By Counterforce Health Team in Aldurazyme (laronidase) —

Getting Aldurazyme (Laronidase) Covered by UnitedHealthcare in Florida: Copay Assistance, Appeals, and Cost-Saving Strategies

Answer Box: Fast Track to Aldurazyme Coverage

UnitedHealthcare requires prior authorization for Aldurazyme (laronidase) with genetic/enzymatic confirmation of MPS I and specialist oversight. Commercial members can use Sanofi's CareConnectPSS copay assistance (up to $15,000 annually), while Medicare/Medicaid members cannot. Florida's 2024 Patient Timely Access to Healthcare Act requires 30-day standard appeal resolution and specialist-to-specialist review. First step: Gather enzyme activity test results and IDUA genetic testing, then contact CareConnectPSS at 1-800-745-4447 (option 3) for copay enrollment while your provider submits PA documentation through UnitedHealthcare's provider portal.

Table of Contents

What Drives Aldurazyme Costs

Understanding your UnitedHealthcare plan's cost structure helps you navigate the financial landscape for Aldurazyme, which carries a manufacturer-disclosed price of approximately $1,113.38 per 2.9 mg vial as of January 2025.

Benefit Design Basics

Specialty Tier Placement: UnitedHealthcare typically classifies Aldurazyme as a specialty medication, requiring use of their preferred specialty pharmacy network like Optum Specialty Pharmacy. Specific tier placement varies by plan type—commercial PDL, Medicare Part D, or exchange plans may place it in Tier 3 or 4.

Prior Authorization Requirements: All UnitedHealthcare plans require prior authorization for Aldurazyme, using enzyme-replacement therapy criteria for MPS I. Unlike many medications, step therapy typically doesn't apply since Aldurazyme is the only FDA-approved laronidase for MPS I.

Medical vs. Pharmacy Benefit: Aldurazyme infusions may fall under your medical benefit (if administered in a clinical setting) or pharmacy benefit (if processed through specialty pharmacy), affecting your cost-sharing structure.

Note: For Medicare Part D members, the 2025 $2,000 annual out-of-pocket cap applies to pharmacy benefit drugs, but infused biologics covered under Part B are exempt from this cap.

Investigating Your UnitedHealthcare Benefits

Before starting the approval process, gather key information about your specific coverage.

Essential Questions for UnitedHealthcare

Call Member Services (number on your insurance card) and ask:

  1. Is Aldurazyme covered under medical or pharmacy benefit?
  2. What tier is Aldurazyme on my formulary?
  3. What's my copay/coinsurance for specialty drugs?
  4. Does my plan use copay accumulators or maximizers?
  5. Which specialty pharmacies are in-network?
  6. Are there quantity limits or site-of-care restrictions?

Information to Record

Document the representative's name, date, and reference number. Request written confirmation of coverage details, especially if you receive conflicting information.

Coverage at a Glance:

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage UHC Provider Portal UHC PA Requirements
Specialty Pharmacy Must use preferred network Plan documents/member portal OptumRx Network
Enzyme Testing IDUA activity confirmation required Lab results from CLIA-certified lab UHC ERT Policy
Genetic Testing IDUA gene sequencing preferred Genetic counselor/metabolic specialist UHC ERT Policy

Manufacturer Assistance Programs

Sanofi offers comprehensive support for Aldurazyme patients through CareConnectPSS, but eligibility depends on your insurance type.

CareConnectPSS Copay Assistance

Eligibility Requirements:

  • Primary commercial insurance with prescription drug coverage
  • U.S. resident
  • No Medicare, Medicaid, VA, TRICARE, or other government insurance
  • Prescribed Aldurazyme by U.S. provider

Benefits:

  • Up to $15,000 annual copay assistance
  • May cover 100% of eligible out-of-pocket costs up to program maximum
  • Covers drug costs and certain infusion-related expenses

Enrollment Process:

  1. Call CareConnectPSS: 1-800-745-4447, option 3
  2. Complete application with insurance and prescription details
  3. Verification: Sanofi confirms commercial coverage within 7-10 days
  4. Automatic renewal annually if still eligible
Important: UnitedHealthcare commercial members can typically use this program, but check if your plan uses copay accumulators that prevent manufacturer payments from counting toward your deductible.

Patient Assistance Program (PAP)

For patients who don't qualify for copay assistance:

Eligibility:

  • Household income ≤400% Federal Poverty Level
  • No adequate insurance coverage or repeated denials
  • U.S. or Puerto Rico residents

Benefits:

  • Free Aldurazyme for eligible patients
  • Case management support for coverage appeals

Application: Contact CareConnectPSS at 1-800-745-4447, option 3, to request PAP forms.

Counterforce Health helps patients navigate these assistance programs while simultaneously building strong appeals for insurance coverage, ensuring you have multiple pathways to access your medication.

Requesting Formulary Tier Exceptions

If Aldurazyme is non-formulary or placed in a high-cost tier, you can request a formulary exception.

When to Request Exceptions

  • Non-formulary status: Drug not covered at any tier
  • High tier placement: Excessive cost-sharing on Tier 4 or specialty tier
  • Step therapy requirements: If incorrectly applied (rare for Aldurazyme)

Required Documentation

Clinical Rationale Must Include:

  • Confirmed MPS I diagnosis with enzyme/genetic testing
  • Documentation that no suitable formulary alternatives exist
  • Medical necessity for FDA-approved dosing
  • Specialist attestation of treatment need

Submission Process:

  1. Provider submits via UnitedHealthcare Provider Portal
  2. Standard review: 72 hours
  3. Urgent review: 24 hours if delay risks health
  4. Appeal option if denied

Success Factors

Highest approval rates occur when documentation shows:

  • Allergies or contraindications to alternatives
  • Previous treatment failures
  • Genetic confirmation requiring specific therapy
  • Specialist recommendation with clinical guidelines support

Choosing the Right Pharmacy

Your pharmacy choice significantly impacts costs and coverage approval.

Specialty Pharmacy Requirements

UnitedHealthcare Preferred:

  • Optum Specialty Pharmacy (primary)
  • Limited network of approved specialty pharmacies
  • Required for specialty tier coverage

Benefits of In-Network Specialty Pharmacy:

  • Lower cost-sharing
  • Coordinated prior authorization
  • Clinical support and monitoring
  • Direct billing to manufacturer assistance programs

Coordination Tips

  • Verify network status before first fill
  • Confirm PA approval before shipment
  • Coordinate with assistance programs during enrollment
  • Track refill timing to avoid gaps
Tip: Optum Specialty Pharmacy can often coordinate directly with CareConnectPSS for seamless copay assistance application.

Appeals Process in Florida

Florida's 2024 Patient Timely Access to Healthcare Act strengthens appeal rights and timelines for UnitedHealthcare members.

Internal Appeal Process

Standard Timeline:

  • 30-day resolution required under Florida PTAHA
  • Expedited appeals for urgent cases with faster resolution
  • Specialist-to-specialist review required for complex cases

Required Steps:

  1. Obtain written denial with specific reasons
  2. File internal appeal within 180 days of denial notice
  3. Request expedited review if delay risks health deterioration
  4. Demand specialist reviewer experienced in lysosomal storage disorders

External Review Rights

After exhausting internal appeals:

  • Independent external review available for medical necessity denials
  • 120-day filing deadline from final internal denial
  • No cost to patient for external review
  • Binding decision if reviewer overturns denial

Florida-Specific Resources:

  • Consumer Hotline: 1-800-FL-HEALTH for reporting delays
  • Division of Consumer Services for insurance complaints
  • State oversight of insurer compliance with PTAHA timelines

Documentation for Appeals

Strengthen Your Case With:

  • Enzyme activity test results showing IDUA deficiency
  • IDUA genetic testing confirming biallelic pathogenic variants
  • Specialist consultation notes detailing MPS I severity
  • Clinical guidelines supporting Aldurazyme as standard therapy
  • Evidence of progressive disease without treatment

Annual Renewal Planning

Plan ahead for coverage changes and renewal requirements.

What Can Change Annually

  • Formulary placement (up to 3 times per year for some plans)
  • Prior authorization criteria updates
  • Specialty pharmacy network changes
  • Cost-sharing structure modifications

Renewal Reminders

Before January 1:

  • Re-enroll in CareConnectPSS copay assistance
  • Verify continued formulary coverage
  • Update prior authorization if required
  • Confirm specialty pharmacy network status

Documentation Maintenance:

  • Keep current enzyme/genetic testing results
  • Maintain specialist consultation notes
  • Document ongoing clinical benefit
  • Track treatment response metrics

Conversation Scripts

Use these templates for effective communication with key stakeholders.

UnitedHealthcare Member Services Script

"I'm calling about prior authorization for Aldurazyme, also called laronidase, for mucopolysaccharidosis type I. I need to confirm: Is this covered under my medical or pharmacy benefit? What's my cost-sharing for specialty drugs? Does my plan allow manufacturer copay assistance? Can you transfer me to someone who handles specialty drug appeals?"

Provider Office Script for PA Submission

"We're submitting prior authorization for Aldurazyme for confirmed MPS I. The patient has enzyme testing showing IDUA deficiency and genetic confirmation of biallelic IDUA variants. This is the only FDA-approved enzyme replacement therapy for MPS I. We're including baseline assessments and specialist consultation notes. Can you confirm receipt and expected timeline?"

Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for Aldurazyme denial. The patient has biochemically and genetically confirmed MPS I requiring enzyme replacement therapy. There are no alternative treatments. I'd like to speak with a reviewer experienced in lysosomal storage disorders, as required under Florida law."

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Missing genetic confirmation Submit IDUA gene sequencing Genetic test results showing biallelic pathogenic variants
Insufficient baseline assessments Provide comprehensive evaluation Enzyme levels, uGAG, PFTs, 6-minute walk test, cardiac echo
Prescriber not recognized as specialist Document specialist involvement Metabolic geneticist consultation or co-management letter
Experimental/investigational Cite FDA approval and guidelines FDA label, clinical practice guidelines, payer policy language
Lack of medical necessity Demonstrate disease burden Clinical notes, functional assessments, progression documentation

FAQ

How long does UnitedHealthcare prior authorization take in Florida? Standard PA decisions are typically made within 72 hours, with urgent cases reviewed within 24 hours. Florida's PTAHA requires appeals to be resolved within 30 days.

What if Aldurazyme is non-formulary on my plan? You can request a formulary exception with clinical documentation showing medical necessity and lack of suitable alternatives. Your provider submits this through the UHC Provider Portal.

Can I use manufacturer copay assistance with UnitedHealthcare? Yes, if you have commercial UnitedHealthcare coverage (not Medicare Advantage, Part D, or Medicaid). Check if your plan uses copay accumulators that may limit benefits.

Does step therapy apply to Aldurazyme? Generally no, since Aldurazyme is the only FDA-approved laronidase for MPS I. However, some plans may require documentation that HSCT is not appropriate or has been completed.

How do I request an expedited appeal in Florida? Contact UnitedHealthcare and explicitly state that delay in treatment could seriously jeopardize health or ability to regain function. Provide clinical documentation supporting urgency.

What happens if UnitedHealthcare denies my external review request? External review decisions are binding under Florida and federal law. If the external reviewer overturns the denial, UnitedHealthcare must cover the treatment.

About Counterforce Health

Counterforce Health transforms insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes, turning coverage obstacles into approved treatments through systematic documentation and strategic advocacy.

Sources & Further Reading

This article provides educational information and should not be considered medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Consult your healthcare provider and insurance plan documents for specific guidance. For assistance with insurance issues in Florida, contact the Division of Consumer Services at 1-877-MY-FL-CFO.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.