By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) —

How to Get Elevidys Gene Therapy Covered by Aetna CVS Health in Illinois: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Elevidys Covered by Aetna CVS Health in Illinois

Elevidys requires prior authorization from Aetna CVS Health. First step: Have your physician submit a precertification request through Availity or their EMR with genetic testing confirming DMD, anti-AAV antibody titers <1:400, and ambulatory status documentation. Timeline: 30-45 days for standard review, 72 hours for expedited. If denied: You have 180 days to appeal internally, then 30 days for Illinois external review through an Independent Review Organization. Key requirement: Treatment must occur at an Aetna-designated Center of Excellence.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Distribution
  5. Cost-Share Considerations
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Process in Illinois
  9. When to Escalate
  10. FAQ

Plan Types & Coverage Implications

Aetna CVS Health offers several plan types in Illinois, each with different coverage pathways for Elevidys:

Commercial Plans (HMO/PPO/EPO): All require prior authorization and use of designated Centers of Excellence. PPO plans may offer out-of-network coverage at higher cost-sharing, but gene therapy typically requires in-network administration for coverage.

Medicare Advantage: Coverage follows CMS guidelines where applicable, but in the absence of specific National or Local Coverage Determinations, Aetna's own clinical policy bulletins apply. Members have enhanced appeal rights under Medicare regulations.

Medicaid (Aetna Better Health Illinois): Must comply with Illinois Medicaid requirements alongside Aetna's policies. Genetic testing codes are limited to one unit per 1095 days.

Note: Regardless of plan type, Elevidys administration must occur at facilities meeting both Sarepta Therapeutics' requirements and Aetna's Center of Excellence standards.

Formulary Status & Tier Placement

Elevidys is classified as a specialty drug on Aetna's formulary and requires prior authorization across all plan types. The medication is not subject to traditional tier placement due to its unique administration requirements and high cost (~$3.2 million list price).

Key Formulary Considerations:

  • No generic alternatives available
  • Cannot be dispensed through retail pharmacies
  • Must be distributed via CVS Specialty Pharmacy
  • Subject to medical necessity review regardless of formulary status

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Genetic Testing DMD mutation confirmation required Lab reports with specific mutation details Aetna DMD Policy
Anti-AAV Antibodies Titers must be <1:400 Anti-AAVrh74 total binding antibody test Elevidys Precert Form
Ambulatory Status Patient must be able to walk Clinical documentation of mobility Aetna DMD Policy
Specialist Involvement DMD specialist must prescribe/consult Physician credentials verification Aetna DMD Policy
Center of Excellence Administration at designated facility Aetna COE directory GCIT Requirements

Medical Necessity Criteria

Required Documentation:

  • Genetic testing confirming pathogenic DMD mutation
  • Anti-AAVrh74 antibody testing with quantitative titers
  • Clinical notes documenting ambulatory status
  • Exclusion of exon 8/9 deletions
  • Confirmation patient is not receiving other exon-skipping therapies

Exclusions:

  • Non-ambulatory patients
  • Pre-existing high anti-AAV antibodies (≥1:400)
  • Exon 8/9 deletions in DMD gene
  • Concurrent use with other DMD gene therapies

Specialty Pharmacy Distribution

Elevidys must be distributed exclusively through CVS Specialty Pharmacy for Aetna members. The process involves:

Step-by-Step Enrollment Process

  1. Prior Authorization Approval (Physician)
    • Submit complete PA request via Availity portal
    • Timeline: 30-45 days standard, 72 hours expedited
    • Required: All clinical documentation
  2. CVS Specialty Enrollment (Patient/Clinic)
    • Contact: 1-800-237-2767
    • Complete patient consent forms
    • Benefits investigation and financial assistance coordination
  3. Site Coordination (CVS Specialty)
    • Verify Center of Excellence designation
    • Schedule delivery to approved facility
    • Coordinate administration timing
  4. Administration Preparation
    • Steroid prophylaxis protocol implementation
    • Hepatic monitoring plan establishment
    • Emergency response procedures review

Cost-Share Considerations

Given Elevidys's high cost, cost-sharing can be substantial even with insurance coverage. Educational information only - not financial advice:

Typical Cost-Share Structures:

  • Deductible: May apply to the full list price initially
  • Coinsurance: Often 10-30% for specialty drugs
  • Out-of-pocket maximums: Annual limits provide some protection

Financial Assistance Options:

  • Sarepta Therapeutics patient support programs
  • Foundation grants for rare diseases
  • State pharmaceutical assistance programs
  • Hospital charity care programs
Tip: Contact CVS Specialty Pharmacy's financial counselors during enrollment to explore all available assistance options.

Submission Process & Forms

For Healthcare Providers

Primary Submission Method: Availity Provider Portal or integrated EMR system

Required Forms:

Contact Information:

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

For Patients

While providers typically handle submissions, patients should:

  • Ensure all medical records are complete
  • Verify genetic testing results are available
  • Confirm specialist involvement in care
  • Understand appeal rights and timelines

Common Approval Patterns

Strong submissions typically include:

  • Comprehensive genetic testing report with specific DMD mutation identified
  • Quantitative anti-AAV antibody results clearly below 1:400 threshold
  • Detailed clinical notes documenting ambulatory function
  • Specialist letter confirming DMD diagnosis and treatment appropriateness
  • Confirmation of Center of Excellence administration site

Common denial reasons and fixes:

Denial Reason How to Overturn
Missing genetic testing Submit complete DMD gene panel results (CPT 81161)
High anti-AAV antibodies Provide quantitative titers; if >1:400, therapy contraindicated
Non-ambulatory status Document current mobility with video/clinical assessment
Non-designated facility Transfer care to Aetna Center of Excellence
Incomplete medical records Submit comprehensive clinical documentation package

Appeals Process in Illinois

Internal Appeals with Aetna

Timeline: 180 days from denial date to file Process: Submit written appeal with additional documentation Decision timeframe: 30 days standard, 72 hours expedited

Illinois External Review

Under the Illinois Health Carrier External Review Act, members have the right to independent review after exhausting internal appeals.

Key Requirements:

  • Must request within 30 days of final internal denial
  • Independent Review Organization (IRO) conducts binding review
  • No cost to member
  • Expedited review available for urgent cases (72-hour decision)

How to Request:

  • Contact Aetna Member Services (number on ID card)
  • Call National External Review Unit: 1-877-848-5855
  • Submit all supporting medical documentation

Timeline:

  • Standard review: 30 calendar days
  • Expedited review: 72 hours with physician certification of urgency

When navigating complex insurance appeals for high-cost therapies like Elevidys, many families find success working with specialized advocacy services. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific requirements.

When to Escalate

Illinois Department of Insurance

  • Office of Consumer Health Insurance: 877-527-9431
  • File complaints about unfair claim denials or delays
  • Assistance with understanding appeal rights

Illinois Attorney General's Health Care Helpline

  • Phone: 1-877-305-5145
  • Can intervene informally with insurers
  • Provides guidance on complex appeal cases

When to Contact:

  • Procedural violations in appeal process
  • Unreasonable delays in coverage decisions
  • Suspected bad faith claim handling
  • Need assistance understanding Illinois insurance laws
From our advocates: We've seen families succeed with Elevidys appeals by focusing on the specific anti-AAV antibody requirements and ensuring all genetic testing documentation clearly identifies the pathogenic DMD mutation. The key is often in the details – quantitative antibody titers and ambulatory status documentation that directly addresses Aetna's published criteria. This is a composite example for illustrative purposes only.

FAQ

How long does Aetna CVS Health prior authorization take for Elevidys in Illinois? Standard review takes 30-45 days. Expedited review (with physician certification of urgency) takes up to 72 hours.

What if Elevidys is denied as "experimental" or "investigational"? Submit FDA approval documentation and peer-reviewed efficacy studies. The drug has full FDA approval for eligible DMD patients.

Can I request an expedited appeal in Illinois? Yes, if delay would seriously jeopardize your health. Your physician must certify medical urgency for expedited processing.

Does step therapy apply to Elevidys? Step therapy typically doesn't apply to gene therapies, but documentation of prior DMD treatments may strengthen the medical necessity case.

What happens if my preferred facility isn't a Center of Excellence? You'll need to transfer care to an Aetna-designated COE. Contact [email protected] for current Illinois facilities.

Are there age limits for Elevidys coverage? Coverage is based on ambulatory status and meeting FDA labeling criteria, not specific age cutoffs.

How do I verify current formulary status? Check your member portal or call the number on your insurance card for real-time formulary information.

What if I'm denied due to high anti-AAV antibodies? Unfortunately, titers ≥1:400 are a clinical contraindication. Alternative DMD therapies should be discussed with your specialist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria can change. Always verify current requirements with Aetna CVS Health and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals, consider working with Counterforce Health, which specializes in turning insurance denials into successful appeals through targeted, evidence-backed advocacy.

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