By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by UnitedHealthcare in New Jersey: Prior Authorization, Appeals & Alternatives Guide

Answer Box: Getting Tysabri Covered by UnitedHealthcare in New Jersey

UnitedHealthcare requires prior authorization for Tysabri (natalizumab) in New Jersey, with strict documentation requirements including TOUCH program enrollment, JCV antibody testing, and MRI results. If denied, you have 180 days to file an internal appeal, followed by New Jersey's Independent Health Care Appeals Program (IHCAP) for external review.

Fastest path to approval:

  1. Ensure TOUCH program enrollment is complete and current
  2. Gather recent MRI results and JCV antibody test within 6 months
  3. Submit prior authorization via UnitedHealthcare provider portal with complete medical necessity documentation

Start today: Contact your neurologist to schedule necessary testing and verify TOUCH enrollment status.

Table of Contents

When Formulary Alternatives Make Sense

If Tysabri isn't initially approved by UnitedHealthcare, formulary alternatives may be appropriate depending on your specific clinical situation. UnitedHealthcare typically requires patients to try preferred formulary medications first unless there are documented contraindications or previous failures.

Alternatives make sense when:

  • You're newly diagnosed and haven't tried other disease-modifying therapies (DMTs)
  • Your MS is stable with mild to moderate activity
  • You're JCV antibody positive with high titers (making Tysabri riskier)
  • Cost considerations are significant for your specific plan

Alternatives may not be appropriate when:

  • You have highly active relapsing MS requiring immediate high-efficacy treatment
  • You've already failed multiple first-line therapies
  • You're JCV antibody negative
  • Your neurologist has documented medical necessity for Tysabri specifically
Note: UnitedHealthcare's step therapy requirements don't preclude Tysabri approval—they simply require documentation of why preferred alternatives aren't suitable.

Typical Formulary Alternatives for Multiple Sclerosis

UnitedHealthcare's formulary typically includes these MS medications on lower tiers than Tysabri:

Injectable Therapies

  • Copaxone (glatiramer acetate): Daily or three-times-weekly injections
  • Rebif (interferon beta-1a): Three-times-weekly injections
  • Avonex (interferon beta-1a): Weekly intramuscular injections
  • Betaseron (interferon beta-1b): Every-other-day injections

Oral Therapies

  • Tecfidera (dimethyl fumarate): Twice-daily oral capsules
  • Gilenya (fingolimod): Daily oral capsules (requires cardiac monitoring)
  • Aubagio (teriflunomide): Daily oral tablets

Infusion Therapies (Higher Tier)

  • Ocrevus (ocrelizumab): Every 6 months IV infusion
  • Kesimpta (ofatumumab): Monthly self-injections after loading doses

Pros and Cons Overview

Formulary Alternatives

Access Considerations:

  • Lower copays and coinsurance
  • Faster approval process
  • No TOUCH program requirements
  • Available through regular specialty pharmacies

Testing and Monitoring:

  • Less intensive monitoring than Tysabri
  • Some require cardiac monitoring (Gilenya) or regular blood tests (Tecfidera)
  • No PML risk monitoring needed

Efficacy Considerations:

  • Moderate efficacy (29-53% relapse reduction vs. Tysabri's 68-70%)
  • May be sufficient for mild to moderate disease activity
  • Established safety profiles with known side effects

Tysabri

Access Considerations:

  • Higher specialty tier placement
  • Requires prior authorization and annual renewal
  • Mandatory TOUCH program enrollment
  • Limited to specific infusion centers

Testing and Monitoring:

  • JCV antibody testing every 6 months
  • Regular MRI monitoring for PML detection
  • More intensive safety surveillance

Efficacy Considerations:

  • High efficacy for relapse reduction and disability progression
  • Particularly effective for highly active MS
  • Risk of progressive multifocal leukoencephalopathy (PML)

Exception Strategy: When to Request Tysabri

Request a formulary exception for Tysabri when you can document:

Medical Necessity Criteria

  1. Inadequate response to preferred alternatives with specific metrics (relapse rates, MRI progression)
  2. Contraindications to formulary options (allergies, drug interactions, medical conditions)
  3. Intolerance to preferred therapies with documented side effects
  4. Highly active MS requiring immediate high-efficacy treatment

Evidence That Helps

  • Detailed treatment history with outcomes
  • Recent MRI showing active lesions
  • Neurological assessments documenting progression
  • JCV antibody negative status
  • Peer-reviewed literature supporting Tysabri for your specific situation
From our advocates: We've seen formulary exceptions succeed when neurologists provide comprehensive letters addressing each denial reason point-by-point, include relevant MRI reports, and reference clinical guidelines supporting high-efficacy therapy selection. The key is thorough documentation rather than generic requests.

Switching Logistics and Coordination

Provider Coordination

  1. Schedule neurologist appointment to discuss treatment options and document rationale
  2. Obtain current MRI and lab work to establish baseline before switching
  3. Complete TOUCH enrollment if planning to request Tysabri exception
  4. Document washout period if switching from immunosuppressive therapies

Pharmacy Coordination

  • Verify specialty pharmacy networks for each option
  • Confirm infusion center capabilities for IV therapies
  • Check copay assistance program eligibility
  • Coordinate timing to avoid treatment gaps

Insurance Coordination

  • Submit prior authorization for alternative first (if required by step therapy)
  • File formulary exception request simultaneously if appropriate
  • Track approval timelines and follow up promptly
  • Prepare appeal documentation in advance

Re-trying for Tysabri Later

If you start with a formulary alternative, document everything for a future Tysabri request:

What to Document During Alternative Therapy Trial

  • Baseline measurements: MRI findings, relapse frequency, EDSS scores
  • Treatment response: New relapses, MRI changes, side effects
  • Adherence: Injection site reactions, missed doses, compliance issues
  • Quality of life impacts: Work/activity limitations, symptom progression

Timeline for Re-evaluation

  • Minimum 6-month trial of alternative therapy (unless safety issues arise)
  • Annual MRI to assess disease activity
  • Regular neurological assessments
  • Document any breakthrough disease activity

Building Your Case

Keep detailed records showing:

  • Continued disease activity despite adequate trial
  • Side effects limiting adherence or quality of life
  • Progression in disability measures
  • New MRI lesions or gadolinium enhancement

Step-by-Step: Fastest Path to Approval

  1. Contact neurologist's office (Patient action) - Schedule appointment to discuss Tysabri and gather required documentation. Timeline: 1-2 weeks. Find UnitedHealthcare providers
  2. Complete TOUCH enrollment (Patient + Provider) - Both patient and prescriber must enroll in Biogen's TOUCH Prescribing Program. Timeline: 1-2 weeks. TOUCH Program enrollment
  3. Order required testing (Provider action) - JCV antibody testing (within 6 months) and recent MRI (within 12 months). Timeline: 1-2 weeks for results.
  4. Gather medical records (Clinic staff) - Compile treatment history, prior therapy failures, and supporting documentation. Timeline: 3-5 days.
  5. Submit prior authorization (Provider) - Use UnitedHealthcare provider portal or OptumRx system with complete documentation package. Timeline: Submit 2-3 weeks before needed.
  6. Follow up on decision (Patient + Provider) - Monitor PA status and respond to any requests for additional information. Timeline: 72 hours standard, 24 hours expedited.
  7. Prepare for potential appeal (All parties) - If denied, immediately begin internal appeal process with enhanced documentation. Timeline: Must file within 180 days of denial.

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
Missing TOUCH enrollment Complete enrollment for patient and prescriber TOUCH confirmation forms
Inadequate step therapy documentation Provide detailed history of prior DMT failures Treatment records with specific outcomes and side effects
Missing JCV antibody testing Submit recent test results (within 6 months) Lab report with JCV antibody status and titer
Insufficient MRI documentation Provide recent MRI showing disease activity Radiology report with gadolinium enhancement or new lesions
Not medically necessary Comprehensive medical necessity letter Neurologist letter addressing clinical guidelines and patient-specific factors

Appeals Playbook for UnitedHealthcare in New Jersey

Internal Appeals Process

  • Level 1: File within 180 days of denial
  • Timeline: UnitedHealthcare has 60 days for decision
  • Submission: Via provider portal, phone (800-711-4555), or fax
  • Required: Denial letter, additional medical evidence, physician letter

External Review (IHCAP)

  • When: After exhausting internal appeals
  • Timeline: 45 days for standard review, 72 hours for urgent
  • Cost: Free to patients
  • Administrator: Maximus Federal Services
  • Contact: NJ DOBI Consumer Hotline

Required Documentation for Appeals

  1. Original denial letter with specific reasons
  2. Complete medical records supporting necessity
  3. Physician letter addressing each denial reason
  4. Clinical guidelines supporting treatment choice
  5. Evidence of prior therapy failures or contraindications
Tip: New Jersey's IHCAP has a strong record of overturning denials when medical necessity is well-documented. The external review is binding if decided in your favor.

FAQ

How long does UnitedHealthcare prior authorization take in New Jersey? Standard prior authorization decisions are made within 72 hours. Expedited requests (when delay could cause harm) are decided within 24 hours.

What if Tysabri is non-formulary on my plan? You can request a formulary exception by demonstrating that covered alternatives are inappropriate due to contraindications, previous failures, or medical necessity.

Can I request an expedited appeal in New Jersey? Yes, if a delay in treatment could cause serious harm to your health. Expedited appeals through IHCAP are completed within 72 hours.

Does step therapy apply if I've failed therapies outside New Jersey? Treatment failures from other states count toward step therapy requirements. Provide complete documentation of previous therapies and outcomes.

What happens if my appeal is successful? If IHCAP overturns the denial, UnitedHealthcare must comply and cover the treatment. The decision is legally binding under New Jersey law.

How much does Tysabri cost with UnitedHealthcare coverage? Costs vary by plan, but Tysabri is typically on specialty tier with higher copays. Biogen offers copay assistance up to $3,250 annually for eligible commercial patients.

Can my doctor file appeals on my behalf? Yes, New Jersey allows providers to file external appeals on behalf of patients with proper consent.

What if I need treatment while waiting for appeals? Contact your neurologist about bridge therapy options or temporary alternatives. Some situations may qualify for expedited review to prevent treatment gaps.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes. Our platform analyzes denial letters, identifies specific requirements, and drafts targeted appeals with evidence-backed rebuttals. By turning insurance denials into successful approvals, we ensure patients get timely access to necessary medications like Tysabri. Learn more about our coverage advocacy services.

When facing UnitedHealthcare denials in New Jersey, having expert support can significantly improve your chances of success. Counterforce Health's specialized approach to appeals has helped numerous patients secure coverage for high-cost specialty medications through comprehensive documentation and strategic advocacy.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may vary by specific plan and change over time. Always consult with your healthcare provider and insurance company for the most current requirements and your specific situation. For questions about New Jersey insurance regulations, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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