Pharmacy Prior Authorization Criteria

Igalmi (dexmedetomidine)

Indications for Prior Authorization

Igalmi (dexmedetomidine)

• For diagnosis of Agitation
  Indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Limitations of Use: The safety and effectiveness of Igalmi has not been established beyond 24 hours from the first dose.

Criteria

Igalmi

Prior Authorization

Length of Approval: 14 Days [A]

• One of the following diagnoses:
• Schizophrenia
• Bipolar I or II disorder
AND
• For the treatment of acute agitation [B, 1]
AND
• Trial and failure, contraindication or intolerance to at least two products used in acute agitation (e.g., olanzapine, ziprasidone) [C, 2-5]
AND
• Patient is currently being managed with maintenance medication for their underlying disorder (e.g., aripiprazole, olanzapine, quetiapine, lithium, valproic acid)

P & T Revisions

2024-06-13, 2023-06-27, 2022-06-09

References

1. Wilson, M., Pepper, D. et al. The Psychopharmacology of Agitation: Consensus Statement of the American Association for Emergency Psychiatry Project BETA Psychopharmacology Workgroup. West J Emerg Med. 2012 Feb; 13(1): 26–34. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298219/. Accessed June 6, 2022.
2. Garriga M, Pacchiarotti I, Kasper S, Zeller SL, Allen MH, Vazquez G, et al. Assessment and management of agitation in psychiatry: expert consensus. World J Biol Psychiatry. (2016) 17:86–128. doi: 10.3109/15622975.2015.1132007. Accessed June 6, 2022.
3. Zeller, S., Citrome, L. Managing Agitation Associated with Schizophrenia and Bipolar Disorder in the Emergency Setting. West J Emerg Med. 2016 Mar; 17(2): 165–172. doi: 10.5811/westjem.2015.12.28763. accessed June 6, 2022.
4. Miller, J. Managing acute agitation and aggression in the world of drug shortages. Mental Health Clinician (2021) 11 (6): 334–346. https://doi.org/10.9740/mhc.2021.11.334. Accessed June 6, 2022.
5. Schleifer, J. Management of acute agitation in psychosis: an evidence-based approach in the USA. Jan 2, 2018. Available at https://www.cambridge.org/core/journals/advances-in-psychiatric-treatment/article/management-of-acute-agitation-in-psychosis-an-evidencebased-approach-in-the-usa/AC36BE73F3238B40EBDFC719B62D93E6. Accessed June 6, 2022.
6. Roppolo, L., Morris, D. et al. Improving the management of acutely agitated patients in the emergency department through implementation of Project BETA (Best Practices in the Evaluation and Treatment of Agitation). https://doi.org/10.1002/emp2.12138. Accessed June 6, 2022.
7. Zyprexa Prescribing Information. Lilly USA, LLC. Indianapolis, IN. February 2022.
8. Risperdal Prescribing Information. Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2022..
9. Geodon Prescribing Information. Pfizer Inc. New York, NY. February 2022.
10. Abilify Prescribing Information. Otsuka America Pharmaceutical, Inc. Rockville, MD. August 2021.
11. Seroquel Prescribing Information. AstraZeneca Pharmaceuticals, LP. Wilmington, DE. January 2022.
12. Saphris Prescribing Information. Breckenridge Pharmaceuticals, Inc. Berlin, CT. July 2021.
13. Igalmi Prescribing Information. BioXcel Therapeutics, Inc. New Haven, CT. April 2022.
14. Marder, S. Uptodate. Psychosis in adults: Initial management. Available at https://www.uptodate.com/contents/psychosis-in-adults-initial-management?sectionName=INITIAL%20MANAGEMENT&search=AGITITAION%20IN%20SCHIZOPHRENIA&topicRef=14805&anchor=H4035521878&source=see_link#H4035521878. Accessed June 6, 2022.
15. Curry, A., Malas, N., Mroczkowski, M., et al. Updates in the Assessment and Management of Agitation. Available at: https://focus.psychiatryonline.org/doi/10.1176/appi.focus.20220064. Accessed June 13, 2024.
16. UptoDate. Assessment and emergency management of the acutely agitated or violent adult. Available at: https://www.uptodate.com/contents/assessment-and-emergency-management-of-the-acutely-agitated-or-violent-adult. Accessed June 13, 2024.

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End Notes

1. The safety and effectiveness of Igalmi has not been established beyond 24 hours from the 1st dose. Clinical studies were done on patients who were admitted to a clinical research unit or a hospital and remained under medical supervision for at least 24 hours following treatment. If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart. [13]
2. We consider agitation to be a psychiatric emergency. Agitation is a state of motor restlessness or excitement and is often accompanied by mental tension and irritability. [14]
3. With the emergence of second generation (atypical) antipsychotics(SGA's), the expert consensus-based guidelines recommend SGA's as 1st line therapy [2]

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Revision History

• 2024-06-13: 2024 Annual Review.
• 2023-06-27: 2023 Annual Review.
• 2022-06-09: New UM PA Criteria

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