MMIT Reality Check on Seizure Emergency

Payer Coverage:

A review of market access for seizure emergency treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions. Around 17% of the lives under health exchange formularies are not covered for at least one of the drugs.

For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 31% require multiple steps. Around 38% of payer-controlled pharmacy benefit covered lives require prior authorization, with 38% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Valtoco

In January 2020, the FDA approved Neurelis, Inc.’s Valtoco (diazepam nasal spray) for use by a care partner outside of the medical setting for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients with epilepsy who are 6 years of age and older. The agency granted extended expiration dating for the drug in October 2020.

FDA Approves Nayzilam

In May 2019, the FDA approved UCB’s Nayzilam (midazolam) nasal spray for the short-term treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. It was the first FDA-approved nasal spray option for treating seizures of any kind.

Key Findings:

Market Events Drive Changes

In January 2020, the FDA approved Neurelis, Inc.’s Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients with epilepsy who are 6 years of age and older. In May 2019, the agency approved UCB’s Nayzilam (midazolam) nasal spray for the short-term treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

Competitive Market Landscape

There are three branded products in this class for seizure emergency or cluster seizures. These are formulations of highly genericized therapies and are providing relief for seizure emergencies because they deliver the therapy much more quickly.

Pharmacy Benefit Implications

Prior to the recent approvals, most of the products in the class are oral generic products that do not work well in an emergency setting. While they are predominantly on generics tiers, they are not treatment options for emergency situations. The nasal formulations developed give patients a treatment option when they have seizures while on stable doses of their maintenance medications.

Key Players in Market:

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• Reality Check