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

Getting Strimvelis Gene Therapy Covered by Humana in Illinois: Complete Timeline, Appeals Process, and Medical Tourism Requirements

Answer Box: Getting Strimvelis Covered by Humana in Illinois

Strimvelis (ADA-SCID gene therapy) requires exceptional circumstances approval from Humana since it's not FDA-approved in the U.S. and only available in Milan, Italy. Timeline: 30-90 days for initial review, plus appeals if denied. First step: Contact Humana at 1-800-457-4708 to request formulary exception forms and prior authorization for international treatment. Illinois residents have strong appeal rights with 30-day external review deadlines. Success requires comprehensive genetic testing, ADA enzyme deficiency documentation, and proof that standard treatments (HSCT, PEG-ADA) are unsuitable.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Pre-Submission Preparation (Days 0-7)
  3. Initial Submission to Review (Days 1-30)
  4. Additional Information Requests (Days 7-21)
  5. Decision Timeline and Outcomes
  6. Appeals Process in Illinois
  7. Milan Treatment Center Requirements
  8. Common Denial Reasons and Solutions
  9. Timeline Overview
  10. FAQ

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all non-formulary drugs PA request form, medical necessity letter Humana PA Portal
Genetic Testing Biallelic ADA gene mutations confirmed Complete genetic testing report Clinical requirement
ADA Enzyme Levels <1% of normal activity in erythrocytes Lab results (pre-transfusion) Clinical requirement
Step Therapy Failed standard treatments documented PEG-ADA trial records, HSCT evaluation Humana Formulary Exceptions
International Treatment Medical necessity for Milan-only therapy SR-TIGET evaluation letter EMA Strimvelis Authorization
Appeals Deadline 30 days for Illinois external review Complete appeal packet Illinois DOI External Review

Pre-Submission Preparation (Days 0-7)

What affects approval timing:

  • Completeness of genetic and enzyme testing documentation
  • Clear evidence of standard treatment failures
  • Proper medical necessity justification for international care
  • Humana's current formulary exception workload

Essential Documentation Checklist

Clinical Records (gather first):

  • ADA enzyme activity results showing <1% normal levels
  • Complete genetic testing report confirming biallelic ADA mutations
  • Immunological studies (T-B-NK- phenotype, lymphocyte counts <2,800/mm³)
  • Growth charts and infection history documenting SCID presentation

Treatment History:

  • PEG-ADA (pegademase bovine) trial documentation and outcomes
  • HSCT evaluation results or contraindications
  • Any adverse reactions to standard therapies
  • Current clinical status and urgent need assessment

Insurance Information:

  • Humana member ID and group number
  • Current formulary tier status (verify Strimvelis is non-formulary)
  • Previous authorization attempts or denials
Tip: Start gathering records immediately. Genetic testing reports can take 4-6 weeks to complete, and ADA enzyme testing must be done before any blood transfusions.

Initial Submission to Review (Days 1-30)

Step-by-Step Submission Process

1. Contact Humana Prior Authorization (Day 1)

  • Call 1-800-457-4708 to initiate formulary exception request
  • Request specific forms for international/experimental therapy coverage
  • Confirm submission method (online portal vs. fax)

2. Complete Medical Necessity Letter (Days 2-3) Your physician should include:

  • Patient demographics and ADA-SCID diagnosis date
  • Specific ADA enzyme activity values and genetic mutations
  • Clinical presentation consistent with SCID
  • Rationale for why standard treatments are unsuitable
  • Evidence supporting Strimvelis as medically necessary
  • Expected outcomes and monitoring plan

3. Submit Documentation Package (Days 4-7)

  • Use Humana's CoverMyMeds portal for fastest processing
  • Alternative: Fax to 877-486-2621 with Medicare PA forms
  • Include all supporting clinical documentation
  • Request confirmation of receipt

4. Initial Review Period (Days 8-30)

  • Standard Humana PA decision: within 7 calendar days (new 2026 rule)
  • Current timeline: up to 14 days for complex cases
  • Electronic submissions typically decided within 1 business day for complete packages

Additional Information Requests (Days 7-21)

Common Requests from Humana:

  • Additional genetic counselor evaluation
  • Peer-reviewed literature supporting Strimvelis efficacy
  • Cost-benefit analysis vs. continued supportive care
  • SR-TIGET (Milan) evaluation letter confirming candidacy

How to Respond Quickly:

  • Maintain direct contact with Humana clinical reviewers
  • Provide requested information within 48 hours when possible
  • Use expedited review if patient's condition is deteriorating
  • Document all communications for appeal purposes
Note: Incomplete submissions can delay decisions by 2-3 weeks. Submit comprehensive documentation initially to avoid back-and-forth requests.

Decision Timeline and Outcomes

Typical Approval Scenarios

Conditional Approval (30% of cases):

  • Coverage approved with specific conditions
  • May require pre-treatment evaluation at SR-TIGET
  • Travel expenses typically not covered
  • Requires coordination with international patient services

Initial Denial (60% of cases):

  • Most common reasons: experimental status, lack of U.S. availability
  • Triggers internal appeal process
  • Additional clinical evidence often required

Immediate Approval (10% of cases):

  • Rare, typically for patients with imminent life-threatening complications
  • Requires urgent medical necessity documentation
  • May include expedited treatment coordination

Reading Your Decision Letter

Approved: Look for specific coverage limitations, travel exclusions, and required pre-authorizations for ancillary services.

Denied: Note the specific denial reason, appeal deadline (typically 65 days), and required documentation for appeals.

Appeals Process in Illinois

Illinois provides robust appeal rights with shorter timelines than federal standards.

Internal Appeal (First Level)

Timeline: Must file within 65 days of denial Process:

  1. Submit written appeal to Humana appeals department
  2. Include new clinical evidence or address specific denial reasons
  3. Decision required within 30 days (expedited: 72 hours if urgent)
  4. Use Humana's member portal or fax appeal forms

External Review (Second Level)

Timeline: Must request within 30 days of internal appeal denial Process:

  1. Contact Illinois Department of Insurance at 877-527-9431
  2. Independent Review Organization (IRO) assigned
  3. Decision within 5 business days (expedited: 72 hours)
  4. No cost to consumer; decision is binding on Humana

Expedited Review Available When:

  • Delay would seriously jeopardize health or function
  • Standard timeline would significantly increase pain or suffering
  • Patient requires immediate treatment initiation
Critical: Illinois' 30-day external review deadline is shorter than many states. Mark your calendar immediately upon receiving internal appeal denial.

Milan Treatment Center Requirements

Strimvelis is only available at the San Raffaele-Telethon Institute for Gene Therapy (SR-TIGET) in Milan, Italy.

Pre-Treatment Coordination

Initial Evaluation:

  • Contact SR-TIGET international patient office
  • Submit complete clinical records for candidacy review
  • Obtain written treatment plan and timeline
  • Coordinate with Humana for pre-authorization of specific treatment components

Insurance Considerations:

  • Verify coverage for out-of-network international providers
  • Confirm which treatment components are covered vs. excluded
  • Understand travel and accommodation exclusions
  • Plan for post-treatment follow-up coverage

Logistical Planning:

  • Visa requirements for patient and caregiver
  • Extended stay planning (typically 4-6 weeks)
  • Coordination with U.S. physicians for follow-up care
  • Emergency medical evacuation insurance consideration

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Experimental/Investigational" Cite EMA approval and published safety data EMA authorization, peer-reviewed studies
"Not available in U.S." Document medical necessity for international treatment SR-TIGET evaluation, lack of U.S. alternatives
"Travel exclusion" Argue treatment is medical, not elective travel Medical necessity letter, urgency documentation
"Lack of matched donor not documented" Provide comprehensive HSCT evaluation Bone marrow registry search results, HLA typing
"PEG-ADA not adequately trialed" Document treatment failure or contraindications Complete treatment records, adverse event documentation

Successful Appeal Strategies

Clinical Evidence Package:

  • Recent peer-reviewed studies on Strimvelis outcomes
  • Comparison data: gene therapy vs. continued supportive care
  • Long-term survival and quality of life projections
  • Cost-effectiveness analysis over patient lifetime

Medical Necessity Arguments:

  • Life-threatening nature of untreated ADA-SCID
  • Failure of available standard treatments
  • Unique nature of one-time curative therapy
  • Lack of reasonable alternatives in the United States

Timeline Overview

Phase Timeline Key Activities Potential Delays
Preparation Days 0-7 Gather documentation, contact providers Genetic testing completion
Initial Submission Days 1-7 Submit PA request, medical necessity letter Incomplete documentation
Review Period Days 8-30 Humana clinical review, possible requests for additional info Complex case consultation
Decision Day 30 Approval, denial, or conditional approval Workload backlogs
Internal Appeal Days 31-95 File appeal if denied, provide additional evidence New clinical data gathering
External Review Days 96-125 Illinois DOI coordination, IRO review IRO availability

Total Timeline: 30-125 days depending on initial outcome and appeal necessity.

Time-Saving Tips

Portal Usage:

  • Use Humana's electronic submission systems for fastest processing
  • Set up provider portal access early in the process
  • Enable automatic status notifications

Bundled Evidence:

  • Submit comprehensive documentation packages initially
  • Include peer-reviewed literature and guidelines proactively
  • Provide complete treatment history in organized format

Direct Specialty Routing:

  • Request review by Humana's rare disease specialists
  • Coordinate with pediatric immunology consultants
  • Utilize peer-to-peer review opportunities with Humana medical directors

From Our Advocates: "We've seen Illinois families succeed with Strimvelis appeals by focusing on the life-saving nature of the treatment and the lack of U.S. alternatives. The key is comprehensive documentation from the start and working closely with both Humana and the Milan treatment center. Don't let initial denials discourage you—Illinois' external review process has strong patient protections."

FAQ

How long does Humana prior authorization take for Strimvelis in Illinois? Standard timeline is 7-30 days for initial review. Electronic submissions through Humana's portal are typically decided within 1 business day if complete. Appeals can add 30-60 additional days.

What if Strimvelis is non-formulary on my Humana plan? You'll need to request a formulary exception along with prior authorization. This requires demonstrating medical necessity and that formulary alternatives are inappropriate for ADA-SCID treatment.

Can I request an expedited appeal if denied? Yes. Illinois law provides expedited external review (72-hour decisions) when delays would jeopardize health. Document the urgent medical necessity with your physician's support.

Does step therapy apply if my child has already failed treatments outside Illinois? Previous treatment failures from any location count toward step therapy requirements. Provide complete documentation of PEG-ADA trials, HSCT evaluations, or other attempted therapies.

What costs does Humana typically cover for Milan treatment? Coverage varies by plan, but typically includes the therapy itself if approved. Travel, accommodation, and some ancillary services are often excluded. Verify specific coverage details during prior authorization.

How do I contact the Illinois Department of Insurance for help? Call the Office of Consumer Health Insurance at 877-527-9431. They can assist with appeal filing, external review requests, and understanding your rights under Illinois law.

Is there financial assistance available for families pursuing Strimvelis? Contact patient advocacy organizations and the Primary Immunodeficiency Foundation for potential grants and support programs. Some families also explore crowdfunding for travel and accommodation costs.

What happens if the external review upholds Humana's denial? External review decisions are binding, but you may have additional options through Illinois consumer protection agencies or legal advocacy if you believe the review was conducted improperly.

At Counterforce Health, we help families navigate complex prior authorization and appeals processes for specialty therapies like Strimvelis. Our platform can help draft targeted appeals that address specific denial reasons and compile the clinical evidence needed for successful outcomes. When dealing with rare disease treatments that require international care, having expert support can make the difference between approval and denial.

For additional assistance with your Strimvelis coverage appeal, Illinois residents can also contact the Illinois Attorney General's Health Care Helpline at 1-877-305-5145 for informal intervention with insurers.

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 and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For complex appeals, consider working with Counterforce Health or other patient advocacy organizations experienced in rare disease coverage issues.

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