J2507, Injection, pegloticase, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Submission of a citation to one or more standard medical reference compendia adopted by HHS supporting the off‑label use, OR
- Submission of two articles from major peer‑reviewed professional medical journals that present data confirming safety and efficacy for the proposed off‑label use.
- Evidence that the member is a resident of Ohio (to establish applicability of the statutory exception).
- Medical record documentation demonstrating patient is ≥18 years old and refractory to conventional therapies (e.g., failure or intolerance to appropriate prior therapies).
Key Coverage Criteria
- Coverage of any FDA‑approved drug when prescribed for a use recognized as safe and effective for a given indication in one or more standard medical reference compendia adopted by HHS, even if the FDA has not approved that indication.
- Coverage of any FDA‑approved drug for an off‑label indication when safety and efficacy are confirmed in medical literature consisting of two articles from major peer‑reviewed professional medical journals presenting supporting data.
- Treatment of chronic gout in adult patients 18 years of age or older who are refractory to conventional therapies, as documented in the medical record.
- Baseline serum uric acid (SUA) ≥ 6 mg/dL.
- Symptomatic gout with ≥ 2 gout flares in the previous 12 months OR ≥ 1 episode of gout tophus or gouty arthritis.
- Documented contraindication, intolerance, or failure to normalize SUA to < 6 mg/dL after ≥ 3 months of therapy with BOTH: a xanthine oxidase inhibitor (allopurinol or febuxostat) AND a uricosuric agent (e.g., probenecid) at maximum medically appropriate doses.
12 Active Policies
UHC-POL-krystexxa-pegloticase, Krystexxa (Pegloticase)
RX501.120, Pegloticase
BCBSIL-RX501.120, Pegloticase
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
BCBSMT-RX501.120, Pegloticase
Related Codes
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