USE OF HEALTH ECONOMIC/ PHARMACOECONOMIC INFORMATION BY DECISION-MAKERS ISSUES

IP3: DO ECONOMISTS HAVE ANYTHING TO CONTRIBUTE TO HEALTH ECONOMICS?

Moderator: Joakim Ramsberg, PhD, Health economist, Pharmaceutical Benefits Board, Solna, Sweden
Panelist(s): Bengt Liljas, PhD, Value Demonstration Leader, AstraZeneca, Mölndal, Sweden; F. Reed Johnson, PhD, Senior Fellow and Principal Economist, Research Triangle Institute, Research Triangle Park, NC, USA; Peter Zweifel, PhD, Professor, University of Zurich, Zurich, Switzerland

ISSUE: By emphasizing incentives and constraints facing insured and uninsured patients, physicians, hospital administrators, and policy makers, economists have provided important insights into how healthcare systems function and react to regulation. These insights have helped inform efficiency-enhancing health policies at the systems level. However, there often exists a gap between basic economic concepts and practical implementation in evaluating specific products and treatments.
OVERVIEW: Economists have applied their theoretical tools with considerable success in analyzing healthcare-related behaviour. Some examples include confirming the nonzero price elasticity of demand for medical services, identifying the existence of moral-hazard effects, explaining the slow growth of physician group practices, and explaining why politicians supply so much subsidization and regulation in the healthcare sector. Economic evaluation of specific treatments and products, particularly pharmaceuticals, has been much less successful. The ratio of marginal benefits to extra cost (or marginal net benefits) indicate whether innovations are efficiency-enhancing. However, economists and health economists often disagree about whether to monetize benefits and which costs to include. Benefits are instead measured using QALYs, a concept foreign to conventional economics and widely criticized for inconsistency with standard economic assumptions. One possible explanation is that many health economists do not accept economists' traditional distinction between efficiency and equity. While cost-benefit analysis is widely practiced in other areas of applied economics, it is typically rejected on equity grounds in health economics. However, incorporating implicit equity criteria in the analysis limits the contribution that standard economics can make and creates problems in defining unambiguous decision rules. The much-discussed lack of a defensible threshold value of a QALY is an obvious example. Another possible explanation is that policy makers in health care prefer economic evaluations without strict efficiency criteria. The panel will offer perspectives on these issues from the perspectives of academia, government, pharmaceutical industry and consulting.

IP7: EUROPEAN NETWORK FOR HEALTH TECHNOLOGY ASSESSMENT (EUnetHTA); MISSION AND EXPECTED OUTCOMES

Moderators:  Finn Borlum Kristensen PhD, Danish Centre for Evaluation and Health Technology Assessment, Copenhagen, Denmark;
Panelists: Camilla Palmhøj Nielsen, Danish Centre for Evaluation and Health Technology Assessment, Copenhagen, Denmark; Debbie Chase, National Coordinating Centre for Health Technology Assessment, Wessex Institute for Health Research & Development, University of Southampton, Southampton, UK; Kristian Lampe or representative, Finnish Office for Health Technology Assessment, Helsinki, Finland; Dr. Alric Rüther, German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information, Cologne, Germany; Hans-Peter Dauben MD, PhD, Head, International Affairs, German Institute for Medical Documentation and Information, Cologne, Germany speaking for the National Authority of Health, France.

ISSUE: Each country within the European Union has its own health technology agency to assess new technology. There is overlap and duplication of efforts by these agencies.
OVERVIEW: The European Network for Health Technology Assessment (EUnetHTA) coordinates the efforts of 27 European countries in evaluating health technology in Europe. The objectives of EUnetHTA is to establish the organizational and structural frameworks of the Network; to develop a clearinghouse for disseminating HTA results, stimulate information sharing and coordinate HTA activities; to develop a methodological framework for HTA; to develop and implement tools for adapting assessments made for one country to new contexts; develop and implement tools to transfer HTA results into applicable health policy advice in the EU; and to develop effective monitoring of emerging health technologies. During this session, the overall EUnetHTA structure and aim of the EUnetHTA projects, the communication and knowledge management - a clearinghouse, the methodological framework, the transferability of HTA information, the evaluation and adoption of assessments and involvement of stakeholders and decision makers will each briefly be discussed.


Issue Panel Session II
Tuesday, 31 October, 2006, 10:30-11:30

HEALTH CARE REIMBURSEMENT / COVERAGE ISSUES

IP4: ARE INTERVENTIONS TO INFLUENCE UTILIZATION AND COSTS OF PHARMACEUTICALS COST-EFFECTIVE?

Moderator: Kjeld Møller Pedersen, PhD, Professor, University of Southern Denmark, Odense, AL, Denmark
Panelists: Ivar S Kristiansen, MD, PhD, MPH, Professor, University of Oslo, Oslo, Norway; Douglas Lundin, PhD, Health Economist, LFN Pharmaceutical Benefits Board, Solna, Sweden; Eivind Jorgensen, MPhil, Health Economics Manager, AstraZeneca Norway, Oslo, Norway

ISSUE: Pharmaceutical expenditure has been increasing in industrialized countries, sometimes with double-digit annual growth rates. This growth has resulted in an array of policy interventions aimed at containing costs or improving cost-effectiveness. Such interventions may in principle target the demand side (patients) or the supply side of the market. Interventions include price regulation, reference price, budget restrictions, co-payments, use of economic evaluation to guide reimbursement decisions, and clinical guidelines to mention a few.
OVERVIEW: This issue panel will first review the evidence that such interventions have an effect on price and utilization of pharmaceuticals and of total health care costs. Second it will present results of economic evaluation of such interventions. In other words: what are the total costs and health consequences of influencing pharmaceutical expenditure? The issue panel will advocate the future use of economic evaluation, not only of pharmaceuticals, but also of interventions to influence pharmaceutical costs and utilization.

HEALTH POLICY ISSUES

IP5: RISK-BENEFIT AND PHASED RELEASE: A NEW PARADIGM FOR RISK MANAGEMENT AND ACCELERATED APPROVAL?

Moderator: Adrian Towse, MPhil, Director, Office of Health Economics, London, United Kingdom
Panelist(s): Louis P. Garrison, PhD, Professor, University of Washington, Seattle, WA, USA; Nicky Lilliott, Director of Regulatory Affairs, ABPI, London, United Kingdom

ISSUE: Accelerated, Phased Release to Address Industry Safety and Productivity Problems?
OVERVIEW: Recent prominent examples of drug safety problems and concerns about the apparent declining productivity of the global pharmaceutical industry have prompted regulators in Europe and the United States to undertake initiatives and reforms. There are several examples of withdrawn drugs that would have been safe if used within the label indication: this has raised questions about how to better manage these risks. Both EU and US authorities have recently established new risk management guidances and procedures to address this. Additionally, both the EMEA via “Road Map to 2010” and the FDA via the “Critical Path Initiative” have established a broader process to examine potential reforms that address whether a new approach to drug development and marketing could improve safety assessment while improving or at least maintaining incentives for development. For example, the EU has recently instituted the practice of “conditional licensing” and the question arises whether this could or should be expanded more broadly to what is termed “phased release.” One panelist will argue this expansion is not warranted given that current processes, recently amended with new risk management procedures, will improve matters and should be tested before implementing further reforms. The other panelist will present the case for an alternative model of drug approval and related safety assessment that would involve an accelerated but phased release into the market. Initial uptake would be slower, but more information on drug safety could be available. The moderator will frame the economic issues, including the potential for value of information approaches and the implications for pricing and reimbursement. Each panelist will present their case for 15 minutes; the moderator will then comment and set the stage for a discussion with the audience in the final 20 minutes.

PHARMACOECONOMIC / HEALTH ECONOMIC STUDY METHODOLOGY ISSUES

IP6: EVENT BASED ANALYSIS FOR ECONOMIC ANALYSIS: SENSIBLE RESPONSE TO REDUCE NOISE OR DANGEROUS VIOLATION OF THE RANDOMISATION PRINCIPLE?

Moderator: Andrew Briggs, DPhil, Professor, University of Glasgow, Glasgow, United Kingdom
Panelist(s): Mark J Sculpher, PhD, Professor, University of York, York, United Kingdom

ISSUE: The purpose of this panel will be to use recent examples of event based economic analyses from the cardiovascular and respiratory disease areas to compare and contrast the two approaches and to engage the audience in a debate about their appropriateness – in particular whether the benefits of event based analyses in terms of increased precision are worth the additional structural assumptions imposed.
OVERVIEW: Economic analyses of patient level data are typically hampered by the large amounts of noise in the data. In particular, it is well known that there are high levels of variability in cost and health related quality of life data. This can lead to problems of power, particularly in randomised controlled trials, where the sample size calculations are rarely based on economic outcomes. As a consequence, standard approaches to economic evaluation alongside trials often result in high levels of uncertainty reflected by wide confidence intervals on cost-effectiveness. One solution to this problem has been to explicitly design studies as ‘event based' analyses. This approach is based on the assumption that it is events that drive the cost and quality of life effects of treatment interventions. These events could be the primary efficacy endpoints in a clinical trial, but might also include unintended effects (adverse events) associated with treatment. Use of regression models with these events as explanatory for cost and quality of life offer the potential for the precise estimation of cost and disutility associated with these events, while disregarding the background variability or ‘noise'. Some commentators may argue that such use of post randomisation variables violates the randomisation principle. While others may counter that through the use of a conditional independence assumption (that treatment only affects cost or quality of life through the impact on event rates) the validity of randomisation is preserved.

IP8: EUROPEAN DEVELOPMENTS IN EMERGING TECHNOLOGIES DETECTION AND ASSESSMENT: USING PATIENT REGISTRIES TO MONITOR NEW TECHNOLOGIES, PHARMACOGENOMICS

Moderator: Hans-Peter Dauben MD, PhD, Head, International Affairs, German Institute for Medical Documentation and Information, Cologne, Germany
Panelists: Prof. Angela Brand, FH Bielefeld, Public Health Genomics European Network, Bielefeld, Germany;
Dr. N. Banik, GlaxoSmithKline, München, Germany; Dr. Claus-Steffen Stürzebecher, Schering, Berlin, Germany

ISSUE: As the actual effectiveness and cost-effectiveness of many health technologies put to practice cannot be fully evaluated with use in real conditions, there is a need to monitor the use and the outcomes associated with a technology in clinical practice.
OVERVIEW: One of the projects of the European Network for Health Technology Assessment (EUnetHTA) is development of monitoring tools for emerging /new technologies led by the French National Authority for Health (HAS). During this session, the issues in using patient registries to monitor new technologies especially in the context of pharmacogenomics will be debated. What are the expectations of the public, what is the industry perspective, what are the scientific challenges and issues in conducting good epidemiological practices in the development and implementation of patient registries in Europe will be discussed.
 

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