CurrentHealth NetPolicy CP PHAR.115

Pegloticase (Krystexxa) Coverage

Defines medical necessity criteria, dosing limits, and authorization requirements for pegloticase (Krystexxa) for treatment of chronic gout for Health Net lines of business (Commercial, HIM, Medicaid). Affects providers requesting prior authorization for Krystexxa.

Policy Summary

PayerHealth Net

PolicyPegloticase (Krystexxa) Coverage

Policy CodePolicy CP PHAR.115

Change TypeNo material change

Effective DateJun 1, 2013

Next Review DateFeb 25, 2025

Key ActionPrior authorization is required and the provider must document that the member meets the listed initial approval criteria for chronic gout refractory to conventional therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 mgmaximum dose

every 2 weeksdosing interval

6 moinitial approval (Medicaid/HIM)

6 moinitial approval (Commercial)

G6PDcontraindication

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Initial Therapy

Covered when ALL of the following are met for initial approval (Chronic Gout):

Initial Approval Criteria: 1) Diagnosis of chronic gout in an adult (>= 18 years); 2) Symptomatic disease demonstrated by one or more of: at least 3 gout flares in the prior 18 months; chronic gouty arthritis; or at least 1 gout tophus; 3) Failure to normalize serum uric acid to < 6 mg/dL with allopurinol and febuxostat at maximally indicated doses, each used for at least 3 months unless clinically significant adverse effects or both are contraindicated; 4) Failure of one uricosuric agent (e.g., probenecid or losartan) at maximally indicated doses in combination with allopurinol or febuxostat unless clinically significant adverse effects or contraindicated; 5) Krystexxa is not prescribed concurrently with oral urate-lowering agents (allopurinol, febuxostat, probenecid); 6) Dose does not exceed 8 mg (uricase protein) every two weeks.age >= 18; serum uric acid < 6 mg/dL target

Medicaid/HIM initial approval duration 6 months; Commercial 6 months or to member renewal date.

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy Criteria: Member is currently receiving Krystexxa via the benefit or has previously met initial approval criteria; Member is responding positively to therapy as evidenced by a decrease in plasma (serum) uric acid levels; Krystexxa is not prescribed concurrently with oral urate-lowering agents (allopurinol, febuxostat, probenecid).response shown by decreased serum uric acid

If request is for a dose increase, new dose must not exceed 8 mg every two weeks. Medicaid/HIM continued approval duration 12 months; Commercial 6 months or to member renewal date.

Non‑FDA approved indications are not authorized under this policy unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or unless coverage is established in the member’s evidence of coverage documents.

Coverage determinations and the administration of benefits for requests under this policy are governed by the member’s coverage documents and applicable law. All terms, conditions, exclusions, and limitations in the evidence of coverage, certificate of coverage, policy, contract of insurance, and any Health Plan‑level administrative policies apply and may affect approval or payment.

Uses that are not listed in the section titled "Diagnoses/Indications for which coverage is NOT authorized" and that are not supported by the referenced off‑label use policies may be considered not medically necessary and therefore are not authorized. For requests involving uses not specifically addressed, follow the applicable formulary, non‑formulary, or off‑label use policy for the member’s line of business as referenced in the policy guidance.

Initial Therapy

Initial coverage criteria and dosing

Initial Therapy: Diagnosis of chronic gout in adults with symptomatic disease (≥3 flares in 18 months, chronic gouty arthritis, or ≥1 tophus); failed trials of allopurinol and febuxostat at maximally indicated doses for ≥3 months unless intolerant or contraindicated; failed one uricosuric agent in combination with an XOI unless intolerant/contraindicated; Krystexxa must not be co‑prescribed with oral urate‑lowering agents; dosing: 8 mg IV every 2 weeks (may co‑administer weekly oral methotrexate 15 mg unless contraindicated).

Medicaid/HIM initial approval 6 months; Commercial 6 months or to member renewal date.

Continuation Criteria

Continuation

Criteria for continued coverage

Continued Therapy: Member must be responding to therapy demonstrated by a decrease in plasma (serum) uric acid or have previously met initial approval criteria; therapy must not be co‑administered with oral urate‑lowering agents; if a dose increase is requested, the new dose must not exceed 8 mg every 2 weeks.

Approval durations: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date.

Provider Actions & Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document that the member meets the listed initial approval criteria for chronic gout refractory to conventional therapy (see Initial Approval Criteria).

Provider must submit supporting documentation such as office chart notes, laboratory results (including serum uric acid levels), prior medication trial history, and any relevant imaging or pathology.
Prior authorization requests will be reviewed against the coverage criteria in this policy and applicable benefit terms.

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation supporting that the member has met all approval criteria. Examples include office visit notes detailing gout history and flares, documentation of tophi or chronic gouty arthritis, serum uric acid measurements, and notes describing intolerance, contraindications, or adverse effects to prior therapies.

Prior Authorization

Required Prior Trials

Failure of oral urate‑lowering therapy is required prior to approval. Provider must document trials of allopurinol and febuxostat at maximally indicated doses (each for at least 3 months unless discontinued for clinically significant adverse effects or contraindicated) and failure of at least one uricosuric agent (e.g., probenecid or losartan) at maximally indicated doses, unless contraindicated or not tolerated.

Document dates, doses, and reasons for discontinuation or inadequate response for each prior oral urate‑lowering agent.
Document serum uric acid values demonstrating failure to normalize uric acid to < 6 mg/dL despite prior therapy.

Denial Risk

Concurrent Oral Urate‑Lowering Therapy

Krystexxa must not be prescribed concurrently with oral urate‑lowering agents. Concurrent prescribing of Krystexxa with agents such as allopurinol, febuxostat, or probenecid is a trigger for non‑approval unless explicitly allowed by continuation-of-care rules; providers should document any clinical rationale and receive prior authorization approval before concurrent use.

Concurrent use with allopurinol, febuxostat, or probenecid is generally not permitted.
If concurrent therapy is claimed to be clinically required, submit detailed justification and supporting records for review.

Denial Risk

Non‑FDA Indications May Be Denied

Requests for non‑FDA approved indications not addressed by this policy may be denied unless sufficient documentation per the applicable off‑label use policy is provided (see applicable off‑label policies CP CPA.09, HIM.PA.154, CP PMN.53, and evidence of coverage documents).

Note

Provider Responsibility & Coverage Terms

Coverage decisions are governed by the member's coverage documents and Health Net procedures. Providers remain responsible for exercising professional medical judgment in the care of members.

Coverage is subject to all terms, conditions, exclusions, and limitations of the member's evidence of coverage/certificate of coverage.
Providers are expected to exercise professional medical judgment and are responsible for medical advice and treatment.

Coding & Clinical Thresholds

HCPCS CodesHCPCS

J2507

Injection, pegloticase, 1 mg

inv-07: serum uric acid — treatment goal/value

Target serum uric acid for treatment goal< 6 mg/dL

Context for thresholdRequired failure to normalize serum uric acid to < 6 mg/dL on allopurinol and febuxostat (each ≥3 months) before Krystexxa

Continuation response criterionContinued therapy requires response evidenced by decreased plasma/serum uric acid

Step Therapy / Prior Trials

Required prior trial	Details / required dose & duration
Failure of xanthine oxidase inhibitor: allopurinol	Allopurinol at maximally indicated dose used ≥3 months (up to 800 mg/day) or titrated until serum urate < 6 mg/dL unless clinically significant adverse effects or contraindication
Failure of xanthine oxidase inhibitor: febuxostat	Febuxostat at maximally indicated dose used ≥3 months (40–80 mg/day) unless clinically significant adverse effects or contraindication
Failure of at least one uricosuric agent (e.g., probenecid or losartan) in combination with an XOI	Uricosuric agent (e.g., probenecid up to 2 g/day; losartan 50 mg/day) used at maximally indicated doses in combination with allopurinol or febuxostat unless adverse effects or contraindicated

Quantity Limits / Dosing

inv-22: Krystexxa (pegloticase) — quantity / maximum dose (8 mg)

Maximum dose per administration8 mg (uricase protein) per IV administration

Dosing interval associated with limitEvery 2 weeks (8 mg IV every 2 weeks)

Product strength / vial sizeVial: 8 mg uricase protein / 1 mL

Site of Care / Administration

Step Therapy

Infusion center administration and methotrexate co‑therapy

Krystexxa is administered via intravenous infusion; co‑administration of weekly oral methotrexate 15 mg is recommended unless contraindicated — document a clinical rationale if methotrexate is not used.

Dose: 8 mg IV every 2 weeks
Recommend weekly oral methotrexate 15 mg unless contraindicated; document rationale if omitted

Definitions

inv-18: Pegloticase (Krystexxa) — PEGylated uric acid specific enzyme used to lower serum uric acid in refractory chronic gout

Agent descriptionPEGylated uric acid–specific enzyme used to lower serum uric acid in refractory chronic gout

FDA indicationIndicated for treatment of chronic gout in adult patients refractory to conventional therapy

Administration noteGiven as 8 mg IV every 2 weeks; may be co‑administered with weekly oral methotrexate 15 mg unless contraindicated

Background

Pegloticase (Krystexxa) is a PEGylated uric acid–specific enzyme indicated for the treatment of chronic gout refractory to conventional therapy in adults. It is reserved for patients with symptomatic disease (for example, frequent flares, chronic gouty arthritis, or tophi) who have failed or are intolerant of standard urate‑lowering therapies.

Policy Summary

PayerHealth Net

PolicyPegloticase (Krystexxa) Coverage

Policy CodePolicy CP PHAR.115

Change TypeNo material change

Effective DateJun 1, 2013

Next Review DateFeb 25, 2025

Key ActionPrior authorization is required and the provider must document that the member meets the listed initial approval criteria for chronic gout refractory to conventional therapy.

SourceLink

On This Page

OpenPayer

Pegloticase (Krystexxa) Coverage

Coverage Criteria

Initial Therapy

Continuation Criteria

Provider Actions & Responsibilities

Coding & Clinical Thresholds

Step Therapy / Prior Trials

Quantity Limits / Dosing

Site of Care / Administration

Definitions

Background