Monoclonal Antibodies in Cancer Care: Is Underinsurance An Access Barrier?

描述（由申请人提供）：与几种创新癌症疗法相关的高成本，尤其是单克隆抗体（mab），引起了人们的关注，即使在有保险的癌症患者中，由于相关的高额自付，mab可能在经济上无法负担。如此高的费用造成了一个脆弱的癌症患者群体，被称为“保险不足”。我们研究的目的是使用索赔数据来检查创新单克隆抗体制剂在65岁以下有私人保险的癌症患者中的扩散；探讨保险不足是否可能构成获得这些新疗法的障碍；并确定它们对癌症治疗成本的影响。本研究有五个具体目的：(1)描述有私人保险的非老年癌症患者使用单抗的趋势；(2)检查单抗使用模式是否因患者特征和/或保险慷慨程度而异，在已批准单抗使用适应症的癌症类型中；(3)估计单抗对癌症治疗成本的影响，以及单抗适应症批准使用的癌症类型的成本随时间的增长；(4)确定与标签外单抗使用相关的因素；(5)估计癌症治疗的总成本和成本随时间的增长，并确定相关的成本驱动因素。对于每个研究目标，将采用适当的计量经济学方法来分析与单抗使用和癌症治疗费用相关的因素。将对所有癌症进行单独的分析，并对最有可能用单克隆抗体治疗的三种癌症部位进行分析：非霍奇金淋巴瘤、结直肠癌和乳腺癌。随着免疫疗法，特别是单克隆抗体在癌症治疗中变得越来越重要，本研究将为政策制定者提供最新治疗创新在癌症患者中的传播以及单克隆抗体等创新药物对癌症治疗成本的影响的信息。这些信息将有助于预测癌症的未来成本。这项研究的发现还将提醒决策者注意由于获取障碍而可能无法从创新药物（如单克隆抗体）中获益的患者亚组。

DESCRIPTION (Provided by the Applicant): The high costs associated with several innovative cancer therapies, most notably monoclonal antibodies (mAbs), have raised a concern that even among cancer patients with insurance, mAbs may be financially unaffordable due to the associated high out-of-pocket payment. Such high costs create a vulnerable group of cancer patients known as the "under-insured." The objectives of our study are to use claims data to examine the diffusion of innovative monoclonal antibody agents among cancer patients younger than 65 years who have private insurance; to explore whether underinsurance may constitute a barrier to the access of these novel therapies; and to determine their impact on the costs of cancer care. The study has five specific aims: (1) to describe the trend of mAb use among non-elderly cancer patients with private insurance; (2) to examine whether mAb utilization patterns differ by patient characteristics and/or insurance generosity in the types of cancer with approved indication for mAb use; (3) to estimate the impact of mAbs on the costs of cancer care and cost increases over time in the types of cancer with approved indication for mAb use; (4) to determine factors associated with off-label mAb use; (5) to estimate the overall costs of cancer care and cost increases over time and to ascertain the associated cost drivers. For each study aim, appropriate econometric methods will be applied to analyze factors associated with mAb use, and cancer treatment costs. Separate analyses will be performed for all cancers, and for each of the three cancer sites that are most likely to be treated with mAbs: non-Hodgkin's lymphoma, colorectal cancer, and breast cancer. As immunotherapy, in particular, mAbs, becomes increasingly important in cancer care, this study will inform policymakers of the diffusion of recent therapeutic innovations among cancer patients and the impact of innovative agents such as mAbs on the costs of cancer care. This information will help project the future costs of cancer. Findings from this study will also alert policymakers to the subgroups of patients who may not benefit from innovative agents such as mAbs due to access barriers.