By Counterforce Health Team in Krystexxa (pegloticase) —

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

Answer Box: Get Krystexxa Covered by Aetna CVS Health in California

Krystexxa (pegloticase) requires prior authorization from Aetna CVS Health for chronic gout patients who've failed allopurinol AND febuxostat. Submit complete documentation including G6PD test results, prior therapy records, and rheumatologist notes via medical benefit (J2507). If denied, California patients can file an Independent Medical Review (IMR) through DMHC with a 55% overturn rate for specialty drugs. First step today: Contact your rheumatologist to gather G6PD screening and document prior XOI failures.

Table of Contents

  1. Aetna CVS Health Plan Types & Coverage
  2. Krystexxa Formulary Status & Tiers
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Setup
  5. Cost-Share Basics
  6. Submission Process
  7. Appeals Strategy for California
  8. Common Denial Reasons & Solutions
  9. When to Escalate to California DMHC
  10. FAQ

Aetna CVS Health Plan Types & Coverage

Aetna CVS Health covers Krystexxa under medical benefits (not pharmacy) across HMO, PPO, and EPO plans in California. The drug requires prior authorization regardless of plan type, but referral requirements vary:

  • HMO plans: May require rheumatology referral before PA submission
  • PPO/EPO plans: Direct specialist access; rheumatologist prescriber strongly preferred
  • Medicare Advantage: Part B coverage with same PA criteria plus CMS guidelines

All Aetna plans route specialty infusions through CVS Specialty Pharmacy for coordination and patient support services.

Krystexxa Formulary Status & Tiers

Formulary Coverage: Krystexxa is covered on Aetna's medical benefit formulary when prior authorization criteria are met. The medication is not listed on standard pharmacy formularies since it's billed as J2507 (medical benefit).

Alternative Agents: Aetna requires documented trials of first-line agents before approving Krystexxa:

  • Step 1: Allopurinol (≥3 months at maximum tolerated dose)
  • Step 2: Febuxostat (≥3 months at maximum tolerated dose)
  • Step 3: Krystexxa eligibility with documented failure/intolerance

Source: Aetna formulary guidelines

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
PA Required Yes, medical benefit only Aetna provider portal Aetna PA policy
Diagnosis Chronic gout (ICD-10 M1A.***) Clinical notes FDA labeling
Prior Therapies Allopurinol + febuxostat failure Treatment records Aetna step therapy
G6PD Testing Normal results required Lab reports FDA safety requirements
Prescriber Rheumatologist preferred Provider credentials Aetna PA criteria
Billing Code J2507 (per 1 mg, 8 units/dose) Billing department CMS HCPCS

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient + Clinic)
    • Insurance cards and policy details
    • Complete treatment history with dates and outcomes
    • Recent lab results (G6PD, serum uric acid trends)
    • Timeline: 1-2 business days
  2. Complete G6PD Screening (If not done)
    • Required safety test before Krystexxa initiation
    • Order through rheumatologist or primary care
    • Timeline: 3-5 business days for results
  3. Document Prior Therapy Failures (Clinic)
    • Allopurinol trial ≥3 months with dosing and outcomes
    • Febuxostat trial ≥3 months with dosing and outcomes
    • Include intolerance/contraindication details if applicable
    • Timeline: Same day if records available
  4. Submit Prior Authorization (Clinic)
    • Use Aetna provider portal or fax submission
    • Include all required documentation
    • Request expedited review if clinically urgent
    • Timeline: Standard 15-30 days, expedited 72 hours
  5. CVS Specialty Enrollment (Post-approval)
    • Patient authorization and demographic setup
    • Infusion site coordination
    • Timeline: 2-3 business days

Source: CVS Specialty enrollment process

CVS Specialty Pharmacy Setup

Once Aetna approves Krystexxa, CVS Specialty handles medication distribution and patient support. Required enrollment documents include:

  • Complete patient authorization form (signatures required, stamps not acceptable)
  • Prescriber certification confirming clinical appropriateness
  • Insurance verification and benefit investigation
  • Infusion facility designation (prescriber's office or alternative site)
  • No Known Drug Allergies (NKDA) documentation

Patient Support Resources: CVS Specialty provides injection training, side effect monitoring, and insurance advocacy. Patients can contact support at the number provided during enrollment.

Tip: Enrollment processing adds 2-3 business days after PA approval. Start the CVS Specialty enrollment process immediately upon receiving Aetna authorization to minimize treatment delays.

Cost-Share Basics

Krystexxa costs approximately $30,000 per 8mg infusion, with patients typically receiving treatment every two weeks. Your out-of-pocket costs depend on:

  • Deductible status: Medical deductible applies before coinsurance kicks in
  • Coinsurance percentage: Typically 10-30% after deductible for in-network providers
  • Out-of-pocket maximum: Annual limit on your total cost-sharing

Financial Assistance Options:

  • Amgen patient assistance programs (verify eligibility at manufacturer website)
  • Foundation grants for qualifying patients
  • Hospital charity care programs for infusion services

This information is educational only and not financial advice. Contact your plan directly for specific benefit details.

Submission Process

Required Forms and Documentation

Submit via Aetna's provider portal or fax with complete documentation package:

Clinical Documentation:

  • Rheumatologist consultation notes
  • Complete gout treatment timeline with specific medications, doses, and duration
  • Documentation of treatment failures or intolerance
  • Current serum uric acid level and trends
  • G6PD test results (normal required)
  • ICD-10 diagnosis code (M1A.*** series for chronic gout)

Administrative Requirements:

  • Current Aetna prior authorization form
  • Provider NPI and clinic information
  • Patient demographics and insurance details
  • Requested infusion site and administration plan

What Fields Matter Most

Critical elements that determine approval:

  • Specific prior therapy details (drug names, doses, duration, outcomes)
  • Clear documentation of refractory gout despite optimal conventional therapy
  • Normal G6PD enzyme activity
  • Rheumatologist involvement in care

Source: Aetna PA requirements

Appeals Strategy for California

Internal Appeal Process

If Aetna denies your Krystexxa request, you have 180 days to file an internal appeal with supporting documentation:

  1. Standard Appeal (30-45 days)
    • Submit written appeal with denial letter
    • Include additional clinical evidence
    • Request peer-to-peer review with Aetna medical director
  2. Expedited Appeal (72 hours)
    • Available when health is seriously jeopardized
    • Requires physician attestation of urgent need
    • Same documentation requirements as standard appeal

California Independent Medical Review (IMR)

After exhausting Aetna's internal appeals, California patients can request an Independent Medical Review through the Department of Managed Health Care (DMHC). California's IMR has a 55% overturn rate for specialty drug denials.

How to File an IMR:

  • Deadline: 6 months after final internal denial
  • Process: Online at healthhelp.ca.gov or call 888-466-2219
  • Timeline: 45 days for standard review, 7 days for expedited
  • Cost: Free to patients

Required Documents for IMR:

  • Final denial letter from Aetna
  • Complete medical records
  • Specialist letters supporting medical necessity
  • FDA labeling and clinical guidelines

Source: DMHC IMR process

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient prior therapy Document specific XOI trials Treatment records with dates, doses, outcomes
Missing G6PD results Submit normal test results Lab report within last 6 months
Non-rheumatologist prescriber Specialist consultation Rheumatology evaluation and ongoing care plan
Coding errors Correct billing submission J2507 with proper units (8 per dose)
"Not medically necessary" Medical necessity letter FDA labeling, guidelines, treatment history

Medical Necessity Letter Checklist for Clinicians

Essential components for successful appeals:

  • Patient's specific gout history and current status
  • Detailed prior treatment failures with allopurinol and febuxostat
  • Clinical rationale for Krystexxa based on FDA labeling
  • References to ACR gout management guidelines
  • Monitoring plan and expected outcomes
  • G6PD screening results and safety considerations
From our advocates: We've seen Aetna denials overturned when providers include specific dosing details and duration for failed prior therapies, rather than general statements about "inadequate response." Document the highest tolerated doses and exact treatment periods to strengthen your case.

When to Escalate to California DMHC

Contact the DMHC Help Center if:

  • Aetna fails to meet appeal deadlines (30 days standard, 72 hours expedited)
  • You need assistance filing an IMR application
  • The plan is not following California insurance regulations

DMHC Help Center: 888-466-2219
Online IMR Application: healthhelp.ca.gov

The DMHC can intervene directly with health plans and has authority to impose penalties for non-compliance with California insurance laws.

FAQ

How long does Aetna CVS Health prior authorization take in California? Standard PA decisions are made within 15-30 business days. Expedited reviews for urgent situations are completed within 72 hours when health is seriously jeopardized.

What if Krystexxa is considered non-formulary by my plan? Krystexxa is covered under medical benefits when PA criteria are met. If denied as non-formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal if Aetna denies coverage? Yes, expedited appeals are available within 72 hours when your physician attests that the delay would seriously jeopardize your health or recovery.

Does step therapy apply if I failed these medications outside California? Yes, documented treatment failures from any location count toward step therapy requirements, as long as you have complete medical records showing the trials and outcomes.

How much does Krystexxa cost without insurance? Approximately $30,000 per 8mg infusion. Patients typically receive infusions every two weeks, making annual costs substantial without coverage.

What happens if the IMR overturns Aetna's denial? The IMR decision is binding on Aetna. The plan must authorize coverage and cannot appeal the independent medical reviewer's determination.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, policy-aligned medical necessity letters. The platform analyzes denial reasons and crafts targeted rebuttals using the right clinical evidence and payer-specific requirements to improve approval rates for complex therapies like Krystexxa.

When navigating Aetna's complex prior authorization requirements, having expert support can make the difference between approval and prolonged treatment delays. Counterforce Health's specialized approach to insurance appeals has helped many patients access critical gout treatments by addressing the specific documentation gaps that lead to denials.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information with your insurance plan and healthcare providers. For personalized guidance on California insurance appeals, contact the DMHC Help Center at 888-466-2219.

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