By Counterforce Health Team in Tegsedi (inotersen) —

Getting Tegsedi (Inotersen) Covered by Humana in Illinois: Complete Guide to Prior Authorization and Appeals

Answer Box: Your Fastest Path to Tegsedi Coverage

To get Tegsedi (inotersen) covered by Humana in Illinois: First, ensure you and your prescriber are enrolled in the mandatory REMS program at tegsedirems.com. Submit a formulary exception request with genetic testing confirming TTR mutation, detailed neurological documentation, and a comprehensive lab monitoring plan. Humana must respond within 72 hours for standard requests. If denied, you have 65 days to appeal and can request Illinois external review within 30 days of final denial. Start with REMS enrollment today—it's required before any coverage consideration.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Essential Coding and Billing Information
  4. REMS Program Requirements
  5. Common Denial Reasons & How to Fix Them
  6. Illinois Appeals Process
  7. Cost Assistance Options
  8. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Always required for Tegsedi Humana provider portal Humana PA List
REMS Enrollment Patient, prescriber, and pharmacy must be certified tegsedirems.com FDA REMS
Genetic Testing TTR mutation confirmation required Lab results or genetic counselor report Humana Policy
ICD-10 Code E85.1 (Neuropathic heredofamilial amyloidosis) Medical records CMS Guidelines
Specialist Involvement Neurologist, geneticist, or amyloidosis specialist Provider credentials in PA Humana Coverage Determination

Step-by-Step: Fastest Path to Approval

1. Complete REMS Enrollment (Start Here)

Who: Patient and prescriber
What: Register at tegsedirems.com and complete safety training
Timeline: Allow 3-5 business days for processing
Why this matters: No coverage consideration without REMS certification

2. Gather Required Documentation

Who: Medical team
What: Collect genetic testing, neurological assessments, and baseline labs
Documents needed:

  • TTR gene mutation results
  • Clinical notes documenting polyneuropathy symptoms
  • Baseline platelet count and kidney function tests
  • Previous treatment history (if applicable)

3. Submit Formulary Exception Request

Who: Prescriber or patient
What: Complete Medicare Prescription Drug Coverage Determination form
How: Submit via Humana provider portal or fax to 1-855-681-8650
Timeline: Humana responds within 72 hours (24 hours for expedited)

4. Include Comprehensive Medical Necessity Letter

Who: Prescriber
What: Detailed letter explaining why Tegsedi is medically necessary
Must include:

  • Confirmed hATTR polyneuropathy diagnosis
  • Previous treatment failures or contraindications to alternatives
  • Expected clinical benefits
  • Monitoring plan for safety labs

5. Monitor Response and Follow Up

Who: Patient or clinic staff
What: Track request status and prepare for potential appeal
Timeline: Standard determination within 72 hours

Essential Coding and Billing Information

ICD-10 Diagnosis Coding

Primary code: E85.1 (Neuropathic heredofamilial amyloidosis)
This specific code is crucial for coverage approval as it directly corresponds to Tegsedi's FDA-approved indication for hATTR polyneuropathy.

HCPCS and NDC Information

HCPCS Code: J3490 (Unclassified drugs - specify "Tegsedi (inotersen)")
NDC: 72126-0120-01 (verify from dispensed vial)
Billing units: 284 mg per injection (one prefilled syringe)
Quantity limits: Maximum 4 syringes per 28 days

Billing Tip: Claims often reject due to unit confusion. Always bill as 284 mg per dose, not "1 unit" per syringe, unless your specific payer requires otherwise.

Common Billing Pitfalls

  • Incorrect unit calculations leading to quantity limit violations
  • Missing prior authorization numbers on claims
  • Inadequate diagnosis documentation supporting medical necessity
  • REMS enrollment status not verified before dispensing

REMS Program Requirements

Tegsedi requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to serious safety risks including thrombocytopenia and glomerulonephritis.

Enrollment Requirements

Prescribers must:

  • Complete online training at tegsedirems.com
  • Obtain REMS certification number
  • Counsel patients on risks and monitoring requirements

Patients must:

  • Sign informed consent acknowledging risks
  • Agree to required laboratory monitoring schedule
  • Understand symptoms requiring immediate medical attention

Pharmacies must:

  • Be REMS-certified to dispense Tegsedi
  • Verify patient and prescriber enrollment before dispensing
  • Document REMS compliance in pharmacy records

Laboratory Monitoring Plan

Weekly: Platelet count monitoring (risk of thrombocytopenia)
Monthly: Kidney function tests including creatinine and urinalysis (risk of glomerulonephritis)
Baseline: Comprehensive metabolic panel before starting treatment

Counterforce Health helps patients and providers navigate complex REMS requirements by organizing documentation and ensuring all safety protocols are properly documented for insurance approval.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
REMS enrollment incomplete Submit proof of certification REMS enrollment numbers for patient, prescriber, pharmacy
Insufficient genetic documentation Provide comprehensive genetic testing TTR mutation analysis report from certified lab
Lack of specialist involvement Include specialist consultation Notes from neurologist, geneticist, or amyloidosis specialist
Inadequate monitoring plan Submit detailed safety protocol Weekly platelet and monthly kidney function monitoring schedule
Prior therapy not documented Show treatment history Records of previous medications tried and outcomes

Medical Necessity Letter Checklist

Your prescriber's letter should include:

  • ✓ Confirmed hATTR polyneuropathy diagnosis with genetic testing
  • ✓ Clinical symptoms and functional impairment documentation
  • ✓ Previous treatment attempts and why they failed or are contraindicated
  • ✓ Expected benefits from Tegsedi therapy
  • ✓ Comprehensive monitoring plan for safety labs
  • ✓ Specialist credentials and experience with hATTR amyloidosis

Illinois Appeals Process

Illinois provides strong patient rights for insurance appeals, including independent external review by qualified physicians.

Internal Appeal (First Step)

Timeline: File within 65 days of denial
Humana response time: 15 business days for standard, 24 hours for expedited
How to file: Use Humana appeals form or write a letter
Required: Copy of denial letter, additional medical records, prescriber statement

External Review (If Internal Appeal Fails)

Timeline: Request within 30 days of final internal denial
Process: Independent Review Organization (IRO) conducts physician review
Decision timeline: 5 business days after IRO receives all materials
Cost: Free to patients (insurers pay IRO fees)
How to request: Contact Illinois Department of Insurance at (877) 527-9431

Illinois-Specific: The 30-day deadline for external review is shorter than many states' 4-month window, so act quickly after a final denial.

State Resources for Help

Illinois Department of Insurance Office of Consumer Health Insurance (OCHI):
Phone: (877) 527-9431
Assists with appeals, external reviews, and insurance complaints

Illinois Attorney General Health Care Bureau:
Phone: (877) 305-5145
Can intervene informally with insurers on complex cases

Cost Assistance Options

Manufacturer Support

Ionis Pharmaceuticals offers patient assistance programs for eligible individuals. Contact their patient support team for current program details and eligibility requirements.

Medicare Extra Help

If you have Medicare Part D, you may qualify for Extra Help (Low Income Subsidy) to reduce prescription costs. Apply at ssa.gov or call (800) 772-1213.

State and Foundation Programs

Illinois residents may qualify for additional assistance through:

  • Patient Advocate Foundation
  • NeedyMeds prescription assistance programs
  • Local community health center sliding fee programs

FAQ

How long does Humana prior authorization take for Tegsedi in Illinois?
Standard determinations: 72 hours. Expedited reviews (when health is at risk): 24 hours. Source: Humana Coverage Determination Policy

What if Tegsedi is non-formulary on my Humana plan?
You can request a formulary exception with medical necessity documentation. Your prescriber must explain why formulary alternatives are less effective or would cause adverse effects.

Can I request an expedited appeal in Illinois?
Yes, if waiting for a standard timeline would seriously jeopardize your health. Both Humana and Illinois external review processes offer expedited options (24-72 hours).

Do I need to complete step therapy before getting Tegsedi?
This varies by plan. If step therapy is required, document previous treatments and their outcomes. Failed trials or contraindications to other hATTR therapies can support an exception request.

What happens if I miss the REMS monitoring requirements?
Missing required labs may result in therapy interruption until monitoring is completed. Maintain strict adherence to weekly platelet counts and monthly kidney function tests.

How do I find REMS-certified pharmacies in Illinois?
Use the pharmacy locator at tegsedirems.com to find certified dispensing pharmacies near you.

From our advocates: We've seen patients successfully obtain Tegsedi coverage by ensuring all three components—genetic documentation, REMS enrollment, and detailed monitoring plans—are submitted together in the initial request. This comprehensive approach often prevents the back-and-forth that delays approval.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful approvals for complex specialty medications like Tegsedi. Our platform analyzes denial letters, identifies specific coverage gaps, and generates evidence-backed appeals tailored to each payer's requirements. We help patients, clinicians, and specialty pharmacies navigate the intricate prior authorization process while ensuring compliance with safety programs like REMS.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage policies may change, and individual circumstances vary.

Sources & Further Reading

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