在Medicare对二代测序作出全国性覆盖决定后靶向治疗在肺癌中的应用

Background: Despite its clinical importance and growing utilization, access to genomic testing remains uneven, with insurance coverage emerging as a persistent barrier. The Centers for Medicare & Medicaid Services (CMS) implemented a National Coverage Determination (NCD) in March 2018 for genetic testing using next-generation sequencing (NGS). Implementing nationally standardized coverage policy is expected to promote the use of targeted anticancer therapies with proven efficacy. However, whether this policy change increased the use of genomically targeted therapies, which often require testing results for reimbursement, remains unclear. We evaluated the association between the NCD and the use of oral targeted anticancer therapies among Medicare beneficiaries with lung cancer, a disease characterized by a high prevalence of actionable mutations. Methods: We conducted a retrospective cohort study using SEER-Medicare Part D claims from 2016-2020. Medicare beneficiaries aged ≥65 with lung cancer were followed for up to 12 months after diagnosis. The primary outcome was initiation of Medicare Part D-covered oral targeted therapies. Key exposures included (1) diagnosis before vs. after the NCD and (2) whether the beneficiary lived in a region whose Medicare Administrative Contractor (MAC) had NCD-equivalent NGS coverage before 2018. Multivariable logistic regression models adjusted for demographics (age, sex, race/ethnicity), clinical factors (stage, comorbidity, and initial cancer therapy), geographic region, urbanicity, and neighborhood socioeconomic indicators. Results: The cohort included 30,855 beneficiaries with a diagnosis of lung cancer. Overall use of targeted therapies declined over time (7.3% before vs. 6.8% after the NCD). The NCD was not significantly associated with targeted therapy use (p=0.78). However, regional variation was substantial. Compared with beneficiaries in regions with pre-existing NCD-equivalent NGS coverage, those in regions without such coverage had lower baseline targeted therapy use (OR=0.77; 95% CI: 0.62-0.97; p=0.02). Following the NCD, regions that previously lacked NGS coverage experienced a greater increase in targeted therapy use relative to regions with prior coverage (interaction OR=1.24; 95% CI: 1.03-1.51; p=0.03). Conclusions: Medicare's NCD for NGS was not associated with an overall increase in targeted therapy use among beneficiaries with lung cancer, but it reduced regional disparities linked to earlier differences in NGS coverage standards. These findings highlight how pre-existing local coverage policies can shape downstream access to precision oncology treatments even after national policy changes.