Stakeholder views of managed entry agreements: A literature review of national studies.

Access to highly expensive and innovative medicine is a challenge. Managed entry agreements/ arrangements (MEAs) consist of various forms of confidential agreements between pharmaceutical manufacturers and payers (hospitals, social insurance), which are mainly negotiated when there is uncertainty of the actual clinical benefit of the medicines, but high public expenditures are required. Continued and expanding use of these schemes requires a greater understanding of payer perceptions, experience, and orientation towards their current and future use. This literature review aimed to identify the stakeholders' concerns with regards to MEAs. A total of 20 articles were identified between 2007 and 2018. MEAs are mostly studied in the first world countries, whereas limited documentation is available for other nations. The reasons for rejection of proposed MEAs could possibly be related to existing low-cost effective treatments, lack of trust between stakeholders, high administrative burden and if the authorities believe they are funding the substantial proportion of the drug's development cost. Lack of well-designed and easy-to-use data collection methods for MEAs has an impact on the evidence generation. Most articles highlighted the lack of transparency of the agreements which may not benefit other health systems, especially for systems that are dependent on international referencing price. Stakeholders also identified the lack of expertise in assessing the pharmacoeconomic and health outcomes data and challenges in assessing risks up-front due to the complexity of the real-world data. Lack of transparency in most health systems are also a hindrance to further understanding and confidence in the MEAs. However, the views of the stakeholders may also evolve with experience. Though there are challenges in the designing and implementation of MEAs, close networking, improved human capital development especially in the area of health technology assessment and health economics would be able to close the gap in the implementation.