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

Get Xenpozyme (Olipudase Alfa) Covered by UnitedHealthcare in California: Complete Guide to Prior Authorization and Appeals

Quick Answer: Getting Xenpozyme Covered by UnitedHealthcare in California

Xenpozyme (olipudase alfa-rpcp) requires prior authorization from UnitedHealthcare and is typically covered under the medical benefit for ASMD (Niemann-Pick disease types A/B). Key requirements: confirmed ASMD diagnosis with enzyme assay showing <10% ASM activity, genetic testing showing two pathogenic SMPD1 variants, and documentation of medical necessity. First step: Have your doctor submit a prior authorization request through the UnitedHealthcare Provider Portal with complete diagnostic documentation. If denied, California's Independent Medical Review (IMR) process offers a 50%+ success rate for specialty drug appeals through the DMHC.

Table of Contents

  1. Coverage Basics: Is Xenpozyme Covered?
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Medical Necessity Criteria
  5. Costs and Coverage
  6. Denials and Appeals
  7. Specialty Pharmacy Requirements
  8. Troubleshooting Common Issues
  9. FAQ

Coverage Basics: Is Xenpozyme Covered?

Yes, UnitedHealthcare covers Xenpozyme for confirmed ASMD (acid sphingomyelinase deficiency) under their medical benefit drug policy effective October 1, 2025. Coverage applies to both commercial and Medicare Advantage plans, though cost-sharing differs.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Doctor must get approval before prescribing UHC Provider Portal
Medical Benefit Covered as medical service, not pharmacy Plan benefits summary
Specialty Pharmacy Must use designated pharmacies UHC Specialty Vendor List
Site of Care Specific infusion locations required Prior authorization approval
Diagnosis Confirmation ASMD confirmed by enzyme assay + genetics Lab reports required

Which Plans Cover Xenpozyme:

  • UnitedHealthcare Commercial (employer/individual plans)
  • UnitedHealthcare Medicare Advantage
  • Some UnitedHealthcare Medicaid plans (varies by state contract)

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Confirm ASMD Diagnosis (Patient/Doctor)

  • Obtain ASM enzyme assay showing <10% activity
  • Complete genetic testing for two pathogenic SMPD1 variants
  • Timeline: 1-2 weeks for test results

2. Gather Required Documentation (Doctor's office)

  • Complete diagnostic reports
  • Prior treatment history
  • Medical necessity letter
  • Timeline: 2-3 business days

3. Submit Prior Authorization (Doctor)

4. UnitedHealthcare Review (Automated)

  • Initial review: 15 business days (standard)
  • Expedited review: 72 hours (urgent cases)
  • Timeline: Varies by request type

5. Approval or Denial Notice (Sent to doctor/patient)

  • Approval: Proceed to specialty pharmacy coordination
  • Denial: Begin appeal process immediately
  • Timeline: Within review period
Tip: Request expedited review if the patient has severe symptoms or rapid disease progression. Include clinical justification for urgency.

Timing and Urgency

Standard Timeline

  • Prior authorization review: 15 business days
  • Appeal (internal): 30 days for decision
  • External review (IMR): 45 days (expedited: 7 days)

When to Request Expedited Review

UnitedHealthcare offers expedited (urgent) prior authorization for:

  • Patients with severe organ dysfunction
  • Rapid disease progression documented in chart notes
  • Risk of serious adverse health consequences

How to request: Include "URGENT" in submission and provide clinical justification for expedited timeline.

Medical Necessity Criteria

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

✓ Confirmed ASMD Diagnosis

  • ASM enzyme activity <10% of normal controls
  • Genetic testing showing biallelic pathogenic SMPD1 variants
  • Clinical presentation consistent with ASMD

✓ Disease Severity Documentation

  • Organ involvement (spleen, liver, lungs)
  • Functional impairment measures
  • Laboratory abnormalities (lipid profile, liver function)

✓ Treatment Rationale

  • No FDA-approved alternatives for ASMD
  • Expected clinical benefits based on FDA labeling
  • Monitoring plan for efficacy and safety

✓ Supporting Evidence

  • Reference FDA approval for non-CNS ASMD manifestations
  • Include relevant clinical guidelines when available
  • Cite peer-reviewed literature supporting enzyme replacement therapy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Insufficient diagnostic documentation Submit complete enzyme assay and genetic test results
Request for CNS disease treatment Clarify Xenpozyme is for non-CNS manifestations only
Missing baseline assessments Provide spleen/liver imaging, pulmonary function tests
Lack of monitoring plan Include detailed follow-up schedule and safety monitoring
Site-of-care issues Confirm infusion location is in UHC specialty network

Costs and Coverage

Cost Differences by Plan Type

Medicare Advantage Plans:

  • Part B coverage: $0 copay for infused drugs
  • No deductible: Coverage begins immediately
  • Annual cap: Protected by Medicare out-of-pocket maximum

Commercial Plans:

  • Medical benefit: 20-30% coinsurance typical
  • Specialty copay: May range $100-$500+ per infusion
  • Annual maximum: Subject to plan's out-of-pocket limit

Savings Options

  • Sanofi Patient Support: Contact manufacturer for assistance programs
  • State programs: California may offer additional support for rare diseases
  • Nonprofit grants: Research foundations may provide financial assistance
Note: Xenpozyme costs approximately $1,515-$7,576 per vial depending on strength. Monthly costs can reach $20,000+ based on patient weight and dosing.

Denials and Appeals

Appeals Playbook for UnitedHealthcare in California

Level 1: Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for UnitedHealthcare decision
  • How to file: UnitedHealthcare member portal or mail/fax per denial letter
  • Required: Denial letter, medical records, physician statement

Level 2: Independent Medical Review (IMR)

  • When: After internal appeal denial or 30 days with no response
  • Timeline: 45 days (expedited: 7 days)
  • How to file: DMHC online application
  • Cost: Free to patient
  • Success rate: 50%+ for specialty drugs

California IMR Process

California's Independent Medical Review offers strong patient protections:

  1. File with DMHC: After exhausting UnitedHealthcare's internal appeals
  2. Expert review: Independent physicians evaluate medical necessity
  3. Binding decision: UnitedHealthcare must comply with IMR ruling
  4. High success rates: Studies show 50-61% overturn rate for specialty drugs

Contact DMHC Help Center: 888-466-2219 for assistance with IMR applications.

Specialty Pharmacy Requirements

Approved Specialty Pharmacies for Xenpozyme

UnitedHealthcare requires Xenpozyme distribution through designated specialty pharmacies:

  • Option Care Health
  • Caremark Specialty
  • Optum Specialty Pharmacy (select plans)

Site-of-Care Requirements

Approved infusion locations:

  • Home infusion (via approved specialty pharmacy)
  • Outpatient hospital infusion centers (in-network)
  • Provider offices (if contracted for specialty drugs)

Not typically covered:

  • Standard retail pharmacies
  • Hospital inpatient administration (unless emergency)
  • Non-contracted infusion centers
Important: Confirm your infusion site is both in-network with UnitedHealthcare and contracted with an approved specialty pharmacy before starting treatment.

Troubleshooting Common Issues

When Prior Authorization is Delayed

  • Check status: Use UnitedHealthcare provider/member portal
  • Follow up: Call 888-397-8129 for provider inquiries
  • Request expedited review: If patient condition is urgent
  • Prepare appeal: Gather additional documentation while waiting

If Specialty Pharmacy Coordination Fails

  • Verify network status: Confirm pharmacy and infusion site contracts
  • Contact member services: 1-800-member services number on insurance card
  • Request exception: For out-of-network providers if medically necessary

Portal or System Issues

  • Alternative submission: Fax or mail prior authorization if portal down
  • Backup contacts: Use phone numbers provided in denial letters
  • Document attempts: Keep records of submission attempts for appeals

FAQ

How long does UnitedHealthcare prior authorization take for Xenpozyme in California? Standard review takes 15 business days. Expedited review for urgent cases can be completed within 72 hours. Request expedited review if the patient has severe symptoms or rapid disease progression.

What if Xenpozyme is denied as "not medically necessary"? File an internal appeal with UnitedHealthcare within 180 days. Include comprehensive medical records, genetic testing results, and physician documentation of ASMD diagnosis. If denied again, request California IMR through DMHC.

Can I get an expedited appeal in California? Yes. Both UnitedHealthcare and California's IMR process offer expedited reviews for urgent medical situations. Expedited IMR decisions are made within 7 days, often within 72 hours.

Does step therapy apply to Xenpozyme? Xenpozyme is the only FDA-approved treatment for ASMD, so traditional step therapy may not apply. However, UnitedHealthcare may require documentation that supportive care options have been considered or tried.

What happens if my doctor isn't in-network with UnitedHealthcare? Out-of-network providers can still submit prior authorization requests, but you may face higher out-of-pocket costs. Consider requesting a network exception if no in-network specialists are available for ASMD treatment.

How much will Xenpozyme cost me with UnitedHealthcare? Costs vary significantly by plan type. Medicare Advantage members typically pay $0 for Part B covered infusions. Commercial plan members may pay 20-30% coinsurance or specialty copays ranging from $100-$500+ per infusion.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals for prescription drugs. The platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements, significantly improving approval rates for complex medications like Xenpozyme.

For Xenpozyme appeals, Counterforce Health can help identify the specific denial basis—whether it's missing diagnostic documentation, site-of-care issues, or medical necessity challenges—and draft point-by-point rebuttals using the right clinical evidence and payer-specific language to maximize your chances of approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider for medical decisions. For assistance with insurance appeals and coverage issues, contact the California Department of Managed Health Care at 888-466-2219.

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