By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (agalsidase beta) Covered by UnitedHealthcare in New York: Complete PA and Appeals Guide

Answer Box: Quick Start Guide

Is Fabrazyme covered by UnitedHealthcare in New York? Yes, but requires prior authorization and specialist documentation. Fastest path: Have your Fabry specialist submit PA through the UnitedHealthcare provider portal with genetic testing, enzyme levels, and medical necessity letter. Start today: Call UnitedHealthcare at the number on your card to verify your plan's specialty pharmacy requirement and download the current PA form. Most approvals take 7-15 business days; expedited review available for urgent cases.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Requirements
  9. New York External Appeals
  10. Troubleshooting Common Issues

Coverage Basics

Is Fabrazyme Covered by UnitedHealthcare?

Fabrazyme (agalsidase beta) is covered by most UnitedHealthcare plans in New York as a specialty tier medication requiring prior authorization. The drug appears on OptumRx formularies for commercial, Medicare Part D, and Medicaid managed care plans.

Which UnitedHealthcare Plans Cover Fabrazyme?

  • Commercial plans (employer-sponsored)
  • Individual/family marketplace plans
  • Medicare Advantage with Part D
  • Medicaid managed care plans
  • FEHB (federal employee) plans
Note: Self-funded ERISA plans may have different coverage policies. Check your Summary Plan Description.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before first fill UnitedHealthcare Provider Portal
Formulary Tier Usually Tier 4-5 (specialty) Your plan's drug list
Step Therapy May require trial of Galafold first PA decision letter
Specialty Pharmacy Must use designated vendors Vendor list in provider resources
Age Restriction FDA-approved for ages 2+ FDA label

Prior Authorization Process

Who Submits the PA?

Your prescribing physician (typically a geneticist, nephrologist, or cardiologist experienced in Fabry disease) must submit the prior authorization request through:

  • UnitedHealthcare Provider Portal (preferred)
  • OptumRx PA system for pharmacy benefit
  • Fax submission (verify current number with plan)

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic)
    • Genetic testing showing pathogenic GLA mutation
    • Alpha-galactosidase A enzyme levels
    • Recent clinic notes (within 6 months)
    • Prior therapy records if applicable
  2. Complete PA Form (Prescriber)
    • Use UnitedHealthcare's enzyme replacement therapy PA form
    • Include ICD-10 code E75.21 (Fabry disease)
    • Specify dosing: 1 mg/kg every 2 weeks IV
  3. Submit Medical Necessity Letter (Prescriber)
    • Document confirmed Fabry diagnosis
    • Explain organ involvement (renal, cardiac, neurologic)
    • Address why Fabrazyme vs. alternatives
    • Include supporting literature
  4. Choose Specialty Pharmacy (Patient/Clinic)
    • Select from approved network: Accredo, CVS Caremark Specialty, Orsini, or Amber Specialty
    • Coordinate infusion site (home, office, outpatient)
  5. Submit and Track (Clinic)
    • Submit via provider portal
    • Note confirmation number
    • Follow up in 7-10 business days
  6. Arrange Infusion (Patient)
    • Contact specialty pharmacy once approved
    • Schedule with infusion provider
    • Verify insurance verification is complete
  7. Monitor and Document (All)
    • Track treatment response
    • Maintain infusion records for renewals
    • Report any adverse events

Timing and Urgency

Standard Timeline

  • PA review: 7-15 business days
  • Expedited review: 72 hours (urgent cases)
  • Appeal decision: 30 days (internal), 72 hours (expedited)

When to Request Expedited Review

Request expedited processing if:

  • Patient is currently hospitalized
  • Delay would seriously jeopardize health
  • Interruption of existing therapy poses immediate risk
  • Progressive organ damage is occurring

How Long Does Approval Last?

Initial approvals typically last 12 months. Reauthorization required annually with updated clinical documentation.

Clinical Criteria

Diagnostic Requirements

UnitedHealthcare requires confirmed Fabry disease diagnosis through:

Genetic Testing (Preferred)

  • Pathogenic or likely pathogenic GLA gene mutation
  • Laboratory report with variant classification
  • Required for all females; strongly preferred for males

Biochemical Confirmation

  • Alpha-galactosidase A enzyme deficiency
  • Typically <1% of normal activity
  • Plasma, leukocyte, or fibroblast assay

Specialist Prescriber Requirements

PA must be submitted by or in consultation with:

  • Clinical geneticist
  • Nephrologist
  • Cardiologist
  • Neurologist
  • Lysosomal storage disease specialist

Step Therapy Considerations

Some UnitedHealthcare plans require documentation that:

  • Galafold (migalastat) is not appropriate due to non-amenable mutation
  • Patient has contraindication to oral therapy
  • Previous ERT failure or inadequate response

Medical Necessity Elements

Documentation must include:

  • Current organ involvement (kidney function, cardiac status, neurologic symptoms)
  • Disease progression risk without treatment
  • Treatment goals and monitoring plan
  • Dosing rationale (1 mg/kg every 2 weeks)

Costs and Financial Assistance

Typical Cost Structure

  • Specialty tier coinsurance: 20-40% after deductible
  • Annual deductible: May apply to specialty drugs (2025 plans)
  • Out-of-pocket maximum: $2,000 for Medicare Part D (2025+)

Patient Assistance Programs

Sanofi Patient Connection

  • Copay assistance for commercially insured patients
  • Bridge therapy during coverage gaps
  • Free drug program for qualifying uninsured patients
  • Call: 1-800-633-1610

Medicare Extra Help

  • Low-income subsidy for Part D premiums and cost-sharing
  • Apply through Social Security Administration
  • Can significantly reduce Fabrazyme costs

Financial Planning Tips

  • Use monthly smoothing for Part D to spread costs evenly
  • Track progress toward out-of-pocket maximum
  • Coordinate with specialty pharmacy for payment plans
  • Consider infusion site impact on costs (home vs. facility)

Denials and Appeals

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"No genetic testing" Submit complete GLA sequencing report
"Not medically necessary" Add detailed organ involvement documentation
"Step therapy required" Document Galafold non-amenability or contraindication
"Non-preferred agent" Provide clinical rationale for Fabrazyme specifically
"Quantity limits exceeded" Verify dosing matches FDA labeling (1 mg/kg q2w)

Internal Appeals Process

Timeline: File within 180 days of denial

Required Documents:

  • Original denial letter
  • Updated medical records
  • Peer-reviewed literature supporting use
  • Specialist appeal letter addressing denial reasons

Submission: UnitedHealthcare member/provider portal or fax (verify current number)

Expedited Appeals

Available when delay would:

  • Seriously jeopardize life or health
  • Impair ability to regain maximum function
  • Cause severe pain or suffering

Timeline: Decision within 72 hours

Renewals and Reauthorization

When to Start Renewal Process

Begin 60 days before current authorization expires to avoid treatment interruption.

Required Documentation for Renewal

  • Updated specialist note (within 3-6 months)
  • Laboratory results: eGFR, proteinuria, GL-3/lyso-GL-3 if available
  • Treatment adherence records: ≥85% compliance required
  • Clinical response documentation: stable or improved organ function

Renewal Checklist

  • Confirm current authorization end date
  • Schedule specialist appointment for updated assessment
  • Gather recent lab results
  • Obtain infusion center adherence records
  • Submit renewal PA 30-60 days in advance
  • Follow up on approval status

Specialty Pharmacy Requirements

Approved Network Pharmacies for New York

Based on UnitedHealthcare's vendor assistance list for New York:

  • Accredo Specialty Pharmacy
  • CVS Caremark Specialty
  • Orsini Pharmaceutical Services
  • Amber Specialty Pharmacy

Why Specialty Pharmacy is Required

Fabrazyme requires:

  • Cold chain storage and handling
  • Patient education on infusion procedures
  • Insurance coordination for high-cost biologics
  • Adherence monitoring and reporting

Coordinating Infusion Services

Home Infusion Options:

  • Optum Infusion Services
  • Option Care Health
  • BioMatrix Specialty Pharmacy

Outpatient Infusion:

  • Hospital-based infusion centers
  • Physician office administration
  • Ambulatory surgery centers

New York External Appeals

When UnitedHealthcare's internal appeals process doesn't resolve your denial, New York residents have strong additional rights through the New York State Department of Financial Services (DFS).

When External Appeals Apply

You can file a DFS external appeal if UnitedHealthcare denies Fabrazyme as:

  • Not medically necessary
  • Experimental/investigational
  • Out-of-network (if no in-network alternative available)

External Appeal Process

Timeline: File within 4 months of final internal denial

Required Elements:

  • Completed DFS External Appeal Application
  • Physician attestation from qualified specialist
  • Supporting medical records and literature
  • Copy of all denial letters

Cost: Up to $25 (waived for Medicaid/hardship)

Decision Timeline:

  • Standard: 30 days
  • Expedited: 72 hours (24 hours for urgent drug denials)

DFS External Appeal Success Factors

External appeals are more likely to succeed when they include:

  • Board-certified specialist attestation specifically for Fabry disease
  • Peer-reviewed literature supporting Fabrazyme use
  • Documentation of disease progression risk without treatment
  • Evidence that standard treatments have failed or are inappropriate
Important: DFS external appeal decisions are binding on UnitedHealthcare. If you win, the insurer must cover the treatment and refund your appeal fee.

Troubleshooting Common Issues

Portal and System Issues

Provider Portal Down

  • Use backup fax submission (verify current number)
  • Call UnitedHealthcare provider services for alternative submission methods
  • Document attempts for appeal purposes if delays occur

Missing PA Forms

Communication Problems

No Response to PA Submission

  • Call to confirm receipt and review status
  • Request confirmation number for tracking
  • Follow up weekly until decision received

Conflicting Information

  • Request written confirmation of coverage decisions
  • Ask for specific policy section references
  • Escalate to supervisor if staff provide inconsistent answers

Coordination Issues

Specialty Pharmacy Problems

  • Verify pharmacy is in UnitedHealthcare network
  • Confirm PA approval before prescription transfer
  • Use three-way calls with insurer, pharmacy, and clinic

Infusion Site Challenges

  • Verify provider is in-network for medical benefit
  • Confirm drug sourcing requirements
  • Check if prior authorization covers specific administration site

FAQ: Most Common Questions

Q: How long does UnitedHealthcare PA take for Fabrazyme in New York? A: Standard review takes 7-15 business days. Expedited review (for urgent cases) takes up to 72 hours.

Q: What if Fabrazyme is non-formulary on my plan? A: File a formulary exception request with medical necessity documentation. Non-formulary drugs can be covered with appropriate clinical justification.

Q: Can I request an expedited appeal in New York? A: Yes, both UnitedHealthcare and New York DFS offer expedited appeals when delay would jeopardize health or ability to regain function.

Q: Does step therapy apply if I've failed treatments outside New York? A: Previous treatment failures from other states/insurers should be documented and submitted with your PA to support step therapy exceptions.

Q: What happens if my specialist isn't in UnitedHealthcare's network? A: Out-of-network specialists can still submit PAs, but you may need an in-network consultation or referral for optimal coverage.

Q: How do I find my plan's exact Fabrazyme coverage? A: Check your plan's formulary (drug list) available through the UnitedHealthcare member portal or call the customer service number on your ID card.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed responses. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's own rules. For Fabrazyme denials, we help gather the right clinical evidence—from FDA labeling to peer-reviewed Fabry disease studies—and weave them into appeals that address UnitedHealthcare's specific medical necessity criteria.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider about treatment decisions and contact UnitedHealthcare directly to verify current coverage policies. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400 or visit Counterforce Health for specialized denial appeal assistance.

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