Esketamine nasal spray for major depressive disorder with acute suicidal ideation or behavior: description of treatment access, utilization, and claims-based outcomes in the United States

References

• Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville, MD. [updated 2021 Oct]. Available from: https://www.samhsa.gov/data/sites/default/files/reports/rpt35325/NSDUHFFRPDFWHTMLFiles2020/2020NSDUHFFR1PDFW102121.pdf.
   Google Scholar
• Otte C, Gold SM, Penninx BW, et al. Major depressive disorder. Nat Rev Dis Primers. 2016;2:16065.
   PubMed Web of Science ®Google Scholar
• Gelenberg A, Freeman M, Markowitz J. Practice guideline for the treatment of patients with major depressive disorder. Am J Psychiatry. 2010;167:1–118.
   PubMed Web of Science ®Google Scholar
• Jacobs DG, Baldessarini RJ, Conwell Y, et al. Assessment and treatment of patients with suicidal behaviors. APA Practice Guidelines. 2010;1:183.
   Google Scholar
• Cai H, Xie XM, Zhang Q, et al. Prevalence of suicidality in major depressive disorder: a systematic review and meta-analysis of comparative studies. Front Psychiatry. 2021;12:690130.
   PubMed Web of Science ®Google Scholar
• Holma KM, Melartin TK, Haukka J, et al. Incidence and predictors of suicide attempts in DSM-IV major depressive disorder: a five-year prospective study. Am J Psychiatry. 2010;167(7):801–808.
   PubMed Web of Science ®Google Scholar
• Substance Abuse and Mental Health Services Administration. Results from the 2020 National Survey on Drug Use and Health – Appendix B: List of tables Rockville, MD2020 [cited 2022 March 30]. Available from: https://www.samhsa.gov/data/sites/default/files/reports/rpt35323/NSDUHDetailedTabs2020/NSDUHDetailedTabs2020/NSDUHDetTabsAppB2020.htm.
   Google Scholar
• Sheehan L, Dubke R, Corrigan PW. The specificity of public stigma: a comparison of suicide and depression-related stigma. Psychiatry Res. 2017;256:40–45.
   PubMed Web of Science ®Google Scholar
• Yakunina ES, Rogers JR, Waehler CA, et al. College students’ intentions to seek help for suicidal ideation: accounting for the help-negation effect. Suicide Life Threat Behav. 2010;40(5):438–450.
   PubMed Web of Science ®Google Scholar
• Gunnell D, Appleby L, Arensman E, et al. Suicide risk and prevention during the COVID-19 pandemic. Lancet Psychiatry. 2020;7(6):468–471.
   PubMed Web of Science ®Google Scholar
• Ornell F, Schuch JB, Sordi AO, et al. Pandemic fear" and COVID-19: mental health burden and strategies. Braz J Psychiatry. 2020;42(3):232–235.
   PubMed Web of Science ®Google Scholar
• Hao F, Tan W, Jiang L, et al. Do psychiatric patients experience more psychiatric symptoms during COVID-19 pandemic and lockdown? A case-control study with service and research implications for immunopsychiatry. Brain Behav Immun. 2020;87:100–106.
   PubMed Web of Science ®Google Scholar
• Pilon D, Neslusan C, Zhdanava M[, et al. In press] economic burden of commercially insured patients with major depressive disorder and acute suicidal ideation or behavior in the United States. J Clin Psychiatry. 2022;83(3):21m14090.
   PubMed Web of Science ®Google Scholar
• Benson C, Singer D, Carpinella CM, et al. The health-related quality of life, work productivity, healthcare resource utilization, and economic burden associated with levels of suicidal ideation among patients self-reporting moderately severe or severe major depressive disorder in a national survey. Neuropsychiatr Dis Treat. 2021;17:111–123.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic [cited 2020 Mar 18]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
   Google Scholar
• Janssen Pharmaceuticals Inc. SPRAVATO (esketamine) nasal spray prescribing information Titusville, NJMarch 2019 [cited 2022 Mar 28]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243lbl.pdf.
   Google Scholar
• Janssen Pharmaceuticals Inc. SPRAVATO (esketamine) nasal spray prescribing information Titusville, NJJuly 2020 [cited 2022 Mar 28]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf.
   Google Scholar
• Canuso CM, Singh JB, Fedgchin M, et al. Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study. Am J Psychiatry. 2018;175(7):620–630.
   PubMed Web of Science ®Google Scholar
• Canuso CM, Ionescu DF, Li X, et al. Esketamine nasal spray for the rapid reduction of depressive symptoms in major depressive disorder with acute suicidal ideation or behavior. J Clin Psychopharmacol. 2021;41(5):516–524.
   PubMed Web of Science ®Google Scholar
• Joshi K, Pilon D, Shah A, et al. Treatment patterns, healthcare utilization, and costs of patients with treatment-resistant depression initiated on esketamine intranasal spray and covered by US commercial health plans. J Med Econ. 2023;26(1):422–429.
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services. 45 CFR 46: pre-2018 requirements [cited 2020 Oct 16]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.101.
   Google Scholar
• Hedegaard H, Schoenbaum M, Claassen C, et al. Issues in developing a surveillance case definition for nonfatal suicide attempt and intentional self-harm using international classification of diseases, tenth revision, clinical modification (ICD-10-CM) coded data. Natl Health Stat Report. 2018;(108):1–19.
   PubMedGoogle Scholar
• The Academy of Managed Care Pharmacy (AMCP). AMCP partnership forum: optimizing prior authorization for appropriate medication selection. J Manag Care Spec Pharm. 2020;26(1):55–62.
   PubMed Web of Science ®Google Scholar
• The National Board of Prior Authorization Specialists (NBPAS). What is prior authorization? Oradell, NJ2020 [updated 2020 Dec 15, cited 2023 Apr 5]. Available from: https://www.priorauthtraining.org/prior-authorization/.
   Google Scholar
• American Medical Association (AMA). 2022 AMA Prior authorization (PA) physician survey 2023. Available from: https://www.ama-assn.org/system/files/prior-authorization-survey.pdf
   Google Scholar
• Janssen. Supporting appropriate payer coverage decisions. [updated 2017 Sep]. Available from: https://www.janssencarepath.com/sites/www.janssencarepath-v1.com/files/supporting-appropriate-payer-coverage-decisions.pdf.
   Google Scholar
• Szanto K, Dombrovski AY, Sahakian BJ, et al. Social emotion recognition, social functioning, and attempted suicide in late-life depression. Am J Geriatr Psychiatry. 2012;20(3):257–265.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Risk evaluation and mitigation strategies | REMS 2021 [cited 2023 Apr 12]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
   Google Scholar
• Voelker J, Cai Q, Daly E, et al. Mental health care resource utilization and barriers to receiving mental health services among us adults with a major depressive episode and suicidal ideation or behavior with intent. J Clin Psychiatry. 2021;82(6):20m13842.
   PubMed Web of Science ®Google Scholar
• Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191.
   PubMed Web of Science ®Google Scholar
• Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22–31.
   PubMed Web of Science ®Google Scholar
• Sokero TP, Melartin TK, Rytsala HJ, et al. Prospective study of risk factors for attempted suicide among patients with DSM-IV major depressive disorder. Br J Psychiatry. 2005;186:314–318.
   PubMed Web of Science ®Google Scholar