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

How to Get Strimvelis Gene Therapy Covered by Blue Cross Blue Shield in New York: Complete Guide with Forms and Appeals

Answer Box: Getting Strimvelis Covered by Blue Cross Blue Shield in New York

Strimvelis is not routinely covered by Blue Cross Blue Shield New York and requires a comprehensive medical exception request. Since Strimvelis is only available at SR-TIGET in Milan, Italy, you'll need both drug coverage approval and international treatment authorization. Start today by: 1) Contacting BCBS Member Services to request prior authorization forms, 2) Having your physician document ADA-SCID diagnosis with genetic testing, and 3) Exploring supplemental GeoBlue international coverage. New York's external appeal rights through the Department of Financial Services provide strong backup options if initially denied.

Table of Contents

  1. Coverage Basics: Is Strimvelis Covered?
  2. Prior Authorization Process
  3. International Treatment Coverage
  4. Medical Necessity Requirements
  5. Timing and Urgency
  6. Cost Considerations
  7. Denials and Appeals in New York
  8. Specialty Pharmacy Requirements
  9. Alternative Coverage Options
  10. FAQ: Common Questions

Coverage Basics: Is Strimvelis Covered?

The short answer: Not routinely. Strimvelis (autologous CD34+ ADA-SCID gene therapy) is not included in standard Blue Cross Blue Shield New York formularies or medical benefit drug lists. This ultra-rare gene therapy, manufactured by Orchard Therapeutics, is only available in Europe at the SR-TIGET center in Milan, Italy.

Coverage at a Glance

Requirement Status What This Means Next Step
Prior Authorization Required Case-by-case medical exception needed Submit comprehensive PA request
Formulary Status Not listed Requires medical policy exception Document medical necessity
International Coverage Limited Standard BCBS covers emergencies only Consider GeoBlue supplemental
FDA Approval Not approved in US EU-approved only Emphasize lack of US alternatives
Note: Different Blue Cross Blue Shield plans in New York (Anthem, Excellus, etc.) may have varying policies, but none routinely cover Strimvelis as of 2024-2025.

Prior Authorization Process

Since Strimvelis requires a medical exception, your prior authorization request must be exceptionally thorough. Here's the step-by-step process:

Step 1: Contact Your BCBS Plan

Call the member services number on your insurance card to:

  • Request prior authorization forms for gene therapy
  • Ask about medical policy exception procedures
  • Confirm your plan's international coverage benefits

Step 2: Physician Documentation Package

Your immunologist or treating physician must provide:

Required Clinical Documentation:

  • Confirmed ADA-SCID diagnosis with genetic testing results
  • Adenosine deaminase enzyme deficiency lab values
  • Complete medical history and current clinical status
  • Documentation of failed or contraindicated treatments (including why HSCT isn't suitable)
  • Letter of medical necessity citing peer-reviewed literature

Supporting Evidence to Include:

  • FDA orphan drug designation information
  • European Medicines Agency approval documentation
  • Published clinical trial data on Strimvelis efficacy
  • SR-TIGET center credentials and treatment protocol

Step 3: Submit Complete Request

Most BCBS New York plans accept submissions via:

  • Provider portal (confirm current link with member services)
  • Fax to utilization management department
  • Mail to medical review department
Tip: Request expedited review if the patient's condition is deteriorating or if there are timing constraints for treatment scheduling.

International Treatment Coverage

This is where Strimvelis coverage becomes particularly complex. Standard BCBS New York plans offer very limited international coverage.

Standard BCBS International Benefits

  • Emergency care only in most cases
  • No coverage for planned treatments at international facilities
  • Upfront payment required with potential reimbursement

GeoBlue Supplemental Coverage

For planned treatment at SR-TIGET, consider purchasing GeoBlue international health insurance:

  • Covers non-emergency international care
  • Direct billing to overseas providers
  • 24/7 support for treatment coordination
  • Can be purchased as standalone or employer add-on

Action Item: Contact both BCBS New York and GeoBlue customer service to understand your options and get written coverage verification before traveling.

Medical Necessity Requirements

For any chance of coverage approval, your medical necessity letter must address these key points:

Clinical Criteria Checklist

  • Confirmed ADA-SCID diagnosis with genetic testing
  • Enzyme deficiency documentation (adenosine deaminase levels)
  • Failure of standard treatments or contraindications to HSCT
  • Lack of suitable bone marrow donor if applicable
  • Progressive clinical deterioration without treatment
  • Age and clinical status suitable for gene therapy

Evidence-Based Justification

Include citations from:

  • Published Strimvelis clinical trials
  • European regulatory approval documents
  • Medical society guidelines on ADA-SCID treatment
  • Peer-reviewed literature on gene therapy efficacy
From our advocates: In our experience with rare disease appeals, the most successful cases include comprehensive documentation of why standard treatments failed or aren't appropriate, combined with strong literature support for the requested therapy. While we can't guarantee outcomes, thorough preparation significantly improves approval chances.

Timing and Urgency

Standard Review Timeline

  • Initial PA review: 10-15 business days
  • Medical exception review: 30-45 days
  • Appeal process: 30 days internal, additional time for external

Expedited Review Options

Request expedited review if:

  • Patient's condition is rapidly deteriorating
  • Immune system compromise poses immediate risk
  • Treatment scheduling has specific timing requirements

For urgent cases: BCBS must respond to expedited requests within 72 hours.

Cost Considerations

Strimvelis carries a substantial cost burden that extends beyond the therapy itself.

Total Cost Components

  • Gene therapy: €594,000 (approximately $650,000) list price
  • Travel and accommodation in Milan
  • Pre-treatment evaluations and preparation
  • Post-treatment monitoring and follow-up care

Financial Assistance Options

  • Manufacturer patient assistance programs (contact Orchard Therapeutics)
  • Rare disease foundations and grant programs
  • Medicaid coverage for eligible children in New York
  • Child Health Plus for additional pediatric coverage

Denials and Appeals in New York

New York provides robust appeal rights that are particularly valuable for experimental treatment denials.

Internal Appeals Process

  1. File internal appeal within 180 days of denial
  2. Provide additional evidence not included in original request
  3. Request peer-to-peer review with medical director
  4. Await determination (30 days standard, 72 hours expedited)

New York External Appeal Rights

If your internal appeal is denied, you have powerful options through the New York State Department of Financial Services:

External Appeal Process:

  • File within 4 months of final internal denial
  • Independent medical review by certified experts
  • Binding decision on the insurance company
  • Expedited options for urgent cases (72 hours)

Key Advantage: New York's external appeal system has successfully overturned many denials for experimental treatments when supported by appropriate medical evidence.

Appeals Documentation Checklist

  • Copy of original denial letter
  • All medical records and test results
  • Physician letters supporting medical necessity
  • Published literature on Strimvelis efficacy
  • Documentation of failed alternative treatments

Specialty Pharmacy Requirements

While Strimvelis is manufactured and administered only at SR-TIGET, understanding BCBS specialty pharmacy requirements helps with coverage coordination.

BCBS Specialty Network

  • Prior authorization required for all gene therapies
  • Network facility requirements for administration
  • Coordination with international providers may be needed

Important: Since Strimvelis can't be transferred to US specialty pharmacies, work with BCBS to understand how international treatment coordination affects coverage.

Alternative Coverage Options

New York Public Programs

For eligible children:

Medicaid Coverage:

  • Covers medically necessary treatments
  • Requires prior authorization for gene therapies
  • May cover international treatment in exceptional cases

Child Health Plus:

  • Comprehensive coverage for children
  • Similar prior authorization requirements
  • May coordinate with Medicaid for high-cost treatments

Essential Plan:

  • Low-income coverage option
  • Comprehensive benefits with minimal cost-sharing
  • Gene therapy coverage follows medical necessity criteria

Medicaid Coverage Process

  1. Confirm eligibility (income limits: verify current thresholds)
  2. Submit prior authorization through NY Medicaid Pharmacy Program
  3. Provide clinical justification for gene therapy
  4. Request medical exception if not on preferred drug list

FAQ: Common Questions

How long does BCBS prior authorization take in New York?

Standard review takes 10-15 business days, but medical exceptions for experimental treatments like Strimvelis can take 30-45 days. Request expedited review if clinically urgent.

What if Strimvelis is denied as experimental?

File an internal appeal immediately, then pursue external appeal through NY Department of Financial Services. Include published efficacy data and documentation that standard treatments aren't suitable.

Does BCBS cover travel costs for treatment in Italy?

Standard BCBS plans don't cover travel costs. However, if the treatment itself is approved, some plans may consider travel as part of medical necessity. Confirm this in writing before proceeding.

Can I get coverage if we move from another state?

Yes, but you'll need to restart the prior authorization process with your new BCBS New York plan. Gather all previous documentation to expedite the new request.

What happens if BCBS approves the drug but not international treatment?

This creates a coverage gap. Work with BCBS case management to find solutions, and consider purchasing supplemental GeoBlue coverage for the international treatment component.

How do I find specialists who understand ADA-SCID in New York?

Contact major academic medical centers like NewYork-Presbyterian, Mount Sinai, or NYU Langone. Pediatric immunology departments typically have experience with rare immune deficiencies.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and creates point-by-point rebuttals aligned to each payer's specific criteria, pulling the right clinical evidence and procedural requirements to maximize approval chances.

When facing a complex coverage challenge like Strimvelis, having expert support can make the difference between approval and denial. Counterforce Health specializes in transforming difficult prior authorization and appeal cases into successful outcomes through data-driven, payer-specific strategies.

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 policy terms, medical circumstances, and payer policies that change frequently. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For personalized assistance with insurance appeals and prior authorizations in New York, contact Community Health Advocates at 888-614-5400 or the NY Department of Financial Services consumer helpline.

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