Limited coverage criteria – cannabidiol for tuberous sclerosis complex
Last updated on December 3, 2025
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Generic name |
cannabidiol |
|
Brand name |
Epidiolex® | |
Strength & form |
100 mg/mL oral solution |
|
Special Authority criteria |
Approval period |
|---|---|
|
As adjunctive therapy for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 2 years and older if ALL the following conditions are met:
AND
AND
AND
|
Indefinite |
Practitioner exemptions
- None
Special notes
- Special Authority coverage will not be provided for cannabidiol in patients concurrently using mTOR (mechanistic target of rapamycin) inhibitors (e.g., sirolimus, everolimus) for TSC or cannabis products (i.e., prescription or recreational), or other cannabinoid-based medications (e.g., nabilone, nabiximols)
- Treatment with cannabidiol should be discontinued upon the occurrence of severe toxicity, lack of beneficial treatment effect, or intolerance
- 1TSC-associated seizures are defined as focal motor seizures without impairment of consciousness or awareness, focal seizures with impairment of consciousness or awareness, focal seizures evolving to bilateral generalized convulsive seizures, and generalized seizures (tonic-clonic, tonic, clonic and atonic) that are countable
- 2Documented baseline values for TSC-associated seizure frequency must have been observed over the 28 days immediately prior to the initiation of cannabidiol. Estimations, averages, and/or remote values will not be accepted
- Additional information expected to assist with the processing of coverage requests is detailed on the forms linked below (and on the eForms published online)