By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (galsulfase) Covered by Aetna CVS Health in California: Prior Authorization, Appeals, and Cost Strategies

Answer Box: Getting Naglazyme Covered by Aetna CVS Health in California

Naglazyme (galsulfase) requires prior authorization from Aetna CVS Health and must be dispensed through CVS Specialty Pharmacy. Standard approval takes 30-45 days, but expedited reviews are available for urgent cases (72 hours). Essential requirements: confirmed MPS VI diagnosis via enzyme assay or genetic testing, prescription from a metabolic specialist, and documented medical necessity. If denied, California residents have strong appeal rights through Independent Medical Review (IMR) with 50-68% overturn rates for specialty medications.

First step today: Contact your metabolic specialist to gather enzyme test results and request a medical necessity letter while your clinic submits the CVS Specialty enrollment form.

Table of Contents

  1. What Drives Naglazyme Costs
  2. Understanding Your Aetna CVS Health Benefits
  3. Prior Authorization Requirements
  4. Financial Assistance Options
  5. Appeals Process in California
  6. CVS Specialty Pharmacy Coordination
  7. Renewal and Annual Changes
  8. Scripts for Key Conversations
  9. FAQ

What Drives Naglazyme Costs

Naglazyme carries one of the highest price tags in medicine—roughly $600,000 to $1.8 million annually depending on your weight. The drug costs approximately $2,437 per 5mL vial, with weekly dosing at 1mg/kg requiring multiple vials per infusion.

Key cost factors:

  • Specialty tier placement: Naglazyme sits on Aetna's highest specialty tier, typically requiring 20-40% coinsurance
  • Medical vs. pharmacy benefit: Covered under medical benefits using HCPCS code J1458, not pharmacy
  • Site of care restrictions: Initial infusions must occur in hospital outpatient settings; later infusions may move to infusion centers
  • No alternatives: As the only FDA-approved treatment for MPS VI, there's no step therapy requirement but also no lower-cost options
Note: California law requires insurers to cover FDA-approved orphan drugs when medically necessary, providing stronger protections than many states.

Understanding Your Aetna CVS Health Benefits

Before starting the approval process, gather this essential information by calling the member services number on your insurance card:

Questions to ask Aetna:

  1. "What's my specialty medication coinsurance percentage?"
  2. "What's my annual out-of-pocket maximum for medical benefits?"
  3. "Do I need a referral to see a metabolic specialist?"
  4. "Is prior authorization required for HCPCS code J1458 (Naglazyme)?"
  5. "Which CVS Specialty locations serve California?"

Information to record:

  • Policy/group number and member ID
  • Specialty coinsurance rate (typically 20-40%)
  • Annual deductible and out-of-pocket maximum
  • Prior authorization department phone and fax numbers

Prior Authorization Requirements

Aetna CVS Health requires prior authorization for all Naglazyme infusions. The process typically takes 30-45 days, with expedited reviews available for urgent cases.

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
Confirmed MPS VI Diagnosis Enzyme deficiency or genetic confirmation Arylsulfatase B enzyme assay results OR genetic testing showing ARSB mutations Aetna Policy 0442
Specialist Prescription Metabolic disease specialist involvement Prescription and medical necessity letter from geneticist or metabolic specialist Aetna Policy 0442
Baseline Assessments Functional capacity measurements 6-minute walk test, stair climbing capacity, joint range of motion CVS Specialty Form
Site of Care Approval Hospital outpatient for initial doses Medical necessity for continued hospital vs. infusion center Aetna Policy 0442

Step-by-Step: Fastest Path to Approval

  1. Schedule specialist appointment (Patient) - Contact a metabolic disease specialist or geneticist; expect 2-4 week wait
  2. Gather diagnostic evidence (Clinic) - Collect enzyme assay results and genetic testing confirming MPS VI diagnosis
  3. Submit CVS Specialty enrollment (Clinic) - Complete Lysosomal Storage Disorders form with all required documentation
  4. Request expedited review (Clinic) - If patient has urgent symptoms, request 72-hour expedited prior authorization
  5. Monitor PA status (Patient/Clinic) - Follow up weekly with CVS Specialty and Aetna for approval status
  6. Coordinate infusion scheduling (CVS Specialty) - Once approved, schedule first infusion at hospital outpatient facility
  7. Plan ongoing monitoring (Clinic) - Establish baseline measurements for future reauthorization requirements
Clinician Corner: Your medical necessity letter should address: confirmed MPS VI diagnosis with specific enzyme levels, functional limitations documented by objective testing, treatment goals (improved mobility, reduced pain), and why weekly infusions are medically necessary. Include references to FDA labeling and current MPS VI management guidelines.

Financial Assistance Options

BioMarin RareConnections Program

BioMarin offers comprehensive patient support through their RareConnections program, including potential copay assistance for commercially insured patients.

Eligibility and benefits:

  • Available regardless of income level (case-by-case assessment)
  • Covers patients with commercial insurance, Medicaid, and uninsured individuals
  • No published income limits or copay caps
  • Contact: 1-866-906-6100 or [email protected]

Foundation Grants

Several foundations provide grants for rare disease treatments:

  • National Organization for Rare Disorders (NORD): Medication assistance program
  • HealthWell Foundation: Copay assistance for eligible conditions
  • Patient Access Network (PAN) Foundation: Rare disease fund

California-Specific Programs

California residents have additional resources:

  • Medi-Cal coverage: If eligible, Medi-Cal covers Naglazyme with prior authorization
  • Covered California subsidies: Premium tax credits and cost-sharing reductions may apply
  • Hospital charity care: Many California hospitals offer financial assistance programs

Appeals Process in California

California offers some of the strongest patient appeal rights in the nation, with particularly high success rates for specialty medications.

Internal Appeals with Aetna CVS Health

Timeline: 30 days to file after denial notice Process: Submit written appeal with supporting documentation Decision timeframe: 30 days for standard appeals, 72 hours for expedited

California Independent Medical Review (IMR)

If Aetna upholds the denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC).

Key advantages:

  • High success rates: 50-68% of specialty medication denials are overturned through IMR
  • No cost to patient: California law prohibits IMR fees
  • Binding decision: Aetna must comply with IMR determinations
  • Expert reviewers: Independent physicians specializing in metabolic disorders review cases

How to file IMR:

  1. Wait for internal appeal decision (or 30 days if no response)
  2. File IMR application within 30 days via DMHC website
  3. Submit supporting documents: Medical records, specialist letters, research citations
  4. Receive decision: Standard IMRs decided within 45 days, expedited within 7 days
From our advocates: We've seen several California patients successfully overturn Naglazyme denials through IMR by submitting comprehensive documentation from their metabolic specialists, including detailed functional assessments and peer-reviewed research supporting enzyme replacement therapy. The key is demonstrating clear medical necessity with objective evidence.

DMHC Help Center: 888-466-2219 for assistance with filing complaints or IMR applications

CVS Specialty Pharmacy Coordination

Naglazyme must be dispensed through CVS Specialty Pharmacy and requires careful coordination for infusion scheduling.

Enrollment Process

  1. Provider submits referral using CVS Specialty Lysosomal Storage Disorders form
  2. CVS Specialty contacts patient within 24-48 hours to verify insurance and schedule
  3. Prior authorization processed concurrently with enrollment
  4. Infusion site coordination for hospital outpatient or approved infusion center
  5. Medication shipped to infusion facility with cold-chain handling

Infusion Requirements

Safety protocols: All infusions must occur in facilities with full resuscitation capabilities due to risk of severe allergic reactions Premedication: Antihistamines and antipyretics recommended before each infusion Monitoring: Vital signs checked throughout 4-6 hour infusion process

At Counterforce Health, we've helped numerous patients navigate the complex specialty pharmacy requirements for enzyme replacement therapies. Our platform can identify specific denial reasons and draft targeted appeals that address Aetna's coverage criteria point by point.

Renewal and Annual Changes

Naglazyme requires ongoing reauthorization, typically every 6-12 months.

Reauthorization Requirements

Clinical documentation needed:

  • Urinary glycosaminoglycan (uGAG) level reductions
  • Functional improvement measurements (6-minute walk test, stair climbing)
  • Physician assessment of treatment benefit
  • Updated medical necessity letter

Annual benefit changes to monitor:

  • Specialty tier coinsurance rates (can increase January 1st)
  • Out-of-pocket maximums and deductibles
  • Formulary status changes
  • Site of care restrictions

Budget planning tips:

  • Review Summary of Benefits and Coverage (SBC) during open enrollment
  • Consider supplemental insurance if available
  • Plan for potential mid-year formulary changes
  • Track progress toward annual out-of-pocket maximum

Scripts for Key Conversations

Calling Aetna Member Services

"Hi, I'm calling about prior authorization for Naglazyme, HCPCS code J1458, for my MPS VI diagnosis. Can you tell me the status of my PA request submitted on [date]? I also need to confirm my specialty medication coinsurance percentage and annual out-of-pocket maximum."

Requesting Expedited Review

"My patient with MPS VI is experiencing [specific symptoms] and needs expedited prior authorization for Naglazyme. This is an urgent medical situation requiring 72-hour review. Can you please escalate this request and provide the expedited review confirmation number?"

CVS Specialty Follow-up

"I'm calling about my Naglazyme prescription. My prior authorization was approved on [date] and I need to schedule my first infusion. Can you confirm which hospital outpatient facilities in [your city] are approved for Naglazyme administration?"

FAQ

How long does Aetna CVS Health prior authorization take in California? Standard prior authorization takes 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours. California law requires insurers to process prior authorizations within these timeframes.

What if Naglazyme is denied as "experimental"? MPS VI is an FDA-approved indication for Naglazyme, so "experimental" denials are typically overturned on appeal. Submit FDA labeling and current treatment guidelines as supporting evidence.

Can I request an expedited appeal in California? Yes, if your condition is urgent or your health could be seriously jeopardized by delays. Both Aetna internal appeals and California IMR offer expedited processes.

Does step therapy apply to Naglazyme? No, because Naglazyme is the only FDA-approved treatment for MPS VI. However, some plans may require documentation of supportive care attempts.

What happens if I move to another state? Appeal rights and processes vary by state. California's IMR system is particularly patient-friendly, so moving may affect your appeal options.

How much will I pay out-of-pocket? This depends on your specific plan's specialty tier coinsurance (typically 20-40%) and annual out-of-pocket maximum. BioMarin's patient assistance program may help reduce costs.

Can I get Naglazyme at a local pharmacy? No, Naglazyme must be dispensed through CVS Specialty Pharmacy and administered at approved infusion facilities due to its specialized handling and safety requirements.

Medical Disclaimer: This article provides general information about insurance coverage and is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company for specific coverage determinations.

For additional help with insurance appeals and coverage challenges, Counterforce Health provides specialized support for patients, clinicians, and pharmacies navigating complex prior authorization and appeal processes.

California Resources:

Sources & Further Reading

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