By Counterforce Health Team in Fintepla (fenfluramine) —

How to Get Fintepla (fenfluramine) Covered by Aetna CVS Health in Georgia: Complete Appeals Guide with Templates

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

Fastest path to approval: 1) Ensure REMS enrollment for prescriber, patient, and pharmacy via FinteplaREMS.com, 2) Document failed trials of preferred antiseizure medications with specific doses and outcomes, 3) Submit baseline echocardiogram showing no valvular disease. First step today: Call Aetna at the number on your member card to confirm prior authorization requirements and obtain the PA form. If denied, you have 180 days to appeal internally and 60 days after final denial to request external review through the Georgia Department of Insurance.

Table of Contents

  1. Understanding Your Denial Letter
  2. REMS Requirements: The Foundation of Approval
  3. Step Therapy Documentation
  4. First-Level Appeal Strategy
  5. Peer-to-Peer Review Process
  6. Georgia External Review Process
  7. Appeal Letter Templates
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Programs
  10. When to Escalate
  11. FAQ

Understanding Your Denial Letter

When Aetna CVS Health denies Fintepla coverage, the denial letter will specify the exact reason using standardized codes. The most common reasons include:

  • Prior authorization not submitted - Your doctor hasn't completed the PA process
  • REMS documentation missing - Patient, prescriber, or pharmacy not enrolled
  • Step therapy not met - Preferred medications haven't been tried first
  • Non-formulary status - Fintepla isn't on your plan's preferred drug list
  • Insufficient medical documentation - Missing diagnosis confirmation or clinical notes
Tip: Look for the denial date on your letter—this starts your 180-day appeal clock with Aetna.

REMS Requirements: The Foundation of Approval

Fintepla requires strict compliance with FDA's Risk Evaluation and Mitigation Strategy (REMS) due to cardiac risks. All three parties must be enrolled before any coverage consideration:

Required REMS Documentation

Requirement Who Completes Frequency Portal Action
Prescriber Certification Doctor Once FINTEPLA REMS Prescriber Portal
Patient Enrollment Patient/Caregiver Per patient Complete Patient Enrollment Form
Pharmacy Certification Dispensing pharmacy Once REMS pharmacy certification
Patient Status Form Doctor Baseline + every 6 months Upload echo results and monitoring data

Cardiac Monitoring Requirements

  • Baseline echocardiogram before starting treatment
  • Follow-up echos every 6 months during therapy
  • Documentation must show no valvular heart disease or pulmonary hypertension

All REMS documentation processes through the FINTEPLA REMS portal. Without complete REMS enrollment, Aetna will automatically deny coverage.

Step Therapy Documentation

Aetna requires documented trials and failures of preferred antiseizure medications before approving Fintepla. For Dravet syndrome and Lennox-Gastaut syndrome, typical required medications include:

Preferred Medications to Try First

  • Clobazam (Onfi) - often first-line requirement
  • Valproate (Depakote) - if no contraindications
  • Levetiracetam (Keppra) - broad-spectrum option
  • Stiripentol (Diacomit) - for Dravet syndrome specifically

Documentation Requirements for Each Failed Medication

  1. Medication name and dosage - specific mg/kg or total daily dose
  2. Duration of trial - minimum 4-6 weeks at therapeutic dose
  3. Outcome documentation - lack of efficacy, adverse effects, or contraindications
  4. Clinical rationale - why the medication was stopped or deemed inappropriate
Note: Trials from other states are valid as long as outcomes and timelines are clearly documented in your medical records.

First-Level Appeal Strategy

When Aetna denies Fintepla coverage, your first-level appeal must address the specific denial reason with comprehensive documentation.

Appeal Submission Process

  1. Obtain the appeal form - Available through Aetna member portal or by calling customer service
  2. Gather all documentation - REMS enrollment, failed medication history, echo results, diagnosis confirmation
  3. Submit within 180 days - Use certified mail or portal submission with tracking
  4. Request expedited review - If seizures pose immediate health risk (72-hour decision)

Required Documentation Checklist

  • Completed Aetna appeal form
  • Copy of original denial letter
  • REMS enrollment confirmation for all parties
  • Baseline echocardiogram report
  • Diagnosis confirmation with ICD-10 codes (G40.83 for Dravet, G40.81 for LGS)
  • Detailed medication trial history
  • Prescriber letter of medical necessity
  • Current seizure frequency documentation

Peer-to-Peer Review Process

If your first-level appeal is denied, request a peer-to-peer review where your neurologist speaks directly with an Aetna medical director.

Preparing for the Peer-to-Peer Call

Your neurologist should have ready:

  • Complete medical record and seizure diary
  • Specific details about failed antiseizure medications
  • REMS enrollment confirmation
  • Baseline echocardiogram results
  • Clinical rationale for why Fintepla is uniquely necessary

Key Discussion Points

  1. Seizure frequency and severity - Impact on daily functioning
  2. Prior treatment failures - Specific reasons each medication didn't work
  3. FDA approval basis - Fintepla's unique mechanism for Dravet/LGS
  4. REMS compliance - Safety monitoring plan in place
  5. Clinical urgency - Risk of status epilepticus or developmental regression

Georgia External Review Process

If Aetna upholds the denial after internal appeals, Georgia law provides an independent external review process that's binding on the insurer.

Georgia External Review Timeline

  • 60-day deadline - Must request within 60 days of Aetna's final denial
  • 30-day standard review - Decision within 30 business days
  • 72-hour expedited review - For urgent medical situations
  • Free for consumers - No cost to request external review

How to Request External Review

  1. Call Georgia DOI Consumer Services: 1-800-656-2298
  2. Complete the external review form - Available at oci.georgia.gov
  3. Submit all documentation - Include denial letters, medical records, and treatment history
  4. Track your request - Follow up with DOI to confirm receipt
Important: The external review decision is legally binding on Aetna. If the independent reviewers approve coverage, Aetna must pay for Fintepla.

Appeal Letter Templates

Medical Necessity Letter Template

[Date]

Dear Aetna Medical Director,

I am writing to request reconsideration of the denial for [Patient Name] for Fintepla (fenfluramine) treatment. Your company denied this claim stating: [specific denial reason].

DIAGNOSIS CONFIRMATION:
Patient has [Dravet syndrome/Lennox-Gastaut syndrome], confirmed by:
- ICD-10 code: [G40.83 for Dravet/G40.81 for LGS]
- EEG findings: [specific abnormalities]
- Genetic testing: [SCN1A mutation if Dravet syndrome]

PRIOR MEDICATION FAILURES:
1. Clobazam: [dose, duration, reason for discontinuation]
2. Valproate: [dose, duration, reason for discontinuation]
3. [Additional medications tried]

REMS COMPLIANCE:
- Prescriber REMS enrollment: Confirmed [date]
- Patient REMS enrollment: Completed [date]
- Pharmacy REMS certification: Verified
- Baseline echocardiogram: Normal [date]

MEDICAL NECESSITY:
Fintepla is FDA-approved specifically for seizures associated with [patient's diagnosis]. The patient continues to experience [frequency] seizures despite optimal trials of preferred agents. Uncontrolled seizures pose significant risks including status epilepticus, developmental regression, and injury.

I respectfully request expedited reconsideration of this denial. Delaying access to this FDA-approved therapy risks irreversible harm to this patient.

Sincerely,
[Prescriber name and credentials]

Patient Phone Script for Aetna

"Hi, I'm calling about a prior authorization denial for Fintepla. My member ID is [number]. I'd like to understand the specific requirements for approval and request the appeal form. Can you also confirm if my doctor can request a peer-to-peer review?"

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
REMS not enrolled Complete all REMS requirements Enrollment confirmations from portal
Step therapy not met Document failed preferred medications Detailed trial history with outcomes
Not medically necessary Submit comprehensive clinical rationale Seizure diary, functional impact assessment
Non-formulary drug Request formulary exception Evidence preferred alternatives failed
Insufficient documentation Provide complete medical records Diagnosis confirmation, treatment history

Cost Assistance Programs

While appealing coverage, consider these cost assistance options:

Manufacturer Support

  • UCB Patient Assistance Program - Income-based free medication
  • Fintepla Copay Card - May reduce out-of-pocket costs for commercially insured patients

Foundation Grants

  • The Assistance Fund - Provides grants for specialty medications
  • Good Days - Copay assistance for chronic disease medications

Contact information and eligibility requirements are available on each program's official website.

When to Escalate

If appeals fail, escalate through these channels:

Georgia Department of Insurance

  • Consumer Services: 1-800-656-2298
  • File a complaint if Aetna doesn't follow proper procedures
  • External review is your strongest tool for overturning denials

Additional Resources

  • Georgians for a Healthy Future - Consumer assistance organization
  • Georgia Legal Services Program - For Medicaid appeals

From our advocates: We've seen Fintepla denials overturned most often when families provide comprehensive REMS documentation alongside detailed medication trial histories. The key is addressing every specific requirement Aetna lists in their denial letter—missing even one element often leads to continued denials.

FAQ

How long does Aetna prior authorization take in Georgia? Standard PA decisions take 15-30 days. Expedited reviews (for urgent medical needs) are completed within 72 hours.

What if Fintepla is non-formulary on my plan? Request a formulary exception by documenting that preferred alternatives have failed or are contraindicated.

Can I request an expedited appeal? Yes, if uncontrolled seizures pose immediate health risks. Aetna must decide expedited appeals within 72 hours.

Does step therapy apply if I tried medications in another state? Yes, prior medication trials from other states count as long as they're properly documented in your medical records.

What happens if the external review denies coverage? External review decisions in Georgia are final and binding. Further disputes would require legal action.

How much does Fintepla cost without insurance? Cash prices typically range around $1,595 for a 30-mL bottle, with total monthly costs varying by prescribed dose.

For families navigating insurance denials, Counterforce Health helps turn denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements. Their platform identifies denial reasons and drafts appeals with the right medical evidence and procedural compliance for better approval rates.

Getting Fintepla covered requires patience and persistence, but Georgia's consumer protection laws provide strong appeal rights. Document everything, meet all deadlines, and don't hesitate to use the external review process—it's free and legally binding on insurers.

For additional help with your Fintepla appeal, Counterforce Health provides specialized support in navigating complex prior authorization and appeals processes for specialty medications.

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 guidance specific to your situation. Coverage policies and appeal procedures may change—verify current requirements with your insurer and state insurance department.

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