By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (natalizumab) Covered by Aetna CVS Health in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tysabri Covered by Aetna CVS Health in North Carolina

Tysabri (natalizumab) requires prior authorization from Aetna CVS Health with mandatory TOUCH Prescribing Program enrollment, recent JCV antibody testing, and brain MRI documentation. Submit requests via phone (1-855-582-2025), fax (1-855-330-1716), or mail with complete medical records. If denied, appeal within 180 days or use North Carolina's Smart NC external review program (855-408-1212) within 120 days of final denial.

First step today: Verify your prescriber and infusion site are enrolled in TOUCH at touchprogram.com, then gather JCV antibody results and recent brain MRI before submitting your prior authorization request.

Table of Contents

  1. Aetna CVS Health Policy Overview
  2. TOUCH Program Requirements
  3. Medical Necessity Documentation
  4. Step Therapy and Exceptions
  5. Site of Care Requirements
  6. Fastest Path to Approval
  7. Common Denial Reasons
  8. Appeals Process in North Carolina
  9. Cost and Financial Assistance
  10. FAQ

Aetna CVS Health Policy Overview

Aetna CVS Health classifies Tysabri as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug is typically managed through CVS Caremark's specialty pharmacy network, with strict adherence to FDA's TOUCH Prescribing Program due to the risk of progressive multifocal leukoencephalopathy (PML).

Key Policy Points:

  • Prior authorization required for all new starts and renewals
  • TOUCH enrollment mandatory for all parties (prescriber, patient, infusion site, pharmacy)
  • Coverage limited to FDA-approved indications: relapsing forms of multiple sclerosis and Crohn's disease (restricted use)
  • Standard dosing: 300 mg IV every 4 weeks
  • Renewal typically required every 12 months with updated documentation
Note: Aetna follows CMS policies for Medicare Advantage plans, which may have additional requirements beyond commercial coverage.

TOUCH Program Requirements

The TOUCH Prescribing Program is FDA-mandated and non-negotiable for Tysabri coverage. All parties must enroll before the first infusion:

Required Enrollments

Prescribers:

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

Patients:

  • Sign Patient Enrollment Form
  • Receive and acknowledge 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
  • Complete Pre-infusion Checklist within 1 business day

Pharmacies:

  • Must be TOUCH-certified to dispense
  • Can only ship to authorized infusion sites
  • Home infusion not permitted

Enroll at touchprogram.com or call Biogen at 1-800-456-2255.

Medical Necessity Documentation

Coverage at a Glance

Requirement What It Means Documentation Needed Timeline
JCV Antibody Test PML risk assessment Lab results from validated assay Within 6 months
Brain MRI Disease activity proof T2/gadolinium-enhanced lesions Within 6 months
Prior DMT Failures Step therapy compliance Treatment dates, reasons for discontinuation 3+ month trials
TOUCH Enrollment Safety monitoring Confirmation numbers for all parties Before first dose
Diagnosis Confirmation MS or Crohn's verification ICD-10 code G35 or K50.x Current

Essential Clinical Documentation

For Multiple Sclerosis:

  • Confirmed relapsing MS diagnosis (ICD-10: G35)
  • EDSS score and recent neurological assessment
  • Evidence of disease activity: new relapses, MRI progression, or inadequate response to current therapy
  • Documentation of failure, intolerance, or contraindication to at least 1-2 first-line disease-modifying therapies
  • JCV antibody status with index value if positive (>0.9 indicates higher PML risk)

For Crohn's Disease:

  • Confirmed moderate to severe Crohn's disease diagnosis
  • Inadequate response to conventional therapy including corticosteroids and immunomodulators
  • Evidence of active inflammation via endoscopy, imaging, or biomarkers
  • Documentation that anti-TNF therapy is inappropriate or has failed

Step Therapy and Exceptions

Aetna typically requires trial and failure of first-line therapies before approving Tysabri. However, medical exceptions are available with proper documentation.

Standard Step Therapy Requirements

For MS:

  1. Trial of at least one first-line DMT (interferons, glatiramer acetate, or oral agents like dimethyl fumarate)
  2. Minimum 3-month trial unless contraindicated
  3. Documentation of inadequate response, intolerance, or disease progression

Exception Pathways:

  • Contraindications: Document medical reasons why first-line therapies cannot be used
  • Prior Failures: Include dates, dosing, duration, and specific reasons for discontinuation
  • Aggressive Disease: Rapid progression or severe relapses may justify direct approval
Clinician Corner: When documenting prior therapy failures, be specific about outcomes. Instead of "patient failed interferon," write "patient experienced continued relapses (3 in 6 months) and new T2 lesions on brain MRI despite 8 months of interferon beta-1a therapy."

Site of Care Requirements

Tysabri must be administered at TOUCH-authorized infusion centers. Home infusion is not permitted under the FDA's risk evaluation and mitigation strategy (REMS).

Approved Sites Include:

  • Hospital-based infusion centers
  • Outpatient infusion clinics
  • Specialty pharmacies with infusion capabilities
  • Physician office-based infusion suites (if TOUCH-certified)

Administration Protocol:

  • 300 mg in 100 mL normal saline over approximately 1 hour
  • Observation during infusion required
  • Post-infusion monitoring: 1 hour for first 12 infusions, then per clinical judgment

For site verification, check with your prescriber or call Biogen at 1-800-456-2255.

Fastest Path to Approval

7-Step Process

  1. Verify TOUCH Enrollment (Day 1)
    • Confirm prescriber, patient, infusion site, and pharmacy are enrolled
    • Obtain enrollment confirmation numbers
  2. Gather Required Documentation (Days 1-3)
    • JCV antibody test results (within 6 months)
    • Brain MRI report (within 6 months)
    • Prior therapy documentation
    • Current clinical assessment
  3. Submit Prior Authorization (Day 4)
    • Call: 1-855-582-2025 or 1-866-782-2779 for injectables
    • Fax: 1-855-330-1716
    • Mail: Aetna PA, 1300 E. Campbell Rd.
    • Include complete medical records from attending physician
  4. Track Application Status (Days 5-14)
    • Standard decisions typically within 30-45 days
    • Expedited reviews available for urgent cases (≤72 hours)
  5. Address Information Requests (As needed)
    • Respond promptly to any requests for additional documentation
    • Consider peer-to-peer review if initial denial
  6. Receive Decision (Day 15-45)
    • Approval: Coordinate with infusion site for scheduling
    • Denial: Proceed to appeals process
  7. Appeal if Necessary (Within 180 days)
    • Internal appeal first, then external review through Smart NC

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing TOUCH enrollment Complete enrollment for all parties Confirmation numbers
Insufficient prior therapy trials Document specific failures/intolerances Treatment dates, outcomes, reasons for discontinuation
Outdated lab/imaging Obtain recent results JCV antibody and MRI within 6 months
Non-formulary status Request formulary exception Medical necessity letter with clinical rationale
Experimental/investigational Cite FDA approval and guidelines FDA label, treatment guidelines, peer-reviewed studies
Quantity/frequency limits Justify standard dosing Clinical guidelines supporting 300mg q4w

Appeals Process in North Carolina

If Aetna denies your Tysabri coverage, North Carolina offers robust appeal rights through both internal and external review processes.

Internal Appeals (Aetna)

  • Timeline: 180 days from denial notice
  • Levels: Standard and expedited options available
  • Submit via: Member portal, phone, or written request
  • Response time: 30 days standard, 72 hours expedited

External Review (Smart NC)

After exhausting internal appeals, North Carolina residents can request external review through the Department of Insurance's Smart NC program.

Key Details:

  • Deadline: 120 days from final internal denial
  • Cost: Free to consumer
  • Contact: 855-408-1212
  • Submit: Online form or mail to 1201 Mail Service Center, Raleigh, NC 27699-1201

Timeline for External Review:

  • Standard review: 45 days from DOI receipt
  • Expedited review: 72 hours (24 hours for urgent cases)
  • IRO decisions are binding on Aetna
From Our Advocates: In our experience helping patients navigate specialty drug appeals, cases with complete TOUCH documentation and clear evidence of prior therapy failures have significantly higher success rates. One key tip: when submitting additional information to the IRO, focus on clinical guidelines that specifically support Tysabri's use in your situation rather than general disease information.

Smart NC provides free advocacy assistance and can help gather supporting documentation. Their staff includes nurses who understand complex medication appeals and can guide you through the process.

For more information about North Carolina's external review program, visit the NC Department of Insurance website.

Cost and Financial Assistance

Tysabri is an expensive specialty medication, but several assistance programs can help reduce out-of-pocket costs:

Manufacturer Programs:

  • Tysabri QuickStart: Up to 3 free doses for commercially insured patients
  • Biogen Above MS: Copay assistance and additional support services
  • Patient Access and Support: Case management for coverage issues

Foundation Assistance:

  • National Multiple Sclerosis Society
  • Patient Access Network Foundation
  • HealthWell Foundation

State Resources:

  • North Carolina's Smart NC program provides free advocacy
  • Medicaid expansion (effective 2024) may provide additional coverage options

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Tysabri. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with each payer's specific requirements, potentially saving patients months of delays and thousands in out-of-pocket costs.

FAQ

How long does Aetna CVS Health prior authorization take for Tysabri in North Carolina? Standard decisions typically take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours. Submit complete documentation to avoid delays.

What if Tysabri is not on Aetna's formulary? Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate due to contraindications, prior failures, or medical reasons.

Can I request an expedited appeal if my MS is worsening? Yes. Both Aetna and North Carolina's Smart NC program offer expedited reviews for urgent medical situations. Contact your prescriber to document the urgency and submit an expedited appeal request.

Does step therapy apply if I tried other DMTs outside North Carolina? Yes, prior therapy trials from other states count toward step therapy requirements. Ensure you have complete documentation of previous treatments, including dates, dosing, duration, and reasons for discontinuation.

What happens if the external review upholds Aetna's denial? The IRO's decision is binding, ending the administrative appeal process. You may still have legal options to pursue, but these would be outside the Smart NC program.

How often do I need to renew Tysabri prior authorization? Typically every 12 months. Renewal requires updated clinical documentation showing continued medical necessity, recent MRI results, and ongoing TOUCH compliance.

Can I switch infusion sites after approval? Yes, but the new site must be TOUCH-enrolled and you may need to update your prior authorization to reflect the site change. Coordinate with your prescriber and Aetna.

What if I have both Medicare and Medicaid in North Carolina? Dual-eligible patients should coordinate between plans. Medicare Part B typically covers infused medications like Tysabri, while Medicaid may cover copays and deductibles.

When to Escalate

If you encounter persistent issues with Aetna's coverage decisions or appeals process, consider these escalation options:

North Carolina Department of Insurance

Federal Resources

  • CMS for Medicare Advantage issues
  • Department of Labor for employer-sponsored plans

Professional Advocacy Services like Counterforce Health can provide expert assistance with complex denials and appeals, using data-driven approaches to identify the strongest arguments for coverage approval.

Disclaimer

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may vary by plan and can change over time. Always verify current requirements with your specific Aetna plan and consult with your healthcare provider about treatment decisions. For the most up-to-date information about North Carolina's external review program, visit the NC Department of Insurance website.

Sources & Further Reading

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