By Counterforce Health Team in Vyondys 53 (golodirsen) —

How to Get Vyondys 53 (Golodirsen) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Vyondys 53 Covered by Aetna CVS Health in Virginia

Eligibility: Patients with confirmed Duchenne muscular dystrophy (DMD) and a genetic mutation amenable to exon 53 skipping. Fastest approval path: Submit prior authorization through your DMD specialist with genetic testing, baseline assessments, and corticosteroid documentation. Start today: Contact your neurologist to request genetic confirmation and begin gathering required clinical documentation. Virginia offers strong external review rights if initially denied.

Key Steps: 1) Confirm genetic eligibility, 2) Submit PA with specialist documentation, 3) Appeal denials through Virginia's Bureau of Insurance external review process.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for all Aetna plans Aetna Precertification List 5-7 business days
Genetic Testing DMD with exon 53 amenable mutation CLIA-certified lab report Must be current
Specialist Prescription Neurologist or neuromuscular specialist Provider credentials verification Required for PA
Baseline Monitoring Kidney function, functional assessments Vyondys 53 Prescribing Information Before treatment start
Step Therapy (Medicaid) Trial of preferred alternatives Virginia Medicaid PDL Unless contraindicated

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Eligibility

Who: Your neurologist or genetic counselor
What: Order genetic testing to confirm DMD with exon 53 amenable mutation
How: CLIA-certified laboratory (MLPA or comparative genomic hybridization)
Timeline: 2-4 weeks for results

Note: Only about 8% of DMD patients have mutations amenable to exon 53 skipping. Genetic confirmation is absolutely required.

2. Gather Clinical Documentation

Who: Your care team
What: Compile comprehensive clinical records including:

  • Current neurologist consultation notes
  • Baseline functional assessments (6-minute walk test, North Star Ambulatory Assessment)
  • Corticosteroid therapy documentation (≥6 months stable dosing)
  • Baseline kidney function tests (cystatin C, urine protein/creatinine ratio)

3. Submit Prior Authorization

Who: Your prescribing physician
How: Aetna Provider Portal or fax to 1-888-267-3277
Timeline: 5-7 business days standard, 24-48 hours expedited
Required: Vyondys 53 Precertification Request Form

4. Coordinate Specialty Pharmacy

Who: Your clinic and CVS Specialty
What: Arrange infusion logistics and monitoring plan
Timeline: 1-2 weeks after approval

5. Monitor for Approval Decision

Who: You and your clinic
What: Track PA status via provider portal or member services
Contact: 1-866-752-7021 for status updates

6. Appeal if Denied (if needed)

Who: You with physician support
What: Internal appeal within 180 days
How: Virginia Bureau of Insurance external review if internal appeal fails

7. Begin Treatment

Who: Infusion center
What: Weekly 30 mg/kg IV infusions with monitoring
Ongoing: Monthly urine dipstick, quarterly kidney function tests

Coding and Billing Basics

Understanding the coding requirements helps ensure clean claims submission and reduces delays in coverage decisions.

Medical vs. Pharmacy Benefit Pathways

Vyondys 53 typically falls under the medical benefit as an infused specialty medication. This means:

  • Claims process through the medical side of your Aetna plan
  • Requires prior authorization through medical management
  • Subject to medical deductibles and coinsurance
  • Administered in outpatient infusion centers or hospitals
Tip: Confirm your plan's benefit structure, as some high-deductible plans may have different cost-sharing for specialty infusions.

ICD-10 and Documentation Requirements

Primary Diagnosis Code

ICD-10: G71.01 - Duchenne or Becker muscular dystrophy

Supporting Documentation

Your medical records should include specific language that supports the diagnosis:

  • "Confirmed Duchenne muscular dystrophy"
  • "Genetic testing positive for dystrophin gene mutation"
  • "Mutation amenable to exon 53 skipping therapy"
  • "Progressive muscle weakness consistent with DMD"

Product Coding: HCPCS, NDC, and Units

HCPCS/J-Code

J1429 - Injection, golodirsen, 10 mg

NDC Numbers

  • 60923-0465-01: 100 mg/2 mL single-dose vial
  • 60923-0465-05: 500 mg/10 mL single-dose vial

Dosing and Units Calculation

  • Standard dose: 30 mg/kg body weight weekly
  • Billing units: Each J1429 unit = 10 mg
  • Example: 70 kg patient = 2,100 mg dose = 210 billing units

Administration Codes

  • CPT 96413: IV infusion, up to 1 hour (initial)
  • CPT 96415: Each additional 30 minutes
  • Typical infusion time: 35-60 minutes (usually requires both codes)

Clean Prior Authorization Request

Essential Components

  1. Patient Demographics
    • Full name, DOB, Aetna member ID
    • Virginia address confirmation
  2. Clinical Information
    • ICD-10: G71.01
    • Genetic testing results with lab name and date
    • Current weight for dosing calculation
    • Baseline functional assessments
  3. Prescriber Details
    • Neurologist/neuromuscular specialist credentials
    • NPI number and practice information
    • DEA number if required
  4. Treatment Plan
    • Dosing: 30 mg/kg weekly IV infusion
    • Duration: Ongoing (typically 1-year authorization)
    • Monitoring plan per FDA labeling
  5. Medical Necessity Justification
    • FDA-approved indication match
    • Genetic mutation specificity
    • Prior treatment history
    • Clinical progression without treatment

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Not medically necessary Submit specialist letter with FDA indication match Genetic testing, clinical notes, FDA labeling
Missing genetic confirmation Provide CLIA-certified lab report Complete genetic analysis with exon 53 mutation
Step therapy requirement Document contraindications to preferred agents Prior therapy records, adverse event documentation
Non-formulary status Request formulary exception Medical necessity letter, no suitable alternatives
Quantity/frequency limits Justify FDA-approved dosing Prescribing information, weight-based calculation
From our advocates: We've seen cases where genetic testing was initially submitted without the specific exon analysis. Always ensure your genetic report explicitly states the mutation is "amenable to exon 53 skipping" - this exact language can make the difference between approval and denial.

Virginia Appeals Process

Internal Appeals

  • Deadline: 180 days from denial notice
  • Method: Written appeal to Aetna with supporting documentation
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Required: Copy of denial, medical records, physician letter

External Review Through Virginia Bureau of Insurance

If your internal appeal is denied, Virginia offers robust external review rights:

Virginia State Corporation Commission Bureau of Insurance

  • Phone: 1-877-310-6560
  • Website: scc.virginia.gov
  • Process: Independent medical review by qualified specialists
  • Timeline: 45 days standard, 72 hours expedited
  • Cost: Free to consumers

External Review Requirements:

  • Complete internal appeals process first
  • Submit within 120 days of final internal denial
  • Use Form 216-A External Review Request
  • Include all medical records and denial notices

Virginia Managed Care Ombudsman: Available through the SCC to help navigate the appeals process and resolve issues informally.

Verification and Audit Checklist

Before submitting your prior authorization:

Clinical Documentation

  • Genetic testing confirms exon 53 amenable mutation
  • Current neurologist consultation notes
  • Baseline kidney function tests completed
  • Functional assessments documented
  • Corticosteroid therapy history (if applicable)

Coding Verification

  • ICD-10 G71.01 documented in medical records
  • Weight-based dosing calculation correct
  • J1429 units match calculated dose
  • Administration codes (96413/96415) appropriate for infusion time

Administrative Requirements

  • Prior authorization form complete
  • Prescriber credentials verified
  • Virginia address confirmed
  • All required signatures obtained

FAQ

How long does Aetna prior authorization take for Vyondys 53 in Virginia? Standard prior authorization decisions take 5-7 business days. Expedited reviews (when delays could harm health) are completed within 24-48 hours.

What if Vyondys 53 is non-formulary on my Aetna plan? You can request a formulary exception by demonstrating medical necessity and that no suitable formulary alternatives exist for your specific genetic mutation.

Can I get expedited appeals in Virginia? Yes, if your physician certifies that waiting could seriously jeopardize your health. Expedited external reviews are decided within 72 hours for urgent medical necessity.

Does step therapy apply if I haven't tried other DMD treatments? For Virginia Medicaid (Aetna Better Health), step therapy may require trial of preferred exon-skipping therapies unless contraindicated. Commercial plans typically don't require step therapy for genetically-specific treatments.

What monitoring is required during Vyondys 53 treatment? Monthly urine dipstick tests and quarterly kidney function monitoring (cystatin C, urine protein/creatinine ratio) as outlined in the FDA prescribing information.

How much does Vyondys 53 cost without insurance? Cash prices can exceed $300,000 annually. Sarepta Therapeutics offers patient assistance programs for eligible patients.

What if my appeal is denied by Virginia's external review? The external review decision is binding on the insurance company. If denied, you may explore other options like employer appeals (for self-funded plans) or legal consultation.

Can I switch infusion sites if my current center isn't in-network? Yes, work with your care team to identify in-network infusion centers. Aetna typically covers treatment at hospital outpatient departments and certified infusion centers.

About This Guide: Counterforce Health helps patients, clinicians, and specialty pharmacies navigate insurance denials for prescription drugs. Our platform turns denial letters into targeted, evidence-backed appeals by analyzing plan policies and crafting point-by-point rebuttals aligned with payer requirements.

For complex cases involving multiple denials or appeals, Counterforce Health's platform can help identify specific denial reasons and generate targeted appeal strategies based on your plan's own coverage policies.

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 medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with Virginia insurance issues, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.