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

Getting Elevidys Gene Therapy Covered by Aetna CVS Health in Texas: Complete Prior Authorization and Appeal Guide

Answer Box: Fast Track to Elevidys Coverage

Elevidys requires prior authorization from Aetna CVS Health and must be administered at designated Gene Based, Cellular and Other Innovative Therapy (GCIT) Centers of Excellence in Texas. Start by confirming your child meets FDA criteria (age 4-5, ambulatory, confirmed DMD genetic mutation without exon 8/9 deletions), then have your neurologist submit the PA request through Availity at least two weeks before treatment. If denied, you have 180 days to appeal internally, followed by binding external review through Texas Department of Insurance within 4 months.

First step today: Contact one of Texas's six Aetna-approved GCIT centers and verify your insurance benefits.

Table of Contents

Eligibility Requirements

Elevidys (delandistrogene moxeparvovec-rokl) is FDA-approved for a very specific patient population. Your child must meet all these criteria:

Requirement Details Documentation Needed
Age 4-5 years at time of treatment Birth certificate, medical records
Diagnosis Duchenne muscular dystrophy confirmed by genetic testing Genetic test results showing DMD mutation
Genetic Exclusion NO deletion in exon 8 and/or exon 9 of DMD gene Genetic report specifying exon involvement
Ambulatory Status Able to walk without assistive devices Physician assessment, functional testing
Antibody Status Anti-AAVrh74 total binding antibody titer < 1:400 Laboratory screening results
Prior Therapy No previous gene therapy treatments Medical history documentation
Note: These FDA requirements are non-negotiable. Aetna follows the exact FDA label criteria for coverage decisions.

Texas Aetna-Approved Treatment Centers

Elevidys must be administered at an Aetna-designated GCIT Center of Excellence. Texas has six approved facilities:

Houston Area:

  • Memorial Hermann-Texas Medical Center
  • Memorial Hermann Memorial City Medical Center
  • Children's Memorial Hermann Hospital

Dallas-Fort Worth:

  • Children's Medical Center of Dallas
  • Cook Children's Medical Center, Fort Worth
  • Neurology and Neuromuscular Care Center (CureDuchenne Clinic), Denton
Tip: The CureDuchenne Clinic in Denton specializes specifically in DMD gene therapy and may have shorter wait times.

Contact your preferred center early to discuss scheduling and insurance verification. Each center has dedicated coordinators who work directly with Aetna on prior authorizations.

Prior Authorization Process

Step-by-Step Submission

1. Insurance Verification (1-2 days) Your treatment center will verify your Aetna benefits and confirm GCIT center coverage. Request a written benefit verification summary.

2. Clinical Documentation Gathering (3-5 days) Collect all required medical records:

  • Genetic testing results
  • Anti-AAV antibody screening
  • Functional assessments
  • Corticosteroid treatment history
  • Prior therapy documentation

3. Prior Authorization Submission (Same day) Your neurologist submits the PA request through:

  • Availity provider portal (preferred method)
  • Electronic submission via EMR system
  • Fax for urgent cases: (verify with current Aetna provider directory)

4. Aetna Review Timeline

  • Standard review: 30 days for pre-service requests
  • Expedited review: 72 hours if medically urgent
  • Additional information requests: 10-14 days for response
Important: Submit PA requests at least two weeks before your planned treatment date to account for potential delays.

Required PA Information

Aetna requires comprehensive clinical documentation:

  • Complete medical history and physical exam
  • Genetic confirmation of DMD with specific mutation details
  • Anti-AAVrh74 antibody titer results
  • Current functional status (6-minute walk test, North Star Ambulatory Assessment)
  • Corticosteroid regimen (minimum 12 weeks stable dosing)
  • Liver function, platelet count, and troponin-I baseline values
  • Treatment center's GCIT certification status

Medical Necessity Documentation

Letter of Medical Necessity Template

Your neurologist should include these key elements:

Patient Demographics & Diagnosis

  • Full name, DOB, Aetna member ID
  • Confirmed DMD diagnosis with genetic mutation details
  • Exclusion of exon 8/9 deletions

Clinical Justification

  • Current ambulatory status without assistive devices
  • Stable corticosteroid regimen ≥12 weeks
  • Anti-AAV antibody screening results (<1:400)
  • No prior gene therapy treatments
  • Pre-infusion safety monitoring plan

Supporting Evidence

  • FDA approval letter and prescribing information
  • Peer-reviewed studies on Elevidys efficacy
  • Clinical practice guidelines supporting gene therapy in DMD
From our advocates: We've seen the strongest approvals when families include a detailed timeline showing their child's functional decline and how Elevidys fits into their long-term care plan. This personal context helps medical reviewers understand the urgency beyond clinical criteria.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not medically necessary" Submit additional functional assessments, progression data, and peer-reviewed studies showing clinical benefit
"Experimental/investigational" Provide FDA approval letter, prescribing information, and coverage policy precedents from other payers
"Age outside criteria" Verify exact birthdate and treatment timing; request expedited review if aging out of eligibility window
"Inadequate genetic confirmation" Ensure genetic report specifically identifies DMD mutation and excludes exon 8/9 deletions
"Elevated anti-AAV antibodies" Retest if initial results were borderline; provide lab certification of testing methodology
"Non-approved treatment center" Verify center's current GCIT status; transfer to approved facility if necessary

Appeals Process in Texas

If Aetna denies your initial PA request, Texas law provides a structured appeals pathway with binding external review.

Internal Appeals (Required First Step)

Timeline: Must file within 180 days of denial notice

Standard Appeal Process:

  1. Submit written appeal with additional clinical documentation
  2. Request peer-to-peer review with Aetna medical director
  3. Aetna responds within 30 days (72 hours for urgent cases)

Expedited Appeals: Available when delay could seriously jeopardize health or functional ability. Your doctor must support the urgency request.

Contact Information:

  • Commercial plans: 1-888-632-3862 (TTY: 711)
  • Medicare plans: 1-800-624-0756 (TTY: 711)

External Review (Independent Review Organization)

If Aetna upholds the denial after internal appeals, Texas provides binding external review through the Texas Department of Insurance.

Key Details:

  • Filing deadline: Within 4 months of final internal denial
  • Standard review: Decision within 20 days
  • Expedited review: Decision within 5 business days for urgent cases
  • Cost: No charge to you (Aetna pays for the review)
  • Decision: Binding on Aetna - they must cover if IRO approves

How to File: Contact Texas Department of Insurance at 1-800-252-3439 or visit their website for IRO request forms.

Note: During appeals, Texas law generally requires Aetna to continue covering ongoing therapy until a final decision is made.

Cost and Financial Assistance

Elevidys has a list price of approximately $3.2 million for the one-time treatment. Even with insurance coverage, families may face significant out-of-pocket costs.

Financial Support Options:

Sarepta Therapeutics Patient Support:

  • Co-pay assistance programs
  • Patient access and reimbursement support
  • Financial counseling services

Nonprofit Organizations:

  • Parent Project Muscular Dystrophy
  • CureDuchenne Foundation
  • National Organization for Rare Disorders (NORD)

State Resources:

  • Texas Department of Insurance consumer assistance
  • Office of Public Insurance Counsel (OPIC): 1-877-611-6742

FAQ

How long does Aetna prior authorization take in Texas? Standard PA requests receive decisions within 30 days. Expedited reviews for urgent cases are completed within 72 hours. Submit requests at least two weeks before planned treatment.

What if Elevidys is not on Aetna's formulary? Elevidys requires prior authorization regardless of formulary status. Non-formulary placement doesn't prevent coverage if medical necessity criteria are met and PA is approved.

Can I request an expedited appeal if my child is aging out of eligibility? Yes. If your child is approaching age 6 (the upper age limit), request expedited review citing the time-sensitive nature of treatment eligibility.

Does Aetna require step therapy for Elevidys? No traditional step therapy applies since Elevidys is a first-line gene therapy. However, Aetna may require documentation of current standard DMD treatments (corticosteroids, supportive care).

What happens if my preferred center isn't Aetna-approved? Treatment must occur at an Aetna GCIT Center of Excellence for coverage. Work with your current neurologist to coordinate care with an approved Texas facility.

How do I get help with the appeals process? Contact the Texas Department of Insurance consumer helpline at 1-800-252-3439. For complex cases, consider working with specialized advocacy organizations like Counterforce Health, which helps families navigate insurance denials and draft targeted appeals using payer-specific requirements.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Elevidys. Their platform analyzes denial letters, identifies specific coverage criteria, and drafts evidence-backed appeals tailored to each payer's requirements. For families facing Aetna denials in Texas, Counterforce Health can help navigate the appeals process and increase approval chances through targeted clinical documentation and payer-specific strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies and appeal procedures may change. Always consult with your healthcare provider and verify current requirements with Aetna and the Texas Department of Insurance before making treatment decisions.

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