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

Getting Strimvelis Gene Therapy Covered by Cigna in Illinois: Complete Guide to Costs, Appeals, and Financial Assistance

Answer Box: Your Path to Strimvelis Coverage with Cigna in Illinois

Getting Strimvelis covered by Cigna requires prior authorization and international treatment approval since it's only available at SR-TIGET in Milan, Italy. Start by having your specialist submit a formulary exception request with genetic testing confirming ADA-SCID and documentation that standard treatments (HSCT) aren't suitable. Cigna typically requires pre-authorization for out-of-network international care, and you'll need to work with Orchard Assist (1-833-672-4278) for financial support. Illinois residents have strong appeal rights with 30-day external review deadlines after internal appeals.

First step today: Contact your immunologist to begin the prior authorization process and call Orchard Assist to start financial assistance screening.

Table of Contents

  1. What Drives Strimvelis Costs with Cigna
  2. Benefit Investigation: Questions to Ask
  3. Financial Assistance Options
  4. Formulary Exception Process
  5. International Treatment Coordination
  6. Appeals Process in Illinois
  7. Annual Planning and Renewals
  8. Scripts for Key Conversations
  9. FAQ
  10. Sources & Further Reading

What Drives Strimvelis Costs with Cigna

Understanding your Cigna plan's structure helps predict out-of-pocket costs for Strimvelis, which carries a list price of €594,000 (approximately $650,000) per patient.

Benefit Design Basics

Formulary Status: Strimvelis isn't listed on Cigna's standard 2024 formularies, meaning it requires a formulary exception for any coverage consideration. Without an exception, you'd face 100% of costs.

International Treatment: Since Strimvelis is only available at San Raffaele Hospital in Milan, Italy, coverage depends on your plan's out-of-network and international treatment benefits. Most Cigna plans require prior authorization for international care.

Specialty Drug Tiers: If approved through exception, Strimvelis would likely be classified as a specialty tier drug, typically requiring 20-40% coinsurance rather than a flat copay.

Note: Gene therapies often hit annual out-of-pocket maximums quickly. For 2024, ACA-compliant plans cap out-of-pocket costs at $9,450 for individuals and $18,900 for families.

Benefit Investigation: What to Ask

Before starting the approval process, gather specific information about your Cigna coverage:

Questions for Cigna Customer Service

  1. "Does my plan cover international treatment for conditions not treatable in the US?"
  2. "What's my out-of-network annual deductible and out-of-pocket maximum?"
  3. "How do I request a formulary exception for a non-covered specialty drug?"
  4. "What documentation is required for international treatment pre-authorization?"

Information to Record

  • Policy number and group number
  • Out-of-network benefits percentage
  • Prior authorization requirements for specialty drugs
  • International treatment coverage limits
  • Appeal deadlines and processes

Contact Cigna: Use the customer service number on your insurance card or log into your member portal at cigna.com.

Financial Assistance Options

Multiple programs can help reduce your out-of-pocket costs for Strimvelis:

Orchard Assist Program

Orchard Therapeutics offers comprehensive support through Orchard Assist, including:

  • Insurance benefits investigation
  • Prior authorization assistance
  • Financial aid evaluation based on income and insurance status
  • Travel and lodging support guidance for Milan treatment
  • Ongoing reimbursement support

Contact: 1-833-672-4278 (1-833-ORCHAST)

Tip: Contact Orchard Assist early in the process. They can help coordinate with Cigna and provide case management throughout the approval journey.

Commercial Insurance Copay Programs

If you have commercial Cigna coverage (not Medicare or Medicaid), you may be eligible for manufacturer copay assistance. Orchard Assist will evaluate your eligibility during the benefits investigation.

Foundation Support

Several organizations provide grants for rare disease treatments:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)
  • Immune Deficiency Foundation

Illinois-Specific Resources

Illinois residents can access additional support through:

  • Illinois Department of Insurance consumer assistance: 877-527-9431
  • Illinois Attorney General Health Care Helpline: 1-877-305-5145

Formulary Exception Process

Since Strimvelis isn't on Cigna's formulary, you'll need an exception based on medical necessity.

Required Documentation

Your physician must provide:

Clinical Evidence:

  • Genetic testing confirming ADA-SCID (bi-allelic ADA gene mutations)
  • Laboratory results showing absent/very low ADA enzyme activity (<1% of normal)
  • Documentation of immune deficiency symptoms

Treatment Rationale:

  • Why standard treatments (HSCT with matched donor) aren't suitable
  • Evidence that gene therapy is medically necessary
  • Citations from peer-reviewed literature supporting gene therapy for ADA-SCID

Specialist Attestation:

  • Letter from immunologist or hematologist/oncologist
  • Confirmation of ADA-SCID diagnosis
  • Statement of medical necessity for gene therapy

Submission Process

  1. Physician completes Cigna formulary exception form
  2. Include all supporting documentation listed above
  3. Submit via fax or Cigna provider portal
  4. Request expedited review if delay would jeopardize health (decision within 24 hours)

Standard timeline: 72 hours for non-expedited requests

International Treatment Coordination

Getting Cigna coverage for treatment in Milan requires careful coordination:

Pre-Authorization Requirements

Before traveling to Italy, ensure you have:

  • Written pre-authorization from Cigna for international treatment
  • Confirmation of coverage percentage and out-of-pocket costs
  • Understanding of direct billing vs. reimbursement process
  • Emergency contact information for Cigna International

Working with SR-TIGET

San Raffaele Hospital's billing department can often coordinate directly with international insurers. Provide them with:

  • Your Cigna policy information
  • Pre-authorization approval letter
  • Contact information for your Cigna case manager
Important: Gene therapy at SR-TIGET requires advance scheduling and coordination. The treatment has a very short shelf-life once manufactured.

Appeals Process in Illinois

If Cigna denies coverage, Illinois provides strong appeal rights:

Internal Appeals

First Level: Submit written appeal within 180 days of denial

  • Include additional clinical evidence
  • Cite peer-reviewed literature supporting gene therapy for ADA-SCID
  • Request peer-to-peer review with Cigna medical director

Timeline: Cigna must respond within 15 business days (24 hours if expedited)

External Review

Illinois residents can request independent external review if internal appeals are denied:

Deadline: 30 days after final internal denial (shorter than most states) Process: Illinois Department of Insurance coordinates with Independent Review Organization (IRO) Timeline: Decision within 5 business days after IRO receives all materials Cost: Free to consumers

Contact: Illinois Department of Insurance at 877-527-9431

Critical: Illinois' 30-day external review deadline is shorter than the federal 4-month standard. Don't delay after receiving a final denial.

Annual Planning and Renewals

What Changes Annually

  • Formulary lists (typically updated January 1st)
  • Prior authorization requirements
  • Out-of-pocket maximums and deductibles
  • Provider networks and international coverage

Renewal Reminders

October-December: Review plan changes for the following year January: Verify continued coverage if treatment spans multiple years Quarterly: Check for formulary updates that might affect coverage

Budget Planning

If approved for Strimvelis:

  • Plan to hit out-of-pocket maximum early in the year
  • Consider timing of treatment relative to plan year
  • Understand how international payments affect domestic out-of-pocket calculations

Scripts for Key Conversations

Calling Cigna Customer Service

"Hi, I need information about coverage for a gene therapy called Strimvelis for ADA-SCID that's only available in Italy. Can you tell me about my international treatment benefits and how to request a formulary exception?"

Requesting Peer-to-Peer Review

"We're requesting a peer-to-peer review for our formulary exception denial. The patient has ADA-SCID confirmed by genetic testing, and gene therapy is the standard of care per current clinical guidelines. We need to speak with a medical director who understands primary immunodeficiencies."

Orchard Assist Initial Call

"I'm a patient/caregiver for someone with ADA-SCID, and we're exploring Strimvelis gene therapy. We have Cigna insurance in Illinois and need help with the prior authorization process and understanding our financial assistance options."

FAQ

How long does Cigna prior authorization take for Strimvelis? Standard review takes 72 hours; expedited review (if health is at risk) takes 24 hours. International treatment coordination may add additional time.

What if Strimvelis isn't on my Cigna formulary? You'll need a formulary exception. Your doctor must demonstrate medical necessity and provide clinical documentation supporting gene therapy over standard treatments.

Can I get expedited appeals in Illinois? Yes, if delay would seriously jeopardize your health. Both internal appeals and external reviews can be expedited, with decisions in 24-72 hours.

Does Cigna cover travel costs to Milan? Most plans don't cover travel expenses, but some may have provisions for treatments not available domestically. Orchard Assist can help explore options.

What happens if I'm denied after external review? External review decisions are binding in Illinois. If denied, you may need to explore other insurance options or payment arrangements with the manufacturer.

From our advocates: We've seen families successfully navigate the Strimvelis approval process by starting early and staying organized. One key is having your immunologist and Orchard Assist work together from day one—they can coordinate the clinical documentation and insurance processes simultaneously, which saves crucial time. Keep detailed records of every conversation and always ask for reference numbers.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals for complex treatments like gene therapies. Our platform analyzes denial letters and creates targeted, evidence-backed rebuttals that align with payer policies and clinical guidelines. Learn more at CounterforceHealth.org.

The approval process for rare disease gene therapies requires persistence and detailed documentation. Working with experienced advocates like Counterforce Health can significantly improve your chances of success by ensuring your appeal addresses the specific criteria payers use for coverage decisions.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. Illinois insurance laws and Cigna policies may change; verify current requirements with official sources.

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