By Counterforce Health Team in Vigabatrin (generic; Sabril originator Lundbeck) —

How to Get Vigabatrin (Sabril) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Vigabatrin Covered by Aetna CVS Health in Virginia

Fast track to approval: Vigabatrin requires prior authorization from Aetna CVS Health with mandatory REMS enrollment for prescriber, patient, and pharmacy. Document two failed antiepileptic drugs, complete baseline vision testing, and submit through CVS Specialty Pharmacy. If denied, Virginia's Bureau of Insurance offers external review within 120 days. Start today: Have your neurologist enroll in the Vigabatrin REMS program and schedule your baseline vision assessment.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Requirements
  5. Required Documentation Packet
  6. Submission Process
  7. CVS Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Virginia Appeals Process
  11. Frequently Asked Questions
  12. Quick Reference Checklist

Who Should Use This Guide

This guide helps Virginia residents with Aetna CVS Health coverage get prior authorization for Vigabatrin (generic) or brand Sabril. You'll need this if your doctor has prescribed Vigabatrin for:

  • Infantile spasms in children 1 month to 2 years (as monotherapy)
  • Refractory complex partial seizures in adults and children ≥2 years (as add-on therapy)

Expected outcome: With proper documentation and REMS compliance, most medically appropriate requests are approved within 30-45 days. Generic Vigabatrin typically costs around $4,557 for a 100-tablet supply without insurance, while brand Sabril can exceed $19,000.

Note: Vigabatrin carries an FDA black box warning for permanent vision loss and requires strict monitoring protocols.

Member & Plan Basics

Coverage Requirements

  • Active Aetna CVS Health plan (commercial, Medicare Advantage, or Medicaid managed care)
  • Specialty drug coverage through CVS Caremark/CVS Specialty
  • Prior authorization required for both generic and brand versions

Plan Type Considerations

Plan Type Key Requirements
Commercial PPO/HMO Standard PA process, 30-45 day decisions
Medicare Advantage May require additional Medicare-specific documentation
Medicaid Managed Care State formulary restrictions may apply

Verify your coverage: Call the member services number on your insurance card to confirm specialty drug benefits and any applicable deductibles.

Clinical Criteria Requirements

Aetna CVS Health requires specific clinical documentation based on your diagnosis:

For Infantile Spasms (Monotherapy)

  • Age requirement: 1 month to 2 years at treatment start
  • Diagnosis confirmation: Clinical or EEG evidence of infantile spasms
  • First-line consideration: May be approved as initial therapy for appropriate patients

For Refractory Complex Partial Seizures (Add-on Therapy)

  • Age requirement: ≥2 years (children and adults)
  • Prior treatment failures: Documentation of at least two alternative antiepileptic drugs that were:
    • Ineffective at therapeutic doses
    • Not tolerated due to side effects
    • Contraindicated due to medical conditions
  • Ongoing seizure activity: Evidence that seizures remain inadequately controlled
Critical requirement: All patients must have documented counseling about vision loss risk and agree to regular vision monitoring.

Coding & Documentation Requirements

ICD-10 Codes

Use the most specific code for your diagnosis:

Infantile Spasms:

  • G40.823: Epileptic spasms, not intractable, without status epilepticus
  • G40.824: Epileptic spasms, intractable, without status epilepticus

Complex Partial Seizures:

  • G40.204: Localization-related symptomatic epilepsy with complex partial seizures, intractable, without status epilepticus
  • G40.109: Localization-related symptomatic epilepsy with simple partial seizures, not intractable

NDC Numbers and Billing Codes

  • Generic Vigabatrin tablets: Various NDCs depending on manufacturer
  • Sabril tablets: 54092-544-01
  • Sabril powder: 54092-545-01
  • HCPCS: Use J3490 (unclassified drug) if no specific J-code available

Required Documentation Packet

Provider Letter of Medical Necessity Must Include:

  1. Patient demographics and insurance information
  2. Primary diagnosis with ICD-10 code
  3. Detailed seizure history including frequency, type, and impact
  4. Prior antiepileptic drug trials with:
    • Drug names, doses, and duration of each trial
    • Specific reasons for discontinuation
    • Documentation of therapeutic levels when applicable
  5. Clinical rationale for Vigabatrin specifically
  6. Vision risk counseling documentation
  7. Baseline vision assessment results
  8. Treatment goals and monitoring plan

Required Attachments:

  • Recent clinic notes (last 3-6 months)
  • EEG reports (if available)
  • Prior medication trial documentation
  • Baseline ophthalmologic evaluation
  • REMS enrollment confirmation
  • Insurance card copy

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and crafting point-by-point rebuttals aligned to each plan's own rules. Their platform can help ensure your documentation meets Aetna's specific requirements from the start.

Submission Process

Step-by-Step Submission Guide

Step 1: Complete REMS Enrollment

  • Prescriber enrolls at vigabatrinrems.com
  • Patient enrollment completed by prescriber
  • Pharmacy must be REMS-certified

Step 2: Gather Documentation

  • Complete medical necessity letter
  • Collect all required attachments
  • Verify baseline vision testing is complete

Step 3: Submit Prior Authorization

Step 4: Route to CVS Specialty

  • Prescription must go to CVS Specialty Pharmacy
  • Provide CVS Specialty with PA approval number
  • Coordinate shipment and patient counseling
Tip: Submit requests early in the week to avoid weekend delays in processing.

CVS Specialty Pharmacy Requirements

Vigabatrin can only be dispensed through specialty pharmacies with REMS certification. CVS Specialty Pharmacy handles most Aetna CVS Health specialty medications.

CVS Specialty Requirements:

  • REMS certification for all staff handling Vigabatrin
  • Patient enrollment verification before first fill
  • Ongoing compliance monitoring for vision assessments
  • Coordination with prescriber for refill authorizations

Patient Responsibilities:

  • Maintain REMS program enrollment
  • Attend all scheduled vision assessments
  • Report any vision changes immediately
  • Comply with medication monitoring requirements

After Submission: What to Expect

Timeline Expectations

Process Step Standard Timeline Expedited (if applicable)
Initial Review 15-30 days 72 hours
Additional Information Request 5-10 days for response 24-48 hours
Final Decision 30-45 days total 72 hours

Status Monitoring

  • Confirmation number: Record your PA request number
  • Status checks: Call CVS Caremark at 1-800-294-5979
  • Documentation: Keep copies of all submissions and correspondence

What to Record:

  • PA request number and submission date
  • Representative names and call reference numbers
  • Any additional information requests
  • Decision dates and approval/denial reasons

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing REMS enrollment Complete enrollment process REMS confirmation for prescriber, patient, pharmacy
Insufficient prior failures Document additional AED trials Detailed medication history with specific failure reasons
Missing vision documentation Submit ophthalmology reports Baseline vision assessment and monitoring plan
Non-formulary status Request formulary exception Medical necessity justification and clinical evidence
Step therapy not met Document contraindications/failures Prior authorization override request with supporting evidence

Prevention Tips:

  1. Verify REMS enrollment for all parties before submitting
  2. Document specific failure reasons for each prior AED trial
  3. Include baseline vision testing with initial request
  4. Use Aetna-specific forms and follow their submission guidelines
  5. Submit complete packages to avoid delays from missing information

Virginia Appeals Process

If your initial request is denied, Virginia law provides strong appeal rights through the Bureau of Insurance.

Internal Appeals with Aetna CVS Health

  • Timeline: 30 days for pre-service denials, 60 days for post-service
  • Expedited appeals: 72 hours for urgent medical situations
  • Required: Must complete internal appeals before external review

Virginia External Review Process

After exhausting internal appeals, you can request independent external review:

Key Details:

  • Deadline: 120 days from final internal denial
  • Forms: Form 216-A (External Review Request)
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to patients
  • Decision: Binding on Aetna CVS Health

Submission Options:

  • Fax: 804-371-9915
  • Email: [email protected]
  • Mail: State Corporation Commission Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
Virginia advantage: The state's external review process has helped many patients access specialty medications that were initially denied.

For complex denials involving rare conditions like those treated with Vigabatrin, Counterforce Health can help craft appeals that address the specific clinical criteria and procedural requirements that led to the denial.

Frequently Asked Questions

Q: How long does Aetna CVS Health prior authorization take for Vigabatrin in Virginia? A: Standard decisions take 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours.

Q: What if Vigabatrin is not on Aetna's formulary? A: You can request a formulary exception with medical necessity documentation. Generic versions are typically preferred over brand Sabril.

Q: Can I get expedited approval for infantile spasms? A: Yes, if your doctor certifies that delays could harm your child's health. Submit expedited PA requests with physician attestation of urgency.

Q: Does Virginia step therapy apply if I failed medications in another state? A: Yes, documented failures from other states count toward step therapy requirements. Include detailed records from previous providers.

Q: What happens if I miss a vision assessment? A: CVS Specialty may hold future fills until vision monitoring is current. Schedule assessments every 3 months as required.

Q: Can I appeal if my child ages out during the approval process? A: For infantile spasms, contact Aetna immediately if your child approaches 2 years old during review. Age at treatment initiation typically governs coverage.

Q: What if CVS Specialty is not in my area? A: CVS Specialty ships nationwide. They'll coordinate with your local pharmacy for any additional services needed.

Q: How much will I pay out of pocket? A: Costs depend on your specific plan. Check for manufacturer copay assistance programs and patient foundation grants to reduce expenses.

Quick Reference Checklist

Before You Start

  • Verify active Aetna CVS Health coverage with specialty benefits
  • Confirm diagnosis meets FDA indications
  • Document at least 2 prior AED failures (for complex partial seizures)
  • Complete baseline vision assessment
  • Gather all medical records and clinic notes

REMS Requirements

  • Prescriber enrolled in Vigabatrin REMS program
  • Patient enrolled by prescriber
  • CVS Specialty Pharmacy REMS-certified
  • Vision monitoring plan established

Documentation Packet

  • Completed Aetna Specialty Medication Precertification Request form
  • Medical necessity letter with all required elements
  • Prior medication trial documentation
  • Baseline ophthalmology report
  • Recent clinic notes
  • Insurance card copy
  • REMS enrollment confirmations

Submission

  • Submit complete packet via provider portal or fax
  • Record PA request number and submission date
  • Route prescription to CVS Specialty Pharmacy
  • Schedule regular status check calls

After Approval

  • Coordinate with CVS Specialty for medication shipment
  • Schedule 3-month vision assessments
  • Set calendar reminders for PA renewals
  • Monitor for any vision changes

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact Virginia's Bureau of Insurance or a qualified advocate for personalized assistance with insurance appeals. Coverage policies and requirements may change; verify current information with official sources before making decisions.

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