EU risk-sharing agreements between 2000−2015

Submitted: 20 June 2018; Revised: 14 August 2018; Accepted: 18 August 2018; Published online first: 31 August 2018

The ageing population, longer life expectancies, and the increasing cost of drugs are expected to significantly increase the burden on healthcare systems in the coming years. To reduce this burden and increase access to new, innovative and effective drugs in the European Union (EU), risk-sharing agreements (RSAs) between national healthcare payers, health technology assessment (HTA) agencies and the pharmaceutical industry, have been put in place. A recent study published in PharmacoEconomics – Open [1] explores RSAs in the EU from 2000–2015. It shows that during this period there was increased interest in, and uptake of, RSAs and discusses the reasons for this increase.

Risk sharing agreements to facilitate universal access to medicines

In the EU, near universal healthcare coverage is the norm and budgets are limited. To ensure universal access to new, innovative and effective drugs at an acceptable and manageable cost, innovative approaches to pricing and reimbursement of drugs are needed. Pharmaceutical manufacturers are increasingly expected to demonstrate the real-world value for money of their products. Their attempts to demonstrate value are often assessed by HTA agencies, but generally, there are limited data available on products at the time of launch. This means that HTA decisions can be slow, meaning manufacturers can lose out financially and/or payers are left only able to access more expensive and less effective medicines. To address this problem, at the time of launch when the value of a new or innovative medicine is not fully understood, national healthcare payers, HTA agencies and the pharmaceutical industry, have formal agreements by which they share the financial risk associated with the medicine’s launch and introduction. These are called managed entry agreements (MEAs); which are most commonly referred to as RSAs.

An extensive literature review the history of RSAs in the EU

Over the last 15 years (2000 to 2015), an increase in RSAs has been reported. By carrying out a systematic literature review, researchers at the University of Copenhagen in Denmark and Ghent University in Belgium have identified the underlying trends in RSAs that took place in the EU during this time. To do this review, Trevor Piatkiewicz of the University of Copenhagen and first author of the paper, looked at ‘grey literature’ from Google, Google Scholar, and the official websites of international organizations such as the World Health Organization (WHO), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the Organization for Economic Cooperation and Development (OECD) to create a list of keywords that could be used to identify relevant peer-reviewed articles. Once the keywords had been defined, Piatkiewicz used them to identify peer-reviewed articles about RSAs published between 2000–2015 by searching some commonly used databases (PubMed, Scopus, Web of Science and Embase). All articles that were included in this review were published in English and were conducted or published in and/or about EU Member States. In addition, only agreements or schemes relating to pharmaceutical products and/or involving the sale of pharmaceutical products were included, and only if the title of the article included or alluded to at least one of the keywords selected to indicate the content of the article was relevant to the objective of the review. There were also a number of exclusion criteria that are laid out in detail in the paper.

Potentially relevant articles found in the literature search were then divided into two groups, ‘quantitative articles’ which were used to explore changes in the level of interest in RSAs, and ‘qualitative articles’ which were used to explore the underlying reasons for the changes.

The literature screening enabled data from 238 scientific articles published between 2000 and 2015 to be extracted. Of these, 100 were said to contain quantitative data of interest and 138 qualitative data of interest. Overall, the literature search and evaluation showed that there has been a rise in the number of publications related to RSAs during this period. Piatkiewicz and co-authors Marie Traulsen and Tove Holm-Larsen, found that the increase in the number of publications related to RSAs was particularly significant between 2014–2015, which they attribute to an overall increased interest in, and knowledge of, RSAs.

Four key factors which influenced RSAs over time

A qualitative analysis of the articles was used to identify information about possible underlying reasons for the fluctuations in the yearly number of articles published between 2000–2015. Four overall themes emerged that appeared to influence interest in RSAs over time. These are summarized as follows:

1. 2000–2007: A push for value-based pricing (VBP)
During the early 2000s, across Europe there were increasing demands for VBP made by national healthcare payers. Publications on the subject during this time generally reflected VBP policies discussed by the UK and many articles questioned the necessity of such schemes.

2. 2007–2009: The economic crisis and a greater push to contain costs
Following the economic crisis of 2007–2008, healthcare resources came under increased stress and across Europe budgets were cut. Healthcare providers and HTAs became more concerned with cost-effectiveness and the budget impact of product approvals. Pharmaceutical companies experienced increase pressure to ensure the value of new drug products. Many countries implemented cost-containment strategies to reduce the price of new pharmaceuticals. The economic crisis during this time period pushed VBP implementation and ended the era of free pharmaceutical pricing in Europe. In addition, HTAs started to play an ever more important role as intermediaries between healthcare providers and pharmaceutical companies. These actions prompted an increase in reporting and discussion of VBPs, as has been reflected in an increase in publications during this period.

3. 2009–2011: General discussion about RSAs
From 2009–2010, there was a spike in the number of qualitative articles discussing the pros and cons of European RSAs. Schemes that had been introduced in preceding years were analysed, discussed and criticized. With the increased level of interest in RSAs, came valid arguments and questions surrounding their use. This resulted in a steady increase in the overall number of publications on performance-based schemes.

4. 2011–2015: RSAs diversified to be fit for purpose
Between 2011–2015 a steady increased interest in, and discussion of, RSAs was maintained. This is reflected by the increasing number of publications discussing RSAs during this time. Many existing schemes were adapted and developed across Europe and were made fit for purpose. Many studies noted there is no ‘one size fits all’ approach to RSAs that can be adopted, and each situation should be addressed individually, from both a country and product perspective. The total number of schemes reported plateaued between 2011–2013. Many existing schemes were adapted during this period, rather than new ones being created.

Overall, the review identified several countries that have had a major influence on RSA development and uptake between 2000–2015. These include France, Germany, Italy and the UK, although Eastern European nations began to play an increasing role in the latter years. Each country within the EU has adopted different strategies and developed different relationships with HTAs, which have led to noticeable differences in drug benefit evaluations, recommendations, and overall access to EU markets.

The uncertain future of RSAs

The review showed that increased reporting on pricing and reimbursement practices across the EU has led to an improved understanding of RSAs and that RSAs have evolved dramatically since their first conception and implementation. The report concludes by stating that RSAs may play an increasingly important role in the future of drug availability, particularly when it comes to high-priced personalized medicine options. However, the authors point out that pharmaceutical companies could negate the necessity for RSAs if they become better at creating and gathering the data necessary to allow them to build stronger approval arguments for their new drug products. Such data are needed to lower the risks of being rejected by HTA agencies. If successful, RSA conception, uptake and evolution will have played an important role in helping to reduce the financial burden on EU healthcare systems and allowing patients increased access to new, innovative and effective drugs.

Competing interests: None.

Provenance and peer review: Article abstracted based on published scientific or research papers recommended by members of the Editorial Board; internally peer reviewed.

Alice Rolandini Jensen, MSci, GaBI Journal Editor

1. Piatkiewicz TJ, Traulsen JM, Holm-Larsen T. Risk-sharing agreements in the EU: a systematic review of major trends. Pharmacoecon Open. 2018;2(2):109-23.

Disclosure of Conflict of Interest Statement is available upon request.

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