Comparative and cost effectiveness of diabetes medications

糖尿病药物的比较和成本效益

• 批准号: 10620191
• 负责人: PAUL R CONLIN
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10620191
• 关键词: Academic Detailing; Acceleration; Adherence; Affect; Agonist; Ambulatory Care; Area; Attenuated; Benefits and Risks; Blood Vessels; Cardiovascular Diseases; Caring; Characteristics; Chronic Kidney Failure; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical effectiveness; Collaborations; Complex; Complications of Diabetes Mellitus; Congestive Heart Failure; Cost Effectiveness Analysis; Costs and Benefits; Data; Diabetes Mellitus; Disease Progression; Dual Enrollment; Education; Elderly; Emergency department visit; Equilibrium; Event; Eye diseases; GLP-I receptor; Glucose; Glycosylated hemoglobin A; Goals; Guidelines; Health; Health Care Costs; Health Personnel; Healthcare Systems; Heart failure; Hospitalization; Hyperglycemia; Hypoglycemia; Incidence; Kidney Diseases; Life Expectancy; Marketing; Measures; Medicare; Metformin; Methodology; Methods; Modeling; Neuropathy; Observational Study; Outcome; Patients; Pattern; Pharmaceutical Preparations; Pharmacy facility; Policy Maker; Provider; Quality-Adjusted Life Years; Quasi-experiment; Recommendation; Retinal Diseases; Risk; Risk Factors; Risk Reduction; Sampling; Services; Sodium; Subgroup; Sulfonylurea Compounds; Techniques; Treatment Protocols; Uncertainty; Veterans; Work; adverse outcome; age group; cardiovascular disorder risk; care costs; care systems; cohort; comorbidity; comparative effectiveness; cost; cost comparison; cost effective; cost effectiveness; cost-effectiveness ratio; diabetes risk; economic evaluation; evidence base; health care service utilization; improved outcome; incremental cost-effectiveness; inhibitor; innovation; insight; markov model; medical specialties; medication compliance; mortality; mortality risk; pharmacy benefit; programs; risk/benefit ratio; side effect; symporter

Background: Diabetes is a significant cause of cardiovascular disease (CVD), kidney and eye diseases, and mortality. Diabetes and its complications also generate substantial healthcare utilization. Medications contribute to both the benefits and costs of diabetes care. Newer diabetes medications have been developed and marketed, but there remains a mismatch in our understanding of their net benefits, risks, and cost- effectiveness. This is particularly relevant for older adults (≥65 years), where benefits and risks are more finely balanced. Clinical practice guidelines recommend initial treatment with metformin across all age groups but are unclear about next steps when metformin is ineffective. This is a frequent treatment transition. Medications such as glucagon-like peptide-1 receptor agonists (GLP1) and sodium-glucose co-transporter-2 inhibitors (SGLT2) have favorable effects on CVD and renal disease but also carry greater costs and side-effects. Within VA, their usage is accelerating. It remains uncertain if these medications have specific advantages over the frequently used generic medications, sulfonylureas (SU). Thus, we hypothesize that diabetes medication usage is influenced by a complex interplay of patient factors and provider practice patterns. We further hypothesize that when studied using real-world data, GLP1 and SGLT2 medications will reduce major adverse outcomes and be cost-effective in comparison to SU when used as add-on treatment to metformin. Significance: There are major gaps in the evidence base that informs clinical and cost-effective diabetes treatment decisions among older Veterans (≥65 years), which comprise >70% of the VA diabetes cohort. Innovation and Impact: We will employ a large nationwide sample of Veterans with diabetes who are dually enrolled in VA/Medicare and apply advanced methods to reduce the impact of unmeasured factors. By using real-world data, our study will add significant new information that informs the care of older Veterans, VA’s diabetes and pharmacy programs, and clinical guidelines. Specific Aims: Aim 1. Determine prescribing patterns for SU, GLP1 and SGLT2. We will examine the extent to which patient characteristics and clinician prescribing patterns influence initiating an SU, GLP1 or SGLT2 as add-on to metformin. Aim 2. Estimate the relationships between SU, GLP1, and SGLT2 usage as add-on to metformin with healthcare utilization and adverse outcomes. Using clinician prescribing patterns as an instrumental variable, we will measure the effects on emergency department (ED) visits, hospitalizations, healthcare costs, hypoglycemia events, medication adherence, new diabetes complications and mortality. Aim 3. Investigate the cost-effectiveness of initiating an SU, GLP1 or SGLT2 as add-on to metformin. Methodology: This is a retrospective observational study of secondary data from patient-level administrative and claims data from VA and Medicare, and uses a quasi-experimental design involving instrumental variables. We will conduct the cost-effectiveness analyses using the IQVIA Core Diabetes Model (CDM) v9.0, which is a well-validated Markov model. Next Steps/Implementation: We will collaborate with Pharmacy Benefits Management Academic Detailing Service (ADS) and VA Specialty Care Services (SCC) throughout the project. At its completion we will work with ADS and SCC to develop education and dissemination plans to inform front-line clinicians, specialty-care leads and VA policymakers.

背景：糖尿病是心血管疾病（CVD），肾脏和眼部疾病以及 死亡。糖尿病及其并发症也会产生大量的医疗保健利用。药物 促进糖尿病护理的收益和成本。已经开发了较新的糖尿病药物 并被销售，但我们对他们的净福利，风险和成本的理解仍然不匹配 效力。这尤其与老年人（≥65岁）有关，其中收益和风险更细微 均衡。临床实践指南建议在所有年龄组中对二甲双胍进行初始治疗，但 关于二甲双胍无效的下一步尚不清楚。这是一个经常的治疗过渡。药物 例如胰高血糖素样肽-1受体激动剂（GLP1）和钠 - 葡萄糖转移蛋白-2抑制剂 （SGLT2）对CVD和肾脏疾病有利，但成本和副作用也更高。之内 VA，它们的用法正在加速。这些药物是否比 经常使用的通用药物，磺酰尿菌（SU）。那我们假设糖尿病药物 用法受患者因素和提供者实践模式的复杂相互作用的影响。我们进一步 假设在使用现实世界数据研究时，GLP1和SGLT2药物将减少主要对立 与SU相比，结果和成本效益，用作二甲双胍的附加处理。 意义：证据基础上存在主要差距，以告知临床和具有成本效益的糖尿病 老年退伍军人（≥65岁）的治疗决定，其中占VA糖尿病队列的70％。 创新和影响力：我们将采用大量的国家退伍军人样本，他们的糖尿病是双重的 参加VA/Medicare并采用高级方法来减少未衡量的因素的影响。通过使用 现实世界中的数据，我们的研究将添加重要的新信息，以告知老年退伍军人的护理 糖尿病和药房计划以及临床指南。 具体目的： 目标1。确定SU，GLP1和SGLT2的处方模式。我们将检查患者的程度 特征和临床处方模式影响启动SU，GLP1或SGLT2作为附加组件 二甲双胍。 目标2。估计SU，GLP1和SGLT2用法之间的关系是与二甲双胍的附加组件 医疗保健利用和不良结果。使用临床处方模式作为仪器变量， 我们将衡量对急诊科（ED）访问，住院，医疗保健费用的影响， 低血糖事件，药物依从性，新糖尿病并发症和死亡率。 AIM 3。研究启动SU，GLP1或SGLT2的成本效益作为二甲双胍的附加成本。 方法论：这是一项回顾性的观察性研究，对患者级行政的辅助数据 并索赔来自VA和Medicare的数据，并使用准实验设计涉及仪器变量。 我们将使用IQVIA核心糖尿病模型（CDM）v9.0进行成本效益分析，这是一个 经过验证的马尔可夫模型。 下一步/实施： 我们将与药房福利管理学术细节服务（ADS）和VA专业合作 整个项目的护理服务（SCC）。完成后，我们将与广告和SCC合作开发 教育和传播计划为前线临床医生，专科服务线索和VA决策者提供信息。