APTIOM (eslicarbazepine)

APTIOM (eslicarbazepine)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of partial-onset seizures in patients 4 years of age and older

Coverage Criteria:

For diagnosis of partial-onset seizures:

• Dose does not exceed the Food and Drug Administration (FDA) labeled maximum:
  • Pediatrics: dose is based on weight (see additional information section)
  • Adults: 1,600 mg once daily; AND
• Patient is 4 years of age or older; AND
• Patient has a diagnosis of partial-onset seizures; AND
• Prescribed by or in consultation with a neurologist; AND
• Failure of two preferred anticonvulsants indicated for partial seizures (e.g., carbamazepine, clorazepate, divalproex sodium, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, pregabalin, primidone, tiagabine, topiramate, valproic acid, zonisamide)

Reauthorization Criteria:

For diagnosis of partial-onset seizures:

• Dose does not exceed the Food and Drug Administration (FDA) labeled maximum:
  • Pediatrics: dose is based on weight (see additional information section)
  • Adults: 1,600 mg once daily; AND
• Documentation of a positive clinical response to therapy

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Adult dose:
  • Recommended initial dose is 400 mg administered orally once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions during initiation
  • Recommended maintenance dosage of 800 mg to 1600 mg once daily
• Pediatric dose (4 to 17 years of age): 
  • Recommended dosing regimen is dependent upon body weight and is administered orally once daily
  • 

Policy Updates:

• 8/16/2022 – New policy approved by P&T

References:

• Aptiom Prescribing Information. Sunovion Pharmaceuticals Inc. Marlborough, MA. March 2019.