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Historical and Futuristic Perspective on the Global

Market Access to Care

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BACKGROUND

Changes and practical challenges to market access planning In the past, the pharmaceutical industry relied on old conventional ways of building influence with Key Opinion Leaders (KOLs), believing the key to product success was merely conveying effective messages through efficient communication with physicians who prescribed the drugs. Currently, a need for new conventional wisdom has arisen due to the increasing types of hurdles for market access, especially when confronted with a complex environment in which multiple stakeholders come with multiple requirements, in addition to multiple (and costly) HTA. The key to product success is effective management of payers.1 Payers are healthcare budget holders, including insurers, pharmacy benefits managers and government agencies. As a result of this balance shift, in which payers become more powerful, the impact of physician detailing on launch outcome drops. Since payers are increasingly the most influential stakeholder, they must be approached as customers ensuring that payer needs are fully understood, recognized, and met during product development. This requires meeting payers’ evidence requirements while effectively communicating value propositions. This ‘payer marketing’ can be efficient only after attaining all the necessary skills and knowledge related to payer marketing, including applying creativity, qualitative and quantitative research, and efficient ongoing communication. Pharmaceutical companies are driven to find many new and innovative approaches in order to secure market access for new pharmaceuticals. A challenge to market access may include expensive medication for novel treatments which boost drug spending. To succeed in meeting the challenge of creating innovative approaches, pharmaceutical executives need first to revamp their methods for developing and marketing drugs. Market access planning should be an integral part of their organization, while balancing clinical and economic value in product development and commercialization decisions.2 New set of assessments for successful ‘payer marketing’ The measures of market access have changes to new trends and regulations accordingly. In the past, national/government bodies had the role of negotiating price and/or reimbursement namely within internal or external referencing. While current local and regional bodies have the responsibility to determine how to spend healthcare funds through HTA, guidelines and substitution, we can foresee a need for proactive investment into health care areas of focus or relevance through commissioning and payer funded trials.1 To ensure meeting goals of ‘payer marketing’ requires a number of novel approaches: determining investment in payer research vs. physician

1 Janice Haigh Market Access – practical challenges for the pharmaceutical industry 2010 Astellas Pharma Europe

2 Cameron McClearn and Thomas Croisier (2010) Big Pharma’s Market Access Mission

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research; researching payer needs and views in addition to their attitude to price; using payer research to inform the TPP or trial design; determining the process for defining unmet needs; shaping new measures for R&D performance and finally testing value messages with payers before submitting a dossier. To overcome inadequate launching of new medications, new arrangements need to be made between customers and pharmaceutical manufacturers. These arrangements will, on one hand secure market access and on the other hand they are conditioned to have a reduced risk to the payers.3 Executives at pharmaceutical companies can no longer rely on the existing set of brand strategies for market access. Instead they need to integrate the payer perspective throughout the full set of decisions they make.2 Hurdles to market access Gaining market access for new pharmaceuticals can be successful with the awareness of various hurdles. In the past, overcoming the three (3) hurdles to Obtain Regulatory Approval entailed proving Efficacy, Safety, and Quality of a product at launch. This was sufficient to gain market access and patient access to new drugs and new biopharmaceuticals. The changing pricing and reimbursement environment requires focusing on the time lag between applications for approval and granting of marketing authorization. The fourth and fifth hurdles pertain to reimbursement and pricing of approved drugs.4 Within the last decade government agencies have started sharing best practice of technology assessments (health economics) around the world, comparing pricing and reimbursement mechanisms in an attempt to find a local solution. Achieving market access was, in nationally regulated reimbursement countries, essentially a presentation of clinical benefits and a “negotiation.” Clinical benefits were driving the process; bringing to market drugs with unmet clinical needs has been the driving force behind “state” reviews. Stimulating innovation, R&D and local investments by the pharmaceutical industry have been key elements in these negotiations. In the last 15 years, increasing data and evidence is demanded from the pharmaceutical industry when they launch new products. Risk benefits requirements have also increased safety focus. Risk management programs are now required for all New Chemical Entities; effectiveness versus established gold standard is required rather than just placebo controlled.5

3 Jeanette Marchant (2010) New Approaches to Gaining Market Access for Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of HTAs

4 Cohen J, et al (2006) Comparing patient access to pharmaceuticals in the UK and US. Appl Health Econ Health Policy. 2006;5(3):177-87. 5 Blansett, L. and Colasante, W. (2009), "Pricing, reimbursement and market access issues in the United States and Europe", in Moss, G.D. (ed.), Pharmaceutical Marketing: Latest insights, challenges, solutions and trends, The Biomedical & Life Sciences Collection, Henry Stewart Talks Ltd, London

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The fifth hurdle to market access is pricing. Proving “value” for money has increased ‘Pharma-economics’: cost effectiveness and cost utility. Economic evaluation has become part of the equation in pricing and reimbursement decisions. Measuring “value” is challenging since it is not an exact science. This is what Pharmacoeconomics studies aim to deliver: an unmet clinical need. By showing that the clinical and economic burden of the disease is not addressed by current treatment, it could rather be fulfilled by a new product so its “value” can be quantified. Impact on clinical management has impact on drug budget as well.5 Showing patient-relevant outcomes with a new treatment can show “value” in adopting a new treatment. Showing the adoption of a newer more expensive drug can impact direct or indirect costs of managing a patient, is another way of showing value. As payers seek to reduce uncertainty for paying for drugs for which evidence of clinical and/or economic benefits is insufficiently robust at launch, new arrangements are being made between payers and manufacturers to enable market access under conditions that limit the risk to payers.3 As the measurement of “value” is subjective, a new drug value and its adoption can vary enormously. Variation of Perceived and Quantified “value” consisting of the same compound, with the same development program, with the same promotion strategy and expenses and the same “global commercial strategy” can lead to various adoption rate and speed in different countries. Thus delays and perceived “value” are measured and perceived differently.5 The future of value-based pricing To elaborate and clarify the notion of price as a function of value there are four (4) basic situations. When prices are high, and perceived incremental, value to patient is strong and will result in broad market access with wide adoption. The same result occurs when prices are low, with a limited perceived incremental value to patient, although wide adoption will happen if there’s a lack of alternates. When prices are high with a limited perceived incremental value to patient, it will result in payer restrictions, while providers will relegate to late lines of therapy. Finally when prices are low and perceived incremental value to patient is strong, there will result in foregone profits to pharmaceutical manufacturers. This favorable pricing environment will continued through 2010, while conditions facilitating higher prices will erode beyond 2010, since patient cost sharing increases price elasticity of demand. Direct government involvement, first through federal programs, is increasingly likely 2014 onward. Generics and biomarkers mitigate pricing pressure. Generics provide “head room” for innovative and new products. Biomarkers improve payers/employers’ perceived value. The key is innovation, matched to outcomes.6

6 Mattson Jack DaVinci Oncology Marketing Strategies™, 2007; Influencer Study, May 2007

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Pharmaceutical policies Pharmaceutical manufacturers, when debating which marketing access scheme to implement, must take into consideration a number of factors, starting with pharmaceutical policies, which have a direct affect on drug use, healthcare utilization, health outcomes and expenditures. These pharmaceutical policies are laws, or financial orders, which are made not only by governments, but also by non-government organizations and private insurers. As already stated, one of the major challenges to many health systems is the growing expenditures on prescription drugs. Pharmaceutical policies are different according to the country. In the United States, for example, direct patient drug payment policies include:

Caps meaning the maximum number of prescription drugs reimbursed Fixed co-payments meaning the patients pay a fixed cost for each

prescription drug (direct cost-share). Coinsurance meaning patients pay a percentage of the price of

prescription drugs reimbursed. Ceilings meaning patients pay the full price (or up to a ceiling cost, then

availability is reduced or free). Tier co-payments meaning co-payments assigned accordingly, generic

or brand drugs.

The original intention in caps and co-payment policies are to be an incentive to discourage unnecessary or subsidiary utilization, and furthermore to reduce the financial burden on third-party payers by shifting parts of the expenditure from the insurer to the patients, consequently increasing their financial responsibility for prescription drugs. A recent Cochrane review indeed concluded introducing or increasing direct co-payments reduced drug use and saved plan drug expenditures. Patients accordingly chose the option of drug discontinuation or cost-sharing. Furthermore, they found this policy brought forth reductions for life-sustaining drugs or drugs crucial for treating chronic conditions as well as other drugs.7 In order to address the hurdles to market access, innovative strategies are being employed by payers and manufacturers alike. These approaches and strategies have been employed in international markets including the US and Japan as well as the main European markets: France, Germany, Italy, Spain and the UK. The development of innovative approaches to market access requires first an examination of the existing market access schemes in key pharmaceutical markets, including awareness to the pros and cons of these different types of market access schemes.

7 Austvoll-Dahlgren A et al. Pharmaceutical policies: effects of cap and co-payment on rational drug use. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD007017.

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Market access schemes Gaining market access for new products during the pricing and reimbursement process has become more challenging for pharmaceutical companies. Initiatives are under way to improve market access of innovative products, including patient, value-based pricing and pre-licensing access schemes, risk-sharing agreements, and pay-for-performance schemes (or rebates for non-responders). Generally speaking, innovative market access schemes, which recognize the value of patient access, are classified in two types: finance-based in which discounts and rebates are linked to usage at patient or population level; or performance-based/outcomes-based in which reimbursement is linked to performance guarantees or the generation of further clinical evidence. While some overlap between the two may exist, finance-based schemes that link rebates or discounts to the response of patients treated with the drug comprise an outcomes element. Finance-based schemes are preferred by payers since they are simple to administer and do not involve patient monitoring. Market access schemes place the emphasis on offering patients access to needed medications. One aim of patient access schemes is to give earlier access to innovative drugs for small patient populations. Typically in patient access schemes drugs are provided free for a period of time; some pharmaceutical manufacturers are building into their patient access schemes, in order to minimize the burden on the payers. Pre-licensing access schemes offer earlier access to medicines that have yet to receive official approval. Outcomes-based schemes These performance-based contracts can link pricing and reimbursement to a predetermined specific endpoint or to a defined patient response. These 'coverage with evidence development' schemes, or payment by result schemes, are based on outcomes achieved in practice. These schemes enable patient access to novel treatments for diseases with unknown long-term outcomes and/or cost-effectiveness. These efficiency stipulation schemes or effectiveness guarantee schemes offer a way of enabling the pharmaceutical manufacturer to gain market access earlier without compromising the launch price and reducing the uncertainty of product performance. They are regarded as complex, however, involving additional costs and resources. Schemes involving rebates, discounts or free supplies maintain the pharmaceutical manufacturers' list prices.8

8 Jeanette Marchant (2010) New Approaches to Gaining Market Access for

Pharmaceuticals: Pricing & Reimbursement, Policy Development, and the Role of

HTAs

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Risk -sharing schemes In the Adamski et al (2010) review on risk-sharing schemes in Europe, they explain the incentive for payers to adopt these risk-sharing schemes is a way to limit the growth in pharmaceutical expenditure while ensuring a maximum health gain within limited budgets, furthermore limiting 'off label' prescribing or insuring prescribing only to identified sub-populations where the value of the technology is greatest. The new definition they propose relates to the fact that in practice, the risk-sharing agreement depends on the setting and scope while realizing the mutual obligations of both payers and pharmaceutical companies. This depends on the condition defined as a "risk." This "risk" can result in pharmaceutical expenditure higher than agreed thresholds or a lower health gain from a new product which reduces its value. One result of this new definition is that a large number of 'risk sharing' schemes with pharmaceuticals incorporate not only performance-based/outcomes-based models, rather also financial-based models. These include price-volume agreements/budget impact schemes that focus on controlling financial expenditure with pharmaceutical companies refunding over budget situations, as well as patient access schemes which include price-capping schemes, which focus on controlling the financial impact, but from an individual patient perspective.9 There are many and various schemes that have been developed and implemented in different countries with different financial outcomes for the pharmaceutical companies including the United States with patient access schemes and Canada with price-volume agreements; the UK and Italy are leading the way in Europe with the development of risk sharing schemes. US Patient access schemes were adopted by Genentech to help address public concern over the rising prices for oncology drugs. In 2006, patient access schemes were used to cap the total cost of Bevacizumab at $55,000 per year for patients below an income of $75,000 per year. Costs are a particular issue especially for patients with breast cancer, as well as earlier stages of lung and colon cancer, with the scheme resulting in a 50% reduction or more in costs for one year of treatment. ImClone Systems and Bristol-Myers Squibb also adopted patient access schemes. In 2006, they announced lower-income patients who reached a price cap of approximately US$10,000 monthly for Cetuximab would be supplied a large discount with extra medicine, or even for free. Amgen, in 2006, introduced an oncology patients scheme to provide financial assistance for patients prescribed Panitumumab for the treatment of

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Adamski et al (2010) Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010; 10: 153.

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metastatic colorectal cancer when co-payments reached 5% of patient's adjusted gross income.9 Italy Risk-sharing agreements enable early schemes as early access to new expensive drugs, mainly oncology products. Risk-sharing agreements have become the norm for gaining market access for cancer drugs in Italy. For example, Bevacizumab (for the management of approved cancers) cannot exceed €25,941 per year.8 Earlier access to expensive and innovative drugs in Italy is facilitated through the growing use of risk-share agreements. Italy pioneered one of the earliest risk-sharing schemes in 2000 when the government launched the Cronos project to assess the possible reimbursement of Alzheimer drugs. The Italian authorities have engaged in a risk-sharing scheme, thus providing patient access to new drugs in a managed system. Rebates for non-responders as the case of Aclasta in Italy (and Germany) is a variation on the pay-for-performance scheme.8 UK A key issue in gaining UK market access is through cost-effectiveness schemes. Other initiatives include patient access schemes, value-based pricing, and pre-licensing access which are all focused on improving access to innovative products. Taking into consideration the environment for pricing and pre-licensing and market access in major markets is currently undergoing a period of change. One of the earliest schemes was risk-sharing agreements in the UK, which enabled early access to new expensive drugs for multiple sclerosis treatment, leading the way for future outcomes-based schemes. Pay-for-performance schemes are in place in the UK (for example for Velcade) where payment is received only in the case of patients with a positive response to the medication7. NICE (National Institute for Health and Clinical Excellence) in the UK has adopted patient access schemes to increase the value of new medicines. One example includes cetuximab for the treatment of metastatic colorectal cancer. According to this patient access scheme, Cetuximab will be rebated as free stock (1 vial per 8 utilized) when used in combination with Folfox. Another example includes Sunitinib for patients with metastatic renal cell carcinoma, in which the first treatment cycle (6-weeks costing an average of GB£3139/patient) is provided free via through the patient access scheme. Subsequent cycles are funded by the NHS until disease progression. The Department of Health considered the scheme did not constitute an excessive administration burden on the NHS.9 France Finance-based schemes, such as price-volume agreements, are the norm in France. Price-volume agreements cap costs per patient, dose, or overall expenditure. France uses payback schemes for excessive sales by therapeutic class, based on the pharmaceutical company’s agreed turnover with annual financial adjustments. These change yearly and include regular

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price reviews, based on the average daily costs/dose at time of reimbursement. Adoption of these payback schemes in 2008 involved Naglazyme® for the treatment for mucopolysaccharide type VI disease, and Soliris® for the treatment of paroxysmal nocturnal haemoglobinuria.9 Price -volume agreements are common in Canada and Australia as well. The rate of development of price-volume agreements in France is comparable to the situation in Australia where some 80 price-volume agreements have been developed with the Pharmaceutical Benefits Advisory Committee (PBAC). While in Canada, price-volume agreements are almost mandatory in the major provinces.8 Germany Examples of price volume agreements in Germany are the rebate contracts existing between the Sickness Funds and pharmaceutical companies to accelerate access and/or boost market access of certain drugs where there are concerns with their value. Current schemes include the insulin analogues, olanzapine, risperidone, clopidogrel, zolendronate (Aclasta®), mycophenolic acid (Myfortic®), everolimus (Certican®), and cyclosporine (Sandimmun®).8 Hungary The price volume agreement in Hungary includes a general payback scheme based on individual products as well as total pharmaceutical expenditure, which has been in operation since 2003. Introduction of the law regulation in 2007 concerned with the pricing criteria for pharmaceuticals has only limited exceptions. Under this scheme, pharmaceutical companies are obligated to pay the Ministry 12% of their total reimbursed sales each year. In addition, the first 9% of any budget overspend for a given class; the cost is shared by the social health insurance and pharmaceutical companies (who pay a greater percentage). When overspend exceeds 9% of the agreed budget, all the additional costs are covered by the pharmaceutical companies. The payback in 2006 was 22.5 billion HUF (€90 mn - 5.69% of the budget).9 Japan The strict regulatory requirements and the time it takes getting new drugs registered in Japan often causes a serious delay in access to the Japanese market. This situation causes delaying Japanese market access by up to five years after a drug's initial market launch in the US or the EU.8

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Potential Key Innovation Leaders

Person's Name Title/Expertise

Alan Sager

Professor of health services at the Boston University School of Public Health and serves on the Massachusetts Attorney-General’s Advisory Group on Health Care Reform, and on the state Secretary of Health and Human Services’ Working Group on Health Care Finance

Ansgar Gerhardus Department of Health Systems Research, Hanover Medical School, D-30623 Hanover, Germany.

Isabelle Durand-Zaleski Chief of the Department of Public Health at the Henri Mondor Hospital in Paris, France.

A. Mark Fendrick, MD

Co-director of the University of Michigan's Center for Value-Based Insurance Design and professor of Health Management and Policy in the School of Public Health; also named one of the nation’s top 20 health care leaders by Health Leaders Media.

Adrian Towse Director of the Office of Heath Economics, Health Economics Research Centre, Department of Public Health University of Oxford, UK.

Alan Lyles, ScD, MPH, RPh Professor, Public, Private and Non-Profit Partnerships, University of Baltimore, Bel Air, MD

Alastair Gray Director of the Health Economics Research Centre, Division of Public Health and Primary Care, University of Oxford, UK.

Alcides S Miranda

Public Health Department, State University of Ceará, Brazil. Author of "Intergovernmental health policy decisions in Brazil: cooperation strategies for political mediation."

Person's Name Title/Expertise

Alessandra Gelera

Health Economics & Public Affairs Manager at Boston Scientific; Alessandra Gelera has a 6 years experience in public policy and health economics in the healthcare industry, in the fields of both pharmaceuticals and medical devices. Alessandra joined Boston Scientific (BSC) Italy as Health Economics (HE) Specialist in 2006. In 2009 she was promoted to Health Economics & Public Affairs (HEPA) Manager and is responsible for the activities in the Italy Group, directly reporting to the BSC Italy Group General Manager and Vice President. She is responsible for the design and implementation of the Italian Health Economic strategic and operational plan supporting all Business Units (BUs), i.e. Cardiac Rhythm Management, Interventional Cardiology, Peripheral Vascular, Neurovascular, Endosurgery, Uro-Gynaecology, Neuromodulation.

Ana Rico Assistant Professor of Public Policy at the Department of Politics and Social Sciences, Pompeu Fabra University, Barcelona, Spain.

Anne E. Cowan, MPH

Child Health Evaluation and Research Unit and Department of Health Management and Policy, School of Public Health; Has performed research on Vaccine Purchase Prices and Payer Reimbursement issues

Anthony B Zwi Senior lecturer in health policy, School of Public Health and Community Medicine, The University of New South Wales, Sydney, NSW 2052, Australia

Antón Losada Departamento de CC Política e da Administración, Facultade de Ciencias Políticas, Campus Universitario Sur, Spain-España.

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Cassandra L. Mitchell, CPC Associate Vice President, Reimbursement, UConn Health Center / John Dempsey Hospital

Deborah Outlaw

The Principal of The Outlaw Group in Washington, DC, where she provides legislative and regulatory services to physician specialty groups, allied health providers, medical device manufacturers, and non-profit organizations interested in medical research.

Denzil Fiebig President of Australian Health Economics Society.

Dirk Sauerland Dean, Faculty of Economics, Department of Health Management, University of Witten, Germany.

Anarfi Asamoa-Baah

Dr. Asamoa-Baah started in WHO as a senior policy adviser to the Director-General. He has served as Executive Director for External Relations and Governing Bodies and Executive Director for Health Technology and Pharmaceuticals under Dr Brundtland. Under Dr Lee, he initially served as Assistant Director-General, Communicable Diseases. From October 2005 to January 2007, he was Assistant Director-General, HIV/AIDS, Tuberculosis and Malaria.

Margaret Chan

Margaret Chan is the Director-General of WHO, appointed by the World Health Assembly on 9 November 2006. Before being appointed Director-General, Dr Chan was WHO Assistant Director-General for Communicable Diseases as well as Representative of the Director-General for Pandemic Influenza. Prior to joining WHO, she was Director of Health in Hong Kong. During her nine-year tenure as director, Dr Chan confronted the first human outbreak of H5N1 avian influenza in 1997. She successfully defeated the spate of severe acute respiratory syndrome (SARS) in Hong Kong in 2003. She also launched new services to prevent disease and promote better health.

Person's Name Title/Expertise

Mary Archer Board of Directors Chairman of Cambridge University Hospitals NHS Foundation Trust (Innovation and excellence in health and care), UK.

Tony Jewell Chief Medical Officer Wales, Director of Department of Public Health and Health Professions, UK.

Wolf Rogowski

Head of the Research at Institute for Health Economics and Management in Health Care, Institut für Gesundheitsökonomie und Management im Gesundheitswesen Institute for Health Economics and Management in Health Care, Germany.

Lloyd Sansom Chair, Pharmaceutical Benefits Advisory Committee (PBAC), Australian Government, Department of Health and Aging, Australia.

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Francesco Scarpa

Health Economics & Reimbursement Manager at W.L. Gore & Associates, Medical Division Italy & Iberia Francesco Scarpa has over 10 years experience in reimbursement policy and health economics in the healthcare industry, in the fields of medical devices. In collaboration with sales and marketing department during this time he has supported the strategic development of different businesses, providing a specific consultancy competence on the National Health Reimbursement System and developing health economics analysis to support the introduction of innovative new therapies.

Frank-Ulrich Fricke PhD, MSc Principal, IMS Health Economics & Outcomes Research, Nuremburg, Germany.

Gabriel Ferragut Ensenyat Centre de Recerca en Economia i Salut (CRES), Universitat Pompeu Fabra, Barcelona, Spain.

Gabriel Manuell-Lee Mexican Society of Public Health, Mexico.

Gérard de Pouvourville Professor, Healthcare Management Department; Health Economics Chair, ESSEC Business School, France.

Gerd Glaeske

Co-Director, Department of Health Economics, Health Policy and Health Services Research, Center for Social Policy, University of Bremen, Center for Social Policy Health Economics, Health Policy and Health Services Research, Germany.

Gustavo Nigenda National Institute of Public Health, Avenida Universidad No. 655, Sta. Ma. Ahuacatitlan, Cuernavaca, 62508, Morelos, Mexico.

Hendrik Jürges

Member of Committee on Health Economics; German Economic Association (Gesundheitsökonomischer Ausschuss des Vereins für Socialpolitik), Mannheim Research Institute for the Economics of Aging (MEA), University of Mannheim, Germany.

Jacob Hacker, PhD

Stanley B. Resor Professor of Political Science at Yale University, and a Resident Fellow at the Institution for Social and Policy Studies. He is also a Fellow at the New America Foundation in Washington, D.C., and a former Junior Fellow of the Harvard Society of Fellows. He is an expert on the politics of U.S. health and social policy,

Person's Name Title/Expertise

Jaime Sepúlveda Mexican Ministry of Health and Author of "Evidence-based health policy: three generations of reform in Mexico."

James J. Mongan, MD Professor of health care policy and social medicine at Harvard Medical School and chair of the Fund's Commission on a High Performance Health System.

Jean-Paul Moatti

Professor of Health Economics at the University of the Mediterranean (Marseilles, South Eastern France), Director of the INSERM/IRD (French Public Institute for Research in Developing Countries) Unit 912 (Economic and Social Sciences, Health Systems & Societies, SE4S), Director of the Federative Research Institute on Human, Economic & Social Sciences Applied to Health of Aix-Marseille Universities, INSERM and French National Center For Scientific Research (CNRS).

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Jean-Yves Fagon Director of Medical Policy, AP-HP Assistance Publique - Hôpitaux de Paris, France.

Jennifer A Nelson Public Health Policy, Medical and Health Research Association of New York City (MHRA).

Jenny Watts

Senior Lecturer in the Centre for Health Economics; research interests include measuring hospital efficiency in the acute care sector, hospital clinical costing systems, payment policy in the acute care sector and health care technology assessment.

John Iglehart

Founding Editor, Health Affairs, a bimonthly policy journal that he started in 1981 under the aegis of Project HOPE, a not-for-profit international health education organization. Over this same period, Iglehart also has served as a national correspondent of The New England Journal of Medicine, for which he has written more than 100 essays called Health Policy Reports

Karen Davis, PhD

President of the Commonwealth Fund and a nationally recognized economist with a distinguished career in public policy and research. Before joining the Fund, she served as chairman of the Department of Health Policy and Management at The Johns Hopkins School of Public Health, where she also held an appointment as professor of economics.

Katharine London, M.S. Areas of expertise are in health care policy development and analysis in the areas of health care financing, cost containment, and quality improvement.

Kenichi Hanioka Director, Health Policy Institute, Japan; Associate Professor, Healthcare & Social Policy Leadership Program, University of Tokyo

Klaus-Dirk Henke Chair of the disciplines of public finance and health economics at the Institute of Economics and Business Law at the Technical University of Berlin.

L.J. Tan, PhD

Director of Medicine and Public Health at the American Medical Association, serves as a member of the Scientific Advisory Board for the Immunization Action Coalition and the Coalition for Safe Needle Disposal, of the Advisory Committee for Immunization Practices (ACIP), of the Advisory Council for the Elimination of Tuberculosis (ACET), of the Steering Committees for the National Viral Hepatitis Roundtable, Voices For Vaccines, the 317 Coalition, and the Partnership to End Cervical Cancer (and on the Board for its Foundation), chairs the National Influenza Vaccine Summit, co-sponsored by the AMA and the CDC, and recently organized the first National Immunization Congress.

Person's Name Title/Expertise

Lawton Robert Burns, PhD

Associate Professor of Healthcare Systems in the Wharton School at the University of Pennsylvania. He is also Director of Research at the Leonard Davis Institute of Health Economics.

Len Nichols, PhD

Highly respected healthcare economist, headed New America's Health Policy Program from 1995 until 2010, when he left to become a professor of health policy and director of the Center for Health Policy Research and Ethics at George Mason University

Linda Gorman, PhD Director of the Health Policy Center at the Independence Institute, a free market think tank, focuses on state health care issues.

Lynne Dunbrack Program Director, Provider/Health Payer Research IDC Health Industry Insight.

Maria Goddard Director Centre of Health Economics at the University of York, UK.

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Maria-Luisa Vazquez Health Policy and Health Services Research Group, Health Policy Research Unit, Consortium for Health Care and Social Services of Catalonia, Barcelona, Spain.

Martina Garau, PhD

Economist, Office of Health Economics. Current research interests include the use of “risk-sharing” arrangements between health care payers and pharmaceutical companies; the economics of pharmacogenetics for health care payers and the pharmaceutical industry; economic issues around access to, and R&D for the development of, treatments for less developed country diseases; the economics of medical negligence; and measuring productivity in health care.

Martine M. Bellanger Professor of Health Economics, ESSEC Business School, Paris, France.

MaryLou Fleming Head of School of Public Health at the Queensland University of Technology, Australia.

Masaakira James Kondo

Vice Chairman and President, Health Policy Institute, Japan; Associate Professor, Healthcare & Social Policy Leadership Program, University of Tokyo

Mattias Kyhlstedt

CEO and Founder of Synergus AB and Synergus Corp. Mattias Kyhlstedt has 15 years of experience in reimbursement and Quality & Regulatory in the Medical Device industry. He has unique management knowledge and insights within medical device companies based on previous positions within business development, production, quality, logistics and R&D in global corporations as well as start-ups. Mattias Kyhlstedt has considerable experience in development of Pan-European regulatory and reimbursement strategies for medical device companies. He is also a frequent speaker at various international conferences in the area of reimbursement, quality and regulatory.

Michael Chernew, PhD Professor of healthcare policy in the Department of Health Care Policy at Harvard Medical School and co-editor of the American Journal of Managed Care.

Person's Name Title/Expertise

Michael Shields Professor in the Department of Economics at the University of Melbourne; an affiliate of the Health Econometrics Data Group (HEDG), Australia.

Miguel Gonzalez-Block

Instituto National de Salud Publica, Fco. de P. Miranda, Mexico. Author of "Health services decentralization in Mexico: formulation, implementation and results of policy".

Naoki Ikegami, M.D., PhD Professor & Chair, Department of Health Policy & Management, Keio University.

Pablo Kur-Morales Mexican Society of Public Health, Mexico and the School of Medicine, National Autonomous University, Mexico City, Mexico.

Pascal Garel European and international affairs at the Fédération Hospitalière de France (French Public Hospitals Federation).

Philip Davies Professor in Health Systems and Policy; previous Deputy Secretary, Department of Health and Ageing, Queensland University of Technology, Australia.

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Giovanni Fattore

President of AIES (Italian Health Economics Association), Researcher at CERGAS (Research Centre on Healthcare Management of Bocconi University), Professor in Healthcare and Public Management at Bocconi University Professor Giovanni Fattore holds a degree in Economics from Bocconi University and had its post graduate studies at the Harvard School of Public Health and the London School of Economics. He is Professor in Healthcare and Public Management at Bocconi University where he was Director of the Master of International Healthcare Management Economics and Policy (MIHMEP) from 2002 to 2008. He was Research Officer at the London School of Economics (1996-1997) and Deputy Director of CERGAS (2000-2002), the Research Centre on healthcare management of Bocconi University. His research activities focus on health economics, health planning and management and economic evaluation of healthcare programmes. He has been partner leader in various EU research projects, including HealthBasket, Eurohope, Euprimecare.

Reinhard Busse

Professor and department head for health care management as well as Dean of the Faculty of Economics and Management at Technische Universität Berlin, Germany.

Richard Tarplin

The founder of Tarplin Strategies in Washington, DC, where he provides strategic advice and lobbying services to clients in the financial services and health care sectors. He served for almost 20 years in the US House of Representatives and US Senate and as a senior Presidential Executive Branch appointee.

Robert Blendon, ScD

Senior Associate Dean for Policy Translation and Leadership Development Professor of Health Policy and Political Analysis, Department of Health Policy and Management at Harvard School of Public Health.

Robert Field, JD, PhD, MPH, AB

Nationally known expert on health law and public health whose research focuses on ethical issues in managed care, public policy and legal facets of health care reform and genetic screening. He holds a joint appointment as professor of health management and policy at the Drexel School of Public Health.

Person's Name Title/Expertise

Robert Moffit, PhD

Former senior official at the U.S. Department of Health and Human Services and the Office of Personnel Management; specializes in Medicare reform, health insurance, and other health policy issues.

Ronald Leslie Akehurst Dean and Professor of Health Economics, School of Health and Related Research (ScHARR), The University of Sheffield, Australia.

Russell Gray

Senior regulatory consultant, The Anson Group, expertise through a broad array of product development and technical management positions with a number of companies in the medical device, in vitro diagnostic, and analytical instrumentation markets.

Sara Rosenbaum, PhD Professor of Health Law and Policy, George Washington University

Sashi Gregory, MPH

Child Health Evaluation and Research Unit and Department of Health Management and Policy, School of Public Health; Has performed research on Vaccine Purchase Prices and Payer Reimbursement issues, University of Michigan.

Sharon Willcox Director of Health Policy Solutions, Victorian Department of Human Services, Australia.

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Shunya Ikeda Department of Health Policy and Management, Keio University School of Medicine, Tokyo, Japan

Simone Sandier Conseil Scientifique en Economie de la Sante, ARgSES (Paris); CHP/PCOR Adjunct Associate, France.

Sir Liam Donaldson Chief Medical Officer (CMO); UK Government's principal medical adviser and the professional head of all medical staff in England, Department of Health, UK.

Stephanie Anthony, JD, MPH

Conducts health policy and health law research, analysis, writing, and consulting for public and nonprofit clients, including state governments and foundations. Ms. Anthony’s health policy work at the Center for Health Law and Economics and in other public and private sector posts has focused on state and national health care reform, Medicaid, the State Children’s Health Insurance Program (CHIP), long-term care financing, Medicaid and Medicare managed care, low-income and vulnerable populations, and the uninsured.

Stephen Hull

Sr. Vice President for Global Reimbursement at AdvaMed, Medicare Modernization Act, Principal at Covance Health Economics and Outcomes Services, chairman of the Medical Devices Council for the International Society for Pharmacoeconomics and Outcomes Research, Johns Hopkins Bloomberg School of Public Health, Principal and Founder Hull Associates

Theodore Marmor, PhD

Professor Emeritus of Public Policy and Management & Professor Emeritus of Political Science, focus on the welfare state politics and policy in North America and Western Europe. He particularly emphasizes the major spending programs, which is reflected in the second edition of The Politics of Medicare (Aldine de Gruyter, 2000) and the book written with colleagues Mashaw and Harvey in the early l990s, America's Misunderstood Welfare State (Basic Books, l992).

Timothy Jost

Holds the Robert L. Willett Family Professorship of Law at the Washington and Lee University School of Law. He is a co-author of a casebook, Health Law, used widely throughout the United States in teaching health law, and of a treatise and hornbook by the same name. He is also the author of Health Care Coverage Determinations: An International Comparative Study; Disentitlement? The Threats Facing our Public Health Care Programs and a Rights-Based Response; and Readings in Comparative Health Law and Bioethics, the second edition of which appeared this spring.

Person's Name Title/Expertise

Tom Stargardt

Deputy Director of Health Services Management Working Group at the Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH).

Vicente Ortun

Universitat Pompeu Fabra - Department of Economics and Business, Barcelona,Spain and Author of "The Impact of Economics on Health Policy and Management in Spain."

Wilfried von Eiff Director, Center for Hospital Management, Westfälische Wilhelms-Universität Münster, Germany.

Yasuhisa Nakamura

Deputy Director, International Cooperation Division Ministry of Health, Labour and Welfare Government of Japan

Yukio Matsutani, M.D., Director General, MHLW Health Policy Bureau, Ministry of Health Labour and Welfare, Government of Japan.