OBJECTIVES : Managed Entry Agreements (MEA) are defined as arrangements between manufacturer and payer to enable access to a health technology subject to specific conditions. In the recent working paper on MEA, the OECD observed that there are no MEA in Germany legally affecting coverage. However, based on a more comprehensive definition such arrangements do exist in Germany. This study analyses (1) which arrangements exist in Germany, (2) what is the rationale behind them and (3) what are potential implications for the broader understanding of the future role of MEA.

METHODS : This analysis focuses on advanced therapy medicinal products (ATMP), approved by EMA. For all ATMPs the official product index is searched for reference to existing agreements. In addition, PubMed, press releases, and arbitration board procedures were checked for information on agreements not officially included in the index.

RESULTS : Currently, 9 EMA approved ATMPs are available in Germany. For 5 of these products MEA could be identified: Imlygic®, Kymriah®, Yescarta®, Zynteglo®, Alofisel®. Three ATMPs have risk share arrangements with individual sick funds with either a defined rebate in case patients die within a certain period after treatment or incremental payments. Some arrangements are limited until completing of the AMNOG process, whereas in other cases it is unclear if this agreement extends beyond. According to press releases the rationale in each case was to proactively address concerns regarding value for money. Two other products have performance-based agreements for all payers linked to duration of treatment or need for re-intervention, both negotiated with German reimbursement authorities effective after the AMNOG process.

CONCLUSIONS : For this sample more than 50% of all ATMPs have MEA in Germany, each linked to product performance. Some of them are intended to support product adoption, others as part of the official pricing. This indicates that MEA more applications beyond the abovementioned definition.