OBJECTIVES: To identify trends and current challenges with managed entry agreements (MEAs) in oncology across Italy, Spain and the UK. The implications of these trends for companies and the healthcare system will be discussed to facilitate companies successfully developing MEAs.

METHODS: A targeted literature review (TLR) was conducted using PubMed to identify articles published between 2010 and 2020 and relevant publications were used to identify key challenges and trends in MEAs. Publicly available information about the existing MEAs for countries in scope were retrieved through agency websites.

RESULTS: The literature search retrieved 296 scientific articles. After abstract review, data were extracted from 77 articles. As a result of the TLR some country-specific historical trends emerged: in the UK a transition from risk-sharing agreements to financial based schemes has been observed overtime to reduce administrative burden; in Italy where strong patient registries exist, the adoption of risk-sharing agreements is more likely; in Spain originally MEAs were often decided at the hospital and regional level but a few initiatives at national level have started. Key factors to be considered for successful implementation of MEAs were identified and categorized: clinical endpoint measurement, data infrastructure, legal risk, readiness of supply chain. Challenges and opportunities of MEAs were identified based on the approach of each country with regards to data collection, governance, reporting and evaluation. Based on this external analysis, the potential impact of MEAs on the country’s healthcare system and on the different departments of a pharmaceutical company (e.g., market access, legal, finance, supply chain and medical) was evaluated.

CONCLUSIONS: MEAs in oncology are gaining more prominence and should be included in the market access strategy for novel assets in scope markets. Despite differences in implementation of MEAs between countries some common factors should be considered by companies when engaging in this type of agreements.