1 Comprehensive Health Insights, Louisville, Kentucky.
2 Astellas Pharma Global Development, Northbrook, Illinois.
J Manag Care Spec Pharm. 2017 Jan;23(1):27-37. doi: 10.18553/jmcp.2017.23.1.27.
The impact of formulary management strategies on utilization and expenditures in overactive bladder (OAB) treatment has not been extensively investigated. In 2013, step therapy (ST) policies for 2 branded OAB treatments, mirabegron and fesoterodine, were removed from Humana Medicare Advantage Prescription Drug (MAPD) plans and Medicare prescription drug plans (PDP), allowing for an examination of the effect of ST policies on OAB medication use patterns and costs.
To assess the impact of removal of formulary restriction policies for mirabegron and fesoterodine on medication utilization patterns and costs associated with OAB treatment in Medicare patients.
A retrospective cross-sectional study design was utilized. Subjects included individuals enrolled in Humana MAPD plans or PDPs, aged ≥ 65 years, with ≥ 1 prescription for an OAB medication in 2013. Patient demographic characteristics, OAB medication utilization, and pharmacy cost trends in 2013 were described. OAB medication use was calculated as the number of 30-day-supply equivalent medication claims and reported as a percentage of the total number of 30-day-supply equivalent claims across all OAB products. OAB medication expenditures were calculated as a percentage of the sum of pharmacy costs for OAB medications and reported separately for each month and drug during 2013. Temporal trends of OAB medication utilization and expenditures in 2013 were calculated using ordinary least squares regression.
Of 194,511 patients, trends in utilization of OAB medications indicated that on average, there was a statistically significant monthly increase in utilization of mirabegron (regression coefficient [B] = 274; P < 0.001; 95% CI: 218, 330), fesoterodine (B = 167; P < 0.001; 95% CI = 129, 205), oxybutynin extended release (ER; B = 357; P = 0.011; 95% CI = 99, 614), and trospium ER (B = 33; P = 0.001; 95% CI = 17, 50) and statistically significant decreases in utilization of solifenacin (B = -202; P = 0.048; 95% CI = -402, -2), tolterodine ER (B = -287; P = 0.002; 95% CI = -437, -137), darifenacin (B = -94; P < 0.001; 95% CI = -128, -61), and trospium immediate release (IR; B = -22; P = 0.001; 95% CI = -32, -12). Total OAB medication expenditures significantly increased an average of 0.12% for each month during the course of 2013 (B = 0.12; P = 0.026; 95% CI = 0.017, -0.223). While monthly oxybutynin IR utilization did not change significantly throughout 2013 (B = 228; P = 0.169; 95% CI = -114, -570), it demonstrated the largest average monthly expenditure increase (B = 0.082; P < 0.001; 95% CI = 0.056, 0.108). When removing oxybutynin IR costs from the total OAB medication costs, the trend in total OAB medication average monthly expenditures was not significant (B = 0.038; P = 0.365; 95% CI = -0.051, -0.126). An over 4-fold per-unit-cost increase for oxybutynin IR was noted.
Utilization of 2 branded OAB products increased in the months after ST removal with minimal cost impact. One of the possible reasons total OAB expenditures increased may have been due to the increased cost of the largest-volume generic product, oxybutynin IR.
This research was funded by Astellas Pharma Global Development and was conducted as part of the Astellas-Humana Research Collaboration. Ng, Kristy, Schermer, and Bradt are employees of Astellas. Astellas manufactures mirabegron (Myrbetriq) and solifenacin (VESIcare). Abbass, Caplan, Collins, and Suehs are employees of Comprehensive Health Insights, a subsidiary of Humana, which received funding from Astellas for this study. Suehs owns stock in Humana. Chan is an employee of Humana Pharmacy Solutions. Portions of this study were presented as a poster at Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; Orlando, Florida. Study concept and design were contributed by Ng, Chan, Suehs, and Abbass, along with Collins. Abbass took the lead in data collection, along with Collins and with assistance from Caplan, Chan, and Suehs. Data interpretation was provided by Kristy and Bradt, along with Abbass, Caplan, Ng, Suehs, Collins, and Chan. The manuscript was written primarily by Caplan, along with Schermer, Suehs, and Abbass, and revised by Caplan, Schermer, and Ng, along with the other authors.
药物处方管理策略对治疗膀胱过度活动症（OAB）的利用和支出的影响尚未得到广泛研究。2013 年，2 种品牌 OAB 治疗药物米拉贝隆和非索罗定的阶梯治疗（ST）政策从 Humana Medicare Advantage 处方药（MAPD）计划和 Medicare 处方药计划（PDP）中删除，这使得可以检查 ST 政策对 OAB 药物使用模式和成本的影响。
评估米拉贝隆和非索罗定的处方限制政策取消对 Medicare 患者 OAB 治疗相关药物使用模式和成本的影响。
采用回顾性横截面研究设计。研究对象包括 2013 年在 Humana MAPD 计划或 PDP 中登记、年龄≥65 岁且有≥1 种 OAB 药物处方的患者。描述患者人口统计学特征、OAB 药物使用情况和 2013 年的药房费用趋势。OAB 药物使用量计算为 30 天供应量等效药物的索赔数量，并作为所有 OAB 产品的 30 天供应量等效索赔数量的百分比报告。OAB 药物支出作为 OAB 药物药房费用的百分比报告，并分别报告每月和每种药物在 2013 年的支出。使用普通最小二乘法回归计算 2013 年 OAB 药物使用和支出的时间趋势。
在 194511 名患者中，OAB 药物利用趋势表明，平均而言，米拉贝隆（回归系数[B]=274；P<0.001；95%置信区间[CI]：218，330）、非索罗定（B=167；P<0.001；95%CI=129，205）、奥昔布宁缓释（B=357；P=0.011；95%CI=99，614）和曲司氯铵缓释（B=33；P=0.001；95%CI=17，50）的使用每月呈统计学显著增加，而索利那新（B=-202；P=0.048；95%CI=-402，-2）、托特罗定缓释（B=-287；P=0.002；95%CI=-437，-137）、达非那新（B=-94；P<0.001；95%CI=-128，-61）和曲司氯铵即时释放（B=-22；P=0.001；95%CI=-32，-12）的使用每月呈统计学显著减少。2013 年期间，OAB 药物总支出平均每月增加 0.12%（B=0.12；P=0.026；95%CI=0.017，-0.223）。虽然 2013 年期间奥昔布宁 IR 的每月利用量没有显著变化（B=228；P=0.169；95%CI=-114，-570），但它的平均每月支出增长最大（B=0.082；P<0.001；95%CI=0.056，0.108）。当从 OAB 药物总支出中去除奥昔布宁 IR 成本时，OAB 药物总支出的平均每月支出趋势不显著（B=0.038；P=0.365；95%CI=-0.051，-0.126）。奥昔布宁 IR 的单位成本增加了 4 倍以上。
ST 取消后，2 种品牌 OAB 产品的使用量增加，对成本的影响很小。OAB 总支出增加的一个可能原因是最大剂量的通用产品奥昔布宁 IR 的成本增加。
本研究由 Astellas Pharma Global Development 资助，是 Astellas-Humana 研究合作的一部分。Ng、Schermer 和 Bradt 是 Astellas 的员工。Astellas 生产米拉贝隆（Myrbetriq）和索利那新（VESIcare）。Abbass、Caplan、Collins 和 Suehs 是 Astellas 全资子公司 Comprehensive Health Insights 的员工，该公司为这项研究向 Astellas 提供了资金。Suehs 拥有 Humana 的股票。Chan 是 Humana Pharmacy Solutions 的员工。本研究的部分内容作为海报在 Academy of Managed Care Pharmacy Nexus 2015 上展示；2015 年 10 月 26-29 日；佛罗里达州奥兰多。研究概念和设计由 Ng、Chan、Suehs 和 Abbass 提出，Collins 也参与了该设计。Abbass 主要负责数据收集，同时 Collins 还得到了 Caplan、Chan 和 Suehs 的协助。数据解释由 Kristy 和 Bradt 提供，同时 Abbass、Caplan、Ng、Suehs、Collins 和 Chan 也参与了数据解释。手稿主要由 Caplan 撰写，同时 Schermer、Suehs 和 Abbass 也参与了手稿的撰写，并由 Caplan、Schermer 和 Ng 进行了修订，其他作者也对其进行了修订。
