MMIT Reality Check on Bipolar Disorder (3Q2023)

Payer Coverage:

A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 21% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 4% of the lives under commercial policies are covered with utilization management restrictions. Almost 86% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 72% 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 53% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Abilify Asimtufii

In April 2023, the FDA approved the New Drug Application for Otsuka America Pharmaceutical, Inc. and Lundbeck’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) for 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.

FDA Approves Igalmi

In April 2022, the FDA approved BioXcel Therapeutics, Inc.’s Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with those conditions, according to the company.

Key Findings:

Market Events Drive Changes

In April 2023, the FDA approved the New Drug Application for Otsuka America Pharmaceutical, Inc. and Lundbeck’s Abilify Asimtufii (aripiprazole) for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. In January 2023, the agency approved Luye Pharma Group’s Rykindo (risperidone) for 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. In April 2022, the FDA approved BioXcel Therapeutics, Inc.’s Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Competitive Market Landscape

The market contains multiple strong oral generics. Competition among brand-name products after failure of oral generics is expected. There are multiple products in the pipeline in phase III clinical trials or later.

Pharmacy, Medical Benefit Implications

Coverage is primarily under the pharmacy benefit, but medical coverage is available for some medications. Coverage is restricted for most brand-name products. Where PA/ST is defined, it is mostly through failure of an oral generic mood stabilizer, antipsychotic or antidepressant. Antipsychotics are a Medicare-protected class, which ensures good coverage for branded agents and more rapid inclusion on formularies. Medicaid carve-outs will impact coverage.

Key Players in Market:

reality-check-bipolar disorder-3q2023-player

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© 2024 MMIT
AIS Health Staff

AIS Health Staff

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