By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by Cigna in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tysabri Covered by Cigna in Georgia

Cigna requires prior authorization for Tysabri (natalizumab) in Georgia with strict medical necessity criteria including TOUCH program enrollment, failed first-line DMTs, and comprehensive safety monitoring. Start by having your neurologist submit a PA request with documented step therapy failures, JCV antibody results, and baseline MRI. If denied, file a Level 1 internal appeal within 180 days, then pursue Georgia's external review through the Office of Insurance and Safety Fire Commissioner within 120 days of final internal denial.

First step today: Contact your prescribing neurologist to confirm TOUCH enrollment and gather documentation of prior DMT failures for the PA submission.

Table of Contents

  1. Cigna's Tysabri Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Dosing Requirements
  5. Required Diagnostics and Safety Monitoring
  6. Site of Care and Specialty Pharmacy Rules
  7. Evidence to Support Medical Necessity
  8. Appeals Process for Georgia Patients
  9. Common Denial Reasons and Solutions
  10. Cost Assistance and Patient Support
  11. FAQ

Cigna's Tysabri Coverage Policy Overview

Cigna covers Tysabri (natalizumab) under its Medical Coverage Policy IP0690 for both commercial and Medicare Advantage plans in Georgia. The drug requires prior authorization across all plan types, with coverage typically managed through the medical benefit for infusion therapies.

Plan Types and Coverage Differences

  • Commercial PPO/HMO: Standard PA requirements with 180-day internal appeal window
  • Medicare Advantage: Additional CMS oversight with 65-day appeal timelines
  • Employer Self-Funded: May have plan-specific modifications to standard criteria
Note: Tysabri is processed under the medical benefit, not pharmacy benefit, for most Cigna plans due to its infusion administration requirement.

Medical Necessity Requirements

Cigna's medical necessity criteria for Tysabri focus on FDA-approved indications and safety requirements:

For Relapsing Multiple Sclerosis

Primary Requirements:

  • Confirmed diagnosis of relapsing forms of MS by a neurologist or MS specialist
  • Enrollment in the mandatory TOUCH Prescribing Program
  • Baseline brain MRI within 3 months of treatment initiation
  • JCV antibody testing with index value

Clinical Criteria:

  • Evidence of inadequate response to first-line DMTs, OR
  • Rapidly advancing disease where delay is inappropriate, OR
  • Documented contraindications to preferred agents

For Crohn's Disease

  • Moderate to severely active Crohn's disease in adults
  • Inadequate response to conventional therapy and at least one anti-TNF biologic
  • Prescribing by or consultation with a gastroenterologist

Step Therapy and Exception Pathways

Cigna typically requires documented failure of at least two preferred disease-modifying therapies before approving Tysabri for MS patients.

Preferred First-Line DMTs

  1. Injectable agents: Interferon beta products, glatiramer acetate
  2. Oral agents: Dimethyl fumarate, teriflunomide, fingolimod

Documenting Treatment Failures

For each prior DMT, include:

  • Treatment dates and duration (minimum 3 months typically required)
  • Specific reasons for discontinuation:
    • Inadequate efficacy (≥2 relapses, MRI progression, EDSS worsening)
    • Intolerance or adverse events
    • Contraindications

Medical Exception Pathways

Rapidly Progressive Disease: Document with:

  • Multiple relapses in past 12 months
  • Significant disability progression (EDSS increase)
  • MRI evidence of highly active disease

Contraindications to Preferred Agents: Provide specific medical rationale with supporting clinical notes.

Clinician Corner: The medical necessity letter should explicitly state why Tysabri is superior to alternative DMTs for this specific patient, referencing clinical guidelines and the patient's unique circumstances.

Quantity Limits and Dosing Requirements

Standard Coverage Parameters

  • Approved dose: 300 mg IV infusion every 4 weeks
  • Quantity limit: One dose per 28-day period (maximum 13 infusions annually)
  • Initial authorization period: 6-12 months
  • Renewal requirements: Documentation of clinical benefit and safety monitoring

Dosing Modifications

Extended interval dosing (>4 weeks) may be covered under standard quantity limits if medically justified. More frequent dosing typically requires special exception with strong clinical rationale.

Required Diagnostics and Safety Monitoring

Pre-Treatment Requirements

Baseline MRI:

  • Must include FLAIR and DWI sequences
  • Completed within 3 months of treatment initiation
  • Serves as reference for PML surveillance

JCV Antibody Testing:

  • Baseline serum anti-JCV antibody with index value
  • Results guide PML risk stratification and monitoring frequency

Ongoing Monitoring Schedule

Risk Category JCV Status MRI Frequency Documentation Required
Lower Risk JCV-negative Annual JCV retesting annually
Intermediate Risk JCV-positive, <2 years treatment Every 6 months Risk-benefit discussion
High Risk JCV-positive, >2 years, prior immunosuppressants Every 3 months Enhanced monitoring plan

Site of Care and Specialty Pharmacy Rules

TOUCH Program Requirements

All participants must enroll in the TOUCH program:

  • Prescribers: Complete enrollment and training
  • Infusion sites: Certified facilities only
  • Patients: Enrolled with signed consent forms

TOUCH Enrollment: Call 1-800-456-2255 or use the TOUCH Online portal.

Infusion Site Requirements

Tysabri must be administered at TOUCH-certified infusion centers. Home infusion may be available in limited circumstances with prior approval.

Evidence to Support Medical Necessity

Key Documentation to Include

  1. Specialist consultation notes with complete disease history
  2. MRI reports showing baseline and any disease activity
  3. Prior DMT history with specific failure criteria
  4. JCV antibody results with index values
  5. TOUCH enrollment confirmation

Citing Clinical Guidelines

Reference established guidelines such as:

  • FDA prescribing information for approved indications
  • American Academy of Neurology practice parameters
  • National Multiple Sclerosis Society treatment recommendations

Appeals Process for Georgia Patients

Internal Appeals Timeline

Level 1 Internal Appeal:

  • Deadline: 180 days from denial notice (commercial plans)
  • Cigna response time: 30 days for pre-service, 60 days for post-service
  • Submission: Cigna Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422

Level 2 Internal Appeal:

  • Deadline: 60 days from Level 1 denial
  • Process: Reviewed by different medical professionals

Georgia External Review

After exhausting internal appeals, Georgia residents can request external review through the Georgia Office of Insurance and Safety Fire Commissioner.

Key Details:

  • Deadline: 120 days from final internal denial
  • Cost: Free to consumers
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Contact: 1-404-656-2070
Important: Georgia's external review decision is binding on Cigna and must be implemented if favorable.

Expedited Appeals

For urgent situations where delays could cause serious harm:

  • Timeline: 72-hour decision requirement
  • Qualification: Immediate medical risk if treatment delayed
  • Process: Mark submissions "EXPEDITED-URGENT" and call 1-800-88-CIGNA

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing TOUCH enrollment Complete enrollment before resubmission TOUCH confirmation number
Inadequate step therapy Document specific DMT failures Treatment dates, failure criteria
Missing MRI documentation Submit baseline brain MRI FLAIR/DWI sequences report
JCV status unclear Provide complete antibody results Lab report with index value
Non-specialist prescriber Transfer care or obtain consultation Neurologist/specialist note

Peer-to-Peer Review Strategy

Request a peer-to-peer review with Cigna's medical director:

  • Timing: Within 5-7 days of denial
  • Preparation: Have clinical data and guidelines ready
  • Focus: Medical necessity and safety monitoring plan

Cost Assistance and Patient Support

Manufacturer Support Programs

Biogen Support Programs:

  • TOUCH Ongoing Support Program (automatic enrollment)
  • Financial assistance for eligible patients
  • Copay assistance programs

State and Federal Resources

Georgia-Specific:

  • Georgians for a Healthy Future (consumer assistance)
  • Georgia Legal Services Program (appeals support)

Federal Programs:

  • Medicare Extra Help for Part D costs
  • Patient Access Network Foundation grants
From our advocates: "We've seen patients successfully overturn Tysabri denials by ensuring their neurologist includes specific EDSS scores and relapse frequencies in the medical necessity letter. The key is quantifying disease activity, not just describing it generally."

FAQ

How long does Cigna's prior authorization process take in Georgia? Standard PA decisions are made within 15 business days. Expedited requests receive decisions within 72 hours when medical urgency is documented.

What if Tysabri isn't on my Cigna formulary? Submit a formulary exception request with clinical justification. Non-formulary status doesn't automatically mean denial if medical necessity is established.

Can I start appeals while continuing other treatments? Yes, you can continue alternative DMTs during the appeals process. Discuss bridging strategies with your neurologist.

Does step therapy apply if I've tried DMTs in another state? Yes, documented treatment history from any location counts toward step therapy requirements. Ensure complete medical records transfer.

What constitutes "urgent" for expedited appeals? Immediate risk of MS relapse, disease progression, or serious deterioration in neurological function qualifies for expedited review.

How successful are Tysabri appeals in Georgia? While specific success rates aren't published, appeals with comprehensive clinical documentation and proper specialist involvement have higher approval rates.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes for specialty medications like Tysabri. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that align with payer-specific criteria. Learn more about our services.

For additional support with your Tysabri coverage challenges, Counterforce Health provides specialized assistance in turning insurance denials into successful approvals through data-driven appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with insurance appeals in Georgia, contact the Georgia Office of Insurance and Safety Fire Commissioner at 1-404-656-2070.

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