Dolon Ltd., London, United Kingdom.
Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milan, Italy.
Int J Technol Assess Health Care. 2022 Mar 11;38(1):e23. doi: 10.1017/S0266462322000095.
An increasing number of innovative therapies (e.g., gene- and cell-based treatments) have been developed in the past 20 years. Despite the significant clinical potential of these therapies, access delays may arise because of differing perspectives of manufacturers and payers regarding issues such as the value of the product, clinical and financial uncertainties, and sustainability.Managed entry agreements (MEAs) can enable access to treatments that would not be reimbursed by conventional methods because of such concerns. However, although MEA typologies exist, there is currently no structured process to come to agreements on MEAs, which can be difficult to decide upon and implement.To facilitate more structured MEA negotiations, we propose a conceptual "value-based negotiation framework" with corresponding application tools.
The framework was developed based on an iterative process of scientific literature review and expert input.
The framework aims to (i) systematically identify and prioritize manufacturer and payer concerns about a new treatment, and (ii) select a mutually acceptable combination of MEA terms that can best address priority concerns, with the lowest possible implementation burden.
The proposed framework will be tested in practice, and is a step toward supporting payers and manufacturers to engage in more structured, transparent negotiations to balance the needs of both sides, and enabling quicker, more transparent MEA negotiations and patient access to innovative products.
在过去的 20 年中，已经开发出越来越多的创新疗法（例如，基于基因和细胞的治疗方法）。尽管这些疗法具有重要的临床潜力，但由于制造商和支付方对产品价值、临床和财务不确定性以及可持续性等问题的看法不同，可能会出现获得治疗的延迟。管理准入协议（MEA）可以使那些由于这些问题而无法通过常规方法报销的治疗方法获得准入。然而，尽管存在 MEA 类型，但目前没有关于 MEA 的结构化决策过程，这可能难以做出决策并实施。为了促进更结构化的 MEA 谈判，我们提出了一个具有相应应用工具的概念性“基于价值的谈判框架”。
该框架是基于对科学文献的迭代审查和专家意见的基础上开发的。
该框架旨在（i）系统地识别和优先考虑制造商和支付方对新治疗方法的关注，以及（ii）选择能够最好地解决优先关注问题、实施负担最低的相互可接受的 MEA 条款组合。
拟议的框架将在实践中进行测试，是朝着支持支付方和制造商进行更结构化、透明的谈判以平衡双方需求的方向迈出的一步，从而能够更快、更透明地进行 MEA 谈判并使患者获得创新产品。
