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L.5.01.407
Caplyta (lumateperone)Fanapt (iloperidone)Secuado (asenapine patch)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Atypical antipsychotics, as a group, have diverse pharmacodynamic profiles differing considerably from the typical antipsychotics, but in general have an increased affinity for serotonin 5-HT2 receptors compared with D2 receptors. They act on several neurotransmitter systems, including antagonism at 1 or more types of dopamine receptors (e.g., D1, D2, D4, D5); selectivity for limbic dopamine receptors; antagonism at 1 or more types of serotonin receptors (e.g., 5-HT1, 5-HT2); antagonism at alpha-1 adrenergic receptors; and activity at muscarinic or histamine H1 receptors.
Caplyta (lumateperone) is indicated for the treatment of schizophrenia in adults and depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
Fanapt (iloperidone) is indicated for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Secuado (asenapine patch) is indicated for treatment of adults with schizophrenia.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Caplyta (lumateperone) and Secuado (asenapine patch) are currently not covered on any BCBSMS formularies.
Fanapt (iloperidone) may be considered medically necessary for individuals who meet ALL of the following criteria:
ONE of the following:
The individual has had an intolerance or treatment failure of two generic atypical antipsychotics (aripiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone);OR
The individual has previously used (or is currently using) the requested agent at any time in the past with success;
The individual does not have any FDA-labeled contraindications to requested agent; AND
The dosage prescribed is within the program quantity limits based on approved FDA-labeled dosing.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
Medication failure is defined as inadequate response to therapy despite maximally tolerated dose (>4 weeks use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.
Medication IntoleranceMedication intolerance is defined as the inability to digest, metabolize, or mitigate the expected adverse effects of a prerequisite medication for ≥4 weeks use as evidenced by documented attempted intervention(s) to minimize sensitivity where appropriate (i.e., dose titration, dose reduction, administered with food, administration at different times of day, use of alternative formulation(s) etc.) and claims history. Experience of common side effects of medication will not be considered medication intolerance for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If a member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: New policy added.
07/06/2015: Code Reference section updated for ICD-10.
10/26/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.
05/26/2016: Policy number L.5.01.407 added.
02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
06/01/2017: Policy description updated regarding indications for Saphris and Latuda. Policy statements unchanged.
02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
04/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Policy description updated regarding indications for Latuda (lurasidone). Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources updated.
04/15/2020: Policy description updated to add indications for Caplyta (lumateperone) and Secuado (asenapine patch). Policy section updated to state that Caplyta (lumateperone) and Secuado (asenapine patch) are currently not covered on any BCBSMS formularies. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to remove Invega (paliperidone), Latuda (lurasidone), and Saphris (asenapine). Policy description updated regarding indications for Caplyta (lumateperone) and Fanapt (iloperidone). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary statement updated to remove Invega (paliperidone), Latuda (lurasidone), and Saphris (asenapine). Revised list of generic atypical antipsychotics and added criteria regarding contraindications and dose requirements. Policy Exceptions updated to remove statement that atypical antipsychotic prior authorization is not required for Federal Employee Program (FEP) members. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding medication failure and medication intolerance. Sources updated.
Caplyta prescribing information. Intra-Cellular Therapies, Inc. June 2023. Last accessed March 2025.
Fanapt prescribing information. Vanda Pharmaceuticals Inc. February 2025. Last accessed March 2025.
Invega prescribing information. Janssen Pharmaceuticals, Inc. February 2025. Last accessed March 2025.
Latuda prescribing information. Sumitomo Pharma America, Inc. January 2025. Last accessed March 2025.
Saphris prescribing information. Allergan, Inc. January 2025. Last accessed March 2025.
Secuado prescribing information. Noven Therapeutics, LLC. January 2025. Last accessed March 2025.
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