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

How to Get Xenpozyme (olipudase alfa-rpcp) Covered by UnitedHealthcare in Ohio: Complete Requirements Checklist

Answer Box: Getting Xenpozyme Covered by UnitedHealthcare in Ohio

Xenpozyme (olipudase alfa-rpcp) requires prior authorization from UnitedHealthcare OptumRx for acid sphingomyelinase deficiency (ASMD). Fastest approval path: Submit PA through the UnitedHealthcare Provider Portal with confirmed ASMD diagnosis (genetic testing + enzyme assay), metabolic specialist consultation, and baseline organ assessments. If denied, Ohio residents have 60 days for internal appeals, then 180 days for external review through an Independent Review Organization. Start today: Verify active UnitedHealthcare coverage and gather genetic test results showing SMPD1 mutations.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Billing Requirements
  5. Documentation Packet Checklist
  6. Submission Process
  7. After Submission: What to Expect
  8. Appeals Process in Ohio
  9. Common Denial Reasons & Solutions
  10. Cost Assistance Options
  11. FAQ

Who Should Use This Guide

This guide helps patients and providers navigate UnitedHealthcare's prior authorization process for Xenpozyme in Ohio. You'll need this if:

  • Your doctor prescribed Xenpozyme for confirmed ASMD (Niemann-Pick disease types A/B)
  • UnitedHealthcare is your primary insurance
  • You're an Ohio resident seeking coverage or appealing a denial
  • You need to understand the step-by-step approval requirements

Expected outcome: With proper documentation, most medically appropriate Xenpozyme requests get approved within UnitedHealthcare's standard 72-hour review window.

Member & Plan Basics

Coverage Verification

Before starting your prior authorization:

✓ Confirm active UnitedHealthcare coverage through your member portal
✓ Check if OptumRx manages your prescription benefits (most UnitedHealthcare plans)
✓ Verify your plan covers specialty medications (rare disease drugs like Xenpozyme)
✓ Review your specialty pharmacy network and preferred infusion centers

Note: Self-funded employer plans follow federal ERISA rules, not Ohio state insurance laws. Check your plan documents to confirm which appeals process applies.

Formulary Status

Xenpozyme appears on UnitedHealthcare formularies with prior authorization requirements. It's typically classified as:

  • Tier 3 with PA for commercial plans
  • Non-preferred specialty for Medicare plans
  • Prior authorization required across all plan types

Clinical Criteria for Approval

FDA-Approved Indication

UnitedHealthcare covers Xenpozyme for non-CNS manifestations of acid sphingomyelinase deficiency (ASMD) in adults and pediatric patients. This includes Niemann-Pick disease types A/B but excludes CNS-predominant disease.

Required Clinical Documentation

According to OptumRx prior authorization criteria, approval requires:

Requirement Documentation Needed
Specialist consultation Prescription by or consultation with metabolic disease specialist or geneticist
Confirmed ASMD diagnosis Genetic testing (SMPD1 mutations) + enzyme assay (ASM activity <10% normal)
Baseline assessments Spleen/liver imaging, pulmonary function tests, lipid panels
Monitoring plan Schedule for response assessment and safety monitoring

ICD-10 Diagnosis Codes

Use appropriate ASMD-specific ICD-10 codes:

  • E75.240: Niemann-Pick disease type A
  • E75.241: Niemann-Pick disease type B
  • E75.244: Niemann-Pick disease type A/B (intermediate)
  • E75.249: Other Niemann-Pick disease

Coding and Billing Requirements

HCPCS and Billing Units

Xenpozyme billing uses temporary code C9469 pending permanent J-code assignment:

  • HCPCS Code: C9469 (injection, olipudase alfa-rpcp, 1 mg)
  • Dosing: 3 mg/kg IV every 2 weeks
  • Units per dose: Weight (kg) × 3 (rounded to nearest mg)
  • Infusion codes: CPT 96365 + 96366 for extended infusions

Required Modifiers

  • JW modifier: Report discarded drug waste for Medicare/commercial claims
  • Appropriate place of service codes for infusion center or office administration

Documentation Packet Checklist

Provider Letter of Medical Necessity

Your prescribing physician should include:

✓ Patient demographics and UnitedHealthcare ID number
✓ Confirmed ASMD diagnosis with genetic test results and enzyme levels
✓ Clinical presentation including organ involvement and symptoms
✓ Treatment rationale explaining why Xenpozyme is medically necessary
✓ Dosing plan (3 mg/kg every 2 weeks with escalation schedule)
✓ Monitoring plan for efficacy and safety assessments
✓ Specialist credentials (metabolic disease or genetics specialty)

Required Attachments

✓ Genetic test report showing biallelic SMPD1 mutations
✓ Enzyme assay results (ASM activity <10% of normal)
✓ Recent imaging (abdominal MRI/CT showing spleen/liver involvement)
✓ Pulmonary function tests if lung involvement present
✓ Laboratory results (lipid panels, liver function tests)
✓ Prior treatment history if applicable

Submission Process

Step-by-Step Submission

  1. Gather documentation (genetic tests, enzyme assays, imaging)
  2. Complete prior authorization form through UnitedHealthcare Provider Portal
  3. Submit via secure portal or call 888-397-8129 for assistance
  4. Obtain confirmation number and save submission receipt
  5. Follow up within 48-72 hours if no acknowledgment received

Portal vs. Alternative Methods

Preferred: UnitedHealthcare Provider Portal offers 24/7 submission and real-time status tracking.

Alternative: Fax submissions to number provided on denial letter (verify current fax number through portal).

Tip: Portal submissions typically process faster and provide better tracking than fax submissions.

After Submission: What to Expect

Review Timeline

  • Standard review: 72 hours for prior authorization decisions
  • Expedited review: 24 hours if urgency documented
  • Status updates: Check portal daily or call member services

Confirmation Steps

✓ Save confirmation number from submission
✓ Document submission date and method
✓ Set calendar reminder to check status in 48 hours
✓ Prepare for potential peer-to-peer review if requested

Appeals Process in Ohio

If your Xenpozyme request is denied, Ohio residents have specific appeal rights:

Internal Appeals (Required First)

  • Filing deadline: 60 days from denial notice
  • Response time: 30 days for pre-service denials, 60 days for post-service
  • Expedited option: 72 hours if health at risk
  • Submission: UnitedHealthcare Provider Portal or written appeal

External Review (After Internal Appeals)

Ohio residents can request external review through an Independent Review Organization:

  • Filing deadline: 180 days from final internal denial
  • Review timeline: 30 days standard, 72 hours expedited
  • Cost: No charge to patient
  • Contact: Ohio Department of Insurance at 1-800-686-1526
Important: Self-funded employer plans follow federal ERISA rules, not Ohio's external review process.

Common Denial Reasons & Solutions

Denial Reason Required Documentation Solution
No confirmed ASMD diagnosis Genetic testing + enzyme assay Submit SMPD1 sequencing results and ASM activity <10% normal
CNS disease request Clinical assessment Clarify non-CNS manifestations in appeal letter
Missing specialist consultation Provider credentials Include metabolic specialist or geneticist consultation notes
Inadequate monitoring plan Safety protocol Submit detailed monitoring schedule for efficacy/safety
Site of care restrictions Infusion center requirements Verify approved infusion locations in network

Peer-to-Peer Review Strategy

If offered a peer-to-peer review:

✓ Accept the opportunity - it often resolves denials
✓ Prepare clinical summary with key diagnostic evidence
✓ Emphasize FDA approval for ASMD and lack of alternatives
✓ Document the call including reviewer name and outcome

Cost Assistance Options

Manufacturer Support

Sanofi offers patient assistance through CareConnectPSS:

  • Co-pay assistance: For commercially insured patients (excludes government programs)
  • Patient assistance program: For uninsured US patients
  • Contact: 1-800-745-4447, option 3

Additional Resources

  • NORD (National Organization for Rare Disorders): Financial assistance programs
  • HealthWell Foundation: Copay assistance for rare disease medications
  • Ohio pharmaceutical assistance programs: Income-based support

FAQ

How long does UnitedHealthcare prior authorization take for Xenpozyme? Standard review is 72 hours, with expedited review available in 24 hours if urgency is documented.

What if Xenpozyme isn't on my formulary? Xenpozyme appears on UnitedHealthcare formularies with prior authorization. Non-formulary requests require additional medical necessity documentation.

Can I request expedited appeal in Ohio? Yes, if your treating physician certifies that delayed treatment could seriously jeopardize your health. Contact UnitedHealthcare immediately.

Does step therapy apply to Xenpozyme? Currently, UnitedHealthcare's step therapy programs don't list Xenpozyme, but policies can change. Check your specific plan requirements.

What happens if my employer plan is self-funded? Self-funded plans follow federal ERISA rules rather than Ohio state appeals processes. Check your plan documents for specific appeal procedures.

How do I find an approved infusion center? Use the UnitedHealthcare provider directory to locate in-network infusion centers that can administer Xenpozyme safely.

Counterforce Health helps patients and providers navigate complex prior authorization and appeals processes for specialty medications. Our platform analyzes denial letters and insurance policies to create targeted, evidence-based appeals that align with payer-specific requirements, turning insurance denials into successful approvals.

When dealing with rare disease medications like Xenpozyme, having expert support can make the difference between approval and prolonged delays. Counterforce Health's automated system identifies the specific denial basis and drafts point-by-point rebuttals using the right clinical evidence and procedural requirements for your insurance plan.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific coverage questions. For assistance with Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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