By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by UnitedHealthcare in New Jersey: Complete Prior Authorization Guide

Answer Box: Getting Tegsedi Covered by UnitedHealthcare in New Jersey

To get Tegsedi (inotersen) covered by UnitedHealthcare in New Jersey, you need: (1) confirmed hATTR polyneuropathy with genetic testing showing TTR mutation, (2) REMS program enrollment for both patient and prescriber, and (3) prior authorization through UnitedHealthcare's provider portal. Submit complete documentation including genetic test results, neurologist consultation, and lab monitoring plan. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review through Maximus within 45 days. Start by confirming your coverage type and gathering genetic testing documentation.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Coverage
  4. Coding and Billing Documentation
  5. Documentation Packet Requirements
  6. Submission Process
  7. REMS Program and Specialty Pharmacy
  8. After Submission: Tracking Your Request
  9. Common Denial Prevention Tips
  10. Appeals Process in New Jersey
  11. Costs and Financial Assistance
  12. Frequently Asked Questions

Who Should Use This Guide

This guide is for patients diagnosed with hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR) who have UnitedHealthcare coverage in New Jersey and need Tegsedi (inotersen) approved. You'll also find this helpful if you're a caregiver, neurologist, or clinic staff member managing prior authorization requests.

Expected outcome: With complete documentation and proper submission, most medically appropriate Tegsedi requests receive approval within 5-7 business days. If initially denied, New Jersey's robust external review process gives you strong appeal rights.

Member & Plan Basics

Coverage Requirements

  • Active UnitedHealthcare coverage: Verify your plan is active and covers specialty medications
  • Plan type matters: Fully-insured New Jersey plans qualify for state external review; self-funded employer plans follow different federal rules
  • Prior authorization required: Tegsedi requires prior authorization for all UnitedHealthcare plans
  • Specialty tier placement: Typically placed on highest formulary tier with significant cost-sharing
Note: Check your Summary of Benefits to understand your specialty medication copay or coinsurance before starting treatment.

Deductible and Authorization Timeline

UnitedHealthcare processes Tegsedi prior authorization requests within 5-7 business days for standard review. Urgent requests (when delay could cause serious harm) receive expedited review within 72 hours.

Clinical Criteria for Coverage

Primary Requirements

UnitedHealthcare requires all of the following criteria for Tegsedi approval:

Requirement Details Documentation Needed
Diagnosis Confirmed hATTR polyneuropathy Genetic testing showing pathogenic TTR mutation (e.g., V30M)
Prescriber Neurologist prescription Consultation note or prescription from neurologist
Disease Severity PND score ≤ IIIb OR FAP Stage 1-2 OR NIS score 10-130 Clinical assessment documenting baseline severity
Clinical Signs Peripheral sensorimotor polyneuropathy, autonomic neuropathy, or motor disability Physical exam findings and symptom documentation
Exclusion No prior liver transplant Medical history confirmation

Baseline Laboratory Requirements

Before starting Tegsedi, patients must have:

  • Platelet count ≥ 100 x 10⁹/L
  • Normal kidney function (creatinine and urinalysis)
  • Liver function tests within acceptable range
Important: These lab values must be documented in your prior authorization request, as Tegsedi carries FDA black box warnings for thrombocytopenia and kidney problems.

Coding and Billing Documentation

ICD-10 Diagnosis Code

Use E85.1 (Neuropathic heredofamilial amyloidosis) as the primary diagnosis code. This directly corresponds to Tegsedi's FDA-approved indication.

HCPCS and NDC Numbers

HCPCS Codes:

  • J3490 (Unclassified drugs - specify as Tegsedi/inotersen)
  • C9399 (Unclassified drugs or biologicals - specify as Tegsedi)

NDC Numbers:

  • 72126-0007-02: Tegsedi 284mg/1.5mL prefilled syringe
  • 72126-0007-01: Alternative NDC for same formulation

Billing Units: Always specify 284 mg per dose, not "1 unit" per syringe, to prevent claim rejections.

Documentation Packet Requirements

Medical Necessity Letter Components

Your neurologist should include these elements in the letter of medical necessity:

  1. Patient identification and confirmed hATTR diagnosis
  2. Genetic testing results showing specific TTR mutation
  3. Clinical presentation including neurological symptoms and functional impairment
  4. Disease progression and current severity scores (PND, FAP stage, or NIS)
  5. Treatment rationale explaining why Tegsedi is appropriate
  6. Monitoring plan for required lab surveillance
  7. Alternative treatments considered and why Tegsedi is preferred

Required Attachments

  • Genetic testing report confirming TTR mutation
  • Neurologist consultation notes
  • Baseline laboratory results (CBC with platelets, comprehensive metabolic panel, urinalysis)
  • Clinical assessment tools (PND score, FAP staging, or NIS score)
  • REMS enrollment confirmation for both patient and prescriber

Submission Process

Online Portal Submission

  1. Access the UnitedHealthcare Provider Portal at UHCprovider.com
  2. Sign in with your One Healthcare ID and password
  3. Select "Prior Authorization and Notification" from your dashboard
  4. Choose "Pharmacy Benefits" (not medical benefits) for Tegsedi
  5. Complete all required fields including patient demographics, diagnosis codes, and clinical justification
  6. Upload supporting documentation as PDF files
  7. Submit and record confirmation number
Alternative: Call 866-889-8054 for assistance with prior authorization submission.

Critical Submission Requirements

  • Complete REMS enrollment before submission
  • Include all required attachments (missing documents cause automatic denials)
  • Use correct diagnosis code (E85.1)
  • Specify exact dosing (284 mg weekly subcutaneous)
  • Document monitoring plan for ongoing lab surveillance

REMS Program and Specialty Pharmacy

REMS Enrollment Process

Both patient and prescriber must enroll in the FDA Risk Evaluation and Mitigation Strategy (REMS) program before Tegsedi can be dispensed:

  1. Prescriber enrollment: Complete REMS training and certification
  2. Patient enrollment: Review safety information and monitoring requirements
  3. Pharmacy certification: Only REMS-certified specialty pharmacies can dispense Tegsedi

Specialty Pharmacy Routing

UnitedHealthcare typically directs Tegsedi to OptumRx specialty pharmacy or other contracted specialty pharmacies. Confirm your plan's preferred specialty pharmacy network to avoid coverage issues.

Transfer steps:

  1. Prior authorization approval received
  2. Prescription sent to REMS-certified specialty pharmacy
  3. Pharmacy verifies REMS enrollment
  4. Patient contacted for delivery coordination
  5. First shipment includes injection training materials

After Submission: Tracking Your Request

Status Check Schedule

  • Day 1-2: Confirmation of receipt and preliminary review
  • Day 3-5: Clinical review and determination
  • Day 5-7: Final decision and notification

What to Record

Keep detailed records of:

  • Confirmation number from submission
  • Date and time of submission
  • Representative names from any phone calls
  • Reference numbers for status checks
  • Decision letters and any denial reasons
Tip: Check status through the UnitedHealthcare provider portal or member portal for real-time updates.

Common Denial Prevention Tips

Five Pitfalls to Avoid

Common Issue Prevention Strategy
Incomplete REMS enrollment Verify both patient and prescriber REMS status before submission
Missing genetic testing Include complete genetic report showing specific TTR mutation
Incorrect diagnosis code Always use E85.1, not general amyloidosis codes
Insufficient clinical documentation Include baseline severity scores and functional assessments
Wrong submission pathway Submit through pharmacy benefits, not medical benefits

Documentation Checklist

Before submitting, confirm you have:

  • ☐ Genetic testing report with TTR mutation
  • ☐ Neurologist consultation note
  • ☐ Baseline lab results (platelets ≥ 100 x 10⁹/L)
  • ☐ Clinical severity assessment
  • ☐ REMS enrollment confirmation
  • ☐ Medical necessity letter
  • ☐ Correct ICD-10 code (E85.1)

Appeals Process in New Jersey

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal:

  • Timeline: File within 180 days of denial
  • Response time: 30 days (72 hours for urgent)
  • Submit via: UnitedHealthcare provider portal or member services

Level 2 Internal Appeal:

  • Timeline: File within 60 days of Level 1 denial
  • Response time: 30 days (72 hours for urgent)
  • Required: Must complete before external review

New Jersey External Review (IHCAP)

After completing internal appeals, New Jersey residents can request external review through the Independent Health Care Appeals Program (IHCAP):

Eligibility:

  • Fully-insured UnitedHealthcare plan issued in New Jersey
  • Completed internal appeal process
  • Denial based on medical necessity

Filing Process:

  1. Submit online through Maximus Portal for NJ IHCAP
  2. Timeline: File within 4 months of final internal denial
  3. Review period: Decision within 45 days (expedited within 48 hours)
  4. Cost: Free to patients

Contact: Maximus Federal at 1-609-292-5316

Important: IHCAP decisions are binding on UnitedHealthcare and have strong success rates for medically appropriate requests.

Costs and Financial Assistance

Manufacturer Support

Ionis Pharmaceuticals offers patient assistance programs for eligible patients. Contact their patient support services to explore:

  • Copay assistance programs for commercially insured patients
  • Patient assistance programs for uninsured or underinsured patients
  • Bridge programs during prior authorization review

State Resources

New Jersey residents may qualify for additional support through:

  • NJ FamilyCare (Medicaid expansion)
  • Pharmaceutical Assistance to the Aged and Disabled (PAAD)
  • Senior Gold Prescription Discount Program

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Tegsedi in New Jersey? Standard review takes 5-7 business days. Urgent requests receive expedited review within 72 hours when medical urgency is documented.

What if Tegsedi is non-formulary on my plan? Tegsedi requires prior authorization but is typically covered when medical necessity criteria are met. Non-formulary status doesn't prevent coverage with proper documentation.

Can I request an expedited appeal in New Jersey? Yes, both UnitedHealthcare internal appeals and New Jersey external review offer expedited processes when delay could cause serious harm to your health.

Does step therapy apply to Tegsedi? UnitedHealthcare does not explicitly require step therapy for Tegsedi, but they may request documentation of why Tegsedi is preferred over alternatives.

What happens if my appeal is denied? After exhausting UnitedHealthcare's internal appeals, you can request external review through New Jersey's IHCAP program, which provides independent medical review.

How do I find a REMS-certified specialty pharmacy? Your prescriber or UnitedHealthcare can provide a list of REMS-certified specialty pharmacies in your network.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, pulling the right medical evidence and ensuring procedural compliance for stronger appeal outcomes.

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and follow your specific insurance plan's procedures. For official guidance on New Jersey insurance appeals, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

Sources & Further Reading

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