CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1078-26

Prior Authorization/Notification - Anticonvulsants

Prior authorization/notification criteria for multiple anticonvulsant medications (listed) covering initial authorization and reauthorization criteria, indications, continuation rules, and program-level notes for UnitedHealthcare Pharmacy Clinical Pharmacy Programs effective 2025-09-01.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization/Notification - Anticonvulsants

Policy CodePolicy 2025 P 1078-26

Change TypeMultiple drug additions and administrative updates

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization/notification required for listed anticonvulsant medications; authorizations are issued for 12 months when criteria met.

POLICY UPDATE CHANGES

Added Vigadrone to criteria and added up to 2 years of age for infantile spasms.

Added Vigafyde and Vigpoder to criteria; noted brand Sabril typically excluded from coverage.

Added Libervant to criteria.

Removed note that Sympazan is typically excluded from coverage.

Added Ztalmy to criteria.

19Medications Listed

12Auth duration (months)

>=3Prior anticonvulsant failures required

<=2

Coverage Summary

This policy (2025 P 1078-26) is CURRENT and effective 2025-09-01 with last program updates through 2025-06. It establishes prior authorization/notification criteria for multiple anticonvulsant medications (19 listed products) covering initial authorization and reauthorization, indications, continuation rules, and program-level notes for UnitedHealthcare Pharmacy Clinical Pharmacy Programs. The coverage stance is covered_with_criteria; authorizations are generally issued for 12 months when criteria are met. Providers must obtain prior authorization/notification for the listed anticonvulsants and document the specific diagnosis and, for reauthorization, positive clinical response to therapy.

Initial Therapy Criteria (by medication)

Initial Authorization - Aptiom, Briviact, Xcopri

Approved based on ONE of the following:

ANY of the following

ALL of the following
- Diagnosis of partial-onset seizures
- For continuation of prior therapy for a seizure disorder

Initial Authorization - Banzel

Approved based on ONE of the following:

ANY of the following

ALL of the following
- Diagnosis of seizures associated with Lennox-Gastaut syndrome (LGS)
- Used as adjunctive therapy (defined as accessory treatment used in combination to enhance primary treatment.)
- Not used as primary treatment
For continuation of prior therapy for a seizure disorder

Initial Authorization - Onfi or Sympazan

Approved based on ONE of the following:

Initial Authorization - Sabril, Vigadrone, Vigafyde, Vigpoder

Approved based on ONE of the following:

ANY of the following

ALL of the following
- Diagnosis of partial-onset seizures
- Used as adjunctive therapy (defined as accessory treatment used in combination to enhance primary treatment.)
- Not used as primary treatment
- Patient has had inadequate response to several (at least three) alternative anticonvulsants>=3
  Prior anticonvulsant failures required for vigabatrin adjunctive use

Initial Authorization - Diacomit

Approved based on ONE of the following:

ANY of the following

Diagnosis of Dravet syndrome and currently taking clobazam
For continuation of prior therapy for a seizure disorder

Initial Authorization - Epidiolex

Approved based on ONE of the following:

ANY of the following

Diagnosis of Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex
For continuation of prior therapy for a seizure disorder

Initial Authorization - Libervant, Nayzilam, Valtoco

Approved based on the following criterion:

ALL of the following

Diagnosis of seizure clusters or acute repetitive seizures that are distinct from the patient's usual seizure pattern

Initial Authorization - Fintepla

Approved based on ONE of the following:

ANY of the following

Diagnosis of Lennox-Gastaut syndrome or Dravet syndrome
For continuation of prior therapy for a seizure disorder

Initial Authorization - Ztalmy

Approved based on ONE of the following:

ANY of the following

Diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
For continuation of prior therapy for a seizure disorder

Continuation / Reauthorization Criteria

Reauthorization

Approved based on the following criterion:

Documentation of positive clinical response to therapy

Applicable Medications (policy list)

Medications covered by policy (drugs listed)mixedCovered

Aptiom	eslicarbazepine acetate
Briviact	brivaracetam
Xcopri	cenobamate
Banzel	rufinamide
Fycompa	perampanel
Onfi	clobazam
Sympazan	clobazam (oral film)
Sabril	vigabatrin (brand typically excluded)
Vigadrone	vigabatrin
Vigafyde	vigabatrin

1–10 of 18

1/2

Medications covered by policy (drugs listed)mixedCovered

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for the anticonvulsant medications listed in this policy. When the applicable criteria are met, authorizations are issued for 12 months.

Documentation Required

Documentation of diagnosis and therapy response

Providers must document the patient’s specific diagnosis (examples include Lennox‑Gastaut syndrome, Dravet syndrome, cyclin‑dependent kinase‑like 5 [CDKL5] deficiency disorder, tuberous sclerosis complex, partial‑onset seizures, and seizure clusters). For reauthorization, providers must supply documentation of a positive clinical response to therapy.

Background & Definitions

Background: The policy lists FDA-indicated uses across the listed anticonvulsants, including treatment of partial-onset seizures (Aptiom, Briviact, Xcopri), adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) (Banzel, Onfi, Sympazan), treatment for Dravet syndrome (Diacomit, Epidiolex, Fintepla, Onfi/Sympazan), seizures associated with tuberous sclerosis complex (Epidiolex), management of seizure clusters/acute repetitive seizures (Libervant, Nayzilam, Valtoco), treatment for CDKL5 deficiency disorder (Ztalmy), and infantile spasms (vigabatrin products) when benefits outweigh risks. The policy defines adjunctive therapy as treatment administered in addition to another therapy, and notes program-level administrative considerations including that brand Sabril is typically excluded from coverage and that automated approvals based on claims/medication history and diagnosis codes may be used.

Adjunctive therapy: Treatment administered in addition to another therapy; accessory treatment used in combination to enhance primary treatment.

Clinical Evidence

No formal evidence entries are provided in this brief. There are no trial/evidence metric cards included; the policy is based on labeled indications, package-insert indications, and the program-level prior authorization and reauthorization criteria described herein.

Revision History

2022-10added

Added Ztalmy to criteria.

2023-12revised

Removed note that Sympazan is typically excluded from coverage.

2024-09added

Added Libervant to criteria.