CurrentCignaPolicy IP0338

Antiseizure Medications - Nayzilam

Cigna coverage policy governing prior authorization and medical necessity criteria for Nayzilam (midazolam nasal spray) for treatment of seizure clusters in patients age 12 and older under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyAntiseizure Medications - Nayzilam

Policy CodePolicy IP0338

Change TypeAnnual revision with material deletions

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization; approvals are provided for 1 year when Nayzilam is prescribed by or in consultation with a neurologist and the patient is on maintenance antiseizure medication(s).

SourceLink

POLICY UPDATE CHANGES

Policy title updated from 'Midazolam Nasal Spray' to 'Antiseizure Medications - Nayzilam' and wording changed from 'antiepileptic medications' to 'antiseizure medications'.

Removed age requirement from the criteria.

Removed requirement for documentation of use for the acute treatment of seizure activity from the criteria.

Removed reauthorization criteria from the criteria.

1 yearapproval duration when criteria met

≥12FDA-indicated age

Prior Authadministrative requirement

No changes 12/15/2024

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Coverage Criteria for Nayzilam (midazolam nasal spray)

Initial Approval (FDA-Approved Indication)

Approve when ALL of the following are met

FDA-Approved Indication: Initial Approval: Patient has intermittent episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) AND patient is currently receiving maintenance antiseizure medication(s) AND medication is prescribed by or in consultation with a neurologistApprove for 1 year

Matches FDA indication; specialist prescriber requirement present in policy

Nayzilam (midazolam nasal spray) for any use not specified in this policy is not medically necessary. Coverage is limited to indications and clinical scenarios defined under the policy criteria; requests for other uses will be denied.

Use of Nayzilam for indications other than intermittent episodes of frequent seizure activity (seizure clusters) is considered not medically necessary. This policy will be updated if new published evidence emerges. Note that receipt of sample product does not satisfy coverage criteria or documentation requirements.

Coding and Approval Duration

Coding guidance / claim submissionmixed

affected codes

Policy instructs to use most appropriate codes as of effective date; specific covered codes not listed in document.

Approval duration / FDA age

Approval durationApprove for 1 year when criteria are met.

FDA-indicated minimum agePatients ≥ 12 years of age (per product overview).

Approval condition — maintenance therapyPatient must be currently receiving maintenance antiseizure medication(s).

Approval condition — specialist involvementMedication must be prescribed by or in consultation with a neurologist.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization required; approvals issued for 1 year

Prior Authorization is required for benefit coverage of Nayzilam. All approvals are provided for the duration noted in the policy (approve for 1 year when criteria are met).

Approvals are provided for 1 year when the patient meets the coverage criteria.

Step Therapy

Specialist prescriber and concomitant maintenance antiseizure therapy required

Approval requires that Nayzilam be prescribed by or in consultation with a physician who specializes in the condition being treated, and the patient must be currently receiving maintenance antiseizure medication(s).

Prescriber must be a specialist or consult with a specialist (neurologist).
Patient must be on maintenance antiseizure medication(s) at time of approval.

Background on Nayzilam

Nayzilam is midazolam nasal spray, a benzodiazepine formulation indicated for the acute treatment of seizure clusters (intermittent, stereotypic episodes of frequent seizure activity). Seizure clusters are episodes of grouped seizures with short interictal periods that differ from a patient’s usual seizure pattern and are associated with increased emergency care and risk of status epilepticus; benzodiazepine rescue therapies like Nayzilam are used to abort clusters and reduce emergency interventions. Prior Authorization is required for coverage, and when criteria are met approvals are provided for 1 year.

Definitions

Seizure clusters (acute repetitive seizures)

DefinitionSeizure clusters (acute repetitive seizures) — acute episodes of deterioration in seizure control, often described as a series of grouped seizures with short interictal periods; no consensus numeric definition.

Clinical significanceSeizure clusters can increase emergency department visits or hospitalization and are associated with risk of status epilepticus.

Therapeutic implicationBenzodiazepine rescue medications are the primary acute therapy to abort clusters and reduce emergency care.