450 �� US$ 595Registration After May 1, 2002 �� US$ 550 �� US$ 695

Full-Time Government and AcademiaRegistration Before May 1, 2002 �� US$ 300 �� US$ 445Registration After May 1, 2002 �� US$ 400 �� US$ 545

Full-Time Students (must provide current enrollment documentation)

Registration Before May 1, 2002 �� US$ 100 �� US$ 150Registration After May 1, 2002 �� US$ 150 �� US$ 200

One-Day Registration (per day)* �� US$ 250 �� US$ 250�� Monday, May 20 �� Tuesday, May 21 �� Wednesday, May 22

Continuing Education Accreditation �� US$ 30 �� US$ 30

Breakfast With The Experts (each) �� US$ 20 �� US$ 20Student Fee �� US$ 10 �� US$ 10

Tuesday, May 21 Wednesday, May 22

�� Milton Weinstein PhD �� Andrew H. Briggs DPhil �� Joan Rovira PhD �� J. Jaime Caro MD

�� Pennifer Erickson PhD �� Marc Berger MD �� Henry Glick PhD �� C. Daniel Mullins PhD

REGISTRATION FEE: $_________ $ ___________

TOTAL REGISTRATION FEE WITH SHORT COURSES : $_________ $ ___________


In the Competitive Marketplace,VALUE IS WHAT … the Competitive Marketplace,VALUE IS WHAT COUNTS! ... 2 Letter From the Editor ... you will participate in bi-monthly conference calls,

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