Clinical Chart Documentation

Clinical chart documentation is provided for review to substantiate the above listed requirements. If the above prior authorization criteria are met for the applicable indication, lurasidone (Latuda) will be approved 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;
2. The member maintains adherence to the prescribed dosing regimen as evidenced by pharmacy claims record.

Experimental or Investigational / Not Medically Necessary

lurasidone (Latuda) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

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11. DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and safety of lurasidone in children and adolescents with bipolar I depression: a double-blind, placebo-controlled study. J Am Acad Child Adolesc Psychiatry. 2017;56(12):1015-1025.
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13. Hasan A, Falkai P, Wobrock T, et al; World Federation of Societies of Biological Psychiatry (WFSBP) Task Force on Treatment Guidelines for Schizophrenia. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance. World J Biol Psychiatry. 2012;13(5):318-378. doi:10.3109/15622975.2012.696143

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Clinical Guideline Revision / History Information

Original Date: 11/05/2020

Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023