MMIT Reality Check on Epilepsy (1Q2023)
A review of market access for epilepsy treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions. Around 11% of the lives under Medicare formularies are not covered for at least one of the drugs.
For about 71% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 55% require multiple steps. Around 47% of payer-controlled pharmacy benefit covered lives require prior authorization, with 44% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
FDA Approves Sezaby
In November 2022, the FDA approved Sun Pharmaceutical’s Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, the medication became the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants.
FDA Approves Zonisade
In July 2022, the FDA approved Azurity Pharmaceuticals, Inc.’s Zonisade (zonisamide oral suspension) 100 mg/5 mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.
FDA Expands Indication for Diacomit
In July 2022, the FDA expanded the patient population of Biocodex, Inc.’s Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in people between the ages of 6 months to 2 years and weighing at least 7 kg who are taking clobazam. The agency first approved the treatment on Aug. 20, 2018. The drug is available as a capsule and an oral suspension. Dosing is 50 mg/kg/day for both routes of administration. Drugs.com lists the price of 60 250 mg capsules and 60 250 mg powder for reconstitution as more than $1,589.
Market Events Drive Changes
In November 2022, the FDA approved Sun Pharmaceutical’s Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. In July 2022, the agency approved Azurity Pharmaceuticals, Inc.’s Zonisade (zonisamide oral suspension) 100 mg/5 mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.
Competitive Market Landscape
Many generic options are used in the treatment of seizures. New-to-market products will face competition from multiple established brand products for preferred coverage status.
Pharmacy, Medical Benefit Implications
Coverage of this class is mainly under the pharmacy benefit except for Sezaby, which will fall under the medical benefit. Policies may require documentation of baseline and periodic imaging or lab tests depending on the product. They may also require evidence of clinical improvement for reauthorization.
Key Players in Market: