By Counterforce Health Team in Onpattro (patisiran) —

Do You Qualify for Onpattro (patisiran) Coverage by Aetna (CVS Health) in New Jersey? Decision Tree & Next Steps

Answer Box: Getting Onpattro (patisiran) Covered by Aetna (CVS Health) in New Jersey

Most likely to get approved: Patients with confirmed hATTR polyneuropathy (genetic testing required), neurologist evaluation, documented baseline mNIS+7 and 6-minute walk test scores, and no concurrent use of other hATTR medications. First step today: Have your neurologist complete Aetna's Onpattro precertification form with genetic test results and clinical documentation. If denied, you have 180 days to appeal and access to New Jersey's Independent Health Care Appeals Program (IHCAP) with 30-50% overturn rates for specialty drugs.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist & Submission
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternatives & Exception Requests
  6. If Denied - New Jersey Appeal Path
  7. Common Denial Reasons & How to Fix Them
  8. FAQ
  9. Sources & Further Reading

How to Use This Guide

This decision tree helps patients and clinicians navigate Aetna (CVS Health) coverage for Onpattro (patisiran) in New Jersey. Start with the eligibility triage below to determine your approval likelihood, then follow the appropriate pathway.

Key facts about Onpattro coverage:

  • Annual cost: ~$450,000-$500,000+ depending on weight
  • Requires prior authorization from Aetna
  • Must be administered at approved infusion centers
  • New Jersey offers strong external appeal rights through IHCAP
Note: This guide focuses on commercial Aetna plans. Medicare Advantage and Medicaid managed care may have different requirements.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible

You meet these criteria:

  • Confirmed diagnosis: Pathogenic TTR gene variant documented by genetic testing
  • Clinical documentation: Neurologist-confirmed hATTR polyneuropathy with symptoms
  • Baseline testing: mNIS+7 score and 6-minute walk test results documented
  • Age: 18 years or older
  • No conflicts: Not using other hATTR medications (Amvuttra, Tegsedi, Wainua, Vyndamax, Attruby)
  • Specialist involvement: Prescription from or consultation with neurologist/amyloidosis specialist

🔄 Possibly Eligible

You have some gaps:

  • Genetic testing ordered but results pending
  • Neurologist evaluation scheduled but not completed
  • Missing baseline functional assessments (mNIS+7, 6MWT)
  • Prior hATTR medication use that needs documentation of failure/intolerance

❌ Not Yet Eligible

Missing key requirements:

  • No genetic testing for TTR variants
  • No neurologist evaluation
  • Requesting for non-FDA approved uses (e.g., cardiac amyloidosis only)
  • Using concurrent hATTR medications without documented medical necessity

If "Likely Eligible" - Document Checklist & Submission

Required Documentation

Document Purpose Source
Aetna Onpattro Precertification Form Primary authorization request Aetna official form
Genetic test results Confirm pathogenic TTR variant Lab report
Neurologist evaluation Clinical diagnosis confirmation Specialist notes
Baseline mNIS+7 score Disease severity documentation Clinical assessment
6-minute walk test results Functional status baseline Clinic testing
Prior medication history Document failures/intolerances Medical records

Submission Process

Step 1: Complete the precertification form with your neurologist Step 2: Gather all supporting documents listed above Step 3: Submit via CVS Specialty Pharmacy or fax to designated number on form Step 4: Track submission and respond to any information requests within 5 business days

Tip: CVS Specialty typically processes complete requests within one week. Incomplete submissions cause delays.

If "Possibly Eligible" - Tests to Request

Missing Genetic Testing

  • Request TTR gene sequencing from your neurologist
  • Ensure lab uses comprehensive panel covering all known pathogenic variants
  • Timeline: Results typically available in 2-4 weeks

Incomplete Clinical Assessment

Ask your neurologist to document:

  • Detailed neurological examination findings
  • Polyneuropathy symptoms and progression
  • Family history of amyloidosis
  • Exclusion of other neuropathy causes

Missing Baseline Assessments

  • mNIS+7: Composite neuropathy score including strength, reflexes, and sensation
  • 6-minute walk test: Functional endurance measure
  • Both required for therapy monitoring and insurance approval

If "Not Yet" - Alternatives & Exception Requests

When Standard Criteria Aren't Met

For off-label requests (e.g., cardiac amyloidosis):

  • Document why FDA-approved alternatives are inappropriate
  • Provide peer-reviewed literature supporting off-label use
  • Request medical necessity exception with detailed rationale

For patients using other hATTR medications:

  • Document failure, intolerance, or contraindications to current therapy
  • Provide clinical justification for switching to Onpattro
  • Consider step therapy override request

Alternative Medications to Discuss

  • Amvuttra (vutrisiran): Subcutaneous injection every 3 months
  • Tegsedi (inotersen): Weekly subcutaneous injection
  • Wainua (eplontersen): Monthly subcutaneous injection
  • Supportive care: Symptomatic management options

If Denied - New Jersey Appeal Path

New Jersey offers excellent appeal rights through the Independent Health Care Appeals Program (IHCAP), administered by Maximus Federal Services.

Internal Appeals (Required First)

Level 1 Appeal:

  • Deadline: 180 days from denial
  • Process: Submit to Aetna Provider Resolution Team
  • Address: PO Box 981106, El Paso, TX 79998-1106
  • Timeline: ~45 days for decision

Level 2 Appeal (if required):

  • Follow Aetna's specific process for second-level review
  • Same 45-day timeline applies

External Review via IHCAP

Eligibility: Must complete all Aetna internal appeals first

How to Apply:

  • Deadline: 4 months (120 days) from final Aetna denial
  • Contact: IHCAP Direct Line 1-888-393-1062
  • Administrator: Maximus Federal Services (contracted by NJ DOBI)
  • Cost: Free to patient; insurer pays all fees

Timeline:

  • Preliminary review: 5 business days to confirm eligibility
  • Full review: 45 days for standard cases, 48 hours for urgent
  • Success rate: 30-50% overturn rate for specialty drug appeals
From our advocates: "We've seen several hATTR cases succeed at external review when the initial denial focused on 'experimental' claims. The key was providing the FDA approval letter, clinical trial data, and a detailed neurologist letter explaining why alternatives weren't appropriate. The independent physician reviewers understood the complexity better than the initial utilization management team."

Peer-to-Peer Review Option

Before or during appeals, request a peer-to-peer review where your neurologist speaks directly with Aetna's medical director. This can resolve denials faster than formal appeals.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"No genetic confirmation" Submit TTR gene test results Lab report showing pathogenic variant
"Not medically necessary" Provide neurologist letter with clinical rationale Detailed medical necessity letter citing FDA approval and guidelines
"Experimental/investigational" Cite FDA approval for hATTR-PN FDA approval letter and prescribing information
"Step therapy required" Document failures/contraindications to alternatives Medical records showing prior medication trials
"Non-formulary" Request formulary exception Exception request form with clinical justification

FAQ

How long does Aetna (CVS Health) prior authorization take in New Jersey? Standard decisions typically take 30-45 days. Expedited review is available within 72 hours for urgent cases with physician support.

What if Onpattro (patisiran) is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and documenting why preferred alternatives are inappropriate.

Can I request an expedited appeal if my condition is worsening? Yes, both Aetna internal appeals and New Jersey's IHCAP external review offer expedited processes for urgent medical situations.

Does step therapy apply if I've tried medications outside New Jersey? Medical records from any location showing prior therapy failures or intolerances should satisfy step therapy requirements.

What's the difference between CVS Specialty and CVS Caremark? CVS Caremark handles prior authorizations and formulary decisions, while CVS Specialty manages the actual medication dispensing and administration coordination.

Who can help me with the appeal process in New Jersey? Contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 or the IHCAP Direct Line at 1-888-393-1062.

Getting specialized help: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals using the right clinical evidence and regulatory requirements. For complex cases like Onpattro appeals, having expert assistance with medical necessity documentation and appeal strategy can significantly improve approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical or legal advice. Coverage decisions vary by individual plan and circumstances. Always verify current requirements with your insurance plan and healthcare providers. For assistance with insurance issues in New Jersey, contact the Department of Banking and Insurance at 1-800-446-7467.

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