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Luciene Schluckebier

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-045 - Companion Diagnostic Tests for EGFR, ALK and ROS-1 vs NGS in Advanced NSCLC Patients - Which Is the Best in Terms of Cost and Effective? (ID 10464)

      09:30 - 16:00  |  Presenting Author(s): Luciene Schluckebier

      • Abstract

      Success of a target therapy is directly correlated with the accuracy of its companion diagnostic test. Without a corresponding biomarker, target therapy may yield shorter survival, waste time, increase burdens and costs. As important as conducting cost-effectiveness studies for therapies, it is also valuable to compare different molecular tests. In lung cancer, the mutational status of EGFR and translocation of ALK and ROS-1 are commonly tested to offer the best intervention. Our objective is to evaluate the cost-effectiveness of a unique exam using NGS versus other routinely used tests such as the ones which involve RT-PCR and FISH.

      Target population is NSCLC, adenocarcinoma, and candidates to first-line therapy. Strategy 1: test EGFR mutation if EGFR test negative, individual follow to FISH for ALK; if FISH negative, follow to FISH for ROS-1. Strategy 2: differs from 1 since FISH for ALK and ROS are requested together. Strategy 3: all individuals are submitted to NGS (multicomplex platform which include EGFR/ALK/ROS-1 and other genes). Prevalence of biomarker, test accuracy and proportion of unknown results were used to calculate each decision tree branch. Sensitivity and specificity was obtained from literature review using Sanger as reference standard for RT-PCR tests and NGS. The study was analyzed from a healthcare-payer perspective based on Brazilian private sector. Costs were based on data from diagnostic companies, ANS and AMB-CBHPM 2016. Survival time and utilities were based from randomized clinical trials. Decision tree model was designed to select an appropriate treatment regimen according to test results; and microsimulation model (M) simulate costs and survival from the corresponding treatment. If EGFR test was positive, M1: gefitinib 1Âșline>pemetrexed+cisplatin>docetaxel; if ALK or ROS1 were positive, M2: crizotinib1Âșline>pemetrexed+cisplatin>docetaxel; if EGFR/ALK/ROS negative or test unknow, M3: pemetrexed+cisplatin>docetaxel>gemcitabine.

      The use of NGS added 24% extra cases correct identified as well as extra costs (US$ 800.76; PPP 2015) attributed to the molecular testing. The ICER comparing NGS with sequential tests was US$ 3,381.82/correct case detected. Comparing strategy 2:1, the ICER was US$937.86/correct case detected. Therefore, when treatment was incorporated into the model, the effectiveness was diluted between arms. The NGS improves slight gain in life years and quality-adjusted life years, but this could be explained by minor differences in global survival time between treatments.

      : this study is part of an effort to integrate companion diagnostics discussions on precision medicine and covered drugs in the Brazilian health system. Studies considering liquid biopsy could be worth value to highlight effectiveness between tests in clinical routine.