By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Aetna (CVS Health) in Michigan: Complete Timeline & Appeals Guide

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

Aldurazyme (laronidase) requires prior authorization from Aetna (CVS Health) for all Michigan plans. The fastest approval path involves: (1) confirming MPS I diagnosis with genetic/enzyme testing, (2) having your specialist submit complete PA documentation via Availity portal, and (3) enrolling with CVS Specialty Pharmacy. Standard approvals take 1-5 days with complete documentation; expedited reviews are decided within 72 hours for urgent cases. If denied, Michigan patients have 180 days for internal appeals and 127 days for external review through Michigan DIFS.

First step today: Call Aetna member services (number on your ID card) to confirm your plan's specialty drug pathway and verify CVS Specialty is required for Aldurazyme dispensing.

Table of Contents

What Affects Aldurazyme Approval Timing

Several factors influence how quickly Aetna (CVS Health) approves Aldurazyme in Michigan:

Benefit Structure: Aldurazyme is classified as a Tier 4/5 specialty medication requiring dispensing through CVS Specialty Pharmacy. This adds coordination steps but streamlines the approval process once properly routed.

Documentation Completeness: Aetna reports that over 95% of eligible prior authorizations are approved within 24 hours when submitted electronically with complete clinical information.

Clinical Complexity: MPS I (mucopolysaccharidosis type I) requires specific diagnostic confirmation—genetic testing of the IDUA gene and enzymatic confirmation of deficient alpha-L-iduronidase activity. Missing these elements causes delays.

Pre-Submission Preparation (0-2 Days)

Checklist: What to Gather Before Starting

  • Insurance verification: Aetna member ID, group number, and current coverage details
  • MPS I diagnosis confirmation: Genetic testing results showing IDUA gene mutations
  • Enzymatic testing: Alpha-L-iduronidase enzyme activity results (typically <10% of normal)
  • Baseline assessments: Cardiac echo, pulmonary function tests, liver function, growth parameters
  • Specialist documentation: Notes from geneticist or metabolic disease specialist
  • ICD-10 codes: E76.01 (Hurler), E76.02 (Hurler-Scheie), or E76.03 (Scheie syndrome)
  • Prior therapy history: Any previous treatments attempted or contraindications

Verify Your Benefit Pathway

Call Aetna member services and ask:

  • Is Aldurazyme covered under medical benefit or pharmacy benefit?
  • Is CVS Specialty Pharmacy mandatory for dispensing?
  • Are there site-of-care requirements for infusions?
  • What's your current deductible status and specialty drug copay?

Submission to Initial Review (1-5 Days)

Step-by-Step: Fastest Path to Approval

  1. Specialist Completes PA Form (Same Day)
  2. CVS Specialty Enrollment (1-2 Days)
    • Call CVS Specialty: 1-866-814-5506
    • Patient registers at caremark.com
    • Verify shipping address and infusion site coordination
  3. PA Processing (1-5 Days Standard)
    • Aetna reviews against MPS I clinical criteria
    • Standard decisions: up to 15-30 days allowed, typically 1-5 days
    • Expedited reviews: 72 hours for urgent cases
  4. Approval Notification (Same Day)
    • Provider receives approval via portal
    • CVS Specialty coordinates drug shipment and infusion scheduling
Tip: Request expedited review if delaying treatment could cause irreversible organ damage or disease progression. Your specialist must document medical urgency in the PA request.

If Additional Information is Requested

Aetna may request clarification on:

  • Genetic testing specifics: IDUA gene sequencing results with variant classification
  • Disease severity: Baseline organ function assessments
  • Dosing rationale: Weight-based calculations and infusion frequency
  • Monitoring plan: Safety protocols for infusion reactions

Response timeline: Submit additional information within 14 days to avoid PA expiration. Use the same Availity portal or fax number provided in the request.

Decision Window & Outcomes

Approval Letter Elements

  • Drug coverage: Aldurazyme 2.9 mg/5 mL vials
  • Quantity limits: Per FDA labeling (weekly infusions)
  • Duration: Typically 12 months with annual reauthorization
  • Dispensing: CVS Specialty Pharmacy exclusive
  • Site of care: Approved infusion centers or home infusion

If Approved

CVS Specialty will contact you within 24-48 hours to coordinate:

  • Drug shipment (temperature-controlled)
  • Infusion site scheduling
  • Patient assistance program enrollment

Appeals Process in Michigan

Internal Appeal with Aetna (First Level)

Timeline: File within 180 days of denial notice Decision window: 30 days (standard), 72 hours (expedited) How to file:

  • Online via Aetna member portal
  • Phone: Member services number on ID card
  • Written appeal with additional clinical evidence

Michigan External Review (Final Level)

Michigan's Department of Insurance and Financial Services (DIFS) provides independent review under the Patient's Right to Independent Review Act.

Key Details:

  • Filing deadline: 127 days after Aetna's final denial
  • Standard review: Decision within 60 days
  • Expedited review: 72 hours for urgent cases requiring physician letter
  • How to file: Online at difs.state.mi.us or mail to DIFS Office of General Counsel, P.O. Box 30220, Lansing, MI 48909-7720
  • Contact: 877-999-6442 for questions

The external review is conducted by independent medical experts and the decision is binding on Aetna.

Timeline Overview

Milestone Timeline Key Actions
Pre-submission prep 0-2 days Gather documentation, verify benefits
PA submission Same day Specialist submits via Availity
Initial review 1-5 days Aetna reviews against criteria
Additional info (if needed) 1-7 days Respond to requests promptly
Final decision Up to 15-30 days Approval or denial notification
Internal appeal 30 days Submit additional evidence
External review 60 days Michigan DIFS independent review

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing MPS I confirmation Submit genetic/enzyme testing IDUA gene sequencing, enzyme activity results
Insufficient baseline assessment Provide comprehensive evaluation Cardiac echo, PFTs, liver function, growth charts
Non-formulary status Request formulary exception Medical necessity letter citing no alternatives
Site-of-care issues Verify approved infusion center CVS Specialty coordination documentation
Experimental/investigational Cite FDA approval FDA label, clinical guidelines, peer-reviewed studies

Medical Necessity Letter Checklist

Your specialist should include:

  • Diagnosis: Confirmed MPS I with genetic/enzymatic evidence
  • Disease progression: Current organ involvement and functional status
  • Treatment rationale: FDA-approved indication, expected benefits
  • No alternatives: Aldurazyme is the only approved enzyme replacement therapy for MPS I
  • Monitoring plan: Infusion reaction protocols, efficacy assessments

Cost Assistance Options

Annual drug cost: $200,000-$400,000+ with typical patient responsibility of 25-40% coinsurance after deductible.

Manufacturer Support

  • Sanofi CareConnect: Copay assistance up to 100% for eligible commercial plans
  • Phone: 1-800-745-4447
  • Patient assistance program: Free drug for uninsured/underinsured (income-based)

Foundation Grants

  • HealthWell Foundation
  • MPS Society assistance programs
  • State-specific rare disease foundations

CVS Specialty automatically screens for assistance programs and handles enrollment.

Clinician Corner: Strengthening Your PA

Key elements for approval success:

  1. Diagnostic precision: Include specific IDUA gene variants and enzyme activity levels
  2. Baseline documentation: Comprehensive organ function assessments establish treatment need
  3. Guideline alignment: Reference FDA labeling and MPS I treatment guidelines
  4. Urgency justification: For expedited review, document risk of irreversible progression

Counterforce Health helps clinicians navigate complex prior authorization requirements by analyzing denial patterns and crafting evidence-backed appeals. Our platform identifies the specific criteria insurers use and ensures submissions align with payer policies, reducing approval timelines and improving success rates.

FAQ

How long does Aetna PA take for Aldurazyme in Michigan? Standard approvals typically take 1-5 days with complete documentation. Expedited reviews are decided within 72 hours for urgent cases.

What if Aldurazyme is denied as experimental? Appeal with FDA approval documentation (2003) and clinical evidence. Aldurazyme has established efficacy for MPS I treatment.

Does step therapy apply to Aldurazyme? No, step therapy is rarely required since Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I.

Can I get expedited review in Michigan? Yes, if your doctor documents that delay could cause serious harm. Submit physician letter with expedited PA request.

What's the difference between internal and external appeals? Internal appeals are reviewed by Aetna (30-day decision). External appeals are reviewed by independent medical experts through Michigan DIFS (60-day decision, binding).

How often does Aldurazyme need reauthorization? Typically annually, though some plans may require more frequent reviews based on clinical response.

From our advocates: We've seen cases where initial denials were overturned simply by including the specific IDUA enzyme activity percentage in the appeal. One family's approval was expedited when the specialist clearly documented progressive cardiac involvement that could worsen without immediate treatment. These details make the medical necessity unmistakable to reviewers.

When to Escalate

Contact Michigan DIFS if:

  • Aetna exceeds standard appeal timelines
  • You believe the denial violates state insurance laws
  • You need assistance with the external review process

Michigan DIFS: 877-999-6442 or file complaints online at difs.state.mi.us

For patients and families navigating insurance coverage for rare disease treatments, Counterforce Health provides specialized support in converting denials into successful appeals through targeted, evidence-based advocacy that aligns with each insurer's specific requirements.

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, medical circumstances, and current policies. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies and procedures may change without notice.

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