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L.5.01.425
Felbatol (felbamate)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Felbatol (felbamate) is not indicated as a first line antiepileptic treatment and is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
Felbatol (felbamate) can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Criteria
Felbatol (felbamate) may be considered medically necessary when ALL of the following criteria are met:
ONE of the following:
The individual is 14 years of age or older and has a documented diagnosis of partial seizures with or without generalization; OR
The individual is 2 to 14 years of age and has a documented diagnosis of Lennox-Gastaut syndrome;
The individual has a history of failure (see definition of Medication Failure in the Policy Guidelines section), contraindication, or intolerance to TWO other anti-epileptic formulary alternatives for treatment of requested condition;
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on the FDA approved labeled dosage.
Length of Approval: 12 months
Renewal Evaluation
Felbatol (felbamate) may be considered approved for RENEWAL when ALL of the following criteria are met:
The individual has previously been approved through the BCBSMS PA process;
The individual is currently taking medication as prescribed with positive results;
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on the FDA-approved labeled dosage.
Length of Approval: 12 months
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Medication failure is defined as disease progression at generally accepted doses as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure for the purpose of this review.
BCBSMS determines individual medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: New policy added.
07/20/2015: Code Reference section updated for ICD-10.
05/26/2016: Policy number L.5.01.425 added. Investigative definition updated in Policy Guidelines section.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
07/30/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title updated to add "(felbamate)." Added drug name to the top of the policy. Policy description updated. Policy section updated to add that prior authorization is required and that the use of samples by a member will not be considered current or stable therapy for purposes of Medical Policy review. First medically necessary statement updated to add criteria that member has an FDA-approved diagnosis for treatment with the requested agent and that the dosage is within the dosing limits approved by the FDA. Added renewal evaluation criteria. Policy Exceptions updated to include "(felbamate)." Policy Guidelines updated to define medication failure and medically necessary. Sources updated.
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to revise initial and renewal criteria. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Removed definition of investigative. Added information regarding BCBSMS request for medical records and revised definition of medication failure. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to change "member" to "individual." Sources updated.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Felbatol (felbamate). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial criteria updated regarding age requirement, contraindications to therapy, and dose requirements. Renewal criteria updated regarding contraindications to therapy and dose requirements. Sources updated.
Felbatol prescribing information. Meda Pharmaceuticals Inc. November 2011. Last accessed June 2025.
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