By Counterforce Health Team in Krystexxa (pegloticase) —

Krystexxa (Pegloticase) Approval with UnitedHealthcare in California: Answers to the Most Common Questions

Answer Box: Getting Krystexxa Covered by UnitedHealthcare in California

UnitedHealthcare requires prior authorization for Krystexxa (pegloticase) in California with strict step therapy requiring documented failure of both allopurinol and febuxostat at maximum doses, plus G6PD testing and rheumatologist oversight. Submit PA via UnitedHealthcare provider portal with complete clinical documentation. If denied, file internal appeal within 180 days, then request California DMHC Independent Medical Review (IMR) for binding external review. Start today: Call UnitedHealthcare member services to verify PA requirements and gather your medication trial history.

Table of Contents

  1. Coverage Basics
  2. The Authorization Process
  3. Timing and Deadlines
  4. Clinical Criteria Requirements
  5. Understanding Costs
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Coordination
  9. Troubleshooting Common Issues
  10. Key Terms Glossary

Coverage Basics

Is Krystexxa covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Krystexxa (pegloticase) under its medical benefit as HCPCS code J2507, but prior authorization is required for virtually all commercial and Community Plan members. The drug is not typically found on standard pharmacy formularies because it's administered by IV infusion in clinical settings.

Which UnitedHealthcare plans cover Krystexxa?

Coverage applies to:

  • Commercial plans (employer-sponsored and individual marketplace)
  • Community Plan (Medicaid managed care)
  • Medicare Advantage plans (with Part B coverage)

Each plan type has slightly different criteria, but all require prior authorization through UnitedHealthcare's medical drug policies.

Note: California's Covered California marketplace plans from UnitedHealthcare follow the same PA requirements as commercial plans.

The Authorization Process

Who submits the prior authorization?

Your prescribing physician (typically a rheumatologist) must submit the PA request. Patients cannot submit medical benefit PAs directly, but you can help gather required documentation.

How to check authorization status

  1. Provider portal: Clinicians can check status via the UnitedHealthcare provider portal
  2. Member services: Call the number on your insurance card for status updates
  3. Written confirmation: UnitedHealthcare will send written PA approval/denial notices

Timing and Deadlines

Timeline Standard Review Expedited Review
PA Decision 15 business days 72 hours
Internal Appeal 30 calendar days 72 hours
External Review (DMHC IMR) 45 calendar days 7 calendar days

When can you request expedited review?

Expedited review applies when delays could seriously jeopardize your health. For Krystexxa, this might include:

  • Severe, frequent gout flares causing disability
  • Rapidly progressive tophaceous gout
  • Failed previous therapies causing ongoing joint damage

Clinical Criteria Requirements

Step-by-Step: Meeting UnitedHealthcare's Requirements

1. Diagnosis Documentation

  • Chronic gout diagnosis with appropriate ICD-10 codes (M1A.* series)
  • Evidence of refractory disease (≥2 flares per year, tophi, or chronic gouty arthropathy)

2. Laboratory Requirements

  • Serum uric acid ≥6 mg/dL at baseline
  • Normal G6PD test results (Krystexxa is contraindicated in G6PD deficiency)
  • Recent comprehensive metabolic panel

3. Step Therapy Documentation Must show documented failure or intolerance of both:

  • Allopurinol at maximum tolerated dose (typically ≥300 mg/day) for ≥3 months
  • Febuxostat at appropriate dose or documented contraindication

4. Prescriber Requirements

  • Prescription by or consultation with a rheumatologist or nephrologist
  • Letter of medical necessity addressing each criterion

5. Safety and Monitoring Plan

  • Plan for premedication (antihistamines, corticosteroids)
  • Commitment to check serum uric acid before each infusion
  • Agreement to discontinue if uric acid rises above 6 mg/dL
Clinician Corner: Consider documenting methotrexate co-therapy plans or contraindications, as emerging evidence supports combination therapy for improved outcomes.

Understanding Costs

What you'll pay depends on your plan

  • Deductible: May apply to medical benefit drugs like Krystexxa
  • Coinsurance: Typically 10-30% of the allowed amount after deductible
  • Out-of-pocket maximum: Annual limit on your total costs

Manufacturer Support Available

Amgen SupportPlus offers copay assistance for eligible commercial plan members, potentially reducing costs to $0 per infusion.

Denials and Appeals

Common Denial Reasons & How to Fix Them

Denial Reason Solution
Insufficient step therapy Provide detailed medication trial logs with dates, doses, and outcomes
Missing G6PD test Order and submit normal G6PD results
Not prescribed by specialist Include rheumatology consultation notes
Baseline uric acid <6 mg/dL Submit recent lab showing elevated uric acid
Lack of clinical severity Document flare frequency, tophi, functional impact

Appeals Playbook for California

Level 1: Internal Appeal

  • Deadline: 180 days from denial date
  • Submit via: UnitedHealthcare member/provider portal
  • Timeline: 30 days standard, 72 hours expedited
  • Required: Denial letter, additional clinical documentation, appeal form

Level 2: California DMHC Independent Medical Review (IMR)

  • When: After internal appeal denial or 30-day delay
  • Cost: Free to patients
  • Submit: Online at healthhelp.ca.gov or call 888-466-2219
  • Timeline: 45 days standard, 7 days expedited
  • Binding: UnitedHealthcare must comply with favorable IMR decisions
From our advocates: We've seen Krystexxa denials successfully overturned at the IMR level when providers submitted comprehensive documentation showing clear medical necessity and proper step therapy completion. The key is thorough documentation of failed conventional therapies and ongoing disease severity.

Renewal Requirements

When to submit reauthorization

Submit renewal requests 30 days before your current authorization expires, typically every 6-12 months.

What UnitedHealthcare looks for in renewals

  • Clinical response: Serum uric acid maintained <6 mg/dL
  • Symptom improvement: Reduced flares, tophus shrinkage
  • No consecutive elevated uric acid levels (>6 mg/dL on two tests)
  • Ongoing medical necessity: Continued specialist oversight

Specialty Pharmacy Coordination

Why Krystexxa uses buy-and-bill

Unlike oral medications, Krystexxa is administered in clinical settings and billed as a medical benefit using J2507 (per mg). Your infusion center or rheumatologist's office purchases and bills the drug directly.

Your role in the process

  • Ensure your clinic has current PA approval before scheduling infusions
  • Verify your insurance information is up to date
  • Coordinate with your provider on scheduling around PA renewal dates

Troubleshooting Common Issues

Portal or system problems

If UnitedHealthcare's online systems are down:

  • Call member services at the number on your insurance card
  • Fax requests to provider services (verify current fax number)
  • Document all communications with dates and reference numbers

Missing forms or documentation

  • Contact your prescriber's office for clinical notes and lab results
  • Request medication history from previous providers
  • Gather pharmacy records showing step therapy attempts

Key Terms Glossary

  • Prior Authorization (PA): Insurance approval required before receiving certain medications
  • Step Therapy: Requirement to try less expensive treatments first
  • Medical Necessity: Clinical justification that a treatment is appropriate and needed
  • J2507: HCPCS billing code for Krystexxa (per 1 mg)
  • G6PD: Glucose-6-phosphate dehydrogenase enzyme test required before Krystexxa
  • IMR: Independent Medical Review - California's external appeal process
  • DMHC: Department of Managed Health Care - California's HMO regulator

About Counterforce Health: Counterforce Health helps patients and providers navigate insurance denials by creating targeted, evidence-backed appeals. Our platform analyzes denial letters and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements to improve approval rates.

When dealing with complex specialty drug approvals like Krystexxa, having the right documentation and understanding payer-specific criteria can make the difference between approval and denial. Counterforce Health specializes in turning these challenging cases into successful outcomes through systematic appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with California insurance issues, contact the DMHC Help Center at 888-466-2219.

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