An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine

Vaccine

Volumn 33, Issue 37, 2015, Pages 4727-4736

  Lee, Bruce Y ^a   Bartsch, Sarah M ^a   Mvundura, Mercy ^b   Jarrahian, Courtney ^b   Zapf, Kristina M ^a   Marinan, Kathleen ^a   Wateska, Angela R ^a   Snyder, Bill ^b   Swaminathan, Savitha ^b   Jacoby, Erica ^b   Norman, James J ^c   Prausnitz, Mark R ^c   Zehrung, Darin ^b  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b PATH   (United States)

^c Georgia Institute of Technology   (United States)

Author keywords

Cost effectiveness; Economics; Influenza; Influenza vaccination; Microneedle patch

Indexed keywords

INFLUENZA VACCINE; SEASONAL INFLUENZA VACCINE; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CHILD; COMPARTMENT MODEL; COST EFFECTIVENESS ANALYSIS; DRUG DELIVERY DEVICE; DRUG EFFICACY; DRUG MARKETING; HUMAN; INFLUENZA VACCINATION; MAJOR CLINICAL STUDY; MICRONEEDLE; MICRONEEDLE PATCH; MONTE CARLO METHOD; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; SEASONAL INFLUENZA; ADOLESCENT; ADVERSE EFFECTS; DRUG DELIVERY SYSTEM; ECONOMIC MODEL; ECONOMICS; FEMALE; INFANT; INTRADERMAL DRUG ADMINISTRATION; MALE; MIDDLE AGED; NEWBORN; PRESCHOOL CHILD; PROCEDURES; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; INFLUENZA VACCINES; INJECTIONS, INTRADERMAL; MALE; MIDDLE AGED; MODELS, ECONOMIC; UNITED STATES; YOUNG ADULT;

EID: 84940447009     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.02.076     Document Type: Article

References (70)

1. Molinari N.-A., Ortega-Sanchez I.R., Messonnier M.L., Thompson W.W., Wortley P.M., Weintraub E., et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine 2007, 25:5086-5096.
2. Santibanez T.A., Yusheng Z., O'Halloran A., Khan K., Srivastav A., Lu P.-J., et al. Flu vaccination coverage, United States, 2012-13 influenza season 2013, Centers for Disease Control and Prevention, Atlanta, GA.
3. Jones T.F., Ingram L.A., Craig A.S., Schaffner W. Determinants of influenza vaccination, 2003-2004: shortages, fallacies and disparities. Clin Infect Dis 2004, 39(December (12)):1824-1828.
4. Hemingway C.O., Poehling K.A. Change in recommendation affects influenza vaccinations among children 6 to 59 months of age. Pediatrics 2004, 114(October (4)):948-952.
5. Allison M.A., Reyes M., Young P., Calame L., Sheng X., Weng H.Y., et al. Parental attitudes about influenza immunization and school-based immunization for school-aged children. Pediatr Infect Dis J 2010, 29(August (8)):751-755.
6. Hofmann F., Ferracin C., Marsh G., Dumas R. Influenza vaccination of healthcare workers: a literature review of attitudes and beliefs. Infection 2006, 34(June (3)):142-147.
7. Christini A.B., Shutt K.A., Byers K.E. Influenza vaccination rates and motivators among healthcare worker groups. Infect Control Hosp Epidemiol 2007, 28(February (2)):171-177.
8. Willis B.C., Wortley P. Nurses' attitudes and beliefs about influenza and the influenza vaccine: a summary of focus groups in Alabama and Michigan. Am J Infect Control 2007, 35(February (1)):20-24.
9. Harris K.M., Maurer J., Uscher-Pines L. Seasonal influenza vaccine use by adults in the US. Detailed survey data tables for the 2009-2010 vaccination season: RAND Corporation. Contract No.: OP-311/1-GSK 2010.
10. Sullivan S.P., Koutsonanos D.G., Del Pilar Martin M., Lee J.W., Zarnitsyn V., Choi S.O., et al. Dissolving polymer microneedle patches for influenza vaccination. Nat Med 2010, 16(August (8)):915-920.
11. Fernando G.J., Chen X., Prow T.W., Crichton M.L., Fairmaid E.J., Roberts M.S., et al. Potent immunity to low doses of influenza vaccine by probabilistic guided micro-targeted skin delivery in a mouse model. PLoS ONE 2010, 5(4):e10266.
12. Koutsonanos D.G., Vassilieva E.V., Stavropoulou A., Zarnitsyn V.G., Esser E.S., Taherbhai M.T., et al. Delivery of subunit influenza vaccine to skin with microneedles improves immunogenicity and long-lived protection. Sci Rep 2012, 2:357.
13. Song J.M., Kim Y.C., Lipatov A.S., Pearton M., Davis C.T., Yoo D.G., et al. Microneedle delivery of H5N1 influenza virus-like particles to the skin induces long-lasting B- and T-cell responses in mice. Clin Vaccine Immunol 2010, September (17)(9):1381-1389.
14. Lee B.Y., Burke D.S. Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles. Vaccine 2010, 28:2806-2809.
15. Russell L.B., Gold M.R., Siegel J.D., Daniels N., Weinstein M.C. Panel on cost-effectiveness in health and medicine, the role of cost-effectiveness analysis in health and medicine. J Am Med Assoc 1996, 276(14):1172-1177.
16. United States Census Bureau State & county quickfacts 2012, Available from: http://quickfacts.census.gov/qfd/states/00000.html [accessed 09.08.12].
17. Biggerstaff M., Cauchemez S., Reed C., Gambhir M., Finelli L. Estimates of the reproduction number for seasonal, pandemic, and zoonotic influenza: a systematic review of the literatures. BMC Infect Dis 2014, 14:480.
18. Luksic I., Clay S., Falconer R., Pulanic I.R., Campbell H., Nair H. Effectiveness of seasonal influenza vaccine in children - a systematic review and meta-analysis. Croat Med J 2013, 54:135-145.
19. Demicheli V., Jefferson T., Al-Ansary L.A., Ferroni E., Rivetti A., Di Pietrantonj C. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2014, 3:CD001269.
20. Jefferson T., Di Pietrantonj C., Al-Ansary L.A., Ferroni E., Thorning S., Thomas R.E. Vaccine for preventing influenza in the elderly. Cochrane Database Syst Rev 2012, 2:CD004876.
21. Lee B.Y., Tai J.H.Y., Bailey R.R., Smith K.J., Nowalk A.J. Economics of influenza vaccine administration timing for children. Am J Manag Care 2010, 16(3):e75-e85.
22. Brown S.T., Tai J.H.Y., Bailey R.R., Cooley P.C., Wheaton W.D., Potter M.A., et al. Would school closure for the 2009 H1N1 influenza epidemic have been worth the cost? A computational simulation of Pennsylvania. BMC Public Health 2011, 11(1):353.
23. Lee B.Y., Bacon K.M., Donohue J.M., Wiringa A.E., Bailey R.R., Zimmerman R.K. From the patient perspective: the economic value of seasonal and H1N1 influenza vaccination. Vaccine 2011, 29:2149-2158.
24. Lee B.Y., Bartsch S.M., Willig A.M. The economic value of a quadrivalent versus trivalent influenza vaccine. Vaccine 2012, 30(December (52)):7443-7446.
25. Lee B.Y., McGlone S.M., Bailey R.R., Wiringa A.E., Zimmer S.M., Smith K.J., et al. To test or to treat? An analysis of influenza testing and antiviral treatment strategies using economic computer modeling. PLoS ONE 2010, 5(6):e11284.
26. Lee B.Y., Tai J.H.Y., Bailey R.R., Smith K.J. The timing of influenza vaccination for older adults (65 years and older). Vaccine 2009, 27:7110-7115.
27. Lee B.Y., Stalter R.M., Bacon K.M., Tai J.H.Y., Bailey R.R., Zimmer S.M., et al. Cost-effectiveness of adjuvanted versus nonadjuvanted influenza vaccine in adult hemodialysis patients. Am J Kidney Dis 2011, 57(5):724-732.
28. Lee B.Y., Tai J.H.Y., McGlone S.M., Bailey R.R., Wateska A.R., Zimmer S.M., et al. The potential economic value of a "universal" (multi-year) influenza vaccine. Influenza Other Respir Viruses 2012, 6(3):167-175.
29. Neumann P.J., Sandberg E.A., Bell C.M., Stone P.W., Chapman R.H. Are pharmaceuticals cost-effective? A review of the evidence. Health Affairs 2000, 19(2):92-109.
30. Bureau of Labor Statistics Occupational employment statistics: May 2012 national occupational employment and wage estimates, United States 2012, U.S. Bureau of Labor Statistics Division of Occupational Employment Statistics, Washington, DC, Available from: www.bls.gov [cited 2013 April 20].
31. Human Mortality Database [database on the Internet]. University of California, Berkeley (USA), and Max Planck Institute for Demographic Research (Germany); 2010. Available from: [cited June 14, 2011]. http://www.mortality.org/.
32. Gold M.R., Siegel J.E., Russell L.B., Weinstein M.C. Cost-effectiveness in health and medicine 1996, Oxford University Press Inc., New York.
33. Centers for Disease Control Prevention CDC - seasonal influenza (Flu) 2012, Centers for Disease Control and Prevention, Atlanta, Georgia, Available from: http://www.cdc.gov/flu/about/season/flu-season.htm [cited 2012 11-19-2012].
34. Norman J.J., Arya J.M., McClain M.A., Frew P.M., Meltzer M.I., Prausnitz M.R. Microneedle patches: usability and acceptability for self-vaccination against influenza. Vaccine 2014, 32:1856-1862.
35. Ray G.T., Pelton S.I., Klugman K.P., Strutton D.R., Moore M.R. Cost-effectiveness of pneumococcal conjugate vaccine: an update after 7 years of use in the United States. Vaccine 2009, 27(November (47)):6483-6494.
36. Zhou F., Reef S., Massoudi M., Papania M.J., Yusuf H.R., Bardenheier B., et al. An economic analysis of the current universal 2-dose measles-mumps-rubella vaccination program in the United States. J Infect Dis 2004, 189(Suppl. 1):S131-S145.
37. Mehrotra A., Lave J.R. Visits to retail clinics grew fourfold from 2007 to 2009, although their share of overall outpatient visits remains low. Health Affairs (Millw) 2012, 31(September (9)):2123-2129.
38. Goad J.A., Taitel M.S., Fensterheim L.E., Cannon A.E. Vaccinations administered during off-clinic hours at a national community pharmacy: implications for increasing patient access and convenience. Ann Fam Med 2013, 11(September-October (5)):429-436.
39. Cryz S.J. Patient compliance in the use of Vivotif Berna vaccine, typhoid vaccine, live oral Ty21a. J Travel Med 1998, 5:14-17.
40. Gilmartin H.M. Provider-pharmacist education and adherence rates for the oral typhoid vaccine: a pilot study. J Travel Med 2005, 12:113-114.
41. Lee B.Y., McGlone S.M. Pricing of new vaccines. Hum Vaccines 2010, 6(8):619-626.
42. Kennedy E., Santibanez T., Bridges C., Singleton J., CDC/NCIRD March flu vaccination coverage, United States, 2011-12 influenza season 2012, Available from: http://www.cdc.gov/flu/professionals/vaccination/nfs-survey-march2012.htm [cited 2012 June 3].
43. Lessler J., Reich N.G., Brookmeyer R., Perl T.M., Nelson K.E., Cummings D.A. Incubation periods of acute respiratory viral infections: a systematic review. Lancet Infect Dis 2009, 9(May (5)):291-300.
44. Carrat F., Vergu E., Ferguson N.M., Lemaitre M., Cauchemez S., Leach S., et al. Time lines of infection and disease in human influenza: a review of volunteer challenge studies. Am J Epidemiol 2008, 167(7):775-785.
45. Thomson Healthcare MarketScan research database 2008, Ann Arbor, MI.
46. Centers for Medicare and Medicaid Services Physicians fee schedule 2009, U.S. Department of Health & Human Services, Baltimore, MD, Available from: http://www.cms.hhs.gov/ [cited 2011 March 16].
47. Agency for Healthcare Research and Quality HCUPnet. Healthcare Cost and Utilization Project.: US Department of Health and Human Services 2009, Available from: http://hcupnet.ahrq.gov/ [cited 2012 July 11].
48. Pereira C.C., Bishai D. Vaccine presentation in the USA: economics of prefilled syringes versus multidose vials for influenza vaccination. Expert Rev Vaccines 2010, 9(November (11)):1343-1349.
49. Mitchell D. Microinjection flu vaccine product approved by FDA 2011, Available from: www.aafp.org/online/en/home/publications/new/news-now/health-of-the-public/20110512intradermalfluvacc.html [accessed 12.12.12].
50. Centers for Disease Control and Prevention CDC vaccine price list 2012, GA, Atlanta, Available from: http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html [cited 2012 July 11].
51. Glazner J.E., Beaty B., Berman S. Cost of vaccine administration among pediatric practices. Pediatrics 2009, 124(Suppl. 5):S492-S498.
52. Bureau of Labor Statistics Occupational employment statistics: May 2013 national occupational employment and wage estimates, United States 2013, U.S. Bureau of Labor Statistics Division of Occupational Employment Statistics, Washington, DC, Available from: www.bls.gov [cited 2013 April 20].
53. Yoo B.-K., Szilagyi P.G., Schaffer S.J., Humiston S.G., Rand C.M., Albertin C.S., et al. Cost of universal influenza vaccination of children in pediatric practices. Pediatrics 2009, 124:S499-S506.
54. Coleman M.S., Fontanesi J., Meltzer M.I., Shefer A., Fishbein D.B., Bennett N.M., et al. Estimating medical practice expenses from administering adult influenza vaccinations. Vaccine 2005, 23:915-923.
55. Washington M.L., Humiston S.G., Fauerbach P.B., Glezen W.P., Black S., Shinefield H., et al. A personnel time-motion study of intranasal influenza vaccination in healthy children. Vaccine 2005, 23(September (40)):4879-4885.
56. Molinari N.A., Ortega-Sanchez I.R., Messonnier M.L., Thompson W.W., Wortley P.M., Weintraub E., et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine 2007, 25(June (27)):5086-5096.
57. Kreech M., Beardsworth P. The impact of influenza on working days lost. A review of the literature. Pharmacoeconomics 2008, 26(11):911-924.
58. Nettleman M.D., White T., Lavoie S., Chafin C. School absenteeism, parental work loss, and acceptance of childhood influenza vaccination. Am J Med Sci 2001, 321(March (3)):178-180.
59. Gold M.R., Franks P., McCoy K.I., Fryback D.G. Toward consistency in cost-utility analyses: using national measures to create condition-specific values. Med Care 1998, 36(June (6)):778-792.
60. Smith K.J., Lee B.Y., Nowalk M.P., Raymund M., Zimmerman R.K. Cost-effectiveness of dual influenza and pneumococcal vaccination in 50-year-olds. Vaccine 2010, 28:7620-7625.
61. Khazeni N., Hutton D.W., Garber A.M., Hupert N., Owens D.K. Effectiveness and cost-effectiveness of vaccination against pandemic influenza (H1N1) 2009. Ann Intern Med 2009, 151(December (12)):829-839.
62. Luce B.R., Nichol K.L., Belshe R.B., Frick K.D., Li S.X., Boscoe A., et al. Cost-effectiveness of live attenuated influenza vaccine versus inactivated influenza vaccine among children ages 24-59 months in the United States. Vaccine 2008, 26(23):2841-2848.
63. Perlroth D.J., Glass R.J., Davey V.J., Cannon D., Garber A.M., Owens D.K. Health outcomes and costs of community mitigation strategies for an influenza pandemic in the United States. Clin Infect Dis 2010, 50(January (2)):165-174.
64. Michaelidis C.I., Zimmerman R.K., Nowalk M.P., Smith K.J. Estimating the cost-effectiveness of a national program to eliminate disparities in influenza vaccination rates among elderly minority groups. Vaccine 2011, 29(April (19)):3525-3530.
65. Mauskopf J.A., Cates S.C., Griffin A.D., Neighbors D.M., Lamb S.C., Rutherford C. Cost effectiveness of zanamivir for the treatment of influenza in a high risk population in Australia. Pharmacoeconomics 2000, 17(June (6)):611-620.
66. Rothberg M.B., Rose D.N. Vaccination versus treatment of influenza in working adults: a cost-effective analysis. Am J Med 2005, 118(1):68-77.
67. Smith K.J., Roberts M.S. Cost-effectiveness of newer treatment strategies for influenza. Am J Med 2002, 113:300-307.
68. Talbird S.E., Brogan A.J., Winiarski A.P., Sander B. Cost-effectiveness of treating influenza like illness with oseltamivir in the United States. Am J Health-Sys Pharm 2009, 66:469-480.
69. Jit M., Cromer D., Baguelin M., Stowe J., Andrews N., Miller E. The cost-effectiveness of vaccinating pregnant women against seasonal influenza in England and Wales. Vaccine 2010, 29(December (1)):115-122.
70. Kennedy E.D., Santibanez T.A., Bryan L.N., Wortley P.M., Euler G.L., Singleton J.A., et al. Place of influenza vaccination among adults - United States, 2010-11 influenza season. MMWR 2011, 60(23):781-785.