By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Cigna in Illinois: Complete Prior Authorization and Appeals Guide

Quick Answer: Cigna covers Onpattro (patisiran) for hereditary transthyretin-mediated amyloidosis (hATTR-PN) with prior authorization requiring genetic confirmation, neurologist evaluation, and functional assessments. Submit via CoverMyMeds or fax to 855-840-1678. Standard review takes 5 business days. If denied, you have 180 days to appeal internally, then 30 days for Illinois external review through the Department of Insurance.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Coordination
  9. Troubleshooting Common Issues
  10. Glossary

Coverage Basics

Is Onpattro Covered by Cigna in Illinois?

Yes, Onpattro (patisiran) is covered by Cigna as a preferred first-line treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. The drug is on Cigna's specialty tier and requires prior authorization but does not require step therapy.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all plans Cigna PA Form
Formulary Status Preferred specialty tier Cigna Policy IP0418
Step Therapy Not required Cigna Policy IP0418
Age Requirement ≥18 years old Cigna Policy IP0418
Specialty Pharmacy Accredo (preferred) Cigna Specialty Network

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic)
    • Check Cigna member portal or call 800-88-CIGNA
    • Confirm Onpattro is on your specific plan's formulary
    • Expected timeline: Same day
  2. Gather Required Documentation (Clinic)
    • Genetic testing results showing pathogenic TTR variant
    • Neurologist evaluation confirming hATTR-PN diagnosis
    • Baseline functional assessments (mNIS+7, 6MWT, or NIS scores)
    • Expected timeline: 1-3 days
  3. Complete Prior Authorization Form (Prescriber)
    • Use Cigna's Onpattro PA form
    • Include patient weight for dosing (≤0.3 mg/kg IV, max 30 mg every 3 weeks)
    • Specify infusion site (home, office, or outpatient facility)
    • Expected timeline: 30 minutes
  4. Submit Application (Clinic)
    • Preferred: CoverMyMeds online portal
    • Alternative: Fax to 855-840-1678
    • Urgent cases: Call 800-882-4462
    • Expected timeline: 5 business days for standard review
  5. Coordinate with Accredo (Patient/Clinic)
    • Complete Accredo enrollment form
    • Arrange infusion logistics (home nursing or clinic administration)
    • Expected timeline: 2-3 days after PA approval

Medical Necessity Letter Checklist

Your neurologist should include these key elements:

  • Diagnosis confirmation: Polyneuropathy of hereditary transthyretin-mediated amyloidosis
  • Genetic evidence: Specific pathogenic TTR variant identified via CLIA-certified laboratory
  • Clinical presentation: Neurological symptoms, progression, functional impact
  • Prior treatments: Document any previous therapies tried and their outcomes
  • FDA indication alignment: Reference that Onpattro is FDA-approved for hATTR-PN
  • Monitoring plan: Baseline and follow-up functional assessments

Timing and Urgency

Standard Review Timeline

  • Submission to decision: 5 business days
  • Appeal decisions: 30 days (pre-service), 60 days (post-service)
  • External review: 5 business days after IRO receives materials

When to Request Expedited Review

Call 800-882-4462 for urgent review if:

  • Delay would seriously jeopardize your health or ability to regain maximum function
  • Standard timeline would subject you to severe pain
  • Your neurologist certifies the urgency in writing

Expedited decisions are made within 24-72 hours.

Clinical Criteria

Required Documentation

Criteria Acceptable Evidence
Genetic Confirmation CLIA-certified lab report showing pathogenic TTR variant (not variant of uncertain significance)
Specialist Evaluation Neurologist assessment confirming hATTR-PN diagnosis
Functional Status Baseline mNIS+7, 6MWT, NIS, or FAP stage I-II scores
No Contraindications Documentation of no concurrent Tegsedi or tafamidis use
Age Verification Patient ≥18 years old

Common Denial Reasons and Solutions

Denial Reason How to Address
Missing genetic testing Submit CLIA-certified lab report with specific pathogenic variant
Insufficient specialist documentation Provide detailed neurologist evaluation with diagnosis confirmation
Lack of functional assessments Include baseline mNIS+7, 6MWT, or equivalent neuropathy scores
Off-label use request Confirm diagnosis is hATTR-PN (FDA-approved indication)

Costs and Financial Assistance

Typical Cost Structure

  • Annual list price: $450,000-$500,000+ (varies by patient weight)
  • Specialty tier coinsurance: Typically 20-50% after deductible
  • Exact copay: Check your specific plan via Cigna member portal

Financial Support Options

  • Alnylam Assist: Copay assistance and patient support services
  • State programs: Illinois residents may qualify for additional assistance through state pharmaceutical programs

Denials and Appeals

Internal Appeals Process

Filing Deadline: 180 calendar days from denial notice

Required Documents:

  • Original denial letter with reference numbers
  • Cigna Appeal Request Form
  • Updated medical records supporting medical necessity
  • Enhanced letter from neurologist addressing specific denial reasons

Submission Methods:

  • Online: Cigna provider portal
  • Fax: Number provided in denial letter
  • Mail: Address provided in denial letter

Illinois External Review

If your internal appeal is denied, Illinois law guarantees your right to independent external review.

Key Details:

  • Deadline: 30 days from final internal denial (shorter than most states)
  • Cost: Free to patients
  • Reviewer: Board-certified physician with expertise in amyloidosis
  • Timeline: 5 business days for decision (24-72 hours if expedited)
  • Binding: If approved, Cigna must cover the treatment

How to File:

  1. Contact Illinois Department of Insurance at 877-527-9431
  2. Complete external review application
  3. Submit with all denial letters and medical records
  4. Request expedited review if medically urgent

Appeals Script for Patients

When calling Cigna at 800-882-4462:

"I'm calling about the denial of prior authorization for Onpattro for my hereditary transthyretin amyloidosis. My reference number is [X]. I have genetic confirmation of a pathogenic TTR variant and my neurologist has documented progressive polyneuropathy. I'd like to request a peer-to-peer review and understand my appeal options."

Renewals and Reauthorization

Annual Renewal Requirements

Cigna requires reauthorization annually, typically initiated 60-90 days before expiration.

Updated Documentation Needed:

  • Current neurologist evaluation
  • Functional assessments: Updated mNIS+7 and 6MWT scores showing stability or improvement
  • Treatment response documentation
  • Confirmation of no contraindications

Evidence of Treatment Benefit

Assessment Required Evidence
mNIS+7 Stability or improvement from baseline (≤2-point change indicates benefit)
6MWT Maintained or increased walking distance
Clinical Response Slowed disease progression, improved symptoms, better quality of life
Tip: Providers should collect mNIS+7 and 6MWT scores every 6-12 months during treatment to support smooth renewals.

Specialty Pharmacy Coordination

Accredo Integration

Accredo Specialty Pharmacy is Cigna's preferred network for Onpattro, handling:

  • Drug fulfillment and shipping
  • Home infusion coordination with nursing support
  • Insurance benefit verification
  • Patient education and support

Infusion Options in Illinois

  • Home infusion: Preferred option with skilled nursing visits
  • Physician office: Requires appropriate infusion capabilities
  • Hospital outpatient: Available if medically necessary

Prescribing to Accredo

  • NCPDP: 4436920
  • Fax: 888-302-1028
  • Verbal: 866-759-1557

Troubleshooting Common Issues

Portal and System Problems

  • CoverMyMeds down: Use fax backup (855-840-1678) or call 800-882-4462
  • Missing forms: Download current versions from Cigna provider resources
  • Status updates: Call after 7 business days if no response

Documentation Issues

  • Genetic testing delays: Contact lab directly for expedited results
  • Specialist availability: Telemedicine consultations may be acceptable
  • Functional assessment scheduling: Some tests can be performed by trained clinic staff

From Our Advocates

Based on our experience helping patients navigate Onpattro approvals, the most common stumbling block is incomplete genetic testing documentation. Many patients have older genetic reports that don't clearly identify the specific pathogenic variant. Getting an updated, comprehensive genetic report from a CLIA-certified lab often resolves denials quickly and prevents lengthy appeals.

Glossary

Prior Authorization (PA): Insurance approval required before coverage begins

Medical Necessity: Treatment that meets accepted standards of medical practice for your condition

Formulary: List of covered medications by insurance plan

Step Therapy: Requirement to try less expensive alternatives first (not required for Onpattro)

Peer-to-Peer (P2P): Discussion between your doctor and insurance medical reviewer

External Review: Independent physician review after internal appeals are exhausted

mNIS+7: Modified Neuropathy Impairment Score plus 7 tests - measures nerve function

6MWT: Six-minute walk test - measures functional walking capacity

hATTR-PN: Hereditary transthyretin-mediated amyloidosis with polyneuropathy

IRO: Independent Review Organization - conducts external reviews in Illinois

Sources and Further Reading

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals with evidence-backed strategies. Our platform analyzes denial letters, identifies specific coverage criteria, and drafts targeted rebuttals using the right clinical evidence and payer-specific workflows. Learn more at www.counterforcehealth.org.

This guide is for informational purposes only and does not constitute medical or legal advice. Insurance policies vary by plan and may change. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions. For personalized assistance with complex cases, consider working with Counterforce Health or contacting the Illinois Department of Insurance at 877-527-9431.

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