By Counterforce Health Team in Aldurazyme (laronidase) —

Do You Qualify for Aldurazyme (Laronidase) Coverage by UnitedHealthcare in Michigan? Decision Tree & Next Steps

Answer Box: Getting Aldurazyme Covered by UnitedHealthcare in Michigan

UnitedHealthcare requires prior authorization for Aldurazyme (laronidase) with confirmed MPS I diagnosis via enzymatic/genetic testing plus specialist attestation. The fastest approval path: (1) Submit PA via UHC Provider Portal with complete diagnostic documentation, (2) Include baseline assessments and monitoring plan, (3) If denied, file internal appeal within 180 days, then Michigan DIFS external review within 127 days. Start today by verifying your plan's PA requirements through the UnitedHealthcare Provider Portal.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternative Options
  6. If Denied - Michigan Appeal Path
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Fixes
  9. Frequently Asked Questions
  10. Sources & Further Reading

How to Use This Guide

This decision tree helps patients and clinicians navigate UnitedHealthcare's prior authorization process for Aldurazyme (laronidase) in Michigan. Start with the eligibility triage below, then follow the appropriate path based on your current status.

Before you begin: Gather your UnitedHealthcare member ID, policy documents, and any previous denial letters. Contact your prescribing physician to discuss the medical necessity documentation you'll need.

Eligibility Triage: Do You Qualify?

Work through these questions with your healthcare team:

✅ Likely Eligible if you have:

  • Confirmed MPS I diagnosis via IDUA enzyme testing (reduced/absent alpha-L-iduronidase activity)
  • Genetic confirmation with biallelic pathogenic IDUA variants
  • Clinical features consistent with Hurler, Hurler-Scheie, or Scheie syndromes
  • Specialist (geneticist/metabolic specialist) supporting treatment
  • Baseline assessments completed (urinary GAGs, pulmonary function, cardiac evaluation)

⚠️ Possibly Eligible if you have:

  • Clinical suspicion of MPS I but incomplete diagnostic workup
  • Some testing completed but missing genetic confirmation or specialist evaluation
  • Previous Aldurazyme use under different insurance with documented benefit

❌ Not Yet if you have:

  • No confirmed MPS I diagnosis
  • Missing required baseline assessments
  • No specialist evaluation or support letter

If "Likely Eligible" - Document Checklist

Submit your prior authorization with these documents:

Required Clinical Documentation

  • IDUA enzyme assay results showing deficiency
  • Genetic testing report confirming biallelic IDUA mutations
  • Specialist letter of medical necessity from geneticist or metabolic specialist
  • Baseline assessments:
    • Elevated urinary GAG levels
    • Pulmonary function tests (patients ≥6 years)
    • 6-minute walk test results
    • Joint range of motion documentation
    • Echocardiogram results
    • Imaging showing hepatosplenomegaly

Submission Process

  1. Access UHC Provider Portal at uhcprovider.com
  2. Select "Prior Authorization" under specialty pharmacy
  3. Use codes: HCPCS J1931, ICD-10 E76.01
  4. Attach all documentation listed above
  5. Request expedited review if clinically urgent (≤72 hours vs. standard timeline)
Tip: UnitedHealthcare processes standard PA requests within 72 hours for Part B drugs. Submit complete documentation to avoid delays from requests for additional information.

If "Possibly Eligible" - Tests to Request

Work with your healthcare team to complete:

Diagnostic Testing Needed

  • IDUA enzyme activity testing in blood or skin fibroblasts
  • IDUA gene sequencing to identify pathogenic variants
  • Urinary GAG measurement for elevated baseline levels

Specialist Referral

  • Request referral to genetics specialist or metabolic disease expert
  • Many centers offer MPS specialty clinics (verify in-network status with UnitedHealthcare)

Timeline to Re-apply

  • Complete testing typically takes 2-4 weeks
  • Specialist appointments may require 4-8 weeks wait time
  • Plan to resubmit PA within 60-90 days of initial inquiry

If "Not Yet" - Alternative Options

Immediate Steps

  1. Discuss with prescriber whether supportive care can bridge treatment gap
  2. Explore manufacturer assistance through Sanofi's patient support programs
  3. Consider clinical trials if available in your area

Building Your Case

  • Document progression of symptoms while awaiting approval
  • Gather family history of MPS I or related lysosomal storage disorders
  • Prepare for exception request if standard criteria aren't fully met

If Denied - Michigan Appeal Path

Michigan provides strong patient protections through the Department of Insurance and Financial Services (DIFS).

Internal Appeals (First Step)

  • Timeline: 180 days from denial date to file
  • Method: Submit via UnitedHealthcare member portal or written appeal
  • Include: All original documentation plus additional clinical evidence

Michigan DIFS External Review

If internal appeals are unsuccessful:

  1. File within 127 days of final internal denial
  2. Use Michigan DIFS External Review Form (FIS 0018)
  3. Submit online at michigan.gov/difs or by mail/fax
  4. Include physician letter supporting medical necessity

For expedited review (72-hour decision):

  • Treating physician must verify that delay would "seriously jeopardize life, health, or ability to regain maximum function"
  • Submit written physician substantiation with request
From our advocates: We've seen success when families include detailed progression photos and functional assessments showing decline without treatment. One family's 6-minute walk test improvements after starting Aldurazyme helped overturn a "not medically necessary" denial during external review.

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to payers' own rules.

Contact Information

  • DIFS Consumer Services: 877-999-6442
  • Online external review: michigan.gov/difs (search "external review")

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plans UHC Provider Portal
Diagnostic Confirmation IDUA enzyme + genetic testing Lab reports, specialist notes
Specialist Attestation Geneticist/metabolic expert support Medical necessity letter
Baseline Assessments Pre-treatment evaluations Clinical documentation
Monitoring Plan Infusion safety protocol FDA prescribing information
Billing Codes J1931 (HCPCS), E76.01 (ICD-10) UHC policy documents

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Missing genetic confirmation" Submit IDUA gene sequencing results showing biallelic pathogenic variants
"Insufficient baseline assessments" Provide complete workup: GAGs, PFTs, echo, imaging, functional tests
"Not medically necessary" Include specialist letter citing FDA approval, treatment guidelines, patient-specific rationale
"Experimental/investigational" Reference FDA approval (2003) and established standard of care documentation
"Quantity over plan limits" Document weight-based dosing calculation (100 U/kg weekly) with prescriber attestation

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Michigan? Standard requests: 72 hours for Part B drugs. Expedited requests (with clinical justification): 24 hours.

What if Aldurazyme is non-formulary on my plan? Request formulary exception with medical necessity documentation. Non-formulary doesn't mean non-covered if medically necessary.

Can I request expedited appeal in Michigan? Yes, if your physician certifies that delay would seriously jeopardize your health. DIFS must decide within 72 hours.

Does step therapy apply to Aldurazyme? Aldurazyme is not listed in UnitedHealthcare's Medicare Part B step therapy policy. No FDA-approved alternatives exist for MPS I enzyme replacement.

What if I'm already on Aldurazyme and switching to UnitedHealthcare? Submit "existing utilizer" documentation showing use within past 365 days. UnitedHealthcare typically continues coverage for stable patients.

How much does Aldurazyme cost without insurance? Manufacturer-disclosed wholesale acquisition cost: approximately $1,113.38 per 2.9 mg vial (as of January 2025). Annual costs can exceed $300,000.

Are there financial assistance programs? Yes, Sanofi offers patient support programs. Contact their specialty pharmacy network for eligibility screening.

What happens if Michigan DIFS rules against me? You can seek judicial review in circuit court within 60 days of the external review decision.

When navigating complex prior authorization requirements, Counterforce Health provides expertise in crafting appeals that address specific payer policies and procedural requirements, helping ensure that medically necessary treatments like Aldurazyme receive appropriate coverage consideration.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual circumstances, plan benefits, and clinical factors. Consult your healthcare provider and insurance plan for guidance specific to your situation. For assistance with Michigan insurance regulations, contact DIFS Consumer Services at 877-999-6442.

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