By Counterforce Health Team in Tysabri (natalizumab) —

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

Answer Box: Tysabri (natalizumab) requires prior authorization from Aetna CVS Health for all California plans. Success requires: (1) TOUCH program enrollment by both patient and neurologist, (2) documented MS diagnosis with MRI evidence, (3) JCV antibody testing results, and (4) step therapy documentation for Crohn's disease. Submit the complete Aetna precertification form with all supporting clinical documentation. If denied, California's Independent Medical Review (IMR) shows 50-68% success rates for specialty MS drugs. Start today: Ensure TOUCH enrollment is complete before submitting your PA request.

Table of Contents

Aetna's Coverage Policy Overview

Aetna CVS Health requires prior authorization for Tysabri (natalizumab) across all plan types in California—commercial HMO, PPO, and Medicare Advantage plans. The drug is typically classified as a specialty medication requiring specialized handling through CVS Specialty Pharmacy.

Key Policy Points:

  • PA is mandatory for all Aetna plans
  • Must be prescribed by a neurologist (MS) or gastroenterologist (Crohn's disease)
  • TOUCH program enrollment is required before any approval
  • Site of care restrictions may apply per Aetna's drug infusion policy

You can find Aetna's current precertification requirements in their 2025 Precertification List and specific Tysabri criteria in their clinical policy bulletin.

Medical Necessity Requirements

Aetna defines medical necessity for Tysabri based on FDA-approved indications and specific clinical criteria:

Approved Indications:

  • Relapsing forms of multiple sclerosis (RRMS, CIS, active SPMS)
  • Moderately to severely active Crohn's disease (restricted use after biologic failure)

Required Clinical Documentation:

  • Confirmed diagnosis with appropriate ICD-10 codes (G35 for MS, K50.x for Crohn's)
  • Clinical notes from specialist (neurologist or gastroenterologist)
  • Disease activity evidence (recent relapses, MRI changes, or clinical progression)
  • Prior treatment history with documented failures or intolerances
  • Contraindications to other therapies (if applicable)
Clinician Corner: Your medical necessity letter should include: (1) specific MS subtype or Crohn's severity, (2) timeline of prior DMTs with dates and outcomes, (3) current disease activity markers, (4) rationale for Tysabri over alternatives, and (5) monitoring plan including PML risk assessment.

Step Therapy & Exceptions

Step therapy requirements vary by indication:

For Multiple Sclerosis:

  • Step therapy is generally not enforced
  • Must demonstrate medical necessity and appropriate specialist management
  • Document any prior therapy failures or contraindications

For Crohn's Disease:

  • Mandatory step therapy: Must have tried and failed at least one prior biologic
  • Acceptable prior biologics include adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia), vedolizumab (Entyvio), or ustekinumab (Stelara)
  • Medical exceptions possible for documented contraindications or intolerance

Exception Documentation:

  • Detailed clinical notes explaining why standard therapies are inappropriate
  • Allergy documentation or adverse event reports
  • Drug interaction concerns with supporting evidence

Required Diagnostics & Testing

Specific testing is required both for approval and ongoing safety monitoring:

Baseline Requirements:

  • Brain MRI: Required before starting Tysabri to rule out PML and establish baseline
  • JCV antibody testing: Mandatory baseline test due to PML risk stratification
  • Complete blood count and liver function tests
  • Tuberculosis screening (chest X-ray, TB skin test or interferon-gamma release assay)

Ongoing Monitoring:

  • JCV antibody testing every 6 months during treatment
  • Annual brain MRI (minimum) to monitor for PML and disease activity
  • Regular clinical assessments by specialist
  • Laboratory monitoring as clinically indicated

The frequency and timing of these tests must be documented in renewal requests to maintain coverage.

TOUCH Program Enrollment

TOUCH enrollment is absolutely mandatory for Tysabri approval and ongoing coverage. This FDA-required Risk Evaluation and Mitigation Strategy (REMS) program exists due to PML risk.

Enrollment Requirements:

  • Both prescriber and patient must complete and sign enrollment forms
  • Prescriber must be certified and trained in the TOUCH program
  • Patient must receive counseling on PML risks and acknowledge understanding
  • Infusion site must be TOUCH-certified

Documentation for Insurance:

  • Completed TOUCH enrollment forms (signed by both parties)
  • Evidence of patient counseling and education
  • Confirmation of prescriber and site certification

Contact the TOUCH Hotline at 1-800-456-2255 for enrollment assistance. Without proper TOUCH documentation, Aetna will deny coverage regardless of medical necessity.

Site of Care Requirements

Tysabri infusions must occur at Aetna-approved sites according to their drug infusion site of care policy:

Approved Sites:

  • Physician offices with infusion capability
  • Hospital outpatient infusion centers
  • Aetna-contracted infusion centers
  • Home infusion (CVS Specialty/Coram) if clinically appropriate and pre-approved

Coordination Requirements:

  • CVS Specialty Pharmacy typically handles drug distribution
  • Prior authorization needed for both drug and site of care
  • Site must maintain TOUCH certification and complete required safety monitoring

Step-by-Step Approval Process

Coverage at a Glance:

Requirement Details Timeline Source
PA Required Yes, all plans Submit before treatment Aetna PA List
TOUCH Enrollment Mandatory Complete before PA submission TOUCH Program
Specialist Required Neurologist (MS) or GI (Crohn's) Must prescribe and submit PA Aetna Policy
Decision Timeline 30-45 days standard Expedited available for urgent cases Aetna member services

Step-by-Step Process:

  1. Complete TOUCH Enrollment (Patient & Prescriber)
    • Download forms from TOUCH website
    • Both parties sign and submit to program
    • Verify enrollment before proceeding
  2. Gather Required Documentation
    • Recent MRI reports
    • JCV antibody test results
    • Complete treatment history
    • Current clinical assessment
  3. Submit Prior Authorization
  4. Track Your Request
    • Standard decisions: 30-45 days
    • Expedited requests: 72 hours for urgent cases
    • Follow up if no response within expected timeframe
  5. Coordinate Infusion Setup
    • Work with CVS Specialty for drug distribution
    • Confirm infusion site is Aetna-approved and TOUCH-certified
    • Schedule first infusion only after full approval

At Counterforce Health, we help patients and clinicians navigate complex prior authorization processes by analyzing denial letters, identifying specific policy requirements, and crafting targeted appeals with the right clinical evidence and citations. Our platform streamlines the documentation process and improves approval rates for specialty medications like Tysabri.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing TOUCH enrollment Complete enrollment before resubmission Signed TOUCH forms, certification proof
Inadequate MRI documentation Submit complete MRI reports with radiologist interpretation Recent brain MRI with formal report
Missing JCV antibody results Obtain and submit current JCV testing Lab results within last 6 months
Step therapy not met (Crohn's) Document prior biologic failures Treatment records showing inadequate response
Non-formulary status Request formulary exception Medical necessity letter with clinical rationale
From our advocates: We've seen many Tysabri denials overturned by ensuring the TOUCH enrollment documentation is complete and clearly referenced in the PA submission. A common mistake is submitting the medical request before confirming both patient and prescriber are fully enrolled and certified in the safety program.

California Appeals Process

California offers robust appeal rights through two regulatory agencies depending on your plan type:

Internal Appeals (Required First Step):

  • File grievance with Aetna within 180 days of denial
  • Standard review: 30 days
  • Expedited review: 72 hours for urgent cases
  • Submit additional clinical documentation and specialist support

Independent Medical Review (IMR):

  • Available after internal appeal denial or 30-day non-response
  • Success rate for specialty MS drugs: 50-68% based on California data
  • No cost to patient
  • Legally binding decision

How to Request IMR:

Required IMR Documentation:

  • All denial letters and correspondence
  • Complete medical records supporting Tysabri necessity
  • Specialist letters explaining why Tysabri is medically necessary
  • Evidence of TOUCH enrollment and safety compliance

The Counterforce Health platform can help identify the specific denial reasons and craft targeted rebuttals aligned with California's IMR requirements, increasing your chances of a successful appeal.

Costs & Financial Assistance

Insurance Coverage:

  • Tysabri is typically covered as a specialty medication with higher cost-sharing
  • Copays vary by plan but can range from $50-500+ per infusion for commercial plans
  • Medicare Part B may cover infusions with 20% coinsurance after deductible

Financial Assistance Options:

  • Biogen Patient Support Program: Copay assistance and free drug programs
  • MS Society Financial Assistance: Grants for treatment costs
  • Patient Access Network (PAN) Foundation: Copay assistance for eligible patients
  • California Medicaid (Medi-Cal): May cover Tysabri for eligible low-income patients

Contact Biogen's patient support at 1-800-456-2255 to explore available assistance programs.

FAQ

How long does Aetna PA take in California? Standard decisions take 30-45 days, but expedited reviews for urgent cases are completed within 72 hours. You can request expedited review if delays could seriously jeopardize your health.

What if Tysabri is non-formulary on my plan? Request a formulary exception by submitting clinical documentation showing medical necessity. If denied, appeal through California's IMR process, which has favorable success rates for medically necessary specialty drugs.

Can I request an expedited appeal? Yes, if waiting for standard review timelines could seriously harm your health. Provide documentation from your neurologist explaining the urgency.

Does step therapy apply if I've tried therapies outside California? Yes, document all prior therapies regardless of where you received them. Out-of-state treatment records are valid for step therapy requirements.

What happens if my TOUCH enrollment lapses? Tysabri infusions must stop immediately, and insurance coverage will be suspended. Re-enrollment is required before resuming treatment.

Can I get Tysabri at home through CVS Specialty? Home infusion may be possible through CVS Specialty/Coram, but requires separate approval based on clinical appropriateness and Aetna's site-of-care policies.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and requirements may change. Always verify current requirements with your insurance plan and healthcare providers.

Sources & Further Reading:

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