By Counterforce Health Team in Fintepla (fenfluramine) —

How to Get Fintepla (Fenfluramine) Covered by Aetna CVS Health in North Carolina: Appeals Timeline and Medical Necessity Templates

Answer Box: Getting Fintepla Covered by Aetna CVS Health in North Carolina

Fastest Path: 1) Ensure REMS enrollment and baseline echocardiogram documentation, 2) Submit prior authorization with evidence of failed standard antiseizure medications (minimum 2), and 3) Include neurologist consultation confirming Dravet syndrome or Lennox-Gastaut syndrome diagnosis. If denied, appeal within 180 days to Aetna, then request external review through Smart NC within 120 days. Expedited appeals get 72-hour decisions for urgent cases.

Table of Contents

Understanding Aetna's Fintepla Coverage Requirements

Aetna CVS Health requires prior authorization for Fintepla (fenfluramine) with specific clinical criteria that must be documented before coverage approval. The medication is typically managed under the specialty pharmacy benefit through CVS Caremark.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Diagnosis Confirmed Dravet syndrome or Lennox-Gastaut syndrome, age ≥2 years ICD-10 codes G40.83 (Dravet) or G40.81 (LGS), genetic testing for Dravet preferred Aetna Policy
REMS Enrollment Both patient and prescriber enrolled in FDA-mandated safety program REMS enrollment confirmation, baseline echocardiogram results FDA REMS
Step Therapy Trial of 2+ standard antiseizure medications Documentation of failed trials: names, doses, duration, reasons for discontinuation Aetna Formulary
Prescriber Neurologist or epilepsy specialist Current consultation notes from qualified specialist Aetna Policy
Monitoring Ongoing echocardiograms every 6 months Baseline and follow-up echo reports showing no valvular disease FDA Label

Read the Denial: Decode Reason Codes

When Aetna denies Fintepla coverage, the denial letter will specify the exact reason. Common denial codes include:

  • PA Required: Prior authorization not submitted or incomplete
  • Non-Formulary: Drug not on preferred list, formulary exception needed
  • Step Therapy: Must try preferred alternatives first
  • Medical Necessity: Clinical criteria not met
  • REMS Non-Compliance: Safety program enrollment not documented
Tip: Look for the denial date and your appeal deadline (typically 180 days for Aetna commercial plans). This countdown starts from the denial notice date, not when you received it.

Fixable Causes Before Appealing

Before filing a formal appeal, check if the denial can be resolved by resubmitting with missing information:

Missing Documentation Checklist

  • REMS enrollment confirmation for both patient and prescriber
  • Baseline echocardiogram results (must show no valvular disease)
  • Diagnosis confirmation with ICD-10 codes
  • Documentation of failed standard antiseizure medications
  • Current neurologist consultation notes
  • Prescription with correct NDC and dosing

Coding Issues

Ensure your diagnosis codes are specific:

  • G40.83: Dravet syndrome
  • G40.81: Lennox-Gastaut syndrome
  • Avoid generic epilepsy codes like G40.9

First-Level Appeal: Medical Necessity Letter

Your neurologist should submit a comprehensive medical necessity letter addressing Aetna's specific criteria. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the exact denial basis and crafting point-by-point rebuttals aligned to each plan's requirements.

Medical Necessity Letter Template

Header Information:

  • Patient name, DOB, member ID
  • Prescriber credentials and specialty certification
  • Date of appeal submission

Body Structure:

  1. Diagnosis Confirmation
    • Specific syndrome (Dravet or LGS) with ICD-10 code
    • Age at seizure onset and current seizure frequency
    • Genetic testing results (for Dravet syndrome)
    • EEG findings supporting diagnosis
  2. Prior Treatment Failures
    • List each antiseizure medication tried
    • Dosage, duration, and clinical response
    • Reasons for discontinuation (inefficacy, intolerance, contraindications)
    • Document at least 2 adequate trials per Aetna requirements
  3. Clinical Rationale for Fintepla
    • FDA-approved indication for add-on therapy
    • Expected seizure reduction based on clinical trials
    • Impact of continued seizures on development and quality of life
    • Why alternative treatments are not appropriate
  4. Safety Monitoring Plan
    • REMS program enrollment status
    • Baseline echocardiogram results
    • Plan for ongoing cardiac monitoring every 6 months
    • Drug interaction screening completed
Clinician Corner: Include specific citations from the FDA prescribing information and relevant epilepsy treatment guidelines. Quantify seizure frequency reduction goals and functional improvement expectations.

Peer-to-Peer Call Strategy

If your initial appeal is denied, request a peer-to-peer review where your neurologist speaks directly with Aetna's medical director.

Preparation Checklist

  • Patient's complete medical record
  • Seizure diary showing frequency and severity
  • Documentation of all prior antiseizure medication trials
  • REMS enrollment confirmation
  • Baseline and any follow-up echocardiogram reports
  • Current neurologist consultation notes

Key Talking Points

  1. Diagnosis specificity: Emphasize confirmed Dravet syndrome or LGS with genetic/EEG support
  2. Treatment resistance: Detail inadequate response to standard therapies despite adequate trials
  3. FDA indication: Fintepla is specifically approved for these rare epilepsy syndromes
  4. Safety compliance: REMS enrollment and cardiac monitoring plan in place
  5. Clinical urgency: Ongoing seizures pose developmental and safety risks

Second-Level & External Review in North Carolina

After exhausting Aetna's internal appeals, North Carolina residents can request external review through Smart NC.

Smart NC External Review Process

Timeline for Standard Review:

  • File within 120 days of Aetna's final denial
  • Smart NC responds within 10 business days
  • Independent Review Organization decision within 45 calendar days

Expedited Review for Urgent Cases:

  • Decision within 72 hours for life-threatening situations
  • Can bypass internal appeals if urgency documented
  • Available when seizure control delay poses serious health risks

How to Request:

  1. Complete external review form
  2. Include all medical records and Aetna denial letters
  3. Submit to Smart NC via mail, fax, or online portal
  4. No cost to patient

Contact Smart NC:

Note: Smart NC's external review decisions are binding on Aetna. If they overturn the denial, Aetna must provide coverage within 3 business days.

Appeal Templates & Scripts

Patient Phone Script for Aetna

"Hello, I'm calling about a prior authorization denial for Fintepla for my [child/family member] with Dravet syndrome. The denial reference number is [X]. I'd like to request a first-level appeal and speak with someone who can help me understand what additional documentation is needed. Can you also tell me the exact deadline for submitting my appeal?"

Clinic Staff Script for Peer-to-Peer

"I'm calling to request a peer-to-peer review for [patient name], member ID [X], regarding the denied prior authorization for Fintepla. Dr. [Name] is a board-certified pediatric neurologist who would like to discuss the medical necessity with your medical director. The patient has treatment-resistant Dravet syndrome with documented failures of multiple standard antiseizure medications."

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
REMS not documented Submit enrollment confirmation REMS enrollment letter, baseline echo
Diagnosis not supported Provide genetic testing/EEG SCN1A results for Dravet, EEG showing slow spike-wave
Step therapy not met Document failed standard ASMs Detailed trial history with doses, duration, outcomes
Not medically necessary Clinical justification letter Neurologist letter citing FDA indication, guidelines
Experimental/investigational Cite FDA approval FDA approval letter, prescribing information

Costs & Patient Support Options

Manufacturer Support:

  • UCB Patient Support Program may offer copay assistance
  • Contact: Check UCB's official website for current programs

Foundation Grants:

  • Epilepsy Foundation may have emergency medication funds
  • State pharmaceutical assistance programs in North Carolina

Alternative Coverage:

  • If commercial insurance fails, check Medicaid eligibility (North Carolina expanded Medicaid in 2024)
  • State Health Plan (for state employees) has separate appeal process
From Our Advocates: "We've seen several Fintepla denials overturned when families provided comprehensive documentation of the REMS enrollment alongside detailed seizure diaries showing the impact of breakthrough seizures on daily functioning. The key is demonstrating both medical necessity and safety compliance in one organized submission."

Counterforce Health helps patients and clinicians navigate these complex requirements by creating evidence-backed appeals that address each insurer's specific criteria, potentially saving months of back-and-forth communications.

FAQ

Q: How long does Aetna's prior authorization process take for Fintepla? A: Standard prior authorizations typically take 15-30 business days. Expedited reviews (for urgent cases) are processed within 72 hours.

Q: What if Fintepla is non-formulary on my Aetna plan? A: You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are not appropriate for your specific condition.

Q: Can I request an expedited appeal if my child is having frequent seizures? A: Yes, if continued seizures pose immediate health risks or could cause irreversible harm, you can request expedited review at both the Aetna level and through Smart NC external review.

Q: Does step therapy apply if we tried medications outside of North Carolina? A: Yes, document all prior antiseizure medication trials regardless of where they occurred. Include medical records showing the medications tried, dosages, duration, and outcomes.

Q: What happens if Smart NC upholds Aetna's denial? A: Smart NC's decision is final for the administrative process. You may still have legal options, but most families explore alternative treatments or manufacturer assistance programs at this point.

Q: How much does Fintepla cost without insurance? A: The typical cash price for a 30-mL bottle is around $1,595, though total monthly costs vary based on the prescribed dose and frequency.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage approval. Always consult with your healthcare provider about treatment decisions and contact your insurance company directly for plan-specific requirements. For personalized assistance with insurance appeals, consider consulting with organizations like Counterforce Health that specialize in coverage advocacy.

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