MMIT Reality Check on Schizophrenia (3Q2023)

Payer Coverage:

A review of market access for schizophrenia treatments shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 10% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 10% of the lives under commercial policies are covered with utilization management restrictions. Around 88% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 71% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 44% of the lives require multiple steps. Around 23% of payer-controlled pharmacy benefit covered lives require prior authorization, with 61% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Uzedy

In April 2023, the FDA approved Teva Pharmaceuticals and MedinCell’s Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. This is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone, according to the manufacturers.

FDA Approves Abilify Asimtufii

In April 2023, the FDA approved the New Drug Application for Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S’s Abilify Asimtufii (aripiprazole) extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.

FDA Approves Rykindo

In January 2023, the FDA approved Luye Pharma Group’s Rykindo (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

Key Findings:

Market Events Drive Changes

In April 2023, the FDA approved Teva Pharmaceuticals and MedinCell’s Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. The same month, the agency approved Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S’s Abilify Asimtufii (aripiprazole), an extended-release injectable, for the treatment of schizophrenia in adults.

Competitive Market Landscape

Alkermes, Inc.’s Lybalvi (olanzapine and samidorphan), a combination (atypical antipsychotic plus opioid antagonist) product, brought another treatment option to an otherwise crowded market with its May 2021 approval. Competitive contracting on brand name oral atypical antipsychotics is expected. The injectable antipsychotic landscape is trending towards longer-acting treatments for schizophrenia.

Pharmacy, Medical Benefit Implications

Coverage is primarily under the pharmacy benefit, but medical benefit coverage is available for some medications. Coverage is restricted for most brand name oral atypical antipsychotics, which will require a step through generic products.

Key Players in Market:

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