ACCESSPOINT - IMS Health

ACCESSPOINT
IMS HEALTH ECONOMICS & OUTCOMES RESEARCH
New priorities for HEOR?
The U.S. reforms in focus
HTA moves center stage
Taking an early, real-world view
Volume 1, Issue 2
MAY 2011
News, views and
insights from
leading experts
in HEOR
Advances in medical adherence
Joshua Benner
Dr. Olaf Pirk
Adam Lloyd
considers HEOR
discusses AMNOG
examines country
Page OUTCOMES 1 - Issue
and the
1
U.S.
reforms
implications IMS HEALTH in ECONOMICS AND OUTCOMES adaptation RESEARCH Page of1
Germany
economic models
Page 6
Page 10
Page 22
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ACCESSPOINT
IMS HEALTH ECONOMICS & OUTCOMES RESEARCH
From global to local
Adapting economic models to local
requirements is key to implementing value
arguments in diverse markets
page 22
Putting the P
into Outcomes Research
As the patient perspective becomes
increasingly important, we consider a
framework for its effective capture
page 31
News, views and insights
from leading experts in HEOR
New priorities for HEOR?
The U.S. reforms are reshaping the
landscape and the outlook for health
economics and outcomes research
page 6
All change for market access
in Germany
The recent introduction of AMNOG is set to
radically alter market access in this country
page 10
Modeling for
success in Canada
Cost-effectiveness assessments must take
account of the pricing that is possible within
the rules of a powerful regulator
page 18

Welcome to the second issue of AccessPoint, a
twice-yearly round-up of news and insights from the
international team of HEOR specialists in the IMS
Consulting Group – offering a timely outlook on the
pivotal dynamics driving change, challenge and new
potential for health economics and outcomes research.
In a year that is signaling important developments in several key
areas of healthcare, we have already seen significant advancements
across a number of fronts: in Germany, the recent drug
reimbursement law (AMNOG) heralds a new era for market
access in this country with far greater emphasis on demonstrating
additional benefit (Page 10); in the U.S., innovations in patientlevel
data and wider use of comparative effectiveness research
have the potential to move HEOR to the forefront of reform
efforts well into the future (Page 6); globally, collaboration in
HTAs is gathering pace at the national and regional level (Page
14); and everywhere we see a patient-centered focus rising to the
fore of outcomes research (Page 31).
Underpinning these trends is increasing recognition of the
growing international need for more and better information
comparing the clinical and economic value of medical
technologies. IMS Health is committed to supporting the
advancement of evidence-based healthcare with insights based on
appropriate analysis of the best bespoke and available information
– including our proprietary data assets. The recent launch of the
IMS Institute for Healthcare Informatics, highlighted in this issue
of AccessPoint (Page 2), further strengthens our resolve to
accelerate understanding and innovation, and better serve the
needs of patients worldwide through the stronger linkage of
healthcare decisions and information.
IMS’ international team of more than 300 highly-qualified,
multi-disciplinary researchers and consultants in HEOR and
Pricing & Market Access is dedicated to generating the realworld
evidence that enables more informed decision making. We
continue to invest in new capabilities to ensure that our services
leverage the very latest technological advances. Our new
collaboration with BaseCase.com (Page 5) is already helping
customers more clearly articulate economic value to a broad
range of healthcare decision makers. Please stay tuned for more…
I hope you find our perspective on these exciting times for
global healthcare both informative and enlightening. I would also
like to thank our guest contributor Joshua Benner, of the
Engelberg Center for Health Care Reform at the Brookings
Institution, for his insightful take on the progress of the critical
U.S. reforms (Page 6).
Jon Resnick
VICE PRESIDENT AND GLOBAL LEADER, HEOR
IMS CONSULTING GROUP
JResnick@imshealth.com
“2011 is signaling important developments
in several key areas of healthcare”
WELCOME CONTENTS
NEWS SECTION
2 IMS Institute for Healthcare Informatics
3 Five-level EQ-5D progresses
4 New analysis on treatment non-adherence
5 IMS collaboration boosts value
communications
INSIGHTS
6 U.S. HEALTH REFORMS
Increased visibility for HEOR
10 MARKET ACCESS IN GERMANY
Radical changes for pricing & market access
14 HTA CONVERGENCE
Early focus on health economics key
18 COST-EFFECTIVENESS IN CANADA
Working with a powerful regulator
22 GLOBAL TO LOCAL
Country adaptation of economic models
26 MEDICAL ADHERENCE
Advances from a decade of research
31 PATIENT-REPORTED OUTCOMES
Capturing the patient perspective
36 IMS SYMPOSIUM
Growing use of observational research
PROJECT FOCUS
40 ACUTE RESPIRATORY FAILURE
Modeling techniques add insight
42 HTA STRATEGY
Past decisions help future submissions
IMS OVERVIEW
44 IMS HEOR
45 Office locations
46 Our senior experts
53 IMS Lifelink TM : Longitudinal patient data
AccessPoint is published twice yearly by the Health
Economics & Outcomes Research team of the IMS Consulting
Group. ISSUE 2. PUBLISHED MAY 2011.
IMS HEALTH® 7 Harewood Avenue, London NW1 6JB, UK
Tel: +44 (0) 20 3075 4800 • HEORInfo@uk.imshealth.com
• www.imshealth.com
©2011 IMS Health Incorporated or its affiliates.
All Rights Reserved.
AccessPoint - Issue 2 Page 1
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NEWS | IMS INSTITUTE LAUNCH
A new initiative from IMS Health underscores the company’s resolute
commitment to advancing healthcare with transformational insights globally.
IMS Institute for Healthcare Informatics
drives strong research agenda
Marking an important milestone in a long history of
supporting the advancement of evidence-based
healthcare around the world, IMS Health has
recently announced the launch of the IMS Institute
for Healthcare Informatics. This major new
initiative will leverage collaborative relationships in
the public and private sectors to strengthen the
vital role of information in accelerating the
understanding and innovation that are critical to
sound decision making and improved patient care.
UNIQUE, RELEVANT INSIGHTS
At a time of immense challenges, but also tremendous
possibilities, for technological innovation and healthcare
advancement worldwide, the Institute will provide key policy
setters and decision makers in the sector with unique and
transformational insights into healthcare dynamics, derived
from granular analysis of information. With access to
unparalleled IMS data assets and analytics, and working in
tandem with government agencies, academic institutions, the
life sciences industry and payers, its research agenda will be
dedicated to addressing the issues that impact healthcare in
every country worldwide.
DEFINED FOCUS
Led by Executive Director, Murray Aitken, the Institute will
focus on five key areas of research:
1. Use of information by healthcare stakeholders globally
to improve health outcomes, reduce costs and increase
access to available treatments
2. Performance of medical care through a better
understanding of disease causes, treatment consequences
and measures to improve quality and cost of healthcare
delivered to patients
3. Future global role for biopharmaceuticals, the dynamics
that shape the market, and implications for manufacturers,
public and private payers, providers, patients, pharmacists
and distributors
4. Role of innovation in health system products, processes
and delivery systems, and the business and policy
systems that drive innovation
5. Advancement of healthcare agendas in developing
nations based on information and analysis.
CLOSE LINKS WITH IMS HEOR
Reflecting the extensive role of information in all key areas
from healthcare policy and health economics and outcomes
research, to healthcare reform and healthcare systems, the
Institute will be working in close liaison with the IMS global
team of experts in health economics and outcomes research.
Indeed, the Institute’s first comprehensive publication,
HealthIQ – The Frontiers of Healthcare Advancement,
which was released in March 2011, draws on their extensive
work in value demonstration and evidence generation as well
as other recently published research supported by IMS
Health. Topics covered in this report include patterns and
effects in the diffusion of innovation, the impact of
regulatory advisories and guidelines on clinical practice,
insights from research into medication adherence, and an
overview of evolving techniques and approaches in
comparative effectiveness research.
IMS CHINA INSTITUTE
Given the critical and growing importance of China and its
healthcare system in the global arena, the Institute has also
now launched a branch in Beijing, where a team will
collaborate with government agencies and institutions to
enhance the role of information in policymaking and
healthcare improvement. Within the overall objectives of the
Institute, the local agenda will be tailored towards helping
accelerate actions that are critical to China’s healthcare
system, including support for the government's aggressive
healthcare goals.
Among key priorities are the establishment of a China Health
Services Research Network and a platform of professional
training programs to support hospital executives, policy
makers and healthcare industry executives. Several attendees
at the launch in April have already expressed interest in
exploring partnerships with the Institute, including the
Director of the Department of Health Economics at Shanghai
Fudan University.
LATEST RELEASE DELIVERS NEW INSIGHTS INTO U.S.
PHARMACEUTICAL SPENDING
At this critical juncture for U.S. healthcare, with the impact
of reforms still playing out and the slowing growth trends of
the previous decade reinforced in 2010, the Institute has just
released a major new report placing the last year into context
for healthcare decision makers. Featuring additional details
on the U.S. pharmaceutical market, including top therapeutic
continued opposite (bottom)
Page 2 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

First developed over twenty years ago by the
EuroQol Group – a network of international,
multilingual, multidisciplinary researchers – the
EQ-5D is a standardized instrument for describing
and valuing health-related quality of life 1 . Non
disease-specific and measuring health using three
levels of severity in five dimensions, it has been
widely applied across a range of medical
conditions.
FROM EQ-5D TO EQ-5D-5L
In a move to improve the EQ-5D as a measure of health status
in the clinical setting (randomized controlled trial or
observational), a EurQol Group task force which includes Dr
Xavier Badia, Global Leader Observational Outcomes Research
and Senior Principal at IMS, has been exploring ways of
enhancing the tool’s sensitivity and reducing ceiling effects
– by increasing the number of severity levels. Three years on,
the first results of these efforts have just been published
online2 , based on developing the working and concepts of
the possible 5 levels.
In the study, which was conducted in the U.S. and Spain,
severity labels were identified for 5 levels in each dimension,
leveraging response scaling. The face and content validity of
the new versions, including hypothetical health states
generated from them, were tested in a series of focus groups.
NEW VERSION OF EQ-5D | NEWS
The EQ-5D is a standardized, broadly-used measure of health status.
Enhancements underway promise greater sensitivity in a range of diseases.
New five-level EQ-5D progresses
through preliminary testing
The selection of labels at approximately the 25th, 50th and
75th centiles yielded two alternative 5-level versions. Focus
group members showed a slight preference for the wording
“slight-moderate-severe” problems, with anchors of “no
problems” and “unable to do” in the EQ-5D functional
dimensions. Similar wording was used in the Pain/Discomfort
and Anxiety/Depression dimensions. The hypothetical health
states were well understood although participants did stress
the need for the internal coherence of health states.
With the development phase of the 5-level version now
complete, the EQ-5D-5L will next undergo further testing to
determine whether it does indeed improve sensitivity and
lower ceiling effects. A EuroQol Group task force will also be
working on the development of a methodology to obtain a
set of societal values for the EQ-5D-5L.
1http:/www.euroqol.org/euroqol-group/about-us.html. Accessed April 29,
2011.
2Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G,
Badia X. Development and preliminary testing of the new five-level version
of EQ-5D (EQ-5D-5L). Qual Life Res, 2011; Apr 9 [Epub ahead of print]
IMS Institute for Healthcare Informatics drives strong research agenda continued
classes, products and dispensing locations, The Use of
Medicines in the United States: 2010 Review reveals the
key dynamics that are driving historically low levels in the
volume of prescription medicines consumed.
FURTHER INFORMATION
For further information on the IMS Institute for Healthcare
Informatics or for copies of its published reports, contact
Murray Aitken at MAitken@theimsinstitute.org or visit
www.theimsinstitute.org. The website hosts an extensive
array of resources on the Institute’s work, including news
features, publications, topical webinars and podcasts on
leading healthcare issues, the China IMS Institute and the
opportunity to share feedback and proposals for
collaboration, consistent with its research agenda.
The EuroQol Group has
been exploring ways of
enhancing the tool’s
sensitivity
Celebrating the launch of the China Institute, from left, Davey
Han, Director General, IMS China Institute; Sati Sian, President,
IMS China; Zhao Yajun, Director General, China Center for
Pharmaceutical International Exchange, SFDA; Deng Haihua,
Deputy Director General, MOH General Office; and Murray
Aitken, Executive Director, IMS Institute for Healthcare
Informatics.
AccessPoint - Issue 2 Page 3

NEWS | COST-EFFECTIVENESS IN ADHERENCE
Treatment non-adherence has important economic and health implications.
Findings from IMS research bring new insights into cost-effective approaches.
IMS explores cost-effectiveness
of adherence interventions at
WHO self-care meeting
Poor adherence with medical treatment both limits
the effectiveness of healthcare interventions as
well as increasing disease burden. Despite
extensive research, progress has been slow in
achieving demonstrable improvements, particularly
in the case of chronic medications. Complexities
abound, many findings cannot be generalized and
patients differ in their attitudes and motivators.
Among a growing body of programs to improve adherence are
efforts involving patient self-monitoring, self-education and
self-report. However, these approaches are generally timeconsuming
and expensive versus less intensive interventions
such as patient reminders, while generally less expensive
than clinician-directed methods such as pharmacist
counseling. Recognizing that comparisons of programs for
improving adherence may benefit from an analysis of costs
alongside their results, IMS HEOR experts set out to compare
the cost-effectiveness of different interventions that have
been shown to improve adherence with antihypertensive and
lipid-lowering therapy.
In April 2011, the results of this work formed part of a
program of research presentations at a WHO meeting in
Geneva1 exploring innovative approaches to helping people
with non-communicable diseases better manage their own
conditions. Self-care programs have the potential to improve
outcomes as well as lower costs in this patient population.
COST-EFFECTIVENESS OF SELF-MANAGING ADHERENCE IN
CARDIOVASCULAR DISEASE
The analysis, led by Richard Chapman, PhD, Principal, HEOR
in the IMS Consulting Group, focused on exploring the
cost-effectiveness of adherence-improving interventions,
including self-monitoring and self-education, for
cardiovascular medications. The approach combined a burden
of non-adherence model framework with literature-based data
on adherence-improving interventions. Outputs from the
model included life-years gained, direct medical costs and
incremental costs per quality-adjusted life-year (QALY)
gained. Costs were standardized to 12 months and adjusted
to 2007 US$.
Understanding the relative
cost-effectiveness of adherence
interventions may guide
efficient programs
A total of 22 eligible adherence-improving interventions were
identified from 18 studies. A program with self-monitoring,
reminders, and educational materials incurred total
healthcare costs of $17,520 and compared with no
adherence intervention had an incremental cost-effectiveness
ratio (ICER) of $4984 per QALY gained. Pharmacist/nurse
management incurred total healthcare costs of $17,896, and
versus self-monitoring, reminders, and education had an ICER
of $6,358 per QALY gained.
The results suggest that, among published interventions
which have been shown to improve adherence, reminders and
educational materials, and a pharmacist/nurse management
program are cost-effective, and should thus be considered
ahead of other approaches. Understanding the relative
cost-effectiveness of adherence interventions may guide
design and implementation of efficient adherence-improving
programs, and allow comparisons of programs involving selfcare
with those that require other external resources.
WHO RECOMMENDATIONS IN DEVELOPMENT
Among other topics explored at the WHO meeting were the
effectiveness of self-care interventions on morbidity and
mortality, self-monitoring components in cardiovascular risk
management, and self-care programs for non-communicable
diseases in developing countries. The WHO is currently
developing recommendations on the self-care of
non-communicable diseases.
1 WHO Meeting on Self Care of Noncommunicable Diseases, Geneva,
Switzerland, 19-20 April, 2011.
Jonothan Tierce, CPhil, considers a decade of research
into medication non-adherence on Page 26 in this issue
of AccessPoint.
Page 4 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

Building on our extensive capabilities in evidencebased
messaging and compelling articulation of
product value to a range of healthcare decision
makers, we are delighted to announce a major
enhancement to our services. Leveraging the
cutting-edge platform of BaseCase.com, this
exciting development brings tremendous
possibilities for communicating the output of
health economic (HE) models to both internal and
external stakeholders.
VISUAL, REAL-TIME, INTERACTIVE FORMAT
BaseCase.com is an internet-based software platform
developed by a team of health economists to deliver health
economic data in a visual, real-time and interactive format.
It enables clear and effective manipulation and
communication of complex HE model outputs for both
technical and non-technical audiences.
With the BaseCase platform, complex models can be
manipulated in real time using an online interface to
immediately assess the impact of changes to model variables.
VALUE COMMUNICATION | NEWS
IMS value communications support drives clearer, more informed
healthcare decision making worldwide. An exciting development adds
a new cutting edge.
IMS HEOR and BaseCase.com
collaboration takes value
communications to a new level
FIGURE 1: BUDGET IMPACT EXAMPLE ON BASECASE.COM – YOUR
HE MODEL OR CORE VALUE DOSSIER IS EASY TO USE,
DISTRIBUTE AND MAINTAIN INSIDE THE WEB BROWSER
With the BaseCase platform,
complex models can be
effectively manipulated
and communicated
Such instant functionality and clarity opens up new
dimensions for communicating health economic value to
internal affiliates and commercial teams – as well as to our
clients’ key customers. Additionally, BaseCase supports the
distribution and maintenance of interactive Core Value
Dossiers via the internet.
KEY TOOL, FULL SUPPORT
Working in collaboration with BaseCase, IMS will provide full
global consulting support for this valuable communications
resource. At any stage in the development of product
evidence – whether core models and local adaptations have
been completed or not – we will work with our clients to
manage the installation of evidence into BaseCase and ensure
maximum benefit is gained from the communications
potential it can offer.
BaseCase and IMS are currently implementing an HEOR
communication platform for a top 5 pharmaceutical client.
The platform delivers budget impact and cost-effectiveness
models from global HQ to the worldwide affiliates. The format
is intuitive, comprehensible and flexible so it can be adapted
for immediate local usage by commercial teams. It further
offers a real-time distribution mechanism for health
economic models to any computer device including iPads,
with full visibility for the global HQ over country adaptations
(Figure 1).
For further details on this collaborative service please
contact: IMS Consulting Group: Richard Mee
(RMee@imshealth.com +447960 163 560),
BaseCase.com: Gijs Hubben
(G.Hubben@basecase.com +49 1522 3056714)
AccessPoint - Issue 2 Page 5

INSIGHTS | INTERVIEW
A year has passed since the U.S. Health
Reforms were enacted, along with other
important legislative changes, all with the
potential to significantly impact health
economics and outcomes research (HEOR).
While many of these initiatives will roll out
over time, others are taking effect more
quickly. What has been their impact? And to
what extent are they already redefining
approaches to evidence generation?
The interviewees
Joshua S Benner, PHARM D, SCD
is Fellow at the Brookings Institution and
Research Director at its Engelberg Center
for Health Care Reform, Washington D.C.
JBenner@brookings.edu
Michael Nelson, PHARM D
is Regional Leader Americas, HEOR,
IMS Consulting Group.
MNelson@us.imshealth.com
Page 6 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

New priorities for HEOR?
As major changes in U.S. health policy start to
play out in the healthcare sector, Michael Nelson,
Regional Leader Americas, HEOR at the IMS
Consulting Group and Joshua Benner, Fellow at
the Brookings Institution and Research Director
at its Engelberg Center for Health Care Reform,
discuss their take on the reforms so far and the
key implications for health economics and
outcomes research.
Michael Nelson: How do you think the reforms
are progressing, one year down the line?
Joshua Benner: The Affordable Care Act of 2010
(ACA) – the major health reform legislation enacted
last year – includes significant steps in the areas of
insurance market reforms and coverage expansion;
demonstrations of new models for payment and delivery
of care; and improving the evidence on which
healthcare decisions are made. Implementation of these
reforms is only just beginning, with some provisions not
coming into effect until 2014, so it’s really still too early
to tell whether they will ultimately improve quality and
reduce avoidable costs.
It is also important to remember that some key reforms
were set in motion by the Recovery Act of 2009 (which
contained provisions to expand the use of health
information technology as well as a bolus of funding
for comparative effectiveness research), the FDA
Amendments Act of 2007 (which mandated the FDA to
establish a new system for monitoring the safety of
medical products), and other legislation. These elements
are further along, laying a foundation for subsequent
reforms by improving our capacity to develop better
evidence and coordinate care.
MN: Yes, the previous legislation from 2007 and
2009 and, one could argue, even legislation dating
back to the 2003 Medicare Modernization Act,
established a foundation for comparative
effectiveness research. The Affordable Care Act
seems to go much further in that it also creates
an environment where the information generated
from this research will be utilized in a more
effective way by decision makers. These changes
also are being phased in over a number of years.
INTERVIEW | INSIGHTS
What are the main achievements of the reforms
so far?
JB: One year into the implementation of ACA, most of
the focus has been on changes to the insurance market:
children can now stay on their parents’ insurance until
they reach the age of 26 years; individuals can no longer
be denied coverage for pre-existing conditions; and
lifetime coverage limits have been banned. Tax credits are
available for small businesses that provide health
insurance. The process of gradually closing the “donut
hole” coverage gap in Medicare Part D began with
issuing $250 rebate checks for enrolees who reached the
coverage gap in 2010, and some preventive services such
as mammograms and colonoscopies are now free to
Medicare enrolees. The Patient-Centered Outcomes
Research Institute (PCORI) has also been established to
coordinate the national agenda on comparative
effectiveness research.
I think in the coming years we’ll learn more about the
impacts of other planned reforms still to be implemented,
including accountable care organizations, patientcentered
medical homes, the insurance exchanges, the
path for development and approval of biosimilars, and the
Independent Payment Advisory Board, among others.
MN: The success of these changes seems to be
heavily dependent on the generation and synthesis
of better evidence on effectiveness and efficiency
in support of optimizing decisions in healthcare.
This process of generating and synthesizing
evidence has been variously referred to in global
circles as health technology assessment (HTA),
health economics and outcomes research, and
comparative effectiveness research (CER). While
one could debate subtle or more obvious
differences between these terms, CER seems to be
the focus of much of the recent legislation. How
is its role evolving?
JB: More and better evidence on what works best in
healthcare (referred to as “patient-centered outcomes
research” in the health reform legislation of 2010) is
necessary to deliver more effective, individualized care.
But it’s not enough to just do the research – the results
have to be synthesized and disseminated to patients and
AccessPoint - Issue 2 Page 7

INSIGHTS | INTERVIEW
...continued from previous page
consumers, healthcare providers, payers, and policy
makers. Then we need incentives for that evidence to be
applied in patient care and policy making. Ideally,
enhanced quality measurement and reporting,
performance-based payment systems, and value-based
benefit designs will combine to encourage more
evidence-based care.
MN: Several of the provisions in the 2009
Recovery Act and 2010 ACA refer to infrastructure
and technology investments to support CER.
While this likely extends to a range of potential
innovations, there are specific initiatives
mentioned and/or underway to support the
implementation of electronic medical records and
aggregation and analysis of secondary data. What
sort of developments are you seeing in real-world
data collection and management?
JB: Electronic health information is becoming more
readily available, enabling the generation of much needed
evidence on the safety, effectiveness, and costs of health
care products and services. One of the exciting
developments over the past three years has been
Mini-Sentinel, the FDA’s pilot system for post-market
surveillance of medical product safety. Mini-Sentinel uses
a distributed data network to remotely query databases
held by participating health plans and delivery systems.
The model is appealing because it employs a common
data format to facilitate consistent analysis at multiple
sites, and for most analyses, data can remain securely
behind owners’ firewalls. A similar data network is being
developed now in the Department of Health and Human
Services (HHS) to make data from Medicare, Medicaid,
and other payers available to qualified researchers for
comparative effectiveness research. The Agency for
Healthcare Research and Quality has also recently
awarded grants to support the development of this kind
of infrastructure.
MN: How are these developments likely to impact
our ability to conduct outcomes research?
JB: Large-scale data infrastructure investments improve
our capacity to conduct observational outcomes
research. However, for this research to have maximum
impact, we also need to use the most appropriate
methods. The risks of misclassification and selection bias
in observational studies are well-documented, and so
further work is needed to match the best methods to the
available data. And ultimately, these data could be useful
for measuring the outcomes of large experiments to
Healthcare reform legislation
is shaping the landscape of
health economic and
outcomes research in the U.S.
While recent changes
represent a significant shift in
the emphasis on effectiveness
in decision making, other
developments continue to
influence the outlook.
evaluate different benefit designs, formularies, payment
strategies, and other reforms.
MN: Yes, this is an important point. An increasing
amount of data that will be available to decision
makers will come from observational research.
There is clearly a need for applying appropriate
research methods to analyzing data, but equally
important will be an awareness among decision
makers of how to interpret these results. For
example, clinicians are well-versed in interpreting
randomized controlled clinical trials, but studies
using observational methods are often foreign to
them. Effective communication of research
including HEOR will be essential to achieve the
intended improvements in quality and efficiency
of healthcare in the U.S. Going forward, how do
you see the role of HEOR evolving?
JB: As stakeholders demand more convincing evidence
of the safety, effectiveness and value of new medical
technologies, the process of developing this evidence will
begin earlier in the product development cycle,
informing development decisions. Once approved, new
products will be subject to greater monitoring for safety
and comparative effectiveness in patient-care settings.
For some medical technologies, payers are beginning to
tie reimbursement to these endpoints. As we continue to
see innovation at the interface between payers and
manufacturers, the importance of data, methods, and
experienced researchers will continue to grow. •
The process of developing evidence
of safety, effectiveness and value
will begin earlier in the product
development cycle
Page 8 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

INTERVIEW | INSIGHTS
Selected milestones in U.S. Health Reform
IMPLICATIONS FOR HEALTH ECONOMICS AND OUTCOMES RESEARCH
2003
Medicare Modernization Act – The legislation which gave AHRQ
a congressional mandate to support comparative effectiveness
research (CER). Since 2003, AHRQ has supported CER and has
established networks and research centers (Evidence-based
Practice Centers, DEcIDE network) which support ongoing CER 1 .
2007
Food & Drug Administration Amendments Act (FDAAA) – Title
IX of FDAAA provides FDA with additional authority with regard
to both pre- and post-market drug safety including the authority
to require post-market studies and clinical trials, safety labeling
changes, and Risk Evaluation and Mitigation Strategies (REMS).
FDAAA requires increased activities for active post-market risk
identification and analysis 2 .
2009
The American Recovery and Reinvestment Act of 2009 –
Allocated $1.1 billion for CER with funding distributed between NIH,
AHRQ, and HHS to establish CER infrastructure and studies 1 .
2010
Patient Protection and Affordable Care Act – Landmark U.S.
healthcare legislation impacts the healthcare system in a variety
of ways. Research and programs focused on quality and cost
outcomes include 3 :
• Patient-Centered Outcomes Research Institute
(PCORI) –Establishes a private, non-profit institute to identify
national priorities and provide for research to compare the
effectiveness of health treatments and strategies.
• Quality Infrastructure – Additional resources provided to HHS
to develop a national quality strategy and support quality
measure development and endorsement for the Medicare,
Medicaid and CHIP quality improvement programs.
2011
• Health Care Quality and Efficiency – Establishes a new Center
for Medicare & Medicaid Innovation to test innovative payment
and service delivery models to reduce healthcare costs and
enhance the quality of care provided to individuals 3 .
Sources:
1 Sox HC, Comparative effectiveness research: A progress report, Annals. org, August 2, 2010.
http://www.annals.org/content/early/2010/08/02/0003-4819-153-7-201010050-00269.full?aimhp
2 U.S. Department of Health and Human Services, Last updated 10/2/2009.
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/Foodand
DrugAdministrationAmendmentsActof2007/ucm184271.htm
3 Committees on ways and means, energy and commerce, and education and labor, April 2, 2010.
http://docs.house.gov/energycommerce/TIMELINE.pdf
2012
• Linking Payment to Quality Outcomes – Establishes a
hospital value-based purchasing program to incentivize
enhanced quality outcomes for acute care hospitals 3 .
• Reducing Avoidable Hospital Readmissions – Directs CMS to
track hospital readmission rates for certain high-volume or
high-cost conditions and uses new financial incentives to
encourage hospitals to undertake reforms needed to reduce
preventable readmissions, which will improve care for
beneficiaries and rein in unnecessary healthcare spending 3 .
2013
• Administrative Simplification – Health plans must adopt and
implement uniform standards and business rules for the
electronic exchange of health information to reduce paperwork
and administrative burdens and costs 3 .
• Fee for patient-centered outcomes research – Annual fee
becomes effective on insured and self-insured plans to fund
the patient-centered outcomes research trust fund 3 . It has
been estimated that this fee will generate $500 million in
funds annually to support PCORI 1 .
2014
• Quality Reporting for Certain Providers – Places certain
providers, including ambulatory surgical centers, long-term care
hospitals, inpatient rehabilitation facilities, inpatient psychiatric
facilities, PPS-exempt cancer hospitals and hospice providers,
on a path toward value-based purchasing by requiring the
Secretary to implement quality measure reporting programs in
these areas and also pilot test value-based purchasing for each
of these providers in subsequent years 3 .
2015
• Continuing Innovation and Lower Health Costs – Establishes
an Independent Payment Advisory Board to develop and submit
proposals to Congress and the private sector aimed at extending
the solvency of Medicare, lowering healthcare costs, improving
health outcomes for patients, promoting quality and efficiency,
and expanding access to evidence-based care 3 .
• Paying Physicians Based on Value Not Volume – Creates a
physician value-based payment program to promote increased
quality of care for Medicare beneficiaries 3 .
AccessPoint - Issue 2 Page 9

INSIGHTS | MARKET ACCESS IN GERMANY
The recent introduction of a mandatory benefit
assessment process in Germany is set to
radically alter market access in this country,
with new stipulations for real-world evidence
in clinical trials and a significantly altered
pricing process based on discount negotiation.
The implications – both within and beyond
Germany’s borders – are considerable.
The author
Olaf Pirk, MD, PhD
is a Principal HEOR,
IMS Consulting Group, Germany.
OPirk@de.imshealth.com
Page 10 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

MARKET ACCESS IN GERMANY | INSIGHTS
All change for market access
in Germany
On 1 January, 2011, the status of Germany as a fast-entry,
premium-priced market changed with the introduction
of AMNOG (law to restructure the drug market). In
place of manufacturer-set prices – a feature this market
has shared with the UK for many years - is a system with
a benefit assessment-based discount negotiation during
the first 12 months on the market. Figure 1 shows the
new process.
EMPHASIS ON ADDITIONAL BENEFIT
For every NCE, manufacturers are now required to
submit a “benefit dossier” to the federal joint committee
(Gemeinsamer Bundesausschuss: GBA) for assessment
either by the GBA itself or, alternatively, IQWiG. The
outcome (additional benefit/no additional benefit) will
be published on the internet within three months. The
manufacturer and defined stakeholder groups will then
have the opportunity to comment in a hearing. Over the
next three months, the GBA will reach a decision, based
on the results of the assessment.
Manufacturer
Market
Launch
Manufacturer’s
price (set freely)
Institute for quality
and efficiency in
Health Care
Benefit
Assessment
Commission possible Report
Dossier
Federal Joint
Commitee
Benefit
Assessment
(Publication)
Hearing Additional
benefit
Federal Joint
Commitee
No additional
benefit
Benefit
Assessment
(Decision)
Reference
price
1. No additional benefit: If the drug is considered to
offer no additional benefit, it will be given a reference
price in relation to the comparator used during the
benefit assessment. Should that comparator belong to
an existing reference price group (Festbetragsgruppe)
the new drug will be classified immediately into that
group if possible (this applies when the two products
are comparable on ATC level 4). If no reference price
group exists, the new drug will be discounted to set a
reimbursement price no higher than the reimbursed
price of the comparator. This new price will be
effective from the beginning of month 13 after launch.
2. Additional benefit: If the NCE is considered to offer
an additional benefit then a discount will be negotiated
based on the reimbursed price of the comparator and
the additional benefit. The reimbursed price should be
as high as the comparator plus a surplus for the
additional benefit (the head association of the German
sick fund thinks of the following algorithm: 10%
additional benefit would equal 10% higher reimbursed
price.) The discount will be taken from the premium
price set by the manufacturer. The new reimbursed
price will be effective from month 13 after launch.
FIGURE 1: THE NEW GERMAN MARKET ACCESS PROCESS
AS DEFINED IN SOCIAL CODE BOOK NO. 5
No
agreement
Manufacturer Head association
of the
SMI scheme
Arbitration panel
Decision
Rebate Negotiations
(e.g. based on
international prices)
Reference price not available Agreement
Discount
Retroactive
Discount
Valid until the end
of the process
AccessPoint - Issue 2 Page 11
Decision
Market Launch 3 months 6 months 12 months 15 months
Not
accepted
Institute Quality and
Efficiency in
Health Care
Cost/benefit
assessment

INSIGHTS | MARKET ACCESS IN GERMANY
Healthcare politicians
believe that current
health economic
assessments in
Germany are
virtually dead
...continued from previous page
REBATE NEGOTIATIONS
All the pricing negotiations are conducted between the
manufacturer and the head association of the German sick funds
(GKV-SV) from months 7-12 post launch (ie after the GBA
decision has been reached). Should negotiations fail, the
reimbursed price will be set by an arbitration body between
months 13 to 15, based on the international reference price.
This will come into force retroactively beginning with month
13 after launch.
BENEFIT DOSSIER
The basis for the benefit assessment, as well as the negotiation
process, is the benefit dossier which must be structured
according to the GBA’s code of procedure (Figure 2).
The dossier consists of five modules, each of which forms the
base for the module above. Module 1 is the executive summary
of Modules 2-4. For each of the Modules there is at least one
Word template defining the contents to be provided. The core
of the dossier is Module 4 – the benefit dossier to be compiled
by the manufacturer. This must prove additional benefit over
the appropriate comparator, which is the cheapest drug to be
used on label while treating a patient. If there are no drugs in
the indication, the comparator might even be a non-drug
treatment. The dossier is comparable to the kind of HTA
formerly performed by IQWiG.
Ideally, the additional benefit should be demonstrated on the
basis of head-to-head trials with the appropriate comparator.
To facilitate the fulfillment of this goal, there are opportunities
to consult with the GBA during the whole drug development
process; ideally the manufacturer should approach the
committee before commencing the Phase III program. The
dossier should be based on all clinical trial data known to the
manufacturer, including both published and unpublished data
for aborted trials as well as for investigator-driven trials. In
Module 4 publications are also requested. Even if only one trial
is missing, the dossier will be judged incomplete and the
additional benefit will not be shown.
LENGTHY PROCESS
Since no one really yet knows how the process will work, the
GBA has defined the period through 31 July 2011 as
transitional. All benefit dossiers sent to the GBA during this
time will be reviewed, whether they are complete or not and
whether the comparator is appropriate or not. The
manufacturer will then have the opportunity to adapt and
resubmit the dossier within three months. Should the deadline
be missed or omissions occur, the additional benefit will not be
shown; in other words, the GBA will reach a “no additional
Page 12 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

MARKET ACCESS IN GERMANY | INSIGHTS
benefit” decision, leaving the GKV-SV to set the
reimbursement price.
If the manufacturer or GKV-SV is unhappy with the
decision of the arbitration body, they can ask for a cost
benefit analysis to be undertaken by IQWiG. This should
be financed by the company, completed within three
years, and be based on a prospective, non-interventional
study, according to GBA specifications. Time wise,
manufacturers must therefore plan for 6 months
List of
approved
indications
General info. about
the medicinal product
AMNOG in a nutshell
MODULE 1
• Administrative information
• Summary of statements in the dossier
MODULE 2
• List of approved indications
• General information about the medicinal product
negotiation with the GBA, 3 years study duration, and 2
years for the IQWiG assessment – with results available
at the earliest 7 years post-launch.
Healthcare politicians believe that current health
economic assessments in Germany are virtually dead:
instead of requesting a cost benefit analysis, manufacturers
should take the opportunity to initiate a new benefit
assessment using new data after one year, since by law the
process can be repeated annually. •
Appropriate comparative therapy
Patients with therapeutically
meaningful additional benefit
Cost of therapy for SHI
MODULE 3 (A-Z by indication)
• Indication of the appropriate comparative therapy
• Number of patients for whom there is a therapeutically meaningful additional benefit
• Cost of therapy for statutory health insurance
• Requirements for quality-assured application
Requirements for quality-assured application
Methodology for determining the medical
benefit and additional medical benefit
MODULE 4 (A-Z by indication)
• Systematic overview regarding the medical benefit and additional medical
Results regarding the medical benefit and the
additional medical benefit
benefit (description of the methodology and results)
• Indication of the patient groups for whom there is a therapeutically
Patient groups with therapeutically meaningful
additional benefit
meaningful additional benefit
Full text of
quoted resources
Files documenting the
procurement of info.
Study reports
CTD sections 2.5,
2.7.3, 2.7.4
Assessment report of
the regulatory agency
Checklist for formal
completeness
MODULE 5
• Full text of the quoted sources
• Files documenting the
procurement of information
• Reports on all studies of the
pharmaceutical entrepreneur
FIGURE 2: THE ORGANIZATION OF THE BENEFIT DOSSIER
AS DEFINED BY THE GBA
• Essential common technical documents
(CTDs)
• Assessment report of the regulatory agency
• Checklist for formal completeness
verification
• Since the beginning of 2011, each NCE must be supported by a benefit dossier defining the additional
benefit of the drug in relation to the appropriate comparator.
• If a benefit is shown, the new reimbursed price after one year on the market will be a surplus on the
reimbursed comparator price, according to the additional benefit. If no additional benefit is shown, the
reimbursed price after one year may not be higher than that of the appropriate comparator.
• The decision is based on a dossier submitted by the manufacturer, which draws on all the available clinical
trials. An incomplete dossier means no additional benefit is shown, in which case the reimbursement price
will be set and/or negotiated by the head association of the sick funds.
• If the negotiation fails, an arbitration body will determine the reimbursed price on the basis of international
reference prices. No health economic data are requested during the entire process. The negotiation is based
on the drug price accruing for the sick funds plus extra costs, based on additional resources used as mentioned
in the physician’s information leaflet.
AccessPoint - Issue 2 Page 13

INSIGHTS | HTA CONVERGENCE
After years of focusing first and
foremost on clearing the traditional
hurdles to market, companies now
face a growing need to place health
economics and the payer view at the
center of their development activities.
Jacco Keja, PhD
is Regional Leader EMEA, HEOR, IMS
Consulting Group.
JKeja@nl.imshealth.com
Page 14 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

HTA moves center stage
EARLY FOCUS KEY TO FUTURE SUCCESS
For many years, drug development was very much a
staged affair, primarily geared towards regulatory approval
and the three traditional clinical hurdles of quality,
efficacy and safety. Value was based on retrospective
review of the Phase III trial program; drugs were targeted
at the widest indication and highest line of therapy
possible; and pricing & reimbursement (P&R) was
essentially a one-step affair, centered on a dossier
submission. Only then, or at best in parallel, was the HTA
and payer view drawn into the mix.
Today, a new model is emerging. One where product
value is defined as much by health economic endpoints
- clinical outcomes, patient-related outcomes and quality
of life - as harder clinical endpoints; where payers have
started segmenting patients into populations that will
benefit most from a product or where its use will be most
cost-effective; and where protocols that were traditionally
designed for regulatory and drug approval studies,
based on a review of trial data and validation by
KOLs, now require complementary insights - from
prescribers, patients and real-world data (Figure 1). All
these parameters must be identified, investigated and
understood well in advance, in order to frame clinical
programs accordingly. The key point is this: that
generating real-world evidence for health technology
assessments (HTAs) must begin even before Phase II.
Regulatory focus
Internal study validity
Literature
review
Endpoint
design
KOLs
KOLs/ad
board
Protocol
validation
Regulatory
agency
HTA CONVERGENCE | INSIGHTS
KEY DRIVERS
FIGURE 1: TODAY’S ENDPOINT DESIGN IS MOVING FROM REGULATORY TOWARDS HTA FOCUS
Within the broader context of ongoing change and
increasing complexity in the global healthcare arena, the
shift towards outcomes and value for money is being
spurred by a number of developments and trends in
several of the major markets:
• France: In France, the fall-out from the safety scandal
involving Servier’s Mediator (benfluorex) has placed
drugs and their assessment under greater scrutiny than
ever. Withdrawn from the market in 2009, the drug
has since been alleged to have caused 500-2000 deaths
during its 30+ years on the market. Amid reports of a
promise to reform the French pharmaceutical
regulatory system, six multi-stakeholder groups have
been established by the Ministry of Health, charged
with reviewing drug evaluation at every stage of the
process: from licensing, pharmacovigilance and offlabel
use to information, organizational aspects and
medical devices. Reports detailing their findings are
expected to result in recommendations for legislative
change by mid-2011.
• Germany: As a consequence of budget strains and a
general perception that few new products are bringing
additional benefits, pharmaceutical companies
launching a new chemical entity in Germany are now
HTA and real-world data centric
External validity
Real-world
data
Prescribers
& KOL
HTA
insights
Literature
review
Endpoint
design
Patient
insights
KOLs/ad
board
Protocol
validation
Regulatory
agency
AccessPoint - Issue 2 Page 15
Payers

INSIGHTS | HTA CONVERGENCE
...continued from previous page
required to submit an early “benefit dossier” showing
a medicine’s added value over the most appropriate
comparator (see article in this issue on page 10).
Although pricing freedom is still allowed at launch, in
the event that a subsequent GBA/IQWiG review
completed within 6 months concludes that the
product fails to show an additional benefit, then direct
reimbursed price restrictions will be imposed. With a
deemed “no added value”, pharmaceutical companies
will be forced into secondary negotiations to set a
rebate level from the list price at launch on the basis
of this benefit assessment.
• UK: In the UK, the long-established PPRS pricing
process, built around the concept of profit control, is
set to be replaced by a new value-based system of
pricing pharmaceuticals by 2014. Intent on improving
access to medicines, based on assessing the outcomes
they achieve, this is driving much greater emphasis on
overall value and is already the basis for a number of
risk-sharing agreements or rebates to the NHS.
Alongside these important developments is growing unrest
at the continued decrease in patient access to medicines in
Europe, highlighted in the latest Patients W.A.I.T Indicator
report (EFPIA, 2010). Long delays in accessing treatments
abound, with the rate of availability to patients down in
most of the countries included in the survey compared
with the previous period studied (2004-2007). Average time
elapsing between EU market approval and accessibility
varies from 88 to 392 days, meaning that in some countries
patients are waiting for more than a year before they can
benefit from new technologies being prescribed elsewhere 1 .
Much of this can be attributed to the wide and strong
fragmentation at the national and sub-national level.
Nor is this broad trend unique to the EU: In the U.S.
more than 5 years ago requests from the FDA included
statistically significant functional outcomes as a
co-primary endpoint as context for the more typical
endpoints. More recently, research into comparative
effectiveness has become an important element of the
country’s healthcare reform in an effort to drive more
informed decision making.
INCREASING MOVES TO INTERNATIONAL
COLLABORATION
Against this background, and with more countries turning
to HTAs as the basis for healthcare decision making,
the need for more unified, consistent approaches to
health economics and outcomes research has become
increasingly apparent. Growing recognition of this
imperative is already driving moves towards stronger
There are moves towards stronger
regional and global collaboration
in HTAs focused on greater
coordination and the sharing
of information
regional and even global collaboration in HTAs with
networks of agencies such as EUnetHTA and INAHTA
focused on greater scientific coordination and the
sharing of reliable, transferable information to improve
technology assessments.
These goals are further underscored by the objectives laid
out in the European Medicine Agency’s strategic
roadmap to 2015 in its efforts to facilitate access to
medicines and meet the challenges of drug development
into the future2 . These embrace the need for increased
interaction at stakeholder level with optimal flow of
information between the EMA, the industry, patient
groups and HTA bodies.
Other ongoing initiatives in European HTA
collaboration include project-based joint actions between
the European Commission and EUnetHTA to further
develop “Core HTA” methods, with an emphasis on
early dialogue between major players and the
establishment of an information system and long-term
business model. Proposed directives for the future further
strengthen these trends, with a move from project-based
to permanent cooperation on HTA.
Just how these aims will translate into new ways of working,
new interactions and some element of standardization
remains to be determined. However, they clearly
underscore the growing perception that EU cooperation
in HTAs offers clear benefits, pooling expertise and
minimizing duplication of effort, and that all stakeholders
will need to find ways of working together to achieve this.
TRANSATLANTIC HARMONIZATION
The move towards harmonized approaches has also
seen a notable increase in collaborative activities between
the EMA and FDA in recent years, including the
“Transatlantic Administrative Simplification Action Plan”,
focused on ensuring greater access to innovative products
on both sides of the Atlantic. Sharing of clinical trial
inspections and a bilateral good clinical practice initiative
to ensure that “clinical trials submitted in drug marketing
applications in the U.S. and Europe are conducted
Page 16 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

PRECLINICAL
R&D
• Epidemiology
(prevalence,
incidence)
• Medical care
practice
• Target population
• Early indicators of
outcome and
benefits
• P&R landscape for
therapy area
CLINICAL DEVELOPMENT
PHASE I PHASE II PHASE III
uniformly, appropriately and ethically” 3 have paved the
way for further areas of potential harmonization to be
explored (eg biomarkers, trial design and comparators).
Among proposed projects in the transatlantic plan are an
invitation to the pharmaceutical industry to compare the
EU and U.S. approaches to risk management formats
(eg, E2E, Volume 9a RMP guidance, REMS, etc.) and
identify opportunities for convergence, as well as
intensifying bilateral discussion on proposed specific risk
management initiatives4 .
BUSINESS IMPERATIVES
For the industry, these developments have major
implications. Companies must prepare for a world where
regulatory bodies are increasingly focused on value-based
issues, where national payers are increasingly adept at
conducting HTAs, and where networks of agencies are
coming together in a more intense, collaborative way. To
succeed, they will need to:
1. Forget about old and current regulatory
“pathways” to obtain product registration. At best
these will result in a “me too” and they will fail with
the HTA bodies and payers. Early development and
articulation of value, leveraging metrics and systems to
collect supporting data is key (Figure 2).
2. Focus on early and deep patient-level
segmentation potentially leveraging growing
knowledge in the field of pharmacogenomics, and use
the conclusions from this analysis to drive the agenda
HTA CONVERGENCE | INSIGHTS
Observational Research for Pre-Launch Market
Insight
• Burden of disease
• HE models (treatment cost and cost-effectiveness
studies); Budget impact models
• Guide/oversee quantitative price value studies
• Value demonstration studies (eg, QoL)
• Develop key value proposition for HTA/payers and
finalize strategy implementation planning
• Test value message for
payers/physicians/patients
REGULATORY
SUBMISSION
FIGURE 2: COMPANIES MUST MEASURE AND ARTICULATE PRODUCT VALUE EARLY BY DEVELOPING METRICS AND
SYSTEMS TO COLLECT SUPPORTING DATA
for regulatory approaches. There is little point, for
example, in registering a product in primary insomnia
and onset of sleep if chronic (secondary) insomnia and
restorative sleep is what the market needs.
3. Understand the patient beyond claims analyses
and optimize trials accordingly, recognizing the
somewhat different RWE data dimension and needs
for late development products. This is especially
relevant in the fields of CNS/psychiatry, pain and
behavioral disorders as well as others such as somatized
diseases, where current approaches involving
(administrative) claims analyses and often noninterventional
studies quickly meet their limitations.
Both sources, in their current form, can have
questionable validity and often lack the level of detail
needed to quantify unmet needs, burden of disease and
comparative effectiveness. In this case, it is important
to understand signals of improvement and characterize
patient groups often at the level of symptom,
cognition, etc and be able to relate improvements to
functional and economic advantages. •
1http://www.efpia.org/Content/Default.asp?PageID=517 2http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011 /01/WC500101373.pdf
3 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1
74983.htm
4 http://ec.europa.eu/health/files/international/doc/eu_fda_action_plan_20
0806_en.pdf
POST-APPROVAL LIFECYCLE
P&R MANAGEMENT
Post-Launch Observational Research
• Safety commitment/Requirement studies;
estimate of the evolving risk-benefit profile
• Comparative effectiveness real-life studies in
clinical practice vs. efficacy data in clinical trials
• Comparison of multiple alternative interventions
to inform optimal therapy strategy
• Joint population
• Drug use in clinical practice (indication, dosage,
treatment period, compliance, adherence, QoL,
etc)
• Ongoing P&R optimization & price management
AccessPoint - Issue 2 Page 17

INSIGHTS | ROLE OF REGULATORS IN CANADA
One of the unique features of the Canadian
market is the existence of a powerful federal
regulator charged with ensuring that
pharmaceutical prices are not “excessive”.
Already responsible for multi-million dollar
repayments, the Patented Medicine Prices
Review Board (PMPRB) cannot be overlooked.
Cost-effectiveness assessments in Canada will
be significantly enhanced by considering the
pricing that is possible within the PMPRB rules.
The author
Joan McCormick, MBA
is a Principal, IMS Brogan, Canada.
JMccormick@ca.imsbrogan.com
Page 18 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

ROLE OF REGULATORS IN CANADA | INSIGHTS
Modeling for success in Canada
UNDERSTANDING THE ROLE OF THE PMPRB
Cost-effectiveness modeling for a Canadian launch can
be effective in having government payers reimburse a
new drug product. However, regardless of the findings
of a cost-effectiveness study, the product’s price must be
compliant with the rules set out by the Patented
Medicine Prices Review Board (PMPRB).
The PMPRB is a federal regulatory agency, established
in 1987, which reviews the prices of all patented drugs
sold in Canada – including purchases by both the private
and public sectors – to ensure they are not excessive.
Complying with PMPRB rules early in the development
of health economics evidence is therefore of the utmost
importance, particularly because cost-effectiveness results
which are modeled into the future are heavily influenced
by drug price.
STRICT GUIDELINES BUT SUCCESS ACHIEVABLE
The PMPRB has established a set of guidelines that
allow for assessment of a range of potential pricing
outcomes. These take into account the scientific evidence
concerning the safety and efficacy of the new drug, the
pricing of comparators, international prices (for 7
countries) and potential changes in the market ahead of
first sales.
FIGURE 1: CANADIAN PHARMACEUTICAL PRICES DECLINED TO AN
AVERAGE BELOW THE INTERNATIONAL MEDIAN BETWEEN 1987-98
Source: PMPRB Annual Report, 2009
Average Ratio of Median International Price to Canadian Price of Patented Drug Products, 1987-2009
Ratio
1.2
1.0
0.8
0.6
0.4
0.2
The Board interprets the definition of patent and
medicine very broadly. Indeed, any patent pertaining to
a product means it falls under PMPRB jurisdiction.
Companies should consider the implications of filing
applications for patents that offer no intellectual property
protection before filing in Canada.
The PMPRB is certainly a powerful force, yet companies
have been successful in achieving reasonable prices and
this regulatory hurdle need not dissuade a company from
entering the market.
HIGH-PRICE COUNTRY
At the time of the Board's creation, Canadian prices were
well above the median international price, based on a
comparison against the list of 7 countries (6 European
countries and the U.S.) defined in the Patented
Medicines Regulations, (the "Regulations"). From 1987
to 1998 Canadian prices declined to an average below
the international median (Figure 1).
According to data from the PMPRB, Canada has now
returned to being a high-priced country, on average
falling behind only the U.S. and Germany (Figure 2).
Arguably, taking purchasing power into account, Canada
may even surpass Germany.
0.81 0.85 0.93 0.89 0.88 0.90 0.94 1.01 1.08 1.11 1.12 1.14 1.12 1.09 1.05 1.01 1.05 1.10 1.09 1.02 0.98 0.97 0.98
0
1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
AccessPoint - Issue 2 Page 19
Year

INSIGHTS | ROLE OF REGULATORS IN CANADA
The expectation is that
the PMPRB will effect
change by reducing the
complexity of some of
the rules; decreasing the
amount of enforcement
activity but increasing
the strictness of
adherence to the rules
that are still in place
...continued from previous page
International pricing is one of the criteria used to restrict prices
in Canada in a process that is designed to harmonize Canadian
pricing into global standards. A rule introduced by the Board
FIGURE 2: CANADA HAS RETURNED TO BEING A HIGH-PRICED COUNTRY
Source: PMPRB Annual Report, 2009
Average Foreign-to-Canadian Bilateral Price Ratios at Market Exchange Rates,1998, 2003, 2009
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0
0.86
0.80
0.80
Italy France UK Sweden Switzerland
Year
Canada Germany US
in 1994 stipulated that the Canadian price could not exceed
the highest price of the product among the 7 countries listed
in the Regulations. Furthermore, the international median price
is used as a price test for the review of select new products as
outlined below.
INTRODUCTORY PRICE TESTS
For new chemical entities entering an established therapeutic
class, and which do not offer moderate or substantial
improvement, the price will be limited to that of the highest
priced comparator in the class. This is known as the Therapeutic
Class Comparison (TCC) test. For products where there are no
therapeutic comparators, the rules permit the price to be as high
as the international median.
Products offering a substantial improvement in therapy, for
which the threshold is very high, will be permitted to price at
the level of the higher of the international median or the TCC
test. In 2010, a new category – moderate improvement – was
introduced. In this case, relevant products are permitted to price
at the level of the mid-point between the international median
and the TCC - thus offering half of the premium which would
be granted to a breakthrough medicine or one offering
substantial improvement. This, of course, assumes that the
median international price is, in fact, a premium price.
Where the median price is lower than the TCC, a drug offering
moderate improvement is permitted to price at the level of the
TCC, the same price as a medicine offering slight or no
improvement. Table 1 summarizes the relationship between the
level of therapeutic improvement and the introductory price
tests applied.
Page 20 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH
0.92
0.84
0.84
1.07
1.07
0.90
1.08
0.94
0.93
1.18
1.11
0.98
1.00
1.00
1.00
1.09
1.01
1.08
1.60
1.75
1.71
1998
2003
2009

ROLE OF REGULATORS IN CANADA | INSIGHTS
TABLE 1: RELATIONSHIP BETWEEN LEVEL OF THERAPEUTIC IMPROVEMENT AND INTRODUCTORY PRICE TESTS
Slight/No
Improvement Price Test
Slight/No
Improvement Test 1
Slight/No
Improvement Test 2
Slight/No
Improvement
Highest in
Therapeutic Class
N/A
Regardless of which test is used, no price in Canada
can exceed the highest international price (i.e., the
highest price among the 7 countries monitored by the
Board). If launch sequence or exchange rate fluctuation
result in the Canadian price exceeding the highest
international price, it will be required to roll back
and a penalty may be imposed. However, the level of
transparency provided by the PMPRB in publishing
its rules has resulted in relatively limited enforcement
interventions.
A DEGREE OF FLEXIBILITY
The Board appears to recognize that strict
interpretation of a regulatory framework does not
result in appropriate results in all cases. An example
of this is Faslodex (fulvestrant) for breast cancer.
Under the PMPRB guidelines the price of this
product would have been restricted to that of existing
agents used in the same place in therapy - about one
third of the lowest price in any of the comparator
countries. In the event, the PMPRB took into account
the premium over Arimidex (anastrozole) afforded in
each of the comparator countries. The resulting
Faslodex price was several times higher than the
guidelines had proposed but Canada in this case
remained the lowest priced country at a discount of 15%
below the lowest priced country in the basket.
The opportunity to resolve the Faslodex case outside the
framework of the standard introductory review process
is a reflection of the discretion allowed by leadership.
Moderate
Improvement
Substantial
Improvement
HIGHER OF HIGHER OF
Highest in
Therapeutic Class
Mid-point between
therapeutic class
and international
median
Highest in
Therapeutic Class
International
Median
Never higher than the highest international price
Breakthrough
International
Median
At the PMPRB the leadership influence stems from
two sources:
1. Board Staff, led by an Executive Director, who conducts
the day-to-day operation of the price review process.
2. Board, led by a Chair, who directs policy decisions
and sit at hearings.
In August 2010, a new Executive Director, Michelle
Boudreau, joined the Board staff, followed in March 2011
by the appointment of a new Chair of the Board, Mary
Catherine Lindberg, the former Vice-Chair since June
2006. Board members can be appointed for up to two
5-year terms. This means the new Chair will be eligible
for renewal later in 2011, potentially serving on the
Board until 2016.
The expectation is that this new leadership team at the
PMPRB will effect change by reducing the complexity
of some of the rules; decreasing the amount of
enforcement activity but increasing the strictness of
adherence to the rules that are still in place. It remains to
be seen how this prediction bears out over the coming years.
The PMPRB continues to play a substantive role in the
Canadian pharmaceutical landscape. Cost-effectiveness
modeling for this market is enhanced when the PMPRB
rules are layered into the analysis to understand
compliance status of prices being studied. •
AccessPoint - Issue 2 Page 21
N/A

INSIGHTS | HEALTH ECONOMIC MODELING
Implementing value arguments in diverse markets
requires flexibility to meet country needs within a
global positioning and value strategy. Adapting
economic models to local requirements is a key part
of this process, providing critical support for product
launch. Here we consider the issues involved and an
approach to achieving best practice.
The authors
Adam Lloyd, MPhil, BA
is Global Leader Health Economic Modeling,
and Senior Principal HEOR,
IMS Consulting Group, U.K.
ALloyd@uk.imshealth.com
Yumiko Asukai, MSC
is an Engagement Manager HEOR,
IMS Consulting Group, U.K.
YAsukai@uk.imshealth.com
Page 22 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

HEALTH ECONOMIC MODELING | INSIGHTS
From global to local
COUNTRY ADAPTATION OF ECONOMIC MODELS
Model adaptations refer to the process of taking a health
economic model and amending or adapting the inputs in
a way that enables their application to different settings.
Adaptations are characterized by:
• A model that assesses or describes the impact of an
intervention that needs to be applied to different settings
• A set of common assumptions that are consistent
across analyses
• Some coordination of the applications between different
settings
WHY THE NEED FOR ADAPTATION?
Economic analysis is a component of market access in a
growing number of countries. Crucially, however, the exact
requirements differ: analysis conducted in the U.K., for
example, may not be relevant in France, Korea or elsewhere.
Prices, patient characteristics, treatment practices and
methods of measuring value vary between countries or
regions. That said, the core package of evidence supporting
a product is usually the same across geographies, and the
intent is a coherent international value strategy. The purpose
of model adaptation is to balance the need for arguments
that support local requirements against the needs of
companies to generate a consistent strategy.
Model adaptation may meet several goals:
1. Transfer expertise from the center to the markets
This is particularly important in the peri-launch period
when most knowledge about a new product lies within
the central functions of a company, but when affiliates
Therapy area
CV/metab x x x x x x x x x x
Oncology x x x x x x x x x x x x
need to rapidly gain skills and understanding around the
value of a new intervention. Coordination of value
delivery allows the local markets to get to grips with and
benefit from global strategic thinking.
2. Facilitate a coherent global strategy
Market variations in comparators and treatments can give
rise to tensions between individual country versus central
priorities. The strategy must thus be sufficiently flexible to
accommodate market needs, while allowing for consistency
in the product value story across countries. Coordination
between global and local functions allows the strategy to
be clearly communicated to the markets, and decisions
about local variation in approach to be taken after
considering implications for other countries.
3. Provide affiliate support with technical skills
Not all country organizations who will use economic
information during a launch will have the relevant in-house
expertise to conduct or commission the necessary work.
A harmonized approach allows central expertise to be made
available to meet local needs.
WHAT COUNTRIES ARE TYPICALLY INVOLVED?
Based on our experience at IMS, while model
adaptations do take place in the Asia Pacific, Australia,
Canada and the U.S., the majority are conducted in
Europe, with the Nordic and CEE countries wellrepresented.
Figure 1 shows the geographic spread of
models adapted by IMS for eleven projects in four key
therapy areas. Requirements vary between molecules
and companies.
CV/metab x x x x x x x x x x x x x x x x x x
CV/metab x x x x x x x x x x x x x x x x x
Oncology x x x x x x x
Respiratory x x x x
Respiratory x x x x x x x x x x x
CV/metab x x x x x x x x x
CV/metab x x x x x x x x x x x x x x x x x x x x x
Oncology x x x x x x x x x x x x x x
Anti-infective x x x x x x x x
Countries
Included
FIGURE 1: RECENT MODEL ADAPTATIONS ACROSS VARIOUS DISEASE AREAS COVERED A MAGNITUDE OF COUNTRIES, ALSO IN
EMERGING MARKETS
AccessPoint - Issue 2 Page 23

INSIGHTS | HEALTH ECONOMIC MODELING
Model adaptations
enable companies to
leverage evidence
smoothly into country
settings in support of
affiliate needs
...continued from previous page
ISSUES TO CONSIDER IN ADAPTATION PROJECTS
1. When do we start?
Model adaptations can start sooner (eg, 18 months pre-launch) or
later (eg, 6 months pre-launch). Each timing has its own pros and
cons as shown in Figure 2.
Early, say 18
months
pre-launch
Later, say 6
months
pre-launch
• Early results input to global
strategy
• Data available to help
affiliates plan local access
• Can move data collection
off critical path
• Affiliates are engaged and
resourced to participate
• Lower risk of product
failure
• Much more focused
projects
FIGURE 2: WHEN DO WE START?
Advantages Disadvantages
• Starting too soon limits
affiliate ability to invest
• Phase III results often
surprise
• Need to update final
deliverables before use
• Models get crowded out in
the busy pre-launch period
• We need to prioritize, usually
putting countries into waves
• Unexpected events can
lead to extremely intense
needs for manpower
2. Who collects the local data?
Local data collection – evaluating prices, guidelines and treatment
practice, and interviewing local clinicians – is a key part of model
adaptation. Understanding where to source local expertise is
important.
Again, there are important issues to consider: Organizing data
collection centrally with a single core vendor can be expensive
but ensures accountability; sub-contractors extend potential
coverage but imply some loss of relationship control; and
contracting data collection locally may be lower cost but could
also result in variable quality (Figure 3).
Core vendor
Vendor
sub-contracts
Countries
Advantages Disadvantages
• Accountability
• Internalize admin costs
• Extends our coverage
• Can work with local experts
• Apparently lower cost
• User owns local data
FIGURE 3: WHO COLLECTS THE LOCAL DATA?
• Can be expensive
• Limited by coverage
• When things go wrong
lose control over
relationship
• Quality variable
• QC still needed so
unexpected costs occur
Page 24 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

HEALTH ECONOMIC MODELING | INSIGHTS
3. Who pays for adaptations?
Model adaptations can be either funded centrally or by local
country affiliates themselves. Central financing ensures core
control of strategy but runs the risk of poor local buy-in.
Conversely, resourcing at the country level may ensure
greater follow-through but has the potential for increased
congestion and a higher administrative burden (Figure 4).
Centre
• The budget is there
• Maintain control of strategy
• We can start early
• We can prioritize
Countries • Local buy-in and
engagement
Advantages Disadvantages
• Payer is the user
• More likely to follow through
FIGURE 4: WHO PAYS FOR ADAPTATIONS?
• Risks lack of buy-in
• Scope creep
• Blame transfer
• Loss of control over strategy
• Local budget available later
• Congestion
• Administrative burden
BEST PRACTICE APPROACH
A rigorous focus on three key areas – consistency, timing,
and data collection – is pivotal to achieving best practice
in the adaptation of economic models.
1. Ensuring consistency between countries
• Incorporating affiliate input into the design of central
cost-effectiveness models from the start increases buyin
and shares ownership of the final strategy. Affiliates
can be approached selectively – not necessarily simply
choosing the largest countries – as an economical
way of gaining input from engaged individuals.
• Central control of financial support for technical work
ensures adequate funding and strategic coherence and
minimizes the administrative burden. Countries
can be cross-charged if buy-in to the project or
deliverables is doubtful.
• Adaptation plans can include a set of core analyses that
support a clearly articulated global positioning, but
also a fall-back strategy for exceptions/challenges.
• Clear channels of communication within the client
company are needed to resolve issues and to allow the
strategy to adapt as market feedback solidifies. This
requires a strong central project manager with time
available to support the adaptation.
A rigorous focus on
consistency, timing and data
collection is pivotal to
achieving best practice
2. Timing
• A central model can be created before first Phase III
data is available (>18 months before launch) to move
this task off the critical path.
• A structured program of country adaptations that
starts once Phase III data is known. Countries
appreciate early warning of likely value arguments to
allow planning of local activities.
• A process should be in place to respond to late
arriving trial data, unexpected events, and
competitor activities.
• Adequate resource from both vendor and client
company is essential for timely delivery.
3. Local data collection
• There are significant advantages to having model
development and data collection run by the same
company: collecting data is quicker and more reliable
and, importantly, if problems do occur there is clear
accountability for addressing them.
• Vendors will have to sub-contract in smaller markets.
Priorities for a sub-contractor should be technical
experience rather than perceived influence. It is also
helpful to have clear ownership of the relationship
with the sub-contractor.
• Company data collection imposes additional
requirements on the commissioning firm, to
coordinate affiliate involvement to protect timelines,
and to QC data that is delivered.
EFFECTIVE APPLICATION OF EVIDENCE
Model adaptations enable companies to leverage
evidence smoothly into country settings in support
of affiliate needs. Done well, based on good
communication, flexibility and adequate time and
resource, they can ensure better consistency with global
strategy and smoother delivery of critical value messages
to relevant local audiences. •
AccessPoint - Issue 2 Page 25

INSIGHTS | MEDICATION ADHERENCE
It is well known that many patients fail to
take their medication doses while some never
even fill their prescriptions. All stakeholders
can agree on the importance of addressing
this critical issue. Progress has been slow,
but advances are being made, as Jonothan
Tierce explains.
The author
Jonothan Tierce, CPHIL
is a Senior Scientific Consultant to IMS
in the U.S.
JTierce@us.imshealth.com
Page 26 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

Over the last few years, a significant body of research
has been created – much of it using IMS or other
administrative data – to understand the parameters of
medication non-adherence, determine some of its causes
and point the way to improvements. Taken together, this
decade-long effort – involving many well-known clinical
and health services research experts and many types of
health informatics resources – begins to paint a corner
of the vast adherence landscape.
Here we consider the progress that has been made and
the insights that can be drawn from the findings
published in four key areas of adherence research:
1. Adherence research methods
2. Patterns and predictors of poor adherence
3. Impact of non-adherence
4. Adherence improvement
ADHERENCE RESEARCH METHODS
Research by Benner in the early 2000s provided an
improved “repeated measures” methodology for
understanding patterns and predictors of adherence in
administrative databases. In part the basis for overcoming
some of the limitations of research relying on patient selfreported
adherence, this new approach has impacted our
ability to use and interpret adherence study results and
has since been employed by other researchers.
Subsequent insights from Wang, Benner and colleagues1 showing that patients “markedly overstated” adherence,
led to the use of other approaches to understanding this
issue, and, somewhat later, improvements in the methods
for querying patients about their medication-taking
behaviors. These involved correlating questions about
health knowledge, attitudes and behaviors with
prescription or other medical claims data, and
drug-cap devices to measure the time and frequency of
pill-bottle openings.
PATTERNS AND PREDICTORS OF POOR ADHERENCE
Researchers have conducted numerous so-called
“patterns and predictors” studies across many therapeutic
areas. One recent analysis of a managed care health plan
found differential, but uniformly suboptimal, adherence
MEDICATION ADHERENCE | INSIGHTS
Getting to grips
with medication adherence
A DECADE OF RESEARCH INSIGHTS
and persistence with medications across 6 chronic
medication areas, with rates continuing to decline over
the two-year study period – findings which offer a useful
baseline for the development of initiatives to improve the
quality of drug therapy management2 .
Insights from many of these studies involve
cardiovascular (CV) agents, particularly longer-term use of
antihypertensive agents and statins – both important targets
for their poor rates of adherence. Adherence with CV
medications has wide applicability to other treatment areas
that share some or all of these characteristics: chronic daily
treatment; therapy for life, often consisting of multiple pills;
symptoms that are undetectable by the patient; some level
of side effects; and a range of patient factors.
Among the key insights from a decade of CV adherence
research are:
1. Adherence with CV medications is remarkably
low using the newer approach
In an early study by Benner, persistence with statin
therapy was shown in an elderly (65+) population of
patients to decline substantially over time, with the
greatest drop occurring in the first six months of
treatment. Despite slightly better persistence among
patients who began treatment in recent years, longterm
use overall remained low. The mean Proportion
of Days Covered (PDC) was 79% in the first three
months of treatment, 56% in the second quarter, and
42% after 12 months. Only one patient in four
maintained a PDC of at least 80% after five years3 .
2. Adherence is a particular problem in people
with dual CV disease
In a large retrospective study of patients in a U.S.
managed care plan, Chapman and colleagues showed
that adherence with concomitant antihypertensive
and lipid-lowering therapy is poor: only one in three
patients is adherent with both medications at six
months4 . In a further analysis of the same population,
the authors demonstrated that adherence to
concomitant antihypertensive and lipid-lowering
therapy among older adults is poor. Modifiable factors
that may improve this in Medicare-eligible patients
include initiating therapy concurrently and reducing
overall pill burden5 .
AccessPoint - Issue 2 Page 27

INSIGHTS | MEDICATION ADHERENCE
...continued from previous page
3. The greater the pill burden, the greater the risk
of non-adherence
Among patients in a large managed care database
taking antihypertensive and lipid-lowering
medications, “adherence to those regimens became
less likely as the number of prescription medications
increased. The reduction in adherence with additional
prescription medications was greatest in patients with
the fewest pre-existing prescriptions” 6 .
4. Early adherence behavior with CV medications
leads to long-term adherence
In a recent study of Medi-Cal patients, those either fully
adherent or non-adherent with both lipid-lowering
and antihypertensive drugs at baseline were more likely
to maintain their adherence status. Race, insurance
coverage and type of lipid-lowering medication were
significantly associated with transitioning from any
adherence status to non-adherence 7 .
5. Physician interaction early in treatment is key
to down-stream adherence
In a unique study of a health plan claims database, the
authors found that early and frequent follow-up by
physicians, especially lipid testing, was associated with
improved adherence to lipid-lowering therapy. They
hypothesized that the role of the physician in
reinforcing the need for, and value of, the treatment was
a key factor in this association, although further testing
would be needed to determine if this was causative 8 .
6. Early success with statin therapy is associated
with greater adherence
The authors of this study of the short-term effectiveness
of statins and long-term adherence to lipid-lowering
therapy found that patients who had early treatment
success (in terms of lowered cholesterol) were more
likely to be adherent to treatment9 .
7. Therapeutic substitution of statins is more
likely to destabilize therapy than generic
substitution
In a large study of CV patients in over 90 health plans
using the health plan data, therapeutic substitution
The best results were seen from
adherence programs involving
medical professional-to-patient
contact on a regular basis
was more likely to involve a subsequent disruption to
statin therapy than generic substitution. The authors
conclude that “therapeutic substitution could
potentially lead to adverse impacts on patients'
outcomes, and should be studied further” 10 .
8. Single-pill combinations lead to better
adherence than 2-pill regimens
Using the health plan data in a propensity-matched
cohort of patients prescribed amlodipine who
switched to amlodipine/atorvastatin or added a statin
to their amlodipine regimen, the authors found that
hypertensive patients who initiated statin therapy via
a single-pill (amlodipine/atorvastatin) were more
likely to remain adherent to their statin than patients
adding a separate statin to their antihypertensive
regimen11 . Similarly, a large retrospective study using
the health plan data confirms previous observations
that a single-pill CV treatment regimen can help
improve adherence versus two-pill regimens. The
authors noted, however, that “greater improvements
in adherence are likely to be observed in patients with
prior experience of either calcium channel blocker
or statin therapy than in those either naive to, or
experienced with, both therapies” 12 .
IMPACT OF NON-ADHERENCE
Studies evaluating the clinical and/or economic impact
of non-adherence have also focused primarily on patients
with CV disease. Among noteworthy insights are findings
to suggest that in the specified population:
1. The costs of improving adherence are justified
In a study using the 1999-2002 National Health and
Nutrition Examination Survey, the authors estimated
15.2 million cases of uncontrolled hypertension, of
which 84.8% had low/moderate cholesterol levels
and 16.7% had >/=3 additional risk factors with no
history of CHD. On that basis, nearly 200,000
coronary events are expected to occur within four
years, generating more than $2.5 billion in direct
medical costs. It was further estimated that 64% of
4-year risk was attributable to uncontrolled blood
pressure and lipids13 . The adverse outcomes and high
costs associated with uncontrolled CV disease would
thus appear to justify the costs of improving
adherence with lipid-lowering and antihypertensive
medications.
2. Statins may be clinically valuable in the
presence of other CHD risk factors
Using the health plan data, a study of patients
beginning antihypertensive treatment found that
those with established CHD or CHD risk factors
Page 28 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

were more likely to receive statins. However, a
substantial fraction did not fill any statin prescription,
suggesting a treatment gap and excess, modifiable CV
risk. The authors concluded that “the increased use
of statin therapy could benefit many hypertensive
patients with additional CHD risk factors” 14 .
3. Non-adherence reduces clinical trial benefit
by 50%
Applying an innovative modeling technique, this
study simulated patient characteristics, matched those
of participants in the Anglo-Scandinavian Cardiac
Outcomes Trial (ASCOT) Lipid-Lowering Arm, and
calculated event probabilities with Framingham Heart
Study risk equations. The authors estimated that
patients taking antihypertensive and statin therapy at
real-world adherence levels would receive
approximately 50% of the potential benefit seen in
clinical trials. This adds to the body of evidence
suggesting that adherence-improving programs may
well be cost justified as well as clinically necessary15 .
ADHERENCE IMPROVEMENT
Researchers have also been striving to understand what
can be done to improve medication adherence. The
results of a 30-year literature review (1972-2002)
conducted by IMS researchers show that relatively few
interventions designed to improve compliance with
antihypertensive or lipid-lowering medications have been
studied in a scientifically meaningful way: only 62 studies
describing 79 interventions were identified. Overall, 56%
of interventions were reported to improve patient
compliance. When only those studies meeting minimum
criteria for methodological quality were considered,
22 interventions remained and a scant 12 were
recommended, because they demonstrated a significant
improvement in compliance.
Best results involve regular medical contact
The best results were seen from adherence programs
involving medical professional-to-patient contact on a
regular basis. Other approaches, such as medication
reminders, only demonstrate modest benefits. Those
recommended include fixed-dose combination drugs;
once-daily or once-weekly dosing schedules; unit-dose
packaging; educational counseling by telephone; case
management by pharmacists; treatment in pharmacist- or
nurse-operated disease management clinics; mailed refill
reminders; self-monitoring; dose-tailoring; rewards; and
various combination strategies16 .
Based on an updated literature search (up to 2007), two
follow-on analyses to determine what types of interventions
were the most effective and cost-effective found that:
MEDICATION ADHERENCE | INSIGHTS
We can see that the frontier of
research in this area lies in a
deeper understanding of the
multiple factors that impact
adherence
• Typically, the higher-cost adherence-improving
interventions, the ones that involve frequent contact
with medical professionals, were the most effective17 .
• Lower-cost interventions, such as reminders and
educational materials, and a pharmacist/nurse
management program, can provide some benefit
and may be cost-effective as a first attempt to
improve adherence18 .
Adherence research in a number of specific disease areas
found potential value in interventions that focused on
the role of the physician, patient behavior modification,
pill size, and a nurse-based management program:
• Cardiovascular: A physician-implemented CHD risk
evaluation/communication program was able to
improve patients' modifiable risk factor profile and
lower predicted CHD risk compared with usual care.
By combining this strategy with more intensive
treatment to reduce residual modifiable risk, the
authors suggest that substantial improvement in
CV disease prevention could be achieved in
clinical practice19,20 .
• Overactive bladder: Patient support of medication
adherence may be enhanced by simultaneously
supporting the use of non-pharmaceutical lifestyle
modifications and behavioral interventions21 .
• Valproate usage: Patients taking valproate would
prefer a formulation that is easier to swallow, even
if it needs to be taken twice per day. The authors
conclude that physicians choosing between
medications with similar efficacy and safety may
consider patient preferences to optimize conditions
for medication adherence22 .
• Hepatitis-C: A retrospective cohort analysis
demonstrated that hepatitis-C patients in a
telephone-based, nurse drug management program
refilled significantly and progressively more injections
than did controls when measured at 12 weeks,
24 weeks and 48 weeks23 .
AccessPoint - Issue 2 Page 29

INSIGHTS | MEDICATION ADHERENCE
...continued from previous page
NEXT FRONTIERS
Research has generated many useful and actionable
insights into adherence and persistence with medication
and other treatment. Many of these efforts are still
underway as other important clinical, behavioral and
scientific issues continue to be discovered and addressed.
As we move into the second decade of the 21st century,
and IMS and others continue to enhance their databases
with clinical, patient preference and behavioral
information, we can expect these studies to yield deeper
and more useful results. But at the same time we can also
see that the frontier of research in this area lies in a deeper
understanding of the multiple factors that impact
adherence: physician and other provider/patient
interactions; patient (and perhaps caregiver) knowledge,
attitudes and behaviors; and finally external factors
(insurance coverage, patient finances, etc). •
1 Wang PS, Jenner JS, Glyn RJ, Winkelmayer WC, Mogun H, Avorn J. How
well do patients report noncompliance with antihypertensive medications?
A comparison of self-report versus filled prescriptions. Pharmacoepidemiol
Drug Saf, 2004; 13(1):11-9.
2 Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and
persistence across 6 chronic medication classes. J Manag Care Pharm, 2009;
15(9): 728-40.
3 Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J.
Long-term persistence in use of statin therapy in elderly patients. JAMA,
2002; 228:445-61.
4 Chapman RH, Benner JS, Petrilla AA, Tierce, JC, Collins R, Battleman DS,
Sanford Schwartz J. Predictors of adherence with antihypertensive and
lipid-lowering therapy. Arch Intern Med, 2005;165(10):1147-1152.
5 Chapman RH, Petrilla AA, Benner JS, Schwartz JS, Tang SS. Predictors of
adherence to concomitant antihypertensive and lipid-lowering medications
in older adults: A retrospective cohort study. Drugs Aging, 2008;25(10):
885-92.
6 Benner JS, Chapman RH, Petrilla AA, Tang SS, Rosenberg N, Schwartz JS.
Association between prescription burden and medication adherence in
patients initiating antihypertensive and lipid-lowering therapy. Am J Health
Syst Pharm, 2009; 66(16):1471-7.
7 Nichol MB, Knight TK, Wu J, Tang SS, Cherry SB, Benner JS, Hussein M.
Transition probabilities and predictors of adherence in a California
Medicaid population using antihypertensive and lipid-lowering
medications. Value Health, 2009; 12(4):544-50.
8 Benner JS, Tierce JC, Ballantyne CM, Prasad C, Bullano MF, Willey WJ, et
al. Follow-up lipid tests and physician visits are associated with improved
adherence to statin therapy. Pharmacoeconomics, 2004; 22 (Suppl 3): 13-23.
9 Benner JS, Pollack MF, Smith TW, Bullano MF, Willey VJ, Williams SA.
Association between short-term effectiveness of statins and long-term
adherence to lipid-lowering therapy. Am J Health Syst Pharm, 2005; 62:
1468-75.
10 Chapman RH, Benner JS, Girase P, Benigno M, Axelsen K, Liu LZ,
Nichol MB. Generic and therapeutic statin switches and disruptions in
therapy. Curr Med Res Opin, 2009; 25(5): 1247-60.
11 Chapman RH, Pelletier EM, Smith PJ, Roberts CS. Can adherence to
antihypertensive therapy be used to promote adherence to statin therapy?
Patient Prefer Adherence, 2009; 3: 265-75.
12 Hussein MA, Chapman RH, Benner JS, Tang SS, Solomon HA, Joyce A,
Foody JM. Does a single-pill antihypertensive/lipid-lowering regimen
improve adherence in US Managed Care enrolees? A non-randomized,
observational, retrospective study. Am J Cardiovasc Drugs, 2010;
10(3):193-202.
13 BennerJS, Smith TW, Petrilla AA, Klingman D, Goel S, Tang SS, Wong ND.
Estimated prevalence of uncontrolled hypertension and multiple
cardiovascular risk factors and their associated risk of coronary heart
disease in the United States. J Am Soc Hypertens, 2008; 2(1):44-53.
14 Chapman RH, Petrilla AA, Berman L, Benner JS, Tang SS. Are high-risk
hypertensive patients being prescribed concomitant statin therapy? A
retrospective cohort study. Am J Cardiovasc Drugs, 2009; 9(5): 299-308.
15 Cherry SB, Benner JS, Hussein MA, Tang SS, Nichol MB. The clinical and
economic burden of nonadherence with antihypertensive and lipidlowering
therapy in hypertensive patients. Value Health, 2009; 12(4): 489-
97. Epub 2008, Sept 9.
16 Petrilla AA, Benner JS, Battleman DS, Tierce JC, Hazard EH. Evidencebased
interventions to improve patient compliance with antihypertensive
and lipid-lowering medications. Int J Clin Pract 2005; 59(12): 1441-1451.
17 Chapman RH, Ferrufino CP, Kowal SL, Classi P, Roberts CS. The cost
and effectiveness of adherence-improving interventions for
antihypertensive and lipid-lowering drugs. Int J Clin Pract, 2010; 64(2):
169-81.
18 Chapman RH, Kowal SL, Cherry SB, Ferrufino CP, Roberts CS, Chen L.
The modeled lifetime cost-effectiveness of published adherenceimproving
interventions for antihypertensive and lipid-lowering
medications. Value Health, 2010; 13(6):685-94.
19 Benner JS, Cherry SB, Erhardt L, et al. Rationale, design and methods for
the risk evaluation and communication health outcomes and utilization
trial (Reach out). Contemp Clin Trials, 2007;28(5): 662-73. Epub 2007
Mar 15.
20 Benner JS, Erhardt L, Flammer M, et al. Reach out investigators. A novel
programme to evaluate and communicate 10-year risk of CHD reduces
predicted risk and improves patients’ modifiable risk factor profile. Int J
Clin Pract, 2008; 62(10): 1484-98. Epub 2008, Aug 7.
21 Schabert VF, Bavendam T, Goldberg EL, Trocio JN, Brubaker L. Challenges
for managing overactive bladder and guidance for patient support. Am J
Manag Care, 2009; 15 (4 Suppl): S118-22.
22 Bhosle M, Benner JS, Dekoven M, Shelton J. Difficult to swallow: Patient
preferences for alternative valproate pharmaceutical formulations. Patient
Prefer Adherence, 2009; 3:161-71.
23 Hussein M, Benner JS, Lee D, Sesti AM, Battleman DS, Brock-wood C.
Propensity score matching in the evaluation of drug therapy management
programs: An illustrative analysis of a program for patients with hepatitis C
virus. Qual Manag Health Care, 2010; 19(1): 25-33.
Page 30 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

PATIENT-REPORTED OUTCOMES | INSIGHTS
Putting the P
into Outcomes Research
Growing emphasis on real-world data as a
key element of treatment comparisons and
decision making has opened up new
opportunities for outcomes research,
including the ability to incorporate relevant
patient-reported measures. As the patient
perspective becomes increasingly important,
we consider a framework for its effective
capture within the broader context of
outcomes research.
The authors
Xavier Badia, MD, MPH, PHD
is Global Leader Observational Outcomes
Research, and Senior Principal HEOR, IMS
Consulting Group, Spain.
XBadia@es.imshealth.com
Christina Donatti, BSC, MSC, CLIN PSYD
is a Senior Consultant HEOR,
IMS Consulting Group, U.K.
CDonatti@uk.imshealth.com
Charles Makin BSPharm, MS, MBA, MM
is a Principal HEOR,
IMS Consulting Group, U.S.
CMakin@us.imshealth.com
AccessPoint - Issue 2 Page 31

INSIGHTS | PATIENT-REPORTED OUTCOMES
Putting the P into Outcomes Research
THE INCREASING RELEVANCE OF PROs
Outcomes Research (OR) is a commonly-used term and
longstanding concept which focuses on improving the
practice of medicine as applied to patients treated outside a
clinical trial1 . The key feature that sets it apart from clinical
research is the emphasis on effectiveness rather than efficacy,
reflecting the attempt of outcomes researchers to identify
the effect of an intervention as applied to a broad
population which most reflects the ‘real world’.
The three main areas of OR are clinical, economic and
patient-reported, which together provide evidence for
comparative effectiveness and economic evaluation:
1. Clinical: Most of the data from Phase III trials is
clinical in focus (eg, blood pressure, symptom relief,
overall survival).
2. Economic: Economic outcomes focus on
medical and non-medical resource utilization and
associated costs.
3. Patient-reported outcomes (PROs): PROs report
on a health condition and the benefits of treatment
on a patient’s health-related quality of life (HRQoL),
symptoms, treatment satisfaction, medication
adherence and functional status, as reported by
the patient.
Thus OR essentially describes, interprets, and predicts
the impact of various influences, especially interventions,
on final endpoints – ranging from survival to satisfaction
with care – which matter to decision makers, including
patients and society at large.
GROWING AUDIENCE FOR PROs
PROs have developed out of a growing trend to
demonstrate the effectiveness of health care interventions;
policy makers, health technology assessment (HTA)
authorities, physicians and patients all play a part in
determining both the availability and pricing of
medicinal products. This increasing number of
stakeholders has resulted in a broad audience with an
interest in PROs today.
WHAT PROs ARE OF GREATEST INTEREST TO KEY
STAKEHOLDERS?
• Regulatory: From a regulatory perspective, the
FDA requests PRO data to be collected within a
clinical trial program – but with a focus primarily
on symptom-based PRO labelling claims2 . The
European Medicines Agency (EMA) provides broad
recommendations on the use of PROs along with a
Biomarker’s Qualification program to provide a formal
mechanism for ratifying clinical trial endpoints,
including new and existing PROs3 .
• HTA/Reimbursement Authorities: Health
Technology Assessment (HTA) and reimbursement
authorities broadly recommend quality of life
measurement as part of their evaluations (eg, NICE,
PBAC, PMPRB). And, while the U.S. does not have a
formal HTA agency, there has been growing interest
in comparative effectiveness research4 .
• Clinical: PROs can be used to better understand the
disease experience from a patient’s perspective,
including satisfaction with treatment. In addition to
providing a framework for assessing interventions from
a clinical point of view, a patient perspective is essential
to understanding how a treatment affects quality of life
in a broader context, beyond the obvious impairments
and activity limitations assessed by HRQoL.
Despite the fact that the FDA currently focuses on
demonstrating symptom improvement, ultimately this
will not be sufficient as patient views become
incorporated into pricing models of healthcare.
Moreover, while the use of generic scales such as the EQ
5D or SF 36 provides a broad picture of a patient’s
perception of their quality of life, it does not afford
sufficient information on their perception of the direct
impact of the specific health condition or the treatment.
Issues such as disease-specific impact on productivity loss,
caregiver burden and broader quality of life dimensions,
will be crucial in identifying the competitive advantage
that lies with PRO outcomes and in communicating
PRO value propositions.
Page 32 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

REAL-WORLD EFFECTIVENESS
PATIENT-REPORTED OUTCOMES | INSIGHTS
The key to OR is to demonstrate in the real world (as opposed
to a clinical trial) that a product or device has a benefit to the
patient above and beyond effectiveness in a controlled setting.
It addresses such important issues as whether an intervention
improves adherence and therefore outcomes (eg, mortality,
remission or cure), whether it increases patient satisfaction (eg,
by reducing side effects), or whether it leads to an improvement
in HRQoL.
Unless an intervention is completely ‘novel’ the ability to prove
a statistically significant improvement in effectiveness over
existing treatments is challenging. In which case, how do you
differentiate your intervention from your competitor? By using
real-world evidence/outcomes research to demonstrate
significant, real-world benefits to patients, clinicians, payers and
other stakeholders.
More and more, manufacturers and stakeholders are required
to show that their intervention works in the real world and has
a patient benefit. Data is collected in actual practice (rather than
in theory or an artificially-imposed environment) for many
purposes and applied to prove or disprove a hypothesis.
PATIENT-REPORTED OUTCOMES
It is important to remember that the umbrella term of “patientreported
outcomes” (PROs) includes functional status, quality of
life (QoL) and health-related quality of life (HRQoL). It covers
all health data reported by the patient and can include more than
just the effects of health on wellbeing (Figure 1). For the measure
of QoL to be related to health, there is a need to focus more
specifically on health-related quality of life (HRQoL), which is
health-related, subjective, self-assessed (or caregiver/parentreported)
and multi-dimensional. The PRO definition enables a
broad measure of patient perception at different points of both
the disease and treatment burden spectrum.
Preference
to treatment
Treatment or
health service
satisfaction
Adherence
to treatment
Burden of
symptoms –
eg pain
HRQoL
FIGURE 1: PROs COVER ALL PATIENT-REPORTED HEALTH DATA
More and more,
manufacturers and
stakeholders are
required to show that
their intervention
works in the real
world and has a
patient benefit
AccessPoint - Issue 2 Page 33

INSIGHTS | PATIENT-REPORTED OUTCOMES
...continued from previous page
FIGURE 2: A FRAMEWORK
FOR CAPTURING EXPLICIT
PATIENT-REPORTED
OUTCOMES
Type of PRO
measure
Constructs
assessed
Determines impact
primarily from...
Symptoms Functioning Participation
Impairments
Clinical
perspective
Clinical perspective
Activity
limitations
PRO framework
The PRO questionnaire should be designed to inform
on explicit patient-reported concepts such as HRQoL,
symptoms or functional status, as well as meet key quality
standards (Figure 2).
PROs, if designed well and in accordance with standard
practice will for the most part, ‘behave’ quite logically. In
other words, patients or groups with better health will
tend to have higher mean scores. A good instrument
registers increases in mean scores for patients and groups
with truly improved health. However, as always, the
quality of the results from the analysis of PRO
instruments can only be as good as the quality of the data
that is collected.
To this end, it is essential to ensure that the choice and
development of a PRO to measure a patient-reported
concept is completed to the highest scientific standards.
As part of a detailed, systematic process (Figure 3),
this involves:
• Identifying the concepts and developing the
conceptual framework that are required to select the
patient group
• Creating a PRO questionnaire, generating items,
choosing the method of administration (paper or
electronic) and piloting the draft instrument
PRO Framework
Clinical/social
perspective
Participation
restrictions
Social
perspective
HRQoL
(Health status)
Impairment,
disability &
some QoL
Clinical/social
perspective
Needs-based
QoL
Needs-based
QoL
Patient
perspective
Patient perspective
• Assessing the reliability, validity and ability of the PRO
questionnaire to detect changes
• Modifying the questionnaire where necessary to
ensure that it targets the right patient concept in a
particular health condition.
It is clear from the EMA and FDA that patient perception
of treatment and outcome is a key focus – a perspective
best measured by using PROs5 . With the right skills,
expertise and analytical support, patient perception of a
treatment (or procedure) on a disease can be gathered:
• At the start of the clinical pathway: For example,
to determine the ability of pre-treatment PRO scores
to predict overall survival and, to some extent, the
response of a patient's cancer to treatment6,7 .
Essentially, the use of PROs is
intended to understand which
medication or treatment
pathway works better from a
humanistic perspective
Page 34 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

Conceptual
framework
PATIENT-REPORTED OUTCOMES | INSIGHTS
Literature
review
These two steps define the
contents of the tool.
Generate
items:
Physicians
and patients
in-depth
interviews
FIGURE 3: A SYSTEMATIC PROCESS FOR PRO CREATION AND DEVELOPMENT
• Through to Phase II and III: Changes in PROs
during treatment may presage disease recurrence or
failure to respond to treatment. In one particular cancer
study where patients were receiving adjuvant
chemotherapy for breast cancer, changes in
physical wellbeing and nausea/vomiting significantly
predicted recurrence 8 .
• Post-submission: For example, to determine longterm
adverse events and fulfil other post-marketing
study requirements.
ENABLING CHOICE OF EFFICIENT TREATMENT
Essentially, the use of PROs is intended to understand
which medication or treatment pathway works better
from a humanistic perspective, thus enabling selection of
the most efficient and “high-value” or “high net-benefit”
treatments. PROs can assist in persuading clinicians,
payers, sponsors and other stakeholders that a switch
should be made from treatment A to treatment B. This
requires an a priori hypothesis and a methodology that
can determine the clinically important difference between
these two treatments. Thus, going back to the beginning,
this ‘real-world’ evidence calls for consideration of the
effects of treatment on HRQoL in very specific and
measurable terms. •
Create
instrument
Qualitative
analysis
Through in-depth interviews with
experts and patients and the
subsequent qualitative analysis,
tool items are determined.
Pilot study
(small
sample size)
Preliminary
measurement
properties
The objective of the pilot study is to
identify and exclude those items ‘not
applicable’ to the target population
(rasch analysis) and to assess the
questionnaire’s preliminary measurement
properties (reliability and validity)
before its administration to a higher
sample of patients.
1 Lee S, Earle C, Weeks J. Outcomes Research in Oncology: History,
Conceptual Framework and Trends in the Literature. Natl Cancer Inst.,
2000; 92:195-204.
2 Caron M, Emery MP, Marquis P, Piault E, Scott J: Recent trends in the
inclusion of patient-reported outcomes (PRO) data in approved drugs
labelling by the FDA and EMA. Patient Reported Outcomes Newsletter,
2008; 40:8-10.
3 EMA (Committee for Medicinal Products for Human Use (CHMP)):
Reflection paper on regulatory guidance for the use of Health Related
Quality of Life (HRQL) measures in the evaluation of medicinal products.
2005. Doc. Ref. EMA/CHMP/EWP/139391/2004. London & EMA
(Consultation committee for medicinal products for human use (CHMP)):
Draft biomarkers Qualification: Guidance to applicants. 2008. Doc. Ref.
EMA/CHMP/SAWP/72894/2008. London.
4 Brixner D: Comparative Effectiveness: What Are We Comparing?
http://www.ispor.org/News/articles/Mar08/president.asp] ISPOR
Connections 2008. Accessed 8th April, 2011.
5 FDA Definition: “A PRO is any report of the status of a patient’s condition
that comes directly from the patient, without interpretation of the patient’s
response by a clinician or anyone else. (…) In clinical trials, a PRO
instrument can be used to measure the effect of a medical intervention on
one or more concepts (…)”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryIn
formation/Guidances/UCM193282 EMEA Definition: “Any outcome
evaluated directly by the patient himself and based on patient’s perception
of a disease and its treatment(s) is called patient-reported outcome (PRO)”.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_gui
deline/2009/09/WC500003637.pdf
6 Montazeri, A. (2009) Quality of life data as prognostic indicators of survival
in cancer patients: an overview of the literature from 1982 to 2008. Health
Qual Life Outcomes 7: 102.
7 Gotay, C.C., Kawamoto, C.T., Bottomley, A. and Efficace, F. (2008) The
prognostic significance of patient-reported outcomes in cancer clinical
trials. J Clin Oncol 26: 1355–1363.
8 Kenne Sarenmalm, E., Odén, A., Ohlén, J., Gaston-Johansson, F. and
Holmberg, S.B. (2009) Changes in health-related quality of life may predict
recurrent breast cancer. Eur J Oncol Nurs 13: 323–329.
AccessPoint - Issue 2 Page 35

INSIGHTS | IMS SYMPOSIUM
An IMS Symposium at the 13th Annual
European Congress of ISPOR considered the
growing use of observational studies and
their challenges in design, execution and
appropriate use by decision makers. With all
signs pointing to an even greater role for
observational research in future, these are
increasingly important issues.
The authors
Jorge Arellano, MSC, MPHIL
is Director IHE, Evidence Generation,
Amgen UK.
jorge.arellano@amgen.com
Jonothan Tierce, CPHIL
is a Senior Scientific Consultant to
IMS in the U.S.
JTierce@us.imshealth.com
Jacco Keja, PhD
is Regional Leader EMEA HEOR,
IMS Consulting Group.
JKeja@nl.imshealth.com
Page 36 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

The growing global need for more useable information
comparing the relative clinical and economic value of
medical technologies and treatment approaches has seen a
corresponding rise in the number of observational studies
(OS) attempting to meet this demand. With their greater
focus on functional outcomes (patient-reported, resource
use and costs) and on following rather than driving medical
practice, observational studies provide a key link between
clinical trials, where there is strong internal validity, and the
“real-world” use of a medical technology, where the goal
is to provide external validation among other available
products, treatment programs and diagnostic approaches.
Increasingly aggressive post-marketing surveillance, the
continued importance of value messages and growth of
mandatory risk-management programs are likely to witness
an even greater role for observational research in future.
However, these studies present their own rigor and
challenges that are different from traditional clinical trials,
with emphasis on providing evidence of value to a broad
range of decision makers - who themselves may not be
familiar with interpreting and incorporating this kind of
data into their decision making.
Understanding the issues involved in designing, executing,
and delivering so-called “real-world” observational studies
is essential to having them appropriately interpreted and
utilized for healthcare decision making. Key among these
are the internal organizational hurdles to generating
real-world evidence (RWE) and the practical challenges
facing health economists in this environment.
CHALLENGES FROM AN ORGANIZATIONAL PERSPECTIVE
Pharmaceutical manufacturers in today’s healthcare
sector face a new and increasingly important imperative
in the development of medical technologies – the need
to provide evidence of product value in the real-world,
clinical setting. This key shift in focus to external validity
not only adds to the existing complexities of bringing a
drug to market, but also has significant implications for
internal organizational processes.
Generating RWE is a growing core competence for
pharma but determining who owns which part of the
process is no easy task. A typical transactional study, for
example, will often be undertaken by market researchers;
safety assessments and long-term follow-up studies,
on the other hand, are usually conducted by
IMS SYMPOSIUM | INSIGHTS
Addressing the challenges of
real-world observational studies
pharmacoepidemiology groups. There are many different
owners in RWE generation, with different SOPs,
different standards, different backgrounds and also
different power within the organization. This is a
complex field with numerous interpretations of RWE
and its associated stakeholders.
In moving towards a better understanding of the issues
involved in developing RWE, the results of some recent
primary research to explore the need for observational
research (OR) and obstacles hindering its development,
are enlightening. The survey among pharmaceutical
companies, government and academic institutions, CROs
and consultancies in Europe yielded feedback from more
than 80 respondents, most from within the industry, and
offers several key insights into perceptions of OS, relevant
guidelines, and the need for improved harmonized/
international guidance:
• Late-stage focus: Typically, among individuals who
were heavily involved with RWE and OR, this was for
planning development purposes, and late-stage for
assessment, review and execution of studies. At the
same time, most RWE was generated not for market
segmentation studies or for identifying the ideal
patient population but rather to fulfill post-launch
obligations: collecting effectiveness data, meeting P&R
commitments, and also to some extent addressing the
lack of safety data. Thus, it is very much weighted
towards late and post-launch development.
• Internal hurdles: Among the main hurdles
encountered with OS are the lack of regulatory
guidance and, more particularly, the lack of dedicated
SOPs for this type of research. Even more of an issue,
reflecting some uncertainty in pharma around the
ROI from observational studies, is the ability to sell
this type of work internally and the consequent
constraints on budgets. This is quite a surprising
finding given that most of these studies are for postlaunch
commitments and failing to complete them
will likely impact P&R status. They are a given, yet
apparently difficult to justify.
• Low awareness: Lack of internal recognition around
the value of RWE and OS appears to be creating
frustration and sometimes skepticism among those
working in this area.
AccessPoint - Issue 2 Page 37

INSIGHTS | IMS SYMPOSIUM
...continued from previous page
• Describe epidemiology of
disease
• Quantify unmet medical
need
• Assist in assessment of new
indications
• Genetic research
Source: Adapted, ABPI
RESEARCH DEVELOPMENT POST-REGISTRATION
• Refine understanding of
disease epidemiology
• Supply data for economic
modeling
• Assess co-morbidities and
potential safety issues
• Inform clinical trial
protocol design
• Contribute to risk
management planning
FIGURE 1: OBSERVATIONAL DATA HAS RECOGNIZED POTENTIAL ACROSS THE ENTIRE PRODUCT LIFECYCLE
• Poor knowledge of guidelines: Awareness of
existing guidelines on conducting OS, such as those
published by the AHRQ (Registries for Evaluating
Patient Outcomes: A User’s Guide, 2007), STROBE
(Strengthening the Reporting of Observational
Studies in Epidemiology; Explanation and Elaboration,
2007) and IEGES (International Ethical Guidelines for
Epidemiological Studies, 2008) appears to be low –
even for individuals involved in this work.
• Need for guideline consistency: Perceived
inconsistency in the use of guidelines by stakeholders
further underscores the importance of harmonization at
the international level and the need for education around
these guidelines and their role in facilitating the
generation of RWE. Content improvements would be
welcomed, with particular emphasis on the need for
more detail in pricing guidelines – in terms of statistics,
analysis, and more particularly, design. In some ways, this
is analogous to the situation with PROs about 10 years
ago: despite a good deal of scientific effort, many
pharmaceutical companies struggled with implementing
PROs in the clinical trial setting and following through
with approval from regulatory bodies.
What is clear from these findings that some companies
are more advanced than others in generating RWE, but
in all cases there is a shortfall in recognizing the need to
start early. OS have a key role to play in this area and
companies should be looking to invest more in their use.
Knowledge of current guidelines is limited and in the
absence of an established gold standard, there remains a
strong need for harmonized guidelines with particular
emphasis on standardizing statistical confounders, analysis
and methodology.
• Provide input to
reimbursement/formulary
submissions
• Evaluate compliance
• Support pharmacovigilance
• Conduct pharmacoepidemiology
studies
• Supply real-world data on
cost and resource
utilization
CHALLENGES FROM THE HEALTH ECONOMIST PERSPECTIVE
In the past, a very few OS were conducted within the
context of pharmaceutical R&D. Those that were
undertaken focused primarily on disease epidemiology,
generally during drug development or occasionally, early
post-registration. More recently, however, with new hurdles,
new challenges and more intense competition, companies
have come to recognize the potential of observational data
across the entire product lifecycle (Figure 1).
Today, OS have increasing validity across a range of
scientific issues associated with product use in nonexperimental
circumstances. Most of the new
applications relate to health economics, such as
quantifying unmet medical need, providing input for
economic models, and evaluating compliance - not only
with medication, but also with the growing number of
treatment guidelines that are now being developed in
many therapy areas.
The result is something of an explosion in the topics,
objectives and applications of OS in recent years. A topline
literature search provides some indication of just how
extensive this growth has been since the 1990s,
particularly in the wake of key events such as the
In many cases, people are simply
used to doing things a certain way
within the context of clinical trials
and the confines of their own role
and personal experience
Page 38 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

establishment of NICE in England and Wales and
IQWiG in Germany, for example. The ISPOR task force
has also confirmed that payers and decision-makers alike
are requesting more and more observational data.
For every post-authorization product entering the
pricing and market access process, it is the task of the
health economist to generate evidence of its value in the
real-world, clinical setting. Not in isolation, but by
working closely with the research group, medical team,
biostatistics, data management, study management,
possibly an epidemiologist, and other operational units –
all of whom have a great deal of expertise but, in most
cases, minimal-to-no experience of observational
research. For the health economist, this can often mean
that efforts to bridge the scientific/real-world divide
trigger questions and challenges across a number of areas.
Among the most typically encountered are:
1. Questions regarding the need for RWE
• Why do we need to replicate what we saw in
better designed RCTs?
• What is the validity and credibility of these
studies?
• Who requested this data? By when?
• Which countries need this type of evidence?
Will it impact our P&MA?
2. Questions regarding how to generate RWE
• Prospective versus retrospective
• All comers (comparative?) versus single-arm
• Sample size
• What to collect? PROs - is this an intervention?
We did it in our RCTs!
• Recruitment of patients: feasibility &
confounding by indication
• Informed consent & selection bias
3. Practical challenges
• How to follow patients between different levels
of care?
• Standard dataset structures are designed for RCTs
4. Challenges for the analysis
• Analysis too flexible for the analyst liking
• Methods are unusual
• Dissatisfaction & distancing by some functions
/individuals
5. Challenges for the findings
• What if unexpected safety signals are found?
• Asymmetries in reporting AEs of new versus
existing therapies due to familiarity
• Are the results “representative” of each country?
• What can actually be said?
IMS SYMPOSIUM | INSIGHTS
The key is to help every function
appreciate that the need for RWE
is now a given for every product
ADDRESSING THE ISSUES
Some of these challenges are extreme examples, and not
all of them will apply in every situation, but they do
underscore the need for a lot of internal work. In many
cases, people are simply used to doing things a certain way
within the context of clinical trials and the confines of
their own role and personal experience. The key to
addressing and forestalling their concerns over the use of
real-world data is inclusion: helping every function to fully
appreciate that in the current environment, with so many
payers, HTAs, and new decision makers at the national
and regional level, the need for RWE is now a given for
every product and they must be a part of the process.
Internally, communication is key. This implies an element
of training and motivating, explaining to the different
functions about what can be done and why it is needed,
and sharing respected medical publications on
observational research, so that rather than feeling led
down a strange route, they understand the need for
RWE, realize it is here to stay and even accept it as a
potential opportunity for their careers. Crucially, the
health economist should not be seen internally as a
second-class citizen: RWE needs solid investment and
clear ownership in every organization.
Externally, there is a need for more standards, more clarity
and a structural framework for establishing appropriate
practice in RWE generation, to set the benchmark for
good OS design and good analysis. There needs to be
more effort in establishing standards in collaboration with
the industry, with a means of making sure they are
enforced. Fundamentally, this is about attitudinal change
and working together with well-developed, scientific
guidelines. ISPOR members and health economics and
outcomes researchers have a key role to play in helping
to achieve this goal. •
AccessPoint - Issue 2 Page 39

PROJECT FOCUS | ACUTE RESPIRATORY FAILURE
Rigorous, complementary
modeling techniques
support new innovations
with informed insights
into multiple dimensions
of their real-world clinical,
cost and economic
implications
The Authors:
Karl–Johan Myrén, MSC
is a Principal HEOR,
IMS Consulting Group, Sweden.
KMyren@se.imshealth.com
Jonas Hjelmgren, MSC
is a Senior Consultant HEOR,
IMS Consulting Group, Sweden.
JHjelmgren@se.imshealth.com
Demonstrating
cost-effectiveness and
budget impact in acute
respiratory failure
Innovative treatments and breakthrough technologies continue to
open up new possibilities for advancing patient care, but often at
a cost that has challenging implications for health policies, budgets
and payers.
Facilitating the ability of healthcare stakeholders to understand the
true value of a new intervention from a clinical, patient and
financial perspective is increasingly relevant to ensuring its optimal
utilization. Rigorous cost-effectiveness and budget impact analyses
can play a key role in informing this process, with their powerful
and complementary insights into the cost, outcomes and potential
system savings arising from new innovations. This is particularly
true in areas that are resource-intensive, such as critical care, where
the introduction of a new technology can significantly increase an
already high economic burden.
COUNTERING PAYER RESISTANCE
Facing just this situation, a leading provider of medical products
for use in intensive care units (ICUs) needed to understand the
health economics evidence for its new device in acute respiratory
failure (ARF) – a condition typically requiring mechanical ventilation
in patients admitted to ICUs. The technology’s unique approach,
based on monitoring diaphragm activity, resulted in an improved
patient breathing pattern compared to alternative techniques. This
paved the way for IMS Consulting to demonstrate a reduction in the
required length of stay in intensive care.
Despite its acknowledged benefits, the device had met with some
resistance from hospital payers and reimbursement bodies in the
U.S. and several European countries. By engaging with the
Nordic HEOR team in the IMS Consulting Group, the company found
a partner with the skills and experience in developing evidencebased
health economic models, combined with powerful analytics
and the local market knowledge to understand and place the
results in context.
Page 40 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

ACUTE RESPIRATORY FAILURE | PROJECT FOCUS
SYSTEMATIC PROCESS DELIVERS COMPREHENSIVE EVIDENCE
The IMS HEOR experts began by conducting an extensive and
systematic review of available clinical data on the device.
Studies deemed to be of sufficiently high-evidence value –
primarily RCTs and meta-analyses – were identified for
inclusion. They next reviewed and summarized the health
economic evidence for mechanical ventilation, together with
relevant cost information for the ICU setting.
The results of this analysis were then incorporated into a
validated, interactive model built in Excel. As the model
was designed to combine patient-level data of clinical
effectiveness with unique resource intensity data at the ICU
level, it addressed both cost-effectiveness per patient as well
as budgetary impact per ICU department. Ease of use and
flexibility were key features, with an interface that facilitated
communication with payers.
This first phase was followed by extensive internal and
external evaluation of the model, with simulations to test
and determine price sensitivity (Figure 1).
Inventory
of available
data
1. Model development phase
Processing
of available
data
Model
design
Model development phase
• Systematic literature review to collect clinical
evidence
• Selection and processing of data in order to
define model outcomes
• Development and validation of model
FIGURE 1: THE TWO-PHASE APPROACH TO MODEL DEVELOPMENT
NEW PRICE POTENTIAL – AND COST SAVINGS
The findings of the analysis provided the company with
key insights into the price potential of their new device,
and robust economic evidence of the cost savings that
could be achieved for ICUs through its use. As a result of
working with the IMS team, they now have the ways and
means of discussing not only the clinical but also the
economic implications of introducing the new device into
clinical practice.
The model has been rolled out to a number of markets and
serves as an important payer tool in the company’s active
market access strategy, supporting key discussions with
hospital payers and ICU Heads of Department. •
Internal
evaluation
Determination
of price
2. Model application
Publication
of results
External evaluaion
Justification
of price
Model application phase
• Internal use of model to test and evaluate price
sensitivity of product
• Publication of model and findings from model
simulations
• Using the model to justify the price for payers
(TLV, county councils)
AccessPoint - Issue 2 Page 41

PROJECT FOCUS | HTA STRATEGY
Understanding the diverse
international HTA
environment can be key to
an optimal value
development strategy
The Authors:
Joe Caputo, BSC
is a Principal HEOR,
IMS Consulting Group, U.K.
JCaputo@uk.imshealth.com
David Bertwistle, BSC, MSC, PhD
is a Consultant HEOR,
IMS Consulting Group, U.K.
DBertwistle@uk.imshealth.com
Leveraging historical HTA
decisions to optimize
future submissions
Greater emphasis on maximizing health service efficiency and cost
containment has seen healthcare payers increasingly challenged by
issues around comparative value, affordability and healthcare
priorities. The result has been the use of more sophisticated
approaches by decision makers to restrict access to products,
including greater reliance on Health Technology Assessments (HTAs).
CHALLENGING VARIATION IN HTAs
In addition to meeting traditional regulatory hurdles that have
historically served to support use of a new product in clinical
practice, the pharmaceutical industry is becoming well versed in the
need to demonstrate the product’s clinical and economic value via
HTA submissions. However, the process of HTA varies widely between
countries; HTA bodies differ in their approach to clinical and
economic evaluation, utilizing a variety of assessment criteria and
methodologies. For example, in France, the Commission de la
Transparence (CT) places greater emphasis on the level of clinical
improvement offered relative to competitors, whilst in the UK, the
National Institute for Health and Clinical Excellence (NICE) and the
Scottish Medicines Consortium (SMC) quantitatively convert level
of benefit offered into Quality Adjusted Life Years (QALYs) to allow
direct comparisons of costs between therapy areas.
Furthermore, HTA opinions and recommendations are not static. The
HTA bodies themselves are evolving over time, resulting in altered
perceptions of value and constantly changing evidence
requirements. The heterogeneity and variability of the international
HTA landscape presents a considerable challenge for pharmaceutical
companies, with disparate assessment outcomes and guidance
across different markets (Figure 1).
This lack of consistency and uniformity among HTAs means that drug
development programs must be tailored carefully and in a timely
fashion to allow for product value to be developed and
demonstrated across multiple markets, thereby maximizing the
likelihood of its success.
PLANNING FOR FUTURE REQUIREMENTS
In order to help plan for future HEOR and market access strategy
across several therapeutic areas, a leading global pharmaceutical
company was keen to understand historical HTA evaluations and
decisions and determine the key drivers behind them.
Recognizing the complexity of searching, identifying and capturing
data from HTA decisions in 8 countries, the company approached
HEOR experts in the IMS Consulting Group for help. In IMS it found
a partner with the global reach, HEOR presence and a network of
Page 42 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

local contacts in the majority of markets where formal HTA
processes existed, as well as the ability to complement the
company’s own skill set by providing in-depth therapeutic
knowledge and HTA expertise.
GATHERING THE EVIDENCE
The analysis was focused on a core list of products – either
in current practice or considered to be key competitors –
within each therapeutic area of interest. In a coordinated
program of data collection and supplementary research, the
IMS experts set about identifying the data and information
sources to be used in collecting relevant information on
market access and HTA decisions for each country. Where
information was available only in the local language,
IMS locally-based experts were able to translate the findings
into English.
Additionally, for selected markets where the drivers behind
the HTA decision were less transparent, the on-the-ground
IMS teams were able to conduct primary research in order to
confirm and understand the rationale for key findings from
the desk-based research.
HTA and market access information was supplemented by
extracting data on the uptake of marketed products using
IMS MIDAS data, a unique integration, viewing and analysis
platform for IMS Health audits. This enabled the IMS experts
to track sales versus competitor products as well as assess
the impact of HTA decisions – both positive and negative –
on sales over time.
HTA STRATEGY | PROJECT FOCUS
In this example for one drug, its value was considered to differ between 4 different
cost-effectiveness-focused agencies
Key
drivers
HTA
decision
Impact
on market
access
SMC
(Scotland)
Insufficient
information on
primary endpoint, and
lack of robust
economic argument
Not
recommended
Access denied by
Scottish NHS
NICE
(UK)
Benefit only for
patients who have not
been treated with
other products
Should only be used
in patient
population where
effectiveness is
demonstrated
Restricted to first line
use only by PCTs
CVZ
(Netherlands)
Benefit unclear due to
lack of experience.
Concerns over unknown
long term side effects
Should be restricted
for use when other
treatments have
failed
Restricted to patients
who have failed on
previous therapy
FIGURE 1: PERCEPTION OF A DRUG’S VALUE VARIES WIDELY BETWEEN MARKETS, RESULTING IN DIFFERENCES IN
ASSESSMENT OUTCOMES AND GUIDANCE
DRIVERS, PITFALLS AND A DEEPER UNDERSTANDING
The result of the analysis was a sizeable body of evidence
which provided an understanding of current trends in HTA
decisions and market access within and across markets. The
key drivers behind them were drawn out in each market with
respect to clinical and economic data, and countries
highlighted where HTA bodies posed a greater or lesser
challenge to new products in each therapeutic area.
By understanding previous decisions and drivers, the client
was able to identify potential pitfalls to be avoided in future
submissions and better understand the data requirements in
each market (eg, the need to present indirect cost data in
Sweden). Critically, this project was undertaken sufficiently
early in the drug development cycle for the client to benefit
from the insights provided by addressing potential data
gaps within the clinical trial program and other targeted
HEOR projects.
A CLEAR ADVANTAGE
TLV
(Sweden)
High unmet need,
even though costeffectiveness
has a high
level of uncertainty
Recommended for
inclusion for
conditional
reimbursement
Fully reimbursed as
label indication
(conditional – to be
reassessed when more
data is available)
The collection and synthesis of HTA information on an
international scale can be a great advantage to
pharmaceutical companies during their drug development
programs, providing both a better understanding of the
HTA environment and the opportunity to learn from
competitor failures and successes. •
AccessPoint - Issue 2 Page 43

IMS HEOR | OVERVIEW
The IMS Consulting Group offers a spectrum of world-class expertise in
HEOR to deliver the local excellence you need.
Realizing product value
• Insights and experience of more than 300 highlyqualified,
multi-disciplinary experts in Health Economics,
Outcomes Research and Pricing & Market Access
• Market expertise combined with local presence and a
relationship network of key healthcare decision makers
and opinion leaders worldwide
• Scientifically-sound, commercially-relevant solutions for
the entire product lifecycle
• Highly respected, world-leading skills in strategic
planning, evidence development and market access
• Experience in virtually all therapy areas with a
bibliography of over 2000 references
• Outstanding results with the world’s most comprehensive
pharmaceutical and medical information, analytics and
consulting resources
• Relied on and consulted by policy makers and regulatory
authorities globally
REALIZE
COMMUNICATE
DEMONSTRATE
DETERMINE
IMS HEOR brings unrivalled experience and specialist
expertise to help you determine, demonstrate, communicate
and realize product value.
Strategy
HEOR STRATEGY &
DETERMINING VALUE
Evidence
Development
DEMONSTRATING
VALUE
Communication
COMMUNICATING
VALUE
Our integrated approach – spanning world-leading skills in
strategy, evidence development and value communications –
is reflected in all of our work.
IMS HEOR ONLINE
Visit us online at www.imshealth.com/heor
IMS HEOR BIBLIOGRAPHY
Please ask us for a copy of our
current bibliography covering
publications from 2008-2011
or access the full online
catalog of more than 2000
references at
www.imsheorbibliography.com
Page 44 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

Global scope, local expertise
IMS HEOR office locations worldwide
LOCATIONS | IMS
IMS HEOR is located in 14 countries worldwide and has published on
projects completed in 40 countries on all continents.
IMS HEOR experts are located in key markets around the world.
YOUR PRIMARY CONTACTS:
Dr. Michael Nelson
Regional Leader Americas
Health Economics and Outcomes Research
IMS Health
1725 Duke Street, Suite 510
Alexandria, VA 22314
USA
Tel: +1 703.837.5150
Email: MNelson@us.imshealth.com
NORTH AMERICA
REGIONAL HEADQUARTERS
200 Campus Drive
Collegeville, PA 19426
USA
Tel: +1 610.244.2000
UNITED STATES
1725 Duke Street
Suite 510
Alexandria, VA 22314
USA
Tel: +1 703.837.5150
The Arsenal on the Charles
311 Arsenal Street
Watertown, MA 02472
USA
Tel: +1 800.783.6362
CANADA
303 Terry Fox Drive
Suite 300
Ottawa K2K 3J1, Ontario
Canada
Tel: +1 613.599.0711
EUROPE
REGIONAL HEADQUARTERS
7 Harewood Avenue
London NW1 6JB
United Kingdom
Tel: +44 (0) 20 3075 4800
BELGIUM
Medialaan 38
1800 Vilvoorde
Belgium
Tel: +32 2 627 3211
FRANCE
91 rue Jean Jaurès
92807 Puteaux cedex
France
Tel: +33 1 41 35 1000
GERMANY
Hefnersplatz 10
90402 Nürnberg
Germany
Tel: +49 911 24270 6300
Max-Lebsche-Platz 32
81377 München
Germany
Tel: +49 (0)89 45 79 126411
ITALY
Viale F. Restelli 1/A
20124 Milan
Italy
Tel: +39 02 69 786 1
Dr. Jacco Keja
Regional Leader EMEA
Health Economics and Outcomes Research
IMS Health
7 Harewood Avenue
London NW1 6JB,
UK
Telephone: +31 (0) 631 693 939
Email: JKeja@nl.imshealth.com
SPAIN
Dr Ferran, 25-27
08034 Barcelona
Spain
Tel: +34 93 749 63 00
SWEDEN
Sveavägen 155/Plan9
11346 Stockholm
Sweden
Tel: +46 8 508 842 00
SWITZERLAND
Theaterstr. 4
4051 Basle
Switzerland
Tel: +41 61 204 5071
UNITED KINGDOM
7 Harewood Avenue
London
NW1 6JB
United Kingdom
Tel: +44 (0)20 3075 4800
ASIA PACIFIC
REGIONAL HEADQUARTERS
10 Hoe Chiang Road
Keppel Towers #23-01/02
Singapore 089315
Tel: +65 6227 3006
AUSTRALIA
Level 5, Charter Grove
29 - 57 Christie Street
St Leonards, NSW 2065
Australia
Telephone: +61 2 9805 6800
CHINA
7/F Central Tower
China Overseas Plaza
Jianguomenwai Avenue,
Chaoyang District
Beijing 100001
China
Tel: +86 10 8567 4255
KOREA
9F Handok Building
735 Yeoksam1-dong
Kangnam-ku Seoul
135-755
S. Korea
Tel: +82 2 3459 7307
TAIWAN
8th Floor
No 2, Tun Hwa South Road
Section 1
Taipei 10506
Taiwan
ROC
Tel: +886 2 2721 5337
FOR FURTHER INFORMATION: email HEORinfo@uk.imshealth.com or visit www.imshealth.com/HEOR
AccessPoint - Issue 2 Page 45

armaceutical companies worldwide rely on LifeLink to drive patient-centered decisions – from the first explorator
IMS | EXPERTISE
Expertise in depth
We apply unrivalled experience and specialist
expertise to help our clients meet the demands of
an increasingly complex global, regional and local
pharmaceutical landscape.
IMS has one of the largest global teams of experts
in health economics, outcomes research, pricing
and market access of any organization in the
world. We have more than 300 highly-qualified
consultants and researchers with multi-disciplinary
experience and proven skills covering all key
therapy areas.
Our experts have extensive capabilities in a wide
range of health economic & outcomes research
disciplines in industry, consulting, government and
academia, with a global grasp, local experience,
and a unique, inside perspective of key market
access issues.
OUR SENIOR TEAM
The strength of our
ability to support
clients in
healthcare decision
making for
HEOR, pricing &
market access is
built on the
quality of our
global team.
Franck Amalric, PHD
• Dr. Franck Amalric is a Principal, Health Economics & Outcomes Research at the IMS Consulting Group
in France.
• Formerly Deputy Director of Human Sciences and Economics at the French National Cancer Institute,
Franck has extensive experience in the management and development of economic projects, gained
in roles as a Program Director at the Society for International Development (SID) in Rome, a Senior
Economist at UBS in Switzerland, and as Head of Research at the Center for Corporate Responsibility
and Sustainability.
• A graduate of the Ecole Polytechnique in France, Franck completed his training at the Ensaé
(National School of Statistics and Economic Administration) and holds a PhD in Economics from
Harvard University.
Xavier Badia, MD, MPH, PHD
• Dr. Xavier Badia is Global Leader Observational Outcomes Research, and Senior Principal HEOR at the
IMS Consulting Group in Spain.
• A founder of Health Outcomes Research Europe, Xavier has extensive experience in consulting and
research outcomes, patient-reported outcomes, and effectiveness and cost-effectiveness
evaluations. A respected scientific speaker and member of EuroQol since 1993, he serves on several
international advisory and editorial boards and has published over 150 peer-reviewed papers.
• Xavier holds an MD, a PhD in Medicine, and a Masters in Public Health and Health Economics from
the University of Barcelona.
Page 46 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

y questions that drive clinical development to tactical sales planning for mature brands.
EXPERTISE | IMS
Karin Berger, MBA
• Karin Berger is a Senior Scientific Consultant to IMS and previously Principal, Health Economics &
Outcomes Research, at IMS in Germany with a particular focus on outcomes research, patientreported
outcomes, and cost-effectiveness evaluation analyses at a national and international level.
• Formerly Managing Director of MERG (Medical Economics Research Group), an independent German
organization providing health economics services to the pharmaceutical industry, university
hospitals and European Commission, Karin has more than 14 years experience in the health
economics arena. She lectures at several universities, has published extensively in peer-reviewed
journals, and regularly presents at economic and medical conferences around the world.
• Karin graduated as Diplom-Kaufmann (German MBA equivalent) from the Bayreuth University,
Germany, with a special focus on health economics.
Nevzeta Bosnic, BA
• Nevzeta Bosnic is a Principal at IMS Brogan in Canada, where she manages projects to meet the
broad spectrum of client needs in the Canadian pharmaceutical market.
• Formerly Director of Economic Consulting at Brogan Inc, Nev has led many strategic consulting,
policy and data analyses for pharmaceutical clients, government bodies and academic institutions in
Canada. She has extensive knowledge of public and private drug plans across the country and
in-depth expertise and experience on the drug reimbursement process.
• Nev holds a Bachelors degree in Business Economics from the School of Economics and Business at
the University of Sarajevo, Bosnia-Herzegovina.
Joe Caputo, BSC
• Joe Caputo is a Principal, Health Economics & Outcomes Research at the IMS Consulting Group in
the U.K., leveraging more than 15 years experience in the pharmaceutical sector to help clients
address the challenges of global reimbursement and market access throughout the drug development
program. He has led numerous projects involving payer research, value dossiers, local market access
models and HTA submissions.
• With a background that spans industry roles in drug development, sales & marketing and UK &
global health outcomes, and consulting in health economics, Joe has wide-ranging knowledge of
the drug development process at both local and international level and a unique understanding of
evidence gaps in light of reimbursement and market access requirements.
• Joe holds a BSc in Applied Statistics and Operational Research from Sheffield Hallam University, UK.
Richard H. Chapman, PHD
• Dr. Rick Chapman is a Principal, Health Economics & Outcomes Research at the IMS Consulting
Group in the U.S., directing the design and analysis of economic evaluations and health
outcomes studies addressing a range of client issues.
• Formerly a Senior Director at ValueMedics Research, and Research Associate at the Center for Risk
Analysis, Rick has considerable experience in designing and conducting cost-effectiveness analyses,
and particular expertise in the methodological quality of health economic analyses, medication
adherence and patient-reported outcomes, including quality of life and patient preferences.
• Rick holds a PhD in Health Policy (Decision Sciences) from Harvard University and an MS in
Health Policy and Management from the Harvard School of Public Health.
Mandy Chui, MBA
• Mandy Chui is Regional Practice Leader, Pricing & Market Access at IMS in the Asia Pacific,
helping clients formulate growth strategies, optimize price and reimbursement, and address
issues in business model, sales force and marketing optimization.
• In a career spanning more than 15 years at IMS Health, including roles as Country Principal for
China and Director of Area Sales & Marketing in Singapore, Mandy has developed an exceptional
understanding of Asian market dynamics and an extensive network of major stakeholder
contacts in this rapidly evolving region. She has also authored various publications on China
and emerging markets.
• Mandy holds an honors degree in Biology from the University of Hong Kong and an MBA from
McGill University, Montreal.
AccessPoint - Issue 2 Page 47

IMS | EXPERTISE
Frank-Ulrich Fricke, PHD, MSC
• Dr. Frank-Ulrich Fricke is a Principal, Health Economics & Outcomes Research at the IMS Consulting
Group and Professor for Health Economics, Georg-Simon-Ohm University of Applied Sciences,
Nuremberg in Germany, with a focus on health economic evaluations, market access strategies and
health policy.
• Formerly a Managing Director of Fricke & Pirk GmbH, and previously Head of Health Economics at
Novartis Pharmaceuticals, Frank-Ulrich has conducted health economic evaluations across a wide
range of therapeutic areas, developing a wealth of experience in pricing, health affairs and health
policy. As a co-founder of the NIG 21 association, he has forged strong relationships with health
economists, physicians and related researchers working in the German healthcare system.
• Frank-Ulrich holds a PhD in Economics from the Bayreuth University, and an MBA equivalent from
the Christian-Albrechts-University, Kiel.
David Grant, MBA
• David Grant is a Senior Principal and Global Leader, Strategic & Applied Health Economics &
Outcomes Research, at the IMS Consulting Group in the U.K., specializing in reimbursement and
market access, environmental analysis, prospective and retrospective data collection and
communications for product support.
• A co-founder and former Director of Fourth Hurdle, David’s experience spans 10 years in health
economics and outcomes research consulting, and 15 years in the pharmaceutical industry, including
roles in clinical research, new product marketing and health economics in the U.K. and Japan.
• David holds a degree in Microbiology and an MBA from the London Business School.
Jacco Keja, PHD
• Dr. Jacco Keja is Regional Leader, EMEA, Health Economics & Outcomes Research, at the IMS
Consulting Group, drawing on deep expertise in global market access, operational and strategic
pricing, and health economics and outcomes research.
• Jacco’s background includes four years as global head of pricing, reimbursement, health outcomes
and market access consulting services at a large clinical research organization and more than
13 years experience in the pharmaceutical industry, including senior-level international and global
roles in strategic marketing, pricing and reimbursement and health economics.
• Jacco holds a PhD in Biology (Neurophysiology) from Vrije Universiteit in Amsterdam, a Masters in
Medical Biology, and an undergraduate degree in Biology, both from Utrecht. He is also visiting
Professor at the Institute of Health Policy & Management at Erasmus University, Rotterdam.
Mark Lamotte, MD
• Dr. Mark Lamotte is a Principal and Group Manager, Health Economics & Outcomes Research at
the IMS Consulting Group in Belgium with responsibility for the content and quality of all
health economic evaluations conducted by his team.
• A physician by training (cardiology), Mark spent a number of years in medical practice before
joining Rhône-Poulenc Rorer as Cardiovascular Medical Advisor and later becoming Scientific
Director at the Belgian research organization, HEDM. He has since worked on more than 150
projects, involving expert interviews, patient record reviews, extensive modeling and report
writing across a wide range of therapy areas, and authored many peer-reviewed publications.
• Mark holds an MD from the Free University of Brussels (Vrije Univeristeit Brussel, Belgium) and
is fluent in Dutch, French, English and Spanish.
Won Chan Lee, PHD
• Dr. Won Chan Lee is a Principal, Health Economics & Outcomes Research at the IMS Consulting
Group in the U.S., specializing in prospective and retrospective health economics research.
• Over the course of his career, Won has completed numerous international economic evaluations
employing a variety of analytical methods across a range of diseases and geographies. His expertise
includes econometric database analysis, quality of life assessment and advanced economic modeling
to establish the economic and humanistic value of new and existing therapeutic interventions.
• Won holds a Masters in Economics from the University of Grenoble II, and a PhD in Economics from
the Graduate Center of the City University of New York.
Page 48 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

EXPERTISE | IMS
Claude Le Pen, PHD
• Dr. Claude Le Pen is a member of the strategic committee of IMS France and Professor of Health
Economics at Paris-Dauphine University providing expert economic advisory services to the
consulting practice.
• A renowned economist, leading academic, and respected public commentator, Claude has served
as an appointed senior member of several state commissions in the French Ministry of Health and
is an expert for a number of parliamentary bodies, bringing a unique perspective and unparalleled
insights into the economic evaluation of pharmaceutical technologies at the highest level.
• Claude studied Business Administration in HEC Business School in Paris and holds a PhD in
Economics from Panthéon-Sorbonne University.
Adam Lloyd, MPHIL, BA
• Adam Lloyd is Global Leader Health Economic Modeling and Senior Principal, Health Economics &
Outcomes Research at the IMS Consulting Group in the U.K., where he leads the economic modeling
practice with a particular focus on economic analysis and the global application of economic tools to
support the needs of local markets.
• A former founder and Director of Fourth Hurdle, and previously Senior Manager of Global Health Outcomes
at GlaxoWellcome, Adam has extensive experience leading economic evaluations of pre-launched and
marketed products, developing submissions to NICE and the SMC, decision-analytic and Markov modeling,
and in the use of health economics in reimbursement and marketing in continental Europe.
• Adam holds an MPhil in Economics, and a BA (Hons) in Philosophy, Politics and Economics from the
University of Oxford.
Charles Makin, BSPharm, MS, MBA, MM
• Charles Makin is a Principal, Health Economics & Outcomes Research at the IMS Consulting
Group in the U.S. focusing on naturalistic trials, adherence interventions, chart abstractions,
patient-reported outcomes and other studies involving primary data collection.
• During a career that includes senior roles at the UnitedHealth Group and Wellpoint, Charles has
led numerous studies involving database analyses, economic modeling, multi-country patient
registries, systematic literature reviews and survey-based research.
• Charles holds a BS in Pharmacy from the University of Pune, India, an MS in Pharmacy
Administration from Purdue University, Indiana, U.S. and an MBA in Marketing Management and
a Master in Management, both from Goldey Beacom College, Delaware, U.S.
Eva Marchese, PHD
• Dr. Eva Marchese is a Principal, Pricing & Market Access at the IMS Consulting Group in Italy,
with a particular focus on market access, regulatory, pharmacovigilance, pricing and
reimbursement, and health economics and outcomes research.
• An experienced consultant and founding partner of S&M Consulting, Eva has been involved in
several ministerial committees at the Italian Ministry of Health, looking at cost evaluation and
analysis of day surgery procedures. She was previously Professor of Public Management and
Policy at Bocconi-SDA, the foremost Italian Business School, and a contracted Research Fellow
at the Centre for Research on Healthcare and Social Management at Bocconi University.
• Eva holds a PhD in Public Management from the Parma State University, and a degree in
Business Administration from Bocconi University in Milan.
Frédérique Maurel, MS, MPH
• Frédérique Maurel is a Principal, Health Economics & Outcomes Research at the IMS Consulting
Group in France, with a particular focus on observational research and health economics studies.
• A skilled consultant and project manager, Frédérique has extensive experience in the economic
evaluation of medical technologies gained in roles at ANDEM, Medicoeconomie, and AREMIS Consultants.
• Frédérique holds a Masters degree in Economics – equivalent to an MS – and completed a postgraduate
degree equivalent to an MPH with a specialization in Health Economics at the University
of Paris-Dauphine (Paris IX) as well as a degree in Industrial Strategies at the Pantheon-Sorbonne
University (Paris I).
AccessPoint - Issue 2 Page 49

IMS | EXPERTISE
Joan McCormick, MBA
• Joan McCormick is a Principal at IMS Brogan in Canada, leading a team providing strategic
advice to companies with new products coming to market and ongoing consultation on the
rules for existing drugs post launch.
• Formerly Head of Price Regulation Consulting at Brogan Inc, Joan has supported many major
pharmaceutical companies with the preparation of pricing submissions to the Patented
Medicine Prices Review Board (PMPRB), gaining extensive insights into the operation of the
Canadian pharmaceutical market.
• Joan holds a Bachelors degree in Life Sciences from Queen’s University in Kingston, Canada,
and an MBA from the University of Ottawa, Canada.
Dana Morlet-Vigier, MD
• Dana Morlet-Vigier is a Principal and Team Leader, Health Economics & Outcomes Research at the
IMS Consulting Group in France, applying in-depth expertise and extensive experience in
pharmaceutical pricing, reimbursement and market access to help clients meet the growing
challenges of today’s increasingly complex product launch process.
• A medical doctor and INSEAD executive, Dana’s background spans 15 years in pharmaceuticals and
includes roles in R&D, commercial, market access, strategy and government affairs at
GlaxoSmithKline, Organon and 3M Pharma. She has worked on numerous pricing and reimbursement
negotiations and designed and implemented national and international Phase II, III and IV studies
across a wide range of therapy areas.
• Dana holds an MD from Bucharest Medical University, Romania and the Paris-Cochin Faculty, Paris, France.
Juliet Munakata, MS
• Juliet Munakata is a Principal, Health Economics & Outcomes Research at the IMS Consulting Group
in the U.S., with a particular focus on global economic modeling, value development planning, and
survey data analysis.
• An accomplished researcher and author of more than 25 original articles, Juliet has extensive
experience in managing clinical trials, health economic studies and decision analytic modeling work,
gained in senior roles at ValueMedics Research LLC, the VA Health Economics Resource Center and
Stanford Center for Primary Care & Outcomes Research, and Wyeth Pharmaceuticals.
• Juliet holds an MS in Health Policy and Management from the Harvard School of Public Health and a
BS in Psychobiology from the University of California, Los Angeles.
Karl-Johan Myrén, MSC
• Karl-Johan (Kalle) Myrén is a Principal, Health Economics & Outcomes Research at the
IMS Consulting Group, with responsibility for the Nordic region. He has extensive expertise in
global and affiliate pricing, market access, reimbursement and health economics and a deep
understanding of many different national healthcare systems.
• Karl-Johan’s career spans more than 13 years experience in global health economics gained in
roles at the Swedish Institute of Health Services Development, Astra Zeneca and Eli Lilly,
latterly as Senior Area Health Economist coordinating and managing health economic activities
for the European middle-sized (EMS) countries, including the Nordic markets, Belgium,
Switzerland, the Netherlands and Portugal.
• Karl-Johan holds an MSc in Economics and a BSc in Mathematics from the University of Stockholm.
Michael Nelson, PHARM D
• Dr. Michael Nelson is Regional Leader, Americas, Health Economics & Outcomes Research at the
IMS Consulting Group in the U.S., with particular expertise in retrospective database research,
prospective observational research, health program evaluation, and cost-effectiveness analysis.
• During a career that includes leadership roles in HEOR at PharmaNet, i3 Innovus, SmithKline
Beecham, and DPS/UnitedHealth Group, Mike has gained extensive experience in health
information-based product development, formulary design, drug use evaluation, and disease
management program design and implementation.
• A thought leader in health economics for more than 20 years, Mike holds a doctorate in Pharmacy
and a Bachelor of Science degree, both from the University of Minnesota College of Pharmacy. He
also served as an adjunct clinical faculty member at the University of Minnesota whilst in clinical
pharmacy practice.
Page 50 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

EXPERTISE | IMS
Tini Nguyen, PHARM D
• Dr. Tini Nguyen is Regional Principal, Health Economics & Outcomes Research at the IMS Consulting
Group in France.
• Previously European Market Access Director at Sanofi-Aventis in Paris, Tini has more than 15 years
experience in the global pharmaceutical industry, including 7 years in senior roles focusing on
health economics, health outcomes, pharmacoeconomics and market access in the Asia Pacific,
Russia, Latin America, Middle East and Africa.
• Tini holds a diploma in Health Economics for Healthcare Professionals from the University of York, and a
diploma in Marketing and a doctorate in Pharmaceutical Sciences from the Université René Descartes in Paris.
Olaf Pirk, MD, PHD
• Dr. Olaf Pirk is a Principal, Health Economics & Outcomes Research at the IMS Consulting Group in
Germany, with a particular focus on health technology assessment, healthcare system research,
health policy and health economic modeling across a range of countries and therapeutic areas.
• Formerly a Managing Director of Fricke & Pirk GmbH, Olaf has considerable pharmaceutical
industry experience gained in roles within health economics, pricing, health policy, marketing
and clinical research. As a co-founder of the NIG 21 association, he has forged strong
relationships with health economists, physicians and related researchers working in the German
healthcare system.
• Olaf holds an MD and PhD in Medicines from the Medical University of Lübeck.
Jon Resnick, MBA
• Jon Resnick is Vice President and Global Leader Health Economics & Outcomes Research at the
IMS Consulting Group, advising pharmaceutical and biotech companies on a wide range of strategic,
pricing and reimbursement issues.
• A former Legislative Research Assistant in Washington DC and member of the Professional Health
and Social Security staff for the U.S. Senate Committee on Finance, Jon combines public policy
and industry expertise to provide a unique grasp of the healthcare market place. He has
co-authored several major U.S. healthcare initiatives, including proposals to reform managed care.
• Jon holds an MBA from the Kellogg School of Management, Northwestern University, where he
majored in Management and Strategy, Finance, Health Industry Management, and Biotechnology.
Javier Sabater, MPHARM, MHE
• Javier Sabater is a Principal, Health Economics & Outcomes Research at the IMS Consulting Group in
Spain, where he leads a wide range of projects across many therapy areas for major international
pharmaceutical companies, healthcare providers and national policy institutions.
• A pharmacist by training, Javier has considerable industry experience in clinical research, medical
information, health economics, market access and outcomes research gained in roles at GlaxoSmithKline,
Roche and Schering-Plough. He has co-authored a number of publications and abstracts in HEOR.
• Javier holds a Bachelors degree in Pharmacy, a Masters in Health Economics and has completed a
post-graduate course in Pharmaceutical Marketing.
Vernon Schabert, PHD
• Dr. Vernon Schabert is a Senior Principal and Global Leader Retrospective Outcomes Research at
the IMS Consulting Group in the U.S., leading the assessment and validation of patientreported
outcomes (PRO) instruments, retrospective analyses of claims and survey databases,
and primary data collection surveys.
• A founder and former President of Integral Health Decisions, Inc, Vernon has extensive
experience in conducting claims analyses, creating custom administrative databases,
developing business intelligence software, and leading national quality research projects,
gained in roles with Thomson Reuters, Strategic Healthcare Programs LLC, and CIGNA
HealthCare. His expertise spans numerous disease areas and diverse topics including medication
adherence, in-patient safety and outcomes in post-acute care.
• Vernon holds a PhD in Personality and Social Psychology from Stanford University and a BA in
Psychology from Princeton University.
AccessPoint - Issue 2 Page 51

e best results were seen from adherence programs involving medical professional to patient contact on a
gular basis.
IMS | EXPERTISE
Núria Lara Surinach, MD, MSC
• Dr. Núria Lara is a Principal, Health Economics and Outcomes Research at the IMS Consulting Group
in Spain, where she leads the Outcomes Research group in the design and coordination of local and
international observational and patient-reported outcomes studies.
• A former practicing GP and clinical researcher, Núria’s experience spans roles in outcomes research
at the Institute of Public Health in Barcelona and in Catalan Health Authorities, and consulting
positions within the pharmaceutical and medical device industries focusing on medical regulatory
and pricing affairs, pharmacoeconomics and market access strategies.
• Núria holds an MD (specializing in Family and Community Medicine in Barcelona), and a Masters in
Public Health from the London School of Hygiene and Tropical Medicine and London School of Economics.
Jonothan Tierce, CPHIL
• Jonothan Tierce is a Senior Scientific Consultant to IMS in the U.S., and former global leader of
the IMS HEOR practice, supporting the industry’s growing need for real-world evidence of the
clinical and economic value of new technologies in advancing health.
• A pioneer in applied pharmacoeconomics and value strategy development, and co-founder of
ValueMedics Research LLC, Jonothan has nearly 25 years experience in health economics,
working with clients to identify customized strategies and tactics for product access, value
propositions and evidence-based demonstrations of value.
• Jonothan holds a C Phil, MA, and BA in Political Science from the University of California in Los
Angeles. He also received two years of post-graduate training in econometrics and experimental design.
Meng Zhang, MBA
• Meng Zhang is a Principal, Pricing & Market Access at IMS in China, applying evidence-based
analytics to help clients address key business issues in global pricing, product launch readiness,
market opportunity assessment and product portfolio optimization.
• During the course of his career in the U.S. and China, Meng has developed extensive expertise
in pricing and reimbursement, new market entry, competitive analysis and corporate strategic
planning, in consulting roles at SDI Health and Accenture, business development at J&J, and
as a professional representative at Xian-Janssen Pharmaceutical Ltd in China.
• Meng holds a degree in Biology from Nanjing University, a Masters in Biochemistry from the
University of New Brunswick, Montreal and an MBA from the Wharton School of the University
of Pennsylvania, with a major in Healthcare Management.
Page 52 IMS HEALTH ECONOMICS & OUTCOMES RESEARCH

IMS | LIFELINK
Pharmaceutical companies worldwide rely on IMS LifeLink TM
to drive
patient-centered decisions – from clinical development to mature brands.
Powering a patient perspective
Your business models have changed. So have the metrics that
keep the healthcare industry moving forward. Today, a patient
perspective is a must.
Through the global IMS LifeLink program, we provide a
powerful patient lens to drive focus and alignment across
your business, deepening your understanding of critical
patient, physician and payer dynamics. LifeLink allows you
to identify the right patient segments early on, in order to
gain competitive advantage in today’s complex environment.
We make a patient-centered perspective simple – by
integrating patient-level intelligence into our industryleading
offerings and giving you expert consultants who
apply it to your key issues.
IMS LifeLink provides insights of primary research with the
benefits of secondary – lower cost, repeatable, faster and a
larger sample size.
IMS LifeLink has everything you need to succeed in a
patient-centered universe.
CANADA
• Longitudinal Rx
• Health Plan Claims
Database
•Longitudinal drug
utilization data
(Oncology, hospital)
UNITED STATES
• Longitudinal Rx
• Health Plan Claims
Database
• Oncology Analyzer
POWERING A PATIENT PERSPECTIVE
We make a patient perspective easy, with familiar tools,
integration into our industry-leading offerings and expert
consultants who apply patient insights to your business issues.
A PARTNER YOU CAN TRUST
Pharmaceutical companies worldwide rely on LifeLink to drive
patient-centered decisions – from the first exploratory
questions that drive clinical development to tactical sales
planning for mature brands. They are recognizing significant
benefits, such as:
• Better global decision making through consistent insights
across all brands and across the product lifecycle
• Improved internal alignment with consistent patient
segments defined across research & development and
commercial functions
• Enhanced communication with healthcare payers and
other stakeholders with the use of a consistent patient
view and common language
• Faster and more accurate views across three key
dimensions: patients, payers and prescribers
• Confidence working with a partner who is committed to
driving new metrics for new business models
AN UNPARALLELED ARRAY OF ANONYMIZED PATIENT-LEVEL DATA WORLDWIDE
EUROPE
• Longitudinal Rx
(Germany, UK, Netherlands and Belgium)
• Anonymized Patient-Level Data
from Electronic Medical Records
(France, Germany, Italy, UK)
• Oncology Analyzer
(France, Germany, Netherlands, Italy,
Spain, Turkey, UK)
• Stroke Database
(France, Germany, Italy, Spain, UK)
• Hospital Disease Database
(Belgium)
• Longitudinal Patient Database
(Sweden)
ASIA
• Oncology Analyzer
(China, Japan, Korea, Taiwan)
• Longitudinal Rx
(Japan)
AUSTRALIA
• Longitudinal Rx
IMS has made extensive investments in anonymized patient-level data in markets around the world.
Today, we capture information for more than 260 million patient lives – for unparalleled treatment insights.
AccessPoint - Issue 2 Page 53

IMS helps you realize
the potential of
your products
Maximizing market access
demands the best scientific evidence
and the right commercial awareness to deliver the insights you need.
The IMS Consulting Group has built a global team of more than 300 experts in Health
Economics & Outcomes Research and Pricing & Market Access – with publication and project
experience in more than 40 countries across all continents.
We combine rigorous scientific research – evidenced by nearly 200 publications
each year – with commercially-focused consulting to help you determine, demonstrate,
communicate and realize product value.
Our HEOR experts leverage unparalleled claims, medical, hospital and patient-centered
pharmaceutical databases to create an Evidence-Based ConsultingSM powerhouse.
So the next time you think about product value, think about us.
MORE INFORMATION
For additional information on the IMS Consulting Group and our HEOR expertise and offerings,
please email HEORinfo@uk.imshealth.com or visit: www.imshealth.com/HEOR
IMS HEOR EXPERTS ARE LOCATED IN MANY COUNTRIES AROUND THE WORLD WITH PRINCIPAL OFFICES IN:
UNITED STATES 1725 Duke Street, Suite 510, Alexandria, VA 22314, USA • Tel: +1 (703) 837-5150
UNITED KINGDOM 7 Harewood Avenue, London NW1 6JB, United Kingdom • Tel: +44 20 3075 4800
ASIA PACIFIC 7/F Central Tower, China Overseas Plaza, Jianguomenwai Avenue, Chaoyang District, Beijing 100001, China
• Tel: +86 10 8567 4255
©2011 IMS Health Incorporated or its affiliates. All Rights Reserved.