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Coverage criteria policies

Pegloticase (Krystexxa®)

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. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

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. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial approvals will be for six months.

Reauthorization for tweleve months will be provided when the following criteria are met:

  1. The patient has been seen within the past 12 months; and,
  2. Demonstrated serum uric acid or clinical response; and,
  3. Documentation or attestation that consecutive serum uric acid levels are less than 6 mg/dL.

Definitions

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.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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.

HCPCS

Codes

Description

J2507

Injection, pegloticase, 1 mg

NDC

Codes

Description

60809080101

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.

Products

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.

References

  1. Krystexxa Package Insert. Savient Pharmaceuticals, Inc. September 2016.
  2. FDA Advisory Committtee. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf (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

  • 07/01/2011 - Date of origin
  • 01/01/2017 - Effective date
Review date
  • 08/2017
Revision date
  • 10/01/2016

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