By Counterforce Health Team in Raxone (idebenone) —

Aetna (CVS Health) Coverage Criteria for Raxone (idebenone) in Georgia: What Counts as "Medically Necessary"?

Answer Box: Getting Raxone (idebenone) Covered by Aetna (CVS Health) in Georgia

Raxone is not on Aetna's 2024 formularies, requiring a non-formulary exception with prior authorization. For LHON patients in Georgia: (1) Submit PA request with genetic confirmation and clinical documentation, (2) If denied, file internal appeal within 60 days, (3) Request Georgia external review within 60 days of final denial. Start by calling Aetna member services to confirm your plan's PA process and required forms.

Table of Contents

  1. Aetna's Policy Overview
  2. Indication Requirements
  3. Step Therapy & Exceptions
  4. Required Diagnostics
  5. Site of Care Requirements
  6. Evidence to Support Medical Necessity
  7. Sample Medical Necessity Narrative
  8. Appeals Process in Georgia
  9. Common Denial Reasons & Solutions
  10. When to Escalate
  11. FAQ

Policy Overview

Coverage Status

Raxone (idebenone) does not appear on Aetna's 2024 formulary lists, including the Standard Plan Formulary or Advanced Control Plan. This means it's considered non-formulary and requires a coverage exception request.

Plan Types That Apply

  • ACA/Individual Family Plans (IFP): Subject to non-formulary exception process
  • Employer Group Plans: May have custom formularies; check with HR benefits
  • Medicare Advantage: Requires Part D formulary exception
  • Medicaid: Appeals through Georgia Department of Community Health (different process)
Note: Since Raxone is not FDA-approved in the US, coverage typically requires demonstrating medical necessity based on EU approval and clinical trial data.

Indication Requirements

FDA Status vs. Coverage Considerations

  • FDA Status: Not approved in the US (has orphan drug designation for LHON)
  • EMA Status: Approved for LHON in patients ≥12 years (EU marketing authorization September 2015)
  • Coverage Approach: Non-formulary exception citing international approval and lack of alternatives

Required Diagnosis Documentation

For LHON coverage requests, include:

Requirement Documentation Needed ICD-10 Code
Genetic Confirmation mtDNA testing showing m.11778G>A, m.3460G>A, or m.14484T>C mutations G32.81
Clinical Presentation Bilateral central vision loss, optic disc changes H47.22
Ophthalmologic Evidence Visual field defects, OCT showing RNFL changes H53.40
Exclusion of Mimics Normal MRI, negative inflammatory workup -

Step Therapy & Exceptions

Typical Step Therapy Requirements

Since no FDA-approved LHON treatments exist, traditional step therapy doesn't apply. However, Aetna may require documentation of:

  1. Supportive care trials: Low-vision rehabilitation, vitamin supplementation
  2. Alternative approaches: Occupational therapy, assistive devices
  3. Contraindications to alternatives: Why other mitochondrial treatments aren't appropriate

Medical Exception Pathways

Immediate exception criteria (no step therapy required):

  • No FDA-approved alternatives exist for LHON
  • Progressive, irreversible condition requiring urgent intervention
  • Patient within optimal treatment window (ideally <12 months from onset)

Required Diagnostics

Essential Testing for PA Approval

Test Type Timing Purpose Documentation
Genetic Testing Confirmatory Prove LHON diagnosis CPT 81401 results
Visual Acuity Baseline + ongoing Establish severity ETDRS preferred
Visual Fields Baseline Central/cecocentral scotoma Humphrey or Goldman
OCT Baseline + monitoring RNFL swelling/atrophy Quantitative measurements
MRI Brain/Orbits Rule out mimics Exclude MS, compression With and without contrast
Tip: Recent testing (within 3 months) carries more weight for urgent PA requests.

Site of Care Requirements

Specialty Pharmacy Routing

  • CVS Specialty: Likely required for specialty drug handling
  • Retail Pharmacy: May not be available due to specialty designation
  • Mail Order: Check if 90-day supplies allowed

Prescriber Requirements

Aetna may require:

  • Specialist prescriber: Neuro-ophthalmologist or neurologist
  • Rare disease experience: Documentation of LHON management experience
  • Monitoring plan: Regular follow-up schedule with objective measures

Evidence to Support Medical Necessity

Key Clinical Evidence to Cite

Primary Studies:

Regulatory Support:

Dosing and Administration

  • Standard dose: 300 mg three times daily with food
  • Duration: Minimum 12-24 months based on clinical response
  • Monitoring: Visual acuity, visual fields, OCT every 3-6 months

Sample Medical Necessity Narrative

Clinician Corner: Use this template structure for your medical necessity letter:

"This [age]-year-old patient presents with genetically confirmed LHON (mtDNA mutation: [specify]) manifesting as bilateral central vision loss beginning [onset date]. Current visual acuity is [measurements] with central scotomas on visual field testing and [RNFL findings] on OCT.

There are no FDA-approved treatments for LHON. Idebenone (Raxone) is the only EMA-approved therapy, supported by the randomized RHODOS trial demonstrating improved visual recovery when initiated early. The International Consensus Statement (2017) recommends idebenone as first-line therapy for LHON.

This patient is within the optimal treatment window [<12 months from onset] where clinical trials show greatest benefit. Without treatment, progressive irreversible vision loss is expected. Request approval for idebenone 900 mg daily (300 mg TID) with regular ophthalmologic monitoring."

Appeals Process in Georgia

Internal Appeal Timeline

  1. File within 60 days of denial notice
  2. Standard review: 30 days for decision
  3. Expedited review: 72 hours if urgent medical need
  4. Required documents: Denial letter, medical records, supporting literature

Georgia External Review

If internal appeal fails, Georgia law provides independent external review:

Eligibility: Denials for "not medically necessary" or "experimental/investigational" Deadline: 60 days from final internal denial Process: Contact Georgia Department of Insurance at 1-800-656-2298 Cost: Free to consumer Decision: Binding on Aetna if favorable

Important: Georgia's external review is particularly powerful for rare disease denials where established alternatives don't exist.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Documents to Include
Not FDA-approved Cite EMA approval, orphan status, lack of alternatives EMA product information, FDA orphan designation
Experimental/Investigational Reference published trials, consensus guidelines RHODOS/LEROS studies, international consensus
Not medically necessary Demonstrate progressive disease, no alternatives Genetic testing, visual function decline
Off-label use Emphasize this is the approved indication in EU EMA label for LHON indication

When to Escalate

Contact Georgia Department of Insurance Consumer Services if:

  • Aetna delays processing beyond stated timeframes
  • Required forms or processes aren't clearly explained
  • External review rights aren't properly communicated

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, identifying coverage gaps, and crafting evidence-backed rebuttals aligned with payer policies. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeals processes for specialty medications like Raxone. Learn more about their services.

FAQ

Q: How long does Aetna's prior authorization take in Georgia? A: Standard PA decisions typically take 15-30 days. Expedited requests (with medical urgency documentation) may be processed within 72 hours.

Q: What if my employer plan has different rules? A: Self-funded employer plans may not be subject to Georgia insurance laws. Check with HR and consider ERISA appeal rights if state external review isn't available.

Q: Can I get Raxone through compassionate use while appealing? A: Currently no formal expanded access program exists in the US. Contact Chiesi Global Rare Diseases to inquire about individual patient access.

Q: Does Aetna cover genetic testing for LHON? A: Yes, genetic testing (CPT 81401) is typically covered when medically indicated for suspected mitochondrial disorders.

Q: What if I'm past the 12-month optimal treatment window? A: While early treatment is preferred, the EMA approval doesn't specify an upper time limit. Emphasize any remaining visual function worth preserving.

Q: How do I request a peer-to-peer review? A: Call the number on your denial letter or contact Aetna provider services to schedule a discussion between your prescriber and their medical director.

When navigating complex coverage decisions for rare disease treatments, having expert support can make the difference between approval and denial. Counterforce Health's platform analyzes your specific denial reasons and generates targeted appeals that address each payer concern with appropriate clinical evidence and policy citations, significantly improving approval rates for medications like Raxone.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurance carrier and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals, consider consulting with patient advocacy services or legal professionals specializing in healthcare coverage.

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