Caplyta (lumateperone)

Caplyta (lumateperone) is an atypical antipsychotic medication used in the treatment of schizophrenia in adults, as well as depressive episodes associated with bipolar I or II disorder in adults, both as a monotherapy and as adjunctive therapy with lithium or valproate.

Bipolar Depression and Schizophrenia

Bipolar depression and schizophrenia are different types of mental health conditions. Treatment plans for both conditions usually include both drug and non-drug treatments. Medicines, such as Caplyta (lumateperone), are often a part of treatment for both bipolar depression and schizophrenia. Other medications in the group of second generation antipsychotics include, but are not limited to aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. Tolerance and response to antipsychotic agents vary, and patients who do not tolerate or respond to a specific agent may be treated with a different agent and expect a different response or adverse effect(s). The choice of an antipsychotic agent depends on a multitude of factors, including but not limited to response (or lack thereof) to previously used medications, safety and tolerability of each agent, and patient-specific considerations.

Definitions

• Adjunctive therapy is treatment with an additional medication added to the main therapy.
• Atypical antipsychotics are second generation antipsychotic medications used to treat conditions like schizophrenia and bipolar disorder. Examples include aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone.
• Bipolar depression refers to depressive episodes associated with bipolar disorder.
• Bipolar disorder is a mental health condition characterized by extreme mood swings between manic and depressive episodes.
• Monotherapy means treatment with a single medication.
• Schizophrenia is a chronic mental health condition characterized by hallucinations, delusions, disorganized thinking and behavior.
• Schizoaffective disorder (ScAD) is a mental health condition which has both psychotic symptoms and mood (affective) disorder symptoms. People with ScAD may have symptoms of depression (e.g., feeling sad, empty) or mania (e.g., raised mood, feel powerful and can do anything).

Clinical Indications

Medical Necessity Criteria for Initial Authorization

The Plan considers Caplyta (lumateperone) medically necessary when ALL of the following criteria are met:

1. The medication is prescribed by or in consultation with a psychiatrist; AND
2. The member is 18 years of age or older; AND
3. The member meets the applicable indication-specific criteria listed below:

Bipolar Disorder:

1. The medication is being requested for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression); AND
2. The member has tried and failed at least a one-month trial of ONE of the following:
   • Lurasidone; and/or
   • Quetiapine immediate-release or extended-release; and/or
   • Olanzapine and fluoxetine in combination.

Schizophrenia:

1. The member has a diagnosis of schizophrenia; AND
2. The member is unable to use or has adequately tried and failed at least a one-month trial to TWO (2) of the following:
   • Aripiprazole; and/or
   • Olanzapine; and/or
   • Risperidone; and/or
   • Paliperidone; and/or
   • Quetiapine; and/or
   • Ziprasidone.

Schizoaffective Disorder:

1. The member has a diagnosis of schizoaffective disorder; AND
2. The member is unable to use or has adequately tried and failed at least a one-month trial to BOTH of the following:
   • Paliperidone; and
   • ONE of the following:
     1. Aripiprazole; or
     2. Olanzapine; or
     3. Risperidone; or
     4. Quetiapine; or
     5. Ziprasidone.

If the above prior authorization criteria are met, Caplyta (lumateperone) will be authorized for 12- months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. Chart documentation shows the member has experienced clinical response to the requested therapy as evidenced by one of the following:
   • Clinical improvement (e.g., reduction in intensity or severity of symptoms) since starting the requested medication; or
   • Stability in condition (e.g., stabilizing mood, return to normal psychosocial functioning) since starting the requested medication;
   AND
2. The member maintains adherence to the prescribed dosing regimen as evidenced by pharmacy claims record.

Experimental or Investigational / Not Medically Necessary

Caplyta (lumateperone) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Agitation in Dementia, Including Alzheimer's Disease
• Borderline Personality Disorder (BPD)
• Major Depressive Disorder (MDD)

References

1. Caplyta (lumateperone) [prescribing information]. New York, NY: Intra-Cellular Therapies Inc; June 2023.
2. Corponi F, Fabbri C, Bitter I, et al.

References

2. Corponi F, Fabbri C, Bitter I, et al. Novel antipsychotics specificity profile: a clinically oriented review of lurasidone, brexpiprazole, cariprazine and lumateperone. Eur Neuropsychopharmacol. 2019;29(9):971-985. doi:10.1016/j.euroneuro.2019.06.008
3. Keepers GA, Fochtmann LJ, Anzia JM, et al. The American Psychiatric Association practice guideline for the treatment of patients with schizophrenia. Am J Psychiatry. 2020;177(9):868-872. doi:10.1176/appi.ajp.2020.177901
4. Reus VI, Fochtmann LJ, Eyler AE, et al. The American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia. Am J Psychiatry. 2016;173(5):543-546. doi:10.1176/appi.ajp.2015.173501
5. World Federation of Societies of Biological Psychiatry; Ihl R, Frölich L, Winblad B, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of Alzheimer's disease and other dementias. World J Biol Psychiatry. 2011;12(1):2-32. doi:10.3109/15622975.2010.538083

Clinical Guideline Revision / History Information

Original Date: 9/21/2023

Reviewed/Revised: 4