By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Aetna CVS Health in Florida: Prior Authorization, Appeals & Approval Scripts

Answer Box: Getting Aldurazyme Covered by Aetna CVS Health in Florida

Aldurazyme (laronidase) requires prior authorization from Aetna CVS Health in Florida for all plan types. The fastest path to approval: (1) Have your specialist submit a complete PA request through Availity with genetic/enzymatic confirmation of MPS I, (2) Include documentation of baseline disease severity and monitoring plan, (3) Allow 2+ weeks for processing. If denied, you have 180 days to appeal and can request external review through Florida's Department of Financial Services.

First step today: Contact your MPS I specialist to initiate the prior authorization request with complete clinical documentation.

Table of Contents

Plan Types & Coverage Implications

Aetna predominantly offers HMO plans in Florida, with limited PPO/EPO availability. Understanding your plan type is crucial for Aldurazyme access:

Plan Type PCP Required Specialist Referral Network Restrictions Aldurazyme Impact
HMO (most common) Yes Yes In-network only Must get PCP referral to MPS specialist; use CVS Specialty only
Medicare Advantage Yes Sometimes In-network only Follows CMS coverage determinations; CVS Specialty required
Medicaid (Aetna Better Health) Yes Yes In-network only PA required except emergencies; state formulary applies
Note: Aetna's HMO plans in Florida require you to stay within the provider network except for emergencies. This means your MPS I specialist and infusion site must be in-network.

Formulary Status & Tier Placement

Aldurazyme is classified as a specialty medication on Aetna CVS Health formularies and typically placed on Tier 4 or 5 (highest cost-sharing tiers). Key details:

  • Prior authorization required for all plan types
  • No step therapy typically required (given lack of alternatives)
  • CVS Specialty Pharmacy exclusive for dispensing
  • Quantity limits rarely applied for this orphan drug

You can verify your specific plan's coverage by checking the Aetna specialty drug list or calling member services.

Prior Authorization Requirements

All Aetna CVS Health plans require prior authorization for Aldurazyme. The approval hinges on documenting:

Medical Necessity Criteria

  • Confirmed MPS I diagnosis via genetic testing or enzymatic assay
  • Baseline disease severity assessment (cardiac, pulmonary, hepatic function)
  • Treatment goals and monitoring plan
  • Specialist attestation from geneticist, metabolic specialist, or pediatric subspecialist

Required Documentation

✓ Complete medical records and clinic notes
✓ Genetic test results confirming MPS I
✓ Baseline imaging (echocardiogram, pulmonary function tests)
✓ Prior therapy history (if applicable)
✓ Detailed treatment and monitoring plan

Clinician Corner: Your medical necessity letter should address the specific MPS I phenotype (Hurler, Hurler-Scheie, or Scheie syndrome), baseline organ involvement, and expected treatment outcomes. Reference the FDA label and current MPS I management guidelines.

Specialty Pharmacy Setup

Once approved, Aldurazyme must be dispensed through CVS Specialty Pharmacy and administered via Coram infusion services in most Florida markets.

Enrollment Process

  1. Prescription sent to CVS Specialty by your provider
  2. Benefit verification completed by CVS Specialty with Aetna
  3. Patient intake by Coram for home or suite-based infusion
  4. Clinical assessment and education provided
  5. First infusion scheduled with nursing support

Infusion details: Weekly 3-4 hour IV infusions, typically with premedication (antihistamines, acetaminophen) to prevent reactions. Contact CVS Specialty directly after your prescription is submitted to expedite enrollment.

Cost-Share Dynamics

Aldurazyme's high cost (approximately $1,113 per 2.9 mg vial as of January 2025) means significant out-of-pocket expenses even with insurance:

  • Tier 4/5 placement typically means 25-40% coinsurance
  • Annual deductible may apply before coverage begins
  • Out-of-pocket maximum provides yearly cost protection

Financial Assistance Options

  • Manufacturer copay assistance through Sanofi/BioMarin patient support programs
  • State pharmaceutical assistance programs for eligible Florida residents
  • Foundation grants for rare disease treatments

Contact Aldurazyme patient support for current assistance program details.

Submission Process

For Providers: Fastest Path to Approval

Step 1: Submit via Availity provider portal using Novologix for specialty drugs

Step 2: Include complete documentation package:

  • ICD-10 diagnosis codes for MPS I
  • Detailed clinical notes justifying therapy
  • Genetic/enzymatic test results
  • Baseline organ function assessments

Step 3: Allow 2+ weeks processing time; Aetna processes >95% of authorizations within 24-48 hours, though complex cases require clinical review

Step 4: Monitor portal for coverage determination and respond promptly to any requests for additional information

Provider Contact: For questions, call Aetna provider services at 1-888-632-3862 (commercial) or 1-800-624-0756 (Medicare).

Appeals Process for Florida

If Aetna denies coverage for Aldurazyme, Florida residents have strong appeal rights:

Internal Appeal (First Level)

  • Timeline: Must file within 180 days of denial notice
  • Decision timeframe: 30 days (standard) or 72 hours (expedited)
  • How to file: Phone, mail, or fax; providers can file on your behalf
  • Required: Complete medical records and specialist letter supporting medical necessity

External Review (Independent)

  • When: After internal appeal denial
  • Timeline: Request within 120 days of final internal denial
  • Process: Independent clinical expert reviews case
  • Contact: Florida Department of Financial Services at 1-877-693-5236
From our advocates: We've seen MPS I cases succeed on external review when providers clearly document the progressive nature of the disease and cite the lack of therapeutic alternatives. The key is comprehensive clinical documentation showing both current organ involvement and expected deterioration without treatment.

Success factors for appeals:

  • Detailed specialist letter explaining MPS I progression
  • Baseline imaging showing organ involvement
  • Clear treatment goals and monitoring plan
  • Citation of FDA approval and clinical guidelines

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide specialist letter detailing MPS I severity and prognosis Genetic testing, baseline organ assessments, specialist attestation
"Experimental/investigational" Cite FDA approval for MPS I (approved 2003) FDA label, prescribing information
"Missing prior authorization" Resubmit complete PA with all required elements Full clinical documentation package
"Insufficient documentation" Provide comprehensive medical records Complete clinic notes, test results, imaging

FAQ

How long does Aetna CVS Health prior authorization take in Florida? Most decisions within 24-48 hours via electronic submission, though complex cases requiring clinical review may take up to 30 days. Submit at least 2 weeks before therapy is needed.

What if Aldurazyme is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Aetna must cover medically necessary treatments even if non-formulary when no covered alternatives exist.

Can I request an expedited appeal in Florida? Yes, if delay could harm your health. Expedited appeals receive decisions within 72 hours (36 hours for two-level processes).

Does step therapy apply to Aldurazyme? Rarely, given the lack of therapeutic alternatives for MPS I. However, some plans may require documentation that standard supportive care is insufficient.

What happens if I move within Florida? Your Aetna coverage continues, but ensure your new providers and infusion site are in-network. Notify CVS Specialty of address changes.

Who can help if my appeal is denied? Contact the Florida Insurance Consumer Helpline at 1-877-693-5236 or file a complaint with the Department of Financial Services online.

Getting specialized help with insurance appeals can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements—pulling the right citations and weaving them into appeals that meet procedural requirements while tracking deadlines and required documentation.

Whether you're navigating Aetna's prior authorization process or preparing for an appeal, having the right documentation and understanding Florida's specific appeal rights gives you the best chance of getting Aldurazyme covered. Work closely with your MPS I specialist, leverage available financial assistance programs, and don't hesitate to use Florida's external review process if needed. With persistence and proper documentation, most medically necessary treatments for rare diseases like MPS I ultimately receive coverage.

For additional support with the appeal process or questions about your specific situation, Counterforce Health provides specialized assistance in navigating complex insurance coverage challenges for specialty medications.

Sources & Further Reading

This article is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage details. Insurance policies and procedures may change; verify current requirements with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.