Cannabidiol (Epidiolex) coverage
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This policy governs medical necessity criteria, approvals, and coverage parameters for Epidiolex (cannabidiol) for treatment of seizures associated with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex for Meridian Health Plan (Illinois Medicaid line of business). It affects providers requesting prior authorization for Epidiolex for covered members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Epidiolex (cannabidiol)
Initial Therapy (FDA indications)
Covered when ALL of the following are met:
Approval duration: Medicaid/HIM - 12 months
Continuation Therapy
Continued therapy covered when ALL of the following are met:
Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less
Other Indications / Label Changes
Dosing criteria for covered indications
Dosing and indication-specific prescribing guidance provided in appendix (supporting coverage determinations):
Supported by Appendix D dosing table
Supported by Appendix D dosing table
Requests for uses of Epidiolex that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (for Medicaid, see CP.PMN.53) or other evidence of coverage documents.
This clinical policy is a guide to medical necessity and coverage determinations but is subject to the terms, conditions, exclusions and limitations of the member’s coverage documents. For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this policy; consult the applicable state Medicaid manual for any differing coverage rules.
Use of Epidiolex for non‑FDA approved indications without adequate documentation of efficacy and safety is handled under the off‑label use policy and will be considered not authorized unless the required supporting evidence is provided.
Within the sections cited here there are no explicit statements
Product Codes and Dosing Key Values
| NDC not listed | Product availability: Epidiolex oral solution 100 mg/mL (100 mL) — no specific NDC provided in this section |
Actions Required by Providers / Prior Authorization
Prior authorization required
Prior authorization is required; approval is granted when the specified initial or continued therapy criteria are met (see Initial Approval Criteria and Continued Therapy sections).
Verify dosing and product
Reviewers should verify the prescribed product and dosing against the policy's dosing and product information, including Epidiolex oral solution concentration (100 mg/mL) and the indication-specific maximum and maintenance doses.
- Epidiolex oral solution: 100 mg/mL (100 mL)
- Maximum doses: 20 mg/kg/day (DS/LGS); 25 mg/kg/day (TSC)
- Maintenance dosing examples provided in Appendix D
Therapeutic alternatives
Therapeutic alternatives (standard antiepileptic drugs) listed in the appendices may be considered prior to Epidiolex per usual formulary management.
- Appendix lists AEDs such as topiramate, lamotrigine, valproate, levetiracetam, vigabatrin, zonisamide, carbamazepine, phenytoin, primidone and others
- Some agents are noted as off-label for certain indications
Consideration of standard therapies
Documented use or consideration of standard first-line or adjunctive anti-epileptic therapies for DS, LGS, or TSC may be relevant to the authorization decision per guideline recommendations cited in the appendices.
- NICE and specialty guidelines recommend agents such as sodium valproate, topiramate, lamotrigine, and others as first-line or adjunctive therapies depending on syndrome
- Vigabatrin is recommended first-line for TSC-associated infantile spasms
Provider attestation required
Provider attestation that the member has met all approval criteria is required to support the prior authorization request.
Reference prescribing information
Consult the references and prescribing information (Epidiolex Prescribing Information, January 2023) to support the authorization and clinical decisions.
- Epidiolex Prescribing Information. Greenwich Biosciences, Inc; January 2023. (link in Appendix D references)
Coverage not authorized for non‑FDA indications without evidence
Requests for non‑FDA approved indications that are not addressed in this policy will not be authorized unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policy (e.g., CP.PMN.53 for Medicaid).
- Non‑FDA indications require documentation according to off‑label use policies or evidence of coverage documents
Coverage decision constraints
Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents; state Medicaid provisions take precedence when in conflict.
- This policy is a guide to medical necessity and does not guarantee payment; coverage documents and legal/regulatory requirements govern
Background on Epidiolex and Indications
Epidiolex (cannabidiol) is indicated for seizures associated with Lennox‑Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged ≥ 1 year. The product is provided as an oral solution (Epidiolex oral solution 100 mg/mL); dosing and administration guidance, including initial, maintenance and maximum dose thresholds for each indication, are provided in the appendices to support coverage determinations.
Definitions and Abbreviations
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