CurrentCentenePolicy CP.PMN.216

Clinical Policy: Diazepam (Libervant, Valtoco)

Covers medical necessity and prior authorization criteria for Libervant and Valtoco for acute treatment of seizure clusters in patients with epilepsy; applies to Centene-affiliated health plans and affects prescribers and prior authorization reviewers.

Policy Summary

PayerCentene

PolicyClinical Policy: Diazepam (Libervant, Valtoco)

Policy CodePolicy CP.PMN.216

Change TypeNo material changes

Effective Date12.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of epilepsy with seizure clusters, neurologist involvement, age eligibility, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Approval duration (months)

Libervant 2–5; Valtoco ≥2FDA age indications

2 doses/episodeDose limits

≤1/5 days; ≤5/moEpisode frequency

Libervant, ValtocoProducts

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Initial Therapy

Covered when ALL of the following are met

Epilepsy with Seizure Cluster Episodes - Initial: 1. Diagnosis of partial or generalized epilepsy; 2. Prescribed by or in consultation with a neurologist; 3. Age: (a) Libervant: >= 2 years and <= 5 years; OR (b) Valtoco: >= 2 years; 4. Member is experiencing stereotypic episodes of frequent seizure activity (seizure clusters/acute repetitive seizures); 5. One of the following: (a) request is for a member in a State with limitations on step therapy (see Appendix E) OR (b) member is currently on a stable regimen of antiepileptic drugs (AEDs) (e.g., lamotrigine, gabapentin, topiramate, oxcarbazepine) (Note: for Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 6. Dose does not exceed 2 doses per single episode and use does not exceed 1 episode every 5 days or 5 episodes per month; Approval duration: 12 monthsdose limits: 2 doses/episode; <=1 episode/5 days; <=5 episodes/month

Step therapy exception referenced for Illinois HIM as of 1/1/2026

Continuation Therapy

Covered when ALL of the following are met

Epilepsy with Seizure Cluster Episodes - Continuation: 1. Member is currently receiving medication via Centene benefit, or documentation supports at least 30 days of prior therapy with Libervant or Valtoco for a covered indication; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the new dose does not exceed 2 doses per single episode and does not exceed 1 episode every 5 days or 5 episodes per month; Approval duration: 12 monthsdose limits: 2 doses/episode; <=1 episode/5 days; <=5 episodes/month

Requires evidence of prior use >=30 days and positive response

Other/Off-label pathway

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary/non‑formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/PDL or CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary); OR 2. If the requested use (diagnosis, age, dosing) is not specifically listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Refer to specific policy numbers depending on line of business

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety per the applicable off‑label use policies. Refer to the off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) or other evidence of coverage documents when evaluating such requests.

Within the provided document fragments there are no explicit coverage exclusions listed beyond the general statement regarding non‑FDA indications; dosing table fragments are present but do not specify additional exclusionary conditions.

Requests for non‑FDA approved (off‑label) indications will not be authorized unless the request includes sufficient clinical documentation demonstrating efficacy and safety and follows the referenced off‑label policy pathway appropriate to the line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

No explicit statements labeling any use as 'not medically necessary' appear in the provided fragments; the excerpts include dosing and administration fragments but do not contain formal not‑medically‑necessary determinations.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Libervant and Valtoco. Requests must demonstrate that the member meets the applicable initial or continuation approval criteria in this policy (including diagnosis, prescriber specialty, age limits, seizure cluster characteristics, prior AED stability or applicable state step therapy exceptions, and dosing limits). Approval duration for both initial and continuation requests is 12 months when criteria are met.

Approval duration: 12 months
Initial criteria include diagnosis of epilepsy, neurologist involvement, age limits (Libervant: ≥2 and ≤5 years; Valtoco: ≥2 years), seizure cluster definition, step therapy / state exception conditions, and dosing limits (≤2 doses per episode; not to exceed 1 episode every 5 days or 5 episodes per month).
Continuation criteria include documentation of current therapy for ≥30 days and positive response to therapy; dose increases must not exceed dosing limits.

Prior Authorization

Prior Authorization — When Not Stated

If prior authorization is not explicitly stated elsewhere in external materials, providers should still submit a prior authorization request per Centene process when seeking coverage for Libervant or Valtoco because coverage decisions are governed by the clinical policy and benefit terms.

When not otherwise specified, submit clinical documentation to support medical necessity per this policy and the plan's PA process.

Billing Rule

Prior Authorization — Codes Not Specified Here

This policy excerpt does not list billing or procedure codes for prior authorization. Providers must follow the payer's standard PA submission process and include clinical documentation indicated in this policy (chart notes, labs, documentation of seizure clusters, prior AED regimen or applicable state exception evidence).

No CPT/HCPCS/NDC codes are specified in this section; include relevant medication identifiers and clinical notes in the PA submission.

Note

No Explicit Automatic Authorization/Denial Triggers

There are no explicit operational triggers (e.g., automatic approval or automatic denial conditions) provided in this excerpt beyond meeting the listed initial/continuation criteria and documentation requirements. Authorization decisions are made based on whether the member meets the policy criteria and benefit terms.

Submit full clinical documentation; absence of required documentation or unmet criteria may result in denial.

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation (office notes, lab results, evidence of current AED regimen, documentation of seizure cluster frequency/timing, and any state-specific step therapy exception evidence) to demonstrate that the member meets the policy criteria.

Failure to submit sufficient documentation or requests for non‑FDA indications without appropriate off‑label justification per Centene off‑label policies may result in denial.
Examples of acceptable documentation: chart notes describing stereotypic seizure clusters, neurologist consultation notes, medication history showing stability on AEDs, and records validating state step therapy exceptions (Appendix E).

Documentation Required

Documentation and Coverage Governance

Coverage decisions under this clinical policy are governed by the policy criteria and are also subject to the member's benefit terms, exclusions, limitations, and applicable state and federal requirements.

Providers should verify member benefits and any state-specific rules (see Appendix E for states with step therapy/redirection limitations).
This policy does not guarantee payment; final determination depends on benefit documents (EOC, certificate of coverage).

Step Therapy

Step Therapy / State Exceptions

Step therapy applies unless a state limitation or exception applies. The policy includes a step therapy bypass/redirection exception for members in states with limitations on step therapy in certain settings (see Appendix E) and a specific bypass for Illinois HIM per IL HB 5395.

Appendix E lists states with limitations and notes any applicable Medicaid-only stipulations.
For requests claiming a step therapy exception, include documentation supporting the exception (e.g., current stable AED regimen or state-specific evidence).

Step Therapy

Step Therapy — Notes

Notes on step therapy: the policy allows a redirection bypass for members in states with limitations on step therapy in certain settings and specifically documents that Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 (effective 1/1/2026).

When a state exception applies, the member may qualify under the 'State with limitations' pathway in the initial approval criteria.
Providers must include evidence supporting the state-based exception when submitting the PA.

Definitions

Diazepam (Libervant, Valtoco)

Drug classDiazepam (Libervant, Valtoco) is a benzodiazepine.

Indication (policy scope)Used for acute treatment of seizure clusters (acute‑repetitive seizures, seizure flurries) in patients with epilepsy.

Formulations noted in policyLibervant (buccal film) and Valtoco (nasal spray) referenced in coverage criteria and dosing tables.

Seizure clusters

Study definitions examplesExamples include 2–4 seizures in <48 hours; 3 seizures in 24 hours; or 2 generalized tonic‑clonic or 3 complex partial seizures in 4 hours.

Alternate terminologyAlso called acute‑repetitive seizures, serial seizures, crescendo seizures, seizure flurries; may progress to prolonged seizures or status epilepticus.

Weight-based dosing and device‑administered spray

Weight-based dosing noteSome dosing regimens are specified as 'Dosing Regimen = Weight (kg)', indicating weight‑based calculations for certain age groups.

Device-administered spray referencesDosing tables reference 'device' and 'spray' administration (nasal spray/nostril) with single‑spray maximums noted in the tables.

Example device dosing strataDevice dosing rows show strata such as 12-22, 19-37, 28-50 with 'One 10' (10 mg) or '1 spray' entries corresponding to those weight/age bands.

OpenPayer

Clinical Policy: Diazepam (Libervant, Valtoco)

Coverage Criteria

Coding and Numeric Ranges

Provider Actions and Prior Authorization

Background

Definitions