Chapman Katerina, Torres-Rueda Sergio, Metzler Mutsumi, Young Holt Bethany, Kahn-Woods Elijah, Thornton Douglas, Gomez Gabriela B
Global Access, IAVI, New York, NY, United States.
Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Front Reprod Health. 2024 Apr 18;6:1272950. doi: 10.3389/frph.2024.1272950. eCollection 2024.
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.
产品开发是一项高风险的事业,在将投资优先用于低收入和中等收入国家(LMICs)时尤其如此,因为这些国家的市场可能较小、脆弱且资源有限。新的艾滋病毒预防技术,如达匹韦林阴道环(DVR)和长效注射用卡博特韦(CAB-LA),正以一种适应症引入这些市场,以满足艾滋病毒负担较高环境中青少年女孩和年轻女性(AGYW)以及女性性工作者(FSW)等群体的不同需求。然而,供应和需求有限使其推广成为一项挑战。在三期试验之前进行的经济评估有助于在早期研发(R&D)中优化产品的潜在公共卫生价值主张,针对开发路径中的投资,以确保产品有可能上市并被采用。艾滋病毒预防领域的公共投资者,特别是那些专注于创新剂型(如多功能预防技术(MPT))的投资者,可以利用早期经济评估来了解市场特征中的内在不确定性。在这篇观点文章中,我们思考了经济评估在早期产品开发中的作用以及这些分析的核心方法学考量。我们还讨论了可用于早期经济评估以应对不确定性的定量和定性研究方法,并举例说明了这些方法在未来艾滋病毒预防技术和MPT开发中的应用。