Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, 3584 CG Utrecht, The Netherlands.
National Health Care Institute (ZIN), 1112 ZA Diemen, The Netherlands.
Int J Environ Res Public Health. 2020 Nov 10;17(22):8309. doi: 10.3390/ijerph17228309.
The reimbursement of expensive, innovative therapies poses a challenge to healthcare systems. This study investigated the feasibility of managed entry agreements (MEAs) for innovative therapies in different settings and combinations. First, a systematic literature review included studies describing used or conceptual agreements between payers and manufacturers (i.e., MEAs). Identical and similar MEAs were clustered and data were extracted on their benefits and limitations. A feasibility assessment was performed for each individual MEA based on how it could be applied (financial/outcome-based), on what level (individual patients/target population), in which payment setting (centralized pricing and reimbursement authority yes/no), for what type of therapies (one-time/chronic), within what payment structures, and whether combinations with other MEAs were feasible. The literature search ultimately included 82 papers describing 117 MEAs. After clustering, 15 unique MEAs remained, each describing one or multiple similar agreements. Four of those entailed payment structures, while eleven entailed agreements between payers and manufacturers regarding price, usage, and/or evidence generation. The feasibility assessment indicated that most agreements could be applied throughout the different settings that were assessed and could be applied in different payment structures and in combination with multiple other agreements. The potential to combine multiple agreements leads to a multitude of different reimbursement mechanisms that may manage the price, usage, payment structure, and additional conditions for an innovative therapy. This overview of the feasibility of combinations of MEAs can help decision-makers construct a reimbursement mechanism most suited to their preferences, the type of therapy under evaluation, and the applicable healthcare system.
昂贵的创新疗法的报销给医疗保健系统带来了挑战。本研究调查了在不同环境和组合中管理准入协议（MEA）对创新疗法的可行性。首先，进行了系统的文献回顾，包括描述支付者和制造商之间使用或概念性协议的研究（即 MEA）。对相同和相似的 MEA 进行聚类，并提取关于其益处和局限性的数据。根据其应用方式（基于财务/结果）、适用级别（个体患者/目标人群）、支付设置（集中定价和报销权限是/否）、治疗类型（一次性/慢性）、支付结构以及与其他 MEA 的组合是否可行，对每个单独的 MEA 进行可行性评估。文献检索最终包括 82 篇描述 117 个 MEA 的论文。聚类后，剩下 15 个独特的 MEA，每个 MEA 都描述了一个或多个类似的协议。其中四个涉及支付结构，而十一个则涉及支付者和制造商之间关于价格、使用和/或证据生成的协议。可行性评估表明，大多数协议可以在评估的不同设置中应用，并且可以在不同的支付结构中应用，并与多个其他协议结合使用。结合多个协议的潜力导致了许多不同的报销机制，这些机制可以管理创新疗法的价格、使用、支付结构和附加条件。MEA 组合的可行性概述可以帮助决策者构建最适合他们偏好、评估的治疗类型和适用的医疗保健系统的报销机制。
