By Counterforce Health Team in Tysabri (natalizumab) —

Getting Tysabri (Natalizumab) Covered by Aetna CVS Health in Pennsylvania: Complete Coverage Guide

Answer Box: Fastest Path to Approval

Aetna CVS Health requires prior authorization for Tysabri (natalizumab) in Pennsylvania. You'll need: neurologist prescription, TOUCH program enrollment, JCV antibody testing, recent MRI, and documentation of prior treatment failures. Standard approval takes 30-45 days; expedited reviews complete within 72 hours for urgent cases. First step today: Contact CVS Specialty Pharmacy at (866) 814-5506 to begin enrollment and benefits verification while your neurologist gathers required documentation.

Table of Contents

  1. Coverage at a Glance
  2. Policy Overview: How Aetna Handles Tysabri
  3. Medical Necessity Requirements
  4. Step Therapy and Exceptions
  5. Required Diagnostics and Documentation
  6. Specialty Pharmacy and Site of Care
  7. Step-by-Step: Fastest Path to Approval
  8. Common Denial Reasons and Solutions
  9. Appeals Process in Pennsylvania
  10. Costs and Patient Support
  11. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Aetna plans Call (866) 752-7021 or fax (888) 267-3277 Aetna Precertification
Prescriber Neurologist (MS) or gastroenterologist (Crohn's) Must be documented in PA request Aetna Medical Policy
TOUCH Enrollment FDA-mandated safety program Patient and prescriber must enroll TOUCH Program
JCV Testing Anti-JCV antibody status required Within 6 months of treatment start Aetna Clinical Criteria
Step Therapy May require trial of preferred agents first Varies by plan; exceptions available Aetna Policy Guidelines
Appeals Deadline 180 days for internal appeal Check your denial letter PA External Review

Policy Overview: How Aetna Handles Tysabri

Aetna CVS Health covers Tysabri (natalizumab) across all plan types in Pennsylvania—HMO, PPO, and Medicare plans—but prior authorization is mandatory. The drug is typically classified as a specialty medication requiring coordination through CVS Specialty Pharmacy.

Plan-Specific Considerations

Commercial Plans: Standard 30-45 day review timeline with step therapy requirements that may vary by employer group.

Medicare Part D: Stricter timelines (72 hours for expedited appeals) with additional CMS oversight of coverage decisions.

Medicaid Plans: Follow Pennsylvania Medicaid guidelines with additional state-specific documentation requirements.

Note: Self-funded employer plans may have different criteria than standard Aetna policies. Always verify your specific plan's coverage rules.

Medical Necessity Requirements

Aetna's medical policy for Tysabri requires specific clinical criteria to establish medical necessity:

For Multiple Sclerosis

  • Diagnosis: Relapsing forms of MS or clinically isolated syndrome
  • Disease Activity: Evidence of ongoing relapses or MRI progression
  • Specialist Oversight: Prescribed by or in consultation with a neurologist
  • Safety Monitoring: JCV antibody testing and ongoing PML risk assessment

For Crohn's Disease

  • Severity: Moderate-to-severe active disease
  • Prior Failures: Inadequate response to conventional therapies and TNF-alpha inhibitors
  • Specialist Care: Gastroenterologist involvement required
  • Monitoring: CD-TOUCH program enrollment with 3-month review milestones

The Aetna medical policy outlines these requirements in detail and is updated regularly.

Step Therapy and Exceptions

Step therapy typically applies for Tysabri, meaning you may need to try and fail other MS treatments first. However, medical exceptions are available with proper documentation.

Common Step Therapy Requirements

  1. First-line agents: Interferons, glatiramer acetate, or oral medications
  2. Documentation needed: Treatment dates, doses, duration, and reason for discontinuation
  3. Failure criteria: Lack of efficacy, intolerance, or contraindications

Medical Exception Pathways

  • Contraindications: Document medical reasons why preferred agents cannot be used
  • Prior failures: Include records from other insurance plans or time periods
  • Clinical urgency: Rapidly progressing disease requiring immediate intervention
Tip: Keep detailed records of all MS treatments, including those tried under previous insurance plans. This documentation can support exception requests.

Required Diagnostics and Documentation

Comprehensive documentation strengthens your prior authorization request and reduces denial risk.

Essential Lab Work

  • JCV antibody testing: Required within 6 months of treatment initiation
  • Complete blood count: Baseline and monitoring labs
  • Liver function tests: Pre-treatment assessment

Imaging Requirements

  • Brain MRI: Within 6-12 months showing active lesions or disease progression
  • Contrast studies: May be required to demonstrate enhancing lesions
  • Comparative imaging: Serial MRIs showing disease evolution over time

Clinical Documentation

  • Neurologist notes: Detailed clinical assessment and treatment rationale
  • Prior treatment records: Complete history of MS therapies and outcomes
  • Disability assessments: EDSS scores or functional status measures

Specialty Pharmacy and Site of Care

Tysabri requires coordination through specialty pharmacy and approved infusion sites due to REMS requirements.

CVS Specialty Coordination

CVS Specialty Pharmacy manages Tysabri distribution and can assist with:

  • Benefits verification and prior authorization support
  • TOUCH program enrollment coordination
  • Site of care arrangement and network verification
  • Patient education and adherence monitoring

Contact CVS Specialty at (866) 814-5506 to begin the enrollment process.

Infusion Site Requirements

  • Network status: Must be Aetna-contracted provider in Pennsylvania
  • TOUCH enrollment: Site must be registered with the safety program
  • Clinical capabilities: Appropriate for managing infusion reactions
  • Documentation: Maintain infusion records and adverse event monitoring

Step-by-Step: Fastest Path to Approval

1. Initiate Specialty Pharmacy Enrollment

Who: Patient or caregiver
Action: Call CVS Specialty at (866) 814-5506
Timeline: Same day
Outcome: Benefits verification and enrollment packet

2. Complete TOUCH Program Registration

Who: Patient and prescriber
Action: Enroll at TOUCH Program website
Timeline: 2-3 business days
Outcome: Safety program compliance for FDA requirements

3. Gather Required Documentation

Who: Neurologist's office
Action: Compile clinical records, MRI results, JCV testing
Timeline: 3-5 business days
Outcome: Complete prior authorization packet

4. Submit Prior Authorization Request

Who: Prescriber
Action: Submit via Aetna portal or fax (888) 267-3277
Timeline: Same day submission
Outcome: PA reference number and review timeline

5. Monitor Review Status

Who: Patient or clinic staff
Action: Check Aetna provider portal or call member services
Timeline: Weekly during review period
Outcome: Approval notification or additional information request

6. Coordinate First Infusion

Who: CVS Specialty and infusion site
Action: Schedule and confirm network status
Timeline: Within 1-2 weeks of approval
Outcome: Treatment initiation

7. Establish Ongoing Monitoring

Who: Neurologist and patient
Action: Schedule regular follow-ups and safety assessments
Timeline: Every 3-6 months
Outcome: Continued coverage and safety monitoring

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Missing TOUCH enrollment Complete safety program registration TOUCH confirmation letter
Inadequate prior failures Document step therapy attempts Treatment records with dates and outcomes
Non-network prescriber Transfer to neurologist or get consultation Specialist referral or consultation note
Insufficient MRI evidence Provide recent imaging with interpretation Radiology report showing active disease
Missing JCV testing Complete antibody assessment Lab results within 6 months
Experimental/investigational Cite FDA approval and guidelines FDA label and clinical guidelines

Appeals Process in Pennsylvania

Pennsylvania offers a robust appeals system with a 50% overturn rate for external reviews in 2024.

Internal Appeal (First Level)

  • Timeline: Submit within 180 days of denial
  • Process: Use Aetna appeal form with supporting documentation
  • Decision: 30-45 days for standard appeals, 72 hours for expedited

Pennsylvania External Review

After exhausting internal appeals, you can request external review through the Pennsylvania Insurance Department.

Key Benefits:

  • Independent physician review
  • 50% success rate in overturning denials
  • Binding decisions on insurers
  • Free process for consumers

Timeline:

  • Request deadline: 4 months after final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases
From our advocates: We've seen Pennsylvania's external review process successfully overturn Tysabri denials when patients provided comprehensive documentation of treatment failures and specialist support. The independent reviewers often focus on whether the denial aligns with current medical standards, making strong clinical documentation crucial for success.

Costs and Patient Support

Manufacturer Assistance

Biogen offers patient support programs that may help with:

  • Copay assistance for eligible patients
  • Benefits verification and prior authorization support
  • Patient education and adherence resources

Contact the Tysabri Above MS program at 1-800-456-2255 for enrollment information.

Foundation Support

Several organizations provide financial assistance for specialty medications:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • Good Days (formerly Chronic Disease Fund)

State Programs

Pennsylvania residents may qualify for additional support through:

  • Pennsylvania PACE/PACENET for prescription assistance
  • County assistance programs
  • Medicaid coverage for eligible individuals

FAQ

How long does Aetna prior authorization take for Tysabri in Pennsylvania? Standard reviews take 30-45 days, but expedited reviews for urgent cases are completed within 72 hours. Submit requests at least two weeks before your planned infusion date.

What if Tysabri is non-formulary on my Aetna plan? You can request a formulary exception with documentation of medical necessity and prior treatment failures. The appeals process allows for coverage of non-formulary medications when medically appropriate.

Can I get an expedited appeal if my MS is worsening? Yes, if your neurologist documents that delay could harm your health, you can request expedited review. Include a physician statement about urgency with your appeal.

Does step therapy apply if I failed treatments under previous insurance? Document all prior treatments regardless of which insurance covered them. Aetna may accept this history to satisfy step therapy requirements.

What happens if Pennsylvania's external review overturns my denial? Aetna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.

How do I find an Aetna network infusion center in Pennsylvania? Use Aetna's provider directory online or call member services. CVS Specialty can also help identify network infusion sites in your area.

What if my neurologist isn't familiar with Tysabri prior authorization? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps clinicians navigate complex prior authorization requirements and draft compelling medical necessity letters that align with payer policies.

Can I appeal if Aetna requires a different infusion schedule than prescribed? Yes, quantity limit appeals are possible with clinical justification. Your neurologist should document why the prescribed dosing schedule is medically necessary for your specific case.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For complex prior authorization challenges, platforms like Counterforce Health can help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-backed documentation that aligns with payer requirements.

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