Cost savings associated with timely treatment of botulism with botulism antitoxin heptavalent product


Autoři: Deborah M. Anderson aff001;  Veena R. Kumar aff002;  Diana L. Arper aff003;  Eliza Kruger aff003;  S. Pinar Bilir aff003;  Jason S. Richardson aff001
Působiště autorů: Emergent BioSolutions Canada Incorporated, Winnipeg, Manitoba, Canada aff001;  Emergent BioSolutions Incorporated, Gaithersburg, Maryland, United States of America aff002;  IQVIA, San Francisco, California, United States of America aff003
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224700

Souhrn

Background

Botulism is a rare, serious, and sometimes fatal paralytic illness caused by exposure to neurotoxins produced by Clostridium botulinum bacteria. Patients with documented or suspected exposure to botulinum toxin serotypes A-G can be treated with BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)–(Equine)] product, which was approved in 2013 in the United States (US). Patients with botulism have demonstrated greater clinical benefit with early BAT product treatment (≤2 days from symptom onset) versus late treatment (>2 days).

Objective

Economic outcomes associated with improved clinical outcome benefits of BAT product treatment have not yet been reported. This ad hoc analysis aimed to estimate and compare costs associated with hospitalization, intensive care unit stay, and mechanical ventilation for patients with botulism administered BAT product treatment early or late.

Methods

Clinical outcomes data for early and late BAT product treatment were obtained from a patient registry conducted between October 2014 and July 2017. Total per patient mean daily costs were estimated based on information from published literature. Total population costs per group were calculated by multiplying estimated mean cost per patient by the average annual number of non-infant botulism cases in the US.

Results

Mean per patient costs were 2.5 times lower for patients treated with BAT product early versus late. On average in the US, early BAT product treatment could save greater than $3.9 million per year versus late treatment.

Conclusion

Substantial economic savings can be achieved with early BAT product treatment. The findings support the recommendation for public health authorities to ensure antitoxin treatment is readily available in sufficient quantities to manage botulism cases, including sporadic outbreaks and potential mass exposure biological attacks.

Klíčová slova:

Antitoxins – Botulinum toxin – Botulism – Hospitals – Intensive care units – Neurotoxins – Public and occupational health – Toxins


Zdroje

1. Centers for Disease Control and Prevention. Botulism—About Botulism. 2018 [Available from: https://www.cdc.gov/botulism/general.html].

2. Centers for Disease Control and Prevention. National Botulism Surveillance. 2018 [Available from: https://www.cdc.gov/botulism/surveillance.html].

3. World Health Organization. Botulism. 2018 [Available from: http://www.who.int/en/news-room/fact-sheets/detail/botulism].

4. Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, et al. Botulinum toxin as a biological weapon: medical and public health management. JAMA. 2001;285(8):1059–70. doi: 10.1001/jama.285.8.1059 11209178

5. Weir E. Botulism in Canada. CMAJ. 2001;164(4):538. 11233878

6. Centers for Disease Control and Prevention. Botulism—Kinds of Botulism. 2018 [Available from: https://www.cdc.gov/botulism/definition.html].

7. Centers for Disease Control and Prevention. Botulism—Symptoms. 2018 [Available from: https://www.cdc.gov/botulism/symptoms.html].

8. Centers for Disease Control and Prevention. Botulism—Diagnosis and Treatment. 2018 [Available from: https://www.cdc.gov/botulism/testing-treatment.html].

9. Shapiro RL, Hatheway C, Swerdlow DL. Botulism in the United States: a clinical and epidemiologic review. Ann Intern Med. 1998;129(3):221–8. doi: 10.7326/0003-4819-129-3-199808010-00011 9696731

10. Koenig MG, Spickard A, Cardella MA, Rogers DE. Clinical and laboratory observations on type E botulism in man. Medicine. 1964;43(5):517–46.

11. Gangarosa EJ, Donadio JA, Armstrong RW, Meyer K, Brachman PS, Dowell V. Botulism in the United States, 1899–1969. Am J Epidemiol. 1971;93(2):93–101. doi: 10.1093/oxfordjournals.aje.a121239 4925448

12. Centers for Disease Control and Prevention. Investigational heptavalent botulinum antitoxin (HBAT) to replace licensed botulinum antitoxin AB and investigational botulinum antitoxin E. MMWR. 2010;59(10):299. 20300057

13. Opila T, George A, El-Ghanem M, Souayah N. Trends in outcomes and hospitalization charges of infant botulism in the United States: a comparative analysis between Kids' Inpatient Database and National Inpatient Sample. Pediatr Neurol. 2017;67:53–8. doi: 10.1016/j.pediatrneurol.2016.10.009 28041655

14. Souayah N, Mehyar LS, Khan HM, Yacoub HA, Abed A, Nasar A, et al. Trends in outcome and hospitalization charges of adult patients admitted with botulism in the United States. Neuroepidemiology. 2012;38(4):233–6. doi: 10.1159/000336354 22555681

15. U.S. Food and Drug Administration. BabyBIG. 2018 [Available from: https://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm089339.htm].

16. Emergent BioSolutions. BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)—(Equine)]. 2018 [Available from: https://www.emergentbiosolutions.com/sites/default/files/inline-files/LBL040010.pdf]

17. U.S. Department of Health and Human Services. Strategic National Stockpile (SNS). 2019 [Available from: https://chemm.nlm.nih.gov/sns.htm].

18. Yu PA, Lin NH, Mahon BE, Sobel J, Yu Y, Mody RK, et al. Safety and improved clinical outcomes in patients treated with new equine-derived heptavalent botulinum antitoxin. Clin Infect Dis. 2017;66 (suppl_1):S57–S64. doi: 10.1093/cid/cix816 29293928

19. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, et al. Safety and clinical outcomes of an equine-derived heptavalent botulinum antitoxin treatment for confirmed or suspected botulism in the United States. Clin Infect Dis. 2019 [Available from: https://doi.org/10.1093/cid/ciz515].

20. Payne JR, Khouri JM, Jewell NP, Arnon SS. Efficacy of Human Botulism Immune Globulin for the Treatment of Infant Botulism: The First 12 Years Post Licensure. J Pediatr. 2018;193:172–7. doi: 10.1016/j.jpeds.2017.10.035 29229452

21. Armada M, Love S, Barrett E, Monroe J, Peery D, Sobel J. Foodborne botulism in a six-month-old infant caused by home-canned baby food. Ann Emerg Med. 2003;42(2):226–9. doi: 10.1067/mem.2003.259 12883510

22. Arnon S. Infant Botulism In: Feigin RD, Cherry JD, Demmler GJ, Kaplan SL, eds. Textbook of Pediatric Infectious Diseases. Philadelphia: WB Saunders; 2004.

23. U.S. Bureau of Labor Statistics. Consumer Price Index; Medical care services in U.S. city average, all urban consumers, not seasonally adjusted. 2018 [Available from: https://data.bls.gov/timeseries/CUUR0000SAM2].

24. Becker's Hospital Review. Average cost per inpatient day across 50 states. 2016 [Available from: https://www.beckershospitalreview.com/finance/average-cost-per-inpatient-day-across-50-states-2016.html]

25. Kramer AA, Dasta JF, Kane-Gill SL. The impact of mortality on total costs within the ICU. Crit Care Med. 2017;45(9):1457–63. doi: 10.1097/CCM.0000000000002563 28658024

26. Klompas M. Complications of mechanical ventilation—the CDC's new surveillance paradigm. N Engl J Med. 2013;368(16):1472–5. doi: 10.1056/NEJMp1300633 23594002

27. Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, et al. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009;37(11):2888–94. doi: 10.1097/CCM.0b013e3181ab86ed 19770733

28. Kirk MD, Pires SM, Black RE, Caipo M, Crump JA, Devleesschauwer B, et al. World Health Organization estimates of the global and regional disease burden of 22 foodborne bacterial, protozoal, and viral diseases, 2010: a data synthesis. PLoS Med 2015;12(12):e1001921. doi: 10.1371/journal.pmed.1001921 26633831

29. Centers for Disease Control and Prevention. Bioterrorism Agents/Diseases. 2018 [Available from: https://emergency.cdc.gov/agent/agentlist-category.asp].

30. Durcan R, Murphy O, Reid V, Lynch T. Guillain-Barré syndrome mimicking botulism in early disease course. Pract Neurol. 2018;18(6):501–4. doi: 10.1136/practneurol-2018-001891 30061335

31. World Health Organization. Rabies—Treatment. 2019 [Available from: https://www.who.int/rabies/about/home_treatment/en/].

32. World Health Organization. Rabies—The disease. 2019 [Available from: https://www.who.int/rabies/about/en/].


Článek vyšel v časopise

PLOS One


2019 Číslo 11