CurrentCentenePolicy CP PMN.54

Clobazam (Onfi, Sympazan)

Clinical policy governing medical necessity criteria, prior authorization requirements, dose limits, covered indications (Lennox-Gastaut syndrome, intractable/refractory epilepsy off‑label, Dravet syndrome off‑label), approval durations, and product availability for Onfi, Sympazan, and generic clobazam across Commercial, HIM, and Medicaid lines of business for Centene-affiliated plans.

Policy Summary

PayerCentene

PolicyClobazam (Onfi, Sympazan)

Policy CodePolicy CP PMN.54

Change TypeAnnual reviewselective revisions

Effective DateNov 1, 2012

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2024 annual review: no significant changes; references reviewed and updated.

For LGS and intractable/refractory epilepsy, added redirection bypass for members in a State with limitations on therapy in certain settings with Appendix D (includes Nevada) for Medicaid single redirection.

Revised approval duration for Commercial line from length of benefit to 12 months or duration of request, whichever is less.

3Covered indications

40 mg/dayGeneral max dose

2 mg/kg/day

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12 monthsTypical approval duration

Coverage Summary

Scope: Centene clinical policy CP PMN.54 governs medical necessity criteria, prior authorization, dose and formulation limits, covered indications, approval durations, and product availability for clobazam (Onfi, Sympazan, and generic clobazam) across Commercial, HIM, and Medicaid lines of business. The policy covers the FDA‑approved indication Lennox‑Gastaut syndrome (adjunctive treatment of seizures) and recognizes off‑label uses including intractable/refractory epilepsy and Dravet syndrome with specified clinician, prior‑therapy, and dosing requirements. Approval durations: Medicaid/HIM = 12 months; Commercial = 12 months or duration of request, whichever is less. Dose thresholds: general maximum 40 mg/day (formulation limits: max 2 tablets/day or 2 films/day) and Dravet maximum 2 mg/kg/day. Product formulations noted include tablets (10 mg, 20 mg), oral suspension (2.5 mg/mL), and oral films (5, 10, 20 mg).

Key thresholds & policy facts

Policy numberCP PMN.54

General max dose40 mg/day

Dravet max dose2 mg/kg/day

Typical approval duration12 months

Covered indications count3

Last review date2024-11-24

Effective date2012-11-01

Initial Approval Criteria - Lennox-Gastaut Syndrome (LGS)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Lennox-Gastaut Syndrome (LGS)
Prescribed by or in consultation with a neurologist
Age > 2 years
Redirection/Step therapy bypass note
- Request is for the treatment of a member in a State with limitations on therapy in certain settings (see Appendix D)

Initial Approval Criteria - Intractable/Refractory Epilepsy (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of intractable/refractory epilepsy
Prescribed by or in consultation with a neurologist
Age ≥ 2 years
State redirection/step therapy bypass
- Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)

Initial Approval Criteria - Dravet Syndrome (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Dravet syndrome
Prescribed by or in consultation with a neurologist
Age ≥ 2 years
Generic-first requirement
- For Onfi and Sympazan requests, member must use generic clobazam tablets or oral suspension, unless clinically significant adverse effects are experienced or both are contraindicated

Continued Therapy Criteria

Continued Therapy (All Indications in Section I)

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member has been receiving Onfi or Sympazan for a covered indication for at least 30 days
Member is responding positively to therapy
Dose change limits
- If request is for a dose increase, new dose does not exceed 40 mg per day (general limit)
- Dravet syndrome: new dose does not exceed 2 mg/kg per day

Other Indications and Off‑Label Use

Other diagnoses/indications

Coverage for other uses is governed by formulary and off-label policies

ANY of the following

For drugs on formulary/PDL, follow no-coverage criteria policy for relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (health insurance marketplace), CP PMN.255 (Medicaid)
For drugs NOT on formulary/PDL, follow non-formulary policy for relevant line of business: CP.CPA.190 (commercial), HIM.PA.103 (health insurance marketplace), CP PMN.16 (Medicaid)
If requested use is not listed and criterion 1 above does not apply, refer to off-label use policy: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP.PMN.53 (Medicaid)

Diagnoses/Indications Not Authorized

ALL of the following

Product Formulations / Code Table

Product NDC / formulations (informational)NDC

10 mg tablet	Clobazam tablet 10 mg (Onfi)
20 mg tablet	Clobazam tablet 20 mg (Onfi)
2.5 mg/mL oral suspension 120 mL	Clobazam oral suspension 2.5 mg/mL (Onfi)
5 mg oral film	Clobazam oral film 5 mg (Sympazan)
10 mg oral film	Clobazam oral film 10 mg (Sympazan)
20 mg oral film	Clobazam oral film 20 mg (Sympazan)

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Onfi, Sympazan, and generic clobazam require prior authorization and must meet the clinical criteria listed in the policy (covered indications, prescriber/specialist requirements, prior therapy requirements, and dosing/formulation limits).

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation with the prior authorization request, such as office chart notes and laboratory results, that demonstrate the member meets all approval criteria (diagnosis, prior therapy failures or redirection rules, neurologist involvement when required, age, dosing and formulation limits, and response for continued therapy).

Office chart notes documenting diagnosis and prior therapy trials
Laboratory results or other clinical information as applicable
Documentation of prior agent failures, contraindications, or adverse effects

Background & Evidence

Background: Clobazam is a benzodiazepine with an FDA indication as adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome. The policy addresses both the FDA indication and recognized off‑label uses (intractable/refractory epilepsy and Dravet syndrome) and requires prescriptions to be by or in consultation with a neurologist, documents prior therapy failures where specified, and enforces dosing and formulation limits. Appendices provide therapeutic alternatives, contraindications and boxed warnings (including opioid interaction, abuse/dependence risks, hypersensitivity), and state‑specific step therapy/redirection limitations (Appendix D; e.g., Nevada Medicaid single‑redirection rules).

Evidence	Reference
Onfi/Sympazan prescribing information	Onfi Prescribing Information; Sympazan Prescribing Information (March 2024)
Guideline citations	Cochrane review and multiple expert consensus/guideline publications (e.g., Cochrane 2013; expert consensus and treatment algorithms cited)

Definitions

LGSLennox-Gastaut syndrome

RedirectionState-specific modification of step therapy requirements allowing bypass or single redirection per Appendix D

Revision History

4Q 2024annual_reviewLatest

4Q 2024 annual review: no significant changes; references reviewed and updated (Approval Date = 11.24).

08.31.23policy_addition

August 31, 2023 addition (material): For LGS and intractable/refractory epilepsy, added redirection/step therapy bypass for members in a State with limitations on therapy in certain settings with Appendix D; Appendix D includes Nevada with requirements for single redirection for Medicaid requests.

01.20.22 / 05.22

Policy Summary

PayerCentene

PolicyClobazam (Onfi, Sympazan)

Policy CodePolicy CP PMN.54

Change TypeAnnual reviewselective revisions

Effective DateNov 1, 2012

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Standard redirection/step therapy requirements apply (see Appendix D)

Prior therapy requirement

Failure of 2 preferred agents for LGS (examples listed in Appendix B: clonazepam, valproic acid/divalproex, lamotrigine, topiramate, felbamate), unless clinically significant adverse effects are experienced or all are contraindicated
Where applicable per Appendix D/state rules, failure of ONE agent may suffice for Medicaid in certain states (e.g., Nevada) per redirection rules

For Onfi and Sympazan requests, member must use generic clobazam tablets or oral suspension, unless clinically significant adverse effects are experienced or both are contraindicated; dose does not exceed 40 mg per day; dose form limits: 2 tablets per day OR 2 films per day

Prior therapy requirement

Failure of ≥ 4 anti-seizure drugs (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated
Where applicable per Appendix D/state rules, failure of ONE agent may suffice for Medicaid in certain states per redirection rules

Dose does not exceed 2 mg/kg per day

Dose form limits: 2 tablets per day OR 2 films per day

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53)

Documentation Required

Specialist involvement requirement

Requests must be prescribed by or in consultation with a neurologist for all covered indications (LGS, intractable/refractory epilepsy, and Dravet syndrome).

Billing Rule

Approval duration

Approval durations are specified by line of business: for Medicaid and Health Insurance Marketplace (HIM) the approval duration is 12 months; for Commercial the approval is 12 months or the duration of the request, whichever is less.

Denial Risk

Dose limit denial risk

Requests that exceed the policy dose or formulation limits may be denied. Policy limits include a general maximum of 40 mg per day, a Dravet-specific maximum of 2 mg/kg per day, and formulation limits of no more than 2 tablets per day or no more than 2 films per day.

Step Therapy

Preferred agent failure requirement

Prior therapy failures are required before approval for LGS and intractable/refractory epilepsy: for LGS failure of 2 preferred agents (examples listed include clonazepam, valproic acid/divalproex, lamotrigine, topiramate, felbamate) unless contraindicated or adverse effects are documented; for intractable/refractory epilepsy failure of 4 anti‑seizure drugs is required unless contraindicated or adverse effects are documented. State-specific redirection/step therapy exceptions in Appendix D may modify these requirements (for example, Nevada Medicaid allows single redirection/failure rules).

LGS: failure of 2 preferred agents unless contraindicated or adverse effects documented
Intractable/refractory epilepsy: failure of 4 anti‑seizure drugs unless contraindicated or adverse effects documented
State-specific redirection/step therapy exceptions per Appendix D (e.g., Nevada Medicaid single redirection)

approval_duration_change

January/May 2022 change (material): Revised approval duration for Commercial line from length of benefit to 12 months or duration of request, whichever is less.