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Coverage criteria policies

Pegloticase (Krystexxa®) - Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Krystexxa requires prior authorization from Pharmacy Administration.


Krystexxa is generally covered when the following criteria are met:

  1. Prescribed and followed by a specialist; and,
  2. Used for treatment of chronic gout refractory to conventional therapy including allopurinol, probenacid and febuxostat; and,
  3. Due to a risk of anaphylaxis, it must be given by a professional in a healthcare setting.

Authorizations will be provided for 6 months of use.

Reauthorization will be provided when the following criteria are met:

  1. Demonstrated serum uric acid or clinical response; and
  2. Documentation or attestation that consecutive serum uric acid levels are less than 6 mg/dL.


Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia.

A uric acid-specific enzyme, pegloticase is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain on Escherichia coli. It achieves its therapeutic effect by catalyzing the oxidation of uric acid to allantoin, thereby lowering serum uric acid. Allantoin is an inert and water soluble purine metabolite. It is readily eliminated, primarily by renal excretion.

Serum uric acid levels should be monitored prior to any infusions. Discontinuing treatment should be considered if uric acid levels rise to above 6 mg/dL, particularly if two consecutive readings exceed this level. NSAIDs or colchicine, or both, should be administered for at least 7 days before implementing pegloticase treatment and for at least 6 months, unless medically contraindicated or not tolerated, as gout flare prophylaxis.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.





Injection, pegloticase, 1 mg





Krystexxa 8mg/mL solution, single dose vial

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. Krystexxa Package Insert. Savient Pharmaceuticals, Inc. September 2016.
  2. FDA Advisory Committtee. (Accessed 2/17/2011).
  3. Pegloticase for Treatment of Refractory Gout. The Medical Letter. 2/7/2011, 53; 1357:9-10.

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Policy activity

  • 01/01/2017 - Date of origin
  • 01/01/2017 - Effective date
Review date
  • 08/2017

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