By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Aetna CVS Health in Illinois: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tegsedi (Inotersen) Covered by Aetna CVS Health in Illinois

Tegsedi (inotersen) requires prior authorization from Aetna CVS Health for hATTR polyneuropathy coverage in Illinois. Key requirements: confirmed TTR gene mutation, documented polyneuropathy symptoms, specialist prescription (neurologist/geneticist), and REMS program enrollment. Submit via Aetna provider portal with genetic testing, clinical notes, and baseline assessments. Standard PA decision: 30 days. If denied, file internal appeal within 180 days, then Illinois external review within 4 months. First step today: Verify your plan type (commercial vs. Medicaid vs. Medicare) on your insurance card and gather TTR genetic test results.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Setup
  5. Submission Process & Forms
  6. Common Denial Reasons & Solutions
  7. Illinois Appeals Process
  8. Cost Considerations
  9. FAQ

Plan Types & Coverage Implications

Your Aetna plan type determines specific procedures and timelines for Tegsedi coverage in Illinois:

Commercial Plans (Employer/ACA Marketplace)

  • Standard PA process through Aetna provider portal
  • 180-day appeal deadline
  • External review through Illinois Department of Insurance

Aetna Better Health of Illinois (Medicaid)

Aetna Medicare Advantage/Part D

Tip: Check your insurance card for "Aetna," "Aetna Better Health of Illinois," or "Aetna Medicare" to apply correct timelines and procedures.

Formulary Status & Tier Placement

Tegsedi appears in Aetna's 2024 formulary guides as a specialty medication requiring prior authorization. The drug is typically placed on:

  • Tier 5 (Specialty) for most commercial plans
  • Non-formulary status requiring exception requests on some plans
  • CVS Specialty Pharmacy dispensing requirement

Alternative Agents: Aetna may require consideration of Onpattro (patisiran), Amvuttra (vutrisiran), or Wainua (eplontersen) depending on your plan's step therapy requirements.

Prior Authorization Requirements

Medical Necessity Criteria

Aetna's Tegsedi clinical policy requires ALL of the following documentation:

Requirement Documentation Needed Where to Find
TTR Gene Mutation Genetic test confirming pathogenic TTR variant Lab report from genetics clinic
hATTR Polyneuropathy Clinical signs/symptoms of progressive neuropathy Neurology exam notes, EMG/NCS
Age ≥18 years Date of birth verification Medical record
Specialist Prescription Neurologist, geneticist, or amyloidosis specialist Provider credentials
Monotherapy No concurrent hATTR medications Current medication list

Required Clinical Documentation

Initial Authorization Package:

  1. Genetic Testing Report showing specific TTR mutation (e.g., Val30Met, Thr60Ala)
  2. Neurology Assessment documenting:
    • Progressive sensory-motor polyneuropathy
    • Functional impairment (walking, daily activities)
    • Baseline severity scores (mNIS+7, Norfolk QoL-DN, PND score)
  3. REMS Program Enrollment confirmation for patient, prescriber, and pharmacy
  4. Baseline Laboratory Results (platelet count, kidney function, liver enzymes)

Clinician Corner: Medical Necessity Letter Checklist

Your specialist should include these elements in the PA submission:

  • Problem Statement: "Patient has genetically confirmed hATTR polyneuropathy with progressive neurological decline"
  • Prior Treatments: Document any previous therapies and outcomes
  • Clinical Rationale: Reference FDA labeling for hATTR polyneuropathy indication
  • Monitoring Plan: Weekly platelet counts, monthly kidney function per REMS requirements
  • Treatment Goals: Slow disease progression, maintain functional status

CVS Specialty Pharmacy Setup

Tegsedi requires dispensing through CVS Specialty Pharmacy due to REMS program requirements. Use the CVS Specialty enrollment form with these key steps:

  1. Complete Patient Information: Include insurance details, emergency contacts
  2. Prescriber Section: Verify DEA number, NPI, and REMS certification status
  3. Clinical Details: Height/weight for dosing, injection training needs
  4. Submit Documentation: Fax form with prescription and insurance cards to CVS Specialty

CVS Specialty Contact: 1-800-237-2767

Note: REMS enrollment must be completed before CVS can dispense Tegsedi. Verify enrollment status at the FDA REMS website.

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Verify REMS Enrollment (Patient/Clinic)
  2. Gather Documentation (Clinic Staff)
    • TTR genetic test, neurology notes, baseline labs
    • Timeline: Same day if records available
    • Source: Patient chart, genetics lab
  3. Submit PA Request (Prescriber)
  4. Track PA Status (Clinic/Patient)
    • Monitor portal for updates
    • Timeline: 30-day standard decision
    • Expedited: 72 hours if urgent
  5. CVS Specialty Setup (Upon Approval)
    • Complete enrollment form
    • Timeline: 3-5 business days
    • Contact: 1-800-237-2767
  6. Schedule Delivery (Patient)
    • Coordinate injection training if needed
    • Timeline: Within 1 week of approval
    • Source: CVS Specialty coordination
  7. Begin Treatment (Patient)
    • Weekly subcutaneous injections
    • Required monitoring: Weekly platelets, monthly kidney function
    • Follow-up: 12-month reauthorization

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing TTR mutation Submit genetic test report Lab report with specific variant
Insufficient neuropathy evidence Provide detailed neurology exam EMG/NCS, clinical assessment
No REMS enrollment Complete program registration REMS confirmation certificates
Non-formulary status Request formulary exception Medical necessity letter
Step therapy required Document alternative failures Prior therapy records, contraindications

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to payer policies. Their platform identifies denial reasons and pulls appropriate clinical evidence to strengthen appeal submissions.

Illinois Appeals Process

Internal Appeal with Aetna CVS Health

Commercial Plans:

  • Deadline: 180 days from denial date
  • Standard Review: 30 days for pre-service appeals
  • Expedited Review: 72 hours if delay risks health
  • Submit Via: Aetna provider portal, mail, or fax

Required Appeal Documents:

  • Copy of denial letter
  • Updated medical necessity letter
  • Additional clinical evidence (peer-reviewed studies, guidelines)
  • Urgency statement if expedited review requested

Illinois External Review

If Aetna upholds the denial, Illinois residents have strong external review rights:

Timeline: Must request within 4 months (120 days) of final internal denial Process: Independent Review Organization (IRO) review by board-certified physician Decision Time: 45 days standard, 72 hours for urgent cases Cost: Free to patients (insurers pay IRO fees) Binding: IRO decision compels coverage if overturned

Illinois Resources:

  • Department of Insurance: 877-527-9431
  • Attorney General Health Care Helpline: 1-877-305-5145
From Our Advocates: We've seen Illinois external reviews successfully overturn Aetna denials for specialty medications when the appeal included comprehensive clinical evidence and clear documentation of medical necessity. The key is submitting a complete package that directly addresses the original denial reasons with updated supporting evidence.

For more guidance on strengthening your appeal, Counterforce Health provides specialized support for complex prior authorization and appeal cases, helping patients navigate payer-specific requirements.

Cost Considerations

Typical Cost-Sharing:

  • Tier 5 specialty copay/coinsurance applies
  • Annual deductible may apply before coverage begins
  • Out-of-pocket maximum provides yearly cap

Financial Assistance Options:

  • Manufacturer patient assistance programs
  • Copay assistance cards (commercial insurance)
  • State pharmaceutical assistance programs
  • Disease-specific foundations
Note: Verify current cost-sharing through your Aetna member portal or by calling the number on your insurance card.

FAQ

How long does Aetna CVS Health PA take in Illinois? Standard prior authorization decisions are made within 30 days. Expedited reviews (when delay could jeopardize health) are completed within 72 hours.

What if Tegsedi is non-formulary on my plan? You can request a formulary exception by submitting a medical necessity letter demonstrating that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal in Illinois? Yes, if waiting for a standard decision could seriously jeopardize your health or ability to regain function. Include a supporting statement from your prescriber.

Does step therapy apply if I've failed treatments outside Illinois? Treatment failures from other states should count toward step therapy requirements. Include documentation of prior therapies and outcomes in your PA submission.

What happens if I miss the appeal deadline? Contact Aetna member services and the Illinois Department of Insurance to explore "good cause" extensions or alternative complaint processes.

How do I verify my current formulary status? Check your plan's drug guide through the Aetna member portal or call the member services number on your insurance card.

Is peer-to-peer review available for Tegsedi denials? Yes, your prescribing specialist can request a peer-to-peer discussion with an Aetna medical director to discuss the clinical rationale for Tegsedi.

What if Tegsedi is discontinued by the manufacturer? Existing stock may remain available through specialty pharmacies. Continuation therapy for established patients typically qualifies for coverage under Aetna policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional support with insurance appeals and prior authorization challenges, consider consulting resources like Counterforce Health, which specializes in helping patients navigate complex coverage decisions.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.