Daniel A Goldstein1, Qiushi Chen2, Turgay Ayer2, David H Howard3, Joseph Lipscomb3, R Donald Harvey4, Bassel F El-Rayes4, Christopher R Flowers4. 1. Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA. Electronic address: dgolds8@emory.edu. 2. H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, Atlanta, GA. 3. Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA; Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA. 4. Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
Abstract
BACKGROUND: Dosing chemotherapy based on BSA results in marked interindividual variability in drug exposure. A randomized trial showed increased OS and decreased toxicity with PK-guided compared with BSA-based 5-FU dosing in patients with mCRC. The objective of this study was to compare the cost effectiveness of PK-based 5-FU dosing with BSA-based 5-FU dosing in patients with mCRC receiving FOLFOX (5-FU, leucovorin, and oxaliplatin). MATERIALS AND METHODS: We developed a Markov model to evaluate the cost effectiveness of PK FOLFOX compared with BSA FOLFOX. Progression risks and cause-specific mortality were extrapolated from the fitted survival models. Costs for administration and management of adverse events were estimated based on 2013 Medicare reimbursement rates and average sale prices. RESULTS: PK FOLFOX provided 2.03 QALYs at a cost of $50,205 compared with BSA FOLFOX, which provided 1.46 QALYs at a cost of $37,173. The incremental cost-effectiveness ratio (ICER) was $22,695 per QALY. The ICER remained < $50,000 per QALY in all univariate and multivariate sensitivity analyses. CONCLUSION: At a $50,000 per QALY threshold, PK FOLFOX is cost effective for mCRC. Because of the cost effectiveness profile and OS advantage with PK FOLFOX, it should be evaluated further in comparative effectiveness studies.
BACKGROUND: Dosing chemotherapy based on BSA results in marked interindividual variability in drug exposure. A randomized trial showed increased OS and decreased toxicity with PK-guided compared with BSA-based 5-FU dosing in patients with mCRC. The objective of this study was to compare the cost effectiveness of PK-based 5-FU dosing with BSA-based 5-FU dosing in patients with mCRC receiving FOLFOX (5-FU, leucovorin, and oxaliplatin). MATERIALS AND METHODS: We developed a Markov model to evaluate the cost effectiveness of PK FOLFOX compared with BSA FOLFOX. Progression risks and cause-specific mortality were extrapolated from the fitted survival models. Costs for administration and management of adverse events were estimated based on 2013 Medicare reimbursement rates and average sale prices. RESULTS: PK FOLFOX provided 2.03 QALYs at a cost of $50,205 compared with BSA FOLFOX, which provided 1.46 QALYs at a cost of $37,173. The incremental cost-effectiveness ratio (ICER) was $22,695 per QALY. The ICER remained < $50,000 per QALY in all univariate and multivariate sensitivity analyses. CONCLUSION: At a $50,000 per QALY threshold, PK FOLFOX is cost effective for mCRC. Because of the cost effectiveness profile and OS advantage with PK FOLFOX, it should be evaluated further in comparative effectiveness studies.
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