By Counterforce Health Team in Fintepla (fenfluramine) —

How to Get Fintepla (fenfluramine) Covered by Humana in Pennsylvania: Prior Authorization Requirements and Appeal Rights

Answer Box: Getting Fintepla (fenfluramine) Covered by Humana in Pennsylvania

Fintepla (fenfluramine) requires prior authorization from Humana Medicare Advantage with specific documentation: confirmed Dravet syndrome or Lennox-Gastaut syndrome diagnosis, failed trials of at least two prior antiseizure medications, REMS program enrollment, and baseline echocardiogram. Submit through Humana's portal or fax 877-486-2621. If denied, you have 65 days to appeal internally, then can pursue Pennsylvania's external review program (for non-Medicare plans) which overturns ~50% of denials. Start today: Gather your diagnosis documentation, prior medication trial records, and contact your neurologist to begin REMS enrollment.

Table of Contents

  1. Humana's Coverage Policy for Fintepla (fenfluramine)
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. REMS Program and Cardiac Monitoring
  5. Prior Authorization Submission Process
  6. Common Denial Reasons and Solutions
  7. Appeals Process: Humana and Pennsylvania Rights
  8. Cost Assistance Programs
  9. Quick Reference: PA Requirements
  10. FAQ: Common Questions

Humana's Coverage Policy for Fintepla (fenfluramine)

Humana Medicare Advantage covers Fintepla (fenfluramine) as a specialty-tier medication with strict prior authorization requirements. The drug is FDA-approved for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (LGS) in patients 2 years and older.

Plan Types Affected:

  • Humana Medicare Advantage (Part C)
  • Humana Medicare Part D prescription drug plans
  • Some Humana commercial plans (verify with your specific policy)
Note: Humana maintains one of the lowest prior authorization denial rates among major insurers at approximately 3.5%, but denials often stem from incomplete documentation or missing REMS requirements.

Medical Necessity Requirements

FDA-Approved Indications

Fintepla is covered only for its FDA-approved uses:

  • Dravet syndrome: Seizures in patients ≥2 years with confirmed diagnosis
  • Lennox-Gastaut syndrome: Seizures in patients ≥2 years with confirmed diagnosis

Diagnosis Documentation Required

For Dravet Syndrome:

  • Onset of seizures between 1-20 months of age (typically first year)
  • Initially normal development with impairment after seizure onset
  • Specific seizure types: focal clonic, focal to bilateral tonic-clonic, or generalized clonic
  • SCN1A gene mutation documentation (when available)
  • EEG reports and clinical notes supporting diagnosis

For Lennox-Gastaut Syndrome:

  • Onset before 18 years (typically 1-8 years)
  • Multiple seizure types, especially tonic seizures
  • EEG showing slow spike-and-wave pattern (<2.5Hz) or paroxysmal fast activity
  • Progressive developmental/cognitive decline

Step Therapy and Exceptions

Required Prior Medication Trials

Dravet Syndrome - Must have tried:

  • At least two other antiseizure medications (such as valproic acid, topiramate, clonazepam, levetiracetam, or zonisamide), OR
  • One of the following: clobazam, Epidiolex (cannabidiol), or Diacomit (stiripentol)

Lennox-Gastaut Syndrome - Must have tried:

  • At least two other antiseizure medications from different drug classes

Documentation for Failed Therapies

For each prior medication, include:

  • Medication name and dosage
  • Duration of trial (minimum 8-12 weeks at therapeutic dose)
  • Reason for discontinuation (lack of efficacy, intolerance, contraindication)
  • Seizure frequency before, during, and after trial
  • Any adverse effects experienced

Medical Exception Pathways

Step therapy exceptions may be granted if:

  • Patient has contraindications to preferred medications
  • Prior medications caused serious adverse effects
  • Clinical urgency requires immediate Fintepla initiation
  • Patient was previously stable on Fintepla

REMS Program and Cardiac Monitoring

Mandatory REMS Enrollment

The Fintepla REMS program requires enrollment due to cardiac risks:

Prescriber Requirements:

  • Complete REMS training and knowledge assessment
  • Submit Prescriber Enrollment Form
  • Receive REMS certification

Patient Requirements:

  • Complete Patient Enrollment Form with healthcare provider
  • Receive REMS certification
  • Commit to required cardiac monitoring schedule

Baseline Echocardiogram Requirements

Required Before Starting Fintepla:

  • Echocardiogram confirming no mild or greater aortic regurgitation
  • No moderate or greater mitral regurgitation
  • Pulmonary arterial systolic pressure ≤35 mm Hg
  • No other significant cardiac abnormalities

Ongoing Monitoring:

  • Echocardiogram every 6 months during treatment
  • Final echo 3-6 months after discontinuation
  • All results reported to REMS program
Clinician Corner: The baseline echocardiogram is the most common missing piece in PA submissions. Ensure the cardiology report explicitly states the required measurements and that no contraindications exist before submitting to Humana.

Prior Authorization Submission Process

Step-by-Step: Fastest Path to Approval

  1. Complete REMS enrollment (prescriber and patient) - Allow 5-7 business days
  2. Obtain baseline echocardiogram - Schedule within 2 weeks of REMS completion
  3. Gather documentation - Diagnosis records, prior therapy documentation, REMS certificates
  4. Submit PA request via Humana provider portal or fax 877-486-2621
  5. Include medical necessity letter from neurologist or epilepsy specialist
  6. Track submission - Humana reviews within 7 calendar days for standard requests
  7. Follow up if needed - Call Humana Customer Care for status updates

Required Documentation Checklist

  • Completed Humana prior authorization form
  • REMS certificates (prescriber and patient)
  • Baseline echocardiogram report
  • Diagnosis documentation (clinical notes, EEG, genetic testing if available)
  • Prior medication trial documentation
  • Medical necessity letter from neurologist
  • Current seizure frequency logs

Common Denial Reasons and Solutions

Denial Reason How to Fix Required Documentation
Missing REMS enrollment Complete enrollment process REMS certificates for both prescriber and patient
Insufficient prior trials Document additional failed therapies Detailed trial records with doses, duration, outcomes
Missing cardiac clearance Obtain compliant echocardiogram Echo report meeting all REMS cardiac criteria
Diagnosis not supported Provide comprehensive diagnostic workup EEG reports, genetic testing, specialist consultation notes
Non-neurologist prescriber Obtain neurologist consultation Consultation note or co-signature from neurologist

Medical Necessity Letter Template

Your neurologist should include:

  • Patient's specific diagnosis with ICD-10 codes
  • Current seizure frequency and impact on quality of life
  • Detailed prior medication trials and outcomes
  • Clinical rationale for Fintepla based on published evidence
  • Treatment goals and expected monitoring plan
  • References to FDA labeling and clinical guidelines

Appeals Process: Humana and Pennsylvania Rights

Humana Internal Appeals

Timeline for Appeals:

  • File within: 65 days of denial notice
  • Humana decision timeframe: 7 calendar days for Part D drugs
  • Expedited appeals: 72 hours for urgent medical needs

How to Submit:

  • Online through Humana member portal
  • Mail to address on denial notice
  • Fax: Use number provided in denial letter
  • Phone: Customer Care number on member ID card

Pennsylvania External Review (Non-Medicare Plans Only)

Important: Pennsylvania's external review process does not apply to Medicare plans. Humana Medicare appeals follow federal CMS regulations.

For non-Medicare Humana plans in Pennsylvania:

  • Must complete internal appeal first and receive "Final Adverse Benefit Determination"
  • Have 4 months to request external review through Pennsylvania Insurance Department
  • Independent review organizations overturn approximately 50% of denials
  • Standard timeline: 45 days for decision
  • Expedited review: 72 hours for urgent cases

Pennsylvania External Review Contact:

From Our Advocates: We've seen multiple Fintepla approvals after initially being denied for "insufficient documentation." The key is ensuring every REMS requirement is met and clearly documented before resubmission. Don't assume the reviewer knows what REMS entails—spell it out completely.

Cost Assistance Programs

Manufacturer Support

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

Foundation Grants

  • The Assistance Fund: Medication copay assistance for rare disease patients
  • Patient Advocate Foundation: Copay relief programs
  • Epilepsy Foundation: Local affiliate assistance programs

State Resources

  • Pennsylvania PACE/PACENET: Prescription assistance for seniors
  • Pennsylvania Insurance Department: Consumer assistance with coverage issues

Quick Reference: PA Requirements

Requirement Dravet Syndrome Lennox-Gastaut Syndrome Documentation Needed
Age ≥2 years ≥2 years Date of birth verification
Diagnosis Confirmed Dravet Confirmed LGS Clinical notes, EEG, genetic testing
Prior Trials 2+ ASMs OR clobazam/Epidiolex/Diacomit 2+ ASMs Trial records with outcomes
Prescriber Neurologist or consultation Neurologist or consultation Medical license verification
REMS Both prescriber and patient enrolled Both prescriber and patient enrolled REMS certificates
Cardiac Baseline echo meeting criteria Baseline echo meeting criteria Echocardiogram report
Review Time 7 calendar days standard 7 calendar days standard Track via portal

FAQ: Common Questions

Q: How long does Humana prior authorization take in Pennsylvania? A: Standard PA requests are reviewed within 7 calendar days. Expedited requests for urgent medical needs are processed within 72 hours.

Q: What if Fintepla is not on Humana's formulary? A: You can request a formulary exception by demonstrating medical necessity and that no covered alternatives are appropriate. Include comprehensive documentation supporting the exception.

Q: Can I request an expedited appeal if my child's seizures are worsening? A: Yes. Contact Humana immediately to request expedited review if there's urgent medical need. Your physician may need to provide supporting documentation of the medical urgency.

Q: Does step therapy apply if we tried medications in another state? A: Yes, properly documented medication trials from other states count toward step therapy requirements. Ensure you have complete records from previous providers.

Q: What happens if REMS enrollment is delayed? A: Humana will not approve coverage until both prescriber and patient REMS enrollment is complete. Start the enrollment process early to avoid delays.

Q: Are there age restrictions for Fintepla coverage? A: Fintepla is FDA-approved and covered for patients 2 years and older with Dravet syndrome or LGS. There is no upper age limit.

Q: How often do I need follow-up echocardiograms? A: Every 6 months during treatment, with a final echo 3-6 months after stopping Fintepla. All results must be reported to the REMS program.

Q: Can a pediatric neurologist prescribe Fintepla? A: Yes, pediatric neurologists meet the specialist requirement. The key is that Fintepla must be prescribed by or in consultation with a physician specializing in the condition being treated.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-backed, payer-specific guidance. Our platform analyzes denial letters and creates targeted rebuttals that align with each plan's specific requirements, significantly improving approval rates for complex medications like Fintepla. Learn more at www.counterforcehealth.org.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies may vary by specific plan and change over time. Always verify current requirements with your insurance plan and healthcare provider. For personalized assistance with coverage issues, contact the Pennsylvania Insurance Department's Office of Consumer Services or consult with a qualified healthcare advocate.

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