Regenerative medicine (RM) has considerable potential to address the needs of aging-related and uncurable diseases. However, its incorporation into reimbursement of health insurance benefits poses many challenges, including uncertain evidence and insufficient investment. This paper examines the wide gap between manufacturers, regulatory bodies, and health technology bodies regarding reimbursements for RMs focused cell therapy products. In this mixed-methods study, we first analyzed the sales of RMs approved in South Korea. In addition to exploring beliefs related to the market value of RMs, in-depth interviews were conducted with 24 experts (17 from bio-industries, two from the regulatory body, three from a health technology assessment (HTA) body, and two from the Pharmaceutical Benefit Coverage Assessment Committee [PBCAC]). Lastly, we surveyed PBCAC members about the market value of RMs. In total, 15 of the 20 developed cell therapy products are on the market in South Korea, and amounted to 0.24% of total pharmaceutical expenditures in 2018. We identified a wide gap between stakeholders and regulators regarding the market value and pricing of RMs. The interviewees from the pharmaceutical manufacturer association raised the issue of rising manufacturing costs and proposed a specific pricing policy for RMs. To bridge the gap between approval and reimbursement, stakeholders demand an alternative framework of value-based pricing. Conditional health insurance reimbursement may be an alternative to the traditional process in order to generate evidence of the effects of RMs using "risk-based" or "outcome-based" approaches.

中文翻译：

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韩国的再生医学：弥合授权和报销之间的差距。

再生医学 (RM) 在解决与衰老相关和无法治愈的疾病的需求方面具有相当大的潜力。然而，将其纳入医疗保险福利的报销带来了许多挑战，包括证据不确定和投资不足。本文探讨了制造商、监管机构和健康技术机构之间在 RM 专注于细胞治疗产品的报销方面的巨大差距。在这项混合方法研究中，我们首先分析了在韩国获批的 RM 的销售情况。除了探索与 RM 市场价值相关的信念外，还对 24 位专家（17 位来自生物行业、两位来自监管机构、三位来自卫生技术评估 (HTA) 机构、两位来自药品福利覆盖评估委员会 [PBCAC]）。最后，我们就 RM 的市场价值对 PBCAC 成员进行了调查。总共有 20 种开发的细胞治疗产品中有 15 种在韩国上市，占 2018 年总医药支出的 0.24%。我们发现利益相关者和监管机构在 RM 的市场价值和定价方面存在巨大差距。制药商协会的受访者提出了制造成本上升的问题，并提出了针对RM的具体定价政策。为了弥合批准和报销之间的差距，利益相关者需要一个基于价值的定价的替代框架。有条件的健康保险报销可能是传统流程的替代方案，以便使用“基于风险”或“基于结果”的方法生成 RM 效果的证据。