T ISPOR a non-profit 501(c)(3) organization 20 Nassau Street, Suite 307 Princeton, NJ 08542 USA Tel: 609-252-1305 Fax: 609-252-1306 email: [email protected]Internet: www.ispor.org 1999-2000 EXECUTIVE BOARD President Bryan Luce PhD, MBA MEDTAP International [email protected]President-Elect Jon Clouse RPh, MS Ingenix-Kern McNeil [email protected]Past President Robert S. Epstein MD, MS [email protected]Directors Diana Brixner RPh, PhD [email protected]Peter Davey MD, FRCP [email protected]Karen Rascati RPh, PhD [email protected]Adrian Towse MA, Mphil [email protected]Gordon Vanscoy PharmD, MBA [email protected]Executive Director Marilyn Dix Smith RPh, PhD [email protected]ISPOR NEWS Editor Donna Rindress PhD [email protected]UNITING SCIENCE AND PRACTICE VOL. 6, NO. 2 MAR/APR 2000 INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH IN THIS ISSUE ▼ Distinguished ISPOR Members Head Up the ISPOR Health Science Steering Committee N ews 1_ ISPOR’s Health Science Steering Committee 3_ Fireside Chat with ISPOR President Bryan Luce PhD, MPH 4_ ISPOR’s Board of Directors Actions 6_ News Briefs from Around the World 8_ Student Corner 8_ Student Networking Group 9_ Bulletin Board 10_ Using Pharmacoeconomics & Outcomes Research Innovatively 17_ ISPOR 5th Annual International Meeting Events Chart 18_ ISPOR 5th Annual International Meeting Summary of Events 19_ ISPOR 5th Annual International Meeting Registration The ISPOR Board of Directors recently approved the formation of the ISPOR Health Science (HS) Steering Committee. The objective of this HS Steering Committee is to build on the initiatives of the multi- disciplinary Cost-effectiveness in Health and Medicine Panel appointed by the US Public Health Service (whose recommendations were published in Cost-effectiveness in Health and Medicine, edited by Gold, Siegel, Russell, and Weinstein), the ISPOR Advisory Panels on Pharmacoeconomics Issues (whose recom- mendations were published in VALUE IN HEALTH Vol. 2, No. 2 [March-April, 1999]), and other outcomes research practice standard publications. The goals of the ISPOR Health Science Policy Task Forces are to: 1. Develop and disseminate good practice standards in health outcomes research and its use in decision making: • To address the specific methodological issues identified for each pharma- coeconomic / outcomes research methodology; • To develop consensus on solutions to these issues through programming, surveys, or other means of promotion. • To publish these results as good research practices, code of ethics, or policy statements. 2. Develop other resources for influencing public healthcare policy.
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TISPORa non-profit 501(c)(3) organization
20 Nassau Street, Suite 307Princeton, NJ 08542 USA Tel: 609-252-1305 Fax: 609-252-1306 email: [email protected] Internet: www.ispor.org
VOL. 6, NO. 2 MAR/APR 2000 INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH
IN THISISSUE
▼
Distinguished ISPOR Members Head Up theISPOR Health Science Steering Committee
News
1_ ISPOR’s Health Science Steering Committee
3_ Fireside Chat with ISPOR President Bryan Luce PhD, MPH
4_ ISPOR’s Board of Directors Actions
6_ News Briefs from Around the World
8_ Student Corner
8_ Student Networking Group
9_ Bulletin Board
10_ Using Pharmacoeconomics & Outcomes Research Innovatively
17_ ISPOR 5th Annual International Meeting Events Chart
18_ ISPOR 5th Annual International Meeting Summary of Events
19_ ISPOR 5th Annual International Meeting Registration
The ISPOR Board of Directors recently
approved the formation of the ISPOR Health
Science (HS) Steering Committee. The
objective of this HS Steering Committee is
to build on the initiatives of the multi-
disciplinary Cost-effectiveness in Health and
Medicine Panel appointed by the US Public
Health Service (whose recommendations
were published in Cost-effectiveness in Health
and Medicine, edited by Gold, Siegel, Russell,
and Weinstein), the ISPOR Advisory Panels
on Pharmacoeconomics Issues (whose recom-
mendations were published in VALUE IN
HEALTH Vol. 2, No. 2 [March-April, 1999]),
and other outcomes research practice
standard publications.
The goals of the ISPOR Health SciencePolicy Task Forces are to:
1. Develop and disseminate good practice
standards in health outcomes research and
its use in decision making:
• To address the specific methodological
issues identified for each pharma-
coeconomic / outcomes research
methodology;
• To develop consensus on solutions to
these issues through programming,
surveys, or other means of promotion.
• To publish these results as good research
practices, code of ethics, or policy
statements.
2. Develop other resources for influencing
public healthcare policy.
2
3. Influence public healthcare policy-making on the basis of goodscientific practices to improve the use of scientific information(i.e. pharmacoeconomic/health economic and healthcareoutcomes information) in healthcare decision-making and todevelop awareness of these good research practices, code ofethics, or policy statements through programs, workshops, ortraining programs with healthcare decision-makers.
The HS Steering Committee Chair is:Nicolaas Otten PharmD, Director Pharmaceutical & ExtramuralResearch, Canadian Coordinating Office for Health Technology,Ottawa, Ontario, Canada
The HS Steering Committee Task Forcesand Chairs are:Task Force on Good Research Practices – Prospective StudiesLouis A. Morris PhD, Senior Vice President and ManagingDirector of the Marketing and Regulatory Consulting Division ofSCP Communications, Melville, New York, USA
Task Force on Good Research Practices – Modeling StudiesMilton Weinstein PhD, Professor Health Policy & Management,Harvard School of Public Health, Center for Risk Analysis,Boston, Massachusetts, USA
Task Force on Good Research Practices – RetrospectiveDatabase StudiesBrenda Motheral RPh, PhD, MBA, Assistant Professor, Universityof Arizona, College of Pharmacy, Tuscon, Arizona, USA
Task Force on Good Research Practices-Outcomes Assessmentusing Quality of Life IndicatorsPaul Kind Mphil, Senior Research Fellow, University of York,Centre for Health Economics, York, UK
Task Force on Use of Pharmacoeconomic / Health EconomicInformation in Healthcare Decision-makingMichael Drummond PhD, Director, University of York,Centre for Health Economics, York, UK
Task Force on Medical Information AccessKarl Matuszewski MS, PharmD, Director, Technology Assessment, University HealthSystem Consortium, ClinicalPractice Advancement Center, Oak Brook, Illinois, USA
Task Force on Code of EthicsFrank Palumbo JD, PhD, Director, University of Maryland Centeron Drugs & Public Policy, Baltimore, Maryland, USA
Each of the Task Force will have its own agenda, but areascommon to two or more Task Forces will be coordinated throughthe Steering Committee. In particular, we want to develop
comprehensive good research practices (‘toolboxes’) for themajor methodological areas to provide guidance to theresearchers. Second, we would like to develop ‘levels of evidence’or checkboxes for those components that are consideredessential. In some areas, such as use of administrative databases,there is very little in the way of current published good researchpractices. For others, some work has begun (e.g., modeling) fromwhich we can provide further clarification and enhancementwhile others (e.g. quality of life) have been clarified and acceptedin some jurisdictions.
The four Task Forces which will be primarily developing‘toolboxes’ for the outcomes researcher are:• Task Force on Good Research Practices – Prospective Studies• Task Force on Good Research Practices – Modeling Studies• Task Force on Good Research Practices – Retrospective
Database Studies• Task Force on Good Research Practices – Outcomes Assessment
using Quality of Life Indicators
The Task Forces must address the ethical issues to consider whenconducting the types of outcomes research given above, as well asthe issues to address in assuring access to medical information(such as assuring patient confidentiality), are:• Task Force on a Code of Ethics• Task Force on Medical Information Access
The Task Force must act as a ‘two-way’ street to assure that thegood research practices incorporate the needs and ‘reality checks’of healthcare decision-maker and must be the translator of thesegood research practices as well as develop a ‘toolbox’ for thehealthcare decision-maker in interpreting and using outcomesstudies is:• Task Force on Use of Pharmacoeconomic / Health Economic /
Outcomes Research Information in Healthcare Decision-making
The diagram below illustrates the overlap in missions.
continued from cover…
•
Good ResearchPractices –
Prospective Studies
Good ResearchPractices –
Retrospective Database Studies
Code of Ethics
Medical Info Access
Good Research Practices – QoL
Outcomes Assessment
Good Research Practices –
Modeling Studies
Use of Pharmacoeconomics / Health Economic / Outcomes Research Information
on Healthcare Decision Making
A
3
from Bryan Luce PhD, MPH, 1999-2000 ISPOR President
FIRESIDE CHATwith the ISPOR President
Bridging the Gap: AWake-up Call!
The mission of theInternational Society forPharmacoeconomics andOutcomes Research is totranslate pharmacoeconomicsand outcomes research intopractice to ensure that societyallocates health care resourceswisely, fairly and efficiently.
At our Strategic Planning Retreat last
Autumn, the ISPOR Board decided that
its highest priorities for new initiatives
was ‘bridging the gap’ between the
production of health economic and
outcomes research information and the
use of it in health care decision-making.
We have yet to make significant
progress in closing this gap…a term
which may be better labeled ‘chasm’.
The issue was brought to the fore at
Hilton Head earlier this month where I
participated in a session at the annual
DIA Quality of Life conference. My job
was to describe ISPOR’s role and
activities relative to health-related
quality of life. I shared the platform
with Dr. Ivan Borovsky, President-elect
of the International Society of Quality
of Life (ISOQOL) who was to give a
parallel presentation as to his Society’s
role. Without coordinating
presentations, our respective remarks
made obvious that we had very
different views of the roles of our two
societies. According to Dr. Borovsky,
ISOQOL’s role is primarily focused on
technically improving the state of
health-related quality of life (HRQL)
research, while I saw ISPOR as more
focused on the policy of disseminating
and using HRQL information for health
care decision-making. When asked my
opinion as to whether the HRQL
evidence was being used systematically
in health care decisions, I had to answer
that I saw very little evidence of it.
This is both ironic and unfortunate.
Ironic in that health-related quality of
life endpoints are now virtually
standard elements of most major drug
clinical protocols and are increasingly
included as measures of clinical efficacy
and even part of the labeling. Further,
health-related quality of life is almost
purely a patient issue, secondarily a
patient family issue. When patients seek
health care, they seek first and foremost
improvement of their
health status.
Thus, we have a market that is
supplying a good (HRQL information)
which end users (patients) desire.
So, where is the break-down. I believe it
is the intermediaries who are at fault.
This includes the marketers within
manufacturers who may not be
promoting the HRQL message to
patients, the FDA who may be reluctant
to allow the message to be disseminated
to patients and the health care decision
makers themselves who do not seem to
sufficiently value the HRQL messages
that are available.
Unfortunately, the same basic story is
true for the health economics and
outcomes research field as a whole.
Health care decision-making today
does not, in the main, take into account
the full value which drugs and other
health care products and services
deliver to patients, their families, the
health care system, the employer and
society as a whole.
Thus, the wake up call noted above.
The leadership of ISPOR seeks ideas
and volunteers to "bridge the gap".
In keeping with the remarks I made in
Hilton Head and note in this message,
I call on the ISPOR Quality of Life
Special Interest Group (QLSPIG),
ISPOR Managed Care Special Interest
Group, (MCSPIG), and the ISPOR
Disease Management Special Interest
Group (DMSIG) to focus on bridging
this gap and I call on the health
economists, other analysts, educators
and clinicians in the Society to do the
same. If you have ideas and/or time to
volunteer, please join an ISPOR Special
Interest Group via the web at
www.ispor.org under Special Interest
Groups. •
The Board of Directors took thefollowing actions at recent Board ofDirectors Meetings
Board of Directors Meeting, November 14, 1999,Edinburgh, Scotland:1. The Board approved the following goals and objectives
and organizational structure for the ISPOR Health Science
Steering Committee recommended by the Health Policy
Ad Hoc Committee. The ISPOR Health Science Steering
Committee consists of the Health Science (HS) Task Force
Chairs and a member of the Board of Directors. The
objectives of the HS Steering Committee are to establish
goals, timetables, and desired outcomes (deliverables) for
the HS Task Forces and communicate and coordinate
activities between the Task Forces.
1.1. The ISPOR HS Task Forces are: 1) to develop and
disseminate good practice standards in health
outcomes research and its use in decision-making;
2) develop other resources for influencing public
healthcare policy; 3) influence public healthcare
policy-makers to improve the use of scientific
information in healthcare decision-making
1.2. The Task Forces are as follows:
• Task Force On Good Research Practices –
Prospective Studies
• Task Force On Good Research Practices –
Modeling Studies
• Task Force On Good Research Practices –
Retrospective Database Studies
• Task Force On Good Research Practices –
Quality Of Life Studies
• Task Force On Use Of Pharmacoeconomic /
Health Economic Information In Healthcare
Decision-Making
• Task Force On Medical Information Access
• Task Force On A Code Of Ethics
2. The Board requested an analysis of Annual Meeting and
European Conference attendee work environment to assess
ISPOR’s growth characteristics.
3. The Board approved the development of a 3-year ISPOR
Business Plan. The ISPOR Business Ad Hoc Committee is
composed of Jon Clouse (Chair), Diana Brixner, Rob
Epstein, Jean Paul Gagnon, and Adrian Towse.
4. The 2000 ISPOR Budget with modification was approved.
5. The Board approved the Finance Committee policy
recommendations on meeting press passes, complimentary
and one-day Annual Meeting and European Conference
registrations and leadership travel reimbursement policy.
6. The Board approved the new composition of the Finance
Committee (Treasurer, as chair, President-elect, and a
Director appointed by the Board).
7. The Board approved the membership fee to be increased
from $125 to $135 to cover the increase in VALUE IN
HEALTH publication expenses for 2000.
Board of Directors’ Meeting, February 8, 2000(Teleconference):1. The Board approved that PhRMA Foundation Faculty
Development Awards in Pharmacoeconomics be presented
at the ISPOR Annual Meeting.
2. The Board approved ISPOR as a co-sponsor for the
following events as a non-revenue / non-risk-sharing
sponsor: International & Research: Society for
Pharmacoepidemiology’s Health Care Databases A
symposium on the Power and Perils of Health Data used
In Epidemiologic and Economic Research April 14, 2000,
Chapel Hill, NC; and the European Association of Clinical
Pharmacologists and Therapeutics’ Meeting, September
12-14 2001. Based on previous Board action, non-
revenue/non risk sharing co-sponsorship can include the
use of the ISPOR name and logo and displaying event
brochures at an ISPOR Meeting at no cost; announcement
of the event in the ISPOR NEWS at the prevailing rate;
mailing an event brochure to ISPOR members at the
prevailing mailing list rate.
3. The Board approved the following description, criteria,
selection process, and nature of award for the ISPOR
Research Award for Methodology Excellence and ISPOR
Research Award for Practical Application Excellence as
recommended by the Awards Committee.
ISPOR Board of Directors Actions
4
1999-2000 Executive BoardFrom left to right, Peter Davey MD, FRCP, University of Dundee; Jon Clouse
RPh, MS, Ingenix-Kern McNeil; Robert S. Epstein MD, MS, Merck-Medco
Managed Care, LLC; Diana Brixner RPh, PhD, Novartis Pharmaceuticals
Corporation; Bryan Luce PhD, MBA, MEDTAP International; Adrian Towse
MA, Mphil, Office of Health Economics; Jean Paul Gagnon PhD, Hoechst
Marion Roussel, Inc; Karen Rascati RPh, PhD, University of Texas
5
ISPOR Research Award for Methodology ExcellenceDESCRIPTION:
The ISPOR Research Excellence Award for Methodology Excellence was established in 1997 to recognize outstanding
research in the field of pharmacoeconomics and outcomes research methodology.
CRITERIA: The winner of ISPOR Research Excellence Award for Methodology Excellence is selected by the Awards Committee
based upon publications that have appeared in respected peer-review journals and other communication venues
(e.g., books, reports) during the preceding eighteen months from January 1 of the year awarded. The award selection is
based upon the publication’s clear description of methods, along with the appropriate and creative applications
(or proposal thereof in conceptual methodology work) of techniques to answer important questions in the field of
pharmacoeconomics and outcomes research. Such publications will be expected to have much impact on the field, due
to their acceptance and application by others.
SELECTION PROCESS:A call for nominations is placed in November-December ISPOR NEWS for articles published during the past eighteen
months to be considered for the ISPOR Research Excellence Award for Methodology Excellence. In addition, each
Awards Committee member selects relevant publications in respected peer-reviewed journals during the preceding
eighteen months to be considered by the Awards Committee in the selection process. The Awards Committee meets via
teleconference in February to discuss each of the nominated publications. They select the best demonstration of
scientific excellence for that time period. The senior author on the publication is given the award.
NATURE OF AWARD:The Award, presented at the ISPOR Annual International meeting, consists of a plaque, complimentary Annual
International Meeting registration, roundtrip air fare, hotel, meal and miscellaneous expenses for two days, based upon
current ISPOR travel policies.
ISPOR Research Award for Practical Application ExcellenceDESCRIPTION:
The ISPOR Excellence Award for Practical Application Excellence was established in 1997 to recognize outstanding
practical application of pharmacoeconomics and outcomes research in healthcare decision-making.
CRITERIA: The winner of ISPOR Research Excellence Award in Practical Application Excellence is selected by the Awards
Committee based upon publications that have appeared in respected peer-review journals or other communication
venues (e.g., guidelines, reports, books) during the preceding eighteen months from January 1 of the year awarded.
The award selection is based upon the article's clear description of methods, along with the appropriate and creative
applications of techniques to answer important questions in the field of pharmacoeconomics and outcomes research.
Such publications will be expected to have much impact on the field, due to their acceptance and wide-spread use.
SELECTION PROCESS:A call for nominations is placed in November-December ISPOR NEWS for articles published during the past eighteen
months to be considered for the ISPOR Research Excellence Award for Application Excellence. In addition, each Awards
Committee member selects relevant publications in respected peer-reviewed journals during the preceding eighteen
months to be considered by the Awards Committee in the selection process. The Awards Committee meets via
teleconference in February to discuss each of the nominated publications. They select the best demonstration of
scientific excellence for that time period. The senior author on the publication is given the award.
NATURE OF AWARD:The Award, presented at the ISPOR Annual International meeting, consists of a plaque, complimentary Annual
International Meeting registration, roundtrip air fare, hotel, meal and miscellaneous expenses for two days, based upon
current ISPOR travel policies.
NEUROPENew EC regulations offering financialincentives to companies that developproducts for rare diseases came into forceat the end of January. A budget forfunding should be established byFebruary. (Scrip 2509:3) ■ The head of theEC Commission’s pharmaceuticals andcosmetics unit has called for thedevelopment of guidelines on goodregulatory practice as the EU prepares toadmit new members. EU expansion isforcing regulators to consider how tobalance various marketing, confidentialityand transparency issues. (Scrip 2513:2) ■ According to the Pan-EuropeanRegulatory Forum on Pharmaceuticals(PERF), all regulatory agencies shouldattempt to keep scientific assessments freeof political influences despite the lack ofan organizational model. (Scrip 2514:5) ■ The EC Commission may extendEudraNet, its electronic network forpharmaceutical data, to countriesnegotiating to enter the EU. The networkallows for the rapid transmission of databetween regulatory authorities.(Scrip2515:5)
CroatiaChronic healthcare fund shortages haveresulted in payment delays that arethreatening medicine supplies. Croatia’slargest wholesaler is reportedly owedDM128 million ($64.6 million) by the statehealth insurance agency. (Scrip 2519:7)
CzechoslovakiaThe lower chamber of the CzechParliament has rejected a proposal toinclude a "Roche-Bolar" provision innational patent legislation. The decisionwas influenced by the current EUchallenge of similar legislation in Canada.(Scrip 2521:3)
FrancePharmaceutical spending remains resistantto government cost-containmentmeasures. CNAM, the health insurancebody, suggests that a number of delistingscould be imminent. (Scrip 2516:2)
GermanyKrankenkassen pharmaceutical spendingreached DM35.1 billion ($18.2 billion) in
1999, 4% over the budget ceiling and 7%more than 1998. As a basis for furtherreform, the health ministry is looking atthe therapeutic added value of "me-too"products and encouraging the use ofgenerics. (Scrip 2512:3) ■ The HealthMinistry expects to implement anamendment to the negative listwithin a few months. Theamendment contains about400 products deemed tobe uneconomic interms of efficacy orformulation. (Scrip2519:3)
HungaryThe government isproposing legislationthat would increase the share of totalreimbursement given to generics to at least35% from the current 21%. The legislationis an attempt to cut spending inpreparation for EU entry in 2003. (Scrip2517:6)
ItalyAfter its first major overhaul, Italy’sreimbursement list will more closelyresemble an aid to prescribing completewith a list of generics, cost comparisonsand prescribing restrictions. The firstedition should be available this July.(Scrip 2512:8)
NorwayNorway is the latest European country topublish pharmacoeconomic guidelines.Companies are being asked to use the newguidelines for preparing cost-effectivenessdata for their products. (Scrip 2522:6)
PortugalThe Health Minister has suspended a 6-month review and called for a re-evaluation of plans by Infarmed (thepharmacy and medicines institute) to limitOTC ingredients. Under Infarmed’s planmany currently available OTC items wouldbecome prescription only. (Scrip 2512:6) Russia: The Russian pharmaceutical market isexpected to grow by 5% because of anincrease in the population’s disposableincome. The market is currently valued at$1.9 billion. (Scrip 2509:5)
SpainThe Spanish government expects that theintroduction of reference pricing willpromote the use of generics and helpcontain spending in 2000. Spending onpharmaceuticals is currently 25% of thehealthcare budget. (Scrip 2509:5) ■ Spanish generic manufacturers claim thegovernment is not adequately supportinggenerics, citing the implementation of lastyear’s 6% general price reduction on allpharmaceuticals. As of mid-January 351generics were approved for use in Spain.(Scrip 2517:3) ■ A Spanish court has ruledthat additional payments demanded by theHealth Ministry from the pharmaceuticalindustry may be suspended until theirlegality is assessed. The government askedfor the payment when pharmaceuticalspending rose above levels set in anagreement with industry. (Scrip 2521:2)
UKThe National Audit Office is to endorseplans to combine antibiotic prescribinginformation with data on hospitalacquired infection. Proper infectioncontrol could reduce infections by 15%leading to savings of £150 million. (Scrip2519:4) ■ Patient groups are lobbying thegovernment for wider prescribing ofinnovative but costly pharmaceuticals.Several such drugs are currently underreview by the National Institute forClinical Excellence (NICE). (Scrip 2523:2)■ As part of a plan to modernize the
News Briefs from around the World
6
7
National Health Service (NHS), thegovernment has decided to expand the range of drugs that nurses canprescribe. Specialist nurses are expected to be the first to gain the new authority.(Scrip 2523:3)
AFRICASouth AfricaThe Constitutional Court has thrown out South Africa’s medicines act. The actrepealed all of the country’s previouspharmaceutical legislation but was passedbefore necessary regulations, regulatorystructures and medicines schedules wereput in place. (Scrip 2522:19)
ASIAAustraliaThe government’s new National MedicinesPolicy encourages all levels of governmentto work together with health professionals,educators, the medicines industry,consumers and the media to ensure thatpatients have timely and cost-efficientaccess to safe, high quality medicines.The report also recommends theimplementation of a nationallystandardized, rational and transparentregulatory process. (Scrip 2515:17)
ChinaProvincial authorities are continuing toimplement price controls in an effort tocurb pharmaceutical spending in state-runinsurance schemes. Overall price cuts of10% are expected to save Yuan 3.2 billion.(Scrip 2513:17; 2514:15) ■ The State DrugAdministration (SDA) has issued newregulations for contract manufacture ofpharmaceuticals. Companies must getprior SDA approval before transferringproduction or outsourcing to externalcompanies. (Scrip 2515:18) ■ Citing safetyconcerns, China has banned all Internettrade of pharmaceuticals. (Scrip 2517:16)Malaysia: ■ The Health Ministry hasintroduced a new national essential druglist. Compliance is voluntary and as yet itis uncertain if the list will replaceMalaysia’s Blue Book. (Scrip 2514:17)New Zealand: ■ The Ministry of Healthhas asked the government to revise theMedicines Act to allow prosecution forsupplying medicines via the Internetwithout prescriptions. Pharmaceuticalsales through local web sites in 1999 were
estimated at NZ$50 million ($25 millionUS). (Scrip 2519:21)
PhilippinesThe pharmaceutical sector faces an uphillstruggle against political and publicpressure to reduce prescription productprices. The industry denies overchargingand claims that net profits are only 5-15%of net sales. (Scrip 2510:17)
South KoreaThe government has established guidelinesfor determining equivalence andbioavailability of products thatpharmacists will be allowed to substitute.Doctors are continuing their opposition tothe split of prescribing and dispensingsince many rely on the dispensing marginfor income. (Scrip 2523:19)
VietnamThe government is looking at a range ofmeasures to increase foreign investment inthe pharmaceutical sector. The recentprivatization of two state-ownedpharmaceutical companies has generatedstrong investor interest. (Scrip 2509:16)
THE AMERICASBrazilThe Brazilian National HealthcareMonitoring Agency (ANVS) has issued thefirst marketing authorization for generics.Generics will be priced 30-55% cheaperthan branded products. ANVS is alsodrafting new legislation to governpharmaceutical advertising and to prohibitsampling. (Scrip 2514:17) ■ The HealthMinistry wants to change its tenderingprocess for medicines purchases by settingup a price register to encouragetransparent competition and make iteasier for public purchasers to obtainmedicines at low prices. The governmentis proposing that pharmaceutical supplierscompete to be included on the register.(Scrip 2517:14)
CanadaThe World Trade Organization (WTO) has made an interim ruling againstCanada in a recent patent dispute. Theruling says Canada should grant 20-yearpatents to all patents existing as of January1st 1999. (Scrip 2521:16) ■ The CanadianPharmaceutical Association (CPhA) hascalled for the suspension of the personalinformation protection and electronicdocuments act as it relates to health.
According to the CphA, patients coveredby public and private health plans will betreated differently leading to higher costsfor pharmacists. (Impact 10 no.1:2)
USAOnline pharmaceutical sales are expectedto dominate health e-commerce by 2004,accounting for $15 billion. Doctors areexpected to be a key factor in this growthas the number of prescriptions writtenelectronically increases. (Scrip 2509:15) ■ President Clinton is calling for theprovision of affordable drug coverage forthe elderly. The pharmaceutical industry isafraid that a government-run programmight slow down R&D because of theimposition of price controls. (Scrip2510:15) ■ President Clinton has addedcatastrophic coverage to the Medicaredrug benefit he proposed last year.(Scrip2513) ■ The FDA has been given ayear to develop new standards for theprevention of medical errors arising fromconfusion over proprietary drug namesand packaging. The Institute of Medicine(IOM) estimates indicate that between44,000 and 98,000 deaths per year resultfrom preventable medical errors. (Scrip2517:13; Managed Healthcare News 16no.2:13)
THE WORLDThe WTO has reached an interimagreement in the EU/Canada patentdispute. The WTO has decided againstallowing Canada to retain its stockpilingprovision under which products aremanufactured and stockpiled 6 monthsprior to patent expiry. (Scrip 2511:14) ■
The WHO is offering to organize a jointworking group with the WTO to studyaccess to essential medicines. IFPMA, theinternational pharmaceutical industryassociation, questions the need for thegroup since discussions are alreadyunderway between the WHO and industryrepresentatives. (Scrip 2514:16) ■
Pharmaceutical sales in the 12 leadingworld markets grew by 10% in 1999.Growth rates were driven by particularlystrong performances in the US andCanada. (Scrip 2518:17) •
M8
Student Corner
A message from Mohamed Omar MS RPh,Outgoing Chair of the ISPOR StudentNetworkMy interest in creating a formal structure for students at ISPORbegan with the creation of the first student chapter at the Universityof Texas in July 1998. I envisioned a student chapter of ISPOR atevery academic institution in the country that offers a program inpharmacoeconomics and/or health outcomes research. Since thattime, three more student chapters have been established at theUniversities of Arizona, Toronto and Louisiana at Monroe. Inaddition, the ISPOR Student Network (SN) that comprises morethan 180 student members has been established, as well as theISPOR Student Council whose members include the Presidents ofthe student chapters and the Student Advisor.
The objectives of the SN are very much parallel to those of theparent organization. The network provides a forum for the exchangeof information and the delivery of programs designed specifically forthe benefit of the student membership of ISPOR. As the leader of
this network, I have had the opportunityto represent students at the ISPORStrategic Planning Retreats regardingvarious issues such as those pertaining toeducation, fellowships, annual meetings,and career launching. Currently,members of the Student Council andmyself are working on establishing anemail-mentoring program for studentsthat will link each ISPOR student with a working member of ISPOR.We hope that this program will empower students to get a head starton utilizing the networking resources of professionals in the field.
My experiences in serving as the voice of students of ISPOR studentshave been very rewarding indeed. In the process of helping set thefoundation for students, I’ve learned the dynamics of a largeprofessional organization. I hope to carry this understanding withme to serve other areas of ISPOR. Finally, my endeavors have beensuccessful primarily because of the support I have received from theISPOR Board of Directors, who have continuously recognized thevalue of the student membership.
Student Networking Group
Mohamed Omar RPh, MS,1999-2000 Student Networkand Student Council Chairand Student NetworkFounderGraduate StudentUniversity of Texas at AustinE-mail:[email protected]
Veronica Sendersky PharmD,1999-2000 Student NetworkChair-electGraduate StudentUCLA School of Public PolicyE-mail:[email protected]
Deirdre Monroe RPh, MBA,President ISPOR StudentChapter – University of Texasat AustinDoctoral CandidateUniversity of Texas at AustinE-mail: [email protected]
Thomas Delate MS, PresidentISPOR Student Chapter-University of ArizonaHealth Outcomes FellowUniversity of ArizonaE-mail:[email protected]
Ateequr Rahman MBA,President ISPOR StudentChapter – University ofLousiana at MonroeGraduate StudentUniversity of Lousiana at MonroeE-mail: [email protected]
Kostas Trakas MSc, PresidentISPOR Student Chapter –University of TorontoGraduate StudentUniversity of TorontoE-mail:[email protected]
Zeba Khan MS,PhD, ISPORStudent AdvisorSenior Health OutcomesScientistGlaxo Wellcome Inc.US Medical Affairs,Health OutcomesE-mail:[email protected]
ISPOR STUDENT COUNCILThe Board recently approved the organizational structure of the
ISPOR Student Council. The ISPOR Student Council is composed
of the ISPOR Student Networking Chair and chair-elect, the
Presidents of the ISPOR Student Chapters, and the Student
Advisor. The Council meets about once a month via teleconference
to discuss topics of interest to ISPOR students. The ISPOR Student
Network Chair chairs the Student Council.
ELECTION OF ISPOR 2000-2001 ISPORSTUDENT NETWORK CHAIRIn the January and February ISPOR STUDENT NETWORK
BULLETINs, nominations for 2000-2001 ISPOR Student Network
Chair were requested. Veronica Sendersky PharmD, a graduate
student at UCLA School of Public Policy is now the Chair-elect of
the ISPOR Student Network Group. Veronica will join the other
members of the ISPOR Student Council and will represent the
students at the ISPOR Leadership Retreat 2000.
1999-2000 ISPOR STUDENT COUNCIL
I
IVeronica Sendersky, to be new Chair of the Student NetworkI would like to introduce myself to you. My name is Veronica
Sendersky. I am currently pursuing a Master of Public Policy
degree at UCLA, specializing in Health Economics and Policy.
I received my PharmD degree last year. I have been very active in
professional organizations. I was elected to represent my
pharmacy class on the board of the Academy of Students of
Pharmacy (ASP). My biggest achievement as ASP officer was a drastic increase in the
membership. I was able to increase the number of members in our class by about 100%
by initiating an early membership drive. I am very excited about being the new chair of
the Student Network, and look forward to my new responsibilities.
ISPOR STUDENT RECEIVES TOPHONORS AT DIA EUROMEETINGMr. Sanjay Merchant, DoctoralCandidate at the University ofMaryland, School of Pharmacy, wasawarded top honors for his posterpresentation at the 12th Annual DIAEuroMeeting held in Nice, France,March 2000.
Title: Impact of Illness Severity onCost of Community AcquiredPneumonia Patients.
Authors: Sanjay Merchant, C DanielMullins, and Catherine Cooke.
The Carnegie FoundationHonors UA College ofPharmacy Professor;JoLaine R. Draugalis, PhD,Appointed to Serve withElite Scholars Group
JoLaine R. Draugalis, PhD, professorand assistant dean at the University ofArizona College of Pharmacy, hasbeen named a 2000-2001 CarnegieScholar by the Carnegie Academy forthe Scholarship of Teaching andLearning. Dr. Draugalis is one of 40outstanding faculty chosennationwide, who will work together toinvent and share new conceptualmodels for teaching.
Much more than an honorary title,Dr. Draugalis’ research interestsinclude pharmacy education, programdesign, administration and evaluation,as well as educational applications inpharmacoeconomics. She joined theCollege faculty in 1989, teachingDoctor of Pharmacy students andparticipating in several graduate-levelcourses. She received the BasicScience Pharmacy Educator of theYear Award from the College in 1990,1992, 1994 and 1997 and was namedthe Distinguished Pharmacy Educatorby the American Association ofColleges of Pharmacy in 1998.
A few words from the ISPOR StudentNetwork Advisor, Zeba M Khan PhDI am very proud and honored to serve as your ISPOR Student
Network Advisor. I would first like to thank the ISPOR Board
of Directors, especially Dr. Marilyn Dix Smith, for their
support with the Student Network (SN). Special thanks to
Mohamed Omar for his hard work in establishing and
coordinating the SN.
As your ISPOR Student Network Advisor, I will do my best to coordinate network
activities and provide assistance in planning for long-term goals for the SN. Now, all
current ISPOR students are members of the SN. However, if you would like your name
to appear in the ISPOR Student Network Directory, you must complete the form at the
ASSOCIATE DIRECTOR / Clinical Development – PharmacoeconomicsTHE COMPANYThe Company, considered one of the worlds most successful biotechnology companies, is a pace setting international company that discovers,develops, and markets biotechnology drugs. The company is dedicated to being the world leader in developing and delivering important, cost-effectivetherapeutics based on advances in cellular and molecular biology.
SCOPE OF THE JOBThe Pharmacoeconomic Program (PE) includes Phase IIIb and Phase IV outcomes research on all of the Company’s products. The Associate Director willguide and coordinate a multidisciplinary team of: healthcare professionals; doctoral trained health services researchers; data analysts; and economist andepidemiologists. There are three major areas of responsibility: 1) developing and managing both internal and external research teams; 2) interacting withscientific thought leaders; 3) participating in program management and strategic planning and design for outcomes research. Research responsibilities willinclude: 1) supporting the development and design of new strategic research initiatives and new research proposals for current and new Company productsthrough identifying, selecting and developing PE research protocols utilizing internal and external clinical data base resources; 2) supervising manuscriptdevelopment for publication and key account presentations based on PE clinical outcomes and comprehensive reviews and analyses of the literature; 3)identifying and creating protocols, proposals, reports and manuscripts for internal and external research resources; 4) supervising and coordinating researchprojects with external database researchers and related manuscript writing and publication; 5) providing review and critique of protocols/manuscripts forinternal staff; 6) close collaborative efforts with marketing and sales managers and national account managers to create and design studies, analyses, andcriteria for evaluating data and database clinical data collection; and 7) assuring quality and timely progress on all programs.
CANDIDATE REQUIREMENTS
We are a retained Executive Health Care search firm. Please respond: Mr. Fred A. Barnette, Fred A. Barnette & Associates, [email protected] or fax 910-256-1183.
1. Doctoral training (MD degree) board certification in internal medicineand licensed in the U.S.
2. Subspecialty in Oncology, Hematology, or Rheumatology is considereda plus.
3. Clinical experience required.4. Demonstrated research training (e.g., MPH, research fellowship or
other training in research methodology) is a plus.
5. Clinical and outcomes research experience in a corporate orpharmaceutical industry environment and/or applied research setting.
6. Experience developing research grants or projects, supervision of datacollection and analysis of results demonstrated by publication ofresearch findings.
7. Strong leadership skills and self-assurance qualities.
Harvard
This advanced program is for outcomes analysts and economists in thepharmaceutical and medical device industry, and others in academia and government, who conduct or monitor cost-effectiveness analyses
of medical technologies.
You will be introduced to the latest methods in the measurement andanalysis of health outcomes data in the context of the most widelyapplied research designs for clinical decision making, health care
Where theory informs practice and practice informs theory ®
OR
Code: CEA/MDA0600
School of Public Health
COST-EFFECTIVENESS ANALYSIS FOR MEDICALTECHNOLOGIES AND PHARMACEUTICALS
June 26 - 29, 2000
MEASUREMENT, DESIGN AND ANALYSIS METHODS FOR HEALTH OUTCOMES RESEARCH
June 20 - 22, 2000
16
Career OpportunitySenior Information AnalystHealthcare Economics DepartmentBristol-Myers SuibbPlainsboro, NJ
The Healthcare Economics Group supports the Oncology, MedicalAffairs and U.S. Marketing Divisions through the design andexecution of health economic, outcomes research and financial dataanalyses.This position will analyze the pharmaceutical, hospital, andother clinical and financial databases for the purpose of conductinghealth economic reports and outcomes analyses. In the absence ofof primary clinical and financial databases, the Senior InformationalAnalyst will conduct modeling studies as proxies for true clinicalpractice data. The successful candidate should have a Bachelors orMasters in Public Health, and a strong background inepidemiology, phamacy administration or health economics. Astrong clinical background is essential for this position. Experiencein statistical analysis with a background in clinical research isstrongly recommended. Experience with Microsoft Access, Excel,statistical analysis and decision analysis software is required. Thecandidate should be comfortable working under specified projectdeadlines as well as preparing and delivering oral and writtenreports of study results.
For consideration, please visit www.bms.com/joinus and follow theinstructions on "How To Send A Resume" or mail your resumewith Ad Code PL99-5082 to Human Resources, Bristol-MyersSquibb, P.O. Box 5335, Princeton, NJ 08543-5335. We are anEqual Opportunity Employer.
Outcomes Manager Infomedics, a leader in interactive web and IVR-basedinteractions with patients, is looking for an Outcomes Managerto be responsible for the data and statistical analysis of allmajor Infomedics' programs such as its pharmaceutical basedmarketing support programs.
This position is also responsible for providing report design anddevelopment, supporting sales efforts, serving as the analyticrepresentative in database and data warehouse development,and offering analytic support in product development efforts.Ideal candidate should have bachelor's degree with 3 years ofexperience in analysis and reporting of pharmaceutical or otherhealth care data. The candidate should be skilled in usingstatistical software and experienced in preparing, analyzing, andpresenting health care data to diverse audiences.
Masters degree in Health Care Administration or PublicHealth preferred.
Please submit resume to: Demonda Giokas800 West Cummings Park, Suite 4400Woburn, Ma 01801 Fax number: 781-938-5303, Email: [email protected]
Research Scientist, Quality of Life (Global Pharmaceutical Company): Design, plan and create outcomes research/healtheconomic evaluations with an emphasis on the Quality ofLife components. PhD/MS required. Contact CheriBuonaguidi, Bench International, (310) 854-9900,[email protected]
Research Scientist, Senior Economist (Global Pharmaceutical Company – Midwest): As part of the Global Economic Affairs group, review andsynthesize the epidemiological, clinical, economic andhumanistic literature related to disease prevention andtreatment across the therapeutic areas. Participate in thedevelopment of protocols and analysis plans for Phase II,II, III and IV clinical trials; lead the development ofinnovative studies or methodological applications insupport of commercialization plans. Advanced degree(PhD/MS) required. Expertise in statistics, economics,databases and or decision-analytic modeling and industryor international experience preferred.
Director, Health Outcomes ResearchIt's our solid dedication, vision and constant search for answers that allow us totouch millions of people around the world every day. As a major division ofFortune 500 American Home Products Corporation, we help people leadhealthier lives through the development of innovative pharmaceutical, vaccineand nutritional products. We achieve this through our superior research,manufacturing, sales and marketing capabilities. Enjoy the freedom to developyour own career while having the support of a valuable team.
In this position, you will design, implement and supervise research projects in HealthOutcomes & Disease Management, which supports products on a global basis. Youwill identify and direct expert consultants for Medical Affairs and Marketing regardinghealth outcomes and economics support. You will also maintain health outcomesresponsibility for assigned products. Providing support to Sales and Marketing trainingand the training of new health outcomes managers will also be required.
Qualifications include either a degree in a health science, a PharmD or a PhD in aclinically relevant field, and 5 or more years’ experience in health outcomes research,managed care, and/or pharmaceutical R&D. Expertise in Marketing, projectmanagement, health outcomes and database research is also required.
Wyeth-Ayerst offers competitive compensation and benefits programs including stockoptions, child-care subsidies, flex time, business casual Fridays, educational assistanceand professional development programs. Please forward your resume with salaryrequirements to: Wyeth-Ayerst, Reference OIISP, P.O. Box 7886, Philadelphia, PA19101-7886. Fax in fine mode to: (610) 989-4854. Email:[email protected] (ASCII format, no attachments, subject: resume).
Registration Fee Before May 1, 2000 ■■ US$ 125 [ x no. of courses= ]
Registration Fee After May 1, 2000 ■■ US$ 175 [ x no. of courses= ]
Student Fee Before May 1, 2000 ■■ US$ 50 [ x no. of courses= ]
Student Fee After May 1, 2000 ■■ US$ 75 [ x no. of courses= ]
Total: ___________
PRE-MEETING QUALITY OF LIFE SYMPOSIUM (no fee)Sunday, May 21, 5:30-8:30 PM (check box if participating)■■ Quality of Life Promotional Claims: Methodological Issues and
Practical Solutions
Please enclose a check payable in US dollars to: International Society for Pharmacoeconomics and Outcomes Research or ISPOR and send to the ISPOR address given below or charge to: ■■ VISA ■■ MasterCard ■■ American Express
NAME: AUTHORIZED SIGNATURE:
ACCOUNT NUMBER: EXPIRATION DATE:
Payment must be made in US dollars. Payment may be made by check or travelers check. VISA, MasterCard, or American Express will be charged in US dollars.Signature, account number, and expiration date must be included. Non-US checks written in US$ must be written on banks with a US counterpart. Phone chargeswill NOT be accepted. If payment is being made by your company, please make sure your name is indicated on the check stub or correspondence. *When you register as a non-member, you receive ISPOR membership until December 31, 2000 and a one-year subscription to VALUE IN HEALTH-The Journal of theInternational Society for Pharmacoeconomics and Outcomes Research.
Cancellation fee before May 1, 2000 is US $100. No refunds given after May 1, 2000.
SEND REGISTRATION FORM (OR FAX, IF USING CREDIT CARD) TO:International Society for Pharmacoeconomics and Outcomes Research
20 Nassau Street, Suite 307, Princeton, NJ 08542 USA Tel: 1-609-252-1305 Fax: 1-609-252-1306 Email: [email protected] Internet: www.ispor.org
ISPOR 5th Annual International MeetingMay 21-24, 2000 ■ Crystal Gateway Marriott ■ Arlington, VA (Washington, DC area)
International Society for Pharmacoeconomics and Outcomes Research20 Nassau Street, Suite 307 Princeton, NJ 08542 USA
Nonprofit Org
US Postage
PAIDPrinceton NJ
Permit 783
ISPOR Newsletter is published bimonthly by ISPOR20 Nassau Street, Suite 307, Princeton, NJ 08542 USA Phone: 609-252-1305 Fax: 609-252-1306
ISPOR Newsletter Committee: Anita Burrell, Mireille Goetghebeur, Bonnie Korenblat, Steve E. Marx, Richard J. Milne, Helma Monteban, Mohamed Omar, Donna Rindress, Malcolm Weiss, Sharon Welner, Peter K. Wong, Albert Wertheimer
somethingfor ?better
New York • Chicago • Philadelphia • Southport • Orlando
You will find something better at Smith Hanley
Pharmaceutical Permanent & ContractOpportunities for
Outcomes ResearchPharmacoeconomicsEpidemiologyBiostatisticsSAS® ProgrammingData ManagementClinical Information Systems
Smith Hanley offers a diversity of placementopportunities for recent graduates to senior professionals in pharmacoeconomics, outcomesresearch and epidemiology.
Choose from a wide variety of permanent employment opportunities at prestigious companies, or join Smith Hanley Consulting and work onassignments at the same companies.
You will find something better at Smith Hanley.
Contact: Kevin McGrath800.989.5627 • Fax: 212.818.9067E-mail: [email protected]