Asenapine (Saphris)

Asenapine (Saphris) is a second generation antipsychotic, also referred to as an atypical antipsychotic. It is FDA-approved for the treatment of:

1. schizophrenia in adults.
2. bipolar I disorder in patients 10 years of age and older.

Bipolar disorder 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 asenapine (Saphris), are often a part of treatment for both bipolar disorder 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

Bipolar disorder is a mental health condition which includes episodes of emotional highs (mania) and lows (depression). It may cause extreme changes in behavior and mood, such as feeling much happier or sadder than normal.

Schizophrenia is a psychiatric disorder involving chronic or recurrent psychosis and is commonly associated with impairments in social and occupational functioning.

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

The Plan considers asenapine (Saphris) medically necessary when ALL the following criteria are met for the applicable indication listed below:

Medical Necessity Criteria for Initial Authorization

Bipolar Disorder:

1. The requested medication is prescribed by or in consultation with a psychiatrist; AND
2. The member is 10 years of age or older; AND
3. The member has a diagnosis of bipolar disorder; AND
4. 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; AND
5. Clinical chart documentation is provided for review to substantiate the above listed requirements.

Schizophrenia:

1. The requested 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 has a diagnosis of schizophrenia; AND
4. 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; AND
5. Clinical chart documentation is provided for review to substantiate the above listed requirements.

Schizoaffective Disorder:

1. The requested 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 has a diagnosis of schizoaffective disorder; AND
4. 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; AND
5. 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, asenapine (Saphris) will be approved for 12 months.

Agitation/Aggression associated with psychiatric disorders, substance intoxication, or other organic causes

1. The requested 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 has severe agitation/aggression requiring pharmacotherapy associated with one of the following:
   • Psychiatric disorder (e.g. bipolar disorder, schizophrenia); or
   • Substance intoxication; or
   • Other organic causes (e.g., CNS diseases including Parkinson’s, Alzheimer’s, other dementias, encephalitis, meningitis, or brain trauma); AND
4. The member has not responded to less invasive management strategies, such as verbal de-escalation; AND
5. The member is characterized by ONE of the following:
   • Has a contraindication to or has failed a trial of first-line immediate-acting intramuscular (e.g., aripiprazole IM, lorazepam IM, olanzapine IM) or inhaled medications (e.g., loxapine inhaled); or
   • Exhibits milder symptoms and is willing to take oral medication; AND
6. The requested dose is within FDA approved labeling or generally accepted guidelines (i.e., 10 mg as a single dose); AND

Chart documentation is provided detailing the symptoms and management that support the criteria above. If the above prior authorization criteria are met for the applicable indication, asenapine (Saphris) will be approved for up to 7-days.

Medical Necessity Criteria for Reauthorization:

Bipolar Disorder, Schizophrenia, Schizoaffective Disorder:

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.

Agitation/Aggression associated with psychiatric disorders, substance intoxication, or other organic causes

Reauthorization for up to 14-days will be granted if there is documentation indicating that symptoms have responded (i.e., improvement in agitation/aggression symptoms) but aggressive behavior is not yet fully resolved or controlled.

Experimental or Investigational / Not Medically Necessary

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

References

1. Azorin JM, Sapin C, Weiller E. Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses. J Affect Disord 2013; 145:62.
2. Citrome L, Weiden PJ, McEvoy JP, et al. Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study. CNS Spectr. 2014;19(4):330-339.
3. Vázquez, Leonardo Baldaçara, Luis San, R. Hamish McAllister-Williams, Konstantinos N. Fountoulakis, Philippe Courtet, Dieter Naber, Esther W. Chan, Andrea Fagiolini, Hans Jürgen Möller, Heinz Grunze, Pierre Michel Llorca, Richard L. Jaffe, Lakshmi N. Yatham, Diego Hidalgo- Mazzei, Marc Passamar, Thomas Messer, Miquel Bernardo & Eduard Vieta (2016) Assessment and management of agitation in psychiatry: Expert consensus, The World Journal of Biological Psychiatry, 17:2, 86-128, DOI: 10.3109/15622975.2015.1132007
4. 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
5. Inoue Y, Suzuki H...

   Clinical Guideline Revision / History Information

   Original Date: 11/05/2020

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

   1. Inoue Y, Suzuki H... (Text truncated intentionally)