By Counterforce Health Team in Naglazyme (galsulfase) —

Work With Your Doctor to Get Naglazyme (galsulfase) Approved by Aetna (CVS Health) in New Jersey

Answer Box: Getting Naglazyme Covered by Aetna (CVS Health) in New Jersey

Eligibility: Patients with confirmed MPS VI diagnosis via enzyme assay or genetic testing can get Naglazyme (galsulfase) covered through Aetna's prior authorization process. Fastest path: Work with your metabolic specialist to submit the Naglazyme Precertification Form with enzyme deficiency lab results and functional assessments. First step today: Call your provider to schedule a visit focused on gathering required documentation—enzyme assay results, 6-minute walk test data, and baseline functional measures that Aetna requires for approval.

Table of Contents

  1. Set Your Goal: What Approval Requires
  2. Visit Preparation: Documenting Your Journey
  3. Building Your Evidence Kit
  4. Medical Necessity Letter Structure
  5. Supporting Peer-to-Peer Reviews
  6. After Your Visit: Documentation Strategy
  7. Respectful Persistence: Follow-Up Protocol
  8. New Jersey Appeals Process
  9. Costs and Patient Assistance
  10. FAQ

Set Your Goal: What Approval Requires

Getting Naglazyme (galsulfase) approved by Aetna (CVS Health) requires meeting specific clinical criteria and working closely with your healthcare team. Here's what you're aiming for together:

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before first dose Aetna Naglazyme Precert Form
Confirmed Diagnosis MPS VI via enzyme assay or genetics Lab results showing arylsulfatase B deficiency
Specialist Involvement Metabolic/genetic disorder specialist Provider credentials documentation
Functional Assessments 6-minute walk test, stair climbing capacity Baseline measurements required
Billing Code HCPCS J1458 (per mg) Medical benefit, not pharmacy

Partnership Strategy

Your success depends on clear communication with your provider about Aetna's specific requirements. Come prepared to discuss:

  • Diagnosis confirmation: Ensure your enzyme assay or genetic test results are recent and clearly documented
  • Functional impact: Be ready to quantify how MPS VI affects your daily activities
  • Treatment timeline: Understand that approval typically takes 2-3 weeks once complete documentation is submitted

Visit Preparation: Documenting Your Journey

Before your appointment, organize your medical history to help your provider build the strongest possible case for approval.

Symptom Timeline Preparation

Create a chronological record of your MPS VI symptoms:

Physical Function Changes:

  • Walking distance limitations (how far you could walk 6 months ago vs. now)
  • Stair climbing difficulties (number of steps, need for rest breaks)
  • Joint stiffness and range of motion changes
  • Breathing difficulties during activity

Daily Life Impact:

  • Activities you've had to stop or modify
  • Work or school accommodations needed
  • Family activities affected by your condition

Treatment History Documentation

Gather records of:

  • Previous therapies tried: Physical therapy, pain management, surgical interventions
  • Current medications: Including dosages and effectiveness
  • Specialist consultations: Cardiology, pulmonology, orthopedics, genetics
  • Hospitalizations or ER visits: Related to MPS VI complications

Functional Assessment Notes

If you've had formal testing, bring results from:

  • 6-minute walk tests
  • Stair climbing assessments
  • Pulmonary function tests
  • Cardiac evaluations
  • Joint range of motion measurements

Building Your Evidence Kit

Work with your provider to assemble the documentation Aetna requires for Naglazyme approval.

Required Laboratory Evidence

Your provider will need to submit:

Enzyme Assay Results:

  • Arylsulfatase B (N-acetylgalactosamine-4-sulfatase) activity levels
  • Reference ranges and your specific values
  • Laboratory certification and methodology

Genetic Testing (if enzyme assay unavailable):

  • ARSB gene mutation analysis
  • Pathogenic variant identification
  • Genetic counselor interpretation

Clinical Guidelines Support

Your provider should reference established treatment protocols:

  • FDA labeling: Naglazyme's approved indication for MPS VI enzyme replacement therapy
  • Published guidelines: International consensus on MPS VI management
  • Specialty society recommendations: Metabolic disorder treatment standards

Functional Assessment Documentation

Objective measures that demonstrate medical necessity:

Baseline Function Tests:

  • 6-minute walk distance (normal adults: 400-700 meters)
  • Stair climbing capacity (steps per minute or total steps climbed)
  • Quality of life assessments using validated tools
  • Joint range of motion measurements

Medical Necessity Letter Structure

Your provider's letter of medical necessity should address Aetna's specific coverage criteria systematically.

Essential Letter Components

1. Diagnosis Confirmation

Patient [Name] has a confirmed diagnosis of MPS VI (Maroteaux-Lamy syndrome) 
based on [enzyme assay showing arylsulfatase B deficiency of X units/mg protein 
(normal range: Y-Z) / genetic testing revealing pathogenic ARSB mutations].

2. Clinical Rationale

  • Current functional limitations with objective measurements
  • Progressive nature of MPS VI without treatment
  • Expected benefits of enzyme replacement therapy
  • Lack of alternative therapeutic options

3. Treatment Plan

  • Dosing: 1 mg/kg IV weekly (standard FDA-approved regimen)
  • Administration site: [Infusion center with emergency capabilities]
  • Monitoring plan: Functional assessments every 6 months
  • Duration: Ongoing, as MPS VI is a chronic, progressive condition

4. Supporting References Your provider should cite:

Supporting Peer-to-Peer Reviews

If Aetna requests a peer-to-peer review, help your provider prepare for this crucial conversation.

Pre-Call Preparation

Offer Your Availability:

  • Provide flexible time windows when you can be reached
  • Ensure your provider has your current contact information
  • Be prepared to join the call if requested

Case Summary for Your Provider: Create a one-page summary including:

  • Diagnosis date and confirming test results
  • Current functional limitations (specific measurements)
  • Impact on daily activities and quality of life
  • Previous treatments attempted and outcomes

Key Points for Provider Discussion

Clinical Necessity Arguments:

  • MPS VI is progressive without treatment
  • Naglazyme is the only FDA-approved ERT for MPS VI
  • Early treatment provides better outcomes
  • Patient meets all coverage criteria per Aetna policy

Safety and Monitoring:

  • Infusion site has appropriate emergency protocols
  • Provider experience with enzyme replacement therapies
  • Planned monitoring schedule for efficacy and safety

After Your Visit: Documentation Strategy

Maintain organized records to support your approval request and any potential appeals.

What to Save

From Your Provider:

  • Copy of the prior authorization request
  • Medical necessity letter
  • All supporting lab results and test reports
  • Specialist consultation notes

From Aetna:

  • Confirmation of prior authorization submission
  • Any requests for additional information
  • Approval or denial determination letters
  • Reference numbers for all communications

Portal Communication Tips

When messaging your provider through patient portals:

Be Specific:

  • Reference exact dates and test results
  • Include Aetna reference numbers
  • Attach relevant documents or photos of forms

Stay Organized:

  • Use clear subject lines ("Naglazyme PA - Additional Info Needed")
  • Number your questions if asking multiple items
  • Include deadlines for any requested information

Respectful Persistence: Follow-Up Protocol

Maintain appropriate follow-up without overwhelming your healthcare team.

Timeline for Updates

Week 1-2: Allow time for initial review Week 3: Gentle check-in if no update received Week 4+: More frequent contact if approaching treatment urgency

Escalation Strategy

If facing delays:

  1. Contact your provider's office manager to understand any bottlenecks
  2. Reach out to Aetna member services for status updates
  3. Consider involving a patient advocate if available through your healthcare system
  4. Prepare for appeals process if initial request is denied

Professional Communication

When following up:

  • Express appreciation for your provider's efforts
  • Offer to help gather additional information
  • Share any new symptoms or functional changes
  • Maintain a collaborative, problem-solving approach

New Jersey Appeals Process

If Aetna denies your Naglazyme request, New Jersey offers strong patient protections through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals First

Aetna's Process:

  • Submit appeal within 180 days of denial
  • Include additional clinical documentation
  • Request expedited review if medically urgent
  • Expect decision within 30-45 days (72 hours if expedited)

External Review Through IHCAP

When to Use: After completing Aetna's internal appeals process

How to Apply:

  • Submit request to Maximus Federal Services (New Jersey's external review contractor)
  • File within 4 months of final internal denial
  • Include all medical records and denial letters

Timeline:

  • Standard appeals: Decision within 45 days
  • Expedited appeals: Decision within 48 hours for urgent cases

Success Factors:

  • Complete medical documentation
  • Clear demonstration of medical necessity
  • Compliance with all procedural requirements
From our advocates: We've seen cases where patients initially denied for specialty enzyme replacement therapies succeeded on external review by ensuring their providers included detailed functional assessments and cited specific FDA labeling language. The key is often in the details—quantified walking distances, stair climbing capacity, and clear documentation of progressive symptoms without treatment.

For assistance with the IHCAP process, contact the New Jersey Department of Banking and Insurance at 888-393-1062.

Costs and Patient Assistance

Naglazyme costs approximately $600,000-$1.8 million annually depending on patient weight, making financial assistance programs crucial.

Manufacturer Support

BioMarin RareConnections:

  • Coverage investigation and prior authorization support
  • Copay assistance programs for eligible patients
  • Patient assistance for uninsured/underinsured individuals
  • Care coordination services

Contact: BioMarin RareConnections

Additional Resources

State Programs: New Jersey residents may qualify for additional assistance through state pharmaceutical programs

Foundation Grants: Organizations supporting rare disease patients often provide emergency financial assistance

CVS Specialty Support: As Aetna's specialty pharmacy partner, CVS offers case management and benefits investigation services

FAQ

How long does Aetna prior authorization take for Naglazyme in New Jersey? Standard prior authorization decisions typically take 30-45 days once complete documentation is submitted. Expedited reviews for urgent cases can be completed within 72 hours.

What if Naglazyme is not on Aetna's formulary? Non-formulary medications can still be covered through formulary exceptions. Your provider will need to demonstrate medical necessity and lack of suitable formulary alternatives.

Can I request an expedited appeal if my condition is worsening? Yes, both Aetna and New Jersey's external review process offer expedited appeals when delays could cause serious harm to your health.

Does step therapy apply to Naglazyme? Step therapy typically doesn't apply to orphan drugs like Naglazyme since there are no alternative treatments for MPS VI. However, some plans may require documentation that supportive therapies were tried first.

What if I need to start treatment before approval? In urgent situations, your provider can request an expedited prior authorization. Some patients may need to pursue treatment and seek retroactive coverage, though this carries financial risk.

How often do I need reauthorization? Most plans require reauthorization every 6-12 months with updated functional assessments demonstrating continued clinical benefit.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify specific denial reasons and draft point-by-point rebuttals aligned with each plan's requirements, making the appeals process more efficient and successful.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage policies and procedures may change; verify current requirements with your specific plan.

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