ELEPSIA XR (levetiracetam extended-release)

ELEPSIA XR (levetiracetam XR)

Self-Administration – Oral

Diagnosis considered for coverage:

• Seizures: Indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.

Coverage Criteria:

For diagnosis of partial-onset seizures:

• Requested drug is being used for a Food and Drug Administration (FDA)-Approved indication; AND
• Dose does not exceed 3000mg/day; AND 
• One of the following:
  • Trial and failure of a minimum 30-day supply, or intolerance to generic levetiracetam extended-release.
  • For continuation of prior therapy.

Reauthorization Criteria:

For diagnosis of partial-onset seizures:

• Dose does not exceed 3000mg/day; AND
• Documentation of positive clinical response to therapy

Coverage Duration:

• 1 year

Dosing:

• Initial dose of 1000 mg orally once daily.
• Titrate by increasing in increments of 1000 mg/day every 2 weeks up to 3000 mg/day.

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:

• Elepsia XR should be taken whole and should not be crush, chew, or split.
• Not recommended for use in patients with moderate or severe renal impairment and recommending a maximum dose of 2000mg in mild renal impairment.
• Suicidal behavior and ideation can occur when taking Elepsia XR and patients should be monitored for unusual changes in mood or behavior.
• Patients taking Elepsia XR should watch out for any dermatological reaction including Steven-Johnson syndrome (SJS) and topic epidermal necrolysis (TEN) which occurs within 14-17 days of taking.

Policy Updates:

• 08/15/2023 – New policy approved by P&T.

References:

• Elepsia XR Prescribing Information. Tripoint Therapeutics, LLC. Westfield, NJ. December 2020.