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CONNECTIONSCONNECTIONSUNITING SCIENCE AND PRACTICEISP R

MAY/JUNE 2008 VOL. 14, NO. 3

INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH

LETTER FROM THE EDITOR

PRESIDENT’S MESSAGE

Outgoing Presidential Address: International Transition - A Year in Review

OUTCOMES ASSESSMENT

The EMEA Guideline on Health Related Quality of Life and Its Impact on Drug Development

POLICY ANALYSIS

Conditional Reimbursement Based on Future Research

Same Language, Different Country: Do All Roads Lead to Rome?

Pharmaceutical Outcomes Research and Policy in Canada - Context and RecentDevelopments

ISPOR CORNER

Oh, Canada! ISPOR 13th Annual International Meeting Goes “North of the Border!”

ISPOR 3rd Asia-Pacific Conference Information

ISPOR 13th Annual Meeting Award Recipients

ISPOR 13th Annual Meeting Photo Gallery

Board of Directors New Elected Members Take Office on July 1, 2008

Looking Back and Moving Forward: Last Year was Huge and This Year is Going to be Even Bigger!

News Briefs From Around the World

Recently Published Works: Using Pharmacoeconomics Innovatively

ISPOR 11th Annual European Congress Program

ISPOR 11th Annual European Congress Short Courses

ISPOR 11th Annual European Congress Information

ISPOR 11th Annual European Congress Registration

Copyright © 2008 International Society of Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved under International and Pan-AmericanCopyright Conventions. Published in the United States of America by the International Society for Pharmacoeconomics and Outcomes Research. No part ofthis publication may be used or reproduced in any manner whatsoever or by any means – graphic, electronic, or mechanical, including photocopying, taping,or information storage and retrieval systems without express written permission of the 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 addressedto: International Society for Pharmacoeconomics and Outcomes Research, 3100 Princeton Pike, Building 3, Suite E, Lawrenceville, NJ 08648 USA

ISPOR 2007-2008 BOARD OF DIRECTORS

PRESIDENT – Diana Brixner PhD, RPh, University ofUtah/Pharmacotherapy, [email protected]

PAST PRESIDENT – Michael F. Drummond PhD, University ofYork, [email protected]

PRESIDENT-ELECT – Chris L. Pashos PhD, HERQuLES HealthEconomic Research and Quality of Life Evaluation Services AbtBio-Pharma Solutions, Inc., [email protected]

DIRECTORS – Marc Berger MD, Eli Lilly and Company, [email protected]; Lou Garrison, PhD, University ofWashington, [email protected]; Shu-Chen Li PhD,University of Newcastle, [email protected]; UweSiebert MD, University of Health Sciences, Medical Informatics& Technology, [email protected]; Richard J. Willke PhD,Pfizer, [email protected]

TREASURER – Karen Rascati RPh, PhD, University of Texas,[email protected]

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

ISPOR CONNECTIONS EDITOR & EDITORIAL BOARDEDITOR-IN-CHIEF – Steven E. Marx PharmD, MS, AbbottLaboratories, [email protected]

ASSOCIATE EDITORS-IN-CHIEF – Thomas Mittendorf PhD,University of Hannover, [email protected]; DavidThompson PhD, i3 Innovus, [email protected]

EDITORIAL BOARD – Rajesh Balkrishnan PhD, MS, Ohio StateUniversity; Benjamin Craig PhD, H. Lee Moffitt Cancer Center &Research Institute; Bonnie M. Korenblat Donato PhD, BristolMyers Squib; Marc Nuijten PhD, MD, MBA, Imta, ErasmusUniversity; Michael Wonder BSc, BPharm, NovartisPharmaceuticals Australia; Peter Wong RPH, MS, MBA, PhD,Sister of Charity, Leavenworth Health Systems

ISPOR CONNECTIONS PUBLISHING, SUBSCRIPTION,AND ADVERTISING OFFICE: ISPOR CONNECTIONS (ISSN 1538-5108) (USPS 019121) is published bi-monthly by the International Society forPharmacoeconomics and Outcomes Research, 3100 PrincetonPike, Building 3, Suite E, Lawrenceville, NJ 08648 USA. Phone: 609-219-0773 Toll Free: 1-800-992-0643Fax: 609-219-0774 Website: www.ispor.orgAnnual membership dues include $30 for regular members and$15 for student members for a 1-year subscription to ISPORCONNECTIONS.

Periodicals Postage paid at Trenton, New Jersey and at additional mailing offices. POSTMASTER: Send address changesto ISPOR CONNECTIONS, 3100 Princeton Pike, Building 3, SuiteE, Lawrenceville, NJ 08648 USA.Managing Editor: Stephen L. Priori, email: [email protected] Advertising Manager: Danielle Mroz, email: [email protected]

Direct advertising, photocopy permission, and reprint requests,to Managing Editor. All members of the Board of Directors serve in their personal capacity and do notrepresent the views of their organization during Board activities. All members of theBoard of Directors annually disclose any conflicts of interest concerning businessrelationships with the Society. See: http://www.ispor.org/board/index.asp.

2 May/June 2008 ISPOR CONNECTIONS

LETTER FROM THE EDITOR

Well, after eight years as your Editor-in-Chief of this out-

standing news and technical journal, I will be stepping

down to allow others the opportunity to serve you. I

have truly enjoyed this challenge and I have grown through this

experience. I will stay on the ISPOR CONNECTIONS Editorial

Board and look forward to continuing to contributing articles and

cartoons to ISPOR CONNECTIONS. I hope to identify a new role

that I may be able to serve this organization in the future, and I look forward to the direction

that the co-Editors-in-Chief will bring to this publication. I would like to thank the ISPOR staff

for their support, and especially thank ISPOR CONNECTIONS Managing Editor Stephen

Priori for his assistance and direction throughout the years.

As I thought about my final sign-off as your Editor-in-Chief, I reminisced about how others

have signed-off. Casey Kasem, a radio host, use to always say "Keep your feet on the

ground and keep reaching for the stars. And until you get the one you want, I hope you'll

stay with the station of the stars." Walter Cronkite always ended his programs with "…and

that's the way it is". Carol Burrett, a famous comedian, use to tug on her earlobe as a mes-

sage to her grandmother. But the most memorable sign-off for me was Red Skelton, who

used to sign-off by saying “Good night and may god bless”.

May your research touch the lives of others.

Steve Marx, Editor-in-Chief

ISPOR CONNECTIONS

Dr. Odds By Steve Marx

It is hard to believe that a year has passed sinceour last international meeting. Only after being

President, can you really appreciate some of thecomments that previous presidents have madebefore you. I remember last year, MichaelDrummond gave his outgoing address, and itwas entitled, “A Year is a Long Time in ISPOR. Itis amazing to see firsthand how much this organ-ization accomplishes in one year. I also remembera few years ago when Sean Sullivan gave his out-going address, and noted that he was counting

down the days until the next president took over.I believe all past presidents would agree, thedemands of this organization are intense, howev-er the reward of the dedicated membership, lead-ership and staff are seen around the world againand again.

The theme of my comments for you this morningis International Transition: A Year in Review.Despite the fact that it is clear the goals of thisorganization has been to be truly internationalfrom the beginning, 13 years ago, in this particu-lar year some significant milestones haveoccurred, truly confirming our growing interna-tional strength for this organization. I have organ-ized my comments as follows: 1) background onwho we are: our membership and our global rep-resentation; 2) a review of what it is we do as anorganization; and 3) where we are going,reminding you of our vision and what we haveachieved to get there. Finally, I would like to takethe opportunity for some appreciations.

Who is ISPOR?Membership. ISPOR's numbers and statisticsare really impressive. We now have a member-ship of over 4,100 individuals and these mem-bers come from 96 different countries. When Isaw this statistic I was curious as to what is thedenominator? How many countries are there inour world anyway? So I googled, as we allwould, “how many countries are in the world,”and came back with 195 countries. So the reali-ty is that almost 50% of the countries in the worldare members and represented by ISPOR. It isalso interesting to note that out of our 4,100members we have over 2,000 attendees at thismeeting. So it is impressive to know that 50% ofour membership is at the 13th AnnualInternational Meeting in Toronto.

In terms of representation of our membership, ifwe look by work environment, the groups that arerepresented include health researchers, as wellas health care decision makers worldwide includ-ing pharmacists, physicians, economists, nursesand researchers from academic, pharmaceuticaland biotech industry, government, managedcare, health research organizations, and pur-

chasers of healthcare. It is of greatinterest is to look atour decision maker practitioner representation,clinical practice, and managed care, and the gov-ernment. Last year, those numbers were 1%foreach of those pie pieces. We have grown ourmembership in clinical practice managed careand government to 6% and 11% respectively.This is really impressive and again, very much inline with one of our key strategies to grow themembership in the area of decision makers.

We can also look at our membership by researchinterest. Based on all of the abstract submissionsfor this meeting we have presentations andposters in the area of cost studies and also inclinical outcome studies, patient reported out-comes, health care use and policy studies andthen also research methods. We continue to rep-resent a diverse perspective on the research thatwe do.

As to our representation by geographic region wecontinue to decrease the presence of the UnitedStates in order to make this more of a global andinternational organization. Since last year, wewent from 49% to 48% representation in NorthAmerica, and the gain was in Canada whichmakes sense as our 13th Annula Meeting is inToronto. We continue to have 34% of our mem-bership that comes from Europe and growingrepresentation from the Asia- Pacific region,Russia, Africa, and Latin America regions. Butwhat strikes me more than the growing globalrepresentation for the organization whichchanges slowly from year to year, is a significantincrease in infrastructure around our global initia-tives and membership. First let me share withyou our regional consortia. We have the ISPORAsia Consortium and now also the ISPOR LatinAmerica Consortium. I had the great privilege ofopening the inaugural ISPOR Latin AmericaConference in Car tagena, Columbia, inSeptember 2007. It was a real joy to be wel-comed by our warm colleagues in Latin Americaas well as the warm and humid climate ofColumbia. But nonetheless it was really excitingto see almost 300 members of the consortium


Outgoing Presidential Address: International Transition –A Year in ReviewDiana Brixner PhD, 2007-2008 ISPOR President and Professor and Chair of the Department of

Pharmacotherapy and Executive Director of the Pharmacotherapy Outcomes Research Center at the

University of Utah College of Pharmacy, Salt Lake City, UT, USA

May/June 2008 ISPOR CONNECTIONS 3

>

IN THIS ISSUELETTER FROM THE EDITOR 2


Outgoing Presidential Address: InternationalTransition - A Year in Review 3

OUTCOMES ASSESSMENT

The EMEA Guideline on Health Related Quality ofLife and Its Impact on Drug Development 6

POLICY ANALYSIS

Conditional Reimbursement Based on FutureResearch 9

Same Language, Different Country: Do All Roads Lead to Rome? 11

Pharmaceutical Outcomes Research and Policy in Canada - Context and Recent Developments 13

ISPOR CORNER

Oh, Canada! ISPOR 13th Annual InternationalMeeting Goes “North of the Border!” 15

ISPOR 3rd Asia-Pacific Conference Information

ISPOR 13th Annual Meeting Award Recipients 17

ISPOR 13th Annual Meeting Photo Gallery 20

Board of Directors New Elected Members TakeOffice on July 1, 2008 22

Looking Back and Moving Forward: Last Year was Huge and This Year is Going to be Even Bigger! 23

News Briefs From Around the World 24

Recently Published Works: Using Pharmacoeconomics Innovatively 24

ISPOR 11th Annual European CongressProgram 26

ISPOR 11th Annual European CongressShort Courses 27

ISPOR 11th Annual European Congress Information 29

ISPOR 11th Annual European Congress Information 30


were at the meeting in Latin America and atremendous enthusiasm for learning the princi-ples of pharmacoeconomics and outcomesresearch and how to apply them to drug reim-bursement. Of course we are all looking forwardto our 3rd Asia-Pacific Conference which will bein Seoul, Korea in September.

Local Chapters. We have also seen someimpressive growth in our local chapters. Just inthe last year we have added seven new localchapters to the organization and at the mostrecent ISPOR Board Meeting, we approved threemore; Australia, Croatia, and Jordan, to a total of10 added in the last year, and a total of 28 localchapters. The amount of activity that goes on inthese local chapters is really impressive. Duringthe last year I had the privilege to visit two of thelocal chapter organizations. First in Greece, lastSeptember, I was invited to the (HELSPOR)Group, the Hellenic Society of Pharma-coeconomics and Outcome Research, and metwith Dr. Mary Geitona who is the President of theGreek Chapter and also with John Yfantopouloswho is one of our two program co-chairs for ourupcoming European Congress in Athens, Greece.

Just last month I had the privilege to attend thesummer school and co-host this program withthe President of the Turkey Chapter, in AntalyaTurkey. Once again, there were over 100 peopleat this meeting, individuals from the reimburse-ment agencies, industry and from universities, alltrying to learn the principles of pharmacoeco-nomics and understand how they can be appliedto drug reimbursement in their country. My co-host there was Dr. Cankat Tulunay. The capacityof these local chapters to bring the tools of ISPORto the local environment is truly impressive, aswell as all the size of the membership of thesechapters. The members of the local chapters donot need to be members of ISPOR which allowsthem to appreciate the resources and tools of thisorganization. And in fact, if we look at all of themembers of local chapters that are then affiliatedwith ISPOR our true membership with affiliationsis close to 10,000 individuals around the world.

So once again the activity of our local chapters isimpressive, and the obligation of our organizationto provide the resources to support these chap-ters is also very important.

What ISPOR DoesMeetings. I will now switch gears to focus onwhat we do as an organization. One of the mostimportant things we do is to have meetingsaround the world to give us all the opportunity toget together and share our research and ideas forapplication to reimbursement. First our meetingsin North America, we are all here in Torontotoday, and our next meetings will be in Orlando,Atlanta, and Baltimore, respectively. Next let'stake a look at our Congresses that will be happen-ing in Europe. We will all be in Athens this fall forour next European congress. Our program chairsthere will be John Yfantopoulos and Uwe Siebert.From there, we will be going to Paris, France in2009, Prague, Czech Republic in 2010, andpotentially Vienna, Austria in 2011.

As previously mentioned, we now have ourregional Coferences to support our regional con-sortia. For the Asia-Pacific Conference we will behaving the meeting in Seoul in September, andthen the next meeting will be in Phuket, Thailandin 2010. And for our Latin America Consortium,in 2009 the meeting will be in Brazil, and then thefollowing meeting two years later, will be inMexico in 2011.

Resources. ISPOR's extensive resources provid-ed to our members and our chapters around theworld include access to various databases on theISPOR website, www.ispor.org. We have data-bases of international pharmacoeconomicsguidelines; compilations of all of the databasesavailable around the, and also a new Roadmapthat presents the different reimbursement struc-tures in various regions and countries around theworld. We also have information, reports, arti-cles, on the various outputs from our specialinterest groups and task forces such as theHealth Technology Assessment and EvidenceBased Decisions, and the Good ResearchPractices on Retrospective Databases, Med-ication Compliance and Drug Standards. At ourrecent ISPOR Leadership Retreat we wentthrough all the special interest groups, taskforces, and various committees and used theISPOR website as our guide throughout the day.So again, I encourage all of you to recognize thetrue depth and value of the resources and infor-mation that are contained within our own ISPORwebsite.

Publications. Again, this is the primary tool forus to communicate and disseminate the science

and current research to our membership and ourcolleagues around the world. Specifically ISPORCONNECTIONS; this journal has really pro-gressed over the last few years to provide ourmembership with technical articles on methodol-ogy and health care policy issues. Value in Healthcontinues to grow as an international peerreviewed journal. Our impact factor is 3.4 and isfar ahead of most of other journals in our field.We also have Health Care Costs, Quality, andOutcomes: ISPOR Book of Terms, which has nowbeen translated into many different languages toaccommodate the growing local chapters. Wehave many other publications that are in develop-ment, and future books that are planned. Later in2008 will be our book on medical device anddiagnostic outcomes research in pharmacoeco-nomics and also future books that will be outputsof the various good research practice documentsthat have been published.

How does all of this get done? How do the meet-ings get organized? How do we get these goodresearch practices, the publications, the outputs?It is all done by the working groups that are creat-ed through the membership of ISPOR. Theseworking groups include our special interestgroups, our ISPOR Task Forces, our ISPORAdvisory Councils, and also our student member-ship. We have over 200 students that are here atthis meeting, which is really terrific. As you lookedat the very large group at the student receptionlast night, we all need to recognize that these indi-viduals are our future and we welcome them.

Where is ISPOR Going?Let me take a moment to talk about the ISPORvision. Remember that our vision is to assurethat what we do is being utilized and applied bypatients, providers, and payers. We also have aresponsibility to continuously test the relevancyof our work, to those that we expect to benefit. Iwas able to participate in two important eventsduring the last year that really helped to move ourvision forward. The first was participation in aQALY workshop that was held in Philadelphia inNovember 2007. We had experts from around theworld address the methodology of the QALY andalso the application of the quality adjusted life yeartowards drug reimbursement decisions. The pro-ceedings of this workshop are in development.

I also was able to attend, along with our FoundingExecutive Director, Marilyn Dix Smith, a meetingof the Joint Commission of PharmacyPractitioners. ISPOR is an invited participant tothis group, and we were able to contribute themission of our organization and what we doaround outcomes measurements. We look for-ward to following up with a subset of this group,

continued from page 3...

I remember last year, Michael

Drummond gave his outgoing

address, and it was entitled,

“A Year is a Long Time in ISPOR.”

It is amazing to see firsthand

how much this organization

accomplishes in one year.

< advertisement >


the Pharmacy Quality Alliance, to assist them inusing outcomes measurement to determine thevalue of medication therapy management andother pharmacy interventions.

In summary of who we are, what we do, andwhere we are going, I'd like to take the opportu-nity to thank some of the key individuals thathave assisted in making these many accomplish-ments happen, over the last year. First and fore-most, it is a tremendous pleasure to give specialthanks to the ISPOR staff. This is a tremendousorganization of individuals that are truly respon-

sible for the day to day activities to make ourorganization such a success. They are now 20individuals strong. Our incoming President,Chris Pashos and I had the privilege of visitingthem in February of 2008 in their offices inLawrenceville, New Jersey. It is truly impressiveto see how much activity goes on in those officesto support our organization.

I also would like to thank the faculty, staff, fel-lows, and students of our PharmacotherapyOutcomes Research Center, Salt Lake City, Utah.The staff, for managing my travel and putting upwith AM board teleconference calls, and the fac-ulty, for being tolerant of my absence and absent-mindedness when the multitasking got out ofcontrol. I would also like to thank the Dean of theCollege of Pharmacy, Dr. John Mauger for hisongoing support, and I am particularly pleasedthat he and his wife Karen are attending the 13thAnnual International Meeting.

Thank you. IC

Remember that our vision is

to assure that what we do is

being utilized and applied by

patients, providers, and payers.

We also have a responsibility to

continuously test the relevancy

of our work, to those that

we expect to benefit.

FUTURE ISPOR MEETINGSISPOR 3rd Asia-PacificConference7-9 September 2008 Grand Hilton SeoulSeoul, South Korea

Early Registration Deadline:15 July 2008

ISPOR 11th Annual European Congress8-11 November 2008Hilton AthensAthens, Greece

Abstract Submission Deadline:23 June 2008

Early Registration Deadline:30 September 2008


The following was presented during from theSecond Plenary Session, “Patient ReportedOutcomes: A European Perspective,” at theISPOR 10th Annual European Congress, 22October 2007, Dublin, Ireland.

IntroductionSeveral working parties have been working on thebehalf of the Committee of Human MedicinalProducts (CHMP) at the European MedicinesAgency (EMEA). The role of the Efficacy WorkingParty (EWP) is to elaborate guidelines for clinicaldevelopment of medicinal products in differentfields of medicine.

In some of the EMEA/EWP guidelines [1] patientsrelated outcomes (PRO) and health related quali-ty of life (HRQL) have been mentioned as a partof drug development programme either as effica-cy variables (primary, secondary, supportive),safety variables, or measures useful for benefitrisk assessment, but neither define HRQL norPRO in general nor recommend how to assessHRQL/PRO claims in marketing authorisationapplications. The impression of both regulatorsand pharmaceutical companies has been thatHRQL/PRO claims have been granted rarely andon case by case basis.

For all these reasons the EMEA EWP has decidedto draft a specific reflection paper on HRQL/PROassessment in registration trials. The aim was todefine the place and to give recommendation forthe use and assessment of PRO, in particularHRQL, in the drug evaluation process. In addition,the definitions of PRO and HRQL frequently usedinterchangeably both by sponsors and regulatorswere also provided.

Patient-reported outcome (PR0) defines any out-come evaluated directly by the patient himselfand based on patient's perception of a diseaseand its treatment(s). The term PRO is proposedas an umbrella term to cover simple patient-assessed measures (such as pain or itching),multi-item, single concept measures (such asHealth Assessment Questionnaire, HAQ), multi-item, multi-concept measures (such as theWestern Ontario and McMaster UniversitiesOsteoarthritis Index (WOMAC) or Activities ofDaily Living ADL)) as well as broad multidimen-

sional measures (such as HRQL). In addition,PRO may also cover health status, adherence andsatisfaction with treatment.

For the purpose of drug development, the PROscope was considered to be too large. From oneside, simple patient-assessed measures are acore symptoms of a disease assessed by patienthimself and well established primary and second-ary efficacy endpoints in registration trials, anddo not need any specific regulatory requirements.From the other side, HRQL, a specific subset ofPROs, is a broad concept which can be definedas the patient's subjective perception of theimpact of his disease and its treatment(s) on hisdaily life, physical, psychological and social func-tioning and well-being. The notion of multidimen-sionality is a key component of definition ofHRQL. A single domain, e.g., physical functioningor fatigue, is not considered as a HRQL (i.e. itcannot be the basis for a claim for a global HRQLimprovement), even though it is a patient-report-ed. In addition, HRQL should be clearly differenti-ated from the core symptoms of a disease whichare, as stated, well-accepted primary and sec-ondary efficacy endpoints in registration trials.

Therefore, the scope of the reflection paper wasnarrowed to include only HRQL as a specifictype/subset of PRO and to define the place ofHRQL in the context of drug approval and to givesome broad recommendation on its use in thecontext of already existing guidance documents.No specific recommendation has been given fordevelopment and validation of HRQL measures inclinical trials, as it is available elsewhere [2].

The reflection paper was adopted by the CHMP inJuly 2005 and came into effect in January 2006[3]. It stressed the notion of multidimensionalityas a key component of definition of HRQL.

Basic RecommendationsThe basic recommendations are:

• Efficacy and safety of a medicinal product inthe given condition are the basis of approval, and• HRQL claim always goes beyond efficacy andsafety assessments, is optional, and should besupported by data collected by instruments vali-dated for use in the corresponding condition.

Both generic and disease specific questionnairesmay be used for a given condition. In practice, itis very important to choose the questionnairewhich contains/is adapted to explore the domainsrelevant for the disease and its treatment(s).

HRQL claims may be global and more specific. Inorder to approve a global claim that a product“improves HRQL”, it would be necessary todemonstrate robust improvements in all or mostof these domains. Indeed, “HRQL improvement”as a claim implies that the most important andclinically relevant health-related domains of func-tioning that impact patient's quality of life areknown and measured. In all cases a full disclo-sure of complete results should be provided (sec-tion 5.1 of the SmPC).

Whatever the HRQL claim (specific or global),changes observed in all HRQL domains shouldalways be specified.

Specific HRQL claim (product “improves physicalfunctioning”), based on the subset (one or two)of domains of HRQL, is acceptable if:

• Whole HRQL instrument is adequately devel-oped and validated before the trial; • Subset of domains of interest is pre-specified;and• Clinical relevance (on the subset of domains)predefined and documented.

EMEA paper does not explicitly require that HRQLinstrument be validated to measure the subset ofdomains independently from the other domainsprior to the trial. However, a sponsor needs todocument the change on the predefined domainsof interest and to provide information on theamount of change (on the subset of domains)that is considered to be clinically and not onlystatistically relevant. In case of positive/relevantresults, a specific claim reflecting domain(s) withimprovement might be mentioned in the SmPC.

The claim in the SmPC with the respect to HRQL(i.e. in section 5.1) will always be considereddepending on the strength of the evidence and therelevance (pertinence and importance) of thefinding. The strength of the evidence should bebased on the rationale for HRQL assessment in

OUTCOMES ASSESSMENT

The EMEA Guideline On Health Related Quality OfLife And Its Impact On Drug DevelopmentMira Pavlovic MD, Scientific Advice Unit, Agence Française de Securité Sanitaire des Produits de Santé, Direction

des Médicaments et des Produits Biologiques, Saint-Denis Cedex, France


the context of the disease/medicinal product, thejustification of the choice of the HRQL question-naire(s), the objectives of HRQL assessment andthe hypotheses of HRQL changes, the evidenceof validation (and of cultural adaptation/transla-tion if applicable) of the HRQL questionnaire(s),the adequacy of the statistical analysis plan, andthe relevance of observed changes.

Study Design for HRQLAssessmentThe HRQL is considered to be an endpoint simi-lar to any other endpoint. Thus the study designshould not be different from any other ran-domised, preferably double-blind, comparativetrials (placebo and/or active comparator con-trolled). However, the study design might slightlydiffer depending of the stage of development of amedicinal product.

If a medicinal product has no marketing authori-sation, the HRQL (using a validated and appropri-ate questionnaire) may be studied simultaneous-ly with the efficacy/safety of the medicinal prod-uct in pivotal (phase III) trials. The HRQL may bethe part of a co-primary endpoint or it may be akey secondary endpoint. Whatever the design,the study should be powered for both endpoints.

If a medicinal product has obtained a marketingauthorisation (or if efficacy and safety of the testdrug have already been convincingly shown), theHRQL may be assessed in an active comparatortrial as placebo comparison might not be feasibleany more; in addition to the HRQL endpoint, effi-cacy endpoints should also be incorporated toensure that efficacy is sustained.

Study DurationBoth in relapsing and remitting symptom-drivenconditions and in chronic stable conditions, long-term trials (6 months or more) are recommend-ed. HRQL assessment during very short-term tri-als (less than one month) are not currentlyencouraged as it assesses more the improve-ment of the daily living due to the effective treat-ment in a given condition rather than the HRQL inits multidimensionality.

Statistical Analysis PlanThe methodology for analysing HRQL data issimilar to the methodology used for any efficacytrial, except that by its nature, HRQL assessment(multi-items, multi-domains, repeated over time)renders such issues as multiplicity and missingdata more problematic. The following pointshould be specifically defined:

1. Timing and number of HRQL assessments.2. Sample size/power of the study based on

expected difference between groups : definitionof the Minimal Important Difference (MID), defini-tion of a responder (minimal important of changewithin a patient).

Indeed, the relevance of HRQL changes shouldalways be justified by the sponsor. This relevanceshould have been defined a priori in the protocol,as it constitutes the basis for generating hypothe-ses. The minimal important difference (MID) maybe used when powering the studies. It should bekept in mind however that the determination ofMID should be upon a combination of statisticalreasoning and clinical judgment and none ofthem on its own is sufficient.

One approach for controlling multiplicity acrossdifferent endpoints is a hierarchical testing. Themost important (efficacy) endpoint is tested first;if it is significant, then the second endpoint(HRQL) can be tested. If the first endpoint is notsignificant, then no further testing is undertaken.The number of patients, necessary to support thechange in the primary endpoint, is frequently suf-ficient to test for the HRQL change. In some situ-ations the trial is even overpowered and results insignificant but not relevant and very small differ-ences in HRQL scores. Therefore, every effortshould be made to ensure that the sample sizecalculated for the primary endpoint is adequatefor demonstrating hypotheses made a priori onthe HRQL assessment.

The approach to overcome multiplicity will alsodepend on the number of domain scores. Asstated earlier is may be of interest to pre-specifya subset of HRQL domains which will be thebasis for a specific claim. Other methods mayinclude correction of p-values, hierarchical test-ing among multidomain scores (if the compari-son of the domain score considered as the mostimportant is significant, then the second domainis tested) or global test procedures. To reportonly a global score across domains, although itmay reduce the number of tests, is not consid-ered adequate as it will reduce the information onHRQL multidimensionality and may mask oroverestimate HRQL treatment differences inimportant domains. The method for handlingmultiplicity should be stated a priori in the statis-tical analysis plan.

HRQL Assessment in Cancer:Design of Chemotherapy Trials(Taxotere) [4]As already stated, the HRQL assessment has pri-marily an interest in chronic diseases, both innon-life threatening and in severe life threateningdiseases such as cancer. A comparison of twochemotherapy regimens, where one confers bet-

ter HRQL than the other, is, at least in theory,important information for patient management.The EMEA reflection paper recommends compar-ative randomised trials (a face to face compari-son or an add-on design) with the overall survivalrate or the progression-free survival (dependingon cancer) as the primary endpoint and the HRQLas a co-primary or a secondary endpoint.However, for gaining a HRQL claim, the HRQLbenefit must be achieved without any reduction intreatment efficacy (e.g. through reduceddoses/toxicity). Open-label studies are not rec-ommended although achieving double-blind maybe difficult in some chemotherapy trials.Therefore, at least patients should be masked forthe treatment assignment. A particular attentionshould be paid to the management of missingdata due to patient deterioration and death. Insummary, there are several problems to take intoaccount in the analysis of results: lack of investi-gators commitment, cumbersome instruments,duration of trial to capture a change of HRQL(independent of survival benefit), handling ofmissing data, and, most importantly, clinical sig-nificance of apparent HRQL differences.

However, in situations where two treatmentregimes show no significant survival differences,an improvement of HRQL becomes an importantelement of decision making. Taxotere (docetaxel)marketing authorisation file is an excellent exam-ple. QoL assessment was done from the follow-ing indications:• Breast cancer: in combination with doxoru-bicin (1st line);• Non small cell lung cancer: in combinationwith platinum agents (1st line);• Hormone-refractory prostate cancer in combi-nation with prednisone;• Gastric adenocarcinoma in combination withcisplatin and 5-FU (1st line); and• Head and neck squamous cell carcinoma: incombination with cisplatin and 5-FU (1st line).

Studies were open-label, long-term, parallelgroup comparative randomised trials, with overallsurvival as a primary endpoint and HRQL as asecondary endpoint. The HRQL was assessed byusing validated instruments: FACT-P for prostatecancer, EORTC QLQ-C30 (global QoL domain)and QLQ-HN35 (4 modules) for head and necksquamous cell carcinoma, and LCSS, and EQ5Dfor non small cell lung cancer (TAX 326 study).The TAX 326 study compared two drug combina-tions of docetaxel plus cisplatin or carboplatin tovinorelbine plus cisplatin in chemotherapy-naïvepatients with unresectable or metastatic non-small cell lung cancer. Even if there was no differ-ence in overall survival and time to progressionbetween docetaxel + carboplatin and vinorelbin >


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+ cisplatin treatment arms, patients on docetaxel + carboplatin had betterHRQL, (both on LCSS and EQ5D scales), as well as better Karnofsky statusand less weight loss than patients treated with vinorelbin + cisplatin.

The HRQL improvement-related claim for docetaxel + carboplatin treatmentarm was mentioned in the section 5.1 of Taxotere SmPC, even if no detail ofHRQL results could be found neither in the EMEA reports on docetaxel, in itsEPAR or in its SmPC. The HRQL improvement was also mentioned for allother indications even in case of non-conclusive results:

1. “QoL measured by the EORT questionnaire was comparable and stableduring treatment and follow-up” (breast cancer)2. “QoL results consistently indicated improvement in favour of … arm”(gastric adenocarcinoma)3. “No statistical differences were observed between treatment groups forglobal QoL” (prostate cancer)4. “Patients treated with… experienced significantly less deterioration of theirGlobal health score assessed with EORTC QLQ-C30 scale” (head and necksquamous cell carcinoma)

Other ExamplesAnother example of the HRQL assessment in oncology was given from thepublished literature: doxorubicin and paclitaxel regimen was compared todoxorubicin and cyclophosphamide as the first-line chemotherapy in patientswith metastatic breast cancer [5]. This was a short-term (3-month), open-label, randomised controlled trial with the overall survival as the primary end-point and validated HRQL questionnaires (EORTC QLQ-C30, QLQ-BR23Breast module, disease specific) as secondary endpoints. Five scales fromthese two questionnaires were pre-selected for primary analysis and theexpected minimally important difference (MID) was pre-defined. The samplesize was based on the primary endpoint, but the study was also powered todetect 10-point shift on the overall HRQL scale. All HRQL results were dis-played, both for pre-specified and non pre-specified HRQL domains.

If we compare the conduct of this trial to the recommendations given by reg-ulatory authorities, there are several remarks which may be formulated: thefull disclosure of results is valuable, as well as the power of the study basedon both overall survival and 10-point improvement in the HRQL scale. Theopen-label character of the trial is understood, however, it was not clear ofpatients were blinded or not for treatment assignment. In addition, it was notclear if the five predefined scales were previously validated to be used sepa-rately. Finally, the short trial duration (3 months) was questioned, as theobserved HRQL changes may have reflected more efficacy/safety of treat-ments than their impact on HRQL long-term.

The last example is coming from a recent marketing authorisation file of anepoetin similar to an already approved reference product (biosimilar epoetin).These biological medicinal products, administered to improve anaemia inpatients with renal insufficiency and cancer, are also believed to improve theHRQL. The file was analysed to see if and how the HRQL was assessed. Thepivotal trial was a randomised, double-blind 6-month equivalence trial inhaemodialysis patients to compare the new epoetin to a reference product forthe maintenance treatment of anaemia. The primary endpoint was haemoglo-bin-based; secondary endpoints were: “QoL assessment” of “energy level”,“ability to work” and “overall QoL”. However, all these items were assessedby a simple question: “Rate your energy level/ability to work/overall QoL dur-ing the past week” by using a linear analogue self assessment scales. Therewas no real HRQL assessment in any of epoetin files and in any of the grant-ed indications.

ConclusionWith the recent release of the EMEA reflection paper on HRQL and of the FDAguidance on patient-reported outcomes (PRO), these patient-based meas-ures have gained acknowledgment of their value in the drug evaluationprocess. The two papers issued by regulatory authorities set the principles ofthe assessment of PRO and HRQL in clinical trials and the requirements forgaining a specific claim based on these measures. However, it might be stilltoo early to know whether these recommendations have been put into prac-tice by sponsors from one side and whether they have already had an impacton the assessment of medicinal products and PRO/HRQL-related claims byregulators. The given examples show rather disparate picture. The review ofnew trials and marketing authorisation requests will test whether the EMEAreflection paper on HRQL is a useful tool for sponsors for gaining HRQLclaims in the drug development process.

References1. Szende A, Leidy NK, Revicki D. Value Health 2005;8:534-548.

2. FDA Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical ProductDevelopment to Support Labelling Claims. 2006

3. CHMP reflection paper on the regulatory guidance for the use of health-related quality of life(HRQL) measures in the evaluation of medicinal products. EMEA/CHMP/EWP/139391/2004

4. EPAR Taxotere.

5. Bottomley A, Biganzoli L, Cufer T et al. J Clin Oncol 2004;22:2576-2586.

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The following was presented during the Third Plenary Session, “ConditionalReimbursement Based On Future Research,” at the ISPOR 10th AnnualEuropean Congress, 23 October 2007, Dublin, Ireland.

The option of recommending the use of a technology in the context ofresearch or data collection has been part of NICE's statutory rights from thevery beginning. In addition to the yes and no type decisions, NICE hasalways had the option of recommending further research particularly forpromising interventions where the evidence base is weak; “only in research”OIR recommendations indicate the questions that the research should beaddressing and advise clinicians that in the meantime the technologiesshould be used in the context of this research. Of course, it is a very chal-lenging decision option to implement. There are important questions aroundwho pays for this research: will it be public or private funding or mixed?What happens in the meantime, while this research or data collection isongoing? That depends again on the type of the research, the extent towhich patient access is restricted the type of uncertainty to be addressed.And finally what are the mechanisms to then use the research results toinform updates of the guidance?

We can explore some of these issues through examples of previous NICEdecisions. In the case of photodynamic therapy NICE recommended the useof the technology only in the context of research. NHS R&D funded aprospective cohort study that is still ongoing; the study's findings will informthe next NICE update. Setting the study up has not been without challenges,however it is now up and running; the London School of Hygiene has set upan interesting website on this study that addresses some of the issues of OIRin the context of NICE (http://www.lshtm.ac.uk/hsru/vpdt/). This is a studywith public funding in terms of participation and access. Almost all patientsthat are eligible to get this intervention do get it across the country in thosecenters that participate and almost every center is part of this work. As anexample of private funding, NICE issued an OIR recommendation in 2002 forthe use of CCBT technologies only in the context of research. Since then theguidance has been updated: for two of the technologies, “Beating the Blues”and “Fear Fighter”, additional RCT evidence was submitted by the manufac-turers and NICE recommended that these technologies are reimbursed in thecontext of the NHS. For two more technologies, NICE recommended thatmore information is needed and this only in research recommendations stillholds because of the existing uncertainty. To give an overview of what wehave been doing so far, about one in 20 NICE's technology appraisal recom-mendations have been only in research. Almost half of recommendationsaround the use of surgical procedures have similarly been OIR. Finally, inNICE clinical and public health guidance, where there is a lot of uncertaintymainly around established and well-diffused interventions that may requirethe OIR option has been used extensively by our decision makers.

Risk sharing could well be thought of as another way of collecting the infor-mation to inform definitive decisions on coverage and multiple sclerosis is anexample of such a scheme that was set up by the Department of Health andit is still ongoing. Most recently, the NICE decision on Velcade for multiplemyeloma, it is an interesting example of risk sharing where manufacturers

and decision makers agreed that the drug could be reimbursed as long asmore evidence was collected and the evidence was used to inform reim-bursement rates on a case-by-case basis. This evidence will also be usedto inform the NICE update in three years time.

Risk-sharing schemes form part of the current discussion on value based pric-ing. In their 2007 report, the Office of Fair Trading acknowledge risk sharing asa means for coordinating expectations of both payers and manufacturers andparticularly in cases where it is very hard to reach an agreement fairly early onin the decision making process because of the weak evidence base:

“Where sufficient information at the time of launch was not available to takean informed view…risk sharing arrangements can help coordinate theexpectations of the payer and manufacturers…allow for more predictableuptake for manufacturers, and predictable health gains for a given expendi-ture [when] an agreement may not be able to be reached otherwise.”

– OFT Report, February 2007

We have so far been talking a lot about costs: some people have argued thatNICE only cares about the cost per QALY and that the OIR option may beanother way for restricting access to treatment to save money. This is farfrom true; NICE involves patients and the public in developing individual rec-ommendations and, with the help of its Citizens Council, it involves the pub-lic in shaping its general social value principles that inform the broader deci-sion making process. In this context we asked the Citizens' Council whatthey thought of the OIR option, of recommending a technology only in thecontext of research when we are not certain about its effects. The Councilconcluded that “patients would be reassured to know that clinicians and thesystem in general can face up to uncertainty and are confident enough todeal with it in a mature and scientific way, avoid wasting resources onunproven technologies.” In their report which can be found on the NICEwebsite, the Citizens' Council has listed a number of key consideration deci-sion makers should take into account before making an OIR recommenda-tion, including whether the uncertainty can be reduced through furtherresearch, whether the research is feasible, whether patient access will becompromised during the research. Patient access to the research rather thanpatient access to the technology was their main concern, as were the time-liness and the value for money of the research.

There are three key conditions for the OIR to work: a) we have to develop andapply consistently clear decision criteria that can guide policy makers assesshow much uncertainty is enough to warrant an OIR recommendation; b) thehealth care system, including professionals, commissioners, researchers,patients and industry have to work towards developing the right frameworksfor implementing OIR recommendation in the real world; and finally c) Wehave to make sure that the right mechanisms are in place to allow promptupdate of the guidance in light of the research evidence. In a way the thirdcondition is the easier to meet in the context of the NICE regular reviewprocess. A lot of progress is made with regard to the second condition: weare developing, in the UK, an effective infrastructure through the efforts of

POLICY ANALYSIS

Conditional Reimbursement Based on FutureResearchKalipso Chalkidou MD, Associate Director, Research and Development, National Institute for Health and Clinical

Excellence (NICE), London, UK

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the Clinical Research Collaboration, and, in the post-Cooksey world, theOffice for Strategic Coordination of Health Research (OSCHR). Furthermore,the potential of Connecting for Health for generating outcomes data to informOIR recommendations is considerable.

The Cooksey Report on health research in the UK, published in December2006, recommended that NICE and NHS R&D work more closely togetherand that funding is allocated to direct implementation of NICE recommenda-tions calling on the NHS to use technologies in the context of research. Thisreport was endorsed by Gordon Brown in the pre-budget report and therecent comprehensive spending review report so it will be fully supportedfinancially. In fact there has been an announcement recently for an increasein public HTA funding, for the National Institute of Health Research to supportthis sort of HTA, real world studies that seek to address decision makers'questions and inform policy and practice. Another fairly recent announce-ment in the Darzi Report of the Health Innovation Council was $100 millionwas given to support good value innovation. Reducing decision makers'uncertainty on the effectiveness and value of new and existing technologiesthe NHS pays for could and should be part of the remit of the InnovationCouncil and this broader initiative. Finally, the new critical path modeledalong the lines of the FDA critical path raised also by Cooksey is anotherimportant development where NICE, NIHR and ABPI, and individual manu-facturers can work together throughout the licensing process to inform deci-sions and fill evidence gaps.

NICE has been working closely with NIHR over the past two years with a spe-cific focus on primary research coming out of NICE technology appraisals

but also clinical guidelines and public health guidance. We hold regular jointprioritization meetings to look at NICE research recommendations and haveset up what we call “direct access” to support specific questions that NICEdecision makers have, head to head trials most of the time, which industrymight not be willing to fund. The results of such research will directly informNICE updates and be translated into policy and, hopefully, clinical and publichealth practice.

One of the biggest challenges facing NICE is how to deal with uncertainty.Should we say 'no' when we do not know? This is a very important ques-tion. It is a methodology question and it is a policy question. “yes/no' deci-sions are no longer adequate to deal with uncertainty in a pragmatic way. Alldifferent stakeholders need to come together to develop this third option thatallows access while encouraging evidence generation, that promotes innova-tion while preventing waste and protecting patients from potentially harmfuleffects of untested treatments. I think it is no longer sustainable to say 'no'when the evidence is weak as it is no longer sustainable to say 'yes' and givetechnologies the benefit of the doubt particularly within a resource con-strained system that is the NHS. Only in research is the third option that canaddress this dilemma.

On a different note, in the United States, millions of children are going unin-sured because of President Bush's veto against a joint Democratic/Republican proposal by Congress to expand coverage for poor children andtheir families. The reason: such expansions could lead to socialized medicineand universal coverage, which is what the case is in most European coun-tries today.

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Due to increasing interest in assessing Patient Reported Outcomes inmulti-national clinical trials, it is necessary to have cross-culturally valid

instruments in order to pool data across countries. With the changing ofboundaries and the fluidity of populations, choosing a language to corre-spond to a study site is an increasingly pertinent issue, and can be compli-cated. While one country can host several languages, certain languages arespoken in multiple countries, for example English, French, Spanish, Russian,and Arabic.

Determining Appropriate MethodologyThose involved in conducting multinational studies have sought to determinethe methodology that should be employed for translating a questionnaire forparticular groups of countries that share a language. However, there is noconsensus on this issue, and certainly an absence of systematic evidence tosupport any single methodology over another. Thus, decisions are currentlybased on the ad hoc accumulation of experience and discussion by thoseinvolved in the planning of multinational trials and those involved in the trans-lation and linguistic validation of PROs.

Despite the absence of guidance on the best strategy for same language/different country translations, we have chosen to outline the relevant issuesand to describe and critique current translation methodologies. It is hopedthat this paper will be helpful in assisting with the decision making processin this area.

Potential MethodologyFour key methodologies exist for the development of a measure in one lan-guage for use in different countries. The first and simplest of these is todevelop a single translation in a single country, to be used worldwide, on theassumption that because of its “simplicity”, the translated measure will beunderstood in other countries where the same language is spoken. The sec-ond methodology is to create a single version in one country which isreviewed early in the translation process in order to assess its comprehen-sion in another target country. A third, alternative approach is to determinefrom the outset that a separate translation will be produced for each country,with translators working independently. Finally, it is also possible to establishfrom the outset that representatives from all countries involved will worktogether to a produce a single, universal language version to be used in mul-tiple countries.

The methodologies are described below in the form of responses to frequent-ly asked questions in this area.

Is It Possible To Create A Single Version In One Country And Use ItWorldwide? There are advantages as well as disadvantages to this methodology, many ofwhich are highlighted from the opposite perspective in subsequent sections.The key benefits are time and money: with only one translation needed, thetranslation can be used throughout the world as soon as it is completed.However, there are significant risks when using one language version thathas not been checked for its suitability in other countries, including using lan-

guage that is unfamiliar to respondents, brand names with which respon-dents cannot identify, and inappropriate idioms. One way of overcomingsome of these may be to pilot test the translation in the appropriate patientgroups in each of the countries where it is needed. Though more costly andtime-consuming, should any changes be required as a result of the testing,the end result would be country-specific versions.

Would A Better Alternative Be To Develop A Single Translation In OneCountry And Review It To Assess Its Comprehension In Another TargetCountry? Preferably performed early in the translation process, one or two in-countryconsultants (native speakers of the target language, residing in the countryin question and preferably with expertise in health outcomes and relatedmedical research as well as in translation and/or translation management)can review the translation, and pilot testing in the appropriate patient groupwould usually be conducted. If a language version already exists this methodwill be quicker, but this may not be possible (see point b below). Based onthe review the following actions can be taken:

a. Where no issues arise, there is no need for a separate version to be devel-oped.b. If issues do arise, they can be fed into the translation process with the aimof producing a single harmonised version of the measure. This may not bepossible if the original version has already been used in trials or as the basisfor other translations. In these cases it is necessary to create separate lan-guage versions, as in point c below.c. Where significant irreconcilable differences arise, separate language ver-sions can be developed for each country.

The in-country review of an existing language version will therefore result inlanguage versions that are appropriate for use in different countries, whetherthis means separate language versions or one single version for use in mul-tiple countries.

Again, several advantages and disadvantages are associated with thismethod. For example, checking that the vocabulary used is appropriate foreach country ensures that the translation is more understandable and famil-iar to respondents, which may make them more comfortable completing themeasure. This may especially be the case with older patients who are usedto a more traditional language with fewer foreign loan words.

The inclusion of some items may have been due to their particular impor-tance in the culture within which the measure was developed. These itemsmay be less relevant in other cultures, where there may be certain relatedquestions of greater importance that have not been included. Where this isthe case, and if the developer can be consulted, decentering can occur. Withthe insertion of additional phrases or words into the translation for the newcountry, the original measure may consequently also be altered, if deemedacceptable and necessary by the developer. This can only happen if themeasure has not already been translated in its original form.

POLICY ANALYSIS

Same Language, Different Country: Do All Roads Leadto Rome?Caroline Houchin MA, Translation Coordinator, and Diane Wild MSc, BSc, Director, Oxford Outcomes Ltd., Oxford, UK, and

Sheryl Pease MBA, Pfizer, Inc., Ann Arbor, MI, USA

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On a non-linguistic level, there are other aspects which should be consideredin terms of cultural relevance. For example, with the use of the metric sys-tem in some countries and the imperial system in others, cultural adaptationis required. When culturally adapting an item which includes a unit of meas-urement, the employment of a sensible degree of accuracy is recommend-ed, for example 100 yards is better adapted to 100 metres than the more pre-cise 91 metres. Similarly, product brand names may not be known in allcountries. Substituting a cultural equivalent in these cases is a necessity.Another non-linguistic issue is the choice of response scales; an additionalexplanatory sentence or an example may be necessary in some countries toaid comprehension. Finally, the content of the measure might be deemedunsuitable for particular countries. For example, a questionnaire with itemsabout sexual behaviour or alcohol consumption may cause offence in somecultures.

There are several disadvantages associated with developing a translation inone country and reviewing it for use in another country. It can be difficult todetermine whether the changes suggested during a review of an existingtranslation are essential or rather the preferences of those doing the review-ing. It may also be a challenge for alternative, culturally sensitive wording tobe found. In addition, logistically, using just one language version rather thannumerous versions is more straightforward.

To demonstrate the variety in the types of changes necessary when review-ing an existing version, some examples are as follows. The Catalan for Spaintranslation of “education” (“Educació“) in the Polytrauma-Outcome Charthad to be changed to estudis for use with Catalan speakers in France. Thisis a simple vocabulary change.

A grammatical change was necessary when reviewing the BrazilianPortuguese translation of the same measure, for use in Portugal. In Brazil, thepronoun “you” (você) needs to be inserted in the phrase “have you become...”but pronouns are rarely used in this way in Portuguese for Portugal; instead theverb ending is relied upon to indicate the subject of the verb.

Cultural changes can also be necessary: in the Parkinson's Disease Qualityof Life Questionnaire (PDQ-39) one question asks the respondent whetherthey “lacked support in the ways you need from your spouse or partner?”.There was no problem translating this into Russian for use in Russia, butwhen the translation was reviewed for Ukraine it was necessary to remove“or partner” as Russian-speaking Ukrainians still mean “business partner”by this term. Another cultural change, this time in the Disabilities of the Arm,Shoulder and Hand (DASH) questionnaire, was to change “10lbs” to “5kg”in South African English. Lastly, in the Mini Mental State Examination(MMSE) respondents are asked “What is the county [we are in now]?” Thiswas translated as Bundesland in German for use in Germany but whenrevised for Switzerland the term had to be replaced by kanton, as Switzerlandis divided into cantons.

Should Separate Versions Be Produced For Each Country? The advantages and disadvantages of this approach are similar to those ofthe previous approach. However, one clear disadvantage with this processover the previous method is that creating separate language versions fromthe outset leads to a high risk of different translations, simply due to transla-tor styles. It cannot be determined if one version would have been appropri-ate for use in both or all countries in question, or if all the differences betweenversions were absolutely necessary.

One advantage of this approach, however, is that the translators are notrestricted by vocabulary and terms that may not be optimal for their country.

For countries that share the same language but are different culturally, geo-graphically or linguistically, this is also a benefit.

Is It Feasible To Create A Universal Language Version For Use In AllCountries?This approach involves discussion at every stage between representatives ofall countries involved, and also pilot testing with a relevant patient group ineach of the target populations.

The production of a single harmonised version to be used in more than onecountry can be time consuming. Agreement is required at all points betweenconsultants and reaching consensus might be difficult. This differs accord-ing to the countries and languages involved. One example of a problemencountered when trying to create a unified Spanish translation for use inboth Spain and Mexico was in an Interactive Voice Response System (IVRS)bowel study script. When respondents were asked to “enter your PIN,” eachin-country consultant used a different term for “enter” and could not acceptthe other country's word, as this had a different meaning in their own coun-try. In the same measure, translations for AM and PM had to differ becausewhile people living in Mexico use these terms, they are not frequently usedor understood in Spain. This latter country used “morning” and“afternoon/evening” instead. In the Satisfaction with Oral Anti-DiabeticAgents Scale (SOADAS) a compromise was reached between France andCanada as numbers under ten are spelt out as words in Canada, whereas inFrance these are left as numerals. The final unified translation included theword followed by the figure in brackets. As we can see, when creating a uni-fied translation, the final version may end up being a compromise: “accept-able” and not “ideal” for any of the countries concerned. It may also lack therichness of idioms that is often present in a language version for use in justone country. The principal advantage of this method, though, is that if onlyone version exists this will be simpler for those involved in running multina-tional trials.

Decision-making CriteriaHaving explored the key methods for producing translations of a measureinto one language for use in multiple countries, it is necessary to considerthe following issues:

A. How much time and financial resources are available and what is the atti-tude to risk and error margin?

B. Developer requirements must be adhered to. Many developers do notadvocate a specific strategy with regard to same language/different countrytranslations; however there are some notable exceptions, including theEuroQol and the EORTC group. Thus it is necessary to take account of:• The developer's translation requirements. • Previously employed translation strategies of the measure in question.

C. The measure itself should be examined in order to determine the pres-ence of characteristics that are likely to result in country-specific languagedifferences. Such characteristics include:• References to country-specific health care or education systems;• References to product names;• Complicated vocabulary that will present challenges to the respondent;• Response scales that can present cognitive challenges to the respondent;• Areas of enquiry that may offend the respondent; and• Technical details; for example ePRO scripts may include terminology thatis unfamiliar in certain countries.


D. Thinking about the languages and countries in question is also important.The strategy to be employed will differ according to which language andwhich countries are being considered as certain countries and languagesshare more linguistically and culturally than others. Languages that are com-monly translated for multiple countries include: English, Spanish, French,Portuguese, Chinese, Russian, Arabic, and Malay.

E. Finally there is a need to determine whether a language version is alreadyin existence.

Conclusions There are no hard and fast rules relating to the method that should beemployed when translating a measure into one language for use in multiplecountries. Guidelines can be followed which take into account the above cri-teria, but with the high number of factors involved in deciding on the besttranslation methodology to use, a number of options may still be available.

The complexity and characteristics of the questionnaire might well be asimportant to the decision-making process as the language and countriesinvolved. It may be beneficial to conduct more research into the methodsdescribed above, including comparing psychometric results of translationsfor use in the same countries but obtained by different methods. However,should conclusions be reached as a result of this research, it is still impor-tant to consider future projects on a case-by-case basis, due to differingcharacteristics of individual measures? Considering the highlighted pros andcons of each method should nonetheless facilitate the decision-makingprocess.

Canadian academic institutions have proven fertile for pharmaceutical out-comes research. Innovative research contributions have been made in

the fields of pharmacoeconomics, pharmacoepidemiology, pharmaceuticalpolicy and health-related quality of life. While multifactorial in nature, thisfocus on high quality outcomes research has arisen in part because of thestructure and organization of health care in Canada.

CONTEXT The Canadian health care system is often identified as an example wherepublicly funded health care coverage is made available to all citizens. Whilethis is largely true for the cost of physician and hospital services, the situa-tion with coverage for medications is more complicated. Delivery of healthcare falls under provincial jurisdiction while regulatory approval is mandatedfederally and the setting of prices is, in reality, a shared responsibility. All tenprovinces and three territories, as well as several other federally-fundedrecipient groups in Canada, have drug benefit programs which subsidize thecost of medications for eligible beneficiaries. The amount of these subsidiesand definition of eligible beneficiaries varies from province to province.

The Canada Health Act describes agreed upon desired characteristics of thehealth care system. The Act is federal health insurance legislation which pro-vides universal, publicly financed coverage of most hospital and physicianservices. This means that when a Canadian seeks medical care, the individ-ual goes to a physician or hospital of his or her choice and presents a healthinsurance card, which is issued to each eligible resident of the province.The individual does not pay directly for medically necessary services and nodollar limits or deductibles apply. Thus, the Canada Health Act ensures thatthe provision of health care services do not depend on an individual's abilityto pay. However, while legislation creates national standards, the Canadianhealth care system is actually a complex arrangement of funding mecha-nisms worked out between the governments at the federal, provincial and ter-ritorial levels. It is worthwhile noting that the Canada Health Act focuses onfunding mechanisms, and in contrast to the United Kingdom's National

Health Service, the health care system in Canada is not centrally organizedor coordinated. This mean that, in Canada, hospitals are not-for-profit pri-vately owned institutions, most physicians are private contractors to the pub-lic system, and the roles of governments include funding, legislation, regula-tion and the delivery of a small number of programs. The system is not pop-ulation-based insofar as hospitals do not have defined catchment areas andfamily physicians do not have defined patient populations. Thus, Canadianshave freedom to choose their own physicians and hospitals.

Prescription drugs are not considered an insurable benefit under the CanadaHealth Act. The direct costs of paying for medications falls to provincial andterritorial drug plans and the payment arrangements differ in each of Canada'sjurisdictions. Overall, the medications for approximately one-quarter of theCanadian population are paid for by governments (ranging from 9% inManitoba to 43% in Quebec). The elderly over 65 years of age and recipientsof social assistance have been covered in all provinces since the 1970s. In amajority of provinces, universal coverage only starts for persons who haverelatively high drug costs. The actual plans differ substantially betweenprovinces such that, while the net effect is that subsidies are typically biggerfor lower income households, out of pocket expenses vary widely. Manyemployed individuals have the costs of medications subsidized throughextended health benefits plans provided by private insurance companies.

The federal government in Canada has two fundamental roles for new med-ications entering the market. First, new drugs must meet national standardsof efficacy and safety set by the ministry called Health Canada (analagous tothe process undertaken by the Food and Drug Administration in the UnitedStates). Second, the Federal government is charged with regulating thecountry-wide price manufacturers can charge for newly patented medica-tions through the Patented Medicine Price Review Board.

This division of responsibilities creates tension between the provincial gov-ernments which have to pay for medications and the federal government

POLICY ANALYSIS

Pharmaceutical Outcomes Research and Policyin Canada - Context and Recent Developments Adrian Levy PhD, Associate Professor, University of British Columbia, Director, Oxford Outcomes, Vancouver,

BC, Canada

IC

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which regulates prices. Transfer payments from the federal government off-set a portion of health care costs. Provincial and territorial ministries faceperennial shortfalls in health care budgets and constantly seek ways of deliv-ering the same or better health care within budget constraints.

Following a trend established in Australia in the early 1990s, first Ontario andthen Canadian provinces inplemented reimbursement review processes fornewly marketed pharmaceutical products. As the trend for reimbursementreview spread, there was an obvious and rapid multiplication of the efforts.For example, there were ten health ministries, three territories and at least fivefederal funding programs that each required definitions of eligibility criteriafor registrants, levels of pharmaceutical coverage, reimbursement criteriaand independently reviewed economic submissions.

In response to variations in coverage of prescription medications and sub-stantial duplication of efforts in reviewing the economic submissions, in2002 the federal, provincial and territorial health ministers established theCommon Drug Review process within the Canadian Agency for Drugs andTechnologies in Health. This centralized reimbursement review process nowprovides recommendations to 18 participating publicy-funded drug plans(the province of Quebec, which inlcudes approximately one quarter of thepopulation of Canada, does not participate). Despite the centralized reviewprocess, there continues to exist wide variability in the medications that areincluded on formularies in different Canadian jurisdictions and the amountthat is paid by the public purse.

PHARMACEUTICAL OUTCOMES RESEARCH INCANADAPerhaps as a result of the circumstances in delivering health care in Canada,university scholars have taken leading roles in the various domains of phar-maceutical outcomes research and health technology assessment.

PharmacoepidemiologyOne reason for Canada's pivotal role in pharmacoepidemiological research isthe availability of many population-based sources of data. Canadian admin-istrative health databases are among the most well developed anywhere andprovide an excellent resource for pharmacoepidemiologic research. For thisreason, Canada has been characterized as an “information-rich” environ-ment. Canadian investigators have taken a leading role in using population-based administrative databases for pharmacoepidemiologic studies of boththe intended and unintended effects of medications. In addition to routinecollection of administrative data, supplementary information may be collect-ed through population-based disease and treatment registries. Canadianscholars have written seminal descriptions of various forms of bias and con-founding, developed innovative study designs, and made other importantmethodological and statistical advances, in pharmacoepidemiologic studies.

PharmacoeconomicsThe early implementation of reimbursement review processes in various jur-sidictions in Canada has led to continuously improving guidelines on the sub-mission requirements and processes. Also, there has been a large numberof published economic appraisals in the Canadian context as the reportssubmitted to public drug plans go on to appear in the peer-reviewed litera-ture. Many of these studies have been published by investigators outside ofacademic environments, including the industry and government sectors.These developments have provided incentives for developing robust methodsand interpretations of economic evaluations.

Pharmaceutical PolicyThe structure of the health care system, with provincial governments respon-sible for the delivery of health care and public drug plans being the largest

payors in the country, has led to the implementation of new policies aimed atmaking drug coverage more equitable, limiting the reimbursed amounts with-in specific classes of medication, and increased cost-sharing. These newpolicies have led to changes in coverage status of different sectors of thepopulation and typically led to decreases in public reimbursement for pre-scribed medications. Several groups of investigators have focused on thesystem outcomes such as the changes in prescribing and the estimatedreduced expenditures occuring after a new policy is implemented. Muchless is known about the effects on patient outcomes of the new policies.

Health-related Quality-of-LifeCanadian scholars have also been at the forefront of designing techniques formeasuring and valuing health-related quality of life. Utility elicitiation tech-niques that are now used ubiquitously, such as the time trade off, were pio-neered in Canada. Also developed in Canada, the Health Utilities Index® isa generic, preference-scored, comprehensive system for measuring healthstatus and producing utility scores.

RECENT DEVELOPMENTS IN PHARMACEUTICALPOLICY INNOVATIONS IN CANADAThe Common Drug Review was established in March 2002, began reviewingin September 2003, and since then has reviewed over 100 submissions.The process has undergone two reviews and many positive changes haveoccurred in response. Some of the notable changes have been: 1) to includetwo members of the public in all deliberations. These persons' opinions arehelpful in identifying the non-evidentiary factors that may be considered andincluded in the process; 2) to enhance transparency through several meansincluding developing non-technical versions of the recommendations; and 3)to establish standardized approaches for reviewing both “first-in-class” med-ications and those for rare disorders.

Joint Oncology Drug Review (JODR)Implemented in March 2007, the inter-provincial Joint Oncology Drug ReviewProcess was established to create a more consistent review process ofambulatory-based oncology medications across the country. This processis now distinct from Common Drug Review.

Progressive LicensingIn response to the advances in pharmaceutical sciences, drug development,and changes in public expectations, many countries are changing theprocesses around regulatory approval for medications. The Government ofCanada is keeping pace through a new program called the ProgressiveLicensing project. Under this system, the current point-in-time licensing sys-tem will evolve in a cyclical progressive licensing model. The daunting taskof jointly evaluating benefits and risks of medications in an environment inwhich different and often conflicting objectives must be balanced will requiresubstantial input and compromise from all interested parties.

CONCLUSIONThere is a growing need worldwide for high quality drug outcomes researchand discourse on pharmaceutical policy. Canadian academics, policy- anddecision-makers and industry employees have assumed leadership roles tofill that need. ISPOR is responding in kind by providing a forum for broadcommunications between different sectors and its members continue to gen-erate leading outcomes research. The 13th annual ISPOR meeting inToronto, with its record-breaking attendance, entertaining and informativeoral and poster presentations around the meeting theme “Vive la Différence -Enhancing/Expanding Outcomes Research One Country at a Time”, attests tothe fact that both outcomes research on medications and ISPOR are thrivingin Canada. IC


ISPOR CORNER

Oh, Canada! ISPOR 13th AnnualInternational Meeting Goes North of the Border! Stephen L. Priori, Director, ISPOR Publications

For the first time in the Society's history, the ISPOR Annual InternationalMeeting (the North America Meeting) was held “North of the Border” in

Canada. Another first was in ISPOR’s Meeting attendance of over 2,000attendees (with over 1,500 attending the 23 pre-meeting short courses), anda record number of over 900 presentations. The meeting, held at theSheraton Centre Toronto, Toronto, ON, Canada, from May 2-7, was co-chaired by Adrian Levy PhD, Associate Professor, University of BritishColumbia, Vancouver, BC, Canada, and C. Daniel Mullins PhD, Professor andChair, Pharmaceutical Health Services Research Department, University ofMaryland School of Pharmacy, Baltimore, MD, USA.

Among the highlights were the Plenary Sessions. The First Plenary Session,“New Evidence on Evidence-Based Technology Assessment in the USA vs.Canada,” was moderated by Mark Sculpher PhD, Professor of HealthEconomics, Centre for Health Economics, University of York, York, UK. Thesession covered the growing importance of health technology assessment inCanada and the USA, and addressed the need for credible evidence in tech-nology assessment and adoption. It reviewed the differences across publicand private payers in Canada and the USA. The session featured three note-worthy speakers: David Yoder PharmD, MBA, Executive Director, FederalEmployee Health Plan Pharmacy Programs, Blue Cross Blue ShieldAssociation, Washington DC, USA; Sean Tunis MD, MSc, Director, Center forMedical Technology Policy, Baltimore, MD, USA; and Leslie Levin MB, MD,FRCP, FRCPC, Senior Medical, Scientific and Health Technology Advisor andHead, Medical Advisory Secretariat, Ministry of Health and Long-Term Care,Toronto, ON, Canada.

The Second Plenary Session, “Drug Safety andRisk-Benefit Decision-Making” was moderatedby 13th Annual International Meeting co-chairAdrian Levy PhD. This session explored howregulators and payers determine the risk-benefittradeoffs and act upon that information.Speakers included Gerald J. Dal Pan MD, MHS,Director, Office of Surveillance andEpidemiology, FDA, Silver Spring, MD, USA;Rober t Powell PharmD, Director,Pharmacometrics, Offices of Clinical Pharma-cology and Translation Sciences, Center forDrug Evaluation and Research, FDA, SilverSpring, MD, USA; F. Reed Johnson PhD, Senior

Fellow and Principal Economist, RTI International, Research Triangle Park, NC,USA; and Robyn Lim PhD, Scientific Advisor, Progressive Licensing Project,Therapeutic Products Directorate, Health Products and Food Branch, HealthCanada, Ottawa, ON, Canada.

The Third Plenary Session, “Patient Reported Outcomes: Implementing GoodResearch Practices,” was moderated by Stephen Joel Coons PhD, Professor,Department of Pharmacy Practice and Science, College of Pharmacy,University of Arizona, Tucson, AZ, USA. This final plenary session highlight-ed the established role of PROs in medical product development, reviewed

the FDA Guidance on PROs and recommendations from the ISPOR PRO Task Force and explored improvements in methodology and applicationof PROs, Speakers included Ron Hays PhD, Professor of Medicine, UCLADepartment of Medicine, Division of General Internal Medicine & HealthServices Research, Los Angeles, CA, USA; Nancy E. Mayo BSc, MSc, PhD,James McGill Professor, Department of Medicine, School of Physical andOccupational Therapy, McGill University Division of Clinical Epidemiology,Division of Geriatrics, McGill University Health Center, Montreal, QC, Canada;and Margaret Rothman PhD, Senior Director, WW PRO Center of Excellence,Johnson & Johnson Pharmaceutical Services, LLC, Raritan, NJ, USA.

Meeting attendees also attended their choice of 4 Podium Sessions-with 72quality presentations; 2 Poster Sessions, with over 900 poster presenta-tions; 10 Issues Panel Sessions; 12 Health Care Decision-Maker's CaseStudies (6 posters; 6 podiums), and 24 Workshops.

The ISPOR Monte Carlo's entertained all at this year's social event, “AnEvening by Lake Ontario,” which took place at Atlantis with a view of theToronto skyline.

ISPOR will meet next at the 3rd Asia-Pacific Conference in Seoul, SouthKorea, at the Grand Hilton Seoul, on 7-9 September, and then at the 11thAnnual European Congress in Athens, Greece, at the Hilton Athens, on 8-11November 2008. Thanks for being a part of ISPOR, eh!

THANKS TO ALL OUR 13TH ANNUAL INTERNATIONAL MEETING COMMITTEE CO-CHAIRSPROGRAM PLANNING COMMITTEE CO-CHAIRS:Adrian Levy PhD, Associate Professor, University of British Columbia, Vancouver, BC,CanadaC. Daniel Mullins PhD, Professor and Chair, Pharmaceutical Health Services ResearchDepartment, University of Maryland School of Pharmacy, Baltimore, MD, USA

WORKSHOP REVIEW COMMITTEE CO-CHAIRS: Michael Iskedjian MSc, President, PharmIdeas Research and Consulting Inc., Oakville,ON, CanadaFrederic Lavoie MSc, PhD, Director, Outcomes Research, Pfizer Canada Inc., Kirkland,QC, Canada

HEALTH DECISIONS CASE STUDY ABSTRACT REVIEW COMMITTEE CO-CHAIRS:Thomas R. Einarson PhD, Associate Professor, Leslie Dan Faculty of Pharmacy,University of Toronto, Toronto, ON, Canada Dev Menon PhD, Professor, Health Policy and Management, School of Public Health,University of Alberta, Edmonton, AB, Canada

ISSUE PANEL REVIEW COMMITTEE CO-CHAIRS: Yola Moride FISPE, University of Montreal, Faculty of Pharmacy, Montreal, QC, Canada Penny E. Mohr, Director, Division of Research on Health Plans and Drugs, Centers forMedicare and Medicaid Services, Baltimore, MD, USA

RESEARCH REVIEW COMMITTEE CO-CHAIRS: Wendy J. Ungar MSc, PhD, Senior Scientist, The Hospital For Sick Children, Toronto, ON, CanadaJohn M. Brooks PhD, Associate Professor, Pharmaceutical Socioeconomics and DeputyDirector, Health Effectiveness Research Center, The University of Iowa, Iowa City, IA, USA

Third Plenary Session

Second Plenary Speaker:Gerald J. Dal Pan MD, MHS

IC


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ISPOR CORNER

ISPOR 13th Annual Meeting Awards Recipients Stephen L. Priori, Director, ISPOR Publications

At the ISPOR Thirteenth Annual International Meeting, May 3-7, 2008,Sheraton Centre Toronto, Toronto, ON, Canada, the ISPOR AwardsCommittee, chaired by Daniel C. Malone PhD, recognized recipients ofISPOR Research Excellence Awards, Contributed Paper Awards andDistinguished Service Awards.

The Sixth ISPOR Avedis Donabedian OutcomesResearch Lifetime Achievement AwardThe ISPOR Avedis Donabedian Outcomes Research Lifetime AchievementAward was established in honor of the late Avedis Donabedian MD. Dr.Donabedian was a renowned faculty member of the University of Michigan,School of Public Health who dedicated his life to improving the quality ofhealth care and health care systems. After a long process that involvednominations, selection of a panel of finalists, the ISPOR LifetimeAchievement Awards Committee, Chaired by Kevin Schulman MD, MBA,selected the recipient:

Bryan R. Luce PhD, MBA, Senior Vice President, SciencePolicy, United BioSource Corporation, Bethesda, MD, USA

A special thanks to Kevin Schulman MDA, MBA and theAvedis Donabedian Outcomes Research Lifetime

Achievement Award Committee for their efforts!

2008 ISPOR Bernie J. O'Brien New InvestigatorAwardThe ISPOR Bernie O'Brien New Investigator Award was established in 2004to honor the long-standing commitment of Bernie J. O'Brien, PhD to trainingand mentoring new scientists in the fields of outcomes research and phar-macoeconomics. The ISPOR Bernie J. O'Brien New Investigator AwardCommittee, chaired by Sean D. Sullivan, PhD, selected the recipient:

Patrick W. Sullivan PhD, Assistant Professor,Pharmaceutical Outcomes Research Program School ofPharmacy, University of Colorado Denver, Aurora, CO, USA

A special thanks to Sean D. Sullivan, PhD, and the BernieO'Brien New Investigator Award Committee for their efforts!

2008 ISPOR Research Excellence AwardsThe recipients of the 2008 ISPOR Research Excellence Award (one forMethodology Excellence and one for Practical Application Excellence) areselected by the Awards Committee based upon publications that haveappeared in respected peer-review journals and other communication venues(e.g., books, reports) during the preceding eighteen months from January 1of the year awarded. The award selection is based upon the publication'sclear description of methods, along with the appropriate and creative applica-tions (or proposal thereof in conceptual methodology work) of techniques toanswer important questions in the field of pharmacoeconomics and out-comes research. Such publications will be expected to have much impact onthe field, due to their acceptance and application by others.

The 2008 recipient of the ISPOR Research Excellence Award forMethodology Excellence is:

Andrea Manca PhD, MSc as the senior author of theresearch paper:

“Cost-Effectiveness Analysis Using Data fromMultinational Trials: The Use of Bivariate Hierarchical

Modeling.” Med Decision Making 2007;27:471-90.

The 2008 recipient of the ISPOR Research Excellence Award for PracticalApplication Excellence is:

Gregory Zaric PhD as senior author of the research paper:

“A Little Planning Goes a Long Way: Multilevel Allocationof HIV Prevention Resources.” Medical Decision Making2007;27:71-81.

A Special thanks to Andrew Briggs DPhil, Chair, ISPOR ResearchExcellence Award in Methodological Excellence and Jalpa Doshi, PhD,Chair, ISPOR Research Excellence Award in Practical ApplicationExcellence and their Committees for selecting the recipients!

ISPOR 2008 International Fellowship AwardsThe ISPOR International Fellowship Award was established in 2006 to rec-ognize key individuals who would contribute to the development of pharma-coeconomics and outcomes research or the use of outcomes research inhealth care decision in their own country/region.The 2008 Awardees who were announced at the 13th AnnualInternational Meeting were:

Professor Federico Augustovski MD, MSc, Director, HealthEconomic Evaluation and Technology Assessment, Institutefor Clinical Effectiveness and Health Policy, Buenos Aires,Argentina

Mohammed Fouad Jabr, RPh, PharmD, MBA, MSc, BSc,Head, Center for Drug Policy & Evaluation, King HusseinCancer Center, Amman, Jordan

Yot Teerawattananon MD, PhD, Health Economist, HealthIntervention and Technology Assessment Program, Ministryof Public Health, Nonthaburi, Thailand

A special thanks to Isao Kamae MD, DrPH and the ISPORInternational Fellowship Committee for selecting the recipients!

13th Annual International Meeting ContributedPresentation AwardsThe ISPOR Best Contributed Podium and Poster Presentation Awards wereestablished in 1998 to recognize the scientific merit of podium and posterpresentations of the ISPOR Annual International Meetings, Annual EuropeanCongresses, and Asia-Pacific Conferences. At this year's InternationalMeeting,


This year, the ISPOR Research Award judges evaluated 72 podium presen-tations and over 100 nominated poster presentations. All podium presenta-tions are considered for an award. Poster presentations in the top 20%,based on abstract review score, are considered and eligible for a posterpresentation award. Evaluations of scientific merit were based upon the following criteria: • Background provides appropriate perspective / context for the subject • Objectives / research questions are clearly stated • Research design / methods / modeling is appropriate and transparent

(scores on this will determine winners in case of ties) • Data sources and/or sampling procedures are clear and appropriate • Data analyses are appropriate • Research objectives are met/addressed • Implications of findings are discussed • Factual information is kept separate from interpretations or implications • Abstract is presented in an unbiased manner • Clarity of presentation

A special thanks goes to Rajesh Balkrishnan PhD, MS, Chair, ISPORContributed Research Paper Awards Committee -- Podium Presentations,AS WELL AS TO Judith Shinogle PhD, MSc, Chair, ISPOR ContributedResearch Paper Awards Committee -- Poster Presentations, for all theirefforts in selecting the winners!

And the recipients are... BEST CONTRIBUTED PAPER AWARDS PODIUM PRESENTATIONSAC7: COMPARING ADHERENCE TO FIXED DOSE COMBINATION VERSUS MULTI-PILL COMBINATION THERAPIES AMONG PATIENTS WITH DYSLIPIDEMIA IN AMANAGED CARE POPULATIONBalu S1, Simko RJ1, Burge RT1, Quimbo R2, Cziraky MJ2, 1Abbott Laboratories, AbbottPark, IL, USA, 2HealthCore, Inc, Wilmington, DE, USA

AC8: ASSOCIATION OF MEASURES OF MEDICATION ADHERENCE AND SEVERERELAPSES WITH MULTIPLE SCLEROSIS DISEASE-MODIFYING THERAPYDickson M1, Kozma C2, Okuda DT3, Fincher C4, Meletiche D4, 1University of SouthCarolina, College of Pharmacy, Columbia, SC, USA, 2University of South Carolina,West Columbia, SC, USA, 3University of California, San Francisco, San Francisco,CA, USA, 4EMD Serono, Inc, Rockland, MA, USA

PR3: IMPACT OF UNCONTROLLED PEDIATRIC ASTHMA ON HEALTH-RELATEDQUALITY OF LIFE (HRQOL)Dean BB1, Calimlim B1, Aguilar D1, Sacco P2, Maykut R2, Tinkelman D3, 1CernerLifeSciences, Beverly Hills, CA, USA, 2Novartis Pharmaceuticals Corporation, EastHanover, NJ, USA, 3National Jewish Medical and Research Center, Denver, CO, USA

BEST NEW INVESTIGATOR PODIUM PRESENTATIONCN2: ECONOMIC EVALUATION OF EGFR-GUIDED TREATMENT IN ADVANCEDREFRACTORY NON SMALL-CELL LUNG CANCERCarlson JJ1, Garrison L1, Ramsey S2, Veenstra DL1, 1University of Washington,Seattle, WA, USA, 2Fred Hutchinson Cancer Research Center, Seattle, WA, USA

CN4: COSTS ASSOCIATED WITH NEUTROPENIA IN ELDERLY PATIENTS TREATEDFIRST-LINE FOR ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)Stokes ME1, Muehlenbein CE2, Marciniak MD2, Faries D2, Motabar S3, BueschingDP2, Gillespie TW4, Lipscomb J4, Knopf KB5, 1United BioSource Corporation, Dorval,QC, Canada, 2Eli Lilly and Company, Indianapolis, IN, USA, 3United BioSource,Bethesda, MD, USA, 4Emory University and Veterans Affairs Medical Center, Atlanta,GA, USA, 5California Pacific Medical Center, San Francsico, CA, USA

MD1: MEDICARE PART D: EARLY EVIDENCE ON PRESCRIPTION DRUG TREAT-MENT PATTERNS, HOSPITALIZATION OFFSETS AND MEDICARE SPENDINGZhang Y1, Newhouse JP2, Hanlon J1, Lave J1, Donohue JM1, 1University of Pittsburgh,Pittsburgh, PA, USA, 2Harvard University, Boston, MA, USA

BEST STUDENT PODIUM PRESENTATIONCA3: A COST-EFFECTIVENESS ANALYSIS OF HEPATITIS C SCREENING AMONGIMMIGRANTS IN CANADAChen W1, Dinner K2, Wong T2, Heathcote J3, Krahn MD3, 1University of Toronto,Toronto, ON, Canada, 2Public Health Agency of Canada, Ottawa, ON, Canada,3University Health Network, Toronto, ON, Canada

MD2: THE IMPACT OF MEDICARE PART D ON THE PERCENT GROSS MARGINEARNED BY TEXAS INDEPENDENT PHARMACIES FOR DUAL ELIGIBLE BENEFI-CIARY CLAIMS Winegar AL, Shepherd MD, Lawson K, Richards KM, University of Texas at Austin,Austin, TX, USA

PM1: RASCH RATING SCALE ANALYSIS OF THE EQ-5D USING THE 2003 MED-ICAL EXPENDITURE PANEL SURVEY (MEPS)Gu NY, Doctor JN. University of Southern California, Los Angeles, CA, USA

BEST CONTRIBUTED PAPER AWARDS POSTER PRESENTATIONSPHP62: HOW EVIDENCE-BASED AND TIMELY ARE MEDICARE COVERAGE DECISIONS FOR NEW TECHNOLOGIES: AN EMPIRICAL ANALYSIS, 1999-2007 Kamae M, Palmer JA, Neumann PJ, Tufts-New England Medical Center, Boston,MA, USA

PMH47: THE RELATIONSHIP BETWEEN THE ANTIPSYCHOTIC MEDICATIONADHERENCE AND PATIENT OUTCOMES AMONG BIPOLAR DISORDER PATIENTS Lage MJ1, Hassan M2, 1HealthMetrics Outcomes Research, LLC, Groton, CT, USA,2AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA

PSY14: ECONOMIC EVALUATION OF LENOLIDOMIDE USE FOR MULTIPLE MYELO-MA IN SCOTLAND IN PATIENTS WHO HAVE RECEIVED ONE PRIOR THERAPY Deniz B1, Ishak KJ2, Shearer A3, Dale P4, Caro JJ1, 1United BioSource Corporation,Concord, MA, USA, 2United BioSource Corporation, Montreal, QC, Canada, 3CelgeneCorporation, Windsor, UK, 4United Biosource, London, England, UK

BEST NEW INVESTIGATOR POSTER PRESENTATIONPMH46: PREDICTORS OF MEDICATION ADHERENCE AMONG SCHIZOPHRENIAPATIENTS TREATED WITH CONVENTIONAL AND ATYPICAL ANTIPSYCHOTICS INA LARGE STATE MEDICAID PROGRAM Lee SP1, Lang K2, Jackel J2, Crivera C3, Dirani RG4, Menzin J5, 1Ortho McNeil JanssenScientific Affairs, LLC, Titusville, NJ, USA, 2Boston Health Economics, Inc, Waltham,MA, USA, 3Ortho-McNeil Janssen Scientific Affairs, L.L.C, Titusville, NJ, USA,4Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA, 5Boston HealthEconomics, Waltham, MA, USA

PMH66: ETHNICITY AND THE IMPACT OF HIGHER MEDICATION COPAYMENTSAMONG VETERANS WITH SCHIZOPHRENIA Zeber JE1, Copeland LA1, Miller AL2, Kilbourne AM3, Velligan DI2, Mortensen EM2,1Veterans Affairs HSRD / UTHSCSA, San Antonio, TX, USA, 2UTHSCSA, San Antonio,TX, USA, 3Veterans Affairs HSRD / University of Michigan, Ann Arbor, MI, USA

PND46: THE RISKS OF MULTIPLE GENERIC SUBSTITUTION OF ANTIEPILEPTICDRUGS : THE CASE OF TOPIRAMATE Lelorier J1, Duh MS2, Paradis PE3, Latremouille-Viau D4, Sheehy O5, Greenberg P2,Lee SP6, Rupnow MF7, 1Universite de Montreal, Montreal, QC, Canada, 2AnalysisGroup, Inc, Boston, MA, USA, 3Groupe d'analyse, Ltd, Montreal, QC, Canada,4Groupe d'analyse, Ltee, Montreal, QC, Canada, 5Centre hospitalier de l'Université deMontréal, Montréal, QC, Canada, 6Ortho McNeil Janssen Scientific Affairs, LLC,Titusville, NJ, USA, 7Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA

BEST STUDENT POSTER PRESENTATIONPCV72: ENHANCING THE EFFECTIVENESS OF COMMUNITY STROKE RISKSCREENING: A RANDOMIZED CONTROL TRIAL Anderson RT1, Camacho F1, Kharbanda A2, Iaconi A2, Balkrishnan R3, 1Wake ForestUniversity School of Medicine, Winston Salem, NC, USA, 2The Ohio State University,Columbus, OH, USA, 3The Ohio State University College of Pharmacy, Columbus,OH, USA


PMH14: DIFFERENTIAL EFFECTS OF OLANZAPINE AND CLOZAPINE ON TYPE IIDIABETES: FINDINGS FROM A CLAIMS DATABASE Donga PZ, Pandey GS, Chen H, University of Houston, Houston, TX, USA

PMH15: ANALYSIS OF POTENTIAL DRUG-DRUG INTERACTION PAIRS ASSOCIAT-ED WITH ANTIPSYCHOTICS AMONG MEDICAID PATIENTS WITH SCHIZOPHRENIAOR BIPOLAR DISORDER Jing Y1, Guo JJ1, Patel NC2, Kelton CM1, Fan H3, Keck P1, 1University of Cincinnati,Cincinnati, OH, USA, 2University of Georgia, Augusta, GA, USA, 3Covance Inc, SunPrairie, WI, USA

ISPOR would like to thank all the judges who have volunteered their timeand efforts during the meeting to score podium and poster presentations.

ISPOR SERVICE AWARDEESThe ISPOR Service Awards recognize members who have served on theISPOR Board of Directors or have significantly contributed to the vision andmission of the Society.

ISPOR 2006 - 2008 BOARD OF DIRECTORS SERVICE AWARDEESPRESIDENT (2006-2007) & PAST PRESIDENT (2007-2008) Michael F.Drummond PhD, Professor of Health Economics, University of York, York, UKDIRECTOR (2006-2008) Marc L. Berger MD, Vice President, GlobalHealth Outcomes, Eli Lilly and Company, Indianapolis, IN, USADIRECTOR (2006-2008) Shu-Chuen Li PhD, Professor, Chair, Head,Discipline of Pharmacy & Experimental Pharmacology, School ofBiomedical Sciences, University of Newcastle, Callaghan, NSW, AustraliaDIRECTOR (2006-2008) Uwe Siebert MD, MPH, MSc, ScD, Professor ofPublic Health, Chair of the Department of Public Health Medical DecisionMaking and Health Technology Assessment at the University of HealthSciences, Medical Informatics and Technology, Hall, Innsbruck, Austria

2007 ISPOR DISTINGUISHED SERVICE AWARDEESTHIRTEENTH ANNUAL INTERNATIONAL MEETING PROGRAM CO-CHAIRSAdrian Levy PhD, Associate Professor, University of British Columbia,Vancouver, BC, CanadaC. Daniel Mullins PhD, Professor and Chair, Pharmaceutical HealthServices Research Department, University of Maryland School ofPharmacy, Baltimore, MD, USA

VALUE IN HEALTH CO-EDITORSAndrew Briggs MSc, DPhil, Professor, University of Glasgow, Glasgow, UKRichard Milne PhD, Associate Professor, University of Auckland, Auckland,New ZealandA. David Paltiel PhD, Yale University, New Haven, CT, USAWilliam Lenderking PhD, UnitedBioSource, Bethesda, MD, USA

ISPOR CONNECTIONS EDITOR-IN-CHIEF (2001-2008)Steve Marx PharmD, MS, Associate Director, Global PharmaceuticalResearch & Development, Health Economics & Outcomes Research,Abbott Laboratories, Abbott Park, IL, USA

ISPOR FELLOWSHIP STANDARDS TASK FORCE CHAIRAlan Bakst MBA, PharmD, Senior Director, Global Health Economics andReimbursement, Baxter Healthcare Corporation, McGaw Park, IL, USA

ISPOR EPRO TASK FORCE CHAIRStephen Joel Coons PhD, Professor, College of Pharmacy, University ofArizona, Tucson, AZ, USA

ISPOR CHAPTER AWARDISPOR presented a Chapter Service Award to the Russia Chapter for 10years of collaboration and service to the Society.

ISPOR STUDENT AWARDSISPOR STUDENT CHAPTER PRESIDENTSThe following students served as 2007-2008 President of the StudentCouncil or 2007-2008 President of the ISPOR Student Chapter at the uni-versity indicated below:

STUDENT NETWORK CHAIR (2007-2008)Sienna Lee MS, PharmD, Thomas Jefferson University, Philadelphia, PA,USAHarvard University-Chapter PresidentSengwee (Darren) Toh BPharm, MSc

Ohio State University-Chapter PresidentZaina Qureshi MS

Thomas Jefferson University-Chapter PresidentParesh Chaudhari PharmD, MS

Rutgers University-Chapter PresidentJiyoon C. Choi PharmD

University of Arizona-Chapter PresidentKim Saverno RPh

University of Houston-Chapter PresidentManvi Sharma MBA

University of Illinois, Chicago-Chapter PresidentCaitlyn Wilke MS

University of Southern California-Chapter PresidentAniket Kawatkar MS, BSPharm

West Virginia University-Chapter PresidentAbhijeet Bhanegaonkar MPH

OUTSTANDING ISPOR STUDENT CHAPTER OF THE YEAR AWARDThe Outstanding ISPOR Student Chapter of the Year Award was establishedin 2007 to recognize ISPOR Student Chapters, which provide exemplaryservice to its university.AWARD RECIPIENT:First Prize: University of PurdueSecond Prize: University of Illinois, ChicagoThird Prize: University of Southern California

STUDENT TRAVEL GRANT AWARDSISPOR Student Travel Grant Awards provide selected students with anopportunity to attend the ISPOR Annual International Meeting.

STUDENT TRAVEL GRANT RECIPIENTS:Samira ToghanianUniversity of Gothenburg, Gothenburg, SwedenZaho YingjiaoNational Univerisity of Singapore (NUS), Singapore, Singaproe

SPONSORS:Novartis and F. Hoffmann La Roche

STUDENT RESEARCH COMPETITIONStudent competed in the second annual Student Research Competition atthe ISPOR 13th Annual International Meeting. Questions were based oncontents from Health Care Costs, Quality, and Outcomes; ISPOR Book ofTerms.

STUDENT RESEARCH COMPETITION RECIPIENT:University of Tennessee IC


Case Studies in Pharmaceutical/Biotech Pricing II - Advanced Short Course

Patient-Reported Outcomes Research Issues Panelist F. Reed Johnson PhD, moderator:A. Brett Hauber PhD, Paul Kind PhD, and William Furlong MSc

Research on Medicare Part D and Reimbursement Policies Podium Presenter,Angela Winegar MS and John M. Brooks PhD

ISPOR 13th Annual International Meeting Exhibitors

Poster Viewing Session

ISPOR GoodResearch Practices

for ISPORRetrospective

Database AnalysisTask Force Forum

Moderator MichaelJohnson PhD

First Plenary Speaker: Sean Tunis MD, MSc

PhotoISPOR 13th Annual


Pharmacoeconomics forDecision-Makers Short Course

Health Care Policy Development Using Outcomes Research Issues Panelist(s):Dennis W. Raisch PhD (l), Scott Ramsey MD, PhD, and Mike F. Drummond PhD

Drug Use Research Podium PresenterJoshua W. Devine PharmD, PhD

Third Plenary Session SpeakerMargaret Rothman PhD

GalleryInternational Meeting

Economic Outcomes Research Workshop Discussion LeaderKatia Noyes PhD, MPH

The ISPOR Monte Carlos in concert


ISPOR CORNER

Board of Directors New Elected Members Take Office onJuly 1, 2008The new elected members of the ISPOR Board of Directors will take office on July 1, 2008. They are: Michael Barry MD, PhD, FRCPI, 2008-2009 President-elect and 2009-2010 President, and 2008-2010 Directors are: Paul Kind, Penny Mohr MA, Zeba M. Khan RPh, PhD, Don Husereau BScPharm, MSc, andShanlian Hu MD, MSc. These board members will join incumbent Board Members: 2008-2009 President Chris L. Pashos PhD; 2007-2008 Past PresidentDiana Brixner PhD, and 2007-2009 Directors: Lou Garrison PhD, and Richard Willke PhD.

President (2008-2009)Chris L. Pashos PhDVice President and Executive DirectorHERQuLES Health Economic Researchand Quality of Life Evaluation ServicesAbt Bio-Pharma Solutions, Inc.Email: [email protected]

Past President (2007-2008) Diana Brixner PhD Associate Professor & Executive DirectorPharmacotherapy Outcomes ResearchCenter University of Utah, College of Pharmacy Email: [email protected]

Director (2007 - 2009)Lou Garrison PhD ProfessorUniversity of Washington, Department ofPharmacyEmail: [email protected]

Director (2008 - 2010)Zeba Khan , PhD, RPhHead of U.S. Pricing, Novartis Pharmaceuticals Corporation Email: [email protected]

Director (2008 - 2010)Shanlian Hu, MD, MSc Director and ProfessorTraining Center for Health Management,School of Public Health, Fudan UniversityEmail: [email protected]

Treasurer (2007 - 2010) Karen Rascati RPh, PhDProfessorUniversity of Texas, College of PharmacyEmail: [email protected]

President -Elect (2009-2010)Michael Barry PhD, MD, BScClinical Director Pharmacoeconomics Centre St. James's HospitalEmail: [email protected]

Director (2008 - 2010)Paul Kind, MScPrincipal InvestigatorCentre for Health EconomicsAlcuin College, University of YorkE-mail: [email protected]

Director (2008 - 2010)Penny Mohr, MADirector, Division of Research on Health Plans and DrugsCenters for Medicare and Medicaid ServicesEmail: [email protected]

Director (2008 - 2010)Don Husereau, MScDirector, Project Development - HTA, CADTH

Email: [email protected]

Director (2007 -2009)Richard Willke PhD Senior DirectorGlobal Outcomes Research,PfizerEmail: [email protected]

Founding Executive DirectorMarilyn Dix Smith RPh, PhDFounding Executive DirectorISPOREmail: [email protected]

2008-2009 ISPOR Board of Directors


ISPOR CORNER

Looking Back And Moving Forward: Last Year Was HugeAnd This Year Is Going To Be Even Bigger! Caitlyn Wilke, MS, ISPOR Student Network Chair, University of Illinois at Chicago, Chicago, IL, USA; and Seina Lee, PharmD, MS,

ISPOR Past Student Network Chair, Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA

The 13th Annual ISPOR International Meeting in Toronto, ON, Canada wasa hit for the ISPOR Student Network. Over 200 student members from all

over the world attended this meeting and over 50 poster presentations and 6podium presentations were given by student members. Many ISPOR StudentChapter presidents were recognized for their outstanding service. As ourStudent Network continues to grow, the future leaders in pharmacoeconom-ics and outcomes research continue to excel.

The conference started off with the ISPOR Student Network LeadershipRetreat on Sunday, May 4 with the presidents of local student chapters fromUniversities. The leadership retreat provided a forum for sharing chapter-levelexperiences / best practices so all incoming and outgoing presidents couldlearn from the successes and challenges faced locally. Incoming presidentswere able to start the process of brainstorming for the continued success oftheir chapters. Of particular interest to students was how local ISPOR stu-dent chapters fund their events, which led to the formation of a new position,Treasurer/Financial Committee for the Student Network.

Following the leadership retreat, the Second Annual Student ResearchCompetition took place and was a great success. The competition consistedof eight teams (four students each) representing various universities whobuzzed in to answer a series of questions derived from HEALTH CARE COST,QUALITY, AND OUTCOMES: ISPOR Book of Terms. The questions reflectedthe field of health economics, pharmacoeconomics, epidemiology, statistics,and outcomes research. Dr. Zeba Khan PhD, RPh, moderated the competi-tion and Drs. Steve E. Marx PharmD and Renée J.G. Arnold RPh, PharmDwere judges for the competition. After three challenging rounds of competi-tion, the first place team, The University of Texas at Austin received a plaqueand $750.00! West Virginia University and University of Illinois at Chicagofollowed in second and third place and received $500.00 and $250.00,respectively. With crowds cheering each team on, our Students were able toshowcase the excellence of our educational and fun programs.

Sunday night was reserved for the Student Networking Reception. Studentswere given T-Shirts designed by the University of Arizona Chapter. Studentswere also entered in a raffle for a variety of prizes and were given an oppor-tunity to meet and establish future working relationships. It was a trulyenjoyable end to a great day!

However, our student events did not end there. On Monday, May 5, immedi-ately following a student presentation on “How to Interview Well”, mockinterviews were offered for students prospectively looking for jobs in consult-ing, industry, or academia. About 30 students participated in the mock inter-view sessions. On Tuesday, May 6, during the ISPOR Award session, theOutstanding Chapter Award was given to Purdue University and the distin-guished service awards were given to the ISPOR student network chair andselected chapter presidents.

The Student Network organized an educational forum on “Overview ofDecision Analysis,” presented by Dr. Grant H. Skrepnek PhD, RPh, MS.

Finally, the ISPOR Student Council met again on Tuesday afternoon for awrap-up lunch, where members decided on goals and objectives for the2008-2009 year and were able to share their conference experiences.

“This year was a huge success for the Student Network and next year will beeven bigger.” said Seina Lee, past ISPOR Student Network Chair. As theincoming Student Network Chair, I am excited to be part of the continuedgrowth and excellence of the Student Network. We have a great StudentCouncil of active leaders who will promote success on the local as well asthe international level. IC

Student Research Competition: First Place - University of Texas, Austin

Student Mock Interview

Second Annual Research Competition-Zeba Khan PhD, RPh (moderator),and our two judges: Renee Arnold RPh, PharmD and Steve Marx PharmD


ISPOR CORNER

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

WESTERN EUROPEFRANCE Pharmaceutical retailing in France is to be shaken up later in thesecond quarter with regulatory changes allowing around 200 non-prescrip-tion medicines to be sold from over-the-counter to prescription. (SCRIP 3350:7)

EASTERN/CENTRAL EUROPEBULGARIA Sales of pharmaceuticals in Bulgaria increased by almost byalmost 12% to Lev1.4 billion ($1.1 billion) in 2007, compared with growthof19% in the previous year. The number of packs sold was up by 54% toLev240 million. (SCRIP 3346:6)ESTONIA Estonia's state medicines agency says that combined sales ofprescription medicines and OTC products in the country increased by 18%

to Eek2.7 billion ($261.7 million) at wholesaler's prices last year. (SCRIP3346:6)

THE AMERICASUS US prescription drug spending at wholesale prices grew by just 3.8% to$286.5 billion last year, say data from IMS Health-the lowest increase sincea 3.3% rise in 1961. (SCRIP 3346:16)

AFRICASOUTH AFRICA The South African minister of health, Manto Tshabalata-Msimang, is proposing to introduce legislation to regulate the private healthcare industry, because of its rapidly escalating charges. (SCRIP 3346:18).

Disease Related Research

CARDIOVASCULAR DISEASEClinical and public health assessment of benefits and risks ofstatins in primary prevention of coronary events: resolved andunresolved issues. Comment in: Can J Cardiol. 2008Apr;24(4):301-3. Can J Cardiol 2008;24:293-300.

Marshall RJ, Milne RJ, Lynn R, Jackson R. Quantifying the effectof age on short-term and long-term case fatality in 14,000patients with incident cases of cardiovascular disease. Eur JCardiovasc Prev Rehabil 2008;15:179-84.

Murray MD, Tierney WM, Brater DC. Determining the effective-ness of torasemide and furosemide in heart failure: design of arandomised comparison using the regenstrief medical recordsystem. Clin Drug Investig 1998;16:45-52.

Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E,Watson DJ, Norquist JM, McCrary Sisk C, Bays HE. Measuringflushing symptoms with extended-release niacin using the flush-ing symptom questionnaire((c)): results from a randomisedplacebo-controlled clinical trial. Int J Clin Pract 2008 Apr [Epubahead of print]

Pinto CG, Carrageta MO, Miguel LS. Cost-effectiveness of rosu-vastatin in the prevention of ischemic heart disease in Portugal.Value Health. 2008;11:154-9.

Stiell IG, Nesbitt LP, Nichol G, Maloney J, Dreyer J, Beaudoin T,Blackburn J, Wells GA; OPALS Study Group. Comparison of theCerebral Performance Category Score and the Health UtilitiesIndex for Survivors of Cardiac Arrest. Ann Emerg Med 2008 Apr[Epub ahead of print]

DERMATOLOGYGupta AK, Cooper EA, Bowen JE. Meta-analysis: griseofulvinefficacy in the treatment of tinea capitis. J Drugs Dermatol2008;7:369-72.

Huang W, Cordoro KM, Taylor SL, Feldman SR. To test or not totest? An evidence-based assessment of the value of screeningand monitoring tests when using systemic biologic agents to treatpsoriasis. J Am Acad Dermatol 2008 Apr [Epub ahead of print]

ENDOCRINOLOGY, METABOLISM & DIABETESChirakup S, Chaiyakunapruk N, Chaikledkeaw U,Pongcharoensuk P, Ongphiphadhanakul B, Roze S, Valentine WJ,Palmer AJ. Cost-effectiveness analysis of thiazolidinediones inuncontrolled type 2 diabetic patients receiving sulfonylureas andmetformin in Thailand. Value Health. 2008;11(Suppl. 1):S43-51.

Risebrough N, Oh P, Blanchette V, Curtin J, Hitzler J, Feldman BM.Cost-utility analysis of Canadian tailored prophylaxis, primary pro-phylaxis and on-demand therapy in young children with severehaemophilia A. Haemophilia 2008 Apr [Epub ahead of print]

GASTRO-INTESTINALAl-Naamani K, Alzadjali N, Barkun AN, Fallone CA. Does bloodurea nitrogen level predict severity and high-risk endoscopiclesions in patients with nonvariceal upper gastrointestinal bleed-ing? Can J Gastroenterol 2008;22:399-403.

Guest JF, Valovirta E. Modelling the resource implications andbudget impact of new reimbursement guidelines for the manage-ment of cow milk allergy in Finland. Curr Med Res Opin2008;24:1167-77.

Halling K, Kulich K, Carlsson J, Wiklund I. An international com-parison of the burden of illness in patients with dyspepsia. DigDis 2008;26:264-73.

GYNECOLOGYHancock RL, Ungar WJ, Einarson A, Goodstadt M, Koren G.Providing information regarding exposures in pregnancy: A sur-vey of North American Teratology Information Services. ReprodToxicol 2008 Mar [Epub ahead of print]

Lee VY, Liu DT, Li CL, Hoi-Fan, Lam DS. Central retinal veinocclusion associated with clomiphene-induced ovulation. FertilSteril 2008 Mar [Epub ahead of print]

INFECTIOUS DISEASEHeyse JF, Kuter BJ, Dallas MJ, Heaton P. Evaluating the safety ofa rotavirus vaccine: the REST of the story. Clin Trials2008;5:131-9.

Hockenhull JC, Dwan K, Boland A, Smith G, Bagust A, Dundar Y,Gamble C, McLeod C, Walley T, Dickson R. The clinical effec-tiveness and cost-effectiveness of central venous catheterstreated with anti-infective agents in preventing bloodstreaminfections: a systematic review and economic evaluation. HealthTechnol Assess 2008;12:1-154.

Schackman BR, Teixeira PA, Weitzman G, Mushlin AI, JacobsonIM. Quality-of-life tradeoffs for hepatitis C treatment: do patientsand providers agree? Med Decis Making 2008;28:233-42.

Veenstra DL, Sullivan SD, Lai MY, Lee CM, Tsai CM, Patel KK.HBeAg-negative chronic hepatitis B: cost-effectiveness of pegin-terferon alfa-2a compared to lamivudine in Taiwan. Value Health2008;11:131-8.

Walensky RP, Wood R, Weinstein MC, Martinson NA, Losina E,Fofana MO, Goldie SJ, Divi N, Yazdanpanah Y, Wang B, PaltielAD, Freedberg KA; CEPAC-International Investigators. Scaling UpAntiretroviral Therapy in South Africa: The Impact of Speed onSurvival. J Infect Dis. 2008;197:1324-32.

Yuan Y, Iloeje U, Li H, Hay J, Yao GB. Economic implications ofentecavir treatment in suppressing viral replication in chronichepatitis B (CHB) patients in China from a perspective of theChinese Social Security program. Value Health 2008;11(Suppl.1):S11-22.

KIDNEYWeber ML, Farooqui M, Nguyen J, Ansonoff MA, Pintar JE,Hebbel RP, Gupta K. Morphine Induces Mesangial Proliferation

This column includes books, articles, and abstracts recently published by ISPOR members. To ensurethat your published work in pharmacoeconomic or outcomes research is reported here, please keepyour contact information up to date with the Society. Any questions, comments, or submissions concerning this review can be directed to Stephen Priori at [email protected].

ISPOR CORNER

Recently Published Works: UsingPharmacoeconomics InnovativelyBy Stephen Priori, Director, ISPOR Publications

IC


and Glomerulopathy via Kappa Opioid Receptors. Am J PhysiolRenal Physiol 2008 Apr [Epub ahead of print]

NEUROLOGY & MENTAL HEALTHBrown SL, Brown RM, House JS, Smith DM. Coping withspousal loss: potential buffering effects of self-reported helpingbehavior. Pers Soc Psychol Bull 2008;34:849-61.

Edelsberg J, Oster G. Summary measures of number needed totreat: How much clinical guidance do they provide in neuropathicpain? Eur J Pain 2008 May [Epub ahead of print]

Cumming JN, Le TX, Babu S, Carroll C, Chen X, Favreau L,Gaspari P, Guo T, Hobbs DW, Huang Y, Iserloh U, Kennedy ME,Kuvelkar R, Li G, Lowrie J, McHugh NA, Ozgur L, Pan J, ParkerEM, Saionz K, Stamford AW, Strickland C, Tadesse D, Voigt J,Wang L, Wu Y, Zhang L, Zhang Q. Rational design of novel,potent piperazinone and imidazolidinone BACE1 inhibitors.Bioorg Med Chem Lett 2008 Apr [Epub ahead of print]

Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Sniadecki JL, Kane JM. Predicting response to atypi-cal antipsychotics based on early response in the treatment ofschizophrenia. Schizophr Res 2008 [Epub ahead of print]

Kirbach S, Simpson K, Nietert PJ, Mintzer J. A markov model ofthe cost effectiveness of olanzapine treatment for agitation andpsychosis in Alzheimer's disease. Clin Drug Investig2008;28:291-303.

Alvidrez J, Shumway M, Boccellari A, Green JD, Kelly V, MerrillG. Reduction of state victim compensation disparities in disad-vantaged crime victims through active outreach and assistance:a randomized trial. Am J Public Health 2008;98:882-8.

Langmead CJ, Austin NE, Branch CL, Brown JT, Buchanan KA,Davies CH, Forbes IT, Fry VA, Hagan JJ, Herdon HJ, Jones GA,Jeggo R, Kew JN, Mazzali A, Melarange R, Patel N, Pardoe J,Randall AD, Roberts C, Roopun A, Starr KR, Teriakidis A, WoodMD, Whittington M, Wu Z, Watson J. Characterization of a CNSpenetrant, selective M(1) muscarinic receptor agonist, 77-LH-28-1. Br J Pharmacol. 2008 May [Epub ahead of print]

Manca A, Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M,Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G,Buchser E, Fortini G, Richardson J, Taylor RJ, Goeree R,Sculpher MJ. Quality of life, resource consumption and costs ofspinal cord stimulation versus conventional medical managementin neuropathic pain patients with failed back surgery syndrome(PROCESS trial). Eur J Pain 2008 Mar [Epub ahead of print]

McKenna SP, Doward LC, Davey KM. The Development andPsychometric Properties of the MSQOL: A Migraine-SpecificQuality-of-Life Instrument. Clin Drug Investig 1998;15:413-23.

Soumerai SB, Zhang F, Ross-Degnan D, Ball DE, Lecates RF,Law MR, Hughes TE, Chapman D, Adams AS. Use Of AtypicalAntipsychotic Drugs For Schizophrenia In Maine MedicaidFollowing A Policy Change. Health Aff (Millwood). 2008 Apr[Epub ahead of print]

Stensland MD, Schultz JF, Frytak JR. Diagnosis of UnipolarDepression Following Initial Identification of Bipolar Disorder: ACommon and Costly Misdiagnosis. J Clin Psychiatry 2008 Mar[Epub ahead of print]

Unick GJ, Shumway M, Hargreaves W. Commentary: are weready for computerized adaptive testing? Psychiatr Serv2008;59:369.

Zhu B, Ascher-Svanum H, Faries DE, Correll CU, Kane JM. Costof antipsychotic polypharmacy in the treatment of schizophrenia.BMC Psychiatry 2008;8:19.

Armstrong EP, Malone DC, Erder MH. A Markov cost-utility analy-sis of escitalopram and duloxetine for the treatment of majordepressive disorder. Curr Med Res Opin 2008;24:1115-21.

Doshi JA, Cen L, Polsky D. Depression and retirement in latemiddle-aged u.s. Workers. Health Serv Res 2008;43:693-713.

ONCOLOGYBerger A, Edelsberg J, Kallich J, Oster G. Use of darbepoetin alfaand epoetin alfa in clinical practice in patients with cancer-relat-ed anemia. Clin Ther 2008;30:206-18.

Cormier JN, Ross MI, Gershenwald JE, Lee JE, Mansfield PF,Camacho LH, Kim K, Webster K, Cella D, Palmer JL. Prospectiveassessment of the reliability, validity, and sensitivity to change ofthe functional assessment of cancer Therapy-Melanoma ques-tionnaire. Cancer 2008;112:2249-57.

Lee FY, Borzilleri R, Fairchild CR, Kamath A, Smykla R, KramerR, Vite G. Preclinical discovery of ixabepilone, a highly activeantineoplastic agent. Cancer Chemother Pharmacol 2008 Mar18 [Epub ahead of print]

Lee FY, Smykla R, Johnston K, Menard K, McGlinchey K, PetersonRW, Wiebesiek A, Vite G, Fairchild CR, Kramer R. Preclinical effi-cacy spectrum and pharmacokinetics of ixabepilone. CancerChemother Pharmacol 2008 Mar [Epub ahead of print]

McMahon PM, Kong CY, Johnson BE, Weinstein MC, Weeks JC,Kuntz KM, Shepard JA, Swensen SJ, Gazelle GS. EstimatingLong-term Effectiveness of Lung Cancer Screening in the MayoCT Screening Study. Radiology 2008 May [Epub ahead of print]

Teitz-Tennenbaum S, Li Q, Okuyama R, Davis MA, Sun R,Whitfield J, Knibbs RN, Stoolman LM, Chang AE. Mechanismsinvolved in radiation enhancement of intratumoral dendritic celltherapy. J Immunother 2008;31:345-58.

Yu W, Jia L, Wang P, Lawson KA, Simmons-Menchaca M, ParkSK, Sun L, Sanders BG, Kline K. In vitro and in vivo evaluation ofanticancer actions of natural and synthetic vitamin E forms. MolNutr Food Res 2008;52:447-56.

Cashin RP, Lui P, Machado M, Hemels ME, Corey-Lisle PK,Einarson TR. Advanced cutaneous malignant melanoma: a sys-tematic review of economic and quality-of-life studies. ValueHealth 2008;11:259-71.

PEDIATRICSTeufel RJ 2nd, Basco WT Jr, Simpson KN. Cost effectiveness ofan inpatient influenza immunization assessment and deliveryprogram for children with asthma. J Hosp Med 2008;3:134-41.

Uppal NK, Dupuis LL, Parshuram CS. Documentation of pedi-atric drug safety in manufacturers' product monographs: across-sectional evaluation of the canadian compendium of phar-maceuticals and specialities. Paediatr Drugs 2008;10:193-7.

RESPIRATORY DISORDERSDelea TE, Hagiwara M, Stanford RH, Stempel DA. Effects of fluti-casone propionate/salmeterol combination on asthma-relatedhealth care resource utilization and costs and adherence in chil-dren and adults with asthma. Clin Ther 2008;30:560-71.

Korelitz JJ, Zito JM, Gavin NI, Masters MN, McNally D, Irwin DE,Kelleher K, Bethel J, Xu Y, Rubin J, Mattison DR. Asthma-relatedmedication use among children in the United States. Ann AllergyAsthma Immunol 2008;100:222-9.

Sullivan SD, Turk F. An evaluation of the cost-effectiveness ofomalizumab for the treatment of severe allergic asthma. Allergy2008;63:670-84.

Guest JF, Helter MT, Morga A, Stradling JR. Cost-effectiveness ofusing continuous positive airways pressure in the treatment ofsevere obstructive sleep apnoea/hypopnoea syndrome in theUK. Thorax 2008 Apr [Epub ahead of print]

Lederman SA, Becker M, Sheets S, Stein J, Tang D, Weiss L,Perera FP. Modeling exposure to air pollution from the WTC dis-aster based on reports of perceived air pollution. Risk Anal2008;28:287-301.

Ramsey SD, Blough DK, Sullivan SD. A Forensic Evaluation ofthe National Emphysema Treatment Trial Using the ExpectedValue of Information Approach. Med Care 2008;46:542-8.

SKELETAL/ARTHRITISWijbrandts CA, Klaasen R, Dijkgraaf MG, Gerlag DM, van Eck-Smit BL, Tak PP. Bone mineral density in rheumatoid arthritispatients 1 year after adalimumab therapy: arrest of bone loss?Ann Rheum Dis 2008 Apr [Epub ahead of print]

Yun HR, Lee SO, Choi EJ, Shin HD, Jun JB, Bae SC.Cyclooxygenase-2 polymorphisms and risk of rheumatoid arthri-tis in koreans. J Rheumatol 2008;35:763-9.

Doward LC, McKenna SP, Whalley D, Tennant A, Griffiths B,Emery P, Veale DJ. The development of the L-QoL: A quality oflife instrument specific to Systemic Lupus Erythematosus. AnnRheum Dis 2008 Apr [Epub ahead of print]

Kim I, Hur NW, Shin HD, Park BL, Cheong HS, Bae SC.Associations of DNase IV polymorphisms with autoantibodies inpatients with systemic lupus erythematosus. Rheumatology(Oxford) 2008 Apr [Epub ahead of print]

Thorpe CT, Devellis RF, Blalock SJ, Hogan SL, Lewis MA,Devellis BM. Patient perceptions about illness self-management

in ANCA-associated small vessel vasculitis. Rheumatology(Oxford) 2008 Apr [Epub ahead of print]

Farley JF, Blalock SJ, Cline RR. Effect of the women's health ini-tiative on prescription anti-osteoporosis medication utilization.Osteoporos Int 2008 Mar [Epub ahead of print]

SURGERYBlough DK, Ramsey S, Sullivan SD, Yusen R; for the NettResearch Group. The impact of using different imputation meth-ods for missing quality of life scores on the estimation of thecost-effectiveness of lung-volume-reduction surgery. HealthEcon 2008 Apr 24 [Epub ahead of print]

Burch J, Epstein D, Baba-Akbari A, Weatherly H, Fox D, GolderS, Jayne D, Drummond M, Woolacott N. Stapled haemor-rhoidectomy (haemorrhoidopexy) for the treatment of haemor-rhoids: a systematic review and economic evaluation. HealthTechnol Assess 2008;12:1-214.

Singh CN, Klein MB, Sullivan SR, Sires BS, Hutter CM, Rice K,Jian-Amadi A. Orbital compartment syndrome in burn patients.Ophthal Plast Reconstr Surg 2008;24:102-6.

Sobolev B, Harel D, Vasilakis C, Levy A. Using the Statechartsparadigm for simulation of patient flow in surgical care. HealthCare Manag Sci 2008;11:79-86.

UROLOGYMorant SV, Reilly K, Bloomfield GA, Chapple C. Diagnosis andtreatment of lower urinary tract symptoms suggestive of overac-tive bladder and bladder outlet obstruction among men in gener-al practice in the UK. Int J Clin Pract 2008;62:688-94.

Szeinbach SL, Jackson M. Here is the case for the urge inadministrative claims database research about overactive blad-der therapies. J Manag Care Pharm 2008;14:309-11.

General Interest

HEALTH SERVICESBahensky JA, Jaana M, Ward MM. Health care information tech-nology in rural America: electronic medical record adoption sta-tus in meeting the national agenda. J Rural Health 2008;24:101-5.

Cline RR, Gupta K, Singh RL. Older adults' drug benefit beliefs:construct definition and measure development. Res Social AdmPharm 2008;4:23-36.

Drummond MF, Iglesias CP, Cooper NJ. Systematic reviews andeconomic evaluations conducted for the National Institute forHealth and Clinical Excellence in the United Kingdom: A game oftwo halves? Int J Technol Assess Health Care 2008;24:146-50.

Parshuram CS. Pharmacotherapeutic friendly fire in the intensivecare unit: high stakes seeking high calibre. Crit Care2008;12:137.

Polsky D, Jha AK, Lave J, Pauly MV, Cen L, Klusaritz H, Chen Z,Volpp KG. Short- and Long-Term Mortality after an Acute Illnessfor Elderly Whites and Blacks. Health Serv Res 2008 Mar [Epubahead of print]

Singer ME. Cost-effectiveness analysis: developing nations leftbehind. Pharmacoeconomics. 2008;26:359-61.

Smith DG. The uninsured in the U.S. healthcare system. JHealthc Manag 2008;53:79-81.

METHODOLOGYDolan JG, Iadarola S. Risk communication formats for low prob-ability events: an exploratory study of patient preferences. BMCMed Inform Decis Mak 2008;8:14.

Pierre-Jacques M, Safran DG, Zhang F, Ross-Degnan D, AdamsAS, Gurwitz J, Rusinak D, Soumerai SB. Reliability of new meas-ures of cost-related medication nonadherence. Med Care2008;46:444-8.

Roy S, Madhavan SS. Making a case for employing a societalperspective in the evaluation of Medicaid prescription drug inter-ventions. Pharmacoeconomics. 2008;26:281-96.

Wehby GL, Ohsfeldt RL, Murray JC. 'Mendelian randomization'equals instrumental variable analysis with genetic instruments.Stat Med 2008 Mar [Epub ahead of print] IC


ISPOR 11th Annual European Congress

8-11 November 2008 | Athens, GreeceEarly Registration Deadline: 30 September 2008

“Moving and Improving Concepts & Evidence for Health Care Decisions”

International Society for Pharmacoeconomics and Outcomes Research

PROGRAMSUNDAY, 9 NOVEMBERPlenary SessionHealth Technology Assessment (HTA) in Europe - IsHarmonization Possible?

European countries have established independent evaluation processesfor health technologies. Although initiatives to harmonize European evalu-ation processes are underway such as the EUnetHTA initiative, individualcountries still have different HTA requirements, especially for economicevaluations such as UK's NICE versus Germany's IQiWG. This plenarysession will focus on the reasons for the diversity in HTA processes andtheir use in decision-making and the efforts to harmonize these HTAprocesses in Europe.

Moderator: Uwe Siebert MD, MPH, MSc, ScD, Professor of PublicHealth, Chair of the Department of Public Health, Medical DecisionMaking and Health Technology Assessment at the University of HealthSciences, Medical Informatics and Technology, Hall/Innsbruck, Austria

Speakers:Peter Sawicki MD, PhD, Director, Institute for Quality and Efficiency inHealth Care (IQWiG), Cologne, Germany

Finn Boerlum Kristensen MD, PhD, Director & Professor, Danish Centrefor Health Technology Assessment, National Board of Health,Copenhagen, Denmark; Adjunct Professor, University of SouthernDenmark; Project Leader, European Network for HTA (EUnetHTA)

*40 Podium Presentations *Exhibits *Poster Presentations-Session 1

MONDAY, 10 NOVEMBERPlenary Session

Improving Equity of Access to Pharmaceutical Therapies in Europe & Africa

Despite improvements in indicators of health over the past few decades,health care inequities, specifically access to drugs, between and withincountries in Eastern Europe, Middle East, and Africa have persisted. Thisplenary session will present address equity of access to drugs in theseregions and priorities for research.

Moderator: John Yfantopoulos PhD, Professor of Health Economics,University of Athens and President of the National Centre for SocialResearch, Athens, Greece

HEALTH CARE EQUITY ISSUES IN RUSSIASpeakers: Professor Pavel Vorobyev MD, PhD, Professor, Head, Department ofHematology and Geriatrics, Moscow Medical Academy, Moscow, Russia

Oleg Borisenko MD, Executive Director, Russian Society forPharmacoeconomics and Outcomes Research, Moscow, Russia

HEALTH CARE EQUITY ISSUES IN MIDDLE EASTSpeakers: Mohammed Fouad Jabr RPh, PharmD, MBA, MSc, Head, Center for DrugPolicy & Evaluation, King Hussein Cancer Center Amman, Jordan

Ibrahim Al-Abbadi PhD, MBA, Assistant Professor, University of Jordan,Faculty of Pharmacy, Amman, Jordan

HEALTH CARE EQUITY ISSUES IN AFRICASpeaker: Professor Tienie Stander MBChB, MBA, Honorary Professor, North WestUniversity, School of Pharmacy, Johannesburg, South Africa

*40 Podium Presentations *14 Workshops *2 Educational Symposia *Exhibits

*Poster Presentations - Session 2 *Evening Social Event* 5 Issue Panels

TUESDAY, 11 NOVEMBERPlenary Session

Advancing Methods in Personalized Medicine for ClinicalDecision Making

Personalized medicine is the use of a patient's genetic or clinical data tostratify a disease and select a preventive, diagnostic or therapeutic pro-cedure, that is particularly suited to that patient. Personalized medicinemakes it possible to give: "the appropriate drug, at the appropriate dose,to the appropriate patient, at the appropriate time". Personalized medi-cine has the potential to revolutionize the practice of medicine, butdespite significant scientific advances, very few genomics-based tests ortreatments have reached consumers. The opportunities and challengesof developing, applying and evaluating strategies of personalized medi-cine will be discussed.

Speakers: TBD

*5 Issue Panels *14 Workshops *Educational Symposium *Exhibits *Poster Presentations - Session 3

* ISPOR Group Forums


ISPOR 11th Annual European Congress8-11 November 2008 | Athens, Greece


SHORT COURSESSATURDAY 8 NOVEMBER 2008 ALL DAY (9:00 - 18:00)Pharmacoeconomic / Economic Methods

PHARMACOECONOMICS FOR DECISION-MAKERSFaculty: Lieven Annemans PhD, MSc, Professor, GhentUniversity, Faculty of Medicine, Ghent, BelgiumCourse Description: This course is designed to teach clini-cians and new researchers how to incorporate pharma-coeconomics into study design and data analysis.Participants will learn how to collect and calculate the costsof different alternatives, determine the economic impact ofclinical outcomes, and how to identify, track and assign coststo different types of health care resources used. The develop-ment of economic protocols and data collection sheets willbe discussed. Different pharmacoeconomic models and tech-niques will be demonstrated and practiced in lectures andcase studies. These include cost-minimization, cost-of-illness,cost-effectiveness, cost-benefit, and cost-utility analysis.Decision analysis, sensitivity analysis, and discounting, will allbe demonstrated and practiced. Participants will also learn tocompare and evaluate interventions such as drugs, devicesand clinical services. This course is suitable for those with lit-tle or no experience with pharmacoeconomics.

Modeling Methods

DISCRETE EVENT SIMULATION FOR ECONOMICANALYSESFaculty: J. Jaime Caro MDCM, FCRPC, FACP, AdjunctProfessor of Medicine, Adjunct Professor of Epidemiologyand Biostatistics, McGill University, Montreal PQ and SeniorVice President of Health Economics, United BioSourceCorporation, Concord, MA, USA; Jörgen Möller MSc MechEng, Vice President, Modeling, United BioSource Corporation,Eslov, SwedenCourse Description: This course will provide a basic under-standing of the key concepts of discrete event simulation. Thefocus will be on the use of these simulation models toaddress pharmacoeconomic (and device-related) problems.The course will be structured around practical exercises.Topics to be covered are: Why DES? Dynamic simulation as atool; Components of a DES; How do you build a model?Modeling of processes and resource use; Modeling of vari-ables and decisions. Simple animation will be demonstrated.We will use ARENA to build simple models. Instructors willdistribute training versions of Arena. Participants who wish tohave hands-on experience should bring their personal lap-tops. This course is designed for those with some experiencewith modeling.

SATURDAY 8 NOVEMBER 2008 MORNING (9:00 - 13:00)Quality of Life / Patient-Reported Outcomes /Preference-Based Methods

INTRODUCTION TO PATIENT-REPORTEDOUTCOMES ASSESSMENT: INSTRUMENTDEVELOPMENT & EVALUATIONFaculty: Andrew Lloyd DPhil, Director, Oxford Outcomes,Oxford, UKCourse Description: Patient-reported outcomes (PROs) arewidely used to evaluate the impact of health technologies,practice innovations or changes in health policy from thepatients' perspective. This course is designed to familiarisepeople with the range and scope of what PROs are used for;how they are developed and evaluated, and how PRO datacan be used to support licensing and reimbursement applica-tions. The course content will describe the scope and rangeof what patient reported outcomes measure. This includes

generic and disease specific measures of health-relatedquality of life (HRQL), as well as measures of patient prefer-ence, utility, treatment satisfaction and measures of work pro-ductivity. We will describe the steps that researchers gener-ally go through in order to develop and test a new PRO. Thiswill include qualitative work, item development and testingand then validation studies. Finally in the last hour we willframe this in terms of what the FDA and EMEA expect to seewhen PROs form an important part of a licensing submission.In addition we will describe the approach of bodies such asNICE and how they review PRO data use it to guide reim-bursement decisions. This is an entry level course whichassumes only a passing familiarity with patient-reported outcomes.

Use of Pharmacoeconomics / Economic / OutcomesResearch Information

ELEMENTS OF PHARMACEUTICAL/BIOTECHPRICING I - INTRODUCTIONFaculty: Jack Mycka, President & Partner, MME LLC,Montclair, NJ, USA; Renato Dellamano PhD, President,ValueVector (Value Added Business Strategies), Milan, ItalyCourse Description: This course will give participants a basicunderstanding of the key terminology and issues involved inpharmaceutical pricing decisions. It will cover the tools tobuild and document product value including issues, informa-tion and processes employed (including pricing research); therole of pharmacoeconomics and the differences in paymentsystems that help to shape pricing decisions. These tools willbe further explored through a series of interactive exercises.This course is designed for those with limited experience inthe area of pharmaceutical pricing and will cover topics with-in a global context.

Modeling Methods

PHARMACOECONOMIC MODELINGFaculty: Uwe Siebert MD, MPH, MSc, ScD, Professor ofPublic Health, Head of the Department of Public Health,Medical Decision Making and Health TechnologyAssessment, University of Health Sciences, MedicalInformatics and Technology, Hall/Innsbruck, Austria, &Associate Professor of Radiology, Harvard Medical School,Director of the Cardiovascular Research Program, Institutefor Technology Assessment, Massachusetts General Hospital,Boston, MA, USACourse Description: This course will present an introductorydiscussion of pharmacoeconomic modeling techniques suchas Monte Carlo analysis, Markov modeling, and probabilisticsensitivity analysis, including a review of the ISPOR Principlesof Good Practice for Decision Analytic Modeling in HealthCare Evaluations. This course is designed for those withsome familiarity with modeling techniques.

Outcomes Research & Real World Data Methods

NEW! INTRODUCTION TO STATISTICSFaculty: TBD

Course Description: This course will provide an overview ofthe uses and applications of statistical software in pharma-coeconomics and outcomes research. We will begin by dis-cussing the foundations upon which major statistical tests arebased and the application of these tests to pharmacoeco-nomic problems. Considerations of planning and analyzingstudies, as well as the interpretation of results will also bereviewed, with a focus on increasing the understanding ofgeneral principles associated with elementary statistics. Thelatter half of the course will focus entirely on instruction forthe use and applications of the software, using specific exam-ples. This is an introductory level course. It is recommendedas a precursor to “Propensity Scores & Comorbidity RiskAdjustment” and “European Databases & RetrospectiveDatabase Analysis”.

NEW! META-ANALYSIS & SYSTEMATICLITERATURE REVIEWFaculty: TBD

Course Description: Meta-analysis may be defined as the sta-tistical analysis of data from multiple studies for the purposeof synthesizing and summarizing results, as well as for quanti-tatively evaluating sources of heterogeneity and bias. A sys-tematic literature review often includes meta-analysis andinvolves an explicit, detailed description of how a review wasconducted. This course highlights and expounds upon fourkey areas: 1) impetus for meta-analysis and systematicreviews, 2) basic steps to perform a quantitative systematicreview, 3) statistical methods of combining data, and 4)appraisal and use of meta-analytic reports. The material ismotivated via applications in pharmacoeconomics, outcomesresearch, and clinical studies from the published literatureand hypothetical examples. Interactive exercises are part ofthe course. This course is designed for those with little expe-rience with meta-analysis.

SATURDAY 8 NOVEMBER 2008 AFTERNOON (14:00 - 18:00)Outcomes Research & Real World Data Methods

EUROPEAN DATABASES AND RETROSPECTIVEDATABASE ANALYSISFaculty: TBD

Course Description: Large administrative patient databasesprovide a unique opportunity to examine retrospectively theeffects of drug use on clinical and economic outcomes in"real world" settings. This course will take a methodologicalapproach to the practical usage of existing patient databasesin Europe and cover a discussion of the ISPOR Checklist forRetrospective Database Studies - Report of the ISPOR TaskForce on Retrospective Databases, and selected topics relat-ed to estimators and sampling distributions, properties ofsampling distributions (unbiasedness, efficiency, mean squareerror), and ordinary least squares (OLS) regression. Morecomplex topics beginning with the problem of endogeneity,identification, instrumental variables, sample selection mod-els, and propensity score models, maximum likelihood meth-ods and the estimation of limited dependent variables modelsincluding logit, multinomial logit, count models, and survivalmodels will be discussed. Discussion will include a referenceto the ISPOR Digest of International Databases and its “realworld” applications to retrospective database analysis. Thiscourse assumes participants have knowledge of statisticalmethods and understanding in the analysis of administrativepatient databases. The short course “Introduction toStatistics” is recommended as a precursor to this course.

PATIENT REGISTRIES: OVERVIEW & APPLICATIONFaculty: Jeffrey Trotter MBA, Senior Vice President, ICONLifecycle Sciences Group, Lake Forest, IL, USA; LeanneLarson MHA, Vice President, Registry Consulting, ICONLifecycle Sciences Group, Lake Forest, IL, USACourse Description: This course is designed to provide anoverview of patient registries and its applications in identify-ing ‘real world’ clinical, safety, and patient-perspectiveissues. The advantages and disadvantages of patient registryversus other ‘real world’ data collection will be presented.The course will address safety and clinical objectives, as wellas regulatory trends and requirements. Key operational com-ponents and challenges, and measures of program successwill be discussed. Management issues, including creatingeffective partnerships with patient-oriented organizations andfacilitating long-term program operations within a changingorganizational structure will be addressed. This course isdesigned for those with some or no experience with patientregistries.


Modeling Methods

BAYESIAN METHODS IN ECONOMIC EVALUATIONSFaculty: TBD

Course Description: This course is designed to provide anoverview of the Bayesian approach and its application tohealth economics and outcomes research. The course willcover basic elements of Bayesian statistics, discuss differ-ences between Bayesian and classical (frequentist)approaches, and demonstrate how to apply the Bayesianapproach to clinical trials and cost-effectiveness analyses.Available software will be discussed, and examples of studieswill be presented. This course is for those with a basic appre-ciation of statistics and probability.

Quality of Life / Patient-Reported Outcomes /Preference-Based Methods

UTILITY MEASUREMENTS (PREFERENCE-BASEDTECHNIQUES)Faculty: Jan Busschbach PhD, Associated Professor,Department for Medical Psychology and Psychotherapy atErasmus Medical Center, Rotterdam, The Netherlands &Viersprong Institute for Studies on Personality Disorders,Halsteren, The Netherlands; Elly Stolk PhD, MSc, Institute forMedical Technology Assessment (iMTA), Erasmus UniversityMedical Center Rotterdam, The NetherlandsCourse Description: Utility measurement is a method of deter-mining an individual's preference for a certain outcome rep-resented by a quantitative score (utility). During this course,methods for measuring preference-based outcomes like thestandard gamble, time trade-off, and visual analogue scalewill be demonstrated. Utility measurement however is notonly about mastering these techniques; it is about using themin such a way that health care decision-makers can apply theresults, for instance in QALY-analyses. For this purpose, oneneeds to be aware of shortcomings of the available utilitymeasures and potential solutions. Furthermore one should beaware of the decision-making context and the way results areinterpreted. To equip participants with expertise in the field ofutility measurement, the most important issues will be dis-cussed: for instance we will consider potential insensitivity ofgeneric instruments for particular disease specific problems,and discuss to what extent adaptation of generic or disease-specific quality of life instruments may offer a solution. Thiswill be demonstrated with an exercise. Also the issue of"whose values count: patient values or values from the gener-al public?" will be discussed. Finally we turn to the interpreta-tion in the context of resource allocation. This course is forthose with some experience with quality-of-life measures inhealth economic evaluation.

Pharmacoeconomic / Economic Methods

COST ESTIMATION AND ASSESSING FINANCIAL(BUDGET) IMPACT OF NEW HEALTH CARETECHNOLOGIESFaculty: Josephine Mauskopf PhD, Vice President, HealthEconomics, RTI Health Solutions, Research Triangle Park, NC,USA; C. Daniel Mullins PhD, Professor and Chair ofPharmaceutical Health Services Research, University ofMaryland, School of Pharmacy, Baltimore, MD, USACourse Description: This course will describe methods todetermine the costs associated with a health condition andthe budget impact of new technologies for that condition. Thecourse will present incidence and prevalence based costingstrategies. Treatment algorithms and event-based approach-es will be demonstrated for disease-specific costs from dif-ferent decision-maker perspectives. Both static and dynamicmethods for estimating the budget impact of adding a newdrug to a health plan formulary will be presented. Issuesrelated to imputing missing data will also be discussed. Thiscourse is designed for those with some experience with phar-macoeconomic analysis.

SUNDAY 9 NOVEMBER 2008 MORNING (8:00 - 12:00)Use of Pharmacoeconomics / Economic / OutcomesResearch Information

CASE STUDIES IN PHARMACEUTICAL/BIOTECHPRICING II - ADVANCEDFaculty: Jack Mycka, President & Partner, MME LLC,Montclair, NJ, USA; Renato Dellamano PhD, President,ValueVector (Value Added Business Strategies), Milan, ItalyCourse Description: Case studies will be employed to leadparticipants through the key steps of new product pricing,with focus on the need to thoroughly analyze the businessenvironment and its constraints and opportunities and theneed to closely integrate the pricing, reimbursement and PE

strategy for the new product with the clinical developmentand marketing strategies. Practical exercises will allow par-ticipants to consolidate the concepts delivered in the“Elements” introductory session and expanded here. Areascovered will include the post-launch issues of reimburse-ment and pricing maintenance as a part of life-cycle man-agement in a global environment. This course is for individu-als who have completed Elements of PharmaceuticalPricing I - Introduction or are familiar with both the keydeterminants of pharmaceutical pricing and the main inter-national health systems.

REIMBURSEMENT SYSTEMS IN EUROPEFaculty: James Furniss, Director, Pricing and Reimbursement,Bridgehead International Limited, Melton Mowbray, UK; KevinW. Mayo PhD, Director, Health Outcomes Research, DaiichiSankyo Inc. & Adjunct Professor, University of the Sciences inPhiladelphia, Philadelphia, PA, USA; Sasha Richardson PT,MBA, Principle Consultant, Bridgehead InternationalConsulting, London, UKCourse Description: This course is designed to provide partic-ipants with an understanding of the various proceduresemployed by European health authorities to regulate marketaccess based upon the appraisal of the clinical and in somecountries economic value of new medical technologies. Thefaculty will systematically describe the reimbursement legis-lation, processes and organizations within each nation anddescribe the role of the pharmaceutical and/or medicaldevice manufacturer. This course is designed for individualswith intermediate experience within a single healthcare sys-tem wishing to broaden their appreciation of other reimburse-ment systems.

Pharmacoeconomic / Economic Methods

TRANSFERABILITY OF COST-EFFECTIVENESS DATABETWEEN COUNTRIESFaculty: TBD

Course Description: Although the number of countries requir-ing an economic dossier as part of the submission dossier forpublic reimbursement of new drugs is growing, the pharma-ceutical industry cannot conduct economic evaluations inevery potential market. Clinical trials are increasingly done ininternational settings in order to quickly recruit a sufficientnumber of patients and to have at least some economic datafrom multiple countries. However, national decision makersrequire country-specific or region-specific data on health carecosts and are only willing to accept foreign data or interna-tional data when they are translated to their own specific set-ting. But little guidance on how to do this exists. This coursestarts with a discussion of factors that make economic datamore difficult to transfer from one country to other countriesthan clinical data, and the evidence on the variability of cost-effectiveness results across countries. Then we will reviewthe methods that have been presented to offer a solution tothis problem and their pros and cons. Finally, we will discussthe emerging international guidance for dealing with issues oftransferability, including the suggestions made by the ISPORGood Practices Task Force on this topic. The methods to bediscussed include various types of regression basedapproaches and Markov models. This course is for those withbasic understanding of cost calculation and modeling.

COST-EFFECTIVENESS ANALYSIS ALONGSIDECLINICAL TRIALSFaculty: Scott Ramsey MD, PhD, Full Member and Professor,Fred Hutchinson Cancer Research Center, Seattle, WA, USA;Richard Willke PhD, Senior Director, Group Leader, GlobalOutcomes Research, Worldwide Outcomes Research, USDevelopment Sites Pfizer, Inc., Bridgewater, NJ, USACourse Description: The growing number of prospective clini-cal/economic trials reflects both widespread interest in eco-nomic information for new technologies and the regulatoryand reimbursement requirements of many countries that nowconsider evidence of economic value along with clinical effi-cacy. This course will present the design, conduct, andreporting of cost-effectiveness analyses alongside clinical tri-als based on, in part, the Good Research Practices for Cost-Effectiveness Analysis alongside Clinical Trials: The ISPORRCT-CEA Task Force Report. Trial design, selecting data ele-ments, database design and management, analysis, andreporting of results will be presented. Trials designed to eval-uate effectiveness (rather than efficacy), as well as clinicaloutcome measures will be discussed. How to obtain healthresource use and health state utilities directly from study sub-jects and economic data collection fully integrated into thestudy will also be discussed. Analyses guided by an analysisplan and hypotheses, an incremental analysis using an inten-tion to treat approach, characterization of uncertainty, and

standards for reporting results will be presented. This courseis an introductory/intermediate level. Familiarity with econom-ic evaluations will be helpful.

Modeling Methods

PHARMACOECONOMIC MODELING - ADVANCEDFaculty: Uwe Siebert MD, MPH, MSc, ScD, Professor ofPublic Health, Head of the Department of Public Health,Medical Decision Making and Health TechnologyAssessment, University of Health Sciences, MedicalInformatics and Technology, Hall/Innsbruck, Austria, &Associate Professor of Radiology, Harvard Medical School,Director of the Cardiovascular Research Program, Institutefor Technology Assessment, Massachusetts General Hospital,Boston, MA, USACourse Description: This course will provide an in-depth lookat modeling techniques and their application in a “real world”setting. It will discuss the ISPOR Principles of Good Practicefor Decision Analytic Modeling in Health Care Evaluations andevaluate its implications for the application of various model-ing methods. Using a series of related examples, the coursewill carefully review the practical steps involved in develop-ing and using these kinds of models. This course will coverthe practical steps involved in the selection and modeling ofdata inputs and practical aspects related to the determinationof when, why and how to handle stochastic (i.e., first orderMonte Carlo Simulations) and probabilistic uncertainty (i.e.,second order Monte Carlo Simulations). Participants will havethe opportunity to apply the discussed methods using variousmodeling software on their personal laptops. This course isintended as a follow-up to the short course, “Pharma-coeconomic Modeling”, and is designed for those with inter-mediate to advance knowledge of modeling methods.Participants who wish to have hands-on experience shouldcome equipped with their personal laptops.

Quality of Life / Patient-Reported Outcomes /Preference-Based Methods

NEW! ADVANCED PATIENT-REPORTED OUTCOMESASSESSMENT: PSYCHOMETRIC METHODSFaculty: TBD

Course Description: This course will discuss psychometricanalysis and the application of various techniques such asstructural equation modeling (SEM), factor analysis (FA) anditem response theory (IRT) in testing patient-reported out-comes (PRO) instruments, measures and construct / criterionvalidity. Validity indicates how well a measurement toolallows us to infer something about the true nature and valueof the object or system being considered. Instructors willexplain and demonstrate how to analyze observed and latentconstructs and variables within a model as well as to test thevalidity of a PRO measure. Specific examples will be given tohighlight how researchers can apply these techniques to testmethods, criteria and new measures. This is an advancedcourse designed for those with a working knowledge ofQoL/PRO methods.

Outcomes Research & Real World Data Methods

PROPENSITY SCORES AND COMORBIDITY RISKADJUSTMENTFaculty: Fadia Shaya MPH, PhD, Associate Professor andAssociate Director, University of Maryland School ofPharmacy, Center on Drugs and Public Policy, Baltimore, MD,USACourse Description: A large part of the evidence about theeffectiveness of different treatments is based on retrospec-tive studies. Issues of bias and confounding relate to the non-random assignment of subjects and co-morbidity burden. Thiscourse will outline the concerns about bias and explain themethods for causal inference in observational studies, whereresearchers have no control over the treatment assignment.A lack of balance in the covariates between the treatmentand control groups can produce biased estimates of thetreatment effects. We will explain how propensity scores canbe used to reduce bias, through stratification, matching orregression. Confounding and the pros and cons of standardadjustment, propensity scoring methodology (sub classifica-tion on one confounding variable, overlap in treatmentgroups, variable selection) will be discussed. In the secondpart, we will elaborate on risk adjustment models, focusing onmorbidity indices, e.g the Charlson Comorbidity Index, andChronic Disease Scores. Examples using a step by stepapproach will be presented. This is an introductory course,designed for those with little experience with this methodolo-gy but some knowledge of observational databases. Theshort course “Introduction to Statistics” is recommended asa precursor to this course.


ISPOR 11th Annual European Congress

8-11 November 2008 | Athens, GreeceEarly Registration Deadline: 30 September 2008

Congress Promotional opportunities

Hotel Information

EXHIBITRegister now for exhibit space!Over 1700 attendees in 2007! Present your products and services to key outcomes researchers and health care decision makers in pharmaceutical,medical device & diagnostics, biotechnology industries, clinical practice, government agencies, academia, and health care organizations. Benefits to Exhibitors:• Listing & 1/4 page advertisement in the Program & Schedule of Events• Listing & 1/4 page advertisement on the ISPOR website• One complimentary registration per exhibit booth• Pre-registrant mailing labels

ADVERTISEAdvertise in the Program & Schedule of Events!• Company promotion• Job opportunities• Publications• Journals

- Full page, full color advertising available- 1/4, 1/2, and full page, one color advertising available. Prices start from $900.

Advertising Deadline: 23 SEPTEMBER 2008

SPONSORIncrease your visibility! Give your company increased visibility and prominence.Benefits to Sponsors:• Sponsorship recognition at the plenary sessions• Event signage • Listing & 1/4 page advertisement in the Program & Schedule of Events• Listing & 1/4 page advertisement on the ISPOR website• One complimentary registration• Preferential exhibit booth location

“Moving and Improving Concepts & Evidence for Health Care Decisions”


For more information: www.ispor.org

Hilton Athens46 Vassilissis Sofias AvenueAthens, Greece 11528Telephone: 30-210-728-1000Fax: 30-210-7281111Website: www.athens.hilton.com

ISPOR Rates:

The discounted room rate for ISPOR Congress attendees is j200 (approximately 315 US) plusapplicable service charges and taxes.Please note: Rates are available for the dates of 8-11 November 2008. Discounted rates are available until July 6, 2008 (subject to availability).Cancellations of reservations without penalty must be made by September 6, 2008.To make hotel reservations go to: www.ispor.org.

The hotel is conveniently situated in the commercial and tourist district of the city, within minutes to historical sites and attractions. Athens International Airport isapproximately 45 minutes by taxi, servicing a variety ofdirect flights from cities worldwide.


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Please enclose a check payable in US dollars or Euro C= to: International Society for Pharmacoeconomics and Outcomes Research or ISPOR and send to the ISPOR address given

below or charge to: nn VISA nn MasterCard nn American Express ACCOUNT NUMBER: _____________________________________________________ EXPIRATION DATE: __________________

NAME: _______________________________________________________________________ AUTHORIZED SIGNATURE: _________________________________________________________

SHORT COURSE REGISTRATION FEESHALF DAY COURSESBEFORE 30 SEPTEMBER 2008 AFTER 30 SEPTEMBER 2008

nn US$235 ;150 REGULAR FEE nn US$315 ;200 REGULAR FEEnn US$120 ;75 STUDENT FEE nn US$160 ;100 STUDENT FEE

FULL DAY COURSES BEFORE 30 SEPTEMBER 2008 AFTER 30 SEPTEMBER 2008

nn US$470 ;300 REGULAR FEE nn US$630 ;400 REGULAR FEEnn US$235 ;150 STUDENT FEE nn US$315 ;200 STUDENT FEE

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ISPOR Social Event

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TOTAL REGISTRATION FEE:

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StandardRegistration Before 30 September nn US$785 j500 nn US$940 j600 Registration After 30 September nn US$940 j600 nn US$1100 j700

Clinical Practitioners (Clinical Practice, Hospital)Registration Before 30 September nn US$550 j350 nn US$710 j450 Registration After 30 September nn US$710 j450 nn US$855 j545

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Full-Time Students (must provide current enrollment documentation)

Registration Before 30 September nn US$160 j100 nn US$190 j120 Registration After 30 September nn US$235 j150 nn US$270 j170

One Day Registration (per day)** (One Day registrations cannot be combined)

nnnn 9 Nov nnnn 10 Nov nnnn 11 Nov nn US$470 j300 nn US$630 j400

Continuing Education Accreditation nn US$50 j34 nn US$50 j34

ISPOR Social Event nn US$100 nn j65Monday, 10 November, 20:00-23:30

exchange rate as of June 2008

REGISTRATION FEES

Online registration available at www.ispor.org

Mail Details: If not paying by credit card online, send registration form and payment to:International Society for Pharmacoeconomics and Outcomes Research, 3100 Princeton Pike,Building 3 Suite E, Lawrenceville, New Jersey 08648, USA Tel: 1-609-219-0773 Fax: 1-609-219-0774 • E-Mail: [email protected] • Internet: www.ispor.org

Payment Details: Payment may be made by check, travelers check, bank transfer (there is a USD$40 charge) or credit card. VISA, MasterCard, or American Express will be charged in US dollars.Signature, account number and expiration date must be included. Non-US checks written in US$ onbanks with a US counterpart are at no charge. For Non-US checks written in US$ on banks withNO US counterpart there is USD $25 charge. 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. For bank transfers, please designate the registrationname and/or registration number.

* Membership Details: If ISPOR cannot verify your current membership, you will be charged the non-member registration rate. When you register as a non-member, you receive an ISPOR membershipwhich includes a one year online subscription to Value in Health - The Journal of the InternationalSociety for Pharmacoeconomics and Outcomes Research.

** One Day Registration Details: One day registration does not include ISPOR membership benefits and cannot be combined.

Cancellation Details: Cancellation fee before 30 September 2008 is US $160. No refunds givenafter 30 September 2008.

Member ID# ________________

SATURDAY, 8 NOVEMBER 2008 - ALL DAY (9:00 - 18:00)nn Pharmacoeconomics for Decision-Makers

nn Discrete Event Simulation for Economic Analyses

SATURDAY, 8 NOVEMBER 2008 - MORNING (9:00 - 13:00)nn Introduction to Patient-Reported Outcomes Assessment: Instrument Development &

Evaluation

nn Elements of Pharmaceutical/Biotech Pricing I - Introduction

nn Pharmacoeconomic Modeling - Introduction

nn Introduction to Statistics

nn Meta-Analysis & Systematic Literature Review

SATURDAY, 8 NOVEMBER 2008 - AFTERNOON (14:00 - 18:00)nn European Databases and Retrospective Database Analysis

nn Patient Registries: Overview & Application

nn Bayesian Methods in Economic Evaluations

nn Utility Measurements (Preference-Based Techniques)

nn Cost Estimation and Assessing Financial (Budget) Impact of New Health CareTechnologies

SUNDAY, 9 NOVEMBER 2008 - MORNING (8:00 - 12:00)nn Case Studies in Pharmaceutical/Biotech Pricing II - Advanced

nn Reimbursement Systems in Europe

nn Transferability of Cost-Effectiveness Data between Countries

nn Cost-Effectiveness Analysis alongside Clinical Trials

nn Pharmacoeconomic Modeling - Advanced

nn Advanced Patient-Reported Outcomes Assessment: Psychometric Methods

nn Propensity Scores and Comorbidity Risk Adjustment

ISPOR 11th Annual European Congress8 - 11 November 2008 | Athens, Greece


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