By Counterforce Health Team in Zolgensma (onasemnogene abeparvovec-xioi) —

Getting Zolgensma Covered by Cigna in Washington: Complete Guide to Prior Authorization, Appeals, and IRO Process

Answer Box: Your Fastest Path to Approval

To get Zolgensma (onasemnogene abeparvovec-xioi) covered by Cigna in Washington, you need: (1) genetic confirmation of bi-allelic SMN1 mutation, (2) anti-AAV9 antibody titer ≤ 1:50, and (3) steroid protocol documentation. Submit Cigna's prior authorization form with all clinical records to their specialty pharmacy team. If denied, you have 180 days for internal appeal, then can request external review through Washington's IRO process. Start today by gathering genetic test results and contacting your pediatric neurologist to initiate the prior authorization request.

Table of Contents

Plan Types & Network Requirements

Cigna's Washington plans include HMO, PPO, and point-of-service options, each with different rules for accessing gene therapy:

HMO Plans

  • Require in-network providers only (except emergencies)
  • Need PCP referral for specialist visits (except OB/GYN)
  • Gene therapy must be at an in-network certified facility

PPO Plans

  • Allow out-of-network access at higher cost-share
  • No referrals required for specialists
  • More flexibility for accessing specialized SMA treatment centers
Note: If no in-network provider can administer Zolgensma within reasonable distance, you can request a network adequacy exception for out-of-network coverage at in-network rates.

Formulary Status & Coverage

Zolgensma is not assigned a pharmacy formulary tier because it's covered under Cigna's medical benefit, not the prescription drug benefit. This means:

  • No traditional copay tiers apply
  • Covered as a medical procedure/infusion
  • Subject to medical deductible and coinsurance
  • Requires specialized facility administration

The treatment is distributed exclusively through Accredo specialty pharmacy for Cigna members and must be administered at pre-approved, in-network facilities.

Prior Authorization Requirements

Cigna requires mandatory prior authorization with these strict criteria:

Coverage at a Glance

Requirement Details Documentation Needed
Age Less than 2 years old Birth certificate, medical records
Genetic Testing Bi-allelic SMN1 mutation confirmed Genetic test report with SMN1/SMN2 results
Anti-AAV9 Antibodies Titer must be ≤ 1:50 Laboratory results within 30 days
Steroid Protocol Oral corticosteroids ≥24h pre-infusion, ≥30d post Treatment plan and monitoring schedule
Specialist Care SMA or pediatric neurology specialist Provider credentials and clinical notes
Prior Therapy No previous gene therapy for SMA Medical history documentation

Required Forms

Submit the Cigna Zolgensma Prior Authorization Form with:

  • Complete medical history
  • Genetic testing results
  • Anti-AAV9 antibody titers
  • Steroid protocol plan
  • Provider attestation of medical necessity

Specialty Pharmacy Setup

Step-by-Step Enrollment Process

  1. Complete Zolgensma START Form - Provider fills out prescription and enrollment paperwork
  2. Insurance Verification - Submit both sides of medical and pharmacy insurance cards
  3. Benefits Investigation - Novartis OneGene Program verifies coverage
  4. Prior Authorization - Fax completed forms to Cigna's Zolgensma Intake Team at 866-544-1204
  5. Accredo Coordination - Once approved, Accredo handles procurement and delivery
  6. Facility Scheduling - Coordinate infusion at certified in-network facility
Tip: Use the Zolgensma enrollment portal to upload forms securely or fax to 855-951-GENE (4363).

Cost-Share Basics

With Zolgensma's $2.1 million list price, understanding your cost-share is crucial:

  • Medical deductible applies (not pharmacy deductible)
  • Coinsurance typically 10-30% after deductible
  • Out-of-pocket maximum caps your annual costs
  • Pay-over-time options may be available through Novartis

Financial Assistance

  • OneGene Patient Support - Novartis copay assistance program
  • Foundation grants - Various rare disease foundations
  • State programs - Washington Apple Health (Medicaid) coverage

Submission Process

For Providers

  1. Gather documentation - genetic tests, clinical notes, treatment history
  2. Complete PA form - ensure all required fields are filled
  3. Submit via secure fax - 866-544-1204 for Zolgensma requests
  4. Track status - follow up within 5-7 business days
  5. Respond to requests - provide additional information promptly

For Patients/Families

  1. Work with your care team - ensure all tests are completed
  2. Understand your plan - review benefits and coverage details
  3. Stay organized - keep copies of all communications
  4. Be persistent - follow up on pending requests

Appeals Process in Washington

If Cigna denies coverage, Washington provides strong consumer protections:

Internal Appeal (First Step)

  • Timeline: Submit within 180 days of denial
  • Form: Cigna Customer Appeal Request
  • Documentation: Include denial letter, medical records, provider statement
  • Decision: Cigna has 30-60 days to review and respond

External Review (IRO Process)

If internal appeal fails, Washington's Independent Review Organization process provides an impartial review:

  • Timeline: Request within 90 days of final internal denial
  • Process: State assigns certified IRO with SMA expertise
  • Standard Review: Decision within 30 days
  • Expedited Review: Decision within 72 hours for urgent cases
  • Binding: IRO decision is legally binding on Cigna
From our advocates: "We've seen families successfully overturn Zolgensma denials by providing comprehensive genetic testing documentation and detailed clinical notes showing disease progression. The key is demonstrating that all criteria are met and that treatment is medically necessary. While outcomes vary, thorough preparation significantly improves appeal success rates."

Washington State Resources

Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900 for:

  • Appeal guidance and support
  • Template appeal letters
  • IRO process assistance
  • Consumer advocacy services

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing genetic confirmation Submit complete SMN1/SMN2 testing Genetic laboratory report with mutation details
Age over 2 years Provide birth certificate and medical records Official age documentation
Positive AAV9 antibodies Retest if results are outdated Recent antibody titer ≤ 1:50
No steroid protocol Submit detailed treatment plan Corticosteroid dosing and monitoring schedule
Non-certified facility Find in-network certified site List of approved Zolgensma administration centers
Prior gene therapy Clarify treatment history Complete medical records showing no previous gene therapy

FAQ

How long does Cigna's prior authorization take? Standard review takes 5-15 business days. Expedited reviews for urgent cases can be completed in 72 hours.

What if Zolgensma is considered experimental? Zolgensma has FDA approval for SMA. If denied as experimental, appeal with FDA labeling and clinical evidence of efficacy.

Can I get coverage if I'm over 2 years old? Cigna follows FDA labeling, which doesn't specify an upper age limit. Age restrictions vary by plan and clinical circumstances.

Does step therapy apply to Zolgensma? Some plans may require trying other SMA treatments first. This can often be appealed with medical necessity documentation.

How do I request expedited review? Contact Cigna directly and request expedited processing due to urgent medical need. Provide documentation of clinical urgency.

What if my employer plan is self-funded? Self-funded ERISA plans may have different appeal rights. Contact the U.S. Department of Labor for ERISA-specific guidance.

When to Escalate

Contact these resources if you need additional help:

  • Washington Insurance Commissioner: 1-800-562-6900 for coverage disputes
  • Counterforce Health: Specializes in turning insurance denials into targeted, evidence-backed appeals for prescription drugs like Zolgensma
  • Patient advocacy organizations: CureSMA and other rare disease groups
  • Legal counsel: For complex cases or pattern of unfair denials

Filing Complaints

If Cigna fails to follow proper procedures, file a complaint with:

  • Washington Office of the Insurance Commissioner
  • U.S. Department of Health and Human Services (for ACA violations)
  • Department of Labor (for ERISA plan violations)

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules, pulling the right evidence from FDA labeling, peer-reviewed studies, and specialty guidelines.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan. Always consult with your healthcare provider and insurance company for specific coverage decisions. For personalized assistance with Cigna appeals in Washington, consider working with Counterforce Health or other qualified patient advocacy services.

Sources & Further Reading

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