By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Approved by Cigna in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Onpattro (patisiran) Covered by Cigna in Virginia

Onpattro (patisiran) requires prior authorization from Cigna for coverage through Accredo or Express Scripts specialty pharmacies in Virginia. The fastest path to approval: (1) Confirm hATTR-PN diagnosis with genetic testing and neurologist evaluation, (2) Submit Cigna's Onpattro PA form via CoverMyMeds with comprehensive clinical documentation, (3) Coordinate with Accredo for infusion setup. Standard review takes 5 business days. If denied, Virginia's external review process through the State Corporation Commission Bureau of Insurance provides an independent second opinion within 45 days.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather What You Need
  4. Submit the Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. If You're Asked for More Information
  7. If Your Request is Denied
  8. Virginia External Review Process
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This comprehensive guide helps patients with hereditary transthyretin-mediated amyloidosis (hATTR) and their healthcare providers navigate Cigna's prior authorization process for Onpattro (patisiran) in Virginia. We'll walk through every step from initial submission to appeals, including Virginia-specific external review rights.

Onpattro is a first-in-class siRNA therapy that costs approximately $450,000-$500,000 annually, making thorough documentation essential for approval. With proper preparation, many patients successfully obtain coverage—and when initial denials occur, Virginia's robust appeals process provides meaningful recourse.

Before You Start: Verify Your Coverage

Check Your Plan Type and Pharmacy Benefits

Confirm these details before beginning:

  • Plan verification: Call the customer service number on your insurance card to verify Onpattro coverage under your specific Cigna plan
  • Specialty pharmacy: Most Cigna plans require Accredo Specialty Pharmacy for Onpattro fulfillment
  • Formulary tier: Onpattro is typically placed on Tier 5 (Specialty Drug tier) with higher cost-sharing
  • Medical vs. pharmacy benefit: Onpattro may be covered under medical benefits for infusion administration
Note: Virginia residents with Cigna Medicare Advantage plans may have different formulary placement and requirements than commercial plans.

Gather What You Need

Essential Documentation Checklist

Clinical Requirements:

  • ✅ Confirmed diagnosis of hATTR-PN with genetic testing showing pathogenic TTR variant
  • ✅ Neurologist evaluation and assessment notes
  • ✅ Baseline functional assessments (mNIS+7, NIS, or FAP staging)
  • ✅ ICD-10 diagnosis code E85.1 (hereditary amyloidosis)
  • ✅ Documentation of symptomatic polyneuropathy
  • ✅ Patient age ≥18 years

Administrative Requirements:

Key Clinical Criteria

According to Cigna's coverage policy, patients must have:

Requirement Documentation Needed
Genetic confirmation CLIA-certified lab report showing pathogenic TTR variant
Specialist evaluation Neurologist assessment confirming hATTR-PN diagnosis
Age requirement Patient must be ≥18 years old
Functional status Baseline scores (mNIS+7, NIS, or FAP stage I-II)
No contraindications No concurrent use with Tegsedi or tafamidis

Submit the Prior Authorization Request

Step-by-Step Submission Process

1. Complete the PA Form (Provider)

2. Choose Your Submission Method

  • Preferred: Submit via CoverMyMeds for fastest processing
  • Alternative: Fax to 855-840-1678
  • Urgent cases: Call 800-882-4462 for expedited review

3. Attach Supporting Documentation

  • Clinical notes from neurologist
  • Genetic testing results
  • Functional assessment scores
  • Patient insurance card copy

4. Specify Infusion Details

  • Indicate preferred infusion site (home, clinic, hospital outpatient)
  • Coordinate with Accredo for drug delivery logistics
Tip: Submit requests early in the week to avoid weekend processing delays.

Follow-Up and Timeline Expectations

Standard Processing Times

  • Standard review: 5 business days from complete submission
  • Expedited review: 72 hours for urgent medical necessity
  • Additional information requests: 2-3 business days for response

When and How to Follow Up

Call Cigna at the number on your denial letter or insurance card if:

  • No response after 7 business days
  • Request status shows "pending additional information"
  • Clinical circumstances change requiring expedited review

Sample Follow-Up Script: "I'm calling to check the status of prior authorization request #[reference number] for Onpattro (patisiran) for patient [name], member ID [number]. Can you tell me if any additional information is needed and the expected decision timeline?"

If You're Asked for More Information

Common Information Requests

Cigna may request additional documentation to establish medical necessity:

Request Type How to Respond
More detailed clinical notes Submit comprehensive neurologist assessment with symptom progression
Functional assessment scores Provide baseline mNIS+7, 6-minute walk test, or FAP staging
Genetic testing clarification Ensure pathogenic (not "variant of unknown significance") TTR mutation documented
Treatment history Document any prior therapies tried and their outcomes

Medical Necessity Letter Components

Your neurologist should include:

  • Specific hATTR-PN diagnosis with genetic confirmation
  • Current functional status and symptom severity
  • Expected treatment benefits based on FDA-approved indication
  • Why Onpattro is medically appropriate for this patient

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
"Not medically necessary" Submit detailed specialist letter with functional scores and disease progression
"Experimental/investigational" Emphasize FDA approval for hATTR-PN and include prescribing information
"Genetic testing insufficient" Provide CLIA-certified lab report showing pathogenic TTR variant
"Missing specialist evaluation" Submit comprehensive neurologist assessment and treatment plan

Internal Appeals Process

First-Level Appeal:

  • Timeline: File within 180 days of denial
  • Method: Written appeal to Cigna Appeals Unit, PO Box 188011, Chattanooga, TN 37422
  • Decision: 60 days (standard), 72 hours (expedited)
  • Include: Original PA request, denial letter, additional clinical evidence

Peer-to-Peer Review Request: Contact Cigna to schedule a peer-to-peer discussion between your neurologist and Cigna's medical director. This often improves approval chances by allowing direct clinical dialogue.

From our advocates: "We've seen peer-to-peer reviews significantly improve approval rates for complex cases like hATTR. The prescribing neurologist can address nuanced clinical factors that may not be clear from written documentation alone."

Virginia External Review Process

When Internal Appeals Are Exhausted

If Cigna upholds the denial after internal appeals, Virginia residents can request an independent external review through the State Corporation Commission Bureau of Insurance.

Virginia External Review Timeline

Step Timeline Action Required
File request Within 120 days of final denial Submit Form 216-A
Standard review 45 days Independent Review Organization (IRO) decision
Expedited review 72 hours (urgent cases) Physician certification of medical urgency required
Implementation 1-3 days if overturned Cigna must authorize coverage

Required Documentation for External Review

  • Completed Form 216-A (External Review Request)
  • Final denial letter from Cigna
  • All medical records supporting medical necessity
  • Signed medical release form

Contact Virginia Bureau of Insurance:

  • Phone: 1-877-310-6560
  • Mailing Address: P.O. Box 1157, Richmond, VA 23218

Virginia's external review process is free and binding on insurers. Independent medical experts review cases, and approximately 40-50% of denials are overturned with strong clinical documentation.

Renewal and Re-Authorization

Annual Renewal Requirements

Onpattro typically requires annual re-authorization. Begin the renewal process 60-90 days before your current authorization expires.

Renewal Documentation:

  • Updated neurologist assessment
  • Functional status measurements showing stability or improvement
  • Treatment response documentation
  • Any changes in clinical status or concurrent medications

Evidence of Treatment Benefit: Document improvements in:

  • Neuropathy symptoms and progression
  • Functional assessments (mNIS+7, walking ability)
  • Quality of life measures
  • Disease stabilization

Quick Reference Checklist

Before Submitting PA Request

  • Confirm hATTR-PN diagnosis with genetic testing
  • Obtain neurologist evaluation and functional assessments
  • Complete Cigna PA form with all required fields
  • Coordinate with Accredo Specialty Pharmacy
  • Submit via CoverMyMeds or fax to 855-840-1678

If Denied

  • Review denial reason and gather additional documentation
  • File internal appeal within 180 days
  • Request peer-to-peer review with Cigna medical director
  • If still denied, file Virginia external review within 120 days
  • Contact Virginia Bureau of Insurance at 1-877-310-6560

For Ongoing Coverage

  • Begin renewal process 60-90 days before expiration
  • Document treatment response and functional improvements
  • Maintain regular neurologist follow-up appointments

FAQ

Q: How long does Cigna prior authorization take for Onpattro in Virginia? A: Standard review is 5 business days from complete submission. Expedited reviews are available in 72 hours for urgent cases.

Q: What if Onpattro is non-formulary on my Cigna plan? A: Submit a formulary exception request along with the PA, demonstrating medical necessity and lack of formulary alternatives.

Q: Can I request an expedited appeal if my condition is worsening? A: Yes. Virginia allows expedited external review within 72 hours if your physician certifies that delays could seriously jeopardize your health.

Q: Does step therapy apply to Onpattro? A: Cigna generally does not require step therapy for the FDA-approved hATTR-PN indication, but verify with your specific plan.

Q: What happens if Virginia's external review overturns Cigna's denial? A: The decision is binding on Cigna, and they must authorize coverage within 1-3 days of the favorable determination.

Q: Can I get help with the appeals process? A: Yes. The Virginia Bureau of Insurance provides free guidance, and specialized services like Counterforce Health can help create comprehensive, evidence-based appeals for complex cases like hATTR.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like Onpattro. Their platform analyzes denial letters, identifies specific payer requirements, and creates targeted appeals with the right clinical evidence and citations. For patients facing repeated denials or complex coverage challenges, their payer-specific approach can significantly improve approval outcomes while reducing the administrative burden on healthcare providers.

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions and work with your insurance plan's specific requirements. Coverage policies and procedures may vary by plan and can change over time. For the most current information, contact Cigna directly or consult your plan documents.

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