CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fintepla (fenfluramine) for treatment of seizures in Dravet syndrome or Lennox-Gastaut syndrome

Defines medical necessity and prior authorization criteria for Fintepla (fenfluramine) for treatment of seizures associated with Dravet syndrome or Lennox-Gastaut syndrome, including initial and continuation criteria, quantity limit, and coverage durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFintepla (fenfluramine) for treatment of seizures in Dravet syndrome or Lennox-Gastaut syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic documentation (EEG, MRI, or SCN1A genetic test), clinical history, and documentation of at least two prior anti-epileptic therapy failures; initial approvals are 6 months and renewals 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6Initial authorization duration

12Renewal authorization duration

360Quantity limit (mL/month)

>=2Minimum member age (years)

Authorization Criteria for Fintepla (fenfluramine)

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Initial Approval (6 months)

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Member is at least 2 years of age>= 2 years
Therapy is prescribed by or given in consultation with a neurologist
Fintepla will not be taken concurrently with, or within 14 days, of the administration of monoamine oxidase inhibitors
Contraindication / drug interaction window
Member is not using the requested medication concomitantly with phentermine due to the potential for serious adverse effects
Member has a documented inadequate response to prior therapy with at least two anti-epileptic drugs
Examples listed: valproic acid, clobazam, Diacomit (stiripentol), topiramate, Epidiolex (cannabidiol), levetiracetam
ANY of the following
- Inadequate response to vagal nerve stimulation
- Inadequate response to ketogenic diet
ALL of the following
- EEG, MRI, or SCN1A gene mutation confirmed by genetic testing
  Any one of EEG, MRI, or positive SCN1A genetic test is acceptable
- Age at seizure onset, seizure types, and frequency of episodes documented
- Review of risk factors, other causes of seizures (e.g., other medical conditions and medications), family history, and developmental history documented

Continuation / Renewal Approval (12 months)

Authorization of 12 months may be granted for all members (including new members) who meet BOTH of the following:

ALL of the following

Documentation of EEG, MRI, or SCN1A gene mutation confirmed by genetic testing has been submitted
Same diagnostic documentation as initial criteria
Member has achieved and maintained positive clinical response with the requested medication as evidenced by reduction in frequency or duration of seizures
Clinical documentation of seizure reduction required

What Providers Must Do

Prior Authorization

Prior authorization required with documentation

Obtain prior authorization that meets either the Initial (6-month) or Continuation (12-month) criteria before initiating or continuing Fintepla. Submit required diagnostic documentation (EEG, MRI, or SCN1A genetic test) plus clinical history and records of prior anti-seizure treatment failures. Initial approvals are granted for 6 months; renewals (continuation approvals) are granted for 12 months.

Required diagnostic evidence: EEG, MRI, or SCN1A gene mutation confirmed by genetic testing.
Include clinical history and documentation of prior treatment failures with at least two anti-epileptic drugs.

Documentation Required

Document prior AED failures and adjunctive therapy attempts

Provide documentation demonstrating inadequate response to at least two anti-epileptic drugs and inadequate response to vagal nerve stimulation OR to a ketogenic diet. Include detailed seizure history (age at seizure onset, seizure types, and frequency) and review of risk factors, family history, and developmental history.

List prior anti-epileptic drugs tried and reasons for inadequate response (insufficient control or intolerable adverse effects).
Document attempts and outcomes of vagal nerve stimulation or ketogenic diet as applicable.
Provide age at seizure onset, seizure types, and seizure frequency.

Denial Risk

Contraindicated combinations

Requests may be denied for safety reasons if Fintepla is ordered to be used concurrently with monoamine oxidase (MAO) inhibitors or phentermine, or if it is to be administered within 14 days of MAOI use.

Do not prescribe Fintepla concurrently with MAO inhibitors or within 14 days after MAOI administration.
Do not prescribe Fintepla concomitantly with phentermine.

Billing Rule

Quantity limit enforcement

Adhere to the quantity limit of 360 mL per month; requests that exceed 360 mL/month will require supporting justification.

Include rationale and clinical justification for any request exceeding the 360 mL/month limit.

Clinical and Administrative Background

Fintepla (fenfluramine) is indicated for the treatment of seizures associated with Dravet syndrome or Lennox-Gastaut syndrome. Initial authorization criteria require that the member be at least 2 years of age, and that therapy be prescribed by or given in consultation with a neurologist. Approval is contingent on documentation that the member has had an inadequate response to at least two anti-epileptic drugs (examples include valproic acid, clobazam, stiripentol/Diacomit, topiramate, cannabidiol/Epidiolex, levetiracetam) and an inadequate response to adjunctive anti-seizure treatments such as vagal nerve stimulation or a ketogenic diet.

The policy requires objective diagnostic testing prior to approval: submission of EEG, MRI, or confirmation of an SCN1A gene mutation by genetic testing is required, along with documentation of age at seizure onset, seizure types and frequency, and review of risk factors, other causes of seizures, family history, and developmental history. Requests will be denied if Fintepla is to be used concurrently with or within 14 days of a monoamine oxidase inhibitor or concomitantly with phentermine due to safety concerns. Initial approvals are for 6 months with renewals for 12 months, and a quantity limit of 360 mL per month is enforced.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFintepla (fenfluramine) for treatment of seizures in Dravet syndrome or Lennox-Gastaut syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Fintepla (fenfluramine) for treatment of seizures in Dravet syndrome or Lennox-Gastaut syndrome

Authorization Criteria for Fintepla (fenfluramine)

Codes and Billing Notes

What Providers Must Do

Clinical and Administrative Background

Defined Terms

Numeric and Clinical Thresholds

Policy Dates & Reviews