Eslicarbazepine
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Defines initial and continuation authorization criteria, quantity limits, and coverage duration for eslicarbazepine tablets (Aptiom/generic) for treatment of partial-onset seizures in members age 4 and older.
No material changes
Coverage Summary
Coverage stance: covered_with_criteria. Scope: Defines initial and continuation authorization criteria, quantity limits, and coverage duration for eslicarbazepine tablets (Aptiom/generic) for treatment of partial-onset seizures in members age 4 and older. Age restriction: minimum age >= 4 years. Covered indication: treatment of partial-onset seizures. Quantity limits: enforced per tablet strength (see quantity limit details). Coverage duration: 12 months.
Initial Therapy Criteria
Initial Approval
An authorization may be granted when all the following criteria are met:
Initial Approval criteria
- Prescriber specialty: The prescriber is a neurologist or prescribed in consultation with a neurologist
- Minimum age: The patient is 4 years of age or older>= 4 years
- Indication: The medication is used for the treatment of partial-onset seizures
- Prior therapy: Documentation that the patient has had a 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>= 2 prior antiepileptic drug trials
Trials must be titrated to maintenance or documented failures due to intolerable side effects
- DRESS counseling: Prescriber is aware and counseled the patient on the potential for the side effect of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
- Seizure documentation: Documentation of seizure frequency is provided
Continuation Therapy Criteria
Continuation of Therapy
Eslicarbazepine will continue to be covered within the quantity limit after the initial approval if at least one of the following is met:
Continuation of Therapy criteria
- Paid claim lookback: There is at least one paid claim of at least a 28-day supply within the last 365 days for eslicarbazepine>= 1 paid claim of >= 28-day supply within last 365 days
- Clinical response: The member has documentation of a positive clinical response (e.g., decrease in seizure frequency)
Provider Actions & Authorization Requirements
Prior authorization required per initial criteria
Prior authorization is required. Document that the prescriber is a neurologist or that the prescription is in consultation with a neurologist; the patient is age 4 years or older; the medication is being used for treatment of partial-onset seizures; the patient has had trials of at least two other antiepileptic drugs titrated to an appropriate maintenance dose or documented failures of at least two other antiepileptic drugs due to intolerable side effects; documentation of seizure frequency; and that the prescriber counseled the patient about the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multiorgan hypersensitivity.
- Prescriber specialty: neurologist or consultation with neurologist
- Patient age: ≥ 4 years
- Indication: partial‑onset seizures
- Prior trials: ≥ 2 other antiepileptic drugs titrated to maintenance or documented failures due to intolerable side effects
- Documentation of seizure frequency
- Prescriber counseling on DRESS/multiorgan hypersensitivity
Documentation for continuation
For continuation of therapy, retain documentation meeting at least one of the continuation criteria: either evidence of a paid claim for eslicarbazepine of at least a 28‑day supply within the prior 365 days, or documentation of a positive clinical response such as a decrease in seizure frequency.
- At least one paid claim of ≥ 28‑day supply within the last 365 days
- Evidence of positive clinical response (e.g., decreased seizure frequency)
Quantity limit enforcement
Dispense and bill in accordance with the policy quantity limits for each tablet strength; ensure adherence to the specified per‑day tablet limits when processing claims.
- Quantity limit details are specified in the policy by tablet strength (see quantity limit section)
Applicable Codes
| No codes listed |
Clinical Evidence & References
Aptiom (eslicarbazepine) package insert, Sumitomo Pharma America, Inc.; March 2019. The brief provides no additional trial metrics or numerical trial results beyond the referenced package insert.
Background
Eslicarbazepine (Aptiom) is an antiepileptic medication indicated for the treatment of partial-onset seizures. Policy requires that the prescriber be a neurologist or that treatment be prescribed in consultation with a neurologist, the patient be at least 4 years old, and that the patient have documentation of a trial of at least two other antiepileptic drugs titrated to an appropriate maintenance dose or documented failures due to intolerable side effects. Prescribers must counsel patients on the potential for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity and provide documentation of seizure frequency. Quantity limits are specified by tablet strength for dispensing and billing.
Definitions:
DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms / Multiorgan Hypersensitivity
Revision History
Policy reviewed (no material change indicated)
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