1University of Utah College of Pharmacy, Salt Lake City.
2Novartis Pharmaceuticals, East Hanover, New Jersey.
J Manag Care Spec Pharm. 2019 Aug;25(8):859-866. doi: 10.18553/jmcp.2019.25.8.859.
Discarding unused drugs after dose changes or discontinuation can significantly affect pharmacy budgets. This is especially concerning for expensive oncology agents. However, few economic studies account for drug wastage, providing an inaccurate estimate of a drug's actual economic cost, cost-effectiveness, and value.
To (a) compare the economic impact of drug wastage between ribociclib and palbociclib-clinically similar oral medications for metastatic breast cancer-using 3 approaches (Markov model, pharmacy acquisition cost model, and a retrospective claims analysis) and (b) compare the modeling results with a published estimate of drug wastage for palbociclib from a claims analysis.
A Markov model and a pharmacy acquisitions cost model were developed to evaluate the economic impact of dose reductions for ribociclib and palbociclib over a 1-year time period. Data inputs were pharmacy costs (RED BOOK wholesale acquisition cost) and proportion of patients experiencing dose reductions from either ribociclib randomized clinical trials (MONALEESA-2, -3, or -7) or real-world observational data (Symphony Health retrospective claims analysis). The latter constituted the third approach for quantifying drug wastage. The economic impact of dose reductions for ribociclib and palbociclib in postmenopausal women with previously untreated HR-positive/HER2-negative advanced breast cancer was assessed. Drug wastage was defined as drug doses that could not be used by a patient following a dose reduction. The cost of drug wastage was defined as the cost associated with an unused drug resulting from a dose reduction. The predicted results from the 2 models were compared with a previously published claims analysis that estimated the effect of treatment costs and drug wastage for palbociclib based on the observed dosing patterns from the Symphony Health Solutions database.
In the Markov model, relative to ribociclib, palbociclib users experienced drug wastage of $112,382 total, or $1,124 per treated patient, per year due to dose changes. In the pharmacy acquisition cost model, relative to ribociclib, palbociclib usage was associated with an increased cost of $7,196 per patient per year (based on a mid-cycle dose reduction) comprising dosing-based cost differences and drug wastage cost for palbociclib of $3,727. The previously published claims analysis found that palbociclib users experiencing a dose reduction had drug wastage costs of $5,471 per patient.
In both models, dose reductions for ribociclib patients resulted in no wastage, since unused tablets could be administered in subsequent cycles, while dose reductions for palbociclib resulted in drug wastage and increased costs. The results from both models were consistent with previously published results from the claims analysis, demonstrating drug wastage costs for palbociclib.
This study received financial support from Novartis Pharmaceuticals, which has products approved for treatment of breast cancer. Tang was employed by Novartis during this study; Zacker and Dalal are employed by Novartis and own company stock. Biskupiak, Brixner, and Oderda received payment from Novartis for this study. Brixner serves as a consultant for Millcreek Outcomes Group and also declares consulting fees from Abbvie, AstraZeneca, Abbott, Becton Dickinson, and Xcenda, unrelated to this study.
剂量改变或停药后丢弃未使用的药物会显著影响药房预算。对于昂贵的肿瘤药物来说,这尤其令人担忧。然而,很少有经济研究考虑到药物浪费,从而对药物的实际经济成本、成本效益和价值提供了不准确的估计。
(a)使用 3 种方法(Markov 模型、药房采购成本模型和回顾性索赔分析)比较瑞博西利和帕博西利(转移性乳腺癌的临床相似口服药物)药物浪费的经济影响;(b)将建模结果与来自索赔分析的帕博西利药物浪费的已发表估计进行比较。
开发了 Markov 模型和药房采购成本模型,以评估在 1 年时间内瑞博西利和帕博西利剂量减少的经济影响。数据输入包括药房成本(RED BOOK 批发采购成本)和因瑞博西利随机临床试验(MONALEESA-2、-3 或-7)或真实世界观察数据(Symphony Health 回顾性索赔分析)而经历剂量减少的患者比例。后者构成了量化药物浪费的第三种方法。评估了先前未经治疗的 HR 阳性/HER2 阴性晚期乳腺癌绝经后妇女中瑞博西利和帕博西利的剂量减少的经济影响。药物浪费定义为剂量减少后患者无法使用的药物剂量。药物浪费的成本被定义为因剂量减少而产生的未使用药物的成本。两种模型的预测结果与之前发表的索赔分析进行了比较,该分析基于 Symphony Health Solutions 数据库中观察到的治疗模式,估计了帕博西利治疗成本和药物浪费的影响。
在 Markov 模型中,与瑞博西利相比,由于剂量改变,帕博西利使用者总共经历了 112382 美元的药物浪费,或每个治疗患者每年 1124 美元。在药房采购成本模型中,与瑞博西利相比,帕博西利的使用与每位患者每年增加的 7196 美元的成本相关,其中包括基于剂量的成本差异和帕博西利药物浪费成本 3727 美元。之前的索赔分析发现,经历剂量减少的帕博西利使用者的药物浪费成本为每位患者 5471 美元。
在两种模型中,瑞博西利患者的剂量减少没有造成浪费,因为未使用的片剂可以在后续周期中使用,而帕博西利患者的剂量减少导致药物浪费和成本增加。两种模型的结果都与之前来自索赔分析的结果一致,表明帕博西利的药物浪费成本。
本研究得到诺华制药公司的资助,该公司拥有批准用于治疗乳腺癌的产品。Tang 在这项研究期间受雇于诺华制药公司;Zacker 和 Dalal 受雇于诺华制药公司并拥有公司股票。Biskupiak、Brixner 和 Oderda 因这项研究而获得诺华制药公司的报酬。Brixner 担任 Millcreek Outcomes Group 的顾问,还宣布了与 Abbvie、AstraZeneca、Abbott、Becton Dickinson 和 Xcenda 相关的咨询费,与本研究无关。