HEOR AccessPoint Report - IMS Health
HEOR AccessPoint Report - IMS Health
HEOR AccessPoint Report - IMS Health
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ACCESSPOINT<br />
<strong>IMS</strong> HEALTH ECONOMICS & OUTCOMES RESEARCH<br />
Running the risk<br />
Managing risk/reward ratio<br />
under intense public scrutiny<br />
Decisive period for pharma<br />
2011 outlook highlights importance of <strong>HEOR</strong><br />
Volume 1, Issue 1<br />
NOVEMBER 2010<br />
Launch issue<br />
News, views and<br />
insights from<br />
leading experts<br />
in <strong>HEOR</strong><br />
Optimizing market access<br />
in a decentralized environment<br />
Mike Nelson on the<br />
Jacco Keja on the<br />
John Tierce reports<br />
many different payers<br />
need for more<br />
on the new pressures<br />
Page OUTCOMES 1 - Issue<br />
with many<br />
1<br />
different<br />
needs in the U.S.<br />
specialized <strong>IMS</strong> market HEALTH ECONOMICS AND OUTCOMES from RESEARCH expanding Page 1CER<br />
positions in Europe<br />
Page 32<br />
Page 12<br />
Page 15
ACCESSPOINT<br />
<strong>IMS</strong> HEALTH ECONOMICS & OUTCOMES RESEARCH<br />
Leap-frogging to value<br />
in the Asia Pacific<br />
The <strong>IMS</strong> Symposium at ISPOR Asia Pacific<br />
Conference considers potential to define a<br />
uniquely Asian model of healthcare delivery<br />
page 24<br />
Optimizing access in a<br />
decentralized European market<br />
John Resnick explores contradictory trends of<br />
convergence and divergence in Europe<br />
page 28<br />
News, views and insights<br />
from leading experts in <strong>HEOR</strong><br />
Outlook 2011<br />
Murray Aitken looks at the priorities<br />
for pharma companies competing in<br />
a challenging landscape - and the<br />
implications for <strong>HEOR</strong><br />
page 8<br />
The transatlantic constant<br />
of change<br />
The complex dynamics and reforms<br />
impacting <strong>HEOR</strong> and market access<br />
in the U.S. and Europe<br />
page 12<br />
The move to HTA in<br />
Central & Eastern Europe<br />
With a focus on Russia, Romania and<br />
Ukraine, we consider the growing need for<br />
evidence-based decision support in CEE<br />
page 18
edit<br />
Welcome to the launch issue of ACCESSPOINT, our<br />
twice-yearly update of news, views and insights from<br />
<strong>IMS</strong> <strong>Health</strong> Economics and Outcomes Research - a new<br />
opportunity to learn about our latest developments,<br />
meet members of our global team of experts, and find a<br />
stimulating perspective on the key trends and changes that are<br />
reshaping the pharmaceutical landscape.<br />
These are challenging, exciting and also potentially very<br />
rewarding times in the healthcare arena. We see decision makers<br />
continuing to wrestle with the need to balance cost and<br />
demand for new innovations, payers everywhere strengthening<br />
their efforts to limit further growth in expenditure, and much<br />
closer scrutiny of pharmaceutical products raising the risks for<br />
drug development. At the same time, we see new dynamic<br />
markets rising to the fore in Eastern Europe and the Asia<br />
Pacific, ripe with potential for healthcare improvement, already<br />
struggling to manage escalating costs, but opening up significant<br />
opportunities to participate in their continued expansion.<br />
As we look ahead through 2011, with reforms playing out in<br />
major markets and manufacturers intensifying their focus on<br />
demonstrating the value of their medicines, one thing is clear:<br />
rigorous, robust health economics and outcomes research will<br />
be essential to ensuring that all key stakeholders are equipped<br />
with the relevant, real-world evidence they need to meet the<br />
challenges, priorities and new opportunities for growth.<br />
<strong>IMS</strong> draws on the experience and knowledge of more than 300<br />
specialists in pricing, market access and health economics and<br />
outcomes research to enable more effective decision making<br />
based on the best available information and analytical<br />
approaches. We hope you find our insights in this first issue of<br />
ACCESSPOINT informative and helpful in providing some<br />
pointers to the way ahead.<br />
Finally, I would like to thank our guest contributor, Murray<br />
Aitken, Senior VP, at <strong>IMS</strong> for his insightful market outlook for<br />
2011 (page 8), and take this opportunity to introduce our two<br />
new <strong>HEOR</strong> Regional Leaders, Dr Michael Nelson in the U.S.<br />
and Dr Jacco Keja in Europe, who bring a wealth of industry<br />
and consulting expertise to lead our teams on both sides of the<br />
Atlantic and offer their take on the critical trends in their region<br />
(page 12).<br />
Gordon Carey<br />
VICE PRESIDENT, GLOBAL LEADER<br />
PRICING & MARKET ACCESS PRACTICE, <strong>IMS</strong> HEALTH<br />
GCarey@imshealth.com<br />
“These are challenging, exciting and<br />
also potentially very rewarding times in the healthcare arena”<br />
WELCOME CONTENTS<br />
NEWS SECTION<br />
2 Informing decisions in key therapy areas<br />
3 Brogan brings new capabilities in Canada<br />
5 Counting the cost in Central & Eastern Europe<br />
6 <strong>IMS</strong> CORE Diabetes Model rises to challenge<br />
INSIGHTS<br />
8 OUTLOOK AND TRENDS 2011<br />
Positioning for future market share<br />
12 REGIONAL REVIEW<br />
Tides of change in U.S. and Europe<br />
18 EMERGING MARKETS:<br />
Central & Eastern Europe (CEE)<br />
19 Moves to HTA<br />
23 Regional experts<br />
25 <strong>IMS</strong> ISPOR SYMPOSIUM<br />
Challenges and opportunities in Asia Pacific<br />
28 MARKET ACCESS<br />
Optimizing access in decentralized Europe<br />
32 RISK EVALUATION<br />
Shifting risk/reward ratio<br />
36 OBSERVATIONAL RESEARCH<br />
Growing role in value demonstrations<br />
PROJECT FOCUS<br />
40 INFLUENZA<br />
Informing the interests of public health<br />
42 DIABETES<br />
Demonstrating cost-effectiveness in China<br />
<strong>IMS</strong> OVERVIEW<br />
44 <strong>IMS</strong> <strong>HEOR</strong><br />
45 Office locations<br />
46 Our senior experts<br />
52 <strong>IMS</strong> Lifelink TM : Longitudinal patient data<br />
<strong>AccessPoint</strong> is published twice yearly by the <strong>Health</strong><br />
Economics and Outcomes Research team of <strong>IMS</strong> <strong>Health</strong>.<br />
ISSUE 1. PUBLISHED NOVEMBER 2010.<br />
<strong>IMS</strong> HEALTH® 7 Harewood Avenue, London NW1 6JB, UK<br />
Tel: +44 (0)20 3075 4800 • <strong>HEOR</strong>Info@uk.imshealth.com<br />
• www.imshealth.com<br />
©2010 <strong>IMS</strong> <strong>Health</strong> Incorporated or its affiliates.<br />
All Rights Reserved.<br />
<strong>AccessPoint</strong> - Issue 1 Page 1
NEWS | PUBLICATIONS<br />
<strong>IMS</strong> <strong>HEOR</strong> has experience in all key therapy areas with a bibliography<br />
of more than 2000 publications.<br />
Informing decision making<br />
50<br />
40<br />
30<br />
20<br />
10<br />
0<br />
Diabetes<br />
Cardiovascular<br />
Oncology<br />
Mental <strong>Health</strong><br />
Dermatology<br />
Gastrointestinal Disorders<br />
<strong>Health</strong> Economics Strategy<br />
We have published nearly 200 papers every year<br />
Neurological Disorders<br />
Rheumatology<br />
in the last decade employing, a wide range<br />
Ophthalmology<br />
Respiratory Diseases<br />
Hematology<br />
Womens <strong>Health</strong><br />
of health economic analyses<br />
Page 2 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH<br />
Nephrology<br />
Immunology<br />
Compliance<br />
Musculoskeletal Disease<br />
Endocrinology<br />
Overactive Bladder<br />
These are some examples of our recent publications in selected therapy classes.<br />
CARDIOVASCULAR DISEASE<br />
Relation of the first<br />
hypertension-associated event<br />
with medication compliance<br />
and persistence in naive<br />
hypertensive patients after<br />
initiating monotherapy<br />
Int J Clin Pharmacol Ther,<br />
2010; 48(3):S173-183<br />
Mathes J, Kostev K,<br />
Gabriel A, et al.<br />
DIABETES, ONCOLOGY<br />
Cancer incidence for insulindependent<br />
diabetics in<br />
Germany: An analysis of the<br />
publication of Hemkens et al.<br />
based on the STROBE criteria<br />
(in German)<br />
Perfusion, 2010; 23:4-10<br />
Fuchs S, Fricke F-U,<br />
Pirk O<br />
ONCOLOGY<br />
Cost-effectiveness analysis of<br />
pemetrexed versus docetaxel<br />
in the second-line treatment<br />
of non-small cell lung cancer<br />
in Spain: Results for the nonsquamous<br />
histology population<br />
BMC Cancer, 2010; 10(1):26 E-pub<br />
Asukai Y,<br />
Valladares A,<br />
Camps C, et al.<br />
CARDIOVASCULAR DISEASE<br />
The cost and effectiveness<br />
of adherence-improving<br />
interventions for<br />
antihypertensive and<br />
lipid-lowering drugs<br />
Int J Clin Pract, 2010;<br />
64(2):169-81<br />
Chapman RH,<br />
Ferrufino CP,<br />
Kowal S, et al.<br />
HEMATOLOGY<br />
Treatment cost of hemophilia<br />
patients with inhibitors in the<br />
National <strong>Health</strong> System in<br />
Morocco<br />
Espérance Méd, 2010; 17:101-7<br />
El Khorassani M,<br />
Hadjkhalifa H,<br />
By Z, et al.<br />
ONCOLOGY<br />
Pegfilgrastim vs filgrastim in<br />
primary prophylaxis of febrile<br />
neutropenia in patients with<br />
breast cancer after chemotherapy:<br />
A cost-effectiveness analysis<br />
for Germany (in German)<br />
Deutsche Med Woch, 2010;<br />
135(9): 385-9<br />
Sehouli J, Goertz A,<br />
Steinle T, et al.<br />
DERMATOLOGY<br />
A retrospective cohort study<br />
of the impact of biologic<br />
therapy initiation on medical<br />
resource use and costs in<br />
patients with moderate to<br />
severe psoriasis<br />
Br J Dermatol, 2010;<br />
163(4):807-16<br />
Fonia A, Jackson K,<br />
LeReun C, et al.<br />
MENTAL HEALTH<br />
Mental health care reforms in<br />
Europe: Rehabilitation and<br />
social inclusion of people with<br />
mental illness in Russia<br />
Psychiatr Serv, 2010; 61(3):<br />
222-24<br />
Jenkins R, McDaid D,<br />
Nikiforov A, et al.<br />
TRANSPLANT<br />
Cost-effectiveness of<br />
immunosuppressive regimens<br />
in renal transplant recipients<br />
in Germany: A model approach<br />
Eur J <strong>Health</strong> Economics, 2010;<br />
11(1):15-25<br />
Juergensen JS,<br />
Arns W, Haß B<br />
<strong>Health</strong> Policy<br />
Pediatrics<br />
Transplant<br />
DIABETES<br />
A meta-analysis of placebocontrolled<br />
clinical trials<br />
assessing the efficacy and<br />
safety of incretin-based<br />
medications in patients with<br />
type 2 diabetes<br />
Pharmacology, 2010;<br />
86(1):44-57<br />
Fakhoury WKH,<br />
LeReun C,<br />
Wright D<br />
NEUROLOGY<br />
Atomoxetine's effect on<br />
societal costs in Sweden<br />
J Attention Disorder, 2010;<br />
13(6): 618-28<br />
Myrén KJ, Thernlund G,<br />
Nylén A, et al.<br />
UROLOGY<br />
Mirror questionnaire.<br />
Satisfaction value in<br />
ostomized patients with the<br />
health care and dispositive<br />
Revista Rol de Enfermeria<br />
2010; 33(5): 328-337<br />
Arias Alvarez M, Fernandez-<br />
García M.A.,<br />
Gonzalez-Buenadicha AM,<br />
et al.
CANADA | NEWS<br />
<strong>IMS</strong> has one of the largest international <strong>HEOR</strong> expert teams in the market.<br />
We now add new core competencies in Canada.<br />
Brogan union brings new capabilities<br />
in Canada<br />
<strong>IMS</strong> has established a strong platform to support the growing<br />
need for real-world evidence of the clinical and economic value<br />
of medical technologies. Further strengthening our capabilities<br />
in key markets, in July 2010 we merged our Canadian<br />
operations with Brogan Inc., a pioneering healthcare market<br />
research and consulting firm, based in Ottawa.<br />
The move has brought together Brogan’s core offerings in drug claims<br />
analysis, market access, health economic analysis, and strategic pricing in<br />
Canada, with <strong>IMS</strong>’ global medical and pharmaceutical information assets,<br />
analytics and consulting capabilities. For our clients, this brings access to<br />
real-world, evidence-based pharmacoeconomic analyses in Canada<br />
supported by the largest drugs claims database in the country to fulfill<br />
critical requirements for drug submissions, develop effective pricing and<br />
market access strategies for expedited formulary listing, and demonstrate<br />
the effectiveness and efficiency of drugs in real-life clinical practice.<br />
It is a pleasure to welcome our Brogan colleagues on board!<br />
LONG HISTORY OF PIONEERING EXCELLENCE<br />
Brogan Inc. has provided government and private sector clients in Canada<br />
with research and consulting services for more than 20 years and is<br />
recognized for the depth, quality and the objectivity of its analyses. The<br />
company's team of economists, researchers and clinical professionals have<br />
spearheaded the development of budget impact analysis (BIA) modeling,<br />
which is now an essential requirement of provincial formularies.<br />
A pioneer of drug claims analysis, Brogan was among the first companies<br />
to amalgamate data from multiple insurers to provide valuable insights into<br />
pharmaceutical utilization behavior in Canada. This has since evolved into<br />
the largest drug claims database in the country, providing services to<br />
governments, payers, and a broad cross-section of pharmaceutical<br />
companies.<br />
<strong>IMS</strong> BROGAN: FROM HEALTH ECONOMICS TO PRICING CONSULTING<br />
<strong>IMS</strong> Brogan services span health economics, market, patient and policy<br />
analysis and pricing and regulatory consulting. We harness costeffectiveness<br />
and cost-benefit modeling, longitudinal data reports,<br />
physician-level data reports, market access data and provincial and private<br />
drug plan data to deliver comprehensive economic analyses at all stages<br />
of the product lifecycle. Our extensive price regulatory consulting<br />
capabilities include price and risk management analysis, pricing strategies<br />
for new patented drugs, compliance monitoring and forecasting,<br />
submissions and data filing and training sessions on the operation and<br />
regulation of the federal drug price review agency, the Patented Medicine<br />
Prices Review Board (PMPRB).<br />
Delivering real-world,<br />
evidence-based<br />
pharmacoeconomic<br />
analyses supported by<br />
the largest drug claims<br />
database in Canada<br />
Meet the <strong>IMS</strong> Brogan<br />
team leaders<br />
See overleaf...<br />
<strong>AccessPoint</strong> - Issue 1 Page 3
NEWS | CANADA<br />
...continued from previous page<br />
The talented <strong>IMS</strong> Brogan team of expert researchers and consultants is<br />
headed by Joan McCormick (Price Regulation Consulting) and Nevzeta<br />
Bosnic (Economic Consulting).<br />
JOAN McCORMICK, MBA<br />
Joan McCormick is Principal Consultant, Price Regulation Consulting at <strong>IMS</strong> Brogan,<br />
with particular expertise in the strategic pricing of new pharmaceutical technologies.<br />
In her role as head of the Price Regulation Consulting Team she has supported many<br />
major pharmaceutical companies with the preparation of pricing submissions to the<br />
Patented Medicine Prices Review Board (PMPRB), gaining extensive insights into the<br />
operation of the Canadian pharmaceutical market. Joan holds a Bachelors degree in<br />
Life Sciences from Queen’s University in Kingston and an MBA from the University of<br />
Ottawa. Email: JMcCormick@ca.imsbrogan.com<br />
NEVZETA BOSNIC, BA<br />
Nev Bosnic is Director, Economic Consulting at <strong>IMS</strong> Brogan with responsibility for<br />
managing the company’s team of expert health economists in meeting the broad<br />
spectrum of client needs in the Canadian pharmaceutical market. She has extensive<br />
knowledge of public and private drug plans across Canada and in-depth expertise on<br />
the drug reimbursement process. Over the course of more than nine years with the<br />
company, Nevzeta has led many strategic consulting, policy and data analyses for<br />
pharmaceutical clients, government and academic institutions across the country. She<br />
holds a Bachelors degree in Business Economics from the School of Economics and<br />
Business at the University of Sarajevo. Email: NBosnic@ca.imsbrogan.com •<br />
<strong>IMS</strong> BROGAN SERVICES SPAN HEALTH ECONOMICS, MARKET,<br />
PATIENT AND POLICY ANALYSIS AND PRICING AND REGULATORY CONSULTING.<br />
HEALTH ECONOMICS<br />
MARKET ANALYSIS<br />
STRATEGIC CONSULTING<br />
LONGITUDINAL PATIENT ANALYSIS<br />
POLICY ANALYSIS<br />
DRUG UTILIZATION FORECASTS<br />
PRICING, REGULATORY CONSULTING<br />
<strong>IMS</strong> Brogan team leaders<br />
Price Evaluation; Budget Impact Analysis<br />
Market Assessment; Payer Segmentation<br />
Pricing and Market Access<br />
Drug Utilization Analysis<br />
Impact of policy and regulatory changes<br />
Drug forecasts; Cost driver analysis<br />
Advice on rules and submissions to PMPRB<br />
Shared goal In CEE markets, a growing need for evidence-based decision<br />
support is opening up new opportunities for health<br />
economics and outcomes research - see page 18.<br />
Page 4 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
PROJECTS | NEWS<br />
<strong>HEOR</strong> is becoming increasingly important in the emerging markets of CEE<br />
including the Czech Republic, Hungary, Poland and Russia.<br />
Counting the cost<br />
in Central and Eastern Europe (CEE)<br />
<strong>IMS</strong> <strong>HEOR</strong> experts in CEE markets employ a wide range of research methodologies, including costeffectiveness,<br />
cost utility and budget impact modeling and prospective observational techniques, to support<br />
customer needs in markets throughout the CEE region in a range of therapy areas.<br />
A cross-section of our recently completed or ongoing studies is shown below.<br />
Country Disease Area Project Type<br />
BULGARIA NEUROLOGICAL DISORDERS Patient-reported outcomes<br />
CZECH<br />
REPUBLIC<br />
CARDIOVASCULAR<br />
DIABETES<br />
INFECTIOUS DISEASE<br />
NEUROLOGICAL DISORDERS<br />
ONCOLOGY<br />
Cost-effectiveness, cost utility, budget impact: NCE<br />
Cost utility and budget impact: NCE<br />
Value for money: Novel therapy<br />
Cost-effectiveness: New pediatric vaccine, extended coverage<br />
Patient-reported outcomes<br />
Budget impact: NCE<br />
Cost-effectiveness: Novel therapy, expanded indication<br />
ESTONIA CARDIOVASCULAR Cost-effectiveness, cost utility, budget impact: NCE<br />
HUNGARY<br />
CARDIOVASCULAR<br />
CNS<br />
DIABETES<br />
INFECTIOUS DISEASE<br />
NEUROLOGICAL DISORDERS<br />
ONCOLOGY<br />
Cost-effectiveness, cost utility, budget impact: NCE<br />
Cost-effectiveness, budget impact: Established product, new indication, psychiatry<br />
Cost minimization, budget impact: NCE launch<br />
Value for money: Novel therapy, market access<br />
Cost-effectiveness: New pediatric vaccine, extended coverage<br />
Patient-reported outcomes<br />
Budget impact: NCE<br />
Cost-effectiveness: Novel therapy, expanded indication<br />
LITHUANIA ONCOLOGY Cost-effectiveness: Novel therapy, expanded indication<br />
POLAND<br />
ROMANIA<br />
RUSSIA<br />
SLOVAKIA<br />
CARDIOVASCULAR<br />
CNS<br />
DIABETES<br />
INFECTIOUS DISEASE<br />
ONCOLOGY<br />
NEUROLOGICAL DISORDERS<br />
DIABETES<br />
NEUROLOGICAL DISORDERS<br />
DIABETES<br />
ONCOLOGY<br />
CARDIOVASCULAR<br />
INFECTIOUS DISEASE<br />
NEUROLOGICAL DISORDERS<br />
Cost-effectiveness, cost utility, budget impact: NCE<br />
Real-world costs and outcomes: NCE, first in class, patients at risk of hospital complications<br />
Value for money, reimbursement support: Established product, new indication, psychiatry<br />
Cost-effectiveness: Adaption, translation, reporting application in Poland<br />
Value for money: Novel therapy<br />
Indirect comparison, economic analysis, budget impact: New therapy, reimbursement<br />
Cost-effectiveness: New pediatric vaccine, extended coverage<br />
Budget impact: NCE<br />
Patient-reported outcomes<br />
Cost-effectiveness, budget impact: NCE launch<br />
Patient-reported outcomes<br />
Value for money: Novel therapy<br />
Cost of illness: Diabetes<br />
Economic analysis: NCE launch, hematological malignancy<br />
Cost-effectiveness, cost utility, budget impact: NCE<br />
Cost-effectiveness: New pediatric vaccine, extended coverage<br />
Patient-reported outcomes<br />
<strong>AccessPoint</strong> - Issue 1 Page 5
NEWS | <strong>IMS</strong> CORE DIABETES MODEL<br />
The <strong>IMS</strong> CORE Diabetes Model leads the field in diabetes modeling with<br />
insights that have been key in market access decisions worldwide.<br />
<strong>IMS</strong> CORE Diabetes Model rises to the<br />
Mount Hood Challenge<br />
The <strong>IMS</strong> CORE Diabetes<br />
Model is able to estimate the<br />
long-term clinical and<br />
economic outcomes of<br />
different therapeutic<br />
interventions for both Type 1<br />
and Type 2 diabetes.<br />
As part of our ongoing<br />
commitment to its continued<br />
development and external<br />
validity, we recently put it to<br />
the test at the Mount Hood<br />
Five Challenge in Malmo.<br />
The results are yet to be<br />
published but have already<br />
triggered initiatives for<br />
further advances in the<br />
model.<br />
The authors<br />
David Grant is Senior Principal at<br />
<strong>IMS</strong> <strong>HEOR</strong> and can be contacted at<br />
DGrant@uk.imshealth.com<br />
Adam Lloyd is Senior Principal, <strong>IMS</strong><br />
<strong>HEOR</strong> and can be contacted at<br />
ALloyd@uk.imshealth.com<br />
<strong>IMS</strong> CORE<br />
Diabetes Model<br />
See our Project Focus on<br />
diabetes on page 42<br />
Diabetes is among the world’s most prevalent, debilitating and<br />
costly chronic diseases. New breakthroughs in prevention and<br />
treatment have the potential to stem its progression, but are<br />
already challenging limited healthcare resources. With research<br />
yielding the promise of further advances in diabetes care, the<br />
need to understand the clinical and economic consequences<br />
of alternative approaches has never been greater.<br />
<strong>IMS</strong> <strong>Health</strong> Economics and Outcomes Research has extensive experience in<br />
demonstrating clinical and economic value in medicine. Computer<br />
simulation modeling has a key role to play in this process, particularly in<br />
a chronic disease like diabetes, with many complications that develop over<br />
time. The <strong>IMS</strong> CORE Diabetes Model is widely recognized as the leading<br />
all-round model of diabetes available. It has been accepted by healthcare<br />
decision makers across the world as a validated tool which brings valuable<br />
insights into the long-term outcomes, costs, and cost-effectiveness of<br />
innovative interventions for diabetes.<br />
EASE OF ACCESS<br />
Available via the internet, the <strong>IMS</strong> CORE Diabetes Model is a software utility<br />
which simulates clinical outcomes and costs for cohorts of diabetes<br />
patients. It is one of the very few models covering patients with either<br />
Type 1 or Type 2 diabetes mellitus. The software has been designed for<br />
ease of use so that non-specialists can evaluate the effects of different<br />
patient characteristics and changing costs on cohorts of diabetes patients<br />
over a range of short- and long-term time horizons.<br />
MULTIPLE FUNCTIONS<br />
The <strong>IMS</strong> CORE Diabetes Model allows users to compare a range of<br />
treatments, or sequences of treatments, by controlling input parameters<br />
relating to:<br />
• Patient demographics (age, race, sex)<br />
• Baseline risk factors and complications<br />
• Change in physiological values due to treatment (e.g. reduction in<br />
HbA1c, BP, lipids and BMI)<br />
• Treatment costs<br />
• Morbidity and mortality risk<br />
• Costs of complications (e.g. MI, stroke)<br />
• Costs of other medication and lab tests<br />
• Disease progression<br />
• Relative risks for complications<br />
• Timing of switching treatments<br />
The model assesses clinical and cost outcomes for a range of therapies,<br />
allows users to undertake detailed cost-effectiveness analyses, and<br />
produces outputs which can be customized to provide the level of detail<br />
appropriate to decision maker needs.<br />
Page 6 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
PUTTING IT TO THE TEST:<br />
THE MOUNT HOOD FIVE CHALLENGE<br />
The Mount Hood Challenges were first introduced in 2000 as<br />
an opportunity for researchers to discuss, compare and crossvalidate<br />
the performance and structure of economic models<br />
of diabetes1 .<br />
Continuing in that vein, the Mount Hood Five Challenge was<br />
held in Sweden in September 2010. In addressing the<br />
economic modeling of diabetes and its complications, the<br />
emphasis was once again on comparing model projections to<br />
real-world or clinical trial outcomes 2 . Within the context of<br />
the “challenge” environment, these meetings offer an<br />
important forum for explaining and discussing potential<br />
differences between models, and are key to identifying areas<br />
of future development for advancing the field 3 .<br />
This year, eight different modeling groups participated in the<br />
challenge, which consisted of two separate elements: In the<br />
first, participants were asked to replicate three recent clinical<br />
studies in order to validate their respective models. This was<br />
The Mount Hood Challenges<br />
offer an important forum for<br />
comparing and cross-validating<br />
economic models of diabetes<br />
achieved using published information on trial cohort baseline<br />
characteristics and effects of the intervention on<br />
intermediate risk factors to model long-term clinical<br />
outcomes, costs and cost-effectiveness. The second element<br />
focused on the way that diabetes simulation models capture<br />
and represent uncertainty around their projected outcomes.<br />
The results from Mount Hood have yet to be published and<br />
must remain under wraps until then. What we can say at this<br />
time is that our move to take part in this respected challenge<br />
reflected our confidence in the <strong>IMS</strong> CORE Diabetes Model and<br />
we were not disappointed in its performance. We are sure<br />
that it will continue to remain at the forefront of economic<br />
analysis and decision making in this area as the leading<br />
diabetes economic model available.<br />
CONTINUING TO DEVELOP THE <strong>IMS</strong> CORE<br />
DIABETES MODEL<br />
<strong>IMS</strong> is committed to continuing investment in the <strong>IMS</strong> CORE<br />
Diabetes Model to ensure that it remains as comprehensive,<br />
reliable, up-to-date and efficient as possible. We are<br />
delighted to share the details of three new initiatives we<br />
have established during 2010:<br />
<strong>IMS</strong> CORE DIABETES MODEL | NEWS<br />
1. EXPERT PANEL: We have recently instituted an expert<br />
panel of five leading specialists in diabetes management,<br />
epidemiology and economic modeling. The panel will advise<br />
on validation and structural refinements to the model as well<br />
as the inclusion of new research and clinical findings as they<br />
become available. As a group they will meet on an ongoing<br />
basis to review new results and plans for further<br />
development. The panel members are:<br />
• Dr Jonathan Brown: Chair of the International Diabetes<br />
Federation Task Force on Diabetes <strong>Health</strong> Economics;<br />
formerly Senior Investigator at the Center for <strong>Health</strong><br />
Research, Kaiser Permanente (KP) Northwest in Portland,<br />
Oregon, USA<br />
• Professor Nick Freemantle: Professor of Clinical<br />
Epidemiology and Biostatistics, University of<br />
Birmingham, UK<br />
• Professor Bill Herman: Director Michigan Diabetes<br />
Research Center, University of Michigan, USA<br />
• Professor Andrew Palmer: Professor of <strong>Health</strong><br />
Economics and Associated Research, Menzies Research<br />
Institute, University of Tasmania, Australia<br />
• Dr Stéphane Roze Senior Consultant, HEVA, Lyon, France<br />
2. USER FORUM: Open to subscribers to the <strong>IMS</strong> CORE<br />
Diabetes Model, our recently launched “User Forum” provides<br />
an informal platform for open discussion with our software<br />
developers and expert panel, around issues of common<br />
interest to users. Our first meeting was held on 20<br />
September in Stockholm, the day after the Mount Hood<br />
meeting. Most of our current license holders attended to<br />
meet our experts, learn about some recent technical changes<br />
and provide feedback on additional facilities for the model –<br />
most of which focused on user-friendliness of the tool and<br />
applicability earlier in the product lifecycle.<br />
3. UPGRADED HARDWARE PLATFORM: We have made a<br />
substantial investment in state-of-the-art computer hardware<br />
which will provide improved efficiency, reliability and<br />
performance. The new platform is hosted in an external data<br />
center which allows us to provide the very highest levels of<br />
security and reliability.<br />
Going forward, we are planning a full and detailed<br />
re-validation of the <strong>IMS</strong> CORE Diabetes Model against<br />
published clinical data, and a program to continuously review<br />
and refresh inputs to ensure that it continues to reflect the<br />
very latest literature and research findings worldwide. •<br />
1 Brown JB, Palmer AJ, Bisgaard P, et al. The Mt. Hood Challenge: Crosstesting<br />
Two Diabetes Simulation Models. Diabetes Res Clin Pract. 2000;<br />
50(Suppl 3):S57–S64<br />
2 Economics, Modeling and Diabetes: The Mount Hood Five Challenge,<br />
Malmo, Sweden, 18-19 September 2010.<br />
3 Palmer AJ, Computer Modeling of Diabetes and its Complications.<br />
Diabetes Care, 2007; 30(6):1638-46<br />
<strong>AccessPoint</strong> - Issue 1 Page 7
INSIGHTS | 2011 TRENDS<br />
As we look ahead through 2011, it is timely to consider<br />
the prospects for the global pharmaceutical market,<br />
both in quantitative and qualitative terms, the priorities<br />
for companies competing in this landscape and the<br />
implications for those who are focused on health<br />
economics and outcomes research.<br />
The author<br />
Murray Aitken, MBA,<br />
Senior VP, <strong>Health</strong>care Insight,<br />
<strong>IMS</strong> <strong>Health</strong>.<br />
MAitken@imshealth.com<br />
Page 8 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
At the aggregate level, <strong>IMS</strong> is forecasting growth of 5-7%<br />
in 2011 for the global pharmaceutical market, taking the<br />
total market value to about $880 to $890 billion (Figures<br />
1 and 2). This growth rate will be about one percentage<br />
point higher than our expectation for 2010. While this<br />
might be seen as a rebound, the underlying constraints<br />
to growth in the developed markets are stronger than<br />
ever, particularly the effect of new payer moves to limit<br />
drug spending that we are seeing in some of the key<br />
European markets, as well as the anticipated impact of<br />
major drugs losing patent protection and for the first time<br />
facing generic competition.<br />
Growth in 2011 will be helped by three key factors:<br />
1. First, in the U.S. we are forecasting 3-5% growth in<br />
2011, up slightly from the 3-4% we are expecting<br />
for 2010. This is mainly due to some factors causing<br />
low growth in 2010 which we are not expecting to<br />
be repeated in 2011. Specifically, the early end to<br />
the flu season last winter, the impact of the severe<br />
weather in February which decreased the number<br />
of doctor visits and prescription volume, and the<br />
earlier than expected entry of generic competition<br />
for a few major drugs. Whilst we see a slight<br />
improvement in the U.S. in 2011, growth will<br />
remain in the historically low range of less than 5%.<br />
2. Second, in Japan where price cuts are applied every<br />
two years, 2011 is a non-price cut year, which helps<br />
growth in the second largest market rise from 1-2%<br />
in 2010, to 5-7% in 2011.<br />
3. The third facilitator of growth in 2011 is stronger<br />
contribution from emerging markets and especially<br />
the 17 countries we classify as “pharmerging”. Their<br />
collective growth will be 15-17% in 2011, up from<br />
about 14% in 2010, helped by recovering economies<br />
and the continued strength of China as an expanding<br />
market. We are forecasting 25% growth in China in<br />
2011, and it will enter the year as the world’s third<br />
largest market after the U.S. and Japan.<br />
CONTINUED CONSTRAINTS<br />
However, while these factors help to support growth in<br />
2011, the constraints from patent expiries and payer<br />
actions to limit growth in drug spending are greater<br />
than ever.<br />
Budgetary control: We are seeing both public and<br />
private payers around the world pursue a wave of<br />
budgetary control mechanisms that target drug spending.<br />
2011 TRENDS | INSIGHTS<br />
Outlook for 2011<br />
PROSPECTS, PRIORITIES AND KEY IMPLICATIONS FOR HEALTH ECONOMICS AND OUTCOMES RESEARCH<br />
Sales US $Bn<br />
For countries with publicly funded healthcare, this is<br />
being implemented in the context of efforts to restore<br />
fiscal balance. In Spain and Canada, we are seeing<br />
substantial reductions in the pricing of generics and in<br />
the case of Canada, the elimination of pharmacy rebates;<br />
in Germany new brands are being subject to new price<br />
negotiation requirements; and Turkey and Greece have<br />
implemented significant across-the-board price cuts for<br />
branded products. And in the U.S., too, private sector<br />
employers and health plans are stepping up their use of<br />
pre-authorizations, and increasing the incentives for<br />
patients to request lower cost options, all in an effort to<br />
limit the rise in drug costs.<br />
2011 will be another important<br />
year to watch in the global<br />
pharmaceutical market<br />
Peak years of patent expiries:We are moving into the<br />
two biggest years of expiries in 2011 and 2012 as<br />
measured by the current value of products that are subject<br />
to loss of exclusivity. In 2011, products with more than<br />
$30bn of sales are expected to face generic competition<br />
in major markets, including, in the U.S., iconic brands<br />
such as Lipitor ® , Plavix ® , and Zyprexa ® . But while the<br />
patents are due to expire in 2011, the full impact will not<br />
be felt until 2012 due to the timing of the expiries and<br />
the number of generic competitors. So, in fact, the<br />
impact of patent expiries will not be significantly<br />
different than in 2010, though it will remain a major<br />
constraint in the marketplace.<br />
FIGURE 1: GLOBAL PHARMA MARKET EXPECTED TO EXCEED<br />
$880 BN IN 2011 WITH GROWTH OF 5-7%<br />
12.1% 9.1% 9.1% 7.7% 7.3% 7.2% 6.9% 5.8% 7.1% 4-6% 5-7%<br />
1000 15%<br />
750<br />
500<br />
250<br />
0<br />
Global sales and growth 2001-2011<br />
$395 $431 $497 $556 $601 $646 $715 $781 $812<br />
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010<br />
Growth<br />
Total world<br />
(f)<br />
Source: <strong>IMS</strong> <strong>Health</strong>, Market Prognosis, Sept 2010<br />
$840 $880<br />
-$850 -$890<br />
<strong>AccessPoint</strong> - Issue 1 Page 9<br />
2011<br />
(f)<br />
10%<br />
5%<br />
0%<br />
Growth const US $Bn
INSIGHTS | 2011 TRENDS<br />
...continued from previous page<br />
NEW INNOVATION<br />
Finally, let me touch on some of the innovative products<br />
we expect to enter the market in 2011. We see significant<br />
The health economics and outcomes<br />
research discipline will be critical to<br />
ensuring that drugs are well<br />
positioned to capture a fair share of<br />
the market expansion in 2011<br />
new breakthroughs on the horizon in several areas,<br />
including stroke prevention, melanoma, multiple sclerosis,<br />
breast cancer and hepatitis C. In each of these areas, we<br />
expect new products that provide patients and their<br />
physicians with new treatment options, and represent a<br />
new understanding about the course of these diseases and<br />
the way they can be tackled. In total, we expect 30 to<br />
35 new chemical or biological entities to be launched<br />
globally in 2011, five of which have the potential to reach<br />
blockbuster status – defined as peak sales in excess of<br />
$1bn. These new products are significant for their science<br />
and patient value; but we do not expect them to provide<br />
market growth beyond that which we have seen in the<br />
past three years, which is at historically low levels.<br />
In summary, 2011 will be another important year to<br />
watch in the global pharmaceutical market: the<br />
introduction of exciting new products, the impact of new<br />
efforts to control drug budgets, the loss of exclusivity in<br />
major markets for some iconic brands, and the further<br />
rise in the importance of pharmerging markets. It will<br />
also be a year where the details of a number of healthcare<br />
reform initiatives that will impact the longer term market<br />
– in the United States and elsewhere – will be hammered<br />
out and clarified.<br />
INDUSTRY PRIORITIES<br />
For pharmaceutical manufacturers operating in this<br />
market environment, 2011 will be dynamic and exciting<br />
as they sharpen their focus across three priority areas:<br />
1. First, the business strategy they are pursuing, in<br />
particular their approach to innovation – and<br />
decisions about balancing internal research with<br />
external partnering, and the number of which<br />
therapeutic areas to invest in; the business sectors<br />
they compete in – and whether to acquire, maintain<br />
or divest generics, consumer health, animal health,<br />
vaccines or diagnostics divisions; and the geographic<br />
Page 10 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
alance of their operations – in particular how<br />
much focus to place on the pharmerging markets.<br />
2. The second and related focus area for each company<br />
in 2011 will be honing the commercial model to<br />
ensure that it is optimized towards the market<br />
characteristics of each major country market and<br />
the company’s product portfolio. The appropriate<br />
focus and approach towards payers, prescribers, and<br />
patients will be further tailored to reflect the realities<br />
of each distinct market’s dynamics and for each<br />
therapeutic area.<br />
3. Finally, manufacturers will need to redouble their<br />
efforts to showcase the value their medicines bring<br />
to the healthcare system. This includes developing<br />
credible evidence of the clinical value based on<br />
outcomes, the necessary support to demonstrate the<br />
health economics of a particular drug relative to<br />
available alternatives, and the communication of this<br />
value to relevant stakeholders. <strong>Health</strong> economics<br />
and outcomes researchers have a primary role to<br />
play in supporting this priority area for 2011. For<br />
existing marketed products, they will help to<br />
reinforce and strengthen the value positioning of<br />
drugs, especially as many alternative treatments are<br />
now available in lower cost generic form. For<br />
FIGURE 2: 2011 SALES AND GROWTH IN GLOBAL REGIONS<br />
U.S.<br />
Size: U.S.$320-330bn<br />
Growth: 3-5%<br />
GLOBAL MMARKET<br />
MARKET 2011<br />
SIZE: $880-890BN<br />
GROWTH: 5-7%<br />
“Pharmerging” Markets<br />
Size: U.S.$170-180bn<br />
Growth: 15-17%<br />
China<br />
Brazil<br />
Russia<br />
India<br />
Mexico<br />
Turkey<br />
Venezuela<br />
Poland<br />
Argentina<br />
Thailand<br />
Romania<br />
Indonesia<br />
2011 TRENDS | INSIGHTS<br />
S. Africa<br />
Egypt<br />
Ukraine<br />
Pakistan<br />
Vietnam<br />
Outlook for 2011<br />
products nearing launch, the value proposition must<br />
be powerful and pertinent to the relevant<br />
stakeholders.<br />
KEY ROLE FOR HEALTH ECONOMICS AND<br />
OUTCOMES RESEARCH<br />
As 2011 brings further implementation of the Sentinel<br />
Initiative in the U.S., Risk Evaluation and Mitigation<br />
Strategies become routine, and observational trials are<br />
more extensively undertaken, the explosion of nonproprietary<br />
clinical information will bring new potential<br />
for benefits – as well as risks – to be identified and better<br />
understood. The health economics and outcomes<br />
research (<strong>HEOR</strong>) function will be central to ensuring<br />
that companies are prepared for this and proactively<br />
pursuing the opportunities it will provide.<br />
As the global market for pharmaceuticals expands by<br />
about $50 billion in 2011, manufacturers will be<br />
wrestling with their priorities and in many cases<br />
anticipating the imminent peak years of patent expiry.<br />
<strong>HEOR</strong> will be a critical component of making sure that<br />
drugs are well positioned to capture a fair share of the<br />
market expansion in 2011, and supporting company<br />
efforts to be well placed for innovation-led growth in the<br />
second half of this decade. •<br />
Top 5 Europe<br />
Size: U.S.$135-145bn<br />
Growth: 1-3%<br />
Japan<br />
Size: U.S. $96-100bn<br />
Growth: 5-7%<br />
Rest of World<br />
Size: U.S. $145-155bn<br />
Growth: 3-5%<br />
Source: <strong>IMS</strong> <strong>Health</strong>, Market Prognosis, Sept 2010<br />
NOTE: <strong>IMS</strong> forecasts are based on the latest release of <strong>IMS</strong> Market Prognosis , the leading annual industry indicator of market dynamics and therapy<br />
performance. The forecasts take account of key issues impacting the pharmaceutical and healthcare industries. Additional factors that may affect overall<br />
growth include major safety events resulting in product withdrawal or prescribing restrictions; shifts in regulatory approval standards from their current levels;<br />
the application of sudden cuts to drug spending levels; public health crises; and a deterioration in economic conditions. Growth is measured in constant<br />
dollars to avoid the influence of currency exchange rates; sales are calculated at the ex-manufacturer level. Market size forecasts are expressed in current<br />
dollars, but exclude off-invoice discounts and rebates that are part of prevailing practices in certain major markets.<br />
<strong>AccessPoint</strong> - Issue 1 Page 11
INSIGHTS | U.S. & EUROPE<br />
The interviewees<br />
Mike Nelson, PHARM D<br />
Dr. Michael Nelson is Regional<br />
Leader, Americas, <strong>Health</strong><br />
Economics and Outcomes<br />
Research at <strong>IMS</strong> <strong>Health</strong> in<br />
the U.S.<br />
MNelson@us.imshealth.com<br />
Jacco Keja, PHD<br />
Dr Jacco Keja is Regional<br />
Leader, EMEA, <strong>Health</strong><br />
Economics and Outcomes<br />
Research, at <strong>IMS</strong> <strong>Health</strong><br />
in the UK<br />
JKeja@nl.imshealth.com<br />
The transatlantic<br />
constant of change<br />
As complex dynamics and<br />
healthcare reforms bring<br />
change through the key<br />
developed markets, we ask our<br />
new regional leaders in the U.S.<br />
and Europe for their take on the<br />
trends, implications and overall<br />
outlook for HTAs, <strong>HEOR</strong> and<br />
market access.<br />
U.S.<br />
INTERVIEW WITH MIKE NELSON<br />
Q: What do you see as the main challenges for<br />
market access in the U.S.?<br />
Mike Nelson: I think that because there are so many<br />
diverse payers in the U.S. market with so many different<br />
needs and levels of understanding about the methods and<br />
approaches to cost-effectiveness analysis, one of the key<br />
challenges for the industry is in defining what decision<br />
makers are looking for and generating information that<br />
helps them to make well-informed decisions. We are seeing<br />
a disconnect between the level of science that we as<br />
researchers employ in health economics and outcomes<br />
research (<strong>HEOR</strong>) and the application of that information<br />
to decision making. A good example in the U.S. is that the<br />
market struggles with using cost per QALY – decision<br />
makers don’t really know how to factor that in or how it<br />
helps them understand the relative value of a product in<br />
their system. I think also, in general, the emphasis of<br />
decision makers on randomized controlled trials (RCTs)<br />
as the gold standard for quality information undervalues the<br />
real-world observational research that can inform decision<br />
making, particularly in terms of cost and utilization.<br />
Page 12 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
Q: Is there a need then, to facilitate a better<br />
understanding of <strong>HEOR</strong>?<br />
MN: Certainly, one pathway is helping payers better<br />
understand the information, but I think both sides need<br />
to move towards a common center: researchers need to<br />
make their methods more transparent and applicable to<br />
the decisions that payers have to make, and payers have to<br />
do their best to understand the methods that are employed<br />
by researchers in doing cost-effectiveness analysis. It may<br />
be that the former is more important because the<br />
endpoints we are using and the way we present data are<br />
not uniformly meeting decision makers threshold for<br />
reliable evidence – as evidenced by discussions at the<br />
recent International Meeting of ISPOR. There is still a<br />
level of distrust regarding information that comes from<br />
the industry and yet the industry does its best to employ<br />
the most rigorous methods available to generate the<br />
information that it puts in front of payers. Researchers<br />
need to appreciate that despite their best efforts to<br />
generate robust, high-quality research it is still in many<br />
ways under-appreciated by decision makers.<br />
Q: What are the implications of healthcare<br />
reform in the U.S.?<br />
MN: I think it will lead to an increase in the impact of<br />
<strong>HEOR</strong>. The shift in coverage decision making from<br />
acquisition cost to overall value will accelerate an<br />
appreciation that economic value is about more than just<br />
the cost of the pharmaceutical. In the private sector and<br />
commercial health plans where coverage decisions have<br />
largely integrated pharmaceutical cost into their decision<br />
making, decisions will start to be based more on overall<br />
product value – not just safety, efficacy, and unit price but a<br />
broader appreciation of its overall impact on health<br />
outcomes. And in the public sector, which traditionally has<br />
not emphasized cost in its decision making, slowly, but<br />
inevitably, cost and cost-effectiveness will have to be<br />
incorporated into understanding the overall value of the<br />
product. There is still some political resistance and fear about<br />
what that means for access to care. Patients in the U.S. have<br />
been used to fairly open access, so there is concern about<br />
decisions being made on cost alone and fear that it will lead<br />
to ‘rationing’ based on cost – particularly among people<br />
who have potentially life-threatening and chronic severe<br />
conditions requiring expensive new technology.<br />
Q: Why is comparative effectiveness research<br />
(CER) so key to reform?<br />
MN: There is a general understanding that healthcare<br />
costs in the U.S. are continuing to rise and that new<br />
U.S. | INSIGHTS<br />
technology is helping to push cost in that direction, but<br />
no one knows whether we are really getting good value<br />
for the money we are spending on healthcare. We<br />
constantly see news about the cost of healthcare in the<br />
U.S. relative to other countries, but when we look at the<br />
quality of care according to information in the press there<br />
is a general perspective that we are spending a lot on<br />
healthcare but ranking much lower than other countries<br />
in terms of overall quality. There is also a general<br />
appreciation that we can’t continue to spend more and<br />
more of our overall resources on healthcare without<br />
understanding what the return is on that investment.<br />
Q: What is the goal of CER?<br />
MN: The goal of CER is to provide information on the<br />
relative “effectiveness” of healthcare technology through<br />
the analysis of safety, efficacy, and real-world outcomes data.<br />
CER is intended to improve the quality of care, but at the<br />
end of the day it is really about achieving better quality<br />
with an appreciation that resources are finite. Costeffectiveness<br />
research analyzes cost and quality together.<br />
Q: IS CER simply ‘more of the same’ for <strong>HEOR</strong><br />
researchers?<br />
MN: Well, certainly, CER is not unfamiliar to <strong>HEOR</strong><br />
researchers. Cost-effectiveness researchers have for years<br />
in my view conducted CER, the only difference being<br />
that cost is part of the basis for comparison, whereas with<br />
CER the emphasis seems to be more on the quality of<br />
outcomes as the primary endpoint. To my mind, they are<br />
very similar and cost-effectiveness is a form of CER<br />
which emphasizes or brings cost into the overall value<br />
assessment.<br />
Q: Will there be a need for guidelines in<br />
conducting CER?<br />
MN: In order for the science to be accepted, guidelines<br />
are probably appropriate. As an example, guidelines for<br />
conducting good clinical research are well understood.<br />
Since RCTs generally don’t capture all the information<br />
needed for CER, we will have to include other forms of<br />
observational research to get the best view of the<br />
effectiveness of technology. To improve the reliability and<br />
validity of this research, there should be some guidance<br />
and recommendations on the best way to conduct each<br />
type of research. This is not because I think there is a lot<br />
of inappropriate research being done but more because<br />
the users of that information need to be comfortable that<br />
there are standards being followed and that the research<br />
they are reviewing has a high level of quality and<br />
methodological rigor.<br />
<strong>AccessPoint</strong> - Issue 1 Page 13
INSIGHTS | U.S.<br />
...continued from previous page<br />
Q: Do these developments imply changes for the<br />
industry?<br />
MN: I believe so, yes. The overall research focus will<br />
continue to be concentrated on clinical development and<br />
getting the products through regulatory approval. Where<br />
there is room for growth is thinking beyond the<br />
regulatory goal to the market access hurdle and what<br />
information and research needs to be done throughout<br />
the lifecycle of the product to support that. There has no<br />
doubt been a general trend in the industry to consider<br />
the market access hurdle earlier and earlier in the<br />
lifecycle, but I think there is room for earlier generation<br />
of evidence that supports the comparative effectiveness<br />
and cost-effectiveness analyses. To do that, there needs to<br />
be investment and rethinking of the amount of resources<br />
that are deployed to those kinds of research earlier in the<br />
lifecycle.<br />
Q: Are regulators starting to look beyond<br />
randomized controlled trials?<br />
MN: I’m not sure that regulators are quite there yet -<br />
the FDA hasn’t started to make cost part of its<br />
requirements for approval in the U.S. Payers, though, are<br />
certainly thinking about this and how to best integrate<br />
that kind of information. The emphasis is more on<br />
getting both the regulatory and market access approval<br />
and planning for that in parallel. This is an increasing part<br />
of what we do at <strong>IMS</strong> – supporting companies both on<br />
the market access side but also being strategic about the<br />
way we think about programs and research studies that<br />
need to be done and when they need to be done in order<br />
to optimally time the information with when the<br />
decisions are being made.<br />
Q: What are the challenges in sourcing<br />
real-world data?<br />
MN: We have some of the same challenges in the U.S. as<br />
in Europe but the one area where we have some<br />
advantage is that there are large retrospective databases<br />
which can be accessed for certain types of research,<br />
particularly in the analysis of overall burden of disease,<br />
treatment patterns across multiple regions of the country<br />
and looking at where there are opportunities for quality<br />
improvement in terms of outcomes related to those<br />
therapies. Ultimately, once a product hits the market, these<br />
databases enable direct comparisons of how products are<br />
being used as well as their outcomes. All of that can be<br />
done in the context of retrospective claims databases,<br />
electronic medical records, and other data collection<br />
methods tied to those two things. But there is a limit to<br />
the endpoints these databases include which is why<br />
robust, prospective observational research is also critically<br />
important. The challenges in the U.S. and Europe in those<br />
kinds of data collection methods are more similar.<br />
Transparency is really important<br />
and that is an area where we<br />
need to do a better job<br />
Q: Why is real-world, observational research so<br />
important?<br />
MN: The real-world data that is available provides a<br />
picture of what really happens outside the context of a<br />
very structured and controlled clinical trial and that is<br />
what effectiveness is really all about and how it differs<br />
from “efficacy”, which is ultimately what an RCT is<br />
designed to measure and compare between two different<br />
interventions. Observational methods, including databases,<br />
give you an opportunity to see what happens outside the<br />
view of an RCT, ‘out in the wild’ where patients and<br />
physicians behave in real practice.<br />
Databases give us some insight into what is happening<br />
without having to design and implement a very expensive<br />
and long-term randomized controlled clinical trial.<br />
Prospective observational studies provide the opportunity<br />
to collect data which form part of what defines overall<br />
product value but which only the patient or physician<br />
provider may have. Examples of endpoints that require a<br />
prospective observational study include: quality of life,<br />
patient satisfaction or qualitative outcomes such as<br />
symptom management, like pain control - anything that<br />
ultimately drives the value of the treatment but which is<br />
often difficult to measure in claims or retrospective<br />
databases. Another good example would be measuring<br />
both hyper- and hypoglycemic events in diabetes which<br />
can be problematic for patients who are trying to tightly<br />
control blood glucose. To some extent those things can be<br />
measured in claims or retrospective databases if they<br />
warrant a doctor visit, but if the patient is able to selfmanage<br />
through guidance or by managing their diet,<br />
those things can’t be captured in retrospective data but<br />
still impact the overall quality of that patient’s outcome<br />
on a particular therapy. Sometimes the only way you can<br />
capture that is through a prospective observational<br />
method. At the end of the day, the patient is the ultimate<br />
Page 14 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
customer of healthcare and we should be incorporating<br />
their perspective in our understanding of the value of the<br />
product and therefore patient-reported outcomes are a<br />
really important component of comparative effectiveness.<br />
Q: How can <strong>HEOR</strong> best support decision<br />
making in the post-reform era?<br />
MN: If you look at the types of difficult decisions that<br />
now are coming more into the limelight, they are the<br />
same as those that <strong>HEOR</strong> researchers have been<br />
struggling with for the last 20 years or more, so this is not<br />
a new challenge without any science behind it. The<br />
methods that have been developed and used over many<br />
years as part of the evolution of <strong>HEOR</strong> research are really<br />
the tools that will help decision making in the postreform<br />
years. There is still resistance to the economic part<br />
of this in the U.S. in particular because of concerns that<br />
decisions will be based only on cost and not overall value,<br />
which incorporates both quality and cost. Thus, a<br />
challenge with <strong>HEOR</strong> is to overcome the fear of overemphasizing<br />
the cost part of the value equation in<br />
decision making. What we can do to move that along is<br />
help people understand that it’s not just about quality or<br />
cost – but the marriage of the two, and that the methods<br />
we have developed over the last 20 plus years really are<br />
the science in bringing those two things together.<br />
Q: Is <strong>HEOR</strong> becoming overly complex?<br />
MN: Well, without doubt, the sophistication of today’s<br />
analyses is far greater than it was 20 years ago. However,<br />
the level of understanding of those methods by the<br />
people using them in applied decision making hasn’t<br />
necessarily tracked evenly with that. If we look at<br />
economic modeling, the methods are very sophisticated<br />
and advanced but that’s not necessarily a good thing<br />
because sometimes their complexity makes it difficult for<br />
strategic and business decision makers to take that<br />
information and utilize it without skepticism about how<br />
it was generated. Transparency is really important and that<br />
is an area where we need to do a better job – helping<br />
decision makers understand that the methods we are<br />
using are more advanced, but have been validated and are<br />
transparent so that they can decide whether these are the<br />
best methods to analyze that particular data. If we don’t<br />
appreciate that the information we are generating has to<br />
be relevant and usable to the decision makers then we<br />
are really not achieving our goal of conducting good<br />
research. •<br />
EUROPE | INSIGHTS<br />
Europe<br />
INTERVIEW WITH JACCO KEJA<br />
Q: What are the key challenges for pharma and<br />
market access in Europe?<br />
Jacco Keja: I think we are seeing three major trends in<br />
the region: The first has to do with an intensification of<br />
international collaboration in HTAs. In the past,<br />
negotiations and HTAs were mainly conducted at the<br />
regional level. Today, not only are national payers<br />
becoming far more adept at these assessments but we are<br />
also seeing networks of HTA agencies, such as<br />
EUnetHTA and INAHTA, gathering strength. There is<br />
a growing need for the industry to deeply understand this<br />
process and to monitor, pre-empt and manage HTA at<br />
these levels.<br />
The second trend is increasing regionalization. Whereas<br />
historically, pricing and reimbursement was either relatively<br />
free or primarily driven by one or two national players, in<br />
the last few years we have seen a big push towards<br />
regionalization – first in Spain and Italy, more recently in<br />
the UK with stronger primary care and GP<br />
commissioning groups and now in France where regional<br />
power is also intensifying. Companies are used to dealing<br />
with national payers and with relationships at the very local<br />
level. Now, they need to start looking at how well they<br />
are organized to operate in what is increasingly a businessto-business<br />
driven market where the ability to negotiate<br />
as a business-to-business partner is becoming imperative.<br />
Finally, in the EMEA region we also are moving closer<br />
to a world where free pricing and the traditional<br />
UK/Germany launch sequence is probably going to be<br />
history in the next year. We have seen with the<br />
deterioration of the English pound that already for most<br />
companies the UK is not as attractive a market any more<br />
from an international pricing reference point of view.<br />
And Germany is essentially giving up its free pricing. So,<br />
again, companies have to completely rethink their<br />
consolidated European launch.<br />
Q: What are the business imperatives<br />
for the industry?<br />
JK: All these factors need to be dealt with from a pricing<br />
point of view, but they cannot be disentangled from HTA<br />
and health economics and outcomes research because yet<br />
another continued trend is that P&R is being achieved<br />
on the basis of a commitment by pharma to deliver what<br />
they promise up front. This means that all kinds of payfor-performance<br />
deals have to be organized by the<br />
industry and payers. Companies get their price and<br />
reimbursement after a process of lengthy negotiation but<br />
there is always some kind of commitment to deliver on<br />
<strong>AccessPoint</strong> - Issue 1 Page 15
INSIGHTS | EUROPE<br />
...continued from previous page<br />
certain performance indicators. To prepare for that<br />
discussion they are going to need firstly an understanding<br />
of HTA and the skills around that, and secondly, realworld<br />
data capabilities – throughout the product lifecycle<br />
- for portfolio management, patient segmentation, P&R,<br />
economic modeling and post-launch commitment.<br />
Q: How is HTA evolving in the region?<br />
JK: Historically, HTA was a very local affair. Now it is<br />
reaching a new level of sophistication, with agencies<br />
collaborating strongly together, asking for more<br />
information and becoming far more protocolized in their<br />
approaches. HTA is becoming just as important as<br />
regulatory approval in Europe and the industry really has<br />
to take this very seriously. Without being sufficiently well<br />
prepared for it, companies will set themselves up for failure<br />
during P&R negotiations – the two go hand in hand and<br />
this is a really important aspect of doing business these<br />
days. The fact that these agencies work together means<br />
there is also a need to understand who relates to whom.<br />
One of the complications with HTA is what do you<br />
define as HTA? Some of the assessors are quite clear and<br />
have well described powers like NICE, but if you take a<br />
wider definition of HTA, many bodies that conduct these<br />
assessments that have an impact on likelihood to prescribe<br />
such as UK Primary Care Trusts – in spite of the fact that<br />
NICE gives clear guidance they decide on particular<br />
implementation themselves. Then again, whole countries<br />
have very fragmented approaches to HTA and that also<br />
needs co-ordination and management.<br />
Q: What is driving this trend in HTA?<br />
JK: To some extent it is driven by certain forces in the<br />
market who feel that at HTA level we might find ourselves<br />
facing a similar situation as we did 10-15 years ago in<br />
regulatory, where every nation had its own decision<br />
making body, and by going through one united application<br />
we could reap the benefits of efficiency and clarity and<br />
consistency at the European level. However, there is the<br />
basic difference that regulatory very strongly depends on<br />
RCTs which means the size and internal validity of studies<br />
are quite important. HTA is all about expectations and<br />
understanding what happens in the day-to-day clinical<br />
setting and is implicitly much more affected by the EU<br />
subsidiarity principle. In other words, real-world data are<br />
important and will continue to be driven by local and<br />
regional healthcare practices. I expect these practices are<br />
and will be for the foreseeable future still quite dissimilar<br />
between the different countries. Care is being<br />
implemented based on individual needs, so it is extremely<br />
important to understand that. At the moment, HTA is on<br />
the middle ground where consistency and methodology<br />
and certain parts of it are more coordinated amongst the<br />
bodies - that is what is happening here right now and what<br />
companies should understand.<br />
Q: How significant is the new Drug<br />
Reimbursement Law (AMNOG) in Germany?<br />
JK:There are two main aspects to AMNOG: on the one<br />
hand when the law is implemented early in 2011,<br />
Germany as a free price country for innovative drugs will<br />
cease to exist. Although the fiction of a free price exists<br />
for at least 12 months, in the following years sick funds<br />
will only pay for the drug if a discount contract with all<br />
statutory health insurances is in place. This in itself is a<br />
dramatic change. Even more significant is that once the<br />
law is in force, companies will be required to negotiate<br />
discounts on a new product’s price on the basis of its<br />
expected additional benefit, supported by a detailed<br />
“value dossier” called benefit dossier by the German law.<br />
We will also see IQWiG becoming more formally<br />
involved in the P&R process in making a judgment as to<br />
whether a product is indeed more beneficial. The value<br />
the product brings to the market is a key element here,<br />
so for the first time considerations on additional benefit<br />
become quite important in the German market.<br />
Companies will have to be prepared for these<br />
negotiations and understand in detail what will happen<br />
with their product in real-life and understand the<br />
efficiencies and inefficiencies in the German healthcare<br />
system. This comes back again to the need and ability to<br />
obtain or generate real-world data and insights.<br />
Q: What do these changes mean for <strong>HEOR</strong> in<br />
the industry?<br />
JK: Well, if you think about products entering Phase III,<br />
companies should start thinking more deeply than ever<br />
before about which patient populations benefit from<br />
their new technology and this includes having a much<br />
better and deeper understanding of co-morbidities and<br />
patient segmentation, which are really important<br />
considerations now because they need to design their<br />
endpoint strategies and outcomes research accordingly.<br />
Historically, and to some extent driven by regulatory<br />
needs, the focus was very much on developing a product<br />
for as wide a population as possible for obvious reasons<br />
to maximize potential. Now we see a great deal of pushback<br />
by payers at that level, and if the industry doesn’t<br />
find the right patient segments then payers will do that<br />
for them. This is a very important aspect of portfolio<br />
Page 16 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
management to really understand the ideal patient for the<br />
product. Alongside that, companies need to understand<br />
what current products are doing in real life so that<br />
<strong>HEOR</strong> goes hand in hand with doing patient registry<br />
analyses or other methodologies to drive that insight.<br />
If we consider pre-launch and international coordination<br />
of HTA, cost-effectiveness analysis is becoming more<br />
important than ever before. Typically in the past,<br />
companies would develop their economic model then<br />
mostly go local for model adaptations which the affiliates<br />
would drive relatively independently. Now they can’t do<br />
that because of HTA collaboration and also because of<br />
the need, for example in rare diseases, to get sufficient<br />
power in the data sources, so international coordination<br />
of <strong>HEOR</strong> is quite important.<br />
Finally, post-launch there is the commitment to deliver<br />
actual data on how a product performs in the market –<br />
again this needs competencies at the level of outcomes<br />
research so setting up prospective observational studies,<br />
for example, or linking up to existing registries to pull<br />
the data in order to maintain the P&R agreed upon at<br />
the regional level. There is a much stronger need for<br />
international resources than ever before and for<br />
companies to manage their IP throughout the lifecycle.<br />
Q: Why is there so much emphasis on<br />
real-world data?<br />
JK: At all levels, it is to prove a company’s claims for<br />
innovation. This burden is being clearly put back on<br />
pharma and very simply that is why real-world data so<br />
important. Much of the projection of that just cannot be<br />
pulled out of the clinical regulatory studies. For example,<br />
compliance is a very important aspect of many new<br />
innovations and should be very relevant to payers, but is<br />
rather difficult to collect from protocolized studies. And<br />
with the market becoming much more of a business-tobusiness<br />
environment with pay-for-performance contracts,<br />
the paying partners of pharma want proof of effectiveness<br />
and safety in real life. This is an extremely important aspect<br />
of the business nowadays and quite a drastic change from<br />
the past which was much more about extrapolation based<br />
on regulatory studies. Now there is a need to go back to<br />
the payers, one, two or three years post-launch with the data.<br />
Q: What are the challenges in collecting<br />
real-world data?<br />
JK: One problem we have with real-world data is the<br />
lack of guidelines on how to do it. Everyone knows how<br />
clinical trials have to be conducted, but there are two<br />
issues for real-world data: one is the fact that clinical trials<br />
EUROPE | INSIGHTS<br />
have been developed to get rid of all the confounding<br />
factors and now it seems we are interested in finding out<br />
about all those confounders, which can be difficult. The<br />
other is that collecting data for prospective observational<br />
studies can be time consuming and expensive and in<br />
Europe in particular, one of the biggest challenges is in<br />
finding the data. You need to have people who are very<br />
familiar with healthcare systems at the local level with<br />
the experience and expertise to find the right sources of<br />
information. This is a big challenge for the industry to<br />
navigate through the real-world data sources.<br />
Q: What are the implications for<br />
outcomes research?<br />
JK: Many markets are now becoming mature and new<br />
products are having to fight for a position and the only<br />
way they can do that is to get into more specialized<br />
positions in the market, for example, by not only<br />
addressing the main disease but also its co-morbidities.<br />
The other element is understanding that the data needs<br />
of increasingly powerful payers are concerned with<br />
knowing what a product is doing in real life, and that<br />
insight can only be obtained by doing observational<br />
studies. Patient empowerment is also an important<br />
aspect. Yet another inroad into real world data is getting<br />
a better understanding of patients and addressing patient<br />
needs so patient reported outcomes become more<br />
important. If you put all of this together, you will<br />
understand that your typical protocolized clinical trial<br />
will not answer all the questions of other stakeholders<br />
who have become much more important in the market.<br />
Q: How is <strong>HEOR</strong> evolving in emerging markets?<br />
JK: The typical cycle for emerging markets is that their<br />
economies are expanding quite dramatically, there is a<br />
population of people with the means to pay for<br />
healthcare, new higher priced technologies come onto<br />
the landscape and when these markets evolve even<br />
further and start to encounter the same sorts of issues that<br />
developed countries have experienced in the past. We see<br />
countries like Korea, for example, trying to learn from<br />
the success and failures of say Western European markets.<br />
So the emerging countries are following a much more<br />
expedited process of adoption of HTA and <strong>HEOR</strong><br />
which cuts short of our learning curve there. We see a<br />
similar pattern in their willingness to adopt biogenerics<br />
far more quickly than has been the case in Europe and<br />
the U.S. •<br />
<strong>AccessPoint</strong> - Issue 1 Page 17
INSIGHTS | EMERGING MARKETS: CEE<br />
The emerging pharmaceutical markets of<br />
Central and Eastern Europe have their own<br />
unique characteristics but share the goal of<br />
improving access to healthcare against a<br />
backdrop of rising costs. With a lens on<br />
Russia, Romania and Ukraine, each at very<br />
different stages of evolution, we consider how<br />
important changes and a growing need for<br />
evidence-based decision support are opening<br />
up new opportunities for health economics<br />
and outcomes research.<br />
The authors<br />
Yevgeniy Samyshkin, MSC is Engagement Manager<br />
<strong>HEOR</strong>; Paula ¸Tele, MD, MPH, MSC is Consultant <strong>HEOR</strong>;<br />
and Wioletta Kotowa, MD is Senior Consultant <strong>HEOR</strong>,<br />
all at <strong>IMS</strong> <strong>Health</strong>.<br />
YSamyshkin@uk.imshealth.com<br />
PTele@uk.imshealth.com<br />
WKotowa@de.imshealth.com<br />
Page 18 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
RUSSIAN FEDERATION: INVESTING IN HEALTH<br />
In Russia, investment in healthcare is considered a longterm<br />
national priority as a means of reducing mortality<br />
rates and increasing life expectancy. A program of<br />
measures for the next ten years has recently been outlined<br />
in the Concept of <strong>Health</strong>care Development 2020.<br />
Vast market, complex system<br />
Before examining these measures in more detail, it is<br />
important to bear in mind the vast and expanding scale<br />
of the Russian healthcare market. Government health<br />
expenditures per capita reached US$590 in 2010<br />
compared to around US$360 in 2005 (at exchange rate).<br />
And their continued growth is anticipated: estimates from<br />
the Federal Ministry of <strong>Health</strong> and Social Development<br />
suggest rates of US$1,400 in 2017 climbing to US$1,800<br />
by 2020 (Figure 1).<br />
<strong>Health</strong>care in the Russian Federation is a complex multitier<br />
system, combining federal and regional programs<br />
financed through a mixture of general tax, mandatory<br />
health insurance contributions, voluntary insurance, and<br />
formal and informal contributions from private patients.<br />
The financing and organization of the nation’s healthcare<br />
service mirrors the tiered government administration and<br />
budgetary system at the federal, regional and municipal<br />
levels. Federal financing tends to support tertiary service<br />
development, and provision of high-cost treatments and<br />
diagnostic procedures through financing of federal<br />
facilities and targeted programs.<br />
To date, the major single systemic change in the Russian<br />
healthcare system has been the establishment of the<br />
Mandatory <strong>Health</strong> Insurance (MHI) system in 1993, with<br />
federal funding of health services to allow more flexible<br />
resource allocation mechanisms. Its creation has enabled the<br />
government to experiment with such key concepts as the<br />
purchaser-provider split; contracting of private insurance<br />
companies to administer health insurance reimbursement;<br />
the increasing use of healthcare information for planning<br />
and management purposes; and ultimately moving away<br />
from the budgeting of healthcare providers to volumebased<br />
contracting of services. Federally, priority is given to<br />
the development of high-tech services, with investment in<br />
regional tertiary service centers to strengthen such areas as<br />
cardiac surgery, endocrinology, prosthetic medicine,<br />
neurosurgery, transplantation, and reproductive medicine.<br />
EMERGING MARKETS: CEE | INSIGHTS<br />
Moves to HTA<br />
in Central & Eastern Europe<br />
Over the last decade, the federal government has<br />
implemented and tested a range of programs and national<br />
projects to improve the healthcare system and increase<br />
patient access to essential pharmaceuticals. Among the<br />
most well-known is the DLO (2005), a supplemental<br />
out-patient pharmaceutical benefits program designed to<br />
increase access to pharmaceuticals for defined population<br />
groups and provide high-cost drugs for rare diseases and<br />
for use in transplantation medicine.<br />
New initiatives<br />
More recently, a new system of Mandatory Pharmaceutical<br />
Insurance has been under discussion in Russia. First<br />
conceptualized in 2008 by the Federal Mandatory <strong>Health</strong><br />
Insurance Fund, this was originally intended for<br />
implementation in 2010. However, these plans have now<br />
been postponed, pending government attempts to regulate<br />
the market and develop mechanisms to ensure<br />
sustainability of the pharmaceutical insurance package.<br />
System-level changes to continue<br />
A number of system-level changes can be expected in<br />
Russia in the coming years including:<br />
• Greater move towards a single-channel health<br />
financing system with MHI as the single payer.<br />
• Transformation of the pharmaceutical landscape led<br />
by stronger emphasis on cost-containment and the use<br />
of pharmacoeconomics in reimbursement decisions.<br />
Provision for universal pharmaceutical insurance is also<br />
on the healthcare agenda.<br />
• Specific regulatory and economic measures to curb<br />
further cost growth and maximize health<br />
improvement, focusing on pricing policies, the greater<br />
use of guidelines, the introduction of patient copayments<br />
and controls to ensure appropriate<br />
prescribing by doctors.<br />
The main vehicle for these changes would be the MHI<br />
system. Given the scale of the Russian economy and the<br />
complexity of its socio-economic environment, the<br />
government has a major challenge ahead in terms of<br />
implementation but one that brings the promise of<br />
continued improvements in healthcare delivery. Certainly,<br />
advances in modern technologies, coupled with the<br />
developments in Russia’s healthcare system over the last<br />
decade, are increasing awareness of the role of<br />
<strong>AccessPoint</strong> - Issue 1 Page 19
INSIGHTS | EMERGING MARKETS: CEE<br />
Russian government<br />
health expenditures per<br />
capita reached<br />
US$590 in 2010<br />
compared to around<br />
US$360 in 2005 (at<br />
exchange rate) and<br />
their continued growth<br />
is anticipated.<br />
...continued from previous page<br />
pharmacoeconomics and outcomes studies in supporting decisions<br />
on the impact and rational use of health innovations in the<br />
country.<br />
USD per capita<br />
FIGURE 1: PROJECTED HEALTHCARE EXPENDITURE PER<br />
CAPITA IN RUSSIA<br />
$2,000<br />
$1,000<br />
$1,600<br />
$1,400<br />
$1,200<br />
$1,000<br />
$800<br />
$600<br />
$400<br />
$200<br />
$0<br />
2010<br />
<strong>Health</strong>care expenditures per capita 2010-2020<br />
Pharmaceuticals<br />
National project health<br />
Federal health facilities<br />
Regional and municipal health budgets<br />
Mandatory health insurance<br />
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020<br />
Source: Ministry of <strong>Health</strong> and Social Development 2009-10<br />
ROMANIA: REACHING OUT TO HEALTH ECONOMICS<br />
After a promising period of economic growth following its<br />
integration into the EU in 2007, Romania has felt the impact<br />
of the global financial crisis more keenly than most countries in<br />
the last two years. Ever shrinking budgets have seen government<br />
strategies progressively more focused on managing costs,<br />
significantly impacting the price of medicines and intensifying<br />
the pressure on market access. Successive governments have now<br />
tried nearly every type of cost-containment measure that has<br />
ever been introduced elsewhere in Europe.<br />
In April 2009, Romania’s status as the lowest priced<br />
pharmaceutical market in Europe was consolidated by the<br />
introduction of international reference pricing rules. Currently,<br />
therapeutic reference pricing applies to products reimbursed at<br />
50% and 90% but this is due to be extended to products<br />
proposed for 100% reimbursement. The budget for fully<br />
reimbursable products in the national program for chronic<br />
diseases has come under particular scrutiny in recent months,<br />
resulting in methods for cost/volume agreements and stricter<br />
reimbursement criteria from October 2010. Medicines in this<br />
list account for a significant share of the pharmaceutical market,<br />
with many higher price products included. This measure will<br />
be accompanied by the introduction of therapy guidelines.<br />
The positive reimbursement list is the main means of controlling<br />
prescribing in Romania, with clear stipulations on the<br />
reimbursement level and conditions of use for each drug. Product<br />
inclusion will continue to be the primary driver of prescribing<br />
in the country and as such is a critical goal for manufacturers<br />
launching new pharmaceutical technologies.<br />
Page 20 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
New role for HTA<br />
Although evidence-based, economic evaluations of new<br />
therapies are now widely used for reimbursement<br />
decisions across Europe, in Romania a national HTA<br />
initiative has only recently been introduced - despite a<br />
long-recognized need for one. Under a Government<br />
Ordinance in March 2008, primarily as a move towards<br />
harmonization under EU pharmaceutical policy, health<br />
economics data was made pre-requisite for drugs<br />
introduced on the reimbursement lists.<br />
Notwithstanding this important advance, it remains<br />
unclear how these data will be used given the absence of<br />
Romanian guidelines on conducting pharmacoeconomic<br />
analyses. Thus far, the decision making process has been<br />
based mainly on studies undertaken in Western Europe,<br />
overlooking critical issues in the transferability of health<br />
economics results from one country to another and the<br />
consequences of such a practice.<br />
Lack of data a key challenge<br />
More recently, under the pressure of the current<br />
government regulations, pharmaceutical companies have<br />
come to appreciate the importance of determining and<br />
demonstrating the value of their products specifically in<br />
the Romanian market, using Romanian data,<br />
understanding that a key requirement in showing costeffectiveness<br />
and ‘value for money’ is to address countryspecific<br />
willingness-to-pay. However, lack of<br />
transparency in the market is an issue, and there is<br />
growing recognition that the biggest challenge for health<br />
economics and outcomes research is finding the necessary<br />
data. In-depth, on-the-ground knowledge, the ability to<br />
retrieve relevant cost, clinical and epidemiological<br />
information across therapy areas, and appropriately<br />
validate the results with local experts will be key to the<br />
successful development of rigorous and relevant value<br />
propositions in Romania.<br />
UKRAINE: HARD HIT BUT RECOVERING<br />
Also hard hit by the global financial crisis, the Ukraine<br />
economy is now showing signs of recovery, with GDP<br />
increasing by 4% in 2010 according to official statistics 1 .<br />
However, healthcare remains severely under-funded, with<br />
expenditure accounting for less than 4% of GDP –<br />
widely accepted to be inadequate. Patients are<br />
responsible for more than a third of total healthcare<br />
spend, but private healthcare remains out of financial<br />
reach for most of the population.<br />
The potential for some form of public health insurance<br />
EMERGING MARKETS: CEE | INSIGHTS<br />
Moves to HTA in Central & Eastern Europe<br />
system in Ukraine has been discussed and explored for a<br />
number of years. Various proposals have been drafted but<br />
to date these have proved too cost-prohibitive to<br />
implement. More recently, under the new government,<br />
the issue of healthcare reform has taken on greater<br />
importance and first steps have been taken with the<br />
introduction of municipal sickness funds in a number of<br />
regions in Ukraine. These have yet to reach the capital<br />
but are indicative of some progress being made.<br />
As patients bear the brunt of total healthcare costs in<br />
Ukraine, via out-of-pocket payments, purchasing power<br />
in the country remains extremely low. There is no system<br />
of national price regulation for pharmaceuticals, the main<br />
control being maximum retail surcharges for<br />
pharmaceuticals and medical devices. However, these<br />
cover only 16% of all products registered.<br />
Strong emphasis on generic medicines<br />
Not surprisingly, given the lack of a reimbursement<br />
system and high level of patient out-of-pocket pay for<br />
medicines, 80% of the Ukraine pharmaceutical market<br />
consists of generic products. The reliance on inexpensive<br />
drugs and branded generics supports a strong local<br />
pharmaceutical industry, which produces just under half<br />
of all medicines sold in the country. The emphasis is on<br />
cardiovascular medicines, analgesics, vitamins, drugs for<br />
respiratory disease and blood system disorders,<br />
gastrointestinal medicines, and antibiotics.<br />
Acknowledged deficiencies<br />
Problems with the availability of medical services and<br />
medicines in Ukraine have recently become more<br />
pronounced. The state is unable to provide sufficient<br />
resources for guaranteeing accessible, quality treatment,<br />
there are acknowledged inefficiencies in the existing<br />
public health system, and a fall in indicators of health<br />
coupled with an adverse demographic situation clearly<br />
point to the need for major change. The fact that the state<br />
should better control medical services is widely accepted 2 .<br />
The search for additional sources of financing of public<br />
health services has been discussed in the context of a<br />
potential tax to be added to the price of medicines. Equally,<br />
the introduction of obligatory medical insurance in<br />
Ukraine would enable the provision of healthcare services<br />
across the population while providing the state with an<br />
essential stream of revenue for compensation of treatment<br />
costs. It would also allow some control to be exercised over<br />
the efficiency and expediency of medical prescribing. Those<br />
who are in favor of introducing obligatory social medical<br />
insurance, hope that the increased financial resources would<br />
<strong>AccessPoint</strong> - Issue 1 Page 21
ANALYSIS INSIGHTS | EMERGING MARKETS: MARKETS CEE<br />
...continued from previous page<br />
be efficiently used under the control of the state.<br />
Trialing drug reimbursement<br />
As a first step towards transitioning from state purchases of medicines<br />
to a compensation system for out-patient drugs in Ukraine, a pilot<br />
project was planned by the Public service of the Ministry of <strong>Health</strong><br />
in 2009, focusing on the reimbursement of insulin for diabetes<br />
patients. However, the Public service was disbanded and all works<br />
were subsequently suspended. Nevertheless, the experience of this<br />
pilot project could prove useful in the future for the development<br />
of a reimbursement system covering all groups of vitally<br />
important medicines 3 .<br />
By drawing on the experience of Western Europe, Ukraine can<br />
and should construct as soon as possible an effective model of<br />
public health services based on the Law of Obligatory Social<br />
Medical Insurance and its provision of free medical care to all<br />
citizens. Adoption of such a law would be a significant turning<br />
point for reform of the system, paving the way for the funding<br />
of medical services and introduction of HTA in the country.<br />
Moves towards HTA<br />
Although the term <strong>Health</strong> Technology Assessment (HTA) is still<br />
new to Ukraine, there has been growing interest in this type of<br />
evaluation and its role in pricing and reimbursement. Indeed,<br />
HTA has been the subject of several national and international<br />
conferences and forums in the country over the last few years 4 .<br />
Attended by senior figures, including members of Ukraine’s<br />
Ministry of <strong>Health</strong>, these signal growing recognition of the<br />
importance of HTA and an eagerness to learn more about the<br />
pricing and reimbursement models existing in different<br />
European countries.<br />
Particular emphasis has been placed on the independence of<br />
HTA institutions, empowering them with advisory or regulating<br />
functions with delegation of the right of decision making. This<br />
principle of independence and objectivity in the system is<br />
currently broken in Ukraine: the Official committee is part of<br />
the State pharmacological center of the Ministry of <strong>Health</strong>, the<br />
body responsible for the State registration of medicines, giving<br />
rise to problems around the maintenance of official management.<br />
Despite recognition that evaluating health technologies is<br />
absolutely necessary for rational use of limited resources in<br />
Ukraine, there is also professional realization that HTA will<br />
require considerable additional resources and this is likely to be<br />
a key issue for its implementation going forward 5 . •<br />
1 http://www.kmu.gov.ua/control/uk/publish/article?art_id=243697161&cat_id=24<br />
3311332<br />
2http://tristar.com.ua/1/art/obiazatelnoe_strahovanie__lekarstvo_dlia_meditsiny_13 978.html<br />
3http://www.expert.ua/articles/16/0/6215/ 4http://www.apteka.ua/article/43962; http://ipr.adcontext.net/10/09/24/61055;<br />
5http://tristar.com.ua/1/art/ukraine_nujen_zakon_ob_obiazatelnom_sotsialnom_me ditsinskom_strahovanii_14052.html.<br />
Page 22 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
EMERGING EMERGING MARKETS: MARKETS CEE | EXPERTISE<br />
| PEOPLE<br />
Understanding CEE markets<br />
INTRODUCING <strong>IMS</strong> SPECIALISTS WITH LOCAL EXPERTISE IN THE CEE REGION<br />
Lusine Breitscheidel, MD, MPH<br />
Lusine Breitscheidel is a Senior Consultant, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong>,<br />
focusing on pharmacoeconomics and pharmacoepidemiology. With more than 12 years experience in<br />
epidemiology and over five years in <strong>HEOR</strong> she has worked on many national and international projects<br />
addressing healthcare issues in the EU, as well as South Caucasus, the Republics of Armenia, Georgia<br />
and Azerbaijan, and Russia. Lusine holds an MD from the University of Munich and an MPH from the<br />
State University of New York.<br />
Lyudmila (Mila) Gorokhovich, MSC<br />
Lyudmila Gorokhovich is an Analyst, <strong>Health</strong> Economics and Outcomes Research, at <strong>IMS</strong> <strong>Health</strong>,<br />
with expertise in cost-effectiveness evaluations and comparative health system data analysis. She<br />
has worked with public healthcare payers to help determine best practice in health system<br />
performance, financing and reform, and developed analyses to support healthcare customers with<br />
commissioning decisions. A native of Ukraine, Mila holds a Masters in International <strong>Health</strong> Policy<br />
and <strong>Health</strong> Economics from London School of Economics and a degree in Economics and Human<br />
Rights from Columbia University.<br />
Wioletta Kotowa, MD<br />
Wioletta Kotowa is a Senior Consultant, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong>, with<br />
responsibility for developing value dossiers, HTAs and health economic evaluations. Formerly a<br />
physician, lecturer and researcher at the Medical University in Charkow, Ukraine, she brings extensive<br />
expertise across a range of medical indications, pharmaceuticals and medical devices as well as<br />
industry experience in Phase IV studies. Wioletta holds an MD from the Medical High School (now<br />
Medical University) of Charkow, Ukraine.<br />
Yevgeniy Samyshkin, MSC<br />
Yevgeniy Samyshkin is an Engagement Manager, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong><br />
<strong>Health</strong> focusing on pharmacoeconomic modeling and reimbursement submissions. He has worked in<br />
Central Asia, designing and implementing national reimbursement systems for hospitals, and as an<br />
independent consultant in health policy and financing for the World Bank, Asian Development Bank,<br />
WHO and USAID. Yevgeniy holds an MSc in <strong>Health</strong> Management and Economics from Imperial College<br />
Business School, London and a first degree in Science from Tomsk University, Russia.<br />
Margarita Shlaen, MPH<br />
Margarita Shlaen is a Consultant, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong>, with<br />
expertise in public health, data management, statistical analysis of health economics studies and<br />
evaluation of epidemiological data. Her experience includes the management and evaluation of<br />
population-based prophylactic and vaccination programs in St. Petersburg, Russia. Margarita holds<br />
a Masters in Public <strong>Health</strong> from the Ludwig-Maximilian University, Munich and a Science degree<br />
from St. Petersburg University School of Epidemiology & Public <strong>Health</strong>, Russia.<br />
Paula ¸Tele, MD, MPH, MSC<br />
Paula is a Consultant, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong>. Formerly with the<br />
European Medicines Agency, she has in-depth knowledge of healthcare systems in CEE, gained in roles<br />
as Assistant Professor in Public <strong>Health</strong> at the Carol Davila University of Medicine in Bucharest, an<br />
adviser for the Romanian National <strong>Health</strong> Insurance Fund, and a health economics specialist at Solvay<br />
in Romania. Paula holds an MD from the University of Medicine in Bucharest, an MSc in <strong>Health</strong> Policy,<br />
Economics and Management from Maastricht University and a <strong>Health</strong> Outcomes Research Diploma from<br />
the Vienna School of Clinical Research.<br />
<strong>AccessPoint</strong> - Issue 1 Page 23
INSIGHTS| <strong>IMS</strong> SYMPOSIUM<br />
Leap-frogging to evidence-based<br />
value in the Asia Pacific<br />
An <strong>IMS</strong> Symposium at the<br />
ISPOR 4th Asia Pacific<br />
Conference considered<br />
lessons, models and<br />
innovative solutions to<br />
facilitate market access<br />
in Asia.<br />
The speakers<br />
Abdulkadir Keskinaslan, MD, MBA, MPH is Market<br />
Pricing Director for Asia Pacific Region, Novartis<br />
Pharma AG<br />
Annie Chicoye, PHD is Development VP,<br />
<strong>Health</strong> Management Institute, ESSEC Santé Business<br />
School France-Singapore<br />
Mandy Chui, MBA is Regional Practice Leader,<br />
Pricing & Market Access, Asia Pacific, <strong>IMS</strong> <strong>Health</strong><br />
MChui@cn.imshealth.com<br />
Jonothan Tierce, CPHIL is Global Manager and<br />
Center of Excellence Leader, Global <strong>Health</strong> Economics<br />
and Outcomes Research at <strong>IMS</strong> <strong>Health</strong>.<br />
JTierce@us.imshealth.com<br />
The emerging markets of the Asia Pacific present both<br />
challenge and potential for healthcare improvement, as<br />
well as the deployment of innovative medical<br />
technologies. Growing quickly and changing fast, their<br />
drive to extend basic healthcare coverage to large<br />
underserved populations must be balanced against the<br />
need to manage escalating costs, achieve quality<br />
improvements across all patient segments and<br />
accommodate spurring innovation in medical<br />
technologies. In determining the best approach to these<br />
issues and achieving greater value from the money they<br />
spend on healthcare, there is a chance for these markets<br />
to gain ground from the lessons of Europe in managing<br />
the adoption of advances in care and controlling further<br />
cost growth. At the same time, as local and multinational<br />
manufacturers look to engage decision makers in these<br />
markets, there are also opportunities for new business<br />
models and innovative solutions to facilitate the move<br />
towards more cost-effective, value-driven care.<br />
STRONG GROWTH, BUT TESTING TIMES<br />
With a rapidly ageing population, growing middle class,<br />
and significant shifts in the pattern of disease that will see<br />
chronic conditions at the forefront of medical need by<br />
2030, the emerging markets of Asia present significant<br />
opportunities for healthcare growth and expansion. For<br />
governments, however, this simply heightens the dilemma<br />
of poor healthcare infrastructure, low accessibility to<br />
quality treatment, rising demand for innovative<br />
products, and limited funding for the healthcare<br />
needs of an expanding population. How to strike<br />
the balance between broadening access, adopting<br />
new technologies and encouraging further<br />
(high-priced) innovation is now a<br />
defining challenge in these markets.<br />
Against this background there are<br />
already signs of major change and<br />
development, including ambitious<br />
programs for healthcare reform and<br />
the establishment of new health<br />
insurance programs – China alone is<br />
investing 125 billion dollars in the next three<br />
years to broaden the access of medicine with<br />
a commitment to expand health insurance<br />
coverage to 90% of its population by 2011.<br />
Most of the emerging Asia Pacific markets have already<br />
Page 24 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
egun imposing various kinds of cost-containment<br />
measures, including sweeping price cuts (e.g. Philippines,<br />
Korea), the use of DRGs and compulsory licensing (e.g.<br />
Thailand), international reference pricing (e.g. Korea,<br />
Taiwan), patient co-payments (e.g. Philippines, China,<br />
Thailand) and greater encouragement of generic<br />
substitution (e.g. Korea, Thailand, China) – all primarily<br />
with a focus on short-term control of drug expenditure<br />
(Figure 1).<br />
Some countries, such as the reimbursed markets of Korea<br />
and Taiwan, have now begun to take a longer-term view<br />
of cost-containment, with the adoption of some form of<br />
<strong>Health</strong> Technology Assessment (HTA) as a way of<br />
Measures<br />
Price cut<br />
International<br />
reference pricing<br />
Patient co-payment<br />
Generic substitution<br />
Hospital budget<br />
capping<br />
Selective<br />
reimbursement<br />
Prescription<br />
restrictions<br />
HTA<br />
China Thailand Philippines Korea Taiwan<br />
Low High<br />
FIGURE 1: VARIOUS COST CONTAINMENT MEASURES ARE<br />
EMERGING IN ASIA PACIFIC MARKETS<br />
optimally utilizing their healthcare resources and at the<br />
same time provide more channels for providing<br />
innovative product access into the market. Elsewhere, in<br />
the semi-reimbursed markets (e.g.China, Thailand) or<br />
those dominated by out-of-pocket payment<br />
(e.g.Philippines, Indonesia), they are still learning about<br />
this system and it has not yet been put into practice. There<br />
is clearly conceptual acceptance of HTA as a way to look<br />
at cost-effectiveness, and an increased willingness to<br />
pursue this approach, but shortage of talent and the right<br />
resources is currently a major barrier. This lack of real<br />
ability to take the critical next step reflects not only a<br />
dearth of pre-requisite skills, but also, importantly, a<br />
paucity of data – both local, clinical and cost-effectiveness<br />
– and overcoming this will be key to the adoption of<br />
HTA in formal review processes in these markets.<br />
OPPORTUNITIES TO LEARN FROM EUROPE<br />
As governments in Asia struggle to find the balance<br />
between access to medicine and rewarding innovation, we<br />
can see in the drug/new technology management systems<br />
<strong>IMS</strong> SYMPOSIUM | INSIGHTS<br />
of France, the UK and Germany, some key lessons that<br />
may help in determining the best approach in the<br />
emerging markets of the Asia-Pacific. These European<br />
regulators have been creative with cost-containment tools<br />
and support for national industry (Figure 2), but the results<br />
have not always been in line with expectations. Their<br />
experience shows that HTA had to be progressively<br />
integrated into these measures to improve the efficiencies<br />
of health expenditure regulations.<br />
Price Control: France<br />
In France, prices for reimbursable drugs have been fixed<br />
by the government since 1948, but for more than three<br />
decades this proved insufficient to control expenditures<br />
or sufficiently reward true innovation: few drugs were<br />
selected for reimbursement; volumes were high to<br />
compensate low prices; price competition was nonexistent;<br />
and there was consequently no sensitivity to the<br />
costs of drugs. The result was double-digit growth in<br />
pharmaceutical expenditures over a number of years.<br />
Efficiency made its way into the system in 1980, when<br />
relative clinical effectiveness was adapted and became the<br />
anchor for fixing the price of new medications. Even<br />
then, it took almost 20 years to improve volume control<br />
in collaboration with the pharmaceutical industry. In the<br />
meantime, additional measures were required to improve<br />
the rationality of prescriptions – including fixed pharma<br />
budgets and generic substitution. Finally, growth in<br />
expenditure has fallen - from 7% in 2000 to 2.8% in 2009<br />
- enabling access to innovative drugs with a relatively<br />
short delay at international prices, because innovation is<br />
truly well-selected.<br />
Profit Control: UK<br />
The UK system was built around the principle of profit<br />
control via the Pharmaceutical Price Regulation Scheme<br />
(PPRS) adopted in 1957. Although not primarily<br />
Patient<br />
co-payments<br />
International<br />
reference pricing<br />
Promotional<br />
limitations<br />
<strong>AccessPoint</strong> - Issue 1 Page 25<br />
Therapy<br />
pricing<br />
Profit<br />
controls<br />
Price<br />
controls<br />
Industry (R&D<br />
production, exports)<br />
Generic<br />
prescriptions<br />
…and HTA<br />
had to be introduced<br />
into the picture<br />
HTA<br />
Relative clinical<br />
effectiveness<br />
Costeffectiveness<br />
Generic substitutions<br />
by pharmacists<br />
Risk-sharing<br />
agreements<br />
Prescription<br />
budgets<br />
Prescription<br />
guidelines<br />
Selective<br />
reimbursement<br />
FIGURE 2: GOVERNMENTS IN EUROPE HAVE BEEN CREATIVE<br />
WITH APPROACHES TO COST CONTROL
INSIGHTS| <strong>IMS</strong> SYMPOSIUM<br />
designed to control prices, but rather to promote a strong<br />
and profitable pharma industry, in practice the system<br />
exists at a global level to control the return on capital<br />
employed (ROC). The result has been a productive UK<br />
pharmaceutical industry in terms of global NCEs<br />
developed, but one with a very low share of the global<br />
market. Indeed, the Office of Fair Trading famously<br />
criticized the PPRS for failing to foster value-for-money<br />
decisions, particularly in relation to across-the-board<br />
price cuts that were not in relation to value. This has since<br />
been integrated to some extent into the new PPRS and<br />
it is value-based pricing which is the ground for risksharing<br />
agreements or rebates to the NHS.<br />
It was the failure of the PPRS to make the best use of<br />
the limited resources allocated to the NHS which<br />
ultimately led to the establishment of NICE (National<br />
Institute for <strong>Health</strong> and Clinical Excellence) in 1999, as<br />
a guiding body to ensure equal access, promote<br />
innovation and achieve the best use of resources,<br />
independently of the PPRS.<br />
Would a PPRS be relevant in Asia Pacific countries?<br />
While there may be a connection between the regulation<br />
of pharmaceutical expenditures and the attractiveness of<br />
a country in terms of pharma investments, the example<br />
of the UK is worthy of a cautious note: If HTA is not<br />
carefully introduced, it may convey aggressive pricing and<br />
restrict access to care – an issue which has proved to have<br />
serious consequences in the UK market, as witnessed by<br />
the outcry following restrictions on access to oncology<br />
drugs.<br />
Capped Budgets and Reference Pricing: Germany<br />
The German government has also been keen to promote<br />
free pricing and a strong pharmaceutical industry but<br />
faced with the need to contain escalating costs introduced<br />
two innovations: Firstly, limited budgets for prescribing,<br />
with penalties for exceeding targets. In practice, this<br />
policy had painful repercussions, encouraging referrals<br />
from office-based practices to hospitals to avoid the costs<br />
for prescriptions.<br />
The lessons to be learned here are that prescribing budgets<br />
have to be very carefully managed. More importantly, is<br />
the need to negotiate with physicians and impose good<br />
clinical practices before limiting budgets in order not to<br />
harm the quality of care. And defining good clinical or<br />
medical practice relies, of course, largely on HTA.<br />
A second innovation from Germany is therapeutic<br />
pricing, where prices for reimbursed drugs remain free,<br />
but products with the same ingredient or therapeutic<br />
effect are clustered together and a unique tariff set for<br />
reimbursement. Should a company not align the price,<br />
the patient must pay the difference; and if alternatives are<br />
available, doctors are encouraged to prescribe them. The<br />
result is that companies invariably do align their prices<br />
to the tariff, otherwise running the risk of losing market<br />
share very quickly.<br />
While this is thus a very rapid and effective tool for<br />
reducing prices, it does have drawbacks: Not all drugs can<br />
be clustered; litigations can arise if the comparable<br />
therapeutic effect is not grounded on a solid health<br />
technology process; and it does mean that companies<br />
tend to charge more for non-clustered products to<br />
compensate for lower prices on referenced products.<br />
KEY TAKEAWAYS<br />
Experience in Europe has shown that cost-containment<br />
measures must address the whole picture and not only<br />
prices or profit. Dialogue between the industry and<br />
decision makers is a key to finding solutions that go<br />
beyond strict, short-term price control. HTA has to be<br />
introduced in the decision process, not only to select<br />
pharmaceuticals for reimbursement or eventually medical<br />
devices, but also to support the rational behavior of all<br />
the stakeholders. And while the role of HTA in the<br />
decision making process may vary from one country to<br />
another, all stakeholders must be clear that it has to be<br />
based on appropriate expertise and data.<br />
NEW MODELS OF ENGAGEMENT<br />
Against this background of change and challenge in the<br />
increasingly cost-sensitive landscape of the Asia Pacific,<br />
companies looking to engage with local decision makers<br />
are already taking innovative approaches to the market,<br />
that have them partnering with other stakeholders, such<br />
as payers, governments and providers, to offer key medical<br />
technologies while accepting some of the cost risk. Some<br />
examples of the contracting and patient access schemes<br />
that are emerging in these markets are discussed below.<br />
APPROACHES TO CONTRACTING<br />
The growing difficulty of obtaining reimbursement for<br />
high-priced innovative drugs in the Asia Pacific has seen<br />
more companies willing to enter into programs built<br />
around the concept of value-based pricing, based on the<br />
principle of risk-sharing to improve a product’s costeffectiveness.<br />
They are a way of facilitating equitable<br />
access to effective care and enabling HTA bodies to<br />
recommend treatments that they would otherwise deem<br />
not cost-effective.<br />
These innovative approaches to contracting, which<br />
include consideration of pricing, can be financial-based,<br />
involving a price/volume agreement; outcomes-based,<br />
involving some form of money-back guarantee; or risk-<br />
Page 26 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
ased, with reimbursement linked to value and level of<br />
risk. Risk-based pricing models are extensively used in<br />
Australia where patient segments or indications are<br />
placed into different risk segments.<br />
Certain sub-categories of financial models involve capped<br />
pricing at the patient or population level. In self-pay<br />
markets, there are also examples at the willingness-to-pay<br />
or affordability level, whereby companies provide<br />
incremental discount based on patient compliance. These<br />
may involve such elements as an upfront discount,<br />
additional services, free diagnostic tests, etc. In the<br />
affordability model, there are examples of where companies<br />
try to address the ability to pay and charge accordingly.<br />
Examples in Asia Pacific<br />
Some recent approaches to innovative contracting and<br />
market access schemes in Asia are shown in Figure 3. In<br />
China, high-price products are identified for face-to-face<br />
negotiations; Patient Assistance Programs (PAPs) are<br />
possible but involve a significant price cut. In the<br />
Philippines and Indonesia, there are many differential<br />
price contracting programs in line with the development<br />
of insurance schemes. These cover partially the lowest<br />
income level of the population or some of the insurance<br />
schemes for governmental workers. Korea, Taiwan and<br />
partially Thailand are working on developing guidelines.<br />
There are also many examples of PAPs in the Philippines,<br />
China<br />
Korea<br />
Hong Kong<br />
Taiwan<br />
Philippines<br />
Indonesia<br />
India<br />
Thailand<br />
Australia<br />
• High price products are identified for a special face-to-face<br />
negotiation<br />
• So far PAPs are possible but punished with significant price cut<br />
• Special agreement is doable; paying copayment, post<br />
reimbursement scope PAP<br />
• Guidelines under development<br />
• Discount for reimbursed drugs<br />
• Special agreements done for priority diseases or when<br />
there is a special funding available<br />
• Considering developing a review guideline with growing number<br />
of proposals<br />
• Discounting is effectively used<br />
• Special brand for DoH sales<br />
• Effective use of most self pay models like: loyalty cards,<br />
differential pricing<br />
• Special brands for ASKES and JAMKESMAS<br />
• Differential pricing and discounts<br />
• Testing environment for almost all consumer pricing models:<br />
assistance programs, loyalty cards, insurance<br />
• Discounts to institutional business<br />
• Patient Assistance Programs - GIPAP<br />
• High price products are identified for a special reimbursement<br />
supplement<br />
• Special pricing agreements is a growing trend for listing<br />
• Since 2008 details of the pricing agreements were not posted<br />
FIGURE 3: TRENDS IN INNOVATIVE CONTRACTING AND PATIENT<br />
ACCESS PROGRAMS IN ASIA PACIFIC<br />
<strong>IMS</strong> SYMPOSIUM | INSIGHTS<br />
including the KAAGAPAY program from Novartis and<br />
the GIPAP affordability-based model, with third party<br />
assessment of patient ability to pay and provision of<br />
additional patient support.<br />
Guiding criteria<br />
For countries struggling with the development of<br />
guidelines to determine whether a product is suitable for<br />
innovative contracting or risk-sharing deals, it is worth a<br />
closer look at the six very simple criteria adopted by the<br />
Pharmaceutical Benefits Advisory Committee (PCAB)<br />
in Australia:<br />
1. Significance of disease<br />
2. Degree of incremental benefit conferred<br />
3. Unique characteristics compared to available<br />
alternatives<br />
4. Effective price is consistent with price recommended<br />
as acceptably cost-effective<br />
5. Significant financial benefit to payer<br />
6. International reference to effective price<br />
SUMMARY<br />
Overall, we can see that the emerging countries of the<br />
Asia Pacific region present challenge along with the<br />
exceptional opportunity to participate in these markets.<br />
Understanding their healthcare challenges is a prerequisite<br />
for being successful, but it also implies a role in helping<br />
to evolve the healthcare structures and systems that are<br />
needed to address the conflicting problem of broad market<br />
access to quality healthcare while managing the costs of<br />
providing that care. Governments and other healthcare<br />
decision makers can draw the lessons from the years of<br />
managing healthcare growth and costs in Europe, but<br />
perhaps can leap-frog more quickly to something<br />
beneficial to all stakeholders.<br />
Manufacturers are already beginning to develop<br />
sometimes innovative partnering relationships with<br />
stakeholders in the region. As they evolve over the<br />
coming years, these relationships may help to define a<br />
uniquely Asia Pacific model of healthcare delivery. •<br />
<strong>IMS</strong> Symposium, Opportunities and Challenges in the<br />
Emerging Markets of Asia: Implications for Pricing, Market<br />
Access and <strong>Health</strong> Economics and Outcomes Research, held<br />
during ISPOR 4th Asia Pacific Conference, Phuket, Thailand,<br />
5-7 September 2010.<br />
To request a copy of the full proceedings please email<br />
aboucsein@de.imshealth.com<br />
<strong>AccessPoint</strong> - Issue 1 Page 27
INSIGHTS | MARKET ACCESS<br />
As decentralization of decision making<br />
continues to evolve across Europe, it is clear<br />
that while payers are developing more<br />
independent ways of working, there is also<br />
evidence of increased co-operation and<br />
converging management philosophies.<br />
Pharmaceutical companies must understand<br />
and address these apparently contradictory<br />
trends, and tailor their organizational<br />
approaches and performance management<br />
tools accordingly.<br />
The author<br />
Jon Resnick, MBA, is VP and Practice<br />
Leader, Pricing & Market Access<br />
at <strong>IMS</strong> <strong>Health</strong>.<br />
JResnick@imshealth.com<br />
Page 28 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
DIVERGENCE AND CONVERGENCE?<br />
In the evolving pricing and market access (P&MA)<br />
landscape in Europe, the seemingly opposing forces of<br />
divergence and convergence are starting to operate<br />
in tandem.<br />
On the one hand, there are signs of diverging decision<br />
making through increased decentralization. Payers with<br />
previously similar approaches are developing more<br />
independent ways of working; at the same time, the<br />
universe of stakeholders is rapidly expanding. The UK,<br />
for example, in addition to NICE, now has 6-8 relatively<br />
active HTAs; in France, regional agencies (ARS) are<br />
already ‘operational’; and the influence of ‘quasi-HTAs’<br />
is fast gaining ground in Spain and Italy.<br />
On the other hand, there are signs of converging<br />
approaches: payers are no longer individuals working in<br />
isolation, but networks of competent bodies, sharing best<br />
practices and consolidating activities, as evidenced by:<br />
MARKET ACCESS | INSIGHTS<br />
Optimizing market access in an<br />
increasingly decentralized landscape<br />
FIGURE 1: CORE APPROACHES TO MANAGING IN A<br />
DECENTRALIZED ENVIRONMENT<br />
Six core<br />
elements of<br />
approaches to<br />
managing in a<br />
decentralized<br />
environment<br />
Vision and strategy<br />
Organization<br />
Capabilities and resources<br />
Processes and roles<br />
Customer focus<br />
Objectives and measurement<br />
Source: <strong>IMS</strong> Consulting<br />
• Merging of health insurance funds (Krankenkasse)<br />
in Germany<br />
• Inter-regional hospital product assessments by<br />
Grupo Genesis in Spain<br />
• UK Primary Care Trust (PCT) alliances for<br />
sub-regional access decision making<br />
• Centralized purchasing through price-sharing at the<br />
sub-national level, e.g.in Italy (inter-regional) and<br />
Spain (intra-regional)<br />
MANAGING THROUGH THE COMPLEXITY<br />
Although the industry has long been responding to the<br />
challenges of decentralization, the complexity and<br />
fragmentation of markets continue to defy successful<br />
P&MA execution. Understanding the best approach to<br />
managing the local complexity, while balancing the need<br />
for central control and local autonomy, is key.<br />
Companies have been experimenting with a wide range of<br />
very different solutions. Despite these differences, a core<br />
set of elements is common across all approaches (Figure 1).<br />
• Clear direction for local affiliates<br />
• Some set high aspiration without articulating a strategy<br />
to achieve it<br />
• Alignment of organization to support payer-related<br />
activities<br />
• Risk of sub-optimizing P&MA in broader commercial<br />
reorganizations<br />
• Many organizations are increasing their P&MA resources<br />
• Customer-facing roles are using more strategic,<br />
relationship-minded skills<br />
• HQ and affiliates are formalizing roles, trying to strike<br />
appropriate balance<br />
• Affiliates have prioritized payers but struggle with<br />
allocating resources based on priorities<br />
• Shared objectives and performance measures align the<br />
organization around payer goals<br />
• Market access key performance indicators can increase<br />
transparency of market-level activity for senior managers<br />
<strong>AccessPoint</strong> - Issue 1 Page 29
INSIGHTS | MARKET ACCESS<br />
Companies must take<br />
time to understand the<br />
sub-national dynamics,<br />
allocating resources on<br />
the basis of prioritized<br />
stakeholders.<br />
...continued from previous page<br />
ITALY IN FOCUS<br />
To better understand the relative effectiveness of various<br />
company strategies, the Italian market is worthy of closer<br />
attention. Here, the rate and impact of change (Figure 2) have<br />
triggered a range of approaches, each yielding markedly<br />
different results. An <strong>IMS</strong> analysis of market access performance<br />
for new products launched across selected Italian regions from<br />
Jan 08-June 09, reveals several key insights:<br />
• Time to formulary access: Average time to regional<br />
formulary listing was around eight months from AIFA<br />
approval, although 20% of approved products were not<br />
included on any of the regional formularies. However,<br />
this finding masks significant differences across regions.<br />
• Regional ability to manage market access:<br />
Differences in listing times reflect various regional and<br />
company issues in managing market access. Factors such<br />
as size, market potential, utilization management and<br />
willingness to engage manufacturers all play a role in a<br />
region’s ability to manage market access and budgets. All<br />
regions had substantially overspent their hospital budget<br />
(set nationally at 2.4% of total healthcare spending) –<br />
ranging from Calabria (132.5%) to Lazio (221.0%).<br />
Impact of Change<br />
FIGURE 2: EUROPEAN DECENTRALIZATION COUNTRY DYNAMICS<br />
Medium/Low<br />
Rate of Change<br />
Managing and measuring market access<br />
Companies with the greatest alignment between market access<br />
goals and payer capabilities/potential are able to allocate<br />
resources most efficiently. However, there is little correlation<br />
between market access inputs (e.g.investment in resources and<br />
infrastructure) and outcomes (e.g.actual sales post-launch<br />
compared with pre-launch forecasts). In practice, some<br />
companies are significantly outspending their rivals without<br />
gaining quantifiable improvements in market access.<br />
Page 30 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH<br />
High/Low<br />
• ARS increasingly<br />
influential over time<br />
• Role and remit uncertain<br />
• Changes are taking time to<br />
come into effect<br />
• HTA proliferation but<br />
national level changes may<br />
supersede sub-national HTA<br />
• Consolidation of local (PCT)<br />
resources to create joined<br />
Low/Low<br />
High/Medium<br />
• HTA proliferation increasing<br />
the regional access hurdle<br />
• Legislative changes<br />
empowering regions<br />
• Information sharing<br />
Medium/Medium<br />
Low/Medium<br />
• Consolidation of the<br />
krankenkassen<br />
• Ever increasing appetite for<br />
aggressive contracting at the<br />
sub-national level<br />
• HTA proliferation<br />
increasing the regional<br />
access hurdle<br />
• Information sharing<br />
High/High<br />
Medium/High<br />
Low/High
Part of the issue concerns the assessment of performance<br />
– while most companies still use sales data as a key<br />
performance indicator (KPI) for access success, this fails<br />
to uncover drivers of under- or over-performance. For<br />
example, low uptake in a region may be the result of poor<br />
formulary listing.<br />
Key takeaways from Italy<br />
Several learnings can be drawn from the Italian<br />
experience:<br />
• Vision and strategy: Successful companies<br />
leverage a good understanding of the regional<br />
system to prioritize/secure access through an<br />
integrated provider and payer strategy.<br />
• Organization: Italian local affiliates use different<br />
organization models but this does not seem to<br />
differentiate performance. Affiliates appear to<br />
separate market access activities focused on national<br />
stakeholders from those focused at the sub-national<br />
level, without linking the sub-national market access<br />
unit to the business unit. These mini-silos decrease<br />
the ability to integrate pull-through efforts with<br />
access status.<br />
• Capabilities and resources: Precise approaches<br />
vary by company portfolio and setting of care.<br />
However, Italian affiliates usually identify 3-5<br />
regional account managers and 8-15 key account<br />
managers at sub-regional level. The best performing<br />
companies deploy resources by the potential and<br />
opportunity/challenge trade-off of the regions and<br />
sub-regions.<br />
• Processes, roles, and responsibilities: Italy<br />
experiences an unusually high level of market<br />
interventions from national, regional (and local)<br />
authorities. Successful companies have clear<br />
processes (including customer relationships) for<br />
gathering market intelligence, forecasting<br />
implications and reallocating resources.<br />
• Customer focus: The relative importance of<br />
stakeholders depends on their decision making<br />
influence and impact on prescribing. A key<br />
distinction between formal and informal influence<br />
requires a deep understanding to leverage:<br />
• Successful companies target the most important<br />
stakeholders in regions with the most ability to<br />
influence prescriber usage, and allocate resources<br />
appropriately.<br />
MARKET ACCESS | INSIGHTS<br />
Optimizing market access<br />
• Several organizations over-invest in market access<br />
resources in some regions and may be spending<br />
unnecessarily in those where access is less<br />
important.<br />
• Objectives and measurement: The exclusive use<br />
of sales-based KPIs to measure market access success<br />
makes it difficult to differentiate regional<br />
performance. The strategic use of market accessbased<br />
KPIs could help to capture company<br />
performance more accurately in the context of<br />
regional market characteristics (e.g., ease of entry,<br />
commercial opportunity) rather than against an<br />
absolute measure of sales:<br />
• At the product or portfolio level, appropriate<br />
metrics can include time to market, formulary<br />
penetration and extent of population covered.<br />
• Companies should track their own performance<br />
against plan to assess success, and against<br />
competitors to ensure they have accurate<br />
expectations and are not at a competitive<br />
disadvantage.<br />
BROADER IMPLICATIONS<br />
Although decentralized markets bring greater complexity,<br />
they also diversify the risk of single-body decision making.<br />
Companies must take time to understand the sub-national<br />
dynamics, allocating resources on the basis of prioritized<br />
stakeholders. Market access KPIs, tailored to regional<br />
specifics, can then help to ensure that markets are<br />
optimizing the potential of those products. These concepts<br />
are not magic bullets, but they do separate out the high<br />
performers. •<br />
“Companies have to<br />
completely rethink<br />
their consolidated<br />
European launch.”<br />
READ OUR INTERVIEW ON<br />
REGIONAL TRENDS WITH<br />
JACCO KEJA<br />
See page 15<br />
<strong>AccessPoint</strong> - Issue 1 Page 31
INSIGHTS | RISK EVALUATION<br />
Growing, intense and very public<br />
scrutiny of pharmaceutical<br />
products in the U.S. has fostered<br />
a high-pressure, higher-risk<br />
environment where development<br />
costs are rising and the<br />
probability of success has<br />
declined. The implications for<br />
pharma are considerable but<br />
with early, focused contingency<br />
planning, companies can<br />
prepare for the shifting<br />
risk/reward ratio.<br />
The author<br />
Jonothan Tierce, CPHIL, is Global<br />
Manager and Center of Excellence Leader,<br />
Global <strong>Health</strong> Economics and Outcomes<br />
Research at <strong>IMS</strong> <strong>Health</strong>.<br />
JTierce@us.imshealth.com<br />
Page 32 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
In the U.S., most companies are by now familiar with<br />
trends in Risk Evaluation and Mitigation Strategies<br />
(REMS), the FDA’s Sentinel Initiative and the comparative<br />
effectiveness research (CER) provisions of the Patient<br />
Protection and Affordable Care Act. But perhaps not all<br />
have yet joined the dots to see the larger theme that is<br />
emerging or to appreciate exactly what this means for the<br />
clinical and commercial side of their business.<br />
Effectively, the CER provision of the recently enacted<br />
U.S. healthcare reform bill, together with the FDA’s<br />
Sentinel Initiative and more aggressive approach to<br />
approval studies and post-approval monitoring, leave<br />
manufacturers with little to no control over the studies<br />
conducted and the results that are published on their<br />
products after Phase III. The very model for generating<br />
evidence on the safety and effectiveness of products is<br />
changing, which in turn is shifting the risk/reward ratio<br />
for product commercialization. All clinical development<br />
decisions should be reflecting this fact.<br />
THE BROAD CONTEXT<br />
The creation of the Patient Centered Outcomes Research<br />
Institute (PCORI), a non-profit, public-private partnership,<br />
to oversee CER has noticeably shifted the post-marketed<br />
environment. The instinctive reaction may be to assume<br />
that CER will be used as a club against manufacturers, but<br />
this becomes less of a concern when considered in the<br />
broader context of the government’s focus on improved,<br />
transparent safety and technology assessment. The U.S. is<br />
grappling with the self-same challenge as every other<br />
advanced society: How do you ensure universal access to<br />
quality healthcare while at the same time contain costs?<br />
Thus far, the answer in the U.S. has been to:<br />
• Increase the requirement for risk evaluation and<br />
mitigation strategies (REMS)<br />
• Apply more Black Box Warnings than ever before<br />
• Deny or delay approval for NMEs and new<br />
formulations more often<br />
• Put vast amounts of post-marketing safety data in the<br />
hands of the pharmacoepidemiological research<br />
community via the Sentinel Initiative<br />
• Establish the PCORI to oversee CER priorities and<br />
funding allocation<br />
RISK EVALUATION | INSIGHTS<br />
The Shifting Risk/Reward Ratio<br />
of Drug Development<br />
THE IMPACT OF CER<br />
Viewed in this light, CER is one more step along a<br />
clearly defined path – but one over which manufacturers<br />
have very limited control. And therein lies part of its<br />
significance. Until recently, most available product<br />
information has been owned and released by<br />
manufacturers. In the future, in addition to requisite premarketed<br />
studies and some company-sponsored Phase IV<br />
and/or registry studies, the landscape will be increasingly<br />
populated by a new breed of transparent, multistakeholder,<br />
publicly-funded or health-plan sponsored<br />
studies, designed to provide safety and comparative<br />
effectiveness information about manufacturers’ products<br />
– all of which creates a landscape dominated by nonproprietary<br />
product information to which manufacturers<br />
will undoubtedly need to react.<br />
Within the context of CER, it is possible to frame an<br />
approach for manufacturers in facing this element of the<br />
new environment:<br />
1. In-line products: It will be several years before CER<br />
studies are conducted and disseminated on products<br />
already on the market. Until then, much information will<br />
be drawn from meta-analyses, since they are relatively<br />
easy to conduct. However, once CER is applied, there<br />
will clearly be winners and losers.<br />
It could be predicted that products showing only limited<br />
incremental benefit relative to other branded and generic<br />
competitors will find it difficult to maintain formulary<br />
status and market share. The recent experience with the<br />
Enhance study on Vytorin and simvastatin sponsored by<br />
Merck1 suggests that payers are willing to make decisions<br />
based on single studies that call into question the cost<br />
justification for a branded drug over a reasonably good<br />
generic alternative 2,3 . Equally, there is nothing to prevent<br />
products offering significant improvements in clinical<br />
benefit from taking advantage of this additional<br />
opportunity to demonstrate value in the real-world setting.<br />
2. Late-stage products: Products in late-stage<br />
development face the prospect of CER upon entering<br />
the market. This is the chance for companies to get out<br />
ahead of payer and publicly-funded studies.<br />
By conducting their own CER evaluations, especially if<br />
they follow the CER model of transparency and arms-<br />
<strong>AccessPoint</strong> - Issue 1 Page 33
INSIGHTS | RISK EVALUATION<br />
Developers and brand<br />
managers should start<br />
picturing their products<br />
in a post-marketing<br />
environment where<br />
someone else controls<br />
the comparative<br />
effectiveness and safety<br />
information that is<br />
made public.<br />
...continued from previous page<br />
length oversight, manufacturers can gain a comparative advantage.<br />
Here, the old adage in retrospective studies should be<br />
remembered: real-world studies are messy studies. Because of the<br />
‘noise’ in the real-world environment the typical finding in these<br />
head-to-head comparisons is non-significance. Certainly, our<br />
experience at <strong>IMS</strong> has shown that in the use of retrospective<br />
claims data in post-marketing studies comparing the effectiveness<br />
of two worthy competitors, it is very difficult to differentiate one<br />
from the other.<br />
Products with studies producing neutral or negative conclusions<br />
will present challenges that must be addressed in their<br />
marketing, contracting and pricing.<br />
3. Early-stage products: For companies with products deep<br />
in the pipeline there is actually the opportunity to benefit from<br />
CER. If they have the foresight and resolve to abandon product<br />
concepts that are unlikely to differentiate themselves in postmarketed<br />
CER studies, they can concentrate on those advances<br />
that move the needle. Companies will disregard products that<br />
offer only incremental improvements over existing therapies;<br />
they will want to focus on guaranteed hits. This suggests the<br />
re-emergence of the blockbuster.<br />
THE IMPACT OF THE SENTINEL INITIATIVE<br />
The Sentinel Initiative is set to transform the FDA’s ability to<br />
track the safety of marketed drugs, biologics, and medical<br />
devices. This new electronic program complements the agency’s<br />
current Adverse Event <strong>Report</strong>ing System (AERS) by testing the<br />
signals it generates and scanning the environment for additional,<br />
possibly weaker, AE signals. It will be game changing in the<br />
number of studies that will be conducted, the number of signals<br />
that will be generated, and in the transparency of the process.<br />
Post-marketing surveillance is thus becoming a proactive search<br />
for weaker signals – a process that will likely generate many false<br />
positives to be validated/invalidated. The axiom in such<br />
research is that you rarely find what you are not looking for and<br />
invariably find what you are looking for. Since signs of adverse<br />
events, whether valid or false positives, may eventually be<br />
identified in the public arena, companies clearly need to be on<br />
the defensive and prepare for this possibility prior to launch.<br />
HIGHER-SCRUTINY POST-LAUNCH ENVIRONMENT<br />
The clear trend is towards subjecting drugs to a new level of<br />
scrutiny on their health outcomes, beginning in Phase III and<br />
continuing post-marketing - a scrutiny fuelled by adequate<br />
central funding and governed by a transparent, public-private<br />
partnership model. Ultimately, this high-pressure, higher-risk<br />
Page 34 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
environment will likely:<br />
• Reduce the number of drugs reaching the market<br />
• Lead to narrower indications<br />
• Strengthen safety labeling<br />
• Taint promotion, uptake, and access with safety concerns<br />
• Increase development costs and diminish probability<br />
of success<br />
By conducting their own CER<br />
studies of late-stage products,<br />
manufacturers can gain a<br />
comparative advantage<br />
ENSURING SUCCESS<br />
To operate successfully in the face of economic<br />
comparisons to alternative technologies and safety studies<br />
that produce false-positive signals, companies should<br />
consider a number of preparatory actions:<br />
1. Involve <strong>HEOR</strong>, pharmacoepidemiology and<br />
commercial teams in clinical development decisions.<br />
Clinical, commercial, pharmacoeconomic and <strong>HEOR</strong><br />
teams must work together, starting early in development,<br />
to consider relative value as a condition of go/no-go<br />
development decisions. This will involve simulating a<br />
product’s effectiveness, driving it to fail quickly, if indeed,<br />
it is going to fail.<br />
2. Apply the CER lens to development decisions.<br />
Companies need to decide which products they are<br />
going to pursue based on either the results of their own<br />
Phase III head-to-head comparative study or their<br />
expectations of what will happen when someone else<br />
undertakes the study after launch. This requires<br />
simulation modeling, scenario testing and evaluation of<br />
different product profiles to assess the risks.<br />
3. Design Phase III studies with competitive positioning<br />
in mind. Phase III studies should be structured to<br />
support the company’s primary goal: post-marketing<br />
approval. Some products may well lose their commercial<br />
attractiveness because they cannot be adequately<br />
differentiated in post-marketing, real-world CER studies.<br />
Again, trial simulations can be a relatively inexpensive<br />
way of managing the possibilities.<br />
RISK EVALUATION | INSIGHTS<br />
Risks and rewards<br />
4. Plan pre-launch for potential false-positive<br />
adverse event signals. This involves benchmarking and<br />
understanding class effects, re-examining dose-relative<br />
adverse effects, and having the staff and other resources to<br />
better understand and manage post-marketing safety<br />
concerns.<br />
5. Manage expectations. Too often, companies cling<br />
to the results of an early forecasting model, even in the<br />
presence of new information about a product’s<br />
performance from a Phase III study or simulation models.<br />
Instead, they should re-set expectations to reflect an<br />
altered view of reality.<br />
6. For late-stage products, find clear differentiation.<br />
Acceptance and adoption are just as important as<br />
measures of success as registration – perhaps more so. To<br />
succeed, trials must be designed to address pricing and<br />
stratification.<br />
7. Contract aggressively for undifferentiated products.<br />
If a product does not prove to be substantially different<br />
from another therapy, companies will need to be clever<br />
in their contracting strategy to encourage uptake.<br />
CONCLUSION<br />
Changes in the model for developing post-marketed<br />
information spell changes in the risk-reward calculus for<br />
drug development. Faced with the prospect of CER and<br />
increasing levels of safety scrutiny downstream,<br />
companies must focus on stronger investment in early<br />
commercial risk planning. With the help of health<br />
economics and outcomes research and other<br />
professionals, developers and brand managers should start<br />
picturing their products in a post-marketing environment<br />
where someone else controls the comparative<br />
effectiveness and safety information that is made public.<br />
To the extent that they can achieve this, companies can<br />
be positioned to make business decisions that benefit all. •<br />
1 Kastelein JJP and the ENHANCE investigators. Simvastatin with or<br />
without ezetimibe in familial hypercholesterolemia. N Eng J Med, 2008, Apr<br />
3; 358 (14): 1431-43. Epub 2008 Mar 30.<br />
2 <strong>IMS</strong> research<br />
3 There is, of course, controversy about whether Enhance was really a<br />
comparative effectiveness study and whether its treatment by Managed Care<br />
as a head-to-head comparison between a branded and a generic statin was<br />
appropriate. Nonetheless, it suggests that US private payers were willing to<br />
make decisions on the perception of such a study.<br />
This is a slightly abridged version of the article that appeared in the July,<br />
2010 issue of PM360.<br />
<strong>AccessPoint</strong> - Issue 1 Page 35
INSIGHTS | OBSERVATIONAL RESEARCH<br />
As reliance on conclusions from randomized<br />
trials gives way to a stronger focus on<br />
real-world effectiveness and impact, we<br />
consider the growing importance of<br />
observational research in providing the<br />
missing evidence base for more informed<br />
market access decision making.<br />
The author<br />
Xavier Badia, MD, MPH, PHD<br />
Dr. Xavier Badia is Global Leader<br />
Observational Center of Excellence,<br />
Senior Principal <strong>HEOR</strong> at <strong>IMS</strong> <strong>Health</strong><br />
in Spain.<br />
XBadia@es.imshealth.com<br />
Page 36 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
OBSERVATIONAL RESEARCH | INSIGHTS<br />
From ideal to real<br />
THE GROWING GLOBAL NEED FOR OBSERVATIONAL RESEARCH<br />
OBSERVATIONAL OR EXPERIMENTAL?<br />
Many scientists in the field of evidence-based medicine<br />
would argue that interventions, whether biological, social<br />
or financial, should be assessed according to the strict<br />
guidelines and principles of controlled research.<br />
Experimental randomized controlled trials (RCTs) are<br />
considered the “gold standard” study methodology for<br />
assessing the effectiveness of therapeutic agents 1 .<br />
However, the controlled environment of experimental<br />
design does not allow for the variability associated with<br />
routine clinical practice. Nor does it take into<br />
consideration the real-life health impact on treatment and<br />
care delivery. It has been claimed that for all their wellknown<br />
methodological strengths, RCTs cannot meet all<br />
our needs as patients, practitioners, managers, and policy<br />
makers. Moreover, there are situations where their use is<br />
finite, either because of problems derived from their<br />
inherent nature or from practical obstacles such as their<br />
limited external validity 2 .<br />
One answer to all the shortcomings of RCTs is<br />
observational research (OR) – so called because we<br />
simply observe what happens under conditions of normal<br />
clinical practice 3 . Since OR reports only data from real<br />
life situations, there are no established interventions<br />
affecting the clinical course of a disease and its related<br />
outcomes. Used correctly, observational studies enable<br />
research on prevalence, incidence, associations, causes, and<br />
outcomes. In some cases, they are often the only realistic<br />
choice of research methodology, particularly where an<br />
experimental design would be impractical or unethical 3 .<br />
Equally, there are times when observational methods, used<br />
with care and rigor, will add and indeed complement the<br />
evidence obtained from randomized controlled designs:<br />
1. Large impact: Some interventions have an impact so<br />
large (e.g., over an extended duration of time as in<br />
HEP-C treatments’ impact on down-stream liver disease;<br />
across multiple settings (hospital, convalescent hospital,<br />
home care); family/caregiver impacts, etc.) that only<br />
observational data are sufficient to show it.<br />
2. Detecting infrequent adverse outcomes: The<br />
detection of infrequent adverse outcomes would take much<br />
larger randomized controlled trials than are typically<br />
conducted. In these cases observational methods, such as<br />
post-marketing surveillance of medicines, are the only<br />
alternative.<br />
3. Assessing long-term outcomes: Observational data<br />
provide a realistic means of assessing the long-term outcome<br />
of interventions beyond the timescale of many trials 4 .<br />
OBSERVATIONAL STUDIES AND MARKET ACCESS<br />
Increasing pressure on healthcare budgets and growing<br />
payer scrutiny of medical technologies in relation to<br />
potential funding have seen a rise in the demand for<br />
observational studies in recent years. They are not only<br />
more time-efficient, less costly and more representative<br />
of patients in everyday clinical care than RCTs, but also<br />
avoid the ethical issue of compromising treatment choice.<br />
As such, they are able to provide critical, relevant, realworld<br />
information quickly on the expected economic<br />
and clinical impact of a new or existing therapy.<br />
Providing support in five key areas<br />
Broadly, observational research can support the provision<br />
of information for clinicians and decision makers in five<br />
key areas (Figure 1). These include monitoring risk<br />
management plans required by regulatory bodies such as<br />
the European Medicines Agency and the U.S. Food and<br />
Drug Administration and performance agreements<br />
among payers and pharmaceutical industry. Increasingly,<br />
payers assess patient-reported outcomes as tools to<br />
measure the clinical efficacy and cost-effectiveness (i.e.<br />
cost per life years gained) of medication in the real-world<br />
setting. Observational studies, in their various designs,<br />
allow the development, validation, and use of such types<br />
of outcomes such as PROs 5 .<br />
Drug utilization studies linked to MA<br />
Innovative agreements<br />
Risk-management plans<br />
Cost-effectiveness decisions<br />
Development and validation of PRO tools to<br />
measure patients’ health<br />
FIGURE 1: OBSERVATIONAL RESEARCH PROVIDES SUPPORT<br />
IN FIVE KEY AREAS<br />
From Phase III onwards<br />
For pharmaceutical manufacturers, the applications of<br />
OR are many and considerable, with relevance spanning<br />
<strong>AccessPoint</strong> - Issue 1 Page 37
INSIGHTS | OBSERVATIONAL RESEARCH<br />
Globally, the use of<br />
real-world data in<br />
demonstrating the<br />
value of medical<br />
technologies is<br />
increasingly relevant<br />
to reimbursement<br />
and market access<br />
decision making.<br />
...continued from previous page<br />
products in Phase 3b, regulatory and post-launch 6 : not only do<br />
they enable a response to regulator and payer questions<br />
regarding the use of a drug or medical device in real-life<br />
situations – shedding light on such critical issues as resource<br />
utilization, health-related quality of life, satisfaction, adherence,<br />
persistence and preferences - the outcomes of OR also provide<br />
an evidence base for patient profiling, determining costs for<br />
patients with particular conditions, fine-tuning or changing<br />
product positioning, safety labeling, and updating physician<br />
messaging based on study analysis and findings. Figure 2 shows<br />
some of the different types of studies that can be used to address<br />
these objectives.<br />
Objectives<br />
Observational studies<br />
Phase 3 - Reg. phase:<br />
Preparing to gain market access<br />
Phases 3b Pre-Reg Reg Launch In-Market<br />
Epidemiology: Targeting and profiling<br />
Burden of disease; Use of resources<br />
In-market phase:<br />
Sustaining market access<br />
Launch Post-Launch<br />
Development, validation and application of PROs (satisfaction and Qol scales)<br />
Patient registry<br />
FIGURE 2: OBJECTIVES AND OBSERVATIONAL STUDIES<br />
Drug utilization studies<br />
THE RIGHT DESIGN<br />
Observational studies can either be prospective, retrospective,<br />
and/or cross-sectional in methodology – each of which has<br />
their own particular advantages and disadvantages.<br />
PROSPECTIVE STUDIES: These follow up patients over time, watching<br />
for outcomes – both clinical and cost-related - during the study<br />
period and relate these to other factors such as medication used.<br />
Their main advantage is having a design which most resembles<br />
experimental studies, enabling comparison among different<br />
treatment arms. They are ethically safe, allow the timing and<br />
directionality of events to be established, and enable patient<br />
eligibility criteria and outcomes to be standardized 7 .<br />
Conversely, it is important to bear in mind that with prospective<br />
study designs there is a greater likelihood of losing patients<br />
during the study period, which may affect the findings. They<br />
are also expensive and time consuming. Overall, however,<br />
particularly when it comes to evaluation of medication postlaunch,<br />
these studies often deliver scientifically-sound and valid<br />
evidence on clinical efficacy and cost-effectiveness of a product<br />
in the market.<br />
Page 38 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
OBSERVATIONAL RESEARCH | INSIGHTS<br />
Prospective studies are the preferred design to target and<br />
profile patients when a new drug comes onto the market.<br />
RETROSPECTIVE DESIGNS: These studies have a backward<br />
focus, examining factors related to healthcare resource use<br />
or medication use in relation to clinical outcome, clinical<br />
and/or cost-related, that is established at the start of the<br />
study. In retrospective designs, existing data have usually<br />
been recorded for reasons other than research. In <strong>HEOR</strong>,<br />
a retrospective study design uses “chart reviews” as a<br />
preferred method to collect the data because the source<br />
of information is the medical record. Medical claims,<br />
electronic medical records (EMR) and other databases can<br />
also be used when the information sought according to<br />
the objectives of the study is contained in the database.<br />
Broadly speaking, there are three general types of<br />
retrospective study:<br />
1. Case report<br />
2. Case series<br />
3. Case-control<br />
While a retrospective study may contain several of the<br />
same study-design elements as a prospective study, payers<br />
often consider these designs as providing weaker evidence<br />
than their prospective counterparts.<br />
Although a retrospective design is usually not adopted<br />
when a prospective study is feasible, there are a number<br />
of instances where it is appropriate:<br />
1. First, a well-designed retrospective chart review study<br />
may serve as a pilot for a prospective study with the<br />
resulting information used to help the <strong>HEOR</strong> team focus<br />
the study question, define the hypothesis, calculate an<br />
appropriate sample size and identify feasibility issues for<br />
a prospective study 8 .<br />
2. Secondly, if companies have only limited knowledge of<br />
clinical management at the launch of a product, as well as<br />
limited resources, a stand-alone retrospective chart review<br />
or EMR analysis can provide valuable information on realworld<br />
practice that will be used to complement the data<br />
from the experimentally controlled, randomized controlled<br />
trials when submitting to payers for reimbursement.<br />
3. Finally, retrospective studies, especially those done with<br />
existing databases, can typically be completely less<br />
expensively and faster than prospective studies. This makes<br />
them especially useful for exploratory and confirmatory<br />
studies.<br />
From ideal to real<br />
CROSS-SECTIONAL DESIGNS. Cross-sectional studies<br />
encompass a class of research methods involving<br />
observation of a total population, or a representative<br />
subset, at a defined time. They can be used, for example,<br />
to estimate the prevalence of a disease or treatment<br />
characteristics and burden of disease. On the plus side, they<br />
are less-time consuming and less costly than prospective<br />
designs, and importantly, they are ethically safe 7 . However,<br />
they do provide descriptive rather than causal evidence,<br />
and are subject to patients’ recall bias 7 .<br />
Most often, a cross-sectional study design is linked to a<br />
retrospective chart review. For example, data are obtained<br />
on healthcare resource use and medication use for a<br />
sample of patients with a particular condition visiting<br />
their physicians from their medical records. Data on<br />
patient-reported outcomes such as productivity and<br />
quality of life for instance, are obtained by interviewing<br />
these patients when they visit their physician as part of<br />
their routine clinical care. (The ability to link claims, chart<br />
review and EMR data is still in its infancy, but studies<br />
employing this linking are on the rise.)<br />
CONCLUSIONS<br />
Globally, the use of real-world data in demonstrating the<br />
value of medical technologies is increasingly relevant to<br />
reimbursement and market access decision making.<br />
Whether prospective, retrospective or cross-sectional,<br />
observational research has a critical and growing role to<br />
play in driving a better understanding of the health<br />
outcomes of medical technologies, facilitating the<br />
development of compelling value dossiers and supporting<br />
appropriate product use in everyday clinical care. •<br />
1Abel U, Koch, A. The Role of Randomization in Clinical Studies: Myths<br />
and Beliefs. Clin Epidemiol, 1999; 52(6):487-97.<br />
2Black, N. Education and Debate: Why We Need Observational Studies to<br />
Evaluate the Effectiveness of <strong>Health</strong>care. BMJ 1996; 312:1215-1218<br />
3Mann, CJ. Observational Research Methods. Research Design II: Cohort,<br />
Cross-sectional and Case-control Studies. Emerg Med J, 2003;20:54-60<br />
doi:10.1136/emj.20.1.54<br />
4Black, N. Experimental and observational methods of evaluation. BMJ<br />
1994; 39:540.<br />
5Badia X, Herdman M. The Importance of <strong>Health</strong>-Related Quality-of-Life<br />
Data In Determining The Value Of Drug Therapy. Clin Ther 2001; 23(1):<br />
168-75<br />
6Badia X, Guyver A, Magaz S, Bigorra J. Integrated health outcomes research<br />
strategies in drug or medical device development, pre- and post-marketing:<br />
time for change. Expert Rev Pharmacoeconomics Outcomes Res 2002;<br />
2(3): 269-78.<br />
7Centre for Evidence-Based Medicine. 2010.<br />
http://www.cebm.net/index.aspx?o=1039. Website accessed 04.10.2010<br />
8Hess, D. Retrospective studies and chart reviews. Respiratory Care 2004,<br />
49(10): 1171-1174.<br />
<strong>AccessPoint</strong> - Issue 1 Page 39
PROJECT FOCUS | INFLUENZA<br />
Longitudinal patient-level<br />
databases have a key role<br />
to play in supporting<br />
analyses to inform and<br />
determine best practice and<br />
cost-effective care.<br />
Informing the interests<br />
of public health<br />
The growing complexity of market access and increasing emphasis<br />
on maximizing health service efficiency have made the need to<br />
demonstrate the value of medicine an imperative for pharmaceutical<br />
companies worldwide. Identifying the economic burden of a disease<br />
and the impact of treatment shortfalls can play a major role in this<br />
process, particularly in areas of potential significance to national<br />
public health. Longitudinal patient-level databases derived from<br />
health insurance claims are able to provide new levels of insight<br />
into disease outcomes, cost, and treatment implications that are<br />
key to determining clinical best practice and advancing costeffective<br />
care.<br />
SCOPING COST AND OUTCOMES IN A COMMON SEASONAL DISEASE<br />
The U.S. brand team of a leading global pharmaceutical company<br />
came to <strong>IMS</strong> for help in generating economic support for its new<br />
antiviral agent. The drug was an important development in the<br />
treatment of seasonal influenza, an infection that results in<br />
significant levels of morbidity and hospitalization. Estimates of<br />
infection rates range from 4% to 15% in adults but are highest in<br />
the pediatric population (14% to 37%). Children who are otherwise<br />
healthy are also more prone to secondary complications than adult<br />
and elderly patients, although the absolute number of healthy<br />
adults who develop complications is high. With its known links to<br />
increased healthcare provider visits, reduced productivity, and<br />
higher absenteeism from work and school, influenza imposes a<br />
considerable socioeconomic burden.<br />
EXPLORING THE EVIDENCE FROM A COMPREHENSIVE BASE<br />
The use of antiviral drugs has been shown to reduce the severity<br />
and duration of influenza in otherwise healthy adults and children.<br />
Studies have also demonstrated cost benefits associated with<br />
reduced consumption of in-patient and out-patient services.<br />
However, many of these analyses have used models to assess direct<br />
and indirect costs; reports on the relationship between antiviral<br />
treatment, healthcare use, and direct costs are limited.<br />
The <strong>IMS</strong> LifeLink <strong>Health</strong> Plan Claims Database enabled the role of<br />
antiviral therapy to be determined in relation to current care,<br />
outcomes and expenditure linked to influenza. The geographical<br />
breadth of the database – which draws on claims from over 95<br />
health plans in the United States - makes it a critical tool for<br />
national and regional benchmarking of patterns of care, drivers of<br />
treatment choice, resource utilization, and direct medical costs. Its<br />
depth allows for comparisons across a range of patient<br />
demographics, including age, gender, diagnosis, concomitant<br />
therapy, and co-morbidities.<br />
Page 40 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
As the first step in their retrospective evaluation of<br />
complications, hospitalizations, and healthcare use and<br />
expenditure associated with influenza and antiviral therapy,<br />
the <strong>IMS</strong> experts began by identifying five influenza seasons<br />
(01 October – 31 March) between 2001 and 2006. Their<br />
analysis focused on a 30-day period following influenza<br />
diagnosis among patients prescribed the antiviral therapy in<br />
usual care versus those with no evidence of receiving the<br />
drug. Patients were included in the treatment group only if<br />
the drug prescription was issued within ±1 day of the<br />
influenza diagnosis – a period chosen as a proxy to ensure<br />
exclusion of patients who had not commenced therapy within<br />
the recommended period of
PROJECT FOCUS | DIABETES<br />
Validated economic<br />
modeling utilizing<br />
short-term clinical data<br />
can deliver insights<br />
into long-term outcomes<br />
and financial impact<br />
that would otherwise<br />
take years to generate.<br />
Demonstrating the costeffectiveness<br />
of a modern<br />
diabetes therapy in China<br />
Rapid economic development, mass urbanization and the adoption<br />
of more Westernized lifestyles have placed China on the verge of a<br />
diabetes epidemic. Of particular concern is growth in Type 2 diabetes,<br />
especially among the middle-aged, with huge implications for<br />
workforce productivity. New therapeutic options are emerging but<br />
are typically more expensive than established agents. With<br />
healthcare resources in China already stretched to capacity, the<br />
ability to demonstrate local cost-effectiveness is increasingly valid<br />
in securing product use over alternative available treatments.<br />
One of the major challenges for cost evaluations in diabetes is the<br />
importance of showing an impact on its associated long-term<br />
complications, which represent by far the largest share of its financial<br />
burden. Robust, validated modeling techniques that can project<br />
potential outcomes over time and in the local setting, have a key<br />
role to play in determining best practice strategies for optimal care.<br />
REQUIREMENT FOR LONG-TERM PROOF<br />
A leading pharmaceutical manufacturer was keen to develop<br />
economic support for use of its new analogue insulin mix in Type 2<br />
diabetics in China. The drug had proven benefits in improving<br />
HbA1c levels and reducing hypoglycemic events when used in place<br />
of standard insulin in a poorly controlled patient sub-group over a<br />
3-month period. Based on the results of this study in Chinese<br />
patients, and mindful that the drug would be competing with<br />
cheaper alternatives, the company was keen to understand its<br />
associated long-term cost and clinical outcomes. This would not be<br />
an easy task, particularly given the paucity of studies on the cost<br />
of diabetes complications in China.<br />
Recognizing the inherent complexities involved and with limited<br />
knowledge of the local market in China, the HQ team approached<br />
<strong>IMS</strong> <strong>HEOR</strong> experts for help. In <strong>IMS</strong> they found a partner that would<br />
complement their own skill set in diabetes with extensive<br />
capabilities in evidence-based economic modeling, in-depth market<br />
knowledge, on-the-ground expertise and a network of local contacts<br />
in China, and access to the <strong>IMS</strong> CORE Diabetes Model – the leading,<br />
validated, all-round model of diabetes available – with the necessary<br />
skills in its optimal interrogation.<br />
<strong>IMS</strong> CORE DIABETES MODEL<br />
In order to determine the cost-effectiveness of the new analogue<br />
insulin mix, the <strong>IMS</strong> experts began by identifying relevant local<br />
inputs for the <strong>IMS</strong> CORE Diabetes Model – a peer-reviewed, policy<br />
analysis tool for simulating the effects of different clinical<br />
characteristics and changing costs on cohorts of diabetes patients<br />
over a range of time frames (Figure 1). It addresses pharmacy,<br />
Page 42 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
management and complication costs, screening and<br />
treatment strategies for micro- and macrovascular<br />
complications, and treatment practices for end-stage<br />
complications. Disease progression is simulated through a<br />
series of inter-dependent Markov sub-models each of which<br />
uses time, health state, time in health state, and diabetes<br />
type-dependent probabilities derived from published sources.<br />
The reliability of the simulated outcomes has been tested<br />
and fully validated against those reported in clinical trials<br />
and epidemiological studies.<br />
GATHERING THE EVIDENCE<br />
In a detailed program of data collection and supplementary<br />
research, the <strong>IMS</strong> experts focused on gathering the wide range<br />
of China-specific clinical and cost information that would be<br />
needed for a robust, comprehensive economic evaluation.<br />
Treatment effects and patient characteristics were drawn from<br />
the original client study and country-specific published<br />
sources. Risks of modeled complications were derived from<br />
landmark clinical trials and epidemiological studies. To fill<br />
the considerable gap in data on patient management<br />
practices, resource use and diabetes-related complication<br />
costs in China, the <strong>IMS</strong> experts also completed a survey of<br />
physicians based in Tier 3 (large with specialist units) and<br />
Tier 2 (community-based) hospitals. These were located in<br />
two demographically and economically dissimilar cities which<br />
went some way towards addressing regional variation in<br />
treating diabetes.<br />
The analysis was performed from a third-party payer<br />
perspective, incorporating future treatment costs, patient<br />
management costs, and the costs of medical complications,<br />
thereby ensuring its direct relevance for decision making<br />
bodies in China. Costs and clinical projections were made<br />
FIGURE 1: <strong>IMS</strong> CORE DIABETES MODEL FLOW<br />
Stop<br />
Microvascular complications<br />
Specific mortality<br />
No<br />
Yes<br />
DIABETES | PROJECT FOCUS<br />
User sets simulation conditions<br />
Generate baseline population<br />
Any patients to run?<br />
Yes<br />
Time horizon reached?<br />
No<br />
Specific mortality<br />
over patient lifetimes and discounted annually. Quality<br />
adjusted life expectancy was also included. The willingnessto-pay<br />
threshold used was based on the mid-point between<br />
the values applied in two recently conducted utility analyses<br />
in China. Finally, extensive sensitivity analyses were<br />
performed to assess the effect of varying key model<br />
parameters on financial outcomes.<br />
CLEAR DEMONSTRATION OF VALUE<br />
The results of the <strong>IMS</strong> study showed that any increase in<br />
lifetime direct medical costs associated with switching poorly<br />
controlled Type 2 diabetes to the new analogue insulin mix<br />
would be largely offset by lower diabetes-related<br />
complication costs, thereby rendering the drug cost-effective<br />
in the Chinese setting from a third-party payer perspective.<br />
Sensitivity analyses supported this demonstration of its value<br />
for money over time. The analysis represented the first ever<br />
compilation of nationwide cost data in China for diabetes<br />
management and complications<br />
A FIRST FOR COSTING DIABETES IN CHINA<br />
The <strong>IMS</strong> cost-effectiveness analysis provided the client with<br />
key insights and the evidence it needed to show the positive<br />
long-term clinical and cost benefits of its new analogue<br />
insulin mix. Critically, too, it also represented the first ever<br />
compilation of nationwide cost data in China for the range<br />
of complications and management costs associated with<br />
diabetes - information that formed the basis of a major<br />
research publication and which enabled the client to pioneer<br />
the way for future economic evaluations in this increasingly<br />
important market. •<br />
Macrovascular complications Non-specific mortality<br />
Overall annual survival<br />
Time counter advances<br />
Update simulation data<br />
<strong>AccessPoint</strong> - Issue 1 Page 43
<strong>IMS</strong> <strong>HEOR</strong> | OVERVIEW<br />
<strong>IMS</strong> <strong>Health</strong> Economics and Outcomes Research offers a spectrum of<br />
world-class expertise delivering the local excellence you need.<br />
Realizing product value<br />
• Insights and experience of more than 300 highlyqualified,<br />
multi-disciplinary experts in <strong>Health</strong> Economics,<br />
Outcomes Research and Pricing and Market Access<br />
• Market expertise combined with local presence and a<br />
relationship network of key healthcare decision makers<br />
and opinion leaders worldwide<br />
• Scientifically-sound, commercially-relevant solutions for<br />
the entire product lifecycle<br />
• Highly respected, world-leading skills in strategic<br />
planning, evidence development and market access<br />
• Experience in virtually all therapy areas with a<br />
bibliography of over 2000 references<br />
• Outstanding results with the world’s most comprehensive<br />
pharmaceutical and medical information, analytics and<br />
consulting resources<br />
• Relied on and consulted by policy makers and regulatory<br />
authorities globally<br />
REALIZE<br />
COMMUNICATE<br />
DEMONSTRATE<br />
DETERMINE<br />
<strong>IMS</strong> <strong>HEOR</strong> brings unrivalled experience and specialist<br />
expertise to help you determine, demonstrate, communicate<br />
and realize product value<br />
Strategy<br />
P&MA STRATEGY &<br />
DETERMINING VALUE<br />
Evidence<br />
Development<br />
DEMONSTRATING<br />
VALUE<br />
Communication<br />
COMMUNICATING<br />
VALUE<br />
Our integrated approach – spanning deep expertise in<br />
strategy, evidence development and value communications –<br />
is reflected in all of our work.<br />
<strong>IMS</strong> <strong>HEOR</strong> ONLINE<br />
Visit us online at www.imshealth.com/heor<br />
<strong>IMS</strong> <strong>HEOR</strong> BIBLIOGRAPHY<br />
Please ask us for a copy of our<br />
current bibliography covering<br />
publications from 2008-2010<br />
or access the full online<br />
catalog of 2000 references at<br />
www.imsheorbibliography.com<br />
Page 44 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
Global scope, local expertise<br />
<strong>IMS</strong> <strong>HEOR</strong> office locations worldwide<br />
LOCATIONS | <strong>IMS</strong><br />
<strong>IMS</strong> <strong>HEOR</strong> is located in 14 countries worldwide and has published on<br />
projects completed in 40 countries on all continents.<br />
<strong>IMS</strong> <strong>HEOR</strong> Experts are located in key markets around the world.<br />
YOUR KEY CONTACTS:<br />
Dr. Michael Nelson<br />
Regional Leader Americas<br />
<strong>Health</strong> Economics and Outcomes Research<br />
<strong>IMS</strong> <strong>Health</strong><br />
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No 2, Tun Hwa South Road<br />
Section 1<br />
Taipei 10506<br />
Taiwan<br />
ROC<br />
Tel: +886 2 2721 5337<br />
FOR FURTHER INFORMATION: email <strong>HEOR</strong>info@uk.imshealth.com or visit www.imshealth.com/<strong>HEOR</strong><br />
<strong>AccessPoint</strong> - Issue 1 Page 45
armaceutical companies worldwide rely on LifeLink to drive patient-centered decisions – from the first explorator<br />
<strong>IMS</strong> | EXPERTISE<br />
The strength of our ability to support clients in healthcare decision making<br />
for pricing and market access is built on the quality of our global team.<br />
Expertise in depth<br />
We apply unrivalled experience and specialist expertise to help our clients meet the demands of an<br />
increasingly complex global, regional and local pharmaceutical landscape.<br />
<strong>IMS</strong> has one of the largest global teams of experts in health economics and outcomes research of any<br />
organization in the world. We have more than 300 highly-qualified consultants and researchers with<br />
multi-disciplinary experience and proven skills covering all key therapy areas.<br />
Our experts have extensive capabilities in a wide range of health economic and outcomes research<br />
disciplines in industry, consulting, government and academia, with a global grasp, local experience,<br />
and a unique, inside perspective of key market access issues.<br />
Here we introduce members of our senior team.<br />
Franck Amalric, PHD<br />
• Dr. Franck Amalric is a Principal and Group Manager, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong> in France.<br />
• Formerly Deputy Director of Human Sciences and Economics at the French National Cancer Institute,<br />
Franck has extensive experience in the management and development of economic projects, gained<br />
in roles as a Program Director at the Society for International Development (SID) in Rome, a Senior<br />
Economist at UBS in Switzerland, and as Head of Research at the Center for Corporate Responsibility<br />
and Sustainability.<br />
• A graduate of the Ecole Polytechnique in France, Franck completed his training at the Ensaé<br />
(National School of Statistics and Economic Administration) and holds a PhD in Economics from<br />
Harvard University.<br />
Xavier Badia, MD, MPH, PHD<br />
• Dr. Xavier Badia is Global Leader Observational Center of Excellence, Senior Principal <strong>HEOR</strong> at <strong>IMS</strong><br />
<strong>Health</strong> in Spain.<br />
• A founder of <strong>Health</strong> Outcomes Research Europe, Xavier has extensive experience in consulting and<br />
research outcomes, patient-reported outcomes, and effectiveness and cost-effectiveness<br />
evaluations. A respected scientific speaker and member of EuroQol since 1993, he serves on several<br />
international advisory and editorial boards and has published over 150 peer-reviewed papers.<br />
• Xavier holds an MD, a PhD in Medicine, and a Masters in Public <strong>Health</strong> and <strong>Health</strong> Economics from<br />
the University of Barcelona.<br />
Marc Benoff, MBA<br />
• Marc Benoff is Vice President and Practice Leader, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong> in the<br />
U.S., applying quantitative and qualitative methodologies to help clients solve pricing and<br />
reimbursement issues and develop global market access strategies for new and existing products.<br />
• A former Director of Commercial Investment and Pricing Strategy at Wyeth Pharmaceuticals, where<br />
he pioneered the incorporation of pricing, reimbursement, policy and health outcomes into the drug<br />
development process, Marc has over 15 years healthcare experience working with physician groups,<br />
hospitals, health plans and pharmaceutical companies across a range of therapeutic areas.<br />
• Marc holds an MBA from the Graduate School of Business at the University of Chicago, and a BA in<br />
Mathematical Economics from Wesleyan University.<br />
Page 46 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
y questions that drive clinical development to tactical sales planning for mature brands.<br />
EXPERTISE | <strong>IMS</strong><br />
Karin Berger, MBA<br />
• Karin Berger is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in Germany with<br />
a particular focus on outcomes research, patient-reported outcomes, and cost-effectiveness<br />
evaluation analyses at a national and international level.<br />
• Formerly Managing Director of MERG (Medical Economics Research Group), an independent German<br />
organization providing health economics services to the pharmaceutical industry, university<br />
hospitals and European Commission, Karin has more than 14 years experience in the health<br />
economics arena. She lectures at several universities, has published extensively in peer-reviewed<br />
journals, and regularly presents at economic and medical conferences around the world.<br />
• Karin graduated as Diplom-Kaufmann (German MBA equivalent) from the Bayreuth University,<br />
Germany, with a special focus on health economics.<br />
Richard H. Chapman, PHD<br />
• Dr. Rick Chapman is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in the<br />
U.S., directing the design and analysis of economic evaluations and health outcomes studies<br />
addressing a range of client issues.<br />
• Formerly a Senior Director at ValueMedics Research, and Research Associate at the Center for Risk<br />
Analysis, Rick has considerable experience in designing and conducting cost-effectiveness analyses,<br />
and particular expertise in the methodological quality of health economic analyses, medication<br />
adherence and patient-reported outcomes, including quality of life and patient preferences.<br />
• Rick holds a PhD in <strong>Health</strong> Policy (Decision Sciences) from Harvard University and an MS in<br />
<strong>Health</strong> Policy and Management from the Harvard School of Public <strong>Health</strong>.<br />
Mandy Chui, MBA<br />
• Mandy Chui is Regional Practice Leader, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong> in the Asia<br />
Pacific, helping clients formulate growth strategies, optimize price and reimbursement, and<br />
address issues in business model, sales force and marketing optimization.<br />
• In a career spanning more than 15 years at <strong>IMS</strong> <strong>Health</strong>, including roles as Country Principal for<br />
China and Director of Area Sales & Marketing in Singapore, Mandy has developed an exceptional<br />
understanding of Asian market dynamics and an extensive network of major stakeholder<br />
contacts in this rapidly evolving region. She has also authored various publications on China<br />
and emerging markets.<br />
• Mandy holds an honors degree in Biology from the University of Hong Kong and an MBA from<br />
McGill University, Montreal.<br />
Frank-Ulrich Fricke, PHD, MSC<br />
• Dr. Frank-Ulrich Fricke is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> and<br />
Professor for <strong>Health</strong> Economics, Georg-Simon-Ohm University of Applied Sciences, Nuremberg in<br />
Germany, with a focus on health economic evaluations, market access strategies and health policy.<br />
• Formerly a Managing Director of Fricke & Pirk GmbH, and previously Head of <strong>Health</strong> Economics at<br />
Novartis Pharmaceuticals, Frank-Ulrich has conducted health economic evaluations across a wide<br />
range of therapeutic areas, developing a wealth of experience in pricing, health affairs and health<br />
policy. As a co-founder of the NIG 21 association, he has forged strong relationships with health<br />
economists, physicians and related researchers working in the German healthcare system.<br />
• Frank-Ulrich holds a PhD in Economics from the Bayreuth University, and an MBA equivalent from<br />
the Christian-Albrechts-University, Kiel.<br />
David Grant, MBA<br />
• David Grant is a Senior Principal and Country Leader, <strong>Health</strong> Economics and Outcomes Research<br />
at <strong>IMS</strong> <strong>Health</strong> in the U.K., specializing in reimbursement and market access, environmental<br />
analysis, prospective and retrospective data collection and communications for product support.<br />
• A co-founder and former Director of Fourth Hurdle, David’s experience spans 10 years in health<br />
economics and outcomes research consulting, and 15 years in the pharmaceutical industry, including<br />
roles in clinical research, new product marketing and health economics in the U.K. and Japan.<br />
• David holds a degree in Microbiology and an MBA from the London Business School.<br />
<strong>AccessPoint</strong> - Issue 1 Page 47
<strong>IMS</strong> | EXPERTISE<br />
Jacco Keja, PHD<br />
• Dr. Jacco Keja is Regional Leader, EMEA, <strong>Health</strong> Economics and Outcomes Research, at <strong>IMS</strong> <strong>Health</strong> in<br />
the UK, drawing on deep expertise in global market access, operational and strategic pricing, and<br />
health economics and outcomes research.<br />
• Jacco’s background includes four years as global head of pricing, reimbursement, health outcomes<br />
and market access consulting services at a large clinical research organization and more than 13<br />
years experience in the pharmaceutical industry, including senior-level international and global roles<br />
in strategic marketing, pricing and reimbursement and health economics.<br />
• Jacco holds a PhD in Biology (Neurophysiology) from Vrije Universiteit in Amsterdam, a Masters in<br />
Medical Biology, and an undergraduate degree in Biology, both from Utrecht. He is also visiting<br />
Professor at the Institute of <strong>Health</strong> Policy & Management at Erasmus University, Rotterdam.<br />
David C. Klingman, PHD<br />
• Dr. David Klingman is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in the<br />
U.S., with expertise in retrospective analyses of survey and administrative databases, medical-record<br />
abstraction, provider, payer, and patient surveys, health-economic modeling, cost-effectiveness<br />
analysis, meta-analysis, and literature synthesis in numerous therapeutic areas.<br />
• In a career that spans both business and academia, including roles at ValueMedics Research<br />
LLC, the Center for Clinical Quality Evaluation, and the <strong>Health</strong> Program of the U.S. Congress<br />
Office of Technology, David has developed extensive experience in health economics, outcomes<br />
research, quality evaluation and analytics.<br />
• David holds a PhD in Political Science from Michigan State University, an MA in Political<br />
Science from the University of Wisconsin-Milwaukee, and a BA in Government from the<br />
University of Texas.<br />
Mark Lamotte, MD<br />
• Dr. Mark Lamotte is a Principal and Location Manager, <strong>Health</strong> Economics and Outcomes<br />
Research at <strong>IMS</strong> <strong>Health</strong> in Belgium with responsibility for the content and quality of all health<br />
economic evaluations conducted by his team.<br />
• A physician by training (cardiology), Mark spent a number of years in medical practice before<br />
joining Rhône-Poulenc Rorer as Cardiovascular Medical Advisor and later becoming Scientific<br />
Director at the Belgian research organization, HEDM. He has since worked on more than 150<br />
projects, involving expert interviews, patient record reviews, extensive modeling and report<br />
writing across a wide range of therapy areas, and authored many peer-reviewed publications.<br />
• Mark holds an MD from the Free University of Brussels (Vrije Univeristeit Brussel, Belgium) and<br />
is fluent in Dutch, French, English and Spanish.<br />
Won Chan Lee, PHD<br />
• Dr. Won Chan Lee is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in the<br />
U.S., specializing in prospective and retrospective health economics research.<br />
• Over the course of his career, Won has completed numerous international economic evaluations<br />
employing a variety of analytical methods across a range of diseases and geographies. His expertise<br />
includes econometric database analysis, quality of life assessment and advanced economic modeling<br />
to establish the economic and humanistic value of new and existing therapeutic interventions.<br />
• Won holds a Masters in Economics from the University of Grenoble II, and a PhD in Economics from<br />
the Graduate Center of the City University of New York.<br />
Claude Le Pen, PHD<br />
• Dr. Claude Le Pen is a member of the strategic committee of <strong>IMS</strong> France and Professor of <strong>Health</strong><br />
Economics at Paris-Dauphine University providing expert economic advisory services to the<br />
consulting practice.<br />
• A renowned economist, leading academic, and respected public commentator, Claude has served<br />
as an appointed senior member of several state commissions in the French Ministry of <strong>Health</strong> and<br />
is an expert for a number of parliamentary bodies, bringing a unique perspective and unparalleled<br />
insights into the economic evaluation of pharmaceutical technologies at the highest level.<br />
• Claude studied Business Administration in HEC Business School in Paris and holds a PhD in<br />
Economics from Panthéon-Sorbonne University.<br />
Page 48 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
EXPERTISE | <strong>IMS</strong><br />
Adam Lloyd, MPHIL, BA<br />
• Adam Lloyd is a Senior Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in the<br />
U.K., where he leads the economic modeling practice with a particular focus on economic analysis<br />
and the global application of economic tools to support the needs of local markets.<br />
• A former founder and Director of Fourth Hurdle, and previously Senior Manager of Global <strong>Health</strong> Outcomes<br />
at GlaxoWellcome, Adam has extensive experience leading economic evaluations of pre-launched and<br />
marketed products, developing submissions to NICE and the SMC, decision-analytic and Markov modeling,<br />
and in the use of health economics in reimbursement and marketing in continental Europe.<br />
• Adam holds an MPhil in Economics, and a BA (Hons) in Philosophy, Politics and Economics from the<br />
University of Oxford.<br />
Eva Marchese, PHD<br />
• Dr. Eva Marchese is a Principal and Location Manager, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong><br />
in Italy, with a particular focus on market access, regulatory, pharmacovigilance, pricing and<br />
reimbursement, and health economics and outcomes research.<br />
• An experienced consultant and founding partner of S&M Consulting, Eva has been involved in<br />
several ministerial committees at the Italian Ministry of <strong>Health</strong>, looking at cost evaluation and<br />
analysis of day surgery procedures. She was previously Professor of Public Management and<br />
Policy at Bocconi-SDA, the foremost Italian Business School, and a contracted Research Fellow<br />
at the Centre for Research on <strong>Health</strong>care and Social Management at Bocconi University.<br />
• Eva holds a PhD in Public Management from the Parma State University, and a degree in<br />
Business Administration from Bocconi University in Milan.<br />
Frédérique Maurel, MS, MPH<br />
• Frédérique Maurel is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in France,<br />
with a particular focus on observational research and health economics studies.<br />
• A skilled consultant and project manager, Frédérique has extensive experience in the economic<br />
evaluation of medical technologies gained in roles at ANDEM, Medicoeconomie, and AREMIS Consultants.<br />
• Frédérique holds a Masters degree in Economics – equivalent to an MS – and completed a postgraduate<br />
degree equivalent to an MPH with a specialization in <strong>Health</strong> Economics at the University<br />
of Paris-Dauphine (Paris IX) as well as a degree in Industrial Strategies at the Pantheon-Sorbonne<br />
University (Paris I).<br />
Juliet Munakata, MS<br />
• Juliet Munakata is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in the U.S.,<br />
with a particular focus on global economic modeling, value development planning, and survey data<br />
analysis.<br />
• An accomplished researcher and author of more than 25 original articles, Juliet has extensive<br />
experience in managing clinical trials, health economic studies and decision analytic modeling work,<br />
gained in senior roles at ValueMedics Research LLC, the VA <strong>Health</strong> Economics Resource Center and<br />
Stanford Center for Primary Care & Outcomes Research, and Wyeth Pharmaceuticals.<br />
• Juliet holds an MS in <strong>Health</strong> Policy and Management from the Harvard School of Public <strong>Health</strong> and a<br />
BS in Psychobiology from the University of California, Los Angeles.<br />
Karl-Johan Myrén, MSC<br />
• Karl-Johan (Kalle) Myrén is an Engagement Manager, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong>,<br />
with responsibility for the Nordic region. He has extensive expertise in global and affiliate<br />
pricing, market access, reimbursement and health economics and a deep understanding of many<br />
different national healthcare systems.<br />
• Karl-Johan’s career spans more than 13 years experience in global health economics gained in<br />
roles at the Swedish Institute of <strong>Health</strong> Services Development, Astra Zeneca and Eli Lilly,<br />
latterly as Senior Area <strong>Health</strong> Economist coordinating and managing health economic activities<br />
for the European middle-sized (EMS) countries, including the Nordic markets, Belgium,<br />
Switzerland, the Netherlands and Portugal.<br />
• Karl-Johan holds an MSc in Economics and a BSc in Mathematics from the University of Stockholm.<br />
<strong>AccessPoint</strong> - Issue 1 Page 49
<strong>IMS</strong> | EXPERTISE<br />
Michael Nelson, PHARM D<br />
• Dr. Michael Nelson is Regional Leader, Americas, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong><br />
<strong>Health</strong> in the U.S., with particular expertise in retrospective database research, prospective<br />
observational research, health program evaluation, and cost-effectiveness analysis.<br />
• During a career that includes leadership roles in <strong>HEOR</strong> at PharmaNet, i3 Innovus, SmithKline<br />
Beecham, and DPS/United<strong>Health</strong> Group, Mike has gained extensive experience in health<br />
information-based product development, formulary design, drug use evaluation, and disease<br />
management program design and implementation.<br />
• A thought leader in health economics for more than 20 years, Mike holds a doctorate in Pharmacy<br />
and a Bachelor of Science degree, both from the University of Minnesota College of Pharmacy. He<br />
also served as an adjunct clinical faculty member at the University of Minnesota whilst in clinical<br />
pharmacy practice.<br />
Tini Nguyen, PHARM D<br />
• Dr. Tini Nguyen is Regional Principal, <strong>Health</strong> Economics and Market Access at <strong>IMS</strong> <strong>Health</strong> in France.<br />
• Previously European Market Access Director at Sanofi-Aventis in Paris, Tini has more than 15 years<br />
experience in the global pharmaceutical industry, including 7 years in senior roles focusing on<br />
health economics, health outcomes, pharmacoeconomics and market access in the Asia Pacific,<br />
Russia, Latin America, Middle East and Africa.<br />
• Tini holds a diploma in <strong>Health</strong> Economics for <strong>Health</strong>care Professionals from the University of York, and<br />
a diploma in Marketing and a doctorate in Pharmaceutical Sciences from the Université René Descartes<br />
in Paris.<br />
Olaf Pirk, MD, PHD<br />
• Dr. Olaf Pirk is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in Germany,<br />
with a particular focus on health technology assessment, healthcare system research, health<br />
policy and health economic modeling across a range of countries and therapeutic areas.<br />
• Formerly a Managing Director of Fricke & Pirk GmbH, Olaf has considerable pharmaceutical<br />
industry experience gained in roles within health economics, pricing, health policy, marketing<br />
and clinical research. As a co-founder of the NIG 21 association, he has forged strong<br />
relationships with health economists, physicians and related researchers working in the German<br />
healthcare system.<br />
• Olaf holds an MD and PhD in Medicines from the Medical University of Lübeck.<br />
Mercedes Prior, MBA<br />
• Mercedes Prior is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in Spain<br />
where she leads the <strong>Health</strong> Economics and Strategic Consulting team helping clients develop and<br />
execute market access strategies at the local and international level.<br />
• With a consulting background that includes senior-level roles at Booz Allen & Hamilton and The<br />
Wilkerson Group (IBM Consulting), Mercedes has in-depth experience of market assessment,<br />
forecasting, identification and evaluation of licensing opportunities, and pricing, financing and<br />
market access strategies.<br />
• Mercedes holds an MBA from Columbia University in New York.<br />
Jon Resnick, MBA<br />
• Jon Resnick is Vice President and Practice Leader, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong> in<br />
the U.K., advising pharmaceutical and biotech companies on a wide range of strategic, pricing<br />
and reimbursement issues.<br />
• A former Legislative Research Assistant in Washington DC and member of the Professional <strong>Health</strong><br />
and Social Security staff for the U.S. Senate Committee on Finance, Jon combines public policy<br />
and industry expertise to provide a unique grasp of the healthcare market place. He has<br />
co-authored several major U.S. healthcare initiatives, including proposals to reform managed care.<br />
• Jon holds an MBA from the Kellogg School of Management, Northwestern University, where he<br />
majored in Management and Strategy, Finance, <strong>Health</strong> Industry Management, and<br />
Biotechnology.<br />
Page 50 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH
EXPERTISE | <strong>IMS</strong><br />
Javier Sabater, MPHARM, MHE<br />
• Javier Sabater is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in Spain,<br />
where he leads a wide range of projects across many therapy areas for major international<br />
pharmaceutical companies, healthcare providers and national policy institutions.<br />
• A pharmacist by training, Javier has considerable industry experience in clinical research, medical<br />
information, health economics, market access and outcomes research gained in roles at GlaxoSmithKline,<br />
Roche and Schering-Plough. He has co-authored a number of publications and abstracts in <strong>HEOR</strong>.<br />
• Javier holds a Bachelors degree in Pharmacy, a Masters in <strong>Health</strong> Economics and has completed a<br />
post-graduate course in Pharmaceutical Marketing.<br />
Vernon Schabert, PHD<br />
• Dr. Vernon Schabert is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in<br />
the U.S., leading the development of prospective trials, the assessment and validation of<br />
patient-reported outcomes (PRO) instruments, retrospective analyses of claims and survey<br />
databases, and primary data collection surveys.<br />
• A founder and former President of Integral <strong>Health</strong> Decisions, Inc, Vernon has extensive<br />
experience in conducting claims analyses, creating custom administrative databases,<br />
developing business intelligence software, and leading national quality research projects,<br />
gained in roles with Thomson Reuters, Strategic <strong>Health</strong>care Programs LLC, and CIGNA<br />
<strong>Health</strong>Care. His expertise spans numerous disease areas and diverse topics including medication<br />
adherence, in-patient safety and outcomes in post-acute care.<br />
• Vernon holds a PhD in Personality and Social Psychology from Stanford University and a BA in<br />
Psychology from Princeton University.<br />
Núria Lara Surinach, MD, MSC<br />
• Dr. Núria Lara is a Principal, <strong>Health</strong> Economics and Outcomes Research at <strong>IMS</strong> <strong>Health</strong> in Spain,<br />
where she leads the Outcomes Research group in the design and coordination of local and<br />
international observational and patient-reported outcomes studies.<br />
• A former practicing GP and clinical researcher, Núria’s experience spans roles in outcomes research<br />
at the Institute of Public <strong>Health</strong> in Barcelona and in Catalan <strong>Health</strong> Authorities, and consulting<br />
positions within the pharmaceutical and medical device industries focusing on medical regulatory<br />
and pricing affairs, pharmacoeconomics and market access strategies.<br />
• Núria holds an MD (specializing in Family and Community Medicine in Barcelona), and a Masters in<br />
Public <strong>Health</strong> from the London School of Hygiene and Tropical Medicine and London School of Economics.<br />
Jonothan Tierce, CPHIL<br />
• Jonothan Tierce is General Manager and Center of Excellence Leader, Global <strong>Health</strong> Economics<br />
and Outcomes Research, at <strong>IMS</strong> <strong>Health</strong> in the U.S., supporting the industry’s growing need for<br />
real-world evidence of the clinical and economic value of new technologies in advancing health.<br />
• A pioneer in applied pharmacoeconomics and value strategy development, and co-founder of<br />
ValueMedics Research LLC, Jonothan has nearly 25 years experience in health economics,<br />
working with clients to identify customized strategies and tactics for product access, value<br />
propositions and evidence-based demonstrations of value.<br />
• Jonothan holds a C Phil, MA, and BA in Political Science from the University of California in Los<br />
Angeles. He also received two years of post-graduate training in econometrics and experimental design.<br />
Meng Zang, MBA<br />
• Meng Zang is a Principal, Pricing and Market Access at <strong>IMS</strong> <strong>Health</strong> in China, applying evidencebased<br />
analytics to help clients address key business issues in global pricing, product launch<br />
readiness, market opportunity assessment and product portfolio optimization.<br />
• During the course of his career in the U.S. and China, Meng has developed extensive expertise<br />
in pricing and reimbursement, new market entry, competitive analysis and corporate strategic<br />
planning, in consulting roles at SDI <strong>Health</strong> and Accenture, business development at J&J, and<br />
as a professional representative at Xian-Janssen Pharmaceutical Ltd in China.<br />
• Meng holds a degree in Biology from Nanjing University, a Masters in Biochemistry from the<br />
University of New Brunswick, Montreal and an MBA from the Wharton School of the University<br />
of Pennsylvania, with a major in <strong>Health</strong>care Management.<br />
<strong>AccessPoint</strong> - Issue 1 Page 51
<strong>IMS</strong> | LIFELINK<br />
Pharmaceutical companies worldwide rely on <strong>IMS</strong> LifeLink TM<br />
to drive<br />
patient-centered decisions – from clinical development to mature brands.<br />
Powering a patient perspective<br />
Your business models have changed. So have the metrics that<br />
keep the healthcare industry moving forward. Today, a patient<br />
perspective is a must.<br />
Through the global <strong>IMS</strong> LifeLink program, we provide a<br />
powerful patient lens to drive focus and alignment across<br />
your business, deepening your understanding of critical<br />
patient, physician and payer dynamics. LifeLink allows you<br />
to identify the right patient segments early on, in order to<br />
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We make a patient-centered perspective simple — by<br />
integrating patient-level intelligence into our industryleading<br />
offerings and giving you expert consultants who<br />
apply it to your key issues.<br />
<strong>IMS</strong> LifeLink provides insights of primary research with the<br />
benefits of secondary — lower cost, repeatable, faster and a<br />
larger sample size.<br />
<strong>IMS</strong> LifeLink has everything you need to succeed in a<br />
patient-centered universe.<br />
CANADA<br />
• Longitudinal Rx<br />
• <strong>Health</strong> Plan Claims<br />
Database<br />
UNITED STATES<br />
• Longitudinal Rx<br />
• <strong>Health</strong> Plan Claims<br />
Database<br />
• Oncology Analyzer<br />
EUROPE<br />
• Longitudinal Rx<br />
(Germany, UK, Netherlands and Belgium)<br />
• Anonymized Patient-Level Data<br />
from Electronic Medical Records<br />
(France, Germany, Italy, UK)<br />
• Oncology Analyzer<br />
(France, Germany, Netherlands, Italy,<br />
Spain, Turkey, UK)<br />
• Stroke Database<br />
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• Hospital Disease Database<br />
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AN UNPARALLELED ARRAY OF ANONYMIZED PATIENT-LEVEL DATA WORLDWIDE<br />
• Longitudinal Patient Database<br />
(Sweden)<br />
Page 52 <strong>IMS</strong> HEALTH ECONOMICS AND OUTCOMES RESEARCH<br />
ASIA<br />
• Oncology Analyzer<br />
(China, Japan, Korea, Taiwan)<br />
• Longitudinal Rx<br />
(Japan)<br />
AUSTRALIA<br />
• Longitudinal Rx<br />
<strong>IMS</strong> has made extensive investments in anonymized patient-level data in markets around the world.<br />
Today, we capture information for more than 260 million patient lives – for unparalleled treatment insights.
Today’s universe<br />
is patient-centered.<br />
Discover its power with <strong>IMS</strong>.<br />
Your business models have changed. So have the metrics that keep the healthcare industry<br />
moving forward. Today, a patient perspective is a must.<br />
Through the global <strong>IMS</strong> LifeLink TM program, we provide a powerful patient lens to drive focus<br />
and alignment across your business, deepening your understanding of critical patient,<br />
physician and payer dynamics. Our tools allow you to identify the right patient segments early<br />
on, in order to gain competitive advantage in today’s complex environment.<br />
We make a patient-centered perspective simple — by integrating patient-level intelligence<br />
into our industry-leading offerings and giving you expert consultants who apply it to your key<br />
issues.<br />
<strong>IMS</strong> LifeLink has everything you need to succeed in a patient-centered universe.<br />
Let us power your patient perspective.<br />
Contact us at <strong>HEOR</strong>info@uk.imshealth.com or visit imshealth.com/<strong>HEOR</strong><br />
© 2010 <strong>IMS</strong> <strong>Health</strong> Incorporated or its affiliates. All rights reserved.
<strong>IMS</strong> helps you realize<br />
the potential of<br />
your products<br />
Maximizing market access<br />
demands the best scientific evidence<br />
and the right commercial awareness to deliver the insights you need.<br />
<strong>IMS</strong> has built a global team of more than 300 experts in <strong>Health</strong> Economics and Outcomes<br />
Research and Pricing & Market Access — with publication and project experience in more<br />
than 40 countries across all continents.<br />
We combine rigorous scientific research — evidenced by nearly 200 publications<br />
each year — with commercially focused consulting to help you determine, demonstrate,<br />
communicate and realize product value.<br />
Our <strong>HEOR</strong> experts leverage unparalleled claims, medical, hospital and patient-centered<br />
pharmaceutical databases to create an Evidence-Based ConsultingSM powerhouse.<br />
So the next time you think about product value, think about us.<br />
MORE INFORMATION<br />
For additional information on our <strong>HEOR</strong> expertise and offerings please<br />
email <strong>HEOR</strong>info@uk.imshealth.com or visit: www.imshealth.com/<strong>HEOR</strong><br />
<strong>IMS</strong> <strong>HEOR</strong> OFFICES ARE LOCATED IN MANY COUNTRIES AROUND THE WORLD WITH PRINCIPAL OFFICES IN:<br />
UNITED KINGDOM<br />
7 Harewood Avenue, London NW1 6JB, United Kingdom • Tel: +44 20 3075 4800<br />
UNITED STATES<br />
300 N. Washington Street, Suite 303 Falls Church, VA 22046, USA • Tel: +1 703.286.2900<br />
ASIA PACIFIC<br />
7/F Central Tower, China Overseas Plaza, Jianguomenwai Avenue, Chaoyang District,<br />
Beijing 100001, China • Tel: +86 10 8567 4255<br />
©2010 <strong>IMS</strong> <strong>Health</strong> Incorporated or its affiliates. All Rights Reserved.