OBJECTIVES: To explore utilization trends and to identify challenges and key factors for successful implementation of Managed Entry Agreements (MEAs) for pharmaceuticals, in order to inform local policy and decision-making.

METHODS: A rapid evidence review was conducted. A systematic search was performed in April-May 2024 in PubMed/Medline and Scopus. The review included articles in English that discussed experience with MEAs internationally. Theoretical pieces and conference abstracts were excluded. The search was limited to articles published from 2014 onwards. Title, abstract and full text screening was performed by three researchers. Data on MEA types, barriers/challenges and success factors were extracted into standardised tables.

RESULTS: Various MEAs are used internationally which aim to mitigate budget impact, address uncertainties in clinical and cost-effectiveness, ensure appropriate clinical use, and enhance patient access to promising therapies. MEAs are more frequently implemented in oncology, neurology, rheumatology, and endocrinology and also in the case of medicines for rare diseases and advanced therapies. Despite their benefits, MEAs (especially performance-based ones) face significant challenges including, but not limited to, methodological adaptation for real-world outcomes assessment, transparency and data collection issues, streamlining administrative processes, infrastructure issues, and engaging healthcare professionals effectively. Integrating patient-reported outcomes (PROs) and navigating data collection issues further complicate MEA effectiveness. Key success factors include the development of a guidance framework; engagement and commitment of stakeholders; communication and transparency; reliable data collection methods and systems; and adjustment of the legal/regulatory framework.

CONCLUSIONS: MEAs have emerged as a means for payers to address issues of affordability, uncertainty and access to new medicines; their successful implementation depends on overcoming multiple challenges. Greece has some experience with financial-based MEAs, but has not yet exploited the potential of performance-based MEAs for managing access to new medicines. Lessons learned from international experience can support decision-making on the introduction of such schemes.