Real-world costs and outcomes associated with biomarker testing by comprehensive genomic profiling (CGP) and non-CGP approaches among patients with metastatic non-small cell lung cancer (mNSCLC).
Authors: DaCosta Byfield Stacey , Bapat Bela , Becker Laura , Reyes Carolina , Chatzitheofilou Ismini , Hostin Damon , Schroeder Brock , Fox John Leonard 
Published: July 2024

e20598 Background: Guideline-recommended molecular testing is essential for identifying appropriate targeted therapies (Rx) for treatment of mNSCLC patients (pts). Biomarker testing can be performed by single gene tests, small NGS panels (e.g., < 50 genes), or CGP approaches. There is little evidence on the rate of biomarker testing in the real world setting and the impact of different approaches on Rx utilization and cost of care. This study examined real-world utilization of biomarker testing among mNSCLC pts and outcomes with CGP and non-CGP testing. Methods: De-identified administrative claims data from the Optum Labs Data Warehouse were analyzed to identify newly diagnosed adult mNSCLC pts from 1/2018 to 8/2021; the date of the first claim indicating metastasis was the index date. Continuous enrollment in a commercial (COM) or Medicare Advantage (MA) plan with medical and pharmacy benefits for 12 mo prior to (baseline), and ≥6 mo post index date (follow-up) was required; pts with < 6 mo follow-up due to death were included. Initiation of a line of therapy (LOT1) during follow-up was required. We categorized pts based on receipt and type of biomarker testing prior to LOT1: CGP ( > 50 gene panel), non-CGP (5-50 gene panels or single gene testing), or no testing. Differences in receipt of targeted Rx, overall survival (OS), and total overall per patient per month (PPPM) costs during LOT1 were examined with multivariable regression analyses. Results: 9,945 mNSCLC pts (1,970 COM, 7,975 MA) were identified: 5,484 with no testing, 2,215 with CGP, and 2,246 with non-CGP testing prior to LOT1. Biomarker testing rates prior to LOT1 were low (45%) but increased during the study period from 42% to 48% (p <0.01). Testing rates were higher for the COM vs MA population (49% vs 44%, p <0.01). A higher percent of pts with CGP received targeted Rx compared to the non-CGP and no testing group (17% vs 11% and 5% respectively, p< 0.01); after adjustment, CGP pts were still more likely to receive targeted Rx. Compared to the no testing group, OS was more favorable for the CGP [HR 0.8, 95% CI 0.8-0.9] and non-CGP [HR 0.9, 95% CI 0.8-0.9] groups. There was no significant difference in PPPM costs between tested groups: CGP [CR 1.2, 95%CI 1.1-1.2] vs non-CGP [CR 1.1, 95%CI 1.1-1.2]. Conclusions: Rates of biomarker testing among mNSCLC pts are far from optimal despite well-established guideline recommendations and insurance coverage for testing. There was evidence of improved intermediate outcomes (receipt of targeted Rx) with CGP compared to non-CGP or no testing. In addition, OS was improved for tested pts compared to untested. Interventions to help improve biomarker testing are needed. Given the potential benefits of CGP testing (including assessment of biomarkers that cannot be evaluated using small panels), increasing CGP testing may improve outcomes.