CurrentCignaPolicy IP0105

Antiseizure Medications - Valtoco (diazepam nasal spray)

This policy governs prior authorization and medical necessity criteria for coverage of Valtoco (diazepam nasal spray) for treatment of seizure clusters in Cigna-administered health benefit plans. It affects prescribers, pharmacists, and utilization review staff handling Valtoco requests.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Valtoco (diazepam nasal spray)

Policy CodePolicy IP0105

Change TypeMaterial clinical/operational updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization documentation showing patient is on maintenance antiseizure medication and meets plan-specific preferred product criteria.

SourceLink

POLICY UPDATE CHANGES

Removed age-related requirement criterion.

Removed criterion pertaining to use for acute treatment of seizure activity.

Added preferred product requirement criteria for Valtoco for Individual and Family Plans.

1 yearapproval duration when criteria met

≥6 yrsFDA-indicated minimum age

≤2max doses per episode

≤5recommended max episodes/month

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Coverage Criteria for Valtoco (diazepam nasal spray)

FDA-Approved Indication

Valtoco is considered medically necessary when ALL of the following are met:

FDA indication: Indication: Intermittent Episodes of Frequent Seizure Activity (seizure clusters, acute repetitive seizures).

based on FDA approval

Maintenance antiseizure therapy: Patient is currently receiving maintenance antiseizure medication(s).

criterion A

Specialist involvement: Medication is prescribed by or in consultation with a neurologist.

criterion B

Individual and Family Plans Preferred Product Criteria

For Individual and Family Plans, the preferred-product criterion is satisfied when ONE of the following is met:

Individual and Family Plans options: Patient has tried Nayzilam; OR Patient is < 12 years of age; OR Patient has previously received Valtoco or is currently receiving Valtoco.

one of these satisfies preferred product requirement

Receipt of sample product does not satisfy any criteria requirements for coverage. Providers should ensure that documentation and an approved prior authorization are in place before submitting claims for Valtoco, as free or promotional samples are not acceptable substitutes for an approved prescription or prior authorization determination.

Valtoco (diazepam nasal spray) for any use not described in this policy is considered not medically necessary. Coverage is limited to the indications and criteria specified in this policy; requests for other indications or uses will be denied as not medically necessary.

Coding and Approval Duration

Covered/related codesmixed

No codes listed

inv-06: Approval duration — 1 year

Approval duration1 year

Approval conditionApprove for 1 year if patient meets all listed criteria (currently receiving maintenance antiseizure medication(s); prescribed by or in consultation with a neurologist; preferred product criteria met)

Authorization typePrior Authorization required for prescription benefit coverage of Valtoco

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of Valtoco. Approvals are provided for 1 year when all listed criteria are met.

Prior authorization required
Approval duration: 1 year

Note

Individual & Family Plans — Operational Provider Actions

For Individual and Family Plans, coverage of Valtoco requires ONE of the following: patient has tried Nayzilam (may require prior authorization); patient is < 12 years of age; OR patient has previously received Valtoco or is currently receiving Valtoco. When coverage is available and medically necessary, dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature. Receipt of sample product does not satisfy criteria.

ONE of the listed conditions must be met for Individual & Family Plans
Samples do not satisfy coverage criteria

Key Definitions

inv-12: Seizure clusters (acute repetitive seizures) — definition and clinical context

TermSeizure clusters (acute repetitive seizures)

DefinitionIntermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern

Clinical significanceAssociated with increased risk of emergency visits, hospitalization, and status epilepticus; benzodiazepine rescue medication is primary acute therapy to abort clusters

Manufacturer dosing guidanceDo not use more than two doses to treat a single episode; recommended no more than one episode treated every 5 days and no more than five episodes per month

Background

Valtoco (diazepam nasal spray) is a benzodiazepine formulation indicated for the treatment of seizure clusters (intermittent, stereotypic episodes of frequent seizure activity). It is intended for acute rescue use in patients meeting the policy criteria; dosing, frequency, and duration should be clinically appropriate and consistent with available evidence and manufacturer guidance.