By Counterforce Health Team in Tysabri (natalizumab) —

Getting Tysabri (Natalizumab) Covered by Cigna in New Jersey: Complete Coverage Guide

Answer Box: Your Path to Tysabri Coverage

To get Tysabri (natalizumab) covered by Cigna in New Jersey:

  1. Ensure your doctor, infusion center, and you are enrolled in the TOUCH Prescribing Program
  2. Complete Cigna's prior authorization with documented step therapy trials and JCV antibody testing
  3. If denied, file internal appeal within 180 days, then external review through New Jersey's IHCAP if needed

Key requirement: TOUCH enrollment is mandatory—without it, approval won't happen regardless of medical necessity.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy & Exception Pathways
  4. Required Diagnostics & Documentation
  5. Specialty Pharmacy Requirements
  6. Appeals Process in New Jersey
  7. Common Denial Reasons & Solutions
  8. Costs & Patient Assistance
  9. FAQ

Policy Overview

Cigna manages Tysabri (natalizumab) as a specialty medication requiring prior authorization across all plan types—commercial PPO/HMO, Medicare Advantage, and Medicaid managed care plans in New Jersey. The drug is typically processed through Express Scripts or Accredo specialty pharmacy.

Plan Types & Coverage:

  • Commercial plans: Standard PA requirements apply
  • Medicare Advantage: Additional CMS guidelines may apply
  • Medicaid managed care: State Medicaid criteria overlay with Cigna's policy
Note: Tysabri is FDA-approved for relapsing forms of multiple sclerosis and moderately to severely active Crohn's disease in adults with inadequate response to conventional therapy.

Medical Necessity Requirements

FDA-Approved Indications

Cigna covers Tysabri for:

  • Relapsing forms of multiple sclerosis (including relapsing-remitting and active secondary progressive MS)
  • Crohn's disease (restricted to patients who've failed conventional treatments)

TOUCH Program Enrollment

Mandatory requirement: All parties must be enrolled in the TOUCH Prescribing Program before Cigna will approve coverage:

  • Prescribing physician
  • Patient
  • Infusion center/pharmacy

This FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program monitors for progressive multifocal leukoencephalopathy (PML) risk.

Step Therapy & Exception Pathways

Required Prior Treatments

Cigna typically requires documentation of inadequate response, intolerance, or contraindication to at least two preferred disease-modifying therapies (DMTs), which may include:

  • Interferon beta preparations (Avonex, Betaseron, Rebif)
  • Glatiramer acetate (Copaxone, Glatopa)
  • Oral DMTs (Tecfidera, Aubagio, Gilenya)

Medical Exception Criteria

You can bypass step therapy if:

  • Clinical contraindications exist to preferred agents
  • Patient is already stabilized on Tysabri
  • Rapid disease progression makes delays inappropriate
  • Prior severe adverse reactions to required step therapies
Tip: Document trials within the past 365 days for best consideration. Older trials may not meet recency requirements.

Required Diagnostics & Documentation

JCV Antibody Testing

Mandatory before treatment initiation:

  • Use validated assay (STRATIFY JCV or equivalent)
  • JCV-negative patients: Retest every 6 months
  • JCV-positive patients: No repeat testing needed
  • Include antibody index values if positive (affects risk stratification)

MRI Requirements

Baseline MRI (within 3 months of treatment start):

  • Establishes reference for PML monitoring
  • Should include FLAIR and DWI sequences

Follow-up MRI schedule:

  • JCV-negative: Annual MRI
  • JCV-positive: Every 6 months
  • High-risk patients (JCV+, >2 years treatment, prior immunosuppressants): Every 3 months

Clinical Documentation Checklist

✓ Diagnosis with ICD-10 codes
✓ Prior DMT trials and outcomes
✓ JCV antibody results
✓ Baseline and follow-up MRI reports
✓ TOUCH program enrollment confirmation
✓ Treatment plan and monitoring schedule

Specialty Pharmacy Requirements

Tysabri must be obtained through Cigna's designated specialty pharmacy network, typically:

  • Express Scripts Specialty Pharmacy
  • Accredo Specialty Pharmacy

Site of Care:

  • Infusion must occur at TOUCH-enrolled facilities
  • Home infusion generally not permitted
  • Hospital outpatient departments and infusion centers preferred

Appeals Process in New Jersey

Internal Appeals with Cigna

Timeline: File within 180 days of denial Decision: Within 60 days (notification within 75 business days) Required documents:

  • Original denial letter
  • Completed Cigna appeal form
  • Supporting clinical documentation
  • Physician letter addressing denial reasons

External Review via IHCAP

After exhausting Cigna's internal appeals, New Jersey residents can request external review through the Independent Health Care Appeals Program (IHCAP).

Key Details:

  • Who handles it: Maximus Federal Services (contracted by NJ DOBI)
  • Timeline: 45 days for standard review, 72 hours for urgent cases
  • Cost: Free to patients (insurers pay all costs)
  • Decision: Binding on Cigna if overturned

IHCAP Contact:

  • Phone: 1-888-393-1062
  • General DOBI Consumer Hotline: 1-800-446-7467
From our advocates: We've seen cases where comprehensive clinical documentation—including detailed physician letters explaining why alternatives failed and current guidelines supporting Tysabri use—significantly improved appeal success rates. The key is addressing every specific reason mentioned in the denial letter with evidence-based responses.

Common Denial Reasons & Solutions

Denial Reason Solution
Missing TOUCH enrollment Submit enrollment confirmation for all parties
Inadequate step therapy Document specific trials, outcomes, and timeframes
Missing JCV testing Provide validated antibody test results
No baseline MRI Submit recent MRI report with FLAIR/DWI sequences
Quantity limit exceeded Request exception with clinical justification
Non-formulary status File formulary exception with medical necessity letter

Costs & Patient Assistance

Manufacturer Support

Biogen Above MS Program:

  • Copay assistance for eligible commercial patients
  • Financial counseling and insurance navigation
  • Contact: Visit Biogen Above MS or call 1-800-456-2255

Additional Resources

  • National MS Society: Financial assistance programs
  • Patient Access Network Foundation: Grants for specialty medications
  • New Jersey pharmaceutical assistance programs (verify current eligibility)

When to Get Help

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to Cigna's own rules. We pull the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals with required clinical facts. For complex cases involving specialty medications like Tysabri, having expert support can significantly improve your chances of approval. Learn more at www.counterforcehealth.org.

FAQ

How long does Cigna prior authorization take for Tysabri in New Jersey? Standard determination within 5 business days; urgent requests may be expedited if clinical justification provided.

What if Tysabri is non-formulary on my Cigna plan? File a formulary exception request with clinical rationale explaining medical necessity within 72 hours for standard review.

Can I request an expedited appeal in New Jersey? Yes, both Cigna internal appeals and IHCAP external reviews offer expedited pathways for urgent medical situations.

Does step therapy apply if I've failed treatments outside New Jersey? Yes, prior treatment failures from other states count if properly documented and within the required timeframe (typically 365 days).

What happens if IHCAP overturns Cigna's denial? The decision is binding on Cigna—they must provide coverage as directed by the external review organization.

How much does the IHCAP external review cost? Nothing. New Jersey law requires insurers to pay all costs of external reviews.

Can my doctor file the appeal for me? Yes, providers can file both internal appeals with Cigna and external appeals through IHCAP with patient consent.

What if I need Tysabri urgently while appealing? Request expedited review at both internal and external levels; also explore manufacturer patient assistance programs for temporary access.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance at 1-800-446-7467 or visit www.nj.gov/dobi.

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