CurrentAvMedPolicy N/A

Fintepla

Pharmacy prior authorization and reauthorization criteria for Fintepla (fenfluramine), including prescriber, age, diagnosis, prior treatment, monitoring (echocardiogram, REMS), dosing guidance, quantity limits, and specialty pharmacy sourcing.

Policy Summary

PayerAvMed

PolicyFintepla

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the request form and fax completed form to 1-305-671-0200; incomplete/illegible information may delay authorization.

SourceLink

POLICY UPDATE CHANGES

No material changes

2Covered Indications

>=2Minimum Age

360 mL/30dQuantity Limit

REMSSafety Program

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Pharmacy prior authorization and reauthorization criteria for Fintepla (fenfluramine) prior authorization, including requirements that the medication be prescribed by or in consultation with a neurologist; member be >= 2 years of age; diagnosis of seizures associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS); verification of prior/concomitant antiepileptic therapies and refractory status per diagnosis (first-line/second-line therapies verified by pharmacy paid claims); requirement that Fintepla be used as adjunctive therapy to ≥1 antiepileptic drug; echocardiogram monitoring before initiation, every 6 months during treatment, and 3–6 months after final dose; prescriber enrollment in the Fintepla REMS program; dosing guidance with weight-based initiation and titration and maximum daily doses of 26 mg/day without stiripentol and 17 mg/day with stiripentol and clobazam; quantity limit of 360 mL per 30 days; 26 mg per day; and specialty pharmacy sourcing (PropriumRx).

Initial Authorization (6 months)

All criteria must be met for approval. To support each line checked, documentation including lab results, diagnostics, and/or chart notes must be provided.

ALL of the following

Medication must be prescribed by or in consultation with a neurologist
Member must be 2 years of age or older>= 2 years
Member must have ONE of the following diagnoses
- Seizures associated with Dravet syndrome (DS)
- Seizures associated with Lennox-Gastaut syndrome (LGS)
Refractory treatment requirements by diagnosis
- Dravet Syndrome: first-line therapy clobazam or valproate AND second-line therapy Diacomit®
  verified by pharmacy paid claims
- Lennox-Gastaut: first-line therapies valproate and clobazam or valproate and lamotrigine AND all second-line therapies: topiramate, rufinamide and Epidiolex® (unless contraindicated)
  verified by pharmacy paid claims
Medication must be used as adjunctive therapy to ≥ 1 antiepileptic drug used for the treatment of Dravet Syndrome or Lennox-Gastaut syndrome (e.g., valproate, clobazam, levetiracetam, topiramate, zonisamide, clonazepam) (verified by pharmacy paid claims)
Echocardiogram monitoring: Provider has obtained and reviewed an echocardiogram assessment before initiating treatment with Fintepla® and will continue to obtain and review an echocardiogram assessment every 6 months during treatment with Fintepla®, and 3 to 6 months after the final dose of Fintepla®every 6 months during treatment; 3-6 months after final dose
documentation required
Serotonin syndrome monitoring: Member will be monitored for emergence of signs and symptoms of serotonin syndrome if there is known concomitant administration of Fintepla® and serotonergic drugs (prescription, OTC, or herbal)
examples include SSRIs, SNRIs, TCAs, trazodone, dextromethorphan, St. John's Wort
REMS enrollment: Prescriber must be enrolled in Fintepla® Risk Evaluation and Mitigation Strategy (REMS) program
evidence of enrollment must be provided

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Reauthorization (12 months)

All criteria must be met for approval. To support each line checked, documentation including lab results, diagnostics, and/or chart notes must be provided.

ALL of the following

Member must continue to meet initial authorization criteria
Positive response: Member has demonstrated a positive response to Fintepla® therapy, defined as: decrease from baseline and stabilization of seizure frequency/severity (submit chart notes)
document chart notes
Tolerability: Member must be absent of unacceptable toxicity from therapy (e.g., significant weight loss, sedation, diarrhea)

Applicable Codes & Limits

Quantity Limit / Dosing ConstraintsmixedCovered

Quantity Limit	360 mL per 30 days; 26 mg per day
Dosing Guidance	Initial and titration dosing based on weight and concomitant stiripentol/clobazam as specified (see policy). Maximum total daily dosage without stiripentol = 26 mg; with stiripentol and clobazam = 17 mg.

ICD-10 / Diagnoses referencedICD-10

	Seizures associated with Dravet syndrome (DS) — ICD code to be provided on form
	Seizures associated with Lennox-Gastaut syndrome (LGS) — ICD code to be provided on form

Fintepla (fenfluramine) thresholds

Age>= 2 years

Quantity Limit360 mL per 30 days; 26 mg per day

Maximum daily dose without stiripentol26 mg per day

Maximum daily dose with stiripentol and clobazam17 mg per day

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Submission

Prescribing physician must sign and clearly print name on the request form (preprinted stamps not valid). Fax the completed form to 1-305-671-0200. If information provided is incomplete, incorrect, or illegible, the authorization process may be delayed.

Documentation Required

Support for Diagnosis and Prior Therapies

Submit chart notes and pharmacy paid claims verifying the diagnosis and prior or concomitant antiepileptic therapies as specified in the criteria (e.g., first-line and second-line therapies by diagnosis). Documentation must be provided to support each line checked.

Documentation Required

Echocardiogram Monitoring

Obtain and review an echocardiogram assessment before initiating Fintepla, continue echocardiogram assessments every 6 months during treatment, and obtain an assessment 3 to 6 months after the final dose. Documentation of these assessments is required for approval.

Documentation Required

REMS Enrollment

Prescriber must be enrolled in the Fintepla Risk Evaluation and Mitigation Strategy (REMS) program. Provide evidence of prescriber enrollment with the request.

Denial Risk

Incomplete Documentation Risk

Requests may be denied if required documentation (lab results, diagnostics, chart notes, pharmacy paid claims) supporting the checked criteria is not provided.

Background & Definitions

Background: Fintepla (fenfluramine) is used as adjunctive therapy for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Due to safety considerations, dosing is weight-based with specified titration and different maximum daily dosages depending on concomitant stiripentol and clobazam use (maximum 26 mg/day without stiripentol; maximum 17 mg/day with stiripentol and clobazam). Monitoring requirements include obtaining and reviewing an echocardiogram before initiation, every 6 months during treatment, and 3–6 months after the final dose; prescribers must be enrolled in the Fintepla Risk Evaluation and Mitigation Strategy (REMS).

Definitions: REMS — Risk Evaluation and Mitigation Strategy required for Fintepla prescribers.

OpenPayer

Fintepla

Coverage Summary

Applicable Codes & Limits

Provider Actions & Authorization Requirements

Background & Definitions

Clinical Evidence