By Counterforce Health Team in Exondys 51 (eteplirsen) —

Renewing Exondys 51 (Eteplirsen) Approval with Aetna CVS Health in Texas: 2025 Requirements and Timeline

Answer Box: Quick Renewal Guide

Exondys 51 renewal with Aetna CVS Health requires 6-month prior authorization cycles with specific documentation. Start 60 days before expiration. Three key steps: (1) Schedule neurologist visit within 6 months, (2) Complete cardiac echo and renal labs within 12 months, (3) Document functional stability using standardized tests like 6-minute walk or time-to-rise. Submit through Aetna's provider portal with genetic confirmation and weight-based dosing calculation. If denied, you have 180 days to appeal and can request emergency bridge supply during review.

Table of Contents

  1. Renewal Triggers: When to Start Early
  2. Evidence Update: What Documentation You Need
  3. Renewal Packet: Must-Include Documents
  4. Timeline: Submission Windows and Decision Periods
  5. If Coverage Lapses: Bridge Options
  6. Annual Changes: What to Re-Verify
  7. Appeals Process: Your Rights in Texas
  8. Costs and Patient Assistance
  9. FAQ

Renewal Triggers: When to Start Early

Exondys 51 (eteplirsen) requires prior authorization renewal every 6 months with Aetna CVS Health. Don't wait until the last minute—coverage gaps can interrupt this critical weekly infusion therapy for Duchenne muscular dystrophy.

Start Your Renewal Process When:

  • 60-90 days before expiration: Begin gathering updated documentation
  • Your neurologist mentions scheduling: Annual or semi-annual DMD follow-ups often align with renewal needs
  • You receive renewal notices: Aetna typically sends reminders 30-45 days before authorization expires
  • Functional changes occur: Significant improvement or decline may require updated assessments
Tip: Set calendar reminders for 75 days before each expiration date. This gives you buffer time if labs are delayed or your specialist's schedule is booked.

Evidence Update: What Documentation You Need

Aetna CVS Health requires proof of continued medical necessity and clinical benefit for Exondys 51 renewal. The documentation requirements are strict and standardized across Texas Medicaid and commercial plans.

Core Clinical Requirements

Neurologist Evaluation (within 6 months)

  • Confirmation of DMD diagnosis with genetic testing showing exon 51 amenable mutation
  • Assessment of current functional status
  • Documentation that patient remains ambulatory or maintains functional capacity
  • Prescriber attestation of treatment compliance

Functional Assessment Documentation

  • Time-to-rise test: Must be <7 seconds for most payers
  • 6-minute walk test (6MWT): Distance maintained or improved from baseline
  • North Star Ambulatory Assessment (NSAA) or Motor Function Measure (MFM)
  • Evidence of clinical stability or improvement (slowing decline is generally sufficient)

Laboratory and Monitoring Requirements

  • Cardiac function: Echocardiogram or cardiac MRI within 12 months
  • Renal function: Serum creatinine and urinalysis within 12 months
  • Current weight: Measured within 30 days (for weight-based dosing calculation)
  • Infusion compliance records: Documentation of regular weekly infusions

Critical Exclusions to Document

  • No concurrent exon-skipping therapies: Confirm patient is not receiving casimersen, viltolarsen, golodirsen, or other DMD antisense drugs
  • No declining physical function: If function has worsened, provide clinical justification for continued therapy

Renewal Packet: Must-Include Documents

Your renewal submission must include specific forms and clinical documentation. Missing items will delay approval or trigger denials.

Required Forms and Documentation

Document Type Requirement Where to Find Timeline
Prior Authorization Form Aetna-specific PA request Aetna Provider Portal (verify current link) Submit 30-60 days before expiration
Genetic Testing Report Confirmation of exon 51 amenable mutation Original diagnostic lab Required if not on file
Neurologist Letter Medical necessity documentation Treating neurologist Within 6 months
Functional Test Results 6MWT, TTR, NSAA, or MFM Clinic or PT evaluation Within 12 months
Cardiac Assessment Echo or cardiac MRI report Cardiology or imaging center Within 12 months
Lab Results Creatinine, urinalysis Primary care or specialist Within 12 months
Weight Documentation Current weight for dosing Any healthcare visit Within 30 days
Infusion Records Proof of compliance Specialty pharmacy or infusion center Recent 3-6 months

Medical Necessity Letter Template

Your neurologist should include these key elements:

Patient Information

  • Name, DOB, diagnosis (DMD with exon 51 amenable mutation)
  • ICD-10 code: G71.01 (Duchenne or Becker muscular dystrophy)

Clinical Justification

  • Current functional status and stability
  • Evidence of continued benefit or slowed progression
  • Rationale for continued weekly infusions
  • Documentation of treatment compliance

Supporting Evidence

  • Reference to FDA approval for exon 51 skipping
  • Cite recent functional assessments showing stability
  • Note absence of significant adverse events

Timeline: Submission Windows and Decision Periods

Understanding Aetna's review timeline helps prevent coverage gaps and plan for potential appeals.

Standard Review Process

60-90 Days Before Expiration

  • Begin gathering updated documentation
  • Schedule neurologist appointment if needed
  • Order cardiac and renal function tests

30-45 Days Before Expiration

  • Submit complete renewal packet
  • Follow up on any missing documentation requests
  • Confirm specialty pharmacy has received authorization update

Aetna Decision Timeline

  • Standard review: 30-45 days for commercial plans
  • Expedited review: 72 hours if urgent medical need documented
  • Medicare plans: Up to 72 hours for expedited, 14 days for standard
Note: Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters and drafting evidence-backed rebuttals aligned to each plan's specific requirements.

If Coverage Lapses: Bridge Options

If your authorization expires before renewal approval, several options can help maintain access to Exondys 51.

Emergency Authorization Options

Temporary Supply Request

  • Aetna can issue 15-30 day temporary authorization during active review
  • Requires prescriber to document "risk of harm" from treatment interruption
  • Submit through provider portal with "continuity of care" justification

Expedited Appeal Process

  • If renewal is denied, request expedited review citing medical urgency
  • Must demonstrate that delay would jeopardize health or functional status
  • Available for both commercial and Medicare plans

Manufacturer Support Programs

Sarepta Patient Assistance

  • Temporary supply programs during coverage gaps
  • Income-based assistance for eligible patients
  • Contact: Sarepta DMD Care (verify current contact)

CVS Specialty Pharmacy Bridge Programs

  • Emergency supply coordination with manufacturer
  • Insurance liaison services during authorization delays

Annual Changes: What to Re-Verify

Plan changes can affect your Exondys 51 coverage even with successful renewals. Stay informed about formulary updates and policy modifications.

2025 Aetna Formulary Status

Current Coverage Status

  • Exondys 51 remains on Aetna's specialty drug formulary for 2025
  • Classified as specialty tier medication (higher cost-sharing)
  • Prior authorization requirements unchanged from 2024

Potential Changes to Monitor

  • Step therapy requirements if new DMD treatments receive FDA approval
  • Site-of-care restrictions (home infusion vs. outpatient center)
  • Quantity limits or dosing frequency modifications

What to Verify Annually

  • Formulary tier placement: Check if Exondys 51 moves to different cost-sharing level
  • Network providers: Confirm your neurologist and infusion center remain in-network
  • Specialty pharmacy: Verify CVS Specialty continues as preferred provider
  • Prior authorization criteria: Review any updates to medical necessity requirements

Appeals Process: Your Rights in Texas

If Aetna denies your Exondys 51 renewal, Texas law provides strong patient protections and multiple levels of review.

Internal Appeals Process

Timeline: 180 days from denial date to file internal appeal Standard Review: 30 days for pre-service requests, 60 days for post-service Expedited Review: 72 hours for urgent situations

Required Documentation

  • Copy of denial letter with specific denial reasons
  • Updated medical necessity letter addressing each denial point
  • Any additional clinical evidence not in original submission

External Review Rights

Independent Review Organization (IRO)

  • Available after internal appeal denial
  • Binding decision that Aetna must follow
  • Timeline: File within 4 months of final internal denial
  • Cost: Free to patient (insurer pays IRO fees)

Texas Department of Insurance Support

  • Consumer hotline: 1-800-252-3439
  • IRO information line: 1-866-554-4926
  • Online complaint filing available
From our advocates: We've seen families successfully overturn Exondys 51 denials by focusing appeals on functional stability data rather than improvement. One renewal appeal succeeded by documenting that the patient maintained 6-minute walk distance within 10% of baseline over 12 months, demonstrating treatment benefit through disease progression prevention.

When to Escalate

Contact Texas regulators if:

  • Aetna fails to meet appeal timeline requirements
  • Denial reasons seem inconsistent with medical evidence
  • External review decision is not implemented promptly

Costs and Patient Assistance

Exondys 51 is expensive—approximately $300,000-400,000 annually. Understanding your coverage and assistance options is crucial.

Aetna Coverage Details

Specialty Tier Cost-Sharing

  • Typically 20-40% coinsurance after deductible
  • Annual out-of-pocket maximums apply
  • Prior authorization required regardless of tier

Financial Assistance Programs

Sarepta Therapeutics Support

Foundation Grants

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • Muscular Dystrophy Association (MDA)

FAQ

How long does Aetna prior authorization take for Exondys 51 renewal? Standard review takes 30-45 days for commercial plans. Medicare plans must respond within 14 days for standard requests, 72 hours for expedited reviews.

What if my neurologist is not in Aetna's network? Out-of-network specialists can still provide medical necessity documentation, but you may face higher cost-sharing. Consider requesting a network exception if no in-network DMD specialists are available.

Can I request expedited renewal review? Yes, if delaying treatment would jeopardize your health. Your prescriber must document medical urgency and submit an expedited review request.

What happens if I miss infusions during coverage gaps? Contact your neurologist immediately. Missing multiple weekly infusions may affect your next renewal if functional assessments show decline. Document any coverage-related interruptions.

Does step therapy apply to Exondys 51 renewals? Step therapy typically applies to initial authorization. Renewals focus on continued medical necessity and clinical benefit rather than trying alternative treatments first.

How do I track my renewal status? Use Aetna's member portal or call the number on your insurance card. CVS Specialty Pharmacy can also provide authorization status updates.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult your healthcare provider and insurance plan directly for specific guidance. Counterforce Health helps patients and clinicians navigate insurance approval processes by analyzing denial letters and creating targeted, evidence-based appeals.

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