Geographic Variation in Qualified Health Plan Coverage and Prior Authorization Requirements for HIV Preexposure Prophylaxis.
Geographic Variation in Qualified Health Plan Coverage and Prior Authorization Requirements for HIV Preexposure Prophylaxis.
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DOI：
10.1001/jamanetworkopen.2023.42781
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发表时间：
2023-11-01
影响因子：
13.8
通讯作者：
McQuade, Elizabeth T. Rogawski
中科院分区：
文献类型：
--
作者：
McManus, Kathleen A.;Fuller, Benjamin;Killelea, Amy;Strumpf, Andrew;Powers, Samuel D.;McQuade, Elizabeth T. Rogawski
这项横断面研究分析了2018年至2020年合格健康计划中艾滋病毒暴露前预防的覆盖面和事先授权要求。艾滋病毒暴露前预防(PrEP)的合格健康计划(QHP)覆盖范围和事先授权(PA)要求在美国各地区有何不同？在这项对58个 087 QHP的横断面研究中，南部和中西部的QHP对恩曲他滨/替诺福韦富马酸酯的PA需求率最高，而不是恩曲他滨/替诺福韦丙氨酰胺，从2019年到2020年，恩曲他滨/替诺福韦富马酸PA的需求率几乎翻了一番。尽管有更广泛的临床适应症，恩曲他滨/替诺福韦富马酸二异丙酯PA的需求率高于恩曲他滨/替诺福韦丙氨酸胺，尤其是在结束艾滋病毒流行倡议优先司法管辖区。这些发现表明，在艾滋病毒诊断率较高的地理地区，PA的高需求率可能直接阻碍PrEP的获取和吸收。艾滋病毒暴露前预防(PrEP)是遏制新的艾滋病毒诊断的结束艾滋病毒流行(EHE)倡议的关键组成部分。2019年10月，除了恩曲他滨/富马酸替诺福韦丙二醇酯之外，恩曲他滨/替诺福韦丙氨酰胺被添加为PrEP的核准配方；尽管有另一种具有类似预防适应症的配方可用，但覆盖范围的变化可能会限制获得。评估恩曲他滨/替诺福韦富马酸酯和恩曲他滨/替诺福韦丙氨酰胺经批准作为PrEP治疗后的合格健康计划(QHP)覆盖范围、事先授权(PA)要求和专科分级。这项横断面研究分析了2018至2020年间美国符合《患者保护和平价医疗法案》的QHP。QHP按区域和EHE优先司法管辖区进行分类。数据分析发生在2022年3月至2023年3月。参加由《患者保护和平价医疗法案》认证的合格健康计划。恩曲他滨/替诺福韦富马酸盐和/或恩曲他滨/替诺福韦丙氨酸胺的QHP覆盖率和PA需求量的年变化。报告了所有结果的描述性统计数据。第二个结果是PrEP配方是否由QHP确定放在特殊药物层上。共分析了58个 087 QHP(2018年19个 533；2019年17个 007；2020年21个 547)。QHP覆盖富马酸恩曲他滨/替诺福韦异丙酚(2018年19 165QHP[98.1%]；2019年16 970 QHP[99.8%]；2020年20 045 QHP[94.8%])，覆盖率高于恩曲他滨/替诺福韦丙氨酸胺(2018年17 QHP 391 QHP[91.9%]；2019年15 QHP 757 QHP[92.7%]；2020年18 QHP[87.4%])。南方的QHP对恩曲他滨/替诺福韦富马酸二异丙酯和恩曲他滨/替诺福韦丙氨酸胺的排他性PA(即，即使QHP涵盖了这两种制剂，也包括其中一种制剂)的使用率是所有3年中最高的。在南方，恩曲他滨/富马酸替诺福韦酯的PA比率从2018年的8023个QHP中的806个(10.0%)增加到2020年的7401个QHP中的3466个(46.8%)。EHE司法管辖区对恩曲他滨/替诺福韦富马酸独家PA要求的QHP高于非EHE司法管辖区(差异：2018年，0.9个百分点；2019年，3.5个百分点；2020年，29.1个百分点)。与恩曲他滨/替诺福韦丙氨酰胺相比，QHP更有可能将恩曲他滨/替诺福韦富马酸酯置于专科级别(差异：2018年，1.8个百分点；2019年，3.7个百分点；2020年，4.1个百分点)。在这项横断面研究中，尽管生物医学预防的适应症相似，但QHP更有可能涵盖富马酸恩曲他滨/替诺福韦异丙醇酯而不是恩曲他滨/替诺福韦丙氨酸胺，而且QHP也更有可能将恩曲他滨/替诺福韦异丙醇酯应用于PA或将其置于专科级别，尽管临床适应症更广泛。在恩曲他滨/替诺福韦丙氨酰胺批准后，QHP PA对恩曲他滨/替诺福韦富马酸酯的PA要求并不反映临床指南。这些要求可能反映了临床适应症、制造商折扣或对法规变化和新兴仿制药的预期的差异。在艾滋病毒诊断率最高和最需要PrEP的地区(例如，南方和欧洲高等教育优先司法管辖区)，恩曲他滨/替诺福韦异丙酚的独家PA使用率很高；解决日益严重的PrEP卫生公平危机的政策解决方案可能包括监管机构的行动和国家PrEP计划。
This cross-sectional study analyzes coverage and prior authorization requirements for HIV preexposure prophylaxis among qualified health plans from 2018 to 2020. How do qualified health plan (QHP) coverage and prior authorization (PA) requirements for HIV preexposure prophylaxis (PrEP) differ across regions of the US? In this cross-sectional study of 58 087 QHPs, QHPs in the South and Midwest had the highest rate of requiring PA for emtricitabine/tenofovir disoproxil fumarate but not emtricitabine/tenofovir alafenamide among all regions, and the emtricitabine/tenofovir disoproxil fumarate PA requirement rate nearly doubled from 2019 to 2020. Despite broader clinical indications, the emtricitabine/tenofovir disoproxil fumarate PA requirement rate was higher than that for emtricitabine/tenofovir alafenamide, most notably in Ending the HIV Epidemic Initiative priority jurisdictions. These findings suggest that high rates of PA requirement may directly impede PrEP access and uptake in geographic areas with high rates of HIV diagnoses. HIV preexposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) Initiative to curb new HIV diagnoses. In October 2019, emtricitabine/tenofovir alafenamide was added as an approved formulation for PrEP in addition to emtricitabine/tenofovir disoproxil fumarate; despite availability of another formulation with a similar prevention indication, variations in coverage may limit access. To assess qualified health plan (QHP) coverage, prior authorization (PA) requirements, and specialty tiering for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide following emtricitabine/tenofovir alafenamide approval as a PrEP treatment. This cross-sectional study analyzed QHPs in the US that were compliant with the Patient Protection and Affordable Care Act from 2018 to 2020. QHPs were categorized by region and EHE priority jurisdictions. Data analysis occurred from March 2022 to March 2023. Enrollment in a qualified health plan certified by the Patient Protection and Affordable Care Act. Annual variation in QHP coverage and PA requirement for emtricitabine/tenofovir disoproxil fumarate and/or emtricitabine/tenofovir alafenamide. Descriptive statistics were reported for all outcomes. A secondary outcome was whether the PrEP formulation was determined by the QHP to be placed on a specialty drug tier. A total of 58 087 QHPs (19 533 for 2018; 17 007 for 2019; and 21 547 for 2020) were analyzed. QHPs covered emtricitabine/tenofovir disoproxil fumarate (19 165 QHPs [98.1%] in 2018; 16 970 QHPs [99.8%] in 2019; 20 045 QHPs [94.8%] in 2020) at a higher rate than emtricitabine/tenofovir alafenamide (17 391 QHPs [91.9%] in 2018; 15 757 QHPs [92.7%] in 2019; 18 836 QHPs [87.4%] in 2020). QHPs in the South required exclusive PA (ie, PA for 1 of the formulations even if the QHP covered both) for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide at the highest rates in all 3 years. In the South, the rate of PA for emtricitabine/tenofovir disoproxil fumarate increased from 806 of 8023 QHPs (10.0%) in 2018 to 3466 of 7401 QHPs (46.8%) in 2020. QHPs with exclusive PA requirement for emtricitabine/tenofovir disoproxil fumarate were higher in EHE jurisdictions than non–EHE jurisdictions (difference: 2018, 0.9 percentage points; 2019, 3.5 percentage points; 2020, 29.1 percentage points). QHPs were more likely to place emtricitabine/tenofovir disoproxil fumarate on a specialty tier compared with emtricitabine/tenofovir alafenamide (difference: 2018, 1.8 percentage points; 2019, 3.7 percentage points; 2020, 4.1 percentage points). In this cross-sectional study, despite similar indications for biomedical prevention, QHPs were more likely to cover emtricitabine/tenofovir disoproxil fumarate than emtricitabine/tenofovir alafenamide, and QHPs were also more likely to subject emtricitabine/tenofovir disoproxil fumarate to PA or place it on a specialty tier despite the broader clinical indication. QHP PA requirements of emtricitabine/tenofovir disoproxil fumarate following emtricitabine/tenofovir alafenamide approval does not reflect clinical guidelines. The requirements could reflect differences in clinical indication, manufacturer discounts, or anticipation of a changing regulations and emerging generics. High rates of exclusive PA for emtricitabine/tenofovir disoproxil fumarate in areas where rates of HIV diagnoses are highest and PrEP is most needed (eg, the South and EHE priority jurisdictions) is concerning; policy solutions to address the growing PrEP health equity crisis could include regulator actions and a national PrEP program.
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DOI：
10.1097/qai.0000000000001165
发表时间：
2017-01-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Elopre L;Kudroff K;Westfall AO;Overton ET;Mugavero MJ
通讯作者：
Mugavero MJ
影响因子：
168.9
作者：
Mayer, Kenneth H.;Molina, Jean-Michel;Thompson, Melanie A.;Anderson, Peter L.;Mounzer, Karam C.;De Wet, Joss J.;DeJesus, Edwin;Jessen, Heiko;Grant, Robert M.;Ruane, Peter J.;Wong, Pamela;Ebrahimi, Ramin;Zhong, Lijie;Mathias, Anita;Callebaut, Christian;Collins, Sean E.;Das, Moupali;McCallister, Scott;Brainard, Diana M.;Brinson, Cynthia;Clarke, Amanda;Coll, Pep;Post, Frank A.;Hare, C. Bradley
通讯作者：
Hare, C. Bradley
影响因子：
4.4
作者：
Eaton LA;Kalichman SC;Price D;Finneran S;Allen A;Maksut J
通讯作者：
Maksut J
影响因子：
39.2
作者：
Juusola JL;Brandeau ML;Owens DK;Bendavid E
通讯作者：
Bendavid E
影响因子：
12.7
作者：
Kay, Emma Sophia;Pinto, Rogerio M.
通讯作者：
Pinto, Rogerio M.