CAPLYTA (lumateperone)

CAPLYTA (lumateperone) 

SELF ADMINISTRATION - oral

Indications for Prior Authorization:

Caplyta is an atypical antipsychotic indicated for the treatment of:

• Schizophrenia in adults.
• Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

Coverage criteria:

For diagnosis of schizophrenia:

• Dose does not exceed the maximum FDA recommendation (42 mg once daily); AND
• 18 years of age or older; AND
• Patient has a diagnosis of schizophrenia; AND
• Patient has tried and failed at least two preferred atypical antipsychotics (e.g., risperidone, quetiapine, olanzapine, ziprasidone, aripiprazole, asenapine, paliperidone).

For diagnosis of bipolar disorder:

• Dose does not exceed the maximum FDA recommendation (42 mg once daily); AND
• 18 years of age or older; AND
• Patient has depressive episodes associated with bipolar disorder; AND
• Trial and failure, contraindication, or intolerance to quetiapine (IR or ER) or olanzapine

Coverage Duration:

• One year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Moderate or severe hepatic impairment: avoid use

Policy Updates:

• 05/19/2020 - Policy reviewed
• 05/17/2022 - Added criteria approved by P&T for updated indication to treat bipolar indication. Updated format.

References:

1. Caplyta Prescribing Information. Intra-Cellular Therapies, Inc. New York, NY. April 2022.