WHA

Asenapine (Secuado®, Saphris®)

SELF-ADMINISTRATION - oral/topical

Indications for Prior Authorization:

  • Secuado (patch) – Indicated for the treatment of adults with schizophrenia in adults

  • Saphris (sublingual tablet) – Indicated for the treatment of:

    • Schizophrenia in adults

    • Acute mania or episodes with mixed features associated with bipolar I disorder (as monotherapy in adult and pediatric patients  great than or equal to 10 years of age or adjunctive treatment with lithium or valproate in adults) and maintenance treatment in adults (as monotherapy)

Patients must meet the following criteria for the indication(s) above:

1. Secuado - for diagnosis of schizophrenia:

  • Dose does not exceed 7.6 mg patch per 24 hours; AND

  • Inadequate response, intolerance, or contraindication to two of the following:
    • Aripiprazole
    • Olanzapine
    • Quetiapine IR/ER
    • Risperidone
    • Clozapine
    • Ziprasidone
    • Paliperidone
    • Asenapine

2. Saphris - for diagnosis of schizophrenia or bipolar I disorder (acute mania and acute episodes with mixed features):

  • Dose does not exceed 10 mg twice daily; AND

  • Inadequate response, intolerance, or contraindication to two of the following:
    • Aripiprazole
    • Olanzapine
    • Quetiapine IR/ER
    • Risperidone
    • Clozapine
    • Ziprasidone
    • Paliperidone
    • Asenapine
Coverage Duration:

  • For diagnosis of schizophrenia or bipolar I disorder: 1 year

Dosing:

1. Secuado:

  • Initiate Secuado at a dosage of 3.8 mg/24 hours (maximum recommended dose: 7.6 mg per 24 hours)

  • Secuado transdermal system is applied once daily and should be worn for 24 hours only

  • Do not cut Secuado, the whole transdermal system should be applied

2. Saphris:

  • For diagnosis of schizophrenia:

    1. Recommended dose is 5 mg twice daily (maximum recommended dose: 10 mg twice daily)

  • For diagnosis of bipolar I disorder:

    1. Monotherapy in adults: recommended starting and treatment dose of 5 mg to 10 mg twice daily (maximum recommended dose: 10 mg twice daily)

    2. Monotherapy in pediatric patients: recommended dose is 2.5 mg to 10 mg twice daily in pediatric patients 10 to 17 years of age(maximum recommended dose: 10 mg twice daily)

    3. Adjunctive therapy in adults: recommended starting dose is 5 mg twice daily when administered as adjunctive therapy with either lithium or valproate (maximum recommended dose: 10 mg twice daily)

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:

  • Drug Interactions:

    • May enhance antihypertensive effects.  Monitor blood pressure and adjust dosage of antihypertensive drugs accordingly

    • Strong CYP1A2 inhibitors: consider dose reduction for Secuado based on clinical response

    • Paroxetine (CYP2D6 substrate and inhibitor): reduce paroxetine dose by half

  • Contraindications

    • Severe hepatic impairment (i.e., Child-Pugh C)

    • Known hypersensitivity to Secuado/Saphris or to any components of the formulation

Policy Updates:

  • 02/15/2022 – New policy approved by P&T. Updated policy and added Saphris

  • 5/19/2020 - Last reviewed

References:

  1. Secuado prescribing information. Hisamitsu Pharmaceuticals Co., Inc. Japan Saga Tosu. October 2019.

  2. Saphris prescribing information. Allergan USA, Inc. Irvine, CA. January 2017

     

Last review date: February 15, 2022