By Counterforce Health Team in Aldurazyme (laronidase) —

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

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

Fastest path to approval: Submit prior authorization through CVS Specialty Pharmacy with genetic confirmation of MPS I, enzyme assay results, and specialist attestation. If denied, you have 180 days for internal appeals, then 4 months for Pennsylvania's external review (50% overturn rate). First step today: Contact CVS Specialty at 1-866-814-5506 to verify benefits and start the PA process.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for Pennsylvania Residents
  5. Medical Necessity Documentation
  6. Cost Assistance and Financial Support
  7. When to Escalate to State Regulators
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Aldurazyme prescriptions Aetna Specialty PA Form
Diagnosis Confirmation Genetic testing + enzyme assay for MPS I FDA-approved prescribing information
Specialty Pharmacy Must use CVS Specialty or contracted provider Aetna Site of Care Policy
Formulary Tier Specialty tier drug Aetna Advanced Control Plan
No Alternatives No formulary alternative ERT for MPS I Aetna formulary documentation
Appeals Deadline 180 days for internal; 4 months for external Pennsylvania Insurance Department

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Benefits

Who: Patient or caregiver
Action: Call Aetna Member Services (number on your ID card) to confirm:

  • Aldurazyme is covered on your specific plan
  • Your specialty drug tier and copay
  • Whether your plan is fully insured in Pennsylvania (needed for external appeals)
  • Current deductible and out-of-pocket maximum

2. Contact CVS Specialty Pharmacy

Who: Patient or prescriber
Phone: 1-866-814-5506
Action: CVS Specialty will:

  • Verify your Aetna benefits
  • Coordinate prior authorization submission
  • Arrange delivery to your infusion center
  • Connect you with Sanofi CareConnect for copay assistance

3. Gather Required Documentation

Who: Your MPS specialist or genetics team
Documents needed:

  • Genetic test results showing pathogenic IDUA variants
  • Enzyme assay confirming α-L-iduronidase deficiency
  • Clinical notes documenting MPS I manifestations
  • Baseline assessments (cardiac echo, pulmonary function, hepatosplenomegaly)

4. Submit Prior Authorization

How: Aetna Specialty PA form or electronic submission
Fax: 1-844-268-7263
Timeline: Standard decisions within 30-45 days; expedited (urgent) within 72 hours

5. Confirm Infusion Site

Requirement: Must use Aetna-approved infusion center or home health agency
Action: Verify your preferred infusion center is in-network and meets Aetna's Site of Care requirements

6. Apply for Financial Assistance

Who: Patient
Programs:

  • Sanofi CareConnect: 1-855-726-3446 (copay assistance up to $0)
  • Patient Assistance Program: Free drug for qualifying uninsured patients
  • HealthWell Foundation: Copay grants for rare diseases

7. Monitor and Plan for Renewal

Timeline: PA typically approved for 12 months
Action: Set reminder at 9-10 months to submit renewal documentation with updated clinical assessments

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing genetic confirmation Submit molecular genetic testing showing pathogenic IDUA gene variants
Insufficient clinical documentation Provide detailed specialist notes documenting hepatosplenomegaly, joint contractures, cardiac/pulmonary involvement
Non-approved infusion site Switch to Aetna-contracted infusion center or home health agency
"Experimental/investigational" Submit FDA prescribing information and ACMG/WORLDSymposium treatment guidelines
Quantity/dose limits exceeded Justify weight-based dosing (100 U/kg weekly) with prescriber attestation
Step therapy requirement Document that no alternative ERT exists for MPS I; laronidase is standard of care

Appeals Process for Pennsylvania Residents

Internal Appeals with Aetna

  • First Level: Submit within 180 days of denial
  • Timeline: 30 days for standard; 72 hours for urgent
  • How to file: Written request to address on denial letter or call Member Services
  • Required: Copy of denial letter, additional clinical documentation, prescriber letter

Pennsylvania External Review (After Internal Appeals)

Pennsylvania's Independent External Review program offers a powerful option for fully insured plans:

  • Success rate: Approximately 50% of denials overturned in 2024
  • Deadline: 4 months after Final Adverse Benefit Determination
  • Timeline: 45 days for standard review; 72 hours for urgent
  • How to file: Pennsylvania Insurance Department online portal
  • Cost: Free to patients
Note: External review is only available for fully insured plans. Self-funded employer plans follow federal ERISA appeals process.

Required Documentation for External Review

  • Final Adverse Benefit Determination letter from Aetna
  • All previous denial and appeal letters
  • Detailed medical necessity letter from prescriber
  • FDA prescribing information for Aldurazyme
  • Clinical practice guidelines supporting ERT for MPS I
  • Patient impact statement (optional but helpful)

Medical Necessity Documentation

Clinician Corner: Essential Elements for PA Success

Diagnosis Confirmation

  • Enzyme assay showing deficient α-L-iduronidase activity
  • Genetic testing confirming pathogenic IDUA variants
  • ICD-10 code (E76.01 for Hurler, E76.02 for Hurler-Scheie, E76.03 for Scheie)

Clinical Manifestations to Document

  • Hepatosplenomegaly (measurements/imaging)
  • Skeletal dysplasia and joint contractures
  • Cardiopulmonary involvement (echo, PFTs)
  • Growth parameters and developmental status
  • Functional assessments (6-minute walk test if age-appropriate)

Treatment Plan

  • Standard dosing: 100 U/kg IV weekly
  • Infusion site and administration plan
  • Monitoring schedule for efficacy and safety
  • Long-term treatment goals

Guideline References

Cost Assistance and Financial Support

Manufacturer Programs

Sanofi CareConnect

  • Copay assistance: Reduce out-of-pocket costs to $0 for eligible commercially insured patients
  • Patient Assistance Program: Free drug for uninsured/underinsured based on income
  • Phone: 1-855-726-3446
  • Website: Sanofi patient support

Foundation Support

HealthWell Foundation

National MPS Society

  • Supportive care grants for travel, equipment
  • Educational resources and advocacy
  • Website: mpssociety.org

Annual Renewal Planning

By November each year:

  • Confirm Aldurazyme remains on formulary
  • Re-enroll in Sanofi CareConnect
  • Update foundation assistance applications
  • Verify CVS Specialty and infusion site remain in-network

When to Escalate to State Regulators

Contact the Pennsylvania Insurance Department if:

  • Aetna is not following proper appeal procedures
  • You're experiencing unreasonable delays in coverage decisions
  • There are issues with the external review process

Pennsylvania Insurance Department Consumer Services

  • Phone: Check current number at pa.gov
  • Online: Submit complaints through the PID consumer portal
  • Services: Free assistance with insurance disputes and appeals guidance

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Aldurazyme in Pennsylvania? A: Standard PA decisions typically take 30-45 days. Urgent requests (when delay could seriously jeopardize health) are decided within 72 hours.

Q: What if Aldurazyme is non-formulary on my Aetna plan? A: Request a formulary exception through the same PA process. Emphasize that no alternative ERT exists for MPS I and provide clinical guidelines supporting laronidase as standard of care.

Q: Can I request an expedited appeal if my child needs to start treatment immediately? A: Yes. If delay in treatment poses a serious risk to life or health, mark your PA request as urgent and have your prescriber provide written attestation of medical urgency.

Q: Does step therapy apply to Aldurazyme in Pennsylvania? A: There is no alternative ERT for MPS I, so traditional step therapy doesn't apply. However, document this clearly in your PA submission to avoid delays.

Q: What happens if Pennsylvania's external review rules in my favor? A: Aetna must provide coverage immediately, including retroactive reimbursement for any out-of-pocket costs you paid during the appeal period.

Q: How much does Aldurazyme cost without insurance? A: The wholesale acquisition cost is approximately $1,113 per 2.9 mg vial (as of January 2025). Weekly doses require multiple vials based on patient weight, making manufacturer assistance programs crucial.

How Counterforce Health Can Help

Navigating insurance approvals for rare disease treatments like Aldurazyme can be overwhelming, especially when dealing with complex prior authorization requirements and potential appeals. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. The platform identifies specific denial reasons—whether PA criteria, medical necessity determinations, or site-of-care restrictions—and drafts point-by-point rebuttals aligned with the payer's own rules, pulling the right clinical evidence and regulatory citations to support your case.

For MPS I patients seeking Aldurazyme coverage, this targeted approach can be particularly valuable given the complexity of documenting genetic confirmation, clinical manifestations, and the lack of therapeutic alternatives. Counterforce Health's systematic methodology helps ensure that appeals address every element payers look for while meeting procedural requirements and deadlines.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice or legal counsel. Coverage decisions depend on your specific plan terms, clinical circumstances, and current policies. Always consult with your healthcare providers about treatment decisions and contact your insurance company or the Pennsylvania Insurance Department for plan-specific guidance.

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