By Counterforce Health Team in Tysabri (natalizumab) —

Myths vs. Facts: Getting Tysabri (Natalizumab) Covered by Aetna (CVS Health) in Virginia

Answer Box: Getting Tysabri Covered by Aetna (CVS Health) in Virginia

Myth: If your doctor prescribes Tysabri, Aetna automatically covers it. Fact: Aetna requires prior authorization with TOUCH REMS enrollment, JCV antibody testing, baseline MRI, and documented step therapy failures for Crohn's disease. The fastest path to approval involves gathering these documents first, then submitting Aetna's Tysabri precertification form via their provider portal. If denied, Virginia's State Corporation Commission offers external review within 120 days using Form 216-A. Start today by enrolling in the TOUCH program at touchprogram.com.

Table of Contents

Why Tysabri Coverage Myths Persist

Specialty drug coverage feels mysterious because the rules differ dramatically from typical prescriptions. Tysabri (natalizumab) carries unique FDA safety requirements through the TOUCH REMS program, creating layers of documentation that many patients and even some clinicians don't fully understand.

At Counterforce Health, we help patients navigate these complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. We've seen how misinformation about Tysabri coverage leads to unnecessary delays and frustration for multiple sclerosis and Crohn's disease patients.

The confusion is understandable. Aetna (CVS Health) has specific policies that aren't always clearly communicated, and Virginia's external review process offers additional protections that many patients don't know exist.

Common Myths vs. Facts

Myth 1: "If my neurologist prescribes Tysabri, Aetna has to cover it"

Fact: Aetna requires prior authorization for all Tysabri prescriptions, regardless of the prescribing specialist. According to Aetna's Clinical Policy Bulletin 0751, coverage depends on meeting specific medical necessity criteria, not just having a prescription.

Myth 2: "TOUCH enrollment is just a formality"

Fact: TOUCH REMS enrollment is mandatory for the patient, prescriber, and infusion site before any PA submission. Missing the TOUCH confirmation number results in automatic denial. The enrollment process at touchprogram.com takes 2-3 business days and must be completed first.

Myth 3: "Prior therapy documentation doesn't matter for MS patients"

Fact: While step therapy requirements are stricter for Crohn's disease, MS patients still need documented evidence of disease activity and prior treatment considerations. Aetna reviews MRI evidence of recent relapses, progression, or lesion activity within the past 3 months.

Myth 4: "JCV antibody testing is optional"

Fact: Baseline JCV antibody testing is mandatory for all Tysabri patients due to PML risk. JCV-negative patients need retesting every 6 months. Positive patients require detailed risk-benefit documentation and more frequent monitoring.

Myth 5: "CVS Specialty automatically handles the approval"

Fact: CVS Specialty Pharmacy handles distribution after approval, but the prior authorization must be obtained separately through Aetna's medical review process. The pharmacy cannot override coverage denials.

Myth 6: "Appeals take forever and rarely work"

Fact: Virginia's external review process is designed to be completed within 45 days (72 hours for expedited cases). The Virginia State Corporation Commission assigns cases to independent review organizations with relevant clinical expertise.

Myth 7: "If Tysabri isn't on formulary, I'm out of luck"

Fact: Non-formulary medications can be covered through formulary exceptions when all formulary alternatives are ineffective or cause adverse effects. This requires detailed clinical documentation but is a standard process.

Myth 8: "Financial assistance programs don't work with insurance"

Fact: Biogen's copay assistance programs can reduce out-of-pocket costs to $0 for eligible commercially insured patients, covering both drug and administration costs separately.

What Actually Influences Approval

Clinical Documentation Requirements

Aetna's approval decisions center on four key areas:

Diagnosis Confirmation: MS (ICD-10 G35) with MRI evidence or Crohn's disease (ICD-10 K50.x) with documented severity. Recent imaging within 3 months strengthens the case.

Safety Monitoring: Complete TOUCH enrollment, baseline brain MRI to rule out PML, JCV antibody status, and baseline labs (CBC, liver function tests, TB screening).

Medical Necessity: For MS, evidence of disease activity or inadequate response to other therapies. For Crohn's disease, documented failures of at least one biologic therapy (Humira, Remicade, Entyvio, etc.).

Prescriber Expertise: Neurologist for MS or gastroenterologist for Crohn's disease. If the primary prescriber isn't a specialist, consultation notes are typically required.

Submission Quality Factors

Based on our experience at Counterforce Health, successful submissions include:

  • Complete Aetna precertification forms with all required attachments
  • Clear medical necessity letters citing FDA labeling and relevant guidelines
  • Organized clinical records showing the progression of treatment decisions
  • TOUCH confirmation numbers and enrollment documentation

Avoid These Preventable Mistakes

1. Submitting Without TOUCH Enrollment

This is the most common reason for immediate denial. Enroll all parties (patient, prescriber, infusion site) at touchprogram.com before submitting any paperwork.

2. Missing or Outdated MRI Documentation

Brain MRI reports must be recent (within 3-6 months) and include radiologist interpretation. Generic "MRI shows lesions" notes aren't sufficient.

3. Incomplete Prior Therapy Documentation for Crohn's

Document specific biologic trials, duration, outcomes, and reasons for discontinuation. "Failed multiple therapies" without details leads to denials.

4. Wrong Submission Pathway

Use Aetna's provider portal or designated fax lines (1-888-267-3277). Submitting through general customer service delays processing.

5. Ignoring Appeal Deadlines

Virginia allows 120 days from final denial to request external review. Missing this deadline eliminates your strongest appeal option.

Quick Action Plan: Three Steps to Take Today

Step 1: Verify Current Coverage Status

Call the member services number on your Aetna ID card to confirm:

  • Whether Tysabri requires prior authorization under your specific plan
  • Your current formulary tier and any quantity limits
  • The status of any existing prior authorization

Step 2: Begin TOUCH Enrollment Immediately

Visit touchprogram.com to start enrollment for yourself, your prescriber, and your intended infusion site. This process cannot be rushed and must be completed before prior authorization submission.

Step 3: Gather Required Documentation

Work with your healthcare team to collect:

  • Recent brain MRI reports (within 3 months)
  • JCV antibody test results
  • Complete treatment history with specific medication names, dates, and outcomes
  • Current clinical notes documenting disease activity
From our advocates: We've seen patients reduce their approval timeline from months to weeks by completing TOUCH enrollment while gathering other documentation in parallel. One Virginia MS patient received approval in 8 days after initially being denied for missing TOUCH confirmation—the key was having everything else ready to resubmit immediately.

Virginia-Specific Appeals Process

Internal Appeals with Aetna

  • Timeline: Submit within 180 days of denial notice
  • Method: Call 1-866-752-7021 or submit via provider portal
  • Decision: 30-45 days standard, 72 hours expedited
  • Required: Original denial letter, additional clinical documentation, prescriber attestation

External Review Through Virginia SCC

Virginia's State Corporation Commission Bureau of Insurance offers independent review when internal appeals are unsuccessful.

Eligibility: Must exhaust Aetna's internal appeals first, unless expedited review is needed for urgent medical situations.

Process: Submit Form 216-A within 120 days of final denial. The SCC assigns an Independent Review Organization (IRO) with relevant clinical expertise.

Timeline: 45 days for standard review, 72 hours for expedited cases involving serious health risks.

Cost: Free to Virginia residents for eligible plans.

When to Request Expedited Review

Contact the Virginia SCC directly if:

  • Ongoing Tysabri treatment is being discontinued due to denial
  • MS relapse activity requires immediate intervention
  • Crohn's disease symptoms are rapidly worsening

Resources and Financial Support

Official Forms and Contacts

Financial Assistance Programs

Biogen Support Services: Call 1-800-456-2255 for enrollment in copay assistance programs that can reduce costs to $0 for eligible patients.

Virginia Prescription Assistance: Contact 211 Virginia for additional state and foundation programs.

Patient Advocacy Resources

  • National MS Society: Local chapter support for appeals
  • Patient Advocate Foundation: Copay relief funds
  • Virginia Poverty Law Center: Legal assistance for coverage disputes

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with your insurance plan and healthcare provider. For personalized assistance with Tysabri appeals, consider consulting with patient advocacy organizations or legal professionals specializing in healthcare coverage.

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