By Counterforce Health Team in Naglazyme (galsulfase) —

Do You Qualify for Naglazyme (Galsulfase) Coverage by Aetna (CVS Health) in Georgia? Decision Tree & Next Steps

Quick Answer: Your Path to Naglazyme Coverage in Georgia

You likely qualify for Naglazyme (galsulfase) coverage through Aetna (CVS Health) if you have confirmed MPS VI diagnosis via enzyme assay or genetic testing, plus documented functional limitations. Aetna requires prior authorization with specialist documentation and baseline assessments (6-minute walk test, pulmonary function). First step: Have your metabolic specialist complete Aetna's precertification form with enzyme/genetic results and medical necessity letter. Standard approval takes 30-45 days; expedited review available for urgent cases within 72 hours. If denied, Georgia residents have strong appeal rights including external review within 60 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Assessment: Do You Qualify?
  3. If "Likely Eligible": Your Approval Checklist
  4. If "Possibly Eligible": Tests and Documentation Needed
  5. If "Not Yet Eligible": Alternative Options
  6. If Denied: Georgia Appeal Path
  7. Common Denial Reasons & Solutions
  8. Costs & Financial Assistance
  9. FAQ: Your Top Questions Answered

How to Use This Decision Tree

This guide helps Georgia patients and clinicians navigate Aetna (CVS Health) coverage for Naglazyme (galsulfase), a life-changing enzyme replacement therapy for MPS VI (Maroteaux-Lamy syndrome) that can cost $600,000-$1.8 million annually.

Start here: Answer the eligibility questions in Section 2, then jump to your matching section for specific next steps. Each path includes required documents, submission instructions, and realistic timelines based on Aetna's published policies.

Note: This covers commercial Aetna plans administered through CVS Health. Medicare Advantage and Medicaid managed care may have different requirements.

Eligibility Assessment: Do You Qualify?

Core Requirements Checklist

✓ Confirmed MPS VI Diagnosis

  • Enzyme assay showing arylsulfatase B deficiency (<10% of normal)
  • OR genetic testing confirming ARSB gene mutations
  • Clinical presentation consistent with MPS VI

✓ Specialist Involvement

  • Prescription from metabolic disease specialist or geneticist
  • Medical necessity letter addressing treatment goals

✓ Baseline Assessments

  • 6-minute walk test (age ≥6 years) OR pulmonary function tests
  • Elevated urinary GAG/dermatan sulfate levels
  • Documentation of functional limitations

✓ Site of Care Plan

  • Initial hospital outpatient setting for safety monitoring
  • Long-term infusion plan (home, clinic, or continued hospital)

Your Eligibility Category

🟢 LIKELY ELIGIBLE - You have 3-4 checkmarks above → Jump to Section 3: Approval Checklist

🟡 POSSIBLY ELIGIBLE - You have 1-2 checkmarks → See Section 4: Additional Testing Needed

🔴 NOT YET ELIGIBLE - You have 0-1 checkmarks → Review Section 5: Alternative Options

If "Likely Eligible": Your Approval Checklist

Step-by-Step: Fastest Path to Approval

1. Verify Benefits (1-2 days)

  • Call Aetna member services: 1-800-872-3862
  • Ask about: coinsurance rates, out-of-pocket maximum, referral requirements
  • Confirm coverage for HCPCS code J1458 (galsulfase injection)
  • Request current precertification requirements

2. Gather Required Documents (3-5 days)

  • Enzyme assay or genetic testing results
  • Specialist consultation notes
  • Baseline functional assessments (6-minute walk test, PFTs)
  • Urinary GAG levels
  • Insurance card and member ID

3. Complete Prior Authorization (1 day)

4. Follow Up Weekly

  • Standard review: 30-45 days
  • Expedited review: 72 hours (if urgent medical need)
  • Track via Aetna provider portal or member services

Medical Necessity Letter Template

Your specialist should include:

Diagnosis: Confirmed mucopolysaccharidosis VI (MPS VI) based on [specific test results and date]

Clinical Rationale: Patient demonstrates [specific functional limitations] with baseline 6-minute walk distance of [X meters] and [other objective measures]. Naglazyme is FDA-approved enzyme replacement therapy shown to improve walking and stair-climbing capacity in MPS VI patients.

Treatment Goals: Improve/stabilize respiratory function, endurance, and quality of life. Monitor via repeat functional assessments every 6 months.

Dosing: 1 mg/kg IV weekly with appropriate premedication and monitoring per FDA labeling.

If "Possibly Eligible": Tests and Documentation Needed

Missing Diagnosis Confirmation

If you need enzyme testing:

  • Contact a metabolic specialist or genetics clinic
  • Request arylsulfatase B enzyme assay in leukocytes or fibroblasts
  • Timeline: 2-4 weeks for results
  • Cost: Often covered as diagnostic testing

If enzyme results are borderline:

  • Request genetic testing for ARSB gene mutations
  • Consider second opinion from MPS specialist
  • Document clinical symptoms supporting MPS VI

Missing Functional Assessments

Required baseline tests:

  • 6-minute walk test: Must be performed by trained staff using standardized protocol
  • Pulmonary function tests: FVC and FEV₁ (percent predicted)
  • Urinary GAG levels: Elevated dermatan sulfate above lab normal

Timeline to reapply: 4-6 weeks after completing missing assessments

Tip: Many insurance plans will approve "rule-out MPS VI" testing when clinical suspicion is documented by a specialist.

If "Not Yet Eligible": Alternative Options

When Diagnosis Is Uncertain

Supportive care options:

  • Orthopedic management for joint limitations
  • Cardiopulmonary monitoring and treatment
  • Physical therapy for mobility
  • Sleep study if airway obstruction suspected

Investigational options:

  • Clinical trials for gene therapy (check ClinicalTrials.gov)
  • Research studies through MPS centers

Preparing for Future Application

  1. Establish care with metabolic disease specialist
  2. Document progression with regular functional assessments
  3. Consider genetic counseling for family planning
  4. Connect with MPS support organizations for resources

If Denied: Georgia Appeal Path

Georgia residents have strong consumer protection rights for insurance appeals, including binding external review through the Georgia Department of Insurance.

Internal Appeal (First Level)

Timeline: Must file within 180 days of denial Process:

  1. Call Aetna appeals: 1-800-872-3862
  2. Request expedited review if urgent (72-hour decision)
  3. Submit additional clinical documentation
  4. Request peer-to-peer review with medical director

Required documents:

  • Copy of denial letter
  • Updated medical necessity letter
  • Any new test results or clinical notes
  • Published treatment guidelines supporting Naglazyme use

External Review (Georgia Department of Insurance)

When to use: After internal appeal denial Deadline: Within 60 days of final Aetna denial letter Cost: Up to $25 fee (refunded if you win)

How to file:

  1. Complete Georgia external review application
  2. Attach all denial letters and medical records
  3. Submit to assigned independent review organization
  4. Decision rendered within 45 days (72 hours if urgent)

Contact: Georgia Office of Commissioner of Insurance

From our advocates: We've seen many successful Georgia external reviews for specialty drugs when the clinical documentation clearly shows medical necessity. The key is mapping your case to the insurer's own policy criteria and providing objective evidence of disease severity.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documents
Diagnosis not confirmed Submit definitive testing Enzyme assay or genetic testing results
Not medically necessary Provide functional baselines 6-minute walk test, PFTs, specialist letter
Experimental/investigational Cite FDA approval FDA labeling, clinical guidelines
Site of care inappropriate Justify hospital setting Safety protocols, reaction history
Prescriber not qualified Verify specialist credentials Board certification, metabolic expertise
Step therapy required Document contraindications Prior therapy failures, adverse reactions

Costs & Financial Assistance

Estimated annual cost: $600,000-$1.8 million (weight-dependent) Typical patient responsibility: Varies by plan design

Financial Support Options

Manufacturer Programs:

Foundation Grants:

  • National MPS Society assistance programs
  • HealthWell Foundation (verify current availability)
  • Patient Advocate Foundation copay relief

State Resources:

  • Georgia Department of Community Health for Medicaid questions
  • Georgians for a Healthy Future consumer assistance

FAQ: Your Top Questions Answered

Q: How long does Aetna prior authorization take in Georgia? A: Standard review takes 30-45 days. Expedited review for urgent cases is completed within 72 hours when medical necessity for immediate treatment is documented.

Q: What if Naglazyme is non-formulary on my plan? A: Request a formulary exception using Aetna's medical exception process. Document why alternative treatments are inappropriate for MPS VI.

Q: Can I start treatment while the appeal is pending? A: Yes, if your doctor documents urgent medical need. Request expedited internal appeal and consider manufacturer patient assistance programs.

Q: Does step therapy apply if I'm already on Naglazyme? A: Generally no. Aetna's step therapy policies typically don't apply to patients already stable on a medication within the past 365 days.

Q: What happens if the external review denies coverage? A: The decision is binding on Aetna, but you may still pursue manufacturer assistance programs or legal remedies where applicable.

Q: How often do I need reauthorization? A: Typically every 6-12 months. Submit updated functional assessments showing continued benefit or disease stabilization.

When navigating complex insurance approvals for rare disease treatments like Naglazyme, having expert support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to create compelling rebuttal letters aligned to each payer's specific requirements.

The platform specializes in payer-specific workflows and produces letters that meet procedural requirements while tracking deadlines and required documentation. For Georgia residents facing Aetna denials, this type of specialized support can be invaluable in navigating the complex appeals process and maximizing the chances of a successful outcome.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms, medical circumstances, and state regulations. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with Aetna and Georgia regulatory authorities.

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