Esketamine (Spravato™)

OFFICE ADMINISTERED - NASAL SPRAY

 

Indications for Prior Authorization:

  • Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults

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

  • Patient is 18 years of age or older, AND
  • Prescribed by a psychiatrist, AND
  • Diagnosis of treatment-resistant depression, AND
  • Proposed trial and failure criteria options:
    1. Trial and failure of at least 2 different antidepressants, each from a different pharmacologic class (e.g. selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs], bupropion, mirtazapine, etc) and each used at therapeutic dosages for at least 6 weeks in the current episode of depression, according to the prescribing physician, AND
    2. Trial and failure of at least 2 different antidepressant augmentation therapies (e.g. second-generation antipsychotic, lithium) and each used at therapeutic dosages for at least 4 weeks
    3. Trial and failure of at least 3 different agents [one of the agents must be used for antidepressant augmentation therapy (e.g. second-generation antipsychotic, lithium)] and each used at therapeutic dosages for at least 8 weeks , AND
  • Patient is concomitantly receiving at least one oral antidepressant (must not be one of the agents previously failed?), AND
  • Patient does not have a contraindication to treatment:
    • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation
    • Intracerebral hemorrhage, AND
  • Patient has one of the following:
    • No history of psychosis, OR
    • History of psychosis and the prescriber believes that the benefits of Spravato outweigh the risks

Dosing:

  • Must be administered under the direct supervision of a healthcare provider and the patient must be observed for at least 2 hours after administration
  • Week 1-4: Administer twice per week
    • Day 1: 56mg
    • Subsequent doses: 56mg or 84 mg
  • Week 5-8: Administer once weekly
    • 56mg or 84mg
  • Week 9 and after: Administer every 2 weeks or once weekly (frequency should be individualized to the least frequent dosing to maintain response/remission)
    • 56mg or 84mg

Approval:

  • Initial: 1 month
  • Renewal: 6 months

Last review date: November 27, 2019