Multilevel factors associated with disparities in the use of targeted cancer therapies in Medicare

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ABSTRACT This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA- 23-044. Identification of patients with pathogenic variants is crucial to enable the use of treatment and guide prevention. Yet, there are important racial disparities in genomic cancer medicine: for example, Black persons experience significant disparities in access to germline cancer genomic services and bear the largest cancer mortality burden of any racial/ethnic group. Preliminary evidence suggests that there may also be disparities in the use of genomically-targeted therapies. While the parent R01 focuses on well-known disparities in germline cancer genomic risk testing, considerably less is known about whether there are disparities in the use of genomically-targeted cancer therapies. We will assess these disparities and the potentially important role of health policy factors as they relate to disparities among cancer cases ages in Medicare. In March 2018, to improve Medicare beneficiaries’ access to targeted genomic cancer therapies, CMS issued a national coverage determination (NCD) paying for Next Generation Sequencing (NGS) based tumor genomic tests for patients with advanced or metastatic cancer and no previous NGS testing. Implementing the new payment policy by Medicare is intended to increase the use of genomically-targeted cancer treatments. However, little is known about how the implementation of the national policy for NGS testing has influenced disparities in the use of genomically-targeted therapies. To inform future healthcare coverage policies around genomic cancer medicine, it is important to assess whether the coverage policy equitably addresses access to effective treatment, given the disparities observed in both genetic testing and targeted treatments. This study will address this gap. Using the most recent five years of SEER-Medicare Part D data, we will first document whether the implementation of NCD for NGS testing has increased the use of genomically-targeted therapies. Then, we will examine whether there are racial and socio-economic disparities in the use of these therapies, accounting for the 2018 NCD for NGS testing. The use of selected genomically-targeted oral anticancer drugs before vs. after the NCD will be the primary outcome of interest. Policy-level variables will include health insurance factors such as patients’ Medicare Advantage enrollment, low-income subsidy status, and patients with coordination of benefits from third parties. The specific aims of the proposed study are to 1) compare the use of orally administered genomically-targeted cancer agents among Medicare beneficiaries before and after the implementation of the 2018 NCD policy for NGS testing; 2) examine racial-ethnic and socioeconomic disparities in the use of oral genomically-targeted cancer drugs associated with insurance benefit designs. Findings from this study can be used to inform policy decisions for advancing cancer health equity and improving access to genomically-targeted cancer therapies. This approach could be applied to other drugs and genomic medications, as well as value-based healthcare initiatives.