AAHIVP, Avella Specialty Pharmacy, Phoenix, Arizona.
J Manag Care Spec Pharm. 2019 Nov;25(11):1244-1254. doi: 10.18553/jmcp.2019.25.11.1244.
U.S. specialty drug spend is expected to reach $400 billion by 2020, with significant growth in oncology. New oral oncology approvals have allowed for more convenient outpatient administration compared with physician-administered chemotherapies; however, patients may encounter challenges with adherence when taking medications at home. Emerging medication adherence technology (MAT) attempts to provide at-home adherence support, and while one such technology, smart pill bottles (SPB), claims to improve medication adherence, few studies have formally assessed their effects.
To assess the effect of an SPB with pharmacist intervention on medication adherence in adult patients with multiple myeloma (MM) new to lenalidomide therapy (≤ 5 cycle dispenses). Secondary objectives were to evaluate treatment cycles completed, evaluate the significance of real-time pharmacist engagement (intervention group only), determine the incremental cost-effectiveness ratio (ICER), and evaluate patient satisfaction and likelihood to use an SPB.
This prospective, random assignment, single-site, and single-blinded study recruited 40 adult patients diagnosed with MM new to lenalidomide at a specialty pharmacy. Recruitment was completed January-February 2016, and the length of study was 6 months. Participants were randomized 1:1 between the intervention and control groups. The intervention group received lenalidomide in activated SPBs with light, chimes, text message reminders, and pharmacist follow-up if weekly SPB adherence rates dropped below 80%. The control group received lenalidomide in identical SPBs with all alerts deactivated. SBPs contained cellular capabilities, enabling around-the-clock data transmission and captured data upon bottle-uncapping events. Patient adherence was calculated by dividing the number of bottle-uncapping events by the total number of doses supplied for each dosing cycle. Lenalidomide cycles completed and pharmacist outreach to the same patient were counted to determine pharmacist intervention. The ICER was calculated to determine SPB cost-effectiveness, and a Likert scale survey was given to the intervention group to evaluate patient satisfaction with the full-service SPB.
Sixteen participants in each arm completed the study; 4 patients in each arm were lost to follow-up. Median adherence was improved for the intervention group compared with the control group (median = 100% vs. 87.4%; = 0.001). The ICER per patient percentage adherence increase was found to be $96.03. Sixty percent of patients in the intervention group who responded to the post-satisfaction survey rated the full SPB service very positively.
In this study, SPB interventions were associated with increased medication adherence and patient satisfaction. This pilot also provides empirical data on the cost-effectiveness of adherence technology used in a specialty pharmacy oncology setting.
This study was supported by Avella Specialty Pharmacy and AdhereTech. All authors are employees of Avella; Eric Sredzinski was an option holder of Avella; and none of the Avella authors had a financial interest in AdhereTech. AdhereTech provided the SPBs and data services for the duration of this study. The authors report no other potential conflicts of interest. Interim study data were presented at the 2016 Southwestern States Residency Conference (SSRC) on June 20, 2016, in Phoenix, AZ.
预计到 2020 年，美国专科药物支出将达到 4000 亿美元，其中肿瘤学的增长显著。新的口服肿瘤学批准使得与医生管理的化疗相比，门诊管理更加方便；然而，当患者在家中服用药物时，可能会遇到坚持用药的挑战。新兴的药物坚持技术（MAT）试图提供家庭用药坚持支持，虽然有一种这样的技术，智能药瓶（SPB），声称可以提高药物坚持性，但很少有研究正式评估其效果。
评估药剂师干预下的 SPB 对新接受来那度胺治疗（≤5 个周期配药）的多发性骨髓瘤（MM）成年患者的药物坚持的影响。次要目标是评估完成的治疗周期，评估实时药剂师参与的意义（仅干预组），确定增量成本效益比（ICER），并评估患者满意度和使用 SPB 的可能性。
这是一项前瞻性、随机分配、单站点和单盲研究，在一家专业药房招募了 40 名新诊断为 MM 的成年患者接受来那度胺治疗。招募工作于 2016 年 1 月至 2 月完成，研究持续时间为 6 个月。参与者以 1:1 的比例随机分为干预组和对照组。干预组接受在激活的 SPB 中给予来那度胺，当每周 SPB 坚持率低于 80%时，会有灯光、钟声、短信提醒和药剂师随访。对照组在所有警报都被停用的相同 SPB 中接受来那度胺。SPB 含有细胞功能，能够进行全天候的数据传输，并在药瓶开盖事件发生时捕获数据。患者坚持性通过将药瓶开盖次数除以每个给药周期的总剂量数来计算。计算完成的来那度胺周期数和药剂师对同一患者的联系次数来确定药剂师的干预次数。计算 ICER 以确定 SPB 的成本效益，并且对干预组进行了 Likert 量表调查，以评估患者对全服务 SPB 的满意度。
每组有 16 名参与者完成了研究；每组有 4 名患者失访。与对照组相比，干预组的坚持用药中位数有所提高（中位数=100%对 87.4%；=0.001）。每个患者坚持用药百分比增加的 ICER 被发现为 96.03 美元。干预组中 60%回答满意度调查的患者对全服务 SPB 给予了非常积极的评价。
在这项研究中，SPB 干预措施与提高药物坚持性和患者满意度有关。该试验还提供了在专业肿瘤学药房中使用坚持技术的成本效益的经验数据。
这项研究得到了 Avella 专业药房和 AdhereTech 的支持。所有作者均为 Avella 的员工；Eric Sredzinski 是 Avella 的期权持有者；Avella 的作者均与 AdhereTech 没有财务利益关系。AdhereTech 为这项研究提供了 SPB 和数据服务。作者报告没有其他潜在的利益冲突。中期研究数据于 2016 年 6 月 20 日在亚利桑那州凤凰城举行的 2016 年西南州住院医师会议（SSRC）上进行了介绍。
