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

Get Strimvelis Gene Therapy Covered by Blue Cross Blue Shield in Georgia: Complete Guide with Forms, Appeals, and Travel Authorization

Quick Answer: Your Path to Coverage

Getting Strimvelis gene therapy covered by Blue Cross Blue Shield in Georgia requires a medical exception since this treatment is only available at SR-TIGET in Milan, Italy and isn't FDA-approved in the U.S. Start by gathering genetic testing confirming ADA-SCID diagnosis, enzyme activity levels below 1% of normal, and documentation of failed standard treatments. Submit a comprehensive prior authorization package through your BCBS provider portal, and prepare for appeals since routine coverage is extremely rare. If denied, you have 30 days to request external review through the Georgia Department of Insurance.

First step today: Call BCBS member services to confirm your plan's international coverage provisions and request the medical exception forms.

Table of Contents

  1. Coverage Basics: Is Strimvelis Covered?
  2. Prior Authorization Process
  3. Required Documentation
  4. Timeline and Urgency
  5. Medical Necessity Criteria
  6. Costs and Financial Support
  7. Appeals Process in Georgia
  8. International Treatment Authorization
  9. Common Denial Reasons and Solutions
  10. Step-by-Step Action Plan

Coverage Basics: Is Strimvelis Covered?

The short answer: Not routinely. Strimvelis (autologous CD34+ ADA-SCID gene therapy) is not FDA-approved in the United States and is exclusively administered at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) in Milan, Italy. Blue Cross Blue Shield plans in Georgia do not include Strimvelis on their standard formularies or medical benefit lists.

However, coverage is possible through:

  • Medical exception requests for life-threatening conditions
  • International treatment authorization for services unavailable in the U.S.
  • Appeals process emphasizing lack of domestic alternatives

Coverage at a Glance

Requirement Status Where to Find It Source
FDA Approval Not approved in U.S. FDA Orange Book FDA
Formulary Status Not listed BCBS formulary documents Plan materials
Prior Authorization Required (medical exception) Provider portal BCBS policy
International Coverage Case-by-case basis Member benefits summary Plan documents
Appeal Rights 30 days for external review Georgia DOI GA Rule 120-2-111

Prior Authorization Process

Blue Cross Blue Shield Georgia requires prior authorization for all experimental or investigational treatments, including gene therapies not approved by the FDA. The process involves multiple steps and extensive documentation.

Who Submits the Request

Your treating physician (typically a pediatric immunologist or hematologist) must submit the prior authorization. Patients cannot submit directly, but you can coordinate with your care team to ensure all required documents are included.

How to Submit

  1. Provider Portal: Most efficient method through the Anthem provider portal
  2. Fax: Submit to the medical management fax line (verify current number with BCBS)
  3. Mail: Send to the address specified in your plan documents
Tip: Always request a confirmation receipt when submitting, regardless of method.

Required Documentation

For ADA-SCID gene therapy coverage, you'll need comprehensive clinical documentation proving both the diagnosis and medical necessity.

Essential Documents

Genetic Testing Results:

  • Biallelic pathogenic mutations in the ADA gene
  • Laboratory report from a certified genetic testing facility
  • Interpretation by a qualified geneticist

Enzyme Activity Testing:

  • ADA enzyme activity levels (must be <1% of normal)
  • Baseline measurements before any enzyme replacement therapy
  • Laboratory certification and normal reference ranges

Clinical Documentation:

  • Complete medical history and physical examination
  • Documentation of severe combined immunodeficiency symptoms
  • Infection history and immune system dysfunction
  • Growth and developmental assessments

Treatment History:

  • Records of all prior treatments attempted
  • Documentation of treatment failures or contraindications
  • Rationale for why standard treatments (HSCT, enzyme replacement) are not suitable

Timeline and Urgency

Standard Review Timeline

  • Initial review: 15-30 business days
  • Additional information requests: 10-15 business days
  • Final determination: Up to 45 days total

Expedited Review

For urgent cases where delay could seriously jeopardize health:

  • Expedited review: 72 hours
  • Concurrent external review: Available in Georgia for urgent cases
  • Emergency authorization: Same-day decisions possible
Critical: ADA-SCID is a life-threatening condition in infants. Always request expedited review and document the urgency clearly.

Medical Necessity Criteria

BCBS typically evaluates medical necessity based on established criteria. For Strimvelis, you must demonstrate:

Primary Criteria

  1. Confirmed ADA-SCID diagnosis through genetic testing or enzyme deficiency
  2. Lack of suitable donor for hematopoietic stem cell transplant
  3. Contraindications or failure of standard treatments
  4. Life-threatening condition requiring immediate intervention
  5. No FDA-approved alternatives available in the United States

Supporting Evidence

  • Peer-reviewed literature supporting gene therapy efficacy
  • European Medicines Agency approval documentation
  • Specialist recommendations from immunology experts
  • Quality of life assessments and prognosis without treatment

Costs and Financial Support

Strimvelis carries a list price of €594,000 (approximately $650,000) per patient, plus travel and accommodation costs for treatment in Milan.

Potential Financial Resources

  • Manufacturer support: Contact Orchard Therapeutics patient access programs
  • Foundation grants: Organizations supporting rare disease treatments
  • State programs: Georgia may have emergency medical assistance programs
  • Crowdfunding: Many families use platforms like GoFundMe for medical travel expenses

Insurance Coverage Scenarios

  • Full coverage: Rare, requires successful medical exception
  • Partial coverage: May cover treatment but not travel expenses
  • No coverage: Most common initial response, requiring appeals

Appeals Process in Georgia

Georgia provides robust appeal rights for insurance denials, especially important for rare disease treatments.

Internal Appeals

Timeline: Must file within 180 days of denial Process: Submit written appeal with additional clinical evidence Decision: Insurer has 30 days to respond (expedited: 72 hours)

External Review

Timeline: Must file within 30 days of internal appeal denial Authority: Georgia Department of Insurance Process: Independent medical reviewers evaluate the case Cost: Free to consumers Decision: Binding on the insurer

Contact: Georgia Department of Insurance Consumer Services at 1-800-656-2298 or through their online complaint system.

International Treatment Authorization

Since Strimvelis is only available in Milan, Italy, you need specific authorization for international medical treatment.

Required Approvals

  1. Medical exception for the therapy itself
  2. International treatment authorization for out-of-area care
  3. Travel coverage (if available through supplemental benefits)

Documentation for International Care

  • Letter from SR-TIGET confirming treatment availability
  • Detailed treatment plan and timeline
  • Estimated costs for all services
  • Evidence that equivalent treatment is unavailable in the U.S.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Experimental/Investigational" Provide EMA approval, peer-reviewed studies European approval documents, clinical literature
"Not FDA-approved" Emphasize lack of U.S. alternatives, orphan disease status FDA orphan drug designation, treatment gap analysis
"Out-of-network" Request international treatment exception SR-TIGET facility certification, treatment necessity
"Not medically necessary" Strengthen clinical justification Additional specialist opinions, prognosis documentation

Step-by-Step Action Plan

Phase 1: Preparation (Weeks 1-2)

  1. Confirm diagnosis with genetic testing and enzyme levels
  2. Gather medical records from all treating physicians
  3. Contact BCBS to understand specific plan requirements
  4. Document treatment history and failures/contraindications

Phase 2: Initial Authorization (Weeks 3-4)

  1. Submit comprehensive PA through provider portal
  2. Request expedited review due to urgency
  3. Follow up weekly on application status
  4. Prepare appeal materials in case of denial

Phase 3: Appeals (If Needed)

  1. File internal appeal within 180 days with additional evidence
  2. Request peer-to-peer review with medical director
  3. File external review within 30 days if internal appeal fails
  4. Contact Georgia DOI for assistance with process

Clinician Corner: Medical Necessity Letter Checklist

Healthcare providers should include these elements in their medical necessity letters:

  • Patient presentation: Age, symptoms, diagnostic timeline
  • Diagnostic confirmation: Genetic testing results, enzyme levels
  • Treatment history: Prior therapies, outcomes, contraindications
  • Clinical rationale: Why Strimvelis is the appropriate treatment
  • Prognosis: Expected outcomes with and without treatment
  • Literature support: Peer-reviewed studies, FDA guidance documents
  • Specialist consensus: Recommendations from immunology experts
From our advocates: We've seen success when families work closely with their medical team to create a comprehensive "patient story" that clearly explains the journey from diagnosis to treatment recommendation. Include photos, timelines, and family impact statements alongside the clinical documentation to help reviewers understand the human side of the medical necessity.

When Treatment is Available

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance approvals for specialty medications like gene therapies. Our platform analyzes denial letters, identifies specific appeal strategies, and drafts evidence-backed responses tailored to individual payer policies—particularly valuable for rare treatments requiring international care coordination.

If your initial authorization is approved, work with Counterforce Health to ensure all procedural requirements are met and appeal deadlines are tracked throughout the treatment process.

FAQ: Common Questions About Strimvelis Coverage

How long does BCBS prior authorization take in Georgia? Standard review takes 15-30 business days, but expedited review for urgent cases can be completed in 72 hours. Always request expedited review for ADA-SCID cases.

What if Strimvelis is considered experimental? Provide European Medicines Agency approval documentation and peer-reviewed literature demonstrating safety and efficacy. Emphasize that experimental status doesn't preclude coverage for life-threatening conditions without alternatives.

Can I request an expedited appeal? Yes, Georgia allows expedited external review for urgent medical situations. You can even request external review concurrent with an expedited internal appeal if delay poses serious risk.

Does my plan cover international medical treatment? Most BCBS plans have limited international coverage, but exceptions may be granted when medically necessary treatment is unavailable in the U.S. Check your benefits summary or call member services.

What happens if I'm denied coverage? You have strong appeal rights in Georgia. File an internal appeal within 180 days, then external review within 30 days if needed. The external review decision is binding on your insurer.

How much will I pay out-of-pocket? This depends on your specific plan and whether coverage is approved. Even with approval, you may face significant costs for travel, accommodation, and any uncovered services.

Sources & Further Reading

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

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