By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by Humana in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Krystexxa Covered by Humana in California

Krystexxa (pegloticase) requires prior authorization for all Humana Medicare Advantage plans in California. The fastest path to approval: 1) Ensure you have a rheumatologist prescriber, documented failure of allopurinol and febuxostat, normal G6PD test results, and current methotrexate therapy (unless contraindicated). 2) Submit the complete prior authorization packet via fax (877-486-2621) or Humana's provider portal. 3) If denied, file an internal appeal within 65 days, then request California's Independent Medical Review (IMR) through the DMHC. Standard review takes 15-30 days; expedited reviews complete within 72 hours for urgent cases.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Humana MA plans Humana PA Lists
Prescriber Must be a rheumatologist Humana clinical criteria
Step Therapy Failed allopurinol AND febuxostat (≥3 months each) Humana PA Forms
G6PD Testing Normal result required (contraindicated if deficient) FDA Label
Methotrexate Current use or documented contraindication Updated 2024 clinical criteria
Serum Uric Acid >6 mg/dL despite prior therapy Lab documentation required
Review Timeline 15-30 days standard, 72 hours expedited Humana Provider Portal

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility and Gather Documentation

Who: Patient and clinic staff
Timeline: 1-2 days

Verify active Humana Medicare Advantage coverage and collect:

  • Insurance card with member ID
  • Complete medical records documenting gout diagnosis
  • Lab results showing persistent uric acid >6 mg/dL
  • Documentation of failed trials with allopurinol and febuxostat
  • G6PD test results (must be normal)
  • Current medication list including methotrexate

2. Complete G6PD Screening (If Not Done)

Who: Prescribing physician
Timeline: 2-3 days for results

Order G6PD deficiency testing immediately if not already completed. Krystexxa is absolutely contraindicated in G6PD deficiency and can cause life-threatening hemolysis. This test is mandatory per FDA labeling.

3. Initiate Methotrexate (If Appropriate)

Who: Rheumatologist
Timeline: Start 4 weeks before planned Krystexxa initiation

Most 2024 Humana policies require methotrexate co-therapy (15-25 mg weekly) unless contraindicated. This reduces immunogenicity and improves response rates based on recent clinical evidence.

4. Complete Prior Authorization Form

Who: Provider office
Timeline: 1-2 hours

Download the Humana-specific PA form and complete all sections, including:

  • Patient demographics and diagnosis codes
  • Detailed treatment history with specific dates, doses, and outcomes
  • Clinical rationale for Krystexxa necessity
  • G6PD test results and methotrexate plan

5. Submit Complete Packet

Who: Provider office
Timeline: Same day

Submit via:

  • Fax: 877-486-2621
  • Provider Portal: Humana provider portal
  • Phone for questions: 1-866-488-5995 (Medicare requests)

Include all supporting documentation: clinical notes, lab results, pharmacy records, and specialist consultations.

6. Track and Follow Up

Who: Provider office and patient
Timeline: Check status after 7-10 days

Monitor submission status through the provider portal or by calling Humana. Standard reviews take 15-30 days; expedited reviews (for urgent cases) complete within 72 hours.

7. Prepare for Potential Appeal

Who: Provider and patient
Timeline: Begin immediately if denied

If denied, you have 65 days to file an internal appeal. Gather additional evidence and prepare for potential peer-to-peer review or California IMR escalation.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Insufficient step therapy documentation Provide detailed pharmacy records with dates, doses, duration, and specific reasons for discontinuation (inefficacy, intolerance, contraindications)
Missing G6PD test results Submit lab report showing normal G6PD activity; ensure test was performed before PA submission
Prescriber not rheumatologist Have rheumatologist submit new PA or provide consultation note supporting medical necessity
No methotrexate co-therapy Start methotrexate 15-25 mg weekly or provide detailed contraindication documentation with clinical rationale
Serum uric acid not documented >6 mg/dL Submit serial lab results showing persistent elevation despite maximum tolerated conventional therapy
Incomplete medical necessity justification Provide comprehensive letter addressing all clinical criteria with supporting literature and guidelines
From Our Advocates: A composite case from California showed success after initial denial by resubmitting with detailed pharmacy printouts showing exact allopurinol titration over six months (starting at 100mg daily, increased to 800mg daily) with documented serum uric acid levels remaining >8 mg/dL throughout the trial period. The key was specificity—exact dates, doses, and measurable outcomes.

Appeals Process: Humana Internal to California IMR

Internal Appeal with Humana

Timeline: Must file within 65 days of denial notice
Review time: 30 days standard, 72 hours expedited

Submit additional documentation addressing the specific denial reasons. Request peer-to-peer review if clinical criteria are disputed. Use Humana's appeals forms and clearly reference the original PA case number.

California Independent Medical Review (IMR)

When to use: After Humana upholds the denial
Timeline: File within 180 days of final internal denial
Review time: 45 days standard, 7 days expedited

California's IMR provides independent physician review of medical necessity denials. File through the DMHC website or call 888-466-2219. The review is conducted by specialty physicians and is binding on Humana.

IMR Success Factors:

  • Comprehensive medical records
  • Peer-reviewed literature supporting Krystexxa use
  • Clear documentation of treatment failures
  • Specialist attestation of medical necessity

At Counterforce Health, we've seen California IMR overturn rates of 25-35% for specialty drug denials when properly documented. The key is addressing each clinical criterion with specific evidence and expert clinical justification.

Medical Necessity Letter Checklist

Clinical Problem Statement

  • Diagnosis of chronic gout with specific ICD-10 codes
  • Frequency of gout flares (≥2 per year typically required)
  • Presence and description of tophi
  • Functional impact and quality of life effects

Prior Treatment Documentation

  • Allopurinol trial: maximum tolerated dose, duration ≥3 months, specific reason for failure/discontinuation
  • Febuxostat trial: appropriate dosing, duration ≥3 months, documented inadequate response
  • Uricosuric agents tried (if applicable): probenecid trials and outcomes
  • Serial serum uric acid levels throughout treatment attempts

Clinical Rationale for Krystexxa

  • Mechanism of action explanation (pegylated uricase converting uric acid to allantoin)
  • Expected clinical benefits: uric acid reduction, tophus resolution, flare prevention
  • Monitoring plan: pre-infusion uric acid levels, infusion reaction protocols
  • Administration setting: appropriate medical facility with emergency management capabilities

Supporting Evidence

  • Reference to FDA labeling for approved indication
  • Cite relevant clinical guidelines (ACR gout management guidelines)
  • Include peer-reviewed studies supporting efficacy in refractory gout
  • G6PD test results confirming normal enzyme activity

Cost Savings and Patient Support

Manufacturer Support Programs

Amgen By Your Side: Provides case management, insurance navigation, and financial assistance for eligible patients. Contact through krystexxahcp.com or 1-844-KRYSTEXXA.

Copay Assistance

Commercial insurance patients may qualify for copay cards reducing out-of-pocket costs. Medicare patients are not eligible for manufacturer copay assistance due to federal regulations.

Foundation Grants

Patient advocacy organizations and rare disease foundations may provide financial assistance for Krystexxa therapy. Research options through:

  • National Organization for Rare Disorders (NORD)
  • Patient Access Network Foundation
  • HealthWell Foundation

Frequently Asked Questions

How long does Humana prior authorization take in California? Standard reviews take 15-30 days. Expedited reviews for urgent cases are completed within 72 hours when properly justified with physician attestation of medical urgency.

What if Krystexxa is not on Humana's formulary? Request a formulary exception through the same prior authorization process. Provide comprehensive medical necessity documentation and consider expedited review if clinically urgent.

Can I appeal directly to California without going through Humana first? No. You must complete Humana's internal appeal process before requesting California IMR. The exception is if Humana fails to respond within required timeframes.

Does step therapy apply if I failed these medications outside California? Yes, documented treatment failures from any location are acceptable if properly documented with medical records, pharmacy records, and physician attestation.

What happens if my G6PD test shows deficiency? Krystexxa is absolutely contraindicated in G6PD deficiency due to risk of severe hemolysis. Alternative treatments should be explored with your rheumatologist.

How much does Krystexxa cost without insurance? Approximately $30,000 per 8mg vial (one infusion), with treatment requiring infusions every two weeks. Annual costs can reach $780,000 for drug costs alone.

Can my primary care doctor prescribe Krystexxa? Most Humana policies require a rheumatologist prescriber. If your PCP initiated the request, obtain a rheumatology consultation and have the specialist submit the prior authorization.

What if I need Krystexxa urgently for a medical emergency? Request expedited prior authorization with physician attestation that delay may seriously jeopardize health. Expedited reviews are completed within 72 hours.

Navigating insurance approvals for expensive specialty medications like Krystexxa requires persistence and detailed documentation. Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed submissions that align with each plan's specific requirements. Our platform helps patients and clinicians prepare comprehensive prior authorization packets and appeal letters that address payer-specific criteria while tracking deadlines and procedural requirements.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance coverage varies by plan and individual circumstances. For specific coverage questions, contact Humana member services or consult with your healthcare provider.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.