By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

Getting Lumizyme (Alglucosidase Alfa) Covered by Humana in Virginia: Cost-Saving Strategies and Appeals Guide

Answer Box: Fast Track to Coverage

Lumizyme requires prior authorization from Humana with diagnostic confirmation of Pompe disease and specialist prescribing. Three steps to start today: (1) Contact your physician to initiate PA through Humana at 1-866-488-5995, (2) Apply for Sanofi's copay assistance if you have commercial insurance (call 1-833-723-5463), and (3) Gather GAA enzyme results and genetic testing. Virginia residents have 120 days to file external appeals through the State Corporation Commission if denied. Annual costs can reach $300,000+ but multiple assistance programs exist.

Table of Contents

  1. What Drives Lumizyme Costs
  2. Understanding Your Humana Benefits
  3. Financial Assistance Options
  4. Getting Coverage Through Prior Authorization
  5. Specialty Pharmacy Coordination
  6. Appeals Process in Virginia
  7. Planning for Annual Renewals
  8. Scripts for Key Conversations

What Drives Lumizyme Costs

Lumizyme (alglucosidase alfa) is one of the most expensive medications available, with each 50-mg vial costing approximately $993 based on wholesale acquisition cost. For the typical adult dose of 20 mg/kg every two weeks, annual treatment costs range from $300,000 to $330,000.

Benefit Design Factors

Your out-of-pocket costs depend on several benefit design elements:

  • Formulary tier placement: Lumizyme typically sits on the highest specialty tier
  • Prior authorization requirements: Universal across all Humana plans
  • Specialty pharmacy mandates: Limited network dispensing
  • Coinsurance vs. copays: Most plans use percentage-based coinsurance for specialty biologics
Note: Even with Medicare Part D's annual out-of-pocket maximum ($2,000 in 2025), the monthly costs before reaching that threshold can be substantial.

Understanding Your Humana Benefits

Coverage Verification Checklist

Before starting treatment, gather this information from your Humana plan:

From Your Member Portal or ID Card:

  • Plan type (Medicare Advantage, commercial, Medicaid)
  • Prescription drug coverage details
  • Specialty pharmacy network requirements
  • Prior authorization status

Questions to Ask Humana Customer Service:

  • What tier is Lumizyme on my specific formulary?
  • What's my specialty drug coinsurance percentage?
  • Do I need to use CenterWell Specialty Pharmacy?
  • Are there quantity limits or step therapy requirements?

Call the customer service number on your member ID card with your policy details ready.

Financial Assistance Options

Manufacturer Copay Programs

For Commercial Insurance Holders: Sanofi offers the CareConnectPSS® Co-Pay Program covering 100% of eligible out-of-pocket costs for commercially insured patients. Key requirements:

  • Must have commercial insurance (not Medicare or Medicaid)
  • Valid U.S. prescription from licensed provider
  • U.S. residency required

Application Process: Contact a Sanofi Case Manager at 1-833-723-5463 to apply.

Medicare-Eligible Programs

Starting January 1, 2025: Medicare Part D beneficiaries can use the Medicare Prescription Payment Plan to spread costs throughout the year rather than paying large amounts upfront.

PAF Co-Pay Relief Program: Provides up to $5,500 annually for Medicare and Medicaid patients.

Uninsured Patient Support

Sanofi Patient Connection: Provides medication at no cost for patients with household income at or below 400% of Federal Poverty Level. For a family of four in 2025, this threshold is $128,600.

From Our Advocates: We've seen patients successfully combine multiple assistance programs—using manufacturer copay cards for the first few months while foundation grants are being processed. The key is applying early and having your care team coordinate the paperwork.

Getting Coverage Through Prior Authorization

Required Documentation

Humana requires comprehensive clinical documentation including:

Diagnostic Confirmation:

  • GAA enzyme activity results (infantile-onset: <1% of normal; late-onset: <40% of normal)
  • GAA gene sequencing showing biallelic pathogenic variants
  • ICD-10 code E74.02 for Pompe disease

Clinical Assessment:

  • Physical examination findings
  • Respiratory function tests (FVC 30-79% predicted for late-onset)
  • Skeletal muscle weakness documentation
  • Weight-based dosing calculation (20 mg/kg IV every 2 weeks)

Prescriber Qualifications: Must be prescribed by a specialist qualified to diagnose Pompe disease (neurologist, geneticist, or metabolic specialist).

Submission Process

Timeline: Standard review takes 30 days; expedited review 72 hours if medically urgent.

How to Submit: Your physician contacts Humana at 1-866-488-5995 or submits through the provider portal.

Common Denial Reasons & Solutions

Denial Reason How to Address
Insufficient diagnostic testing Submit complete GAA enzyme assay and genetic testing
Non-specialist prescriber Transfer prescription to qualified neurologist or geneticist
Dosing beyond label Provide weight-based calculation and FDA label reference
Missing functional assessments Include pulmonary function tests and 6-minute walk test results

Specialty Pharmacy Coordination

Network Requirements

Lumizyme requires dispensing through Humana's specialty pharmacy network, with CenterWell Specialty Pharmacy serving as a key partner. This coordination ensures:

  • Proper cold-chain handling
  • Patient education and monitoring
  • Insurance benefit verification
  • Infusion site coordination

Coordination Tips

Before First Infusion:

  • Verify your infusion center is in-network
  • Confirm HCPCS code J0221 for billing
  • Arrange delivery timing with your treatment schedule
  • Set up automatic refill coordination

Ongoing Management:

  • Schedule deliveries 3-5 days before infusion dates
  • Maintain consistent communication between pharmacy and infusion center
  • Monitor for any formulary changes at renewal

Appeals Process in Virginia

Internal Appeals with Humana

Timeline: You have 65 days from denial notice to file internal appeals.

Required Elements:

  • Copy of denial letter
  • Additional clinical documentation
  • Medical necessity letter from prescriber
  • Patient impact statement

Virginia External Review

If Humana upholds the denial, Virginia law provides independent external review through the State Corporation Commission Bureau of Insurance.

Key Details:

Mailing Address: State Corporation Commission
Bureau of Insurance – External Review
P.O. Box 1157
Richmond, VA 23218

Tip: For cancer treatment denials, Virginia waives the requirement to exhaust internal appeals first, allowing direct filing for external review.

At Counterforce Health, we help patients and clinicians navigate these complex appeals by analyzing denial letters, identifying the specific criteria that weren't met, and drafting evidence-backed rebuttals that align with each payer's own policies.

Planning for Annual Renewals

What Can Change

Formulary Updates: Humana can modify formulary placement with 60-day notice to members.

Prior Authorization Criteria: Clinical requirements may be updated annually.

Network Changes: Specialty pharmacy partnerships can shift.

Renewal Preparation

90 Days Before Renewal:

  • Review new formulary for any Lumizyme changes
  • Confirm continued network status of your providers
  • Update any required clinical documentation

30 Days Before Renewal:

  • Reauthorize prior authorization if required
  • Verify copay assistance program renewal
  • Coordinate with specialty pharmacy for seamless transition

Scripts for Key Conversations

Calling Humana Customer Service

"Hi, I'm calling about prior authorization requirements for Lumizyme, generic name alglucosidase alfa, HCPCS code J0221. My member ID is [ID number]. Can you tell me the current status of my PA request submitted on [date] and what additional documentation might be needed?"

Requesting Expedited Review

"My patient requires expedited prior authorization review for Lumizyme due to disease progression. I can provide clinical documentation showing that delaying treatment would seriously jeopardize their health. What's the fastest way to submit this request?"

Specialty Pharmacy Coordination

"I need to coordinate Lumizyme delivery with CenterWell Specialty Pharmacy. My patient's next infusion is scheduled for [date] at [location]. Can you confirm the delivery timeline and provide the infusion center with advance notice?"

FAQ: Common Questions

Q: How long does Humana prior authorization take for Lumizyme in Virginia?
A: Standard review takes 30 days, but expedited review is available within 72 hours if your doctor certifies medical urgency.

Q: What if Lumizyme isn't on my Humana formulary?
A: You can request a formulary exception by demonstrating medical necessity and explaining why covered alternatives are inappropriate.

Q: Can I use manufacturer copay assistance with Medicare?
A: No, federal law prohibits manufacturer copay cards for Medicare beneficiaries, but alternative assistance programs like PAF Co-Pay Relief are available.

Q: What happens if I miss the Virginia external review deadline?
A: The 120-day deadline is firm, but contact the Bureau of Insurance immediately—they may provide guidance on other options.

Q: Does step therapy apply to Pompe disease treatments?
A: Newly enrolled members may face step therapy, but established patients typically don't need to retry failed treatments when switching plans.

When navigating these complex coverage requirements, Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed responses that speak directly to each payer's criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your insurance carrier and consult with qualified healthcare providers about treatment decisions. For assistance with Virginia insurance appeals, contact the State Corporation Commission Bureau of Insurance.

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