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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Gout

Drug
Krystexxa™  (pegloticase)
Note:

Note: Precertification review for Krystexxa is handled through Aetna Specialty Precert Unit at 1-866-503-0857 
Refer to Medical CPB 0810
 http://aetnet.aetna.com/mpa/cpb/800_899/0810.html



Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary Krystexxa is subject to precertification. If precertification requirements apply Aetna considers pegloticase (Krystexxa) medically necessary for the treatment of adults age 18 years and older with symptomatic gout when all of the following criteria are met:

    For Krystexxa 

    • At least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine [Colcrys] and non-steroidal anti-inflammatory drugs (i.e., ibuprofen, naproxen, indomethacin), or at least 1 gout tophus or gouty arthritis; AND
    • Failure to normalize serum uric acid to less than 6 mg/dL after 3 months of maximum medically appropriate dose of xanthine oxidase inhibitors (maximum recommended dosage of allopurinol [Zyloprim] is 800 mg/day and febuxostat [Uloric] is 80 mg/day or when xanthine oxidase inhibitors are contraindicated; AND
    • Member has undertaken appropriate life style modifications, i.e. limiting of alcohol consumption and other medications known to precipitate gout attacks have been discontinued/changed when possible; AND
    • Member does not have G6PD deficiency. (Persons at higher risk for G6PD deficiency (e.g., those of African and Mediterranean ancestry) should be screened due to the risk of hemolysis and methemoglobinemia. G6PD deficiency is a contraindication for Krystexxa therapy.)

     


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Uy JP, Nuwayhid N, Saadeh C. Unusual presentations of gout. Tips for accurate diagnosis. Postgrad Med. 1996;100(1):253-254, 257-260, 266.
  2. Owen-Smith B, Quiney J, Read J. Salivary urate in gout, exercise, and diurnal variation. Lancet. 1998;351(9120):1932.
  3. Kobayashi K, Morioka Y, Isaka Y, et al. Determination of uric acid in scalp hair for non-invasive evaluation of uricemic controls in hyperuricemia. Biol Pharm Bull. 1998;21(4):398-400.
  4. Fam AG. Gout in the elderly. Clinical presentation and treatment. Drugs Aging. 1998;13(3):229-243.
  5. Harris MD, Siegel LB, Alloway JA. Gout and hyperuricemia. Am Fam Physician. 1999;59(4):925-934.
  6. Pittman JR, Bross MH. Diagnosis and management of gout. Am Fam Physician. 1999;59(7):1799-1806, 1810.
  7. Segal JB, Albert D. Diagnosis of crystal-induced arthritis by synovial fluid examination for crystals: Lessons from an imperfect test. Arthritis Care Res. 1999;12(6):376-380.
  8. Schlesinger N, Baker DG, Schumacher HR Jr. How well have diagnostic tests and therapies for gout been evaluated? Curr Opin Rheumatol. 1999;11(5):441-445.
  9. Agudelo CA, Wise CM. Crystal-associated arthritis in the elderly. Rheum Dis Clin North Am. 2000;26(3):527-546, vii.
  10. McGill NW. Gout and other crystal-associated arthropathies. Baillieres Best Pract Res Clin Rheumatol. 2000;14(3):445-460.
  11. van Doornum S, Ryan PF. Clinical manifestations of gout and their management. Med J Aust. 2000 May;172(10):493-497.
  12. Agudelo CA, Wise CM. Gout: Diagnosis, pathogenesis, and clinical manifestations. Curr Opin Rheumatol. 2001;13(3):234-239.
  13. Cronstein BN, Terkeltaub R. The inflammatory process of gout and its treatment. Arthritis Res Ther. 2006;8 Suppl 1:S3.\
  14. Zhang W, Doherty M, Pascual E, et al; EULAR Standing Committee for International Clinical Studies Including Therapeutics. EULAR evidence based recommendations for gout. Part I: Diagnosis. Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006a;65(10):1301-1311.
  15. Zhang W, Doherty M, Bardin T, et al; EULAR Standing Committee for International Clinical Studies Including Therapeutics.EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006b;65(10):1312-1324.
  16. So A, De Smedt T, Revaz S, Tschopp J. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther. 2007;9(2):R28.
  17. Yue CS, Huang W, Alton M, et al. Population pharmacokinetic and pharmacodynamic analysis of pegloticase in subjects with hyperuricemia and treatment-failure gout. J Clin Pharmacol. 2008;48(6):708-718.
  18. Sundy JS, Becker MA, Baraf HS, et al; Pegloticase Phase 2 Study Investigators. 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.
  19. Schlesinger N. New agents for the treatment of gout and hyperuricemia: Febuxostat, puricase, and beyond. Curr Rheumatol Rep. 2010;12(2):130-134.
  20. Hershfield MS, Roberts LJ 2nd, Ganson NJ, et al. Treating gout with pegloticase, a PEGylated urate oxidase, provides insight into the importance of uric acid as an antioxidant in vivo. Proc Natl Acad Sci U S A. 2010;107(32):14351-14356.
  21. U.S. Food and Drug Administration (FDA). FDA approves new drug for gout. News Release. Silver Spring, MD: FDA; September 14, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225810.htm. Accessed September 27, 2010.
  22. Savient Pharmaceuticals, Inc. FDA approves Krystexxa (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Press Reslease. Savient Pharmaceuticals; 2010. Available at: http://investor.savient.com/releasedetail.cfm?ReleaseID=507578. Accessed September 27, 2010.
  23. Burns CM, Wortmann RL. Gout therapeutics: New drugs for an old disease. Lancet. 2011;377(9760):165-177.
  24. Sundy JS, Baraf HS, Yood RA, et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: Two randomized controlled trials. JAMA. 2011;306(7):711-720.
  25. Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: A NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133-140.
  26. Hamburger M, Baraf HS, Adamson TC 3rd, et al; European League Against Rheumatism. 2011 Recommendations for the diagnosis and management of gout and hyperuricemia. Postgrad Med. 2011;123(6 Suppl 1):3-36.
  27. Krishnan E, Lingala B, Bhalla V. Low-level lead exposure and the prevalence of gout: An observational study. Ann Intern Med. 2012;157(4):233-241.
  28. Becker MA. Clinical manifestations and diagnosis of gout. UpToDate [serial online]. Waltham, MA: UpToDate; reviewed August 2012.
  29. University of Texas at Austin, School of Nursing, Family Nurse Practitioner Program. Management of chronic gout in adults. Austin, TX: University of Texas at Austin, School of Nursing; May 2012.
  30. Spanish Society of Rheumatology (SER). Clinical practice guidelines for management of gout. Madrid, Spain: Spanish Society of Rheumatology (SER); 2013. 
  31. Villaverde V, Rosario MP, Loza E, Perez F. Systematic review of the value of ultrasound and magnetic resonance musculoskeletal imaging in the evaluation of response to treatment of gout. Reumatol Clin. 2014;10(3):160-163.
  32. Becker MA. Clinical manifestations and diagnosis of gout. UpToDate [serial online]. Waltham, MA: UpToDate; reviewed August 2014.
  33. Ogdie A, Taylor WJ, Weatherall M, et al. Imaging modalities for the classification of gout: Systematic literature review and meta-analysis. Ann Rheum Dis. 2014 Jun 10 [Epub ahead of print].
  34. Sivera F, Wechalekar MD, Andres M, et al. Interleukin-1 inhibitors for acute gout. Cochrane Database Syst Rev. 2014 Sep 1;9:CD009993 [Epub ahead of print].
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2017
Aetna
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