75987-0080-XX Krystexxa 8 MG/ML SOLN (HORIZON PHARMA)
Pegloticase is a uric acid-specific enzyme (uricase) which is covalently bonded to ethylene glycol (pegylation) resulting in a more sustained plasma concentration. It catalyzes the oxidation of uric acid into allantoin thus lowering serum uric acid. Allantoin is an inert water soluble metabolite which is readily eliminated, primarily through renal excretion.
Pegloticase for the treatment of gout is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pegloticase for the treatment of other conditions/diseases, including, but not limited to, asymptomatic hyperuricemia is considered investigational.
Pegloticase is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of chronic gout
Individual had ANY ONE of the following:
Minimum of 3 gout flares in the previous 18 months that were inadequately controlled by colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDS) or oral or injectable corticosteroids
Minimum of 1 gout tophus or has chronic gouty arthritis
Documentation of baseline serum uric acid level > 8 mg/dL (current lab reports are required for renewal);
Documented contraindication, intolerance, or clinical failure (inability to reduce serum uric acid to < 6 mg/dL) during a minimum (3) month trial on previous therapy with maximum tolerated dose of xanthine oxidase inhibitors (e.g. allopurinol or febuxostat)
Individual is NOT receiving other urate lowering therapies such as allopurinol, febuxostat probenecid, lesinurad etc.
Individual at higher risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency should be screened and found negative for G6PD before starting pegloticase
Pegloticase is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by reduction of symptoms, reduction of tophi, etc.
Absence of unacceptable toxicity from the drug such as anaphylaxis; infusion reactions; exacerbation of congestive heart failure
Documentation of serum uric acid level <6 mg/dL prior to scheduled infusion
DOSAGE & ADMINISTRATION
8 mg given as an intravenous infusion every two weeks
LENGTH OF AUTHORIZATION
Coverage is provided for six months and will be eligible for renewal.
Click here to view DOSAGE LIMITS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of pegloticase for the treatment of other conditions/diseases.
The U. S. Food and Drug Administration product label states: “Krystexxa® should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
Lexi-Comp Online. (2017). AHFS DI. Pegloticase. Retrieved September 26, 2017 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, June). Pegloticase. Retrieved September 26, 2017 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2016, September). Center for Drug Evaluation and Research. Krystexxa® (pegloticase). Retrieved September 26, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf.
Richette P, Doherty M, Pascual E, et al. 2016 updatedEULAR evidence-based recommendations for the management of gout. Annals of the Rheumatic Diseases 2017; 76:29-42.
ORIGINAL EFFECTIVE DATE: 10/11/2011
MOST RECENT REVIEW DATE: 1/9/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit