By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Aetna CVS Health in Texas: Complete Prior Authorization & Appeals Guide

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

Aldurazyme (laronidase) requires prior authorization for all Aetna CVS Health plans in Texas. The fastest path to approval: have your MPS I specialist submit a complete PA packet via Availity portal with genetic/enzymatic confirmation, baseline assessments, and monitoring plan. CVS Specialty Pharmacy handles dispensing exclusively. If denied, Texas law gives you 4 years to file an internal appeal, then 4 months for external review through an Independent Review Organization (IRO). Start today: Call your specialist to initiate the PA process and verify your plan's formulary status.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization
  5. Follow-Up and Timeline Management
  6. If You Need More Information
  7. Appeals Process in Texas
  8. Renewal and Reauthorization
  9. Cost Assistance Options
  10. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps patients with mucopolysaccharidosis type I (MPS I) and their healthcare teams navigate Aetna CVS Health's prior authorization process for Aldurazyme (laronidase) in Texas. Whether you're facing an initial request, denial appeal, or annual renewal, you'll find the specific forms, timelines, and strategies needed for approval.

Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I, making it essential for patients with this rare genetic disorder. At approximately $1,113 per vial (manufacturer WAC pricing as of January 2025), proper insurance coverage is critical for accessing this life-changing treatment.

Before You Start: Verify Your Coverage

Step 1: Confirm Your Plan Type

Call Aetna member services at 1-800-872-3862 with your member ID to verify:

  • Whether you have commercial, Medicare Advantage, or Medicaid coverage
  • If Aldurazyme falls under medical benefit (typical) or pharmacy benefit
  • Your deductible, copay, and out-of-pocket maximum
  • Whether CVS Specialty Pharmacy is required for dispensing

Step 2: Check Formulary Status

Aldurazyme appears on Aetna's 2025 precertification list as a Tier 4/5 specialty drug requiring prior authorization. It's typically covered under the medical benefit for infusion therapies rather than as a traditional pharmacy formulary drug.

Note: Texas residents with employer-sponsored ERISA plans follow federal appeal rules, while state-regulated plans follow Texas Department of Insurance guidelines.

Gather Required Documentation

Essential Medical Records

Diagnosis Confirmation:

  • Genetic testing results showing biallelic IDUA gene mutations
  • Enzymatic assay confirming deficient alpha-L-iduronidase activity (<10% for severe MPS I)
  • ICD-10 codes: E76.0 (MPS type I), E76.01 (Hurler), E76.02 (Hurler-Scheie), E76.03 (Scheie)

Baseline Assessments:

  • Cardiac evaluation (echocardiogram)
  • Pulmonary function tests
  • Hepatic function studies
  • Documentation of organ involvement (hepatosplenomegaly, joint stiffness, corneal clouding)
  • Growth and developmental assessments

Treatment Documentation:

  • Specialist attestation from geneticist or metabolic disorder expert
  • Weight-based dosing calculation (0.58 mg/kg weekly)
  • Infusion monitoring plan and site-of-care arrangements
  • Emergency response protocols for infusion reactions

Submit Your Prior Authorization

Fastest Submission Method

For Providers: Use Aetna's Availity portal with Novologix integration for electronic PA submissions. Include complete documentation package with ICD-10 codes and specialist attestation.

Timeline: Most approvals process within 24-48 hours for complete submissions, up to 30 days for complex cases requiring additional review.

Required Forms and Contacts

  • Provider PA line: 1-888-632-3862 (commercial) / 1-800-624-0756 (Medicare)
  • CVS Specialty Pharmacy: 1-866-814-5506 for coordination
  • Alternative submission: Fax complete packet (verify current fax number with provider services)

Coverage Requirements Checklist

Requirement Documentation Needed Source
MPS I Diagnosis Genetic/enzymatic testing FDA Label
Baseline Assessments Cardiac, pulmonary, hepatic function Clinical guidelines
Specialist Oversight Geneticist/metabolic specialist attestation Aetna policy
Monitoring Plan Infusion protocols, adverse event management FDA Label
Site of Care Approved infusion center or home health Aetna Policy

Follow-Up and Timeline Management

Standard Review Process

Week 1-2: Submit complete PA packet Week 2-3: Aetna medical review (may request additional information) Week 3-4: Final determination issued Week 4+: If approved, CVS Specialty contacts patient within 24-48 hours

When to Call for Updates

Contact Aetna provider services if:

  • No acknowledgment received within 5 business days
  • Additional information requested with unclear requirements
  • Decision timeline exceeds 30 days without explanation

Sample Call Script: "I'm calling about PA request [reference number] for Aldurazyme submitted on [date]. Can you provide the current status and expected decision timeline?"

If You Need More Information

Common Additional Requests

Medical Necessity Questions:

  • Provide detailed clinical progression notes
  • Include urinary glycosaminoglycan (GAG) levels if available
  • Document functional decline without treatment

Monitoring Plan Clarification:

  • Submit infusion center credentials and protocols
  • Provide emergency response procedures
  • Include adverse event reporting framework

Submit additional documentation within 14 days via the same portal or fax used for initial submission.

Appeals Process in Texas

Internal Appeals Timeline

Filing Deadline: 4 years from denial under Texas law (supersedes Aetna's standard 180-day limit) Aetna Decision Time: 45 business days (standard) / 72 hours (expedited for urgent cases) How to File: Via Availity portal, mail, or call 1-800-872-3862

Common Denial Reasons & Solutions

Denial Reason Documentation to Include Success Strategy
Not medically necessary Specialist letter, genetic tests, progression notes Emphasize FDA approval, no alternatives
Experimental/investigational FDA label (2003 approval), clinical guidelines Reference established standard of care
Insufficient documentation Complete medical records, baseline assessments Provide comprehensive clinical picture
Non-formulary status Exception request with no-alternatives statement Cite lack of therapeutic substitutes

External Review (IRO)

If internal appeal is denied, request Independent Review Organization review:

  • Filing Deadline: 4 months from final internal denial
  • Decision Timeline: 20 days (standard) / 72 hours (expedited)
  • Filing Fee: Up to $650 (waivable based on income)
  • Oversight: Texas Department of Insurance
Tip: For life-threatening conditions, you can request expedited external review concurrently with expedited internal appeal.

Texas-Specific Resources

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel (OPIC): 1-877-611-6742
  • IRO Information Line: 1-866-554-4926

Renewal and Reauthorization

Annual Review Requirements

Most Aldurazyme approvals require annual reauthorization. Begin the renewal process 60-90 days before expiration:

Updated Documentation:

  • Current clinical status and treatment response
  • Continued specialist oversight
  • Monitoring results (cardiac, pulmonary function)
  • Adverse event history
  • Dose adjustments or protocol changes

Calendar Reminders:

  • Set alerts for November to check 2026 formulary changes
  • Track PA expiration dates
  • Schedule specialist appointments for renewal documentation

Cost Assistance Options

Manufacturer Support

Sanofi CareConnect Program:

  • Copay assistance for eligible commercial patients
  • Foundation grants for qualifying families
  • Patient navigation services
  • Contact: Sanofi CareConnect (verify current link)

Additional Resources

  • CVS Specialty Pharmacy: Patient assistance program coordination
  • National Organization for Rare Disorders (NORD): Emergency financial assistance
  • State pharmaceutical assistance programs (verify Texas-specific options)

Quick Reference Checklist

Before Submitting:

  • Genetic testing confirming IDUA mutations
  • Enzymatic assay showing deficient activity
  • Baseline cardiac, pulmonary, hepatic assessments
  • Specialist attestation letter
  • Weight-based dosing calculation
  • Infusion monitoring plan
  • Site-of-care arrangement confirmed

During Review:

  • Track submission via reference number
  • Respond to information requests within 14 days
  • Document all phone calls and correspondence
  • Prepare appeal documentation if needed

If Denied:

  • Review denial reason carefully
  • Gather additional supporting evidence
  • File internal appeal within Texas timelines
  • Consider peer-to-peer review request
  • Prepare for potential external review

Counterforce Health specializes in turning insurance denials into successful appeals for complex specialty medications like Aldurazyme. Our platform helps patients and providers build evidence-backed appeals that address specific payer criteria, reducing approval timelines and improving success rates. Learn more about our prior authorization support services.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Aldurazyme in Texas? Standard reviews take 24-48 hours to 30 days depending on completeness. Expedited reviews (for urgent cases) must be decided within 72 hours under Texas law.

What if Aldurazyme is non-formulary on my plan? Request a formulary exception citing no FDA-approved alternatives. Include specialist attestation and medical necessity documentation.

Can I request an expedited appeal in Texas? Yes, for urgent medical conditions where delay could jeopardize health. Include physician statement on potential harm from treatment delay.

Does step therapy apply to Aldurazyme? No, step therapy typically doesn't apply since Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I.

What happens if I miss infusions during the appeals process? Work with your specialist to develop a bridging plan. Some patients may qualify for emergency/compassionate use programs while appeals are pending.

Who can help if my appeal is denied in Texas? Contact the Texas Department of Insurance (1-800-252-3439) or Office of Public Insurance Counsel (1-877-611-6742) for assistance with external review requests.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage 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.