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:
- Caplyta Prescribing Information. Intra-Cellular Therapies, Inc. New York, NY. April 2022.
Last review date: May 17, 2022