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

Getting Strimvelis Gene Therapy Covered by Aetna in Georgia: Complete Guide to Forms, Appeals, and Approval

Quick Answer: Getting Strimvelis Covered by Aetna in Georgia

Strimvelis (autologous CD34+ ADA-SCID gene therapy) requires prior authorization from Aetna. Since it's only available at SR-TIGET in Milan, Italy, you'll need out-of-network coverage approval. Start by having your doctor submit a prior authorization request with genetic testing confirmation and failed alternative treatments. If denied, file an internal appeal within 180 days, then request Georgia's external review within 60 days. The fastest path: contact Aetna's GCIT Clinical Team at 1-800-237-2767 for gene therapy coverage guidance.

Table of Contents

Start Here: Verify Your Plan & Coverage

Before pursuing Strimvelis coverage, confirm your Aetna plan details through the Aetna member portal. Look for:

  • Gene therapy coverage: Check if your plan includes Aetna's Gene-based, Cellular and Other Innovative Therapies (GCIT) network
  • Out-of-network benefits: Essential since Strimvelis is only administered at SR-TIGET in Milan, Italy
  • International coverage: Verify if your plan covers treatment outside the U.S.
Note: Strimvelis is EU-approved but not FDA-approved in the United States. Coverage requires demonstrating medical necessity and lack of suitable alternatives.

Prior Authorization Forms & Requirements

Required Documentation

Your physician must submit a comprehensive prior authorization package including:

Clinical Requirements:

  • Confirmed ADA-SCID diagnosis with genetic testing
  • ADA enzyme deficiency documentation
  • Absolute lymphocyte count <200 cells/mm³
  • Proof of no suitable HLA-matched related donor
  • Documentation of failed or contraindicated alternatives

Administrative Forms:

Coverage Criteria

Based on Aetna's GCIT program requirements:

  • Primary immunodeficiency diagnosis confirmed by genetic testing
  • Absence of suitable matched sibling donor
  • Failed enzyme replacement therapy or contraindications
  • Adequate CD34+ cell collection potential (minimum 4 x 10⁶ cells/kg)

Submission Portals & Methods

Online Submission

Fax & Mail Options

  • Prior Authorization Fax: 1-866-249-6155
  • Specialty Pharmacy Fax: 1-866-329-2779
  • Mail Address: Submit to address specified in your plan documents (verify current address)
Tip: Include a detailed cover sheet with patient information, diagnosis codes (D81.3 for ADA deficiency), and urgency level.

Medical Necessity Documentation

Clinician Corner: Medical Necessity Letter Checklist

Your physician's letter should include:

  1. Patient Problem: ADA-SCID diagnosis with specific enzyme levels and genetic testing results
  2. Prior Treatments: Documentation of enzyme replacement therapy trials and outcomes
  3. Clinical Rationale: Why Strimvelis is medically necessary vs. alternatives like HSCT
  4. Guideline Support: Reference to primary immunodeficiency treatment guidelines
  5. Treatment Plan: Detailed administration plan at SR-TIGET Milan
  6. Monitoring: Long-term follow-up and safety monitoring plans

Key Supporting Evidence:

  • FDA labeling for similar gene therapies
  • Primary immunodeficiency society guidelines
  • Peer-reviewed literature on ADA-SCID gene therapy outcomes

When dealing with complex prior authorization cases like gene therapy coverage, Counterforce Health helps patients and clinicians create evidence-backed appeals that address payer-specific criteria. Their platform identifies denial reasons and crafts targeted rebuttals using the right clinical evidence and procedural requirements.

Appeals Process for Georgia Residents

Internal Appeal Timeline

  • File within: 180 calendar days of denial
  • Decision timeframe: 45 business days (standard), 72 hours (expedited)
  • Contact: 1-888-632-3862 for non-Medicare plans

Required Appeal Documents

  • Copy of denial letter or Explanation of Benefits
  • Completed Aetna dispute and appeal form
  • Updated medical necessity letter
  • Additional clinical evidence addressing denial reasons
  • Supporting literature and guidelines

Appeal Submission Methods

  • Online: Through Aetna member portal (confirm current process)
  • Fax: Use number provided in denial letter
  • Mail: Address specified in denial notification

Georgia External Review Process

If Aetna's internal appeal is denied, Georgia residents have additional rights:

Timeline & Eligibility

  • File within: 60 days of final internal denial
  • Decision timeframe: 30 business days (standard), 72 hours (expedited)
  • Cost: Free for consumers

How to Request External Review

  1. Contact Georgia DOI: Call 1-800-656-2298 or visit oci.ga.gov
  2. Submit application: Complete external review request form
  3. Include documentation: All appeal materials and denial letters
  4. Await assignment: DOI assigns independent review organization
Important: Georgia's external review decision is binding on Aetna and required by state law.

Specialty Pharmacy & Treatment Coordination

CVS Specialty Pharmacy Role

Since Aetna specialty drugs are handled through CVS Specialty:

  • Contact: 1-800-237-2767
  • Enrollment: Required for specialty medication coordination
  • International coordination: May assist with treatment logistics for Milan administration

Treatment Logistics

  • Travel coordination: Aetna's GCIT program may provide travel and lodging reimbursement for distances >100 miles
  • Cell collection: Coordinate with U.S. centers for CD34+ cell harvest
  • Backup storage: Ensure adequate cell backup per Strimvelis requirements

Support Lines & Contact Information

Key Phone Numbers

  • GCIT Clinical Team: 1-800-237-2767 (gene therapy specialists)
  • Member Services: Number on your Aetna ID card
  • Prior Authorization: 1-866-814-5506 (specialty unit)
  • Appeals (non-Medicare): 1-888-632-3862
  • Georgia Consumer Services: 1-800-656-2298

What to Ask When Calling

  • Current prior authorization requirements for gene therapy
  • Out-of-network coverage for international treatment
  • GCIT network benefits and travel reimbursement
  • Appeal status and next steps
  • Required documentation for medical necessity

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not FDA approved" Cite EU approval, lack of FDA alternatives, compassionate use precedent
"Experimental/Investigational" Provide clinical evidence, treatment guidelines, published outcomes
"No suitable donor available not documented" Include HLA typing results, donor registry search documentation
"Alternative treatments not tried" Document ERT trials, outcomes, contraindications to HSCT
"Out-of-network/International" Emphasize no U.S. alternative, medical necessity, life-threatening condition

Costs & Financial Assistance

Estimated Costs

  • List price: €594,000 (~$650,000) per treatment
  • Additional costs: Travel, lodging, pre-treatment workup

Financial Support Options

  • Aetna GCIT benefits: May include travel/lodging reimbursement
  • Manufacturer support: Contact Orchard Therapeutics for patient assistance
  • Foundation grants: Research rare disease foundations for travel grants
  • Stop-loss protection: Available for self-insured employer plans

For complex coverage determinations involving high-cost therapies, Counterforce Health specializes in turning insurance denials into successful appeals by identifying specific payer criteria and crafting evidence-based responses that meet procedural requirements.

FAQ

How long does Aetna prior authorization take for gene therapy? Standard reviews take up to 45 business days, but Aetna aims to approve over 95% of eligible requests within 24 hours. Gene therapies may require additional review time.

What if Strimvelis is not on Aetna's formulary? Request a formulary exception with medical necessity documentation. Since Strimvelis is the only approved treatment for ADA-SCID, formulary status may not apply.

Can I request expedited review for urgent cases? Yes, if delay poses serious health risks. Expedited appeals are decided within 72 hours for medical services.

Does Aetna cover international treatment? Coverage varies by plan. Aetna International plans may cover GCIT treatments abroad, subject to medical necessity and prior authorization.

What happens if Georgia external review supports coverage? Aetna is legally required to cover the treatment per Georgia state law. The external review decision is binding.

Are there alternatives if Strimvelis is denied? Options include HSCT with matched unrelated donor, continued enzyme replacement therapy, or clinical trials of investigational gene therapies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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