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

Getting Strimvelis Gene Therapy Covered by Cigna in Georgia: Complete Coverage Guide with Appeals Process

Answer Box: Getting Strimvelis Covered by Cigna in Georgia

Strimvelis requires prior authorization and formulary exception from Cigna since it's not FDA-approved in the U.S. and only available at SR-TIGET in Milan, Italy. Key requirements: confirmed ADA-SCID diagnosis with genetic testing, documented ADA enzyme deficiency, and medical necessity letter explaining why standard treatments (HSCT) aren't suitable. First step: Contact your immunologist to begin collecting diagnostic documentation and submit the formulary exception request through Cigna's provider portal. If denied, Georgia residents have 60 days to request external review through the Georgia Department of Insurance.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all gene therapies Cigna provider portal Cigna Gene Therapy Program
Formulary Status Non-formulary (requires exception) Not on standard formulary Cigna Formulary Updates
Diagnosis Confirmation ADA-SCID with genetic testing Lab results required Cigna Genetic Testing Policy
International Coverage Pre-authorization required Must verify network status Contact Cigna International
Appeals Deadline 60 days for external review Georgia DOI requirement Georgia Insurance Code

Policy Overview: How Cigna Handles Gene Therapies

Cigna manages gene therapies through their specialized Gene Therapy Program, which requires treatments at authorized facilities. Since Strimvelis is only available at SR-TIGET in Milan and isn't FDA-approved, it falls under both international coverage and formulary exception policies.

Plan Types That Apply:

  • Commercial PPO and HMO plans
  • Cigna International plans (for expatriates)
  • Self-funded employer plans (varies by employer)

Key Policy Documents:

  • Gene therapy coverage requires pre-authorization regardless of plan type
  • International treatment coverage depends on plan benefits
  • Formulary exceptions follow standard pharmacy benefit procedures

Indication Requirements for Strimvelis

FDA Status: Strimvelis is not FDA-approved but has European Medicines Agency (EMA) approval for ADA-SCID treatment.

Required Clinical Criteria:

  • Confirmed diagnosis of adenosine deaminase severe combined immunodeficiency (ADA-SCID)
  • Bi-allelic mutations in the ADA gene documented by genetic testing
  • ADA enzyme activity less than 1% of normal levels
  • Clinical evidence of severe immunodeficiency

Age Considerations: Typically indicated for pediatric patients, though adult cases may be considered with appropriate documentation.

Step Therapy & Medical Exceptions

Standard Treatment Hierarchy:

  1. First-line: Hematopoietic stem cell transplantation (HSCT) with matched donor
  2. Second-line: Enzyme replacement therapy (ERT) with Revcovi
  3. Third-line: Gene therapy (Strimvelis) when other options aren't suitable

Medical Exception Pathways:

  • No suitable matched donor available for HSCT
  • Previous HSCT failure or complications
  • Contraindications to conditioning regimens
  • Patient/family preference after informed consent discussion
Clinician Tip: Document specific reasons why HSCT isn't appropriate, including donor availability searches and any prior treatment failures.

Required Diagnostics & Documentation

Essential Lab Work:

  • ADA enzyme activity assay (erythrocyte levels)
  • Comprehensive genetic testing for ADA gene mutations
  • Immunological workup (lymphocyte counts, immunoglobulin levels)
  • Infectious disease screening

Clinical Documentation:

  • Complete medical history and physical examination
  • Growth and development assessments
  • Previous treatment attempts and outcomes
  • Family history of immunodeficiency

Timing Requirements:

  • Genetic testing results must be current (within 12 months)
  • Lab values should be recent (within 30-90 days)
  • Clinical notes should document ongoing symptoms

Site of Care & International Treatment

Strimvelis Availability:

  • Only manufactured and administered at SR-TIGET (San Raffaele Telethon Institute for Gene Therapy) in Milan, Italy
  • Cannot be transported due to extremely short shelf-life
  • Requires approximately 6-8 weeks on-site for treatment

Cigna International Coverage:

  • Pre-authorization required for out-of-country treatment
  • Verify network status of SR-TIGET facility
  • Coordinate with Cigna case management for international logistics
Important: Contact Cigna International at least 60 days before planned treatment to verify coverage and coordinate pre-authorization.

Evidence to Support Medical Necessity

Key Clinical Guidelines:

  • Primary Immunodeficiency Committee guidelines for ADA-SCID treatment
  • European Society for Primary Immunodeficiency (ESID) recommendations
  • Published clinical trial data from SR-TIGET

Peer-Reviewed Evidence:

  • Long-term follow-up studies showing sustained immune reconstitution
  • Comparative effectiveness with HSCT outcomes
  • Safety profile documentation

Regulatory Support:

  • EMA approval documentation and clinical assessment reports
  • FDA orphan drug designation (if applicable)
  • International treatment protocols

Fastest Path to Approval

  1. Gather Diagnostic Evidence (Patient/Family): Ensure genetic testing and enzyme assays are completed and documented
  2. Submit Prior Authorization (Physician): Complete formulary exception request with comprehensive medical necessity letter
  3. Coordinate International Coverage (Patient): Contact Cigna to verify SR-TIGET network status and international benefits
  4. Obtain Written Pre-Authorization (Physician): Secure written approval before scheduling treatment in Milan
  5. Schedule Treatment (Patient/Family): Coordinate with SR-TIGET and Cigna case management
  6. Prepare for Appeals (Patient): If denied, immediately begin internal appeal process
  7. File External Review (Patient): If internal appeal fails, submit to Georgia DOI within 60 days

Appeals Playbook for Georgia

Internal Appeals Process:

  • Timeline: Must file within 180 days of denial
  • Method: Submit through Cigna member portal or mail
  • Required: Original denial letter, medical records, physician attestation
  • Decision: Typically within 30 days (expedited: 72 hours for urgent cases)

External Review Process:

  • Timeline: Must file within 60 days of final internal denial
  • Authority: Georgia Department of Insurance
  • Contact: Consumer Services Division at 1-800-656-2298
  • Cost: Free to consumer
  • Decision: Binding on Cigna if approved
Georgia-Specific Resource: Counterforce Health helps patients navigate complex appeals by turning insurance denials into targeted, evidence-backed rebuttals aligned to payer policies.

Expedited Reviews:

  • Available for urgent medical situations
  • Can be requested concurrent with internal appeal
  • Decision typically within 72 hours

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not FDA-approved" Emphasize EMA approval and medical necessity EMA approval documents, clinical guidelines
"Experimental/Investigational" Provide published efficacy data Peer-reviewed studies, long-term outcomes
"Alternative treatments available" Document HSCT contraindications/failures Donor search results, prior treatment records
"Out-of-network facility" Request single-case agreement Medical necessity for SR-TIGET specifically
"International treatment exclusion" Appeal based on no U.S. alternative Documentation that treatment unavailable domestically

FAQ

How long does Cigna prior authorization take for Strimvelis? Standard review is typically 72 hours, but complex cases involving international treatment may take 5-10 business days. Request expedited review if clinically urgent.

What if Strimvelis is non-formulary on my plan? Submit a formulary exception request with comprehensive medical necessity documentation. Include evidence of why formulary alternatives aren't appropriate.

Can I request an expedited appeal in Georgia? Yes, Georgia allows expedited external review for urgent medical situations, with decisions typically within 72 hours.

Does step therapy apply if I've tried treatments outside Georgia? Yes, document all prior treatments regardless of where they occurred. Cigna recognizes out-of-state medical records.

How much does Strimvelis cost, and are there financial assistance programs? The list price is approximately €594,000 ($650,000). Contact Orchard Therapeutics for potential patient assistance programs.

What happens if SR-TIGET isn't in Cigna's network? You may need to request a single-case agreement for out-of-network coverage, emphasizing that this is the only facility where Strimvelis is available.

When facing complex insurance appeals for rare disease treatments, Counterforce Health specializes in transforming denials into targeted, evidence-backed appeals that address payer-specific requirements and maximize approval chances.

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific guidance regarding your situation. For additional consumer assistance in Georgia, contact the Georgia Department of Insurance Consumer Services Division at 1-800-656-2298.

Sources & Further Reading

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