SPRAVATO (esketamine)

SPRAVATO (esketamine)

Office Administration – nasal spray 

Allowed under the pharmacy benefit for ease of access

Indications for Prior Authorization:

• Indicated, in conjunction with an oral antidepressant, for the treatment of:
  • Treatment-resistant depression (TRD) in adults
  • Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior
• Limitations of Use:
  • The effectiveness of Spravato in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of Spravato does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of Spravato.
  • Spravato is not approved as an anesthetic agent. The safety and effectiveness of Spravato as an anesthetic agent have not been established.

Coverage Criteria:

For diagnosis of depression:

• Dose does not exceed FDA approved maximum dosing, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a psychiatrist, AND
• Spravato will be administered under the direct supervision of a healthcare provider, AND
• One of the following (A or B):
  • A. Both of the following (I and II):
    • I. Diagnosis of treatment-resistant major depressive disorder, and
    • II. Patient has not experienced a clinical meaningful improvement after treatment with at least TWO antidepressants from different classes for an adequate duration (at least 4 weeks each) in the current depressive episode, OR
  • B. Both of the following (i and ii):
    • i. Diagnosis of major depressive disorder, and
    • ii. Patient has both depressive symptoms and acute suicidal ideation or behavior, AND
• Used in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline) 

Reauthorization Criteria:

For diagnosis of depression:

• Dose does not exceed FDA approved maximum dosing, AND
• Documentation of positive clinical response to therapy, AND
• Used in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline)

Coverage Duration: 

• Initial: 
  • TRD: 3 months
  • MDD with acute suicidal ideation or behavior: 1 month
• Reauthorization: 
  • TRD: 1 year

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.
 

Spravato is available as a nasal spray.  Other esketamine dosage forms are not Food and Drug Administration (FDA) approved and are not covered.

Additional Information: 

• Dosing:
  • Administer Spravato in conjunction with an oral antidepressant (AD).
  • Treatment-resistant depression (TRD):
    • Week 1-4: Administer twice per week
      • Day 1: 56 mg
      • Subsequent doses: 56 mg or 84 mg
    • Week 5-8: Administer once weekly
      • 56 mg or 84 mg
    • Week 9 and after: Administer every 2 weeks or once weekly (frequency should be individualized to the least frequent dosing to maintain response/remission)
      • 56 mg or 84 mg
  • Major depressive disorder (MDD) with acute suicidal ideation or behavior:
    • 84 mg twice per week for 4 weeks
    • The dosage may be reduced to 56 mg twice per week based on tolerability.
    • After 4 weeks of treatment, evidence of therapeutic benefit should be evaluated to determine need for continued treatment.
    • The use of Spravato, in conjunction with an oral antidepressant, beyond 4 weeks has not been systematically evaluated in the treatment of depressive symptoms in patients with MDD with acute suicidal ideation or behavior.
  • During and after Spravato administration at each treatment session, the patient should be observed for at least 2 hours until the patient is safe to leave.
• According to the American Psychiatric Association, generally, 4–8 weeks of treatment are needed before concluding that a patient is partially responsive or unresponsive to a specific intervention.
• Contraindications include:
  • Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation
  • History of intracerebral hemorrhage
  • Hypersensitivity to esketamine, ketamine, or any of the excipients.
• Spravato contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion.
• Spravato is available only through a restricted program under a REMS.
• Examples of antidepressants classes include but are not limited to the following:
  • Selective serotonin reuptake inhibitors [SSRIs]
  • Serotonin-norepinephrine reuptake inhibitors [SNRIs]
  • Tricyclic antidepressants [TCAs]
  • Bupropion
  • Mirtazapine

Policy Updates:

• 11/15/2022 – MDD with acute suicidal ideation or behavior diagnosis added.  Revised criteria and created reauthorization criteria.  
• 2/18/2020 – New policy approved by P&T.

References:

1.    Spravato Prescribing Information. Janssen Pharmaceuticals, Inc. Titusville, NJ. July 2020. 
2.    American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (3rd Edition). October 2010. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Accessed March 31, 2022. 
3.    Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-17.