PANEL I

The Value of Innovation in Decision Making

Tanja Novakovic

Central and Eastern European healthcare providers face a wide range of unique and difficult challenges which must be addressed in order to meet the ever-growing demands and expectations of their services. A key challenge is to achieve and maintain the quality of healthcare including new innovative technologies within constrained budgets, which requires optimal distribution of limited resources.

From 2010, 139 new medicines were registered in EU, of these; Bulgaria reimbursed 44, Croatia 27 and Serbia only 1. After 5 year of waiting in Serbia, Managing Board of the NHIF made decision to incorporate 23 innovative drug on the positive Drug List, 18 drugs will be put on the list with Managed Entry Agreements and the remaining five drugs intended for the treatment of children will be reimbursed without limitation.

After several years of limited decision making and stalled discussions at what point is budget more important than saving and improving lives?

Managed entry agreements as an instrument to facilitate access to new

medicines – The experience of Central and Eastern European countries

Alessandra Ferrario

Managed entry agreements (MEAs) are a set of instruments countries worldwide are increasingly implementing to improve access to new medicines. They do so by reducing the impact of high-prices, uncertainty around effectiveness and use in real-life on coverage decision. Studies have shown that they are widely implemented in Western Europe, Canada and Australia but less evidence is available on Central and Eastern Europe. This presentation will provide the latest findings of a comparative study on the implementation of MEAs in Central and Eastern Europe. Issues of definition of MEAs, administrative burden of their implementation, price transparency and the need for a monitoring framework to evaluate their impact will addressed in the presentation and further discussed in working groups.

Managed Access to Health Care and Medicines

Bojan Trkulja

There is a general belief that Managed Entry Agreements (MEA) are a solution in markets where reimbursement is challenging and negotiation is not possible. Serbia has just started to gather experience with MEA and it is therefore very important to properly make those first steps as a foundation for even more successful application in the future.

By definition, MEA is an arrangement between a manufacturer and payer/provider that enables access to a health technology subject to specified conditions. These arrangements can use a variety of mechanisms to address uncertainty about the performance of technologies or to manage the adoption of technologies in order to maximize effective of their use, or limit their budget impact. MEAs can be broadly divided into two subtypes – financial based and outcome based agreements, but in order for MEAs to be truly successful, several principles must be implemented:

• Keep it as simple as possible to avoid substantial compliance costs and the potential for unintended consequences
• There needs to be clarity on what the MEA is trying to achieve, whether this relates to evidence on clinical outcomes, the population size, the offsetting costs, the overall budget or the cost effectiveness of the medicine at the list price
• Appropriate type of MEA should be chosen, taking into the account all of reasoning mentioned in the previous bullet
• Implementation should be tailored to the specific country, disease and product needs
• Last but not least, successful use of MEAs requires trust between all parties

RMD (Reimbursement Mode for Development) – HTA-related enhancement tool for industrial investments in a given country

Krzysztof Łanda

ICUR (incremental cost-utility ratio) is the most important criterion on reimbursement in EBHC in developed countries. Countries compete in order to attract pharmaceutical and medical devices companies to invest in a given territory. Some countries do better and some worse. In order to improve chances for success in the competition it is possible to use resources for reimbursement in another way, not only to purchase goods or drugs but also to attract companies to invest in production and R&D. There is a simple idea to improve chances of success in reimbursement if a company has become a partner of economy of a given country. It is feasible to multiply effective cost of a new technology by the RMD factor while assessing its cost-utility against comparator. Such developments are pending in Poland.

PANEL II

The Role of Patient Registries in Access to Medicines and Health Care

Jaroslav Duba

Since 2008 in Czech Republic all medicines, reimbursed from public healthcare, must past through proceedings guided under the law what makes system predictable and transparent despite the time and procedural complexity. Originator products or in case of new indication, it is obligatory to submit data from clinical trials as well as cost-effectiveness (CUA) and budget impact analyses (BIA) and Real-World Evidence (RWE) data become to be critical input.

To obtain RWE data is not always easy but Czech Republic has big advantage and ahead start compared to many other countries mainly due to the following facts: (1) there is legally enshrined free access to public information, (2) during past decade there was boom of registries and since 2016 some of them became to be part of “National Healthcare Information System” under MoH, (3) RWE data is requested by SUKL and payers and considered as relevant source.

The main sources of RWE data are: registries owned by medical associations or HC providers (several tens); data from payers (7 payers); data from HC providers (several hundred); data collected by MoH upon the obligation under the law (currently 21 national registries). Except introduction of wide RWE platform which can be exploited internationally, the aim of the presentation is to introduce to participants the detailed content of National Oncology Registry (since 1976); registry for rheumatoid arthritis ATTRA (since 2002); registry for psoriasis BIOREP (since 2005) and National Registry for Diabetes (key strategic registry stablished by MoH in 2016).

Linking Managed Entry Agreements to Health Technology Assessment

David Danko

Policymakers in Central and Eastern Europe and the Middle East often ask the question how managed entry agreements (MEA) and health technology assessment (HTA) are related, whether they should be implemented together or separately. The short answer is that although HTA and MEA’s serve different purposes and can very easily exist without each other, MEA’s can indeed be used to mitigate clinical and economic uncertainties related to the health technology which the HTA process has revealed. MEA’s can be used to ‘improve’ the cost-effectiveness or to alleviate the budget impact of a health technology—many patient access schemes (PAS) in the United Kingdom serve this purpose through relatively simple arrangements.  In a more complex patient-level and/or outcome-based forms, MEA’s can serve to bridge the gap between clinical efficacy and real-world effectiveness. For HTA and MEA’s to optimally support each other, the pricing & listing decision process must be constructed in a way that HTA captures relevant uncertainties so that MEA negotiations can be seamlessly connected to, or even integrated into, the technology assessment and appraisal phase. This of course enhances the role of deliberative element in the decision process and is likely to introduce a negotiating element into it. The presentation will investigate into the possible ways of linking MEA’s to the assessment and appraisal process and highlight some conceptual and methodological questions that must be answered.

PANEL III

Reform of Health Care Financing

Simo Vukovic

During the last decades major reforms of health care systems have been implemented in almost all European countries. Concerning the inpatient sector, these reforms were in most cases combined with the introduction of diagnosis-related group (DRG) systems.

Prolonged health care reform in Serbia has had as a result lack of effects on increasing of efficiency, quality and transparency. One of the key reasons was unchanged, historical way of public hospital financing.  During 2017 , within the Second Serbia Healt Project ( loan of World Bank), MoH started with implementation of DRG which comprised all public hospitals, Health Insurance Fund  and Public Health Institute . The introduction of per case payments through DRG system represents a major change in the way that  Serbian hospitals will be paid. Payment rates will be fairer and will consequently increase the distinction between well-managed and poorly managed hospitals. The new payment method may have more effective ways of auditing and introduction of new types of payment for intensive care and non-acute inpatient care and  increase complexity and fairness od pyments. Hospital’s revenue will more closely reflect the cost of good care. DRG-based reimbursement system will be introduce to control healthcare expanditure, increase activity levels and standardise care. DRG system will provide valuable data for the analysis and comparson of hospital performance accross the whole hospital system. DRG implementation also means creating prices based on the costs of cases treated by hospitals, which entails costing and data collection and development of a refernce price and DRG price list.

The public economics consequences of health and investments in healthcare

Nikos Kotsopoulos

Changes in health status have economic costs that can extend beyond the health service. Previous studies have indicated that poor health in working aged adults, and similarly with children who represent future workers, represent the major costs of ill-health to government. For example, a study by

the UK government reported non-health costs £62-76 billion annually (2007) of which £29 billion was workless benefits and £28-36 billion in lost tax revenue from poor health. The health sector costs included in typical NICE type cost-effectiveness analysis represented only 8-15% of total government costs.  These figures suggest a “government perspective” framework that accounts for transfer costs and lost tax revenues might be more suitable for informing the benefits of healthcare in tax finance public health systems. To address the value of health and healthcare investments for government, we have developed a fiscal health analytic framework that captures how changes in morbidity and mortality influence tax revenue and transfer costs (e.g. disability, allowances, ongoing health costs). The framework can be used to evaluate the marginal impact of discrete investments or a mix of interventions in healthcare to inform governmental budgetary consequences. In this context, the framework can be considered as a fiscal budget impact, and/or cost-benefit analysis model that accounts for how morbidity and mortality linked to specific programs represent both ongoing costs and tax revenue for government. Several examples applying the public economic impact of vaccines, women’s health, and behavioral disorders will be discussed. Applications of the fiscal modelling approach will be discussed and implications for allocation decisions based on public economic consequences and priority setting will be discussed.

Personalized medicine: equity and accessibility

Antony P. Martin

Personalised Medicine (PM) tailors care for each individual patient based on clinical, environmental and genetic information.  PM offers to revolutionize healthcare by ensuring the ‘right treatment, for the right patient, at the right time.’ The aim is to improve the effectiveness of treatments whilst simultaneously reducing side effects, avoid inappropriate treatment and prevent the need for a trial-and-error approach to medical care. However, the PM revolution has also raised important legal, ethical and social questions that need to be explored, particularly related to the criticism of contributing to widening health disparities.

While significant medical advances have been made across therapeutic areas, inequities remain in health outcomes according to sociodemographic, psychosocial and other factors. Minimizing modifiable health disparities is deemed fundamental for an equitable and progressive healthcare system. There are concerns PM may be taken up less quickly and in lower numbers in different populations due to challenges in access, ability to pay privately, availability and understanding of healthcare information. Moreover, the translation of genomic research may also be hindered by insufficient study participation across diverse racial and ethnic populations.

Proponents accept that deprived populations may temporarily suffer lower initial access but argue that PM will eventually become accessible. However, history has shown that some health disparities take years to rectify and concentrated efforts are required for remediation. Therefore, monitoring how PM work across different groups is paramount to ensure that beneficial aggregate population effects do not conceal widening disparities. Further, initiatives are required to redress any imbalances that widen the equity gap.