Comparative and cost effectiveness of diabetes medications

糖尿病药物的比较和成本效益

• 批准号: 10417481
• 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/10417481
• 关键词: Academic Detailing; Adherence; Affect; Aftercare; Agonist; Ambulatory Care; Area; Attenuated; Benefits and Risks; Cardiovascular Diseases; Caring; Characteristics; Chronic Kidney Failure; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical effectiveness; Complex; Complications of Diabetes Mellitus; Congestive Heart Failure; Cost Effectiveness Analysis; Costs and Benefits; Data; Diabetes Mellitus; Disease Progression; Education; Elderly; Emergency department visit; Enrollment; Equilibrium; Event; Eye diseases; GCG gene; 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; Lead; Life Expectancy; Measures; Medicare; Metformin; Methodology; Methods; Modeling; Neuropathy; Observational Study; Outcome; Patients; Pattern; Pharmaceutical Preparations; Pharmacy facility; Provider; Quality-Adjusted Life Years; Quasi-experiment; Retinal Diseases; Risk Factors; Sampling; Services; Sodium; Subgroup; Sulfonylurea Compounds; Techniques; Treatment Protocols; Uncertainty; Veterans; Work; adverse outcome; age group; cardiovascular disorder risk; care costs; care systems; clinical practice; cohort; comorbidity; comparative cost effectiveness; comparative effectiveness; cost; 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糖尿病的重要原因。 糖尿病及其并发症也产生了大量的医疗保健利用率。 已开发出新的糖尿病药物，以提高糖尿病护理的效益和成本。 并上市，但我们对它们的净收益、风险和成本的理解仍然不匹配—— 有效性对于老年人（≥65 岁）尤其重要，因为老年人的益处和风险更加明确。 临床实践指南建议所有年龄组均使用二甲双胍进行初始治疗，但这是平衡的。 不清楚二甲双胍无效时的后续步骤 这是一种频繁的治疗转换。 例如胰高血糖素样肽 1 受体激动剂 (GLP1) 和钠-葡萄糖协同转运蛋白 2 抑制剂 (SGLT2) 对心血管疾病和肾脏疾病有良好的效果，但也带来更大的成本和副​​作用。 VA，它们的使用正在加速，目前还不确定这些药物是否比其他药物具有特定的优势。 常用的仿制药，磺酰脲类药物 (SU) 因此，我们寻求糖尿病药物。 使用受到患者因素和提供者实践模式的复杂相互作用的影响。 研究发现，当使用真实世界数据进行研究时，GLP1 和 SGLT2 药物将减少主要不良反应 当用作二甲双胍的附加治疗时，与 SU 相比，具有良好的结果和成本效益。 意义：为临床和经济有效的糖尿病提供信息的证据基础存在重大差距 老年退伍军人（≥65 岁）的治疗决策，其中超过 70% 属于 VA 糖尿病队列。 创新和影响：我们将在全国范围内雇用大量患有糖尿病的退伍军人样本，他们患有双重疾病 加入 VA/Medicare 并应用先进方法来减少未测量因素的影响。 真实世界的数据，我们的研究将添加重要的新信息，为老年退伍军人、退伍军人事务部的护理提供信息 糖尿病和药学计划以及临床指南。 具体目标： 目标 1. 确定 SU、GLP1 和 SGLT2 的处方模式 我们将检查患者的程度。 特征和临床医生处方模式影响启动 SU、GLP1 或 SGLT2 作为附加方案 二甲双胍。 目标 2. 估计 SU、GLP1 和 SGLT2 作为二甲双胍附加药物使用之间的关系 使用临床医生处方模式作为工具变量， 我们将衡量对急诊科 (ED) 就诊、住院、医疗费用的影响， 低血糖事件、药物依从性、新的糖尿病并发症和死亡率。 目标 3. 研究启动 SU、GLP1 或 SGLT2 作为二甲双胍附加药物的成本效益。 方法：这是一项对来自患者层面管理的二手数据的回顾性观察研究 以及来自 VA 和 Medicare 的索赔数据，并使用涉及工具变量的准实验设计。 我们将使用 IQVIA 核心糖尿病模型 (CDM) v9.0 进行成本效益分析，该模型是 经过充分验证的马尔可夫模型。 后续步骤/实施： 我们将与药房福利管理学术详细服务 (ADS) 和 VA Specialty 合作 整个项目完成后，我们将与 ADS 和 SCC 合作开发。 教育和传播计划，为一线人员、专业护理领导者和退伍军人事务部决策者提供信息。