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

How to Get Strimvelis Gene Therapy Covered by Humana in New Jersey: Complete Forms & Appeals Guide

Answer Box: Getting Strimvelis Covered by Humana in New Jersey

Strimvelis is not FDA-approved in the U.S. and requires treatment in Milan, Italy. Humana Medicare Advantage and commercial plans do not cover international treatments. Your path forward: (1) Request a formulary exception through your prescriber, (2) If denied, appeal within 65 days, and (3) Consider New Jersey's external review through IHCAP. Start by having your doctor submit a detailed medical necessity letter explaining why no U.S. alternatives work for your ADA-SCID diagnosis.

Table of Contents

  1. Coverage Reality Check
  2. Required Forms and Documentation
  3. Submission Portals and Methods
  4. Appeals Process in New Jersey
  5. Medical Necessity Requirements
  6. Common Denial Reasons
  7. New Jersey External Review (IHCAP)
  8. Support Resources

Coverage Reality Check

Strimvelis presents unique coverage challenges. This ex vivo retroviral gene therapy, priced at approximately €594,000 ($650,000), is only available at SR-TIGET in Milan, Italy. Humana's Medicare Advantage and commercial plans exclude coverage for treatments received outside the United States, including elective gene therapies abroad.

However, you still have options:

  • Formulary exception requests for compassionate use consideration
  • Appeals process through Humana's internal review
  • New Jersey external review if internal appeals fail
  • Alternative treatments like HSCT (hematopoietic stem cell transplantation) that may be covered
Important: Before pursuing Strimvelis, work with your immunologist to explore FDA-approved alternatives like Revcovi (pegademase bovine) for ADA-SCID, which Humana is more likely to cover.

Required Forms and Documentation

Core Documentation Checklist

For ADA-SCID Diagnosis Confirmation:

  • ADA gene sequencing results showing pathogenic variants
  • ADA enzyme activity blood test results
  • Complete immunological workup (T, B, NK cell counts)
  • Newborn screening results (if applicable)
  • Clinical notes documenting recurrent infections or immunodeficiency symptoms

For Humana Submission:

  • Humana Prior Authorization Form for gene therapies
  • Detailed medical necessity letter from prescriber
  • Documentation of failed or unsuitable alternatives
  • Patient demographics and Humana member ID
  • Provider NPI and clinic information

Genetic Testing Requirements

Your doctor must document:

  • Informed consent for genetic testing (required by both labs and insurance)
  • Laboratory reports from recognized facilities like LabCorp or Mayo Clinic
  • Clinical correlation explaining how test results support ADA-SCID diagnosis
  • Treatment history showing inadequate response to standard therapies

Submission Portals and Methods

Electronic Submission (Preferred)

CoverMyMeds Portal:

  • Primary method for Humana prior authorization requests
  • Real-time status tracking available
  • Secure document upload for supporting materials
  • Access at CoverMyMeds Humana portal

Humana Provider Portal:

  • Secondary option for registered providers
  • Links to current PA forms and requirements
  • Status monitoring capabilities

Fax Submission

For Gene Therapy Requests:

  • Clinical Pharmacy Review: 1-877-486-2621
  • Medically Administered Therapies: 1-888-447-2869

Submission Tips:

  • Use clear cover sheets with member information
  • Include all required documentation in single transmission
  • Follow up within 48 hours to confirm receipt
  • Keep fax confirmation receipts

Mail Submission

When faxing isn't possible, mail completed forms to your plan's designated address (verify current address through Humana member services at 1-800-833-2364).

Appeals Process in New Jersey

Internal Appeals Timeline

First Level Appeal (Redetermination):

  • Deadline: 65 days from denial notice
  • Timeline: Standard requests processed within 72 hours
  • Expedited: 24 hours if delay could jeopardize health
  • Required: Additional clinical evidence supporting medical necessity

Second Level Appeal:

  • Automatic if first appeal denied
  • Same timeline as first level
  • Consider requesting peer-to-peer review with medical director

Required Appeal Documentation

  • Original denial letter from Humana
  • Updated medical necessity letter addressing denial reasons
  • Additional clinical evidence (recent labs, imaging, specialist notes)
  • Comparative analysis showing why alternatives aren't suitable
  • Patient impact statement (optional but helpful)
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify the specific denial basis and draft point-by-point rebuttals aligned to Humana's policies.

Medical Necessity Requirements

Clinician Corner: Medical Necessity Letter Checklist

Your prescriber's letter must address:

Clinical Problem:

  • Confirmed ADA-SCID diagnosis with genetic and enzymatic evidence
  • Severity of immunodeficiency and infection history
  • Life-threatening nature without treatment

Prior Treatments:

  • Documentation of standard therapies tried (enzyme replacement, HSCT evaluation)
  • Specific reasons why alternatives failed or aren't suitable
  • Contraindications to available U.S. treatments

Treatment Rationale:

  • Why Strimvelis is medically necessary
  • Expected clinical outcomes
  • Monitoring plan for post-treatment care

Guideline Support:

  • Reference FDA guidance on ADA-SCID treatment
  • Cite immunodeficiency society recommendations
  • Include peer-reviewed literature on gene therapy efficacy

Common Denial Reasons

Denial Reason How to Address Required Documentation
Not FDA-approved Request compassionate use exception FDA orphan drug designation, EU approval documentation
International treatment Appeal based on lack of U.S. alternatives Comprehensive search of U.S. clinical trials, specialist attestation
Experimental/investigational Provide efficacy data Peer-reviewed studies, regulatory approvals, clinical guidelines
Formulary exclusion Request tier exception Medical necessity letter, failed alternatives documentation
Step therapy required Document contraindications Clinical notes showing why standard therapies aren't appropriate

New Jersey External Review (IHCAP)

If Humana's internal appeals fail, New Jersey offers robust external review through the Independent Health Care Appeals Program (IHCAP), administered by Maximus Federal Services.

IHCAP Contact Information

Phone: 888-866-6205 (main inquiry line) Fax: 585-425-5296 Email: [email protected] Portal: https://njihcap.maximus.com

Mailing Address: Maximus Attn: State Appeals/NJ IHCAP 3750 Monroe Avenue, Suite 705 Pittsford, NY 14534

IHCAP Process

Eligibility: Must involve fully insured New Jersey plan (not Medicare or self-funded ERISA plans) Deadline: 4 months (180 days) from final internal denial Timeline: 5 business days for preliminary review, 45 days for final decision Cost: Free to patients (insurers pay all review costs)

Required Documentation:

  • Completed IHCAP application form
  • Copy of final denial letter from Humana
  • All medical records supporting the request
  • Provider's detailed treatment recommendation
Note: IHCAP reviewers are medical experts in relevant specialties who can overturn Humana's decision if they find the treatment medically necessary.

Support Resources

Patient Support Lines

Humana Member Services: 1-800-833-2364

  • Coverage verification
  • Appeal status checks
  • Form requests

CenterWell Specialty Pharmacy: 1-800-486-2668

  • Gene therapy coordination (U.S. treatments only)
  • Financial assistance programs
  • Clinical support services

New Jersey Consumer Assistance

NJ Department of Banking & Insurance:

  • IHCAP Support: 888-393-1062 or [email protected]
  • Consumer Hotline: 1-800-446-7467
  • General Inquiries: 609-777-9470

Financial Assistance

While Strimvelis isn't available through typical patient assistance programs, consider:

  • Rare disease foundations that may provide travel grants
  • Clinical trial opportunities for alternative gene therapies
  • Humana's financial hardship programs for covered alternatives

When to Update Resources

Monthly: Check Humana's prior authorization requirements and formulary updates Quarterly: Verify IHCAP contact information and forms Annually: Review New Jersey insurance regulations and external review procedures As Needed: Monitor FDA approvals for new ADA-SCID treatments

Getting Strimvelis covered by Humana in New Jersey requires persistence and thorough documentation. While international coverage remains unlikely, the appeals process and external review options provide meaningful opportunities for coverage decisions to be overturned.

Counterforce Health helps patients and clinicians navigate these complex coverage challenges by creating targeted, evidence-backed appeals that address specific payer policies and denial reasons. Their platform can significantly improve your chances of success in the appeals process.

FAQ

Q: How long does Humana's prior authorization take for gene therapies in New Jersey? A: Standard requests: 72 hours. Expedited requests (when delay could harm health): 24 hours.

Q: What if Strimvelis isn't on Humana's formulary? A: Request a formulary exception through your prescriber with detailed medical necessity justification.

Q: Can I get expedited appeals for urgent ADA-SCID treatment? A: Yes, if your doctor certifies that delays could seriously jeopardize your health or function.

Q: Does Humana cover travel costs for out-of-state treatments? A: Generally no, but some plans may cover transportation for covered services at designated centers of excellence.

Q: What happens if IHCAP overturns Humana's denial? A: Humana must comply with IHCAP's decision and provide coverage as directed by the external reviewers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare providers and insurance representatives for personalized guidance. For official New Jersey insurance regulations and consumer assistance, visit the NJ Department of Banking and Insurance.

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