CurrentCignaPolicy IP0508

Ztalmy (ganaxolone oral suspension) / Antiseizure Medications - Ztalmy

This Cigna drug coverage policy defines prior authorization, medical necessity criteria, and exclusions for Ztalmy (ganaxolone oral suspension) for treatment of seizures associated with CDKL5 deficiency disorder in patients aged ≥ 2 years. It specifies required documentation, prescriber qualifications, and duration of approval.

Policy Summary

PayerCigna

PolicyZtalmy (ganaxolone oral suspension) / Antiseizure Medications - Ztalmy

Policy CodePolicy IP0508

Change TypeTitle update; added documentation requirements

Effective DateSep 15, 2025

Next Review Date

Key ActionPrior Authorization is required; document molecular confirmation of a pathogenic/likely pathogenic CDKL5 variant, trial or concomitant use of ≥2 other antiseizure medications, and prescription or consultation with a neurologist (approvals provided for 1 year when criteria are met).

POLICY UPDATE CHANGES

Updated coverage policy title from 'Ganaxolone' to 'Antiseizure Medications - Ztalmy'.

Added documentation requirements throughout policy.

1Covered Indication (CDKL5-related seizures)

≥2Minimum patient age (years)

1 yrApproval duration

Coverage Summary

This policy covers Ztalmy (ganaxolone oral suspension) for the FDA-approved indication of seizures associated with CDKL5 deficiency disorder in patients aged ≥ 2 years. Coverage is covered with criteria and requires prior authorization. Approvals are provided for 1 year when all policy criteria are met, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant, trial or concomitant use of at least two other antiseizure medications, and prescription by or consultation with a neurologist.