Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements

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Managed entry agreements (MEAs) comprise a variety of instruments to reduce uncertainty arising from incomplete information on budget impact, cost-effectiveness, use in real life, and access to new therapies. MEAs have a number of advantages and limitations and are sometimes faced with scepticism among decision-makers. Their uptake and use – particularly financial MEAs - has been fast in many European Union Member States and beyond. The use of MEAs highlights their significance as a conduit for satisfying a number of policy imperatives while mitigating risk and the limitations of current approaches to coverage decisions, including health technology assessment (HTA), in securing reasonable prices and addressing uncertainties around therapeutic effect in real life. Despite the large number of agreements implemented, little information is available on their impact. The little amount of available information is hampering cross-country learning and the ability of patients to engage in the process. Despite their proliferation, MEAs should not become a quick-fix solution to addressing the risk and uncertainty arising from the introduction of new therapies; instead, they should be integrated into a process of managed introduction of new therapies starting with horizon scanning and forecasting activities, proceeds to HTA assessment and continues with post-marketing studies and surveillance.

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