CurrentCentenePolicy CP PMN.164

Cannabidiol (Epidiolex)

Defines medical necessity criteria, dosing limits, approval durations, and exclusions for coverage of Epidiolex (cannabidiol) for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC) for Centene lines of business (Commercial, HIM, Medicaid). Includes formulary/off-label navigation and appendices with dosing, alternatives, and state-specific step therapy limitations.

Policy Summary

PayerCentene

PolicyCannabidiol (Epidiolex)

Policy CodePolicy CP PMN.164

Change TypeAdded step therapy bypass; template and duration revisions

Effective DateSep 1, 2018

Next Review Date

Key ActionProvider must attest that the member meets all approval criteria; prior authorization required per Centene processes for Epidiolex requests.

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised template language to require provider attestation that member has met all approval criteria instead of requiring documentation.

Removed neurologist prescriber requirement.

Revised approval duration for Commercial line of business (historic change noted).

3FDA-approved indications

1Minimum age (years)

Approval duration - Medicaid/HIM (months)

12Approval duration - Commercial (months)

Coverage Summary

Scope: This policy defines medical necessity criteria, dosing limits, approval durations, and exclusions for coverage of Epidiolex (cannabidiol) for seizures associated with Lennox‑Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC) for Centene lines of business (Commercial, HIM, Medicaid). Coverage stance: covered_with_criteria when criteria are met. FDA‑approved indications: seizures associated with LGS, DS, and TSC in patients 1 year of age and older. High‑level dosing limits: for DS or LGS maximum dose <= 20 mg/kg/day; for TSC maximum dose <= 25 mg/kg/day. Product is available as a 100 mg/mL oral solution (60 mL and 100 mL). Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Key Coverage Thresholds

Minimum age>= 1 year

Max dose for DS/LGS<= 20 mg/kg/day

Max dose for TSC<= 25 mg/kg/day

Minimum prior therapy duration for continuation>= 30 days on Epidiolex

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

{

"operator":"all",

"children":[

{

"text":"Diagnosis of seizures associated with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC)",

"note":"FDA-approved indications; patient must be ≥ 1 year of age"

Continuation / Renewal Criteria

Continuation/Renewal Criteria

Continuation is medically necessary when ALL of the following are met:

Prior exposure: Member is currently receiving Epidiolex via Centene benefit or documentation supports member has been receiving Epidiolex for at least 30 days>= 30 days
Documentation of prior therapy and response required for continuation
Response: Member is responding positively to therapy
Adjunctive use: Epidiolex will continue to be used as adjunctive therapy with at least one other AED
See Appendix B for examples of AEDs

Other Indications and Exclusions

Other Diagnoses/Indications

If initial criteria are not met for the covered indications, one of the following must apply:

Formulary/PDL pathway: For drugs on the formulary (Commercial/Marketplace) or PDL (Medicaid): follow the 'no coverage criteria' policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP PMN.255 for Medicaid)
Non-formulary pathway: For drugs NOT on the formulary/PDL: follow non-formulary policy (CP.CPA.190 for commercial, HIM.PA.103 for marketplace, CP PMN.16 for Medicaid)
Off-label consideration: If requested use (diagnosis, age, dosing) is not listed and criterion 1 does not apply: refer to off-label use policy (CPCPA.09 for commercial, HIMPA.154 for marketplace, CPPMN.53 for Medicaid)

Applicable Codes & Product Availability

Product NDC / AvailabilityNDC

100 mg/mL (oral solution) - 60 mL	Epidiolex oral solution concentration; 60 mL bottle
100 mg/mL (oral solution) - 100 mL	Epidiolex oral solution concentration; 100 mL bottle

Provider Actions & Workflow

Prior Authorization

Prior authorization and attestation (action)

Prior authorization is required and the provider must attest that the member meets all approval criteria per Centene prior authorization processes (see plan PA procedures).

Documentation Required

Documentation checklist

Provide the following documentation for continuation: evidence of at least 30 days of current Epidiolex use, documentation of positive treatment response, and confirmation that Epidiolex is being used adjunctively with at least one other AED.

Evidence member has received Epidiolex for ≥ 30 days.
Documentation of positive clinical response to therapy.
Confirmation Epidiolex is used as adjunctive therapy with ≥ 1 other AED.

Clinical Evidence & Guidelines

Evidence: Prescribing Information — Epidiolex Prescribing Information, Greenwich Biosciences, March 2024. Guidelines reviewed — AAN/AES, NICE, Cochrane reviews, and international consensus recommendations for DS and TSC (references up to 2024).

Background

Background: Epidiolex (cannabidiol) is FDA‑approved for seizures associated with Dravet syndrome, Lennox‑Gastaut syndrome, and tuberous sclerosis complex in patients aged 1 year and older. Therapeutic alternatives include standard antiepileptic drugs listed in the appendices (e.g., valproate, topiramate, clobazam, rufinamide, lamotrigine, felbamate, levetiracetam, vigabatrin, and others). Dosing guidance: for DS/LGS maintenance dosing up to 20 mg/kg/day (given as 5–10 mg/kg PO BID to 10 mg/kg PO BID) and for TSC titrate from 5 mg/kg/day to a maintenance dose up to 25 mg/kg/day. Contraindication: hypersensitivity to cannabidiol or any product ingredients.

Definitions

AEDantiepileptic drug

DSDravet syndrome

LGSLennox-Gastaut syndrome

TSCtuberous sclerosis complex

Revision History

01.20.22revised

Revised approval duration for Commercial line of business (historic change noted).

05.22revised

Revised approval duration for Commercial line of business (historic change noted).

08.22.23revised

Template change applied: removed neurologist prescriber requirement (template change applied August 2022/November 2022 P&T dates noted).

Policy Summary

PayerCentene

PolicyCannabidiol (Epidiolex)

Policy CodePolicy CP PMN.164

Change TypeAdded step therapy bypass; template and duration revisions

Effective DateSep 1, 2018

Next Review Date

Key ActionProvider must attest that the member meets all approval criteria; prior authorization required per Centene processes for Epidiolex requests.

On This Page

"text":"Age requirement: member is ≥ 1 year"

"text":"Will be used as adjunctive therapy with at least one other antiepileptic drug (AED)",

"note":"See Appendix B for examples of AEDs"

"label":"Dosing and dose limits","children":[

"text":"For Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS): dose ≤ 20 mg/kg per day",

"note":"Maximum for DS or LGS"

"text":"For tuberous sclerosis complex (TSC): dose ≤ 25 mg/kg per day",

"note":"Maximum for TSC"

"label":"LGS-specific requirement","children":[

"text":"Member has tried and had inadequate response to or intolerance of two AEDs from the list: clobazam, clonazepam, felbamate, lamotrigine, rufinamide, topiramate",

"note":"Failure defined as lack of efficacy or clinically significant adverse effects; exceptions apply as noted below"

"text":"OR member is in a State with documented limitations on therapy per Appendix E (see state exceptions)",

"note":"State-specific limits may modify step therapy requirements"

"text":"Provider attestation that documentation of prior therapy and response is provided (including prior AEDs tried, durations, and reasons for discontinuation)",

"note":"Required for initial and continuation requests; supports clinical review"

"text":"For continuation/renewal: member is currently receiving Epidiolex via Centene benefit or documentation supports member has received Epidiolex for at least 30 days and is responding positively to therapy",

"note":"If request is for dose increase, new dose must not exceed dose limits above"

Prior Authorization

Prior authorization required

Provider must obtain prior authorization and attest that the member meets ALL approval criteria for Epidiolex per Centene processes.

Step Therapy

Step therapy for LGS

Step therapy applies for Lennox-Gastaut syndrome (LGS): prior to approval, documentation should show failure (lack of efficacy) or intolerance (clinically significant adverse effects) of two appropriate AEDs from the following list: clobazam, clonazepam, felbamate, lamotrigine, rufinamide, topiramate. State exceptions apply (see items).

Illinois HIM: As of 01/01/2026 the step therapy requirement does not apply per IL HB 5395; provide documentation indicating Illinois HIM coverage when applicable.
Nevada Medicaid: state program limitations may restrict therapy in certain settings per Appendix E — submit documentation consistent with Nevada Medicaid rules.
General state exceptions: if a state or program in Appendix E limits step therapy or provides an explicit bypass, include supporting documentation; clinical exceptions (e.g., contraindication or prior severe adverse reaction to all listed AEDs) should be documented.

If request is for dose increase

DS or LGS dose limit: For DS or LGS: new dose must not exceed 20 mg/kg per day<= 20 mg/kg/day
TSC dose limit: For TSC: new dose must not exceed 25 mg/kg per day<= 25 mg/kg/day

Documentation Required

Documentation required for renewal

For renewal/continuation requests, provide documentation that the member has been on Epidiolex for at least 30 days and is responding positively to therapy, and confirm Epidiolex will continue as adjunctive therapy with at least one other AED.

Billing Rule

Approval duration

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

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

ref(

Step Therapy

State step therapy exceptions

State step therapy exceptions apply; see Appendix E for the full state list and specifics.

IL HIM: bypass of LGS step therapy requirement per IL HB 5395 (effective 1/1/2026).
NV: limitation in Appendix E applies to Medicaid requests only.
Refer to Appendix E for complete state-specific step therapy limitations and redirection rules.

Contraindication: hypersensitivity to cannabidiol or any of the ingredients in the product. Note for prescribing workflows: historic template updates removed a neurologist‑only prescriber requirement (change applied August 2022), and the policy now requires provider attestation of criteria rather than submission of documentation.

08.23.23revised

Revised template language to require provider attestation that member has met all approval criteria instead of requiring documentation.

08.25.25addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (P&T Approval 08.25.25); marked material.