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米拉贝隆(一种新型膀胱过度活动症治疗药物)使用率增加的预估预算影响。

Estimated Budget Impact of Increased Use of Mirabegron, A Novel Treatment for Overactive Bladder.

机构信息

1 Medical Decision Modeling, Indianapolis, Indiana.

2 Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana, and Purdue University College of Pharmacy, West Lafayette, Indiana.

出版信息

J Manag Care Spec Pharm. 2016 Sep;22(9):1072-84. doi: 10.18553/jmcp.2016.22.9.1072.

Abstract

BACKGROUND

Oral pharmacological treatment for overactive bladder (OAB) consists of antimuscarinics and the beta-3 adrenergic agonist mirabegron. Antimuscarinic adverse events (AEs) such as dry mouth, constipation, and blurry vision can result in frequent treatment discontinuation rates, leaving part of the OAB population untreated. Antimuscarinics also contribute to a patient's anticholinergic cognitive burden (ACB), so the Beers Criteria recommends cautious use of antimuscarinics in elderly patients who take multiple anticholinergic medications or have cognitive impairment. Since mirabegron does not affect the cholinergic pathways, it is unlikely to contribute to a patient's ACB.

OBJECTIVE

To estimate the health care costs associated with the pharmacological treatment of OAB with mirabegron and antimuscarinics from U.S. commercial payer and Medicare Advantage perspectives, using a budget impact model.

METHODS

For this budget impact model, 2 analyses were performed. The primary analysis estimated the budgetary impact of increasing the use of mirabegron in a closed patient cohort treated with oral pharmacological treatments. The secondary analysis modeled the economic impact in an open cohort by allowing untreated patients to begin treatment with mirabegron after potential contraindication, intolerance, or lack of effectiveness of antimuscarinics. The analyses were performed over a 3-year time horizon. The economic impact of increased mirabegron use was quantified using direct medical costs, including prescription costs and health resource utilization (HRU) costs. Costs of comorbidities included pharmacy and medical costs of treating OAB-related urinary tract infections (UTI), skin rashes, and depression. An analysis of a large single-site integrated health network database was commissioned to quantify ACB-related HRU in terms of the increases in yearly outpatient and emergency department visits. Based on this analysis, the model associated each unit increase in ACB score with increased HRU and probability of mild cognitive impairment. Clinical outcomes of increased use of mirabegron were presented as the number of AEs and comorbidity episodes that could be avoided. One-way sensitivity analyses were performed to quantify the expected budget impact over the range of uncertainty for the key input variables.

RESULTS

Primary analysis calculated the impact of increasing the use of mirabegron from 4.5% to 5.3%, 7.1%, and 9.4% in years 1, 2, and 3, respectively, among oral pharmacological OAB treatments that included generic and branded antimuscarinics: oxybutynin, tolterodine, trospium, darifenacin, fesoterodine, and solifenacin. For a 1 million-member U.S. commercial payer plan, the total prescription costs increased, and the total medical costs decreased during the 3-year time horizon, yielding increases of $0.005, $0.016, and $0.031 from current per member per month (PMPM) costs and $0.90, $2.92, and $5.53 from current per treated member per month (PTMPM) costs, an average of less than 2% of current OAB treatment costs. For the Medicare Advantage plan, the resulting incremental PMPM costs were $0.010, $0.034, and $0.065, and the incremental PTMPM costs were $0.93, $3.04, and $5.76; all were less than 4% of the current cost. The secondary analysis estimated the budgetary effects of reducing the untreated population by 1% annually by initiating treatment with mirabegron. For a commercial payer, this resulted in PMPM cost increases of $0.156, $0.311, and $0.467 from the current value, while the incremental PTMPM cost increased by $6.17, $11.67, and $16.61. For the Medicare Advantage plan, the incremental increases in PMPM costs were $0.277, $0.553, and $0.830, and in PTMPM costs were $6.42, $12.15, and $17.29. Clinically, treating more OAB patients resulted in fewer OAB-related comorbidities from both health plan perspectives, since most events associated with nontreatment could be avoided. In the Medicare Advantage population of the secondary analysis, the total numbers of avoided events were predicted as 452 UTIs, 2,598 depression diagnoses, and 3,020 skin rashes during the time horizon of the model.

CONCLUSIONS

Mirabegron addresses an unmet need for therapy for certain OAB patients, for whom antimuscarinics are not recommended because of a risk of cognitive impairment and who are intolerant to the anticholinergic AEs. Using mirabegron involves moderate additional economic cost to a commercial or Medicare Advantage health plan for which medical cost savings can offset a substantial part of increased pharmacy costs.

DISCLOSURES

Funding for this study was provided by Astellas. Perk, Wielage, T. Klein, and R. Klein are employed by Medical Decision Modeling, a contract research company that was paid to perform the described outcomes research and build the model contained in this study. Campbell and Perkins are employed by the Regenstrief Institute, which conducted a database analysis for this research. Campbell reports consultancy fees from Astellas, as well as pending grants from Merck, Sharpe, and Dohme Corp. Posta, Yuran, and Ng are employed by Astellas Pharma Global Development, the developer of mirabegron. Study concept and design were contributed by Perk, Wielage, R. Klein, and Ng. Campbell, T. Klein, and Perkins took the lead in data collection, assisted by Perk, Wielage, and Ng. Data interpretation was performed by Posta and Yuran, along with Perk, Wielage, R. Klein, Ng, Campbell, and Perkins. The manuscript was written by Perk and R. Klein, along with Wielage, T. Klein, Posta, Yuran, and Ng, and revised by all the authors.

摘要

背景

治疗膀胱过度活动症(OAB)的口服药物治疗包括抗毒蕈碱药物和 β3 肾上腺素能激动剂米拉贝隆。口干、便秘和视力模糊等抗毒蕈碱药物不良反应(AE)可能导致频繁停药,使部分 OAB 患者未得到治疗。抗毒蕈碱药物还会导致患者出现抗胆碱能认知负担(ACB),因此《Beers 标准》建议谨慎使用抗毒蕈碱药物,特别是对于服用多种抗胆碱能药物或有认知障碍的老年患者。由于米拉贝隆不会影响胆碱能途径,因此不太可能导致患者的 ACB。

目的

从美国商业支付者和医疗保险优势计划的角度,使用预算影响模型估算米拉贝隆和抗毒蕈碱药物治疗 OAB 的医疗保健成本。

方法

该预算影响模型进行了两项分析。主要分析估计了在使用口服药物治疗的封闭患者队列中增加米拉贝隆使用的预算影响。次要分析通过允许未经治疗的患者在抗毒蕈碱药物出现禁忌症、不耐受或无效后开始使用米拉贝隆,对开放队列进行了经济影响建模。分析时间跨度为 3 年。米拉贝隆使用增加带来的经济影响通过直接医疗成本来量化,包括处方成本和健康资源利用(HRU)成本。合并症的成本包括治疗与 OAB 相关的尿路感染(UTI)、皮疹和抑郁相关的药物和医疗成本。委托对大型单一地点综合健康网络数据库进行分析,以量化与 ACB 相关的 HRU 增加情况,即门诊和急诊就诊次数的增加。根据这项分析,模型将每个 ACB 评分的增加与 HRU 和轻度认知障碍的可能性相关联。米拉贝隆增加使用带来的临床结果以可以避免的 AE 和合并症发作次数呈现。进行了单因素敏感性分析,以量化关键输入变量不确定性范围内的预期预算影响。

结果

主要分析计算了在口服 OAB 治疗中,包括通用和品牌抗毒蕈碱药物(如奥昔布宁、托特罗定、曲司氯铵、达非那新、非索罗定和索利那新)中,米拉贝隆的使用率从 4.5%增加到 5.3%、7.1%和 9.4%,分别在第 1、2 和 3 年。对于 100 万成员的美国商业支付者计划,在 3 年时间内,总处方成本增加,总医疗成本降低,与当前每成员每月(PMPM)成本相比,增加了 0.005、0.016 和 0.031 美元,与当前每治疗成员每月(PTMPM)成本相比,增加了 0.90、2.92 和 5.53 美元,不到当前 OAB 治疗成本的 2%。对于医疗保险优势计划,增量 PMPM 成本分别为 0.010、0.034 和 0.065 美元,增量 PTMPM 成本分别为 0.93、3.04 和 5.76 美元,均不到当前成本的 4%。次要分析估计通过每年减少 1%的未治疗人群,减少米拉贝隆的预算影响。对于商业支付者,这导致 PMPM 成本从当前值增加了 0.156、0.311 和 0.467 美元,而增量 PTMPM 成本增加了 6.17、11.67 和 16.61 美元。对于医疗保险优势计划,增量 PMPM 成本分别为 0.277、0.553 和 0.830 美元,增量 PTMPM 成本分别为 6.42、12.15 和 17.29 美元。从临床角度来看,从两个健康计划的角度来看,治疗更多的 OAB 患者可减少与未治疗相关的 OAB 合并症,因为大多数与未治疗相关的事件都可以避免。在次要分析的医疗保险优势人群中,预计在模型时间范围内将有 452 例 UTI、2598 例抑郁症诊断和 3020 例皮疹可避免。

结论

米拉贝隆为某些 OAB 患者提供了一种治疗方法,这些患者因认知障碍风险而不建议使用抗毒蕈碱药物,并且对抗胆碱能 AE 不耐受。使用米拉贝隆会给商业或医疗保险优势健康计划带来适度的额外经济成本,但医疗成本的节省可以抵消大部分增加的药房成本。

披露

这项研究的资金由安斯泰来提供。Perk、Wielage、T. Klein 和 R. Klein 受雇于医疗决策建模公司,该公司受雇于进行所描述的结果研究并构建本研究中的模型。坎贝尔和帕金斯受雷根斯特里夫研究所的委托进行这项研究。坎贝尔报告称他有来自安斯泰来、默克、夏普和多赫姆公司的咨询费,以及即将获得的赠款。波斯塔、尤兰和吴是安斯泰来制药全球开发公司的员工,该公司开发了米拉贝隆。概念和设计由 Perk、Wielage、R. Klein 和 Ng 贡献。坎贝尔、T. Klein 和帕金斯带头进行数据收集,由 Perk、Wielage 和 Ng 协助。数据解释由 Posta 和 Yuran 与 Perk、Wielage、R. Klein、Ng、坎贝尔和帕金斯共同进行。手稿由 Perk 和 R. Klein 与 Wielage、T. Klein、Posta、Yuran 和 Ng 共同撰写,并由所有作者修订。

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