CurrentHealth NetPolicy CP PMN.216

Clinical Policy: Diazepam (Libervant; Valtoco)

Clinical coverage policy governing medical necessity criteria, approval durations, dosing limits, and continuation criteria for Libervant (buccal film) and Valtoco (nasal spray) diazepam formulations across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Diazepam (Libervant; Valtoco)

Policy CodePolicy CP PMN.216

Change TypeMaterial updates (Libervant additionValtoco age/dosing revision)

Effective DateDec 1, 2019

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added newly approved Libervant buccal film to policy.

Revised Valtoco lower age limit to 2 years and relevant dosing per updated FDA labeling.

Removed redirection to diazepam rectal per SDC request.

Multiple annual reviews noting no significant changes; references reviewed and updated across 2020-2024.

2FDA-approved agents in policy (Libervant, Valtoco)

2Minimum age (years) covered by some formulations

30Days required on therapy for continuation

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Coverage Summary

This policy covers Libervant (diazepam buccal film) and Valtoco (diazepam nasal spray) as covered with criteria for the acute treatment of seizure clusters in patients with epilepsy across Commercial, HIM, and Medicaid lines of business. The policy establishes medical necessity criteria including diagnosis requirements, specialist involvement, documentation of a currently stable antiepileptic drug (AED) regimen, and age-specific product eligibility. It also sets dosing and frequency thresholds: ≤ 2 doses per single episode and no more than 1 episode every 5 days and ≤ 5 episodes per month. Initial approvals are provided for 6 months and continuations for 12 months, with continuation requiring evidence of use for at least 30 days and clinical response. Provider documentation and prior authorization requirements are specified to support these decisions.

Key thresholds & quick facts

Dose per single episode<= 2 doses per single episode

Frequency limitNo more than 1 episode every 5 days; no more than 5 episodes per month

Minimum continuous use for continuation>= 30 days

Initial approval duration6 months

Continuation approval duration12 months

Initial Therapy Criteria

Other Diagnoses / Off-Label Pathways

Continuation Therapy Criteria

Diagnoses / Indications Not Authorized

Provider Actions (Prior Authorization & Documentation)

Prior Authorization

Specialist involvement

Initial prescriptions must be written by a neurologist or written in consultation with a neurologist. If prescribed in consultation, document the consultation in the medical record.

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation (office notes, lab results, and other relevant clinical information) that demonstrates the member meets all approval criteria.

Prior Authorization

Dose and frequency limits

Prescribe and document dosing that does not exceed 2 doses per single episode and complies with frequency limits (no more than 1 episode every 5 days and no more than 5 episodes per month). Requests that exceed these dose or frequency limits require justification and will not meet criteria.

Background & Definitions

Libervant (buccal film) and Valtoco (nasal spray) are FDA‑approved diazepam formulations indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters) in patients with epilepsy. Per product labeling Libervant is approved for pediatric patients aged 2 to 5 years and Valtoco is approved for patients aged 2 years and older following the updated labeling.

The formulations differ by route and administration: Libervant is a buccal film applied inside the cheek and allowed to dissolve, while Valtoco is a nasal spray dosed into a nostril. Seizure clusters are defined as multiple seizures occurring in a short period with increased frequency from the patient's baseline (examples in the literature include 2–4 seizures per 48 hours, 3 seizures per 24 hours, or 2 generalized tonic‑clonic/3 complex partial seizures in 4 hours) and may progress to prolonged seizures or status epilepticus. Dosing and administration vary by formulation, patient age, and weight, and product labeling provides age- and weight‑based dosing tables and recommendations for a second dose timing (generally ≥ 4 hours after the first dose).

AED: Antiepileptic drug

Seizure clusters: Multiple seizures in a short period with increased frequency from the patient’s normal pattern; timeframes vary (e.g., 2–4 seizures/48 hrs; 3 seizures/24 hrs; 2 generalized tonic‑clonic or 3 complex partial seizures in 4 hrs).

Clinical Evidence & References

Evidence and reference material for this policy include the Libervant Prescribing Information (April 2024) and the Valtoco Prescribing Information (April 2025), relevant guidelines and literature citations listed in the policy, and documented P&T review actions across multiple years (examples include P&T dates in 11.20, 11.21, 11.22, 11.23, 11.24).

Revision History

05.08.24material_added

RT4: added newly approved Libervant buccal film to policy.

10.28.24removed

Removed redirection to diazepam rectal per SDC request; noted in revision log (P&T approval recorded 12.24).

2020-2024annual_review

Multiple quarterly/annual reviews (4Q 2020 through 4Q 2024) with references reviewed and updated; most reviews noted no significant changes or template/clarifying edits.

CP PMN.216	Clinical policy reference number
CP.CPA.190	No coverage criteria policy (commercial)
HIM.PA.33	No coverage criteria policy (health insurance marketplace)
CP PMN.255	No coverage criteria policy (Medicaid)
CPCPA.09	Off-label use policy (commercial)
HIMPA.154	Off-label use policy (health insurance marketplace)
CP PMN.53	Off-label use policy (Medicaid)
HIM.PA.103	Non-formulary policy (marketplace) referenced in body
CP PMN.16	Non-formulary policy (Medicaid) referenced in body