CurrentCignaPolicy N/A

Krystexxa (pegloticase) prior authorization

This document is a Cigna prior authorization form and criteria checklist for coverage of Krystexxa (pegloticase) for patients with gout; it governs provider submission requirements and clinical information needed to request coverage. It affects prescribers, infusion centers, specialty pharmacies (Accredo), and Cigna reviewers.

Policy Summary

PayerCigna

PolicyKrystexxa (pegloticase) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, prior therapy history and supportive documentation including chart notes and serum uric acid results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

1nationally preferred specialty pharmacy (Accredo) named

>=3 monthsrequired trial duration of xanthine oxidase inhibitor

<6 mg/dLresponse benchmark referenced for continued therapy

Coverage Criteria for Krystexxa (pegloticase)

inv-01: Initial therapy coverage considerations

Covered when ALL of the following are met (information collected on form):

Initial therapy requirements: 1) Documentation of diagnosis: chronic gout OR presence of at least one tophus OR history of ≥2 gout flares in the prior year when no tophus; 2) Medication is prescribed by or in consultation with a rheumatologist or nephrologist; 3) Inadequate response to a xanthine oxidase inhibitor defined as serum uric acid >6 mg/dL after a ≥3-month trial (examples: allopurinol, febuxostat), unless contraindicated/intolerant; 4) Inadequate response to a uricosuric agent after a ≥3-month trial (examples: probenecid, fenofibrate, losartan), or documented renal insufficiency if a uricosuric is not appropriate; 5) Plan to use concomitant immunomodulator (methotrexate, leflunomide, mycophenolate mofetil, or azathioprine) or documentation if not using one; 6) Supportive documentation attached (chart notes, lab/test results including serum uric acid).Serum uric acid >6 mg/dL; trial duration ≥3 months

Form collects these items directly (diagnosis, tophi, prior flares, prescriber specialty, prior medication trials and durations, concomitant immunomodulator use, and required attachments).

inv-02: Continuation therapy considerations

Continued coverage when ALL of the following are met:

Policy Summary

PayerCigna

PolicyKrystexxa (pegloticase) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, prior therapy history and supportive documentation including chart notes and serum uric acid results.

SourceLink

On This Page

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Continuation: 1) Patient is currently receiving Krystexxa and the request is to continue therapy to maintain response/remission; 2) Demonstrated response to therapy defined as serum uric acid <6 mg/dL with continued Krystexxa treatments; 3) Documentation of ongoing clinical benefit and supporting records attached (chart notes, lab results).Serum uric acid <6 mg/dL

Form includes checkboxes asking whether the patient is currently receiving therapy and whether serum uric acid response (<6 mg/dL) has been achieved.

The prior authorization form explicitly asks whether Krystexxa (pegloticase) is being requested for a chronic or long-term condition that may be necessary for the life of the patient. This question is presented on the form to capture whether ongoing, indefinite therapy is being considered and should be answered by the requester to support coverage assessment.

The form requires submission of supporting clinical documentation (chart notes, lab/test results) with the request and makes clear that absence of required prior trials, missing serum uric acid data, or failure to document treatment response may lead to noncoverage. Specifically, the form asks about prior ≥3‑month trials of xanthine oxidase inhibitors and uricosuric agents and documents serum uric acid outcomes; omission of these items or attached evidence may result in denial or delay.

Coding and Clinical Thresholds

Requested medication billing codemixed

J-code

J-Code (field on form to be provided by requester)

inv-06: Serum uric acid — target/threshold value

Serum uric acid threshold6 mg/dL

Context for thresholdDefined as the level used to determine inadequate response after trials of prior urate‑lowering therapy

Use for continuation decisionsSerum uric acid <6 mg/dL is used to define response for continued Krystexxa therapy (see continuation criteria)

inv-07: Trial duration — required trial length for prior therapy

Required trial duration3 months

Applies to xanthine oxidase inhibitors3‑month trial required (examples: allopurinol, febuxostat)

Applies to uricosuric agents3‑month trial required for uricosuric agents (examples: probenecid, fenofibrate, losartan)

Provider Submission & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Krystexxa. Complete the prior authorization form fully and attach all supportive documentation (chart notes, lab/test results) with the request to avoid delays.

Medication/dose, J‑code, duration, frequency, and whether therapy is initial or ongoing must be documented.
Attach evidence of clinical response when continuing therapy (for example serum uric acid < 6 mg/dL).

Documentation Required

Form Completion Requirements

The request must include complete patient and provider identifying information and facility dispensing/administration details.

Patient name, Cigna ID, date of birth, address, and phone.
Physician name, specialty, DEA/NPI/TIN, office contact, phone, fax, and facility name/address/Tax ID.

Denial Risk

Attach Supportive Documentation

This drug requires supportive documentation to be attached with the request. Failure to provide the requested documentation (chart notes, lab results, imaging, or other relevant records) may result in denial or delay of the request.

Examples: clinic notes documenting tophi or gout flares, serum uric acid values, prior medication trials and dates, and response or intolerance details.

Documentation Required

Requires Documentation of Prior Adequate Trials

Documentation of prior adequate trials is required before approval. Provide evidence of an adequate (≥3‑month) trial and serum uric acid response for both: a xanthine oxidase inhibitor and a uricosuric agent, unless contraindicated or not tolerated.

Xanthine oxidase inhibitors: e.g., allopurinol or febuxostat — include dates, dosing, and serum uric acid results showing inadequate response (>6 mg/dL) or documentation of intolerance/contraindication.
Uricosuric agents: e.g., probenecid, fenofibrate, losartan — include dates, dosing, and serum uric acid results showing inadequate response (>6 mg/dL) or documentation of renal insufficiency/contraindication limiting use.

Denial Risk

Missing Prior Trials or Serum Uric Acid Data — Denial Risk

Missing critical information such as prior trial documentation or serum uric acid data may result in non‑approval. Ensure all prior therapy fields and lab values in the form are completed.

If the patient is currently receiving Krystexxa, indicate whether therapy is continuation and provide evidence of response (serum uric acid <6 mg/dL) with ongoing treatment.
If prior trials are not completed or labs are absent, include prescriber rationale and relevant contraindication/intolerance documentation to support the request.

Background

Pegloticase (Krystexxa) is an intravenous uricolytic agent intended for patients with chronic gout who are refractory to standard oral urate‑lowering therapies. The form emphasizes objective evidence of refractory disease by requesting documentation such as presence of tophi, a history of recurrent gout flares, or a persistently elevated serum uric acid level (> 6 mg/dL) after appropriate trials of oral therapies; it also queries whether the prescriber is a rheumatologist or nephrologist and whether concomitant immunomodulator therapy will be used.

Definitions and Clinical Response Criteria

inv-15: Definition of inadequate response

DefinitionSerum uric acid remaining higher than 6 mg/dL after a 3‑month trial of a xanthine oxidase inhibitor or after a 3‑month trial of a uricosuric agent.

Examples of xanthine oxidase inhibitorsAllopurinol, febuxostat (examples listed on form)

Examples of uricosuric agentsProbenecid, fenofibrate, losartan (examples listed on form)

inv-16: Continuation response definition

Continuation response criterionSerum uric acid level less than 6 mg/dL with continued Krystexxa treatments.

Form confirmationForm asks: 'Has the patient responded to therapy with evidence of serum uric acid level less than 6 mg/dL with continued Krystexxa treatments?'

Use in coverage decisionsDocumented serum uric acid <6 mg/dL is required to support continued coverage per the form's continuation section.