Abstract
BACKGROUND: Uncertainty in real-world product profiles is the main barrier to pharmaceutical market access. Managed entry agreements (MEAs) are the formal arrangements to overcome these uncertainties. Despite the extensive experience of developed countries in implementing such agreements, the experience of developing countries is minimal. As health decision-makers in Iran have moved towards implementing MEAs since 2020, seeking stakeholders' insights is crucial for filling this experience gap and facilitating the optimal implementation of these new policies. METHODS: Our research was done in three phases: (1) Focus group interviews to disclose the main objectives of implementing MEAs in Iran, (2) the AHP approach to prioritize uncertainties, and (3) individual semi-structured interviews to carry out strengths, weaknesses, opportunities, and threats (SWOT) analysis. RESULTS: Based on our stakeholders' views, increasing flexibility in improving patients' access to innovative and expensive drugs and responding to budget impact uncertainty seems highly prioritized for conducting MEAs in Iran. The SWOT analysis showed that although MEAs have the chance for success due to their strengths and opportunities, such as providing early and assured access, allocating resources efficiently, and enhancing the efficiency of post-marketing studies, policymakers should consider the weaknesses and threats such as difficulty in defining outcomes, high transaction cost, and lack of suitable infrastructure to increase the success rate. CONCLUSIONS: Efficient implementation of MEAs depends on the weaknesses and threats and considering the views of relevant stakeholders. Constructive interaction among all stakeholders is essential for adequately executing MEAs.