Specialty Pharmacy Services, Vanderbilt University Medical Center, Nashville, TN, USA.
Lipscomb College of Pharmacy, One University Park Dr, Nashville, TN, USA.
J Clin Lipidol. 2019 Mar-Apr;13(2):254-264. doi: 10.1016/j.jacl.2019.01.003. Epub 2019 Jan 14.
Access to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that lower low-density lipoprotein cholesterol in patients at high risk of atherosclerotic cardiovascular disease events has proven challenging. Methods to overcome access barriers are needed to fully realize the benefits of these novel agents.
This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a health care system with integrated specialty pharmacy services.
We performed a single-center, ambispective cohort study of patients prescribed a PCSK9 inhibitor between September 2015 and December 2016 at Vanderbilt University Medical Center outpatient clinics. The primary end point was the percentage of PCSK9 inhibitor prescriptions resulting in access of the total prescriptions triaged to Vanderbilt Specialty Pharmacy. Secondary end points assessed among patients approved for therapy included time between benefits investigation and insurance approval, financial assistance use, and treatment initiation rates.
Two hundred ninety-nine patients met inclusion criteria (average age = 63 years). Forty-six percent were female, 57% held commercial insurance, and 70% had an atherosclerotic cardiovascular disease indication. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor. Most patients were approved with an initial prior authorization (58%) or after one appeal (29%). The median time to approval was 8 days. Among patients approved for therapy, 53% received financial assistance and 94% initiated therapy.
An integrated specialty pharmacy service model in outpatient clinics produced high rates of PCSK9 inhibitor therapy access and initiation. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy.
在患有动脉粥样硬化性心血管疾病高危事件的患者中，降低低密度脂蛋白胆固醇的前蛋白转化酶枯草溶菌素/柯萨奇蛋白酶 9（PCSK9）抑制剂的获得性一直具有挑战性。需要克服获得障碍的方法，以充分实现这些新型药物的益处。
本研究评估了在具有综合专业药房服务的医疗保健系统中，为处方开具 PCSK9 抑制剂的患者的药物获得率。
我们对 2015 年 9 月至 2016 年 12 月期间在范德比尔特大学医学中心门诊诊所处方开具 PCSK9 抑制剂的患者进行了单中心、前瞻性队列研究。主要终点是 PCSK9 抑制剂处方中，通过范德比尔特专业药房分类的总处方获得的比例。次要终点评估了接受治疗的患者，包括受益调查和保险批准之间的时间、财务援助的使用情况和治疗开始率。
299 名患者符合纳入标准（平均年龄 63 岁）。46%为女性，57%拥有商业保险，70%有动脉粥样硬化性心血管疾病的适应证。总体而言，96%的处方获得了 PCSK9 抑制剂。大多数患者最初通过了预先授权（58%）或经一次上诉后（29%）获得批准。批准的中位时间为 8 天。在接受治疗的患者中，53%获得了财务援助，94%开始了治疗。
门诊诊所的综合专业药房服务模式可实现 PCSK9 抑制剂治疗的高获得率和起始率。这种高水平的获得支持了这种模式，是开具 PCSK9 抑制剂治疗的最佳实践。
