Using Managed Entry Agreements as an Effective Tool to Handle the Uncertainty in Health Technology Assessments

Although the access to innovative medicines is usually informed by health technology assessment reports, underlying uncertainties in HTA may delay such access. Managed Entry Agreements may provide a promising solution to handle such uncertainty through focusing on value for information. Notably, majority of MEA designs include volume-based pricing and not outcome-based pricing strategies – which is an optimal access pathway for rare disease drugs. This is attributed to transparency issues regarding MEA content. This article proposes a framework which may be helpful which considering MEA within the context of low-and-middle-income countries using an interdisciplinary approach. This included needs assessment, value framework, governance, and choice of outcomes.