By Counterforce Health Team in Raxone (idebenone) —

How to Get Raxone (Idebenone) Covered by Aetna CVS Health in Florida: Complete Prior Authorization Guide

Quick Answer: Getting Raxone (Idebenone) Covered by Aetna CVS Health in Florida

Raxone (idebenone) is not FDA-approved in the US and requires a medical exception through Aetna CVS Health's prior authorization process. Your doctor must submit comprehensive documentation including genetic testing confirming LHON diagnosis, clinical records, and a medical necessity letter. The process typically takes 30-45 days for standard reviews. If denied, you have 180 days to appeal and can request external review through Florida's Department of Financial Services. Start today by asking your physician to gather genetic test results and initiate the medical exception request through Aetna's provider portal.

Table of Contents

Before You Start: Understanding Your Coverage

Raxone (idebenone) presents unique coverage challenges because it's not FDA-approved in the United States, though it's approved in the European Union for Leber Hereditary Optic Neuropathy (LHON). Here's what you need to know about your Aetna CVS Health coverage:

Coverage Status

  • Not on formulary: Raxone is excluded from Aetna's 2024-2025 formularies
  • Medical exception required: You'll need prior authorization for any coverage consideration
  • Specialty pharmacy only: If approved, the medication must be dispensed through an approved specialty pharmacy in Aetna's network

Plan Type Matters

Check your insurance card to confirm whether you have:

  • Commercial Aetna plan: Use provider portal or call 1-866-752-7021 (TTY 711)
  • Aetna Medicare Advantage: Call 1-866-503-0857 (TTY 711)
  • Medicaid managed by Aetna: Different forms and processes may apply
Tip: Verify your plan's specialty pharmacy network before starting the process. CVS Specialty typically handles most Aetna specialty medications.

What You'll Need to Gather

Success with Raxone prior authorization depends heavily on comprehensive documentation. Here's your complete checklist:

Medical Documentation

  • Genetic testing results confirming LHON diagnosis (typically showing mutations like m.11778G>A, m.14484T>C, or m.3460G>A)
  • ICD-10 diagnosis code: H47.22 (Hereditary optic atrophy)
  • Ophthalmologic records including:
    • Visual acuity measurements
    • Visual field testing results
    • Optic nerve assessment
    • Color vision testing
  • Family history of LHON or related conditions

Treatment History

  • Documentation of any previous treatments tried
  • Records of treatment failures or intolerances
  • Current medications and supplements

Required Forms

Step-by-Step: Submitting Your Prior Authorization

Step 1: Physician Initiates Request

Your prescribing physician (typically an ophthalmologist or neurologist) must submit the prior authorization request. They can:

  • Use Aetna's online provider portal
  • Complete paper forms and fax to the appropriate number
  • Work with your specialty pharmacy to coordinate submission

Step 2: Complete Medical Necessity Letter

Your physician should include:

  • Clinical rationale: Why Raxone is medically necessary for your specific case
  • LHON diagnosis confirmation: Reference genetic testing and clinical findings
  • Treatment timeline: When symptoms began, progression, and timing considerations
  • Alternative treatments: Why other options are inappropriate or have failed
  • International evidence: Reference to European approval and clinical studies
Clinician Corner: The medical necessity letter is crucial since Raxone lacks FDA approval. Include references to peer-reviewed studies supporting idebenone's efficacy in LHON, particularly within the critical treatment window after symptom onset.

Step 3: Submit Complete Package

Ensure your submission includes:

  • Completed prior authorization form
  • Medical necessity letter
  • All supporting clinical documentation
  • Genetic testing results
  • Previous treatment records

Step 4: Specialty Pharmacy Coordination

Work with an Aetna-approved specialty pharmacy to:

  • Verify they can source Raxone if approved
  • Coordinate with your physician's office
  • Handle any additional insurer requirements

Following Up on Your Request

Timeline Expectations

  • Standard review: 30-45 days for commercial plans
  • Expedited review: 24-72 hours if urgent medical need is documented
  • Medicare Advantage: Similar timelines but may vary

When to Call

Contact Aetna if:

  • You haven't heard back within the expected timeframe
  • You receive a request for additional information
  • Your physician's office reports submission issues

Sample Call Script

"Hello, I'm calling to check on the status of a prior authorization request for Raxone (idebenone) submitted on [date]. My member ID is [number]. The request was for treatment of Leber Hereditary Optic Neuropathy. Can you provide an update on the review status and expected decision date?"

Document everything: Keep records of call dates, reference numbers, and representative names.

If You're Asked for More Information

Aetna may request additional documentation, commonly:

Medical Necessity Questions

  • Timing justification: Why treatment is needed now
  • Dosing rationale: How the proposed dose was determined
  • Monitoring plan: How treatment response will be assessed

Additional Evidence

  • Literature review: Peer-reviewed studies supporting idebenone use in LHON
  • International guidelines: References to European treatment protocols
  • Specialist consultation: Additional opinions from LHON specialists

Counterforce Health specializes in helping patients navigate complex prior authorization processes for specialty medications like Raxone. Their platform can help identify the specific evidence needed to strengthen your appeal and draft targeted responses to insurer requests.

If Your Request Is Denied

Common Denial Reasons for Raxone

Denial Reason How to Address
"Not FDA-approved" Emphasize medical necessity, international approval, lack of alternatives
"Experimental/Investigational" Provide peer-reviewed evidence, reference established international use
"Not medically necessary" Strengthen clinical documentation, add specialist support
"Insufficient documentation" Submit comprehensive genetic testing, clinical records

Immediate Next Steps

  1. Request detailed denial letter explaining specific reasons
  2. Gather additional evidence to address cited concerns
  3. Consider peer-to-peer review - your doctor speaks directly with Aetna's medical director
  4. Prepare for formal appeal within required timeframes

Appeals Process in Florida

Florida law provides specific protections for patients facing insurance denials:

Internal Appeal Timeline

  • File within: 180 days of denial notice
  • Insurer decision: 30 days for standard appeals, 24-48 hours for urgent cases
  • Required: Must complete internal appeal before external review

External Review Process

If your internal appeal is denied, you can request external review:

  • Request within: 4 months after internal appeal denial
  • Decision timeline: 45 days for standard, 72 hours for expedited
  • Cost: No fees charged to patients
  • Binding: External reviewer's decision is legally binding on Aetna

How to Request External Review

  1. Contact Florida Department of Financial Services
  2. Submit external review request form
  3. Include all documentation from internal appeal
  4. Independent medical expert reviews your case
Florida-Specific Right: You can call Florida's Insurance Consumer Helpline at 1-877-MY-FL-CFO (1-877-693-5236) for assistance with the appeals process.

Renewal and Re-authorization

If your initial Raxone authorization is approved:

Plan Ahead

  • Calendar renewal dates: Most approvals are for 6-12 months
  • Track treatment response: Document any improvements or stabilization
  • Maintain relationships: Keep your specialty pharmacy and physician's office informed

Renewal Documentation

  • Treatment response data: Visual acuity changes, quality of life measures
  • Continued medical necessity: Why ongoing treatment remains appropriate
  • Compliance records: Proof of adherence to prescribed regimen

FAQ: Common Questions

Q: How long does Aetna CVS Health prior authorization take in Florida? A: Standard reviews typically take 30-45 days. Expedited reviews for urgent medical needs can be completed within 24-72 hours.

Q: What if Raxone is completely non-formulary? A: You'll need a medical exception. Focus on medical necessity, lack of FDA-approved alternatives, and international evidence supporting treatment.

Q: Can I request an expedited appeal if denied? A: Yes, if you can demonstrate urgent medical need or risk of irreversible vision loss without treatment.

Q: Does step therapy apply to Raxone? A: Typically no, since there are no FDA-approved alternatives for LHON. However, Aetna may require documentation that supportive care or low-vision rehabilitation has been considered.

Q: What if I move from another state to Florida? A: Your prior authorization may need to be resubmitted if your plan changes. Florida-specific appeal rights will apply to new denials.

Q: Are there cost assistance programs for Raxone? A: Check with the manufacturer (Chiesi Global Rare Diseases) for patient assistance programs, though availability may be limited given the lack of FDA approval.

Printable Checklist

Before Starting

  • Verify Aetna plan type and specialty pharmacy network
  • Confirm prescribing physician is in-network
  • Gather all medical records and genetic testing results

Documentation Needed

  • ICD-10 code H47.22 documented
  • Genetic testing confirming LHON diagnosis
  • Comprehensive ophthalmologic records
  • Medical necessity letter from physician
  • Prior treatment documentation (if any)

Submission Process

  • Complete Aetna prior authorization form
  • Submit through provider portal or approved method
  • Coordinate with specialty pharmacy
  • Document submission date and reference numbers

Follow-Up Actions

  • Set calendar reminders for follow-up calls
  • Track all communications with reference numbers
  • Prepare appeal documentation if needed
  • Know Florida external review process

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For assistance with insurance appeals and coverage issues, contact Florida's Department of Financial Services at 1-877-MY-FL-CFO.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-based documentation and targeted rebuttals aligned with payer policies. Learn more about their prior authorization support services.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.