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

How to Get Strimvelis Gene Therapy Covered by Cigna in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Strimvelis Covered by Cigna in New York

Strimvelis requires prior authorization from Cigna as a non-formulary, investigational gene therapy available only at SR-TIGET in Milan, Italy. The fastest path to approval involves: (1) confirming your plan covers international/out-of-network care, (2) submitting Cigna's Commercial Drug Prior Authorization Form with genetic ADA-SCID confirmation and failed HSCT documentation, and (3) preparing for appeals using New York's external review system through the Department of Financial Services. Start by calling Cigna member services today to verify coverage and request current forms.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Management
  6. If You're Asked for More Information
  7. If Your Request is Denied
  8. New York External Appeal Process
  9. Renewal and Re-authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This guide helps patients with ADA-SCID (Adenosine Deaminase Severe Combined Immunodeficiency) and their families navigate Cigna's prior authorization process for Strimvelis gene therapy in New York. Strimvelis is a one-time, autologous CD34+ gene therapy manufactured by Orchard Therapeutics, available exclusively at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) in Milan, Italy.

Who this helps:

  • Patients diagnosed with ADA-SCID requiring gene therapy
  • Families navigating insurance coverage for international treatment
  • Clinicians submitting prior authorization requests
  • Advocates supporting patients through the appeals process

Expected outcomes: While approval isn't guaranteed, proper documentation and understanding of Cigna's requirements significantly improve your chances. In New York, patients benefit from robust external appeal rights that have overturned many experimental treatment denials.

Before You Start: Plan Verification

Confirm Your Cigna Plan Type

Call the member services number on your insurance card to verify:

  • International coverage: Does your plan cover treatment outside the U.S.?
  • Out-of-network benefits: What percentage is covered for non-network providers?
  • Annual/lifetime maximums: Strimvelis costs approximately €594,000 ($650,000+)
  • Prior authorization requirements: Confirm gene therapy PA protocols

Check Formulary Status

Strimvelis is not on Cigna's standard formulary and requires a formulary exception request alongside your prior authorization. This is expected for investigational therapies.

Identify Your Pharmacy Benefit

Gene therapies typically fall under the medical benefit rather than pharmacy benefit, but verify with Cigna whether Strimvelis would be processed through Express Scripts/Accredo specialty pharmacy or as a medical claim.

Gather Required Documentation

Essential Clinical Documentation

Genetic Confirmation (Required)

  • ADA gene sequencing results showing pathogenic variants
  • Enzyme activity testing (ADA deficiency <1% of normal)
  • ICD-10 code: D81.3 (Adenosine deaminase deficiency)

Prior Treatment History

  • Documentation of failed or contraindicated hematopoietic stem cell transplantation (HSCT)
  • Records of enzyme replacement therapy (PEG-ADA) if tried
  • Immunological assessments showing SCID pattern (T-, B-, NK-)

Clinical Progression

  • Recent infection history and hospitalizations
  • Current immune status and laboratory values
  • Specialist consultation notes from immunologist/hematologist

Insurance Forms and Letters

Cigna Forms (verify current versions with member services)

  • Commercial Drug Prior Authorization Form
  • Formulary Exception Request Form
  • International Treatment Pre-Authorization Form (if available)

Provider Documentation

  • Medical necessity letter from treating specialist
  • Treatment plan detailing SR-TIGET coordination
  • Prescriber attestation for investigational therapy

Submit Your Prior Authorization Request

Step-by-Step Submission Process

Step 1: Complete Cigna's Prior Authorization Forms

  • Use Cigna's provider portal for fastest processing
  • Include all required clinical documentation in initial submission
  • Mark as "urgent" if patient's condition is deteriorating

Step 2: Submit Medical Necessity Letter Your physician should include:

  • Confirmed ADA-SCID diagnosis with genetic testing results
  • Failed standard therapies (HSCT contraindicated/unsuccessful)
  • Clinical rationale for Strimvelis over alternatives
  • Timeline sensitivity and urgency of treatment
  • Reference to EMA approval and published efficacy data

Step 3: Request Formulary Exception Since Strimvelis is non-formulary, submit concurrent formulary exception request explaining:

  • No suitable formulary alternatives exist
  • Medical necessity for this specific gene therapy
  • Patient-specific contraindications to covered treatments

Clean Request Packet Checklist

  • Completed prior authorization forms
  • Genetic testing confirmation (ADA gene variants)
  • Enzyme deficiency lab results
  • HSCT failure/contraindication documentation
  • Medical necessity letter from specialist
  • Formulary exception request
  • International treatment coordination plan
  • Patient insurance card copy
  • Signed consent forms

Follow-Up and Timeline Management

Standard Review Timelines

Cigna Processing Times:

  • Standard review: 5-14 business days
  • Expedited review: 24-72 hours (urgent cases)
  • International cases may require additional review time

New York Requirements: Commercial plans must respond within 3 calendar days for standard requests and 1 calendar day for expedited requests under New York state law.

When and How to Follow Up

Week 1: Call Cigna to confirm receipt and completeness of submission Week 2: If no response, call to request status update and reference number Week 3: If still pending, escalate to supervisor and document all communications

Sample Call Script: "I'm calling about prior authorization request [reference number] for Strimvelis gene therapy for ADA-SCID. This is an urgent case for a rare genetic condition with limited treatment options. Can you provide a status update and expected decision timeline?"

If You're Asked for More Information

Cigna may request additional documentation to support medical necessity. Common requests include:

Additional Clinical Evidence

  • More detailed genetic counseling reports
  • Second opinion from another immunologist
  • Updated laboratory values showing disease progression
  • Literature supporting Strimvelis efficacy in ADA-SCID

Treatment Logistics

  • Detailed coordination plan with SR-TIGET
  • Travel and accommodation arrangements
  • Post-treatment monitoring protocol
  • Emergency care contingency plans
Tip: Respond to information requests within 48 hours when possible. Delays in providing additional documentation can significantly extend review timelines.

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason How to Address
"Investigational/Experimental" Cite EMA approval, published outcomes data, lack of alternatives
"Not Medically Necessary" Provide updated labs showing deterioration, specialist attestation
"Out-of-Network" Request single-case agreement, emphasize no U.S. alternative
"Benefit Exclusion" Challenge exclusion interpretation, cite rare disease exception

Internal Appeal Process

Timeline: File within 180 days of denial notice Required Documentation:

  • Copy of original denial letter
  • Additional clinical evidence supporting medical necessity
  • Peer-reviewed literature on Strimvelis outcomes
  • Letter from treating physician addressing specific denial reasons

Peer-to-Peer Review Request a peer-to-peer discussion between your specialist and Cigna's medical director. This often resolves denials when clinical expertise can directly address concerns.

New York External Appeal Process

If Cigna upholds the denial on internal appeal, New York residents have strong external review rights through the Department of Financial Services (DFS).

Filing an External Appeal

Eligibility: Available after completing internal appeal process or if Cigna waives internal appeal requirement Timeline: Must file within 4 months of final adverse determination Cost: $25 filing fee (waived for financial hardship or Medicaid enrollees)

Required Documentation:

  • Completed external appeal application
  • Copy of all denial letters and internal appeal decisions
  • Medical records supporting the request
  • Physician attestation for experimental/investigational treatments

Expedited External Appeals

For urgent cases where delayed treatment could seriously jeopardize health:

  • Decision timeline: 72 hours (24 hours for some drug denials)
  • Eligibility: Patient hospitalized or serious health risk from delay
  • Process: Mark application as "expedited" with clinical justification

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps identify the specific denial basis and drafts point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and clinical facts needed for successful appeals.

New York DFS Resources

  • External Appeal Portal: Available on the DFS website for online submission
  • Searchable Database: Review prior external appeal decisions for similar gene therapy cases
  • Consumer Assistance: Community Health Advocates helpline at 888-614-5400

Renewal and Re-authorization

Strimvelis is a one-time treatment, so renewal is typically not required. However, you may need re-authorization for:

  • Pre-treatment procedures at SR-TIGET (conditioning, cell collection)
  • Post-treatment monitoring and follow-up care
  • Complications management if adverse events occur

Calendar reminder: Set alerts for any follow-up authorization deadlines, typically 30-60 days before coverage periods expire.

Quick Reference Checklist

Before Calling Cigna

  • Insurance card and policy information ready
  • ADA-SCID diagnosis confirmation (genetic testing)
  • List of prior treatments tried/failed
  • Specialist contact information

For Prior Authorization Submission

  • Completed PA forms (verify current versions)
  • Medical necessity letter from specialist
  • Genetic testing results (ADA gene variants)
  • HSCT failure/contraindication documentation
  • Formulary exception request
  • International treatment coordination plan

If Denied

  • File internal appeal within 180 days
  • Request peer-to-peer review
  • Gather additional clinical evidence
  • Consider external appeal through NY DFS

FAQ

Q: How long does Cigna prior authorization take for Strimvelis in New York? A: Standard review is 5-14 business days, but New York law requires commercial plans to respond within 3 calendar days. International cases may take longer due to additional review requirements.

Q: What if Strimvelis is considered experimental by Cigna? A: This is common for gene therapies. Address by citing EMA approval, published efficacy data, and lack of alternative treatments. New York's external appeal system frequently overturns experimental treatment denials.

Q: Does Cigna cover international treatment at SR-TIGET in Milan? A: Coverage depends on your specific plan's international benefits. Many Cigna plans cover out-of-network international care, but verify coverage levels and pre-authorization requirements.

Q: Can I request an expedited review for Strimvelis? A: Yes, if the patient's condition is deteriorating or urgent treatment is needed. Mark requests as "urgent" and provide clinical justification for expedited processing.

Q: What happens if I miss the appeal deadline? A: New York allows 180 days for internal appeals and 4 months for external appeals. Missing deadlines can forfeit appeal rights, so calendar all important dates immediately.

Q: How much does Strimvelis cost without insurance? A: The list price is approximately €594,000 ($650,000+) for the one-time treatment, plus travel and accommodation costs for treatment in Milan.

From Our Advocates

"We've seen several ADA-SCID cases where the key to approval was demonstrating that standard HSCT was either attempted and failed or was contraindicated due to lack of suitable donors. The genetic confirmation is just the starting point—insurers want to see that conventional treatments were exhausted first. Having the treating immunologist write a detailed letter explaining why gene therapy is the only viable option often makes the difference between approval and denial."

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules, pulling the right citations for medications and weaving them into appeals with required clinical facts.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for plan-specific guidance. For additional help with insurance appeals in New York, contact Community Health Advocates or the New York Department of Financial Services consumer assistance programs.

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