Doshi Jalpa A, Puckett Justin T, Parmacek Michael S, Rader Daniel J
From the Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Dr Doshi, J.T. Puckett, Dr Parmacek, and Dr Rader) and the Leonard Davis Institute of Health Economics, Philadelphia (Dr Doshi).
Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003939. doi: 10.1161/CIRCOUTCOMES.117.003939.
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers.
We conducted an analysis of 2016 formulary coverage and PA data from a large, proprietary database with information on policies governing >95% of Americans with prescription drug coverage (275.3 million lives) within 3872 plans across the 4 major insurance segments (commercial, health insurance exchange, Medicare, and Medicaid). The key measures included administrative PA criteria (prescriber specialty, number of criteria in PA policy or number of fields on PA form, requirements for medical record submission, reauthorization requirements) and clinical/diagnostic PA criteria (approved conditions, required laboratories or other tests, required concomitant therapy, step therapy requirements, continuation criteria) for each of 2 Food and Drug Administration-approved PCSK9is. Select measures (eg, number of PA criteria/fields, medical record submission requirements) were obtained for 2 comparator cardiometabolic drugs (ezetimibe and liraglutide). Between 82% and 97% of individuals were enrolled in plans implementing PA for PCSK9is (depending on insurance segment), and one third to two thirds of these enrollees faced PAs restricting PCSK9i prescribing to a specialist. For patients with familial hypercholesterolemia, diagnostic confirmation via genetic testing or meeting minimum clinical scores/criteria was also required. PA requirements were more extensive for PCSK9is as compared with the other cardiometabolic drugs (ie, contained 3×-11× the number of PA criteria or fields on PA forms and more frequently involved the submission of medical records as supporting documentation).
PA requirements for PCSK9is are greater than for selected other drugs within the cardiometabolic disease area, raising concerns about whether payer policies to discourage inappropriate use may also be restricting access to these drugs in patients who need them.
前蛋白转化酶枯草溶菌素/克新9型抑制剂（PCSK9i）是治疗家族性高胆固醇血症或临床动脉粥样硬化性心血管疾病患者的一种创新选择，这些患者需要进一步降低低密度脂蛋白胆固醇。然而，这些药物的高昂成本促使支付方实施利用管理政策以确保合理使用。我们研究了美国公私支付方对PCSK9i的预先授权（PA）要求。
我们对一个大型专有数据库中的2016年处方集覆盖范围和PA数据进行了分析，该数据库包含了4个主要保险领域（商业保险、医疗保险交易所、医疗保险和医疗补助）的3872个计划中超过95%有处方药覆盖的美国人（2.753亿人）的政策信息。关键指标包括两种美国食品药品监督管理局批准的PCSK9i各自的行政PA标准（开处方者专业、PA政策中的标准数量或PA表格上的字段数量、病历提交要求、重新授权要求）以及临床/诊断PA标准（批准的病症、所需实验室检查或其他检测、所需联合治疗、阶梯治疗要求、继续治疗标准）。为两种对照心脏代谢药物（依泽替米贝和利拉鲁肽）获取了选定指标（如PA标准/字段数量、病历提交要求）。82%至97%的个体参加了实施PCSK9i PA的计划（取决于保险领域），其中三分之一至三分之二的参保者面临将PCSK9i处方限制为专科医生开具的PA要求。对于家族性高胆固醇血症患者，还需要通过基因检测或达到最低临床评分/标准进行诊断确认。与其他心脏代谢药物相比，PCSK9i的PA要求更为广泛（即PA表格上的PA标准或字段数量多3至11倍，且更频繁地要求提交病历作为支持文件）。
PCSK9i的PA要求高于心脏代谢疾病领域的其他选定药物，这引发了人们对支付方旨在防止不当使用的政策是否也会限制有需求患者获得这些药物的担忧。
