By Counterforce Health Team in Elfabrio (pegunigalsidase alfa-iwxj) —

How to Get Elfabrio (pegunigalsidase alfa-iwxj) Covered by Aetna in Michigan: Requirements, Appeals, and Timeline

Answer Box: Getting Elfabrio Covered by Aetna in Michigan

Elfabrio (pegunigalsidase alfa-iwxj) requires prior authorization from Aetna CVS Health in Michigan. The fastest path to approval: (1) Submit complete clinical documentation proving Fabry disease diagnosis (enzyme assay or genetic testing) through Aetna's electronic portal, (2) Include evidence of medical necessity and dosing plan, and (3) Allow 2+ weeks for review. If denied, you have 180 days to appeal internally, then 127 days for Michigan's external review through DIFS. Start today: Gather your Fabry disease test results, prior treatment records, and contact your specialty pharmacy to begin the prior authorization process.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission
  9. Common Denial Reasons & Solutions
  10. Appeals Process in Michigan
  11. Quick Reference Checklist

Who Should Use This Guide

This guide is for Michigan residents with confirmed Fabry disease who need Elfabrio (pegunigalsidase alfa-iwxj) covered by Aetna CVS Health plans. You'll find this helpful if you're:

  • Starting enzyme replacement therapy for the first time
  • Switching from another Fabry treatment to Elfabrio
  • Facing a denial and need to appeal
  • Working with a specialty pharmacy on prior authorization

Expected outcome: With complete documentation and proper submission, most approvals are processed within 24-48 hours when clinical criteria are met. Denials often stem from incomplete documentation rather than medical necessity.

Member & Plan Basics

Coverage Requirements

  • Active Aetna coverage with specialty drug benefits
  • Prior authorization mandatory for all Elfabrio prescriptions
  • Electronic submission only as of June 2023 (no fax/paper)
  • Specialty pharmacy required for dispensing

Plan Types Covered

  • Commercial Aetna plans
  • Aetna Better Health (Medicaid)
  • Aetna Medicare Advantage plans
  • Self-insured employer plans administered by Aetna
Note: Deductible and coinsurance apply based on your specific plan. Contact Member Services at 1-888-632-3862 to verify your specialty drug benefits.

Clinical Criteria

Primary Requirements

Confirmed Fabry Disease Diagnosis using one of:

  • Alpha-galactosidase A enzyme assay showing deficiency
  • GLA gene mutation testing (genetic confirmation)
  • Clinical symptoms with family history and confirmatory testing

Medical Necessity Criteria

  1. Adult patient (18+ years) - Elfabrio is FDA-approved for adults only
  2. Progressive disease with organ involvement (kidney, heart, neurological)
  3. Appropriate candidate for enzyme replacement therapy
  4. Proper dosing: 1 mg/kg every 2 weeks via IV infusion

Step Therapy Considerations

While Aetna may prefer other enzyme replacement therapies first, Elfabrio can be approved as first-line if:

  • Other ERTs are contraindicated
  • Patient has documented allergic reactions to alternatives
  • Clinical rationale supports Elfabrio specifically

Coding Requirements

Code Type Code Description
ICD-10 E75.21 Fabry disease
HCPCS J-Code J2508 Injection, pegunigalsidase alfa-iwxj, 1 mg
NDC Numbers 10122-0160-02 20 mg/10 mL vial (single)
10122-0165-02 5 mg/2.5 mL vial (single)
Infusion Codes 96365 IV infusion, initial hour
96366 IV infusion, additional hour

Billing Units: Each mg of Elfabrio administered = 1 unit of J2508

Documentation Packet

Provider Letter of Medical Necessity Must Include:

  1. Patient identification and Aetna member ID
  2. Diagnosis confirmation with test results and dates
  3. Clinical rationale for Elfabrio specifically
  4. Dosing plan based on patient weight (1 mg/kg every 2 weeks)
  5. Site of care (infusion center, hospital outpatient)
  6. Treatment goals and expected monitoring plan

Required Attachments:

  • Fabry disease diagnostic test results
  • Recent clinical notes documenting symptoms/progression
  • Previous treatment history (if applicable)
  • Laboratory values (kidney function, cardiac markers)
  • Prescription with complete prescriber information
Clinician Corner: Include specific enzyme levels or genetic test results in your letter. Aetna reviewers need quantitative evidence of alpha-galactosidase A deficiency or confirmed GLA mutations to approve coverage quickly.

Submission Process

Electronic Submission (Required)

  1. Availity Provider Portal - Primary method for most providers
  2. EMR Integration - Direct submission from electronic health records
  3. Aetna Provider Portal - Secondary option

Submission Timeline

  • Submit 2+ weeks before needed to allow processing time
  • Standard review: 24-48 hours for complete submissions
  • Incomplete submissions: 5-10 business days with additional information requests

Required Fields (Common Rejection Causes)

  • Complete prescriber NPI and contact information
  • Patient's exact name matching insurance card
  • Correct member ID and group number
  • Specific NDC code for vial size prescribed
  • Detailed diagnosis with ICD-10 code E75.21

Contact for Questions:

  • Commercial plans: 1-888-632-3862
  • Medicare plans: 1-800-624-0756

Specialty Pharmacy Coordination

Preferred Networks

Aetna typically directs Elfabrio to CVS Specialty Pharmacy or other contracted specialty providers. Your prescription will likely be transferred automatically after prior authorization approval.

Enrollment Process

  1. Chiesi Total Care enrollment (manufacturer program)
  2. Insurance verification by specialty pharmacy
  3. Clinical intake and delivery scheduling
  4. Infusion site coordination for administration

Shipment Verification

  • Confirm delivery address (home vs. infusion center)
  • Verify cold-chain storage requirements
  • Schedule delivery 24-48 hours before infusion appointment
  • Maintain temperature logs for insurance audits

After Submission

Tracking Your Request

  • Confirmation number - Save this for all follow-up calls
  • Status checks - Call every 3-5 business days if no response
  • Additional information - Respond within 24-48 hours to avoid delays

Approval Indicators

  • Electronic notification to prescriber and pharmacy
  • Prior authorization number for claims processing
  • Coverage duration (typically 6-12 months before renewal)

If No Response After 2 Weeks

Contact Aetna immediately at 1-888-632-3862. Federal regulations may require automatic approval if response deadlines are missed.

Common Denial Reasons & Solutions

Denial Reason Solution
Incomplete diagnosis documentation Submit enzyme assay results or genetic testing report
"Not medically necessary" Provide detailed clinical notes showing organ involvement/progression
Dosing concerns Confirm 1 mg/kg every 2 weeks with weight-based calculation
Site of care issues Specify qualified infusion center with proper monitoring capabilities
Step therapy not met Document contraindications to other ERTs or provide clinical rationale

Appeals Process in Michigan

Internal Appeal (First Level)

  • Deadline: 180 days from denial date
  • Timeline: Aetna decides within 30 calendar days
  • Expedited option: 72 hours for urgent cases
  • Required: Original denial letter, additional clinical evidence, updated letter of medical necessity

Michigan External Review

After exhausting internal appeals, Michigan residents can request independent review through the Department of Insurance and Financial Services (DIFS).

Key Details:

  • Deadline: 127 days after final internal denial
  • Cost: Free to patients
  • Timeline: 60 days maximum (72 hours for expedited)
  • Decision: Binding on Aetna

How to File:

  1. Complete DIFS External Review Request form (verify current link)
  2. Submit online, by email, fax, or mail
  3. Include all denial letters and medical records
  4. DIFS assigns to Independent Review Organization (IRO)

Contact DIFS: 1-877-999-6442 for questions about the external review process.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters and crafting point-by-point rebuttals aligned to each payer's specific criteria.

Quick Reference Checklist

Before Starting ✓

  • Confirmed Fabry disease diagnosis with test results
  • Active Aetna coverage with specialty benefits verified
  • Complete prescription from qualified prescriber
  • Patient weight for dosing calculation (1 mg/kg)
  • Preferred infusion site identified

Documentation Ready ✓

  • Enzyme assay or genetic test results
  • Clinical notes documenting symptoms/progression
  • Previous treatment history (if any)
  • Laboratory values (kidney, cardiac function)
  • Letter of medical necessity with all required elements

Submission Complete ✓

  • Electronic submission through Availity or EMR
  • Confirmation number received and saved
  • All required fields completed accurately
  • Specialty pharmacy enrollment initiated
  • Follow-up schedule established (every 3-5 days)

If Denied ✓

  • Internal appeal filed within 180 days
  • Additional clinical evidence gathered
  • Michigan external review prepared if needed
  • Counterforce Health consulted for appeal strategy

FAQ

How long does Aetna prior authorization take for Elfabrio in Michigan? Standard review is 24-48 hours for complete submissions. Incomplete requests may take 5-10 business days with back-and-forth for additional information.

What if Elfabrio is not on my formulary? You can request a formulary exception with clinical justification. Document why Elfabrio is medically necessary compared to covered alternatives.

Can I get expedited review for urgent cases? Yes, if your physician documents that delay would seriously jeopardize your health. Aetna must decide expedited appeals within 72 hours.

What happens if I move from another state to Michigan? Your Aetna coverage continues, but you gain access to Michigan's external review process through DIFS if appeals are needed.

Does step therapy apply if I've failed other treatments outside Michigan? Yes, document all prior treatment failures regardless of where they occurred. This supports medical necessity for Elfabrio.

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and contact Aetna directly for the most current coverage policies and procedures.

Sources & Further Reading

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