By Counterforce Health Team in Myozyme (alglucosidase alfa) —

Get Myozyme (Alglucosidase Alfa) Covered by Aetna CVS Health in Georgia: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Myozyme Covered by Aetna CVS Health in Georgia

Myozyme (alglucosidase alfa) is covered by Aetna CVS Health as a preferred specialty medication for confirmed Pompe disease. To get approval:

  1. Gather diagnostic proof: GAA enzyme deficiency test results and genetic confirmation of pathogenic GAA mutations
  2. Have your specialist submit: Prior authorization through CVS Specialty with medical necessity letter
  3. If denied: File internal appeal within 60 days, then Georgia external review within 60 days of final denial

Start today: Contact your metabolic specialist to request diagnostic documentation and initiate the PA process through CVS Specialty. Standard decisions take 30-45 days; expedited reviews available for urgent cases within 72 hours.

Table of Contents

Coverage Basics: Is Myozyme Covered?

Yes, Myozyme is covered by Aetna CVS Health as a preferred specialty tier medication on their 2025 formulary. However, coverage requires prior authorization and must be filled through an in-network specialty pharmacy, typically CVS Specialty.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required Annual approval needed Aetna specialty drug list
Specialty Tier Higher cost-sharing than standard drugs Your plan's Summary of Benefits
Diagnosis Required Confirmed Pompe disease only Aetna medical policy
Specialist Required Metabolic or neurology specialist Aetna provider directory
CVS Specialty Fill Must use designated specialty pharmacy CVS Specialty enrollment

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Schedule specialist appointment (you or caregiver)
    • Book with metabolic disease specialist or neurologist
    • Request comprehensive diagnostic workup
    • Timeline: 2-4 weeks for appointment
  2. Complete diagnostic testing (specialist orders)
    • GAA enzyme assay (blood test)
    • Genetic testing for GAA mutations
    • Timeline: 1-2 weeks for results
  3. Specialist submits PA (clinic staff)
  4. Aetna reviews documentation (automatic)
    • Standard review: 30-45 days
    • Expedited review: 72 hours if urgent
    • Timeline: Varies by urgency
  5. If approved, coordinate delivery (you + CVS Specialty)
    • Enroll with CVS Specialty: 1-800-237-2767
    • Schedule delivery or pickup
    • Timeline: 3-5 business days
  6. If denied, file appeal (you or specialist)
    • Internal appeal within 60 days
    • External review if internal fails
    • Timeline: 30 days internal, 30 days external

Timing and Deadlines

Standard Timelines

  • Prior Authorization: 30-45 days for standard decisions
  • Expedited Review: 72 hours for urgent medical situations
  • Internal Appeal: 30 days for insurer response
  • External Review: 30 days for independent decision

Georgia-Specific Deadlines

  • File Internal Appeal: 60 days from denial notice
  • Request External Review: 60 days from final internal denial (Georgia law)
  • Expedited External Review: Available for urgent situations with 72-hour decisions
Tip: Always request expedited review if treatment delay poses immediate health risks. Pompe disease progression can be rapid without enzyme replacement therapy.

Required Documentation

Diagnostic Requirements

Essential Documentation:

  • GAA enzyme assay showing deficiency
  • Genetic testing confirming pathogenic GAA mutations
  • Specialist evaluation from metabolic disease expert
  • Current functional assessments (6-minute walk test, muscle strength testing)
  • Treatment history and response documentation

Medical Necessity Letter Checklist

Your specialist's letter must include:

  • ✓ Confirmed Pompe disease diagnosis with test results
  • ✓ Disease subtype (infantile-onset vs. late-onset)
  • ✓ Current functional status and symptoms
  • ✓ Why Myozyme is medically necessary
  • ✓ Expected treatment goals and monitoring plan
  • ✓ Dosing rationale (20 mg/kg every 2 weeks per FDA labeling)

Understanding Your Costs

Myozyme is typically covered under your plan's specialty tier, which means coinsurance rather than flat copays. Your out-of-pocket costs depend on your specific plan design.

Cost-Saving Options

  • Sanofi Patient Support: Contact manufacturer for copay assistance programs
  • PAN Foundation: Offers premium assistance for Pompe disease
  • Medicare Extra Help: If eligible, reduces specialty drug costs significantly
Note: Contact CVS Specialty at 1-800-237-2767 to discuss your specific cost-sharing and available financial assistance programs.

When Denials Happen

Common Denial Reasons & Solutions

Denial Reason How to Fix It Required Documents
"Diagnosis not confirmed" Submit complete diagnostic testing GAA enzyme + genetic testing
"Not medically necessary" Stronger medical necessity letter Functional assessments, treatment goals
"Experimental/investigational" Cite FDA approval and guidelines FDA labeling, specialty society guidelines
"Non-formulary" Request formulary exception Medical justification for Myozyme vs. alternatives

Internal Appeal Process

  1. Gather additional evidence within 60 days of denial
  2. Submit written appeal to address specific denial reasons
  3. Request expedited review if treatment delay poses health risks
  4. Include peer-reviewed literature supporting Myozyme use
  5. Track your appeal through Aetna member portal

Georgia-Specific Appeals Process

If your internal appeal fails, Georgia offers external review through independent medical experts.

External Review Requirements

  • Must exhaust internal appeals first
  • File within 60 days of final internal denial
  • Submit application to Georgia Office of Insurance Commissioner
  • Free to patients (insurer pays review costs)

How to Request External Review

  1. Download Georgia external review form from Georgia DOI website (verify current link)
  2. Submit within 60-day deadline with all supporting documents
  3. Independent medical experts review your case
  4. Binding decision within 30 days (72 hours if expedited)
Important: Georgia's external review decision is binding on Aetna CVS Health and cannot be overturned by the insurer.

CVS Specialty Pharmacy Coordination

Why CVS Specialty?

Aetna CVS Health requires most specialty medications like Myozyme to be filled through CVS Specialty Pharmacy for:

  • Specialized handling and storage
  • Clinical support and monitoring
  • Coordination with your care team
  • Insurance benefit optimization

Enrollment Process

  1. Call CVS Specialty: 1-800-237-2767
  2. Provide insurance information and prescription details
  3. Choose delivery method: Home delivery or CVS store pickup
  4. Set up CareTeam support: 24/7 access to specialty pharmacists
  5. Download CVS Specialty app for prescription management

Patient Support Services

  • One-on-one support from trained specialists
  • 24/7 CareTeam availability
  • Medication adherence monitoring
  • Insurance benefit coordination
  • Digital tools for prescription management

Common Issues and Solutions

Portal and Technical Issues

  • CVS Specialty portal down: Call 1-800-237-2767 for phone support
  • Missing prior authorization forms: Download from CVS Specialty website
  • Prescription transfer delays: Contact both old and new pharmacies

Documentation Problems

  • Missing genetic testing: Contact original testing lab for certified copies
  • Incomplete medical records: Request comprehensive records from all treating physicians
  • Lost appeal documents: Maintain copies of all submissions and confirmations
From our advocates: "We've seen many successful appeals when patients work closely with their specialist to address every point in the denial letter. One family gathered additional functional testing data that wasn't in the original submission, and their appeal was approved within two weeks. The key is being thorough and responding to each specific concern raised by the insurer."

FAQ: Most Asked Questions

How long does Aetna CVS Health prior authorization take for Myozyme in Georgia? Standard decisions take 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Myozyme is denied as "not medically necessary"? File an internal appeal with additional clinical evidence, functional assessments, and a detailed medical necessity letter from your specialist addressing the specific denial reasons.

Can I request an expedited appeal in Georgia? Yes, both Aetna internal appeals and Georgia external reviews offer expedited processing (typically 72 hours) when treatment delays pose immediate health risks.

Does step therapy apply to Myozyme? Step therapy typically doesn't apply to Myozyme as it's considered first-line treatment for confirmed Pompe disease, though documentation of diagnosis is required.

What happens if I miss the appeal deadline? Contact Aetna immediately to request a deadline extension with good cause documentation. Georgia law allows extensions in certain circumstances.

Who can help me navigate the appeals process in Georgia? Contact the Georgia Office of Insurance Commissioner Consumer Services at 1-800-656-2298 for assistance with appeals and external reviews.

Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by creating targeted, evidence-backed documentation that addresses each payer's specific requirements. Our platform analyzes denial letters and plan policies to identify the exact criteria needed for approval, then generates comprehensive appeals with the right clinical evidence and procedural compliance. Visit www.counterforcehealth.org to learn how we can help streamline your prior authorization and appeal process.

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 and insurance plan documents for the most current requirements. Coverage policies and procedures may change. For personalized assistance with insurance appeals in Georgia, contact Counterforce Health or the Georgia Office of Insurance Commissioner Consumer Services.

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