CurrentMass General Brigham Health PlanPolicy N/A

Krystexxa (pegloticase) prior authorization — medical benefit coverage criteria

Covers medical-benefit prior authorization criteria for Krystexxa (pegloticase) in adult members of MassHealth; governs when the plan will authorize treatment for chronic gout refractory to conventional therapy.

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyKrystexxa (pegloticase) prior authorization — medical benefit coverage criteria

Policy CodePolicy N/A

Change TypeRevised clinical criteria and dosing threshold

Effective DateNov 17, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of gout diagnosis, age ≥18, serum urate >6.0 mg/dL after required trials, stepwise trial history or contraindications, and evidence of frequent flares or nonresolving tophi.

SourceLink

POLICY UPDATE CHANGES

Criteria for Krystexxa were updated to require members to have frequent gout flares or nonresolving tophi for approval.

Allopurinol dose threshold in prior criteria was increased to 800 mg/day from 600 mg/day per guidelines and FDA maximum dosing.

≥18minimum member age for approval

>6.0inadequate response threshold

6 moinitial approval duration

12 moreauthorization duration

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyKrystexxa (pegloticase) prior authorization — medical benefit coverage criteria

Policy CodePolicy N/A

Change TypeRevised clinical criteria and dosing threshold

Effective DateNov 17, 2025

Next Review DateN/A

SourceLink

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Coverage Criteria for Krystexxa (pegloticase)

inv-01: Initial Authorization Criteria

Authorization may be granted when ALL of the following are met:

Main eligibility: Member meets all nodes 1–6 as specified

1. Diagnosis: Diagnosis of gout

2. Age: Member is ≥18 years of age≥ 18 years

3. Allopurinol trial or contraindication: Either (a) inadequate response (defined by serum urate > 6.0 mg/dL) to allopurinol at a dose of at least 800 mg/day for four weeks OR (b) adverse reaction or contraindication (e.g., renal dysfunction/CrCl < 30 mL/min) to allopurinolserum urate > 6.0 mg/dL; allopurinol ≥800 mg/day for 4 weeks

4. Febuxostat trial or contraindication: Either (a) inadequate response (defined by serum urate > 6.0 mg/dL) to febuxostat at 80 mg/day (or 40 mg/day if CrCl < 30 mL/min) for a minimum of four weeks OR (b) adverse reaction or contraindication (e.g., cardiovascular disease, elevated LFTs, hepatic insufficiency) to febuxostatserum urate > 6.0 mg/dL; febuxostat 80 mg/day or 40 mg/day if CrCl < 30 mL/min for 4 weeks

5. Uricosuric agent trial or contraindication: Either (a) inadequate response (defined by serum urate > 6.0 mg/dL) to a uricosuric agent (e.g., probenecid, or off-label fenofibrate or losartan) in combination with allopurinol OR febuxostat for four weeks OR (b) adverse reaction or contraindication to a uricosuric agent4-week combination trial; serum urate > 6.0 mg/dL

6. Disease burden: Either (a) frequent gout flares (≥2 flares/year) OR (b) nonresolving subcutaneous tophi≥2 flares/year

Requirement added in latest revision

inv-02: Reauthorization

Continuation of Therapy

Resubmission inference: Resubmission by prescriber will infer a positive response to therapy

No objective response metric specified for continuation

Authorizations will not be granted for products obtained as samples or via manufacturer's patient assistance programs.

Use of Krystexxa is not authorized when the required stepwise trials and/or evidence of disease burden are not met; specifically, authorization requires completion of the specified trials (allopurinol, febuxostat, and a uricosuric agent unless contraindicated) and documentation of either frequent gout flares (≥2 flares/year) or a nonresolving subcutaneous tophus.

Key Clinical Thresholds and Coding-related Metrics

inv-05: Serum urate threshold

Serum urate threshold> 6.0 mg/dL

Clinical relevanceDefines inadequate response to urate-lowering therapy for stepwise criteria

Documentation requiredPrescriber must submit serum urate values showing > 6.0 mg/dL after required trial durations

inv-06: Minimum age

Minimum age≥ 18 years

ApplicabilityApplies to initial authorization for Krystexxa (pegloticase)

Documentation required

Provider Requirements, Documentation, and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization required — Krystexxa (pegloticase) is subject to medical benefit prior authorization for MassHealth members. Authorizations for members new to the plan may be reviewed case-by-case when therapy was initiated prior to plan enrollment; samples or manufacturer patient assistance program supply are excluded from coverage determinations.

MassHealth members only
Medical benefit prior authorization required
New-to-plan authorizations considered case-by-case

Documentation Required

Clinical Criteria for Approval

Clinical criteria for approval — Initial authorizations will be granted only when all of the detailed stepwise clinical criteria below are met. The prescriber must document the diagnosis, age, prior medication trials or documented contraindications/adverse reactions, and objective evidence of inadequate response (serum urate > 6.0 mg/dL) where indicated.

Background

Krystexxa (pegloticase) is a PEGylated uric acid–specific enzyme indicated for the treatment of chronic gout in adults with disease refractory to conventional therapy. It is intended for patients who have not achieved adequate urate lowering despite appropriate trials of xanthine oxidase inhibitors and uricosuric agents, or who have contraindications or adverse reactions to those therapies.

Definitions

inv-16: Krystexxa (pegloticase)

DrugKrystexxa (pegloticase)

DefinitionPegloticase is a PEGylated uric acid–specific enzyme

IndicationTreatment of chronic gout in adults refractory to conventional therapy

inv-17: Inadequate response

Inadequate response definitionSerum urate levels > 6.0 mg/dL after the specified therapy and duration

Contexts referencedApplies to allopurinol, febuxostat, and uricosuric agent trials as specified in stepwise criteria

Documentation required

Prescriber must confirm member age as part of submission

inv-07: Allopurinol trial dose

Allopurinol trial doseAt least 800 mg/day for 4 weeks

Alternate pathwayOr documented adverse reaction/contraindication (e.g., renal dysfunction/CrCl < 30 mL/min)

PurposeRequired step in demonstrating inadequate response before Krystexxa approval

inv-08: Febuxostat trial dose

Febuxostat trial dose80 mg/day (or 40 mg/day if CrCl < 30 mL/min) for a minimum of 4 weeks

Alternate pathwayOr documented adverse reaction/contraindication (e.g., cardiovascular disease, elevated LFTs, hepatic insufficiency)

Definition of inadequate responseSerum urate > 6.0 mg/dL after the specified febuxostat trial

inv-09: Frequent gout flares

Frequent gout flares≥2 flares/year

Role in criteriaMeets disease-burden requirement (alternative to nonresolving tophi) for approval

Documentation requiredPrescriber must provide evidence of frequency of flares in the prior year

Applies to adults (≥18 years) with gout
Documentation of serum urate values and prior therapy trials required

Step Therapy

Required Stepwise Trials

Required stepwise trials — Prior authorization will be approved only after documentation of the following stepwise medication trials or a documented contraindication/adverse reaction to each agent: (1) adequate trial of allopurinol (at least 800 mg/day for 4 weeks) or documented contraindication (e.g., renal dysfunction/CrCl <30 mL/min); (2) adequate trial of febuxostat (80 mg/day, or 40 mg/day if CrCl <30 mL/min) for a minimum of 4 weeks or documented contraindication (e.g., cardiovascular disease, significant LFT elevation, hepatic insufficiency); (3) adequate trial of a uricosuric agent (e.g., probenecid, or off-label fenofibrate or losartan) in combination with allopurinol or febuxostat for 4 weeks, or documented contraindication/adverse reaction to a uricosuric agent.

Allopurinol: ≥800 mg/day ×4 weeks or contraindication (e.g., CrCl <30 mL/min)
Febuxostat: 80 mg/day (or 40 mg/day if CrCl <30 mL/min) ×4 weeks or contraindication (e.g., CVD, high LFTs)
Uricosuric agent: trial in combination with xanthine oxidase inhibitor ×4 weeks or contraindication

Documentation Required

Required Clinical Documentation

Required clinical documentation — Prescribers must submit documentation supporting: diagnosis of gout, patient age (≥18 years), prior medication histories and reasons for failure or contraindication, baseline and recent serum urate values demonstrating inadequate response (>6.0 mg/dL) where applicable, and clinical evidence of disease severity (e.g., ≥2 gout flares/year or nonresolving subcutaneous tophi) to support medical necessity for Krystexxa.

Diagnosis of gout documented
Age ≥18 years
Medication trial records or contraindication documentation for allopurinol, febuxostat, and uricosuric agents
Serum urate laboratory values showing >6.0 mg/dL
Clinical evidence of frequent flares (≥2/year) or nonresolving tophi

Denial Risk

Failure to Meet Clinical Criteria

Failure to meet clinical criteria — Authorization may be denied if the member does not meet ALL required criteria, including: diagnosis of gout, age ≥18, documented inadequate response to or contraindication for all required prior agents, laboratory evidence (serum urate >6.0 mg/dL when applicable), and clinical severity (frequent flares or tophi). Lack of adequate documentation of prior trials, lab values, or contraindications is grounds for denial.

Denial risk if missing documentation of trials or serum urate values
Denial risk if member is <18 years or lacks required clinical severity

Prescriber must submit serum urate results demonstrating > 6.0 mg/dL following the required trial durations