Katerina Chapman, Sergio Torres-Rueda, Mutsumi Metzler, Bethany Young Holt, Elijah Kahn-Woods, Douglas Thornton, Gabriela B. Gomez
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引用次数: 0
摘要
产品开发是一项高风险的工作,尤其是优先投资于市场规模较小、脆弱且资源有限的中低收入国家(LMIC)时更是如此。达匹韦林阴道环(DVR)和长效注射卡博替拉韦(CAB-LA)等新的艾滋病预防技术正以一种适应症进入这些市场,以满足艾滋病高负担环境中少女和年轻女性(AGYW)以及女性性工作者(FSWs)等群体的不同需求。然而,有限的供应和需求使这些药物的使用成为一项挑战。在 III 期试验之前进行的经济评估有助于优化早期研发(R&D)产品的潜在公共卫生价值主张,有针对性地对研发途径进行投资,从而使产品有可能上市并被采用。艾滋病预防管道中的公共投资者,尤其是那些专注于多用途预防技术 (MPT) 等创新演示的投资者,可以利用早期经济评估来了解市场特征的内在不确定性。在这篇视角文章中,我们思考了经济评估在早期产品开发中的作用,以及对这些分析至关重要的方法论因素。我们还讨论了定量和定性研究中可用于早期经济评估以解决不确定性的方法,并举例说明了未来艾滋病预防技术和 MPT 的开发。
The role of economic evaluations in advancing HIV multipurpose prevention technologies in early-stage development
Product development is a high-risk undertaking, especially so when investments are prioritized for low- and middle-income countries (LMICs) where markets may be smaller, fragile, and resource-constrained. New HIV prevention technologies, such as the dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA), are being introduced to these markets with one indication, meeting different needs of groups such as adolescent girls and young women (AGYW) and female sex workers (FSWs) in settings with high HIV burden. However, limited supply and demand have made their uptake a challenge. Economic evaluations conducted before Phase III trials can help optimize the potential public health value proposition of products in early-stage research and development (R&D), targeting investments in the development pathway that result in products likely to be available and taken up. Public investors in the HIV prevention pipeline, in particular those focused on innovative presentations such as multipurpose prevention technologies (MPTs), can leverage early economic evaluations to understand the intrinsic uncertainty in market characterization. In this perspective piece, we reflect on the role of economic evaluations in early product development and on methodological considerations that are central to these analyses. We also discuss methods, in quantitative and qualitative research that can be deployed in early economic evaluations to address uncertainty, with examples applied to the development of future technologies for HIV prevention and MPTs.