Subject: Krystexxa 1803-A SGM P2024
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.
All other indications are considered experimental/investigational and not medically necessary.
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 the requested medication.
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
Place of Service:
Outpatient
The above policy is based on the following references:
- Krystexxa [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; November 2022.
- IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at http://www.micromedexsolutions.com. Accessed October 19, 2023.
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.
April 17, 2024
