Pharmacy Prior Authorization Criteria

Spravato (esketamine) - PA, NF

Indications for Prior Authorization

Spravato (esketamine)

• For diagnosis of Depression
  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.

Criteria

Spravato

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)

• One of the following:
• Both of the following:
• Diagnosis of major depressive disorder
• 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 [1-5, A, B]
OR
• Both of the following:
• Diagnosis of major depressive disorder
AND
• Patient has both of the following:
• Depressive symptoms
• Acute suicidal ideation or behavior
AND
• Used in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline)
AND
• Prescribed by or in consultation with a psychiatrist

Spravato

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy.
AND
• Used in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline)

Spravato

Non Formulary

Length of Approval: 6 Month(s)

• One of the following:
• Submission of medical records (e.g. chart notes) documenting Both of the following:
• Diagnosis of major depressive disorder
• 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 [1-5, A, B]
OR
• Submission of medical records (e.g. chart notes) documenting Both of the following:
• Diagnosis of major depressive disorder
AND
• Patient has both of the following:
• Depressive symptoms
• Acute suicidal ideation or behavior
AND
• Submission of medical records (e.g. chart notes) or paid claims documenting use in combination with an oral antidepressant (e.g., duloxetine, escitalopram, sertraline)
AND
• Prescribed by or in consultation with a psychiatrist

P & T Revisions

2024-04-17, 2023-10-16, 2023-04-10, 2022-06-20, 2022-05-05, 2021-05-04, 2020-10-07, 2020-04-28

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.
4. Per clinical consult with psychiatrist, April 25, 2019.
5. Per clinical consult with psychiatrist, April 18, 2019.

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End Notes

1. 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. [2]
2. Per clinical consults with psychiatrists: A trial of antidepressants should include different classes (mechanisms of action) when defining treatment resistance. [4-5]

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Revision History

• 2024-04-17: Annual Review - no criteria changes
• 2023-10-16: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-10: Annual review - criteria update for clinical clarity
• 2022-06-20: Update Guideline
• 2022-05-05: Annual review: Background updates.
• 2021-05-04: Annual review: Background updates.
• 2020-10-07: Added criteria for new indication.
• 2020-04-28: Annual review: Added examples of oral antidepressants and updated background.

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