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4th International EBHC Symposium 2009
“HTA & Pricing”
The Symposium took place on December 7th and 8th, 2009 in Krakow, at the Jagiellonian University Auditorium Maximum.
The EBHC Symposium, organized for the fourth time, is a unique educational initiative for interested individuals from Poland and other countries of Central and Eastern Europe. Its participants have an opportunity to meet experts from Poland, Europe and the whole world. The Symposium provides also an opportunity to exchange opinions with representatives of ministries and public payers as well as those of European medical and business communities.
In the last year we had the pleasure of organizing the 3rd EBHC Symposium in Krakow, which resulted in sharing of experience, establishing of new relations and further cooperation between scientists in Poland and worldwide. In 2008 our invitation was accepted by more than 300 specialists in the field of EBM and HTA, decision-makers, managers and scientists from Europe and the USA. We noted among them a significant number of worldwide recognized experts, representing European and international organizations engaged in problems of effectiveness, cost-effectiveness and quality of health care services.
The keynote of the last EBHC Symposium was pricing of medicinal products and medical devices. Pricing is an important element of the state health policy. Evolution of health care systems in developed countries tends towards price control of medications and medicinal products in order to rationalize expenses. Transparent regulation of medicinal product prices, mentioned explicitly in the European Council directive (89/105/EEC from 21.12.1988.) becomes a more and more recognized issue in countries of Central and Eastern Europe.
During the 4th Symposium systems of pricing for reimbursed medicinal products and medical devices, problems related to reimbursement arrangements and its influence on prices, negotiation mechanisms and techniques as well as HTA-based principles of assessment of innovation were discussed. Issues related to pricing mechanisms and risk sharing schemes were presented by worldwide recognized experts.

The scientific program of the Symposium was presented over two days in eight thematic sessions:
  1. Discussion panel: need for decalogue for health care politician
  2. Risk sharing schemes: objectives, methods, negotiations – public perspective
  3. Value of drug therapy and the role of HTA in risk sharing arrangements
  4. Value of non-drug technologies – industry perspective
  5. Developments of HTA in CEE countries
  6. Cost-utility thresholds vs efficiency frontier
  7. Managed entry schemes
  8. Scoping

  • Prof. Jack Dowie
    Emeritus Professor of Health Impact Analysis Public Health and Policy Dept London School of Hygiene and Tropical Medicine, UK
  • Prof. Michael Drummond
    Professor of Health Economics Centre for Health Economics, University of York, UK
  • Prof. Bengt Jönsson
    Professor of Health Economics, Stockholm School of Economics, Sweden
  • Prof. Gert van der Wilt
    Department of Epidemiology, Biostatistics and HTA Radboud University Medical Centre Nijmegen, Nederlands
  • Chris Henshall
    Pro Vice Chancellor for External Relations at the University of York, UK
  • Prof. David Banta
    Professor Emeritus, University of Maastricht, Netherlands
  • Alexandre Lemgruber
    Head of the Office of Economic Evaluation of New Technologies, at the Brazilian Health Agency - ANVISA, Brazil
  • Prof. Rod Taylor
    Associate Professor in Health Services Research & Scientific Director of Peninsula Clinical Trials Unit, Peninsula Medical School, UK
  • Rabia Kahveci
    President of Turkish Evidence Based Medicine Association, Turkey
  • J. Jaime Caro
    President and Chief Executive Officer, Senior Vice President, UBC, USA
  • Joanna Mucha
    Member of Parliament, academic lecturer, Poland
  • Wojciech Matusewicz
    Director, AHTAPol, Poland
  • Prof. Zbigniew Szawarski
    Institute of Philosophy, University of Warsaw, Poland
  • Prof. Jacek Ruszkowski
    Director of the Public Health Center, Kozminski University, Poland
  • Jim Furniss
    Director, Global Market Access Strategy Bridgehead International Limited, Leicestershire, UK
  • Prof. Paweł Vorobiev
    President of Russia Society for Pharmacoeconomics Research, Russia
  • Zoltan Kalo
    CEO at Syreon Research Institute, Director of Health Economics Research Centre at Eötvös Loránd University, Hungary
  • Dragana Atanasijevic
    Local Consultant for HTA Project Coordination Unit Ministry of Health of Serbia, Serbia
  • Mitchell Sugarman
    Sr. Director of Health Economics, Policy and Payment, Medtronic, USA
  • Jorge Wernli
    VP Global Pricing & Government Affairs at Vifor Pharma, Switzerland
  • Anita Burrell
    Head, Health Economics & Reimbursement PVD, Sanofi Aventis, France
  • Erin Huntington
    Corporate Affairs Director Elli Lilly Europe, UK
  • Oleg Borisenko
    Executive Director of Russia Society for Pharmacoeconomics Research, Russia
  • Joanna Lis
    Manager of Health Economics Dept., Sanofi-Aventis Group, Poland
  • Krzysztof Łanda
    CEO of HTA Audit, Poland
    Precursor and promoter of EBM/HTA/EBHC in Poland. Author and co-author of numerous papers on methodology, guidelines and systemic studies. Initiator of education and training activities in the field of Health Technology Assessment, including the EBHC Symposium.
  • Magdalena Władysiuk
    Vice-president of HTA Consulting, Poland
    An expert in EBM, HTA and PhE; author of numerous training programs and research analyses in HTA.
  • Katarzyna Bondaryk
    Hogan & Hartson, Poland

1. Discussion panel: need for decalogue for health care politician
This year discussion panel will raise questions concerning attitudes of health care politicians. Health care is a specially vulnerable area with tremendous impact on society and lives of individuals. If health care is so special in various aspects, maybe requirements from health care politicians and decision makers should be higher. Maybe could their attitudes be appraised due to a “Decalogue” or a special code of ethics? Should it be done up front and/or periodically?
2. Risk sharing schemes: objectives, methods, negotiations – public perspective
The number of risk sharing schemes increases systematically. This corresponds to growing expenses on health care, increasing expectations related to progress in medicine and necessity to ensure access to modern health technologies within limited financial means. Increasing awareness of health care consumers and pressure of manufacturers result in increased financial and political pressure on decision makers and/or payers. Thus socially secure methods to increase the range of offered health care services within the resources of basic health insurance must be sought for. The problem of equal access to health care services and just allocation of limited resources in health care becomes more and more socially sensitive, and politicians or decision makers must be prepared for the wrath of public opinion in result of their irrational choices. Risk sharing schemes (RSS) are practicable only if there is some risk for both sides: the regulator/payer and the manufacturer. The mechanisms specified in an appropriate agreement make each side take some risk of the other side. The most important risks of the regulator/payer include wrong reimbursement or pricing decisions, failure to exercise financial discipline or limitation of access to highly cost-effective technologies in result of reimbursement of a new medication. In addition, political risk related to unpredicted high social expectations, charges of unequal or unjust treatment of specific products (i.e. preference of particular manufacturers), or quite common accusations of discrimination of specific groups of patients must be taken into account. It should be stressed that RSS make it possible for decision makers to offer innovative health technologies within the basic package, at the same time maintaining control over budget expenses on health care. Risk sharing schemes may become a useful systemic tool, especially in mid-income countries, i.e. in our region.
During the first session problems related to risk sharing as perceived by the payer/insurer will be discussed.
3. Value of drug therapy and the role of HTA in risk sharing arrangements
From the industry perspective risk sharing schemes are agreements made in order to share possible costs (financial risk) associated with marketing of a new product. The higher are expenses associated with development of a new product and the smaller the target population, the higher is the manufacturer's risk. Decrease of risk may be finally different between the sides; it is therefore important to determine the risks during preparation for negotiations and development of reimbursement or pricing strategy. If the summary risk on each side could be quantitatively estimated, the RSS would allow for decreasing this risk to a small (e.g. 15%) or significant (e.g. 50%) degree.
The most common manufacturer’s risks (financial, political or legal) include:
  • failure to achieve reimbursement (radically lower sales income, lower return on investment, increased losses etc.);
  • achievement of reimbursement on unfavorable or less favorable terms (a lower limit, i.e. higher co-payment; placing of the product in a “jumbo group” on grounds of therapeutic substitution instead of generic substitution resulting in separate listing of the product; restrictive prescription criteria or introduction of a therapeutic program with strict inclusion criteria; limitations concerning initial treatment etc.);
  • apparent fiasco of pricing and reimbursement strategy – ineffective activity for the corporation;
  • many other risks, specific for particular circumstances on a competitive market.
During the session problems related to price regulation and risk sharing schemes will be presented from the pharmaceutical industry’s point of view. The presentations will discuss the scope and characteristics of agreements made, pricing strategies and negotiations.
Price agreements are based on health technology assessment, which makes it possible to estimate therapeutic value of a medication and adequacy of pricing with respect to therapeutic innovativeness. Negotiation strategies and risk sharing methods are secondary issues in relation to basic analyses – systematic reviews and cost-effectiveness studies. It must be stressed that risk sharing schemes may be considered not only in case of very expensive health technologies, but also in situations of significant uncertainty as to actual health benefit or the safety profile of an intervention, or costs related to treatments applied in common diseases. The risk associated with uncertain estimations applies to both the regulator/payer and the manufacturer. Analysis of efficacy and safety as well as economic and financial analyses make it possible (both for the regulator and the manufacturer) to assess therapeutic value of the product and its relation to the price as well as quality of available clinical and economic data. The lower is the uncertainty of estimation for the intervention and its comparators, the lower is the risk of making a wrong reimbursement or pricing decision for the authority, and the more rational is justification of the price for the manufacturer. One thing is sure – without high-quality clinical trials and proper health technology assessment correct evaluation of the actual therapeutic and economic value of a technology in relation to the optional methods of treatment is not possible. In such circumstances it is difficult for the manufacturer to propose a price adequate to health benefit, but – on the other hand – the decision maker must not be expected to agree without hesitation to reimburse the medication unconditionally at any proposed price. Decision on risk sharing between the payer and the product’s marketing authorization holder may be based on:
  • high cost of the technology under consideration,
  • unknown and difficult to predict target number of patients, in whom the technology may be used,
  • uncertain estimation concerning efficacy of treatment,
  • uncertain estimation concerning the safety profile (adverse effects underestimated or not reported in clinical trials),
  • differences between subgroups of patients with respect to efficacy and safety, entailing different cost-effectiveness of treatment depending on the patients’ characteristics,
  • high costs related to use of additional technologies (diagnostics, monitoring, necessity of combination treatment etc.),
  • resources in the state budget allocated for financing of health care services.
During the third session the role of HTA in pricing and price negotiations will be discussed. Examples of effective use of HTA analyses in risk sharing schemes will be presented. Special attention will be paid to evaluation of specific solutions with respect to optimization of drug policy or potential risk to proper functioning of the system.
4. Value of non-drug technologies – industry perspective
Although pricing policy in countries of Central and Eastern Europe has changed over the last years, there is still much to be done in order to fulfill demands of the EU Transparency Directive with this respect. Decision makers apply various methods for pricing of medicinal products on their home markets. Decisions concerning pricing of medications and medicinal products are often based on incomplete information concerning efficacy of a specific technology or algorithms difficult to implement in clinical practice. In such circumstances modern solutions of “financial engineering” concerning services financed from public means, such as: risk sharing agreements, conditional reimbursement (coverage with evidence development – CED) or – in a modified form – payback or price-volume agreements have an increasingly important role to play. These instruments are especially useful in case of medical devices, taking into account the fact that at the time of marketing of a specific product information concerning its efficacy may be very limited. This is due to requirements regarding necessary documentation, relatively less rigorous as compared to those concerning medicinal products, as well as difficulties associated with RCTs in case of such technologies (especially those used in surgery).
During the session possible solutions concerning assessment of therapeutic value and pricing of non-drug technologies as well as opportunities and threats related to specificity of non-drug technologies will be presented.
5. Developments of HTA in CEE countries
During the session recent achievements in the field of EBHC and HTA implementation in countries of our region will be presented. The situation with respect to development of HTA institutions varies considerably among specific countries of Central and Eastern Europe. Regarding common experience, not only in socioeconomic but also historical sense, exchange of experience concerning HTA practice seems especially valuable. On one hand, learning from each other’s experience can make it possible to avoid costly failures in a longer perspective; on the other, such exchange is helpful with respect to promotion of new, innovative solutions which may become our region’s own contribution to HTA development.
During the session a wide range of problems will be discussed, including solutions in organization of HTA agencies, creation of lists of reimbursed drugs, pricing policy and education in HTA/EBM. Representatives of HTA agencies, ministries of health and other institutions involved in HTA development have been invited to take part in this session.
6. Cost-utility thresholds vs efficiency frontier
The Institute for Quality and Efficiency in Health Care (IQWiG) in Germany is an independent scientific institute that assesses the benefits of health care services for patients. It was established on 1 June 2004 as a non-government and non-profit private law foundation, and is commissioned by the Federal Joint Committee or the Federal Ministry of Health.
So far in Germany, the assessment of drugs has been limited to their clinical benefit. IQWiG has presented a concept for cost-benefit assessment methods, called “Efficiency Frontier Analysis”. The methods are used to set the ceiling price for specific drugs that cannot be included in a reference price group. A ceiling price should be set for a superior health technology in a given therapeutic area. This is the precondition for enabling a decision as to which costs for which benefit are appropriate and reasonable for the community of citizens insured by SHI in Germany. It means also that in different therapeutic areas the different cost effectiveness thresholds could be set. Generally in most of European countries one cost-utility threshold are established for all technologies in health care system. During the session differences between the methods will be discussed including their advantages and disadvantages.
[ IQWiK, http://www.iqwig.de/iqwig-presents-a-concept-for-cost-benefit.738.en.html ]
The concept of “efficiency frontier” has been developed with the support of a group of international health economists. It can be used to compare the cost-benefit relation of any number of therapy alternatives. Health economists describe one intervention in comparison to another as being “efficient” if, at the same cost, it displays a higher benefit or is more cost-efficient at the same benefit. This „efficiency frontier” is presented graphically as a curve that joins the most efficient interventions. With the help of this graph, an appropriate price for a new drug (ceiling price) can also be described. Implication of the efficiency frontier, which is addressed only health technologies judged superior:
  • new “inferior”therapies have no place (even if less expensive than existing ones)
  • new “equivalent”therapies not assessed – price equivalence
  • effectiveness component must reflect IQWiG estimates.
For drugs that are more beneficial but more costly than those so far used, it can be determined where their price would have to lie so that the cost-benefit relation lies within the accepted efficiency range.
In January 2008 a consultation document on ‘the methods for assessment of the relation of benefits to costs in the German statutory health care system’ was published by IQWiG. Micheal Drummond with colleague have commented the methods to be used by IQWiG (please find the below the citation of conclusions).
“By imposing the restriction to only consider the efficiency of resource allocation within a therapeutic area and not across therapeutic areas IQWiG has maneuvered itself into a difficult position. This restriction makes it impossible to conduct economic evaluations to international standards and only allows the presentation of information which is of limited value to the decision maker and gives little guidance on how to decide on the introduction and pricing of medical technologies. Furthermore, by not considering the relative efficiency of interventions across different therapeutic areas it runs the risk of allowing clearly inefficient technologies or rejecting clearly efficient technologies. Finally, constructing the efficiency frontiers for each therapeutic area will consume many resources, only a small part of which would be needed to conduct a standard economic analysis, especially as available information on cost-effectiveness from studies abroad can be used. In summary, we are in full support of IQWiG’s efforts to conduct economic analyses but, unfortunately the methods currently proposed are not up to the task.”
[ Michael Drummond M, Rutten F The IQWiG methodology paper version 1.0 ]
7. Managed entry schemes
In Evidence-Based Health Care (EBHC) decisions should be based on valid analyses. Data collection and analysis should be aimed at reduction of the decision-maker’s uncertainty, especially with respect to reimbursement and pricing. Such decisions depend to a high degree on the results of economic analyses and their relation to the cost-effectiveness threshold assumed in a specific country. The results of economic analyses depend in turn on the results of efficacy and safety analyses, i.e. the quality and quantity of available data concerning efficacy and safety of the compared health technologies. Uncertainty of evaluations in this area is therefore of special importance as it increases the risk associated with reimbursement and pricing decisions, affecting both the manufacturer and the regulatory authority. Risk sharing methods, aimed at reduction of the risk associated with uncertainty of the estimations through continuous collection of additional data from ongoing trials, include so-called Managed Access Schemes (MAS), and among them: "Coverage with Evidence Development" (CED), "Only in Research" (OIR) and "Conditionally Funded Field Evaluations" (CFFE) methods.
The methods listed above are based on conditional reimbursement, i.e. it is assumed that accumulation of additional data within a period of time specified in the agreement will allow for verification of the reimbursement decision and/or the product price. It is assumed that data accumulated with time will allow for reduction of the uncertainty of estimation and therefore for an unequivocal reimbursement decision and pricing of the product, adequate to the achieved benefits. Accumulation of data may be based on observational studies (including registries) as well as additional randomized trials; costs of such trials may be incurred either by the regulatory authority or the manufacturer, or they may be shared between the parties according to a specific agreement.
One of the main objectives of conditional financing is to support innovativeness and technological progress through partial reimbursement of expenditure associated with the research and development process.
8. Scoping
The penultimate session of the 4th Symposium will focus on defining of decision problems (scoping). In decisions concerning health care there should be no room for personal, random or subconscious choices. Each decision entails extremely serious consequences. Making a decision without proper analyses or feasibility studies regarding optional solutions is a common mistake. On the other hand, available analyses are sometimes inadequate for decision making. Their scope may be incomplete, analysis wrongly directed, applied analytical tools may leave much to be desired and the conclusions drawn may not answer the decision maker’s questions. As to reimbursement or pricing, evaluation of each health technology should be precisely directed a priori, so as not to become unrealistic or irrelevant to decision needs. These decision needs must therefore be determined before the analysts begin to collect or synthesize data. Guidelines concerning health technology assessment implemented in specific countries represent different ways to high-quality HTA analyses. According to updated Polish (AHTAPol) guidelines, based on those published by the NICE, scoping plays an important role. It must be stressed that definition of a decision problem is not just a description of optional health technologies and the indication, but a foundation for their credible and – in the first place – useful assessment. The scope of comparison is usually defined using the PICO (population, intervention, comparator, outcome) formula. In addition, specific subpopulations, in which a particular technology may be especially cost-effective, specific circumstances, in which an intervention is used, current practice, a time horizon, longer than that of clinical trials, in which costs and benefits are evaluated, or a part of the guaranteed benefit package, in which the technology under consideration will be placed, should often also be taken into account.
During the whole session theory and practice of defining of decision problems in health technology assessment will be discussed.

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