{"title":"医疗保险受益人的抗癌药物支出:分析药物支出的预测因素。","authors":"","doi":"10.1016/j.jcpo.2024.100509","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the factors associated with Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021.</div></div><div><h3>Patient and methods</h3><div>Using a cross-sectional analysis, we searched US FDA new oncology drug approvals (2012–2021). We analyzed clinical attributes and institutional factors influencing the annual cost of new anticancer drugs in the US. Annual treatment cost was calculated based on average spending per beneficiary from the Centers for Medicare and Medicaid Services, with product factors sourced from the FDA’s annual New Drug Therapy Approval reports and drug package inserts at the time of approval.</div></div><div><h3>Results</h3><div>Over a ten-year period, 112 new anticancer drugs were approved, of which 97 met the study's criteria. A significant majority, 93 %, received expedited development designations from the FDA. At the time of approval, 40 % of these drugs had data on progression-free survival, and 19 % had data on overall survival; 29 % were first-in-class. The study found a significant relationship between the year of approval and factors associated with the size of the treatment population. No statistically significant relationship was found between the clinical value of a drug and its price.</div></div><div><h3>Conclusions</h3><div>Spending on anticancer drugs by Medicare are predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value. The study advocates for reforms in reimbursement mechanisms for drugs lacking comparator arms and greater transparency for patients treated with these drugs.</div></div>","PeriodicalId":38212,"journal":{"name":"Journal of Cancer Policy","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Spending on anticancer drugs among Medicare beneficiaries: Analyzing predictors of drug expenditures\",\"authors\":\"\",\"doi\":\"10.1016/j.jcpo.2024.100509\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>To evaluate the factors associated with Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021.</div></div><div><h3>Patient and methods</h3><div>Using a cross-sectional analysis, we searched US FDA new oncology drug approvals (2012–2021). We analyzed clinical attributes and institutional factors influencing the annual cost of new anticancer drugs in the US. Annual treatment cost was calculated based on average spending per beneficiary from the Centers for Medicare and Medicaid Services, with product factors sourced from the FDA’s annual New Drug Therapy Approval reports and drug package inserts at the time of approval.</div></div><div><h3>Results</h3><div>Over a ten-year period, 112 new anticancer drugs were approved, of which 97 met the study's criteria. A significant majority, 93 %, received expedited development designations from the FDA. At the time of approval, 40 % of these drugs had data on progression-free survival, and 19 % had data on overall survival; 29 % were first-in-class. The study found a significant relationship between the year of approval and factors associated with the size of the treatment population. No statistically significant relationship was found between the clinical value of a drug and its price.</div></div><div><h3>Conclusions</h3><div>Spending on anticancer drugs by Medicare are predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value. The study advocates for reforms in reimbursement mechanisms for drugs lacking comparator arms and greater transparency for patients treated with these drugs.</div></div>\",\"PeriodicalId\":38212,\"journal\":{\"name\":\"Journal of Cancer Policy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-10-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cancer Policy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2213538324000432\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH POLICY & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cancer Policy","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2213538324000432","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 0
摘要
目的:评估 2012 年至 2021 年美国新批准的抗癌药物医疗保险支出的相关因素:评估 2012 年至 2021 年美国新批准的抗癌药物医疗保险支出的相关因素:通过横断面分析,我们检索了美国 FDA 批准的新抗肿瘤药物(2012-2021 年)。我们分析了影响美国抗癌新药年度成本的临床属性和机构因素。年治疗成本根据医疗保险和医疗补助服务中心(Centers for Medicare and Medicaid Services)提供的每位受益人的平均支出计算,产品因素则来自美国食品与药物管理局(FDA)的年度新药治疗审批报告和批准时的药品包装说明书:十年间,共有 112 种抗癌新药获得批准,其中 97 种符合研究标准。其中绝大多数(93%)获得了美国食品及药物管理局的加速开发指定。在获得批准时,其中 40% 的药物拥有无进展生存期数据,19% 的药物拥有总生存率数据;29% 的药物属于一类新药。研究发现,批准年份与治疗人群规模的相关因素之间存在显著关系。在药物的临床价值和价格之间没有发现明显的统计学关系:医疗保险对抗癌药物的支出主要取决于参考定价和预期治疗人群的规模,而与治疗价值无关。该研究提倡对缺乏参照物的药物进行报销机制改革,并为接受这些药物治疗的患者提供更大的透明度。
Spending on anticancer drugs among Medicare beneficiaries: Analyzing predictors of drug expenditures
Objective
To evaluate the factors associated with Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021.
Patient and methods
Using a cross-sectional analysis, we searched US FDA new oncology drug approvals (2012–2021). We analyzed clinical attributes and institutional factors influencing the annual cost of new anticancer drugs in the US. Annual treatment cost was calculated based on average spending per beneficiary from the Centers for Medicare and Medicaid Services, with product factors sourced from the FDA’s annual New Drug Therapy Approval reports and drug package inserts at the time of approval.
Results
Over a ten-year period, 112 new anticancer drugs were approved, of which 97 met the study's criteria. A significant majority, 93 %, received expedited development designations from the FDA. At the time of approval, 40 % of these drugs had data on progression-free survival, and 19 % had data on overall survival; 29 % were first-in-class. The study found a significant relationship between the year of approval and factors associated with the size of the treatment population. No statistically significant relationship was found between the clinical value of a drug and its price.
Conclusions
Spending on anticancer drugs by Medicare are predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value. The study advocates for reforms in reimbursement mechanisms for drugs lacking comparator arms and greater transparency for patients treated with these drugs.