Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
J Clin Lipidol. 2019 Sep-Oct;13(5):725-734. doi: 10.1016/j.jacl.2019.06.008. Epub 2019 Jul 2.
Trials have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective as an adjunct to statin therapy, but access and cost issues have limited their use in community practice.
The aim of the study was to better understand patients' experiences when trying to obtain, fill, and use PCSK9 inhibitor therapy in community practice.
We conducted a patient survey to evaluate patient experiences with PCSK9 inhibitors including medication initiation, indication for treatment, insurance approval status, medication persistence, and reason for discontinuation. The survey was emailed to 4740 adults who used a patient access support program.
Overall, 1327 of 4740 adults completed the survey (28.0% response rate). Of those, 75.0% were aged >60 years, 52.8% were male, and 92.4% were White. At the time of PCSK9 inhibitor prescription, 70.2% were not on a statin (with 84.4% of those not on a statin reporting statin intolerance). Overall, 74.6% of patients found the drug approval process to be "somewhat" or "very" burdensome. Among n = 1216 patients who initiated treatment, 33.7% discontinued by the time of the survey, with 50.0% taking the drug for 1 to 6 months. Patient out-of-pocket costs were the leading reported reason for discontinuation.
Most PCSK9 inhibitor users in community practice were not on a statin, presumably because of statin intolerance. The drug approval process and costs continue to be strong reasons for lower initiation of PCSK9 agents, as well as higher discontinuation rates.
临床试验已经证明，前蛋白转化酶枯草溶菌素/糜蛋白酶 9（PCSK9）抑制剂作为他汀类药物治疗的辅助药物非常有效，但由于可及性和成本问题，它们在社区实践中的应用受到限制。
本研究旨在更好地了解患者在尝试获取、使用社区实践中的 PCSK9 抑制剂治疗时的体验。
我们进行了一项患者调查，以评估患者对 PCSK9 抑制剂的体验，包括药物起始、治疗指征、保险批准状况、药物持续性和停药原因。该调查通过电子邮件发送给 4740 名使用患者准入支持计划的成年人。
共有 4740 名成年人中的 1327 人完成了调查（28.0%的回复率）。其中，75.0%的人年龄大于 60 岁，52.8%为男性，92.4%为白人。在开具 PCSK9 抑制剂处方时，70.2%的患者未服用他汀类药物（未服用他汀类药物的患者中，84.4%报告存在他汀类药物不耐受）。总体而言，74.6%的患者认为药物审批过程“有些”或“非常”繁琐。在 n=1216 名开始治疗的患者中，33.7%在调查时已停药，其中 50.0%的患者服药 1 至 6 个月。患者自付费用是停药的主要报告原因。
在社区实践中，大多数使用 PCSK9 抑制剂的患者未服用他汀类药物，推测原因是不耐受他汀类药物。药物审批过程和成本仍然是启动 PCSK9 药物治疗率较低以及停药率较高的主要原因。
