By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (laronidase) Covered by Blue Cross Blue Shield in California: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Aldurazyme Coverage in California

Blue Shield of California covers Aldurazyme (laronidase) as a specialty drug requiring prior authorization for MPS I patients. The fastest path to approval: (1) Gather genetic/enzymatic confirmation of MPS I diagnosis, (2) Document baseline disease severity and prior treatment failures, (3) Submit complete prior authorization with specialist attestation. If denied, California's Independent Medical Review (IMR) system has strong success rates—approximately 50% of specialty drug denials are overturned. Start today by contacting your prescriber to initiate the prior authorization process through Blue Shield's provider portal.

Table of Contents

  1. Coverage Requirements Overview
  2. Patient Profile: Who Qualifies for Aldurazyme
  3. Pre-Authorization Preparation
  4. Submission Process
  5. Common Denial Reasons & Solutions
  6. California Appeals Process
  7. Costs and Financial Assistance
  8. When to Escalate
  9. FAQ

Coverage Requirements Overview

Blue Shield of California designates Aldurazyme as a specialty drug requiring prior authorization for medical necessity. The coverage became effective July 1, 2025, following Blue Shield's laronidase policy guidelines.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before dispensing Blue Shield PA Policy List
Specialty Drug Status Requires specialist prescriber Specialty Drug List (linked above)
Medical Necessity Must meet specific clinical criteria Laronidase policy document
Genetic Confirmation Documented MPS I diagnosis required FDA label requirements
Infusion Monitoring Plan Safety protocols must be in place FDA prescribing information

Patient Profile: Who Qualifies for Aldurazyme

Aldurazyme (laronidase) is FDA-approved enzyme replacement therapy for mucopolysaccharidosis I (MPS I), including Hurler, Hurler-Scheie, and Scheie syndromes. At approximately $1,113.38 per 2.9 mg vial, it's one of the most expensive treatments in medicine, making proper documentation crucial.

Required Diagnostic Confirmation

Insurance approval requires comprehensive diagnostic evidence:

Enzymatic Testing:

Genetic Testing:

Clinician Corner: The most common denial reason is insufficient diagnostic documentation. Ensure your prior authorization includes both enzymatic and genetic confirmation, not just clinical suspicion of MPS I.

Pre-Authorization Preparation

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis Documentation (Patient/Clinic)
    • Gather genetic test results showing IDUA mutations
    • Obtain enzymatic testing confirming alpha-L-iduronidase deficiency
    • Timeline: Same day if records available
  2. Establish Baseline Disease Severity (Clinic)
    • Document pulmonary function tests
    • Record hepatosplenomegaly measurements
    • Assess mobility and developmental status
    • Timeline: 1-2 weeks for complete assessment
  3. Document Prior Treatment History (Clinic)
    • List any previous therapies attempted
    • Record contraindications to alternative treatments
    • Note why HSCT is not appropriate (if applicable)
    • Timeline: 1-3 days for record compilation
  4. Develop Infusion Safety Plan (Clinic/Infusion Center)
  5. Submit Prior Authorization (Clinic)
    • Complete Blue Shield PA forms
    • Submit via provider portal
    • Timeline: Same day submission
  6. Track Decision Timeline (Patient/Clinic)
    • Standard review: 72 hours
    • Expedited review: 24 hours if urgent
    • Timeline: 1-3 business days
  7. Prepare for Potential Appeal (Patient/Clinic)
    • Gather additional literature support
    • Identify peer-to-peer review options
    • Timeline: Ongoing preparation

Submission Process

Required Documentation Package

Your prior authorization submission must include:

Clinical Documentation:

  • Complete medical history and physical examination
  • Genetic testing results with IDUA gene analysis
  • Enzymatic testing showing alpha-L-iduronidase deficiency
  • Baseline organ function assessments
  • Treatment goals and monitoring plan

Insurance-Specific Forms:

Safety Documentation:

  • Infusion center certification
  • Emergency response protocols
  • Patient/caregiver education materials
From our advocates: We've seen the strongest approvals when clinicians include a detailed letter explaining why Aldurazyme is the only viable option, referencing the lack of alternative enzyme replacement therapies and specific contraindications to HSCT. This personalized approach often expedites approval.

How to Submit

Submit through Blue Shield's provider portal or contact Customer Service at the number on your member ID card for assistance. For expedited decisions when standard 72-hour review may jeopardize patient health, specifically request 24-hour expedited review.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Insufficient diagnostic confirmation Submit complete genetic and enzymatic testing results
Missing baseline assessments Provide pulmonary function, hepatosplenomegaly, and mobility evaluations
Lack of specialist attestation Obtain letter from genetics/metabolism specialist
Inadequate safety monitoring plan Submit detailed infusion protocols and emergency procedures
Alternative treatment not attempted Document contraindications to HSCT or previous failures

Medical Necessity Letter Checklist

When appealing a denial, ensure your medical necessity letter includes:

  • Problem statement: Confirmed MPS I diagnosis with specific subtype
  • Prior treatments: Documentation of why HSCT is contraindicated
  • Clinical rationale: Expected benefits based on FDA labeling
  • Guideline citations: Reference to FDA approval and MPS I treatment guidelines
  • Dosing rationale: Weight-based dosing calculation (0.58 mg/kg weekly)
  • Monitoring plan: Detailed safety protocols and outcome measures

California Appeals Process

California offers one of the strongest patient protection systems in the country through its Independent Medical Review (IMR) process.

Appeals Playbook for Blue Shield in California

Level 1: Internal Appeal (Grievance)

  • Timeline: File within 180 days of denial
  • Decision time: 30 days (or expedited if urgent)
  • How to file: Blue Shield grievance process
  • Required: Copy of denial letter, additional medical evidence

Level 2: Independent Medical Review (IMR)

  • Timeline: File within 6 months of internal appeal decision
  • Decision time: 45 days standard, 7 days expedited
  • How to file: DMHC Help Center at 888-466-2219
  • Success rate: Approximately 50% of specialty drug denials overturned for Blue Cross plans

California's IMR Advantage

Recent DMHC data shows that Blue Cross of California had 863 Independent Medical Reviews in 2023, with particularly poor insurer success rates for experimental/investigational denials—only 49.1% of denials were upheld after independent review. This suggests many specialty drug denials lack sufficient medical justification.

Costs and Financial Assistance

Manufacturer Support Programs

Sanofi Patient Assistance:

  • Copay assistance for eligible commercial insurance patients
  • Free drug programs for uninsured/underinsured patients
  • Contact: Aldurazyme patient support

State and Federal Programs

California Medicaid (Medi-Cal):

  • Covers Aldurazyme for eligible patients
  • No copay for most covered services
  • Apply through Covered California

Medicare Coverage:

  • Part B coverage for infusion in clinical settings
  • Part D may cover take-home portions
  • Medicare Advantage plans follow similar PA requirements

When to Escalate

Contact California regulators if Blue Shield fails to follow proper procedures:

Department of Managed Health Care (DMHC):

California Department of Insurance (CDI):

  • Oversees some PPO and indemnity plans
  • Consumer Hotline: 800-927-4357

When to escalate:

  • Blue Shield misses appeal deadlines
  • Requests for expedited review are ignored
  • Procedural violations in the review process

At Counterforce Health, we help patients and clinicians navigate complex prior authorization and appeal processes by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned to plan policies, pulling the right medical evidence and weaving it into appeals that meet procedural requirements.

FAQ

How long does Blue Shield PA take in California? Standard prior authorization decisions are made within 72 hours. Expedited reviews for urgent cases are decided within 24 hours.

What if Aldurazyme is non-formulary on my plan? Submit a formulary exception request with documentation that formulary alternatives are contraindicated or have failed.

Can I request an expedited appeal? Yes, if standard timelines may seriously jeopardize your health. Contact Blue Shield member services to request expedited review.

Does step therapy apply if I've tried treatments outside California? Prior treatment documentation from other states is generally accepted. Ensure your new California provider has complete records of previous therapies.

What counts as medical necessity for Aldurazyme? Confirmed MPS I diagnosis with documented enzyme deficiency, appropriate candidate for ERT (not HSCT), and established monitoring plan for infusion safety.

How much does Aldurazyme cost without insurance? The wholesale acquisition cost is approximately $1,113.38 per 2.9 mg vial, with most patients requiring weekly infusions based on weight.

Can specialty pharmacies help with the PA process? Yes, many specialty pharmacies have dedicated prior authorization teams experienced with rare disease medications and can assist with documentation.

What happens if my appeal is denied? You can request an Independent Medical Review through the DMHC, which provides binding decisions from independent medical experts with strong success rates for specialty drugs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan terms. Always consult with your healthcare provider and insurance plan directly for specific coverage questions. For additional assistance with complex appeals, consider consulting with organizations like Counterforce Health that specialize in insurance authorization support.

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