By Counterforce Health Team in Fintepla (fenfluramine) —

The Requirements Checklist to Get Fintepla (fenfluramine) Covered by UnitedHealthcare in New York: Forms, Appeals, and REMS Documentation

Answer Box: Getting Fintepla Covered by UnitedHealthcare in New York

To get Fintepla (fenfluramine) covered by UnitedHealthcare in New York: First, enroll in the mandatory Fintepla REMS program and complete baseline echocardiography. Then submit prior authorization through UnitedHealthcare's provider portal with diagnosis confirmation (ICD-10 G40.83 for Dravet syndrome or G40.81 for Lennox-Gastaut syndrome), documentation of 2-3 failed antiseizure medications, and REMS enrollment proof. If denied, New York residents have strong appeal rights through the Department of Financial Services external review program, with decisions binding on insurers and 72-hour expedited options for urgent cases.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Required Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking Your Request
  9. Common Denial Prevention Tips
  10. Appeals Process in New York
  11. Printable Checklist

Who Should Use This Checklist

This guide is for patients with Dravet syndrome or Lennox-Gastaut syndrome (LGS) whose doctors have prescribed Fintepla (fenfluramine) and need UnitedHealthcare coverage in New York. You'll also find this useful if you've already been denied and need to appeal.

Expected outcome: With proper documentation and REMS enrollment, most medically appropriate Fintepla requests get approved. UnitedHealthcare's Medicare Advantage prior authorization denial rate runs around 9% (above average), but thorough preparation significantly improves your chances.

Member & Plan Basics

Verify Active Coverage

  • Confirm your UnitedHealthcare plan is active and includes prescription benefits
  • Check if you have OptumRx pharmacy benefits (most UnitedHealthcare plans do)
  • Verify your deductible status and specialty tier copayments

Plan Type Considerations

Commercial plans: Standard prior authorization through OptumRx Medicare Advantage: May have additional step therapy requirements Medicaid managed care: Follow standard PA process but may qualify for expedited review

Tip: Call the member services number on your insurance card to confirm your specific plan's specialty pharmacy requirements and copayment structure.

Clinical Criteria Requirements

FDA-Approved Indications

Fintepla is approved for seizures associated with:

  • Dravet syndrome (patients 2 years and older)
  • Lennox-Gastaut syndrome (patients 2 years and older)

Step Therapy Documentation

UnitedHealthcare typically requires proof of failure, intolerance, or contraindication to 2-3 conventional antiseizure medications, which may include:

  • Clobazam
  • Valproate
  • Stiripentol
  • Cannabidiol (Epidiolex)
  • Rufinamide
  • Topiramate
  • Lamotrigine

Document specific medications tried, doses, duration, and reasons for discontinuation (lack of efficacy, side effects, or contraindications).

REMS Program Enrollment

This is mandatory before any coverage request. Fintepla requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to risks of valvular heart disease and pulmonary arterial hypertension.

Required steps:

  1. Prescriber completes training and enrollment at FinteplaREMS.com
  2. Patient enrollment form completed with prescriber
  3. Baseline echocardiogram performed and results submitted to REMS
  4. Pharmacy enrollment (if using network specialty pharmacy)

Coding and Documentation

ICD-10 Diagnostic Codes

Use the most specific codes available:

Dravet Syndrome:

  • G40.83: Dravet syndrome (general)
  • G40.833: Dravet syndrome, intractable, with status epilepticus
  • G40.834: Dravet syndrome, intractable, without status epilepticus

Lennox-Gastaut Syndrome:

  • G40.81: Lennox-Gastaut syndrome (general)
  • G40.813: Lennox-Gastaut syndrome, intractable
  • G40.814: Lennox-Gastaut syndrome, intractable, with status epilepticus

NDC and Pricing Information

  • Fintepla oral solution comes in 120 mg/120 mL bottles
  • Typical retail pricing around $1,595 for a 30-mL bottle (verify with current sources)
  • Dosing is weight-based, affecting monthly quantities needed

Required Documentation Packet

Provider Clinical Note Elements

Your prescriber's documentation should include:

  • Confirmed diagnosis with supporting evidence (genetic testing for Dravet, EEG findings for LGS)
  • Patient age verification (≥2 years)
  • Comprehensive seizure history and frequency
  • Complete medication trial history with specific details
  • Current seizure control status and treatment goals
  • REMS enrollment confirmation and baseline echo results

Letter of Medical Necessity Components

A strong medical necessity letter should address:

  1. Clinical problem: Specific syndrome diagnosis and seizure burden
  2. Prior treatments: Detailed history of failed conventional ASMs
  3. Rationale: Why Fintepla is appropriate for this patient
  4. Monitoring plan: REMS compliance and ongoing echocardiography schedule
  5. Expected outcomes: Seizure reduction goals and quality of life improvements

Required Attachments

  • REMS enrollment confirmation
  • Baseline echocardiogram results
  • Genetic testing results (particularly SCN1A mutation for Dravet)
  • Recent EEG reports
  • Seizure diary or frequency logs
  • Documentation of previous medication trials and outcomes

Submission Process

OptumRx Prior Authorization

Contact OptumRx directly for current forms and requirements:

  • Provider line: 866-889-8054
  • Submit through: UnitedHealthcare Provider Portal (verify current link with your plan)
  • Required fields: Complete all sections to avoid automatic rejections
Note: Specific prior authorization forms and step therapy requirements for Fintepla may vary by plan type. Always verify current requirements directly with OptumRx.

Timeline Expectations

  • Standard review: 15 business days from complete submission
  • Expedited review: 72 hours for urgent medical situations
  • Incomplete submissions: May result in automatic denials or requests for additional information

Specialty Pharmacy Routing

Network Requirements

UnitedHealthcare requires Fintepla to be dispensed through their specialty pharmacy network:

  • Primary vendor: OptumRx/Optum Specialty Pharmacy
  • Alternative vendor: Biologics (per UHC provider resources)
  • Important: Local pharmacies cannot dispense covered Fintepla

Coordination Steps

  1. Confirm network pharmacy participation with member services
  2. Ensure pharmacy completes REMS enrollment if required
  3. Set up automatic refills and delivery preferences
  4. Link any available manufacturer copay assistance programs

After Submission: Tracking Your Request

What to Record

  • Submission date and confirmation number
  • Case reference number from OptumRx
  • Name of representative if submitted by phone
  • Expected decision timeline

Status Monitoring

  • Check status through UnitedHealthcare member portal
  • Call OptumRx if no response within expected timeframe
  • Document all communications for potential appeals

Common Denial Prevention Tips

Common Pitfall Prevention Strategy
Missing REMS enrollment Complete all REMS steps before PA submission
Inadequate step therapy documentation Provide specific details on failed medications
Incorrect diagnostic coding Use specific ICD-10 codes (G40.83, G40.81)
Missing baseline echo Submit REMS-compliant echocardiogram results
Incomplete prior authorization form Verify all required fields are completed

Appeals Process in New York

New York residents have particularly strong appeal rights that can overturn UnitedHealthcare denials.

Internal Appeals with UnitedHealthcare

  • Timeline: Submit within 180 days of denial
  • Process: Submit through member portal or mail with denial letter
  • Documentation: Include all original PA materials plus any additional supporting evidence

New York External Appeals

If your internal appeal is denied, you can file an external appeal with the New York Department of Financial Services:

Key advantages:

  • Binding decision: The external reviewer's decision is final and binding on UnitedHealthcare
  • Expert review: Independent medical experts evaluate your case
  • Timeline: 30 days for standard appeals, 72 hours for expedited
  • Cost: Maximum $25 fee (waived for financial hardship or Medicaid)

Filing deadline: Within 4 months of your final internal appeal denial

Expedited appeals: Available when a physician attests that waiting 30 days would seriously jeopardize your health

From our advocates: We've seen several successful Fintepla appeals in New York where the external reviewer overturned denials based on incomplete step therapy documentation. The key was providing detailed medication trial histories with specific dates, doses, and documented reasons for discontinuation. These cases typically resulted in immediate coverage approval.

Printable Checklist

Before You Start

  • Active UnitedHealthcare coverage confirmed
  • Specialty pharmacy benefits verified
  • Insurance card and member ID available

Clinical Requirements

  • Confirmed Dravet syndrome or LGS diagnosis
  • Patient age ≥2 years documented
  • 2-3 failed ASM trials documented with specifics
  • Current seizure frequency recorded

REMS Program

  • Prescriber enrolled and trained
  • Patient enrollment form completed
  • Baseline echocardiogram performed
  • REMS confirmation received

Documentation

  • Medical necessity letter prepared
  • Genetic testing results (if available)
  • Recent EEG reports
  • Medication trial history compiled
  • Seizure diary or logs

Submission

  • Current PA form obtained from OptumRx
  • All required fields completed
  • Supporting documents attached
  • Submission confirmation received

Follow-up

  • Status check scheduled
  • Appeal timeline noted (if needed)
  • External appeal rights reviewed

When You Need Additional Help

If you're struggling with the coverage process, Counterforce Health specializes in turning insurance denials into successful appeals. Their platform helps patients and clinicians navigate complex prior authorization requirements and creates evidence-backed appeals that address specific payer criteria.

For free assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400. They provide free counseling on insurance denials and can help you file appeals or understand your rights under New York law.

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical advice. Coverage policies can change, and individual circumstances vary. Always verify current requirements with your insurer and consult with your healthcare provider about treatment decisions.

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