By Counterforce Health Team in Zolgensma (onasemnogene abeparvovec) —

The Complete Guide to Getting Zolgensma (Onasemnogene Abeparvovec) Covered by Cigna in New York

Quick Answer: Getting Zolgensma Covered by Cigna in New York

Cigna requires prior authorization for Zolgensma (onasemnogene abeparvovec) with strict criteria: genetic confirmation of bi-allelic SMN1 mutations, age under 2 years, recent labs, and anti-AAV9 antibody titer ≤1:50. Submit through Cigna's provider portal or Accredo specialty pharmacy. If denied, New York's external appeal process offers binding independent review within 180 days. Start by confirming your child meets age/genetic criteria, then gather required documentation for your SMA specialist to submit.

Table of Contents

Who Should Use This Guide

This guide is for families in New York whose child has been diagnosed with spinal muscular atrophy (SMA) and needs Zolgensma, the one-time gene therapy treatment. You'll also find this useful if you're a clinician helping patients navigate Cigna's prior authorization process.

Expected outcome: With complete documentation meeting Cigna's criteria, approval typically takes 5-15 business days. If initially denied, New York's robust external appeal system has overturned many rare disease denials when proper evidence is presented.

Member & Plan Basics

Before starting the prior authorization process, verify these basics:

Coverage Verification

  • Active Cigna coverage: Log into myCigna.com to confirm current enrollment
  • Plan type: Most Cigna commercial plans cover Zolgensma through their specialty pharmacy benefit
  • Specialty pharmacy: Zolgensma routes through Accredo, Cigna's designated specialty pharmacy for gene therapies

Financial Considerations

  • Deductible: Zolgensma's $2.125 million list price may trigger high deductible requirements
  • Copay assistance: Novartis offers patient support programs - contact 1-833-ZOLGENSMA
  • Prior authorization required: All Cigna plans require PA for Zolgensma due to its specialty status

Clinical Criteria Checklist

Cigna follows strict medical necessity criteria based on FDA labeling and their internal policy. Your child must meet ALL of these requirements:

Requirement Specific Criteria Documentation Needed
Age Under 2 years old Birth certificate, medical records
Genetic Testing Bi-allelic SMN1 mutations confirmed Genetic test results showing pathogenic variants
Weight Within 14 days of infusion Current weight measurement
Laboratory Values (within 30 days) • Creatinine <1.0 mg/dL
• WBC ≤20,000/mm³
• Hemoglobin 8-18 g/dL
• Anti-AAV9 antibody titer ≤1:50		 Recent lab reports
Prior Treatment No previous Zolgensma Medical history confirmation
Prescriber SMA/neuromuscular specialist Board certification documentation
Infusion Site FDA-certified, in-network facility Site verification from Cigna
Note: If your child is currently on Spinraza (nusinersen), document the plan to discontinue it before Zolgensma administration.

Coding & Billing Requirements

Proper coding prevents claim rejections and ensures accurate processing:

Primary Codes

  • HCPCS J-Code: J3399 (Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5×10¹⁵ vector genomes)
  • ICD-10-CM: G12.0 (Infantile spinal muscular atrophy, type I)
  • CPT for Infusion: 96365 (IV infusion, initial, up to 1 hour)

NDC Information

  • Use 10-digit NDC format: 71894-141-09
  • Some payers require 11-digit: 071894-0141-09

Documentation Packet

Letter of Medical Necessity (LMN)

Your SMA specialist must include these elements in the LMN:

Header Section:

  • Patient demographics (name, DOB, weight, insurance ID)
  • Request for expedited review (reduces timeline to 72 hours)
  • Statement of urgent medical need

Clinical Justification:

  • SMA diagnosis with genetic confirmation
  • Description of bi-allelic SMN1 mutations and SMN2 copy number
  • Current symptoms and prognosis without treatment
  • Rationale for one-time gene therapy intervention

Treatment Plan:

  • Proposed Zolgensma dose (weight-based, maximum 1.1×10¹⁴ vg/kg)
  • Planned infusion date and location
  • Expected clinical benefits based on published studies

Required Attachments

  • Genetic test results confirming SMN1 mutations
  • Recent laboratory values (within 30 days)
  • Anti-AAV9 antibody titer results
  • Current weight documentation
  • Prescriber credentials and board certification
  • Infusion site certification documents

Submission Process

Step-by-Step Submission

  1. Prepare Documentation (1-2 weeks)
  2. Submit Prior Authorization
    • Online: Cigna provider portal (preferred method)
    • Fax: Express Scripts at designated PA fax number
    • Include: All documentation checklist items
  3. Confirmation
    • Record confirmation number
    • Note submission date for timeline tracking

Review Timeline

  • Standard: 5-15 business days
  • Expedited: 24-72 hours for urgent cases
  • New York requirement: Cigna must provide written determination within regulatory timelines

Specialty Pharmacy Routing

Once approved, Zolgensma routes through Cigna's specialty pharmacy network:

Accredo Process

  • Automatic routing: Approved prescriptions go directly to Accredo
  • Cold-chain shipping: Accredo handles temperature-controlled delivery to infusion site
  • Coordination: 24/7 pharmacist support for scheduling and logistics
  • Contact: Access through myCigna app or Accredo.com

Infusion Site Requirements

  • Must be FDA-certified for Zolgensma administration
  • In-network with Cigna
  • Experience with gene therapy infusions preferred

After Submission: What to Expect

Status Monitoring

  • Check status: Log into Cigna provider portal every 2-3 business days
  • Contact info: Cigna Prior Authorization department for updates
  • Documentation: Keep records of all communications

Approval Process

  • Notification: Written approval with specific coverage details
  • Coordination: Automatic transfer to Accredo for fulfillment
  • Scheduling: Work with infusion site to schedule administration

Common Denial Reasons & How to Prevent Them

Denial Reason Prevention Strategy
Missing genetic confirmation Submit complete genetic test results showing bi-allelic SMN1 mutations
Age/weight restrictions Verify patient under 2 years with current weight documentation
Incomplete lab values Ensure all required labs are within 30-day window
High anti-AAV9 titer Confirm titer ≤1:50; if higher, discuss alternatives with specialist
Site of care issues Verify infusion facility is FDA-certified and in-network

Appeals Playbook for New York

If Cigna denies your Zolgensma request, New York offers strong patient protections:

Internal Appeals (First Step)

  • Timeline: File within 180 days of denial
  • Process: Submit appeal through Cigna member portal or in writing
  • Documentation: Include additional clinical evidence and peer-reviewed studies

External Appeals (Independent Review)

New York's external appeal process is among the strongest in the nation:

  • Automatic review: As of March 2025, medical necessity denials are automatically forwarded for external review unless you opt out
  • Specialist reviewers: External reviewers must actively practice in the same specialty (neurology/genetics for SMA cases)
  • Binding decisions: External review decisions are binding on Cigna
  • No cost: Free to patients; insurers pay all fees
  • Timeline: Standard 30 days, expedited 72 hours for urgent cases

Filing External Appeals

From our advocates: We've seen families successfully overturn Zolgensma denials in New York by submitting comprehensive genetic documentation and current SMA treatment guidelines. The key is demonstrating that the child meets all FDA criteria and that delay could significantly impact outcomes. While every case is unique, thorough preparation often leads to approval on appeal.

Printable Checklist

Pre-Submission Checklist:

  • Patient under 2 years old
  • Genetic test confirming bi-allelic SMN1 mutations
  • Labs within 30 days (creatinine, CBC, liver function)
  • Anti-AAV9 antibody titer ≤1:50
  • Current weight (within 14 days)
  • SMA specialist prescriber
  • FDA-certified infusion site identified
  • Cigna PA form completed
  • Letter of medical necessity drafted
  • All supporting documents gathered

Post-Submission:

  • Confirmation number recorded
  • Submission date noted
  • Status check schedule established
  • Appeal strategy prepared if needed

FAQ

How long does Cigna prior authorization take for Zolgensma in New York? Standard review is 5-15 business days. Expedited review for urgent cases can be completed in 24-72 hours. New York regulations require timely determinations.

What if Zolgensma is non-formulary on my Cigna plan? Cigna typically covers Zolgensma as a specialty medication through Accredo, even if not on standard formulary. The prior authorization process addresses coverage determination.

Can I request expedited review? Yes. If your child's condition is urgent or rapidly progressing, request expedited review in your initial submission. This reduces the timeline to 24-72 hours.

Does step therapy apply to Zolgensma? Cigna may require documentation of prior treatments or contraindications to other SMA therapies like Spinraza or Evrysdi, but step therapy requirements vary by case.

What happens if I miss the 180-day appeal deadline? New York's extended appeal timeline provides more flexibility, but missing deadlines can limit options. Contact Community Health Advocates immediately for guidance on late appeals.

How much will Zolgensma cost with Cigna coverage? Costs depend on your specific plan's specialty drug coverage. Novartis offers patient assistance programs that may reduce out-of-pocket costs significantly.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex treatments like gene therapies. Our platform analyzes denial letters, identifies specific coverage criteria, and helps families build evidence-backed appeals that align with each insurer's requirements. For families facing Zolgensma denials, we provide targeted support to navigate the appeals process effectively.

When dealing with high-stakes treatments like Zolgensma, having expert guidance can make the difference between approval and denial. Counterforce Health helps families and clinicians understand exactly what documentation insurers need and how to present it persuasively.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations. Coverage policies and requirements may change; verify current information with Cigna and New York state regulators.

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