By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (Eteplirsen) Covered by Blue Cross Blue Shield in Virginia: Complete PA Guide with Appeal Forms and Timelines

Answer Box: Getting Exondys 51 Covered in Virginia

Exondys 51 (eteplirsen) is covered by Blue Cross Blue Shield Virginia as a specialty pharmacy benefit but requires prior authorization with genetic confirmation of an exon 51-amenable DMD mutation. Your fastest path: 1) Confirm genetic testing shows exon 51 skipping eligibility, 2) Have your neuromuscular specialist submit PA with baseline assessments, 3) Use Anthem's provider portal with complete documentation. If denied, Virginia's Bureau of Insurance offers binding external review within 120 days. Start today by verifying your genetic test results specify "exon 51-amenable mutation."

Table of Contents

Plan Types & Coverage Implications

Blue Cross Blue Shield Virginia (operated by Anthem) offers several plan types, each with different coverage pathways for Exondys 51:

Commercial Plans (HMO/PPO/EPO): All require prior authorization through Anthem's utilization management. PPO members can see specialists without referrals, while HMO members need primary care referrals to neuromuscular specialists.

Medicare Advantage: Subject to Medicare Part B coverage rules plus Anthem's additional requirements. May require different forms and have stricter age limitations.

Medicaid (Virginia Medicaid): Follows Virginia Medicaid formulary rules, which may differ from commercial policies. Requires Virginia Medicaid provider enrollment.

Note: Self-funded employer plans may have different criteria even when administered by Anthem. Check your Summary Plan Description for specific coverage details.

Formulary Status & Tier Placement

Exondys 51 is classified as a Tier 4 specialty medication on most Anthem Blue Cross Blue Shield Virginia formularies. This means:

  • Prior authorization required for all requests
  • Specialty pharmacy dispensing only (typically Accredo)
  • Higher cost-sharing than lower-tier medications
  • Quantity limits based on FDA dosing (30 mg/kg weekly)

The medication is covered for its FDA-approved indication: Duchenne muscular dystrophy with a confirmed mutation amenable to exon 51 skipping.

Prior Authorization Requirements

Clinical Criteria Checklist

✅ Confirmed DMD diagnosis with genetic testing showing exon 51-amenable mutation
✅ Male patient (DMD is X-linked)
✅ Neuromuscular specialist prescriber (pediatric neurologist preferred)
✅ Baseline functional assessments completed
✅ Corticosteroid use documented (unless contraindicated)
✅ No concurrent exon-skipping therapies

Required Documentation

Document Type Specific Requirements Where to Find
Genetic Report Mutation amenable to exon 51 skipping Genetics lab report
Clinical Notes Baseline 6MWT, cardiac/pulmonary function Neurology clinic
ICD-10 Code G71.01 (Duchenne muscular dystrophy) Provider documentation
Dosing Calculation 30 mg/kg/week based on current weight Prescriber calculation
Prior Therapies Corticosteroid history or contraindications Medical records

Specialty Pharmacy Network

Exondys 51 must be dispensed through Anthem's contracted specialty pharmacy network. Retail pharmacies cannot fill this prescription.

Primary Specialty Pharmacy: Accredo (most common for Anthem members)
Setup Process: Your prescriber initiates the specialty pharmacy enrollment
Delivery: Direct to home or infusion center
Coordination: Specialty pharmacy handles PA submission and insurance coordination

Tip: Contact your specialty pharmacy within 48 hours of prescription submission to ensure smooth processing and coordinate your first infusion.

Step-by-Step Approval Process

1. Genetic Testing Confirmation (Patient/Family)

Ensure your genetic test report specifically states the mutation is "amenable to exon 51 skipping." If unclear, request clarification from your genetics team.

2. Specialist Consultation (Clinic)

Schedule with a pediatric neurologist or neuromuscular specialist who can document medical necessity and complete baseline assessments.

3. Baseline Testing (Clinic)

Complete required assessments:

  • 6-minute walk test (if ambulatory)
  • Cardiac function (echocardiogram/EKG)
  • Pulmonary function tests
  • Current weight and vital signs

4. Prior Authorization Submission (Prescriber)

Submit through Anthem's provider portal with complete documentation package. Standard processing time: 15 business days.

5. Specialty Pharmacy Setup (Prescriber/Patient)

Upon approval, coordinate with assigned specialty pharmacy for enrollment, insurance verification, and delivery scheduling.

6. Infusion Site Coordination (Patient/Family)

Arrange infusions at approved sites: hospital outpatient departments, accredited infusion centers, or qualified physician offices.

7. Follow-up Documentation (Ongoing)

Maintain records of infusion compliance, functional assessments, and any adverse events for renewal requests (typically every 6 months).

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Genetic testing incomplete Submit detailed genetic report Lab report showing specific exon 51-amenable mutation
Non-specialist prescriber Transfer care to neuromuscular specialist Referral and specialist evaluation
Missing baseline assessments Complete all required testing 6MWT, cardiac, pulmonary function results
Lack of corticosteroid trial Document steroid use or contraindications Treatment history or medical contraindication letter
Age outside parameters Provide clinical justification Detailed medical necessity letter

Appeals Process in Virginia

Internal Appeals (First Step)

  • Timeline: 30 days from denial notice
  • Method: Anthem member portal or written request
  • Documentation: Additional medical records, peer-reviewed studies, clinical guidelines
  • Decision timeframe: 30 days (expedited: 72 hours for urgent cases)

External Review (Virginia Bureau of Insurance)

If internal appeals are unsuccessful, Virginia law provides for binding external review:

  • Eligibility: Must exhaust internal appeals first
  • Timeline: 120 days from final internal denial
  • Process: Submit Form 216-A to Virginia State Corporation Commission
  • Review time: 45 days standard, 72 hours expedited
  • Cost: Free to consumers
  • Decision: Binding on the insurer
Virginia Advantage: The state's external review process has shown favorable outcomes, with approximately 49% of medical/surgical benefit denials overturned in 2023.

Contact Information:
Virginia Bureau of Insurance
1-877-310-6560
External Review Information

Cost Considerations

Insurance Coverage

  • Tier 4 specialty copay/coinsurance applies
  • Annual deductible may need to be met first
  • Out-of-pocket maximum provides annual cap

Patient Assistance Options

  • Sarepta Therapeutics Patient Assistance: Income-based support programs
  • Copay assistance: May be available for eligible commercial insurance patients
  • Virginia Medicaid: Covers approved specialty medications with minimal patient cost-sharing

Note: This information is educational only. Consult with your insurance plan and healthcare team for specific cost estimates.

When to Escalate

Contact Virginia regulators if you encounter:

  • Unreasonable delays in processing (beyond stated timeframes)
  • Repeated denials without clear medical rationale
  • Procedural violations of Virginia insurance law

Virginia State Corporation Commission Bureau of Insurance
Consumer Services: 1-877-310-6560
File a complaint online

FAQ

How long does Blue Cross Blue Shield PA take in Virginia?
Standard prior authorization processing is 15 business days. Expedited reviews (for urgent medical needs) are completed within 72 hours.

What if Exondys 51 is denied as "not medically necessary"?
Appeal with additional clinical documentation, peer-reviewed studies supporting exon 51 skipping therapy, and a detailed medical necessity letter from your specialist.

Can I request an expedited appeal in Virginia?
Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health. Expedited external reviews are decided within 72 hours.

Does step therapy apply if I'm already on corticosteroids?
Anthem typically requires documentation of corticosteroid use (current or prior) unless medically contraindicated. This isn't traditional "step therapy" but rather a clinical requirement.

What happens if my employer plan is self-funded?
Self-funded plans may opt into Virginia's external review process. If not, you may have access to federal external review through HHS. The Virginia Bureau of Insurance can help direct you.

How often do I need to renew prior authorization?
Typically every 6 months. Renewals require demonstration of continued clinical benefit, adherence to treatment, and stable or improved functional status.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify specific denial reasons and draft point-by-point rebuttals aligned with each payer's requirements.

When facing a specialty medication denial like Exondys 51, having the right documentation and understanding payer-specific workflows can make the difference between approval and prolonged delays. Counterforce Health's system pulls appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines while ensuring all required clinical facts are properly documented for Virginia's unique regulatory environment.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation. For assistance with insurance appeals and coverage issues in Virginia, contact the Virginia State Corporation Commission Bureau of Insurance.

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