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

How to Get Vigabatrin (Sabril) Covered by Cigna in Virginia: Complete Appeals Guide with Forms & Timelines

Answer Box: Getting Vigabatrin Covered by Cigna in Virginia

Fastest path to approval: Complete Vigabatrin REMS enrollment for prescriber, patient, and pharmacy, then submit Cigna's prior authorization form with medical necessity documentation. If denied, file internal appeal within 180 days, followed by Virginia external review (Form 216-A) within 120 days. Virginia's Bureau of Insurance provides independent review with decisions binding on insurers.

First step today: Have your neurologist verify REMS certification at vigabatrinREMS.com and request Cigna PA form via member portal or clinical line.

Table of Contents

  1. Understanding Vigabatrin Coverage Requirements
  2. REMS Program Compliance (Required First Step)
  3. Cigna Prior Authorization Process
  4. Common Denial Reasons & How to Fix Them
  5. First-Level Appeal Strategy
  6. Peer-to-Peer Review Process
  7. Virginia External Review Process
  8. Medical Necessity Letter Template
  9. Cost Assistance Options
  10. When to Escalate
  11. FAQ

Understanding Vigabatrin Coverage Requirements

Vigabatrin (generic and brand Sabril) is FDA-approved for two specific indications: infantile spasms as monotherapy in children 1 month to 2 years, and as adjunctive therapy for refractory complex partial seizures in patients 2 years and older. The drug carries a boxed warning for permanent vision loss and is only available through the FDA-mandated Vigabatrin REMS program.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all vigabatrin products Cigna member portal or provider line Cigna Policy
REMS Enrollment Mandatory for prescriber, patient, pharmacy vigabatrinREMS.com FDA REMS
Formulary Status Typically Tier 5 (specialty) Cigna Prescription Drug List Cigna Formulary
Age Restrictions 1 month-2 years (IS); ≥2 years (refractory seizures) FDA labeling FDA Label
Vision Monitoring Baseline and every 3 months REMS requirements REMS Documentation

REMS Program Compliance (Required First Step)

Before any prior authorization can be approved, all three parties must complete REMS enrollment. Cigna will deny requests lacking complete REMS compliance.

Prescriber Certification

Your neurologist must:

  • Complete one-time certification at vigabatrinREMS.com
  • Review prescribing information and agree to counsel patients
  • Arrange baseline and periodic vision assessments
  • Document counseling in patient records

Patient Enrollment

You (or your caregiver) must:

  • Complete Patient/Parent/Legal-Guardian–Physician Agreement Form
  • Acknowledge understanding of vision loss risk
  • Commit to regular eye exams every 3 months
  • Use only REMS-certified pharmacies

Pharmacy Certification

Your pharmacy must:

  • Be certified in the Vigabatrin REMS Program
  • Verify prescriber and patient enrollment before each dispense
  • Obtain authorization for each fill
Tip: Common REMS-certified specialty pharmacies include CVS Specialty, Walgreens Specialty, and Accredo. Verify certification before transferring prescriptions.

Cigna Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify REMS enrollment (all three parties) - Complete within 1-2 business days
  2. Download PA form from Cigna provider portal or member services - Same day
  3. Schedule baseline eye exam with ophthalmologist - Within 1 week
  4. Submit complete PA with medical necessity letter - 1-2 business days
  5. Await decision - Cigna typically responds within 72 hours for standard requests
  6. If approved, coordinate with REMS-certified pharmacy - 1-2 business days
  7. If denied, initiate appeal process immediately - File within 180 days

Required Documentation

Your neurologist must include:

  • Confirmed diagnosis (infantile spasms or refractory complex partial seizures)
  • Age verification and indication-specific criteria
  • Prior treatment history with failures/intolerances
  • REMS enrollment confirmation numbers
  • Vision monitoring schedule
  • Dosing rationale

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing REMS enrollment Provide confirmation numbers for all parties REMS enrollment confirmations
Missing vision monitoring Include baseline exam and monitoring schedule Ophthalmology report
Age outside indication Verify patient meets FDA age criteria Birth certificate, medical records
Non-specialist prescriber Ensure neurologist prescription Neurology consultation note
Insufficient prior failures Document adequate trials of alternatives Medication history with doses/durations
Non-REMS pharmacy Transfer to certified pharmacy Pharmacy REMS certification

First-Level Appeal Strategy

If your initial PA is denied, you have 180 days from the denial date to file an internal appeal with Cigna. This must be done in writing and include:

Appeal Letter Checklist

  • Patient identification (name, DOB, member ID)
  • Specific denial reason being contested
  • Medical necessity justification addressing each denial point
  • Supporting documentation (clinic notes, labs, prior med list)
  • Prescriber attestation of clinical need

Medical Necessity Arguments

For infantile spasms:

  • Vigabatrin is first-line therapy for TSC-related IS
  • Hormonal therapy (ACTH) is contraindicated or failed
  • Rapid seizure control is critical for development

For refractory seizures:

  • Multiple antiseizure drugs have failed at therapeutic doses
  • Patient meets definition of drug-resistant epilepsy
  • Seizures significantly impact quality of life

Peer-to-Peer Review Process

Before or during your appeal, request a peer-to-peer discussion between your neurologist and a Cigna clinical reviewer.

Preparation Checklist

  • Denial letter with specific reason codes
  • Complete treatment history with dates and outcomes
  • Clinical guidelines supporting vigabatrin use
  • Patient-specific factors (age, diagnosis, comorbidities)

Key Talking Points

  • Address each formulary criterion not met
  • Explain why alternatives are inappropriate
  • Cite relevant clinical guidelines (AAN, Child Neurology Society)
  • Emphasize time-sensitive nature of seizure control

Virginia External Review Process

If Cigna denies your internal appeal, Virginia law provides for external review through the State Corporation Commission's Bureau of Insurance.

Eligibility Requirements

  • Completed Cigna's internal appeals process
  • Denial based on medical necessity or experimental treatment
  • Request filed within 120 days of final adverse determination

Filing Process

  1. Download Form 216-A (External Review Request) from Virginia SCC
  2. Complete all sections including authorization for medical records release
  3. Attach required documents:
    • Copy of insurance card (both sides)
    • Final adverse benefit determination letter
    • Any new medical records or supporting documents
  4. Submit to Virginia Bureau of Insurance via address on form

Timeline

  • Standard review: Decision within 45 days
  • Expedited review: 72 hours for urgent cases (requires physician certification on Form 216-C)
  • IRO decision is binding on Cigna and must be implemented within 1-3 days if overturned
Note: Virginia does not charge fees for external review, and the process is available to both fully-insured and many self-funded plans that opt in.

Medical Necessity Letter Template

Re: Appeal for Coverage – Vigabatrin for [Patient Name, DOB, Member ID]

To: Cigna Medical Director
From: [Prescriber Name, Credentials]
Date: [Current Date]

Dear Medical Director,

I am requesting coverage authorization for vigabatrin for my patient with [infantile spasms/refractory complex partial seizures].

DIAGNOSIS AND CLINICAL URGENCY
- Confirmed diagnosis: [Specific diagnosis with ICD-10]
- Age: [X] months/years (meets FDA indication criteria)
- Seizure onset: [Date and clinical description]
- EEG findings: [Hypsarrhythmia for IS / focal abnormalities for CPS]

PRIOR TREATMENTS
[List each medication with dates, doses, duration, and reason for discontinuation]

MEDICAL NECESSITY
Vigabatrin is medically necessary because:
- Patient meets FDA-approved indication criteria
- [Specific clinical factors supporting use]
- Alternative treatments have failed/are contraindicated
- REMS safety monitoring is in place

REMS COMPLIANCE
- Prescriber REMS enrollment: [Confirmation number]
- Patient REMS enrollment: [Confirmation number]
- Pharmacy REMS certification: [Pharmacy name and confirmation]
- Vision monitoring: Baseline exam scheduled [date], with q3month follow-up

This treatment aligns with your policy criteria and FDA labeling. I respectfully request prompt approval.

Sincerely,
[Name, Credentials]

Cost Assistance Options

Manufacturer Support

  • Sabril SHAREPlus (Lundbeck): Copay assistance for commercially insured patients
  • Patient Assistance Program: Free drug for uninsured/underinsured
  • Generic programs: VIGADRONE and other manufacturers offer savings programs

Insurance-Based Options

  • Tier exceptions: Request lower formulary tier placement
  • 90-day supplies: Reduce per-fill copays through specialty pharmacy
  • Medicare Payment Plan: Spread Part D costs over 12 months (starting 2025)

Foundation Support

  • Epilepsy Foundation emergency grants
  • TSC Alliance assistance programs
  • State pharmaceutical assistance programs

Counterforce Health helps patients navigate these complex approval processes by analyzing denial letters, identifying specific policy requirements, and drafting targeted appeals that address each payer criterion with appropriate clinical evidence.

When to Escalate

Contact Virginia's Bureau of Insurance if:

  • Cigna fails to respond within required timeframes
  • Internal appeals are improperly denied
  • You need guidance on external review eligibility

Virginia Bureau of Insurance Consumer Services: 1-877-310-6560

You can also file complaints about improper denials or delays in processing appeals. The Bureau can provide informal resolution assistance and formal complaint investigation.

FAQ

How long does Cigna PA take in Virginia? Standard PA decisions typically within 72 hours; expedited reviews within 24 hours for urgent cases.

What if vigabatrin is non-formulary? Request formulary exception with clinical justification showing alternatives are ineffective or contraindicated.

Can I request expedited appeal? Yes, if delay could seriously jeopardize health. Requires physician certification of urgency.

Does step therapy apply if I failed drugs outside Virginia? Treatment history from any provider should count; include documentation of all prior failures.

What happens if external review fails? IRO decisions are final and binding, but you retain rights to legal action if coverage violations occurred.

How do I find REMS-certified pharmacies? Check vigabatrinREMS.com for certified pharmacy directory or ask your current pharmacy about certification status.

From our advocates: We've seen many Virginia patients succeed with vigabatrin appeals when they provide complete REMS documentation and detailed treatment histories. The key is addressing every policy criterion systematically and using Virginia's external review process when needed. These are composite experiences and individual outcomes may vary.

Through Counterforce Health's platform, patients and clinicians can access template appeals that specifically address Cigna's vigabatrin policy requirements, ensuring all necessary clinical evidence and procedural requirements are met for the strongest possible case.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional support with insurance appeals, contact Virginia's Bureau of Insurance Consumer Services at 1-877-310-6560.

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