By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (laronidase) Covered by Aetna CVS Health in California: Complete Prior Authorization & Appeal Guide

Quick Answer: Getting Aldurazyme Covered by Aetna CVS Health in California

Aldurazyme (laronidase) requires prior authorization from Aetna CVS Health for all plan types in California. Coverage is approved for confirmed MPS I (Hurler, Hurler-Scheie, or moderate-to-severe Scheie forms) with enzyme/genetic testing documentation. The medication is placed on specialty tiers (Tier 4/5) and must be dispensed through CVS Specialty Pharmacy.

Fastest path to approval: Submit prior authorization with MPS I diagnostic confirmation (enzyme assay and/or genetic testing) plus specialist attestation through Aetna's provider portal. Allow 2-3 weeks for review. If denied, California residents can appeal through DMHC Independent Medical Review with 30-55% success rates for specialty drug appeals.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Enrollment
  5. Cost-Share Dynamics
  6. Submission Process
  7. Common Approval Patterns
  8. Appeals Process in California
  9. FAQ

Plan Types & Coverage Implications

Aetna CVS Health offers several plan types in California, each with different implications for Aldurazyme coverage:

HMO Plans: Require referrals to specialists and prior authorization for all specialty medications. Your primary care physician must refer you to a metabolic or genetic specialist who can prescribe Aldurazyme.

PPO Plans: Allow direct access to specialists without referrals, but still require prior authorization for specialty drugs like Aldurazyme. You have more flexibility in choosing providers.

EPO Plans: Combine aspects of HMO and PPO plans. No referrals needed for specialists, but you must stay within the Aetna network for coverage.

Medicare Advantage: Follow Medicare guidelines with additional Aetna requirements. Coverage criteria align with commercial plans but may have different forms and processes.

Note: All Aetna CVS Health plan types in California require prior authorization for Aldurazyme, regardless of plan structure.

Formulary Status & Tier Placement

Aldurazyme is classified as a specialty medication on Aetna formularies and typically placed on Tier 4 or Tier 5 (highest cost-sharing tiers). This placement reflects the medication's high cost and specialized nature.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all plan types Aetna Formulary
Formulary Tier Tier 4/5 (Specialty) CVS Specialty Drug List
Step Therapy Not typically required Aetna Policy
Quantity Limits Per FDA labeling Aetna Policy
Specialty Pharmacy CVS Specialty required CVS Specialty

No Direct Alternatives: Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I. There are no generic versions or therapeutic alternatives that would trigger step therapy requirements.

Prior Authorization Requirements

Aetna CVS Health requires comprehensive documentation for Aldurazyme prior authorization approval:

Required Documentation

1. Confirmed MPS I Diagnosis:

  • Alpha-L-iduronidase enzyme activity assay results showing deficiency
  • Genetic testing confirming MPS I mutations (IDUA gene)
  • Clinical presentation consistent with MPS I

2. Disease Subtype Classification:

  • Hurler form (severe MPS I)
  • Hurler-Scheie form (attenuated MPS I)
  • Scheie form with moderate to severe symptoms

3. Specialist Documentation:

  • Prescription from metabolic, genetic, or relevant pediatric subspecialist
  • Clinical assessment of disease severity
  • Treatment goals and monitoring plan

4. Baseline Assessments:

  • Cardiac evaluation (echocardiogram, EKG)
  • Pulmonary function tests
  • Hepatic status assessment
  • Joint mobility evaluation
Important: Mildly affected Scheie syndrome patients may be denied as the risks/benefits have not been established for this population.

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Strong PA Submissions:

✓ Problem Statement: Clear MPS I diagnosis with subtype specification ✓ Diagnostic Evidence: Enzyme assay results and/or genetic testing ✓ Clinical Rationale: Disease severity and expected treatment benefits ✓ Guideline Support: Reference to FDA labeling and expert consensus ✓ Dosing Plan: Weight-based dosing per FDA recommendations ✓ Monitoring Protocol: Infusion reaction management and clinical assessments

CVS Specialty Pharmacy Enrollment

All Aldurazyme prescriptions must be filled through CVS Specialty Pharmacy. Here's the enrollment process:

Step-by-Step Enrollment

1. Prescriber Completes Enrollment Form

  • Download the CVS Specialty enrollment form
  • Include patient demographics, insurance information, and clinical documentation
  • Submit via ePrescribe, phone, or fax

2. Patient Registration

  • Register at caremark.com using CVS Caremark Prescription ID Card
  • Provide contact information and delivery preferences
  • Set up prescription tracking and refill notifications

3. Insurance Verification

  • CVS Specialty verifies coverage and prior authorization status
  • Coordinates with Aetna for PA approval if not already obtained
  • Confirms specialty pharmacy benefits

4. Infusion Coordination

  • CVS Specialty arranges delivery to infusion site
  • Coordinates with healthcare providers for scheduling
  • Provides infusion supplies and nursing services if needed
Tip: Allow 7-10 business days for initial enrollment and first shipment coordination.

Cost-Share Dynamics

Understanding your out-of-pocket costs helps with financial planning:

Typical Cost Structure

Specialty Tier Coinsurance: 25-40% of the drug cost after deductible Annual Deductible: May apply before coinsurance kicks in Out-of-Pocket Maximum: Protects against catastrophic costs

Example Cost Calculation:

  • Aldurazyme WAC: ~$1,113 per 2.9mg vial
  • Monthly cost (4 vials): ~$4,452
  • Annual cost: ~$53,424
  • Patient responsibility (30% coinsurance): ~$16,027 annually

Financial Assistance Options

Manufacturer Support:

Foundation Grants:

  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation
  • Patient Advocate Foundation

Submission Process

Fastest Path to Approval: 7 Steps

1. Gather Required Documents (Patient/Clinic)

  • Insurance cards (front and back)
  • Enzyme assay and/or genetic test results
  • Specialist evaluation notes
  • Baseline cardiac, pulmonary, and hepatic assessments

2. Complete Prior Authorization Form (Prescriber)

  • Use Aetna's precertification form
  • Include all required clinical documentation
  • Specify exact dosing and frequency

3. Submit Through Provider Portal (Prescriber)

  • Log into Aetna provider portal or use Availity
  • Upload all supporting documents
  • Verify submission confirmation

4. CVS Specialty Enrollment (Prescriber/Patient)

  • Complete specialty pharmacy enrollment simultaneously
  • Provide insurance verification
  • Coordinate delivery logistics

5. Monitor PA Status (Patient/Clinic)

  • Check status through provider portal
  • Follow up if no response within 5 business days
  • Prepare for potential peer-to-peer review

6. Appeal if Denied (Patient/Clinic)

  • File internal appeal within 180 days
  • Provide additional clinical evidence if available
  • Consider peer-to-peer review

7. External Review if Needed (Patient)

  • Request California DMHC Independent Medical Review
  • Submit within 6 months of denial
  • Provide comprehensive medical records

Common Approval Patterns

Strong submissions typically include:

  • Clear diagnostic confirmation with specific enzyme levels or genetic variants
  • Specialist attestation from metabolic or genetic disease expert
  • Comprehensive baseline disease severity assessment
  • Detailed monitoring plan for infusion reactions and clinical response
  • Reference to FDA labeling and treatment guidelines

Weak submissions often lack:

  • Specific enzyme assay results or genetic testing
  • Adequate documentation of disease severity
  • Specialist involvement in diagnosis and treatment planning
  • Clear treatment goals and monitoring protocols

Appeals Process in California

California offers robust appeal rights through the Department of Managed Health Care (DMHC).

Internal Appeals (First Level)

Timeline: 30 days for standard appeals, 72 hours for urgent How to File: Through Aetna member portal or written request Required: Denial letter, medical records, physician statement

Independent Medical Review (External Appeal)

Eligibility: Denials based on medical necessity, experimental/investigational status Timeline: File within 6 months of denial Process: DMHC assigns independent physician reviewers Success Rate: 30-55% for specialty drug appeals

To File an IMR:

  1. Complete DMHC IMR application
  2. Include denial letters and medical records
  3. Submit physician statement supporting medical necessity
  4. Wait for independent review (45 days standard, 7 days expedited)
From our advocates: "We've seen MPS I patients succeed in California IMR by providing comprehensive genetic testing results, specialist evaluations, and clear documentation of disease progression. The key is showing that Aldurazyme is medically necessary and not experimental for the specific MPS I subtype."

When to Escalate

Contact DMHC Help Center: (888) 466-2219

  • If Aetna doesn't respond to appeals within required timeframes
  • For assistance filing IMR applications
  • When you need help understanding your appeal rights

File Complaint with DMHC:

  • Pattern of inappropriate denials
  • Failure to follow California insurance regulations
  • Delays in processing urgent requests

FAQ

Q: How long does Aetna CVS Health prior authorization take in California? A: Standard PA decisions are made within 2-3 business days after all documentation is received. Urgent requests are processed within 24-72 hours.

Q: What if Aldurazyme is non-formulary on my plan? A: Request a formulary exception with medical necessity documentation. Aetna typically covers FDA-approved indications even for non-formulary drugs when medically necessary.

Q: Can I request an expedited appeal if my condition is urgent? A: Yes, if your physician certifies that delays could seriously jeopardize your health. Expedited appeals are processed within 72 hours.

Q: Does step therapy apply if I haven't tried other treatments? A: No, step therapy typically doesn't apply to Aldurazyme because there are no alternative FDA-approved treatments for MPS I.

Q: What happens if CVS Specialty can't fill my prescription? A: CVS Specialty is the exclusive distributor for Aetna plans. If there are supply issues, they'll coordinate with the manufacturer and your healthcare team for alternatives.

Q: How do I track my appeal status? A: Use the Aetna member portal online or call member services. For DMHC IMR, you'll receive written updates on your case status.

Q: Can I get financial assistance while my appeal is pending? A: Yes, consider manufacturer patient assistance programs, foundation grants, or temporary coverage through your healthcare provider's compassionate use programs.

Q: What if my doctor isn't familiar with MPS I? A: Request a referral to a metabolic or genetic disease specialist. Many university medical centers in California have rare disease programs with MPS I expertise.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements. For complex cases like Aldurazyme appeals, Counterforce Health provides the specialized documentation and evidence needed to maximize approval chances.

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 plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with California insurance appeals, contact the DMHC Help Center at (888) 466-2219.

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