OBJECTIVES To identify and describe the challenges regarding implementation of performance-based managed entry agreements (MEA) for advanced therapy medicinal products (ATMPs)

METHODS A literature search in the PubMed and Cochrane databases undertaken in May 2021 resulted in the identification of relevant publications. The findings on the methodologic challenges are included in the subsequent analysis.

RESULTS : The main challenges regarding implementation of performance-based MEAs for ATMPs were identified as: legislative hurdles, lack of digital infrastructure, design of schemes, legal challenges if there are disputes over whether the outcomes have been met, administrative burden, lack of evaluation of MEAs as a whole, uncertainty regarding safety data, affordability, ethical aspects.

CONCLUSIONS : There are still barriers to the widespread and timely adoption of performance-based MEAs, especially for ATMPs. A consensus among the stakeholders is needed regarding sustainability and affordability of these MEAs.