IGALMI (dexmedetomidine film)

IGALMI (dexmedetomidine film)

Medical Administration – sublingual 

Diagnosis considered for coverage:

• 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 have not been established beyond 24 hours from the first dose

Coverage Criteria:

For diagnosis of agitation associated with schizophrenia or bipolar I or II disorder:

• Dose does not exceed FDA label maximum dose:
  • Mild or moderate agitation: 240 mcg daily
  • Severe agitation: 360 mcg daily; AND
• Documented diagnosis of schizophrenia OR bipolar I or II disorder; AND
• Patient is 18 years and older; AND
• Used for the treatment of acute agitation; AND
• Patient has tried and failed, has a contraindication or intolerance to at least two products used in acute agitation (e.g., olanzapine, ziprasidone); AND
• Patient is managed with maintenance medication for their underlying disorder (e.g., aripiprazole, olanzapine, quetiapine, lithium, valproic acid)

Coverage Duration: 

• 14 days

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: 

• Igalmi should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after Igalmi administration to prevent falls and syncope
• If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart
• The safety and effectiveness of Igalmi is not determined past 24 hours from the initial dose

Policy Updates:

• 12/1/2022 – New policy approved by P&T

References:

• 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. 
• 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. 
• 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. 
• 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. 
• 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. 
• 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. 
• Zyprexa Prescribing Information. Lilly USA, LLC. Indianapolis, IN. February 2022. 
• Risperdal Prescribing Information. Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2022.. 
• Geodon Prescribing Information. Pfizer Inc. New York, NY. February 2022. 
• Abilify Prescribing Information. Otsuka America Pharmaceutical, Inc. Rockville, MD. August 2021. 
• Seroquel Prescribing Information. AstraZeneca Pharmaceuticals, LP. Wilmington, DE. January 2022. 
• Saphris Prescribing Information. Breckenridge Pharmaceuticals, Inc. Berlin, CT. July 2021. 
• Igalmi Prescribing Information. BioXcel Therapeutics, Inc. New Haven, CT. April 2022. 
• 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.