MMIT Reality Check on Antiepileptic Drugs

Payer Coverage:

A review of market access for antiepileptic drugs (AEDs) shows that under the pharmacy benefit, about 38% of the lives under commercial formularies are covered with utilization management restrictions. Around 13% of the lives under Medicare formularies are not covered for at least one of the drugs.

For about 75% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 49% require multiple steps. Around 46% of payer-controlled pharmacy benefit covered lives require prior authorization, with 36% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Eprontia

In November 2021, the FDA approved Azurity Pharmaceuticals, Inc.’s Eprontia (topiramate) oral solution as a monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as a preventive treatment of migraine in patients 12 years of age and older. It is the first and only liquid formulation of topiramate to be approved by the FDA.

FDA Expands Indication for Vimpat

In October 2021, the FDA approved UCB, Inc.’s Vimpat (lacosamide) for the treatment of partial-onset seizures in patients 1 month of age and older. The medication was previously approved for this indication in patients 4 years of age and older.

FDA Expands Indication for Briviact

In August 2021, the FDA approved an expanded indication for UCB’s Briviact (brivaracetam) CV tablets, oral solution and injection to treat partial-onset seizures in patients as young as 1 month of age. The medication was approved in 2016 as an add-on therapy for adult patients. It was approved as monotherapy for adults in September 2017 and as monotherapy or adjunctive therapy in patients 4 years of age and older with partial-onset seizures in 2018.

Key Findings:

Market Events Drive Changes

In November 2021, the FDA approved Azurity Pharmaceuticals’ Eprontia (Azurity) as monotherapy for partial-onset or primary generalized tonic-clonic seizures in patients aged 2 years and above; as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and above; and as a preventive treatment of migraine in patients 12 years of age and older. In October 2021, the FDA approved a label extension for UCB’s Vimpat (lacosamide) for the treatment of partial-onset seizures in patients 1 month of age and older.

Competitive Market Landscape

Many generic options are used in the treatment of seizures. New players have emerged, but big prescription sales are illusive in comparison with previous generic and brand AEDs. Significant restrictions are observed for the most recently launched products in this class.

Pharmacy, Medical Benefit Implications

Coverage of this class is under the pharmacy benefit. For most brand AEDs, they are generally covered with a prior authorization. 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:

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