CurrentUnitedHealthcarePolicy N/A

Single-source brand anticonvulsant prior authorization

Requirements and medical necessity criteria for prior authorization of specified single-source brand anticonvulsant medications for UnitedHealthcare members, including trial/failure rules and authorization durations; affects providers requesting coverage for these agents.

Policy Summary

PayerUnitedHealthcare

PolicySingle-source brand anticonvulsant prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document required medication trials (drug names, >=8 weeks each, titration to highest tolerated dose) and reason for failure before seeking coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5named single-source anticonvulsant drugs in this program

8+ weeksminimum trial duration required for most step therapy trials

12 monthstypical authorization duration for continuation

NCexplicitly governed state

Coverage Criteria for Single-Source Anticonvulsants

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Xcopri / Ztalmy Initial Therapy

Xcopri or Ztalmy is approved when ANY one of the following groups is met

Xcopri or Ztalmy approval options

A. Drug-specific diagnosis: One of the following: (1) For Xcopri: diagnosis of partial-onset seizures; OR (2) For Ztalmy: diagnosis of seizures associated with CDKL5 deficiency disorder confirmed with genetic testing.
B. Step therapy trials: History of greater than or equal to 8 week trial of at least two of the listed generic anticonvulsants (any release formulation qualifies).>= 8 weeks
C. Demonstration of treatment failure or intolerance: One of the following: (1) Both of the following: (a) Documented history of persisting seizures after titration to the highest tolerated dose with each medication trial; AND (b) Lack of compliance as a reason for treatment failure has been ruled out; OR (2) Both of the following: (a) Documentation of failure due to intolerable side effects; AND (b) Reasonable efforts were made to minimize the side effect (e.g., change timing of dosing, divide dose, etc.).

Briviact Initial Therapy

Briviact is approved when ALL of the following are met

Briviact initial therapy: (a) Diagnosis of partial-onset seizures; AND (b) History of greater than or equal to 8 week trial of at least one of the listed generic anticonvulsants (any release formulation qualifies); AND (c) One of the following: (1) Both of the following: (i) Documented history of persisting seizures after titration to the highest tolerated dose with each medication trial; AND (ii) Lack of compliance as a reason for treatment failure has been ruled out; OR (2) Both of the following: (i) Documentation of failure due to intolerable side effects; AND (ii) Reasonable efforts were made to minimize the side effect (e.g., change timing of dosing, divide dose, etc.).>= 8 weeks

Continuation Therapy

Continuation of prior therapy

Continuation: Authorization for continuation of prior therapy for a seizure disorder will be issued for 12 months.

State mandates, federal regulatory requirements, and the member's specific benefit plan may further impact coverage determinations for these medications. Providers should confirm applicable state law and any federal requirements when submitting prior authorization requests, and verify the member’s benefit plan for any additional limitations or exclusions that could affect coverage.

Named Drugs and Coding Details

Named single-source anticonvulsantsNDC | mixed

Briviact	brivaracetam (product name listed)
Epidiolex	cannabidiol (product name listed)
Fintepla	fenfluramine (product name listed)
Xcopri	cenobamate (product name listed)
Ztalmy	ganaxolone (product name listed)

Minimum trial duration — typical >= 8 weeks

Minimum trial durationHistory of greater than or equal to 8 week trial of listed generic anticonvulsants (any release formulation qualifies)

Applicable drugs (examples)Carbamazepine; Divalproex; Gabapentin; Lamotrigine; Levetiracetam; Oxcarbazepine; Phenytoin; Pregabalin; Topiramate; Valproic acid; Zonisamide

Titration expectationTrials must include titration to the highest tolerated dose with documentation of persisting seizures or intolerance

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required — Programs and Drugs Affected

Prior authorization is required for specified programs and drugs; ensure criteria and documentation are submitted with the PA request.

Affected agents include: Briviact, Fintepla, Xcopri, Ztalmy, Epidiolex (note: Epidiolex for Dravet syndrome or tuberous sclerosis complex does NOT require prior trial of alternative antiepileptic medications).
Authorization duration for continuation of prior seizure disorder therapy: 12 months.

Step Therapy

Step Therapy Requirements — Required Generic Trials Before Approval

Step therapy requires documented trials of specified generic antiepileptic medications of defined minimum duration before coverage of the requested branded agent will be approved.

Briviact: member must try ≥1 antiepileptic medication prior to coverage.
Fintepla, Xcopri, Ztalmy, and Epidiolex (when used for Lennox-Gastaut syndrome): member must try ≥2 antiepileptic medications prior to coverage.
Acceptable trials: any release formulation of carbamazepine, divalproex, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, pregabalin, topiramate, valproic acid, or zonisamide.
Minimum trial duration: ≥8 weeks per listed medication (unless documentation supports intolerance or other exception).

Documentation Required

Required Documentation — Diagnosis, Prior Medication Documentation, Titration and Response Details

Provide complete documentation with the prior authorization: diagnosis, medication trial details, titration and response, and ruling out nonadherence as cause of failure.

Include the specific seizure diagnosis (e.g. Dravet syndrome, Lennox-Gastaut syndrome, CDKL5 deficiency disorder, partial-onset seizures).
For each prior medication: drug name, formulation, start/stop dates, dose(s), duration (must show ≥8 weeks where required), highest tolerated dose reached, and clinical response.
If a trial failed due to intolerable side effects: provide documentation of the adverse effect and evidence of reasonable mitigation efforts (e.g. dosing adjustments, dose splitting, timing changes).
Confirm lack of noncompliance has been ruled out as the reason for treatment failure.

Denial Risk

Missing Required Medication Trials — Denial Risk if Trials ≥ 8 Weeks Not Documented

Missing or insufficiently documented required medication trials or durations (e.g. trials ≥8 weeks) may result in denial of authorization.

If a required generic trial duration (typically ≥8 weeks) is not documented for the listed agents, authorization may be denied.
Provide clear dates and dosing to demonstrate the trial length and titration; vague or missing information increases risk of denial.

Definitions

Step therapy trial — definition and minimum duration/titration expectations

DefinitionA documented trial of a listed generic antiepileptic medication of at least 8 weeks duration (any release formulation qualifies) with titration to the highest tolerated dose

Minimum number of trials (typical)One generic trial required for Briviact; two generic trials required for Xcopri, Ztalmy, Fintepla, and for Epidiolex when used for Lennox-Gastaut syndrome

Documentation requiredRecord medication name, duration (>= 8 weeks), titration to highest tolerated dose, reason for failure (persistent seizures after titration) or intolerable side effects and mitigation efforts

Formulation noteAny release formulation of the listed generic anticonvulsant qualifies

CDKL5 deficiency disorder — definition and relation to Ztalmy

DefinitionCDKL5 deficiency disorder is a genetic disorder confirmed with genetic testing

Relation to ZtalmyZtalmy is indicated for seizures associated with CDKL5 deficiency disorder when diagnosis is confirmed by genetic testing

Coverage pathwayApproval requires confirmation of CDKL5 diagnosis plus meeting other policy criteria (e.g., required generic trials when applicable)

Revision History

2014-02program_created

Program established as a prior authorization medical necessity program for single‑source brand anticonvulsants.

2014-11program_update

Added Aptiom to the program.

2015-11state_regulation_update

Clarified trial period for Connecticut and Kentucky to comply with state regulations.

2016-06annual_review_and_criteria_change

Annual review: modified criteria to separate failure due to lack of efficacy and adverse events; changed authorization period and updated references.

2016-11coverage_update

Updated to include diagnosis criteria and added Briviact; added state‑specific requirements for Maryland, Indiana, and West Virginia.

2017-06administrative_change

Administrative change: added California coverage information.

2018-09annual_review

Annual review with updated references and state mandate language.

2018-11formulary_addition

Added Epidiolex to the program.

2019-11annual_review

Annual review and references updated.

2020-07formulary_addition

Added Xcopri to the program.

2020-10formulary_addition_and_criteria_update

Added Fintepla and updated Epidiolex criteria to include seizures associated with tuberous sclerosis complex.

2021-10criteria_update

Updated criteria to include seizures associated with tuberous sclerosis complex for Epidiolex and other referenced updates.

2022-01criteria_change

Changed Briviact to require a trial of one generic anticonvulsant prior to coverage.

2022-10program_update

Updated Fintepla to include Lennox‑Gastaut syndrome criteria; moved agents between program categories and updated references and state mandate language.

2022-11formulary_addition

Added Ztalmy to the program.

2023-10criteria_revision

Removed specific medications for Epidiolex step requirement and performed annual review updates.

2024-10annual_review

Annual review with updates to state mandate footnotes and references.

2025-04annual_review_and_program_alignment

Annual review: moved Fycompa to Multi‑Source Brand criteria due to generic launch and aligned trial/failure language for consistency.

2025-08program_update

Moved Aptiom to Multi‑Source Brand criteria due to a generic launch.

2025-11-01effective_dateLatest

Policy effective date (current version) set to 2025-11-01.

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