CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Perampanel (Fycompa) — Coverage Criteria (Prior Authorization and Quantity Limits)

This document governs authorization, continuation, and quantity limits for perampanel (oral tablets and suspension) for Medicaid members, including clinical prerequisites and prescriber requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPerampanel (Fycompa) — Coverage Criteria (Prior Authorization and Quantity Limits)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of neurologist involvement, age-appropriate indication, at least two prior AED trials (or documented failures), counseling about DRESS, and seizure frequency or positive clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

≥2prior AED trials

2/day2 mg tablet limit

1/day4–12 mg tablet limit

8 ml/dayoral suspension limit

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Coverage Criteria for Perampanel (Fycompa)

Initial Authorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Authorization criteria: Prescriber is a neurologist or medication is prescribed in consultation with a neurologist.

Authorization criteria: Medication is used for treatment of partial-onset seizures and patient is ≥ 4 years of age OR medication is used as adjunctive therapy for primary generalized tonic-clonic seizures and patient is ≥ 12 years of age.age criteria

Authorization criteria: Patient has had a documented trial of at least 2 other antiepileptic drugs titrated to an appropriate maintenance dose or documented failure of at least two other antiepileptic drugs due to intolerable side effects.

Authorization criteria: Prescriber has counseled the patient on the potential for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multiorgan hypersensitivity.

Authorization criteria: Documentation of seizure frequency is provided.

Authorization may be granted for 12 months if all conditions are met.

Continuation of Therapy — Continuation covered when ANY of the following are met

Continuation covered when ANY of the following are met

Continuation criteria: At least one paid claim of at least a 28-day supply within the last 365 days for perampanel (tablet) or for perampanel oral suspension.28-day paid claim within 365 days

Perampanel tablets and oral suspension follow the same continuation rule.

Continuation criteria: Documentation of a positive clinical response (e.g., decrease in seizure frequency).

Use of perampanel outside the age ranges specified in the approval criteria is not covered. Specifically, therapy for partial‑onset seizures is limited to patients who are ≥4 years of age, and adjunctive treatment for primary generalized tonic‑clonic seizures is limited to patients who are ≥12 years of age. Requests for members younger than these age thresholds should be denied under these coverage criteria unless a separate, documented exception process is followed.

Product Coding and Quantity Limits

Product-specific quantity limitsmixedCovered

perampanel 2 mg tablet	Quantity limit: 2 tablets per day
perampanel 4 mg tablet	Quantity limit: 1 tablet per day
perampanel 6 mg tablet	Quantity limit: 1 tablet per day
perampanel 8 mg tablet	Quantity limit: 1 tablet per day
perampanel 10 mg tablet	Quantity limit: 1 tablet per day
perampanel 12 mg tablet	Quantity limit: 1 tablet per day
perampanel 0.5 mg/ml oral suspension	Quantity limit: 8 ml per day (quantity limit exception up to 24 ml per day / 12 mg per day if documented inability to take tablets)

Quantity exception threshold — inv-05

Standard quantity limitsPerampanel 2 mg tablet: 2 tablets per day; Perampanel 4–12 mg tablets: 1 tablet per day; Perampanel 0.5 mg/mL oral suspension: 8 mL per day.

Quantity exception thresholdUp to 12 mg per day (equivalent to 24 mL per day) may be granted if there is documented inability to take perampanel tablets.

Exception justification requiredDocumentation must state the patient’s inability to take tablets to qualify for the increased suspension limit.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals may be granted for up to 12 months when criteria are met. Continuation of therapy requires evidence of ongoing use or clinical benefit as described below.

Initial approval: up to 12 months when all approval criteria are met
Continuation: at least one paid claim of ≥28-day supply within the last 365 days for the product formulation OR documentation of positive clinical response (e.g., decreased seizure frequency)

Step Therapy

Prior AED Trials Required

Step therapy (prior AED trials) is required. The member must have a documented trial of at least two other antiepileptic drugs titrated to an appropriate maintenance dose, OR documented failure of at least two other antiepileptic drugs due to intolerable side effects or documented contraindication/intolerance.

Documented trials of ≥2 other antiepileptic drugs (titrated to appropriate maintenance dose) OR documented failure/contraindication/intolerance to ≥2 other AEDs

Background

Perampanel (Fycompa) is an antiepileptic medication indicated for the treatment of partial‑onset seizures and as adjunctive therapy for primary generalized tonic‑clonic seizures. Prior authorization may be granted for up to 12 months when all approval conditions are met, which include neurologist involvement (prescriber or consultation), age‑appropriate indication, documentation of at least 2 prior antiepileptic drug trials (or failures due to intolerability), counseling about the risk of DRESS/multiorgan hypersensitivity, and documentation of seizure frequency.

Key Definitions

DRESS/Multiorgan Hypersensitivity — inv-11

DefinitionDRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)/Multiorgan Hypersensitivity: a rare but serious adverse reaction associated with perampanel that can involve systemic organ involvement and eosinophilia.

Prescriber responsibilityPrescribers must be aware of and counsel the patient on the potential for DRESS/multiorgan hypersensitivity prior to initiating therapy.

DocumentationConfirmation that counseling about DRESS/multiorgan hypersensitivity was provided should be included in the patient record and submitted with prior authorization requests as required.