MMIT Reality Check on Seizure Emergency (2Q2023)

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 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 43% require multiple steps. Around 39% of payer-controlled pharmacy benefit covered lives require prior authorization, with 8% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Gives Tentative Approval to Libervant

In August 2022, the FDA gave tentative approval to Aquestive Therapeutics, Inc.’s Libervant (diazepam buccal film) 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 patients with epilepsy 12 years of age and older. Due to an existing FDA regulatory grant of orphan drug market exclusivity for Neurelis, Inc.’s Valtoco (diazepam nasal spray), Libervant is not yet eligible for marketing in the U.S.

FDA Approves Valtoco

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. 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 August 2022, the FDA gave tentative approval to Aquestive Therapeutics, Inc.’s Libervant (diazepam buccal film) 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 patients with epilepsy 12 years of age and older. Due to an existing FDA regulatory grant of orphan drug market exclusivity for Neurelis, Inc.’s Valtoco (diazepam nasal spray), Libervant is not yet eligible for marketing in the U.S. In January 2020, the agency approved Valtoco 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.

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. New-to-market products should expect to compete with rectal and nasally administered branded benzodiazepine products, as well as an available rectal diazepam gel.

Pharmacy Benefit Implications

Current products in this indication are reimbursed through the pharmacy benefit. 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:

reality-check-seizure-emergency-player-2q2023

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© 2024 MMIT
AIS Health Staff

AIS Health Staff

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