By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (galsulfase) Covered by Aetna (CVS Health) in Illinois: Prior Authorization Guide, Appeal Scripts & Timeline

Answer Box: Getting Naglazyme (galsulfase) Covered by Aetna (CVS Health) in Illinois

Naglazyme requires prior authorization from Aetna CVS Health. Your fastest path to approval: (1) Have your metabolic specialist submit enzyme assay or genetic testing confirming MPS VI diagnosis, (2) Request a medical necessity letter addressing Aetna's coverage criteria, and (3) Submit the precertification form to CVS Specialty Pharmacy. Standard approval takes 30-45 days; expedited review available within 72 hours for urgent cases. If denied, you have 60 days to appeal in Illinois, with external review available through the Illinois Department of Insurance.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required before first infusion CVS Specialty Pharmacy 30-45 days (standard)
Confirmed MPS VI Diagnosis Enzyme assay or genetic testing Metabolic specialist Required for submission
Specialist Prescription Must come from metabolic disease specialist or geneticist Provider referral Required
Medical Necessity Letter Clinical justification from prescriber Treating physician Required for PA
Site of Care Initial infusions in hospital; later at approved centers Aetna policy Ongoing requirement
Billing Code HCPCS J1458 (per mg) Medical benefits, not pharmacy For reimbursement

When Alternatives Make Sense

There are no FDA-approved alternatives to Naglazyme for MPS VI. Unlike other conditions where step therapy might require trying cheaper medications first, Naglazyme (galsulfase) is the only enzyme replacement therapy approved for mucopolysaccharidosis type VI (Maroteaux-Lamy syndrome).

This unique situation means that if you have a confirmed MPS VI diagnosis, Aetna CVS Health cannot require you to try alternative medications—there simply aren't any. However, they can still deny coverage based on:

  • Insufficient diagnostic documentation
  • Lack of specialist oversight
  • Missing functional assessments
  • Billing or site-of-care issues
Note: While experimental treatments like gene therapy and substrate reduction therapy exist in clinical trials, these are not considered viable alternatives for insurance coverage purposes.

Understanding Your Options

Supportive Care Options

While pursuing Naglazyme approval, your care team may recommend supportive treatments that don't require the same level of prior authorization:

Symptom Management:

  • Physical therapy for joint mobility
  • Respiratory support and monitoring
  • Cardiac monitoring and intervention
  • Orthopedic surgery for skeletal complications
  • Pain management strategies

Monitoring Tools:

  • Regular 6-minute walk tests
  • Pulmonary function testing
  • Echocardiograms
  • Urinary glycosaminoglycan (GAG) level tracking

These supportive measures are typically covered under standard medical benefits and can help maintain your health while working toward Naglazyme approval.

Clinical Trial Participation

If Aetna denies coverage, consider investigating clinical trials for:

  • Gene therapy approaches
  • Combination treatments
  • Long-term outcome studies

The BioMarin website maintains current information about ongoing research opportunities.

Exception Strategy: When to Request Coverage

Medical Necessity Documentation

Your metabolic specialist should include these elements in the medical necessity letter:

Diagnostic Confirmation:

  • Enzyme assay results showing arylsulfatase B deficiency
  • Genetic testing identifying ARSB gene mutations
  • Clinical presentation consistent with MPS VI

Functional Impact Documentation:

  • Baseline 6-minute walk test results
  • Stair climbing capacity assessment
  • Joint range of motion measurements
  • Cardiac and pulmonary function status

Treatment Goals:

  • Specific functional improvements expected
  • Monitoring plan for treatment response
  • Long-term care coordination strategy
Clinician Corner: When writing medical necessity letters for Naglazyme, address Aetna's specific coverage criteria point-by-point. Include baseline functional measurements and cite FDA labeling that supports the 1 mg/kg weekly dosing regimen. Reference peer-reviewed studies demonstrating improved endurance and quality of life outcomes in MPS VI patients.

Evidence That Strengthens Your Case

FDA Labeling Support: Reference the FDA-approved indication for MPS VI and the established efficacy data showing improved walking and stair-climbing capacity.

Clinical Guidelines: While MPS VI is rare, metabolic disease societies provide treatment recommendations that support enzyme replacement therapy as standard of care.

Functional Assessments: Document specific, measurable improvements in 6-minute walk tests and activities of daily living that Naglazyme can provide.

Step-by-Step: Fastest Path to Approval

1. Gather Diagnostic Documentation

Who does it: Your metabolic specialist Documents needed: Recent enzyme assay or genetic testing results Timeline: Should be completed during diagnosis Submit to: Include with prior authorization packet

2. Request Medical Necessity Letter

Who does it: Treating physician Documents needed: Letter addressing Aetna's coverage criteria Timeline: Allow 1-2 weeks for completion Submit to: CVS Specialty Pharmacy with PA form

3. Complete Prior Authorization Form

Who does it: Prescribing physician or staff Documents needed: Aetna Naglazyme PA form (verify current version) How to submit: Fax to 1-866-249-6155 (specialty) or online portal Timeline: Submit within 5 business days of request

4. Enroll with CVS Specialty Pharmacy

Who does it: Patient with provider support Documents needed: Insurance information, prescription How to submit: Call 1-866-814-5506 Timeline: Can be done while PA is pending

5. Follow Up on PA Status

Who does it: Patient or clinic staff Contact method: Aetna provider portal or phone 1-866-814-5506 Timeline: Check status after 2 weeks, expedite if urgent

6. Coordinate Infusion Site

Who does it: CVS Specialty Pharmacy and clinic Requirements: Hospital outpatient setting for initial infusions Timeline: Schedule once PA is approved

7. Plan for Reauthorization

Who does it: Treating physician Documents needed: Updated functional assessments every 6-12 months Timeline: Submit 30 days before authorization expires

Appeals Playbook for Aetna CVS Health in Illinois

Internal Appeal Process

Timeline: You have 60 days from receiving the denial letter to file an appeal How to submit:

  • Online: Aetna member portal
  • Phone: 1-800-294-5979
  • Mail: Address provided in denial letter

Required documents:

  • Copy of denial letter
  • Updated medical necessity letter
  • Additional clinical evidence
  • Patient impact statement

Decision timeline: 30 business days (standard), 36-72 hours (expedited)

External Review in Illinois

If Aetna's internal appeal fails, Illinois law guarantees your right to independent external review.

Timeline: 30 days from final internal denial (shorter than many states) How to request: Contact Illinois Department of Insurance at 877-527-9431 Cost: Free to consumers (insurers pay review costs) Decision timeline: 5 business days once IRO receives all materials Reviewer qualifications: Board-certified physician with MPS VI expertise

Important: Illinois has a stricter external review deadline than many states. Don't delay in requesting external review if your internal appeal is denied.

Expedited Appeals

For urgent situations where delay could jeopardize your health:

  • Request expedited internal appeal (72 hours)
  • Request expedited external review (24-72 hours)
  • Provide documentation of medical urgency

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
"Diagnosis not confirmed" Submit enzyme assay or genetic testing Lab reports showing arylsulfatase B deficiency
"Not medically necessary" Provide functional assessments and treatment goals 6-minute walk test, specialist letter
"Experimental/investigational" Cite FDA approval and clinical evidence FDA labeling, peer-reviewed studies
"Site of care not appropriate" Confirm hospital outpatient setting Facility accreditation, infusion protocols
"Prescriber not qualified" Document specialist credentials Metabolic disease or genetics certification

Costs & Financial Support

Insurance Coverage

  • Tier placement: Highest specialty tier (typically 20-40% coinsurance)
  • Annual cost: $600,000-$1.8M+ depending on weight
  • Out-of-pocket maximum: Check your specific plan's annual limit

Financial Assistance Programs

BioMarin RareConnections: Patient support program offering:

  • Insurance navigation assistance
  • Copay support (for eligible patients)
  • Prior authorization support
  • Nursing education

Contact: Visit BioMarin's patient support website or call the number provided with your prescription

State Programs: Illinois residents may qualify for additional support through:

  • Illinois Department of Healthcare and Family Services (Medicaid)
  • Local charitable foundations
  • Hospital financial assistance programs

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and creates point-by-point rebuttals aligned to each payer's specific rules, incorporating the right clinical evidence and procedural requirements for successful appeals.

FAQ

How long does Aetna CVS Health prior authorization take in Illinois? Standard prior authorization decisions take 30-45 days. Expedited review is available within 72 hours if you can demonstrate medical urgency.

What if Naglazyme is non-formulary on my plan? You can request a formulary exception with medical justification. Since there are no alternatives for MPS VI, exceptions are often approved when proper documentation is provided.

Can I get a temporary supply while waiting for approval? Aetna provides a 31-day emergency supply while formulary exceptions are being reviewed. Your physician must request this specifically.

Does step therapy apply to Naglazyme? No. Since Naglazyme is the only FDA-approved treatment for MPS VI, step therapy requirements don't apply.

What happens if I move between infusion sites? Notify CVS Specialty Pharmacy and your care team. Initial infusions must occur in hospital settings, but you may transition to approved infusion centers after demonstrating tolerance.

How often do I need reauthorization? Typically every 6-12 months. Your physician will need to provide updated functional assessments and documentation of ongoing clinical benefit.

What if my appeal is denied in Illinois? You have 30 days to request external review through the Illinois Department of Insurance. An independent physician reviewer will make a binding decision.

Can I appeal if Aetna doesn't respond within their timeline? Yes. If Aetna fails to respond within required timeframes, your appeal may be automatically approved under federal law. Contact the Illinois Department of Insurance for assistance.

From our advocates: "We've seen MPS VI patients succeed in appeals by focusing on functional improvement data. One family documented their child's walking distance and stair-climbing ability before and during treatment interruption, which provided compelling evidence for medical necessity. The key was having objective, measurable data rather than just subjective reports."

For additional support navigating insurance challenges with rare disease treatments, Counterforce Health's evidence-backed approach has helped many families secure coverage for specialty medications by creating targeted appeals that address each insurer's specific denial reasons.

Sources & Further Reading

Disclaimer: This information is for educational purposes and is not medical advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals or questions about your rights in Illinois, contact the Illinois Department of Insurance at 877-527-9431.

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