UnitedHealthcare Prior Auth Brand Anticonvulsants

Coverage Criteria for Single-Source Brand Anticonvulsants

inv-01: Aptiom / Xcopri / Ztalmy initial therapy

Aptiom, Xcopri, or Ztalmy will be approved when ONE of the following criteria sets is met:

Option 1 for initiation: Diagnosis requirement: For Aptiom or Xcopri — diagnosis of partial-onset seizures; for Ztalmy — diagnosis of seizures associated with CDKL5 deficiency disorder confirmed by genetic testing AND History of >=8 week trials of at least two of the listed generic anticonvulsants (any release formulation qualifies): carbamazepine; gabapentin; lamotrigine; divalproex; levetiracetam; phenytoin; oxcarbazepine; pregabalin; topiramate; valproic acid; zonisamide>=8 weeks

Includes documentation of persisting seizures after titration to highest tolerated dose and ruling out noncompliance

Option 2 for initiation (intolerable side effects): Both of the following: documentation of failure due to intolerable side effects, and reasonable efforts were made to minimize the side effect (e.g., change timing of dosing, divide dose into smaller/more frequent doses)

inv-02: Briviact initial and continuation

Briviact will be approved when ALL of the following are met:

Briviact initiation: Diagnosis of partial-onset seizures AND History of >=8 week trial of at least one of the listed generic anticonvulsants (any release formulation qualifies): carbamazepine; divalproex; gabapentin; lamotrigine; levetiracetam; oxcarbazepine; phenytoin; pregabalin; topiramate; valproic acid; zonisamide AND One of the following: either documented persisting seizures after titration to the highest tolerated dose with each medication trial with noncompliance ruled out, OR documentation of failure due to intolerable side effects with reasonable mitigation attempts documented>=8 weeks

Continuation of prior therapy authorized for 12 months

inv-03: Epidiolex initial and continuation

Epidiolex initial criteria differ by indication:

Epidiolex for Dravet or TSC: Diagnosis of seizures associated with Dravet syndrome or tuberous sclerosis complex — approval may be granted without prior trials

Epidiolex for Lennox-Gastaut syndrome: Diagnosis of Lennox-Gastaut syndrome AND History of >=8 week trials of at least two generic anticonvulsants (e.g., divalproex, lamotrigine, topiramate, valproic acid) (any release formulation qualifies) AND One of the following: documented persisting seizures after titration to highest tolerated dose with each medication trial with noncompliance ruled out, OR documentation of failure due to intolerable side effects with reasonable mitigation attempts documented>=8 weeks

Continuation authorizations issued for 12 months

inv-04: Fintepla initial and continuation

Fintepla initial criteria:

Fintepla for Dravet: Diagnosis of seizures associated with Dravet syndrome AND History of >=8 week trials of specified anticonvulsants (any release formulation qualifies): divalproex; levetiracetam; topiramate; valproic acid; zonisamide AND One of the following: documented persisting seizures after titration to highest tolerated dose with each medication trial with noncompliance ruled out, OR documentation of failure due to intolerable side effects with reasonable mitigation attempts documented>=8 weeks

Continuation authorizations issued for 12 months

Fintepla for LGS: Diagnosis of Lennox-Gastaut syndrome AND History of >=8 week trials of at least two of the following (any release formulation qualifies): divalproex; topiramate; lamotrigine; valproic acid AND One of the following: documented persisting seizures after titration to highest tolerated dose with each medication trial with noncompliance ruled out, OR documentation of failure due to intolerable side effects with reasonable mitigation attempts documented>=8 weeks

Continuation authorizations issued for 12 months

inv-05: Continuation therapy

Continuation of prior therapy:

General continuation: Documentation of prior authorized therapy for a seizure disorder supports continuation; authorizations are typically issued for 12 months

Applies across the listed agents when continuation criteria are met

State-specific mandates and regulatory requirements can modify the otherwise stated prior trial durations. Where noted in this policy, for members in Connecticut, Kentucky, and Mississippi the prior trial requirement is reduced to a 30‑day trial rather than the usual ≥8‑week trial. Federal regulatory requirements and member-specific benefit plan language may also affect coverage determinations.

Coverage is limited when required documentation of prior trials or treatment optimization is not provided. Use of a listed single‑source brand anticonvulsant without documentation of the required prior anticonvulsant trials (typically each trial of ≥8 weeks), or without documentation that each comparator was titrated to the highest tolerated dose and noncompliance was ruled out, is not supported by these criteria.

Approval may alternatively be supported by documented intolerable side effects to the required comparator agents provided there is documentation that reasonable efforts were made to mitigate the adverse effect(s). Continuation of previously authorized therapy requires documentation of ongoing need and, when applicable, will be authorized for 12 months.

Initial Therapy Criteria

inv-15: Initial therapy

Initial authorization is contingent on diagnosis-specific criteria plus prior trials of specified generic anticonvulsants.

General initial requirements: Appropriate diagnosis per agent AND documented prior trials of specified generic anticonvulsants (number of trials varies by agent) of generally >=8 weeks OR documented intolerable side effects with reasonable mitigation attempts; certain indications (Epidiolex for Dravet and TSC) do not require prior trials>=8 weeks

Exact drugs and counts listed in each agent-specific section

Prior trial failure documentation: For required trials, documentation must show persisting seizures after titration to the highest tolerated dose for each trial and that lack of compliance has been ruled out; alternatively document failure due to intolerable side effects and efforts to mitigate them

Continuation Therapy Criteria

inv-16: Continuation

Continuation requests for previously authorized therapy:

Continuation documentation and duration: Request for renewal must document continued medical need for the seizure disorder; prior authorized therapy may be renewed and authorizations will generally be issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy for the single‑source brand anticonvulsants covered by this program. Continuation authorizations are generally issued for 12 months when criteria are met.

Effective date: 2025-07-01
Continuation authorizations: generally 12 months

Step Therapy

Step Therapy / Required Prior Drug Trials

Trials of specified alternative generic anticonvulsant agents are required before coverage of brand agents in this policy. The required number of prior drug trials is agent-specific (see criteria). Step therapy must be documented prior to approval.

Briviact (brivaracetam): trial of ≥1 generic antiepileptic (>= 8 weeks)
Aptiom (eslicarbazepine), Fintepla (fenfluramine), Xcopri (cenobamate), Ztalmy (ganaxolone), and Epidiolex (for Lennox‑Gastaut syndrome): trial of ≥2 generic anticonvulsants (each ≥ 8 weeks)

Step Therapy Requirements

Agent / Indication	Required prior trials (number & examples)	Minimum duration per trial	Failure definition
Briviact (brivaracetam) — partial‑onset seizures	Trial of at least one listed generic anticonvulsant (examples include carbamazepine, levetiracetam, lamotrigine, divalproex, topiramate, valproic acid, zonisamide)	>= 8 weeks	Documented persisting seizures after titration to highest tolerated dose with the comparator and noncompliance ruled out, or documented intolerable side effects despite mitigation
Aptiom (eslicarbazepine) — partial‑onset seizures	Trial of at least two listed generic anticonvulsants (examples: carbamazepine, gabapentin, lamotrigine, divalproex, levetiracetam, phenytoin, oxcarbazepine, pregabalin, topiramate, valproic acid, zonisamide)	>= 8 weeks per trial	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation
Xcopri (cenobamate) — partial‑onset seizures	Trial of at least two listed generic anticonvulsants (examples as listed for Aptiom)	>= 8 weeks per trial	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation
Ztalmy (ganaxolone) — CDKL5 deficiency‑related seizures (requires genetic confirmation)	Trial of at least two listed generic anticonvulsants (examples as listed for Aptiom) or documentation of intolerable side effects	>= 8 weeks per trial (state exceptions may apply)	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation
Epidiolex (cannabidiol) — Lennox‑Gastaut syndrome	Trial of at least two generic anticonvulsants (examples: divalproex, lamotrigine, topiramate, valproic acid)	>= 8 weeks per trial	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation
Epidiolex — Dravet syndrome or tuberous sclerosis complex	Prior trials not required for these indications	N/A	N/A (approval may be granted without prior trials for Dravet or TSC)
Fintepla (fenfluramine) — Dravet syndrome	Trials of specified anticonvulsants (examples: divalproex, levetiracetam, topiramate, valproic acid, zonisamide)	>= 8 weeks per trial	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation
Fintepla — Lennox‑Gastaut syndrome	Trial of at least two of divalproex, topiramate, lamotrigine, valproic acid	>= 8 weeks per trial	Documented persisting seizures after titration to highest tolerated dose with each medication trial and noncompliance ruled out, or documented intolerable side effects despite mitigation

Coding and Prior Trial Duration

inv-08: Prior trial duration — minimum documented trial duration required (>= 8 weeks)

Minimum prior trial duration>= 8 weeks per listed anticonvulsant trial

Required documentation for each trialDrug name, formulation, dose, duration (>=8 weeks) and evidence of titration to highest tolerated dose

Failure criteria to satisfy trialPersisting seizures after titration to highest tolerated dose or documented intolerable side effects despite mitigation

Noncompliance exclusionProvider must document that lack of compliance has been ruled out as a reason for treatment failure

State exceptionsState mandates (e.g., CT, KY, MS) may allow a 30-day trial in place of the >=8 week requirement where noted in policy

Background

This policy applies to select single‑source brand anticonvulsants (Aptiom, Briviact, Epidiolex, Fintepla, Xcopri, Ztalmy) used for focal (partial‑onset) seizures and specific genetic or syndrome‑associated seizure disorders (for example, Dravet syndrome, Lennox‑Gastaut syndrome, tuberous sclerosis complex, and CDKL5 deficiency where genetic confirmation is required for Ztalmy).

Initial authorization generally requires an appropriate diagnosis for the agent and documentation of prior trials of the specified generic anticonvulsants (the number of required trials varies by agent and indication). Each required trial is typically for ≥8 weeks, unless a state exception applies, and must include documentation of persisting seizures after titration to the highest tolerated dose or documented intolerable side effects despite mitigation efforts. Continuation requests for previously authorized therapy are documented and typically authorized for 12 months.

Definitions

inv-14: Drug-resistant epilepsy — reference to ILAE consensus definition used as background rationale for prior trials/failure

Definition referencedDrug-resistant epilepsy is referenced to the ILAE consensus definition (Kwan et al., consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies)

Purpose of referenceProvides background rationale for requiring prior anticonvulsant trials and defining failure by lack of efficacy

Supporting references listedPolicy references include Kwan P et al. and other epilepsy treatment guidelines cited in the references section

OpenPayer

Prior Authorization — Single‑Source Brand Anticonvulsants (Aptiom, Briviact, Epidiolex, Fintepla, Xcopri, Ztalmy)

Coverage Criteria for Single-Source Brand Anticonvulsants

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions and Documentation Requirements

Step Therapy Requirements

Coding and Prior Trial Duration

Background

Definitions