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

How to Get Strimvelis Gene Therapy Covered by UnitedHealthcare in Washington: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Strimvelis Covered by UnitedHealthcare in Washington

Strimvelis gene therapy for ADA-SCID requires prior authorization from UnitedHealthcare through OptumRx, with extensive documentation of genetic diagnosis (ICD-10 D81.31), failed standard therapies, and specialist support. Since Strimvelis isn't FDA-approved and is only available in Milan, Italy, you'll need international coverage exceptions. Start by confirming your plan includes international benefits, then work with your immunologist to gather genetic testing, enzyme deficiency results, and treatment history. If denied, Washington's external review process through a certified IRO can override UnitedHealthcare's decision within 72 hours for urgent cases.

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 Tracking
  6. Understanding Timelines
  7. Responding to Information Requests
  8. If Your Request is Denied
  9. Renewal and Re-Authorization
  10. Appeals Process in Washington
  11. Common Denial Reasons and Solutions
  12. Frequently Asked Questions
  13. Quick Reference Checklist

What This Guide Covers

This guide helps patients with ADA-SCID (adenosine deaminase severe combined immunodeficiency) and their families navigate UnitedHealthcare's prior authorization process for Strimvelis gene therapy in Washington state. Strimvelis is a one-time autologous gene therapy that costs approximately €594,000 ($650,000) and is only available at San Raffaele Hospital in Milan, Italy.

Who this helps:

  • Patients diagnosed with ADA-SCID who need Strimvelis
  • Parents and caregivers managing the approval process
  • Healthcare providers submitting prior authorization requests
  • Anyone facing a UnitedHealthcare denial for this therapy

Before You Start: Plan Verification

Confirm Your Coverage Type

First, determine your specific UnitedHealthcare plan type, as this affects your approval pathway:

  • Commercial plans: Standard prior authorization through OptumRx
  • Medicare Advantage: Additional CMS guidelines may apply
  • Medicaid (Apple Health): Different approval process through Washington State
  • International travel insurance: May be required for Milan treatment
Tip: Call UnitedHealthcare customer service at the number on your insurance card to confirm international coverage benefits before proceeding.

Check International Benefits

Since Strimvelis is only available in Milan, verify your plan includes:

  • International medical coverage
  • Treatment at non-contracted facilities
  • Medical evacuation/repatriation benefits
  • Pre-authorization for planned international care

According to UnitedHealthcare's international travel policies, coverage varies significantly by plan type.

Gather Required Documentation

Essential Medical Records

Genetic and Laboratory Evidence:

  • Confirmed ADA gene mutation (pathogenic variant)
  • ADA enzyme activity levels (markedly reduced/absent)
  • Lymphocyte counts and immune function studies
  • Complete blood count with differential

Clinical Documentation:

  • Specialist letter from immunologist or geneticist
  • Complete treatment history with dates and outcomes
  • Documentation of failed or contraindicated therapies:
    • Enzyme replacement therapy (ERT) records
    • Hematopoietic stem cell transplant (HSCT) evaluation
    • Reasons why HSCT isn't suitable (e.g., no HLA-matched donor)

Diagnosis Coding:

  • Primary ICD-10: D81.31 (Adenosine deaminase deficiency)
  • Supporting codes as clinically appropriate

Prior Authorization Forms

UnitedHealthcare requires submission through OptumRx for specialty medications. Access forms via:

Submit Your Prior Authorization Request

Step-by-Step Submission Process

  1. Portal Access: Your physician logs into the UnitedHealthcare Provider Portal
  2. Form Completion: Complete the specialty drug prior authorization form
  3. Document Upload: Attach all medical records, genetic testing, and specialist letters
  4. International Coordination: Include San Raffaele Hospital treatment plan and cost estimate
  5. Submission: Submit electronically or via fax (confirm current fax number with UnitedHealthcare)
Note: As of 2024, OptumRx manages prior authorization for UnitedHealthcare plans using automated tools where possible, but gene therapies typically require manual clinical review.

Clean Request Packet Checklist

  • Completed prior authorization form
  • Specialist medical necessity letter
  • Genetic testing results showing ADA mutation
  • Laboratory results confirming enzyme deficiency
  • Documentation of failed/inappropriate standard therapies
  • San Raffaele Hospital treatment plan and quote
  • Patient insurance card copy
  • Physician DEA and NPI numbers

Follow-Up and Tracking

  • Day 3-5: Confirm receipt of submission
  • Day 10-14: Check processing status
  • Day 20-25: Follow up if no decision received

Sample Call Script: "Hi, I'm calling to check the status of a prior authorization request for Strimvelis gene therapy. The patient name is [name], member ID [number], and the reference number is [if available]. This is for treatment of ADA-SCID, and we submitted on [date]."

Document all interactions with reference numbers, representative names, and next steps.

Understanding Timelines

Standard Processing Times

According to UnitedHealthcare policies and Washington state requirements:

  • Standard review: 15 business days from complete submission
  • Expedited review: 72 hours for urgent medical situations
  • Additional information requests: 14 days to respond (timeline pauses)
Important: For life-threatening conditions like ADA-SCID, request expedited review when submitting.

Responding to Information Requests

If UnitedHealthcare requests additional information, respond promptly with:

Medical Necessity Clarification

  • Detailed explanation of why Strimvelis is medically necessary
  • Literature supporting gene therapy for ADA-SCID
  • Comparison to available alternatives and why they're inadequate

International Treatment Justification

  • Documentation that Strimvelis is only available at San Raffaele
  • Treatment protocol and expected outcomes
  • Coordination plan for Milan-based care

If Your Request is Denied

Understanding Denial Letters

Common denial reasons include:

  • "Experimental/investigational" (not FDA-approved in US)
  • "Out-of-network" (San Raffaele not contracted)
  • "Insufficient documentation" of medical necessity
  • "Alternative treatments available" (HSCT or ERT)

First-Level Appeal Options

  1. Internal Appeal: Submit additional evidence addressing denial reasons
  2. Peer-to-Peer Review: Request discussion between your specialist and UnitedHealthcare medical director
  3. Expedited Appeal: For urgent situations requiring fast decision

Appeals Process in Washington

Washington state provides strong consumer protections for insurance appeals, including access to external review through certified Independent Review Organizations (IROs).

Internal Appeals Process

Timeline: 180 days from denial to file internal appeal Process: Submit written appeal with additional documentation Decision: UnitedHealthcare must respond within specified timeframes

External Review Through IRO

If internal appeals fail, Washington residents can request external review:

Eligibility: After completing UnitedHealthcare's internal appeal process Timeline: 4 months from final internal denial to request external review Process: Independent medical experts review your case Authority: IRO can override UnitedHealthcare's decision - this is binding

Expedited External Review: For urgent cases, decision within 72 hours

Key Resource: Contact the Washington Office of Insurance Commissioner at 800-562-6900 for appeal assistance and templates.

Filing External Review

  1. Complete internal appeals with UnitedHealthcare first
  2. Request external review form from Washington OIC
  3. Submit within 4-month deadline
  4. Provide all medical records and documentation
  5. IRO assigns independent medical experts
  6. Receive binding decision (typically within 30 days)

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Not FDA-approved Emphasize EU approval, lack of alternatives EMA approval documents, specialist letter
Experimental/Investigational Document established use, medical necessity Peer-reviewed studies, treatment guidelines
Out-of-network Request exception for specialized care Proof only available at San Raffaele
Alternative treatments available Document failure/contraindications HSCT evaluation, ERT trial records
Insufficient medical necessity Provide comprehensive clinical picture Genetic testing, enzyme levels, specialist assessment

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Strimvelis? A: Standard review is 15 business days, but gene therapies often require additional review time. Request expedited processing for urgent cases (72 hours).

Q: What if Strimvelis isn't on UnitedHealthcare's formulary? A: Since it's not FDA-approved, it requires formulary exception. Your specialist must demonstrate medical necessity and lack of suitable alternatives.

Q: Can I get expedited appeals in Washington? A: Yes, both UnitedHealthcare internal appeals and Washington's external IRO review offer expedited timelines for urgent medical situations.

Q: Does step therapy apply to Strimvelis? A: Yes, you must typically document failure or contraindications to standard therapies like enzyme replacement therapy and HSCT evaluation.

Q: What if my employer plan is self-funded? A: Self-funded ERISA plans may not be subject to Washington state laws, but many voluntarily follow similar appeal processes. Contact the U.S. Department of Labor if needed.

Q: How much will I pay out-of-pocket? A: Costs depend on your specific plan benefits, international coverage, and whether you receive prior authorization. Contact UnitedHealthcare to understand your potential costs.

Q: Can the Washington Insurance Commissioner help with appeals? A: Yes, the OIC Consumer Advocacy Program at 800-562-6900 provides free assistance with appeals, templates, and guidance for complex cases like gene therapy denials.

Quick Reference Checklist

Before Starting

  • Verify UnitedHealthcare plan includes international benefits
  • Confirm ADA-SCID diagnosis with genetic testing
  • Document failed/contraindicated standard therapies
  • Obtain specialist support letter

Submission Requirements

  • Complete OptumRx prior authorization form
  • Genetic testing showing ADA mutation
  • ADA enzyme deficiency laboratory results
  • Treatment history with outcomes
  • San Raffaele Hospital treatment plan
  • Medical necessity letter from specialist

If Denied

  • Review denial letter for specific reasons
  • Gather additional supporting evidence
  • File internal appeal within timeline
  • Consider peer-to-peer review request
  • Prepare for external IRO review if needed

Washington Resources

  • Washington OIC Consumer Advocacy: 800-562-6900
  • External review request forms
  • IRO process information and templates

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like gene treatments. Their platform analyzes denial letters, identifies specific coverage criteria, and helps generate evidence-backed appeals that address each payer's unique requirements. For patients facing UnitedHealthcare denials for specialized treatments like Strimvelis, having expert support in crafting targeted appeals can significantly improve approval chances.

Disclaimer: This guide provides general information about insurance processes and should not replace professional medical or legal advice. Insurance policies and procedures change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare providers for medical decisions. For personalized assistance with appeals in Washington, contact the Office of Insurance Commissioner Consumer Advocacy Program at 800-562-6900.

Sources and Further Reading

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