By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization Guide

Answer Box: Getting Tysabri Covered by Aetna CVS Health in Georgia

Tysabri (natalizumab) requires prior authorization on all Aetna CVS Health plans in Georgia, with mandatory TOUCH program enrollment before approval. The fastest path: (1) Complete TOUCH enrollment at touchprogram.com for all parties, (2) Submit PA with JCV antibody results and brain MRI within 6 months, (3) Document prior DMT failures. Standard approval takes 30-45 days; expedited decisions within 24-72 hours for urgent cases. If denied, appeal within 180 days or request Georgia external review within 120 days of final denial.

Table of Contents

Plan Types & Coverage Implications

Aetna CVS Health offers multiple plan types in Georgia, each with different coverage rules for Tysabri:

Commercial Plans (Employer/Individual):

  • All require prior authorization for Tysabri
  • Step therapy requirements do not apply to fully insured members in Georgia per state regulations
  • Standard 180-day appeal timeline applies

Medicare Advantage:

  • Subject to Medicare Part B coverage rules
  • Different PA criteria may apply
  • 60-day appeal timeline with separate QIO process

Medicaid (PeachCare):

  • Appeals go through Georgia Department of Community Health
  • Different external review process than commercial plans
Note: Georgia law protects fully insured commercial plan members from step therapy requirements, making Tysabri more accessible than in other states.

Formulary Status & Tier Placement

Tysabri is classified as a Tier 4 Specialty or Non-Preferred Specialty (NPSP) drug on most Aetna CVS Health formularies. Check your specific plan's formulary for exact tier placement and cost-sharing details.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Aetna formulary lookup
Formulary Tier Tier 4 Specialty/NPSP Plan-specific formulary PDF
Step Therapy Not required (GA fully insured) Georgia state regulations
TOUCH Enrollment Mandatory before dispensing touchprogram.com
Site of Care TOUCH-authorized infusion centers only FDA REMS requirements
Appeals Deadline 180 days (commercial) Aetna member materials

Prior Authorization Requirements

Medical Necessity Criteria

For Multiple Sclerosis/CIS:

  • Confirmed diagnosis of relapsing-remitting MS (ICD-10: G35) or clinically isolated syndrome
  • JCV antibody test results within 6 months (include index value if positive)
  • Brain MRI showing T2 or gadolinium-enhanced lesions within 6 months
  • Documentation of inadequate response to 1-2 first-line DMTs
  • Recent EDSS score and neurological assessment
  • Coverage duration: 12 months initial authorization

For Crohn's Disease:

  • Moderately to severely active Crohn's disease
  • Prior use of any other biologic for CD with inadequate response
  • JCV antibody testing required
  • Coverage duration: 12 months

Required Documentation Checklist

✓ Clinical records (6+ months showing disease progression)
✓ JCV antibody test (STRATIFY assay preferred, within 6 months)
✓ Brain MRI report (for MS, within 6 months showing active lesions)
✓ Prior therapy documentation (trials, failures, intolerances)
✓ Specialist evaluation (neurologist for MS, gastroenterologist for CD)
✓ Current assessment (EDSS score, symptom severity)

TOUCH Program Enrollment

All parties must enroll in the FDA-mandated TOUCH Prescribing Program before Tysabri can be dispensed. This is a non-negotiable requirement that often causes delays if not completed early.

Who Must Enroll:

Prescribers:

  • Complete Prescriber Enrollment Form
  • Review Patient Medication Guide with each patient
  • Complete Pre-infusion Patient Checklist

Patients:

  • Complete and sign Patient Enrollment Form
  • Review TOUCH Patient Medication Guide
  • Understand PML risks and monitoring requirements

Infusion Sites:

  • Complete mandatory Biogen training
  • Submit Infusion Site Enrollment Form
  • Confirm patient authorization before each infusion

Pharmacies:

  • Must be TOUCH-certified (CVS Specialty is pre-certified)
  • Can only dispense to authorized infusion sites

Enrollment Process:

  1. Visit touchprogram.com or call 1-800-456-2255
  2. Complete required forms for your role
  3. Wait 2-3 business days for approval confirmation
  4. Obtain confirmation numbers for PA submission
Tip: Start TOUCH enrollment immediately upon Tysabri consideration—don't wait for PA approval, as this can add weeks to the process.

Specialty Pharmacy Requirements

Aetna CVS Health typically routes Tysabri through CVS Specialty Pharmacy, their preferred specialty partner. The medication must be administered at TOUCH-authorized infusion centers—home infusion is not permitted under FDA REMS requirements.

Site of Care Preferences:

  1. Freestanding infusion centers (lowest cost)
  2. Hospital outpatient departments (may require additional authorization)
  3. Physician office infusion (if TOUCH-certified)

Aetna may require prior authorization for higher-cost sites of care, so confirm your infusion center's authorization status before starting treatment.

Cost-Share Dynamics

Tysabri costs vary significantly based on your plan's specialty tier and whether you've met your deductible. Typical cost-sharing structures:

  • Tier 4 Specialty: 25-40% coinsurance after deductible
  • Non-Preferred Specialty: 40-50% coinsurance after deductible
  • Deductible: May apply to specialty drugs depending on plan design

Potential Savings Options:

  • Biogen Support Program: May offer copay assistance for eligible patients
  • Foundation grants: Available through organizations like HealthWell Foundation
  • State programs: Georgia may have additional assistance programs

Note: This is educational information only. Consult your plan documents for specific cost-sharing details.

Submission Process

How to Submit Your Prior Authorization:

Online: Aetna provider portal (fastest method)
Phone: 1-855-582-2025 (provider line)
Fax: 1-855-330-1716
Mail: Address provided on denial letter or member materials

Timeline Expectations:

  • Standard PA: 30-45 business days
  • Expedited PA: 24-72 hours (urgent medical situations)
  • TOUCH enrollment: 2-3 business days additional

When submitting, include the patient's Aetna member ID, prescriber NPI, and all required clinical documentation in a single, complete submission to avoid delays.

Common Approval Patterns

Strong Tysabri submissions typically include:

Clinical Narrative Structure:

  1. Problem statement: Clear diagnosis with ICD-10 code
  2. Prior treatments: Specific DMTs tried, duration, outcomes, reasons for discontinuation
  3. Current status: Recent MRI findings, EDSS scores, relapse history
  4. Medical necessity: Why Tysabri is the appropriate next step
  5. Safety monitoring: JCV status, PML risk mitigation plan

Evidence Citations:

  • FDA prescribing information for Tysabri
  • American Academy of Neurology MS guidelines
  • Recent brain MRI reports with radiologist interpretation
  • Documented prior therapy failures with specific agents
From our advocates: We've seen the strongest approvals when providers include a clear timeline showing disease progression despite standard therapies, paired with recent MRI evidence and a detailed JCV risk assessment. This approach addresses Aetna's medical necessity criteria point-by-point.

Appeals Process in Georgia

If your Tysabri prior authorization is denied, Georgia law provides robust appeal rights for fully insured plans.

Internal Appeal (Level 1):

  • Deadline: 180 days from denial date
  • Timeline: 30-45 business days for decision (72 hours if expedited)
  • How to file: Aetna member portal or written request
  • Required: Denial letter, medical records, physician statement

External Review (Level 2):

  • Deadline: 120 days from final internal denial
  • Timeline: 60 calendar days for decision
  • Process: Filed through Georgia Department of Insurance
  • Cost: Free to consumer
  • Decision: Binding on Aetna

Expedited Appeals:

Available when delays could seriously jeopardize your health. For MS patients, this might include evidence of rapid disease progression or inability to tolerate current therapy.

Georgia External Review Contact:
Georgia Office of Commissioner of Insurance and Fire Safety
Consumer Services: 1-800-656-2298
Online complaint form (verify current link)

When Coverage Gets Complicated

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify the specific denial basis—whether it's PA criteria, step therapy, or "not medically necessary"—then drafts point-by-point rebuttals using the right clinical evidence and payer-specific workflows.

For Tysabri appeals, this might include pulling FDA labeling data, MS treatment guidelines, and JCV risk stratification studies, then weaving them into appeals that meet Aetna's procedural requirements while tracking Georgia's specific deadlines.

FAQ

How long does Aetna CVS Health prior authorization take for Tysabri in Georgia?
Standard PA decisions take 30-45 business days. Expedited reviews for urgent situations are completed within 24-72 hours.

What if Tysabri is non-formulary on my plan?
Request a formulary exception with medical necessity documentation. Georgia fully insured plans cannot require step therapy, improving approval odds.

Do I need to complete TOUCH enrollment before submitting PA?
While not technically required for PA submission, having TOUCH confirmation numbers strengthens your application and prevents delays if approved.

Can I request an expedited appeal in Georgia?
Yes, both internal and external appeals can be expedited if delays could seriously harm your health. Document the urgency clearly.

What happens if I miss the appeal deadline?
Georgia allows 180 days for internal appeals and 120 days for external review. Missing these deadlines typically forfeits your appeal rights.

Does Aetna require step therapy for MS drugs in Georgia?
No, Georgia law prohibits step therapy requirements for fully insured commercial plans, though documentation of prior therapy trials still strengthens PA applications.

Sources & Further Reading

Disclaimer: This information is educational and not medical advice. Coverage policies change frequently—verify current requirements with Aetna CVS Health and your healthcare provider. For personalized assistance with appeals, consult Counterforce Health or Georgia consumer advocacy organizations.

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