Subject: Krystexxa 1803-A SGM P2023
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 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
Place of Service:
Outpatient
The above policy is based on the following references:
- Krystexxa [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; July 2022.
- IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at http://www.micromedexsolutions.com. Accessed November 4, 2022.
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.
May 15, 2023
