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）、肾脏和眼部疾病的重要原因， mortality.糖尿病及其并发症也产生大量的医疗保健利用。药物 有助于糖尿病护理的收益和成本。新的糖尿病药物已经开发出来 但我们对它们的净收益、风险和成本的理解仍然不一致， 有效性这与老年人（≥65岁）尤其相关，因为老年人的获益和风险更精细 平衡临床实践指南建议在所有年龄组中使用二甲双胍进行初始治疗， 不清楚二甲双胍无效时的下一步措施。这是一个频繁的治疗过渡。药物 例如胰高血糖素样肽-1受体激动剂（GLP 1）和钠-葡萄糖共转运蛋白-2抑制剂 （SGLT 2）对CVD和肾脏疾病有良好的效果，但也带来更大的成本和副作用。内 它的使用正在加速。目前还不确定这些药物是否具有特定的优势， 经常使用的仿制药，磺脲类（SU）。因此，我们假设糖尿病药物 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。我们进一步 假设当使用真实世界数据进行研究时，GLP 1和SGLT 2药物将减少主要不良反应 与SU相比，当用作二甲双胍的辅助治疗时，结局和成本效益。 意义：在告知临床和成本效益糖尿病的证据基础方面存在重大差距 老年退伍军人（≥65岁）的治疗决定，其中占VA糖尿病队列的70%以上。 创新和影响：我们将在全国范围内招募大量患有糖尿病的退伍军人样本，这些人患有双重糖尿病。 参加VA/Medicare并应用先进的方法来减少不可测量因素的影响。通过使用 真实世界的数据，我们的研究将增加重要的新信息，通知照顾老年退伍军人，退伍军人事务部的 糖尿病和药学项目，以及临床指南。 具体目标： 目标1.确定SU、GLP 1和SGLT 2的处方模式。我们将检查患者 特征和临床医生处方模式影响启动SU、GLP 1或SGLT 2作为辅助治疗， 二甲双胍。 目标2.估计SU、GLP 1和SGLT 2作为二甲双胍的添加治疗之间的关系， 医疗保健利用和不良后果。使用临床医生处方模式作为工具变量， 我们将测量对急诊科（艾德）就诊、住院、医疗费用 低血糖事件、药物依从性、新发糖尿病并发症和死亡率。 目标3。研究开始SU、GLP 1或SGLT 2作为二甲双胍的添加治疗的成本-效果。 方法：这是一项回顾性观察性研究，来自患者水平的管理数据。 并声称数据来自VA和医疗保险，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-效果分析， 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 在整个项目中提供护理服务（SCC）。在其完成后，我们将与ADS和SCC合作， 教育和传播计划，以告知一线临床医生，专科护理领导和VA决策者。