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

The Requirements Checklist to Get Vigabatrin (Sabril) Covered by UnitedHealthcare in North Carolina: REMS, Prior Auth & Appeals Guide

Answer Box: Your Path to Vigabatrin Coverage

Getting Vigabatrin covered by UnitedHealthcare in North Carolina requires three critical steps: REMS program enrollment for prescriber/patient/pharmacy, prior authorization with step therapy documentation, and specialty pharmacy dispensing. Start today by confirming your prescriber is enrolled in the Vigabatrin REMS program and requesting baseline vision testing. If denied, North Carolina's Smart NC external review (1-855-408-1212) offers binding decisions within 45 days for standard cases or 72 hours for urgent situations.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Essentials
  5. Submission Process
  6. Specialty Pharmacy Requirements
  7. After Submission: What to Expect
  8. Common Denial Reasons & Solutions
  9. Appeals Process in North Carolina
  10. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for patients, caregivers, and healthcare providers seeking UnitedHealthcare coverage for Vigabatrin (generic) or Sabril (brand) in North Carolina. You'll need this checklist if you're dealing with:

  • Infantile spasms in children 1 month to 2 years old
  • Refractory complex partial seizures in patients 2 years and older who've failed multiple antiepileptic drugs

Expected outcome: With proper documentation and REMS compliance, approval rates improve significantly. However, Vigabatrin requires strict safety monitoring due to its FDA boxed warning for permanent vision loss.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics with UnitedHealthcare:

  • Active coverage: Verify your member ID and coverage dates
  • Plan type: Commercial, Medicare Advantage, or Medicaid (if North Carolina expands in 2024)
  • Pharmacy benefits: Confirm OptumRx manages your prescription benefits
  • Deductible status: High-deductible plans may require meeting deductible first
Tip: Call the member services number on your insurance card to verify Vigabatrin requires prior authorization and specialty pharmacy dispensing.

UnitedHealthcare Vigabatrin Status

According to current formulary information, Vigabatrin is:

  • Tier 5 (specialty medication)
  • Prior authorization required
  • Quantity limits apply
  • Specialty pharmacy only
  • Step therapy required (must try preferred alternatives first)

Clinical Criteria Requirements

FDA-Approved Indications

Vigabatrin coverage is limited to these specific uses:

Infantile Spasms (Monotherapy)

  • Age: 1 month to 2 years
  • Diagnosis: Confirmed infantile spasms/West syndrome
  • ICD-10: G40.822 (Epileptic spasms, not intractable)

Refractory Complex Partial Seizures (Adjunctive)

  • Age: 2 years and older
  • Diagnosis: Complex partial seizures refractory to other AEDs
  • ICD-10: G40.219 or G40.229 (depending on intractable status)

Step Therapy Requirements

UnitedHealthcare requires documented failure or contraindication to preferred alternatives:

For Infantile Spasms:

  • ACTH (corticotropin) trial unless contraindicated
  • Documentation of inadequate response within 2-4 weeks

For Refractory Complex Partial Seizures:

  • At least 2-3 preferred AEDs tried and failed
  • Common required trials: carbamazepine, valproic acid, levetiracetam, topiramate
  • Document specific reasons for failure (lack of efficacy, intolerable side effects)

Dosing and Duration Limits

  • Infantile spasms: Reassessment required within 2-4 weeks to continue
  • Complex partial seizures: Reassessment typically required every 3 months
  • Vision monitoring every 3 months is mandatory for continued coverage

Coding & Documentation Essentials

Required ICD-10 Codes

Indication Primary ICD-10 Alternative Codes
Infantile spasms G40.822 G40.823 (with status epilepticus)
Refractory CPS G40.219 G40.229, G40.21

NDC Numbers for Common Products

  • Sabril 500mg tablets: 67386-0822-04
  • Sabril powder packets: 67386-0823-02
  • Generic equivalents: Verify specific NDC with dispensing pharmacy
Note: No specific HCPCS J-code exists for oral Vigabatrin. Bill using NDC numbers through pharmacy benefits.

Documentation Packet Requirements

Provider Notes Must Include:

  • Specific seizure diagnosis with ICD-10 code
  • Complete medication history with dates, dosages, and outcomes
  • Clinical rationale for Vigabatrin over alternatives
  • Baseline and ongoing vision assessment plans
  • Treatment goals and monitoring schedule

Letter of Medical Necessity Components:

  1. Patient demographics and diagnosis
  2. Detailed prior medication trials and failures
  3. Clinical justification referencing FDA labeling or guidelines
  4. Contraindications to preferred alternatives (if applicable)
  5. Dosing plan and monitoring schedule
  6. Provider credentials and contact information

Required Attachments:

  • Office visit notes documenting seizure history
  • Prior medication trial documentation
  • Baseline vision testing results
  • REMS enrollment confirmation
  • Any relevant lab results or imaging

Submission Process

REMS Program Enrollment (MANDATORY FIRST STEP)

All parties must enroll in the FDA-mandated Vigabatrin REMS program:

  1. Prescriber enrollment: Register at vigabatrinrems.com
  2. Patient enrollment: Complete patient enrollment form with prescriber
  3. Pharmacy certification: Confirm dispensing pharmacy is REMS-certified
Critical: No prescription can be filled without complete REMS enrollment. This is the #1 cause of denials.

Prior Authorization Submission

Submit through UnitedHealthcare's preferred channels:

Online Portal (Recommended):

  • UnitedHealthcare Provider Portal
  • OptumRx Clinical Prior Authorization system

Alternative Methods:

  • Phone: 1-800-711-4555 (OptumRx PA team)
  • Fax: (verify current number through provider portal)

Required Fields That Cause Rejections:

  • Complete REMS enrollment confirmation numbers
  • Baseline vision testing date and results
  • Specific prior medication names, dates, and failure reasons
  • Exact diagnosis with ICD-10 code
  • Requested quantity and day supply

Specialty Pharmacy Requirements

Vigabatrin can only be dispensed through UnitedHealthcare-approved specialty pharmacies that are also REMS-certified.

Finding an Approved Pharmacy

  1. Use the Vigabatrin REMS pharmacy locator
  2. Cross-reference with UnitedHealthcare's specialty pharmacy network
  3. Confirm both REMS certification and UHC network status

Prescription Transfer Process

If transferring from another pharmacy:

  1. Confirm receiving pharmacy has both REMS and UHC network status
  2. Coordinate transfer between REMS-certified pharmacies
  3. Provide updated prescription to new pharmacy
  4. Verify patient REMS enrollment transfers automatically
Important: The REMS Coordinating Center manages certification records but does not process prescriptions or coordinate transfers.

After Submission: What to Expect

Timeline Expectations

  • Initial review: 72 hours to 7 business days
  • Additional information requests: 14 days to respond
  • Final determination: Up to 15 business days total

Status Monitoring

Track your request using:

  • Confirmation number from submission
  • UnitedHealthcare member portal
  • OptumRx provider portal
  • Phone follow-up with PA team

What to Record

Document these details for potential appeals:

  • Submission date and confirmation number
  • All communication dates and representatives spoken with
  • Additional information requested and submission dates
  • Denial reasons (if applicable)

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing REMS enrollment Complete enrollment for all parties REMS confirmation numbers
Insufficient step therapy Document additional failed trials Medication history with outcomes
Missing vision testing Schedule baseline assessment Vision testing results
Age outside indication Confirm appropriate use Clinical justification if needed
Inadequate clinical documentation Submit comprehensive medical necessity letter Detailed provider notes

Appeals Process in North Carolina

If your initial request is denied, North Carolina offers robust appeal rights through the Smart NC program.

Internal Appeals (Required First)

UnitedHealthcare provides two levels of internal appeals:

  • Timeline: 180 days from denial notice
  • Standard review: 15-30 days for decision
  • Expedited review: 72 hours for urgent cases

External Review Through Smart NC

North Carolina's external review program offers binding decisions:

Contact Information:

Timeline:

  • Request deadline: 120 days from final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases

Required Documentation:

  • Completed external review request form
  • All denial letters and internal appeal decisions
  • Supporting medical records
  • Additional clinical evidence (optional, submit within 7 days)
From our advocates: We've seen several Vigabatrin denials overturned through North Carolina's external review process when families provided comprehensive REMS documentation and clear evidence of failed step therapy alternatives. The key is thorough preparation and utilizing Smart NC's free guidance services.

At Counterforce Health, we help patients and providers navigate complex prior authorization and appeals processes by turning insurance denials into targeted, evidence-backed appeals that address each plan's specific requirements.

Quick Reference Checklist

Before You Start

  • Confirm active UnitedHealthcare coverage
  • Verify OptumRx manages pharmacy benefits
  • Gather complete medication history
  • Schedule baseline vision testing

REMS Enrollment (Complete First)

  • Prescriber enrolled in Vigabatrin REMS
  • Patient enrolled and counseled
  • Specialty pharmacy confirmed REMS-certified
  • All enrollment confirmation numbers documented

Prior Authorization Submission

  • Medical necessity letter completed
  • Step therapy documentation attached
  • Baseline vision testing results included
  • ICD-10 and NDC codes verified
  • Submission confirmation number recorded

If Denied

  • Review denial reasons carefully
  • File internal appeal within 180 days
  • Gather additional supporting documentation
  • Consider external review through Smart NC
  • Contact Smart NC for free guidance (1-855-408-1212)

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance company. Always verify current policies and procedures with UnitedHealthcare and consult with qualified medical professionals regarding treatment decisions. For personalized assistance with appeals and prior authorizations, consider consulting with Counterforce Health or other qualified patient advocacy services.

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