By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (laronidase) Covered by UnitedHealthcare in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Aldurazyme Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Aldurazyme (laronidase) with specific documentation: confirmed MPS I diagnosis via genetic/enzyme testing, correct dosing (0.58 mg/kg weekly), and specialist attestation. If denied, you have 180 days for internal appeals, then 60 days for Georgia's external review. Start today: Gather your genetic test results, current weight, and diagnosis codes (E76.01-E76.03), then submit via UnitedHealthcare's provider portal or call member services for PA forms.

Table of Contents

  1. UnitedHealthcare's Coverage Policy for Aldurazyme
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Dosing and Quantity Limits
  5. Required Diagnostic Evidence
  6. Specialty Pharmacy Requirements
  7. Supporting Clinical Evidence
  8. Sample Medical Necessity Letter
  9. Special Considerations
  10. Appeals Process in Georgia
  11. Cost Assistance Programs
  12. Quick Reference Checklist

UnitedHealthcare's Coverage Policy for Aldurazyme

UnitedHealthcare covers Aldurazyme (laronidase) under their enzyme replacement therapy policy for commercial, Medicare Advantage, and Medicaid managed care plans in Georgia. The drug requires prior authorization across all plan types, with coverage routed through the medical benefit (not pharmacy) using HCPCS code J1931.

Key policy features:

  • Prior authorization required for all new starts and reauthorizations
  • Medical necessity review based on FDA labeling and clinical guidelines
  • Specialty pharmacy distribution required
  • Site of care restrictions may apply (outpatient infusion centers preferred)

Medical Necessity Requirements

UnitedHealthcare covers Aldurazyme exclusively for FDA-approved indications: enzyme replacement therapy for mucopolysaccharidosis I (MPS I), including Hurler, Hurler-Scheie, and Scheie syndromes.

Required documentation:

  • Confirmed MPS I diagnosis through genetic testing (IDUA gene mutations) or enzyme assay showing α-L-iduronidase deficiency
  • Correct ICD-10 codes: E76.01 (Hurler syndrome), E76.02 (Hurler-Scheie syndrome), or E76.03 (Scheie syndrome)
  • Clinical phenotype consistent with MPS I presentation
  • Age requirement: Patient must be at least 6 months old
Clinician Corner: The diagnosis must include both biochemical confirmation (elevated glycosaminoglycans in urine, deficient IDUA enzyme activity) and genetic confirmation when possible. Recent guidance emphasizes the importance of second-tier GAG testing to reduce false positives in enzyme screening.

Step Therapy and Exception Pathways

Step therapy generally does not apply to Aldurazyme because it's the only FDA-approved enzyme replacement therapy for MPS I. However, UnitedHealthcare may require documentation that:

  • Hematopoietic stem cell transplant (HSCT) has been considered and deemed inappropriate, contraindicated, or declined
  • Patient meets severity criteria warranting enzyme replacement therapy
  • Alternative supportive treatments (physical therapy, respiratory support) are insufficient alone

Medical exception pathway: If step therapy is incorrectly applied, submit a formulary exception request with documentation that no therapeutic alternatives exist for MPS I enzyme replacement.

Dosing and Quantity Limits

Standard dosing: 0.58 mg/kg intravenously once weekly, administered over 3-4 hours.

Quantity limits enforced by UnitedHealthcare:

  • Maximum 667 billable units (HCPCS J1931) per 7-day period
  • Approximately 92 vials (2.9 mg each) per 28-day supply
  • Dose adjustments require current, documented body weight

Renewal requirements:

  • Initial authorization: typically 6-12 months
  • Reauthorization requires evidence of clinical benefit (improved pulmonary function, reduced hepatosplenomegaly, or stabilized disease progression)
  • Weight-based dose recalculation at each renewal

Required Diagnostic Evidence

UnitedHealthcare requires comprehensive diagnostic documentation to establish medical necessity:

Essential lab work:

  • Enzyme activity: IDUA enzyme deficiency in leukocytes or dried blood spot
  • Glycosaminoglycan (GAG) levels: Elevated dermatan sulfate and heparan sulfate in urine
  • Genetic testing: IDUA gene sequencing showing pathogenic variants (when available)

Clinical assessments:

  • Baseline disease severity measures (pulmonary function, echocardiogram, joint range of motion)
  • Documentation of organ involvement (hepatosplenomegaly, cardiac valve disease, corneal clouding)
  • Growth and developmental assessments for pediatric patients

Timing requirements: Diagnostic tests should be recent (within 6 months for initial authorization, within 12 months for renewals) unless clinically stable.

Specialty Pharmacy Requirements

Aldurazyme must be obtained through UnitedHealthcare's contracted specialty pharmacy network and administered in appropriate clinical settings.

Distribution requirements:

  • Specialty pharmacy fulfillment only (no retail pharmacy)
  • Prior authorization must be approved before specialty pharmacy shipment
  • Coordination with infusion center or hospital outpatient department

Site of care:

  • Hospital outpatient infusion centers (preferred)
  • Physician offices with appropriate emergency equipment
  • Home infusion (case-by-case approval, requires demonstrated patient stability)

Safety monitoring: Emergency resuscitation equipment must be available during all infusions due to risk of infusion-associated reactions.

Supporting Clinical Evidence

When submitting prior authorization requests, include evidence from established clinical guidelines and peer-reviewed literature:

Key references to cite:

  • FDA prescribing information for approved indications and dosing
  • International MPS I treatment guidelines from metabolic societies
  • Published efficacy data showing clinical benefit in similar patient populations

Clinical rationale should address:

  • Why enzyme replacement therapy is appropriate for this patient's MPS I severity
  • Expected clinical benefits (respiratory, cardiac, functional improvements)
  • Monitoring plan for treatment response and safety

Sample Medical Necessity Letter

Template structure for clinician letters:

"[Patient name] is a [age]-year-old with genetically confirmed mucopolysaccharidosis I (ICD-10: E76.0X) demonstrated by [genetic testing results/enzyme deficiency]. Clinical presentation includes [specific manifestations: hepatosplenomegaly, joint stiffness, cardiac involvement, etc.]. IDUA enzyme activity is [specific value] (normal >X), and urine GAG levels show elevation of dermatan sulfate ([value]) and heparan sulfate ([value]).

Current weight is [X kg], requiring Aldurazyme 0.58 mg/kg = [calculated dose] weekly via IV infusion. The patient meets FDA-approved criteria for enzyme replacement therapy. Expected benefits include [specific clinical goals]. Hematopoietic stem cell transplant was considered but [deemed inappropriate/contraindicated/declined] due to [specific reasons]. Regular monitoring will include [pulmonary function, echocardiograms, clinical assessments] every [frequency]."

Special Considerations

Pediatric patients:

  • Minimum age 6 months for coverage
  • Growth-based dose adjustments required more frequently
  • Developmental milestone tracking may support reauthorization

Pregnancy and reproductive age:

  • Limited safety data; case-by-case review
  • Risk-benefit analysis required in medical necessity letter

Comorbidities:

  • Respiratory compromise may require expedited review
  • Cardiac involvement supports medical urgency arguments
  • Multiple organ system involvement strengthens necessity case

Escalation for complex cases: Contact UnitedHealthcare's medical director for peer-to-peer review when standard criteria don't fully address patient complexity.

Appeals Process in Georgia

If UnitedHealthcare denies your Aldurazyme prior authorization, Georgia provides robust appeal rights through internal and external review processes.

Internal Appeals with UnitedHealthcare:

  • Timeline: 180 days from denial date to file
  • Standard review: 30 days for decision
  • Expedited review: 72 hours for urgent cases
  • Submission: UnitedHealthcare provider portal or member services

Georgia External Review Process:

  • Eligibility: Must exhaust internal appeals first
  • Timeline: 60 days from final internal denial to file (stricter than federal 120-day standard)
  • Cost: Free to consumers
  • Process: Independent medical review by specialists in the same field
  • Decision timeline: 30 business days (72 hours for expedited)
  • Contact: Georgia Department of Insurance at 1-800-656-2298

Required documentation for appeals:

  • All denial letters from UnitedHealthcare
  • Complete medical records supporting MPS I diagnosis
  • Updated medical necessity letter addressing specific denial reasons
  • Evidence that patient meets all coverage criteria
From our advocates: We've seen successful appeals when families gather comprehensive genetic testing results and document all failed or inappropriate alternative treatments. The key is addressing each specific denial reason with clinical evidence—generic letters rarely succeed, but targeted responses citing UnitedHealthcare's own policy language often overturn denials.

The Georgia external review process is binding on UnitedHealthcare and provides a powerful tool for overturning wrongful denials. Success rates are higher when comprehensive medical documentation demonstrates clear medical necessity.

Cost Assistance Programs

Manufacturer support (Sanofi):

  • Copay assistance programs for commercially insured patients
  • Patient assistance programs for uninsured/underinsured based on financial need
  • Reimbursement support services for prior authorization and appeals
  • Contact: Sanofi CareConnect or through prescriber

Additional resources:

  • National Organization for Rare Disorders (NORD) patient assistance programs
  • HealthWell Foundation grants for eligible rare disease patients
  • Georgia Medicaid coverage for qualifying low-income patients

Financial screening: Most assistance programs require income verification and proof of insurance denial or high out-of-pocket costs.

Quick Reference Checklist

Before submitting your Aldurazyme prior authorization:

✓ Confirmed MPS I diagnosis (genetic testing or enzyme assay)
✓ Correct ICD-10 code (E76.01, E76.02, or E76.03)
✓ Current patient weight for accurate dosing calculation
✓ Specialist evaluation (preferably genetics or metabolic specialist)
✓ Baseline clinical assessments (pulmonary, cardiac, developmental)
✓ Documentation of disease severity and expected treatment benefits
✓ HCPCS code J1931 for billing
✓ Specialty pharmacy coordination arranged
✓ Infusion site identified with emergency equipment available

Common denial reasons and fixes:

Denial Reason Required Fix Where to Find It
Missing genetic confirmation Submit IDUA gene sequencing results Genetics lab report
Incorrect dosing Recalculate based on current weight (0.58 mg/kg) Recent clinic visit
Missing ICD-10 code Add E76.01-E76.03 to medical records Specialist evaluation
Insufficient clinical documentation Provide detailed phenotype description Comprehensive exam notes
Step therapy requirement Document no alternatives exist for MPS I ERT Medical necessity letter

Need help navigating UnitedHealthcare's prior authorization process? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific coverage criteria, and drafts point-by-point rebuttals aligned to each payer's own rules—helping patients, clinicians, and specialty pharmacies get prescription drugs approved faster.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan type and may change. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions. For personalized assistance with Georgia insurance appeals, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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