By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Aetna CVS Health in California: Decision Tree, Appeals, and Next Steps

Answer Box: Getting Tegsedi Coverage in California

Aetna CVS Health requires prior authorization for Tegsedi (inotersen) with strict criteria: confirmed TTR gene mutation, hATTR polyneuropathy diagnosis, specialist prescriber, and REMS enrollment. In California, if denied, you have strong appeal rights through the DMHC's Independent Medical Review (IMR) system, which overturns 68.6% of medical necessity denials. First step: Have your neurologist gather genetic testing results and document your diagnosis, then submit the PA request with all required clinical documentation.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Your Action Plan
  4. If "Possibly Eligible": Tests and Timeline
  5. If "Not Yet Eligible": Alternative Options
  6. If Denied: California Appeal Strategy
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & How to Fix Them
  9. California's Powerful IMR System
  10. Frequently Asked Questions

How to Use This Decision Tree

This guide helps you navigate Aetna CVS Health's prior authorization process for Tegsedi (inotersen) in California. Start with the eligibility triage below to determine your path forward. Each section includes specific documentation requirements, timelines, and contact information.

Important: Tegsedi requires enrollment in a REMS program due to serious risks including thrombocytopenia and kidney problems. Your prescriber and pharmacy must also be certified before you can receive the medication.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible If You Have:

  • Confirmed TTR gene mutation with genetic testing results
  • Documented hATTR polyneuropathy with clinical symptoms
  • Specialist prescriber (neurologist, geneticist, or amyloidosis specialist)
  • Age 18 or older
  • Adequate platelet count (≥100 x 10⁹/L) and kidney function
  • No concurrent use of other hATTR therapies (Amvuttra, Onpattro, Vyndamax, Wainua)

⚠️ Possibly Eligible If You Need:

  • Genetic testing to confirm TTR mutation
  • Specialist referral or second opinion
  • Updated lab work (platelets, kidney function)
  • Documentation of clinical progression

❌ Not Yet Eligible If:

  • No genetic confirmation of hATTR
  • Platelets below 100 x 10⁹/L
  • Severe kidney impairment
  • Using other hATTR medications concurrently

If "Likely Eligible": Your Action Plan

Step 1: Gather Required Documentation

Your prescriber needs to submit:

  • Aetna prior authorization form (verify current version)
  • TTR genetic testing results showing pathogenic mutation
  • Clinical notes documenting hATTR polyneuropathy symptoms
  • Recent lab results: platelet count, kidney function tests
  • Confirmation of REMS enrollment for prescriber, patient, and pharmacy

Step 2: Submit Through Proper Channels

Timeline: Aetna must respond within 72 hours for standard requests, 24 hours for expedited.

Submission options:

  • Provider portal (fastest)
  • Phone: Number on your member ID card
  • Fax: Check current PA form for submission details

Step 3: Monitor and Follow Up

Track your request and be prepared to provide additional information if requested. Counterforce Health specializes in helping patients and providers prepare comprehensive prior authorization submissions that address payer-specific requirements and reduce back-and-forth requests for information.

If "Possibly Eligible": Tests and Timeline

  1. Schedule genetic testing if not completed (covered by most insurance when medically indicated)
  2. Obtain specialist consultation with neurologist or amyloidosis expert
  3. Complete baseline labs: platelet count, kidney function, liver enzymes
  4. Document symptom progression with validated scales if possible

Timeline to Re-apply:

  • Genetic testing results: 2-4 weeks
  • Specialist appointment: varies by availability
  • Lab results: 1-3 days
  • REMS enrollment: 1-2 weeks after prescriber certification

If "Not Yet Eligible": Alternative Options

Immediate Alternatives to Discuss:

  • Other hATTR therapies: Amvuttra (vutrisiran), Onpattro (patisiran), Wainua (eplontersen)
  • Supportive care: symptom management while pursuing genetic confirmation
  • Clinical trials: research opportunities through ClinicalTrials.gov

Preparing for Future Exception Requests:

If standard criteria aren't met, work with your provider to document why Tegsedi is specifically needed over alternatives. This may require peer-reviewed literature support and detailed clinical rationale.

If Denied: California Appeal Strategy

California offers exceptional appeal rights through two regulatory systems depending on your plan type.

Level 1: Internal Appeal with Aetna

Timeline: 7 days for standard appeals, 72 hours for expedited

Required documentation:

  • Copy of denial letter
  • Additional clinical evidence
  • Peer-reviewed studies supporting Tegsedi use
  • Provider letter of medical necessity

Level 2: California Independent Medical Review (IMR)

Who qualifies: Most HMO and managed care plans under DMHC jurisdiction

Success rates: 68.6% of medical necessity denials overturned for Anthem (similar rates across major insurers)

How to file:

  • Contact DMHC Help Center at 888-466-2219
  • Submit IMR application within 6 months of final denial
  • No fee required - California covers all costs

Timeline: 45 days for standard review, 7 days for expedited

From our advocates: We've seen many hATTR patients succeed with California IMR by submitting comprehensive genetic testing results, specialist letters explaining why Tegsedi is uniquely appropriate, and FDA labeling showing approved indications. The key is thorough documentation of medical necessity - California's independent reviewers are favorable to rare disease treatments when properly supported.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must be approved before dispensing PA required list Aetna 2024 Precert List
TTR Mutation Genetic testing confirming pathogenic variant Lab report Aetna Policy
Specialist Prescriber Neurologist, geneticist, or amyloidosis expert Provider credentials Aetna Policy
REMS Enrollment FDA safety program participation REMS documentation FDA Label
Lab Monitoring Platelets ≥100, adequate kidney function Recent lab results FDA Label
Age Restriction 18 years or older Medical record Aetna Policy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Genetic testing not provided" Submit complete TTR gene sequencing results showing pathogenic mutation
"Not prescribed by specialist" Transfer care to neurologist, geneticist, or amyloidosis specialist
"REMS enrollment incomplete" Ensure prescriber, patient, and pharmacy are all REMS-certified
"Inadequate clinical documentation" Provide detailed notes showing hATTR polyneuropathy symptoms and progression
"Alternative therapies not tried" Document contraindications or specific reasons why other hATTR drugs aren't appropriate
"Experimental/investigational" Cite FDA approval for hATTR polyneuropathy and include official labeling

California's Powerful IMR System

California's Independent Medical Review system is uniquely patient-friendly compared to other states. Here's why it matters for Tegsedi appeals:

High Success Rates: 68.6% of medical necessity denials are overturned, and 49.1% of experimental/investigational denials are reversed.

No Cost to You: California law prohibits charging patients for IMR requests.

Binding Decisions: If IMR rules in your favor, Aetna must authorize coverage.

Expert Review: Independent physicians with relevant specialty knowledge review your case.

How Counterforce Health Can Help: Their platform specializes in turning insurance denials into targeted appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to Aetna's own policies, significantly improving your chances of success.

Frequently Asked Questions

Q: How long does Aetna's prior authorization take in California? A: 72 hours for standard requests, 24 hours for expedited once complete documentation is received.

Q: What if Tegsedi is non-formulary on my plan? A: You can request a formulary exception with clinical justification. If denied, California's IMR system has favorable overturn rates for medically necessary treatments.

Q: Can I get a temporary supply while waiting for approval? A: Yes, up to 31 days for Medicare or 30 days for most commercial plans during transition periods or pending decisions.

Q: What makes a strong medical necessity letter? A: Include TTR mutation details, specific hATTR symptoms, why alternatives aren't suitable, treatment goals, and monitoring plan with lab schedules.

Q: Does step therapy apply if I've tried other hATTR drugs outside California? A: Document all prior therapies with outcomes. Aetna should honor previous trial failures regardless of where they occurred.

Q: How do I know if my plan is under DMHC or CDI jurisdiction? A: Most HMO and managed care plans are under DMHC. Check your member handbook or call the DMHC Help Center at 888-466-2219.

Q: What if I can't afford Tegsedi even with insurance? A: Contact the manufacturer about patient assistance programs and explore foundation grants for rare disease treatments.

Q: Can I request an expedited appeal? A: Yes, if delay would seriously jeopardize your health. Document the urgency with your provider's support.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult your healthcare provider and insurance plan documents for personalized guidance. For additional support with insurance appeals in California, contact the DMHC Help Center at 888-466-2219.

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