By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (inotersen) Covered by UnitedHealthcare in Florida: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tegsedi (inotersen) Approved by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Tegsedi (inotersen) with strict criteria: confirmed hATTR polyneuropathy (ICD-10 E85.1), pathogenic TTR mutation, neurologist involvement, and REMS enrollment. No step therapy required, but baseline labs and monitoring plan are mandatory. First step: Gather genetic test results, neurologist notes with PND/FAP staging, and REMS enrollment confirmation. Submit via UnitedHealthcare Provider Portal with complete documentation package. If denied, file internal appeal within 180 days, then Florida external review within 4 months of final denial.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. ICD-10 Coding and Documentation Requirements
  4. HCPCS/J-Code and NDC Information
  5. Common Denial Reasons & How to Fix Them
  6. Appeals Process for Florida Residents
  7. Clinician Corner: Medical Necessity Letter
  8. Cost Assistance and Support Programs
  9. FAQ: Your Most Common Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Tegsedi use UnitedHealthcare Provider Portal UHC PA Policy
Diagnosis Code E85.1 (hATTR polyneuropathy) Medical records, genetic testing UHC PA Requirements
HCPCS Codes J3490 or C9399 (unclassified) Claims submission UHC Self-Admin List
NDC Code 72126-0007-02 Pharmacy dispensing Product labeling
REMS Enrollment Patient, prescriber, pharmacy Tegsedi REMS portal FDA REMS Program
Prescriber Type Neurologist or consultation Medical records UHC PA Policy
Step Therapy None required nationally Plan documents UHC PA Policy

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Benefits

Who: Patient or clinic staff
What: Call UnitedHealthcare member services to confirm pharmacy vs. medical benefit coverage
Timeline: Same day
Source: UHC Member Services

2. Complete REMS Enrollment

Who: Prescriber, patient, and specialty pharmacy
What: Enroll all parties in Tegsedi REMS program before PA submission
Timeline: 1-3 business days
Source: FDA REMS Requirements

3. Gather Required Documentation

Who: Clinic staff
What: Genetic test results, neurologist notes, baseline labs, monitoring plan
Timeline: 1-2 weeks
Source: UHC PA Policy

4. Submit Prior Authorization

Who: Prescriber or authorized staff
What: Complete PA form via UnitedHealthcare Provider Portal with all supporting documents
Timeline: Same day submission
Source: UHC Provider Portal

5. Track Status and Respond to Requests

Who: Clinic staff
What: Monitor PA status; provide additional information if requested
Timeline: 5-7 business days for standard review
Source: UHC PA Process

6. Appeal if Denied

Who: Prescriber with patient support
What: File internal appeal within 180 days using denial letter instructions
Timeline: 30-60 days for appeal decision
Source: UHC Appeals Process

7. External Review (if needed)

Who: Patient or authorized representative
What: Request Florida external review within 4 months of final denial
Timeline: 45-60 days for decision
Source: Florida External Review

ICD-10 Coding and Documentation Requirements

Primary Diagnosis Code

E85.1 - Neuropathic heredofamilial amyloidosis is the primary code for hATTR polyneuropathy. This code must be clearly supported by:

  • Genetic testing showing pathogenic TTR mutation
  • Clinical documentation of polyneuropathy symptoms
  • Neurologist confirmation of hereditary ATTR amyloidosis

Supporting Documentation Words

Your medical records should include these specific terms to support E85.1 coding:

  • "Hereditary transthyretin-mediated amyloidosis"
  • "Pathogenic TTR mutation"
  • "Progressive sensorimotor polyneuropathy"
  • "Autonomic neuropathy" (if present)
  • "Familial amyloid polyneuropathy"
Tip: Ensure your neurologist's notes explicitly link the neuropathy to hereditary ATTR amyloidosis rather than using generic neuropathy terms.

Disease Staging Requirements

UnitedHealthcare requires one of these documented staging measures:

  • PND (Polyneuropathy Disability) score ≤ IIIb
  • FAP Stage 1 or 2
  • NIS (Neuropathy Impairment Score) ≥ 10 and ≤ 130

HCPCS/J-Code and NDC Information

Billing Codes for Tegsedi

  • HCPCS Codes: J3490 (unclassified drugs) or C9399 (unclassified drugs/biologicals)
  • NDC Code: 72126-0007-02 (Tegsedi 284mg/1.5mL prefilled syringe)
  • Units: Typically billed per injection (weekly dosing)

Pharmacy vs. Medical Benefit

Tegsedi is usually covered under the pharmacy benefit as a self-administered subcutaneous injection. Verify with UnitedHealthcare which benefit applies to your specific plan, as this affects the approval pathway.

Note: Claims using J3490 or C9399 will pend for manual review due to the unclassified nature of these codes.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Insufficient REMS documentation Submit REMS enrollment confirmations Patient, prescriber, pharmacy REMS IDs
Missing lab monitoring plan Provide detailed weekly/monthly schedule Written protocol with specific thresholds
Inadequate disease staging Include neurologist assessment PND/FAP/NIS scores in consultation note
No genetic confirmation Attach genetic test report Lab report showing pathogenic TTR mutation
Missing neurologist involvement Document specialist consultation Neurology referral or consultation note
Incomplete baseline labs Submit required lab values Platelets ≥100k, eGFR ≥45, urinalysis

Source: UHC PA Policy

Appeals Process for Florida Residents

Internal Appeals with UnitedHealthcare

  1. File within 180 days of denial notice
  2. Submit electronically via UnitedHealthcare Provider Portal (mandatory for Florida Medicaid as of June 2025)
  3. Include peer-to-peer review request for complex cases
  4. Expedited appeals available for urgent medical situations

Timeline: 30 days for standard appeals, 72 hours for expedited

Florida External Review

If internal appeals fail, Florida law provides independent external review:

  1. Request within 4 months of final UnitedHealthcare denial
  2. Submit to Florida Department of Financial Services
  3. No cost to patient for external review process
  4. Binding decision if reviewer finds treatment medically necessary

Timeline: 45 days standard, 60 days for complex cases

Contact: Florida Division of Consumer Services or call 1-877-693-5236

Source: Florida External Review Process

Clinician Corner: Medical Necessity Letter

Essential Components for Tegsedi Approval

Patient Presentation

  • Detailed description of polyneuropathy symptoms and progression
  • Impact on daily functioning and quality of life
  • Objective neurological examination findings

Diagnostic Evidence

  • Genetic test results with specific TTR mutation identified
  • Pathogenic classification of the mutation
  • Family history of hATTR amyloidosis if applicable

Clinical Rationale

  • Why Tegsedi is medically necessary for this patient
  • Consideration of alternative therapies and why they're not suitable
  • Treatment goals and expected outcomes

Monitoring Plan

  • Weekly platelet monitoring schedule
  • Quarterly renal function assessments
  • Protocols for dose interruption or discontinuation
Evidence Base: Reference FDA prescribing information and published clinical trials demonstrating Tegsedi's efficacy in hATTR polyneuropathy. The NEURO-TTR study showed significant reduction in neuropathy progression compared to placebo.

At Counterforce Health, we help clinicians and patients navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Our platform specializes in identifying denial reasons and crafting point-by-point rebuttals aligned to each payer's specific requirements.

Cost Assistance and Support Programs

Manufacturer Support

  • Tegsedi Patient Support Program (verify current availability with manufacturer)
  • Copay assistance for eligible commercial insurance patients
  • Free drug programs for uninsured patients meeting income criteria

Foundation Assistance

  • Patient Advocate Foundation copay relief programs
  • HealthWell Foundation rare disease assistance
  • National Organization for Rare Disorders (NORD) patient assistance

State Resources

  • Florida Medicaid coverage for eligible low-income residents
  • 340B Drug Pricing Program at qualifying healthcare facilities
Important: Due to manufacturer decisions regarding Tegsedi distribution, verify current availability and support program status before initiating treatment.

FAQ: Your Most Common Questions

How long does UnitedHealthcare prior authorization take in Florida?
Standard review is 5-7 business days. Expedited review for urgent cases can be completed within 24-72 hours when properly justified.

What if Tegsedi is not on my plan's formulary?
Non-formulary drugs can still be covered with prior authorization demonstrating medical necessity. Submit a comprehensive PA with strong clinical justification.

Can I request an expedited appeal in Florida?
Yes, expedited appeals are available for situations where delays could jeopardize your health or ability to regain maximum function. Document the urgency in your appeal.

Does UnitedHealthcare require step therapy for Tegsedi?
No, current UnitedHealthcare national policy does not require prior failure of other hATTR therapies, though individual plan variations may exist.

What happens if my external review is approved?
UnitedHealthcare must cover the treatment as determined by the external reviewer. This decision is binding under Florida and federal law.

How do I find a REMS-certified specialty pharmacy?
Contact OptumRx at 1-855-427-9685 or check the Tegsedi REMS program website for current certified pharmacy networks.

What if I move from Florida to another state during treatment?
Contact UnitedHealthcare member services to understand how your coverage may change. Continue current therapy while transitioning to new state requirements.

Can my family doctor prescribe Tegsedi?
UnitedHealthcare requires prescription by or in consultation with a neurologist. Your family doctor can coordinate with a neurologist for the prescription.

For patients and families facing coverage challenges, Counterforce Health provides specialized support in navigating insurance denials and crafting successful appeals with evidence-backed documentation tailored to each payer's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions vary by individual plan and circumstances. Always consult with your healthcare provider for medical decisions and verify current policy information with UnitedHealthcare and Florida regulatory authorities. For personalized assistance with coverage appeals, consider consulting with qualified patient advocacy services.

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