Epileptic Medication denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Epidiolex.The medical literature supports that the requested medication is medically necessary. Epidiolex is a pharmaceutical formulation of highly purified cannabidiol (CBD) in oral solution, 100 mg/ml, usually administered at 2-10 mg/kg/day. Silvestro and colleagues have explained that CBD is one of the cannabinoids with non-psychotropic action, extracted from Cannabis sativa. They have stated that this compound has shown efficacy as an anti-seizure, antipsychotic, neuroprotective, antidepressant and anxiolytic medication. The compound’s neuroprotective activity appears linked to its excellent anti-inflammatory and antioxidant properties.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for Epidiolex 100 mg/mL, dosed at 150 mg twice a day.Scientists have explained that cannabidiol (CBD) is one of the cannabinoids with non-psychotropic action, extracted from Cannabis sativa. CBD is a terpenophenol, and it has received a great scientific interest thanks to its medical applications. This compound showed efficacy as anti-seizure, antipsychotic, neuroprotective, antidepressant and anxiolytic. The neuroprotective activity appears linked to its excellent anti-inflammatory and antioxidant properties. Researchers state that the results of scientific studies obtained so far on the use of CBD in clinical applications could represent hope for patients who are resistant to all conventional anti-epileptic drugs.

Where the denial was upheld

A 45-year-old enrollee who has been diagnosed with focal partial idiopathic epilepsy and hyponatremia. An electroencephalogram (EEG) in 2020 was noted to be abnormal with frequent right frontal and bifrontal epileptiform discharges. In June 2020, the provider noted that the patient’s sodium level was 130 mEq/L, and a switch from the medication Oxtellar to Aptiom was recommended due to the patient’s high frontal activity. The provider noted that the patient had one seizure in March 2020. The patient has requested authorization and coverage for Aptiom 800 mg tablets. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Aptiom 800 mg tablets are medically necessary for the treatment of the patient’s medical condition.

Nature of Statutory Criteria/Case Summary: The patient’s representative has requested authorization and coverage for brand name Tegretol XR, Lamictal 200 mg, and Lamictal 25 mg. Several recent studies have examined the effectiveness of brand versus generic anti-epileptic medication regimens. Researchers reported on a randomized, double-blind, multiple-dose, bioequivalence study comparing generic lamotrigine to brand Lamictal in generic-brittle epilepsy patients. The researchers found that brand and generic bioequivalence was similar and no patient subpopulation reacted poorly to generic or brand formulations. In addition, the American Epilepsy Society recognizes that well-designed, prospective studies of generic antiepileptic drug substitutions have demonstrated bioequivalence of generic products.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Epileptic Medication, then check the rights and deadlines that apply to your plan.