By Counterforce Health Team in Strimvelis (autologous CD34+ ADA-SCID gene therapy) —

How to Get Strimvelis Gene Therapy Covered by Cigna in Ohio: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Strimvelis Covered by Cigna in Ohio

Strimvelis coverage requires prior authorization with genetic confirmation of ADA-SCID and documentation of failed standard treatments. Since Strimvelis is only available at SR-TIGET in Milan, Italy, you'll need out-of-network authorization. Start by calling Cigna member services to verify international coverage benefits, then submit a comprehensive PA request with genetic testing results, enzyme deficiency confirmation, and clinical justification. If denied, file internal appeals within 180 days, followed by Ohio's external review process through Independent Review Organizations.

First step today: Call the number on your Cigna card to confirm your plan's out-of-network and international treatment benefits.

Table of Contents

Coverage Requirements Overview

Strimvelis (autologous CD34+ ADA-SCID gene therapy) presents unique coverage challenges because it's only available at one center worldwide—SR-TIGET in Milan, Italy—and is not FDA-approved in the United States. Cigna's coverage depends on several critical factors:

Plan Type Considerations

  • Commercial plans: May offer out-of-network benefits with higher cost-sharing
  • Medicare Advantage: Limited international coverage except for emergencies
  • Medicaid managed care: Typically no international coverage
  • Self-funded employer plans: Varies by employer policy design

Key Policy Requirements

Cigna requires prior authorization for all gene therapies, with additional scrutiny for non-FDA approved treatments administered internationally.

Step-by-Step: Fastest Path to Approval

1. Verify Coverage Eligibility

Who: Patient or caregiver
Action: Call Cigna member services at the number on your insurance card
Ask about: Out-of-network benefits, international treatment coverage, and maximum out-of-pocket limits
Timeline: Same day

2. Gather Required Documentation

Who: Healthcare team and patient
Documents needed:

  • Genetic testing confirming ADA gene mutations
  • ADA enzyme activity results showing deficiency
  • Documentation of failed or inappropriate standard treatments (HSCT)
  • Clinical notes supporting urgency and medical necessity Timeline: 1-2 weeks

3. Submit Prior Authorization

Who: Prescribing physician
Action: Submit comprehensive PA request via Cigna's provider portal or appropriate forms
Include: All documentation from step 2 plus clinical rationale
Timeline: 2-3 business days to submit

4. Request Peer-to-Peer Review

Who: Prescribing physician
Action: If initial denial, immediately request peer-to-peer discussion with Cigna medical director
Timeline: Within 3 business days of denial

5. File Internal Appeals

Who: Patient or provider
Action: Submit formal internal appeal with additional supporting evidence
Timeline: Must file within 180 days of denial

6. Pursue External Review

Who: Patient
Action: Request external review through Ohio Department of Insurance if internal appeals fail
Timeline: Within 180 days of final internal denial

Medical Necessity Criteria

Diagnostic Requirements

Cigna requires confirmation of ADA-SCID through:

  • Genetic testing: Bi-allelic pathogenic variants in the ADA gene
  • Enzyme deficiency: ADA activity less than 1% of normal levels
  • Immune dysfunction: Documented T-cell, B-cell, and NK cell deficiencies

Clinical Justification Standards

Your medical team must demonstrate:

  • Severity of condition: Life-threatening immunodeficiency requiring urgent intervention
  • Standard treatment considerations: Documentation that hematopoietic stem cell transplant (HSCT) is not feasible due to:
    • Lack of suitable donor
    • Patient clinical instability
    • Previous HSCT failure
  • Unique therapeutic need: Why Strimvelis is the only viable option

Evidence Requirements

Include supporting documentation from:

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
"Not FDA approved" Emphasize lack of alternatives and EMA approval EMA approval documentation, clinical studies
"Experimental/investigational" Cite established use in Europe and clinical necessity Published outcomes data, regulatory approvals
"No in-network providers" Request out-of-network exception for unique circumstances Letter from SR-TIGET confirming exclusive availability
"Travel not covered" Clarify you're only requesting therapy coverage, not travel Detailed cost breakdown separating therapy from travel
"Insufficient medical necessity" Provide comprehensive clinical timeline and urgency Enhanced medical records, specialist letters

Appeals Process in Ohio

Internal Appeals with Cigna

  • First level: 30 days for standard review, 72 hours for expedited
  • Second level: Additional 30 days if first appeal denied
  • Required: Written request with additional supporting documentation

Ohio External Review

Ohio law provides strong consumer protections for insurance appeals:

  • Eligibility: Available for medical necessity denials after internal appeals
  • Timeline: 180 days from final denial to request external review
  • Process: Independent Review Organizations (IROs) conduct impartial medical reviews
  • Decision timeframe: 30 days for standard review, 72 hours for expedited
  • Binding: IRO decisions are binding on Cigna

To request external review: Contact the Ohio Department of Insurance at 1-800-686-1526 or submit the External Review Request Form.

From our advocates: We've seen families succeed by emphasizing the unique, life-threatening nature of ADA-SCID and the singular global availability of Strimvelis. One key factor was demonstrating that standard HSCT wasn't viable due to the patient's clinical condition and lack of suitable donors. The external review process in Ohio proved crucial when internal appeals failed.

Clinician Corner: Documentation Checklist

Medical Necessity Letter Components

  1. Patient identification: Age, diagnosis, severity markers
  2. Diagnostic confirmation: Genetic testing results, enzyme levels
  3. Treatment history: Prior therapies attempted, outcomes, contraindications
  4. Clinical rationale: Why Strimvelis is medically necessary and urgent
  5. Alternative analysis: Why other treatments are inappropriate
  6. Guideline support: Citations from relevant medical literature
  7. Monitoring plan: Post-therapy follow-up and safety monitoring

Supporting Documentation

  • Complete genetic testing report with pathogenic variant identification
  • Laboratory results showing ADA enzyme deficiency
  • Immunological workup demonstrating SCID phenotype
  • Documentation of HSCT evaluation and contraindications
  • Letters from immunology specialists supporting treatment choice

Cost Considerations

Therapy Costs

  • Strimvelis therapy: Approximately €594,000 (verify with SR-TIGET)
  • Travel and accommodation: Not covered by Cigna (plan separately)
  • Follow-up care: Ongoing monitoring costs

Financial Support Options

  • Orchard Therapeutics: Contact manufacturer for patient assistance programs
  • Rare disease foundations: Organizations like NORD may provide travel grants
  • Hospital financial assistance: SR-TIGET may offer payment plans

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttals. Our platform helps families navigate complex coverage challenges for rare disease treatments like Strimvelis, ensuring that denials are met with targeted, medically sound appeals that align with each insurer's specific requirements.

Frequently Asked Questions

Q: How long does Cigna's prior authorization process take for Strimvelis? A: Standard review takes 14-30 days, but expedited review (24-72 hours) is available for urgent cases. Request expedited review given the life-threatening nature of ADA-SCID.

Q: What if my Cigna plan doesn't cover international treatments? A: Some plans exclude international care except for emergencies. You can appeal this exclusion by demonstrating that Strimvelis is only available at SR-TIGET and constitutes urgent, life-saving treatment.

Q: Can I get coverage for travel expenses to Milan? A: Cigna typically doesn't cover travel, accommodation, or related expenses. Focus your coverage request solely on the therapy itself and seek alternative funding for travel costs.

Q: What happens if Cigna denies coverage after all appeals? A: You retain the right to file complaints with Ohio insurance regulators and may pursue legal remedies. Some families also explore alternative funding through foundations and crowdfunding.

Q: Does step therapy apply to Strimvelis coverage? A: While Cigna may require documentation of HSCT consideration, true step therapy is less applicable given Strimvelis's unique indication and availability constraints.

Q: How do I request an expedited appeal? A: Contact Cigna immediately and provide physician certification that delay would seriously jeopardize the patient's health. Include clinical documentation supporting urgency.

When to Contact Ohio Regulators

If you encounter unreasonable delays, improper denials, or procedural violations, contact:

  • Ohio Department of Insurance: 1-800-686-1526
  • Consumer Services Division: File complaints about insurer conduct
  • External Review Program: Independent medical necessity reviews

The Counterforce Health platform can help streamline this entire process by automatically generating payer-specific appeals that address Cigna's exact coverage criteria while incorporating the clinical evidence most likely to overturn denials for rare disease gene therapies.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms, clinical circumstances, and current policies. Always consult with your healthcare providers and insurance representatives for guidance specific to your situation. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services Division.

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