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

How to Get Strimvelis Gene Therapy Covered by Cigna in North Carolina: Forms, Appeals, and Smart NC External Review

Answer Box: Getting Strimvelis Covered by Cigna in North Carolina

Strimvelis (autologous CD34+ ADA-SCID gene therapy) requires prior authorization from Cigna and is only available at SR-TIGET in Milan, Italy. For North Carolina residents, the fastest path to approval involves: (1) Submit PA request via CoverMyMeds with confirmed ADA-SCID diagnosis and prior therapy documentation, (2) If denied, file internal appeal within 180 days using Cigna's appeal form, (3) Request external review through Smart NC within 120 days of final denial. Start today: Call Cigna Gene Therapy Program at 855-678-0051 to discuss coverage requirements and facility coordination.

Table of Contents

Verify Your Cigna Plan and Coverage

Before starting the prior authorization process, confirm your specific Cigna plan details. Strimvelis, as an EU-approved gene therapy administered only in Milan, presents unique coverage challenges for U.S. patients.

Key verification steps:

  • Log into your myCigna account to review your prescription drug benefits
  • Check if your plan includes international treatment coverage or centers of excellence provisions
  • Verify your plan is state-regulated (eligible for North Carolina external review) versus self-funded employer coverage
  • Contact Cigna Member Services at 1-800-997-1654 to discuss gene therapy benefits
Note: Self-funded employer plans may not be subject to North Carolina's external review process, though some employers opt into state protections.

Required Forms and Documentation

Prior Authorization Submission

Cigna requires comprehensive documentation for Strimvelis prior authorization. Use the Commercial Drug Prior Authorization Form available through Cigna's provider portal.

Essential documentation includes:

  • Confirmed ADA-SCID diagnosis with genetic testing results
  • Complete medical history and current clinical status
  • Documentation of previous therapies attempted (if any) and outcomes
  • Enzyme activity levels and immunological assessments
  • Prescriber attestation of medical necessity
  • Treatment plan including travel arrangements to SR-TIGET Milan

Medical Necessity Letter Checklist

Your physician's medical necessity letter should address:

  • Clinical presentation: Specific ADA-SCID manifestations and severity
  • Diagnostic confirmation: Genetic testing showing ADA gene mutations
  • Treatment rationale: Why Strimvelis is appropriate versus alternatives like HSCT
  • Supporting evidence: FDA orphan drug designation and European approval data
  • Patient-specific factors: Age, overall health status, and transplant candidacy
Tip: Include references to FDA orphan drug designation and peer-reviewed studies supporting gene therapy for ADA-SCID.

Submission Portals and Methods

Electronic Submission (Preferred)

Primary method: CoverMyMeds portal

  • Create provider account if needed
  • Upload all supporting documentation
  • Track submission status in real-time
  • Fastest processing times (typically 5 business days)

Alternative: SureScripts integration through your EHR system

Fax and Mail Options

If electronic submission isn't possible:

  • Fax: 855-840-1678
  • Phone requests: 1-800-882-4462 (if other options unavailable)
  • Include complete cover sheet with patient demographics and Cigna ID

Specialty Pharmacy Coordination

Strimvelis requires specialized handling and coordination with Cigna's gene therapy program.

Key contacts:

  • Gene Therapy Program: 855-678-0051 or [email protected]
  • Accredo Specialty Pharmacy: 877-826-7657 (for coordination and patient support services)

Coordination steps:

  1. Contact Gene Therapy Program to discuss case management assignment
  2. Verify coverage for international treatment and travel
  3. Coordinate with SR-TIGET Milan for treatment scheduling
  4. Arrange for specialized shipping and handling requirements

Counterforce Health helps patients navigate these complex specialty pharmacy requirements by analyzing payer policies and coordinating with treatment centers to ensure all operational details meet insurer expectations.

Appeals Process: Internal and External

Internal Appeals with Cigna

If your initial prior authorization is denied:

Timeline: Submit within 180 days of denial notice Forms: Use Cigna Customer Appeal Request form Response time:

  • Standard appeals: 30 days
  • Expedited appeals: 72 hours (if delay would jeopardize health)

Required documentation:

  • Original denial letter
  • Additional medical records or studies
  • Updated physician statement addressing denial reasons
  • Any new clinical evidence supporting medical necessity

Expedited Appeals

For urgent situations where standard timelines could jeopardize health:

  • Complete standard appeal form, marking "expedited" request
  • Physician must certify that delay poses serious health risk
  • Cigna must respond within 72 hours orally, followed by written confirmation

North Carolina External Review with Smart NC

If Cigna denies your internal appeal, North Carolina residents can request an independent external review through Smart NC.

External Review Process

Eligibility: Must exhaust Cigna's internal appeals (or qualify for expedited review) Deadline: 120 days from final Cigna denial Cost: Free to consumers

Submission methods:

Required documents:

  • External Review Request Form
  • Cigna's final denial letter
  • All medical records and supporting documentation
  • For expedited reviews: Physician Certification Form

Timeline:

  • Standard external review: 45 days
  • Expedited external review: 72 hours

Binding outcome: If the Independent Review Organization (IRO) overturns Cigna's denial, the insurer must provide coverage within 3 business days.

From our advocates: We've seen several rare disease gene therapy cases succeed at external review when the initial appeal included comprehensive genetic testing results and clear documentation that standard treatments weren't viable options. The key was presenting the case as medically necessary rather than experimental.

Support Resources and Contact Numbers

Cigna Support Lines

  • Member Services: 1-800-997-1654
  • Gene Therapy Program: 855-678-0051
  • Provider Appeals: Check your provider portal for current number

North Carolina Consumer Assistance

  • Smart NC Helpline: 855-408-1212
  • Free guidance on appeals process and form completion
  • Cannot serve as official representative but provides navigation support

Genetic Counseling (Cigna In-Network)

  • InformedDNA: 1-800-975-4819
  • Genome Medical: 1-877-688-0992

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Documentation Needed
"Not available in U.S." Emphasize lack of FDA-approved alternatives for ADA-SCID Orphan drug status, EU approval data
"Experimental/investigational" Provide evidence of established efficacy Published studies, regulatory approvals
"Out-of-network facility" Request center of excellence exception SR-TIGET specialization documentation
"Medical necessity not established" Strengthen clinical rationale Genetic testing, enzyme levels, clinical presentation
"Alternative treatments available" Document contraindications to HSCT Transplant evaluation, donor availability

FAQ: Strimvelis Coverage in North Carolina

How long does Cigna prior authorization take for gene therapy? Standard PA decisions are typically made within 5 business days for electronic submissions. Complex cases like Strimvelis may require additional review time.

What if Strimvelis is non-formulary on my Cigna plan? Request a formulary exception using the prior authorization process. Include documentation that no formulary alternatives are appropriate for ADA-SCID.

Can I request an expedited appeal if my child's condition is deteriorating? Yes, if delay would seriously jeopardize health. Your physician must complete the expedited certification, and Cigna must respond within 72 hours.

Does Cigna cover travel costs for treatment in Milan? Coverage for travel and lodging varies by plan. Contact the Gene Therapy Program at 855-678-0051 to discuss your specific benefits.

What happens if Smart NC external review upholds the denial? The IRO decision is binding, ending the administrative appeal process. You may still have legal rights to pursue other remedies.

How can I find out if my employer plan is subject to North Carolina external review? Contact Smart NC at 855-408-1212 or check with your HR department about whether your plan opted into state protections.

Coverage at a Glance

Requirement Details Timeline Source
Prior Authorization Required for all gene therapies 5 business days Cigna PA Forms
Internal Appeal Must exhaust before external review 180 days to file Cigna Appeals
External Review Available for state-regulated plans 120 days from final denial Smart NC
Expedited Process For urgent medical situations 72 hours for decision NC External Review Law

When Treatment Coverage Becomes Complex

Navigating gene therapy coverage requires expertise in both clinical evidence and payer policies. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying specific policy gaps, and crafting evidence-backed rebuttals that address each payer's unique requirements. Their platform helps families and clinicians present the strongest possible case for innovative treatments like Strimvelis.

Update Cadence: Staying Current

Gene therapy policies evolve rapidly. Check these resources quarterly:

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 company for specific guidance regarding your situation.

Sources & Further Reading

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