By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (Agalsidase Beta) Covered by Aetna CVS Health in New Jersey: Forms, Appeals, and Provider Resources

Answer Box: Getting Fabrazyme Covered by Aetna CVS Health in New Jersey

Quick Path to Approval: Aetna requires prior authorization for Fabrazyme with genetic testing confirmation and specialty pharmacy dispensing through CVS Specialty. Submit the Aetna Specialty Pharmacy Prior Authorization Form with enzyme assay or GLA gene testing results. If denied, New Jersey's IHCAP external review through Maximus offers binding decisions within 45 days. Start today: Verify your Aetna plan covers specialty drugs and gather genetic/enzyme testing documentation.

Table of Contents

  1. Start Here: Verify Your Plan Coverage
  2. Prior Authorization Forms and Requirements
  3. Submission Portals and Methods
  4. CVS Specialty Pharmacy Enrollment
  5. Appeals Process: Internal and External Review
  6. Support Lines and Contact Information
  7. New Jersey Consumer Assistance
  8. Common Denial Reasons and Solutions
  9. FAQ

Start Here: Verify Your Plan Coverage

Before starting the Fabrazyme approval process, confirm your specific Aetna plan details. Fabrazyme (agalsidase beta) is typically covered under the medical benefit for infusion therapies, not the prescription drug benefit.

Coverage at a Glance

Requirement Details Where to Find It Source
Prior Authorization Required for all Aetna plans Aetna Specialty Drug List Aetna 2025 Formulary
Age Requirement ≥2 years old Aetna Clinical Policy #0442 Aetna Medical Policy
Genetic Testing Enzyme assay OR GLA gene mutation Aetna Clinical Policy #0442 Aetna Medical Policy
Specialty Pharmacy CVS Specialty or network provider CVS Specialty Services CVS Health
Appeal Deadline 60 days from denial Aetna Appeals Overview Aetna Provider
Note: Female patients often need GLA gene sequencing since enzyme levels may appear normal despite having Fabry disease.

Prior Authorization Forms and Requirements

Required Documentation

Aetna requires comprehensive clinical documentation for Fabrazyme approval. Use the Aetna Fabrazyme Precertification Form or the general Enzyme Replacement Therapy Form.

Medical Necessity Checklist:

  • Diagnosis confirmation: Alpha-galactosidase A enzyme deficiency OR pathogenic GLA gene mutation
  • ICD-10 code: E75.21 (Fabry disease)
  • Clinical documentation: Recent notes (within 6 months) describing symptoms and organ involvement
  • Age verification: Patient must be ≥2 years old
  • Dosing rationale: 1 mg/kg every 2 weeks via IV infusion
  • Treatment goals: Specific outcomes expected from therapy

Step Therapy Considerations

Depending on your Aetna plan, step therapy may apply. Counterforce Health helps patients navigate these requirements by analyzing denial letters and crafting targeted appeals that address each payer's specific criteria. Their platform identifies whether denials are based on step therapy, non-formulary status, or medical necessity—then provides the right evidence to overturn them.

Submission Portals and Methods

Electronic Submission (Preferred)

Aetna Provider Portal: https://provider.aetna.com

  • Fastest processing time (24-48 hours for acknowledgment)
  • Real-time status tracking
  • Secure document upload for labs and clinical notes

Alternative Submission Methods

Fax: 1-855-330-1720 (Fabrazyme-specific case review) Phone: 1-800-237-2767 (CVS Specialty enrollment) Mail: Use address provided in Aetna provider portal

Tip: Always include a cover sheet with patient name, DOB, and "Fabrazyme Prior Authorization Request" clearly marked.

CVS Specialty Pharmacy Enrollment

Most Aetna plans require Fabrazyme to be dispensed through CVS Specialty Pharmacy or another network specialty provider.

Patient Enrollment Process

  1. Complete enrollment form: CVS Specialty General Enrollment Form
  2. Gather required information:
    • Insurance cards (medical and prescription)
    • Complete contact information
    • Current medications and allergies
    • Prescriber details with NPI number
  3. Submit via multiple channels:

Provider Requirements

Prescribers must authorize CVS Specialty to submit prior authorization requests on behalf of the patient. Original signatures are required—stamp signatures are not permitted.

Appeals Process: Internal and External Review

Aetna Internal Appeals

If your initial prior authorization is denied, you have multiple appeal options:

Timeline for Appeals:

  • Standard formulary exception: 72 hours after prescriber's supporting statement
  • Expedited review: 24-72 hours if delay could seriously harm patient health
  • Appeal deadline: 60 days from denial notice

New Jersey External Review (IHCAP)

New Jersey offers one of the nation's strongest external review programs through the Independent Health Care Appeals Program (IHCAP), now managed by Maximus.

Provider Submission Requirements:

  • Written patient consent for provider to file appeal
  • Complete external appeal application via Maximus NJ IHCAP Portal
  • All internal appeal denial letters from Aetna
  • Clinical documentation supporting medical necessity
  • Submit within 4 months of final Aetna denial

Contact Information:

Timeline: Standard decisions within 45 days; expedited reviews within 48 hours. Maximus decisions are binding on Aetna.

Support Lines and Contact Information

For Patients

  • Aetna Member Services: Number on back of insurance card
  • CVS Specialty Patient Services: 1-800-237-2767
  • New Jersey Consumer Hotline: 1-800-446-7467

For Providers

  • Aetna Provider Services: provider.aetna.com
  • Prior Authorization Status: Available through provider portal
  • Peer-to-Peer Review: Can be requested if initial PA is denied

New Jersey Consumer Assistance

New Jersey offers robust consumer protection for insurance appeals:

New Jersey Department of Banking and Insurance (DOBI)

  • Consumer Hotline: 1-800-446-7467
  • IHCAP Information: 1-888-393-1062
  • Website: nj.gov/dobi

The state's external review program has a strong track record of overturning insurer denials when medical evidence supports the treatment need.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
"Not medically necessary" Submit detailed clinical notes showing organ involvement Recent cardiology, nephrology, or neurology reports
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label and specialty society guidelines
"Step therapy not completed" Document contraindications or failures of preferred agents Prior therapy records and intolerance documentation
"Genetic testing insufficient" Provide complete enzyme assay or GLA sequencing report Lab report with reference ranges and interpretation
From our advocates: We've seen Fabrazyme denials successfully overturned when providers include both the genetic testing results and a detailed letter explaining how the patient's specific symptoms align with Fabry disease progression. The key is connecting the lab findings to the clinical picture.

FAQ

How long does Aetna prior authorization take for Fabrazyme? Standard PA decisions are made within 72 hours of receiving complete documentation. Expedited reviews take 24-72 hours if medical urgency is demonstrated.

What if Fabrazyme is non-formulary on my Aetna plan? You can request a formulary exception with clinical justification. If denied, appeal through Aetna's internal process, then New Jersey's external review.

Can I use any specialty pharmacy for Fabrazyme? Most Aetna plans require use of CVS Specialty or another contracted network provider. Using out-of-network pharmacies may result in higher costs or denial of coverage.

Does step therapy apply if I've failed other treatments outside New Jersey? Yes, document all prior therapies regardless of where they were tried. Include records showing failures, intolerances, or contraindications.

How much does Fabrazyme cost without insurance? Cash prices are approximately $1,100 per 5-mg vial and $7,600 per 35-mg vial, making insurance coverage essential for most patients.

When navigating complex coverage decisions, Counterforce Health specializes in turning insurance denials into successful appeals by analyzing each payer's specific requirements and providing targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan documents for specific coverage details. Coverage policies and procedures may change; verify current requirements with your insurer.

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