By Counterforce Health Team in Fintepla (fenfluramine) —

UnitedHealthcare's Coverage Criteria for Fintepla in New Jersey: What Counts as "Medically Necessary"?

Answer Box: Get Fintepla Covered by UnitedHealthcare in New Jersey

Fintepla (fenfluramine) requires prior authorization from UnitedHealthcare's OptumRx for Dravet syndrome and Lennox-Gastaut syndrome. You'll need: (1) REMS enrollment with baseline echocardiogram, (2) documented failure of at least two preferred anti-seizure medications, and (3) confirmed diagnosis with ICD-10 coding. Start by having your neurologist submit the PA request through the UnitedHealthcare Provider Portal or call 866-889-8054. If denied, New Jersey offers two internal appeal levels plus external review through Maximus Federal Services at no cost.

Table of Contents

Policy Overview: How UnitedHealthcare Covers Fintepla

UnitedHealthcare manages Fintepla (fenfluramine) coverage through OptumRx's prior authorization system, regardless of whether you have an HMO, PPO, or Medicare Advantage plan. The medication requires approval before dispensing due to its specialty status and cardiac safety requirements.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before filling UHC Provider Portal
REMS Enrollment Required safety program FinteplaREMS.com
Step Therapy Try 2+ preferred medications first UHC Anticonvulsant Guidelines
Baseline Echo Heart monitoring required FDA Label Requirements

The policy applies to all UnitedHealthcare plans in New Jersey, though specific formulary tiers may vary. You can check your plan's current formulary status through the UnitedHealthcare member portal or by calling the number on your insurance card.

Indication Requirements: FDA-Approved Uses

Fintepla has two FDA-approved indications that UnitedHealthcare recognizes for coverage:

  1. Dravet Syndrome - seizures associated with this rare genetic epilepsy
  2. Lennox-Gastaut Syndrome (LGS) - seizures associated with this childhood epilepsy syndrome

Your neurologist must document the specific diagnosis using appropriate ICD-10 codes and provide clinical evidence supporting the diagnosis. For Dravet syndrome, this often includes genetic testing results showing SCN1A mutations, though UnitedHealthcare's guidelines indicate genetic testing results should be collected when available but don't specify it as mandatory.

Clinician Corner: Documentation Tips

Include these elements in your medical necessity letter:Specific syndrome diagnosis with ICD-10 codeSeizure frequency and type documentationEEG findings supporting the diagnosisGenetic testing results (if available)Weight-based dosing calculationsPlan for ongoing cardiac monitoring

Step Therapy & Exceptions

UnitedHealthcare requires documented failure of at least two antiepileptic drugs before approving Fintepla. According to their anticonvulsant medical necessity guidelines, you must show either:

Acceptable Step Therapy Documentation:

  • Persistent seizures after titration to the highest tolerated dose (with compliance confirmed)
  • Intolerable side effects despite reasonable efforts to minimize them
  • Contraindications to preferred alternatives
  • Continuation of prior therapy for an existing seizure disorder

Preferred First-Line Alternatives:

  • Clobazam
  • Valproate
  • Cannabidiol (Epidiolex)
  • Stiripentol (for Dravet syndrome specifically)

Medical Exception Pathways: If you can't try preferred medications due to contraindications, allergies, or drug interactions, your doctor can request a step therapy exception. Document specific medical reasons why alternatives aren't appropriate for your situation.

Required Diagnostics & REMS Documentation

Fintepla's biggest coverage hurdle is the mandatory Risk Evaluation and Mitigation Strategy (REMS) program due to heart valve and pulmonary hypertension risks.

REMS Requirements:

  1. Prescriber Enrollment: Your neurologist must be certified in the FINTEPLA REMS program
  2. Baseline Echocardiogram: Required before starting treatment with specific measurements:
    • Valve regurgitation assessment (aortic and mitral)
    • Pulmonary arterial pressure evaluation
    • Documentation of any structural abnormalities
  3. Patient Status Form: Must be submitted to FinteplaREMS.com or faxed to 1-833-568-6198
  4. Ongoing Monitoring: Echocardiograms every 6 months during treatment
Note: Missing REMS documentation is the most common reason for automatic denial. Ensure all forms are submitted before requesting prior authorization.

Acceptable Cardiac Findings:

  • Trace or mild mitral regurgitation without structural abnormalities
  • Trace aortic regurgitation without valve thickening
  • Normal pulmonary arterial pressure (<35 mm Hg)

Findings Requiring Risk-Benefit Assessment:

  • Mild or greater aortic regurgitation with valve abnormalities
  • Moderate or greater mitral regurgitation
  • Elevated pulmonary arterial pressure (>35 mm Hg)

Evidence to Support Medical Necessity

When building your case for Fintepla approval, include evidence from these authoritative sources:

Clinical Guidelines:

  • FDA prescribing information for approved indications
  • International League Against Epilepsy (ILAE) recommendations for Dravet syndrome
  • Child Neurology Society practice parameters for LGS

Supporting Documentation:

  • Seizure logs showing frequency and severity
  • EEG reports documenting seizure activity
  • Prior medication trials with specific outcomes
  • Quality of life assessments
  • Developmental milestone tracking (for pediatric patients)

Sample Medical Necessity Narrative: "Patient has confirmed Dravet syndrome with SCN1A mutation and experiences 15-20 tonic-clonic seizures monthly despite maximum tolerated doses of clobazam and valproate. Previous trials of levetiracetam and topiramate were discontinued due to behavioral side effects and cognitive impairment, respectively. Baseline echocardiogram shows normal cardiac function. Fintepla is FDA-approved for this indication and represents the next appropriate therapeutic option per ILAE guidelines."

Appeals Process in New Jersey

If UnitedHealthcare denies your Fintepla request, New Jersey offers comprehensive appeal rights through a two-level internal process followed by external review.

Step 1: Internal Reconsideration

  • Timeline: Submit within 60 days of denial
  • Response: UnitedHealthcare responds within 45 days
  • How to Submit: UnitedHealthcare Provider Portal or mail to address on denial letter

Step 2: Formal Internal Appeal

  • Timeline: Submit within 60 days of original denial
  • Response: Decision within 45 days (72 hours for expedited)
  • Required: Signed appeal form with complete medical records

Step 3: External Review (New Jersey IHCAP)

  • Timeline: Submit within 180 days of final internal denial
  • Cost: Free to you (insurer pays all fees)
  • Process: Managed by Maximus Federal Services
  • Decision: Binding on UnitedHealthcare if overturned
Expedited Appeals: If waiting 45 days could seriously harm your health, request expedited review for a 72-hour decision.

New Jersey Consumer Assistance:

  • DOBI Consumer Hotline: 1-800-446-7467
  • IHCAP Specific Line: 1-888-393-1062

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing REMS enrollment Complete prescriber certification and patient enrollment REMS enrollment confirmation
No baseline echo Submit echocardiogram with required measurements Echo assessment sheet
Insufficient step therapy Document specific medication trials and outcomes Detailed medication history with dates, doses, and reasons for discontinuation
Diagnosis not supported Provide genetic testing, EEG, clinical notes confirming Dravet/LGS ICD-10 coding with supporting clinical evidence
Drug interaction concerns Pharmacist review and safety plan Medication reconciliation and monitoring plan
From Our Advocates: We've seen cases where patients were initially denied for "insufficient documentation," but approval came quickly once the clinic submitted a comprehensive medication history showing clear failure of clobazam and valproate. The key is being specific about why each prior medication didn't work—whether due to lack of efficacy, side effects, or contraindications.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific rules. Their platform helps clinicians save time while ensuring patients get the strongest possible appeal with proper documentation and procedural compliance.

FAQ

How long does UnitedHealthcare prior authorization take in New Jersey? Standard prior authorization decisions take up to 15 business days. Urgent requests can be expedited to 72 hours if medical urgency is documented.

What if Fintepla isn't on my formulary? Even non-formulary drugs can be covered through prior authorization. Your doctor will need to provide stronger medical necessity justification and may need to request a formulary exception.

Can I request an expedited appeal if I'm already having seizures? Yes. Ongoing seizures that could worsen without treatment qualify for expedited internal appeals (72-hour decision) and expedited external review in New Jersey.

Does step therapy apply if I failed medications outside New Jersey? Yes, UnitedHealthcare accepts documented medication failures from other states as long as the clinical documentation is complete and verifiable.

What happens if my echocardiogram shows abnormalities? Your cardiologist and neurologist must document that the benefits of Fintepla outweigh the cardiac risks. UnitedHealthcare may approve with enhanced monitoring requirements.

How much does Fintepla cost with UnitedHealthcare coverage? Costs vary by plan tier and deductible status. The manufacturer offers patient assistance programs that may reduce out-of-pocket expenses significantly.

Can my doctor request a peer-to-peer review? Yes, if the initial PA is denied, your neurologist can request to speak directly with a UnitedHealthcare medical director to discuss the case.

What if I need Fintepla while my appeal is pending? Ask your doctor about requesting a "bridge supply" or temporary approval while the appeal is processed, especially if you're transitioning from another medication.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions. For additional assistance with insurance appeals in New Jersey, contact the Department of Banking and Insurance at 1-800-446-7467.

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