● The results of this study suggest that using the prognostic test to guide ACT decisions in NSCLC is cost-effective compared to a SoC approach according to globally accepted thresholds ● To compare the cost-effectiveness of a prognostic test based on cancer stage and a cell cycle progression expression signature vs. standard of care (SoC) in guiding ACT decisions in stage I/II NSCLC Cost-Utility Analysis of a Prognostic Test for early stage non-small cell lung cancer (NSCLC) BACKGROUND CONCLUSIONS ● Early stages of NSCLC have a poor prognosis (5-year mortality for stages I and II being 40% and 66%, respectively), which may indicate some of these patients may be high risk and would benefit from adjuvant chemotherapy (ACT) 1 ● ACT has been shown to reduce the risk of recurrence in patients with stage II disease, but there is unclear evidence for ACT use in stage I and limited guidance exists when deciding to treat patients with ACT in early NSCLC 2 ● A novel prognostic test has been developed by Myriad Genetics, Inc. to predict the risk of mortality in early-stage NSCLC with adenocarcinoma histology to inform the use of ACT in these patients 3 1. Custodio AB, et al. J Thorac Oncol Pignon JP, et al. J Clin Oncol Wistuba, et al. Clin Cancer Res Pepek JM, et al. J Thorac Oncol Williams BA, et al. Ann Thor Surg Shimada Y, et al. Chest Fox KM, et al. Am J Manag Care Cipriano LE, et al. Value Health Jang RW, et al. J Clin Oncol =1&acrdn=2#reqid=12&step=3&isuri=1&1203=16 =1&acrdn=2#reqid=12&step=3&isuri=1&1203= Zhu CQ, et al. J Clin Oncol DISCUSSION 1. Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT, USA; 2. Huntsman Cancer Institute, Salt Lake City, UT, USA; 3. Myriad Genetic Laboratories, Inc., Salt Lake City, UT, USA; 4. Institute of Public Health, Medical Decision Making and Health Technology Assessment, Tirol, Austria; 5. ONCOTYROL - Center for Personalized Cancer Medicine, Area 4 Health Technology Assessment and Bioinformatics, Innsbruck, Austria; 6. Center for Health Decision Science, Harvard School of Public Health, Boston, MA, USA; 7. Institute for Technology Assessment and Department of Radiology, Harvard Medical School, Boston, MA, USA; 8. Program in Personalized Health Care, University of Utah, Salt Lake City, UT, USA Stenehjem DD 1,2, Bellows BK 1, Kaldate R 3, Jones JT 3, Yager K 3, Siebert U 4-7, Brixner DI 1,2,4,8 OBJECTIVE METHODS ● A Markov model was created to compare the prognostic test to SoC (Figure 1) and consisted of four health states (Figure 2) ● The model was analyzed using a microsimulation of 10,000 patients from a U.S. third-party payer perspective over a lifetime horizon ● Model outcomes included costs, in 2011 US dollars, and effectiveness, in quality-adjusted life-years (QALYs) ● Each patient had a composite prognostic score calculated from disease stage and a cell cycle progression (CCP) gene signature score ● 5-year mortality risk was calculated using the prognostic score and patients were classified as high risk if their 5- year mortality was >22% ● Distribution of NSCLC patients by stage was obtained from the Huntsman Cancer Institute (HCI) tumor registry ● Probability of receiving ACT was calculated from NSCLC patients treated at HCI and was estimated from a survey of 101 physicians and varied dependent upon disease stage and risk classification RESULTS Table 1. Total Cost, Total Effectiveness, and Incremental Cost-Effectiveness Values Table 3. Alternate Time Horizons Figure 3. One-Way Sensitivity Analyses Tornado Diagram Copies of this poster obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without permission from AMCP and the authors of this poster. REFERENCES CostsInc. CostsQALYsInc. QALYs ICER ($/QALY) Overall Prognostic test$131,528$9, $34,334 SoC$121, Stage Ia Prognostic test$112,150$5, $37,215 SoC$106, Stage Ib Prognostic test$140,859$14, $26,530 SoC$126, Stage IIa Prognostic test$170,978$12, $58,844 SoC$158, Stage IIb Prognostic test$146,214$10, $48,848 SoC$135, Costs Inc. Costs QALYs Inc. QALYs ICER ($/QALY) 5 Years Prognostic test $69,420$6, $127,310 SoC$63, Years Prognostic test $100,768$6, $48,150 SoC$94, Figure 4. Cost-Effectiveness Acceptability Curve Figure 2. Health State Transition Diagram Table 2. Alternate ACT Treatment Benefits ● Cost of the prognostic test provided by Myriad; costs and utility values were derived from the literature 7,8,9 ● Costs were inflated to 2011 US$ using Personal Consumption Expenditure where needed 10 ; costs and QALYs were discounted at a 3% annual rate ● One-way and probabilistic sensitivity analyses (SA) examined the relative impact of model inputs Figure 1. Schematic Diagram of the Decision Analytic Model ● Probability of adverse events due to ACT and stopping ACT early were derived from literature 1 ● Benefit of ACT treatment was based on disease stage and CCP score 3 ; ACT treatment benefits from alternate sources were also assessed 1,11 (Table 2) ● Risk of non-cancer death, NSCLC-related death, cancer recurrence, and death after recurrence were derived from literature 1,4,5,6 ● Utility of not having cancer after receiving ACT and ACT treatment benefit were the largest drivers of uncertainty in the model and warrant further study ● Future research should examine how using the prognostic test changes ACT treatment decisions ● In the base case model, 42.6% of patients received ACT in the prognostic test arm and 27.3% in the SoC arm ● Overall lifetime costs were $131,528 and $121,914 and total QALYs gained were 5.45 and 5.17 for the prognostic test and SoC, respectively (Table 1) ● Incremental cost-effectiveness ratio (ICER) for the prognostic test compared to SoC was $34,334/QALY gained (Table 1) ● One-way SA indicated the utility value associated with not having cancer after receiving ACT was the largest driver of cost- effectiveness (Figure 3) ● The ICER ranged from $33,489-$66,824/QALY gained when alternate sources of ACT treatment benefit were used (Table 2) ● The ICER changed to $127,310 and $48,150 when a 5 and 10 year time horizon was utilized, respectively (Table 3) ● The mean ICER from the probabilistic SA was $37,408/QALY gained ● The prognostic test was cost-effective in 65.9% and 89.1% of simulations at a willingness-to-pay threshold of $50,000 and $100,000/QALY, respectively (Figure 4) ACT No Cancer Cancer Recurrence Death ICER (Prognostic test vs. SoC) when risk of NSCLC-related death derived from: Base-case 3 LACE 1 JBR-10 risk groups 11 JBR-10 risk groups by stage 11 Overall$34,334$66,824$33,489$36,451 Stage Ia$37,215$123,656$32,588$34,251 Ib$26,530$47,673$25,339$28,540 IIa$58, 844$90,803$60,046$55,386 IIb$48,848$65,498$47,806$47,205 QR Code