By Counterforce Health Team in Krystexxa (pegloticase) —

UnitedHealthcare's Coverage Criteria for Krystexxa (Pegloticase) in Georgia: What Counts as "Medically Necessary"?

Answer Box: Getting Krystexxa Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Krystexxa (pegloticase) with strict medical necessity criteria: documented failure of both allopurinol and febuxostat, negative G6PD test, rheumatologist prescription, and methotrexate co-therapy plan. First step today: gather your prior therapy records and lab results, then submit via OptumRx provider portal. Standard review takes 15 business days. If denied, you have 180 days for internal appeal and 60 days for Georgia external review through the Department of Insurance.

Table of Contents

  1. Policy Overview: How UnitedHealthcare Covers Krystexxa
  2. Indication Requirements: FDA Status and Medical Necessity
  3. Step Therapy & Exceptions: Required Prior Treatments
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Lab Values
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Documentation
  9. Appeals Process in Georgia
  10. Quick Reference: Coverage Checklist

Policy Overview: How UnitedHealthcare Covers Krystexxa

UnitedHealthcare covers Krystexxa (pegloticase) across all plan types—commercial, Medicare Advantage, and Medicaid—but requires prior authorization through OptumRx for all members. The drug is typically placed on specialty formulary tiers with significant cost-sharing requirements.

Plan-Specific Considerations:

  • Commercial plans: Standard PA requirements apply with 180-day internal appeal rights
  • Medicare Advantage: Enhanced appeal protections with expedited review options
  • Medicaid: State-specific criteria may apply; verify current Georgia Medicaid policy

Find your specific policy documents through the UnitedHealthcare provider portal or member portal to confirm current formulary status and tier placement.

Indication Requirements: FDA Status and Medical Necessity

Krystexxa is FDA-approved for chronic gout in adults refractory to conventional therapy. UnitedHealthcare's medical necessity criteria align closely with the FDA labeling but add specific documentation requirements.

Core Medical Necessity Criteria:

  • Confirmed diagnosis of chronic gout with ICD-10 coding (typically M1A.9)
  • Persistent serum uric acid levels >6 mg/dL despite conventional therapy
  • Evidence of ongoing gout symptoms (recurrent flares, tophi, or joint damage)
  • Not approved for asymptomatic hyperuricemia

Documentation Must Include:

  • Rheumatologist consultation notes
  • Baseline and recent serum uric acid levels
  • Clinical evidence of refractory gout (imaging, physical exam findings)

Step Therapy & Exceptions: Required Prior Treatments

UnitedHealthcare enforces strict step therapy requirements before approving Krystexxa. According to their medical policy, patients must demonstrate failure of conventional urate-lowering therapy.

Required Prior Therapies:

  1. Allopurinol: Maximally tolerated dose (typically 300-800 mg daily) for minimum 3 months
  2. Febuxostat: Adequate trial (typically 80-120 mg daily) for minimum 3 months
  3. Documentation of failure: Either inadequate uric acid lowering OR intolerance/adverse effects

Medical Exception Pathways:

  • Contraindications: HLA-B*5801 allele (for allopurinol), severe renal impairment
  • Intolerance: Documented adverse effects requiring discontinuation
  • Drug interactions: Significant interactions preventing safe use
Tip: Document specific reasons for discontinuation (e.g., "allopurinol discontinued after 4 months due to severe rash; febuxostat discontinued after 6 months due to inadequate uric acid reduction from 9.2 to 7.8 mg/dL").

Quantity and Frequency Limits

UnitedHealthcare follows FDA-approved dosing for Krystexxa with specific quantity limits and renewal requirements.

Standard Dosing Limits:

  • Dose: 8 mg IV every 2 weeks
  • Billing code: J2507 (per 1 mg) - bill 8 units per infusion
  • Site of care: Infusion center or hospital outpatient department
  • Initial authorization: Typically 6 months (13 infusions)

Renewal Requirements:

  • Serial uric acid levels from each infusion visit
  • Continuation criteria: No two consecutive pre-infusion uric acid levels ≥6 mg/dL
  • Clinical response documentation (reduced flares, tophus improvement)
  • Safety monitoring results

If uric acid levels rise above 6 mg/dL on two consecutive measurements, therapy must be discontinued per FDA labeling and UnitedHealthcare policy.

Required Diagnostics and Lab Values

UnitedHealthcare requires specific laboratory testing before and during Krystexxa therapy, following FDA safety requirements.

Pre-Treatment Requirements:

  • G6PD deficiency test: Must be negative (absolute contraindication if positive)
  • Baseline serum uric acid: Document levels >6 mg/dL despite prior therapy
  • Complete blood count: Baseline values
  • Comprehensive metabolic panel: Assess kidney/liver function

Ongoing Monitoring:

  • Pre-infusion uric acid: Required before each dose
  • Safety labs: CBC and CMP as clinically indicated
  • Infusion reaction monitoring: Document any adverse events
Note: G6PD testing is mandatory and non-negotiable. Krystexxa can cause severe hemolysis in G6PD-deficient patients.

Site of Care and Specialty Pharmacy Requirements

UnitedHealthcare requires Krystexxa to be dispensed through OptumRx Specialty Pharmacy and administered at approved infusion centers.

Approved Sites of Care:

  • Hospital outpatient infusion centers
  • Physician office-based infusion suites
  • Freestanding infusion centers
  • Not approved: Home infusion (due to anaphylaxis risk)

Specialty Pharmacy Process:

  1. Prior authorization approval required first
  2. OptumRx coordinates drug delivery to infusion site
  3. Cold-chain shipping and storage requirements
  4. Billing through medical benefit (not pharmacy benefit)

Contact OptumRx Specialty at 1-800-711-4555 for coordination once PA is approved.

Evidence to Support Medical Necessity

Strong clinical documentation significantly improves approval chances. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and crafting point-by-point rebuttals aligned to each plan's criteria.

Key Evidence Sources:

  • FDA labeling: Primary reference for approved indications
  • ACR Gout Guidelines (2020): Support for treatment-refractory patients
  • Peer-reviewed studies: Efficacy data for refractory gout
  • Clinical practice guidelines: Rheumatology society recommendations

Documentation Strategy:

  • Cite specific guideline recommendations
  • Reference published efficacy data
  • Include specialist attestation of medical necessity
  • Document patient-specific factors supporting treatment choice

Sample "Meets Criteria" Documentation

Here's a template paragraph structure for medical necessity letters:

"This 58-year-old male with chronic tophaceous gout has failed conventional urate-lowering therapy despite optimal management. He completed a 6-month trial of allopurinol 300 mg daily with uric acid reduction from 9.8 to 7.2 mg/dL (inadequate response), followed by febuxostat 80 mg daily for 4 months, discontinued due to severe GI intolerance. Current serum uric acid remains elevated at 8.4 mg/dL with ongoing gouty flares (3 episodes in past 6 months) and progressive tophaceous deposits. G6PD testing is negative. Per ACR guidelines, pegloticase is indicated for treatment-refractory chronic gout. Concurrent methotrexate 15 mg weekly will be initiated per current labeling recommendations."

Key Elements:

  • Specific prior therapy details (drugs, doses, duration, outcomes)
  • Objective failure criteria
  • Current disease activity
  • Safety screening results
  • Guideline support
  • Co-therapy plan

Appeals Process in Georgia

If UnitedHealthcare denies your Krystexxa request, Georgia law provides robust appeal rights through both internal and external review processes.

Internal Appeals

Timeline: File within 180 days of denial Process:

  1. Submit appeal via UnitedHealthcare member portal or mail
  2. Include denial letter, medical records, and updated clinical information
  3. Request peer-to-peer review with rheumatologist if available
  4. Standard decision: 30 days; Expedited: 72 hours for urgent cases

Georgia External Review

Timeline: File within 60 days of final internal denial Process:

  1. Contact Georgia Department of Insurance at 1-800-656-2298
  2. Submit external review application (available on DOI website)
  3. Include all denial letters and supporting medical documentation
  4. Independent medical review by specialists
  5. Decision within 30 business days (72 hours for urgent cases)
  6. Binding decision - UnitedHealthcare must comply if approved
From our advocates: We've seen Georgia patients successfully overturn Krystexxa denials at external review by submitting comprehensive documentation of failed prior therapies and clear evidence of ongoing gout symptoms. The key is thorough preparation and meeting all submission deadlines.

Georgia's external review process is free to patients and provides an independent second opinion when insurance companies deny medically necessary treatments.

Quick Reference: Coverage Checklist

Requirement What You Need Where to Find It Status
Prior Authorization OptumRx PA form OptumRx Portal ☐
Step Therapy Documentation Failed allopurinol + febuxostat records Medical records, pharmacy records ☐
G6PD Test Negative result required Lab results ☐
Rheumatologist Prescription Specialist consultation Provider notes ☐
Baseline Labs Uric acid >6 mg/dL Recent lab results ☐
Methotrexate Plan Co-therapy documentation Treatment plan ☐
Site of Care Approved infusion center Facility verification ☐

Common Denial Reasons & Solutions:

  • Missing G6PD test: Order and submit results
  • Inadequate step therapy: Document specific failure reasons
  • Non-specialist prescriber: Obtain rheumatology consultation
  • Missing methotrexate plan: Add co-therapy documentation

Costs and Financial Assistance

Krystexxa costs approximately $30,000 per infusion, with annual treatment costs reaching $780,000. Several programs can help reduce out-of-pocket expenses:

  • Amgen SupportPlus: Patient assistance program for eligible patients
  • Copay assistance: Available for commercial insurance patients
  • Foundation grants: Patient advocacy organizations may provide support
  • Hospital charity care: Many infusion centers offer financial assistance programs

Contact the manufacturer's patient support program at 1-833-KRYSTEXXA for current eligibility requirements.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's requirements, significantly improving approval rates for complex specialty medications like Krystexxa.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently; always verify current requirements with your insurance plan and healthcare providers. For personalized assistance with insurance appeals and coverage issues, consult with qualified healthcare advocates or legal professionals specializing in insurance law.

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