Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seizures
Treatment: Epidiolex
The insurer denied coverage for Epidiolex
The denial is upheld 

This is a patient who was prescribed Epidiolex.
A letter of medical necessity from the treating provider indicates that the patient has tried several antiepileptic medications, including Vimpat, Keppra and clobazam, and continued to have seizures. There is no documentation of any other prior medications or any other current medications. There was no documentation noting why another antiepileptic could not be used. Medical history was of anemia, Crohn's disease, hemorrhagic stroke, requiring craniotomy and poststroke epilepsy.

Office note from the treating provider indicates that the patient was on levetiracetam 1500/1500, clobazam 20/20, and had no focal to bilateral tonic-clonic seizures (FTBTC). The patient continued to have focal seizures with left hand tingling twice weekly and may have more than one per day. The neurological examination was normal, except for decreased amplitude and frequency of rapid alternating movements in the left hand and foot. There was no specific recommendation for Epidiolex at that time.

The patient was noted to have loss of awareness focal seizures and focal to bilateral tonic-clonic seizures that were also captured in an ambulatory electroencephalogram (EEG) with right hemisphere sharp waves during sleep. The patient was initially prescribed Ativan, lacosamide and Keppra and had side effects on lacosamide which was replaced by clobazam. The patient continued to have symptoms despite being on the high dose of Keppra and clobazam. The patient continued to have breakthrough seizures. Epidiolex was being added to the current regimen for better seizure control. It was noted Epidiolex is a naturally driven epilepsy medication that has shown efficacy in treating seizure disorders.

Current listed medications were vitamin D3, clobazam, clonazepam, infliximab, levetiracetam, midazolam and pyridoxine.

A New York State external appeal application faxed indicates a request for an expedited appeal. No additional information was provided.

The health care plan acted reasonably and with sound medical judgment and in the best interests of the patient.

Epidioliex is not considered medically necessary for this patient.

There is no specific medical necessity for Epidiolex. This is a patient with focal to tonic-clonic seizures, meaning that the patient has seizures that begin focally and then generalize (with loss of consciousness and convulsions), and this is considered a form of focal localization-related epilepsy. Other than levetiracetam, lacosamide, and clobazam, there are many evidence-based antiepileptic medications that can be provided, with a short list being divalproex, lamotrigine, zonisamide, topiramate, oxcarbazepine and cenobamate, among others. Epidiolex is evidence-based (resulting from randomized controlled trials) for the treatment of epilepsies associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex. The patient has none of these conditions. All information regarding the efficacy of Epidiolex in localization-related epilepsy comes from open label studies, which cannot definitively determine efficacy. Other antiepileptic medications with indications for localization-related epilepsy have been subject to randomized controlled trials. There are ample antiepileptic medications available for the patient, all of which have a greater degree of evidence-based support than Epidiolex. Epidiolex would therefore not be considered medically necessary for this patient.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Epidiolex is not substantiated.