Real-world rates,predictors, and associated costs of hypoglycemia among patients with type 2 diabetes mellitus treated with insulin glargine: results of a pooled analysis of six retrospective observational studies

Abstract

Objective:

To evaluate the real-world rates of hypoglycemia and related costs among patients with type 2 diabetes mellitus (T2DM) who initiated insulin glargine with either a disposable pen or vial-and-syringe.

Methods:

Pooled data were evaluated from six previously published, retrospective, observational studies using US health plan insurance claims databases to investigate adults with T2DM who initiated insulin glargine. The current study evaluated baseline characteristics, hypoglycemic events, and costs during the 6 months prior to and 12 months following insulin glargine initiation. Comparisons were made between patients initiating treatment with a disposable pen (GLA-P) and vial-and-syringe (GLA-V). Multivariate analyses using baseline characteristics as covariates determined predictors of hypoglycemia after initiating insulin glargine.

Results:

This study included 23,098 patients (GLA-P: 14,911; GLA-V: 8187). Overall annual prevalence of hypoglycemia was low (6.3% overall, 2.2% related to hospital admission or emergency department visit). Prevalence was significantly lower with GLA-P (5.5% vs 7.7%; p?<?0.0001). Furthermore, average glycated hemoglobin HbA1c reduction was higher with GLA-P (?1.22% vs ?0.86%; p?=?0.0012). The average annual hypoglycemia-related cost associated with initiating insulin glargine was $293, with GLA-P being 46% lower than GLA-V ($225 vs $417; p?=?0.001). Patients who had already developed microvascular complications at the time of initiating insulin therapy were at higher risk for developing hypoglycemia.

Limitations:

This study is limited by the use of retrospective data and ICD-9-CM codes, which are subject to coding error. In addition, this pooled analysis used unmatched cohorts, with multivariate regression analyses employed to adjust for between-group differences. Finally, results describe a managed care sample and cannot be generalized to all patients with T2DM.

Conclusions:

Patients with T2DM initiating insulin glargine treatment showed low rates of hypoglycemia, especially when using a disposable pen device. Hypoglycemia-related costs were low, contributing a very small proportion to overall diabetes-related healthcare costs.     

A systematic review of pharmacoeconomic guidelines

Objective: To review, summarize, and analyze both similarities and differences of pharmacoeconomic (PE) guidelines, to enable researchers to access their characteristics and the current state of PE guidelines; furthermore, to learn which methodological issues still remain contested and to promote the methodological development of PE guidelines.

Materials and methods: The authors performed a search for PE guidelines using PubMed, the Cochrane library database, and the websites of the International Society for Pharmacoeconomics and Outcomes Research. Information of each guideline was extracted using a pre-designed extraction template, which included 22 aspects; the guidelines were summarized in the forms of charts, and their characteristics have been described.

Results: A total of 40 PE guidelines were studied. The most common methodological issues include the types of analysis, sources for effectiveness, use of quality-adjusted life-years (QALYs) to measure outcomes, and use of incremental cost effectiveness ratios to present results. The majority of the guidelines preferred a cost utility analysis with outcomes expressed in terms of QALYs. Most of the guidelines preferred meta-analysis or meta-analysis of the randomized controlled trials, and required a systematic review of all evidence. Issues that varied most in the guidelines were the choice of the comparator, recommended costs to be included, methods related to indirect cost calculations, methods of sensitivity analysis, and discounting rate.

Conclusion: A comparison of these guidelines revealed that a number of differences exist among them in several key aspects, and some critical methodological issues still exist, for which no best solution is available. Furthermore, efforts need to be made to develop harmonious methods for the PE, and to improve the transferability of the outcomes of PE evaluations.     

支付制度、医生的行为与药物经济学的应用

制度影响人们的行为选择,引发不同的效率结果。在医疗卫生市场中,不同的支付制度加上一些其他经济因素,使得追求收益最大化的医生具有不同的目标收益函数和行为选择。这些行为选择对社会而言可能具有效率,也可能无效率。通过比较不同支付制度下医生的行为选择及其是否符合效率准则,我们能够发现对药物经济学应用有利的一些制度因素。     

替格瑞洛与氯吡格雷治疗急性冠脉综合征的药物经济学分析

目的利用模型估计方法评价中国ACS患者使用替格瑞洛与氯吡格雷相比的成本-效果。方法本研究总体研究设计、样本病例入组标准、样本病例数、临床医学中心数、参与国家数、给药方案、主要疗效和安全性指标均基于全球PLATO试验。利用PLATO试验数据和全球卫生经济学评价模型,收集本土的成本数据和外部资源数据,从短期决策树模型和长期Markov模型评价中国ACS患者使用替格瑞洛与氯吡格雷相比的成本-效果。结果基于替格瑞洛治疗ACS的长期Markov模型,与氯吡格雷治疗ACS相比,每延长1个QALY需增加的医疗费用为14094元;以2010年上海市人均GDP为标准,替格瑞洛的ICER远低于1倍人均GDP。结论从卫生服务提供者的角度考虑,在上海等经济状况较好的地区使用替格瑞洛治疗ACS具有较好的成本-效果。     

维格列汀与二甲双胍合用治疗糖尿病的药物经济学研究

目的比较维格列汀、吡格列酮、格列美脲分别与二甲双胍合用治疗2型糖尿病时的效果、成本及成本-效果。方法运用Markov模型对三种治疗方案的终身治疗成本及效用（期望寿命、质量调整寿命年）进行经济学评价,通过文献资料和专家问卷咨询获得临床、生命质量、并发症年治疗成本等数据,进行敏感度分析。结果维格列汀、吡格列酮、格列美脲分别与二甲双胍合用治疗2型糖尿病分别延长11.02、10.96、10.90个质量调整生命年,而生命周期中三种治疗方案的治疗费用分别为124892元、134135元、126010元。敏感度分析证明了结果的可靠性。结论与吡格列酮、格列美脲合并二甲双胍质量相比,维格列汀合并二甲双胍治疗获得的健康效果更好,而治疗成本更低。     

药物经济学研究中离散事件仿真模型应用简介

本文对离散事件仿真模型的基本思想和内容、运算模型的常用软件进行了介绍,并分析和展示了一个基于该模型的药物经济学研究案例。     

Economic evaluation of pharmacological treatments for overactive bladder from the perspective of the UK National Health Service

Abstract

Objective:

To evaluate the costs and outcomes associated with different sequences of oral anti-muscarinic agents and the selective β₃-adrenoceptor agonist, mirabegron, for the treatment of overactive bladder (OAB).     

药物经济学在我国药品定价中应用的定位分析

目的为药物经济学在我国药品定价中的正确应用提供政策建议。方法通过介绍我国药品价格管制措施的局限性,探讨药物经济学在药品定价中应用的可行性及必要性,进一步分析药物经济学在药品定价中应用所需的明确定位。结果与结论在药品定价中药物经济学所评价的药物范围应为新药和专利期内的垄断药品。作为应用主体的定价部门应站在全社会角度通过制定权威的药物经济学评价指南,委托第三方专家组对制药企业提交的药物经济学评价报告进行评估,将评估结果作为药品定价部门与制药企业谈判协商价格时的科学依据,在达到对新药和专利期内垄断药品控费的同时,鼓励药品创新和研发,最终保证患者对药品持续的可及性。     

Budget impact of everolimus for the treatment of progressive,well-differentiated,non-functional neuroendocrine tumors of gastrointestinal or lung origin that are advanced or metastatic

Background: Advanced neuroendocrine tumors (NETs) are a rare malignancy with considerable need for effective therapies. Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2016 for treatment of adults with progressive, well-differentiated, non-functional NETs of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic.

Objective: To assess the 3-year budget impact for a typical US health plan following availability of everolimus for treatment of GI and lung NETs.

Methods An economic model was developed that considered two perspectives: an entire health plan and a pharmacy budget. The total budget impact included costs of drug therapies, administration, hospitalizations, physician visits, monitoring, and adverse events (AEs). The pharmacy model only considered drug costs.

Results: In a US health plan with 1 million members, the model estimated 66 patients with well-differentiated, non-functional, and advanced or metastatic GI NETs and 20 with lung NETs undergoing treatment each year. Total budget impact in the first through third year after FDA approval ranged from $0.0568–$0.1443 per member per month (PMPM) for GI NETs and from $0.0181–$0.0355 PMPM for lung NETs. The total budget impact was lower than the pharmacy budget impact because it included cost offsets from administration and AE management for everolimus compared with alternative therapies (e.g. chemotherapies).

Limitations: Because GI and lung NETs are rare diseases with limited published data, several assumptions were made that may influence interpretation of results.

Conclusions: The budget impact for everolimus was minimal in this rare disease area with a high unmet need, largely due to low disease prevalence. These results should be considered in the context of significant clinical benefits potentially provided by everolimus, including significantly longer progression-free survival (PFS) for advanced GI and lung NET patients.     

药物经济学在药品不良反应评价中的应用

目的：了解将药物经济学（Pharmacoeconomics,PE）原理与方法应用于药品不良反应（ADR）评价的研究进展。方法：查阅文献,对近年药物经济学在ADR中的应用进行综述。结果：总结了药物经济学的概念、原理、研究背景,药物经济学在ADR中的重要意义、作用及应用。结论：开展药物经济学在ADR评价中的应用研究,可为医院管理者提供决策依据。对规范临床药物治疗,提高治疗水平具有指导意义。