MMIT Reality Check on Schizophrenia (September 2022)

Payer Coverage:

A review of market access for schizophrenia treatments shows that under the pharmacy benefit, about 26% of the lives under commercial formularies are covered with utilization management restrictions. Around 17% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 11% of the lives under commercial policies are covered with utilization management restrictions. Almost 87% 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 36% of the lives require multiple steps. Around 23% of payer-controlled pharmacy benefit covered lives require prior authorization, with 54% 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 Approves sNDA for Rexulti

In December 2021, the FDA approved the supplemental new drug application (sNDA) of Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S’s Rexulti (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. The agency first approved the drug in July 2015 for the treatment of schizophrenia in adults and for the adjunctive treatment of major depressive disorder in adults.

New Schizophrenia Drug Will Likely Have Familiar Coverage

In September 2021, the FDA approved Invega Hafyera (six-month paliperidone palmitate), a drug that the manufacturer touts as “the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.” Drug benefits experts say it could be a good option for patients who have previously been on extended-release drugs for schizophrenia — with careful monitoring — and will likely be covered similar to existing long-acting treatments.

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 the supplemental new drug application (sNDA) of Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S’s Rexulti (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age.

Competitive Market Landscape

There is a shift towards more integration of Medicaid benefits into managed care contracts, as well as a slight decline in the use of carve-out financing. Competitive contracting on brand name oral atypical antipsychotics is expected. The injectable antipsychotic landscape is trending towards longer-acting treatment for schizophrenia.

Pharmacy Benefit Implication

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. Medicaid is the largest payer for mental health services.

Key Players in Market:

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