Wilkes University, Nesbitt School of Pharmacy, Wilkes-Barre, PA.
Geisinger Center for Health Research, Department of Population Health Sciences, Danville, PA.
J Manag Care Spec Pharm. 2021 Jul;27(7):846-854. doi: 10.18553/jmcp.2021.27.7.846.
Nonmedical formulary switches (NMFS) routinely occur in managed health care plans and involve changing preferred medications for reasons outside of clinical considerations. The cost implications of NMFS are infrequently published and the clinical outcomes rarely assessed. To assess the real-world clinical and cost implications of an NMFS involving sitagliptin and linagliptin. An NMFS was made to the Geisinger Health Plan (GHP) commercial, health care reform, and Medicaid formularies on February 1, 2018, involving a change in preferred medication from sitagliptin to linagliptin. Claims data from GHP and clinical information from electronic health records of the Geisinger Health System were used to evaluate the cost and clinical impact of this change. Patients aged 18 years or older who were continuously enrolled in a GHP commercial, health care reform, or Medicaid plan throughout the entire study period and had at least 1 fill for sitagliptin during the preswitch phase were included in the study. We investigated the differences in various clinical and economic outcomes from pre- to postswitch among those who switched and remained adherent to the new preferred therapy throughout the 12-month postperiod ("linagliptin switch" group) and patients who did not ("other switch" group). Clinical outcomes included all-cause hospitalization, diabetes-related hospitalization, and glycosylated hemoglobin (HbA1c), while economic measures included changes in per member per month (PMPM) spending. The negative binomial regression model was used to estimate utilization counts. A generalized linear model with a log link and gamma distribution was used to analyze cost data. 1,203 patients met the inclusion criteria. Of these, 501 (41.6%) individuals switched to and remained at least 80% adherent to linagliptin in the postperiod, while 702 (58.4%) did not. No difference between groups was found when comparing the pre- to postswitch change in all-cause hospitalization (incidence rate ratio (IRR) = 1.46, 95% CI = 0.66-3.23, = 0.3436) or diabetes-related hospitalization (IRR = 1.39, 95% CI = 0.62-3.10, = 0.4203). Additionally, no difference was found between groups regarding the change in HbA1c 12-month postswitch compared with baseline (difference between groups = -0.10%, 95% CI = -0.39%-0.19%, = 0.4962). Total PMPM spending was 43% higher in the other switch group compared with the linagliptin switch group (IRR = 1.43, 95% CI = 1.25-1.63, < 0.0001). This trend was driven by 92% higher medical PMPM spending in the other switch group compared with the linagliptin switch group (IRR = 1.92, 95% CI = 1.58-2.33, < 0.0001) but was offset by 12% lower pharmacy PMPM spending in the other switch group (IRR = 0.88, 95% CI = 0.82-0.95, = 0.0009). An NMFS from sitagliptin to linagliptin resulted in overall health plan savings with no significant changes in health outcomes. Funding for this study was provided by Geisinger Health System, which had no role in the study outside of a final review of the submitted manuscript. Johns and Gionfriddo are Geisinger employees. The authors report no financial conflicts of interest.
非医疗处方切换(NMFS)在管理式医疗保健计划中经常发生,涉及出于临床考虑以外的原因更换首选药物。NMFS 的成本影响很少公布,临床结果也很少评估。为了评估涉及西他列汀和利拉利汀的 NMFS 的实际临床和成本影响。2018 年 2 月 1 日,对 Geisinger Health Plan(GHP)商业、医疗改革和医疗补助处方进行了 NMFS,涉及将首选药物从西他列汀改为利拉利汀。使用 GHP 的索赔数据和 Geisinger 医疗系统电子健康记录中的临床信息来评估这种变化的成本和临床影响。在整个研究期间,年龄在 18 岁或以上且一直连续参加 GHP 商业、医疗改革或医疗补助计划的患者,并且在预切换阶段至少有一次西他列汀的配药,均符合研究条件。我们研究了切换前后 12 个月内那些对新首选治疗方案保持依从性的患者(“利拉利汀切换”组)和那些没有的患者(“其他切换”组)的各种临床和经济结果从预到后的差异。临床结果包括全因住院、糖尿病相关住院和糖化血红蛋白(HbA1c),而经济措施包括每会员每月(PMPM)支出的变化。负二项回归模型用于估计利用计数。使用对数链接和伽马分布的广义线性模型来分析成本数据。共有 1203 名患者符合纳入标准。其中,501 名(41.6%)患者切换并在 12 个月的后期间至少保持 80%的利拉利汀依从性,而 702 名(58.4%)患者则没有。在比较全因住院的预到后变化时,两组之间没有发现差异(发病率比(IRR)= 1.46,95%CI = 0.66-3.23,= 0.3436)或糖尿病相关住院(IRR = 1.39,95%CI = 0.62-3.10,= 0.4203)。此外,两组之间在 12 个月的 HbA1c 后与基线相比没有发现变化(组间差异= -0.10%,95%CI = -0.39%-0.19%,= 0.4962)。与利拉利汀切换组相比,其他切换组的总 PMPM 支出高出 43%(IRR = 1.43,95%CI = 1.25-1.63,<0.0001)。这种趋势主要是由于其他切换组的医疗 PMPM 支出高出 92%,而利拉利汀切换组的医疗 PMPM 支出高出 12%(IRR = 0.88,95%CI = 0.82-0.95,= 0.0009)。从西他列汀到利拉利汀的 NMFS 导致了总体健康计划的节省,而健康结果没有显著变化。本研究的资金由 Geisinger 医疗系统提供,该系统除了对提交的手稿进行最终审查外,在研究中没有任何作用。约翰斯和吉翁弗里多是 Geisinger 的员工。作者报告没有财务利益冲突。