A Novel Approach to Examine Within-Class Therapeutic Exchangeability of Medications
一种检查药物类内治疗可互换性的新方法
基本信息
- 批准号:10370353
- 负责人:
- 金额:$ 60.8万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-04-01 至 2023-03-31
- 项目状态:已结题
- 来源:
- 关键词:AffectAmputationAnticoagulantsAreaAtherosclerosisAtrial FibrillationAtrial FlutterBrain hemorrhageCardiovascular DiseasesCardiovascular systemCause of DeathCessation of lifeCharacteristicsChronicClinicalClinical MedicineCost SavingsDataDipeptidyl PeptidasesDiseaseDrug InsuranceDrug PrescriptionsDrug usageEconomicsElderlyEnrollmentEnsureEventFaceFormulariesFutureGlucoseHeadHealthcare SystemsHeart failureHydroxymethylglutaryl-CoA Reductase InhibitorsIndividualIschemic StrokeKneeKnowledgeLightManufacturer NameMeasuresMedical RecordsMedicareMedicare claimMeta-AnalysisMethodologyMethodsNatural experimentNon-Insulin-Dependent Diabetes MellitusOralOutcomeOutcome MeasurePatient-Focused OutcomesPatientsPharmaceutical PreparationsPopulationProcessPublic HealthRandomized Controlled TrialsResearchResearch DesignRiskSecondary PreventionSodiumStroke preventionStructureTherapeuticUncertaintyUpdateValidationVariantWithdrawalWorkatorvastatinbasebeneficiaryclinical effectclinically relevantcomparativecomparative effectiveness studycostdata resourcedesigndrug developmenteconomic implicationeconomic incentiveevidence basefinancial incentivehigh riskimprovedindexinginhibitorinnovationnovelnovel strategiesresearch and developmentrosuvastatinstroke risksymportertreatment guidelines
项目摘要
Despite almost complete absence of adequate data from head-to-head randomized controlled trials,
treatment guidelines and prescription drug insurance formularies typically consider individual drugs within
medication classes as equally effective and equally safe. Yet, incorrect assumptions regarding therapeutic
exchangeability expose patients to suboptimal treatments and adverse clinical outcomes, particularly older
adults, who are disproportionately affected by chronic conditions and are the largest per capita consumers of
prescription medications. Despite its substantial clinical and economic implications, therapeutic exchangeability
remains remarkably understudied and represents a problem without a feasible current solution. We thus
propose a novel and feasible approach to evaluate the therapeutic exchangeability of same-class drugs. The
proposed studies will take advantage of natural experiments created by the structure of the Medicare Part D
drug benefit and the variable financial incentives that Part D plans receive from manufacturers. Due to plan-
specific formulary management strategies, Part D enrollees initiating a new medication often face substantially
different out-of-pocket costs for alternative drugs within the same class. The differences in out-of-pocket costs
among alternative same-class drugs among the hundreds of Part D plans will serve as instrumental variables
(IVs). Because these financial incentives strongly affect the choice of one drug of a class over another and are
independent of the patients’ clinical characteristics (as demonstrated by strong preliminary data), they facilitate
valid IV estimation. Outcome validation from primary medical records and cause of death data from the
National Death Index further improve the rigor of the study. Using existing data on >22 million Medicare beneficiaries, the proposed study will examine 4 carefully selected drug classes to establish a new methodological
framework for the systematic assessment of within-class therapeutic exchangeability from observational data:
1) direct oral anticoagulants (DOACs) for stroke prevention in atrial fibrillation or atrial flutter, 2) dipeptidyl
peptidase 4-inhibitors (DPP-4s) for type 2 diabetes, 3) high potency statins for secondary prevention of atherosclerotic cardiovascular (CV) disease, and 4) sodium-glucose co-transporter-2 inhibitors (SGLT-2s) for type 2
diabetes. These were selected based on explicit criteria: high rates of use in Part D beneficiaries, uncertainty
about therapeutic exchangeability within the class, sufficient variation in out-of-pocket costs among alternative
agents, and ability to validly measure outcomes in Medicare claims. We included examples with strong priors
against (DPP-4s and CV outcomes) and for (SGLT-2s and amputations) within-class differences to show we
can reproduce expected findings, and others for which differences are uncertain (e.g., DOACs and ischemic
stroke). This proposal begins a highly promising novel line of work to feasibly generate valid and critically
needed evidence on therapeutic exchangeability within widely-used drug classes among older adults, serve as
the basis for future confirmatory studies, and improve clinical medicine, patient outcomes, and public health.
尽管几乎完全没有来自面对面的随机对照试验的足够数据,
治疗指南和处方药保险处方通常考虑个别药物在
药物被归类为同样有效和同样安全。然而,关于治疗的错误假设
可互换性使患者面临不理想的治疗和不良的临床结果,尤其是老年人
成年人,他们受慢性病的影响不成比例,是最大的人均
处方药。尽管它具有重大的临床和经济影响,但治疗的可互换性
仍然明显缺乏研究,代表着一个没有可行的当前解决方案的问题。因此,我们
提出了一种新的、可行的评价同类药物治疗互换性的方法。这个
拟议的研究将利用由联邦医疗保险D部分的结构创造的自然实验
药品福利和D部分计划从制造商那里获得的可变财务激励。由于计划-
具体的处方管理策略,启动新药的D部分参与者通常面临大量
同一类别内替代药物的不同自付成本。自付成本的差异
在数百种D部分计划中的替代同类药物中,D部分计划将作为工具变量
(静脉注射)。因为这些经济激励强烈地影响着一类药物的选择,而不是另一类药物的选择
与患者的临床特征无关(如强有力的初步数据所证明的),它们有助于
有效的静脉输液估计。来自初级医疗记录和死因数据的结果验证
国家死亡指数进一步提高了研究的严谨性。利用2200万医疗保险受益人的现有数据,这项拟议的研究将检查4个精心挑选的药物类别,以建立一种新的方法
根据观察数据对类内治疗互换性进行系统评估的框架:
1)直接口服抗凝剂(DOAC)用于预防心房颤动或心房扑动中的卒中,2)二肽
用于2型糖尿病的多肽酶4抑制剂(DPP-4s),3)用于二级预防动脉粥样硬化性心血管(CV)疾病的高效他汀类药物,以及4)用于2型糖尿病的钠-葡萄糖共转运体-2抑制剂(SGLT-2s)
糖尿病。这些选择是基于明确的标准:D部分受益者使用率高,不确定性
关于类别内的治疗互换性,不同选择方案之间自付成本的充分差异
代理商,以及有效衡量医疗保险索赔结果的能力。我们列举了有很强前科的例子
反对(DPP-4和CV结果)和(SGLT-2和截肢)阶级内差异,以表明我们
可以复制预期的结果,以及其他差异不确定的结果(例如DOAC和缺血
笔划)。这项提议开始了一项非常有希望的新工作,以可行地产生有效和关键的
在老年人中广泛使用的药物类别中,需要证明治疗互换性的证据如下
为未来的验证性研究奠定基础,并改善临床医学、患者结局和公共卫生。
项目成果
期刊论文数量(0)
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Tobias Gerhard其他文献
Tobias Gerhard的其他文献
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{{ truncateString('Tobias Gerhard', 18)}}的其他基金
A Novel Approach to Examine Within-Class Therapeutic Exchangeability of Medications
一种检查药物类内治疗可互换性的新方法
- 批准号:
10599249 - 财政年份:2020
- 资助金额:
$ 60.8万 - 项目类别:
Strengthening the Evidence-Base for Drug-Disease Interactions in Older Adults
加强老年人药物与疾病相互作用的证据基础
- 批准号:
10115556 - 财政年份:2019
- 资助金额:
$ 60.8万 - 项目类别:
Strengthening the Evidence-Base for Drug-Disease Interactions in Older Adults
加强老年人药物与疾病相互作用的证据基础
- 批准号:
10617649 - 财政年份:2019
- 资助金额:
$ 60.8万 - 项目类别:
Strengthening the Evidence-Base for Drug-Disease Interactions in Older Adults
加强老年人药物与疾病相互作用的证据基础
- 批准号:
10348720 - 财政年份:2019
- 资助金额:
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Safety of Second Generation Antipsychotics for Adult Depression
第二代抗精神病药治疗成人抑郁症的安全性
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8875778 - 财政年份:2014
- 资助金额:
$ 60.8万 - 项目类别:
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