By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (laronidase) Covered by Blue Cross Blue Shield in Pennsylvania: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Getting Aldurazyme Covered by Blue Cross Blue Shield in Pennsylvania

Aldurazyme (laronidase) is covered by Blue Cross Blue Shield plans in Pennsylvania but requires prior authorization and is placed on specialty tier (Tier 5). To get approved: (1) Your doctor must submit a prior authorization request with MPS I diagnosis confirmation and symptom severity documentation, (2) Use an in-network specialty pharmacy, and (3) If denied, file an appeal within 180 days—Pennsylvania's new external review program has a 53% success rate for overturning denials. Start by calling your BCBS member services number to confirm your specific plan's requirements.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Member portal or call member services BCBS PA Policy
Age Requirement 6 months or older Policy documents BCBS PA Policy
Diagnosis MPS I (Hurler, Hurler-Scheie, Scheie) Medical records BCBS PA Policy
Formulary Tier Tier 5 (Specialty) Plan formulary BCBS Formulary
Specialty Pharmacy In-network only Member portal BCBS Specialty Network
Renewal Every 2 years if criteria met Policy documents BCBS PA Policy

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: You and your doctor
What you need: MPS I diagnosis confirmation, genetic testing results, symptom severity assessment
Timeline: 1-2 days

2. Submit Prior Authorization Request

Who: Your prescribing physician
How: Through BCBS provider portal or by calling provider services
Timeline: Submit immediately after diagnosis confirmation
Source: BCBS Provider Portal

3. Coordinate with Specialty Pharmacy

Who: Your doctor's office or you
What: Ensure drug is ordered through in-network specialty pharmacy
Timeline: Can be done simultaneously with PA request
Source: BCBS Specialty Network

4. Arrange Infusion Site

Who: You and your healthcare team
What: Choose between home infusion or clinic administration
Timeline: After PA approval

5. Monitor for Approval/Denial

Who: You
What: Check member portal or call member services
Timeline: Typically 3-15 business days for standard review

6. If Denied, File Appeal Immediately

Who: You or your doctor
What: Submit internal appeal with additional documentation
Timeline: Within 180 days of denial
Source: Pennsylvania External Review

7. Use External Review if Needed

Who: You
What: File with Pennsylvania Insurance Department
Timeline: Within 4 months of final internal denial
Success rate: 53% overturn rate in 2024
Source: PA Insurance Department

Understanding Your Costs

Aldurazyme is classified as a specialty drug under most Blue Cross Blue Shield plans in Pennsylvania, placing it on Tier 5 with higher cost-sharing. The manufacturer's wholesale acquisition cost (WAC) is approximately $1,113.38 per 2.9 mg/5 mL vial as of January 2025.

Your out-of-pocket costs depend on:

  • Your plan's deductible status
  • Specialty tier coinsurance percentage (typically 25-40%)
  • Annual out-of-pocket maximum
  • Whether you receive infusions at home or in a clinic
Tip: Home infusions are often less expensive than clinic infusions because they avoid facility fees, but both are covered under your medical benefit, not pharmacy benefit.

Manufacturer Copay Assistance

Sanofi CareConnect Copay Program can significantly reduce your costs if you have commercial insurance.

Eligibility:

  • Must have commercial (private) insurance
  • Cannot have Medicare, Medicaid, or other government insurance
  • Must be prescribed Aldurazyme by your healthcare provider
  • Must reside in the United States

Benefits:

  • Can cover 100% of eligible out-of-pocket costs up to program maximum
  • Includes copays, coinsurance, and deductibles
  • May cover infusion-related charges

How to Apply: Call 1-800-745-4447, option 3 to speak with a CareConnect Case Manager who will guide you through the application process.

Source: Sanofi CareConnect Program

If you're uninsured or your coverage is denied, ask about the Patient Assistance Program (PAP) which may provide Aldurazyme for free to eligible patients.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documentation Needed
Missing MPS I diagnosis confirmation Submit genetic/enzymatic test results Laboratory reports showing enzyme deficiency, genetic testing
Insufficient symptom severity documentation Provide detailed clinical assessment Specialist notes documenting organ involvement, functional limitations
Request outside labeled use Clarify indication is FDA-approved FDA labeling information, prescriber attestation
Missing monitoring plan Submit infusion safety protocol Plan for managing potential allergic reactions, facility capabilities
Quantity over plan limits Request exception with medical justification Weight-based dosing calculations, specialist recommendation

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with the payer's own rules, pulling the right citations and clinical facts to strengthen your case.

Appeals Process for Pennsylvania

Pennsylvania offers one of the strongest patient protection systems in the country with its new external review program launched in January 2024.

Internal Appeals (First Step)

  • Deadline: 180 days from denial notice
  • Timeline: Plan has 30 days to respond (expedited: 72 hours for urgent cases)
  • How to file: Member portal, phone, or written request
  • Required: Copy of denial letter, additional medical documentation

External Review (Second Step)

Pennsylvania's Independent External Review Program provides state-supervised appeals with impressive success rates.

Key Statistics:

  • 53% success rate in first half of 2024
  • 259 out of 517 appeals resulted in coverage approval
  • 45 days maximum for standard review
  • 72 hours for expedited urgent reviews

How to File:

  1. Complete internal appeals process first
  2. File within 4 months of final internal denial
  3. Submit online at PA.gov External Review
  4. Or call 1-877-881-6388 for assistance

What Happens:

  • PID confirms eligibility within 5 business days
  • Independent physician reviewers evaluate your case
  • Decision is final and binding on the insurer
  • If approved, insurer must provide coverage immediately

Source: Pennsylvania Insurance Department Success Report

Home vs. Clinic Infusion Costs

Setting Typical Cost Structure Patient Out-of-Pocket Coverage Route Administrative Notes
Home Infusion Lower total cost (no facility fee) Medical benefit deductible + coinsurance Medical benefit Requires coordination with home health services
Clinic/Hospital Higher total cost (includes facility fee) Medical benefit deductible + coinsurance (may be higher) Medical benefit Simpler scheduling, immediate medical support available

Both options require:

  • Prior authorization approval
  • Use of in-network specialty pharmacy
  • Qualified healthcare professional administration
  • Coverage under medical benefits (not pharmacy benefits)

Source: BCBS Specialty Drug Coverage

Scripts for Calling Your Insurer

Initial Coverage Inquiry

"Hi, I'm calling about prior authorization requirements for Aldurazyme, also called laronidase, for my [child/family member] with MPS I. Can you tell me what documentation is needed and which specialty pharmacies are in-network for this medication?"

Following Up on Pending Authorization

"I'm calling to check the status of a prior authorization request submitted on [date] for Aldurazyme. The reference number is [if available]. Can you tell me if additional information is needed or when a decision will be made?"

After Receiving a Denial

"I received a denial for Aldurazyme coverage dated [date]. I'd like to understand the specific reasons for denial and start the internal appeals process. Can you walk me through the next steps and required documentation?"

Frequently Asked Questions

How long does BCBS prior authorization take in Pennsylvania? Standard prior authorization typically takes 3-15 business days. Expedited reviews for urgent cases can be completed within 72 hours.

What if Aldurazyme is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity. For MPS I, this is often successful since Aldurazyme is the only FDA-approved enzyme replacement therapy.

Can I request an expedited appeal? Yes, if your condition poses an immediate health threat or if waiting would significantly worsen your condition, you can request expedited review at both internal and external appeal levels.

Does step therapy apply to Aldurazyme? Step therapy may be required, but exceptions are commonly granted for MPS I since there are no alternative FDA-approved enzyme replacement therapies.

What if I move to Pennsylvania from another state? Your prior authorization may need to be resubmitted if you change to a Pennsylvania BCBS plan. Contact member services to confirm coverage continuation.

How much will I pay out-of-pocket? This depends on your specific plan's specialty tier cost-sharing, deductible status, and whether you qualify for manufacturer copay assistance. Many patients with commercial insurance pay little to nothing with the CareConnect program.

What documentation does my doctor need to provide? Your doctor needs to provide MPS I diagnosis confirmation (genetic/enzymatic testing), symptom severity assessment, treatment history if applicable, and a detailed treatment plan including monitoring for infusion reactions.

Can I appeal if my external review is denied? Pennsylvania's external review decisions are final and binding. However, you may have options through federal appeals processes or if new medical evidence becomes available.

From our advocates: We've seen families successfully overturn initial Aldurazyme denials by working closely with their MPS specialist to document not just the diagnosis, but the specific organ involvement and functional limitations. One key is ensuring the genetic testing results clearly show the enzyme deficiency, and that the specialist explains why enzyme replacement therapy is the standard of care for this condition. This comprehensive approach, combined with Pennsylvania's strong external review process, has helped many families get coverage approved.

When navigating insurance coverage for rare disease treatments like Aldurazyme, having the right support makes all the difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed rebuttals that address each payer's specific criteria and requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may vary by specific Blue Cross Blue Shield plan. Always verify current requirements with your insurer and consult with your healthcare provider about treatment decisions. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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