This systematic review examined 96 studies regarding Managed Entry Agreements (MEAs) worldwide. The research covered policies in European, North American, Middle Eastern, and low-income countries. However, the majority of the studies focused on European systems (43%) and North American systems (28%). A significant gap in evidence was found for the Middle East and low-income countries, where very little research exists.
The most common theme in the literature was a situational analysis, which appeared in 63% of the studies. These papers mostly cataloged barriers to using MEAs rather than providing operational solutions. Common barriers identified included inefficient regulatory frameworks in 42% of studies, data infrastructure limitations in 41%, and high administrative burdens in 38%. Only a minority of studies, about 15%, focused on Advanced Therapy Medicinal Products.
Readers should understand that this review highlights where knowledge is missing rather than proving what works. The literature predominantly lists problems instead of giving concrete implementation toolkits or payment models. For health systems looking to adopt MEAs, future efforts must shift from describing barriers to developing practical guides. This review does not report safety concerns or specific patient outcomes.
