By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by UnitedHealthcare in New York: Complete Guide to Prior Authorization, Appeals, and Alternatives

Answer Box: Getting Krystexxa Covered by UnitedHealthcare in New York

UnitedHealthcare requires prior authorization for Krystexxa (pegloticase) with strict step therapy requirements. You must document failed trials of allopurinol and febuxostat, plus G6PD testing and rheumatologist oversight. If denied, New York offers strong external appeal rights through the Department of Financial Services within 4 months of final denial. First step today: Gather documentation of prior gout treatments and serum uric acid levels >6 mg/dL, then submit PA request through UnitedHealthcare's provider portal.

Table of Contents

  1. Understanding UnitedHealthcare's Krystexxa Coverage
  2. When Formulary Alternatives Make Sense
  3. Typical Formulary Alternatives by Class
  4. Coverage Requirements Comparison
  5. Exception Strategy for Krystexxa
  6. Step-by-Step Prior Authorization Process
  7. Appeals Process in New York
  8. Common Denial Reasons & Solutions
  9. Costs & Patient Assistance
  10. FAQ

Understanding UnitedHealthcare's Krystexxa Coverage

Krystexxa (pegloticase) is a pegylated recombinant uricase that rapidly lowers serum uric acid by converting it to allantoin. At approximately $30,000 per infusion, it's reserved for chronic gout refractory to conventional therapy.

UnitedHealthcare requires prior authorization for Krystexxa under HCPCS code J2507. The medication is typically placed on Tier 3 (specialty) with strict step therapy requirements and ongoing monitoring protocols.

Note: Krystexxa is not approved for asymptomatic hyperuricemia or mild gout. It's specifically indicated for chronic gout in adults who haven't responded to conventional therapy.

When Formulary Alternatives Make Sense

Before pursuing Krystexxa, UnitedHealthcare requires documented trials of preferred formulary alternatives. This step therapy approach makes clinical and financial sense for several reasons:

Availability and Access

  • Generic allopurinol and febuxostat are widely available with minimal PA requirements
  • Lower copays and deductibles make adherence more likely
  • Most primary care physicians are comfortable prescribing these agents

Clinical Criteria UnitedHealthcare will only consider Krystexxa when patients have:

  • Persistent serum uric acid >6 mg/dL despite maximally tolerated doses
  • Documented failure, contraindication, or intolerance to xanthine oxidase inhibitors
  • Active gout symptoms (frequent flares, tophi, or gouty arthritis)
  • Rheumatologist or nephrologist oversight

Typical Formulary Alternatives by Class

First-Line Xanthine Oxidase Inhibitors

Allopurinol (Generic)

  • Mechanism: Blocks uric acid production by inhibiting xanthine oxidase
  • UnitedHealthcare Status: Preferred, minimal PA requirements
  • Typical Dosing: Start 100mg daily, titrate to 300-800mg based on serum uric acid
  • Monitoring: Serum uric acid every 2-4 weeks during titration

Febuxostat (Uloric)

  • Mechanism: Non-purine xanthine oxidase inhibitor
  • UnitedHealthcare Status: Non-preferred, requires allopurinol trial first
  • Typical Dosing: 40-80mg daily
  • Considerations: May be used when allopurinol is contraindicated or causes severe reactions

Uricosuric Agents

Probenecid

  • Mechanism: Increases renal uric acid excretion
  • UnitedHealthcare Status: Preferred for patients with adequate kidney function
  • Typical Dosing: 250mg twice daily, increase to 500mg twice daily
  • Requirements: Creatinine clearance >50 mL/min, no history of kidney stones

Lesinurad (Zurampic)

  • Mechanism: URAT1 inhibitor, used with XOI
  • UnitedHealthcare Status: Non-preferred, requires XOI + uricosuric failure
  • Considerations: Must be used in combination with allopurinol or febuxostat

Coverage Requirements Comparison

Medication UnitedHealthcare Tier PA Required Step Therapy Specialist Required
Allopurinol Tier 1 (Generic) No No No
Febuxostat Tier 2-3 Yes Allopurinol trial No
Probenecid Tier 1-2 Minimal No No
Lesinurad Tier 3 Yes XOI + uricosuric failure Preferred
Krystexxa Tier 3 Specialty Yes All conventional therapies Yes (Rheumatology)

Exception Strategy for Krystexxa

When to Request an Exception

Consider pursuing Krystexxa when patients have:

  • Documented treatment failures: At least 3-6 months of maximally tolerated allopurinol (≥300mg daily) without achieving serum uric acid <6 mg/dL
  • Severe intolerance: Documented allergic reactions, severe skin reactions, or hepatotoxicity with XOIs
  • Progressive disease: Worsening tophi, joint damage, or frequent flares despite conventional therapy
  • Contraindications: Kidney stones, severe renal impairment preventing uricosuric use

Evidence That Helps

Clinical Documentation:

  • Serial serum uric acid levels showing persistent elevation >6 mg/dL
  • Documentation of gout flares, tophi measurements, or joint imaging
  • Detailed medication history with specific reasons for discontinuation
  • G6PD testing results (required due to hemolysis risk)

Provider Requirements:

  • Rheumatologist or nephrologist consultation and ongoing management
  • Letter of medical necessity addressing each step therapy requirement
  • Treatment plan including methotrexate co-therapy consideration per 2022 FDA label update

Step-by-Step Prior Authorization Process

Step 1: Gather Required Documentation

Timeline: 1-2 weeks before submission

  • Insurance card and member ID
  • Complete medication history with dates, doses, and outcomes
  • Laboratory results: serum uric acid trends, G6PD level, renal function
  • Clinical notes documenting gout activity and treatment response

Step 2: Submit Prior Authorization Request

Timeline: Submit at least 2 weeks before planned treatment

  • Use UnitedHealthcare Provider Portal for electronic submission
  • Include ICD-10 code M10.9 (gout, unspecified) or specific gout codes
  • Submit J2507 billing code with planned administration schedule

Step 3: Peer-to-Peer Review (If Requested)

Timeline: Usually within 72 hours of PA submission

  • UnitedHealthcare medical director may request discussion with prescribing rheumatologist
  • Prepare clinical rationale and evidence supporting medical necessity

Step 4: Authorization Decision

Timeline: Standard review within 72 hours; expedited if urgent

  • Approval typically includes 6-month authorization with renewal requirements
  • Denials include specific reasons and appeal rights information
Tip: Set calendar reminders for authorization renewals 30 days before expiration to avoid treatment interruptions.

Appeals Process in New York

New York provides robust patient protection through its external appeal process managed by the Department of Financial Services (DFS).

Internal Appeal with UnitedHealthcare

Timeline: Must file within 180 days of denial Process:

  1. Submit written appeal with additional clinical documentation
  2. Include updated lab results and provider attestation
  3. Address specific denial reasons point-by-point
  4. Expect decision within 15-30 days

External Appeal Through NY DFS

Timeline: Must file within 4 months of final internal denial Process:

  1. Complete DFS External Appeal Application
  2. Pay $25 fee (waived for Medicaid or financial hardship)
  3. Include all medical records and denial correspondence
  4. Standard decision within 30-45 days; expedited within 72 hours for urgent cases

Key Advantage: External appeal decisions are binding on UnitedHealthcare, and fees are refunded if denial is overturned.

Consumer Assistance Resources

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Inadequate step therapy Document specific doses, durations, and outcomes of allopurinol/febuxostat trials
Missing G6PD testing Obtain G6PD quantitative level (required due to hemolysis risk)
Non-rheumatologist prescriber Transfer care or obtain rheumatology consultation
Serum uric acid not documented >6 mg/dL Provide serial lab results showing persistent elevation
Lack of active gout symptoms Document recent flares, tophi progression, or joint damage
Missing methotrexate consideration Address why MTX co-therapy is/isn't appropriate per 2022 FDA update

Costs & Patient Assistance

Manufacturer Support

Amgen SupportPlus: Copay assistance for eligible commercially insured patients

Foundation Assistance

  • Patient Access Network Foundation: Grants for specialty medications
  • HealthWell Foundation: Financial assistance for chronic conditions
  • CancerCare Co-Payment Assistance Foundation: May cover inflammatory conditions

State Programs

New York residents may qualify for:

  • Essential Plan: Low-cost coverage for income-eligible individuals
  • Medicaid: Comprehensive coverage including specialty drugs
  • EPIC: Prescription assistance for seniors

At Counterforce Health, we help patients and providers navigate complex prior authorization requirements for specialty medications like Krystexxa. Our platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that address specific coverage criteria. By turning insurance denials into strategic appeals aligned with each plan's own rules, we help ensure patients get access to the treatments they need.

FAQ

How long does UnitedHealthcare prior authorization take for Krystexxa? Standard PA review takes up to 72 hours for complete submissions. Expedited review is available for urgent medical needs, with decisions typically within 24 hours.

What if Krystexxa is non-formulary on my UnitedHealthcare plan? Non-formulary medications require additional clinical justification demonstrating why preferred alternatives are inappropriate. This may include documented allergies, contraindications, or treatment failures.

Can I request an expedited appeal in New York? Yes, if delay would jeopardize your health, you can request expedited external appeal through NY DFS. Decisions are issued within 72 hours for most cases, or 24 hours for urgent drug denials.

Does step therapy apply if I failed treatments outside New York? Yes, documented treatment failures from other states are generally accepted if properly documented with specific medications, doses, durations, and outcomes.

How often does UnitedHealthcare require Krystexxa reauthorization? Typically every 6 months, requiring updated serum uric acid levels, clinical response documentation, and provider attestation of ongoing medical necessity.

What happens if I lose UnitedHealthcare coverage during Krystexxa treatment? Contact Counterforce Health or similar advocacy services to help transition coverage and maintain treatment continuity with your new insurer.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage policies vary by plan and change over time. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions.

Sources & Further Reading

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