Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries

doi:10.1016/j.healthpol.2018.01.006

Health Policy

Volume 122, Issue 3, March 2018, Pages 230-236

https://doi.org/10.1016/j.healthpol.2018.01.006 Get rights and content

Highlights

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In countries in CEE the main role of MEAs and other related policies is to limit the budget impact.
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Uncertainty about outcomes and appropriate utilization seem to be of lower priority in CEE’s.
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Finance-based MEAs are used by all CEE countries reviewed.
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There is limited transparency on the details of MEAs in the CEE countries reviewed.

Abstract

This paper aims to provide an overview of the rationalization strategies for the introduction and use of pharmaceuticals, focusing on the role of managed entry agreements (MEA) in Central and Eastern European (CEE) countries, namely Bulgaria, the Czech Republic, Croatia, Hungary, Poland and Romania. We developed a conceptual framework on MEAs that was used as the basis for a standardized assessment questionnaire sent to country experts to capture their perceptions on their countries’ rationalization strategies and MEAs. Our study shows that the main role of MEAs and other related policies embedded in the health care system is to limit the budget impact of drugs in all examined 6 countries. Uncertainty about outcomes and appropriate utilization seem to be of lower priority. Finance-based MEAs are used by all countries. Performance-based MEAs are scarce and used to a limited extent by Hungary and Poland. The overall transparency of the existence and details of MEAs is limited. Expansion of the use and increased transparency of MEAs is recommended. Still, the informational infrastructure and competencies in implementing MEA’s need to be developed further.

Introduction

Safety, efficacy and quality of manufacturing are mandatory for all new drugs [[1], [2], [3]]. The reimbursement from public finances is linked to discussions on cost-effectiveness, financial risk-sharing and solidarity [[4], [5]]. Likewise, the quality of usage of medicines is an important prerequisite for effectiveness [[6], [7]] and the public payer-purchasing price should contribute to fiscal sustainability [[6], [8]]. Consequently, we believe these four focal points of regulation and governance are inter-related and overlap as is illustrated in the Venn-diagram we developed for this study, to help positioning our topic: managed entry agreements (MEAs) (see Fig. 1).

Decisions on pharmaceuticals reimbursement from public finances (via social health insurance or a national health service) are the competence of individual European Union Member States. To support decision making, in many European countries, health technology assessment (HTA) was introduced to assess the value of (new) drugs. Over the past two decades, HTA has become strongly institutionalized and fine-tuned as a way of informing decision making on pharmaceuticals reimbursement from public funds.

The topic of outcomes observed in routine practice of the reimbursed drugs, has been addressed increasingly over the past decade. It is not uncommon for the clinical efficacy shown in clinical trials not to be confirmed in less controlled real life situations. There can be a difference between the outcomes promised in clinical trials (efficacy) and what is happening in daily clinical practice (effectiveness) producing less value than predicted as part of the decision making on re-imbursement and hence a potential waste of resources [9]. This led to stricter HTA appraisals and the search for real-world evidence to reveal the true health outcomes in daily clinical practice. Therefore, governments began to implement new mechanisms (e.g. patient registries) for assessing effectiveness and hence assuring value for money.

Still, the HTA approaches put in place by European countries cannot guarantee financial sustainability. The public payer-purchasing price is under pressure to be decreased, especially in the aftermath of the 2008 economic crisis, when there was an overall decrease in spending on health care with a relative stronger decrease in spending on pharmaceuticals [10].

Existing HTA approaches showed their limitations in providing the desired financial sustainability and addressing the right set of evidence countries are looking for. One recent example is the debate in the United Kingdom around the reimbursement of the latest hepatitis C treatments. Despite NICE’s long-standing approach of cost per QALY, the reimbursement of the latest hepatitis C treatments is strongly questioned on budget impact grounds [11] and government financial sustainability.

More recently, countries started to struggle to find regulatory and governance strategies for limiting public payer-purchasing price and linking it realized outcomes in routine practice. The natural step was to design new policy interventions for reducing the acquisition price deals (financial-based MEAs) and sharing the financial risk(outcome-based MEAs) amongst the producers of the drugs and the governments or purchasing bodies acting on their behalf [12].

Within this context, the managed entry agreements (MEAs) have been developed. A first definition of the concept was provided in 2011 by Klemp et al. [13]. According to Ferrario et al. [14], a MEA is a tool that aids governments to share the financial risk, implemented as formal arrangements between payers and manufacturers in different shapes (e.g. price-volume agreements, discounts, coverage with evidence development).

Ferrario et al. stress that the main goal of MEAs is to manage uncertainty (or risk) for the payer of unexpected performance of a new medicine. A drug may under-perform and prove less effective than expected.

In the context of existing governance initiatives taken by countries, MEAs can be seen as a government policy strategy enabled by a contractual relationship between a manufacturer and payer/provider that allows reimbursement/coverage from public funds of a drug subject to specified conditions. These arrangements can be shaped as different policy interventions to address uncertainty about the performance of pharmaceutical products or to manage the adoption of pharmaceutical products in order to maximize their effective use, or limit their budget impact. Contrary to Klemp, we consider a MEA to be a policy strategy rather than an arrangement. The foundation of a MEA should be a bilateral contractual agreement between the manufacturer and the payer.

In terms of reimbursement, HTA as a formal part of reimbursement decision-making is still under development in Central and Eastern Europe (CEE) and does not seem to be extremely strong or to gain power [15]. Addressing the concern on the public payer-purchasing price and effectiveness is the next step in the adoption of new pharmaceuticals, by moving forward to regulatory and governance models for financial and outcome risk-sharing, i.e. managed entry agreements.

In this light, our paper has two research questions. Firstly, we aim to find out what is the role of MEAs in CEE countries and the extent of their use. Secondly, we want to find out which drugs are subject to MEAs and to see whether there is a match or not with the ones in Western Europe.

We selected six CEE countries: Bulgaria (BG), Croatia (HR), the Czech Republic (CZ), Hungary (HU), Poland (PL) and Romania (RO). While these countries differ in many respects (e.g. GDP, health spending per capita, organization of health systems etc.) [16], traditionally many policy innovations have diffused to CEE later than in countries of Western Europe (see for instance the limited use of HTA in CEE). It is therefore valuable to see to what extent and how CEE countries adopt and adjust the very recent practice of MEAs.

Section snippets

Methods

The research questions were explored by developing a framework to conceptualize the kind of objectives countries are trying to achieve through MEAs, based on the types implemented (see Fig. 2). It is built on the taxonomy proposed by Ferrario et al. and maps the role of MEAs in six CEE countries, based on their typology. Subsequently, the conceptual framework was turned into a standardized questionnaire (see Appendix 1, Supplementary material) with general and specific questions, to assess the

Results

All CEE countries under review are using MEAs as a policy tool for the rationalization of introduction and use of pharmaceutical products. Also, significant steps have been made in the past 5 years in embedding in the decision-making process specific guidelines and regulations. Nevertheless, there are significant differences among our sample of countries. Table 2 summarizes the main features.

Table 1a highlights the reported policy goals targeted by the CEE countries when applying reimbursement

Discussion and conclusion

MEAs have been gradually introduced in all six CEE countries studied in the past decade as a government policy intervention when reimbursing pharmaceuticals from public funds. The first MEAs were put in place in Hungary in 2005, followed by Romania in 2008. At that time, Romania had no legal framework for such agreements. Therefore, the implementation of MEAs is not conditional to a pre-set legal framework. Still, important steps have been made by CEE countries to embed MEAs in their health

Conflict of interest statement

Alexandru M. Rotar: The view is strictly the personal point of view of the author and it does not reflect the position of Takeda Romania, where he acts as an employee. Alin Preda: The view is strictly the personal point of view of the author and it does not reflect the position of Pfizer Romania, where he acts as an employee. Olga Löblová: Olga Löblová has carried out remunerated consultancy activities for A&R Partners, Baxter AG and Instytut Arcana. Vanesa Benkovic: The view is strictly the

Acknowledgement

Olga Löblová’s research for this paper was partially financially supported by the International Visegrad Fund, grant no. 51400781.

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Cited by (20)

Goals and methods of managed entry agreements – can we get what we want?
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We aimed to examine managed entry agreement (MEA) methods and their relation to nationwide drug reimbursement policy goals in the context of the Hungarian health care system.
First, a targeted literature review was performed that identified the most relevant MEA methods and drug reimbursement goals. Then, by using the findings of the review, a survey was developed: the first part of the survey aimed to ensure that interviewees have similar understanding of different types of MEAs and related policy goals; in the second part the interviewees were asked to prioritize drug reimbursement goals and indicate their perception about the impact of MEA techniques on the reimbursement policy goals.
Three groups of MEA techniques were identified: cap type, clawback type and rebates or free treatment doses. Six policy goals were identified: cost containment, reduction of uncertainty of effectiveness, sustainable finance, patient access improvement, cost-effectiveness improvement, handling administrative burden. None of the MEA techniques showed clear advantage over all others. Cost containment, improvement of patient access and reduction of uncertainty around effectiveness were ranked as most important drug reimbursement goals. Cap type agreements were deemed to uniformly support the policy goals of cost containment and sustainable financing. Clawback type agreements strongly support cost containment policies. Rebates and free treatment dose(s) methods had positive impact on four policy goals.
The implementation of managed entry agreements shall be considered and motivated by pre-defined drug reimbursement policy goals. During the application of MEAs, setting priorities and making trade-offs between different policy goals are inevitable.
Reimbursement and payment models in Central and Eastern European as well as Middle Eastern countries: A survey of their current use and future outlook
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The results are in line with previously reported findings from CEE and ME countries and Western countries, where various studies confirm that finance-based reimbursement models and upfront payments are currently applied more often than outcome-based reimbursement models and delayed payments.8,27,39–42 Ferrario et al. showed that the most common managed entry agreements (MEAs) in CEE countries are confidential discounts, a conclusion that was also found by Rotar et al. where finance-based MEAs are used frequently but performance-based MEAs are scarce and used to a limited extent in CEE countries.28,38 Similar results are shown for ME and North African countries.
There is growing interest in innovative reimbursement and payment models in Central and Eastern European (CEE) and Middle Eastern (ME) countries. A questionnaire was sent to payers from CEE and ME countries regarding the current use of, future preferences for and perceived barriers with these models. Twenty-seven healthcare payers from 11 countries completed the survey. Results showed participants preferred using outcome-based reimbursement models and delayed payment models more often; however, currently they are rarely applied. Barriers hindering implementation were mostly related to IT and data infrastructure, measurement issues, transaction costs and the administrative burden. Given these barriers highlighted in our study, policymakers should focus on the development of an implementation framework with contract templates for the preferred reimbursement and payment schemes to aid the feasibility of a successful implementation.
Stakeholder views of managed entry agreements: A literature review of national studies
2021, Health Policy OPEN
Citation Excerpt :
The domains defined in the study were respondent characteristics, disease areas, drug and disease attributes, accessibility of data, mechanisms for payment and reimbursement, critical components, payer satisfaction/ dissatisfaction, manufacturer and third-party facilitation and contract templates. The questions used in most of the studies assessed the objectives [12,14,15,20,23,26,28], strengths/ weaknesses [7,11–14,16,19,21–23,25–28], types of schemes [4,13–21,25–27], contract framework [11,12,14,15,17,18,20–22,24,25], administrative burden [12,14,19–21,25,27] and its' future implementation [7,12–14,22,26–28]. Some of the less common questions addressed issues related to the role of respondents in the design of MEAs, choice of decision-makers who should be involved in the MEAs related decision making, individual roles and responsibility of health and pharmaceutical organization personnel in implementing MEAs, type of changes or improvement noted, monitoring of MEAs and its’ impact.
Access to highly expensive and innovative medicine is a challenge. Managed entry agreements/ arrangements (MEAs) consist of various forms of confidential agreements between pharmaceutical manufacturers and payers (hospitals, social insurance), which are mainly negotiated when there is uncertainty of the actual clinical benefit of the medicines, but high public expenditures are required. Continued and expanding use of these schemes requires a greater understanding of payer perceptions, experience, and orientation towards their current and future use. This literature review aimed to identify the stakeholders’ concerns with regards to MEAs. A total of 20 articles were identified between 2007 and 2018. MEAs are mostly studied in the first world countries, whereas limited documentation is available for other nations. The reasons for rejection of proposed MEAs could possibly be related to existing low-cost effective treatments, lack of trust between stakeholders, high administrative burden and if the authorities believe they are funding the substantial proportion of the drug’s development cost. Lack of well-designed and easy-to-use data collection methods for MEAs has an impact on the evidence generation. Most articles highlighted the lack of transparency of the agreements which may not benefit other health systems, especially for systems that are dependent on international referencing price. Stakeholders also identified the lack of expertise in assessing the pharmacoeconomic and health outcomes data and challenges in assessing risks up-front due to the complexity of the real-world data. Lack of transparency in most health systems are also a hindrance to further understanding and confidence in the MEAs. However, the views of the stakeholders may also evolve with experience. Though there are challenges in the designing and implementation of MEAs, close networking, improved human capital development especially in the area of health technology assessment and health economics would be able to close the gap in the implementation.
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In terms of decision-making for reimbursement, health technology assessment (HTA) is still under development and MEAs are used within different mechanisms of the healthcare system, such as prescription guidelines and disease budget caps. The study concludes that the type of MEAs most frequently used in central and eastern Europe are financed based agreements, including discounts, and performance-based agreements are limited [8]. On the contrary, performance-based agreements in the form of coverage with evidence development are specifically linked to the development of MEAs in the Netherlands.
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The aim of the study was to review existing agreements, describe the type of uncertainty dealt with, and to analyze incentives created using the literature on performance-based reimbursement schemes in Sweden.
A document review of all agreements made in the period January 2015 to August 2019 was conducted, classifying agreements by the type of uncertainty dealt with.
Agreements were made for 56 products during the studied time period (45 ongoing), mainly in the fields of hepatitis C (n = 10) and oncology (n = 14). Uncertainties addressed in ongoing agreements included size of treated population (10), treatment duration (13), and effectiveness (9). The mechanism for risk-sharing was limited to refunds based on patient numbers, duration or just flat-rate refunds. The estimated refund in 2018 was 50 % of total sales.
This review show that the main driver behind risk sharing in Sweden so far have seem to be affordability rather than managing uncertainty.
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View full text

Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries

Highlights

Abstract

Introduction

Section snippets

Methods

Results

Discussion and conclusion

Conflict of interest statement

Acknowledgement

Health Policy

Health Policy

The European regulatory system for medicines and the European Medicines Agency – A consistent approach to medicines regulation across the European Union

Commission staff working document? Pharmaceutical industry: A strategic sector for the European economy

Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality

Value in pharmaceutical pricing, OECD health working papers, No. 63

Adherence to long-term therapies – evidence for action

Consequences of intermittent treatment for hypertension: the case for medication compliance and persistence

American Journal of Managed Care

The impact of non-compliance on the cost-effectiveness of pharmaceuticals: a review of the literature

Health Economics

Health at a glance: Europe 2012