CurrentCignaPolicy IP0409

Diacomit

Cigna prescription drug coverage policy specifying prior authorization, clinical criteria, and approval durations for Diacomit (stiripentol) for Dravet syndrome and certain treatment-refractory epilepsies; defines required prescriber specialty and continuation criteria.

Policy Summary

PayerCigna

PolicyDiacomit

Policy CodePolicy IP0409

Change TypeAnnual review — no content changes

Effective DateMay 15, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Diacomit is prescribed by or in consultation with a neurologist; approvals are provided for the durations noted (1 year for approved indications).

POLICY UPDATE CHANGES

Annual Review dated 5/1/2024 and Annual Revision dated 5/15/2025 noted 'No content criteria changes.'

2Approval pathways (initial or continuing)

1 yrStandard approval duration

≥2Required prior ASMs for other refractory seizures

≥6 moMinimum age for coverage

Coverage Summary

coverage_stance: covered_with_criteria; approved indications: Dravet syndrome (FDA‑approved for seizures associated with Dravet syndrome in patients ≥ 6 months of age and ≥ 7 kg who are taking clobazam) and specified treatment‑refractory epilepsies (listed supportive conditions). Standard approval duration: 1 year. scope_summary: Cigna prescription drug coverage policy specifying prior authorization, clinical criteria (including minimum age/weight, concomitant clobazam or inability to take clobazam for Dravet, required prior antiseizure trials for other refractory seizures, and neurologist prescriber/consultation), approval pathways for initial and continuing therapy, and continuation criteria requiring that the patient be responding to therapy as determined by the prescriber.

Not Medically Necessary / Exclusions

Diacomit for any other use is considered not medically necessary.

Exclusion: Use of Diacomit for indications other than FDA-approved Dravet syndrome or the listed supportive evidence refractory seizure conditions

Claims for Diacomit billed for conditions or diagnoses not covered under this policy will be denied as not covered.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Diacomit. Approvals are provided for the durations noted in the policy (approved indications: 1 year).

Documentation Required

Specialist prescriber requirement

Initial approval requires the medication to be prescribed by or in consultation with a neurologist (a physician who specializes in the condition being treated).

Documentation Required

Demonstration of response for continuation

For patients currently receiving Diacomit, continuation approvals require documentation that the patient is responding to therapy. 'Responding to therapy' is defined by the prescriber and may include reduced seizure severity, frequency, and/or duration.

Denial Risk

Coverage denial for non-listed uses

Claims for Diacomit billed for conditions or diagnoses not covered under this policy will be denied as not covered.

Documentation Required

Sample product

Receipt of sample product does not satisfy any criteria requirements for coverage.

Background

Background: Diacomit (stiripentol) is indicated for treatment of seizures associated with Dravet syndrome in patients ≥ 6 months of age and weighing ≥ 7 kg when used in combination with clobazam; there are no clinical data supporting monotherapy. The policy also notes supportive evidence for use in other refractory epilepsies such as Lennox‑Gastaut syndrome, infantile spasms, tuberous sclerosis complex, Sturge‑Weber syndrome, Doose syndrome, infection‑related or anoxo‑ischemic epilepsy syndromes, cortical malformation/dysplasia, epileptic encephalopathies associated with sodium channel mutations, and epilepsy with myoclonic absences.

Coverage Thresholds

Age threshold>= 6 months

Weight threshold>= 7 kg

Prior antiseizure trials (for other refractory seizures)>= 2 other antiseizure medications

Standard approval duration1 year

Policy Summary

PayerCigna

PolicyDiacomit

Policy CodePolicy IP0409

Change TypeAnnual review — no content changes

Effective DateMay 15, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Diacomit is prescribed by or in consultation with a neurologist; approvals are provided for the durations noted (1 year for approved indications).

On This Page

OpenPayer

Diacomit

Coverage Summary

Medically Necessary Criteria

Not Medically Necessary / Exclusions

Provider Actions & Requirements

Applicable Codes & Policy Identifiers

Clinical Evidence

Background

Definitions

Revision History