By Counterforce Health Team in Upstaza (eladocagene exuparvovec) —

How to Get Kebilidi (Upstaza) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Kebilidi Coverage from Aetna CVS Health in Georgia

Aetna CVS Health requires prior authorization for Kebilidi (eladocagene exuparvovec), the FDA-approved gene therapy for AADC deficiency. Submit through their Gene-Based, Cellular, and Other Innovative Therapies (GCIT) network with confirmed DDC gene mutations, failed standard therapies, and treatment at a certified neurosurgical center. Processing takes 30-45 days (72 hours expedited). If denied, appeal within 180 days internally, then Georgia DOI external review within 60 days. Start today: Contact your neurologist to begin genetic testing and gather prior therapy records.

Table of Contents

Aetna's Policy Overview

Aetna CVS Health covers Kebilidi (eladocagene exuparvovec-tneq) under their Gene-Based, Cellular, and Other Innovative Therapies policy, which requires prior authorization for all gene therapies. The drug received FDA accelerated approval on November 13, 2024 for AADC deficiency in pediatric and adult patients.

Plan Types Covered:

  • Commercial HMO/PPO plans
  • Medicare Advantage (where applicable)
  • Some Medicaid managed care plans
Note: Kebilidi is not on standard formularies and requires medical exception approval with comprehensive documentation.

Medical Necessity Requirements

Core Eligibility Criteria

Requirement Specific Details Documentation Needed
Confirmed AADC Deficiency Biallelic pathogenic DDC gene variants Genetic test report showing compound heterozygous or homozygous mutations
Age Requirement ≥18 months (patients with immature skulls ineligible) Birth certificate, age verification
Clinical Severity Persistent symptoms despite standard care Neurology notes documenting hypotonia, movement disorders, autonomic dysfunction
Treatment Failures ≥2 failed therapies (carbidopa-levodopa, dopamine agonists, MAO inhibitors) Pharmacy records, physician notes on intolerance/ineffectiveness

Biochemical Confirmation Required

Based on AADC deficiency diagnostic criteria, Aetna requires at least two of three confirmatory tests:

  1. CSF neurotransmitter analysis: Low 5-HIAA, HVA, MHPG; elevated 3-OMD, L-Dopa, 5-HTP
  2. Genetic sequencing: Pathogenic DDC gene variants
  3. Plasma AADC enzyme activity: Severely decreased or undetectable levels

Step Therapy and Exceptions

Aetna requires documentation of failed standard therapies before approving Kebilidi. No direct step therapy protocol exists since this is the first FDA-approved treatment for AADC deficiency.

Required Prior Treatments

  • Carbidopa-levodopa (minimum 3-month trial)
  • Dopamine agonists (pramipexole, ropinirole)
  • MAO inhibitors (selegiline, rasagiline)
  • Supportive therapies (physical therapy, feeding support)

Medical Exception Pathway

Document contraindications or intolerance to standard therapies with:

  • Pharmacy dispensing records
  • Physician notes on adverse reactions
  • Hospital records for severe complications

Required Diagnostics

Pre-Authorization Testing

Test Category Specific Requirements Timing
Genetic Testing DDC gene sequencing with pathogenic variant confirmation Within 12 months
CSF Analysis Neurotransmitter metabolite panel (if genetic testing incomplete) Within 6 months
Imaging Brain MRI to assess skull maturity and anatomy Within 3 months
Laboratory Plasma AADC enzyme activity (if indicated) Within 6 months
Tip: Coordinate testing through a pediatric neurologist familiar with AADC deficiency to ensure proper sample handling and interpretation.

Site of Care Requirements

Kebilidi requires administration at Aetna's GCIT network centers certified for stereotactic neurosurgery and gene therapy.

Georgia Treatment Options

Currently, no confirmed GCIT centers exist in Georgia for Kebilidi administration. Children's Healthcare of Atlanta (CHOA) operates the Marcus Center for Cellular Therapy, but it's focused on CAR-T and other cellular therapies, not intracerebral gene therapy.

Actionable Steps:

  1. Contact Aetna member services at 1-800-872-3862 to identify nearest approved facility
  2. Verify travel/lodging coverage for out-of-state treatment
  3. Confirm surgeon credentials and center certification

Evidence Documentation

Medical Necessity Letter Checklist

Your neurologist's letter should include:

  • Problem Statement: AADC deficiency diagnosis with ICD-10 code E70.8
  • Prior Treatments: Chronological list of failed therapies with dates, dosages, and outcomes
  • Clinical Rationale: Why Kebilidi is medically necessary now
  • FDA Reference: November 2024 approval for AADC deficiency
  • Monitoring Plan: Post-treatment assessment and follow-up schedule

Supporting Evidence to Include

  • FDA prescribing information
  • Clinical trial data showing motor milestone improvements
  • Natural history studies demonstrating disease progression without treatment
  • Peer-reviewed publications on AADC deficiency management

Prior Authorization Process

Step-by-Step Submission

  1. Verify Coverage (Week 1)
    • Call Aetna member services: 1-800-872-3862
    • Confirm gene therapy benefits and GCIT network access
  2. Gather Documentation (Weeks 1-2)
    • Genetic testing results
    • Prior therapy records
    • Comprehensive neurology evaluation
    • Brain MRI results
  3. Submit PA Request (Week 3)
    • Use Aetna provider portal or Availity
    • Include all required documentation
    • Request expedited review if clinically urgent
  4. Track Status (Ongoing)
    • Standard processing: 30-45 days
    • Expedited processing: 72 hours
    • Contact CVS Specialty: 1-855-240-0535

Appeals Process in Georgia

Internal Appeal (Aetna CVS Health)

Timeline: 180 days from denial notice Process: Submit via member portal, phone (1-855-240-0535), or mail Decision Time: 30 days standard, 72 hours expedited

Georgia External Review

If Aetna's internal appeal fails, Georgia law provides external review through the Department of Insurance.

Key Details:

  • Deadline: 60 days from final internal denial
  • Contact: Email [email protected] or call 1-800-656-2298
  • Cost: Free to consumers
  • Timeline: 30 business days standard, 72 hours expedited
  • Binding: Decision is legally binding on Aetna
Important: Georgia's external review overturns approximately 50% of eligible appeals, making it a powerful tool for wrongful denials.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Experimental/Investigational" Submit FDA approval letter and prescribing information
"Not Medically Necessary" Provide genetic testing, failed therapy documentation, specialist letter
"Non-Formulary Drug" Request formulary exception with medical necessity evidence
"Inappropriate Site of Care" Confirm GCIT network certification, provide surgeon credentials
"Insufficient Documentation" Submit complete diagnostic workup, prior authorization form

For specialized help with appeals, Counterforce Health assists patients and clinicians in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to payer policies.

Costs and Patient Support

Financial Assistance Options

  • PTC Therapeutics Patient Support: Contact manufacturer for copay assistance programs
  • State Programs: Georgia Department of Community Health may provide additional resources
  • Nonprofit Organizations: National Organization for Rare Disorders (NORD) offers financial assistance

Insurance Coverage Details

  • Commercial Plans: Typically covered after PA approval
  • Medicare: Coverage varies by plan type
  • Medicaid: State-specific coverage determination

FAQ

How long does Aetna CVS Health PA take for Kebilidi in Georgia? Standard processing takes 30-45 days for gene therapies. Expedited review (72 hours) is available if delay would seriously jeopardize health.

What if Kebilidi is denied as experimental? Submit the FDA approval documentation showing November 2024 approval for AADC deficiency, along with prescribing information.

Can I request expedited appeal in Georgia? Yes, both Aetna internal appeals and Georgia external reviews offer expedited processing (72 hours) when delay poses serious health risks.

Does step therapy apply if treatments failed outside Georgia? No, pharmacy records and physician documentation from any state count toward meeting step therapy requirements.

What happens if no Georgia centers can administer Kebilidi? Aetna typically covers travel and lodging for out-of-state treatment when no in-network providers exist locally. Verify coverage details with member services.

How do I file a Georgia insurance complaint? Contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298 or email [email protected].

From our advocates: We've seen families successfully appeal Kebilidi denials by emphasizing the FDA's accelerated approval and the lack of alternative treatments for AADC deficiency. The key is comprehensive documentation showing genetic confirmation and failed standard therapies, combined with a neurologist's detailed medical necessity letter. While outcomes vary, thorough preparation significantly improves approval chances.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes for specialty medications like Kebilidi. Our platform analyzes denial letters and insurance policies to create targeted, evidence-backed appeals that align with payer-specific requirements, saving time and improving approval rates. Visit www.counterforcehealth.org to learn more about our services.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information with Aetna CVS Health and consult with healthcare providers for medical decisions. For official Georgia insurance regulations and consumer rights, visit the Georgia Department of Insurance website.

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