By Counterforce Health Team in Krystexxa (pegloticase) —

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

Answer Box: Fast Track to Aetna CVS Health Approval

To get Krystexxa (pegloticase) covered by Aetna CVS Health in Michigan, you need prior authorization showing chronic gout refractory to conventional therapy. Key requirements: documented failure of allopurinol and febuxostat, rheumatologist prescription, G6PD deficiency screening, and baseline serum uric acid ≥6 mg/dL. First step today: Contact your rheumatologist to gather documentation of prior treatment failures and submit the prior authorization request through Aetna's provider portal. If denied, Michigan residents have 127 days to file an external review with DIFS.

Table of Contents

Aetna CVS Health Policy Overview

Aetna CVS Health requires prior authorization for Krystexxa (pegloticase) across all plan types in Michigan, including commercial HMO/PPO plans and Medicare Advantage. The policy closely follows FDA labeling and clinical guidelines, focusing on patients with chronic gout who've exhausted conventional treatments.

Plan Coverage Details:

  • Commercial Plans: Prior authorization required; typically covered under medical benefit (not pharmacy)
  • Medicare Advantage: Subject to Medicare Part B rules with additional Aetna requirements
  • Formulary Status: Non-formulary or high-tier specialty drug requiring prior authorization

CVS Specialty Pharmacy handles most Krystexxa distribution for Aetna members, using HCPCS code J2507 (per 1 mg) for billing. Each 8 mg vial requires billing 8 units.

Medical Necessity Requirements

Aetna CVS Health's medical necessity criteria for Krystexxa align with FDA labeling and rheumatology guidelines:

Core Eligibility Criteria

Requirement Details Documentation Needed
Age 18 years or older Date of birth verification
Diagnosis Chronic gout with ICD-10 codes Medical records with specific diagnosis
Prescriber Rheumatologist or consultation Specialist involvement documented
Disease Severity ≥2 flares/year OR tophi OR chronic gouty arthritis Clinical notes, imaging if applicable

Clinical Manifestations Required

Patients must demonstrate at least one of the following:

  • Two or more gout flares per year despite optimal urate-lowering therapy
  • Non-resolving subcutaneous tophi
  • Chronic gouty arthritis with joint damage or persistent symptoms

Step Therapy & Required Failures

Aetna CVS Health requires documented failure, intolerance, or contraindication to conventional urate-lowering therapies before approving Krystexxa. This follows a strict step-therapy protocol.

Required Prior Treatments

  1. Allopurinol: Must document trial at adequate doses (up to 800 mg/day or maximum tolerated) for at least 3 months
  2. Febuxostat: Alternative xanthine oxidase inhibitor trial if allopurinol failed/contraindicated
  3. Uricosurics (if appropriate): Probenecid may be required in select cases

Documenting Treatment Failures

For each failed therapy, include:

  • Start and stop dates
  • Maximum dose achieved
  • Reason for discontinuation (inefficacy, adverse effects, contraindication)
  • Laboratory evidence of persistent hyperuricemia
  • Documentation of adherence
Clinician Tip: Aetna reviewers look for specific details. Instead of "failed allopurinol," document "allopurinol 300 mg daily × 6 months, discontinued due to persistent serum uric acid 8.2 mg/dL despite good adherence and dose optimization to 600 mg daily."

Required Diagnostics & Lab Values

Mandatory Laboratory Testing

Test Requirement Timing Purpose
Serum Uric Acid ≥6 mg/dL (some plans ≥7 mg/dL) Within 30 days of request Demonstrates hyperuricemia
G6PD Activity Normal levels required Before first infusion Safety screening
Complete Blood Count Baseline values Within 30 days Safety monitoring
Comprehensive Metabolic Panel Including creatinine Within 30 days Renal function assessment

G6PD Deficiency Screening

Critical Safety Requirement: Krystexxa is contraindicated in patients with G6PD deficiency due to risk of hemolysis and methemoglobinemia.

Patients requiring G6PD testing:

  • African ancestry
  • Mediterranean ancestry (Southern European, Middle Eastern)
  • Southern Asian ancestry
  • Family history of G6PD deficiency

Site of Care & Specialty Pharmacy

Krystexxa Administration Requirements:

  • Must be administered in healthcare facilities equipped for anaphylaxis management
  • Infusion over 120 minutes with premedication (antihistamines, corticosteroids)
  • Billing code: J2507 (per 1 mg), with 8 units per vial

CVS Specialty Pharmacy Coordination: Most Aetna members receive Krystexxa through CVS Specialty Pharmacy, which coordinates with infusion centers for delivery and billing. The pharmacy handles prior authorization submission and tracks approval status.

Evidence to Support Medical Necessity

Required Clinical Documentation

Medical Necessity Letter Should Include:

  1. Patient history: Gout duration, frequency of flares, functional impact
  2. Prior treatments: Specific medications, doses, durations, outcomes
  3. Current status: Recent lab values, physical exam findings
  4. Treatment rationale: Why Krystexxa is appropriate now
  5. Monitoring plan: Safety assessments, response evaluation

Supporting Guidelines and Evidence

Reference these authoritative sources in your medical necessity letter:

  • FDA Prescribing Information for Krystexxa (pegloticase)
  • American College of Rheumatology 2020 Guideline for gout management
  • Peer-reviewed studies supporting pegloticase efficacy in refractory gout

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Fastest Path to Approval: 7 Steps

  1. Gather Documentation (Patient/Clinic): Collect all prior treatment records, lab results, and specialist notes
  2. Complete G6PD Testing (Clinic): Order G6PD activity test if patient is at risk
  3. Obtain Recent Labs (Clinic): Ensure serum uric acid and safety labs are within 30 days
  4. Submit Prior Authorization (Clinic): Use Aetna provider portal with complete documentation package
  5. Track Decision (Patient/Clinic): Aetna typically responds within 15-30 business days
  6. Coordinate Specialty Pharmacy (Patient): Work with CVS Specialty if approved
  7. Schedule Infusion (Patient): Arrange administration at qualified facility

Expected Timeline: 2-4 weeks from submission to first infusion if approved on initial review.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Inadequate prior therapy documentation Provide detailed treatment history Pharmacy records, clinic notes with dates/doses
Missing G6PD test Complete screening before resubmission Laboratory report showing normal G6PD activity
Non-specialist prescriber Obtain rheumatology consultation Specialist evaluation and recommendation
Insufficient disease severity Document flare frequency and impact Detailed clinical notes, patient diary if available
Formulary non-coverage Request formulary exception Medical necessity letter with supporting evidence

Appeals Process in Michigan

If Aetna CVS Health denies your Krystexxa prior authorization, Michigan residents have specific appeal rights under state law.

Internal Appeals with Aetna

Standard Appeals:

  • Timeline: 30 days for pre-service denials, 60 days for post-service
  • How to file: Aetna member portal, phone, or written request
  • Required: Copy of denial letter, supporting medical records

Expedited Appeals:

  • Timeline: 72 hours for urgent requests
  • Criteria: Delay would jeopardize health or ability to regain function
  • Required: Physician attestation of urgency

Michigan External Review Process

If Aetna's internal appeal is unsuccessful, you can request an external review through the Michigan Department of Insurance and Financial Services (DIFS).

Standard External Review:

  • Deadline: 127 days from Aetna's final denial
  • Timeline: Decision within 60 days
  • How to file: DIFS online form or paper submission
  • Cost: Free to consumers

Expedited External Review:

  • Timeline: 72 hours
  • Requirements: Physician letter stating delay would harm patient
  • Applies to: Pre-service denials only
Michigan Advantage: DIFS external reviews are binding on insurers and have strong consumer protections. Contact DIFS at 877-999-6442 for assistance.

Costs & Patient Support Programs

Krystexxa Cost Overview:

  • Approximately $30,000 per 8 mg vial
  • Typical 6-month course: ~$360,000
  • Annual treatment cost: up to $780,000

Financial Assistance Options:

  1. Amgen KRYSTEXXA Complete - Manufacturer support program
  2. Patient Access Network Foundation - Copay assistance for eligible patients
  3. Michigan Medicaid - Coverage available for eligible low-income residents
  4. Hospital charity care programs - Many infusion centers offer financial assistance

For patients using Counterforce Health's platform, the system automatically identifies relevant patient assistance programs and includes them in appeal documentation when appropriate.

FAQ

How long does Aetna CVS Health prior authorization take for Krystexxa in Michigan? Standard prior authorization decisions typically take 15-30 business days. Expedited requests (with physician attestation of urgency) are decided within 72 hours.

What if Krystexxa is not on Aetna's formulary? Request a formulary exception with your prior authorization. Include medical necessity documentation showing why covered alternatives are inappropriate.

Can I appeal if I've failed treatments outside Michigan? Yes, treatment history from other states is acceptable. Ensure you have complete documentation of prior therapy trials and outcomes.

Does Aetna require methotrexate co-therapy with Krystexxa? While not universally required, many Aetna policies now reference methotrexate co-therapy as best practice. Document clinical rationale if methotrexate is contraindicated.

What happens if my G6PD test is abnormal? Krystexxa is contraindicated in G6PD deficiency. Your physician will need to explore alternative treatments for refractory gout.

Can I use CVS retail pharmacies for Krystexxa? No, Krystexxa must be administered by IV infusion in healthcare facilities. CVS Specialty Pharmacy coordinates distribution to infusion centers.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage policies vary by plan and change frequently. Always consult your healthcare provider for medical decisions and verify current policy details with your insurer. For personalized assistance with complex prior authorization and appeal processes, consider consulting with healthcare coverage advocates who specialize in turning denials into approvals.

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