HEOR AccessPoint Report - IMS Health

ACCESSPOINT 

IMS HEALTH ECONOMICS & OUTCOMES RESEARCH 

Running the risk 

Managing risk/reward ratio 

under intense public scrutiny 

Decisive period for pharma 

2011 outlook highlights importance of HEOR 

Volume 1, Issue 1 

NOVEMBER 2010 

Launch issue 

News, views and 

insights from 

leading experts 

in HEOR 

Optimizing market access 

in a decentralized environment 

Mike Nelson on the 

Jacco Keja on the 

John Tierce reports 

many different payers 

need for more 

on the new pressures 

Page OUTCOMES 1 - Issue 

with many 

1 

different 

needs in the U.S. 

specialized IMS market HEALTH ECONOMICS AND OUTCOMES from RESEARCH expanding Page 1CER 

positions in Europe 

Page 32 

Page 12 

Page 15

ACCESSPOINT 

IMS HEALTH ECONOMICS & OUTCOMES RESEARCH 

Leap-frogging to value 

in the Asia Pacific 

The IMS Symposium at ISPOR Asia Pacific 

Conference considers potential to define a 

uniquely Asian model of healthcare delivery 

page 24 

Optimizing access in a 

decentralized European market 

John Resnick explores contradictory trends of 

convergence and divergence in Europe 

page 28 

News, views and insights 

from leading experts in HEOR 

Outlook 2011 

Murray Aitken looks at the priorities 

for pharma companies competing in 

a challenging landscape - and the 

implications for HEOR 

page 8 

The transatlantic constant 

of change 

The complex dynamics and reforms 

impacting HEOR and market access 

in the U.S. and Europe 

page 12 

The move to HTA in 

Central & Eastern Europe 

With a focus on Russia, Romania and 

Ukraine, we consider the growing need for 

evidence-based decision support in CEE 

page 18

edit 

Welcome to the launch issue of ACCESSPOINT, our 

twice-yearly update of news, views and insights from 

IMS Health Economics and Outcomes Research - a new 

opportunity to learn about our latest developments, 

meet members of our global team of experts, and find a 

stimulating perspective on the key trends and changes that are 

reshaping the pharmaceutical landscape. 

These are challenging, exciting and also potentially very 

rewarding times in the healthcare arena. We see decision makers 

continuing to wrestle with the need to balance cost and 

demand for new innovations, payers everywhere strengthening 

their efforts to limit further growth in expenditure, and much 

closer scrutiny of pharmaceutical products raising the risks for 

drug development. At the same time, we see new dynamic 

markets rising to the fore in Eastern Europe and the Asia 

Pacific, ripe with potential for healthcare improvement, already 

struggling to manage escalating costs, but opening up significant 

opportunities to participate in their continued expansion. 

As we look ahead through 2011, with reforms playing out in 

major markets and manufacturers intensifying their focus on 

demonstrating the value of their medicines, one thing is clear: 

rigorous, robust health economics and outcomes research will 

be essential to ensuring that all key stakeholders are equipped 

with the relevant, real-world evidence they need to meet the 

challenges, priorities and new opportunities for growth. 

IMS draws on the experience and knowledge of more than 300 

specialists in pricing, market access and health economics and 

outcomes research to enable more effective decision making 

based on the best available information and analytical 

approaches. We hope you find our insights in this first issue of 

ACCESSPOINT informative and helpful in providing some 

pointers to the way ahead. 

Finally, I would like to thank our guest contributor, Murray 

Aitken, Senior VP, at IMS for his insightful market outlook for 

2011 (page 8), and take this opportunity to introduce our two 

new HEOR Regional Leaders, Dr Michael Nelson in the U.S. 

and Dr Jacco Keja in Europe, who bring a wealth of industry 

and consulting expertise to lead our teams on both sides of the 

Atlantic and offer their take on the critical trends in their region 

(page 12). 

Gordon Carey 

VICE PRESIDENT, GLOBAL LEADER 

PRICING & MARKET ACCESS PRACTICE, IMS HEALTH 

GCarey@imshealth.com 

“These are challenging, exciting and 

also potentially very rewarding times in the healthcare arena” 

WELCOME CONTENTS 

NEWS SECTION 

2 Informing decisions in key therapy areas 

3 Brogan brings new capabilities in Canada 

5 Counting the cost in Central & Eastern Europe 

6 IMS CORE Diabetes Model rises to challenge 

INSIGHTS 

8 OUTLOOK AND TRENDS 2011 

Positioning for future market share 

12 REGIONAL REVIEW 

Tides of change in U.S. and Europe 

18 EMERGING MARKETS: 

Central & Eastern Europe (CEE) 

19 Moves to HTA 

23 Regional experts 

25 IMS ISPOR SYMPOSIUM 

Challenges and opportunities in Asia Pacific 

28 MARKET ACCESS 

Optimizing access in decentralized Europe 

32 RISK EVALUATION 

Shifting risk/reward ratio 

36 OBSERVATIONAL RESEARCH 

Growing role in value demonstrations 

PROJECT FOCUS 

40 INFLUENZA 

Informing the interests of public health 

42 DIABETES 

Demonstrating cost-effectiveness in China 

IMS OVERVIEW 

44 IMS HEOR 

45 Office locations 

46 Our senior experts 

52 IMS Lifelink TM : Longitudinal patient data 

AccessPoint is published twice yearly by the Health 

Economics and Outcomes Research team of IMS Health. 

ISSUE 1. PUBLISHED NOVEMBER 2010. 

IMS HEALTH® 7 Harewood Avenue, London NW1 6JB, UK 

Tel: +44 (0)20 3075 4800 • HEORInfo@uk.imshealth.com 

• www.imshealth.com 

©2010 IMS Health Incorporated or its affiliates. 

All Rights Reserved. 

AccessPoint - Issue 1 Page 1

NEWS | PUBLICATIONS 

IMS HEOR has experience in all key therapy areas with a bibliography 

of more than 2000 publications. 

Informing decision making 

50 

40 

30 

20 

10 

0 

Diabetes 

Cardiovascular 

Oncology 

Mental Health 

Dermatology 

Gastrointestinal Disorders 

Health Economics Strategy 

We have published nearly 200 papers every year 

Neurological Disorders 

Rheumatology 

in the last decade employing, a wide range 

Ophthalmology 

Respiratory Diseases 

Hematology 

Womens Health 

of health economic analyses 

Page 2 IMS HEALTH ECONOMICS AND OUTCOMES RESEARCH 

Nephrology 

Immunology 

Compliance 

Musculoskeletal Disease 

Endocrinology 

Overactive Bladder 

These are some examples of our recent publications in selected therapy classes. 

CARDIOVASCULAR DISEASE 

Relation of the first 

hypertension-associated event 

with medication compliance 

and persistence in naive 

hypertensive patients after 

initiating monotherapy 

Int J Clin Pharmacol Ther, 

2010; 48(3):S173-183 

Mathes J, Kostev K, 

Gabriel A, et al. 

DIABETES, ONCOLOGY 

Cancer incidence for insulindependent 

diabetics in 

Germany: An analysis of the 

publication of Hemkens et al. 

based on the STROBE criteria 

(in German) 

Perfusion, 2010; 23:4-10 

Fuchs S, Fricke F-U, 

Pirk O 

ONCOLOGY 

Cost-effectiveness analysis of 

pemetrexed versus docetaxel 

in the second-line treatment 

of non-small cell lung cancer 

in Spain: Results for the nonsquamous 

histology population 

BMC Cancer, 2010; 10(1):26 E-pub 

Asukai Y, 

Valladares A, 

Camps C, et al. 

CARDIOVASCULAR DISEASE 

The cost and effectiveness 

of adherence-improving 

interventions for 

antihypertensive and 

lipid-lowering drugs 

Int J Clin Pract, 2010; 

64(2):169-81 

Chapman RH, 

Ferrufino CP, 

Kowal S, et al. 

HEMATOLOGY 

Treatment cost of hemophilia 

patients with inhibitors in the 

National Health System in 

Morocco 

Espérance Méd, 2010; 17:101-7 

El Khorassani M, 

Hadjkhalifa H, 

By Z, et al. 

ONCOLOGY 

Pegfilgrastim vs filgrastim in 

primary prophylaxis of febrile 

neutropenia in patients with 

breast cancer after chemotherapy: 

A cost-effectiveness analysis 

for Germany (in German) 

Deutsche Med Woch, 2010; 

135(9): 385-9 

Sehouli J, Goertz A, 

Steinle T, et al. 

DERMATOLOGY 

A retrospective cohort study 

of the impact of biologic 

therapy initiation on medical 

resource use and costs in 

patients with moderate to 

severe psoriasis 

Br J Dermatol, 2010; 

163(4):807-16 

Fonia A, Jackson K, 

LeReun C, et al. 

MENTAL HEALTH 

Mental health care reforms in 

Europe: Rehabilitation and 

social inclusion of people with 

mental illness in Russia 

Psychiatr Serv, 2010; 61(3): 

222-24 

Jenkins R, McDaid D, 

Nikiforov A, et al. 

TRANSPLANT 

Cost-effectiveness of 

immunosuppressive regimens 

in renal transplant recipients 

in Germany: A model approach 

Eur J Health Economics, 2010; 

11(1):15-25 

Juergensen JS, 

Arns W, Haß B 

Health Policy 

Pediatrics 

Transplant 

DIABETES 

A meta-analysis of placebocontrolled 

clinical trials 

assessing the efficacy and 

safety of incretin-based 

medications in patients with 

type 2 diabetes 

Pharmacology, 2010; 

86(1):44-57 

Fakhoury WKH, 

LeReun C, 

Wright D 

NEUROLOGY 

Atomoxetine's effect on 

societal costs in Sweden 

J Attention Disorder, 2010; 

13(6): 618-28 

Myrén KJ, Thernlund G, 

Nylén A, et al. 

UROLOGY 

Mirror questionnaire. 

Satisfaction value in 

ostomized patients with the 

health care and dispositive 

Revista Rol de Enfermeria 

2010; 33(5): 328-337 

Arias Alvarez M, Fernandez- 

García M.A., 

Gonzalez-Buenadicha AM, 

et al.

CANADA | NEWS 

IMS has one of the largest international HEOR expert teams in the market. 

We now add new core competencies in Canada. 

Brogan union brings new capabilities 

in Canada 

IMS has established a strong platform to support the growing 

need for real-world evidence of the clinical and economic value 

of medical technologies. Further strengthening our capabilities 

in key markets, in July 2010 we merged our Canadian 

operations with Brogan Inc., a pioneering healthcare market 

research and consulting firm, based in Ottawa. 

The move has brought together Brogan’s core offerings in drug claims 

analysis, market access, health economic analysis, and strategic pricing in 

Canada, with IMS’ global medical and pharmaceutical information assets, 

analytics and consulting capabilities. For our clients, this brings access to 

real-world, evidence-based pharmacoeconomic analyses in Canada 

supported by the largest drugs claims database in the country to fulfill 

critical requirements for drug submissions, develop effective pricing and 

market access strategies for expedited formulary listing, and demonstrate 

the effectiveness and efficiency of drugs in real-life clinical practice. 

It is a pleasure to welcome our Brogan colleagues on board! 

LONG HISTORY OF PIONEERING EXCELLENCE 

Brogan Inc. has provided government and private sector clients in Canada 

with research and consulting services for more than 20 years and is 

recognized for the depth, quality and the objectivity of its analyses. The 

company's team of economists, researchers and clinical professionals have 

spearheaded the development of budget impact analysis (BIA) modeling, 

which is now an essential requirement of provincial formularies. 

A pioneer of drug claims analysis, Brogan was among the first companies 

to amalgamate data from multiple insurers to provide valuable insights into 

pharmaceutical utilization behavior in Canada. This has since evolved into 

the largest drug claims database in the country, providing services to 

governments, payers, and a broad cross-section of pharmaceutical 

companies. 

IMS BROGAN: FROM HEALTH ECONOMICS TO PRICING CONSULTING 

IMS Brogan services span health economics, market, patient and policy 

analysis and pricing and regulatory consulting. We harness costeffectiveness 

and cost-benefit modeling, longitudinal data reports, 

physician-level data reports, market access data and provincial and private 

drug plan data to deliver comprehensive economic analyses at all stages 

of the product lifecycle. Our extensive price regulatory consulting 

capabilities include price and risk management analysis, pricing strategies 

for new patented drugs, compliance monitoring and forecasting, 

submissions and data filing and training sessions on the operation and 

regulation of the federal drug price review agency, the Patented Medicine 

Prices Review Board (PMPRB). 

Delivering real-world, 

evidence-based 

pharmacoeconomic 

analyses supported by 

the largest drug claims 

database in Canada 

Meet the IMS Brogan 

team leaders 

See overleaf... 


NEWS | CANADA 

...continued from previous page 

The talented IMS Brogan team of expert researchers and consultants is 

headed by Joan McCormick (Price Regulation Consulting) and Nevzeta 

Bosnic (Economic Consulting). 

JOAN McCORMICK, MBA 

Joan McCormick is Principal Consultant, Price Regulation Consulting at IMS Brogan, 

with particular expertise in the strategic pricing of new pharmaceutical technologies. 

In her role as head of the Price Regulation Consulting Team she has supported many 

major pharmaceutical companies with the preparation of pricing submissions to the 

Patented Medicine Prices Review Board (PMPRB), gaining extensive insights into the 

operation of the Canadian pharmaceutical market. Joan holds a Bachelors degree in 

Life Sciences from Queen’s University in Kingston and an MBA from the University of 

Ottawa. Email: JMcCormick@ca.imsbrogan.com 

NEVZETA BOSNIC, BA 

Nev Bosnic is Director, Economic Consulting at IMS Brogan with responsibility for 

managing the company’s team of expert health economists in meeting the broad 

spectrum of client needs in the Canadian pharmaceutical market. She has extensive 

knowledge of public and private drug plans across Canada and in-depth expertise on 

the drug reimbursement process. Over the course of more than nine years with the 

company, Nevzeta has led many strategic consulting, policy and data analyses for 

pharmaceutical clients, government and academic institutions across the country. She 

holds a Bachelors degree in Business Economics from the School of Economics and 

Business at the University of Sarajevo. Email: NBosnic@ca.imsbrogan.com • 

IMS BROGAN SERVICES SPAN HEALTH ECONOMICS, MARKET, 

PATIENT AND POLICY ANALYSIS AND PRICING AND REGULATORY CONSULTING. 

HEALTH ECONOMICS 

MARKET ANALYSIS 

STRATEGIC CONSULTING 

LONGITUDINAL PATIENT ANALYSIS 

POLICY ANALYSIS 

DRUG UTILIZATION FORECASTS 

PRICING, REGULATORY CONSULTING 

IMS Brogan team leaders 

Price Evaluation; Budget Impact Analysis 

Market Assessment; Payer Segmentation 

Pricing and Market Access 

Drug Utilization Analysis 

Impact of policy and regulatory changes 

Drug forecasts; Cost driver analysis 

Advice on rules and submissions to PMPRB 

Shared goal In CEE markets, a growing need for evidence-based decision 

support is opening up new opportunities for health 

economics and outcomes research - see page 18. 

Page 4 IMS HEALTH ECONOMICS AND OUTCOMES RESEARCH

PROJECTS | NEWS 

HEOR is becoming increasingly important in the emerging markets of CEE 

including the Czech Republic, Hungary, Poland and Russia. 

Counting the cost 

in Central and Eastern Europe (CEE) 

IMS HEOR experts in CEE markets employ a wide range of research methodologies, including costeffectiveness, 

cost utility and budget impact modeling and prospective observational techniques, to support 

customer needs in markets throughout the CEE region in a range of therapy areas. 

A cross-section of our recently completed or ongoing studies is shown below. 

Country Disease Area Project Type 

BULGARIA NEUROLOGICAL DISORDERS Patient-reported outcomes 

CZECH 

REPUBLIC 

CARDIOVASCULAR 

DIABETES 

INFECTIOUS DISEASE 

NEUROLOGICAL DISORDERS 

ONCOLOGY 

Cost-effectiveness, cost utility, budget impact: NCE 

Cost utility and budget impact: NCE 

Value for money: Novel therapy 

Cost-effectiveness: New pediatric vaccine, extended coverage 

Patient-reported outcomes 

Budget impact: NCE 

Cost-effectiveness: Novel therapy, expanded indication 

ESTONIA CARDIOVASCULAR Cost-effectiveness, cost utility, budget impact: NCE 

HUNGARY 


CNS 

DIABETES 



ONCOLOGY 


Cost-effectiveness, budget impact: Established product, new indication, psychiatry 

Cost minimization, budget impact: NCE launch 

Value for money: Novel therapy, market access 




Cost-effectiveness: Novel therapy, expanded indication 

LITHUANIA ONCOLOGY Cost-effectiveness: Novel therapy, expanded indication 

POLAND 

ROMANIA 

RUSSIA 

SLOVAKIA 


CNS 

DIABETES 


ONCOLOGY 


DIABETES 


DIABETES 

ONCOLOGY 





Real-world costs and outcomes: NCE, first in class, patients at risk of hospital complications 

Value for money, reimbursement support: Established product, new indication, psychiatry 

Cost-effectiveness: Adaption, translation, reporting application in Poland 


Indirect comparison, economic analysis, budget impact: New therapy, reimbursement 




Cost-effectiveness, budget impact: NCE launch 



Cost of illness: Diabetes 

Economic analysis: NCE launch, hematological malignancy 





NEWS | IMS CORE DIABETES MODEL 

The IMS CORE Diabetes Model leads the field in diabetes modeling with 

insights that have been key in market access decisions worldwide. 

IMS CORE Diabetes Model rises to the 

Mount Hood Challenge 

The IMS CORE Diabetes 

Model is able to estimate the 

long-term clinical and 

economic outcomes of 

different therapeutic 

interventions for both Type 1 

and Type 2 diabetes. 

As part of our ongoing 

commitment to its continued 

development and external 

validity, we recently put it to 

the test at the Mount Hood 

Five Challenge in Malmo. 

The results are yet to be 

published but have already 

triggered initiatives for 

further advances in the 

model. 

The authors 

David Grant is Senior Principal at 

IMS HEOR and can be contacted at 

DGrant@uk.imshealth.com 

Adam Lloyd is Senior Principal, IMS 

HEOR and can be contacted at 

ALloyd@uk.imshealth.com 

IMS CORE 

Diabetes Model 

See our Project Focus on 

diabetes on page 42 

Diabetes is among the world’s most prevalent, debilitating and 

costly chronic diseases. New breakthroughs in prevention and 

treatment have the potential to stem its progression, but are 

already challenging limited healthcare resources. With research 

yielding the promise of further advances in diabetes care, the 

need to understand the clinical and economic consequences 

of alternative approaches has never been greater. 

IMS Health Economics and Outcomes Research has extensive experience in 

demonstrating clinical and economic value in medicine. Computer 

simulation modeling has a key role to play in this process, particularly in 

a chronic disease like diabetes, with many complications that develop over 

time. The IMS CORE Diabetes Model is widely recognized as the leading 

all-round model of diabetes available. It has been accepted by healthcare 

decision makers across the world as a validated tool which brings valuable 

insights into the long-term outcomes, costs, and cost-effectiveness of 

innovative interventions for diabetes. 

EASE OF ACCESS 

Available via the internet, the IMS CORE Diabetes Model is a software utility 

which simulates clinical outcomes and costs for cohorts of diabetes 

patients. It is one of the very few models covering patients with either 

Type 1 or Type 2 diabetes mellitus. The software has been designed for 

ease of use so that non-specialists can evaluate the effects of different 

patient characteristics and changing costs on cohorts of diabetes patients 

over a range of short- and long-term time horizons. 

MULTIPLE FUNCTIONS 

The IMS CORE Diabetes Model allows users to compare a range of 

treatments, or sequences of treatments, by controlling input parameters 

relating to: 

• Patient demographics (age, race, sex) 

• Baseline risk factors and complications 

• Change in physiological values due to treatment (e.g. reduction in 

HbA1c, BP, lipids and BMI) 

• Treatment costs 

• Morbidity and mortality risk 

• Costs of complications (e.g. MI, stroke) 

• Costs of other medication and lab tests 

• Disease progression 

• Relative risks for complications 

• Timing of switching treatments 

The model assesses clinical and cost outcomes for a range of therapies, 

allows users to undertake detailed cost-effectiveness analyses, and 

produces outputs which can be customized to provide the level of detail 

appropriate to decision maker needs. 


PUTTING IT TO THE TEST: 

THE MOUNT HOOD FIVE CHALLENGE 

The Mount Hood Challenges were first introduced in 2000 as 

an opportunity for researchers to discuss, compare and crossvalidate 

the performance and structure of economic models 

of diabetes1 . 

Continuing in that vein, the Mount Hood Five Challenge was 

held in Sweden in September 2010. In addressing the 

economic modeling of diabetes and its complications, the 

emphasis was once again on comparing model projections to 

real-world or clinical trial outcomes 2 . Within the context of 

the “challenge” environment, these meetings offer an 

important forum for explaining and discussing potential 

differences between models, and are key to identifying areas 

of future development for advancing the field 3 . 

This year, eight different modeling groups participated in the 

challenge, which consisted of two separate elements: In the 

first, participants were asked to replicate three recent clinical 

studies in order to validate their respective models. This was 

The Mount Hood Challenges 

offer an important forum for 

comparing and cross-validating 

economic models of diabetes 

achieved using published information on trial cohort baseline 

characteristics and effects of the intervention on 

intermediate risk factors to model long-term clinical 

outcomes, costs and cost-effectiveness. The second element 

focused on the way that diabetes simulation models capture 

and represent uncertainty around their projected outcomes. 

The results from Mount Hood have yet to be published and 

must remain under wraps until then. What we can say at this 

time is that our move to take part in this respected challenge 

reflected our confidence in the IMS CORE Diabetes Model and 

we were not disappointed in its performance. We are sure 

that it will continue to remain at the forefront of economic 

analysis and decision making in this area as the leading 

diabetes economic model available. 

CONTINUING TO DEVELOP THE IMS CORE 

DIABETES MODEL 

IMS is committed to continuing investment in the IMS CORE 

Diabetes Model to ensure that it remains as comprehensive, 

reliable, up-to-date and efficient as possible. We are 

delighted to share the details of three new initiatives we 

have established during 2010: 

IMS CORE DIABETES MODEL | NEWS 

1. EXPERT PANEL: We have recently instituted an expert 

panel of five leading specialists in diabetes management, 

epidemiology and economic modeling. The panel will advise 

on validation and structural refinements to the model as well 

as the inclusion of new research and clinical findings as they 

become available. As a group they will meet on an ongoing 

basis to review new results and plans for further 

development. The panel members are: 

• Dr Jonathan Brown: Chair of the International Diabetes 

Federation Task Force on Diabetes Health Economics; 

formerly Senior Investigator at the Center for Health 

Research, Kaiser Permanente (KP) Northwest in Portland, 

Oregon, USA 

• Professor Nick Freemantle: Professor of Clinical 

Epidemiology and Biostatistics, University of 

Birmingham, UK 

• Professor Bill Herman: Director Michigan Diabetes 

Research Center, University of Michigan, USA 

• Professor Andrew Palmer: Professor of Health 

Economics and Associated Research, Menzies Research 

Institute, University of Tasmania, Australia 

• Dr Stéphane Roze Senior Consultant, HEVA, Lyon, France 

2. USER FORUM: Open to subscribers to the IMS CORE 

Diabetes Model, our recently launched “User Forum” provides 

an informal platform for open discussion with our software 

developers and expert panel, around issues of common 

interest to users. Our first meeting was held on 20 

September in Stockholm, the day after the Mount Hood 

meeting. Most of our current license holders attended to 

meet our experts, learn about some recent technical changes 

and provide feedback on additional facilities for the model – 

most of which focused on user-friendliness of the tool and 

applicability earlier in the product lifecycle. 

3. UPGRADED HARDWARE PLATFORM: We have made a 

substantial investment in state-of-the-art computer hardware 

which will provide improved efficiency, reliability and 

performance. The new platform is hosted in an external data 

center which allows us to provide the very highest levels of 

security and reliability. 

Going forward, we are planning a full and detailed 

re-validation of the IMS CORE Diabetes Model against 

published clinical data, and a program to continuously review 

and refresh inputs to ensure that it continues to reflect the 

very latest literature and research findings worldwide. • 

1 Brown JB, Palmer AJ, Bisgaard P, et al. The Mt. Hood Challenge: Crosstesting 

Two Diabetes Simulation Models. Diabetes Res Clin Pract. 2000; 

50(Suppl 3):S57–S64 

2 Economics, Modeling and Diabetes: The Mount Hood Five Challenge, 

Malmo, Sweden, 18-19 September 2010. 

3 Palmer AJ, Computer Modeling of Diabetes and its Complications. 

Diabetes Care, 2007; 30(6):1638-46 


INSIGHTS | 2011 TRENDS 

As we look ahead through 2011, it is timely to consider 

the prospects for the global pharmaceutical market, 

both in quantitative and qualitative terms, the priorities 

for companies competing in this landscape and the 

implications for those who are focused on health 

economics and outcomes research. 

The author 

Murray Aitken, MBA, 

Senior VP, Healthcare Insight, 

IMS Health. 

MAitken@imshealth.com 


At the aggregate level, IMS is forecasting growth of 5-7% 

in 2011 for the global pharmaceutical market, taking the 

total market value to about $880 to $890 billion (Figures 

1 and 2). This growth rate will be about one percentage 

point higher than our expectation for 2010. While this 

might be seen as a rebound, the underlying constraints 

to growth in the developed markets are stronger than 

ever, particularly the effect of new payer moves to limit 

drug spending that we are seeing in some of the key 

European markets, as well as the anticipated impact of 

major drugs losing patent protection and for the first time 

facing generic competition. 

Growth in 2011 will be helped by three key factors: 

1. First, in the U.S. we are forecasting 3-5% growth in 

2011, up slightly from the 3-4% we are expecting 

for 2010. This is mainly due to some factors causing 

low growth in 2010 which we are not expecting to 

be repeated in 2011. Specifically, the early end to 

the flu season last winter, the impact of the severe 

weather in February which decreased the number 

of doctor visits and prescription volume, and the 

earlier than expected entry of generic competition 

for a few major drugs. Whilst we see a slight 

improvement in the U.S. in 2011, growth will 

remain in the historically low range of less than 5%. 

2. Second, in Japan where price cuts are applied every 

two years, 2011 is a non-price cut year, which helps 

growth in the second largest market rise from 1-2% 

in 2010, to 5-7% in 2011. 

3. The third facilitator of growth in 2011 is stronger 

contribution from emerging markets and especially 

the 17 countries we classify as “pharmerging”. Their 

collective growth will be 15-17% in 2011, up from 

about 14% in 2010, helped by recovering economies 

and the continued strength of China as an expanding 

market. We are forecasting 25% growth in China in 

2011, and it will enter the year as the world’s third 

largest market after the U.S. and Japan. 

CONTINUED CONSTRAINTS 

However, while these factors help to support growth in 

2011, the constraints from patent expiries and payer 

actions to limit growth in drug spending are greater 

than ever. 

Budgetary control: We are seeing both public and 

private payers around the world pursue a wave of 

budgetary control mechanisms that target drug spending. 

2011 TRENDS | INSIGHTS 

Outlook for 2011 

PROSPECTS, PRIORITIES AND KEY IMPLICATIONS FOR HEALTH ECONOMICS AND OUTCOMES RESEARCH 

Sales US $Bn 

For countries with publicly funded healthcare, this is 

being implemented in the context of efforts to restore 

fiscal balance. In Spain and Canada, we are seeing 

substantial reductions in the pricing of generics and in 

the case of Canada, the elimination of pharmacy rebates; 

in Germany new brands are being subject to new price 

negotiation requirements; and Turkey and Greece have 

implemented significant across-the-board price cuts for 

branded products. And in the U.S., too, private sector 

employers and health plans are stepping up their use of 

pre-authorizations, and increasing the incentives for 

patients to request lower cost options, all in an effort to 

limit the rise in drug costs. 

2011 will be another important 

year to watch in the global 

pharmaceutical market 

Peak years of patent expiries:We are moving into the 

two biggest years of expiries in 2011 and 2012 as 

measured by the current value of products that are subject 

to loss of exclusivity. In 2011, products with more than 

$30bn of sales are expected to face generic competition 

in major markets, including, in the U.S., iconic brands 

such as Lipitor ® , Plavix ® , and Zyprexa ® . But while the 

patents are due to expire in 2011, the full impact will not 

be felt until 2012 due to the timing of the expiries and 

the number of generic competitors. So, in fact, the 

impact of patent expiries will not be significantly 

different than in 2010, though it will remain a major 

constraint in the marketplace. 

FIGURE 1: GLOBAL PHARMA MARKET EXPECTED TO EXCEED 

$880 BN IN 2011 WITH GROWTH OF 5-7% 

12.1% 9.1% 9.1% 7.7% 7.3% 7.2% 6.9% 5.8% 7.1% 4-6% 5-7% 

1000 15% 

750 

500 

250 

0 

Global sales and growth 2001-2011 

$395 $431 $497 $556 $601 $646 $715 $781 $812 

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 

Growth 

Total world 

(f) 

Source: IMS Health, Market Prognosis, Sept 2010 

$840 $880 

-$850 -$890 

AccessPoint - Issue 1 Page 9 

2011 

(f) 

10% 

5% 

0% 

Growth const US $Bn

INSIGHTS | 2011 TRENDS 


NEW INNOVATION 

Finally, let me touch on some of the innovative products 

we expect to enter the market in 2011. We see significant 

The health economics and outcomes 

research discipline will be critical to 

ensuring that drugs are well 

positioned to capture a fair share of 

the market expansion in 2011 

new breakthroughs on the horizon in several areas, 

including stroke prevention, melanoma, multiple sclerosis, 

breast cancer and hepatitis C. In each of these areas, we 

expect new products that provide patients and their 

physicians with new treatment options, and represent a 

new understanding about the course of these diseases and 

the way they can be tackled. In total, we expect 30 to 

35 new chemical or biological entities to be launched 

globally in 2011, five of which have the potential to reach 

blockbuster status – defined as peak sales in excess of 

$1bn. These new products are significant for their science 

and patient value; but we do not expect them to provide 

market growth beyond that which we have seen in the 

past three years, which is at historically low levels. 

In summary, 2011 will be another important year to 

watch in the global pharmaceutical market: the 

introduction of exciting new products, the impact of new 

efforts to control drug budgets, the loss of exclusivity in 

major markets for some iconic brands, and the further 

rise in the importance of pharmerging markets. It will 

also be a year where the details of a number of healthcare 

reform initiatives that will impact the longer term market 

– in the United States and elsewhere – will be hammered 

out and clarified. 

INDUSTRY PRIORITIES 

For pharmaceutical manufacturers operating in this 

market environment, 2011 will be dynamic and exciting 

as they sharpen their focus across three priority areas: 

1. First, the business strategy they are pursuing, in 

particular their approach to innovation – and 

decisions about balancing internal research with 

external partnering, and the number of which 

therapeutic areas to invest in; the business sectors 

they compete in – and whether to acquire, maintain 

or divest generics, consumer health, animal health, 

vaccines or diagnostics divisions; and the geographic 


alance of their operations – in particular how 

much focus to place on the pharmerging markets. 

2. The second and related focus area for each company 

in 2011 will be honing the commercial model to 

ensure that it is optimized towards the market 

characteristics of each major country market and 

the company’s product portfolio. The appropriate 

focus and approach towards payers, prescribers, and 

patients will be further tailored to reflect the realities 

of each distinct market’s dynamics and for each 

therapeutic area. 

3. Finally, manufacturers will need to redouble their 

efforts to showcase the value their medicines bring 

to the healthcare system. This includes developing 

credible evidence of the clinical value based on 

outcomes, the necessary support to demonstrate the 

health economics of a particular drug relative to 

available alternatives, and the communication of this 

value to relevant stakeholders. Health economics 

and outcomes researchers have a primary role to 

play in supporting this priority area for 2011. For 

existing marketed products, they will help to 

reinforce and strengthen the value positioning of 

drugs, especially as many alternative treatments are 

now available in lower cost generic form. For 

FIGURE 2: 2011 SALES AND GROWTH IN GLOBAL REGIONS 

U.S. 

Size: U.S.$320-330bn 

Growth: 3-5% 

GLOBAL MMARKET 

MARKET 2011 

SIZE: $880-890BN 

GROWTH: 5-7% 

“Pharmerging” Markets 

Size: U.S.$170-180bn 

Growth: 15-17% 

China 

Brazil 

Russia 

India 

Mexico 

Turkey 

Venezuela 

Poland 

Argentina 

Thailand 

Romania 

Indonesia 

2011 TRENDS | INSIGHTS 

S. Africa 

Egypt 

Ukraine 

Pakistan 

Vietnam 

Outlook for 2011 

products nearing launch, the value proposition must 

be powerful and pertinent to the relevant 

stakeholders. 

KEY ROLE FOR HEALTH ECONOMICS AND 

OUTCOMES RESEARCH 

As 2011 brings further implementation of the Sentinel 

Initiative in the U.S., Risk Evaluation and Mitigation 

Strategies become routine, and observational trials are 

more extensively undertaken, the explosion of nonproprietary 

clinical information will bring new potential 

for benefits – as well as risks – to be identified and better 

understood. The health economics and outcomes 

research (HEOR) function will be central to ensuring 

that companies are prepared for this and proactively 

pursuing the opportunities it will provide. 

As the global market for pharmaceuticals expands by 

about $50 billion in 2011, manufacturers will be 

wrestling with their priorities and in many cases 

anticipating the imminent peak years of patent expiry. 

HEOR will be a critical component of making sure that 

drugs are well positioned to capture a fair share of the 

market expansion in 2011, and supporting company 

efforts to be well placed for innovation-led growth in the 

second half of this decade. • 

Top 5 Europe 

Size: U.S.$135-145bn 

Growth: 1-3% 

Japan 

Size: U.S. $96-100bn 

Growth: 5-7% 

Rest of World 

Size: U.S. $145-155bn 

Growth: 3-5% 

Source: IMS Health, Market Prognosis, Sept 2010 

NOTE: IMS forecasts are based on the latest release of IMS Market Prognosis , the leading annual industry indicator of market dynamics and therapy 

performance. The forecasts take account of key issues impacting the pharmaceutical and healthcare industries. Additional factors that may affect overall 

growth include major safety events resulting in product withdrawal or prescribing restrictions; shifts in regulatory approval standards from their current levels; 

the application of sudden cuts to drug spending levels; public health crises; and a deterioration in economic conditions. Growth is measured in constant 

dollars to avoid the influence of currency exchange rates; sales are calculated at the ex-manufacturer level. Market size forecasts are expressed in current 

dollars, but exclude off-invoice discounts and rebates that are part of prevailing practices in certain major markets. 


INSIGHTS | U.S. & EUROPE 

The interviewees 

Mike Nelson, PHARM D 

Dr. Michael Nelson is Regional 

Leader, Americas, Health 

Economics and Outcomes 

Research at IMS Health in 

the U.S. 

MNelson@us.imshealth.com 

Jacco Keja, PHD 

Dr Jacco Keja is Regional 

Leader, EMEA, Health 

Economics and Outcomes 

Research, at IMS Health 

in the UK 

JKeja@nl.imshealth.com 

The transatlantic 

constant of change 

As complex dynamics and 

healthcare reforms bring 

change through the key 

developed markets, we ask our 

new regional leaders in the U.S. 

and Europe for their take on the 

trends, implications and overall 

outlook for HTAs, HEOR and 

market access. 

U.S. 

INTERVIEW WITH MIKE NELSON 

Q: What do you see as the main challenges for 

market access in the U.S.? 

Mike Nelson: I think that because there are so many 

diverse payers in the U.S. market with so many different 

needs and levels of understanding about the methods and 

approaches to cost-effectiveness analysis, one of the key 

challenges for the industry is in defining what decision 

makers are looking for and generating information that 

helps them to make well-informed decisions. We are seeing 

a disconnect between the level of science that we as 

researchers employ in health economics and outcomes 

research (HEOR) and the application of that information 

to decision making. A good example in the U.S. is that the 

market struggles with using cost per QALY – decision 

makers don’t really know how to factor that in or how it 

helps them understand the relative value of a product in 

their system. I think also, in general, the emphasis of 

decision makers on randomized controlled trials (RCTs) 

as the gold standard for quality information undervalues the 

real-world observational research that can inform decision 

making, particularly in terms of cost and utilization. 


Q: Is there a need then, to facilitate a better 

understanding of HEOR? 

MN: Certainly, one pathway is helping payers better 

understand the information, but I think both sides need 

to move towards a common center: researchers need to 

make their methods more transparent and applicable to 

the decisions that payers have to make, and payers have to 

do their best to understand the methods that are employed 

by researchers in doing cost-effectiveness analysis. It may 

be that the former is more important because the 

endpoints we are using and the way we present data are 

not uniformly meeting decision makers threshold for 

reliable evidence – as evidenced by discussions at the 

recent International Meeting of ISPOR. There is still a 

level of distrust regarding information that comes from 

the industry and yet the industry does its best to employ 

the most rigorous methods available to generate the 

information that it puts in front of payers. Researchers 

need to appreciate that despite their best efforts to 

generate robust, high-quality research it is still in many 

ways under-appreciated by decision makers. 

Q: What are the implications of healthcare 

reform in the U.S.? 

MN: I think it will lead to an increase in the impact of 

HEOR. The shift in coverage decision making from 

acquisition cost to overall value will accelerate an 

appreciation that economic value is about more than just 

the cost of the pharmaceutical. In the private sector and 

commercial health plans where coverage decisions have 

largely integrated pharmaceutical cost into their decision 

making, decisions will start to be based more on overall 

product value – not just safety, efficacy, and unit price but a 

broader appreciation of its overall impact on health 

outcomes. And in the public sector, which traditionally has 

not emphasized cost in its decision making, slowly, but 

inevitably, cost and cost-effectiveness will have to be 

incorporated into understanding the overall value of the 

product. There is still some political resistance and fear about 

what that means for access to care. Patients in the U.S. have 

been used to fairly open access, so there is concern about 

decisions being made on cost alone and fear that it will lead 

to ‘rationing’ based on cost – particularly among people 

who have potentially life-threatening and chronic severe 

conditions requiring expensive new technology. 

Q: Why is comparative effectiveness research 

(CER) so key to reform? 

MN: There is a general understanding that healthcare 

costs in the U.S. are continuing to rise and that new 

U.S. | INSIGHTS 

technology is helping to push cost in that direction, but 

no one knows whether we are really getting good value 

for the money we are spending on healthcare. We 

constantly see news about the cost of healthcare in the 

U.S. relative to other countries, but when we look at the 

quality of care according to information in the press there 

is a general perspective that we are spending a lot on 

healthcare but ranking much lower than other countries 

in terms of overall quality. There is also a general 

appreciation that we can’t continue to spend more and 

more of our overall resources on healthcare without 

understanding what the return is on that investment. 

Q: What is the goal of CER? 

MN: The goal of CER is to provide information on the 

relative “effectiveness” of healthcare technology through 

the analysis of safety, efficacy, and real-world outcomes data. 

CER is intended to improve the quality of care, but at the 

end of the day it is really about achieving better quality 

with an appreciation that resources are finite. Costeffectiveness 

research analyzes cost and quality together. 

Q: IS CER simply ‘more of the same’ for HEOR 

researchers? 

MN: Well, certainly, CER is not unfamiliar to HEOR 

researchers. Cost-effectiveness researchers have for years 

in my view conducted CER, the only difference being 

that cost is part of the basis for comparison, whereas with 

CER the emphasis seems to be more on the quality of 

outcomes as the primary endpoint. To my mind, they are 

very similar and cost-effectiveness is a form of CER 

which emphasizes or brings cost into the overall value 

assessment. 

Q: Will there be a need for guidelines in 

conducting CER? 

MN: In order for the science to be accepted, guidelines 

are probably appropriate. As an example, guidelines for 

conducting good clinical research are well understood. 

Since RCTs generally don’t capture all the information 

needed for CER, we will have to include other forms of 

observational research to get the best view of the 

effectiveness of technology. To improve the reliability and 

validity of this research, there should be some guidance 

and recommendations on the best way to conduct each 

type of research. This is not because I think there is a lot 

of inappropriate research being done but more because 

the users of that information need to be comfortable that 

there are standards being followed and that the research 

they are reviewing has a high level of quality and 

methodological rigor. 


INSIGHTS | U.S. 


Q: Do these developments imply changes for the 

industry? 

MN: I believe so, yes. The overall research focus will 

continue to be concentrated on clinical development and 

getting the products through regulatory approval. Where 

there is room for growth is thinking beyond the 

regulatory goal to the market access hurdle and what 

information and research needs to be done throughout 

the lifecycle of the product to support that. There has no 

doubt been a general trend in the industry to consider 

the market access hurdle earlier and earlier in the 

lifecycle, but I think there is room for earlier generation 

of evidence that supports the comparative effectiveness 

and cost-effectiveness analyses. To do that, there needs to 

be investment and rethinking of the amount of resources 

that are deployed to those kinds of research earlier in the 

lifecycle. 

Q: Are regulators starting to look beyond 

randomized controlled trials? 

MN: I’m not sure that regulators are quite there yet - 

the FDA hasn’t started to make cost part of its 

requirements for approval in the U.S. Payers, though, are 

certainly thinking about this and how to best integrate 

that kind of information. The emphasis is more on 

getting both the regulatory and market access approval 

and planning for that in parallel. This is an increasing part 

of what we do at IMS – supporting companies both on 

the market access side but also being strategic about the 

way we think about programs and research studies that 

need to be done and when they need to be done in order 

to optimally time the information with when the 

decisions are being made. 

Q: What are the challenges in sourcing 

real-world data? 

MN: We have some of the same challenges in the U.S. as 

in Europe but the one area where we have some 

advantage is that there are large retrospective databases 

which can be accessed for certain types of research, 

particularly in the analysis of overall burden of disease, 

treatment patterns across multiple regions of the country 

and looking at where there are opportunities for quality 

improvement in terms of outcomes related to those 

therapies. Ultimately, once a product hits the market, these 

databases enable direct comparisons of how products are 

being used as well as their outcomes. All of that can be 

done in the context of retrospective claims databases, 

electronic medical records, and other data collection 

methods tied to those two things. But there is a limit to 

the endpoints these databases include which is why 

robust, prospective observational research is also critically 

important. The challenges in the U.S. and Europe in those 

kinds of data collection methods are more similar. 

Transparency is really important 

and that is an area where we 

need to do a better job 

Q: Why is real-world, observational research so 

important? 

MN: The real-world data that is available provides a 

picture of what really happens outside the context of a 

very structured and controlled clinical trial and that is 

what effectiveness is really all about and how it differs 

from “efficacy”, which is ultimately what an RCT is 

designed to measure and compare between two different 

interventions. Observational methods, including databases, 

give you an opportunity to see what happens outside the 

view of an RCT, ‘out in the wild’ where patients and 

physicians behave in real practice. 

Databases give us some insight into what is happening 

without having to design and implement a very expensive 

and long-term randomized controlled clinical trial. 

Prospective observational studies provide the opportunity 

to collect data which form part of what defines overall 

product value but which only the patient or physician 

provider may have. Examples of endpoints that require a 

prospective observational study include: quality of life, 

patient satisfaction or qualitative outcomes such as 

symptom management, like pain control - anything that 

ultimately drives the value of the treatment but which is 

often difficult to measure in claims or retrospective 

databases. Another good example would be measuring 

both hyper- and hypoglycemic events in diabetes which 

can be problematic for patients who are trying to tightly 

control blood glucose. To some extent those things can be 

measured in claims or retrospective databases if they 

warrant a doctor visit, but if the patient is able to selfmanage 

through guidance or by managing their diet, 

those things can’t be captured in retrospective data but 

still impact the overall quality of that patient’s outcome 

on a particular therapy. Sometimes the only way you can 

capture that is through a prospective observational 

method. At the end of the day, the patient is the ultimate 


customer of healthcare and we should be incorporating 

their perspective in our understanding of the value of the 

product and therefore patient-reported outcomes are a 

really important component of comparative effectiveness. 

Q: How can HEOR best support decision 

making in the post-reform era? 

MN: If you look at the types of difficult decisions that 

now are coming more into the limelight, they are the 

same as those that HEOR researchers have been 

struggling with for the last 20 years or more, so this is not 

a new challenge without any science behind it. The 

methods that have been developed and used over many 

years as part of the evolution of HEOR research are really 

the tools that will help decision making in the postreform 

years. There is still resistance to the economic part 

of this in the U.S. in particular because of concerns that 

decisions will be based only on cost and not overall value, 

which incorporates both quality and cost. Thus, a 

challenge with HEOR is to overcome the fear of overemphasizing 

the cost part of the value equation in 

decision making. What we can do to move that along is 

help people understand that it’s not just about quality or 

cost – but the marriage of the two, and that the methods 

we have developed over the last 20 plus years really are 

the science in bringing those two things together. 

Q: Is HEOR becoming overly complex? 

MN: Well, without doubt, the sophistication of today’s 

analyses is far greater than it was 20 years ago. However, 

the level of understanding of those methods by the 

people using them in applied decision making hasn’t 

necessarily tracked evenly with that. If we look at 

economic modeling, the methods are very sophisticated 

and advanced but that’s not necessarily a good thing 

because sometimes their complexity makes it difficult for 

strategic and business decision makers to take that 

information and utilize it without skepticism about how 

it was generated. Transparency is really important and that 

is an area where we need to do a better job – helping 

decision makers understand that the methods we are 

using are more advanced, but have been validated and are 

transparent so that they can decide whether these are the 

best methods to analyze that particular data. If we don’t 

appreciate that the information we are generating has to 

be relevant and usable to the decision makers then we 

are really not achieving our goal of conducting good 

research. • 

EUROPE | INSIGHTS 

Europe 

INTERVIEW WITH JACCO KEJA 

Q: What are the key challenges for pharma and 

market access in Europe? 

Jacco Keja: I think we are seeing three major trends in 

the region: The first has to do with an intensification of 

international collaboration in HTAs. In the past, 

negotiations and HTAs were mainly conducted at the 

regional level. Today, not only are national payers 

becoming far more adept at these assessments but we are 

also seeing networks of HTA agencies, such as 

EUnetHTA and INAHTA, gathering strength. There is 

a growing need for the industry to deeply understand this 

process and to monitor, pre-empt and manage HTA at 

these levels. 

The second trend is increasing regionalization. Whereas 

historically, pricing and reimbursement was either relatively 

free or primarily driven by one or two national players, in 

the last few years we have seen a big push towards 

regionalization – first in Spain and Italy, more recently in 

the UK with stronger primary care and GP 

commissioning groups and now in France where regional 

power is also intensifying. Companies are used to dealing 

with national payers and with relationships at the very local 

level. Now, they need to start looking at how well they 

are organized to operate in what is increasingly a businessto-business 

driven market where the ability to negotiate 

as a business-to-business partner is becoming imperative. 

Finally, in the EMEA region we also are moving closer 

to a world where free pricing and the traditional 

UK/Germany launch sequence is probably going to be 

history in the next year. We have seen with the 

deterioration of the English pound that already for most 

companies the UK is not as attractive a market any more 

from an international pricing reference point of view. 

And Germany is essentially giving up its free pricing. So, 

again, companies have to completely rethink their 

consolidated European launch. 

Q: What are the business imperatives 

for the industry? 

JK: All these factors need to be dealt with from a pricing 

point of view, but they cannot be disentangled from HTA 

and health economics and outcomes research because yet 

another continued trend is that P&R is being achieved 

on the basis of a commitment by pharma to deliver what 

they promise up front. This means that all kinds of payfor-performance 

deals have to be organized by the 

industry and payers. Companies get their price and 

reimbursement after a process of lengthy negotiation but 

there is always some kind of commitment to deliver on 


INSIGHTS | EUROPE 


certain performance indicators. To prepare for that 

discussion they are going to need firstly an understanding 

of HTA and the skills around that, and secondly, realworld 

data capabilities – throughout the product lifecycle 

- for portfolio management, patient segmentation, P&R, 

economic modeling and post-launch commitment. 

Q: How is HTA evolving in the region? 

JK: Historically, HTA was a very local affair. Now it is 

reaching a new level of sophistication, with agencies 

collaborating strongly together, asking for more 

information and becoming far more protocolized in their 

approaches. HTA is becoming just as important as 

regulatory approval in Europe and the industry really has 

to take this very seriously. Without being sufficiently well 

prepared for it, companies will set themselves up for failure 

during P&R negotiations – the two go hand in hand and 

this is a really important aspect of doing business these 

days. The fact that these agencies work together means 

there is also a need to understand who relates to whom. 

One of the complications with HTA is what do you 

define as HTA? Some of the assessors are quite clear and 

have well described powers like NICE, but if you take a 

wider definition of HTA, many bodies that conduct these 

assessments that have an impact on likelihood to prescribe 

such as UK Primary Care Trusts – in spite of the fact that 

NICE gives clear guidance they decide on particular 

implementation themselves. Then again, whole countries 

have very fragmented approaches to HTA and that also 

needs co-ordination and management. 

Q: What is driving this trend in HTA? 

JK: To some extent it is driven by certain forces in the 

market who feel that at HTA level we might find ourselves 

facing a similar situation as we did 10-15 years ago in 

regulatory, where every nation had its own decision 

making body, and by going through one united application 

we could reap the benefits of efficiency and clarity and 

consistency at the European level. However, there is the 

basic difference that regulatory very strongly depends on 

RCTs which means the size and internal validity of studies 

are quite important. HTA is all about expectations and 

understanding what happens in the day-to-day clinical 

setting and is implicitly much more affected by the EU 

subsidiarity principle. In other words, real-world data are 

important and will continue to be driven by local and 

regional healthcare practices. I expect these practices are 

and will be for the foreseeable future still quite dissimilar 

between the different countries. Care is being 

implemented based on individual needs, so it is extremely 

important to understand that. At the moment, HTA is on 

the middle ground where consistency and methodology 

and certain parts of it are more coordinated amongst the 

bodies - that is what is happening here right now and what 

companies should understand. 

Q: How significant is the new Drug 

Reimbursement Law (AMNOG) in Germany? 

JK:There are two main aspects to AMNOG: on the one 

hand when the law is implemented early in 2011, 

Germany as a free price country for innovative drugs will 

cease to exist. Although the fiction of a free price exists 

for at least 12 months, in the following years sick funds 

will only pay for the drug if a discount contract with all 

statutory health insurances is in place. This in itself is a 

dramatic change. Even more significant is that once the 

law is in force, companies will be required to negotiate 

discounts on a new product’s price on the basis of its 

expected additional benefit, supported by a detailed 

“value dossier” called benefit dossier by the German law. 

We will also see IQWiG becoming more formally 

involved in the P&R process in making a judgment as to 

whether a product is indeed more beneficial. The value 

the product brings to the market is a key element here, 

so for the first time considerations on additional benefit 

become quite important in the German market. 

Companies will have to be prepared for these 

negotiations and understand in detail what will happen 

with their product in real-life and understand the 

efficiencies and inefficiencies in the German healthcare 

system. This comes back again to the need and ability to 

obtain or generate real-world data and insights. 

Q: What do these changes mean for HEOR in 

the industry? 

JK: Well, if you think about products entering Phase III, 

companies should start thinking more deeply than ever 

before about which patient populations benefit from 

their new technology and this includes having a much 

better and deeper understanding of co-morbidities and 

patient segmentation, which are really important 

considerations now because they need to design their 

endpoint strategies and outcomes research accordingly. 

Historically, and to some extent driven by regulatory 

needs, the focus was very much on developing a product 

for as wide a population as possible for obvious reasons 

to maximize potential. Now we see a great deal of pushback 

by payers at that level, and if the industry doesn’t 

find the right patient segments then payers will do that 

for them. This is a very important aspect of portfolio 


management to really understand the ideal patient for the 

product. Alongside that, companies need to understand 

what current products are doing in real life so that 

HEOR goes hand in hand with doing patient registry 

analyses or other methodologies to drive that insight. 

If we consider pre-launch and international coordination 

of HTA, cost-effectiveness analysis is becoming more 

important than ever before. Typically in the past, 

companies would develop their economic model then 

mostly go local for model adaptations which the affiliates 

would drive relatively independently. Now they can’t do 

that because of HTA collaboration and also because of 

the need, for example in rare diseases, to get sufficient 

power in the data sources, so international coordination 

of HEOR is quite important. 

Finally, post-launch there is the commitment to deliver 

actual data on how a product performs in the market – 

again this needs competencies at the level of outcomes 

research so setting up prospective observational studies, 

for example, or linking up to existing registries to pull 

the data in order to maintain the P&R agreed upon at 

the regional level. There is a much stronger need for 

international resources than ever before and for 

companies to manage their IP throughout the lifecycle. 

Q: Why is there so much emphasis on 


JK: At all levels, it is to prove a company’s claims for 

innovation. This burden is being clearly put back on 

pharma and very simply that is why real-world data so 

important. Much of the projection of that just cannot be 

pulled out of the clinical regulatory studies. For example, 

compliance is a very important aspect of many new 

innovations and should be very relevant to payers, but is 

rather difficult to collect from protocolized studies. And 

with the market becoming much more of a business-tobusiness 

environment with pay-for-performance contracts, 

the paying partners of pharma want proof of effectiveness 

and safety in real life. This is an extremely important aspect 

of the business nowadays and quite a drastic change from 

the past which was much more about extrapolation based 

on regulatory studies. Now there is a need to go back to 

the payers, one, two or three years post-launch with the data. 

Q: What are the challenges in collecting 


JK: One problem we have with real-world data is the 

lack of guidelines on how to do it. Everyone knows how 

clinical trials have to be conducted, but there are two 

issues for real-world data: one is the fact that clinical trials 

EUROPE | INSIGHTS 

have been developed to get rid of all the confounding 

factors and now it seems we are interested in finding out 

about all those confounders, which can be difficult. The 

other is that collecting data for prospective observational 

studies can be time consuming and expensive and in 

Europe in particular, one of the biggest challenges is in 

finding the data. You need to have people who are very 

familiar with healthcare systems at the local level with 

the experience and expertise to find the right sources of 

information. This is a big challenge for the industry to 

navigate through the real-world data sources. 

Q: What are the implications for 

outcomes research? 

JK: Many markets are now becoming mature and new 

products are having to fight for a position and the only 

way they can do that is to get into more specialized 

positions in the market, for example, by not only 

addressing the main disease but also its co-morbidities. 

The other element is understanding that the data needs 

of increasingly powerful payers are concerned with 

knowing what a product is doing in real life, and that 

insight can only be obtained by doing observational 

studies. Patient empowerment is also an important 

aspect. Yet another inroad into real world data is getting 

a better understanding of patients and addressing patient 

needs so patient reported outcomes become more 

important. If you put all of this together, you will 

understand that your typical protocolized clinical trial 

will not answer all the questions of other stakeholders 

who have become much more important in the market. 

Q: How is HEOR evolving in emerging markets? 

JK: The typical cycle for emerging markets is that their 

economies are expanding quite dramatically, there is a 

population of people with the means to pay for 

healthcare, new higher priced technologies come onto 

the landscape and when these markets evolve even 

further and start to encounter the same sorts of issues that 

developed countries have experienced in the past. We see 

countries like Korea, for example, trying to learn from 

the success and failures of say Western European markets. 

So the emerging countries are following a much more 

expedited process of adoption of HTA and HEOR 

which cuts short of our learning curve there. We see a 

similar pattern in their willingness to adopt biogenerics 

far more quickly than has been the case in Europe and 

the U.S. • 


INSIGHTS | EMERGING MARKETS: CEE 

The emerging pharmaceutical markets of 

Central and Eastern Europe have their own 

unique characteristics but share the goal of 

improving access to healthcare against a 

backdrop of rising costs. With a lens on 

Russia, Romania and Ukraine, each at very 

different stages of evolution, we consider how 

important changes and a growing need for 

evidence-based decision support are opening 

up new opportunities for health economics 

and outcomes research. 

The authors 

Yevgeniy Samyshkin, MSC is Engagement Manager 

HEOR; Paula ¸Tele, MD, MPH, MSC is Consultant HEOR; 

and Wioletta Kotowa, MD is Senior Consultant HEOR, 

all at IMS Health. 

YSamyshkin@uk.imshealth.com 

PTele@uk.imshealth.com 

WKotowa@de.imshealth.com 


RUSSIAN FEDERATION: INVESTING IN HEALTH 

In Russia, investment in healthcare is considered a longterm 

national priority as a means of reducing mortality 

rates and increasing life expectancy. A program of 

measures for the next ten years has recently been outlined 

in the Concept of Healthcare Development 2020. 

Vast market, complex system 

Before examining these measures in more detail, it is 

important to bear in mind the vast and expanding scale 

of the Russian healthcare market. Government health 

expenditures per capita reached US$590 in 2010 

compared to around US$360 in 2005 (at exchange rate). 

And their continued growth is anticipated: estimates from 

the Federal Ministry of Health and Social Development 

suggest rates of US$1,400 in 2017 climbing to US$1,800 

by 2020 (Figure 1). 

Healthcare in the Russian Federation is a complex multitier 

system, combining federal and regional programs 

financed through a mixture of general tax, mandatory 

health insurance contributions, voluntary insurance, and 

formal and informal contributions from private patients. 

The financing and organization of the nation’s healthcare 

service mirrors the tiered government administration and 

budgetary system at the federal, regional and municipal 

levels. Federal financing tends to support tertiary service 

development, and provision of high-cost treatments and 

diagnostic procedures through financing of federal 

facilities and targeted programs. 

To date, the major single systemic change in the Russian 

healthcare system has been the establishment of the 

Mandatory Health Insurance (MHI) system in 1993, with 

federal funding of health services to allow more flexible 

resource allocation mechanisms. Its creation has enabled the 

government to experiment with such key concepts as the 

purchaser-provider split; contracting of private insurance 

companies to administer health insurance reimbursement; 

the increasing use of healthcare information for planning 

and management purposes; and ultimately moving away 

from the budgeting of healthcare providers to volumebased 

contracting of services. Federally, priority is given to 

the development of high-tech services, with investment in 

regional tertiary service centers to strengthen such areas as 

cardiac surgery, endocrinology, prosthetic medicine, 

neurosurgery, transplantation, and reproductive medicine. 

EMERGING MARKETS: CEE | INSIGHTS 

Moves to HTA 

in Central & Eastern Europe 

Over the last decade, the federal government has 

implemented and tested a range of programs and national 

projects to improve the healthcare system and increase 

patient access to essential pharmaceuticals. Among the 

most well-known is the DLO (2005), a supplemental 

out-patient pharmaceutical benefits program designed to 

increase access to pharmaceuticals for defined population 

groups and provide high-cost drugs for rare diseases and 

for use in transplantation medicine. 

New initiatives 

More recently, a new system of Mandatory Pharmaceutical 

Insurance has been under discussion in Russia. First 

conceptualized in 2008 by the Federal Mandatory Health 

Insurance Fund, this was originally intended for 

implementation in 2010. However, these plans have now 

been postponed, pending government attempts to regulate 

the market and develop mechanisms to ensure 

sustainability of the pharmaceutical insurance package. 

System-level changes to continue 

A number of system-level changes can be expected in 

Russia in the coming years including: 

• Greater move towards a single-channel health 

financing system with MHI as the single payer. 

• Transformation of the pharmaceutical landscape led 

by stronger emphasis on cost-containment and the use 

of pharmacoeconomics in reimbursement decisions. 

Provision for universal pharmaceutical insurance is also 

on the healthcare agenda. 

• Specific regulatory and economic measures to curb 

further cost growth and maximize health 

improvement, focusing on pricing policies, the greater 

use of guidelines, the introduction of patient copayments 

and controls to ensure appropriate 

prescribing by doctors. 

The main vehicle for these changes would be the MHI 

system. Given the scale of the Russian economy and the 

complexity of its socio-economic environment, the 

government has a major challenge ahead in terms of 

implementation but one that brings the promise of 

continued improvements in healthcare delivery. Certainly, 

advances in modern technologies, coupled with the 

developments in Russia’s healthcare system over the last 

decade, are increasing awareness of the role of 


INSIGHTS | EMERGING MARKETS: CEE 

Russian government 

health expenditures per 

capita reached 

US$590 in 2010 

compared to around 

US$360 in 2005 (at 

exchange rate) and 

their continued growth 

is anticipated. 


pharmacoeconomics and outcomes studies in supporting decisions 

on the impact and rational use of health innovations in the 

country. 

USD per capita 

FIGURE 1: PROJECTED HEALTHCARE EXPENDITURE PER 

CAPITA IN RUSSIA 

$2,000 

$1,000 

$1,600 

$1,400 

$1,200 

$1,000 

$800 

$600 

$400 

$200 

$0 

2010 

Healthcare expenditures per capita 2010-2020 

Pharmaceuticals 

National project health 

Federal health facilities 

Regional and municipal health budgets 

Mandatory health insurance 

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 

Source: Ministry of Health and Social Development 2009-10 

ROMANIA: REACHING OUT TO HEALTH ECONOMICS 

After a promising period of economic growth following its 

integration into the EU in 2007, Romania has felt the impact 

of the global financial crisis more keenly than most countries in 

the last two years. Ever shrinking budgets have seen government 

strategies progressively more focused on managing costs, 

significantly impacting the price of medicines and intensifying 

the pressure on market access. Successive governments have now 

tried nearly every type of cost-containment measure that has 

ever been introduced elsewhere in Europe. 

In April 2009, Romania’s status as the lowest priced 

pharmaceutical market in Europe was consolidated by the 

introduction of international reference pricing rules. Currently, 

therapeutic reference pricing applies to products reimbursed at 

50% and 90% but this is due to be extended to products 

proposed for 100% reimbursement. The budget for fully 

reimbursable products in the national program for chronic 

diseases has come under particular scrutiny in recent months, 

resulting in methods for cost/volume agreements and stricter 

reimbursement criteria from October 2010. Medicines in this 

list account for a significant share of the pharmaceutical market, 

with many higher price products included. This measure will 

be accompanied by the introduction of therapy guidelines. 

The positive reimbursement list is the main means of controlling 

prescribing in Romania, with clear stipulations on the 

reimbursement level and conditions of use for each drug. Product 

inclusion will continue to be the primary driver of prescribing 

in the country and as such is a critical goal for manufacturers 

launching new pharmaceutical technologies. 


New role for HTA 

Although evidence-based, economic evaluations of new 

therapies are now widely used for reimbursement 

decisions across Europe, in Romania a national HTA 

initiative has only recently been introduced - despite a 

long-recognized need for one. Under a Government 

Ordinance in March 2008, primarily as a move towards 

harmonization under EU pharmaceutical policy, health 

economics data was made pre-requisite for drugs 

introduced on the reimbursement lists. 

Notwithstanding this important advance, it remains 

unclear how these data will be used given the absence of 

Romanian guidelines on conducting pharmacoeconomic 

analyses. Thus far, the decision making process has been 

based mainly on studies undertaken in Western Europe, 

overlooking critical issues in the transferability of health 

economics results from one country to another and the 

consequences of such a practice. 

Lack of data a key challenge 

More recently, under the pressure of the current 

government regulations, pharmaceutical companies have 

come to appreciate the importance of determining and 

demonstrating the value of their products specifically in 

the Romanian market, using Romanian data, 

understanding that a key requirement in showing costeffectiveness 

and ‘value for money’ is to address countryspecific 

willingness-to-pay. However, lack of 

transparency in the market is an issue, and there is 

growing recognition that the biggest challenge for health 

economics and outcomes research is finding the necessary 

data. In-depth, on-the-ground knowledge, the ability to 

retrieve relevant cost, clinical and epidemiological 

information across therapy areas, and appropriately 

validate the results with local experts will be key to the 

successful development of rigorous and relevant value 

propositions in Romania. 

UKRAINE: HARD HIT BUT RECOVERING 

Also hard hit by the global financial crisis, the Ukraine 

economy is now showing signs of recovery, with GDP 

increasing by 4% in 2010 according to official statistics 1 . 

However, healthcare remains severely under-funded, with 

expenditure accounting for less than 4% of GDP – 

widely accepted to be inadequate. Patients are 

responsible for more than a third of total healthcare 

spend, but private healthcare remains out of financial 

reach for most of the population. 

The potential for some form of public health insurance 

EMERGING MARKETS: CEE | INSIGHTS 

Moves to HTA in Central & Eastern Europe 

system in Ukraine has been discussed and explored for a 

number of years. Various proposals have been drafted but 

to date these have proved too cost-prohibitive to 

implement. More recently, under the new government, 

the issue of healthcare reform has taken on greater 

importance and first steps have been taken with the 

introduction of municipal sickness funds in a number of 

regions in Ukraine. These have yet to reach the capital 

but are indicative of some progress being made. 

As patients bear the brunt of total healthcare costs in 

Ukraine, via out-of-pocket payments, purchasing power 

in the country remains extremely low. There is no system 

of national price regulation for pharmaceuticals, the main 

control being maximum retail surcharges for 

pharmaceuticals and medical devices. However, these 

cover only 16% of all products registered. 

Strong emphasis on generic medicines 

Not surprisingly, given the lack of a reimbursement 

system and high level of patient out-of-pocket pay for 

medicines, 80% of the Ukraine pharmaceutical market 

consists of generic products. The reliance on inexpensive 

drugs and branded generics supports a strong local 

pharmaceutical industry, which produces just under half 

of all medicines sold in the country. The emphasis is on 

cardiovascular medicines, analgesics, vitamins, drugs for 

respiratory disease and blood system disorders, 

gastrointestinal medicines, and antibiotics. 

Acknowledged deficiencies 

Problems with the availability of medical services and 

medicines in Ukraine have recently become more 

pronounced. The state is unable to provide sufficient 

resources for guaranteeing accessible, quality treatment, 

there are acknowledged inefficiencies in the existing 

public health system, and a fall in indicators of health 

coupled with an adverse demographic situation clearly 

point to the need for major change. The fact that the state 

should better control medical services is widely accepted 2 . 

The search for additional sources of financing of public 

health services has been discussed in the context of a 

potential tax to be added to the price of medicines. Equally, 

the introduction of obligatory medical insurance in 

Ukraine would enable the provision of healthcare services 

across the population while providing the state with an 

essential stream of revenue for compensation of treatment 

costs. It would also allow some control to be exercised over 

the efficiency and expediency of medical prescribing. Those 

who are in favor of introducing obligatory social medical 

insurance, hope that the increased financial resources would 


ANALYSIS INSIGHTS | EMERGING MARKETS: MARKETS CEE 


be efficiently used under the control of the state. 

Trialing drug reimbursement 

As a first step towards transitioning from state purchases of medicines 

to a compensation system for out-patient drugs in Ukraine, a pilot 

project was planned by the Public service of the Ministry of Health 

in 2009, focusing on the reimbursement of insulin for diabetes 

patients. However, the Public service was disbanded and all works 

were subsequently suspended. Nevertheless, the experience of this 

pilot project could prove useful in the future for the development 

of a reimbursement system covering all groups of vitally 

important medicines 3 . 

By drawing on the experience of Western Europe, Ukraine can 

and should construct as soon as possible an effective model of 

public health services based on the Law of Obligatory Social 

Medical Insurance and its provision of free medical care to all 

citizens. Adoption of such a law would be a significant turning 

point for reform of the system, paving the way for the funding 

of medical services and introduction of HTA in the country. 

Moves towards HTA 

Although the term Health Technology Assessment (HTA) is still 

new to Ukraine, there has been growing interest in this type of 

evaluation and its role in pricing and reimbursement. Indeed, 

HTA has been the subject of several national and international 

conferences and forums in the country over the last few years 4 . 

Attended by senior figures, including members of Ukraine’s 

Ministry of Health, these signal growing recognition of the 

importance of HTA and an eagerness to learn more about the 

pricing and reimbursement models existing in different 

European countries. 

Particular emphasis has been placed on the independence of 

HTA institutions, empowering them with advisory or regulating 

functions with delegation of the right of decision making. This 

principle of independence and objectivity in the system is 

currently broken in Ukraine: the Official committee is part of 

the State pharmacological center of the Ministry of Health, the 

body responsible for the State registration of medicines, giving 

rise to problems around the maintenance of official management. 

Despite recognition that evaluating health technologies is 

absolutely necessary for rational use of limited resources in 

Ukraine, there is also professional realization that HTA will 

require considerable additional resources and this is likely to be 

a key issue for its implementation going forward 5 . • 

1 http://www.kmu.gov.ua/control/uk/publish/article?art_id=243697161&cat_id=24 

3311332 

2http://tristar.com.ua/1/art/obiazatelnoe_strahovanie__lekarstvo_dlia_meditsiny_13 978.html 

3http://www.expert.ua/articles/16/0/6215/ 4http://www.apteka.ua/article/43962; http://ipr.adcontext.net/10/09/24/61055; 

5http://tristar.com.ua/1/art/ukraine_nujen_zakon_ob_obiazatelnom_sotsialnom_me ditsinskom_strahovanii_14052.html. 


EMERGING EMERGING MARKETS: MARKETS CEE | EXPERTISE 

| PEOPLE 

Understanding CEE markets 

INTRODUCING IMS SPECIALISTS WITH LOCAL EXPERTISE IN THE CEE REGION 

Lusine Breitscheidel, MD, MPH 

Lusine Breitscheidel is a Senior Consultant, Health Economics and Outcomes Research at IMS Health, 

focusing on pharmacoeconomics and pharmacoepidemiology. With more than 12 years experience in 

epidemiology and over five years in HEOR she has worked on many national and international projects 

addressing healthcare issues in the EU, as well as South Caucasus, the Republics of Armenia, Georgia 

and Azerbaijan, and Russia. Lusine holds an MD from the University of Munich and an MPH from the 

State University of New York. 

Lyudmila (Mila) Gorokhovich, MSC 

Lyudmila Gorokhovich is an Analyst, Health Economics and Outcomes Research, at IMS Health, 

with expertise in cost-effectiveness evaluations and comparative health system data analysis. She 

has worked with public healthcare payers to help determine best practice in health system 

performance, financing and reform, and developed analyses to support healthcare customers with 

commissioning decisions. A native of Ukraine, Mila holds a Masters in International Health Policy 

and Health Economics from London School of Economics and a degree in Economics and Human 

Rights from Columbia University. 

Wioletta Kotowa, MD 

Wioletta Kotowa is a Senior Consultant, Health Economics and Outcomes Research at IMS Health, with 

responsibility for developing value dossiers, HTAs and health economic evaluations. Formerly a 

physician, lecturer and researcher at the Medical University in Charkow, Ukraine, she brings extensive 

expertise across a range of medical indications, pharmaceuticals and medical devices as well as 

industry experience in Phase IV studies. Wioletta holds an MD from the Medical High School (now 

Medical University) of Charkow, Ukraine. 

Yevgeniy Samyshkin, MSC 

Yevgeniy Samyshkin is an Engagement Manager, Health Economics and Outcomes Research at IMS 

Health focusing on pharmacoeconomic modeling and reimbursement submissions. He has worked in 

Central Asia, designing and implementing national reimbursement systems for hospitals, and as an 

independent consultant in health policy and financing for the World Bank, Asian Development Bank, 

WHO and USAID. Yevgeniy holds an MSc in Health Management and Economics from Imperial College 

Business School, London and a first degree in Science from Tomsk University, Russia. 

Margarita Shlaen, MPH 

Margarita Shlaen is a Consultant, Health Economics and Outcomes Research at IMS Health, with 

expertise in public health, data management, statistical analysis of health economics studies and 

evaluation of epidemiological data. Her experience includes the management and evaluation of 

population-based prophylactic and vaccination programs in St. Petersburg, Russia. Margarita holds 

a Masters in Public Health from the Ludwig-Maximilian University, Munich and a Science degree 

from St. Petersburg University School of Epidemiology & Public Health, Russia. 

Paula ¸Tele, MD, MPH, MSC 

Paula is a Consultant, Health Economics and Outcomes Research at IMS Health. Formerly with the 

European Medicines Agency, she has in-depth knowledge of healthcare systems in CEE, gained in roles 

as Assistant Professor in Public Health at the Carol Davila University of Medicine in Bucharest, an 

adviser for the Romanian National Health Insurance Fund, and a health economics specialist at Solvay 

in Romania. Paula holds an MD from the University of Medicine in Bucharest, an MSc in Health Policy, 

Economics and Management from Maastricht University and a Health Outcomes Research Diploma from 

the Vienna School of Clinical Research. 


INSIGHTS| IMS SYMPOSIUM 

Leap-frogging to evidence-based 

value in the Asia Pacific 

An IMS Symposium at the 

ISPOR 4th Asia Pacific 

Conference considered 

lessons, models and 

innovative solutions to 

facilitate market access 

in Asia. 

The speakers 

Abdulkadir Keskinaslan, MD, MBA, MPH is Market 

Pricing Director for Asia Pacific Region, Novartis 

Pharma AG 

Annie Chicoye, PHD is Development VP, 

Health Management Institute, ESSEC Santé Business 

School France-Singapore 

Mandy Chui, MBA is Regional Practice Leader, 

Pricing & Market Access, Asia Pacific, IMS Health 

MChui@cn.imshealth.com 

Jonothan Tierce, CPHIL is Global Manager and 

Center of Excellence Leader, Global Health Economics 

and Outcomes Research at IMS Health. 

JTierce@us.imshealth.com 

The emerging markets of the Asia Pacific present both 

challenge and potential for healthcare improvement, as 

well as the deployment of innovative medical 

technologies. Growing quickly and changing fast, their 

drive to extend basic healthcare coverage to large 

underserved populations must be balanced against the 

need to manage escalating costs, achieve quality 

improvements across all patient segments and 

accommodate spurring innovation in medical 

technologies. In determining the best approach to these 

issues and achieving greater value from the money they 

spend on healthcare, there is a chance for these markets 

to gain ground from the lessons of Europe in managing 

the adoption of advances in care and controlling further 

cost growth. At the same time, as local and multinational 

manufacturers look to engage decision makers in these 

markets, there are also opportunities for new business 

models and innovative solutions to facilitate the move 

towards more cost-effective, value-driven care. 

STRONG GROWTH, BUT TESTING TIMES 

With a rapidly ageing population, growing middle class, 

and significant shifts in the pattern of disease that will see 

chronic conditions at the forefront of medical need by 

2030, the emerging markets of Asia present significant 

opportunities for healthcare growth and expansion. For 

governments, however, this simply heightens the dilemma 

of poor healthcare infrastructure, low accessibility to 

quality treatment, rising demand for innovative 

products, and limited funding for the healthcare 

needs of an expanding population. How to strike 

the balance between broadening access, adopting 

new technologies and encouraging further 

(high-priced) innovation is now a 

defining challenge in these markets. 

Against this background there are 

already signs of major change and 

development, including ambitious 

programs for healthcare reform and 

the establishment of new health 

insurance programs – China alone is 

investing 125 billion dollars in the next three 

years to broaden the access of medicine with 

a commitment to expand health insurance 

coverage to 90% of its population by 2011. 

Most of the emerging Asia Pacific markets have already 


egun imposing various kinds of cost-containment 

measures, including sweeping price cuts (e.g. Philippines, 

Korea), the use of DRGs and compulsory licensing (e.g. 

Thailand), international reference pricing (e.g. Korea, 

Taiwan), patient co-payments (e.g. Philippines, China, 

Thailand) and greater encouragement of generic 

substitution (e.g. Korea, Thailand, China) – all primarily 

with a focus on short-term control of drug expenditure 

(Figure 1). 

Some countries, such as the reimbursed markets of Korea 

and Taiwan, have now begun to take a longer-term view 

of cost-containment, with the adoption of some form of 

Health Technology Assessment (HTA) as a way of 

Measures 

Price cut 

International 

reference pricing 

Patient co-payment 

Generic substitution 

Hospital budget 

capping 

Selective 

reimbursement 

Prescription 

restrictions 

HTA 

China Thailand Philippines Korea Taiwan 

Low High 

FIGURE 1: VARIOUS COST CONTAINMENT MEASURES ARE 

EMERGING IN ASIA PACIFIC MARKETS 

optimally utilizing their healthcare resources and at the 

same time provide more channels for providing 

innovative product access into the market. Elsewhere, in 

the semi-reimbursed markets (e.g.China, Thailand) or 

those dominated by out-of-pocket payment 

(e.g.Philippines, Indonesia), they are still learning about 

this system and it has not yet been put into practice. There 

is clearly conceptual acceptance of HTA as a way to look 

at cost-effectiveness, and an increased willingness to 

pursue this approach, but shortage of talent and the right 

resources is currently a major barrier. This lack of real 

ability to take the critical next step reflects not only a 

dearth of pre-requisite skills, but also, importantly, a 

paucity of data – both local, clinical and cost-effectiveness 

– and overcoming this will be key to the adoption of 

HTA in formal review processes in these markets. 

OPPORTUNITIES TO LEARN FROM EUROPE 

As governments in Asia struggle to find the balance 

between access to medicine and rewarding innovation, we 

can see in the drug/new technology management systems 

IMS SYMPOSIUM | INSIGHTS 

of France, the UK and Germany, some key lessons that 

may help in determining the best approach in the 

emerging markets of the Asia-Pacific. These European 

regulators have been creative with cost-containment tools 

and support for national industry (Figure 2), but the results 

have not always been in line with expectations. Their 

experience shows that HTA had to be progressively 

integrated into these measures to improve the efficiencies 

of health expenditure regulations. 

Price Control: France 

In France, prices for reimbursable drugs have been fixed 

by the government since 1948, but for more than three 

decades this proved insufficient to control expenditures 

or sufficiently reward true innovation: few drugs were 

selected for reimbursement; volumes were high to 

compensate low prices; price competition was nonexistent; 

and there was consequently no sensitivity to the 

costs of drugs. The result was double-digit growth in 

pharmaceutical expenditures over a number of years. 

Efficiency made its way into the system in 1980, when 

relative clinical effectiveness was adapted and became the 

anchor for fixing the price of new medications. Even 

then, it took almost 20 years to improve volume control 

in collaboration with the pharmaceutical industry. In the 

meantime, additional measures were required to improve 

the rationality of prescriptions – including fixed pharma 

budgets and generic substitution. Finally, growth in 

expenditure has fallen - from 7% in 2000 to 2.8% in 2009 

- enabling access to innovative drugs with a relatively 

short delay at international prices, because innovation is 

truly well-selected. 

Profit Control: UK 

The UK system was built around the principle of profit 

control via the Pharmaceutical Price Regulation Scheme 

(PPRS) adopted in 1957. Although not primarily 

Patient 

co-payments 

International 

reference pricing 

Promotional 

limitations 

AccessPoint - Issue 1 Page 25 

Therapy 

pricing 

Profit 

controls 

Price 

controls 

Industry (R&D 

production, exports) 

Generic 

prescriptions 

…and HTA 

had to be introduced 

into the picture 

HTA 

Relative clinical 

effectiveness 

Costeffectiveness 

Generic substitutions 

by pharmacists 

Risk-sharing 

agreements 

Prescription 

budgets 

Prescription 

guidelines 

Selective 

reimbursement 

FIGURE 2: GOVERNMENTS IN EUROPE HAVE BEEN CREATIVE 

WITH APPROACHES TO COST CONTROL

INSIGHTS| IMS SYMPOSIUM 

designed to control prices, but rather to promote a strong 

and profitable pharma industry, in practice the system 

exists at a global level to control the return on capital 

employed (ROC). The result has been a productive UK 

pharmaceutical industry in terms of global NCEs 

developed, but one with a very low share of the global 

market. Indeed, the Office of Fair Trading famously 

criticized the PPRS for failing to foster value-for-money 

decisions, particularly in relation to across-the-board 

price cuts that were not in relation to value. This has since 

been integrated to some extent into the new PPRS and 

it is value-based pricing which is the ground for risksharing 

agreements or rebates to the NHS. 

It was the failure of the PPRS to make the best use of 

the limited resources allocated to the NHS which 

ultimately led to the establishment of NICE (National 

Institute for Health and Clinical Excellence) in 1999, as 

a guiding body to ensure equal access, promote 

innovation and achieve the best use of resources, 

independently of the PPRS. 

Would a PPRS be relevant in Asia Pacific countries? 

While there may be a connection between the regulation 

of pharmaceutical expenditures and the attractiveness of 

a country in terms of pharma investments, the example 

of the UK is worthy of a cautious note: If HTA is not 

carefully introduced, it may convey aggressive pricing and 

restrict access to care – an issue which has proved to have 

serious consequences in the UK market, as witnessed by 

the outcry following restrictions on access to oncology 

drugs. 

Capped Budgets and Reference Pricing: Germany 

The German government has also been keen to promote 

free pricing and a strong pharmaceutical industry but 

faced with the need to contain escalating costs introduced 

two innovations: Firstly, limited budgets for prescribing, 

with penalties for exceeding targets. In practice, this 

policy had painful repercussions, encouraging referrals 

from office-based practices to hospitals to avoid the costs 

for prescriptions. 

The lessons to be learned here are that prescribing budgets 

have to be very carefully managed. More importantly, is 

the need to negotiate with physicians and impose good 

clinical practices before limiting budgets in order not to 

harm the quality of care. And defining good clinical or 

medical practice relies, of course, largely on HTA. 

A second innovation from Germany is therapeutic 

pricing, where prices for reimbursed drugs remain free, 

but products with the same ingredient or therapeutic 

effect are clustered together and a unique tariff set for 

reimbursement. Should a company not align the price, 

the patient must pay the difference; and if alternatives are 

available, doctors are encouraged to prescribe them. The 

result is that companies invariably do align their prices 

to the tariff, otherwise running the risk of losing market 

share very quickly. 

While this is thus a very rapid and effective tool for 

reducing prices, it does have drawbacks: Not all drugs can 

be clustered; litigations can arise if the comparable 

therapeutic effect is not grounded on a solid health 

technology process; and it does mean that companies 

tend to charge more for non-clustered products to 

compensate for lower prices on referenced products. 

KEY TAKEAWAYS 

Experience in Europe has shown that cost-containment 

measures must address the whole picture and not only 

prices or profit. Dialogue between the industry and 

decision makers is a key to finding solutions that go 

beyond strict, short-term price control. HTA has to be 

introduced in the decision process, not only to select 

pharmaceuticals for reimbursement or eventually medical 

devices, but also to support the rational behavior of all 

the stakeholders. And while the role of HTA in the 

decision making process may vary from one country to 

another, all stakeholders must be clear that it has to be 

based on appropriate expertise and data. 

NEW MODELS OF ENGAGEMENT 

Against this background of change and challenge in the 

increasingly cost-sensitive landscape of the Asia Pacific, 

companies looking to engage with local decision makers 

are already taking innovative approaches to the market, 

that have them partnering with other stakeholders, such 

as payers, governments and providers, to offer key medical 

technologies while accepting some of the cost risk. Some 

examples of the contracting and patient access schemes 

that are emerging in these markets are discussed below. 

APPROACHES TO CONTRACTING 

The growing difficulty of obtaining reimbursement for 

high-priced innovative drugs in the Asia Pacific has seen 

more companies willing to enter into programs built 

around the concept of value-based pricing, based on the 

principle of risk-sharing to improve a product’s costeffectiveness. 

They are a way of facilitating equitable 

access to effective care and enabling HTA bodies to 

recommend treatments that they would otherwise deem 

not cost-effective. 

These innovative approaches to contracting, which 

include consideration of pricing, can be financial-based, 

involving a price/volume agreement; outcomes-based, 

involving some form of money-back guarantee; or risk- 


ased, with reimbursement linked to value and level of 

risk. Risk-based pricing models are extensively used in 

Australia where patient segments or indications are 

placed into different risk segments. 

Certain sub-categories of financial models involve capped 

pricing at the patient or population level. In self-pay 

markets, there are also examples at the willingness-to-pay 

or affordability level, whereby companies provide 

incremental discount based on patient compliance. These 

may involve such elements as an upfront discount, 

additional services, free diagnostic tests, etc. In the 

affordability model, there are examples of where companies 

try to address the ability to pay and charge accordingly. 

Examples in Asia Pacific 

Some recent approaches to innovative contracting and 

market access schemes in Asia are shown in Figure 3. In 

China, high-price products are identified for face-to-face 

negotiations; Patient Assistance Programs (PAPs) are 

possible but involve a significant price cut. In the 

Philippines and Indonesia, there are many differential 

price contracting programs in line with the development 

of insurance schemes. These cover partially the lowest 

income level of the population or some of the insurance 

schemes for governmental workers. Korea, Taiwan and 

partially Thailand are working on developing guidelines. 

There are also many examples of PAPs in the Philippines, 

China 

Korea 

Hong Kong 

Taiwan 

Philippines 

Indonesia 

India 

Thailand 

Australia 

• High price products are identified for a special face-to-face 

negotiation 

• So far PAPs are possible but punished with significant price cut 

• Special agreement is doable; paying copayment, post 

reimbursement scope PAP 

• Guidelines under development 

• Discount for reimbursed drugs 

• Special agreements done for priority diseases or when 

there is a special funding available 

• Considering developing a review guideline with growing number 

of proposals 

• Discounting is effectively used 

• Special brand for DoH sales 

• Effective use of most self pay models like: loyalty cards, 

differential pricing 

• Special brands for ASKES and JAMKESMAS 

• Differential pricing and discounts 

• Testing environment for almost all consumer pricing models: 

assistance programs, loyalty cards, insurance 

• Discounts to institutional business 

• Patient Assistance Programs - GIPAP 

• High price products are identified for a special reimbursement 

supplement 

• Special pricing agreements is a growing trend for listing 

• Since 2008 details of the pricing agreements were not posted 

FIGURE 3: TRENDS IN INNOVATIVE CONTRACTING AND PATIENT 

ACCESS PROGRAMS IN ASIA PACIFIC 

IMS SYMPOSIUM | INSIGHTS 

including the KAAGAPAY program from Novartis and 

the GIPAP affordability-based model, with third party 

assessment of patient ability to pay and provision of 

additional patient support. 

Guiding criteria 

For countries struggling with the development of 

guidelines to determine whether a product is suitable for 

innovative contracting or risk-sharing deals, it is worth a 

closer look at the six very simple criteria adopted by the 

Pharmaceutical Benefits Advisory Committee (PCAB) 

in Australia: 

1. Significance of disease 

2. Degree of incremental benefit conferred 

3. Unique characteristics compared to available 

alternatives 

4. Effective price is consistent with price recommended 

as acceptably cost-effective 

5. Significant financial benefit to payer 

6. International reference to effective price 

SUMMARY 

Overall, we can see that the emerging countries of the 

Asia Pacific region present challenge along with the 

exceptional opportunity to participate in these markets. 

Understanding their healthcare challenges is a prerequisite 

for being successful, but it also implies a role in helping 

to evolve the healthcare structures and systems that are 

needed to address the conflicting problem of broad market 

access to quality healthcare while managing the costs of 

providing that care. Governments and other healthcare 

decision makers can draw the lessons from the years of 

managing healthcare growth and costs in Europe, but 

perhaps can leap-frog more quickly to something 

beneficial to all stakeholders. 

Manufacturers are already beginning to develop 

sometimes innovative partnering relationships with 

stakeholders in the region. As they evolve over the 

coming years, these relationships may help to define a 

uniquely Asia Pacific model of healthcare delivery. • 

IMS Symposium, Opportunities and Challenges in the 

Emerging Markets of Asia: Implications for Pricing, Market 

Access and Health Economics and Outcomes Research, held 

during ISPOR 4th Asia Pacific Conference, Phuket, Thailand, 

5-7 September 2010. 

To request a copy of the full proceedings please email 

aboucsein@de.imshealth.com 


INSIGHTS | MARKET ACCESS 

As decentralization of decision making 

continues to evolve across Europe, it is clear 

that while payers are developing more 

independent ways of working, there is also 

evidence of increased co-operation and 

converging management philosophies. 

Pharmaceutical companies must understand 

and address these apparently contradictory 

trends, and tailor their organizational 

approaches and performance management 

tools accordingly. 

The author 

Jon Resnick, MBA, is VP and Practice 

Leader, Pricing & Market Access 

at IMS Health. 

JResnick@imshealth.com 


DIVERGENCE AND CONVERGENCE? 

In the evolving pricing and market access (P&MA) 

landscape in Europe, the seemingly opposing forces of 

divergence and convergence are starting to operate 

in tandem. 

On the one hand, there are signs of diverging decision 

making through increased decentralization. Payers with 

previously similar approaches are developing more 

independent ways of working; at the same time, the 

universe of stakeholders is rapidly expanding. The UK, 

for example, in addition to NICE, now has 6-8 relatively 

active HTAs; in France, regional agencies (ARS) are 

already ‘operational’; and the influence of ‘quasi-HTAs’ 

is fast gaining ground in Spain and Italy. 

On the other hand, there are signs of converging 

approaches: payers are no longer individuals working in 

isolation, but networks of competent bodies, sharing best 

practices and consolidating activities, as evidenced by: 

MARKET ACCESS | INSIGHTS 

Optimizing market access in an 

increasingly decentralized landscape 

FIGURE 1: CORE APPROACHES TO MANAGING IN A 

DECENTRALIZED ENVIRONMENT 

Six core 

elements of 

approaches to 

managing in a 

decentralized 

environment 

Vision and strategy 

Organization 

Capabilities and resources 

Processes and roles 

Customer focus 

Objectives and measurement 

Source: IMS Consulting 

• Merging of health insurance funds (Krankenkasse) 

in Germany 

• Inter-regional hospital product assessments by 

Grupo Genesis in Spain 

• UK Primary Care Trust (PCT) alliances for 

sub-regional access decision making 

• Centralized purchasing through price-sharing at the 

sub-national level, e.g.in Italy (inter-regional) and 

Spain (intra-regional) 

MANAGING THROUGH THE COMPLEXITY 

Although the industry has long been responding to the 

challenges of decentralization, the complexity and 

fragmentation of markets continue to defy successful 

P&MA execution. Understanding the best approach to 

managing the local complexity, while balancing the need 

for central control and local autonomy, is key. 

Companies have been experimenting with a wide range of 

very different solutions. Despite these differences, a core 

set of elements is common across all approaches (Figure 1). 

• Clear direction for local affiliates 

• Some set high aspiration without articulating a strategy 

to achieve it 

• Alignment of organization to support payer-related 

activities 

• Risk of sub-optimizing P&MA in broader commercial 

reorganizations 

• Many organizations are increasing their P&MA resources 

• Customer-facing roles are using more strategic, 

relationship-minded skills 

• HQ and affiliates are formalizing roles, trying to strike 

appropriate balance 

• Affiliates have prioritized payers but struggle with 

allocating resources based on priorities 

• Shared objectives and performance measures align the 

organization around payer goals 

• Market access key performance indicators can increase 

transparency of market-level activity for senior managers 


INSIGHTS | MARKET ACCESS 

Companies must take 

time to understand the 

sub-national dynamics, 

allocating resources on 

the basis of prioritized 

stakeholders. 


ITALY IN FOCUS 

To better understand the relative effectiveness of various 

company strategies, the Italian market is worthy of closer 

attention. Here, the rate and impact of change (Figure 2) have 

triggered a range of approaches, each yielding markedly 

different results. An IMS analysis of market access performance 

for new products launched across selected Italian regions from 

Jan 08-June 09, reveals several key insights: 

• Time to formulary access: Average time to regional 

formulary listing was around eight months from AIFA 

approval, although 20% of approved products were not 

included on any of the regional formularies. However, 

this finding masks significant differences across regions. 

• Regional ability to manage market access: 

Differences in listing times reflect various regional and 

company issues in managing market access. Factors such 

as size, market potential, utilization management and 

willingness to engage manufacturers all play a role in a 

region’s ability to manage market access and budgets. All 

regions had substantially overspent their hospital budget 

(set nationally at 2.4% of total healthcare spending) – 

ranging from Calabria (132.5%) to Lazio (221.0%). 

Impact of Change 

FIGURE 2: EUROPEAN DECENTRALIZATION COUNTRY DYNAMICS 

Medium/Low 

Rate of Change 

Managing and measuring market access 

Companies with the greatest alignment between market access 

goals and payer capabilities/potential are able to allocate 

resources most efficiently. However, there is little correlation 

between market access inputs (e.g.investment in resources and 

infrastructure) and outcomes (e.g.actual sales post-launch 

compared with pre-launch forecasts). In practice, some 

companies are significantly outspending their rivals without 

gaining quantifiable improvements in market access. 


High/Low 

• ARS increasingly 

influential over time 

• Role and remit uncertain 

• Changes are taking time to 

come into effect 

• HTA proliferation but 

national level changes may 

supersede sub-national HTA 

• Consolidation of local (PCT) 

resources to create joined 

Low/Low 

High/Medium 

• HTA proliferation increasing 

the regional access hurdle 

• Legislative changes 

empowering regions 

• Information sharing 

Medium/Medium 

Low/Medium 

• Consolidation of the 

krankenkassen 

• Ever increasing appetite for 

aggressive contracting at the 

sub-national level 

• HTA proliferation 

increasing the regional 

access hurdle 

• Information sharing 

High/High 

Medium/High 

Low/High

Part of the issue concerns the assessment of performance 

– while most companies still use sales data as a key 

performance indicator (KPI) for access success, this fails 

to uncover drivers of under- or over-performance. For 

example, low uptake in a region may be the result of poor 

formulary listing. 

Key takeaways from Italy 

Several learnings can be drawn from the Italian 

experience: 

• Vision and strategy: Successful companies 

leverage a good understanding of the regional 

system to prioritize/secure access through an 

integrated provider and payer strategy. 

• Organization: Italian local affiliates use different 

organization models but this does not seem to 

differentiate performance. Affiliates appear to 

separate market access activities focused on national 

stakeholders from those focused at the sub-national 

level, without linking the sub-national market access 

unit to the business unit. These mini-silos decrease 

the ability to integrate pull-through efforts with 

access status. 

• Capabilities and resources: Precise approaches 

vary by company portfolio and setting of care. 

However, Italian affiliates usually identify 3-5 

regional account managers and 8-15 key account 

managers at sub-regional level. The best performing 

companies deploy resources by the potential and 

opportunity/challenge trade-off of the regions and 

sub-regions. 

• Processes, roles, and responsibilities: Italy 

experiences an unusually high level of market 

interventions from national, regional (and local) 

authorities. Successful companies have clear 

processes (including customer relationships) for 

gathering market intelligence, forecasting 

implications and reallocating resources. 

• Customer focus: The relative importance of 

stakeholders depends on their decision making 

influence and impact on prescribing. A key 

distinction between formal and informal influence 

requires a deep understanding to leverage: 

• Successful companies target the most important 

stakeholders in regions with the most ability to 

influence prescriber usage, and allocate resources 

appropriately. 

MARKET ACCESS | INSIGHTS 

Optimizing market access 

• Several organizations over-invest in market access 

resources in some regions and may be spending 

unnecessarily in those where access is less 

important. 

• Objectives and measurement: The exclusive use 

of sales-based KPIs to measure market access success 

makes it difficult to differentiate regional 

performance. The strategic use of market accessbased 

KPIs could help to capture company 

performance more accurately in the context of 

regional market characteristics (e.g., ease of entry, 

commercial opportunity) rather than against an 

absolute measure of sales: 

• At the product or portfolio level, appropriate 

metrics can include time to market, formulary 

penetration and extent of population covered. 

• Companies should track their own performance 

against plan to assess success, and against 

competitors to ensure they have accurate 

expectations and are not at a competitive 

disadvantage. 

BROADER IMPLICATIONS 

Although decentralized markets bring greater complexity, 

they also diversify the risk of single-body decision making. 

Companies must take time to understand the sub-national 

dynamics, allocating resources on the basis of prioritized 

stakeholders. Market access KPIs, tailored to regional 

specifics, can then help to ensure that markets are 

optimizing the potential of those products. These concepts 

are not magic bullets, but they do separate out the high 

performers. • 

“Companies have to 

completely rethink 

their consolidated 

European launch.” 

READ OUR INTERVIEW ON 

REGIONAL TRENDS WITH 

JACCO KEJA 

See page 15 


INSIGHTS | RISK EVALUATION 

Growing, intense and very public 

scrutiny of pharmaceutical 

products in the U.S. has fostered 

a high-pressure, higher-risk 

environment where development 

costs are rising and the 

probability of success has 

declined. The implications for 

pharma are considerable but 

with early, focused contingency 

planning, companies can 

prepare for the shifting 

risk/reward ratio. 

The author 

Jonothan Tierce, CPHIL, is Global 

Manager and Center of Excellence Leader, 

Global Health Economics and Outcomes 

Research at IMS Health. 

JTierce@us.imshealth.com 


In the U.S., most companies are by now familiar with 

trends in Risk Evaluation and Mitigation Strategies 

(REMS), the FDA’s Sentinel Initiative and the comparative 

effectiveness research (CER) provisions of the Patient 

Protection and Affordable Care Act. But perhaps not all 

have yet joined the dots to see the larger theme that is 

emerging or to appreciate exactly what this means for the 

clinical and commercial side of their business. 

Effectively, the CER provision of the recently enacted 

U.S. healthcare reform bill, together with the FDA’s 

Sentinel Initiative and more aggressive approach to 

approval studies and post-approval monitoring, leave 

manufacturers with little to no control over the studies 

conducted and the results that are published on their 

products after Phase III. The very model for generating 

evidence on the safety and effectiveness of products is 

changing, which in turn is shifting the risk/reward ratio 

for product commercialization. All clinical development 

decisions should be reflecting this fact. 

THE BROAD CONTEXT 

The creation of the Patient Centered Outcomes Research 

Institute (PCORI), a non-profit, public-private partnership, 

to oversee CER has noticeably shifted the post-marketed 

environment. The instinctive reaction may be to assume 

that CER will be used as a club against manufacturers, but 

this becomes less of a concern when considered in the 

broader context of the government’s focus on improved, 

transparent safety and technology assessment. The U.S. is 

grappling with the self-same challenge as every other 

advanced society: How do you ensure universal access to 

quality healthcare while at the same time contain costs? 

Thus far, the answer in the U.S. has been to: 

• Increase the requirement for risk evaluation and 

mitigation strategies (REMS) 

• Apply more Black Box Warnings than ever before 

• Deny or delay approval for NMEs and new 

formulations more often 

• Put vast amounts of post-marketing safety data in the 

hands of the pharmacoepidemiological research 

community via the Sentinel Initiative 

• Establish the PCORI to oversee CER priorities and 

funding allocation 

RISK EVALUATION | INSIGHTS 

The Shifting Risk/Reward Ratio 

of Drug Development 

THE IMPACT OF CER 

Viewed in this light, CER is one more step along a 

clearly defined path – but one over which manufacturers 

have very limited control. And therein lies part of its 

significance. Until recently, most available product 

information has been owned and released by 

manufacturers. In the future, in addition to requisite premarketed 

studies and some company-sponsored Phase IV 

and/or registry studies, the landscape will be increasingly 

populated by a new breed of transparent, multistakeholder, 

publicly-funded or health-plan sponsored 

studies, designed to provide safety and comparative 

effectiveness information about manufacturers’ products 

– all of which creates a landscape dominated by nonproprietary 

product information to which manufacturers 

will undoubtedly need to react. 

Within the context of CER, it is possible to frame an 

approach for manufacturers in facing this element of the 

new environment: 

1. In-line products: It will be several years before CER 

studies are conducted and disseminated on products 

already on the market. Until then, much information will 

be drawn from meta-analyses, since they are relatively 

easy to conduct. However, once CER is applied, there 

will clearly be winners and losers. 

It could be predicted that products showing only limited 

incremental benefit relative to other branded and generic 

competitors will find it difficult to maintain formulary 

status and market share. The recent experience with the 

Enhance study on Vytorin and simvastatin sponsored by 

Merck1 suggests that payers are willing to make decisions 

based on single studies that call into question the cost 

justification for a branded drug over a reasonably good 

generic alternative 2,3 . Equally, there is nothing to prevent 

products offering significant improvements in clinical 

benefit from taking advantage of this additional 

opportunity to demonstrate value in the real-world setting. 

2. Late-stage products: Products in late-stage 

development face the prospect of CER upon entering 

the market. This is the chance for companies to get out 

ahead of payer and publicly-funded studies. 

By conducting their own CER evaluations, especially if 

they follow the CER model of transparency and arms- 


INSIGHTS | RISK EVALUATION 

Developers and brand 

managers should start 

picturing their products 

in a post-marketing 

environment where 

someone else controls 

the comparative 

effectiveness and safety 

information that is 

made public. 


length oversight, manufacturers can gain a comparative advantage. 

Here, the old adage in retrospective studies should be 

remembered: real-world studies are messy studies. Because of the 

‘noise’ in the real-world environment the typical finding in these 

head-to-head comparisons is non-significance. Certainly, our 

experience at IMS has shown that in the use of retrospective 

claims data in post-marketing studies comparing the effectiveness 

of two worthy competitors, it is very difficult to differentiate one 

from the other. 

Products with studies producing neutral or negative conclusions 

will present challenges that must be addressed in their 

marketing, contracting and pricing. 

3. Early-stage products: For companies with products deep 

in the pipeline there is actually the opportunity to benefit from 

CER. If they have the foresight and resolve to abandon product 

concepts that are unlikely to differentiate themselves in postmarketed 

CER studies, they can concentrate on those advances 

that move the needle. Companies will disregard products that 

offer only incremental improvements over existing therapies; 

they will want to focus on guaranteed hits. This suggests the 

re-emergence of the blockbuster. 

THE IMPACT OF THE SENTINEL INITIATIVE 

The Sentinel Initiative is set to transform the FDA’s ability to 

track the safety of marketed drugs, biologics, and medical 

devices. This new electronic program complements the agency’s 

current Adverse Event Reporting System (AERS) by testing the 

signals it generates and scanning the environment for additional, 

possibly weaker, AE signals. It will be game changing in the 

number of studies that will be conducted, the number of signals 

that will be generated, and in the transparency of the process. 

Post-marketing surveillance is thus becoming a proactive search 

for weaker signals – a process that will likely generate many false 

positives to be validated/invalidated. The axiom in such 

research is that you rarely find what you are not looking for and 

invariably find what you are looking for. Since signs of adverse 

events, whether valid or false positives, may eventually be 

identified in the public arena, companies clearly need to be on 

the defensive and prepare for this possibility prior to launch. 

HIGHER-SCRUTINY POST-LAUNCH ENVIRONMENT 

The clear trend is towards subjecting drugs to a new level of 

scrutiny on their health outcomes, beginning in Phase III and 

continuing post-marketing - a scrutiny fuelled by adequate 

central funding and governed by a transparent, public-private 

partnership model. Ultimately, this high-pressure, higher-risk 


environment will likely: 

• Reduce the number of drugs reaching the market 

• Lead to narrower indications 

• Strengthen safety labeling 

• Taint promotion, uptake, and access with safety concerns 

• Increase development costs and diminish probability 

of success 

By conducting their own CER 

studies of late-stage products, 

manufacturers can gain a 

comparative advantage 

ENSURING SUCCESS 

To operate successfully in the face of economic 

comparisons to alternative technologies and safety studies 

that produce false-positive signals, companies should 

consider a number of preparatory actions: 

1. Involve HEOR, pharmacoepidemiology and 

commercial teams in clinical development decisions. 

Clinical, commercial, pharmacoeconomic and HEOR 

teams must work together, starting early in development, 

to consider relative value as a condition of go/no-go 

development decisions. This will involve simulating a 

product’s effectiveness, driving it to fail quickly, if indeed, 

it is going to fail. 

2. Apply the CER lens to development decisions. 

Companies need to decide which products they are 

going to pursue based on either the results of their own 

Phase III head-to-head comparative study or their 

expectations of what will happen when someone else 

undertakes the study after launch. This requires 

simulation modeling, scenario testing and evaluation of 

different product profiles to assess the risks. 

3. Design Phase III studies with competitive positioning 

in mind. Phase III studies should be structured to 

support the company’s primary goal: post-marketing 

approval. Some products may well lose their commercial 

attractiveness because they cannot be adequately 

differentiated in post-marketing, real-world CER studies. 

Again, trial simulations can be a relatively inexpensive 

way of managing the possibilities. 

RISK EVALUATION | INSIGHTS 

Risks and rewards 

4. Plan pre-launch for potential false-positive 

adverse event signals. This involves benchmarking and 

understanding class effects, re-examining dose-relative 

adverse effects, and having the staff and other resources to 

better understand and manage post-marketing safety 

concerns. 

5. Manage expectations. Too often, companies cling 

to the results of an early forecasting model, even in the 

presence of new information about a product’s 

performance from a Phase III study or simulation models. 

Instead, they should re-set expectations to reflect an 

altered view of reality. 

6. For late-stage products, find clear differentiation. 

Acceptance and adoption are just as important as 

measures of success as registration – perhaps more so. To 

succeed, trials must be designed to address pricing and 

stratification. 

7. Contract aggressively for undifferentiated products. 

If a product does not prove to be substantially different 

from another therapy, companies will need to be clever 

in their contracting strategy to encourage uptake. 

CONCLUSION 

Changes in the model for developing post-marketed 

information spell changes in the risk-reward calculus for 

drug development. Faced with the prospect of CER and 

increasing levels of safety scrutiny downstream, 

companies must focus on stronger investment in early 

commercial risk planning. With the help of health 

economics and outcomes research and other 

professionals, developers and brand managers should start 

picturing their products in a post-marketing environment 

where someone else controls the comparative 

effectiveness and safety information that is made public. 

To the extent that they can achieve this, companies can 

be positioned to make business decisions that benefit all. • 

1 Kastelein JJP and the ENHANCE investigators. Simvastatin with or 

without ezetimibe in familial hypercholesterolemia. N Eng J Med, 2008, Apr 

3; 358 (14): 1431-43. Epub 2008 Mar 30. 

2 IMS research 

3 There is, of course, controversy about whether Enhance was really a 

comparative effectiveness study and whether its treatment by Managed Care 

as a head-to-head comparison between a branded and a generic statin was 

appropriate. Nonetheless, it suggests that US private payers were willing to 

make decisions on the perception of such a study. 

This is a slightly abridged version of the article that appeared in the July, 

2010 issue of PM360. 


INSIGHTS | OBSERVATIONAL RESEARCH 

As reliance on conclusions from randomized 

trials gives way to a stronger focus on 

real-world effectiveness and impact, we 

consider the growing importance of 

observational research in providing the 

missing evidence base for more informed 

market access decision making. 

The author 

Xavier Badia, MD, MPH, PHD 

Dr. Xavier Badia is Global Leader 

Observational Center of Excellence, 

Senior Principal HEOR at IMS Health 

in Spain. 

XBadia@es.imshealth.com 


OBSERVATIONAL RESEARCH | INSIGHTS 

From ideal to real 

THE GROWING GLOBAL NEED FOR OBSERVATIONAL RESEARCH 

OBSERVATIONAL OR EXPERIMENTAL? 

Many scientists in the field of evidence-based medicine 

would argue that interventions, whether biological, social 

or financial, should be assessed according to the strict 

guidelines and principles of controlled research. 

Experimental randomized controlled trials (RCTs) are 

considered the “gold standard” study methodology for 

assessing the effectiveness of therapeutic agents 1 . 

However, the controlled environment of experimental 

design does not allow for the variability associated with 

routine clinical practice. Nor does it take into 

consideration the real-life health impact on treatment and 

care delivery. It has been claimed that for all their wellknown 

methodological strengths, RCTs cannot meet all 

our needs as patients, practitioners, managers, and policy 

makers. Moreover, there are situations where their use is 

finite, either because of problems derived from their 

inherent nature or from practical obstacles such as their 

limited external validity 2 . 

One answer to all the shortcomings of RCTs is 

observational research (OR) – so called because we 

simply observe what happens under conditions of normal 

clinical practice 3 . Since OR reports only data from real 

life situations, there are no established interventions 

affecting the clinical course of a disease and its related 

outcomes. Used correctly, observational studies enable 

research on prevalence, incidence, associations, causes, and 

outcomes. In some cases, they are often the only realistic 

choice of research methodology, particularly where an 

experimental design would be impractical or unethical 3 . 

Equally, there are times when observational methods, used 

with care and rigor, will add and indeed complement the 

evidence obtained from randomized controlled designs: 

1. Large impact: Some interventions have an impact so 

large (e.g., over an extended duration of time as in 

HEP-C treatments’ impact on down-stream liver disease; 

across multiple settings (hospital, convalescent hospital, 

home care); family/caregiver impacts, etc.) that only 

observational data are sufficient to show it. 

2. Detecting infrequent adverse outcomes: The 

detection of infrequent adverse outcomes would take much 

larger randomized controlled trials than are typically 

conducted. In these cases observational methods, such as 

post-marketing surveillance of medicines, are the only 

alternative. 

3. Assessing long-term outcomes: Observational data 

provide a realistic means of assessing the long-term outcome 

of interventions beyond the timescale of many trials 4 . 

OBSERVATIONAL STUDIES AND MARKET ACCESS 

Increasing pressure on healthcare budgets and growing 

payer scrutiny of medical technologies in relation to 

potential funding have seen a rise in the demand for 

observational studies in recent years. They are not only 

more time-efficient, less costly and more representative 

of patients in everyday clinical care than RCTs, but also 

avoid the ethical issue of compromising treatment choice. 

As such, they are able to provide critical, relevant, realworld 

information quickly on the expected economic 

and clinical impact of a new or existing therapy. 

Providing support in five key areas 

Broadly, observational research can support the provision 

of information for clinicians and decision makers in five 

key areas (Figure 1). These include monitoring risk 

management plans required by regulatory bodies such as 

the European Medicines Agency and the U.S. Food and 

Drug Administration and performance agreements 

among payers and pharmaceutical industry. Increasingly, 

payers assess patient-reported outcomes as tools to 

measure the clinical efficacy and cost-effectiveness (i.e. 

cost per life years gained) of medication in the real-world 

setting. Observational studies, in their various designs, 

allow the development, validation, and use of such types 

of outcomes such as PROs 5 . 

Drug utilization studies linked to MA 

Innovative agreements 

Risk-management plans 

Cost-effectiveness decisions 

Development and validation of PRO tools to 

measure patients’ health 

FIGURE 1: OBSERVATIONAL RESEARCH PROVIDES SUPPORT 

IN FIVE KEY AREAS 

From Phase III onwards 

For pharmaceutical manufacturers, the applications of 

OR are many and considerable, with relevance spanning 


INSIGHTS | OBSERVATIONAL RESEARCH 

Globally, the use of 

real-world data in 

demonstrating the 

value of medical 

technologies is 

increasingly relevant 

to reimbursement 

and market access 

decision making. 


products in Phase 3b, regulatory and post-launch 6 : not only do 

they enable a response to regulator and payer questions 

regarding the use of a drug or medical device in real-life 

situations – shedding light on such critical issues as resource 

utilization, health-related quality of life, satisfaction, adherence, 

persistence and preferences - the outcomes of OR also provide 

an evidence base for patient profiling, determining costs for 

patients with particular conditions, fine-tuning or changing 

product positioning, safety labeling, and updating physician 

messaging based on study analysis and findings. Figure 2 shows 

some of the different types of studies that can be used to address 

these objectives. 

Objectives 

Observational studies 

Phase 3 - Reg. phase: 

Preparing to gain market access 

Phases 3b Pre-Reg Reg Launch In-Market 

Epidemiology: Targeting and profiling 

Burden of disease; Use of resources 

In-market phase: 

Sustaining market access 

Launch Post-Launch 

Development, validation and application of PROs (satisfaction and Qol scales) 

Patient registry 

FIGURE 2: OBJECTIVES AND OBSERVATIONAL STUDIES 

Drug utilization studies 

THE RIGHT DESIGN 

Observational studies can either be prospective, retrospective, 

and/or cross-sectional in methodology – each of which has 

their own particular advantages and disadvantages. 

PROSPECTIVE STUDIES: These follow up patients over time, watching 

for outcomes – both clinical and cost-related - during the study 

period and relate these to other factors such as medication used. 

Their main advantage is having a design which most resembles 

experimental studies, enabling comparison among different 

treatment arms. They are ethically safe, allow the timing and 

directionality of events to be established, and enable patient 

eligibility criteria and outcomes to be standardized 7 . 

Conversely, it is important to bear in mind that with prospective 

study designs there is a greater likelihood of losing patients 

during the study period, which may affect the findings. They 

are also expensive and time consuming. Overall, however, 

particularly when it comes to evaluation of medication postlaunch, 

these studies often deliver scientifically-sound and valid 

evidence on clinical efficacy and cost-effectiveness of a product 

in the market. 


OBSERVATIONAL RESEARCH | INSIGHTS 

Prospective studies are the preferred design to target and 

profile patients when a new drug comes onto the market. 

RETROSPECTIVE DESIGNS: These studies have a backward 

focus, examining factors related to healthcare resource use 

or medication use in relation to clinical outcome, clinical 

and/or cost-related, that is established at the start of the 

study. In retrospective designs, existing data have usually 

been recorded for reasons other than research. In HEOR, 

a retrospective study design uses “chart reviews” as a 

preferred method to collect the data because the source 

of information is the medical record. Medical claims, 

electronic medical records (EMR) and other databases can 

also be used when the information sought according to 

the objectives of the study is contained in the database. 

Broadly speaking, there are three general types of 

retrospective study: 

1. Case report 

2. Case series 

3. Case-control 

While a retrospective study may contain several of the 

same study-design elements as a prospective study, payers 

often consider these designs as providing weaker evidence 

than their prospective counterparts. 

Although a retrospective design is usually not adopted 

when a prospective study is feasible, there are a number 

of instances where it is appropriate: 

1. First, a well-designed retrospective chart review study 

may serve as a pilot for a prospective study with the 

resulting information used to help the HEOR team focus 

the study question, define the hypothesis, calculate an 

appropriate sample size and identify feasibility issues for 

a prospective study 8 . 

2. Secondly, if companies have only limited knowledge of 

clinical management at the launch of a product, as well as 

limited resources, a stand-alone retrospective chart review 

or EMR analysis can provide valuable information on realworld 

practice that will be used to complement the data 

from the experimentally controlled, randomized controlled 

trials when submitting to payers for reimbursement. 

3. Finally, retrospective studies, especially those done with 

existing databases, can typically be completely less 

expensively and faster than prospective studies. This makes 

them especially useful for exploratory and confirmatory 

studies. 

From ideal to real 

CROSS-SECTIONAL DESIGNS. Cross-sectional studies 

encompass a class of research methods involving 

observation of a total population, or a representative 

subset, at a defined time. They can be used, for example, 

to estimate the prevalence of a disease or treatment 

characteristics and burden of disease. On the plus side, they 

are less-time consuming and less costly than prospective 

designs, and importantly, they are ethically safe 7 . However, 

they do provide descriptive rather than causal evidence, 

and are subject to patients’ recall bias 7 . 

Most often, a cross-sectional study design is linked to a 

retrospective chart review. For example, data are obtained 

on healthcare resource use and medication use for a 

sample of patients with a particular condition visiting 

their physicians from their medical records. Data on 

patient-reported outcomes such as productivity and 

quality of life for instance, are obtained by interviewing 

these patients when they visit their physician as part of 

their routine clinical care. (The ability to link claims, chart 

review and EMR data is still in its infancy, but studies 

employing this linking are on the rise.) 

CONCLUSIONS 

Globally, the use of real-world data in demonstrating the 

value of medical technologies is increasingly relevant to 

reimbursement and market access decision making. 

Whether prospective, retrospective or cross-sectional, 

observational research has a critical and growing role to 

play in driving a better understanding of the health 

outcomes of medical technologies, facilitating the 

development of compelling value dossiers and supporting 

appropriate product use in everyday clinical care. • 

1Abel U, Koch, A. The Role of Randomization in Clinical Studies: Myths 

and Beliefs. Clin Epidemiol, 1999; 52(6):487-97. 

2Black, N. Education and Debate: Why We Need Observational Studies to 

Evaluate the Effectiveness of Healthcare. BMJ 1996; 312:1215-1218 

3Mann, CJ. Observational Research Methods. Research Design II: Cohort, 

Cross-sectional and Case-control Studies. Emerg Med J, 2003;20:54-60 

doi:10.1136/emj.20.1.54 

4Black, N. Experimental and observational methods of evaluation. BMJ 

1994; 39:540. 

5Badia X, Herdman M. The Importance of Health-Related Quality-of-Life 

Data In Determining The Value Of Drug Therapy. Clin Ther 2001; 23(1): 

168-75 

6Badia X, Guyver A, Magaz S, Bigorra J. Integrated health outcomes research 

strategies in drug or medical device development, pre- and post-marketing: 

time for change. Expert Rev Pharmacoeconomics Outcomes Res 2002; 

2(3): 269-78. 

7Centre for Evidence-Based Medicine. 2010. 

http://www.cebm.net/index.aspx?o=1039. Website accessed 04.10.2010 

8Hess, D. Retrospective studies and chart reviews. Respiratory Care 2004, 

49(10): 1171-1174. 


PROJECT FOCUS | INFLUENZA 

Longitudinal patient-level 

databases have a key role 

to play in supporting 

analyses to inform and 

determine best practice and 

cost-effective care. 

Informing the interests 

of public health 

The growing complexity of market access and increasing emphasis 

on maximizing health service efficiency have made the need to 

demonstrate the value of medicine an imperative for pharmaceutical 

companies worldwide. Identifying the economic burden of a disease 

and the impact of treatment shortfalls can play a major role in this 

process, particularly in areas of potential significance to national 

public health. Longitudinal patient-level databases derived from 

health insurance claims are able to provide new levels of insight 

into disease outcomes, cost, and treatment implications that are 

key to determining clinical best practice and advancing costeffective 

care. 

SCOPING COST AND OUTCOMES IN A COMMON SEASONAL DISEASE 

The U.S. brand team of a leading global pharmaceutical company 

came to IMS for help in generating economic support for its new 

antiviral agent. The drug was an important development in the 

treatment of seasonal influenza, an infection that results in 

significant levels of morbidity and hospitalization. Estimates of 

infection rates range from 4% to 15% in adults but are highest in 

the pediatric population (14% to 37%). Children who are otherwise 

healthy are also more prone to secondary complications than adult 

and elderly patients, although the absolute number of healthy 

adults who develop complications is high. With its known links to 

increased healthcare provider visits, reduced productivity, and 

higher absenteeism from work and school, influenza imposes a 

considerable socioeconomic burden. 

EXPLORING THE EVIDENCE FROM A COMPREHENSIVE BASE 

The use of antiviral drugs has been shown to reduce the severity 

and duration of influenza in otherwise healthy adults and children. 

Studies have also demonstrated cost benefits associated with 

reduced consumption of in-patient and out-patient services. 

However, many of these analyses have used models to assess direct 

and indirect costs; reports on the relationship between antiviral 

treatment, healthcare use, and direct costs are limited. 

The IMS LifeLink Health Plan Claims Database enabled the role of 

antiviral therapy to be determined in relation to current care, 

outcomes and expenditure linked to influenza. The geographical 

breadth of the database – which draws on claims from over 95 

health plans in the United States - makes it a critical tool for 

national and regional benchmarking of patterns of care, drivers of 

treatment choice, resource utilization, and direct medical costs. Its 

depth allows for comparisons across a range of patient 

demographics, including age, gender, diagnosis, concomitant 

therapy, and co-morbidities. 


As the first step in their retrospective evaluation of 

complications, hospitalizations, and healthcare use and 

expenditure associated with influenza and antiviral therapy, 

the IMS experts began by identifying five influenza seasons 

(01 October – 31 March) between 2001 and 2006. Their 

analysis focused on a 30-day period following influenza 

diagnosis among patients prescribed the antiviral therapy in 

usual care versus those with no evidence of receiving the 

drug. Patients were included in the treatment group only if 

the drug prescription was issued within ±1 day of the 

influenza diagnosis – a period chosen as a proxy to ensure 

exclusion of patients who had not commenced therapy within 

the recommended period of

PROJECT FOCUS | DIABETES 

Validated economic 

modeling utilizing 

short-term clinical data 

can deliver insights 

into long-term outcomes 

and financial impact 

that would otherwise 

take years to generate. 

Demonstrating the costeffectiveness 

of a modern 

diabetes therapy in China 

Rapid economic development, mass urbanization and the adoption 

of more Westernized lifestyles have placed China on the verge of a 

diabetes epidemic. Of particular concern is growth in Type 2 diabetes, 

especially among the middle-aged, with huge implications for 

workforce productivity. New therapeutic options are emerging but 

are typically more expensive than established agents. With 

healthcare resources in China already stretched to capacity, the 

ability to demonstrate local cost-effectiveness is increasingly valid 

in securing product use over alternative available treatments. 

One of the major challenges for cost evaluations in diabetes is the 

importance of showing an impact on its associated long-term 

complications, which represent by far the largest share of its financial 

burden. Robust, validated modeling techniques that can project 

potential outcomes over time and in the local setting, have a key 

role to play in determining best practice strategies for optimal care. 

REQUIREMENT FOR LONG-TERM PROOF 

A leading pharmaceutical manufacturer was keen to develop 

economic support for use of its new analogue insulin mix in Type 2 

diabetics in China. The drug had proven benefits in improving 

HbA1c levels and reducing hypoglycemic events when used in place 

of standard insulin in a poorly controlled patient sub-group over a 

3-month period. Based on the results of this study in Chinese 

patients, and mindful that the drug would be competing with 

cheaper alternatives, the company was keen to understand its 

associated long-term cost and clinical outcomes. This would not be 

an easy task, particularly given the paucity of studies on the cost 

of diabetes complications in China. 

Recognizing the inherent complexities involved and with limited 

knowledge of the local market in China, the HQ team approached 

IMS HEOR experts for help. In IMS they found a partner that would 

complement their own skill set in diabetes with extensive 

capabilities in evidence-based economic modeling, in-depth market 

knowledge, on-the-ground expertise and a network of local contacts 

in China, and access to the IMS CORE Diabetes Model – the leading, 

validated, all-round model of diabetes available – with the necessary 

skills in its optimal interrogation. 

IMS CORE DIABETES MODEL 

In order to determine the cost-effectiveness of the new analogue 

insulin mix, the IMS experts began by identifying relevant local 

inputs for the IMS CORE Diabetes Model – a peer-reviewed, policy 

analysis tool for simulating the effects of different clinical 

characteristics and changing costs on cohorts of diabetes patients 

over a range of time frames (Figure 1). It addresses pharmacy, 


management and complication costs, screening and 

treatment strategies for micro- and macrovascular 

complications, and treatment practices for end-stage 

complications. Disease progression is simulated through a 

series of inter-dependent Markov sub-models each of which 

uses time, health state, time in health state, and diabetes 

type-dependent probabilities derived from published sources. 

The reliability of the simulated outcomes has been tested 

and fully validated against those reported in clinical trials 

and epidemiological studies. 

GATHERING THE EVIDENCE 

In a detailed program of data collection and supplementary 

research, the IMS experts focused on gathering the wide range 

of China-specific clinical and cost information that would be 

needed for a robust, comprehensive economic evaluation. 

Treatment effects and patient characteristics were drawn from 

the original client study and country-specific published 

sources. Risks of modeled complications were derived from 

landmark clinical trials and epidemiological studies. To fill 

the considerable gap in data on patient management 

practices, resource use and diabetes-related complication 

costs in China, the IMS experts also completed a survey of 

physicians based in Tier 3 (large with specialist units) and 

Tier 2 (community-based) hospitals. These were located in 

two demographically and economically dissimilar cities which 

went some way towards addressing regional variation in 

treating diabetes. 

The analysis was performed from a third-party payer 

perspective, incorporating future treatment costs, patient 

management costs, and the costs of medical complications, 

thereby ensuring its direct relevance for decision making 

bodies in China. Costs and clinical projections were made 

FIGURE 1: IMS CORE DIABETES MODEL FLOW 

Stop 

Microvascular complications 

Specific mortality 

No 

Yes 

DIABETES | PROJECT FOCUS 

User sets simulation conditions 

Generate baseline population 

Any patients to run? 

Yes 

Time horizon reached? 

No 

Specific mortality 

over patient lifetimes and discounted annually. Quality 

adjusted life expectancy was also included. The willingnessto-pay 

threshold used was based on the mid-point between 

the values applied in two recently conducted utility analyses 

in China. Finally, extensive sensitivity analyses were 

performed to assess the effect of varying key model 

parameters on financial outcomes. 

CLEAR DEMONSTRATION OF VALUE 

The results of the IMS study showed that any increase in 

lifetime direct medical costs associated with switching poorly 

controlled Type 2 diabetes to the new analogue insulin mix 

would be largely offset by lower diabetes-related 

complication costs, thereby rendering the drug cost-effective 

in the Chinese setting from a third-party payer perspective. 

Sensitivity analyses supported this demonstration of its value 

for money over time. The analysis represented the first ever 

compilation of nationwide cost data in China for diabetes 

management and complications 

A FIRST FOR COSTING DIABETES IN CHINA 

The IMS cost-effectiveness analysis provided the client with 

key insights and the evidence it needed to show the positive 

long-term clinical and cost benefits of its new analogue 

insulin mix. Critically, too, it also represented the first ever 

compilation of nationwide cost data in China for the range 

of complications and management costs associated with 

diabetes - information that formed the basis of a major 

research publication and which enabled the client to pioneer 

the way for future economic evaluations in this increasingly 

important market. • 

Macrovascular complications Non-specific mortality 

Overall annual survival 

Time counter advances 

Update simulation data 


IMS HEOR | OVERVIEW 

IMS Health Economics and Outcomes Research offers a spectrum of 

world-class expertise delivering the local excellence you need. 

Realizing product value 

• Insights and experience of more than 300 highlyqualified, 

multi-disciplinary experts in Health Economics, 

Outcomes Research and Pricing and Market Access 

• Market expertise combined with local presence and a 

relationship network of key healthcare decision makers 

and opinion leaders worldwide 

• Scientifically-sound, commercially-relevant solutions for 

the entire product lifecycle 

• Highly respected, world-leading skills in strategic 

planning, evidence development and market access 

• Experience in virtually all therapy areas with a 

bibliography of over 2000 references 

• Outstanding results with the world’s most comprehensive 

pharmaceutical and medical information, analytics and 

consulting resources 

• Relied on and consulted by policy makers and regulatory 

authorities globally 

REALIZE 

COMMUNICATE 

DEMONSTRATE 

DETERMINE 

IMS HEOR brings unrivalled experience and specialist 

expertise to help you determine, demonstrate, communicate 

and realize product value 

Strategy 

P&MA STRATEGY & 

DETERMINING VALUE 

Evidence 

Development 

DEMONSTRATING 

VALUE 

Communication 

COMMUNICATING 

VALUE 

Our integrated approach – spanning deep expertise in 

strategy, evidence development and value communications – 

is reflected in all of our work. 

IMS HEOR ONLINE 

Visit us online at www.imshealth.com/heor 

IMS HEOR BIBLIOGRAPHY 

Please ask us for a copy of our 

current bibliography covering 

publications from 2008-2010 

or access the full online 

catalog of 2000 references at 

www.imsheorbibliography.com 


Global scope, local expertise 

IMS HEOR office locations worldwide 

LOCATIONS | IMS 

IMS HEOR is located in 14 countries worldwide and has published on 

projects completed in 40 countries on all continents. 

IMS HEOR Experts are located in key markets around the world. 

YOUR KEY CONTACTS: 

Dr. Michael Nelson 

Regional Leader Americas 

Health Economics and Outcomes Research 

IMS Health 

300 N. Washington Street 

Suite 303 

Falls Church, VA 22046, USA 

Telephone: +1 703.286.2862 

Email: MNelson@us.imshealth.com 

NORTH AMERICA 

REGIONAL HEADQUARTERS 

660 West Germantown Pike 

Plymouth Meeting, PA 19462 

USA 

Tel: +1 610.834.5000 

UNITED STATES 

300 N. Washington Street 

Suite 303 

Falls Church, VA 22046 

USA 

Tel: +1 703.286.2900 

The Arsenal on the Charles 

311 Arsenal Street 

Watertown, MA 02472 

USA 

Tel: +1 800.783.6362 

CANADA 

303 Terry Fox Drive 

Suite 300 

Ottawa K2K 3J1, Ontario 

Canada 

Tel: +1 613.599.0711 

EUROPE 


7 Harewood Avenue 

London NW1 6JB 

United Kingdom 

Tel: +44 (0) 20 3075 4800 

BELGIUM 

Medialaan 38 

1800 Vilvoorde 

Belgium 

Tel: +32 2 627 3211 

FRANCE 

91 rue Jean Jaurès 

92807 Puteaux cedex 

France 

Tel: +33 1 41 35 1000 

GERMANY 

Hefnersplatz 10 

90402 Nürnberg 

Germany 

Tel: +49 911 24270 6300 

Max-Lebsche-Platz 32 

81377 München 

Germany 

Tel: +49 (0)89 45 79 126411 

ITALY 

Viale F. Restelli 1/A 

20124 Milan 

Italy 

Tel: +39 02 69 786 1 

Dr. Jacco Keja 

Regional Leader EMEA 

Health Economics and Outcomes Research 

IMS Health 


London NW1 6JB, 

UK 

Telephone: +31 (0) 631 693 939 

Email: JKeja@nl.imshealth.com 

SPAIN 

Dr Ferran, 25-27 

08034 Barcelona 

Spain 

Tel: +34 93 749 63 00 

SWEDEN 

Sveavägen 155/Plan9 

11346 Stockholm 

Sweden 

Tel: +46 8 508 842 00 

SWITZERLAND 

Theaterstr. 4 

4051 Basle 

Switzerland 

Tel: +41 61 204 5071 

UNITED KINGDOM 


London 

NW1 6JB 

United Kingdom 

Tel: +44 (0)20 3075 4800 

ASIA PACIFIC 


10 Hoe Chiang Road 

Keppel Towers #23-01/02 

Singapore 089315 

Tel: +65 6227 3006 

AUSTRALIA 

Level 5, Charter Grove 

29 - 57 Christie Street 

St Leonards, NSW 2065 

Australia 

Telephone: +61 2 9805 6800 

CHINA 

7/F Central Tower 

China Overseas Plaza 

Jianguomenwai Avenue, 

Chaoyang District 

Beijing 100001 

China 

Tel: +86 10 8567 4255 

KOREA 

9F Handok Building 

735 Yeoksam1-dong 

Kangnam-ku Seoul 

135-755 

S. Korea 

Tel: +82 2 3459 7307 

TAIWAN 

8th Floor 

No 2, Tun Hwa South Road 

Section 1 

Taipei 10506 

Taiwan 

ROC 

Tel: +886 2 2721 5337 

FOR FURTHER INFORMATION: email HEORinfo@uk.imshealth.com or visit www.imshealth.com/HEOR 


armaceutical companies worldwide rely on LifeLink to drive patient-centered decisions – from the first explorator 

IMS | EXPERTISE 

The strength of our ability to support clients in healthcare decision making 

for pricing and market access is built on the quality of our global team. 

Expertise in depth 

We apply unrivalled experience and specialist expertise to help our clients meet the demands of an 

increasingly complex global, regional and local pharmaceutical landscape. 

IMS has one of the largest global teams of experts in health economics and outcomes research of any 

organization in the world. We have more than 300 highly-qualified consultants and researchers with 

multi-disciplinary experience and proven skills covering all key therapy areas. 

Our experts have extensive capabilities in a wide range of health economic and outcomes research 

disciplines in industry, consulting, government and academia, with a global grasp, local experience, 

and a unique, inside perspective of key market access issues. 

Here we introduce members of our senior team. 

Franck Amalric, PHD 

• Dr. Franck Amalric is a Principal and Group Manager, Pricing and Market Access at IMS Health in France. 

• Formerly Deputy Director of Human Sciences and Economics at the French National Cancer Institute, 

Franck has extensive experience in the management and development of economic projects, gained 

in roles as a Program Director at the Society for International Development (SID) in Rome, a Senior 

Economist at UBS in Switzerland, and as Head of Research at the Center for Corporate Responsibility 

and Sustainability. 

• A graduate of the Ecole Polytechnique in France, Franck completed his training at the Ensaé 

(National School of Statistics and Economic Administration) and holds a PhD in Economics from 

Harvard University. 

Xavier Badia, MD, MPH, PHD 

• Dr. Xavier Badia is Global Leader Observational Center of Excellence, Senior Principal HEOR at IMS 

Health in Spain. 

• A founder of Health Outcomes Research Europe, Xavier has extensive experience in consulting and 

research outcomes, patient-reported outcomes, and effectiveness and cost-effectiveness 

evaluations. A respected scientific speaker and member of EuroQol since 1993, he serves on several 

international advisory and editorial boards and has published over 150 peer-reviewed papers. 

• Xavier holds an MD, a PhD in Medicine, and a Masters in Public Health and Health Economics from 

the University of Barcelona. 

Marc Benoff, MBA 

• Marc Benoff is Vice President and Practice Leader, Pricing and Market Access at IMS Health in the 

U.S., applying quantitative and qualitative methodologies to help clients solve pricing and 

reimbursement issues and develop global market access strategies for new and existing products. 

• A former Director of Commercial Investment and Pricing Strategy at Wyeth Pharmaceuticals, where 

he pioneered the incorporation of pricing, reimbursement, policy and health outcomes into the drug 

development process, Marc has over 15 years healthcare experience working with physician groups, 

hospitals, health plans and pharmaceutical companies across a range of therapeutic areas. 

• Marc holds an MBA from the Graduate School of Business at the University of Chicago, and a BA in 

Mathematical Economics from Wesleyan University. 


y questions that drive clinical development to tactical sales planning for mature brands. 

EXPERTISE | IMS 

Karin Berger, MBA 

• Karin Berger is a Principal, Health Economics and Outcomes Research at IMS Health in Germany with 

a particular focus on outcomes research, patient-reported outcomes, and cost-effectiveness 

evaluation analyses at a national and international level. 

• Formerly Managing Director of MERG (Medical Economics Research Group), an independent German 

organization providing health economics services to the pharmaceutical industry, university 

hospitals and European Commission, Karin has more than 14 years experience in the health 

economics arena. She lectures at several universities, has published extensively in peer-reviewed 

journals, and regularly presents at economic and medical conferences around the world. 

• Karin graduated as Diplom-Kaufmann (German MBA equivalent) from the Bayreuth University, 

Germany, with a special focus on health economics. 

Richard H. Chapman, PHD 

• Dr. Rick Chapman is a Principal, Health Economics and Outcomes Research at IMS Health in the 

U.S., directing the design and analysis of economic evaluations and health outcomes studies 

addressing a range of client issues. 

• Formerly a Senior Director at ValueMedics Research, and Research Associate at the Center for Risk 

Analysis, Rick has considerable experience in designing and conducting cost-effectiveness analyses, 

and particular expertise in the methodological quality of health economic analyses, medication 

adherence and patient-reported outcomes, including quality of life and patient preferences. 

• Rick holds a PhD in Health Policy (Decision Sciences) from Harvard University and an MS in 

Health Policy and Management from the Harvard School of Public Health. 

Mandy Chui, MBA 

• Mandy Chui is Regional Practice Leader, Pricing and Market Access at IMS Health in the Asia 

Pacific, helping clients formulate growth strategies, optimize price and reimbursement, and 

address issues in business model, sales force and marketing optimization. 

• In a career spanning more than 15 years at IMS Health, including roles as Country Principal for 

China and Director of Area Sales & Marketing in Singapore, Mandy has developed an exceptional 

understanding of Asian market dynamics and an extensive network of major stakeholder 

contacts in this rapidly evolving region. She has also authored various publications on China 

and emerging markets. 

• Mandy holds an honors degree in Biology from the University of Hong Kong and an MBA from 

McGill University, Montreal. 

Frank-Ulrich Fricke, PHD, MSC 

• Dr. Frank-Ulrich Fricke is a Principal, Health Economics and Outcomes Research at IMS Health and 

Professor for Health Economics, Georg-Simon-Ohm University of Applied Sciences, Nuremberg in 

Germany, with a focus on health economic evaluations, market access strategies and health policy. 

• Formerly a Managing Director of Fricke & Pirk GmbH, and previously Head of Health Economics at 

Novartis Pharmaceuticals, Frank-Ulrich has conducted health economic evaluations across a wide 

range of therapeutic areas, developing a wealth of experience in pricing, health affairs and health 

policy. As a co-founder of the NIG 21 association, he has forged strong relationships with health 

economists, physicians and related researchers working in the German healthcare system. 

• Frank-Ulrich holds a PhD in Economics from the Bayreuth University, and an MBA equivalent from 

the Christian-Albrechts-University, Kiel. 

David Grant, MBA 

• David Grant is a Senior Principal and Country Leader, Health Economics and Outcomes Research 

at IMS Health in the U.K., specializing in reimbursement and market access, environmental 

analysis, prospective and retrospective data collection and communications for product support. 

• A co-founder and former Director of Fourth Hurdle, David’s experience spans 10 years in health 

economics and outcomes research consulting, and 15 years in the pharmaceutical industry, including 

roles in clinical research, new product marketing and health economics in the U.K. and Japan. 

• David holds a degree in Microbiology and an MBA from the London Business School. 



Jacco Keja, PHD 

• Dr. Jacco Keja is Regional Leader, EMEA, Health Economics and Outcomes Research, at IMS Health in 

the UK, drawing on deep expertise in global market access, operational and strategic pricing, and 

health economics and outcomes research. 

• Jacco’s background includes four years as global head of pricing, reimbursement, health outcomes 

and market access consulting services at a large clinical research organization and more than 13 

years experience in the pharmaceutical industry, including senior-level international and global roles 

in strategic marketing, pricing and reimbursement and health economics. 

• Jacco holds a PhD in Biology (Neurophysiology) from Vrije Universiteit in Amsterdam, a Masters in 

Medical Biology, and an undergraduate degree in Biology, both from Utrecht. He is also visiting 

Professor at the Institute of Health Policy & Management at Erasmus University, Rotterdam. 

David C. Klingman, PHD 

• Dr. David Klingman is a Principal, Health Economics and Outcomes Research at IMS Health in the 

U.S., with expertise in retrospective analyses of survey and administrative databases, medical-record 

abstraction, provider, payer, and patient surveys, health-economic modeling, cost-effectiveness 

analysis, meta-analysis, and literature synthesis in numerous therapeutic areas. 

• In a career that spans both business and academia, including roles at ValueMedics Research 

LLC, the Center for Clinical Quality Evaluation, and the Health Program of the U.S. Congress 

Office of Technology, David has developed extensive experience in health economics, outcomes 

research, quality evaluation and analytics. 

• David holds a PhD in Political Science from Michigan State University, an MA in Political 

Science from the University of Wisconsin-Milwaukee, and a BA in Government from the 

University of Texas. 

Mark Lamotte, MD 

• Dr. Mark Lamotte is a Principal and Location Manager, Health Economics and Outcomes 

Research at IMS Health in Belgium with responsibility for the content and quality of all health 

economic evaluations conducted by his team. 

• A physician by training (cardiology), Mark spent a number of years in medical practice before 

joining Rhône-Poulenc Rorer as Cardiovascular Medical Advisor and later becoming Scientific 

Director at the Belgian research organization, HEDM. He has since worked on more than 150 

projects, involving expert interviews, patient record reviews, extensive modeling and report 

writing across a wide range of therapy areas, and authored many peer-reviewed publications. 

• Mark holds an MD from the Free University of Brussels (Vrije Univeristeit Brussel, Belgium) and 

is fluent in Dutch, French, English and Spanish. 

Won Chan Lee, PHD 

• Dr. Won Chan Lee is a Principal, Health Economics and Outcomes Research at IMS Health in the 

U.S., specializing in prospective and retrospective health economics research. 

• Over the course of his career, Won has completed numerous international economic evaluations 

employing a variety of analytical methods across a range of diseases and geographies. His expertise 

includes econometric database analysis, quality of life assessment and advanced economic modeling 

to establish the economic and humanistic value of new and existing therapeutic interventions. 

• Won holds a Masters in Economics from the University of Grenoble II, and a PhD in Economics from 

the Graduate Center of the City University of New York. 

Claude Le Pen, PHD 

• Dr. Claude Le Pen is a member of the strategic committee of IMS France and Professor of Health 

Economics at Paris-Dauphine University providing expert economic advisory services to the 

consulting practice. 

• A renowned economist, leading academic, and respected public commentator, Claude has served 

as an appointed senior member of several state commissions in the French Ministry of Health and 

is an expert for a number of parliamentary bodies, bringing a unique perspective and unparalleled 

insights into the economic evaluation of pharmaceutical technologies at the highest level. 

• Claude studied Business Administration in HEC Business School in Paris and holds a PhD in 

Economics from Panthéon-Sorbonne University. 



Adam Lloyd, MPHIL, BA 

• Adam Lloyd is a Senior Principal, Health Economics and Outcomes Research at IMS Health in the 

U.K., where he leads the economic modeling practice with a particular focus on economic analysis 

and the global application of economic tools to support the needs of local markets. 

• A former founder and Director of Fourth Hurdle, and previously Senior Manager of Global Health Outcomes 

at GlaxoWellcome, Adam has extensive experience leading economic evaluations of pre-launched and 

marketed products, developing submissions to NICE and the SMC, decision-analytic and Markov modeling, 

and in the use of health economics in reimbursement and marketing in continental Europe. 

• Adam holds an MPhil in Economics, and a BA (Hons) in Philosophy, Politics and Economics from the 

University of Oxford. 

Eva Marchese, PHD 

• Dr. Eva Marchese is a Principal and Location Manager, Pricing and Market Access at IMS Health 

in Italy, with a particular focus on market access, regulatory, pharmacovigilance, pricing and 

reimbursement, and health economics and outcomes research. 

• An experienced consultant and founding partner of S&M Consulting, Eva has been involved in 

several ministerial committees at the Italian Ministry of Health, looking at cost evaluation and 

analysis of day surgery procedures. She was previously Professor of Public Management and 

Policy at Bocconi-SDA, the foremost Italian Business School, and a contracted Research Fellow 

at the Centre for Research on Healthcare and Social Management at Bocconi University. 

• Eva holds a PhD in Public Management from the Parma State University, and a degree in 

Business Administration from Bocconi University in Milan. 

Frédérique Maurel, MS, MPH 

• Frédérique Maurel is a Principal, Health Economics and Outcomes Research at IMS Health in France, 

with a particular focus on observational research and health economics studies. 

• A skilled consultant and project manager, Frédérique has extensive experience in the economic 

evaluation of medical technologies gained in roles at ANDEM, Medicoeconomie, and AREMIS Consultants. 

• Frédérique holds a Masters degree in Economics – equivalent to an MS – and completed a postgraduate 

degree equivalent to an MPH with a specialization in Health Economics at the University 

of Paris-Dauphine (Paris IX) as well as a degree in Industrial Strategies at the Pantheon-Sorbonne 

University (Paris I). 

Juliet Munakata, MS 

• Juliet Munakata is a Principal, Health Economics and Outcomes Research at IMS Health in the U.S., 

with a particular focus on global economic modeling, value development planning, and survey data 

analysis. 

• An accomplished researcher and author of more than 25 original articles, Juliet has extensive 

experience in managing clinical trials, health economic studies and decision analytic modeling work, 

gained in senior roles at ValueMedics Research LLC, the VA Health Economics Resource Center and 

Stanford Center for Primary Care & Outcomes Research, and Wyeth Pharmaceuticals. 

• Juliet holds an MS in Health Policy and Management from the Harvard School of Public Health and a 

BS in Psychobiology from the University of California, Los Angeles. 

Karl-Johan Myrén, MSC 

• Karl-Johan (Kalle) Myrén is an Engagement Manager, Pricing and Market Access at IMS Health, 

with responsibility for the Nordic region. He has extensive expertise in global and affiliate 

pricing, market access, reimbursement and health economics and a deep understanding of many 

different national healthcare systems. 

• Karl-Johan’s career spans more than 13 years experience in global health economics gained in 

roles at the Swedish Institute of Health Services Development, Astra Zeneca and Eli Lilly, 

latterly as Senior Area Health Economist coordinating and managing health economic activities 

for the European middle-sized (EMS) countries, including the Nordic markets, Belgium, 

Switzerland, the Netherlands and Portugal. 

• Karl-Johan holds an MSc in Economics and a BSc in Mathematics from the University of Stockholm. 



Michael Nelson, PHARM D 

• Dr. Michael Nelson is Regional Leader, Americas, Health Economics and Outcomes Research at IMS 

Health in the U.S., with particular expertise in retrospective database research, prospective 

observational research, health program evaluation, and cost-effectiveness analysis. 

• During a career that includes leadership roles in HEOR at PharmaNet, i3 Innovus, SmithKline 

Beecham, and DPS/UnitedHealth Group, Mike has gained extensive experience in health 

information-based product development, formulary design, drug use evaluation, and disease 

management program design and implementation. 

• A thought leader in health economics for more than 20 years, Mike holds a doctorate in Pharmacy 

and a Bachelor of Science degree, both from the University of Minnesota College of Pharmacy. He 

also served as an adjunct clinical faculty member at the University of Minnesota whilst in clinical 

pharmacy practice. 

Tini Nguyen, PHARM D 

• Dr. Tini Nguyen is Regional Principal, Health Economics and Market Access at IMS Health in France. 

• Previously European Market Access Director at Sanofi-Aventis in Paris, Tini has more than 15 years 

experience in the global pharmaceutical industry, including 7 years in senior roles focusing on 

health economics, health outcomes, pharmacoeconomics and market access in the Asia Pacific, 

Russia, Latin America, Middle East and Africa. 

• Tini holds a diploma in Health Economics for Healthcare Professionals from the University of York, and 

a diploma in Marketing and a doctorate in Pharmaceutical Sciences from the Université René Descartes 

in Paris. 

Olaf Pirk, MD, PHD 

• Dr. Olaf Pirk is a Principal, Health Economics and Outcomes Research at IMS Health in Germany, 

with a particular focus on health technology assessment, healthcare system research, health 

policy and health economic modeling across a range of countries and therapeutic areas. 

• Formerly a Managing Director of Fricke & Pirk GmbH, Olaf has considerable pharmaceutical 

industry experience gained in roles within health economics, pricing, health policy, marketing 

and clinical research. As a co-founder of the NIG 21 association, he has forged strong 

relationships with health economists, physicians and related researchers working in the German 

healthcare system. 

• Olaf holds an MD and PhD in Medicines from the Medical University of Lübeck. 

Mercedes Prior, MBA 

• Mercedes Prior is a Principal, Health Economics and Outcomes Research at IMS Health in Spain 

where she leads the Health Economics and Strategic Consulting team helping clients develop and 

execute market access strategies at the local and international level. 

• With a consulting background that includes senior-level roles at Booz Allen & Hamilton and The 

Wilkerson Group (IBM Consulting), Mercedes has in-depth experience of market assessment, 

forecasting, identification and evaluation of licensing opportunities, and pricing, financing and 

market access strategies. 

• Mercedes holds an MBA from Columbia University in New York. 

Jon Resnick, MBA 

• Jon Resnick is Vice President and Practice Leader, Pricing and Market Access at IMS Health in 

the U.K., advising pharmaceutical and biotech companies on a wide range of strategic, pricing 

and reimbursement issues. 

• A former Legislative Research Assistant in Washington DC and member of the Professional Health 

and Social Security staff for the U.S. Senate Committee on Finance, Jon combines public policy 

and industry expertise to provide a unique grasp of the healthcare market place. He has 

co-authored several major U.S. healthcare initiatives, including proposals to reform managed care. 

• Jon holds an MBA from the Kellogg School of Management, Northwestern University, where he 

majored in Management and Strategy, Finance, Health Industry Management, and 

Biotechnology. 



Javier Sabater, MPHARM, MHE 

• Javier Sabater is a Principal, Health Economics and Outcomes Research at IMS Health in Spain, 

where he leads a wide range of projects across many therapy areas for major international 

pharmaceutical companies, healthcare providers and national policy institutions. 

• A pharmacist by training, Javier has considerable industry experience in clinical research, medical 

information, health economics, market access and outcomes research gained in roles at GlaxoSmithKline, 

Roche and Schering-Plough. He has co-authored a number of publications and abstracts in HEOR. 

• Javier holds a Bachelors degree in Pharmacy, a Masters in Health Economics and has completed a 

post-graduate course in Pharmaceutical Marketing. 

Vernon Schabert, PHD 

• Dr. Vernon Schabert is a Principal, Health Economics and Outcomes Research at IMS Health in 

the U.S., leading the development of prospective trials, the assessment and validation of 

patient-reported outcomes (PRO) instruments, retrospective analyses of claims and survey 

databases, and primary data collection surveys. 

• A founder and former President of Integral Health Decisions, Inc, Vernon has extensive 

experience in conducting claims analyses, creating custom administrative databases, 

developing business intelligence software, and leading national quality research projects, 

gained in roles with Thomson Reuters, Strategic Healthcare Programs LLC, and CIGNA 

HealthCare. His expertise spans numerous disease areas and diverse topics including medication 

adherence, in-patient safety and outcomes in post-acute care. 

• Vernon holds a PhD in Personality and Social Psychology from Stanford University and a BA in 

Psychology from Princeton University. 

Núria Lara Surinach, MD, MSC 

• Dr. Núria Lara is a Principal, Health Economics and Outcomes Research at IMS Health in Spain, 

where she leads the Outcomes Research group in the design and coordination of local and 

international observational and patient-reported outcomes studies. 

• A former practicing GP and clinical researcher, Núria’s experience spans roles in outcomes research 

at the Institute of Public Health in Barcelona and in Catalan Health Authorities, and consulting 

positions within the pharmaceutical and medical device industries focusing on medical regulatory 

and pricing affairs, pharmacoeconomics and market access strategies. 

• Núria holds an MD (specializing in Family and Community Medicine in Barcelona), and a Masters in 

Public Health from the London School of Hygiene and Tropical Medicine and London School of Economics. 

Jonothan Tierce, CPHIL 

• Jonothan Tierce is General Manager and Center of Excellence Leader, Global Health Economics 

and Outcomes Research, at IMS Health in the U.S., supporting the industry’s growing need for 

real-world evidence of the clinical and economic value of new technologies in advancing health. 

• A pioneer in applied pharmacoeconomics and value strategy development, and co-founder of 

ValueMedics Research LLC, Jonothan has nearly 25 years experience in health economics, 

working with clients to identify customized strategies and tactics for product access, value 

propositions and evidence-based demonstrations of value. 

• Jonothan holds a C Phil, MA, and BA in Political Science from the University of California in Los 

Angeles. He also received two years of post-graduate training in econometrics and experimental design. 

Meng Zang, MBA 

• Meng Zang is a Principal, Pricing and Market Access at IMS Health in China, applying evidencebased 

analytics to help clients address key business issues in global pricing, product launch 

readiness, market opportunity assessment and product portfolio optimization. 

• During the course of his career in the U.S. and China, Meng has developed extensive expertise 

in pricing and reimbursement, new market entry, competitive analysis and corporate strategic 

planning, in consulting roles at SDI Health and Accenture, business development at J&J, and 

as a professional representative at Xian-Janssen Pharmaceutical Ltd in China. 

• Meng holds a degree in Biology from Nanjing University, a Masters in Biochemistry from the 

University of New Brunswick, Montreal and an MBA from the Wharton School of the University 

of Pennsylvania, with a major in Healthcare Management. 


IMS | LIFELINK 

Pharmaceutical companies worldwide rely on IMS LifeLink TM 

to drive 

patient-centered decisions – from clinical development to mature brands. 

Powering a patient perspective 

Your business models have changed. So have the metrics that 

keep the healthcare industry moving forward. Today, a patient 

perspective is a must. 

Through the global IMS LifeLink program, we provide a 

powerful patient lens to drive focus and alignment across 

your business, deepening your understanding of critical 

patient, physician and payer dynamics. LifeLink allows you 

to identify the right patient segments early on, in order to 

gain competitive advantage in today’s complex environment. 

We make a patient-centered perspective simple — by 

integrating patient-level intelligence into our industryleading 

offerings and giving you expert consultants who 

apply it to your key issues. 

IMS LifeLink provides insights of primary research with the 

benefits of secondary — lower cost, repeatable, faster and a 

larger sample size. 

IMS LifeLink has everything you need to succeed in a 

patient-centered universe. 

CANADA 

• Longitudinal Rx 

• Health Plan Claims 

Database 

UNITED STATES 


• Health Plan Claims 

Database 

• Oncology Analyzer 

EUROPE 


(Germany, UK, Netherlands and Belgium) 

• Anonymized Patient-Level Data 

from Electronic Medical Records 

(France, Germany, Italy, UK) 


(France, Germany, Netherlands, Italy, 

Spain, Turkey, UK) 

• Stroke Database 

(France, Germany, Italy, Spain, UK) 

• Hospital Disease Database 

(Belgium) 

POWERING A PATIENT PERSPECTIVE 

We make a patient perspective easy, with familiar tools, 

integration into our industry-leading offerings and expert 

consultants who apply patient insights to your business issues. 

A PARTNER YOU CAN TRUST 

Pharmaceutical companies worldwide rely on LifeLink to drive 

patient-centered decisions — from the first exploratory 

questions that drive clinical development to tactical sales 

planning for mature brands. They are recognizing significant 

benefits, such as: 

• Better global decision making through consistent insights 

across all brands and across the product lifecycle 

• Improved internal alignment with consistent patient 

segments defined across research & development and 

commercial functions 

• Enhanced communication with healthcare payers and 

other stakeholders with the use of a consistent patient 

view and common language 

• Faster and more accurate views across three key 

dimensions: patients, payers and prescribers 

• Confidence working with a partner who is committed to 

driving new metrics for new business models 

AN UNPARALLELED ARRAY OF ANONYMIZED PATIENT-LEVEL DATA WORLDWIDE 

• Longitudinal Patient Database 

(Sweden) 


ASIA 


(China, Japan, Korea, Taiwan) 


(Japan) 

AUSTRALIA 


IMS has made extensive investments in anonymized patient-level data in markets around the world. 

Today, we capture information for more than 260 million patient lives – for unparalleled treatment insights.

Today’s universe 

is patient-centered. 

Discover its power with IMS. 

Your business models have changed. So have the metrics that keep the healthcare industry 

moving forward. Today, a patient perspective is a must. 

Through the global IMS LifeLink TM program, we provide a powerful patient lens to drive focus 

and alignment across your business, deepening your understanding of critical patient, 

physician and payer dynamics. Our tools allow you to identify the right patient segments early 

on, in order to gain competitive advantage in today’s complex environment. 

We make a patient-centered perspective simple — by integrating patient-level intelligence 

into our industry-leading offerings and giving you expert consultants who apply it to your key 

issues. 

IMS LifeLink has everything you need to succeed in a patient-centered universe. 

Let us power your patient perspective. 

Contact us at HEORinfo@uk.imshealth.com or visit imshealth.com/HEOR 

© 2010 IMS Health Incorporated or its affiliates. All rights reserved.

IMS helps you realize 

the potential of 

your products 

Maximizing market access 

demands the best scientific evidence 

and the right commercial awareness to deliver the insights you need. 

IMS has built a global team of more than 300 experts in Health Economics and Outcomes 

Research and Pricing & Market Access — with publication and project experience in more 

than 40 countries across all continents. 

We combine rigorous scientific research — evidenced by nearly 200 publications 

each year — with commercially focused consulting to help you determine, demonstrate, 

communicate and realize product value. 

Our HEOR experts leverage unparalleled claims, medical, hospital and patient-centered 

pharmaceutical databases to create an Evidence-Based ConsultingSM powerhouse. 

So the next time you think about product value, think about us. 

MORE INFORMATION 

For additional information on our HEOR expertise and offerings please 

email HEORinfo@uk.imshealth.com or visit: www.imshealth.com/HEOR 

IMS HEOR OFFICES ARE LOCATED IN MANY COUNTRIES AROUND THE WORLD WITH PRINCIPAL OFFICES IN: 

UNITED KINGDOM 

7 Harewood Avenue, London NW1 6JB, United Kingdom • Tel: +44 20 3075 4800 

UNITED STATES 

300 N. Washington Street, Suite 303 Falls Church, VA 22046, USA • Tel: +1 703.286.2900 

ASIA PACIFIC 

7/F Central Tower, China Overseas Plaza, Jianguomenwai Avenue, Chaoyang District, 

Beijing 100001, China • Tel: +86 10 8567 4255 

©2010 IMS Health Incorporated or its affiliates. All Rights Reserved.

HEOR AccessPoint Report - IMS Health

Create successful ePaper yourself

Delete template?

Save as template?