By Counterforce Health Team in Xenpozyme (olipudase alfa-rpcp) —

Get Xenpozyme (Olipudase Alfa) Covered by Humana in Washington: Complete Decision Tree & Appeal Guide

Answer Box: Your Fastest Path to Approval

If you have confirmed ASMD (Niemann-Pick Type B or A/B) and meet Humana's criteria, expect 1-30 days for prior authorization approval. Your first step today: Have your doctor submit a prior authorization request through Humana's provider portal with genetic testing results, enzyme activity levels <10% normal, and baseline organ assessments. If denied, Washington residents can appeal through internal review (65 days) then external IRO review (60 days from final denial) with decisions typically within 20 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If Likely Eligible: Your Approval Checklist
  4. If Possibly Eligible: Tests and Timeline
  5. If Not Yet Eligible: Alternative Options
  6. If Denied: Washington Appeals Process
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Solutions
  9. Frequently Asked Questions

How to Use This Decision Tree

This guide helps patients with acid sphingomyelinase deficiency (ASMD) and their healthcare teams navigate Humana's prior authorization process in Washington State. Start with the eligibility triage below to determine your likely approval path, then follow the specific section for your situation.

Important: Xenpozyme is the only FDA-approved enzyme replacement therapy for non-CNS manifestations of ASMD (Niemann-Pick Types B and A/B). It does not treat neurological symptoms of Type A disease.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible

You probably qualify if you have all of these:

  • Confirmed ASMD diagnosis with genetic testing showing biallelic SMPD1 pathogenic variants OR enzyme activity <10% of normal
  • Normal glucocerebrosidase activity (excludes Gaucher disease)
  • Non-CNS manifestations (enlarged spleen/liver, lung disease, low platelets)
  • Age: Adult or pediatric patient
  • Recent liver function tests (ALT/AST within 1 month)
  • Documented baseline assessments (spleen volume, pulmonary function)

⚠️ Possibly Eligible

You may qualify but need additional documentation if you have:

  • ASMD diagnosis but missing recent enzyme activity or genetic confirmation
  • Clinical symptoms consistent with ASMD but incomplete diagnostic workup
  • Previous denials due to insufficient documentation
  • Questions about CNS involvement vs. non-CNS manifestations

❌ Not Yet Eligible

Current barriers to approval:

  • No confirmed ASMD diagnosis
  • CNS-predominant Type A disease (Xenpozyme doesn't cross blood-brain barrier)
  • Concurrent enrollment in investigational ASMD trials
  • Pregnancy (contraindicated during dose escalation)

If Likely Eligible: Your Approval Checklist

Step 1: Gather Required Documentation

Clinical Records Needed:

  • Genetic test results showing biallelic SMPD1 mutations
  • Enzyme activity assay (ASM <10% normal, preferably MS/MS-based)
  • Normal glucocerebrosidase levels
  • ALT/AST within 30 days
  • Baseline spleen/liver imaging or measurements
  • Pulmonary function tests (DLco if available)
  • Complete blood count with platelets

Insurance Information:

  • Humana member ID and policy details
  • Prescribing physician NPI and contact information
  • Preferred infusion site (hospital outpatient or certified infusion center)

Step 2: Prior Authorization Submission

Your healthcare provider should submit through Humana's electronic prior authorization system including:

  1. Medical necessity letter documenting ASMD diagnosis and clinical rationale
  2. Dosing plan starting with 0.1 mg/kg (adults) or 0.03 mg/kg (pediatrics) with escalation schedule
  3. Monitoring plan for liver enzymes and infusion reactions
  4. Site of care specification for dose escalation phase
Tip: Humana commits to electronic decisions within one business day for most specialty drug requests starting in 2026, with current processing already expedited.

Step 3: Expected Timeline

  • Standard review: Up to 30 days for Medicare Advantage pre-service decisions
  • Expedited review: 72 hours if urgent medical need documented
  • Approval notification: Via provider portal and member communication

If Possibly Eligible: Tests and Timeline

Additional Testing to Request

If missing genetic confirmation:

  • Order SMPD1 gene sequencing through a certified laboratory
  • Ensure testing covers full gene (not just common variants)
  • Document any family history of ASMD or consanguinity

If enzyme activity unclear:

  • Request acid sphingomyelinase activity via tandem mass spectrometry
  • Avoid fluorometric assays (high false-negative rates)
  • Include glucocerebrosidase activity to rule out Gaucher disease

Timeline to Reapply:

  • Genetic testing results: 2-4 weeks
  • Enzyme activity assays: 1-2 weeks
  • Allow 4-6 weeks total before resubmitting PA request

If Not Yet Eligible: Alternative Options

For Unconfirmed Diagnosis

  1. Specialist referral: Consult a metabolic geneticist or lysosomal storage disease specialist
  2. Diagnostic testing: Complete ASMD diagnostic workup as outlined above
  3. Clinical trial consideration: Explore ongoing research studies through ClinicalTrials.gov

For CNS-Predominant Disease

Currently no approved treatments exist for neurological manifestations of ASMD Type A. Consider:

When dealing with complex insurance coverage challenges, Counterforce Health helps patients and clinicians turn denials into successful appeals by creating evidence-backed, payer-specific letters that address the exact reasons for denial while meeting procedural requirements.

If Denied: Washington Appeals Process

Internal Appeals (First Level)

Timeline: 65 days from denial notice to submit How to submit:

  • Online: Humana member portal
  • Phone: Member services number on insurance card
  • Mail: Address provided in denial letter

Required documents:

  • Original denial letter
  • Additional clinical evidence
  • Updated medical necessity letter
  • Any new test results

Peer-to-Peer Review

Request a clinical peer review where your prescribing physician speaks directly with Humana's medical director. This often resolves denials faster than formal appeals.

Script for requesting P2P:

"I'm calling to request a peer-to-peer review for my patient's Xenpozyme prior authorization denial. The patient has confirmed ASMD with [specific test results]. When can our physician schedule this review?"

External Review (IRO Process)

If internal appeals fail, Washington residents can request Independent Review Organization (IRO) external review:

Timeline: 60 days from final internal denial to request Process: Submit request to Washington State Office of the Insurance Commissioner Decision deadline: 20 days for standard review, 72 hours for expedited Cost: Free to patient Binding: Yes, on Humana if overturned

Washington Advantage: The state's external review process is particularly strong for rare disease medications, with medical experts from major research institutions often serving as IRO reviewers.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all patients PA form via provider portal Humana PA Policy
Diagnosis Confirmed ASMD Type B or A/B Genetic testing + enzyme activity FDA Label
Age Adults and pediatrics Birth certificate/medical records FDA-approved for all ages
Site of Care Clinical setting for escalation Infusion center certification Prescribing Information
Monitoring Liver enzymes q2 weeks during escalation ALT/AST lab results Required per FDA label
Pregnancy Contraindicated during dosing Pregnancy test if applicable FDA safety information

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documents to Include
"Not FDA-approved indication" Emphasize non-CNS ASMD manifestations Genetic testing, organ involvement documentation
"Experimental/investigational" Reference FDA approval date (Aug 2022) FDA approval letter
"Insufficient documentation" Complete diagnostic workup All required tests from eligibility checklist
"Site of care not covered" Justify clinical setting need Infusion reaction risk, monitoring requirements
"Quantity limits exceeded" Provide weight-based dosing rationale Patient weight, dosing calculation worksheet

Frequently Asked Questions

How long does Humana prior authorization take for Xenpozyme in Washington? Standard reviews take up to 30 days, but most electronic submissions receive decisions within 1-5 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Xenpozyme is non-formulary on my Humana plan? Submit a formulary exception request along with medical necessity documentation. Non-formulary drugs can be covered when medically necessary and no covered alternatives exist.

Can I start treatment while the appeal is pending? Generally no, unless you pay out-of-pocket. However, you can request expedited review if delaying treatment could jeopardize your health.

Does step therapy apply to Xenpozyme? No step therapy requirements exist since Xenpozyme is the only approved ERT for ASMD. However, Humana may require documentation that supportive care measures have been inadequate.

What's the difference between internal and external appeals in Washington? Internal appeals are reviewed by Humana staff, while external IRO reviews use independent medical experts. External reviews often have higher overturn rates for rare disease medications.

How much does Xenpozyme cost without insurance? Wholesale acquisition cost ranges from approximately $1,515 per 4mg vial to $7,576 per 20mg vial. Monthly costs can exceed $20,000 depending on patient weight and dosing phase.

Are there financial assistance programs available? Yes, Sanofi offers patient support programs. Visit Xenpozyme.com or call their patient support line for eligibility and enrollment information.

What if I move to another state while on treatment? Coverage requirements may vary by state. Contact Humana's member services immediately to understand any changes to your benefits or appeal rights.

From Our Advocates

We've seen several ASMD patients successfully overturn initial Humana denials by submitting comprehensive diagnostic documentation upfront, particularly genetic testing results and baseline organ assessments. The key is often working with the prescribing physician to clearly distinguish non-CNS manifestations that Xenpozyme can address from neurological symptoms it cannot treat. This clarity helps medical reviewers understand the appropriate indication and medical necessity.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current coverage policies and medical recommendations. Coverage decisions depend on individual circumstances and plan details.

For additional help with insurance appeals in Washington, contact the Washington State Office of the Insurance Commissioner at 1-800-562-6900.

Organizations like Counterforce Health specialize in helping patients navigate complex prior authorization and appeals processes by creating targeted, evidence-backed submissions that address specific payer requirements and denial reasons.

Sources & Further Reading

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