WHA

LYBALVI (olanzapine/samidorphan)

SELF-ADMINISTRATION - ORAL

FDA Approved Indications:

  • Indicated for the treatment of:

    • Schizophrenia in adults

    • Acute mania or acute episodes with mixed features of bipolar I disorder (as monotherapy or in combination to lithium or valproate), and maintenance monotherapy treatment

Prior Authorization Criteria:

1. For diagnosis of schizophrenia or bipolar I disorder (acute mania and acute episodes with mixed features):

  • Dose does not exceed olanzapine 20 mg/samidorphan 10 mg once daily; AND

  • Inadequate response, intolerance, or contraindication to two of the following:

    • Aripiprazole

    • Olanzapine

    • Quetiapine IR/ER

    • Risperidone

    • Clozapine

    • Ziprasidone

    • Paliperidone

    • Asenapine; AND

  • Provider attestation is required confirming that no opioids will be used in combination with Lybalvi

Coverage Duration

  • 1 year

Dosing

1. For diagnosis of bipolar I disorder (acute mania and acute episodes with mixed features):

  • Monotherapy:

    1. Initiate Lybalvi at 10 mg/10 mg or 15 mg/10 mg once daily

    2. Recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

    3. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on olanzapine component) are recommended

    4. Maximum recommended dosage is 20 mg/10 mg once daily

  • Maintenance monotherapy

    1. Administer Lybalvi at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

  • Adjunctive to lithium or valproate

    1. Initiate Lybalvi at 10 mg/10 mg once daily

    2. Recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg once daily

    3. When dosage adjustments are necessary, dose increments/decrements of 5 mg (based on olanzapine component) are recommended up to a maximum recommended dosage of 20 mg/10 mg once daily

2. For diagnosis of schizophrenia:

  • Initiate Lybalvi at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg orally once daily. 

  • The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily

  • Dosage may be adjusted at weekly intervals of 5 mg (based on olanzapine component) depending upon clinical response and tolerability, up to a maximum recommended dosage of 20 mg/10 mg

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:

  • Administration: Do not divide tablets or combine strengths

  • Warning: Lybalvi is not approved for the treatment of patients with dementia-related psychosis

  • Contraindications:

    • Patients using opioids

    • Patients undergoing acute opioid withdrawal

    • If Lybalvi is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for those products

  • Drug Interactions:

    • Strong CYP3A4 Inducers: Not recommended

    • Strong CYP1A2 Inhibitors: Consider dosage reduction of olanzapine component of Lybalvi

    • CYP1A2 Inducer: Consider dosage increase of the olanzapine component of Lybalvi

    • CNS acting drugs: May potentiate orthostatic hypertension

    • Anticholinergic drugs: Can increase risk for severe gastrointestinal adverse reactions

    • Antihypertensive agents: Monitor blood pressure

    • Levodopa and dopamine agonists: Not recommended

Policy Updates

  • 2/15/2022 – New policy approved by P&T committee

References

  1. Lybalvi prescribing information. Alkermes, Inc. Waltham, MA. May 2021.

 

Last review date: February 15, 2022