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

Tehran University of Medical Sciences Health Technology Assessment in Action 2645-3835 5 4 2022 07 11 Using Managed Entry Agreements as an Effective Tool to Handle the Uncertainty in Health Technology Assessments 110 110 Vatsal Chhaya Genpro Research Pvt. Ltd., Thiruvananthapuram, KL, India Kapil Khambholja Genpro Research Pvt. Ltd., Thiruvananthapuram, KL, India & Genpro Research Inc, Waltham, MA, USA 2021 11 16 2022 03 09 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. https://htainaction.tums.ac.ir/index.php/hta/article/view/110 https://htainaction.tums.ac.ir/index.php/hta/article/download/110/80