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

Authors : Vatsal Chhaya | Kapil Khambholja


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.