Managed Entry Agreements (MEAs) are contracts between pharmaceutical companies/ technology firms and healthcare payers, to establish the conditions for coverage and reimbursement of new medicines/new health technologies. The aim of these agreements is to manage the uncertainty related to the performance of these new therapeutic options, once they are available in the market, maximising their use with the least budget impact possible for the patients.
According to an organisation for Economic co-operation and development (OECD) survey, by 2019, at least 28 of 41 countries that are members of the OECD and/or the European Union were or had been using MEAs. Depending on the country, different terms of MEAs have been established, representing the different policies or nature of agreements across the EU. In Spain most of the deals are risk-sharing agreements, while in Portugal they can be found by the name “price-volume agreements”, or “outcome-guarantee” and “evidence development agreements”. Other widely used terms are “special pricing arrangements” or “patient access schemes”.
Two categories of MEAs have been broadly used around the EU: financial agreements address concerns of the payers around the budget impact of the new medicine or technology, adjusting product prices when necessary. On the other hand, performance-based agreements make financial effects for payers conditioned by the performance and the outcomes of the new healthcare products, creating a link between the cost of the product and the therapeutic value that it actually has on patients.
One would expect that MEA-related information, such as data of how the performance of a drug is measured, or the outcomes of studies conducted under performance-based agreements, would be available for the public to access, as withholding such details certainly raises concerns. However, very little sharing of information currently exists. In Germany, until today, no details about such agreements have been disclosed. In Belgium, all MEAs include a confidentiality appendix, while in the Netherlands no database about MEAs is currently available. According to Stemer et al (2017): “Little is known to which extent MEAs are used in Austrian hospitals to address the increasing budget impact of high-priced medicines’. A Swiss report states that by 2020, 20 MEAs had been negotiated in Switzerland, but they were all kept confidential. In 2017, an overview of the Swedish healthcare system, published by the WHO, offered information on some MEAs of 2016. However little is known regarding the recent Swedish agreements. In Portugal, according to Ferrario et al (2013), a 2012 survey found 84 MEAs, but once again no data on MEAs have been recently disclosed. Italy and the UK, have been the only EU countries that have published records with detailed information on these agreements.
In recent years most of the EU countries are part of the EURIPID collaboration, a database for the pricing and reimbursement of medicinal products, including MEA-related information “if this information is publicly available”, that dates back in 2017. Access to this database is restricted to the experts of the national competent authorities of the participating countries, as well as researchers from the academic sector. According to its website, the main goal of this collaboration is to enhance pricing transparency. EURIPID states that it has taken concrete measures in that direction, by establishing for example the EURIPID Stakeholder Dialogue Platform, or working closely with the OECD and the WHO, and being in discussions with the European Medicines Agency.
There is no doubt that international sharing of data would be greatly beneficial for healthcare payers and would certainly interest stakeholders with legitimate incentives, as well as the general public. Other countries’ efforts could serve as examples on predicting outcomes, especially when it comes to trials with small patient populations or diseases that have not been yet studied extensively, such as several rare diseases. Enhancing the information flow would certainly help in reducing duplication of work among countries, and help predicting the total cost of investing in a specific treatment. Very importantly, a higher level of transparency is a requirement for obtaining fairer prices for patients.
Despite the EURIPID’s efforts on increasing access to MEAs, the findings of a EURIPID survey itself presented in a recent study of Russo et al (2021) suggest that the progress that has been made to improve the medicines’ price transparency across countries is currently very limited. According to the investigators, the next steps could include the achievement of better collaboration among EU countries, in the form of “international institutional engagement”.
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Sources
https://www.eversana.com/2020/08/25/switzerland-cost-containment/
https://www.sciencedirect.com/science/article/abs/pii/S0168851021001652
https://euripid.eu/activities/
https://www.oecd.org/health/health-systems/pharma-managed-entry-agreements.htm
https://www.aifa.gov.it/comunicazioni-managed-entry-agreements-mea-1
https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit