By Counterforce Health Team in Aldurazyme (laronidase) —

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

Answer Box: Getting Aldurazyme (laronidase) Covered by Aetna in Ohio

Aldurazyme (laronidase) is covered by Aetna (CVS Health) plans in Ohio as a specialty medication for MPS I, but requires prior authorization with genetic/enzymatic confirmation and baseline assessments. If denied, you have 180 days to appeal internally, then can request external review through Ohio's Independent Review Organization process.

Fastest path to approval:

  1. Contact CVS Specialty at 1-866-814-5506 to initiate prior authorization
  2. Have your specialist submit genetic testing, baseline assessments, and treatment plan
  3. If denied, file internal appeal within 180 days and consider external review

Start today: Call CVS Specialty to begin the PA process and ensure your provider has all required documentation ready.

Table of Contents

  1. Coverage Requirements & Prior Authorization
  2. Common Denial Reasons & How to Fix Them
  3. Appeals Process in Ohio
  4. Cost Assistance Programs
  5. Step-by-Step Approval Guide
  6. Frequently Asked Questions

Coverage Requirements & Prior Authorization

Aldurazyme (laronidase) appears on Aetna formularies for 2025 as a covered specialty medication for mucopolysaccharidosis type I (MPS I), but requires comprehensive prior authorization documentation.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Aetna plans Aetna 2025 Precertification List
Formulary Status Covered, Tier 4/5 specialty Plan formulary documents
Specialty Pharmacy CVS Specialty required Member services
Genetic Testing MPS I confirmation mandatory Clinical policy
Baseline Assessments Cardiac, pulmonary, hepatic Prior auth criteria
Appeals Deadline 180 days from denial Ohio insurance law

Required Documentation

Your specialist must submit comprehensive clinical evidence including:

  • Genetic/enzymatic confirmation of MPS I (alpha-L-iduronidase deficiency)
  • ICD-10 codes: E76.01 (Hurler), E76.02 (Hurler-Scheie), E76.03 (Scheie)
  • Baseline disease severity assessments:
    • Echocardiogram (cardiac evaluation)
    • Pulmonary function tests
    • Hepatic function tests
    • Clinical symptoms documentation
  • Treatment plan with dosing rationale (0.58 mg/kg IV weekly)
  • Monitoring schedule for treatment response and infusion reactions
  • Specialist attestation from geneticist or metabolic specialist
Clinician Corner: When drafting the medical necessity letter, emphasize the lack of therapeutic alternatives for MPS I and include baseline organ function data showing disease severity. Reference FDA labeling and published efficacy data showing improvements in hepatosplenomegaly and pulmonary function.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Lack of genetic confirmation Submit enzymatic assay results Alpha-L-iduronidase deficiency test
Insufficient disease severity Provide baseline assessments Imaging, PFTs, echo results
"Experimental" designation Submit FDA approval evidence FDA label, clinical trials data
Step therapy required Request exception (no alternatives) Attestation of MPS I diagnosis
Quantity over limits Justify weight-based dosing Patient weight, dosing calculation

When Alternatives Don't Apply

Unlike many specialty medications, Aldurazyme has no direct formulary alternatives or biosimilars for MPS I treatment. Hematopoietic stem cell transplantation (HSCT) exists as a clinical alternative but is typically reserved for severe cases and requires different evaluation criteria.

Key point for appeals: Emphasize that laronidase is the only FDA-approved enzyme replacement therapy for MPS I, making step therapy inappropriate and formulary exceptions medically necessary.

Appeals Process in Ohio

Ohio provides strong consumer protections for insurance appeals, including mandatory external review rights for denied specialty medications.

Internal Appeals Timeline

  1. File within 180 days of denial notice
  2. Standard review: 30 days for decision
  3. Expedited review: 72 hours if delay could harm health
  4. Second level: Additional 30 days if required by plan

External Review Process

After exhausting internal appeals, Ohio residents can request Independent Review Organization (IRO) review through the Ohio Department of Insurance:

  • Timeline: 180 days from final internal denial to request external review
  • Decision timeframe: 30 days standard, 72 hours expedited
  • Binding decision: IRO ruling is final and binding on Aetna
  • No cost: External review is free to patients

Contact Ohio Department of Insurance:

Note: Self-funded employer plans follow federal ERISA rules rather than Ohio's external review process, but many voluntarily provide similar protections.

Cost Assistance Programs

Aldurazyme's manufacturer-disclosed cost is approximately $1,113.38 per 2.9 mg vial, with annual treatment costs potentially exceeding $200,000-$400,000.

Financial Support Options

Manufacturer Programs:

  • Sanofi CareConnect: May reduce copays to $0 for eligible commercial insurance patients
  • BioMarin RareConnections: Patient support and financial assistance

Foundation Grants:

  • Patient Advocate Foundation
  • HealthWell Foundation (rare disease fund)
  • National MPS Society assistance programs

State Resources:

  • Ohio pharmaceutical assistance programs (verify eligibility)
  • Medicaid coverage for qualifying patients

Counterforce Health specializes in turning insurance denials into evidence-backed appeals for specialty medications like Aldurazyme. The platform helps patients and clinicians navigate complex prior authorization requirements and craft targeted rebuttals when coverage is initially denied.

Step-by-Step Approval Guide

Before You Start: Gather These Documents

  • Insurance card and member ID
  • Complete medical records and genetic testing results
  • Prior therapy documentation (if any)
  • Baseline organ function assessments
  • Prescriber contact information

The Approval Process

Step 1: Contact CVS Specialty Pharmacy

  • Call 1-866-814-5506
  • Provide member information and prescription details
  • Request prior authorization forms
  • Timeline: Same day

Step 2: Provider Submits Documentation

  • Complete Aetna prior authorization form
  • Submit via provider portal or fax 1-888-267-3277
  • Include all required clinical evidence
  • Timeline: 1-2 business days

Step 3: Aetna Review Process

  • Standard review: 24-48 hours to 30 days
  • Complex cases may require peer-to-peer review
  • Decision notification by phone/mail
  • Timeline: 30 days maximum

Step 4: If Approved

  • CVS Specialty coordinates delivery and infusion
  • Patient responsibility determined by plan benefits
  • Ongoing monitoring and reauthorization as needed

Step 5: If Denied

  • Request detailed denial reason
  • File internal appeal within 180 days
  • Consider expedited appeal if clinically urgent
  • Prepare for external review if needed
From Our Advocates: "We've seen MPS I denials overturned most successfully when the appeal emphasizes the progressive nature of the disease and includes specific baseline measurements showing organ involvement. Including photos or videos documenting mobility limitations can also strengthen the case for medical necessity."

When appeals are necessary, Counterforce Health can help craft evidence-based rebuttals that address specific denial reasons while meeting Aetna's procedural requirements and Ohio's regulatory standards.

Frequently Asked Questions

How long does Aetna prior authorization take for Aldurazyme in Ohio? Standard review takes 24-48 hours to 30 days. Complex cases requiring peer-to-peer review may take the full 30 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Aldurazyme is non-formulary on my specific plan? Request a formulary exception emphasizing that laronidase is the only FDA-approved ERT for MPS I. Include genetic testing confirmation and specialist attestation of medical necessity.

Can I request an expedited appeal if denied? Yes, if waiting for standard review could seriously jeopardize your health. Your physician must certify the urgent need in writing.

Does step therapy apply to Aldurazyme? Generally no, due to lack of alternatives for MPS I. However, some plans may incorrectly apply step therapy requirements that can be appealed.

What happens during external review in Ohio? An Independent Review Organization with relevant medical expertise reviews your case. The IRO's decision is binding on Aetna and typically comes within 30 days.

Are there age restrictions for coverage? Aldurazyme is approved for all ages with MPS I. Pediatric patients may have additional monitoring requirements but should not face age-based coverage restrictions.

How often do I need reauthorization? Most plans require annual reauthorization with documentation of continued medical necessity and treatment response.

What if I move from another state to Ohio? Your coverage should continue, but you may need to switch to CVS Specialty Pharmacy and update your provider network. Contact member services to ensure seamless transition.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may vary by specific plan and change over time. Always verify current requirements with your insurance plan and healthcare providers. For personalized assistance with appeals and coverage issues, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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