Assessing Gaps in HIV Pre-Exposure Prophylaxis (PrEP) Initiation and Retention using Pharmacy Claims Data

项目总结 尽管美国有近120万人接受了HIV PrEP(暴露前预防)， 许多人未能启动或保留在PrEP护理中。对PrEP处方的处方请求正在上升， 但目前还不清楚实际收到了多少要求和批准的处方，然后又服用了 被病人送回家。当符合条件的患者在药房领取PrEP时，他们可能会选择不购买 他们批准的处方。这一事件被称为处方逆转。处方药遗弃发生 当病人再也没有回来买处方的时候。我们之前发表的定性和定量的 研究表明，成本可能是PrEP逆转和放弃的一个驱动因素。尽管不断增长 认识到自付Copay和免赔额可能会对PrEP的启动和保留构成障碍 准备护理，没有已发表的基于人群的PrEP处方逆转或 遗弃，这使我们无法理解患者是如何脱离PrEP护理的。因此，它的目标是 这项研究旨在(1)确定2015年后HIV PrEP处方的逆转、延迟和弃置率- 2017年；并通过(2)估计HIV PrEP的差异来检测PrEP逆转和放弃方面的差异 按种族、地理区域、性别和自付费用取消或放弃处方。为了这个 第一次研究PrEP处方逆转和放弃，我们将使用一种药物索赔 数据库中有全国最大份额的PrEP处方药索赔与医疗索赔和个人 病人的统计数据。估计全国范围内的处方药逆转和放弃是一种识别 世卫组织无法在药房销售点启动或保留PrEP，并对扩展 国家安全网(如瑞安·怀特)和药物援助计划。对…有有效的估计 处方逆转可以帮助我们改进对真正保留在护理中的人的估计，以及在哪些终点 患者在PrEP护理连续过程中未能取得进展。这项分析是根据患者的反馈而开发的， 鉴于主要媒体的报道和对销售点高昂的PrEP成本的耐心抗议， 对这一现实世界问题的研究也很少。结果将形成初步数据，这样我们就可以 确定PrEP反转发生的地理位置及其之间，并建议使用R34或R01 定性和定量地调查反转发生的原因以及如何干预。我们的发现将 通过确定废弃的成本阈值来通知后续R系列干预措施，并细化哪些 特定的亚组没有保留在PrEP护理中的风险最高。这项研究的长期目标是 通过减少高危人群预防接种的障碍，改善预防接种计划的保留率，并最终降低艾滋病毒发病率 人口。这项研究与减少新的艾滋病毒感染和支持的高度优先领域一致 根据美国国立卫生研究院和美国艾滋病研究办公室的定义，旨在减少艾滋病毒感染的种族差异的研究。

PROJECT SUMMARY Although nearly 1.2 million people in the United States are indicated for HIV PrEP (pre-exposure prophylaxis), many fail to initiate or be retained in PrEP care. Prescription requests for PrEP prescriptions are on the rise, but it is yet unknown how many requested and approved prescriptions are actually received and then taken home by patients. When eligible patients present at pharmacies to pick up PrEP, they may opt not to purchase their approved prescription. This event is known as a prescription reversal. Prescription abandonment occurs when a patient never returns to purchase the prescription. Our previously published qualitative and quantitative research suggests that cost may be a driving factor in PrEP reversals and abandonments. In spite of growing recognition that out-of-pocket copays and deductibles may present barriers to PrEP initiation and retention in PrEP care, there are no published population-based estimates of PrEP prescription reversals or abandonments, which precludes our ability to understand how patients fall out of PrEP care. Thus, the aims of this study are to (1) determine the HIV PrEP prescription reversal, delay, and abandonment rates from 2015- 2017; and detect disparities in PrEP reversals and abandonment by (2) estimating the difference in HIV PrEP prescription reversal or abandonment by racial group, geographic region, sex, and out-of-pocket cost. For this first ever study of PrEP prescription reversals and abandonments, we will use a pharmaceutical claims database with the nation’s largest share of PrEP prescription claims matched to medical claims and individual patient demographics. Estimating prescription reversals and abandonment nationally is a novel way to identify who is lost to PrEP initiation or retention at the pharmacy point-of-sale, and has implications for expansion of national safety-net (e.g., Ryan White) and medication assistance programs. Having valid estimates of prescription reversals can help us refine our estimates of who is truly retained in care, and at what endpoints patients fail to progress in the PrEP care continuum. This analysis, developed in response to patient feedback, is significant in light of major media coverage and patient protests of exorbitant PrEP costs at the point-of-sale, and the paucity of research on this real-world issue. The results will form preliminary data so that we can determine where geographically PrEP reversals happen, and among whom, and propose an R34 or R01 to qualitatively and quantitatively investigate why reversals are happening and how to intervene. Our findings will inform subsequent R series interventions by identifying cost thresholds for abandonment, and refine which specific subgroups are at highest risk of not being retained in PrEP care. The long-term goal of this research is to improve PrEP retention and ultimately decrease HIV incidence by reducing barriers to PrEP among high-risk populations. This study aligns with the high priority areas of reducing new HIV infections and supporting research to reduce racial disparities in HIV infection, as defined by the NIH and US Office of AIDS Research.