Pharmacy Prior Authorization Criteria

Epidiolex (cannabidiol)

Indications for Prior Authorization

Epidiolex (cannabidiol oral solution)

• For diagnosis of Lennox-Gastaut syndrome (LGS)
  Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.

• For diagnosis of Dravet syndrome (DS)
  Indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 1 year of age and older.

• For diagnosis of Tuberous sclerosis complex (TSC)
  Indicated for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Criteria

Epidiolex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Lennox-Gastaut syndrome (LGS)

• Diagnosis of seizures associated with Lennox-Gastaut syndrome (LGS)
AND
• Trial of, contraindication, or intolerance to TWO formulary anticonvulsants (e.g., topiramate, lamotrigine, valproate) [2, A-B]
AND
• Patient is 1 year of age or older
AND
• Prescribed by or in consultation with a neurologist

Epidiolex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Dravet syndrome (DS)

• Diagnosis of seizures associated with Dravet syndrome (DS)
AND
• Patient is 1 year of age or older
AND
• Prescribed by or in consultation with a neurologist

Epidiolex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous sclerosis complex

• Diagnosis of seizures associated with tuberous sclerosis complex (TSC)
AND
• Patient is 1 year of age or older
AND
• Prescribed by or in consultation with a neurologist

Epidiolex

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), Tuberous sclerosis complex (TSC)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-04-22, 2023-09-29, 2023-04-06, 2022-05-05, 2021-09-27, 2021-05-19, 2020-10-07, 2020-04-24

References

1. Epidiolex Prescribing Information. Greenwich Biosciences, Inc. Carlsbad, CA. April 2022.
2. Per clinical consult with neurologist, July 30, 2018.
3. Devinsky O, Patel AD, Cross JH, et al. Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897.
4. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77.

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End Notes

1. The effectiveness of Epidiolex for the treatment of seizures associated with LGS was established in two randomized, double-blind, placebo-controlled trials in patients aged 2 to 55 years. In study 2, 225 patients underwent randomization, of whom 76 were assigned to the 20-mg cannabidiol group, 73 to the 10-mg cannabidiol group, and 76 to the placebo group; Patients in each group had previously received a median of 6 antiepileptic drugs (range, 0 to 22), but the drugs had failed to control the seizures; the patients were receiving a median of 3 antiepileptic drugs concomitantly at the time of trial entry. [3]
2. To improve patient care and facilitate clinical research, the International League Against Epilepsy (ILAE) appointed a Task Force to formulate a consensus definition of drug resistant epilepsy. The following definition was formulated: Drug resistant epilepsy may be defined as failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. [4]

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Revision History

• 2024-04-22: Annual review - No criteria changes
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-06: Annual review - No criteria changes
• 2022-05-05: Annual review, addition of age requirement
• 2021-09-27: 2021 Annual Review, no changes to criteria.
• 2021-05-19: 2021 Annual Review, no changes to criteria.
• 2020-10-07: Updated with new TSC indication and expanded age for all indications.
• 2020-04-24: 2020 Annual Review, no changes to criteria.

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