A Conceptual Framework for Life-Cycle Health Technology Assessment
A Conceptual Framework for Life-Cycle Health Technology Assessment
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DOI：
10.1016/j.jval.2021.11.1373
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发表时间：
2022-06-29
期刊：
影响因子：
4.5
通讯作者：
McCabe, Christopher
中科院分区：
文献类型：
--
作者：
Kirwin, Erin;Round, Jeff;McCabe, Christopher
目标：卫生技术评估 (HTA) 使用证据评估和综合以及经济评估来为采用决策提供信息。标准 HTA 流程有时很难 (1) 支持涉及重大不确定性的决策，以及 (2) 鼓励不断生成和适应新证据。我们提出生命周期 (LC)-HTA 框架，通过为决策者提供额外的工具并改善所有利益相关者的成果来应对这些挑战。方法：在 LC-HTA 框架下，HTA 流程与 LC 管理保持一致。 LC-HTA 引入了 HTA 方法的变化，以最大限度地缩短分析时间，同时优化决策确定性。如果存在决策不确定性，我们建议基于风险的定价和以研究为导向的管理访问（ROMA）。合同采购协议定义了重新评估的条款，并为 HTA 机构提供了额外的决策选项。 LC-HTA 扩展了信息价值方法，为 ROMA 协议提供信息，利用常规、管理数据和登记来减少不确定性。结果：LC-HTA 能够采用高价值高风险创新，同时通过风险分担和减少不确定性来提高卫生系统的可持续性。通过合同嵌入的决策规则来简化重新评估，从而提高对不断变化的证据的响应能力。 ROMA 允许有条件收养以获得更多信息，并确信该收养决策的净价值是积极的。结论：LC-HTA 框架改善了患者、资助者和付款人的结果。患者通过尽早获得新技术而受益。付款人增加了他们投资的技术的价值，并获得了审查投资的机制。赞助商可以通过投资相关结果的更大确定性、更快捷的市场准入以及更多展示价值的机会而受益。
Objectives: Health technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders.Methods: Under the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty.Results: LC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive.Conclusions: The LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value.