Pegloticase (Krystexxa®)
IMPORTANT REMINDER
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication
Krystexxa is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Limitations of Use
Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for continuation of therapy requests: documentation (e.g., chart notes, lab test results) of a response to therapy (e.g., serum uric acid levels < 6 mg/dL, reduction of tophi, reduction of symptoms and/or flares).
III. CRITERIA FOR INITIAL APPROVAL
Chronic gout
Authorization of 12 months may be granted for members with a diagnosis of chronic gout when ALL of the following criteria are met:
A. Member is 18 years of age or older.
B. The requested medication will NOT be used concomitantly with oral urate-lowering therapies.
C. The member has at least 2 flares per year that were inadequately controlled by colchicine or NSAIDs or at least 1 gout tophus or gouty arthritis.
D. Member has had an inadequate response to or a clinical reason for not completing at least a three-month trial (see Appendix A) with the following medications at the medically appropriate maximum doses:
1. Allopurinol or febuxostat
2. Probenecid (alone or in combination with allopurinol or febuxostat)
E. The member meets one of the following criteria:
1. The requested medication will be co-administered with weekly oral methotrexate and folic acid or folinic acid supplementation, or
2. The member has a contraindication to or clinical reason to avoid oral methotrexate therapy (see Appendix B).
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment of chronic gout when ALL of the following criteria are met:
A. Member is 18 years of age or older.
B. The requested medication will NOT be used concomitantly with oral urate-lowering therapies.
C. The member meets one of the following:
1. The requested medication will be co-administered with weekly oral methotrexate and folic acid or folinic acid supplementation, or
2. The member has a contraindication to or clinical reason to avoid oral methotrexate therapy (see Appendix B).
D. Member has NOT had two consecutive uric acid levels above 6 mg/dL since starting treatment with Krystexxa.
E. Member is experiencing benefit from therapy (e.g., serum uric acid levels < 6 mg/dL, reduction of tophi, reduction of symptoms and/or flares).
V. APPENDICES
Appendix A: Clinical reasons for not completing a three-month trial with allopurinol, febuxostat, and probenecid (examples, not all inclusive):
A. Member experienced a severe allergic reaction to the medication
B. Member experienced toxicity with the medication
C. Member could not tolerate the medication
D. Member’s current medication regimen has a significant drug interaction
E. Member has severe renal dysfunction (allopurinol)
F. Member has known blood dyscrasias or uric acid kidney stones (probenecid)
G. Member has renal insufficiency (i.e., glomerular filtration rate 30 mL/minute or less) (probenecid)
H. Member has end stage renal impairment (febuxostat)
I. Member has a history of CVD or a new CV event (febuxostat)
Appendix B: Contraindications/clinical reasons to avoid oral methotrexate therapy (examples, not all inclusive):
A. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease
B. Breastfeeding
C. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia)
D. Elevated liver transaminases
E. History of intolerance or adverse event
F. Hypersensitivity
G. Interstitial pneumonitis or clinically significant pulmonary fibrosis
H. Myelodysplasia
I. Pregnancy or currently planning pregnancy
J. Renal impairment
K. Significant drug interaction
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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.
ADDITIONAL INFORMATION
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).
REFERENCES
1. Krystexxa [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; November 2022.
2. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at http://www.micromedexsolutions.com. Accessed October 19, 2023.
3. Khanna D, Fitzgerald JD, Khanna PP, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res. 2012;64(10):1431-1446.
4. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76:29-42.
5. Khanna D, Khanna PP, Fitzgerald JD, et al. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res. 2012;64(10):1447-1461.
6. Hui M, Carr A, Cameron S, et al. The British Society for Rheumatology Guideline for the Management of Gout. Rheumatology. 2017;56(7):e1–e20. Available at https://doi.org/10.1093/rheumatology/kex156.
7. Sivera F, Andres M, Carmona L, et al. Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative. Ann Rheum Dis. 2014;73(2):328-335.
8. Probenecid [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; December 2016.
9. Febuxostat [package insert]. Eatontown, NJ: Hikma Pharmaceuticals USA Inc.; May 2023.
10. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Care Res (Hoboken). 2020 Aug;72(8):1187]. Arthritis Care Res (Hoboken). 2020;72(6):744-760.
11. Methotrexate [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; August 2021.
ORIGINAL EFFECTIVE DATE: 10/11/2011
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
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.
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