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

Getting Strimvelis Gene Therapy Covered by Humana in Texas: Coverage Criteria and Appeals Process

Quick Answer: Strimvelis Coverage Path

Strimvelis gene therapy for ADA-SCID requires extensive documentation for Humana coverage in Texas. Your fastest path: (1) Confirm ADA-SCID diagnosis with enzyme testing and genetic confirmation, (2) Submit prior authorization with complete clinical records and medical necessity letter, (3) If denied, file internal appeal within 65 days with additional evidence. Strimvelis is not on Humana's formulary, so you'll need a formulary exception. Start by contacting Humana at 1-800-457-4708 to request prior authorization forms.

Table of Contents

Humana's Coverage Framework

Humana Medicare Advantage plans in Texas follow Medicare Part B and Part D guidelines for specialty medications and gene therapies. Since Strimvelis is not FDA-approved in the United States and is only available at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) in Milan, Italy, coverage falls under exceptional circumstances requiring extensive documentation.

Plan Types and Policies:

  • Medicare Advantage plans must follow CMS guidelines for experimental treatments
  • Coverage decisions require demonstration of medical necessity when no domestic alternatives exist
  • International treatment coverage is extremely limited and requires pre-authorization

You can find Humana's current medical coverage policies at their provider portal, though specific Strimvelis policies may not be published due to the treatment's unique status.

ADA-SCID Diagnostic Requirements

Humana will require comprehensive diagnostic confirmation before considering Strimvelis coverage. The diagnosis must be established through multiple laboratory methods:

Required Testing:

  • ADA enzyme activity measurement in erythrocytes (must be done before any blood transfusions)
  • Genetic testing confirming pathogenic variants in the ADA gene
  • Immunologic evaluation showing T-B-NK- phenotype with absolute lymphocyte count <2,800 cells/mm³
  • Serum metabolite levels (adenosine and deoxyadenosine)

The enzyme activity testing can be performed at specialized laboratories including Duke University's Hershfield Laboratory. Genetic testing typically takes 4-6 weeks and should include next-generation sequencing panels for SCID.

Note: ADA-SCID accounts for 20% of all SCID cases with an incidence of 1 in 200,000 live births. Diagnosis is usually made within the first 12 months of life.

Step Therapy and Treatment History

Humana will expect documentation of standard treatment approaches before approving experimental gene therapy:

Required Prior Treatments:

  1. Enzyme replacement therapy (ERT) with pegademase bovine (PEG-ADA)
  2. Hematopoietic stem cell transplant (HSCT) evaluation and outcomes if attempted
  3. Documentation of treatment failures, adverse reactions, or contraindications

Exception Pathways:

  • If HSCT is contraindicated due to lack of matched donor
  • If ERT has failed to provide adequate immune reconstitution
  • If patient has developed antibodies to PEG-ADA

Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing payer policies and crafting evidence-backed rebuttals. Their platform can help identify the specific documentation Humana requires for gene therapy approvals and ensure your appeal addresses each coverage criterion systematically.

Required Clinical Documentation

Your medical necessity submission must include comprehensive clinical records:

Essential Documentation:

  • Complete medical history from diagnosis
  • Laboratory results confirming ADA deficiency
  • Genetic testing reports with pathogenic variant identification
  • Treatment history with outcomes and adverse events
  • Current immune status and infection history
  • Growth and development assessments
  • Specialist evaluations from immunology and hematology

ICD-10 Codes:

  • D81.3 - Adenosine deaminase deficiency
  • D81.9 - Combined immunodeficiency, unspecified

Site of Care and Administration

Strimvelis presents unique coverage challenges due to its administration requirements:

Treatment Location:

  • Only available at SR-TIGET in Milan, Italy
  • Requires travel and extended stay for treatment and monitoring
  • No equivalent treatment available in the United States

Coverage Considerations:

  • International treatment coverage under Medicare is extremely limited
  • May require demonstration that no equivalent domestic treatment exists
  • Travel and accommodation costs typically not covered

Evidence for Medical Necessity

Strong medical necessity documentation should reference established clinical evidence:

Supporting Literature:

  • FDA Orphan Drug designation recognition
  • European Medicines Agency (EMA) approval data
  • Published clinical trial results showing efficacy
  • Professional society recommendations for ADA-SCID treatment

Key Clinical Points:

  • Life-threatening condition without treatment
  • Lack of suitable matched donor for HSCT
  • Failure of or contraindication to standard therapies
  • Potential for immune system reconstitution
Clinician Corner: Your medical necessity letter should specifically address why conventional treatments (HSCT, ERT) are not suitable and include references to published outcomes data for Strimvelis from the SR-TIGET trials.

Appeals Process in Texas

If Humana denies coverage, Texas residents have specific appeal rights:

Internal Appeals

  • Timeline: 65 days from denial notice to file appeal
  • Standard review: 30 days for pre-service requests
  • Expedited review: 72 hours when delay would jeopardize health
  • Submission: Humana provider portal or fax to 1-877-486-2621

External Review

If internal appeal fails, you can request external review:

  • Timeline: 4 months from final internal denial
  • Process: Federally administered through HHS contractor
  • Decision timeframe: 45 days standard, 72 hours expedited
  • Cost: Covered by Humana

The external review is conducted by an Independent Review Organization (IRO) and their decision is final and binding.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Experimental/investigational" Provide EMA approval documentation and published efficacy data
"Not available in US" Document lack of equivalent domestic treatment and medical necessity
"Travel not covered" Request exception based on life-threatening condition and no alternatives
"Insufficient documentation" Submit complete diagnostic workup and treatment history

FAQ

How long does Humana prior authorization take in Texas? Standard prior authorization decisions are made within 72 hours of receiving complete documentation. Expedited requests are processed within 24 hours when delay would endanger health.

What if Strimvelis is non-formulary? You'll need to request a formulary exception. Submit supporting clinical documentation explaining why formulary alternatives are not suitable, including documentation of treatment failures or contraindications.

Can I request an expedited appeal? Yes, if waiting would jeopardize your health. Expedited appeals must be decided within 72 hours for internal appeals and 72 hours for external review.

Does Humana cover international treatment? Coverage for international treatment is extremely limited under Medicare Advantage plans. It typically requires demonstration that the treatment is not available domestically and is medically necessary.

What documentation do I need for the appeal? Complete medical records, diagnostic test results, treatment history, medical necessity letter from your physician, and any relevant clinical literature supporting the treatment.

How do I contact Humana about coverage? Call Humana customer service at 1-800-457-4708 or access their online member portal. For provider inquiries, use the provider portal.

When navigating complex coverage decisions for rare disease treatments like Strimvelis, having expert support can make the difference between approval and denial. Counterforce Health helps patients and clinicians build compelling appeals by analyzing payer policies and crafting evidence-based rebuttals that address each coverage criterion systematically.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. For additional assistance with insurance appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.