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S.D. Ramsey

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    P1.06 - Poster Session 1 - Prognostic and Predictive Biomarkers (ID 161)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P1.06-050 - Cost-Effectiveness of the Pervenio™ Risk-Score (RS) Assay in Early-Stage Non-Small Cell Lung Cancer (ID 2904)

      09:30 - 16:30  |  Author(s): S.D. Ramsey

      • Abstract

      Life Technologies Clinical Services Laboratory has developed a 14-gene molecular assay (Pervenio[TM] Lung RS) that provides mortality risk stratification in resected early-stage non-squamous non-small cell lung cancer (NSCLC). The test classifies patients as low, intermediate, or high-risk (for death), informing decisions about use of adjuvant chemotherapy. Accordingly, a high-risk sub-group can be identified to receive chemotherapy, and a low-risk sub-group can avoid chemotherapy-associated morbidity and costs. The objective of this study was to evaluate the cost-effectiveness of the Pervenio[TM] assay in Stage I/II NSCLC relative to standard care.

      We developed a Markov model to estimate life expectancy, quality-adjusted life-years (QALYs), and costs for Pervenio[TM] testing versus standard care. Risk-group classification was based on Pervenio[TM] validation studies, and chemotherapy uptake was based on a study of pre/post testing recommendations from 58 surgeons and oncologists. We derived overall chemotherapy benefit from Lung Adjuvant Cisplatin Evaluation (LACE) database disease-free survival hazard ratios. In the Pervenio[TM] strategy, we differentially distributed chemotherapy benefit across risk groups, with high-risk patients deriving the greatest benefit, intermediate-risk patients deriving moderate benefit, and low-risk patients experiencing the least benefit (Table 1). Included costs were those related to the Pervenio[TM] test, chemotherapy with cisplatin+vinorelbine, monitoring, post-recurrence care, and chemotherapy adverse events. We calculated the incremental cost-effectiveness ratio (ICER), and evaluated uncertainty using one-way and probabilistic sensitivity analyses. We also evaluated non-predictive and strong predictive (based on Zhu et al.’s JBR.10 reanalysis) chemotherapy benefit scenarios. Our analyses used a lifetime horizon, a payer perspective, and a 3% discount rate.Figure 1

      The Pervenio[TM] and standard care strategies resulted in 55% and 33% of patients receiving chemotherapy, respectively. Life year, QALY, and cost outcomes are displayed in Table 1. The corresponding base case Pervenio[TM] strategy ICER was $22,270/QALY (Stage I: $29,210/QALY; Stage II: $12,190/QALY). One-way sensitivity analyses demonstrated that the proportion of high-risk patients receiving chemotherapy and the high-risk recurrence hazard ratio were the most influential inputs. Probabilistic sensitivity analyses demonstrated that the Pervenio[TM] strategy was cost-effective at a willingness to pay threshold of $50,000/QALY in 68% of simulations.

      The results of our analysis suggest that in the U.S., the Pervenio[TM] Lung RS assay may be a cost-effective alternative to a standard care strategy in early-stage NSCLC. Future studies should evaluate the presence and magnitude of a differential chemotherapy benefit by risk group and post-testing chemotherapy preferences,as these were key determinants of model results.