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

Getting Strimvelis Gene Therapy Covered by Humana in Virginia: Complete Timeline, Forms, and Appeals Guide

Answer Box: Fast Track to Strimvelis Coverage

Getting Strimvelis covered by Humana in Virginia requires prior authorization with documented ADA enzyme deficiency (<1% normal), genetic confirmation of bi-allelic ADA mutations, and proof no suitable bone marrow donor exists. Submit via Humana's Clinical Pharmacy Review (800-555-2546) with medical necessity letter emphasizing international treatment at SR-TIGET Milan. If denied, Virginia's State Corporation Commission Bureau of Insurance offers external review within 120 days. Start today: Gather genetic testing, enzyme levels, and donor search documentation—then contact your prescriber to initiate the prior authorization process.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all gene therapies PA form via Clinical Pharmacy Review Humana PA Portal
Genetic Confirmation Bi-allelic ADA gene mutations Laboratory genetic testing report Medical necessity standards
Enzyme Deficiency ADA activity <1% of normal Erythrocyte/lymphocyte enzyme assay Clinical criteria
No Suitable Donor HLA-matched related donor unavailable Registry search, transplant center letter Treatment protocol
ICD-10 Code D81.31 (ADA deficiency) Provider documentation Coding requirements
Treatment Center SR-TIGET Milan, Italy only Center acceptance letter Manufacturing limitations

Step-by-Step: Fastest Path to Approval

  1. Confirm Eligibility (Day 0-1)
    • Verify active Humana coverage and benefits
    • Check if you have Medicare Advantage or Part D coverage
    • Contact member services: 800-555-2546
  2. Gather Required Documentation (Day 1-3)
    • Genetic testing showing bi-allelic ADA mutations
    • ADA enzyme activity results (<1% normal)
    • HLA typing and donor search results
    • Clinical notes documenting recurrent infections, growth issues
    • SR-TIGET consultation letter and treatment plan
  3. Prescriber Submits Prior Authorization (Day 3-5)
    • Call Humana Clinical Pharmacy Review: 800-555-2546
    • Submit via provider portal or fax: 877-486-2621
    • Include comprehensive medical necessity letter (see template below)
  4. Track Review Process (Day 5-12)
    • Standard decision within 5 business days for complete requests
    • Expedited review (48 hours) available if health is jeopardized
    • Follow up weekly for status updates
  5. If Additional Information Requested (Day 7-14)
    • Respond within 24-48 hours to avoid delays
    • Common requests: recent lab work, specialist consultation, treatment history
  6. Receive Decision (Day 10-15)
    • Approval: Proceed with SR-TIGET coordination
    • Denial: Begin internal appeal process immediately
  7. Appeal if Denied (Day 15-80)
    • Internal appeal within plan timelines
    • Virginia external review if internal appeals exhausted

What Affects Approval Timing

Factors that speed approval:

  • Complete documentation package submitted initially
  • Board-certified immunologist or hematologist/oncologist as prescriber
  • Clear evidence of failed conventional treatments (PEG-ADA enzyme replacement)
  • SR-TIGET acceptance letter included

Common delays:

  • Missing genetic testing or enzyme activity results
  • Incomplete donor search documentation
  • Unclear medical necessity rationale
  • Missing ICD-10 coding (D81.31)
Tip: Humana reports a 3.5% prior authorization denial rate for Medicare Advantage—among the lowest of major insurers—but thorough documentation is still essential for specialty gene therapies.

Pre-Submission Preparation

Before contacting Humana, ensure you have:

Essential Clinical Documentation:

  • Genetic testing report confirming bi-allelic pathogenic ADA variants
  • Laboratory results showing ADA enzyme activity <1% of normal in erythrocytes/lymphocytes
  • Flow cytometry demonstrating absent/reduced T/B/NK cells
  • Clinical history of recurrent infections, failure to thrive
  • Low T-cell receptor excision circles (TREC) on newborn screening (if available)

Treatment History:

  • Documentation of PEG-ADA enzyme replacement therapy failure or intolerance
  • Records of inadequate immune reconstitution despite treatment
  • Evidence of contraindications to conventional therapy

Donor Search Results:

  • HLA typing results for patient and family members
  • National Marrow Donor Program (NMDP) registry search results
  • Transplant center letter confirming no matched related or unrelated donor available

Submission to Initial Review

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting targeted, evidence-backed responses. Their platform helps patients and clinicians navigate complex prior authorization requirements for specialty therapies like gene therapy.

Submission Methods:

  • Phone: 800-555-2546 (Monday-Friday, 8 AM-8 PM ET)
  • Online: Humana provider portal
  • Fax: 877-486-2621
  • Mail: CarePlus Health Plans, Clinical Pharmacy Review, P.O. Box 14601, Lexington, KY 40512-4601

Review Timeline:

  • Standard decisions: 5 business days from complete request
  • Expedited decisions: 48 hours when health jeopardized
  • CMS requirement: 7 calendar days maximum by January 2026

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Experimental/Investigational" Cite EU approval, SR-TIGET protocols EMA approval documents, published outcomes
"No suitable donor not proven" Comprehensive donor search NMDP search, family HLA typing, transplant center letter
"PEG-ADA not tried" Document failure/intolerance Treatment records, infection history, growth charts
"Not available in US" International coverage precedent Other payer approvals, medical tourism policies
"Insufficient documentation" Complete clinical package All required tests, specialist consultation

Appeals Timeline in Virginia

Internal Appeals (Humana):

  • File within 65 days of denial notice
  • Standard review: 30 days for Part C, 7 days for Part D
  • Expedited review: 72 hours if delay could seriously jeopardize health

Virginia External Review:

  • File within 120 days of final internal denial
  • Submit Form 216-A to Virginia State Corporation Commission Bureau of Insurance
  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent cases

Contact Information:

  • Virginia Bureau of Insurance: (804) 371-9740
  • Email: [email protected]
  • Address: P.O. Box 1157, Richmond, VA 23218
Note: Virginia's external review process has helped many patients overturn wrongful denials for specialty treatments. The state even allows expedited external review for certain cases without exhausting internal appeals first.

Clinician Corner: Medical Necessity Letter

Essential Elements for Prescriber Letter:

  1. Patient Identification
    • Full name, date of birth, Humana member ID
    • Diagnosis: ADA-SCID (ICD-10: D81.31)
  2. Clinical Justification
    • Genetic testing results (specific mutations)
    • ADA enzyme activity levels
    • Immunological workup (lymphocyte subsets)
    • Clinical presentation (infections, growth, development)
  3. Treatment Rationale
    • Why conventional HSCT is not suitable (no donor)
    • PEG-ADA failure or contraindication
    • Urgency of treatment (progressive immune dysfunction)
  4. SR-TIGET Protocol
    • Center acceptance and treatment plan
    • Timeline and logistics
    • Expected outcomes based on published data
  5. Prescriber Credentials
    • Board certification in immunology, hematology/oncology, or pediatrics
    • Experience with primary immunodeficiencies
    • Hospital affiliation

Template Opening: "I am writing to request prior authorization for Strimvelis (autologous CD34+ ADA-SCID gene therapy) for [Patient Name], a [age]-year-old with severe combined immunodeficiency due to adenosine deaminase deficiency. This one-time gene therapy represents the only curative option for this patient who lacks a suitable bone marrow donor and has failed conventional enzyme replacement therapy."

Costs and Patient Support Programs

Estimated Costs:

  • Strimvelis list price: €594,000 (~$650,000 USD) per treatment
  • Additional costs: Travel to Milan, accommodation, follow-up care

Financial Support Options:

  • Orchard Therapeutics compassionate use program
  • National Organization for Rare Disorders (NORD) patient assistance
  • Children's Hospital Association financial counseling
  • State Medicaid coverage (if eligible)

Travel Assistance:

  • Corporate Angel Network (free flights on corporate jets)
  • Make-A-Wish Foundation (for qualifying children)
  • Hospital social work departments often coordinate international treatment logistics

When working with Counterforce Health, patients gain access to specialized knowledge about payer policies and evidence requirements that can significantly improve approval odds for complex gene therapies.

FAQ

How long does Humana prior authorization take for Strimvelis in Virginia? Standard decisions within 5 business days of complete submission. Expedited review available within 48 hours if delay could jeopardize health.

What if Strimvelis is not on Humana's formulary? Submit a formulary exception request with medical necessity documentation. Include prescriber statement that all covered alternatives are ineffective or cause adverse effects.

Can I request expedited appeal in Virginia? Yes, both Humana internal appeals and Virginia external review offer expedited options when delay could seriously harm health. Requires prescriber certification of urgency.

Does step therapy apply to gene therapy? Typically yes—must document failure or intolerance of conventional treatments like PEG-ADA enzyme replacement therapy before gene therapy consideration.

What happens if Humana denies coverage? File internal appeal within 65 days. If denied again, Virginia external review within 120 days. State Corporation Commission assigns independent medical review.

Is travel to Milan covered? Not typically covered by insurance. Seek assistance from patient advocacy organizations, hospital financial counselors, and manufacturer support programs.

How do I prove no suitable donor exists? Provide HLA typing results, National Marrow Donor Program search results, and letter from transplant center confirming no matched related or unrelated donor available.

What documentation does SR-TIGET require? Complete medical records, genetic testing, enzyme studies, immunological workup, and clearance for international travel. Contact SR-TIGET directly for current requirements.

This article provides educational information only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance at (804) 371-9740.

Sources & Further Reading

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