CurrentCignaPolicy IP0409

Diacomit (stiripentol) coverage for Dravet syndrome and other refractory epilepsies

Defines Cigna's prior authorization, medical necessity criteria, and coverage stance for Diacomit (stiripentol) for patients with Dravet syndrome and certain treatment-refractory seizure disorders; applies to prescribing clinicians and payers administering Cigna benefit plans.

Policy Summary

PayerCigna

PolicyDiacomit (stiripentol) coverage for Dravet syndrome and other refractory epilepsies

Policy CodePolicy IP0409

Change TypeNo material change

Effective DateN/A

Next Review DateMay 15, 2025

Key ActionObtain prior authorization; initial approvals require prescription by or consultation with a neurologist and are authorized for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearinitial or renewal approval duration

≥6 mominimum patient age for approval

≥7 kgminimum patient weight for approval

neurologistprescriber specialty requirement

prior authutilization control

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Coverage Criteria for Diacomit (stiripentol)

FDA-Approved Indication (Dravet Syndrome)

Approve for 1 year if the patient meets ONE of the following (A or B):

Dravet approval pathways: A) Initial Therapy: Approve if ALL of the following (i, ii, and iii) are met OR B) Patient is currently receiving Diacomit: Approve if responding to therapy

A) Initial Therapy: i. Patient is ≥ 6 months of age and weighs ≥ 7 kg; AND ii. Patient meets ONE of: (a) patient is taking concomitant clobazam; OR (b) patient is unable to take clobazam due to adverse events as determined by the prescriber; AND iii. Medication is prescribed by or in consultation with a neurologist

B) Currently receiving Diacomit: Patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Other Uses with Supportive Evidence (Treatment-Refractory Seizures / Specific Rare Conditions)

Approve for 1 year if the patient meets ONE of the following (A or B):

Other refractory epilepsy approval pathways: A) Initial Therapy: Approve if ALL of the following (i, ii, and iii) are met OR B) Patient is currently receiving Diacomit: Approve if responding to therapy

A) Initial Therapy: i. Patient is ≥ 6 months of age and weighs ≥ 7 kg; AND ii. Patient has tried at least two other antiseizure medications; AND iii. Medication is prescribed by or in consultation with a neurologist

Examples of other antiseizure medications include valproic acid, lamotrigine, topiramate, clonazepam, rufinamide (Banzel), felbamate, clobazam, perampanel (Fycompa), vigabatrin, levetiracetam, zonisamide.

B) Currently receiving Diacomit: Patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber

Diacomit (stiripentol) for any use other than the indications detailed in this policy is considered not medically necessary. This includes uses not specifically listed under the FDA‑approved indication for Dravet syndrome or the specified treatment‑refractory seizure disorders. Coverage will follow the criteria described for those approved indications and will be updated if new evidence emerges.

Use of Diacomit for indications other than Dravet syndrome or the specific treatment‑refractory seizure disorders enumerated in this policy (for example, 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) is considered not medically necessary unless the patient meets the policy’s stated coverage criteria (initial therapy or continuation criteria) for those listed refractory conditions.

Patient Eligibility and Coding-Related Criteria

inv-05: Minimum age/weight

Minimum patient agePatient is ≥ 6 months of age

Minimum patient weightPatient weighs ≥ 7 kg

Approval durationApprovals are provided for 1 year (initial or renewal)

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for Diacomit. Initial approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist). Approvals are provided for the duration noted in the policy (typically 1 year) and continuation approvals require documented clinical response as determined by the prescriber.

Initial approval: must be prescribed by or in consultation with a neurologist (see FDA-Approved Indication and Other Uses).
Continuation approval: patient must be responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.
Typical approval duration: 1 year when criteria are met.

Step Therapy

Step Therapy for Treatment‑Refractory Seizures

Step therapy for certain treatment‑refractory seizure indications requires failure or trial of at least two other antiseizure medications before initiating Diacomit for the specified rare conditions. Examples of other antiseizure medications include valproic acid, lamotrigine, topiramate, clonazepam, rufinamide (Banzel), felbamate, clobazam, perampanel (Fycompa), vigabatrin, levetiracetam, and zonisamide.

Background

Dravet syndrome is a rare genetic epileptic encephalopathy that typically begins in the first year of life with multiple seizure types that are often difficult to control with standard antiseizure medications. Treatment goals include terminating prolonged convulsions, reducing seizure frequency and severity, and minimizing adverse effects. Diacomit (stiripentol) is addressed in this policy as an FDA‑approved adjunctive therapy for seizures associated with Dravet syndrome in patients meeting age and weight thresholds and other criteria; evidence for use in other treatment‑refractory epilepsies is limited and governed by the separate criteria for those conditions.

Definitions

inv-11: Dravet syndrome

DefinitionDravet syndrome is a rare genetic epileptic encephalopathy with frequent and/or prolonged seizures beginning in the first year of life, often with multiple seizure types (myoclonic, tonic-clonic, absence, atypical absence, atonic, focal) and frequently refractory to antiseizure medications.

Typical onsetSeizures generally begin in the first year of life in an otherwise healthy infant.

Seizure typesIncludes myoclonic, tonic-clonic, absence, atypical absence, atonic, focal aware or impaired awareness, and status epilepticus.

Treatment goalsCessation of prolonged convulsions, reduction in overall seizure frequency, and minimization of treatment side effects.