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

How to Get Strimvelis Gene Therapy Covered by UnitedHealthcare in Illinois: Complete PA Guide and Appeals Process

Answer Box: Getting Strimvelis Covered by UnitedHealthcare in Illinois

Strimvelis requires prior authorization from UnitedHealthcare and faces significant coverage challenges since it's only available in Milan, Italy, and lacks FDA approval in the U.S. Your fastest path: (1) Have your immunologist submit PA with confirmed ADA-SCID diagnosis and genetic testing, (2) Request out-of-network exception for Milan treatment center, (3) If denied, file internal appeal within 180 days, then external review within 30 days through Illinois Department of Insurance. Start by calling UnitedHealthcare member services to verify your plan's international coverage provisions.

Table of Contents

  1. Plan Types & Network Implications
  2. Formulary Status & Coverage Requirements
  3. Prior Authorization Process
  4. International Treatment Coverage
  5. Common Denial Reasons & Solutions
  6. Appeals Process in Illinois
  7. Cost Considerations
  8. When to Escalate
  9. FAQ

Plan Types & Network Implications

UnitedHealthcare offers several plan types in Illinois, each with different implications for accessing Strimvelis:

Commercial Plans (HMO/PPO/EPO): Most require prior authorization for specialty drugs. PPO plans typically offer more flexibility for out-of-network providers, which may be crucial since Strimvelis is only available at SR-TIGET in Milan, Italy.

Medicare Advantage: UnitedHealthcare's Medicare Advantage plans have shown PA denial rates around 9% (2023), higher than peer averages, with particular scrutiny on high-cost therapies.

Medicaid Managed Care: Illinois expanded Medicaid covers approximately 3.2 million residents. These plans follow state guidelines for rare disease coverage but may have additional restrictions for international treatments.

Note: Network restrictions are particularly important for Strimvelis since the treatment is only available at one facility worldwide.

Formulary Status & Coverage Requirements

Coverage Criteria

UnitedHealthcare requires comprehensive documentation for ADA-SCID gene therapy coverage:

Requirement Documentation Needed Source
Confirmed ADA-SCID diagnosis Laboratory evidence of adenosine deaminase deficiency UHC Enzyme Replacement Policy
Genetic confirmation CLIA-certified lab results showing biallelic ADA gene variants UHC Clinical Guidelines
Clinical necessity Documentation that patient lacks suitable HLA-matched donor Treatment center requirements
Age considerations Typically pediatric patients, though adult cases possible Case-by-case review

Step Therapy Requirements

Step therapy is often waived for ADA-SCID due to the urgent nature of the condition and limited therapeutic alternatives. However, UnitedHealthcare may require documentation of:

  • Previous enzyme replacement therapy trials (if applicable)
  • Consideration of hematopoietic stem cell transplantation (HSCT)
  • Clinical rationale for gene therapy over available alternatives

Prior Authorization Process

Step-by-Step Submission

  1. Specialist Referral (Patient/Family)
    • Obtain care from pediatric immunologist or genetic specialist
    • Gather complete medical records and genetic testing results
    • Timeline: 1-2 weeks
  2. PA Submission (Provider)
    • Submit through UHCprovider.com portal
    • Include all required documentation listed above
    • Timeline: Submit 2-4 weeks before planned treatment
  3. Clinical Review (UnitedHealthcare)
    • Standard review: 15 business days
    • Expedited review: 24-72 hours (if urgent medical need)
    • May include peer-to-peer review with medical director
  4. Out-of-Network Authorization (Provider)
    • Request specific exception for Milan treatment center
    • Include justification for international travel necessity
    • Timeline: Additional 10-15 business days

Required Documentation Checklist

  • Complete medical history and physical exam
  • CLIA-certified genetic testing results
  • Adenosine deaminase enzyme activity levels
  • Documentation of immune system dysfunction
  • Previous treatment attempts and outcomes
  • Letter of medical necessity from treating specialist
  • Treatment center acceptance letter from SR-TIGET Milan

International Treatment Coverage

Critical Challenge: Strimvelis is only available at one treatment center globally (SR-TIGET in Milan, Italy), creating unique coverage hurdles.

Out-of-Network Exceptions

UnitedHealthcare may approve international treatment under these circumstances:

  • Medical Necessity: Treatment unavailable in the U.S.
  • Center of Excellence: SR-TIGET is the only authorized facility
  • Life-threatening Condition: ADA-SCID is fatal without treatment
Tip: Request a case manager specializing in rare diseases to coordinate international coverage approvals.

Travel and Logistics Coverage

Coverage typically includes:

  • Treatment costs at approved facility
  • Medical travel expenses (may be limited)
  • Accompanying family member (policies vary)

Not typically covered:

  • Extended accommodation costs
  • Non-medical travel expenses
  • Multiple family members

Common Denial Reasons & Solutions

Denial Reason How to Address Supporting Evidence
"Experimental/Investigational" Cite EMA approval and published efficacy data EMA approval documentation
"Not FDA approved in U.S." Request exception based on unavailability of alternatives Medical necessity letter
"Out-of-network provider" Submit out-of-network exception request Treatment center exclusivity documentation
"Insufficient documentation" Provide complete genetic and clinical testing CLIA-certified lab reports

Strengthening Your Appeal

When working with coverage challenges, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific policies.

Appeals Process in Illinois

Internal Appeals (UnitedHealthcare)

Timeline: Must file within 180 days of denial notice

Process:

  1. Submit written appeal through member portal or mail
  2. Include all supporting medical documentation
  3. Request expedited review if medically urgent
  4. Receive decision within 15 business days (standard) or 24-72 hours (expedited)

External Review (Illinois Department of Insurance)

Critical Deadline: Must request within 30 days of final internal denial (shorter than many states)

Process:

  1. File request with Illinois Department of Insurance
  2. Independent Review Organization (IRO) assigned
  3. Board-certified physician reviews case
  4. Decision within 5 business days of complete file receipt
  5. Decision is binding on UnitedHealthcare

Contact Information:

  • Illinois Department of Insurance: (877) 527-9431
  • Illinois Attorney General Health Care Helpline: (877) 305-5145
Important: Illinois has a shorter external review deadline than most states. Don't delay if your internal appeal is denied.

Cost Considerations

Treatment Costs

  • List Price: €594,000 (~$650,000 USD) per patient
  • Additional Costs: Travel, accommodation, follow-up care
  • Insurance Coverage: Varies significantly by plan type and approval status

Financial Assistance Options

Manufacturer Support: Contact Orchard Therapeutics patient support program Foundation Grants: National Organization for Rare Disorders (NORD), HealthWell Foundation State Programs: Illinois may have rare disease assistance programs

Note: As of 2025, Medicare beneficiaries have a $2,000 annual cap on out-of-pocket prescription drug costs, which may apply to coverage situations.

When to Escalate

State Regulator Intervention

Contact the Illinois Department of Insurance if:

  • UnitedHealthcare fails to meet response deadlines
  • Coverage decisions appear to violate state insurance laws
  • You need assistance navigating the external review process

Additional Advocacy Resources

  • Citizen Action/Illinois: Consumer advocacy organization
  • Legal Aid: For complex appeal cases requiring legal intervention
  • Patient Advocacy Groups: ADA-SCID-specific support organizations

Healthcare coverage specialists like Counterforce Health can also help coordinate complex appeals by identifying specific denial criteria and crafting targeted responses that address payer-specific requirements.

FAQ

How long does UnitedHealthcare prior authorization take for Strimvelis? Standard review takes 15 business days, but expedited review (24-72 hours) is available for urgent medical situations. International treatment coordination may add additional processing time.

What if Strimvelis isn't on UnitedHealthcare's formulary? As a rare gene therapy, Strimvelis requires individual medical review rather than standard formulary placement. Coverage decisions are based on medical necessity criteria rather than tier placement.

Can I get expedited approval for ADA-SCID treatment? Yes, ADA-SCID is a life-threatening condition that qualifies for expedited review. Your physician should specifically request urgent processing when submitting the PA.

Does UnitedHealthcare cover travel costs for treatment in Milan? Coverage for medical travel varies by plan. Request specific coverage determination for travel expenses as part of your initial authorization request.

What happens if my appeal is denied in Illinois? After exhausting internal appeals, you have 30 days to request external review through the Illinois Department of Insurance. This independent review is binding and free to patients.

Can I use a patient advocate to help with my appeal? Yes, Illinois allows patient advocates and legal representatives to assist with appeals. Some organizations specialize in rare disease coverage advocacy.

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage policies change frequently; verify current requirements with UnitedHealthcare directly. For additional assistance with Illinois insurance appeals, contact the Illinois Department of Insurance at (877) 527-9431.

Sources & Further Reading

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