CurrentAdvanced HealthPolicy N/A

Levetiracetam XR Drug Use Criteria

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This policy governs prior authorization and renewal requirements for levetiracetam extended-release products, including Keppra XR and generic levetiracetam XR, for Advanced Health members seeking treatment for epilepsy or seizure disorders.

Policy Summary

PayerAdvanced Health

PolicyLevetiracetam XR Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document failure of an adequate trial of immediate-release levetiracetam before requesting levetiracetam XR.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum approval duration

3000 mgMaximum daily dose

1000 mgInitial daily dose

IR trial requiredPrerequisite

Hypersensitivity

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CurrentAdvanced HealthPolicy N/A

Levetiracetam XR Drug Use Criteria

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Policy Summary

PayerAdvanced Health

PolicyLevetiracetam XR Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document failure of an adequate trial of immediate-release levetiracetam before requesting levetiracetam XR.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum approval duration

3000 mgMaximum daily dose

1000 mgInitial daily dose

IR trial requiredPrerequisite

Hypersensitivity

Coverage Criteria

Initial Therapy

Initial therapy is covered when all applicable requirements are met.

ALL of the following

Applicable indication requirement
- Members 21 years of age or older
  - The member is 21 years of age or older.
  - The patient is being treated for epilepsy or a seizure disorder.
    If not, deny because levetiracetam XR is reserved for FDA-approved indications; off-label use is not a covered benefit on OHP.
- The member is under 21 years of age.
The patient has no contraindications to levetiracetam therapy.
If a contraindication is present, deny as not meeting criteria and document the contraindication.
The prescribed dose is consistent with the FDA-approved prescribing information.
If not, deny as not meeting criteria; off-label use is not a covered benefit on OHP.
The patient has failed an adequate trial of immediate-release levetiracetam.
If not, deny as not meeting criteria. A trial of immediate-release levetiracetam is recommended before levetiracetam XR.

Continuation Therapy

Continuation therapy is covered when the patient remains stable on the prescribed regimen and is filling the medication consistently.

ANY of the following

The patient is stable on the prescribed regimen and is filling the medication consistently.
Approve for the requested duration of therapy, up to 1 year, as continued therapy.
The patient is not stable on the prescribed regimen or is not filling the medication consistently.
Approve for one month and coordinate with the provider regarding therapy change or adherence strategies to optimize the patient's outcome.

Off-label use of levetiracetam XR is not a covered benefit on OHP.

Requests are not covered when the patient does not meet the applicable indication requirements, has a contraindication to levetiracetam therapy, receives dosing that is not consistent with FDA-approved prescribing information, has not failed an adequate trial of immediate-release levetiracetam, or otherwise fails related policy requirements.

Dosing Parameters

Initial dose

Initial treatment dose1000 mg

Administration frequencyOnce daily

Initial regimenInitial treatment with a dose of 1000 mg once daily

Dose escalation

Dose increase1000 mg

Increase intervalEvery 2 weeks

Escalation instructionIncrease by 1000 mg every 2 weeks

Authorization and Documentation Requirements

Prior Authorization

Initial Prior Authorization Requirements

Submit an initial prior authorization request only when the member is 21 years of age or older and is being treated for epilepsy or a seizure disorder. Confirm no contraindication, that the prescribed dose is consistent with FDA-approved prescribing information, and that an adequate immediate-release levetiracetam trial has failed.

Covered indication: epilepsy or seizure disorder; off-label use is not covered.
The member must have no contraindication to levetiracetam therapy.
Requested dosing must be consistent with FDA-approved prescribing information.
An adequate immediate-release levetiracetam trial must have failed before XR approval.

Prior Authorization

Renewal Prior Authorization Requirements

For renewal, document that the patient is stable on the prescribed regimen and filling the medication consistently. Stable, adherent patients may be approved for the requested duration up to 1 year; otherwise, approval is limited to 1 month while therapy changes or adherence strategies are coordinated.

Medication Background

Levetiracetam XR is an antiepileptic medication used as adjunctive therapy for partial-onset seizures in patients 12 years of age and older with epilepsy.

Key Definitions

FDA-approved indication

Therapy roleAdjunctive therapy

Seizure typePartial-onset seizure

Eligible patientsPatients 12 years of age and older with epilepsy

Continued therapy

Clinical statusStable on the prescribed regimen

Medication useFilling medication consistently

Renewal durationRequested duration of therapy up to 1 year

Initial Therapy

Levetiracetam XR Renewal

Required Prerequisite Therapy

Step	Medication	Requirement
1	Immediate-release levetiracetam	Patient must fail an adequate trial before levetiracetam XR is approved.

Dose Limit

Levetiracetam XR

DrugLevetiracetam XR

Maximum recommended dose3000 mg

Administration frequencyOnce daily

Policy Summary

PayerAdvanced Health

PolicyLevetiracetam XR Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document failure of an adequate trial of immediate-release levetiracetam before requesting levetiracetam XR.

SourceLink

On This Page

Maximum recommended dose

Maximum recommended dose3000 mg

Administration frequencyOnce daily

Daily dose limit3000 mg once daily

Stable and consistently filling: approve continued therapy for up to 1 year.
Not stable or not consistently filling: approve for 1 month and coordinate with the provider regarding therapy change or adherence strategies.

Step Therapy

Immediate-Release Levetiracetam Prerequisite

Before requesting levetiracetam XR, document an adequate trial of immediate-release levetiracetam and failure of that trial. XR requests without a completed and failed prerequisite trial do not meet criteria.

The prerequisite trial is required before levetiracetam XR approval.
The trial should be adequate and the patient must have failed immediate-release levetiracetam.

Documentation Required

Initial Request Documentation

Include complete clinical documentation with the initial request so the criteria can be evaluated. The submission must identify the patient and diagnosis, address contraindication status, specify the requested dose, and describe the immediate-release levetiracetam trial and failure.

Patient/member identifying information.
Diagnosis and confirmation of epilepsy or a seizure disorder.
Contraindication assessment, including any relevant contraindication details.
Requested levetiracetam XR dose and confirmation it is FDA-approved.
Immediate-release levetiracetam trial details, including adequacy and treatment failure.

Documentation Required

Renewal Documentation

For renewal requests, document clinical stability on the prescribed regimen and consistent medication fills. If the patient is not stable or is not adherent, provide the relevant clinical and adherence documentation and describe the planned therapy change or adherence intervention.

Current regimen and evidence of clinical stability.
Pharmacy fill history or other evidence of consistent fills.
For non-stable or non-adherent patients: explanation of the issue and documentation of the therapy-change or adherence strategy plan.

Denial Risk

Non-Covered Indication

Requests for levetiracetam XR outside the covered indication of epilepsy or a seizure disorder will be denied. Off-label use is not a covered benefit under OHP.

Covered indication: epilepsy or seizure disorder.
Non-covered indication: requests unrelated to epilepsy or a seizure disorder.

Denial Risk

Contraindication

Deny requests when the patient has a contraindication to levetiracetam therapy. Known hypersensitivity to levetiracetam is a contraindication and must be identified in the request when present.

Known hypersensitivity to levetiracetam.
Document the specific contraindication when applicable.

Denial Risk

FDA-Approved Dose Required

Deny requests when the prescribed dose is inconsistent with FDA-approved prescribing information. The FDA-approved XR dosing described in the criteria starts at 1,000 mg once daily, increases by 1,000 mg every 2 weeks, and has a maximum recommended dose of 3,000 mg once daily.

Initial treatment: 1,000 mg once daily.
Titration: increase by 1,000 mg every 2 weeks.
Maximum recommended dose: 3,000 mg once daily.

Denial Risk

Immediate-Release Trial Required

Deny the request when an adequate prerequisite trial of immediate-release levetiracetam has not been completed and failed. Immediate-release levetiracetam is the least costly alternative that must be tried before levetiracetam XR.

The trial must be adequate and completed before the XR request.
Failure of immediate-release levetiracetam must be documented.
If the prerequisite trial has not failed, the request does not meet criteria.