By Counterforce Health Team in Tysabri (natalizumab) —

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

Quick Answer: Getting Tysabri Covered by Aetna in Washington

Tysabri (natalizumab) requires prior authorization from Aetna CVS Health for all plans. You'll need a neurologist (for MS) or gastroenterologist (for Crohn's) to submit clinical documentation proving diagnosis, prior biologic failures, and TOUCH program enrollment. First step today: Have your doctor complete Aetna's Tysabri precertification form with JCV antibody results and recent MRI. If denied, Washington residents can appeal through internal reviews and ultimately request an Independent Review Organization (IRO) through the Washington State Office of Insurance Commissioner.

Table of Contents

  1. Aetna's Tysabri Coverage Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity Limits and Dosing Rules
  5. Required Diagnostics and Monitoring
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Step-by-Step: Fastest Path to Approval
  9. Common Denial Reasons and Solutions
  10. Washington Appeals Process
  11. Costs and Patient Support Programs
  12. FAQ

Aetna's Tysabri Coverage Policy Overview

Aetna CVS Health covers Tysabri (natalizumab) under strict prior authorization requirements across all plan types—HMO, PPO, and Medicare Advantage. The drug requires precertification before starting treatment, and coverage decisions are based on Aetna's Clinical Policy Bulletin 0751.

Key Policy Points:

  • All plans require PA: No exceptions for any Aetna product
  • Specialty prescriber required: Neurologist for MS, gastroenterologist for Crohn's
  • TOUCH program enrollment mandatory: Both patient and prescriber must be enrolled
  • Site of care restrictions apply: May limit to specific infusion centers
Note: Self-funded employer plans may have different requirements. Check with your benefits administrator if your plan is self-insured.

FDA Indication Requirements

Aetna approves Tysabri only for FDA-labeled indications with documented clinical support:

Approved Indications:

  • Relapsing forms of multiple sclerosis (including relapsing-remitting and active secondary progressive MS)
  • Moderately to severely active Crohn's disease (restricted use after biologic failure)
  • Clinically isolated syndrome (CIS) with high risk of developing MS

Documentation Required:

  • ICD-10 diagnosis codes (G35 for MS, K50.x for Crohn's)
  • Clinical notes confirming diagnosis
  • MRI or colonoscopy results supporting diagnosis
  • Evidence of relapsing disease pattern for MS patients
Important: All other uses are considered experimental and will be denied automatically.

Step Therapy and Medical Exceptions

For Crohn's Disease:

Step therapy is mandatory. Patients must have tried and failed at least one other biologic therapy indicated for moderate to severe Crohn's disease before Tysabri approval.

Acceptable prior biologics include:

  • Adalimumab (Humira)
  • Infliximab (Remicade)
  • Certolizumab (Cimzia)
  • Vedolizumab (Entyvio)
  • Ustekinumab (Stelara)

For Multiple Sclerosis:

Step therapy requirements are less stringent for MS, but documentation of disease activity and treatment rationale is required.

Medical Exception Pathways:

If you cannot try required step therapy drugs due to:

  • Contraindications: Document specific medical reasons
  • Previous intolerance: Include records of adverse reactions
  • Drug interactions: Provide medication list and interaction details

Submit exception requests with the initial PA using Aetna's standard forms.

Quantity Limits and Dosing Rules

Standard Dosing:

  • 300 mg every 4 weeks (FDA-approved frequency)
  • Maximum 13 doses per year for standard dosing

Extended Interval Dosing:

Some patients receive Tysabri every 6-8 weeks to reduce PML risk. This requires:

  • Detailed clinical justification
  • Documentation of PML risk factors
  • Patient consent documentation
  • Evidence supporting reduced frequency efficacy

Renewal Requirements:

  • Clinical assessment every 6-12 months
  • Evidence of ongoing benefit (stable/improved EDSS, reduced relapses)
  • Updated MRI showing no PML signs
  • Current JCV antibody status

Required Diagnostics and Monitoring

Before Starting Tysabri:

Test Timing Purpose
Brain MRI Within 3 months Rule out PML, establish baseline
JCV antibody index Within 6 months Risk stratification for PML
Complete blood count Within 30 days Safety monitoring
Liver function tests Within 30 days Baseline assessment

Ongoing Monitoring:

  • MRI: At least annually, more frequent if JCV positive
  • JCV testing: Every 6 months if initially negative
  • Clinical assessments: Every 3-6 months
Tip: Coordinate testing schedules with your infusion appointments to streamline documentation for renewals.

Site of Care and Specialty Pharmacy Requirements

TOUCH Program Requirements:

All Tysabri must be distributed through TOUCH-certified facilities. CVS Specialty Pharmacy is Aetna's preferred specialty pharmacy for Tysabri distribution.

Site of Care Restrictions:

Aetna increasingly limits infusion locations to control costs:

  • Preferred: Freestanding infusion centers
  • May require authorization: Hospital outpatient departments
  • Available in some cases: Home infusion services

Getting Site of Care Exceptions:

If you need treatment at a hospital-based infusion center, document:

  • Medical complexity requiring hospital setting
  • Risk of adverse reactions needing immediate intervention
  • Lack of appropriate alternative sites in your area

Evidence to Support Medical Necessity

Clinical Documentation Checklist:

  • Diagnosis confirmation: MRI findings, clinical symptoms, disease course
  • Prior treatment history: Medications tried, duration, reasons for discontinuation
  • Current disease activity: Recent relapses, MRI changes, disability progression
  • Treatment goals: Specific clinical outcomes expected with Tysabri

Key References to Include:

  • FDA prescribing information for approved indications
  • American Academy of Neurology MS treatment guidelines
  • National MS Society treatment recommendations
  • Relevant peer-reviewed studies supporting your specific clinical scenario

Step-by-Step: Fastest Path to Approval

1. Confirm TOUCH Enrollment (Week 1)

Who: Your prescribing neurologist/gastroenterologist Action: Complete TOUCH program enrollment at touchprogram.com Timeline: 2-3 business days for approval

2. Gather Required Documentation (Week 1-2)

Who: You and your medical team Documents needed:

  • Recent MRI report (within 3 months)
  • JCV antibody test results
  • Complete medical history
  • Prior medication trials and outcomes

3. Submit Prior Authorization (Week 2)

Who: Your doctor's office Action: Complete and submit Aetna's Tysabri precertification form Submit to: Aetna at 1-866-752-7021 or fax 1-888-267-3277

4. Follow Up on Decision (Week 3-4)

Timeline: Standard decisions within 30-45 days Expedited: Within 72 hours if urgent medical need Track status: Through Aetna provider portal or member services

5. Appeal if Denied (Within 180 days)

First step: Internal appeal with additional documentation Final step: External review through Washington State IRO if needed

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing TOUCH enrollment Complete enrollment before resubmission TOUCH confirmation number
Inadequate MRI documentation Submit complete MRI report with radiologist interpretation Recent brain MRI (≤3 months)
Step therapy not met (Crohn's) Document prior biologic trials and failures Treatment records, adverse event notes
Non-formulary status Request formulary exception with medical necessity Clinical justification letter
Quantity limits exceeded Provide dosing rationale for extended interval Clinical notes supporting modified schedule

Washington Appeals Process

Washington State provides robust protections for patients facing insurance denials, including access to independent external review.

Internal Appeals with Aetna:

  • Timeline: Must file within 180 days of denial
  • Process: Submit appeal with additional clinical documentation
  • Decision time: 30-45 days for standard, 72 hours for expedited

External Review (IRO):

If Aetna upholds the denial, you can request an Independent Review Organization review:

Getting Help:

Contact the Washington State OIC Consumer Advocacy line at 1-800-562-6900 for assistance with any step of the appeals process.

From our advocates: We've seen many Tysabri denials overturned at the external review level when patients provide comprehensive documentation of their MS progression and prior treatment failures. The key is organizing all clinical records chronologically and highlighting specific evidence of medical necessity that aligns with published treatment guidelines.

Costs and Patient Support Programs

Manufacturer Support:

  • Tysabri QuickStart Program: Helps with insurance navigation and temporary supply
  • Copay assistance: May reduce out-of-pocket costs for eligible patients
  • Contact: Visit tysabri.com for current programs

Foundation Grants:

  • National MS Society financial assistance programs
  • Patient Advocate Foundation copay relief
  • HealthWell Foundation specialty drug grants

Washington State Resources:

  • Apple Health (Medicaid) may cover Tysabri for eligible low-income residents
  • Washington Prescription Drug Program for additional savings options

FAQ

How long does Aetna prior authorization take for Tysabri in Washington? Standard decisions typically take 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Tysabri is non-formulary on my Aetna plan? Request a formulary exception by documenting medical necessity and providing evidence that preferred alternatives are inappropriate for your condition.

Can I get expedited approval if I'm currently on Tysabri? Yes, if there's urgent medical need. Your doctor must document that delays could seriously jeopardize your health.

Does step therapy apply if I tried biologics outside Washington? Yes, prior treatment history from any location counts toward step therapy requirements. Provide complete medical records from all treating physicians.

What happens if my appeal to Aetna is denied? Washington residents can request external review through an Independent Review Organization (IRO). This decision is binding on Aetna if ruled in your favor.

How often do I need to renew Tysabri authorization? Most plans require renewal every 6-12 months with updated clinical documentation, MRI results, and evidence of ongoing benefit.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and payer policies to create compelling appeals that meet specific plan requirements, increasing approval rates for complex medications like Tysabri.

When dealing with Tysabri coverage challenges, having the right documentation and understanding payer-specific requirements can make the difference between approval and denial. Counterforce Health specializes in navigating these complex prior authorization and appeals processes, ensuring patients get access to the medications they need.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage policies and requirements may change. Always verify current requirements with Aetna and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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