MMIT Reality Check on Bipolar Disorder (July 2022)

Payer Coverage:

A review of market access for bipolar disorder treatments shows that under the pharmacy benefit, about 24% of the lives under commercial formularies are covered with utilization management restrictions. Around 19% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 6% of the lives under commercial policies are covered with utilization management restrictions. Almost 74% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 73% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 35% of the lives require multiple steps. Around 23% of payer-controlled pharmacy benefit covered lives require prior authorization, with 47% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

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.

FDA Grants Caplyta Label Expansion

In December 2021, the FDA approved a label expansion for Intra-Cellular Therapies, Inc.’s Caplyta (lumateperone) to include the treatment of depressive episodes associated with bipolar I or II disorder in adults as monotherapy and as adjunctive therapy with lithium or valproate.

FDA Approves Lybalvi

In May 2021, the FDA approved Alkermes plc’s Lybalvi (olanzapine and samidorphan) for adults with schizophrenia and for adults with bipolar I disorder as a maintenance monotherapy and for the acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate.

Key Findings:

Market Events Drive Changes

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. In December 2021, the agency approved a label expansion for Intra-Cellular Therapies, Inc.’s Caplyta (lumateperone) to include the treatment of depressive episodes associated with bipolar I or II disorder in adults as monotherapy and as adjunctive therapy with lithium or valproate.

Competitive Market Landscape

The market contains multiple strong oral generics. Competition among brand-name products after failure of oral generics is expected.

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:

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