By Counterforce Health Team in Tegsedi (inotersen) —

Do You Qualify for Tegsedi (Inotersen) Coverage by Aetna (CVS Health) in Pennsylvania? Decision Tree & Next Steps

Answer Box: Getting Tegsedi (Inotersen) Covered by Aetna in Pennsylvania

Fastest Path to Approval: 1) Confirm hATTR polyneuropathy diagnosis with TTR gene mutation testing, 2) Enroll in FDA REMS program with weekly lab monitoring, 3) Submit prior authorization through Aetna's Availity portal with complete clinical documentation. First step today: Call your neurologist to order TTR genetic testing if not already done—this is mandatory for coverage. Appeals in Pennsylvania benefit from the state's new external review program with a 50% overturn rate.

Table of Contents

How to Use This Decision Tree

This guide helps you determine if you qualify for Tegsedi (inotersen) coverage through Aetna (CVS Health) in Pennsylvania and provides your next steps based on where you stand today.

Start here: Work through the eligibility questions below with your medical records. Each section tells you exactly what to do next—whether that's gathering documents, requesting tests, or starting an appeal.

Tegsedi requires both prior authorization from Aetna and enrollment in the FDA's Risk Evaluation and Mitigation Strategy (REMS) program due to serious risks of low platelet counts and kidney problems.

Eligibility Triage: Do You Qualify?

Likely Eligible ✅

You probably qualify if you have all of these:

  • Confirmed hATTR polyneuropathy diagnosis with documented TTR gene mutation
  • Progressive nerve symptoms (numbness, weakness, pain in hands/feet)
  • Normal or mildly impaired kidney function (no severe kidney disease)
  • Platelet count ≥100,000 on recent lab work
  • No history of liver transplant or severe heart failure

Possibly Eligible ⚠️

You may qualify with additional testing if you have:

  • Suspected hATTR but no genetic testing yet
  • Family history of similar nerve problems or heart disease
  • Unexplained progressive polyneuropathy in an adult
  • Some lab abnormalities that need evaluation

Not Yet Eligible ❌

You likely don't qualify currently if you have:

  • Different type of amyloidosis (AL, AA, or wild-type ATTR)
  • Severe kidney disease or are on dialysis
  • Platelet count below 100,000
  • Severe heart failure (NYHA Class III or IV)
  • History of liver transplant

If "Likely Eligible": Your Document Checklist

Required Clinical Documentation

Your doctor needs to submit these with the prior authorization:

  1. TTR genetic test results showing pathogenic mutation
  2. Neurological assessment documenting polyneuropathy severity
  3. Recent lab results (within 30 days):
    • Complete blood count with platelets ≥100,000
    • Comprehensive metabolic panel
    • Urinalysis with protein/creatinine ratio
  4. REMS program enrollment confirmation for both prescriber and patient

Submission Process

Submit through Aetna's preferred channels:

Tip: Submit at least two weeks before you need the medication. Standard reviews take 7-15 business days.

If "Possibly Eligible": Tests to Request

Essential Next Steps

Ask your doctor to order:

  1. TTR gene sequencing - This is mandatory and takes 2-3 weeks for results
  2. Comprehensive neurological exam with validated scoring (if not done recently)
  3. Baseline labs including complete blood count, kidney function, and urinalysis
  4. Cardiac evaluation if you have heart symptoms

Timeline to Re-Apply

  • Genetic testing results: 2-3 weeks
  • Complete workup: 4-6 weeks typically
  • Prior authorization after testing: Allow 2-3 weeks for Aetna review

If "Not Yet": Alternative Options

Other hATTR Treatments to Discuss

If Tegsedi isn't appropriate, ask your doctor about:

  • Amvuttra (vutrisiran) - Similar mechanism, different dosing
  • Onpattro (patisiran) - IV infusion every 3 weeks
  • Wainua (eplontersen) - Newer subcutaneous option

Exception Request Strategy

For borderline cases, your doctor can request a formulary exception by documenting:

  • Why standard alternatives won't work
  • Specific medical contraindications
  • Expected clinical benefit from Tegsedi

If Denied: Pennsylvania Appeals Path

Pennsylvania offers one of the strongest patient appeal processes in the country. Here's your step-by-step path:

Level 1: Internal Aetna Appeal

Timeline: File within 60 days of denial; Aetna responds in 7 days (72 hours if urgent)

How to file:

  • Online: Through your Aetna member portal
  • Fax: 1-724-741-4954
  • Mail: Aetna Medicare Part D Appeals, PO Box 14579, Lexington, KY 40512

Level 2: Pennsylvania External Review

New in 2024: Pennsylvania launched its own external review program with impressive results—about 50% of appeals are overturned.

Timeline: Request within 4 months of Aetna's final denial

How to file: Submit online at pa.gov external review portal

What happens: An independent medical reviewer (not affiliated with Aetna) reviews your case within 45 days. If they overturn the denial, Aetna must cover your treatment immediately.

From our advocates: We've seen Pennsylvania's new external review process work particularly well for rare disease medications like Tegsedi. The independent reviewers often have more specialized knowledge than initial insurance reviewers, and they're not bound by the insurer's cost considerations—only medical necessity.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must get approval before filling Aetna Precertification List Aetna 2025 PA List
REMS Enrollment FDA safety program required FDA REMS website FDA Label
TTR Gene Mutation Genetic test confirming hATTR Lab report from genetic testing Aetna Policy
Lab Monitoring Weekly platelet, kidney function checks Your doctor's office FDA REMS Program
Specialty Pharmacy Must use CVS Specialty or approved network Insurance card or member portal CVS Caremark

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Not medically necessary" Submit detailed clinical notes showing progression Neurological assessments, symptom timeline
"REMS not enrolled" Complete enrollment before resubmitting REMS confirmation forms
"Labs insufficient" Provide complete recent lab panel CBC, CMP, urinalysis within 30 days
"Non-formulary" Request formulary exception Prior therapy failures, contraindications
"Quantity limits exceeded" Justify weekly dosing per FDA label Prescription with proper directions

FAQ: Aetna Tegsedi Coverage in Pennsylvania

Q: How long does Aetna's prior authorization take for Tegsedi in Pennsylvania? A: Standard reviews take 7-15 business days. Urgent requests (if you're already on therapy) are processed within 72 hours per Aetna's Medicare guidelines.

Q: What if Tegsedi isn't on Aetna's formulary? A: You can request a formulary exception through the same prior authorization process. Your doctor needs to document why preferred alternatives won't work for your specific case.

Q: Can I get an expedited appeal if I'm already taking Tegsedi? A: Yes, if stopping therapy would seriously jeopardize your health. Pennsylvania requires expedited appeals to be decided within 72 hours for urgent situations.

Q: Does step therapy apply to Tegsedi? A: Not typically, since there's no exact equivalent. However, Aetna may require documentation that you've considered other hATTR treatments like Onpattro or Amvuttra.

Q: What's the success rate for Tegsedi appeals in Pennsylvania? A: Pennsylvania's new external review program has about a 50% overturn rate overall. Rare disease medications often have higher success rates when proper documentation is provided.

Q: How much does Tegsedi cost without insurance? A: List price is over $400,000 annually. However, the manufacturer offers patient assistance programs, and most patients with commercial insurance pay significantly less through Counterforce Health's assistance with appeals and coverage optimization.

When to Get Professional Help

Consider working with a coverage advocate if:

  • You've been denied twice
  • Your case involves complex medical history
  • You're facing urgent timelines
  • You need help gathering documentation

Counterforce Health specializes in turning insurance denials into successful appeals for medications like Tegsedi. Their platform analyzes denial letters and crafts evidence-backed appeals that address payers' specific criteria, significantly improving approval rates for complex specialty medications.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on your specific plan, medical history, and clinical circumstances. Always consult with your healthcare provider about treatment options and work with your insurance company directly for coverage determinations. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department at 1-877-881-6388.

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