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

Getting Vigabatrin Covered by Cigna in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Quick Path to Vigabatrin Coverage

Cigna requires prior authorization for vigabatrin (generic or Sabril) in Michigan. Your neurologist must submit a PA request confirming FDA-approved use (infantile spasms ≤2 years or refractory complex partial seizures ≥2 years), REMS enrollment, and vision monitoring plan. Standard approval takes 1-2 business days; expedited review available within 24 hours for urgent cases. If denied, file internal appeal within 180 days, then Michigan DIFS external review within 127 days. First step today: Verify your neurologist is REMS-certified at vigabatrinrems.com and request PA submission through Cigna's provider portal.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. REMS Requirements
  4. Timing and Urgency
  5. Medical Necessity Criteria
  6. Cost and Financial Assistance
  7. Denials and Appeals Process
  8. Specialty Pharmacy Requirements
  9. Common Issues and Solutions
  10. FAQ

Coverage Basics

Is Vigabatrin Covered by Cigna?

Yes, Cigna covers both generic vigabatrin and brand Sabril, but prior authorization is required for all formulations. Coverage is restricted to FDA-approved indications and requires neurologist involvement. Cigna typically manages vigabatrin through their specialty pharmacy network, including Accredo (part of Express Scripts).

Which Cigna Plans Cover Vigabatrin?

Most Cigna commercial plans, Medicare Advantage, and employer-sponsored plans include vigabatrin on their formularies, though it's typically placed on higher tiers requiring prior authorization. Check your specific formulary through the Cigna member portal or contact customer service.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify REMS Certification (Day 1)
    • Neurologist enrolls at vigabatrinrems.com
    • Complete required training and certification
    • Patient enrollment with signed agreement form
  2. Gather Required Documentation (Days 1-2)
    • ICD-10 diagnosis codes
    • Documentation of prior therapy failures (for refractory seizures)
    • Vision testing plan (baseline + periodic monitoring)
    • Clinical notes supporting medical necessity
  3. Submit PA Request (Day 2-3)
    • Neurologist submits through Cigna provider portal
    • Include all supporting documentation
    • Request expedited review if urgent
  4. Follow Up (Days 3-5)
    • Track status through provider portal
    • Respond promptly to any additional information requests
    • Prepare for potential peer-to-peer review

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all formulations Cigna Policy
Prescriber Neurologist or consultation required Cigna Policy
REMS Enrollment Mandatory for prescriber, pharmacy, patient FDA REMS
Age Restrictions Infantile spasms: ≤2 years; CPS: ≥2 years Cigna Policy
Approval Duration 6 months (IS), 3 months initial/1 year continuation (CPS) Cigna Policy

REMS Requirements

The FDA requires all vigabatrin prescriptions to go through the Vigabatrin REMS program due to the risk of permanent vision loss. This is mandatory regardless of your insurance carrier.

REMS Enrollment Steps

For Prescribers:

  • Complete online certification at vigabatrinrems.com
  • Counsel patients on vision loss risks
  • Complete Patient/Parent/Legal Guardian-Physician Agreement Form
  • Ensure vision monitoring per prescribing information

For Patients:

  • Enroll through prescriber (electronic or fax)
  • Sign agreement form acknowledging risks
  • Commit to regular vision testing (baseline + every 3-6 months)

For Pharmacies:

  • Must be REMS-certified to dispense
  • Verify patient enrollment before dispensing
  • Document authorization codes
Important: REMS enrollment is separate from insurance approval. Both are required before you can receive vigabatrin.

Timing and Urgency

Standard Review Timelines

  • Cigna PA Decision: 1-2 business days for standard requests
  • Expedited Review: 24 hours when medically urgent
  • Appeal Response: 10-30 days for internal appeals

When to Request Expedited Review

Request expedited processing if:

  • Patient is experiencing uncontrolled seizures
  • Delay could result in status epilepticus
  • Current therapy has failed and immediate alternative needed

Your neurologist must provide written justification for urgency when submitting the expedited request.

Medical Necessity Criteria

Infantile Spasms (Monotherapy)

  • Patient age ≤2 years
  • Diagnosis confirmed by neurologist
  • EEG documentation of hypsarrhythmia (when applicable)
  • Approval duration: 6 months

Refractory Complex Partial Seizures (Adjunct Therapy)

  • Patient age ≥2 years
  • Documentation of ≥3 prior antiseizure medications that failed
  • Excludes vigabatrin, rufinamide, tiagabine, felbamate, Diacomit, clobazam
  • Initial approval: 3 months
  • Continuation: 1 year (with evidence of response)

Clinician Corner: Medical Necessity Letter Checklist

When preparing the PA request, neurologists should include:

✓ Diagnosis: ICD-10 codes and clinical presentation
✓ Prior Therapies: Specific medications tried, doses, duration, reasons for discontinuation
✓ Clinical Rationale: Why vigabatrin is appropriate for this patient
✓ Monitoring Plan: Vision testing schedule and provider arrangements
✓ Dosing Justification: Weight-based or clinical rationale for prescribed dose
✓ Treatment Goals: Expected outcomes and monitoring parameters

Reference guidelines from the American Epilepsy Society and FDA prescribing information to strengthen your request.

Cost and Financial Assistance

Copay Assistance Programs

Multiple manufacturers offer copay cards for eligible commercially insured patients:

Manufacturer Savings Contact Eligibility
Dr. Reddy's As low as $20/fill 1-877-442-7398 Commercial insurance or not covered
Teva As low as $0/fill 844-248-7949 Commercial insurance
Amneal Up to $75/monthly 330-757-8402 Commercial insurance
VIGAFYDE $0 copay program Promise of Support™ Commercial insurance
Note: Copay cards cannot be used with Medicare, Medicaid, or other government insurance programs.

Additional Support Programs

  • VIGAFYDE Promise of Support: Includes bridge supply during coverage gaps and free home delivery
  • Par Pharmaceutical PAR Program: Comprehensive support including authorization assistance, REMS enrollment, and copay help (833-727-4357)
  • Patient Assistance Programs: Available for uninsured or underinsured patients through manufacturer programs

Denials and Appeals Process

Common Denial Reasons and Solutions

Denial Reason How to Address
Missing REMS enrollment Submit proof of prescriber, pharmacy, and patient certification
Age outside approved range Verify diagnosis and confirm age criteria per FDA labeling
Insufficient prior therapy documentation Provide detailed records of previous AED trials and outcomes
Missing vision monitoring plan Submit ophthalmology referral and monitoring schedule
Non-specialist prescriber Obtain neurologist consultation or referral

Michigan Appeals Process

Internal Appeals (Required First):

  1. File with Cigna within 180 days of initial denial
  2. Include denial letter, medical records, and physician statement
  3. Standard decision: 10-30 days; expedited: 24-72 hours

External Review through Michigan DIFS:

  1. Must exhaust Cigna's internal appeals first
  2. File within 127 days of final internal denial
  3. Submit External Review Form online or by mail
  4. Standard review: up to 60 days; expedited: 72 hours

Expedited External Review

For urgent cases where delay could seriously jeopardize health:

  • Physician must provide letter stating medical urgency
  • Describe risks of delay (breakthrough seizures, status epilepticus)
  • Submit expedited request with supporting documentation
  • DIFS contact: 877-999-6442
From our advocates: "We've seen Michigan families successfully overturn vigabatrin denials by providing comprehensive documentation of failed prior therapies and clear medical necessity. The key is having your neurologist clearly explain why vigabatrin is the appropriate next step and documenting all previous treatment attempts with specific reasons for discontinuation."

Specialty Pharmacy Requirements

Cigna typically requires vigabatrin to be dispensed through their specialty pharmacy network, primarily Accredo (part of Express Scripts). This ensures proper REMS compliance and monitoring.

Accredo Requirements

  • REMS certification verification
  • Patient enrollment confirmation
  • Prescriber authorization codes
  • Ongoing vision monitoring documentation

Transfer Process

If your prescription is transferred to Accredo:

  1. You'll receive notification from Cigna
  2. Accredo will contact you to set up delivery
  3. Provide insurance and contact information
  4. Confirm REMS enrollment status

Contact Accredo at 1-800-ASK-EXPRESS for questions about specialty pharmacy services.

Common Issues and Solutions

Portal Access Problems

  • Issue: Cannot access Cigna member portal
  • Solution: Call customer service at number on insurance card; verify identity and reset login credentials

Missing REMS Documentation

  • Issue: Pharmacy reports missing REMS enrollment
  • Solution: Contact prescriber to verify enrollment at vigabatrinrems.com; obtain patient ID number for pharmacy verification

Vision Testing Requirements

  • Issue: Unclear about monitoring schedule
  • Solution: Follow FDA prescribing information: baseline exam, then every 3 months for infantile spasms, every 3-6 months for seizures

Quantity Limit Issues

  • Issue: Prescription exceeds plan limits
  • Solution: Neurologist can request quantity limit override with clinical justification for higher doses

FAQ

How long does Cigna PA take for vigabatrin in Michigan? Standard PA requests are typically decided within 1-2 business days. Expedited requests for urgent medical needs are processed within 24 hours.

What if vigabatrin is non-formulary on my plan? Your physician can request a formulary exception if you meet criteria such as contraindication to formulary alternatives or positive response to vigabatrin.

Can I request an expedited appeal in Michigan? Yes, both Cigna internal appeals and Michigan DIFS external reviews offer expedited processing (24-72 hours) when your physician certifies that delay would jeopardize your health.

Does step therapy apply if I've tried medications outside Michigan? Yes, Cigna accepts documentation of prior therapy failures from other states or insurance plans, as long as the medications meet their step therapy requirements.

What happens if my neurologist isn't REMS-certified? The prescription cannot be filled until REMS certification is complete. Your neurologist must enroll at vigabatrinrems.com before prescribing vigabatrin.

How often do I need vision testing? FDA labeling requires baseline vision testing before starting vigabatrin, then every 3 months during treatment for infantile spasms, or every 3-6 months for complex partial seizures.

Can I use a copay card with Cigna Medicare Advantage? No, manufacturer copay cards cannot be used with Medicare plans, including Medicare Advantage. However, you may qualify for patient assistance programs based on income.

What if Accredo denies my prescription transfer? Contact your Cigna case manager to resolve specialty pharmacy issues. Ensure all PA approvals and REMS requirements are met before transfer.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that address specific payer requirements. For complex medications like vigabatrin that require REMS compliance and specialty pharmacy coordination, having the right documentation and appeal strategy can make the difference between approval and denial.

For additional support with vigabatrin appeals or other specialty medication denials, Counterforce Health provides tools and guidance to help you navigate the prior authorization and appeals process more effectively.

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, medical circumstances, and state regulations. Always consult with your healthcare provider and insurance plan for specific coverage questions. For assistance with insurance appeals in Michigan, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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