This version of the policy will become effective 01/13/2020.
The following new policy has been updated to communicate the Dosing and Frequency requirements for pegloticase (Krystexxa®).
When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
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Becker MA, Mount DB. Asymptomatic hyperuricemia. 02/06/19. [UpToDate Web Site]. Available at: http://www.uptodate.com/contents/asymptomatic-hyperuricemia?source=search_result&search=Secondary+hyperuricemia&selectedTitle=1%7E150 . Accessed August 27, 2019.
Becker MA, Gaffo AL. Clinical manifestations and diagnosis of gout. 03/06/19. [UpToDate Web site]. Available at: http://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-gout?source=machineLearning&search=Clinical+manifestations+and+diagnosis+of+gout&selectedTitle=1%7E150§ionRank=1&anchor=H111564623#H111564623 [via subscription only]. Accessed August 27, 2019.
Centers for Disease Control and Prevention. Gout. [CDC Website]. Last reviewed 01/28/19. Available at: http://www.cdc.gov/arthritis/basics/gout.htm. Accessed August 27, 2019.
Elsevier’s Clinical Pharmacology Compendium. Pegloticase (Krystexxa®). 07/19/19. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 27, 2019.
Lexi-Drugs Compendium. Pegloticase (Krystexxa®). 08/21/19. [Lexicomp Online Web site]. Available at:
http://online.lexi.com/lco/action/home . [via subscription only]. Accessed August 27, 2019.
Pegloticase (Krystexxa®). [prescribing information] Lake Forest, WI: Horizon Pharma; 07/2018. Available at: http://www.krystexxa.com/ . Accessed August 27, 2019.
Sriranganathan MK, Vinik O, Bombardier C, Edwards CJ. Interventions for tophi in gout. Cochrane Database Syst Rev. 2014 Oct 20;10:CD010069.
Sundy J, Ganson N, Kelly S, et al. Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinent mammalian urate oxidase in patients with refractory gout. Arthritis Rheum. 2007;56(4):1370.
Sundy J, Becker M, Baraf H, et al. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008;58(9):2882-2891.
Truven Health Analytics Inc. Micromedex® Solutions. Pegloticase (Krystexxa®). [Micromedex® Web site]. 08/26/18. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ [via subscription only]. Accessed August 27, 2019.
US Food and Drug Administration (FDA). Center for Drug evaluation and Research. Drugs @FDA. Pegloticase (Krystexxa®) [FDA Website]. 07/2018. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed August 27, 2019.