By Counterforce Health Team in Elelyso (taliglucerase alfa) —

Get Elelyso (Taliglucerase Alfa) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization Guide

Quick Answer: Aetna CVS Health requires prior authorization for Elelyso (taliglucerase alfa) with confirmed Type 1 Gaucher disease diagnosis, specialist prescriber, and documentation of medical necessity. Submit PA requests through CVS Caremark (phone: 1-800-294-5979). If denied, you have 180 days to file an internal appeal and 60 days for external review through Georgia DOI. Most approvals occur within 24-48 hours when criteria are met.

Table of Contents

  1. Coverage at a Glance
  2. Aetna CVS Health Policy Overview
  3. Medical Necessity Requirements
  4. Step Therapy and Exceptions
  5. Dosing and Quantity Limits
  6. Site of Care Requirements
  7. Prior Authorization Process
  8. Appeals Process in Georgia
  9. Common Denial Reasons and Solutions
  10. Cost Support Programs
  11. FAQ

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all Elelyso prescriptions PA form, clinical notes CVS Caremark
Diagnosis Confirmed Type 1 Gaucher disease Enzyme assay + genetic testing FDA Label
Prescriber Specialist (hematologist, medical geneticist) DEA number, specialty credentials Aetna Policy
Step Therapy May require trial of preferred ERTs Documentation of failure/intolerance CVS Caremark
Dosing 60 units/kg every 2 weeks (standard) Weight-based calculation FDA Label
Site of Care Home/clinic preferred; hospital limited Medical justification for hospital CareFirst Policy

Aetna CVS Health Policy Overview

Aetna CVS Health covers Elelyso through its specialty pharmacy benefit, managed by CVS Caremark. The drug requires prior authorization across all plan types—HMO, PPO, and Medicare Advantage plans in Georgia.

Key Policy Points:

Where to Find Official Policies:

  • Aetna provider portal: precertification lists
  • CVS Caremark formulary documents (updated quarterly)
  • Member-specific formulary available through Aetna member portal

Medical Necessity Requirements

Diagnosis Confirmation

Aetna requires both biochemical and genetic confirmation of Type 1 Gaucher disease:

Required Tests:

  1. Beta-glucocerebrosidase enzyme activity assay - Must show deficient enzyme levels
  2. GBA1 gene sequencing - Must identify pathogenic mutations
  3. Clinical presentation - Documentation of typical symptoms (splenomegaly, hepatomegaly, cytopenias, bone disease)
Clinician Note: Both enzyme testing and genetic confirmation are standard requirements for insurance approval of enzyme replacement therapies.

Age and Indication Requirements

  • FDA-approved age: 4 years and older
  • Indication: Long-term enzyme replacement therapy for Type 1 Gaucher disease
  • ICD-10 code: E75.22 (Gaucher disease)

Specialist Prescriber Requirement

Aetna typically requires prescribing by:

  • Hematologist
  • Medical geneticist
  • Endocrinologist with Gaucher disease experience
  • Pediatric specialist (for patients under 18)

Step Therapy and Exceptions

Preferred Alternatives

Aetna may require documentation of consideration or trial of:

  • Cerezyme (imiglucerase) - Most common first-line ERT
  • VPRIV (velaglucerase alfa) - Alternative ERT
  • Cerdelga (eliglustat) - Oral substrate reduction therapy (for eligible adults)

Medical Exception Pathways

You can bypass step therapy if you document:

  • Contraindications to preferred agents
  • Previous intolerance with specific adverse events
  • Treatment failure on preferred therapy
  • Unique clinical circumstances requiring Elelyso specifically
Tip: Document any previous ERT trials from other insurance plans or clinical settings, even if not with Aetna.

Dosing and Quantity Limits

Standard Dosing

  • Recommended dose: 60 units/kg every 2 weeks
  • Administration: IV infusion over 60-120 minutes
  • Vial size: 200 units per single-use vial

Quantity Calculations

Insurance approvals typically cover:

  • Patient weight × 60 units/kg = total units per dose
  • Round up to nearest whole vial (200-unit increments)
  • 26 doses per year (every 2 weeks)

Example: 70 kg patient = 4,200 units per dose = 21 vials per dose = 546 vials per year

Non-Standard Dosing

Doses outside the 60 units/kg standard require additional justification:

  • Clinical rationale for dose adjustment
  • Treatment response documentation
  • Specialist recommendation

Site of Care Requirements

Preferred Settings

CVS Specialty Pharmacy supports infusion in:

  • Home infusion (most cost-effective)
  • Physician office
  • Ambulatory infusion center
  • Outpatient clinic

Hospital Outpatient Restrictions

Hospital-based infusion is limited to specific circumstances:

  • Severe adverse reactions requiring emergency management
  • Medical instability (cardiovascular, respiratory, renal issues)
  • Venous access complications
  • Patients under 21 or over 65 years
  • No access to alternative infusion sites
Note: Hospital infusion typically requires pre-authorization and may be limited to initial doses only.

Prior Authorization Process

Step-by-Step Submission

  1. Gather Required Documents
    • Insurance card and member ID
    • Diagnosis confirmation (enzyme + genetic testing)
    • Clinical notes documenting symptoms
    • Previous treatment history
    • Weight-based dosing calculation
  2. Submit PA Request
    • Provider portal: Aetna secure provider website
    • Phone: CVS Caremark Prior Authorization: 1-800-294-5979
    • Fax: (verify current number through provider portal)
    • Hours: Monday-Friday, 8 AM to 6 PM CST
  3. Track Status
    • Standard review: 24-48 hours for complete submissions
    • Expedited review: Available for urgent medical situations
    • Status updates available through provider portal
  4. Coordinate Specialty Pharmacy
    • CVS Specialty Pharmacy will contact patient once approved
    • Arrange delivery and infusion logistics
    • Set up ongoing refill schedule

Required Documentation Checklist

  • Completed PA form
  • Specialist prescriber information
  • Diagnosis confirmation (lab results)
  • Clinical notes supporting medical necessity
  • Previous treatment documentation
  • Weight and dosing calculations
  • Site of care justification

Appeals Process in Georgia

When dealing with coverage decisions, it's helpful to understand that platforms like Counterforce Health specialize in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to the plan's own rules.

Internal Appeal Process

Timeline: 180 days from denial date to file

How to Submit:

  • Aetna member portal (fastest method)
  • Phone: Member Services number on ID card
  • Written appeal to address on denial letter

Review Timeline:

  • Standard appeals: 30-45 days
  • Expedited appeals: 72 hours (for urgent situations)

External Review in Georgia

If your internal appeal is denied, Georgia law provides additional protection:

Timeline: 60 days from final internal denial to request external review

How to Request:

  • Contact Georgia Department of Insurance: 1-800-656-2298
  • Submit external review application
  • No cost to consumer

Review Process:

  • Independent medical reviewers (specialty-matched)
  • 30 business days for standard review
  • 72 hours for expedited review
  • Decision is binding on Aetna
Georgia-Specific Tip: You can request external review concurrent with an expedited internal appeal if the situation is urgent and delay poses serious risk.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Not medically necessary" Submit clinical evidence showing symptoms and disease progression Lab values, imaging, symptom documentation
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, treatment guidelines
Step therapy not completed Request medical exception or document previous trials Previous treatment records, intolerance documentation
Non-formulary status Request formulary exception Comparative effectiveness data, clinical rationale
Quantity limits exceeded Justify dosing based on weight and clinical response Weight documentation, treatment response data
Wrong site of care Provide medical justification for requested setting Clinical notes supporting infusion site needs

Sample Medical Necessity Language

"Patient has confirmed Type 1 Gaucher disease with enzyme deficiency (β-glucocerebrosidase activity <X% of normal) and pathogenic GBA1 mutations. Clinical presentation includes [specific symptoms]. Elelyso is FDA-approved for this indication and is medically necessary for enzyme replacement therapy to prevent disease progression and improve quality of life."

Cost Support Programs

Manufacturer Support

  • Pfizer's GPS Program: Patient support services including:
    • Insurance navigation assistance
    • Copay support (for eligible patients)
    • Infusion coordination
    • Contact: Visit Elelyso.com for current program details

Foundation Grants

  • National Gaucher Foundation
  • Patient Access Network (PAN) Foundation
  • HealthWell Foundation
Financial Tip: Apply for foundation grants early in the year when funding is typically most available.

FAQ

Q: How long does Aetna CVS Health prior authorization take in Georgia? A: More than 95% of eligible prior authorizations are approved within 24 hours, with complete submissions often processed within 24-48 hours.

Q: What if Elelyso is not on my formulary? A: You can request a formulary exception by providing clinical documentation showing medical necessity and why preferred alternatives are not appropriate.

Q: Can I request an expedited appeal? A: Yes, expedited appeals are available when delays pose serious risk to health. These are typically decided within 72 hours.

Q: Does step therapy apply if I've used other ERTs outside Georgia? A: Previous treatment history from other states/plans should be documented and may support a medical exception to step therapy requirements.

Q: What happens if my appeal is denied? A: In Georgia, you can request external review through the Department of Insurance within 60 days. This provides an independent medical review that is binding on Aetna.

Q: Can I get Elelyso covered for home infusion? A: Yes, home infusion is actually preferred by most payers as it's more cost-effective than hospital-based administration.

From our advocates: We've seen many Elelyso appeals succeed when families work closely with their specialist to document the complete clinical picture—not just the diagnosis, but how the disease impacts daily life and why this specific therapy is needed. The key is presenting a compelling medical narrative supported by solid evidence.

For complex cases involving multiple denials or unique clinical circumstances, specialized services like Counterforce Health can help analyze your specific situation and develop targeted appeal strategies that align with Aetna's coverage policies.

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 company for the most current policies and procedures. Coverage decisions may vary based on individual circumstances and plan details. For assistance with appeals or complex coverage issues, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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