How to Get Aldurazyme (Laronidase) Covered by Aetna CVS Health in Illinois: Prior Authorization, Appeals & Cost Assistance

Answer Box: Getting Aldurazyme (Laronidase) Covered by Aetna CVS Health in Illinois

Fast track to approval: Have your prescriber submit prior authorization through Aetna's specialty pharmacy portal with genetic confirmation of MPS I, baseline disease assessments, and clinical rationale. First step today: Call CVS Specialty at 1-866-814-5506 to initiate the PA process while your doctor gathers documentation. Illinois advantage: State law limits step therapy for fully insured plans, and you have strong external review rights with 30-day deadlines. Most denials are overturned when proper evidence is submitted.


Table of Contents

  1. What Drives Aldurazyme Coverage Costs
  2. Benefit Investigation: What to Ask Aetna CVS Health
  3. Financial Assistance Options
  4. Prior Authorization Requirements
  5. CVS Specialty Pharmacy Coordination
  6. Appeals Process for Illinois Residents
  7. Annual Renewal Planning
  8. Conversation Scripts
  9. FAQ

What Drives Aldurazyme Coverage Costs

Aldurazyme (laronidase) costs approximately $200,000-$400,000 annually, making it one of the most expensive specialty medications. Your out-of-pocket costs with Aetna CVS Health depend on several key factors:

Formulary Tier Placement

  • Aldurazyme typically sits on Tier 4 or 5 (specialty tier)
  • Aetna's 2024 specialty drug list includes laronidase with prior authorization requirements
  • Copays often range from $500-$1,000+ per month before assistance

Coverage Variables

  • Plan type: Fully insured vs. self-funded (affects Illinois step therapy protections)
  • Deductible: High-deductible plans may require meeting $3,000-$8,000 before coverage begins
  • Out-of-pocket maximum: Typically $8,000-$18,000 annually for specialty drugs
Note: Illinois residents with fully insured Aetna plans may be exempt from step therapy requirements under state law, but this must be verified with your specific plan documents.

Benefit Investigation: What to Ask Aetna CVS Health

Before starting treatment, gather this essential information by calling the number on your insurance card:

Key Questions for Member Services

Coverage Basics

  • "Is Aldurazyme (laronidase) covered on my formulary?"
  • "What tier is it placed on, and what's my copay?"
  • "Do I need prior authorization?"
  • "Is there a step therapy requirement?"

Cost Information

  • "What's my specialty drug deductible and out-of-pocket maximum?"
  • "Does my plan cover infusion administration separately?"
  • "Are there quantity limits per month?"

Pharmacy Requirements

  • "Must I use CVS Specialty, or are other specialty pharmacies covered?"
  • "Can my first fill be at a retail pharmacy?"

Information to Record

Create a coverage summary with:

  • Policy/member ID number
  • Plan year and renewal date
  • Prior authorization phone/fax numbers
  • Specialty pharmacy contact information
  • Representative name and reference number

Financial Assistance Options

Multiple programs can dramatically reduce your Aldurazyme costs:

Sanofi CareConnect Copay Assistance

Eligibility Requirements:

  • Commercial insurance (not Medicare/Medicaid)
  • U.S. resident prescribed Aldurazyme for FDA-approved MPS I indications
  • Coverage up to 100% of out-of-pocket costs including copays and deductibles

How to Apply:

Patient Assistance Program (Free Drug)

For uninsured or underinsured patients:

  • Provides Aldurazyme at no cost based on financial need
  • Requires income documentation and physician participation
  • Contact same CareConnect number for application

Foundation Support

National MPS Society

  • Offers supportive care grants ($500-$2,000)
  • Covers travel, medical equipment, home modifications
  • Does not directly pay for medication costs
  • Apply through their website with diagnosis confirmation

HealthWell Foundation

  • Rare disease copay assistance when available
  • Check eligibility at healthwellfoundation.org

Prior Authorization Requirements

Aetna CVS Health requires prior authorization for all Aldurazyme prescriptions. Here's what your doctor needs to submit:

Required Documentation

Clinical Evidence

  • Confirmed MPS I diagnosis (genetic testing preferred)
  • Baseline disease severity assessments
  • Documentation of symptoms (hepatosplenomegaly, joint stiffness, cardiac involvement)
  • ICD-10 codes: E76.01 (Hurler syndrome), E76.02 (Hurler-Scheie syndrome), E76.03 (Scheie syndrome)

Treatment Plan

  • Dosing rationale (0.58 mg/kg IV weekly)
  • Infusion site and administration plan
  • Monitoring schedule for treatment response
  • Plan for managing infusion reactions

Submission Process

Contact Information:

  • Specialty Drug PA: 1-866-814-5506 (TTY: 711)
  • Fax: 1-866-249-6155
  • Availity Provider Portal: Most efficient method

Timeline Expectations:

  • Standard review: 72 hours after complete submission
  • Expedited review: 24 hours for urgent cases
  • Missing information requests add 1-3 business days
Clinician Corner: Include FDA labeling excerpts and MPS I treatment guidelines in your medical necessity letter. Reference the 2006 FDA approval data showing significant reduction in urinary glycosaminoglycans and liver/spleen size improvements.

CVS Specialty Pharmacy Coordination

Aldurazyme requires specialty pharmacy dispensing due to its complex handling and infusion requirements:

CVS Specialty Benefits

Comprehensive Support

  • Prior authorization submission assistance
  • Insurance verification and appeals support
  • Coordination with infusion centers or home health
  • Temperature-controlled shipping (2-8°C required)
  • Patient education on infusion procedures

Cost Management

  • Automatic enrollment in manufacturer assistance programs
  • Copay card processing
  • Foundation grant application support
  • Appeals assistance for coverage denials

Coordination Tips

  1. Contact CVS Specialty early: Call 1-866-814-5506 as soon as prescribed
  2. Verify infusion site: Confirm your preferred location accepts CVS Specialty deliveries
  3. Schedule consistently: Maintain weekly infusion schedule to avoid treatment gaps
  4. Monitor shipments: Track deliveries to prevent medication from sitting unrefrigerated

Appeals Process for Illinois Residents

Illinois provides robust appeal rights with specific timelines and protections:

Aetna Internal Appeals

Level 1: Standard Appeal

  • Deadline: 180 days from denial date
  • Timeline: Decision within 30 days (15 days for pre-service)
  • How to file: Call Member Services or submit written request
  • Required: Copy of denial letter, medical records, physician statement

Expedited Appeals

  • When to use: Delay would seriously jeopardize health
  • Timeline: 72 hours for decision
  • Documentation: Physician attestation of urgency required

Illinois External Review

After internal appeal denial, Illinois law guarantees independent review:

Key Requirements:

  • Deadline: 30 days from final internal denial (shorter than most states)
  • Cost: Free to consumers
  • Reviewer: Board-certified physician with MPS expertise
  • Timeline: Decision within 5 business days of complete file review

How to Request:

  • Contact Illinois Department of Insurance: 877-527-9431
  • Submit external review application
  • Provide all medical records and appeal correspondence
Illinois Advantage: The state's Health Carrier External Review Act ensures binding decisions. If the independent reviewer approves Aldurazyme, Aetna must cover it.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Lack of genetic confirmation Submit enzyme assay or genetic test results
Insufficient disease severity Provide baseline assessments, imaging, pulmonary function tests
Step therapy not attempted Request exception based on MPS I severity and lack of alternatives
"Experimental" designation Submit FDA approval documentation and published efficacy data

Annual Renewal Planning

Plan ahead to avoid treatment interruptions:

What Changes Annually

  • Formulary placement: Drugs can move tiers or require new restrictions
  • Copay assistance limits: Manufacturer programs reset January 1st
  • Prior authorization: May need renewal even if previously approved

Renewal Checklist (Complete by November)

  • Verify Aldurazyme remains covered for next plan year
  • Re-enroll in Sanofi CareConnect copay assistance
  • Update income documentation for patient assistance programs
  • Schedule infusion appointments to avoid holiday delays
  • Confirm CVS Specialty remains in-network

Conversation Scripts

Calling Aetna Member Services

"Hi, I'm calling about coverage for Aldurazyme, generic name laronidase, for mucopolysaccharidosis type I. My member ID is [number]. I need to know: Is this covered on my formulary? What's my copay? Do I need prior authorization? Is there step therapy? Can you transfer me to specialty pharmacy benefits?"

Provider Peer-to-Peer Request

"I'm requesting a peer-to-peer review for Aldurazyme denial for my patient with confirmed MPS I. The patient has documented enzyme deficiency, progressive organ involvement, and no alternative treatments exist. When can we schedule the clinical discussion?"

CVS Specialty Initial Call

"My doctor prescribed Aldurazyme for MPS I. I have Aetna insurance and need help with prior authorization, checking my benefits, and enrolling in cost assistance programs. Can you assign me a case manager?"


FAQ

How long does Aetna CVS Health prior authorization take for Aldurazyme in Illinois? Standard PA decisions are made within 72 hours of complete submission. Expedited reviews (when delay poses health risks) are completed within 24 hours.

What if Aldurazyme is non-formulary on my Aetna plan? Request a formulary exception through your doctor. Provide clinical rationale showing medical necessity and lack of suitable alternatives. Illinois fully insured plans may have additional protections.

Can I request an expedited appeal in Illinois? Yes, both Aetna internal appeals and Illinois external reviews offer expedited timelines when delays would seriously jeopardize your health. Your doctor must provide supporting documentation.

Does step therapy apply to Aldurazyme with Aetna in Illinois? Step therapy requirements may not apply to fully insured commercial plans in Illinois due to state law protections. Self-funded plans may still require step therapy, but exceptions are available.

How much will Aldurazyme cost with Aetna coverage? With commercial insurance, copays typically range from $500-$1,000+ monthly. Sanofi's CareConnect program can reduce this to $0 for eligible patients. Check current copay structures.

What happens if my appeal is denied? Illinois residents can request external review within 30 days of final internal denial. This independent physician review is binding and free to consumers.


Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals aligned to each plan's own rules, pulling the right citations and clinical evidence to support Aldurazyme coverage requests.

For complex cases involving multiple denials or appeals, consider working with experienced advocates who understand both Aetna's specific requirements and Illinois appeal processes. The right documentation and strategic approach can make the difference between approval and continued denials.


Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always consult your insurance plan documents, healthcare provider, and the Illinois Department of Insurance for the most current requirements and assistance with your specific situation.

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