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

How to Get Strimvelis Gene Therapy Covered by Cigna in California: Complete Forms, Appeals & Travel Guide

Answer Box: Getting Strimvelis Covered by Cigna in California

Strimvelis (autologous CD34+ ADA-SCID gene therapy) requires prior authorization from Cigna and is only available at SR-TIGET in Milan, Italy. For California members, the fastest path involves: (1) Submit Cigna's California General Medication Prior Authorization Form with genetic testing confirmation and ADA enzyme deficiency documentation, (2) Request international/out-of-network coverage review for SR-TIGET treatment, and (3) If denied, file internal appeal within 180 days, then escalate to California DMHC Independent Medical Review. Start today: Contact Cigna Specialty Pharmacy Services at 1-800-351-3606 to verify your plan's international coverage and begin the prior authorization process.

Table of Contents

  1. Verify Your Plan & Coverage
  2. Required Forms & Documentation
  3. Submission Portals & Methods
  4. Specialty Pharmacy Enrollment
  5. Support Lines & Case Management
  6. Appeals Process in California
  7. International Coverage for SR-TIGET Milan
  8. Common Denial Reasons & Solutions
  9. Costs & Financial Assistance
  10. FAQ

1. Verify Your Plan & Coverage

Before starting the approval process, confirm your Cigna plan includes:

  • Specialty drug coverage through Express Scripts/Accredo
  • International medical benefits (required for SR-TIGET treatment)
  • Out-of-network coverage with reasonable cost-sharing
  • Gene therapy coverage (not excluded as experimental)
Tip: Call Cigna member services at 1-800-244-6224 with your member ID to verify these benefits and get your specific coverage details in writing.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all gene therapies Cigna PA Forms
International Coverage Needed for SR-TIGET Milan Check plan documents or call member services
Specialty Pharmacy Must use Accredo for coordination Cigna Specialty Pharmacy Guide
Medical Necessity ADA-SCID diagnosis with enzyme deficiency Clinical documentation required

2. Required Forms & Documentation

Primary Form

Use Cigna's California General Medication Prior Authorization Form for Strimvelis requests.

Essential Documentation Checklist

  • Genetic testing results confirming ADA-SCID diagnosis
  • ADA enzyme activity levels (typically <1% of normal)
  • ICD-10 diagnosis code: D81.3 (Adenosine deaminase deficiency)
  • Previous treatment history (if any HSCT attempts/failures)
  • Clinical notes explaining why HSCT isn't viable
  • SR-TIGET referral letter from treating immunologist
  • Insurance verification for international coverage
Clinician Corner: Your medical necessity letter should emphasize: (1) Confirmed ADA-SCID with severe enzyme deficiency, (2) Lack of suitable HSCT donor or previous HSCT failure, (3) Life-threatening nature without intervention, (4) Strimvelis as the only viable therapeutic option, and (5) SR-TIGET as the sole approved treatment center.

3. Submission Portals & Methods

Electronic Submission (Preferred)

  • CoverMyMeds or SureScripts through your provider's EHR system
  • Faster processing (typically 3-5 business days vs. 7-10 for fax)

Alternative Methods

  • Fax: Use the number on the California PA form (verify current number)
  • Phone: 1-800-882-4462 for urgent cases
  • Mail: Address provided on the PA form
Note: For international gene therapy requests, consider calling first to ensure you're using the correct submission pathway and forms.

4. Specialty Pharmacy Enrollment

Strimvelis coordination requires enrollment with Accredo Specialty Pharmacy:

Enrollment Steps

  1. Provider submits prescription and PA forms to Accredo
  2. Call Accredo at 877-826-7657 to initiate enrollment
  3. Verify insurance and international coverage benefits
  4. Complete patient intake including travel coordination needs
  5. Access patient portal at Accredo.com with your Rx number

What Accredo Provides

  • Insurance authorization assistance
  • Travel coordination for Milan treatment
  • Patient education and support
  • Coordination with SR-TIGET clinical team
  • Post-treatment monitoring support

5. Support Lines & Case Management

Key Contact Numbers

Service Phone Number Hours Purpose
Cigna Member Services 1-800-244-6224 24/7 General coverage questions
Specialty Pharmacy Services 1-800-351-3606 Business hours PA status, specialty drug coordination
Accredo Patient Support 877-826-7657 Mon-Fri 7am-10pm CST Gene therapy coordination
Accredo Physician Services 844-516-3319 Business hours Provider support for rare diseases

What to Ask When You Call

  • "What are my international coverage benefits for gene therapy?"
  • "Is SR-TIGET Milan considered in-network or out-of-network?"
  • "What's my maximum out-of-pocket for international treatment?"
  • "Can you expedite my prior authorization due to the urgent nature?"

6. Appeals Process in California

Step-by-Step Appeals Timeline

Internal Appeal (Required First Step)

  1. File within 180 days of denial notice
  2. Submit written appeal with supporting documentation
  3. Cigna reviews within 30 days (72 hours if expedited)
  4. Receive decision in writing

California DMHC Independent Medical Review (IMR)

If Cigna upholds the denial:

  1. File IMR application within 6 months of final denial
  2. Submit to DMHC at healthhelp.ca.gov or call 888-466-2219
  3. Independent review by specialty experts (45 days standard, 72 hours expedited)
  4. Binding decision that Cigna must follow

Required Appeal Documents

  • Original denial letters from Cigna
  • Complete medical records and genetic testing
  • Provider's clinical justification letter
  • Evidence of medical necessity
  • Any relevant published studies or guidelines
California Advantage: IMR success rates for specialty medications with strong clinical justification range from 20-40%, significantly higher when no alternative treatments exist.

7. International Coverage for SR-TIGET Milan

Coverage Verification Steps

  1. Confirm international benefits in your Cigna plan
  2. Request pre-authorization for out-of-network treatment
  3. Verify coverage limits (Silver: $1M, Gold: $2M, Platinum: unlimited)
  4. Check travel benefit modules if available

SR-TIGET Coordination

  • Direct billing may be possible with pre-authorization
  • Travel expenses may be covered under medical evacuation modules
  • Accommodation costs for extended stay typically not covered
  • Follow-up care coordination between SR-TIGET and U.S. providers

Cost Considerations

  • Out-of-network deductibles and coinsurance apply
  • Currency exchange rates affect final costs
  • Upfront payment may be required with later reimbursement

8. Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not available in U.S." Emphasize SR-TIGET as only approved center; include FDA orphan drug designation
"Experimental/investigational" Cite EMA approval, published efficacy data, lack of alternatives
"Out-of-network exclusion" Request exception based on medical necessity and lack of in-network options
"Travel not covered" Frame as medically necessary treatment, not elective travel
"Insufficient documentation" Provide comprehensive genetic testing, enzyme levels, prior treatment history

9. Costs & Financial Assistance

Expected Costs

  • Treatment cost: €594,000 (~$650,000 USD) per patient
  • Travel expenses: $5,000-15,000 for extended stay
  • Out-of-pocket maximum varies by plan (verify your specific limits)

Financial Assistance Options

  • Orchard Therapeutics patient assistance programs
  • National Organization for Rare Disorders (NORD) grants
  • HealthWell Foundation copay assistance
  • State of California rare disease support programs
From Our Advocates: "Families dealing with ADA-SCID often find success by working with multiple support organizations simultaneously. Start financial assistance applications early—some programs have waiting lists or specific enrollment periods. The combination of manufacturer support and foundation grants can significantly reduce out-of-pocket costs."

10. FAQ

Q: How long does Cigna prior authorization take for Strimvelis? A: Standard review is 5-10 business days, but complex international gene therapy cases may take 14-30 days. Request expedited review if medically urgent.

Q: What if my plan excludes international coverage? A: You can still request a medical necessity exception. Emphasize that SR-TIGET is the only approved treatment center globally.

Q: Can I appeal if Cigna approves treatment but denies travel costs? A: Yes. Travel for this treatment can be considered medically necessary since no alternative locations exist.

Q: What happens if the IMR is denied? A: You may have additional options through federal external review or legal consultation, especially for life-saving treatments.

Q: How do I coordinate care between SR-TIGET and my U.S. doctors? A: Accredo specialty pharmacy helps coordinate this communication, and SR-TIGET has established protocols for international patients.

Q: Are there age limits for Strimvelis coverage? A: No specific age limits, but treatment is most effective in younger patients. Clinical criteria focus on ADA-SCID severity and treatment history.

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like Strimvelis. Our platform analyzes denial letters, identifies the specific coverage barriers, and drafts evidence-backed appeals that align with each payer's policies. For families navigating rare disease coverage challenges, we provide the clinical documentation and procedural expertise that transforms rejections into approvals.

When dealing with ultra-rare therapies requiring international treatment, having expert support can make the difference between coverage approval and financial hardship. Counterforce Health helps patients and providers navigate these complex approval processes with specialized knowledge of payer requirements and appeals strategies.

Sources & Further Reading

This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. For personalized guidance, consult with your healthcare provider and insurance representative. California residents have specific appeal rights through the Department of Managed Health Care that may not apply in other states.

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