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

Aetna's Coverage Criteria for Elevidys in Florida: What Counts as "Medically Necessary"?

Answer Box: Getting Elevidys Covered by Aetna in Florida

Aetna requires prior authorization for Elevidys (delandistrogene moxeparvovec-rokl) with strict medical necessity criteria: confirmed DMD diagnosis with pathogenic gene mutation (excluding exons 8-9 deletions), ambulatory status, age ≥4 years, acceptable anti-AAVrh74 antibody levels, and comprehensive hepatic monitoring plan. Submit PA through CVS Caremark or Availity portal with genetic testing, steroid protocol, and weekly monitoring schedule. If denied, file internal appeal within 180 days, then external review through Florida's independent review process—decisions are binding on Aetna.

First step today: Call Aetna member services to confirm your plan's specific Elevidys policy and required forms.

Table of Contents

  1. Aetna Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy & Exceptions
  4. Quantity & Frequency Limits
  5. Required Diagnostics
  6. Site of Care Requirements
  7. Evidence for Medical Necessity
  8. Sample Medical Necessity Letter
  9. Edge Cases & Special Situations
  10. Appeals Process in Florida
  11. Quick Reference Table

Policy Overview

Aetna classifies Elevidys as a specialty gene therapy requiring prior authorization across all plan types—commercial PPO/HMO, Medicare Advantage, and Medicaid managed care plans in Florida. The drug falls under CVS Caremark's specialty pharmacy benefit, not standard retail pharmacy coverage.

Plan Types and Policy Application

Commercial Plans: Follow Aetna's Clinical Policy Bulletins (CPBs) with federal external review rights after internal appeals are exhausted.

Medicare Advantage: Must comply with CMS coverage determinations while applying Aetna's specific utilization management criteria. Appeals follow Medicare Part D timelines.

Florida Medicaid (Aetna Better Health): Requires CVS Specialty or Publix Specialty pharmacy dispensing with Florida Medicaid fee schedule considerations.

Note: Exact policy text for Elevidys isn't in Aetna's public precertification lists—criteria are accessed through provider portals like Availity or CVS Caremark's electronic PA system.

FDA Indication Requirements

Aetna's coverage criteria closely mirror the FDA-approved indication with additional safety requirements following recent liver injury reports.

Core Eligibility Criteria

  • Age: ≥4 years at time of infusion
  • Diagnosis: Genetically confirmed Duchenne muscular dystrophy
  • Functional Status: Ambulatory (able to walk independently)
  • Genetic Requirements: Pathogenic DMD mutation documented by CLIA-certified testing
  • Contraindications: No deletions involving exons 8 and/or 9 (associated with severe immune-mediated myositis)

Anti-AAVrh74 Antibody Testing

Aetna requires neutralizing antibody titer testing before approval. While exact cut-offs aren't publicly available, most payers require titers below 1:400 using validated assays. Testing must be performed within 3-6 months of planned infusion at a recognized reference laboratory.

Step Therapy & Exceptions

Unlike traditional medications, Elevidys doesn't have direct therapeutic alternatives requiring step therapy. However, Aetna may require documentation of:

Standard DMD Care Optimization

  • Corticosteroid therapy: Current or planned use of prednisone, deflazacort, or equivalent
  • Cardiac monitoring: Baseline echocardiogram and ECG within 6 months
  • Pulmonary assessment: Recent pulmonary function tests if age-appropriate
  • Physical therapy: Documentation of current rehabilitation services

Medical Exception Pathways

If standard DMD therapies are contraindicated or ineffective, provide detailed documentation including:

  • Specific adverse reactions to corticosteroids
  • Cardiac contraindications with cardiology consultation notes
  • Allergic reactions to standard supportive therapies

Quantity & Frequency Limits

Elevidys is approved as a single, lifetime dose. Aetna policies typically include:

  • One-time authorization with no repeats or refills
  • Dose calculation based on patient weight (specific mg/kg from prescribing information)
  • No retreatment coverage for repeat dosing or booster therapy
  • Vial optimization requirements to minimize waste given the ~$3.2 million list price

Required Diagnostics

Comprehensive baseline testing is mandatory before Aetna approval:

Genetic Testing Documentation

  • Complete DMD gene analysis (MLPA, NGS, or comparable)
  • Variant classification: Pathogenic or likely pathogenic
  • Exon mapping: Confirmation that deletions don't involve exons 8-9
  • Laboratory certification: CLIA-approved facility

Baseline Safety Assessments

  • Hepatic panel: AST, ALT, GGT, total bilirubin, albumin, aPTT, INR
  • Cardiac evaluation: Troponin-I, ECG, echocardiogram
  • Hematologic: Complete blood count with platelets
  • Immunologic: Anti-AAVrh74 neutralizing antibody titer
Timing Requirements: All baseline testing must be completed within 30-90 days of PA submission (verify specific timeframes with your plan).

Site of Care Requirements

Aetna restricts Elevidys administration to qualified facilities meeting specific criteria:

Infusion Center Requirements

  • Network status: Must be Aetna-contracted facility
  • Specialty pharmacy coordination: Ability to receive product from CVS Specialty or approved specialty pharmacy
  • Pediatric expertise: Neuromuscular specialist on staff or formal consultation arrangement
  • Emergency capabilities: Advanced life support, resuscitation equipment, PALS/ACLS-certified staff
  • Monitoring infrastructure: Laboratory services for weekly post-infusion testing

Geographic Considerations in Florida

Major qualified centers likely include:

  • Children's hospitals with neuromuscular programs
  • Academic medical centers with gene therapy experience
  • Specialty infusion centers with pediatric capabilities

Contact Aetna provider relations to confirm approved facilities in your area.

Evidence for Medical Necessity

Strong medical necessity documentation should reference:

Clinical Guidelines

  • FDA prescribing information for Elevidys
  • American Academy of Neurology guidance on DMD management
  • Duchenne Registry data supporting gene therapy intervention
  • Peer-reviewed studies from EMBARK trial and related research

Functional Assessment Tools

  • North Star Ambulatory Assessment (NSAA)
  • 6-minute walk test results
  • Timed function tests (10-meter walk/run, time to climb stairs)
  • Quality of life measures appropriate for DMD patients

Sample Medical Necessity Letter

Re: Prior Authorization Request - Elevidys (delandistrogene moxeparvovec-rokl)
Patient: [Name, DOB, Member ID]
Diagnosis: Duchenne Muscular Dystrophy (ICD-10: G71.01)

I am requesting prior authorization for Elevidys for my patient with genetically confirmed Duchenne muscular dystrophy. Genetic testing reveals a pathogenic DMD variant [specify] without deletions involving exons 8 or 9, meeting FDA indication criteria.

Clinical Status: [Age]-year-old ambulatory male with DMD, baseline NSAA score [X], able to walk [distance] in 6 minutes. Baseline cardiac evaluation shows [findings]. Currently maintained on [corticosteroid regimen].

Pre-Infusion Safety Assessment: Comprehensive baseline evaluation completed including hepatic panel (AST [X], ALT [X], normal coagulation studies), anti-AAVrh74 antibody titer [X] (below threshold), and cardiac assessment showing [findings]. No evidence of acute liver disease or contraindications to gene therapy.

Planned Monitoring: We will implement FDA-mandated safety monitoring including:
- Weekly hepatic panel (AST, ALT, GGT, bilirubin, albumin, aPTT, INR) for minimum 3 months
- Weekly troponin-I for 1 month post-infusion
- Weekly platelet counts for 2 weeks
- Systematic corticosteroid protocol per prescribing information

Risk Mitigation: Patient will remain within 2 hours of appropriate medical facility for 2 months post-infusion. Family counseled on signs of liver injury, importance of medication adherence, and emergency contact protocols.

Medical Necessity: Elevidys represents the only FDA-approved gene therapy for DMD, offering potential to modify disease trajectory during critical ambulatory phase. Early intervention is essential to preserve motor function before irreversible muscle degeneration.

Edge Cases & Special Situations

Pediatric Considerations

  • Weight-based dosing calculations for children
  • Growth considerations affecting dose timing
  • School accommodation planning during monitoring period

Cardiac Comorbidities

  • Cardiomyopathy screening with pediatric cardiology
  • Arrhythmia management during steroid therapy
  • Activity restrictions post-infusion

Prior Gene Therapy Exposure

  • AAV vector history (automatic exclusion for most payers)
  • Clinical trial participation documentation
  • Immunologic memory considerations

When facing complex situations, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer-specific requirements.

Appeals Process in Florida

Internal Appeals (Required First Step)

  • Timeline: 180 days from denial notice to file appeal
  • Standard review: 30-45 days for Aetna decision
  • Expedited review: 72 hours for urgent cases
  • Submission: Via Availity portal or written request to address on denial letter

External Review (Independent)

After exhausting internal appeals, Florida members can access:

  • Independent Review Organization (IRO) through Florida Department of Financial Services
  • Timeline: 4 months from final internal denial to request external review
  • Cost: No charge to consumer
  • Decision: Binding on Aetna if overturned
  • Expedited option: 72 hours for urgent cases
Consumer Assistance: Florida Insurance Consumer Helpline at 877-693-5236 can help navigate the appeals process.

For complex appeals requiring specialized expertise, Counterforce Health helps patients, clinicians, and specialty pharmacies develop comprehensive appeal strategies that address specific payer criteria and regulatory requirements.

Quick Reference Table

Requirement What It Means Where to Find It Documentation Needed
Prior Authorization Required for all plans CVS Caremark PA portal Complete PA form with clinical justification
Age Limit ≥4 years FDA prescribing information Birth certificate or medical records
Ambulatory Status Must be able to walk Clinical assessment NSAA scores, 6MWT results
Genetic Testing Pathogenic DMD mutation CLIA-certified lab report Full gene analysis with exon mapping
Antibody Testing Anti-AAVrh74 titer below threshold Reference laboratory Recent serology report
Baseline Labs Normal hepatic function Hospital/clinic labs AST, ALT, GGT, bilirubin, coagulation
Monitoring Plan Weekly labs ≥3 months Provider protocol Written monitoring schedule
Site of Care Approved infusion center Aetna provider directory Facility credentials
Appeals Deadline 180 days (internal) Denial letter Written appeal with supporting documents
External Review 4 months after final denial Florida DFS IRO request form

From Our Advocates

We've seen families successfully appeal initial Elevidys denials by strengthening their genetic documentation and monitoring plans. One case involved a 6-year-old with DMD whose first PA was denied due to incomplete anti-AAV antibody results. After obtaining proper titer testing from a reference lab and submitting a detailed hepatic monitoring protocol, the appeal was approved within 3 weeks. The key was addressing each specific denial reason with concrete documentation rather than general medical necessity arguments.

FAQ

How long does Aetna PA take for Elevidys in Florida? Standard review is 30-45 days, but complex cases may take longer. Submit expedited requests if treatment delay could harm the patient.

What if Elevidys is non-formulary on my plan? Request a formulary exception with detailed medical necessity documentation. Most gene therapies require individual review regardless of formulary status.

Can I request peer-to-peer review? Yes, if initially denied. Your prescriber can request to speak directly with Aetna's medical director to discuss clinical rationale.

Does step therapy apply if I've failed therapies outside Florida? Document all prior treatments with records from previous providers. Out-of-state treatment history should be accepted with proper documentation.

What happens if monitoring shows liver problems? Follow FDA dose-modification guidelines for corticosteroids and consult hepatology immediately. Aetna typically covers additional monitoring and treatments for drug-related complications.

How do I find an approved infusion center? Contact Aetna provider relations or check the online provider directory for facilities with gene therapy capabilities and pediatric expertise.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific guidance regarding your situation. For assistance with complex appeals, consider consulting with coverage advocacy specialists who understand payer-specific requirements and regulatory processes.

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