Glucarpidase for Treating Adults with Delayed Methotrexate Elimination Due to Impaired Renal Function: An Economic Simulation Analysis

References

• Howard SC, McCormick J, Pui C-H, Buddington RK, Harvey RD. Preventing and managing toxicities of high-dose methotrexate. Oncologist. 2016;21(12):1471–1482. doi:10.1634/theoncologist.2015-0164
   PubMed Web of Science ®Google Scholar
• Joerger M, Huitema ADR, Van Den Bongard HJGD, et al. Determinants of the elimination of methotrexate and 7-hydroxy-methotrexate following high-dose infusional therapy to cancer patients. Br J Clin Pharmacol. 2006;62(1):71–80. doi:10.1111/j.1365-2125.2005.02513.x
   PubMed Web of Science ®Google Scholar
• de Miguel D, García-Suárez J, Martín Y, Gil-Fernández JJ, Burgaleta C. Severe acute renal failure following high-dose methotrexate therapy in adults with haematological malignancies: a significant number result from unrecognized co-administration of several drugs. Nephrol Dial Transplant. 2008;23(12):3762–3766. doi:10.1093/ndt/gfn503
   PubMed Web of Science ®Google Scholar
• Drost SA, Wentzell JR, Giguère P, et al. Outcomes associated with reducing the urine alkalinization threshold in patients receiving high-dose methotrexate. Pharmacotherapy. 2017;37(6):684–691. doi:10.1002/phar.1935
   PubMed Web of Science ®Google Scholar
• Gros L, Roldán A, Cabero-Martínez A, et al. Incidence and management of patients with methotrexate delayed elimination in the clinical practice: a Delphi study. J Oncol Pharm Pract. 2022:107815522210795. doi:10.1177/10781552221079568
   Web of Science ®Google Scholar
• May J, Carson KR, Butler S, Liu W, Bartlett NL, Wagner-Johnston ND. High incidence of methotrexate associated renal toxicity in patients with lymphoma: a retrospective analysis. Leuk Lymphoma. 2014;55(6):1345–1349. doi:10.3109/10428194.2013.840780
   PubMed Web of Science ®Google Scholar
• Steward JS, Bullard HM, O’Rourke TJ, et al. Effect of single agent high-dose methotrexate-related acute kidney injury on length of hospitalization and relative dose intensity in adult patients with central nervous system lymphoma. J Oncol Pharm Pract. 2016;23(7):496–501. doi:10.1177/1078155216665244
   PubMed Web of Science ®Google Scholar
• Ramsey LB, Balis FM, O’Brien MM, et al. Consensus guideline for use of glucarpidase in patients with high‐dose methotrexate induced acute kidney injury and delayed methotrexate clearance. Oncologist. 2018;23(1):52–61. doi:10.1634/theoncologist.2017-0243
   PubMed Web of Science ®Google Scholar
• Kitchlu A, Shirali AC. High-flux hemodialysis versus glucarpidase for methotrexate-associated acute kidney injury: what’s best? J Onco-Nephrol. 2019;3(1):11–18. doi:10.1177/2399369319827305
   Google Scholar
• Widemann BC, Schwartz S, Jayaprakash N, et al. Efficacy of glucarpidase (carboxypeptidase G2) in patients with acute kidney injury after high-dose methotrexate therapy. Pharmacotherapy. 2014;34(5):427–439. doi:10.1002/phar.1360
   PubMed Web of Science ®Google Scholar
• VORAXAZE (glucarpidase). Package insert. BTG International Inc; 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125327s064lbl.pdf. Accessed June 10, 2022.
   Google Scholar
• Methotrexate. Package insert. Pfizer Inc; 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011719Orig1s131lbl.pdf. Accessed July 27, 2022.
   Google Scholar
• Widemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. J Clin Oncol. 2010;28(25):3979–3986. doi:10.1200/JCO.2009.25.4540
   PubMed Web of Science ®Google Scholar
• Ward S, King T, Chauhan N. Pooled analysis of time to administration of glucarpidase for methotrexate toxicity versus mortality. Clin Toxicol. 2013;51(7):577–578. doi:10.3109/15563650.2013.817658
   Web of Science ®Google Scholar
• Demiralp B, Koenig L, Kala J, et al. Length of stay, mortality, and readmissions among Medicare cancer patients treated with glucarpidase and conventional care: a retrospective study. Clinicoecon Outcomes Res. 2019;11:129–144. doi:10.2147/ceor.S188786
   PubMed Web of Science ®Google Scholar
• Ghannoum M, Roberts DM, Goldfarb DS, et al. Extracorporeal treatment for methotrexate poisoning: systematic review and recommendations from the EXTRIP workgroup. Clin J Am Soc Nephrol. 2022;17(4):602. doi:10.2215/CJN.08030621
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. NCCN Guidelines Version 1.2022 Acute Lymphoblastic Leukemia. Available from: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1410. Accessed July 27, 2022.
   Google Scholar
• Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314–325.e1. doi:10.1016/j.annemergmed.2017.05.021
   PubMed Web of Science ®Google Scholar
• Truong H, Leung N. Fixed-dose glucarpidase for toxic methotrexate levels and acute kidney injury in adult lymphoma patients: case series. Clin Lymphoma Myeloma Leuk. 2021;21(6):e497–e502. doi:10.1016/j.clml.2021.01.006
   PubMed Web of Science ®Google Scholar
• Widemann BC, Adamson PC. Understanding and managing methotrexate nephrotoxicity. Oncologist. 2006;11(6):694–703. doi:10.1634/theoncologist.11-6-694
   PubMed Web of Science ®Google Scholar
• Singh C, Jain A, Takkar A, et al. Successful use of high dose methotrexate in treatment of primary CNS lymphoma patients without access to serum methotrexate levels monitoring: challenges and outcome. Indian J Hematol Blood Transfus. 2022;38(1):68–77. doi:10.1007/s12288-021-01438-5
   PubMed Web of Science ®Google Scholar
• EVERSANA. NAVLIN price data. Available from: https://navlin.com/. Accessed April 27, 2022.
   Google Scholar
• Candrilli S, Bell T, Irish W, Morris E, Goldman S, Cairo MS. A comparison of inpatient length of stay and costs among patients with hematologic malignancies (excluding Hodgkin disease) associated with and without acute renal failure. Clin Lymphoma Myeloma. 2008;8(1):44–51. doi:10.3816/CLM.2008.n.003
   PubMedGoogle Scholar
• Sanders KN, Aggarwal J, Stephens JM, et al. Cost impact of hydroxocobalamin in the treatment of patients with known or suspected cyanide poisoning due to smoke inhalation from closed-space fires. Burns. 2021;48(6):1325–1330. doi:10.1016/j.burns.2021.10.017
   PubMed Web of Science ®Google Scholar
• CMS. Clinical laboratory fee schedule, 2nd quarter 2022. Available from: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files. Accessed April 27, 2022.
   Google Scholar
• Flombaum CD, Liu D, Yan SQ, et al. Management of patients with acute methotrexate nephrotoxicity with high-dose leucovorin. Pharmacotherapy. 2018;38(7):714–724. doi:10.1002/phar.2145
   PubMed Web of Science ®Google Scholar
• Sacco JJ, Botten J, Macbeth F, Bagust A, Clark P. The average body surface area of adult cancer patients in the UK: a multicentre retrospective study. PLoS One. 2010;5(1):e8933. doi:10.1371/journal.pone.0008933
   PubMed Web of Science ®Google Scholar
• Drugs.com. Leucovorin dosage.; 2021. Available from: https://www.drugs.com/dosage/leucovorin.html. Accessed May 18, 2022.
   Google Scholar
• Widemann BC, Balis FM, Kempf-Bielack B, et al. High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma. Cancer. 2004;100(10):2222–2232. doi:10.1002/cncr.20255
   PubMed Web of Science ®Google Scholar
• Svahn T, Mellgren K, Harila-Saari A, et al. Delayed elimination of high-dose methotrexate and use of carboxypeptidase G2 in pediatric patients during treatment for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2017;64(7):e26395. doi:10.1002/pbc.26395
   Web of Science ®Google Scholar
• Howard S, Harry MT, John S, Marada S, Napier N. Management of delayed elimination of high-dose methotrexate in community oncology practices can mitigate its effect on length of hospital stay, treatment dose-density, acute kidney injury, dialysis, and death. Blood. 2019;134(S1):5889. doi:10.1182/blood-2019-132098
   Google Scholar
• GlobalRPh. Body surface area multi-calculator; 2022. Available from: https://globalrph.com/medcalcs/body-surface-area-multi-calc-multiple-analysis/. Accessed May 30, 2022.
   Google Scholar
• Binder AF, Burdette S, Galanis P, Birchmeier K, Handley N, Piddoubny M. Decreasing cost and decreasing length of stay after implementation of updated high-dose methotrexate discharge criteria. JCO Oncol Pract. 2020;16(8):e791–e796. doi:10.1200/JOP.19.00566
   PubMedGoogle Scholar
• Halpern NA, Pastores SM. Critical care medicine beds, use, occupancy, and costs in the United States: a methodological review. Crit Care Med. 2015;43(11):2452–2459. doi:10.1097/CCM.0000000000001227
   PubMed Web of Science ®Google Scholar