CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Diacomit (stiripentol) for Dravet syndrome — Coverage Criteria

Policy governing prior authorization and coverage criteria for Diacomit (stiripentol) when used to treat patients with Dravet syndrome for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDiacomit (stiripentol) for Dravet syndrome — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJan 1, 2025

Key ActionObtain prior authorization and document diagnosis confirmation by two unaffiliated neurologists/epileptologists, prescriber specialty, patient age/weight, current clobazam use, and baseline neutrophil and platelet counts.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wksinitial auth duration

12 mocontinuation auth

>=6 momin age

7 kgmin weight

50%responder threshold

Coverage Criteria for Diacomit (stiripentol)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDiacomit (stiripentol) for Dravet syndrome — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJan 1, 2025

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met:

Initial criteria: A. Patient has a documented diagnosis of Dravet Syndrome confirmed by two unaffiliated neurologists/epileptologists; B. Medication is being prescribed by a neurologist or epileptologist; C. Patient is 6 months of age or older and documentation that patient weighs 7 kg or more; D. Patient is currently taking clobazam; E. Documentation of baseline neutrophil and platelet count obtained prior to starting treatment.

Authorization of 12 weeks may be granted when all criteria are met.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: Member is tolerating treatment AND has a documented 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures.50% seizure reduction

Authorization of 12 months may be granted.

This policy specifically addresses coverage of Diacomit (stiripentol) for patients with Dravet syndrome when used as adjunctive therapy in combination with clobazam. Uses of Diacomit outside of Dravet syndrome or use without concomitant clobazam are not addressed by these criteria and are therefore not covered under the conditions described in this policy.

Treatment will be considered not medically necessary if the initial approval criteria are not met. Examples include lack of a documented diagnosis of Dravet syndrome confirmed by two unaffiliated neurologists/epileptologists, the medication not being prescribed by a neurologist or epileptologist, patient age under 6 months or weight below 7 kg, absence of current clobazam therapy, or missing baseline neutrophil and platelet counts. Additionally, continuation will be considered not medically necessary if the member is not tolerating treatment or does not have a documented 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures.

Coding, Quantity Limits, and Definitions

Quantity limits (by product/strength)mixedCovered

Diacomit 250mg	180 caps/packets per 30 days
Diacomit 500mg	180 caps/packets per 30 days

Responder definition — 50% reduction

Responder definitionDocumented 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures

Measurement windowPer 30-day period compared to baseline frequency

Seizure types includedGeneralized clonic and tonic-clonic seizures only

Age and weight minimums

Minimum age>= 6 months of age

Minimum weight>= 7 kg

Documentation requiredPatient age and weight must be documented in the medical record

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization durations

Initial prior authorization may be granted for 12 weeks when all initial approval criteria are met. If the member is tolerating treatment and meets the responder definition (documented 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures), continuation authorization may be granted for 12 months.

Initial authorization duration: 12 weeks when all initial criteria are met.
Continuation authorization duration: 12 months if tolerating treatment and documented 50% seizure reduction per 30 days.

Step Therapy

Step therapy requirement

No additional step therapy is required beyond the policy requirement that the patient is currently taking clobazam as a concurrent medication.

Patient must be currently taking clobazam at the time of request.

Documentation Required

Required documentation

Include documentation that verifies the diagnosis, prescriber specialty, patient demographics, concurrent therapy, and baseline labs prior to initiation.

Documented diagnosis of Dravet Syndrome confirmed by two unaffiliated neurologists/epileptologists.
Prescriber is a neurologist or epileptologist.
Patient age ≥ 6 months and weight ≥ 7 kg.
Documentation that patient is currently taking clobazam.
Baseline neutrophil and platelet counts obtained prior to starting treatment.

Denial Risk

Triggers for denial

Authorization may be denied if required criteria or documentation are missing or thresholds are not met.

Lack of documentation confirming diagnosis by two unaffiliated neurologists/epileptologists.
Prescriber is not a neurologist or epileptologist.
Patient is under 6 months of age or weighs less than 7 kg.
Patient is not currently taking clobazam.
Missing baseline neutrophil and platelet counts prior to starting treatment.
For continuation requests, failure to document tolerability or a 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures.

Background

Dravet syndrome is a severe, early-onset epileptic encephalopathy characterized by frequent generalized clonic and tonic-clonic seizures that are often refractory to treatment. Stiripentol (Diacomit) is used as adjunctive therapy with clobazam to reduce seizure frequency in this population. Under this policy, initial authorization of 12 weeks may be granted when documented diagnosis (confirmed by two unaffiliated neurologists/epileptologists), specialist prescribing, minimum age and weight (>= 6 months and >= 7 kg), current clobazam use, and baseline neutrophil and platelet counts are provided. Continued authorization of 12 months requires the member to be tolerating treatment and to have a documented 50% reduction in generalized clonic or tonic-clonic seizure frequency per 30 days compared to baseline.

Definitions

Dravet Syndrome — diagnostic expectation

Diagnostic requirementDocumented diagnosis of Dravet syndrome

Confirmation requirementDiagnosis must be confirmed by two unaffiliated neurologists or epileptologists

Prescriber specialtyMedication should be prescribed by a neurologist or epileptologist (per initial criteria)

Responder for continuation

Responder threshold for continuationDocumented 50% reduction in frequency per 30 days of generalized clonic or tonic-clonic seizures compared to baseline

Tolerability requirementMember must be tolerating treatment to qualify for continuation authorization

Authorization duration if metContinuation authorization may be granted for 12 months when criteria are met