By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Blue Cross Blue Shield in Ohio: Complete Appeals Guide with Forms and Deadlines

Answer Box: Aldurazyme (laronidase) requires prior authorization from Blue Cross Blue Shield Ohio for MPS I treatment. Submit genetic/enzymatic test results, specialist evaluation, and clinical documentation through your provider. If denied, file internal appeal within 180 days, then external review through Ohio Department of Insurance. Start by gathering diagnostic labs and contacting your prescribing specialist today.

Table of Contents

Coverage Basics

Is Aldurazyme covered by Blue Cross Blue Shield Ohio?

Yes, but with restrictions. Aldurazyme (laronidase) is covered by Anthem Blue Cross Blue Shield Ohio as a specialty medication requiring prior authorization. Coverage applies specifically to FDA-approved indications: mucopolysaccharidosis I (MPS I) including Hurler, Hurler-Scheie, and Scheie syndromes with moderate to severe symptoms.

Which Blue Cross Blue Shield plans cover Aldurazyme?

Most Anthem BCBS Ohio commercial plans include Aldurazyme on their specialty drug formulary, but specific coverage varies by plan type. Check your member formulary or call the number on your insurance card to verify coverage under your specific plan.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must get approval before treatment Provider submits request Anthem Ohio Specialty Drug List
Specialty Pharmacy Must use designated pharmacy network Provider coordinates Same as above
Genetic/Enzymatic Testing Must confirm MPS I diagnosis Lab results required Federal MPS I Guidelines
Specialist Evaluation Must be prescribed by genetics/metabolic specialist Specialist letter required Same as above
Site of Care Clinic or outpatient hospital preferred Provider documents administration plan Ohio Provider Guidelines

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm MPS I Diagnosis (Patient/Provider)
    • Obtain enzymatic testing showing deficient α-L-iduronidase activity
    • Get genetic testing confirming IDUA gene mutations
    • Timeline: 1-2 weeks for test results
    • Source: MPS I Diagnostic Guidelines
  2. Schedule Specialist Evaluation (Patient)
    • See genetics or metabolic specialist
    • Document disease severity and organ involvement
    • Timeline: 2-4 weeks for appointment
    • Required for prior authorization approval
  3. Gather Clinical Documentation (Provider)
    • Baseline organ function tests (cardiac, pulmonary, liver)
    • Medical history and physical exam findings
    • Treatment goals and monitoring plan
    • Timeline: 1 week to compile records
  4. Submit Prior Authorization (Provider)
    • Complete Anthem's PA request form
    • Submit via provider portal or designated fax
    • Include all supporting documentation
    • Timeline: Same day submission
    • Portal: Anthem Provider Portal (confirm current link)
  5. Track Request Status (Provider/Patient)
    • Monitor through provider portal
    • Call Anthem if no response within standard timeframe
    • Timeline: Check after 3-5 business days
  6. Coordinate Specialty Pharmacy (Provider)
    • If approved, medication transferred to designated specialty pharmacy
    • Schedule infusion at approved site of care
    • Timeline: 1-2 weeks for coordination
  7. Begin Treatment (Patient)
    • Attend scheduled infusion appointments
    • Monitor for adverse reactions
    • Document clinical response for renewal

Timing and Deadlines

How long does prior authorization take?

Standard prior authorization decisions typically come within 5-15 business days of complete submission. For urgent cases, expedited review may be available within 72 hours.

Appeal Deadlines in Ohio:

  • Internal Appeal: 180 days from denial notice
  • External Review: 180 days from final internal denial
  • Expedited Appeals: Available for urgent medical situations

Source: Ohio Department of Insurance

Medical Necessity Criteria

Blue Cross Blue Shield Ohio requires documentation of:

Required Clinical Evidence

  • Confirmed MPS I diagnosis via enzymatic and/or genetic testing
  • Disease severity assessment showing moderate to severe symptoms
  • Specialist evaluation by genetics or metabolic disease specialist
  • Baseline organ function documentation (cardiac, pulmonary, hepatic)
  • Treatment monitoring plan for infusion reactions and clinical response

Clinician Corner: Medical Necessity Letter Checklist

When submitting prior authorization, include:

✓ Problem Statement: Clear diagnosis of MPS I with specific subtype ✓ Diagnostic Evidence: Enzyme activity levels and genetic test results
✓ Clinical Rationale: Why Aldurazyme is medically necessary for this patient ✓ Monitoring Plan: How clinical response will be tracked ✓ Dosing Justification: Weight-based dosing per FDA labeling ✓ Site of Care: Why chosen administration setting is appropriate

Key references to cite:

Costs and Financial Support

What will Aldurazyme cost with Blue Cross Blue Shield Ohio?

Costs depend on your specific plan's specialty drug tier and benefit design. Aldurazyme typically falls under the highest specialty tier, which may require:

  • High coinsurance (20-40% of drug cost)
  • Specialty copays ($100-500+ per infusion)
  • Annual out-of-pocket maximums apply

Financial Assistance Options:

Manufacturer Support

Sanofi's Aldurazyme Patient Support Program offers:

  • Copay assistance covering up to 100% of eligible out-of-pocket costs
  • Patient enrollment required
  • Program maximum limits may apply
  • Contact manufacturer directly for application

Additional Resources

  • Rare disease foundation grants
  • State pharmaceutical assistance programs
  • Hospital charity care programs
  • Patient advocacy organizations
From our advocates: "We've seen patients successfully combine manufacturer copay assistance with hospital financial aid programs to eliminate out-of-pocket costs entirely. Don't assume you can't afford treatment—multiple funding sources can often be stacked together."

Common Denial Reasons and Appeals

Top Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
Diagnosis not confirmed Submit complete diagnostic workup Enzyme assays, genetic testing, specialist letter
Insufficient medical necessity Document disease severity and progression Imaging, organ function tests, clinical assessments
Missing specialist evaluation Obtain genetics/metabolic specialist consultation Specialist report with treatment recommendation
Incomplete monitoring plan Provide detailed infusion protocol Safety monitoring procedures, adverse reaction plan
Alternative treatments not tried Document contraindications to alternatives Medical records showing why alternatives inappropriate

Appeals Playbook for Blue Cross Blue Shield Ohio

Level 1: Internal Appeal

  • Deadline: 180 days from denial notice
  • How to file: Written request to Anthem with additional clinical evidence
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Required: Copy of denial letter, new supporting documentation

Level 2: External Review

  • Deadline: 180 days from final internal denial
  • How to file: Request form submitted to your health plan
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Process: Independent medical review by Ohio Department of Insurance
  • Binding: Decision is final and binding on the insurer

Contact Information:

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform helps patients and providers navigate complex prior authorization requirements and appeal processes for specialty medications like Aldurazyme.

Renewal Requirements

When do I need to renew prior authorization?

Most Blue Cross Blue Shield Ohio plans require Aldurazyme reauthorization every 12-24 months. Renewal typically requires:

  • Updated specialist evaluation
  • Clinical response documentation
  • Continued medical necessity justification
  • Current organ function assessments

What triggers renewal review?

  • Scheduled reauthorization date
  • Changes in dosing or frequency
  • Changes in site of care
  • New insurance plan or coverage

Start the renewal process 30-60 days before your current authorization expires to avoid treatment interruptions.

Specialty Pharmacy Requirements

Why was my prescription transferred to a specialty pharmacy?

Blue Cross Blue Shield Ohio requires Aldurazyme to be dispensed through their designated specialty pharmacy network. This ensures:

  • Proper cold chain storage and handling
  • Coordination with infusion centers
  • Patient support services
  • Insurance billing compliance

Site of Care Requirements:

  • Clinic or physician office (preferred)
  • Outpatient hospital facility (limited to 6 months, then reassessed)
  • Home infusion (rarely approved, requires special justification)

Source: Ohio Provider Guidelines

Troubleshooting Common Issues

Provider Portal Problems:

  • Clear browser cache and cookies
  • Try different browser or incognito mode
  • Contact Anthem provider services for technical support

Missing Forms or Documentation:

  • Request copies from your provider's office
  • Contact previous specialists for old records
  • Use patient portal to access lab results

Delayed Responses:

  • Follow up with phone call after 5-7 business days
  • Request expedited review if medically urgent
  • Escalate to case manager if needed

FAQ

How long does Blue Cross Blue Shield prior authorization take in Ohio? Standard prior authorization typically takes 5-15 business days. Expedited review is available for urgent cases and provides decisions within 72 hours.

What if Aldurazyme is non-formulary on my plan? Request a formulary exception with clinical justification. Document medical necessity and lack of suitable alternatives. Appeals process applies if initially denied.

Can I request an expedited appeal in Ohio? Yes, expedited appeals are available when delays would seriously jeopardize your health. Both internal appeals and external review offer expedited options with faster timelines.

Does step therapy apply to Aldurazyme? Step therapy requirements vary by plan. Since Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I, step therapy typically doesn't apply, but some plans may require documentation of disease severity first.

What happens if I move to another state? Coverage may change based on your new plan's policies. Contact your insurer immediately to understand coverage in your new location and transfer care to local specialists.

Who can prescribe Aldurazyme? Most Blue Cross Blue Shield plans require prescription by a specialist in genetics, metabolic disorders, or related fields. Primary care physicians typically cannot initiate therapy.

How much does Aldurazyme cost without insurance? The manufacturer's wholesale acquisition cost is approximately $1,113.38 per 2.9 mg vial as of 2025. Treatment requires weekly infusions, making annual costs extremely high without insurance coverage.

Can I appeal if my employer's plan denies coverage? Yes, but self-funded employer plans follow federal ERISA rules rather than Ohio state insurance laws. The appeal process may differ, but external review options are still typically available.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with your healthcare provider regarding treatment decisions. For personalized assistance with insurance appeals and prior authorization, visit Counterforce Health to learn how our platform helps turn denials into approvals through evidence-based appeal strategies.

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