By Counterforce Health Team in Tegsedi (inotersen) —

The Requirements Checklist to Get Tegsedi (inotersen) Covered by Aetna (CVS Health) in New Jersey

Answer Box: Getting Tegsedi (inotersen) Covered by Aetna (CVS Health) in New Jersey

Key Requirements: Confirm TTR gene mutation, specialist prescription (neurologist/geneticist), REMS enrollment, and prior authorization approval. Timeline: PA decision typically 30-45 days; appeals have 180-day deadline. First Step: Contact your prescriber to gather genetic testing results and clinical documentation, then submit Aetna's prior authorization form with REMS enrollment proof. New Jersey residents have strong external appeal rights through IHCAP if initially denied.

Important Note: Tegsedi's manufacturer announced commercial discontinuation as of September 27, 2024. Verify current availability before starting the authorization process.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Setup
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Avoid Them
  10. Appeals Process in New Jersey
  11. Quick Reference Checklist
  12. FAQ

Who Should Use This Guide

This checklist is designed for:

  • Patients diagnosed with hATTR polyneuropathy who need Tegsedi (inotersen) and have Aetna (CVS Health) coverage in New Jersey
  • Healthcare providers submitting prior authorization requests for Tegsedi
  • Caregivers and advocates helping patients navigate the approval process

Expected Outcome: Following this checklist increases your chances of first-time approval by ensuring all required documentation is complete and properly formatted according to Aetna's specific criteria.

Member & Plan Basics

Coverage Verification Steps

  1. Confirm Active Coverage: Verify your Aetna (CVS Health) plan is active and includes prescription benefits
  2. Check Plan Type: Most Aetna plans require prior authorization for Tegsedi, regardless of commercial, Medicare Advantage, or Medicaid status
  3. Specialty Pharmacy Network: Tegsedi is dispensed through CVS Specialty Pharmacy or other approved specialty providers
  4. Deductible Status: Specialty medications may apply to your annual deductible before copay assistance kicks in
Tip: Call the member services number on your insurance card to confirm specialty pharmacy benefits and any step therapy requirements before starting the PA process.

Clinical Criteria Requirements

Based on Aetna's 2024 policy, Tegsedi requires the following clinical criteria:

Required Clinical Elements

Requirement Details Documentation Needed
Age 18 years or older Date of birth verification
Genetic Confirmation TTR gene mutation detected Genetic testing report
Clinical Diagnosis hATTR polyneuropathy with symptoms Clinical notes, exam findings
Specialist Involvement Prescribed by neurologist, geneticist, or amyloidosis specialist Prescriber credentials
Monotherapy Cannot combine with other hATTR treatments Medication reconciliation
REMS Enrollment Patient and prescriber enrolled in safety program REMS documentation

Step Therapy Considerations

Aetna may require documentation of:

  • Previous treatments tried and failed or contraindicated
  • Intolerance to first-line therapies
  • Clinical rationale for Tegsedi as appropriate choice

Coding & Billing Information

Medical Coding Requirements

  • ICD-10 Diagnosis: E85.1 (Neuropathic heredofamilial amyloidosis)
  • HCPCS Code: J3490 (Unclassified drugs) - specify "Tegsedi (inotersen)" in documentation
  • NDC Code: 72126-007-01 (284 mg/1.5 mL prefilled syringe)
  • Administration: Self-administered subcutaneous injection
Note: There is no product-specific J-code for Tegsedi. Claims must use the unclassified code with detailed drug identification.

Documentation Packet

Provider Note Elements

Your healthcare provider's documentation must include:

  1. Patient Demographics: Full name, DOB, insurance information
  2. Diagnosis Confirmation:
    • TTR gene mutation results
    • Clinical symptoms of polyneuropathy
    • Disease progression notes
  3. Treatment History: Previous therapies attempted, outcomes, reasons for discontinuation
  4. Clinical Rationale: Why Tegsedi is medically necessary for this patient
  5. Monitoring Plan: REMS compliance strategy, lab monitoring schedule

Letter of Medical Necessity Components

A comprehensive letter should address:

  • Problem Statement: Clear diagnosis of hATTR polyneuropathy
  • Prior Treatments: Specific medications tried, duration, and outcomes
  • Clinical Evidence: Genetic testing, symptom progression, functional impact
  • Treatment Plan: Tegsedi dosing, monitoring, and expected outcomes
  • Supporting Literature: FDA approval, clinical guidelines, relevant studies

Required Attachments

  • Genetic testing report showing TTR mutation
  • Recent clinical notes documenting polyneuropathy symptoms
  • REMS enrollment confirmation for patient and prescriber
  • Baseline laboratory results (platelets, kidney function)
  • Prior medication trials documentation (if applicable)

Submission Process

Step-by-Step Submission

  1. Complete PA Form: Use Aetna's current prior authorization form (verify latest version on Aetna provider portal)
  2. Gather Documentation: Compile all required clinical documents and attachments
  3. Submit Request:
    • Online: Through Aetna provider portal (preferred method)
    • Fax: To number specified on PA form
    • Phone: For urgent requests requiring expedited review
  4. Confirm Receipt: Obtain confirmation number and expected decision timeline

Timeline Expectations

  • Standard Review: 30-45 days from complete submission
  • Expedited Review: 72 hours for urgent medical situations
  • Incomplete Requests: Additional 15-30 days for missing information

Specialty Pharmacy Setup

CVS Specialty Enrollment Process

  1. Provider Enrollment: Complete CVS Specialty enrollment form
  2. REMS Verification: Confirm both patient and prescriber are enrolled in Tegsedi REMS
  3. Prescription Transfer: If transferring from another pharmacy, provide previous prescription details
  4. Shipment Coordination: CVS will contact patient directly for delivery scheduling

Required REMS Elements

  • Patient Education: Complete Tegsedi patient guide and safety information
  • Monitoring Schedule: Regular platelet and kidney function tests
  • Provider Certification: Prescriber must be REMS-certified
  • Pharmacy Certification: Dispensing pharmacy must participate in REMS program

Counterforce Health specializes in helping patients and providers navigate complex specialty drug approvals like Tegsedi. Their platform can identify specific denial reasons and create targeted appeals that address payer requirements while ensuring all clinical documentation meets industry standards.

After Submission: What to Expect

Tracking Your Request

  1. Confirmation Number: Record the PA reference number for all follow-up calls
  2. Status Checks: Call Aetna provider services weekly if no update after 2 weeks
  3. Additional Information: Respond promptly to any requests for supplemental documentation
  4. Decision Notification: Approval or denial will be sent to both patient and prescriber

If Approved

  • CVS Specialty will contact patient for shipment coordination
  • First dose typically ships within 3-5 business days of approval
  • Patient will receive injection training and ongoing support

If Denied

  • Review denial letter carefully for specific reasons
  • Gather additional documentation to address denial rationale
  • Consider peer-to-peer review with Aetna medical director
  • Prepare for formal appeal process if necessary

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy
Missing REMS enrollment Ensure both patient and prescriber complete REMS before submission
Insufficient genetic documentation Include complete genetic testing report with TTR mutation confirmation
Lack of specialist involvement Have neurologist, geneticist, or amyloidosis specialist submit or co-sign request
Incomplete clinical notes Provide detailed documentation of polyneuropathy symptoms and progression
Missing prior therapy documentation Document previous treatments attempted, even if none were appropriate
From our advocates: We've seen Tegsedi approvals succeed when providers include a clear timeline showing symptom progression alongside genetic confirmation. One effective approach is creating a simple table showing dates, symptoms, and functional impacts to demonstrate medical necessity clearly.

Appeals Process in New Jersey

New Jersey residents have strong appeal rights through the state's Independent Health Care Appeals Program (IHCAP).

Internal Appeals with Aetna

  1. First Level: Submit appeal within 180 days of denial
  2. Peer-to-Peer: Request medical director review
  3. Second Level: If first appeal denied, automatic second review

External Appeals Through IHCAP

If internal appeals are unsuccessful:

  1. File External Appeal: Submit to IHCAP portal within 4 months of final denial
  2. Independent Review: Maximus Federal Services coordinates physician panel review
  3. Timeline:
    • Standard review: 45 days
    • Expedited review: 48 hours (for urgent situations)
  4. Binding Decision: If approved, Aetna must cover the treatment

When to Escalate

Contact New Jersey Department of Banking and Insurance at 1-888-393-1062 if:

  • Aetna doesn't respond within required timeframes
  • You need help understanding the appeal process
  • You believe your rights have been violated

For additional support, Counterforce Health can help create targeted appeals that address specific denial reasons with evidence-based rebuttals tailored to Aetna's policies.

Quick Reference Checklist

Before You Start

  • Confirm active Aetna (CVS Health) coverage
  • Verify Tegsedi availability (note: discontinued September 27, 2024)
  • Ensure specialist prescriber involvement
  • Complete REMS enrollment for patient and prescriber

Documentation Checklist

  • TTR genetic testing report
  • Clinical notes showing polyneuropathy symptoms
  • Prior medication history (if applicable)
  • Baseline laboratory results
  • REMS enrollment confirmation
  • Completed prior authorization form

Submission Checklist

  • Submit through Aetna provider portal
  • Obtain confirmation number
  • Schedule follow-up for status check
  • Prepare for potential peer-to-peer review

Post-Decision

  • If approved: coordinate with CVS Specialty
  • If denied: review reasons and prepare appeal
  • Consider external appeal through IHCAP if needed

FAQ

How long does Aetna prior authorization take for Tegsedi? Standard review is 30-45 days. Expedited reviews for urgent situations are completed within 72 hours.

What if Tegsedi is not on Aetna's formulary? Submit a formulary exception request with your prior authorization, providing clinical justification for why Tegsedi is medically necessary.

Can I request an expedited appeal in New Jersey? Yes, if a delay would risk your health or life. Submit through IHCAP with clinical documentation supporting urgency.

Does step therapy apply to Tegsedi? Aetna may require documentation of previous treatments tried and failed, even if no other hATTR treatments were clinically appropriate.

What happens if my appeal is denied by Aetna? New Jersey residents can file an external appeal through IHCAP within 4 months. The independent review decision is binding on Aetna.

Is there financial assistance available for Tegsedi? Check with the manufacturer for patient assistance programs, though availability may be limited due to the drug's discontinuation.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Insurance policies and state regulations may change. Always consult with your healthcare provider about treatment decisions and verify current policy requirements with your insurer. For questions about New Jersey insurance regulations, contact the Department of Banking and Insurance at 1-888-393-1062.

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