CurrentHealth NetPolicy CP PMN.54

Clinical Policy: Clobazam (Onfi, Sympazan)

Defines medical necessity, prior authorization, and coverage criteria for clobazam (Onfi, Sympazan and generic) across Commercial, HIM, and Medicaid, including FDA‑approved and selected off‑label epilepsy indications.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Clobazam (Onfi, Sympazan)

Policy CodePolicy CP PMN.54

Change TypeNo material changes

Effective DateNov 1, 2012

Next Review Date

Key ActionSubmit prior authorization with clinical documentation that the member meets the listed medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

LGS, Dravet, IntractableIndications

12 moApproval Duration

≤40 mg / 2 mg/kgDose Limits

Opioid interactionBoxed Warnings

Tablets, suspension, filmProduct Forms

Coverage Criteria

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Initial Therapy (LGS)

Covered when ALL of the following are met for LGS (initial approval):

LGS Initial Approval: 1. Diagnosis of Lennox‑Gastaut syndrome (LGS).

Prescriber: 2. Prescribed by or in consultation with a neurologist.

Age: 3. Patient is older than 2 years.

Step therapy/redirection: 4. If request is for a member in a State with limitations on therapy in certain settings, Appendix D rules apply (see policy).

Appendix D includes state-specific redirection/step therapy provisions (e.g., Nevada Medicaid).

Prior therapy: 5. Failure of 2 preferred agents for LGS (examples: clonazepam; valproic acid/divalproex; lamotrigine; topiramate; felbamate), unless clinically significant adverse effects are experienced or all are contraindicated.

Preferred product requirement: 6. 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 limit: 7. Dose does not exceed 40 mg per day or the formulation limit of 2 tablets (or equivalent) per day.dose <= 40 mg/day

LGS weight-based dosing: <30 kg maximum 20 mg/day; ≥30 kg maximum 40 mg/day.

Approval duration: 8. Approval duration: Commercial — 12 months or duration of request, whichever is less; Medicaid/HIM — 12 months.

Initial Therapy (Intractable/Refractory Epilepsy)

Covered when ALL of the following are met for intractable/refractory epilepsy (off‑label):

Diagnosis: 1. Diagnosis of intractable/refractory epilepsy.

Prescriber: 2. Prescribed by or in consultation with a neurologist.

Age: 3. Age requirement referenced in policy (see full policy text).

State limitations: 4. If request is for a member in a State with limitations on step therapy in certain settings, Appendix D rules apply.

Appendix D includes state-specific redirection/step therapy provisions (e.g., Nevada Medicaid).

Initial Therapy (Dravet syndrome)

Covered when ALL of the following are met for Dravet syndrome (off‑label):

Diagnosis: 1. Diagnosis of Dravet syndrome.

Prescriber: 2. Prescribed by or in consultation with a neurologist.

Age: 3. Age ≥ 2 years.

Preferred product requirement: 4. 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 limit:

Continuation Therapy

Continuation of therapy is allowed when ALL of the following are met:

Ongoing therapy documentation: 1. Member is currently receiving medication via the Centene benefit, or documentation supports that member has been receiving Onfi or Sympazan for a covered indication for at least 30 days.

Clinical response: 2. Member is responding positively to therapy.

Dose limit for increases: 3. If the request is for a dose increase, the new dose does not exceed the applicable maximum: 40 mg/day for LGS/intractable epilepsy or 2 mg/kg/day for Dravet syndrome; formulation limits (e.g., 2 tablets or 2 films per day) also apply.see initial dosing thresholds

Approval duration: 4. Approval duration: Commercial — 12 months or duration of request (whichever is less); Medicaid/HIM — 12 months.

Covered Indications with dosing and step therapy notes

Coverage includes LGS, intractable/refractory epilepsy, and Dravet syndrome with dosing and step therapy considerations.

Lennox-Gastaut syndrome: Covered when used for LGS with dosing per weight group and after required prior therapy failures unless contraindicated or intolerant.LGS dosing maxima per weight

LGS dosing: <30 kg — initiate 5 mg/day titrated to max 20 mg/day; ≥30 kg — initiate 10 mg/day titrated to max 40 mg/day. Policy requires failure of alternatives (or generic clobazam forms) unless contraindicated; Nevada Medicaid allows single-redirection exceptions (Appendix D).

Intractable/refractory epilepsy: Covered off‑label when prior alternatives have failed as specified by the policy (see Appendix B) and dosing follows LGS regimen.See LGS dosing maxima

Policy references failure of alternatives and includes redirection/step therapy language; state-specific rules (Appendix D) may modify requirements.

Dravet syndrome:

Non‑FDA approved indications that are not specifically addressed in this policy are excluded unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies. Refer to the off‑label use policies for the member's line of business: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for criteria and evidentiary requirements.

Clobazam is contraindicated in individuals with a documented history of hypersensitivity to clobazam or any of its ingredients. Requests with such a history should not be approved.

Requests for uses not listed in this policy and not supported by the formulary/non‑formulary or applicable off‑label policies may be considered not medically necessary. Providers should follow the line‑of‑business policy pathways (formulary or off‑label) cited in this document when seeking coverage for indications outside the policy scope.

None explicitly listed in this document section.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization required with documentation that member meets the listed medical necessity criteria. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Lack of submitted clinical documentation may trigger denial.

Affected products: Onfi (clobazam), Sympazan (clobazam oral film), and generic clobazam (tablets/oral suspension).
Documentation to include: diagnosis, neurologist consultation or attestation if applicable, prior treatment history (including trials and failures of preferred agents), weight (to support dosing), dosing requested, and clinical rationale for any deviations (e.g., adverse effects or contraindications to preferred agents).
Requests for continued therapy: documentation member currently receiving medication via Centene benefit or has received Onfi/Sympazan for at least 30 days and clinical benefit is demonstrated.

Step Therapy

Step Therapy Requirements

Step therapy requirements — For Lennox-Gastaut syndrome (LGS) and intractable/refractory epilepsy indications, members must have failed specified preferred agents prior to approval unless clinically significant adverse effects are experienced or all are contraindicated. 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.

LGS: Failure of 2 preferred agents (examples: clonazepam, valproic acid/divalproex, lamotrigine, topiramate, felbamate) unless contraindicated or adverse effects prevent use.
Intractable/refractory epilepsy (off-label): Failure of 2–4 anti-seizure drugs per Appendix B unless contraindicated or adverse effects prevent use.
Dose limits: LGS maximum 20 mg/day for <30 kg and 40 mg/day for ≥30 kg; dosing regimens per policy dosing table.

Prior Authorization

State Redirection / Step Therapy Exceptions

Prior authorization with state redirection rules — Prior authorization applies; includes redirection/step therapy state exceptions. Some states (see Appendix D) have limitations that modify step therapy/redirection requirements (for example, Nevada Medicaid allows only a single redirection and requires failure of ONE alternative for Medicaid LGS and intractable epilepsy requests).

Appendix D states with limitations (example): Nevada — for Medicaid requests, LGS: failure of ONE of generic clobazam tablets, generic clobazam oral suspension, or an alternative LGS drug (clonazepam, valproic acid/divalproex, lamotrigine, topiramate, felbamate).
Providers should indicate member's state and line of business on requests to ensure applicable redirection rules are applied.

Documentation Required

Documentation required — Prescribers must document indication, patient weight to support dosing, prior medication trials (including dates, doses, and reasons for discontinuation), neurologist involvement (prescribed by or in consultation with a neurologist when required), and any clinical justification for using brand product instead of generic clobazam. Failure to provide required documentation may result in denial.

Required items: office notes, weight, labs if relevant, neurologist consult notes, prior therapy history (including contraindications or adverse effects), and current dosing.
When requesting brand products (Onfi or Sympazan), document why generic clobazam tablets or oral suspension are not appropriate (e.g., proven adverse reaction or documented therapeutic failure).
For requests impacted by state-specific limitations (Appendix D), include documentation demonstrating attempts or failures per that state’s rules.

Documentation Required

Dose and Product Documentation

Dose and product documentation — Prescribers should document the indication and patient weight to support dosing and the specific product requested (tablet, oral suspension, or oral film). Include the requested dose and confirm it does not exceed the policy maximums.

LGS dosing: <30 kg: initiate 5 mg daily titrate to max 20 mg/day; ≥30 kg: initiate 10 mg daily titrate to max 40 mg/day. Doses >5 mg should be given divided twice daily.
Specify product: generic clobazam tablet, generic oral suspension (2.5 mg/mL), Onfi tablets, or Sympazan oral film strengths.
Approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less.

Denial Risk

Denial Risk / Contraindications

Denial risk — Requests may be denied if required clinical documentation is missing, if step therapy requirements are not met, or if state-specific limitations (Appendix D) are not addressed in the submission.

Boxed warnings/contraindications to consider: risks with concomitant opioid use, abuse/misuse/addiction, dependence and withdrawal; contraindication for history of hypersensitivity to clobazam or its ingredients (see Appendix C).
Ensure documentation of prior agent trials, adverse effects, contraindications, and neurologist involvement to reduce denial risk.

Definitions and Dosing Groups

LGS — Definition of Lennox‑Gastaut syndrome

DefinitionLennox‑Gastaut syndrome (LGS): a severe childhood epilepsy syndrome characterized by multiple seizure types; clobazam is indicated as adjunctive treatment for seizures associated with LGS

Age criterion referenced in policyPolicy requires age > 2 years for LGS initial approval

Therapy contextClobazam (Onfi, Sympazan, generic) is addressed as adjunctive therapy for seizures associated with LGS in this policy

LGS dosing groups — Weight‑based starting and target doses

< 30 kg — starting and target dosesInitiate at 5 mg PO daily and titrate as tolerated up to 20 mg/day; doses >5 mg should be given divided twice daily

≥ 30 kg — starting and target dosesInitiate at 10 mg PO daily and titrate as tolerated up to 40 mg/day; doses >5 mg should be given divided twice daily

Dosing documentation requirementPrescribers should document patient weight to support weight‑based dosing per policy

Dravet syndrome dosing — Initial and maximum dosing notes

Initial dosing (Dravet)Initiate at 0.2–0.3 mg/kg per day PO

Maximum dosing (Dravet) — policy textPolicy states 'Maximum' for Dravet but contains a typographic irregularity in the document (listed as '0 5-2 mg/kg/day'); the approval criteria and continuation sections specify a maximum of 2 mg/kg per day

Age and prescriber requirementsDravet criteria require diagnosis of Dravet syndrome, prescriber is or in consultation with a neurologist, and age ≥ 2 years

OpenPayer

Clinical Policy: Clobazam (Onfi, Sympazan)

Coverage Criteria

Coding and Product Information

Provider Actions and Authorization Requirements

Background

Definitions and Dosing Groups