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

How to Get Strimvelis Gene Therapy Covered by Humana in New York: Appeals Process and External Review Guide

Answer Box: Getting Strimvelis Covered by Humana in New York

Strimvelis (autologous CD34+ ADA-SCID gene therapy) is not FDA-approved and only available at SR-TIGET in Milan, Italy. Humana Medicare Advantage plans typically deny coverage for non-emergency international treatments. Your path to approval: 1) Submit comprehensive prior authorization with genetic testing, enzyme confirmation, and medical necessity letter, 2) Appeal denial through Humana's internal process, 3) File external appeal with New York Department of Financial Services within 4 months. Start by gathering ADA enzyme activity results and biallelic ADA gene variants documentation.

Table of Contents

Understanding Strimvelis Coverage Challenges

Strimvelis faces unique coverage barriers with Humana Medicare Advantage plans in New York. The therapy is EMA-approved but not FDA-approved, available only at a single center (San Raffaele-Telethon Institute for Gene Therapy in Milan), and costs approximately €594,000 per patient according to NICE evaluations.

Humana's standard Medicare Advantage policies exclude elective international treatments, limiting overseas coverage to emergent care only. This creates two primary denial reasons:

  • Non-FDA approved investigational therapy
  • Out-of-country service exclusion

However, New York residents have strong appeal rights through the state's external review system, which has overturned similar experimental treatment denials when supported by compelling medical evidence.

Note: Counterforce Health helps patients navigate complex prior authorization and appeals processes by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with payer-specific requirements.

Pre-Authorization Requirements

Coverage at a Glance

Requirement What it means Where to find it Timeline
ADA enzyme activity <1% of normal in RBCs Clinical lab report 3-5 days
Genetic confirmation Biallelic pathogenic ADA variants CLIA-certified genetic testing 7-14 days
SCID immunophenotype <50 CD3+ T cells/µL Flow cytometry 2-3 days
HSCT evaluation No matched related donor HLA typing/donor search 2-4 weeks
Specialist letter Medical necessity documentation Immunologist/geneticist Same day

Essential Documentation Checklist

Diagnostic Confirmation:

  • Laboratory proof of ADA enzyme deficiency (<1% normal activity)
  • Genetic testing showing biallelic pathogenic ADA gene variants
  • Flow cytometry demonstrating SCID-level T-cell lymphopenia
  • ICD-10 code D81.3 (adenosine deaminase deficiency)

Clinical Evidence:

  • Newborn screening results (if applicable)
  • Infection history and hospitalizations
  • Current supportive care (IVIG, antimicrobials, isolation)
  • Growth and developmental assessments

Treatment History:

  • Enzyme replacement therapy (pegademase/Revcovi) trials and outcomes
  • HSCT evaluation including donor search results
  • Documentation of why standard therapies are inadequate

Step-by-Step: Fastest Path to Approval

1. Verify Plan Coverage and Submit Initial PA

Who: Patient/family with clinic staff
Timeline: 1-2 weeks
Submit through Humana's provider portal or gene therapy prior authorization form. Include complete diagnostic packet and specialist letter.

2. Request Expedited Review

Who: Prescribing physician
Timeline: 24-72 hours for decision
If delay poses serious health risk, physician can request expedited processing citing life-threatening nature of untreated ADA-SCID.

3. Prepare for Likely Initial Denial

Who: Care team
Timeline: Within 72 hours of PA submission
Humana will likely deny based on international service exclusion and non-FDA approval. Use denial letter to identify specific objections.

4. File Internal Appeal

Who: Patient or provider
Timeline: Must file within 65 days
Submit enhanced medical necessity documentation addressing specific denial reasons through Humana appeals process.

5. Request Peer-to-Peer Review

Who: Prescribing physician
Timeline: During internal appeal
Have immunologist discuss case directly with Humana medical director to clarify clinical rationale and address concerns.

6. Escalate to New York External Review

Who: Patient/family
Timeline: Within 4 months of final denial
File with NY Department of Financial Services for independent medical review.

7. Explore Alternative Funding

Who: Patient/family with social worker
Timeline: Parallel to appeals
Contact Telethon Foundation's "Just like home" program and rare disease advocacy organizations for potential support.

Appeals Playbook for Humana in New York

Internal Appeals Process

First Level - Redetermination

  • Deadline: 65 days from denial notice
  • Decision time: 7 days for Part D drugs, 30 days for Part C services
  • How to file: Humana member portal or mail to address on denial letter
  • Required: Enhanced medical documentation, updated clinical letter

Expedited Appeals

  • When available: Serious jeopardy to health, life, or function
  • Decision time: 72 hours
  • Physician requirement: Must attest to urgency and medical necessity

Key Appeal Arguments

  1. Unique availability - Only authorized center worldwide for commercial ADA-SCID gene therapy
  2. Life-saving necessity - Fatal condition without definitive treatment
  3. Standard of care - Recognized therapy per immunodeficiency guidelines
  4. No equivalent alternatives - HSCT unavailable due to lack of matched donor
Tip: Counterforce Health can help craft appeals that directly address Humana's specific denial reasons using payer-aligned language and evidence standards.

New York External Review Process

New York's external appeal system provides a powerful avenue for overturning Humana denials, particularly for experimental treatments with strong clinical evidence.

Filing Requirements

Eligibility: NY-regulated health plans (confirm with DFS)
Timeline: Within 4 months of final internal denial
Fee: Up to $25 (waived for financial hardship/Medicaid)
Forms: NY External Appeal Application

External Review Advantages

  • Independent medical experts review case
  • Binding decision on insurer
  • Expedited option available (72 hours for urgent cases)
  • Searchable database of prior decisions for precedent research
  • Literature-based reviews considering published evidence

Research Prior Decisions

Use the DFS External Appeals Database to search for:

  • Gene therapy appeals
  • Experimental treatment approvals
  • International care exceptions
  • Similar rare disease cases

Common Denial Reasons & How to Overcome Them

Denial Reason How to Address
"Not FDA approved" Emphasize EMA approval, published safety/efficacy data, lack of equivalent US therapy
"International service excluded" Argue unique availability, life-saving necessity, no domestic alternative
"Experimental/investigational" Cite published outcomes, regulatory approvals, standard-of-care status in EU
"Medical necessity not established" Enhanced documentation of failed alternatives, severity, prognosis without treatment

Medical Necessity Letter Template

Essential Components for Immunologist Letter

Patient Identification and Diagnosis

  • Confirmed ADA-SCID with genetic and enzymatic evidence
  • Clinical presentation and severity
  • ICD-10 D81.3 documentation

Treatment History and Failures

  • Detailed enzyme replacement therapy trials
  • HSCT evaluation and contraindications
  • Supportive care requirements and limitations

Medical Necessity Justification

  • Life-threatening nature without definitive treatment
  • Unique availability of Strimvelis at SR-TIGET
  • Published evidence of safety and efficacy
  • Risk-benefit analysis and informed consent

Urgency Statement

  • Progressive nature of condition
  • Risk of irreversible complications
  • Time-sensitive treatment window

Frequently Asked Questions

Q: How long does Humana prior authorization take for Strimvelis? A: Standard PA decisions within 72 hours; expedited reviews within 24 hours if urgency criteria met.

Q: What if Strimvelis is completely non-formulary? A: Request formulary exception demonstrating no covered alternatives are effective for ADA-SCID.

Q: Can I request expedited external review in New York? A: Yes, if delay poses serious health risk. DFS issues decisions within 72 hours for urgent cases.

Q: Does Humana's step therapy apply to gene therapies? A: Yes, Humana requires documentation that standard therapies (enzyme replacement, HSCT) are inadequate.

Q: What documentation does SR-TIGET need to provide? A: Formal eligibility confirmation, cost estimate, clinical protocol summary for Humana review.

Q: Are there financial assistance programs available? A: Telethon Foundation offers logistical support; explore rare disease foundations and charitable organizations.

Q: What if I'm denied at external review? A: DFS decisions are final and binding; consider alternative funding sources or research protocols.

Q: How do I prove "medical necessity" for international treatment? A: Document unique availability, failed standard therapies, life-threatening prognosis, and published outcomes data.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Consult with your healthcare provider and insurance plan for specific guidance. For free assistance with New York insurance appeals, contact Community Health Advocates at 888-614-5400.

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