CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pegloticase (Krystexxa) IV therapy — chronic gout coverage criteria

Covers clinical authorization, dosing, renewal, and coding for Krystexxa (pegloticase) IV treatment of chronic gout for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPegloticase (Krystexxa) IV therapy — chronic gout coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of baseline serum uric acid ≥7 mg/dL and confirm patient is ≥18 and screened negative for G6PD deficiency.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth length

16max HCPCS units

8 mg q2wrecommended dose

SUA ≤6 mg/dLrenewal lab req

G6PD excludedcontraindication

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Coverage Criteria for Pegloticase (Krystexxa)

Renewal Therapy

Covered for renewal when ALL of the following are met:

Renewal: Patient continues to meet the universal and indication-specific criteria used for initial approval; Disease response is demonstrated (for example, reduction of symptoms and/or reduction of tophi); Absence of unacceptable toxicity from the drug (examples include anaphylaxis, infusion reactions, exacerbation of congestive heart failure, hemolytic reactions including methemoglobinemia); Documentation of serum uric acid level ≤ 6 mg/dL prior to the scheduled infusion

Current laboratory reports are required for renewal.

Requests for pegloticase will not be approved when the agent is being used concurrently with other urate‑lowering therapies. Specifically, therapy is excluded in combination with allopurinol, febuxostat, probenecid, lesinurad, or other urate‑lowering agents.

Medicare Part B covered diagnosis codes applicable to existing NCDs/LCDs/LCAs are N/A for this policy.

Initiation of pegloticase requires confirmation that the patient is ≥18 years of age and has been screened for and does not have glucose‑6‑phosphate dehydrogenase (G6PD) deficiency. Requests lacking documentation of required baseline testing or that propose initiation in a patient with G6PD deficiency are not consistent with the policy. In addition, initial approval requires documentation of a baseline serum uric acid ≥ 7 mg/dL and, where specified, prior trial and failure/intolerance/contraindication to xanthine oxidase inhibitors or uricosuric agents.

Coverage is contingent on use that is consistent with FDA‑approved labeling and/or relevant clinical literature and the plan's clinical criteria. Requests that are inconsistent with FDA labeling, the cited literature, or these coverage criteria may be considered not medically necessary; Medicare NCDs/LCDs take precedence where applicable.

Coding — HCPCS, NDC, and Diagnosis Codes

HCPCS CodesHCPCSCovered

J2507

Injection, pegloticase, 1 mg

NDC CodesNDCCovered

75987-0080-xx

Krystexxa 8 mg/mL single-dose vial

Covered ICD-10 diagnosis codes (sample)ICD-10Covered

M1A.00X0	Idiopathic chronic gout, unspecified site, without tophus (tophi)
M1A.00X1	Idiopathic chronic gout, unspecified site, with tophus (tophi)
M1A.0110	Idiopathic chronic gout, right shoulder, without tophus (tophi)

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

M1A.00X0	Idiopathic chronic gout, unspecified site, without tophus (tophi)
M1A.00X1	Idiopathic chronic gout, unspecified site, with tophus (tophi)
M1A.0110	Idiopathic chronic gout, right shoulder, without tophus (tophi)
M1A.0111	Idiopathic chronic gout, right shoulder, with tophus (tophi)
M1A.0120	Idiopathic chronic gout, left shoulder, without tophus (tophi)
M1A.0121	Idiopathic chronic gout, left shoulder, with tophus (tophi)
M1A.0190	Idiopathic chronic gout, unspecified shoulder, without tophus (tophi)
M1A.0191	Idiopathic chronic gout, unspecified shoulder, with tophus (tophi)
M1A.0210	Idiopathic chronic gout, right elbow, without tophus (tophi)
M1A.0211	Idiopathic chronic gout, right elbow, with tophus (tophi)

1–10 of 146

1/15

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA)mixed

No codes listed

Medicare Part B Administrative Contractor (MAC) jurisdictions and contractorsmixed

No codes listed

Serum uric acid — Baseline and Renewal thresholds

Baseline serum uric acid≥ 7 mg/dL (document baseline level required; current lab reports required for renewal)

Renewal serum uric acid≤ 6 mg/dL (must be documented prior to scheduled infusion)

Purpose of thresholdsBaseline and renewal labs used to confirm eligibility and ongoing disease response per renewal criteria

HCPCS billing limit — Maximum 16 billable units every 28 days

HCPCS billing limitMaximum 16 billable units every 28 days

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Requirements

Prior Authorization Required: Prior authorization is required for Krystexxa. Ensure the prescriber documents patient age, G6PD screening status, baseline serum uric acid, and other required clinical information at initial request.

Member age ≥ 18 years required
Screening for G6PD deficiency — patient must not have G6PD deficiency (patients at increased risk by ancestry should be screened)
Baseline serum uric acid level ≥ 7 mg/dL required for initial approval (current labs required for renewal)
Do not combine with other urate-lowering therapies (e.g., allopurinol, febuxostat, probenecid, lesinurad)

Step Therapy

Step Therapy / Prior Trials

Step therapy / prior trials required: request must document prior trials, intolerance, contraindication, or failure of xanthine oxidase inhibitors or appropriate uricosuric therapy per indication. Medicare members who previously received the medication within 365 days are exempt from step therapy requirements; Medicare members are not required to try febuxostat.

Background and Rationale

Krystexxa (pegloticase) is a PEGylated uricase enzyme indicated for adults with chronic gout refractory to conventional therapy. Clinical use has demonstrated reductions in serum uric acid, gout flares, and tophi but is associated with notable risks including infusion reactions and gout flares. The policy requires patients to be ≥18 years old, screened negative for G6PD deficiency, and to have a documented baseline serum uric acid ≥ 7 mg/dL before initiation. For chronic gout, pegloticase is reserved for patients with documented contraindication, intolerance, or clinical failure (inability to reduce serum uric acid to < 6 mg/dL) after an adequate trial of xanthine oxidase inhibitors or uricosurics, and who have clinical features such as ≥2 flares per year, nonresolving tophi, or radiographic gout‑related damage. Neighborhood's P&T Committee reviewed the evidence and adopted these criteria to align use with FDA labeling and relevant clinical literature while managing safety and cost‑effectiveness.

Key Definitions

Krystexxa (pegloticase) — short definition and indication

AgentKrystexxa (pegloticase)

Mechanism/descriptionA PEGylated uric acid–specific enzyme (uricase) for adults with chronic gout refractory to conventional therapy

Indication summaryIndicated for treatment of chronic gout in adult patients who are refractory to conventional therapy; used with methotrexate when appropriate or as single agent if methotrexate contraindicated

Clinical failure — definition used by policy

Policy definition of clinical failureInability to reduce serum uric acid to < 6 mg/dL during a minimum 3-month trial on previous therapy at maximum tolerated dose (xanthine oxidase inhibitors or uricosurics)

Context for failure

Policy Revision History

05/21/2025last_reviewLatest

Policy reviewed and adopted by Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics (P&T) Committee with clinical coverage criteria to align use with FDA labeling and relevant literature; criteria emphasize prior therapies and cost-effective options.

01/01/2020effective_date

Policy effective date established.