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

Getting Strimvelis Gene Therapy Covered by Humana in Washington: Complete Coverage Guide with Appeals Process

Answer Box: Quick Coverage Summary

Is Strimvelis covered by Humana in Washington? Strimvelis requires prior authorization and faces significant coverage challenges since it's only available in Milan, Italy, and not FDA-approved in the U.S. Humana Medicare Advantage typically doesn't cover international treatments except for emergencies.

Fastest path to potential coverage:

  1. Gather complete ADA-SCID diagnostic documentation (genetic testing, enzyme levels)
  2. Submit prior authorization with medical necessity justification
  3. If denied, file internal appeal within 60 days, then external review through Washington's IRO process

Start today: Contact your specialist to begin documenting step therapy failures and medical necessity for the prior authorization request.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals in Washington
  7. Specialty Pharmacy Coordination
  8. Troubleshooting Common Issues
  9. FAQ
  10. Sources and Further Reading

Coverage Basics

Is Strimvelis Covered by Humana?

Strimvelis faces unique coverage challenges with Humana because it's not FDA-approved in the United States and is only available at one facility in Milan, Italy. Humana Medicare Advantage plans do not cover planned international treatments, except for medical emergencies abroad.

However, you can still pursue coverage through:

  • Medical necessity exception requests
  • Appeals process emphasizing lack of U.S. alternatives
  • Documentation of life-threatening condition requiring urgent intervention

Which Humana Plans Apply?

This guidance applies to:

  • Humana Medicare Advantage plans
  • Humana Medicare Part D plans (for related medications)
  • Commercial Humana plans (with similar restrictions)
Note: Self-funded employer plans may have different rules and should contact the U.S. Department of Labor for ERISA appeals guidance.

Prior Authorization Process

Step-by-Step: Submitting Your Prior Authorization

Step 1: Diagnostic Documentation (Patient/Clinic)

  • Complete ADA enzyme testing showing <1% normal activity
  • Genetic testing confirming biallelic pathogenic ADA variants
  • Clinical presentation documentation by pediatric immunologist
  • Submit via Humana provider portal

Step 2: Step Therapy Documentation (Clinic)

  • Document PEG-ADA enzyme replacement therapy trials and outcomes
  • Explain HSCT ineligibility (no matched donor, contraindications)
  • Include supportive care attempts and limitations
  • Timeline: Allow 5-7 business days for compilation

Step 3: Medical Necessity Letter (Prescriber)

  • Justify why gene therapy is required over available alternatives
  • Cite relevant medical literature and guidelines
  • Include treatment goals and expected outcomes
  • Submit with prior authorization packet

Step 4: International Treatment Justification (Clinic/Patient)

  • Document lack of FDA-approved alternatives in the U.S.
  • Explain urgency and life-threatening nature of condition
  • Include facility credentials and treatment protocol from Milan
  • Request exception to international treatment exclusion

Timing and Urgency

Standard Prior Authorization Timeline

  • Initial review: 30 days for Medicare Advantage pre-service decisions
  • Expedited review: 72 hours if delay would jeopardize health
  • Appeals deadline: 60 days from denial notice for Medicare plans

When to Request Expedited Review

Request expedited processing if:

  • Patient's immune system is severely compromised
  • Recurrent serious infections are occurring
  • Standard timeline would seriously jeopardize health or ability to regain function

Contact Humana at the member services number on your insurance card to request expedited review.

Medical Necessity Criteria

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
ADA-SCID Diagnosis Confirmed enzyme deficiency and genetic variants Lab results showing <1% ADA activity, genetic testing Humana medical policy
Step Therapy Prior treatment failures documented PEG-ADA trial records, HSCT evaluation Prior authorization requirements
Specialist Evaluation Assessment by qualified immunologist Consultation notes, treatment recommendations Clinical documentation
Medical Necessity Life-threatening condition requiring intervention Comprehensive clinical justification letter Medical necessity standards

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's letter should include:

Clinical Problem:

  • Severity of ADA-SCID presentation
  • Current immune status and infection history
  • Prognosis without intervention

Prior Treatments:

  • PEG-ADA enzyme replacement therapy: doses, duration, response, limitations
  • HSCT evaluation: donor search results, contraindications, timing issues
  • Supportive care measures and outcomes

Clinical Rationale:

  • Why gene therapy is medically necessary
  • Expected outcomes and monitoring plan
  • Risk-benefit analysis compared to alternatives

Guideline Citations:

Costs and Financial Assistance

Understanding Your Costs

Strimvelis carries a list price of approximately €594,000 ($665,000), making it one of the most expensive single-dose treatments available.

If covered by Humana:

  • Medicare Advantage plans: Standard coinsurance applies (typically 20%)
  • Commercial plans: Varies by specific benefit design
  • Out-of-pocket maximums may apply

Financial Assistance Options

  • Manufacturer support: Contact Orchard Therapeutics for patient assistance programs
  • Foundation grants: Explore rare disease foundations and patient advocacy organizations
  • State programs: Washington may have additional resources for rare disease treatments

Denials and Appeals in Washington

Common Denial Reasons and Solutions

Denial Reason How to Address Required Documentation
"Not FDA-approved" Emphasize lack of U.S. alternatives, medical necessity Comprehensive literature review, specialist letters
"International treatment exclusion" Request medical necessity exception Life-threatening urgency documentation
"Experimental/investigational" Cite European approval, established efficacy EMA approval documents, published outcomes
"Step therapy not met" Document all prior treatment failures Complete treatment history with outcomes

Washington State Appeals Process

Internal Appeals (First Step):

  • File within 60 days of denial notice
  • Submit additional medical documentation
  • Request peer-to-peer review with medical director
  • Timeline: 30 days for standard, 72 hours for expedited

External Review (Independent Review Organization):

From our advocates: "We've seen success with ADA-SCID appeals when families document the truly life-threatening nature of the condition and the lack of viable alternatives. The key is comprehensive clinical documentation showing why standard treatments have failed or aren't appropriate, combined with urgency that makes international travel medically necessary."

Contact Information for Appeals

  • Humana Member Services: Number on your insurance card
  • Washington Office of Insurance Commissioner: 1-800-562-6900
  • External Review requests: Can be filed through OIC or directly with Humana

Specialty Pharmacy Coordination

Working with CenterWell Specialty Pharmacy

Since Strimvelis is only available in Milan, traditional specialty pharmacy coordination doesn't apply. However, for related medications and supportive care:

  • CenterWell Specialty Pharmacy handles Humana's specialty drug coordination
  • Prior authorizations for supportive medications go through standard Humana processes
  • International treatment logistics require separate coordination with the Milan facility

Troubleshooting Common Issues

Portal and System Issues

If Humana's provider portal is down:

  • Use backup fax submission methods
  • Call provider services for alternative submission options
  • Document submission attempts for appeals purposes

Missing required forms:

  • Access current forms through Humana provider resources
  • Verify form versions are current before submission
  • Keep copies of all submitted documentation

Communication Challenges

Language barriers with Milan facility:

  • Request English-speaking coordinators
  • Use professional medical translation services
  • Document all communications for insurance purposes

At Counterforce Health, we help patients navigate complex prior authorization and appeals processes for specialized treatments like gene therapies. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that address payer-specific requirements and medical necessity criteria.

FAQ

Q: How long does Humana prior authorization take for gene therapy in Washington? A: Standard review takes 30 days for Medicare Advantage plans. Expedited review is available within 72 hours if delays would jeopardize your health.

Q: What if Strimvelis is considered non-formulary? A: You can request a formulary exception based on medical necessity. This requires comprehensive documentation of why no formulary alternatives are appropriate.

Q: Can I request an expedited appeal in Washington? A: Yes, both internal appeals and external IRO reviews can be expedited if standard timelines would seriously jeopardize your health or ability to regain function.

Q: Does step therapy apply if previous treatments were tried outside Washington? A: Yes, documented treatment failures from any location count toward step therapy requirements, provided you have complete medical records.

Q: What happens if my appeal is denied? A: After exhausting Humana's internal appeals, you can file for external review through Washington's Independent Review Organization process, which provides binding decisions.

Q: Are there alternatives to traveling to Milan for treatment? A: Currently, no FDA-approved gene therapy for ADA-SCID is available in the U.S. Hematopoietic stem cell transplantation (HSCT) remains the standard alternative when a matched donor is available.

Q: How does Washington's external review process work for rare disease treatments? A: Washington's IRO reviewers can override plan standards they find unreasonable or inconsistent with evidence-based medicine, which is particularly valuable for rare disease cases where standard coverage criteria may not apply.

Q: What documentation do I need for the medical necessity exception? A: Complete diagnostic workup, documented treatment failures, specialist evaluation, literature supporting the treatment, and detailed explanation of why the international treatment is medically necessary and urgent.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare providers and insurance representatives for personalized guidance. For additional help with insurance appeals in Washington, contact the Washington State Office of the Insurance Commissioner at 1-800-562-6900.

Sources and Further Reading

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