By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

How to Get Lumizyme (Alglucosidase Alfa) Covered by Aetna CVS Health in New Jersey: Complete PA Guide and Appeal Process

Answer Box: Getting Lumizyme Covered by Aetna CVS Health in New Jersey

Aetna CVS Health requires prior authorization for Lumizyme (alglucosidase alfa) in New Jersey, with no state-specific variations. To get approval: (1) Submit Aetna's Lumizyme precertification form with enzyme/genetic test results confirming Pompe disease, (2) Ensure prescription comes from a metabolic disease specialist, and (3) Enroll with CVS Specialty Pharmacy using their Lysosomal Storage Disorders form. Standard approval takes 30-45 days; expedited review available in 72 hours for urgent cases. If denied, you have 180 days to appeal and can access New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services.

First step today: Download the Aetna Lumizyme precertification form and gather your enzyme assay or genetic testing results.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Enrollment
  5. Cost-Share Basics
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Process in New Jersey
  9. External Review Through IHCAP
  10. FAQ

Plan Types & Coverage Implications

Aetna CVS Health covers Lumizyme across all plan types in New Jersey—commercial HMO/PPO, Medicare Advantage, and Medicaid managed care—but the approval pathway varies slightly:

Commercial Plans (HMO/PPO/EPO): Standard prior authorization through Aetna's pharmacy benefit management. No referral required for specialist consultation, but the prescriber must be qualified in metabolic or lysosomal storage disorders.

Medicare Advantage: Same PA requirements as commercial, but appeals follow Medicare timelines (72-hour expedited, 30-day standard). External review available through Medicare's Independent Review Entity (IRE) rather than New Jersey's IHCAP.

Aetna Better Health (Medicaid): Prior authorization required with additional documentation of medical necessity. May require state Medicaid approval in some cases.

Note: Self-funded employer plans may have different appeal rights and should verify their specific process with HR or the plan administrator.

Formulary Status & Tier Placement

Lumizyme appears on Aetna's specialty formulary but requires prior authorization across all plans. Aetna prefers Nexviazyme (avalglucosidase alfa) for late-onset Pompe disease as a lower-cost alternative, meaning Lumizyme approval often requires documenting why Nexviazyme isn't appropriate.

Key formulary details:

  • Specialty tier placement with higher cost-sharing
  • No explicit step therapy listed for Pompe treatments
  • Medical necessity criteria focus on confirmed diagnosis and specialist oversight
  • Site of care restrictions apply (outpatient infusion centers preferred)

The 2026 Aetna Precertification List confirms Lumizyme remains subject to prior authorization with no changes to approval criteria.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It
PA Required Yes, all plans Aetna Precert List
Diagnosis Confirmation Enzyme assay or genetic testing Aetna Lumizyme Policy
Specialist Prescriber Metabolic/lysosomal expert required Precertification Form
Dosing 20 mg/kg every 2 weeks FDA Label
Site of Care Outpatient center preferred Aetna Site of Care Policy

Essential Documentation

Initial Approval:

  • Confirmed Pompe disease via acid alpha-glucosidase (GAA) enzyme assay showing deficiency
  • OR genetic testing revealing biallelic GAA mutations
  • Prescription from qualified specialist (neurology, genetics, metabolic disorders)
  • Patient demographics, weight, allergies, insurance information
  • ICD-10 codes (typically E74.02 for Pompe disease)

Continuation Requests:

  • Evidence of treatment response or disease stabilization
  • Functional assessments (6-minute walk test, forced vital capacity)
  • Specialist evaluation confirming ongoing benefit
  • Documentation of adherence to infusion schedule

CVS Specialty Pharmacy Enrollment

Most Aetna members receive Lumizyme through CVS Specialty Pharmacy, which coordinates both the medication dispensing and infusion site logistics.

Enrollment Steps

  1. Provider completes enrollment: Use the CVS Specialty Lysosomal Storage Disorders form
  2. Patient contact: CVS calls within 24-48 hours to verify insurance and coordinate delivery
  3. Site selection: Choose approved infusion center with resuscitation capabilities
  4. Shipment coordination: Medication ships via cold chain to infusion site
  5. Ongoing support: CVS provides refill reminders and insurance coordination

Key Contact: CVS Specialty Pharmacy provider services for enrollment questions and PA status updates.

Cost-Share Basics

Lumizyme typically falls under specialty pharmacy benefits with higher cost-sharing than standard medications. In New Jersey, Aetna members can expect:

  • Commercial plans: Specialty coinsurance (often 10-40% after deductible)
  • Medicare Advantage: Part B coverage if administered in outpatient setting
  • Medicaid: Minimal or no cost-sharing for covered services
Important: These are general patterns only. Contact Aetna member services at the number on your insurance card for your specific cost-sharing details.

Potential cost assistance:

  • Sanofi may offer patient assistance programs (verify eligibility at manufacturer website)
  • State pharmaceutical assistance programs
  • Nonprofit foundations supporting rare disease treatments

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Gather documentation (1-2 days): Enzyme/genetic test results, specialist letter, patient demographics
  2. Complete PA form (same day): Download Aetna Lumizyme precertification form
  3. Submit to Aetna (same day): Fax to 1-888-267-3277 or call 1-866-752-7021
  4. Enroll with CVS Specialty (1-2 days): Submit enrollment form simultaneously
  5. Track status (weekly): Follow up via Aetna provider portal or phone
  6. Receive decision (30-45 days standard, 72 hours expedited)
  7. Coordinate infusion (post-approval): CVS schedules delivery and administration

Required Form Fields

The Aetna precertification form requires complete information in all sections:

  • Patient and insurance details
  • Prescriber information and credentials
  • Clinical diagnosis with ICD codes
  • Requested dose and frequency
  • Site of administration
  • Supporting clinical documentation

Critical tip: Incomplete forms are the most common cause of delays. Double-check all fields before submission.

Common Approval Patterns

Successful Lumizyme approvals typically include:

Strong clinical documentation:

  • Clear Pompe disease diagnosis with specific enzyme levels or genetic variants
  • Specialist letter explaining medical necessity
  • Functional assessments showing disease progression or treatment benefit
  • Documentation of contraindications to preferred alternatives (if applicable)

Proper procedural compliance:

  • All form fields completed accurately
  • Submission from qualified specialist
  • Appropriate ICD-10 and procedure codes
  • Site of care justification when needed

Proactive communication:

  • Early submission (30-45 days before needed)
  • Prompt response to Aetna requests for additional information
  • Coordination between prescriber and CVS Specialty

Appeals Process in New Jersey

If Aetna denies your Lumizyme request, New Jersey provides robust appeal rights through both internal and external review processes.

Internal Appeals

Timeline: 180 days from denial notice Process: Submit appeal letter with supporting documentation Decision time: 30-45 business days (72 hours for expedited)

Required documentation:

  • Original denial letter
  • Medical records supporting medical necessity
  • Specialist letter addressing denial reasons
  • Relevant clinical guidelines or FDA labeling

Contact for appeals:

  • Phone: 1-866-752-7021
  • Fax: 1-888-267-3277
  • Online: Aetna provider portal

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) provides an independent review of medical necessity denials after you complete Aetna's internal appeal process.

Administered by: Maximus Federal Services Timeline: 4 months to file after final internal denial Decision time: 45 days standard, 48 hours expedited Cost: Free to patients and providers

IHCAP Process Steps

  1. Complete internal appeals with Aetna first
  2. File external appeal via Maximus NJ IHCAP portal
  3. Submit documentation: Denial letters, medical records, specialist support
  4. Preliminary review: Maximus confirms eligibility within days
  5. Full review: Independent medical experts evaluate case
  6. Binding decision: Aetna must comply with favorable decisions

Success rates: External appeals succeed in approximately 50% of cases nationally, with higher rates for FDA-approved treatments like Lumizyme.

From our advocates: "We've seen Pompe disease appeals succeed when families include a detailed timeline showing functional decline before treatment and improvement or stabilization afterward. Objective measures like walking distance or breathing capacity carry more weight than subjective symptom reports. The key is painting a clear picture of medical necessity that even non-specialists can understand."

Frequently Asked Questions

How long does Aetna prior authorization take for Lumizyme in New Jersey? Standard PA decisions take 30-45 business days. Expedited review (72 hours) is available if delays would jeopardize your health. Submit requests early to avoid treatment delays.

What if Lumizyme is non-formulary on my Aetna plan? Lumizyme appears on Aetna's specialty formulary but requires PA. If your specific plan excludes it, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal if Aetna denies Lumizyme? Yes, if continuing current treatment or starting new treatment is urgent for your health. Include a physician statement explaining the urgency with your expedited appeal request.

Does step therapy apply if I've tried other Pompe treatments outside New Jersey? Document any prior treatments (including Nexviazyme) with your PA submission. Aetna should consider out-of-state treatment history when making coverage decisions.

What happens if I move from New Jersey to another state with Aetna coverage? Coverage criteria remain the same across states, but appeal rights may differ. Verify your new state's external review process if needed.

How do I find Aetna-approved infusion centers in New Jersey? Contact CVS Specialty Pharmacy after PA approval—they maintain a network of approved infusion centers and will help coordinate your care.

When to Escalate

Contact New Jersey regulators if you experience:

  • Repeated procedural delays beyond stated timelines
  • Denial of expedited review for urgent situations
  • Failure to provide required appeal information

New Jersey Department of Banking and Insurance:

Sources & Further Reading

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed rebuttals. The platform analyzes denial letters and plan policies to draft point-by-point appeals that align with each payer's specific requirements, significantly improving approval rates for specialty medications like Lumizyme.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurance plan and consult healthcare providers for medical decisions. For personalized assistance with Lumizyme appeals, consider working with Counterforce Health or similar advocacy services.

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