Medicare Drug Benefits and High Cost Medications: Antipsychotics Under Part D

医疗保险药物福利和高成本药物：D 部分下的抗精神病药物

基本信息

批准号：
8196947
负责人：
Vicki Fung
金额：
$ 57.86万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-12-01 至 2013-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8196947
关键词：
Accident and Emergency department Adherence Affect Antipsychotic Agents Caring Cessation of life Characteristics Chronic Clinical Cohort Studies Complex Cost Savings Cost Sharing Costs and Benefits Data Diagnosis Drug Prescriptions Drug Utilization Drug usage Enrollment Event Face Formularies Healthcare Hospitalization Income Inpatients Insurance Link Low income Medical Medicare Mental Health Mental disorders Methods National Formulary Outcome Outpatients Patients Pharmaceutical Preparations Pharmacotherapy Pharmacy facility Policies Population Population Study Probability Psychiatric Diagnosis Psychotropic Drugs Regimen Risk Sampling Savings Schizophrenia Structure Time Variant Visit adverse outcome alternative treatment base beneficiary cost design economic outcome evidence base experience federal poverty level improved mortality programs public health relevance trend

项目摘要

DESCRIPTION (provided by applicant): In 2006, Medicare introduced Part D outpatient prescription drug benefits, which could have significant implications for patients requiring chronic and high cost drug therapy, such as antipsychotics. Medicare provides formulary protection for antipsychotics; however, these drugs are subject to potentially substantial and complex cost-sharing requirements included in many Part D plans, such as spending-based coverage gaps. In general, coverage limits have been associated with decreases in necessary drug use, increases in adverse clinical events, and increases in medical costs that offset pharmacy cost savings; however, there is a dearth of evidence on the effects of Part D benefit policies on patients prescribed antipsychotics. This study will examine the impact of Part D coverage on 1) drug use and adherence; 2) adverse clinical events, including emergency department visits, hospitalizations and death; and 3) medical spending, including out-of-pocket drug spending, and pharmacy, outpatient, inpatient, and total medical costs. The study population includes beneficiaries receiving antipsychotics (n=43,217 in 2007) who are enrolled in Medicare Advantage Prescription Drug plans offered by two large Part D sponsors, 2004-2010. It includes plans that vary in cost-sharing levels during the gap, beneficiaries receiving low income subsidies (37% of the sample), and beneficiaries with employer- sponsored insurance, whose benefits do not include a gap or change over time to control for secular trends. We will compare beneficiaries with higher versus lower Part D cost-sharing (e.g., basic gap vs. no gap), as well as examine the impact of low income cost-sharing subsidies. The study period includes two years pre-Part D, 2004-2005, and five years post-Part D, 2006-2010. We will use fixed-effects (conditional) estimation methods to examine changes in annual outcomes associated with Part D cost-sharing levels, as well as within-year, temporal changes associated with the coverage gap (e.g., before and after the reaching the gap). Defining the study cohort based on drug class is consistent with the level at which Medicare has made national formulary policy; however, because we expect the impact of cost-sharing to vary by the clinical appropriateness of antipsychotic use and the availability of treatment alternatives, we will assess variations by psychiatric diagnosis. We will adjust for relevant demographic, clinical, and plan characteristics using Medicare Prescription Drug Event files, as well as plan membership, clinical encounter, and pharmacy data. This study provides a unique opportunity to link Part D drug utilization with clinical event and medical spending data for a large, well-defined population of Medicare beneficiaries prescribed antipsychotic drug therapy. The study findings may inform improvements to the program, such as the need for specific cost-sharing exemptions (e.g., value-based benefit designs), completely or partially filling in the coverage gap, or targeted subsidy expansions, to reduce unintended consequences and improve the value of Part D for beneficiaries using antipsychotics. PUBLIC HEALTH RELEVANCE: Nearly all Medicare Part D drug plans involve substantial and complex patient cost-sharing, including a coverage gap or donut hole. Patients prescribed antipsychotic drug therapy for mental illness may be particularly vulnerable to limited drug coverage; however, little is known about their experiences under Part D. This study will examine the effects of Part D cost-sharing, overall and by psychiatric diagnosis, on drug use, adverse clinical events, and medical spending using comprehensive automated data from before and after the introduction of Part D for a well-defined population of beneficiaries prescribed antipsychotics.

描述（由申请人提供）：2006年，Medicare引入了D部分门诊处方药益处，这可能对需要慢性和高成本药物治疗的患者（例如抗精神病药）具有重要影响。 Medicare为抗精神病药提供了配方保护；但是，这些药物受到许多D部分计划中包含的潜在且复杂的成本分担要求，例如基于支出的覆盖差距。通常，覆盖范围与必要的药物使用的减少，不良临床事件的增加以及抵消药房节省成本的医疗成本增加有关；但是，缺乏证据表明D部分受益政策对处方抗精神病药的患者的影响。这项研究将研究D部分覆盖范围对1）吸毒和依从性的影响； 2）不良临床事件，包括急诊室就诊，住院和死亡； 3）医疗支出，包括自付费用支出，以及药房，门诊，住院和总医疗费用。该研究人群包括接受抗精神病药（2007年n = 43,217）的受益人，这些受益人已入学了Medicare Advantage Presscription药物计划，由两个大型D赞助商提供，2004 - 2010年。它包括在差距期间成本分布水平的计划，受益人获得低收入补贴（占样本的37％）以及与雇主赞助保险的受益人，其利益不包括随着时间的流逝或改变时间的变化来控制世俗趋势。我们将比较受益人与较高的D和D部分成本分担（例如，基本差距与无差距），并研究低收入成本分担补贴的影响。研究期包括2004 - 2005年第2年前的两年和五年后，D年后D年，2006- 2010年。我们将使用固定效应（条件）估计方法来检查与D部分成本分担水平以及与覆盖差距相关的年度变化相关的年度结果的变化（例如，在达到差距之前和之后）。基于药物类别的研究队列与Medicare制定国家配方政策的水平一致；但是，由于我们期望成本分布的影响会因抗精神病药使用的临床适当性和治疗替代方案而有所不同，因此我们将通过精神病诊断评估变化。我们将使用Medicare处方药事件文件以及计划会员资格，临床遭遇和药房数据来调整相关的人口，临床和计划特征。这项研究提供了一个独特的机会，将D部分药物利用与临床事件和医疗支出数据联系起来，用于大量，定义明确的医疗保险受益人处方的抗精神病药疗法。该研究结果可能会为该计划的改进提供信息，例如需要特定的成本分担豁免（例如，基于价值的福利设计），完全或部分填补了覆盖范围或有针对性的补贴扩张，以减少意外后果并改善使用AntipsyChotics的受益人的D部分的价值。公共卫生相关性：几乎所有Medicare D部分药物计划都涉及大量且复杂的患者成本分担，包括覆盖差距或甜甜圈孔。为精神疾病开出的抗精神病药疗法的患者可能特别容易受到有限的药物覆盖范围。然而，这项研究对他们的经验知之甚少，这项研究将研究D部分成本共享，整体和精神诊断，吸毒，不良临床事件以及使用全面的自动化数据在引入D部分的全面自动化数据的影响，以在对良好定义的受益人中引入D部分的全面自动化数据。