By Counterforce Health Team in Tegsedi (inotersen) —

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

Quick Answer: Getting Tegsedi (inotersen) covered by Aetna CVS Health in Texas requires prior authorization with documented hATTR polyneuropathy diagnosis, genetic testing confirming TTR mutation, REMS program enrollment, and specialist prescription. Start by having your neurologist submit the PA request through Aetna's provider portal with complete clinical documentation. If denied, you have 180 days to appeal internally, followed by Texas independent external review within 4 months.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals Process
  7. REMS Program Requirements
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Tegsedi covered by Aetna CVS Health in Texas?

Tegsedi (inotersen) requires prior authorization through Aetna CVS Health and is typically covered when medical necessity criteria are met. However, as of late 2024, Tegsedi has been discontinued by the manufacturer, though existing stock may still be available through specialty pharmacies and appeals for continuation of therapy may still be processed.

Which Aetna plans cover Tegsedi?

Most Aetna commercial plans administered through CVS Caremark include Tegsedi on their specialty drug formulary, subject to prior authorization. Coverage varies by specific plan design, but generally includes:

  • Employer-sponsored plans
  • Individual marketplace plans
  • Some Medicare Advantage plans

Coverage is handled through CVS Specialty Pharmacy for dispensing after approval.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm diagnosis and genetic testing (Patient/Clinician)
  2. Complete REMS enrollment (Prescriber and Patient)
    • Both prescriber and patient must enroll at tegsedirems.com
    • Timeline: 1-2 business days
    • Required before first prescription
  3. Submit prior authorization request (Prescriber)
    • Use Aetna provider portal or standard PA forms
    • Include all required documentation (see criteria below)
    • Timeline: Submit 5-7 days before needed start date
  4. Await determination (Aetna)
  5. Coordinate specialty pharmacy (If approved)
    • CVS Specialty will contact patient for shipment coordination
    • Timeline: 3-5 business days for first shipment

Timing and Deadlines

Process Standard Timeline Expedited Timeline Notes
PA Submission 5-7 days before need Same day if urgent Use Aetna provider portal
PA Decision 30-45 days 72 hours Expedited for urgent cases
Appeal Filing 180 days from denial N/A Texas state requirement
Internal Appeal Decision 30 days (pre-service) 72 hours Aetna policy
External Review Request 4 months from final denial 5 days if urgent Texas IRO process

Medical Necessity Criteria

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
Diagnosis Confirmed hATTR polyneuropathy Clinical notes, neurological exam
Genetic Testing Pathogenic TTR gene mutation Genetic test report
Prescriber Specialist (neurologist/geneticist) DEA number, specialty credentials
REMS Enrollment FDA safety program REMS certificates for prescriber/patient
Lab Monitoring Plan Safety monitoring protocol Baseline labs, monitoring schedule

Clinician Corner: Medical Necessity Letter Checklist

When drafting your medical necessity letter, include:

✓ Patient identification: Full name, DOB, Aetna member ID
✓ Diagnosis: hATTR polyneuropathy with ICD-10 code E85.1
✓ Genetic confirmation: TTR gene mutation details and test results
✓ Clinical presentation: Neurological symptoms, functional impact, progression
✓ Treatment history: Previous therapies tried (if step therapy required)
✓ Contraindications: Why alternatives aren't appropriate
✓ Monitoring plan: Lab schedule per REMS requirements
✓ Dosing rationale: Weekly 284mg subcutaneous injection
✓ Treatment goals: Slow progression, maintain function, improve quality of life

Reference the FDA label and current Aetna precertification requirements.

Costs and Financial Assistance

Patient Cost Options

Commercial Insurance Patients:

  • Manufacturer copay assistance may reduce out-of-pocket costs to $0/month (subject to program terms and availability)
  • Contact Akcea/AstraZeneca Patient Support Program for enrollment
  • Foundation grants may be available through nonprofit organizations

Medicare/Medicaid Patients:

  • Manufacturer copay cards typically not available for federally insured patients
  • Patient assistance programs may cover full drug cost based on income eligibility
  • Some nonprofit foundations offer additional support for rare disease medications
Note: With Tegsedi's discontinuation, confirm program availability before applying for financial assistance.

Denials and Appeals Process

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Not medically necessary Submit comprehensive clinical documentation Genetic test, specialist notes, symptom progression
REMS not enrolled Complete enrollment process REMS certificates for prescriber and patient
Step therapy not met Request formulary exception Documentation of contraindications to alternatives
Non-formulary Submit formulary exception request Medical necessity letter, prior therapy failures

Appeals Playbook for Aetna CVS Health in Texas

Level 1: Internal Appeal

  • Deadline: 180 days from denial date
  • Timeline: 30 days for pre-service, 60 days for post-service decisions
  • How to file: Aetna provider portal or mail/fax
  • Required: Complete appeal form, medical records, denial letter

Level 2: Expedited Appeal (if urgent)

  • Timeline: 72 hours for decision
  • Criteria: Delay would jeopardize health or life
  • Process: Same as Level 1 but mark "URGENT"

External Review: Texas IRO

  • When: After exhausting internal appeals
  • Deadline: 4 months from final denial
  • Timeline: 30-45 days for standard, 3-5 days if expedited
  • Cost: Nominal fee (waived for financial hardship)
  • Outcome: Binding decision on both parties

Contact the Texas Department of Insurance at 1-800-252-3439 for IRO guidance.

REMS Program Requirements

Tegsedi requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to serious safety risks:

Enrollment Steps:

  1. Prescriber certification: Complete training at tegsedirems.com
  2. Patient enrollment: Sign safety agreement and complete education
  3. Pharmacy certification: Only REMS-certified specialty pharmacies can dispense

Monitoring Requirements:

  • Weekly platelet counts: Monitor for thrombocytopenia
  • Monthly kidney function: Serum creatinine and urinalysis for glomerulonephritis
  • Baseline labs: Complete metabolic panel, liver function, eGFR ≥45 mL/min/1.73 m²

Counterforce Health helps patients and providers navigate complex REMS requirements by organizing the necessary documentation and ensuring all safety protocols are properly documented in prior authorization requests.

Specialty Pharmacy Requirements

Why Specialty Pharmacy? Tegsedi must be dispensed through specialty pharmacies due to:

  • REMS program requirements
  • Cold storage and handling needs
  • Patient education and injection training
  • Ongoing safety monitoring coordination

CVS Specialty Process:

  1. After PA approval, prescription is transferred to CVS Specialty
  2. Pharmacist contacts patient for delivery coordination
  3. Injection training provided (if needed)
  4. Ongoing refill coordination and monitoring support

Troubleshooting Common Issues

Portal Access Problems:

  • Verify current Aetna provider portal URL (links may change)
  • Contact Aetna provider services for technical support
  • Use alternative submission methods (fax/mail) if portal unavailable

Missing Documentation:

  • Request complete medical records from all treating physicians
  • Obtain genetic testing reports directly from laboratory
  • Ensure REMS enrollment certificates are current

Delayed Decisions:

  • Follow up weekly after standard timeline expires
  • Request expedited review if patient condition is worsening
  • Document all communication attempts for appeal purposes
From our advocates: "We've seen the most success when providers submit complete documentation upfront, including the genetic test report, REMS enrollment proof, and a detailed timeline of symptom progression. This comprehensive approach often prevents the back-and-forth requests for additional information that can delay approval by weeks."

FAQ

Q: How long does Aetna CVS Health prior authorization take in Texas? A: Standard PA decisions take 30-45 days for pre-service requests. Expedited reviews for urgent cases are decided within 72 hours when medical urgency is documented.

Q: What if Tegsedi is non-formulary on my plan? A: You can request a formulary exception with documentation of medical necessity. Include genetic testing, specialist recommendations, and evidence that formulary alternatives aren't appropriate.

Q: Can I request an expedited appeal in Texas? A: Yes, expedited appeals are available when delays would jeopardize your health. Both internal appeals (72 hours) and external reviews (3-5 days) have expedited timelines.

Q: Does step therapy apply if I tried other treatments outside Texas? A: Yes, Aetna will typically accept documentation of prior therapy trials from any location. Ensure you have complete medical records showing treatment attempts and outcomes.

Q: What happens if Tegsedi is permanently unavailable? A: Work with your neurologist to transition to available alternatives like Amvuttra (vutrisiran) or Onpattro (patisiran). These may require separate prior authorizations.

Q: Who can help if my appeal is denied? A: Contact the Texas Department of Insurance at 1-800-252-3439 for independent external review. The Office of Public Insurance Counsel (1-877-611-6742) also provides consumer assistance.

For patients navigating complex insurance requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with payer-specific policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions. Coverage policies and requirements may change without notice.

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