title: An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine.
abstract: BACKGROUND
  New vaccine technologies may improve the acceptability, delivery (potentially enabling self-administration), and product efficacy of influenza vaccines. One such technology is the microneedle patch (MNP), a skin delivery technology currently in development. Although MNPs hold promise in preclinical studies, their potential economic and epidemiologic impacts have not yet been evaluated.
  
  
  METHODS
  We utilized a susceptible-exposed-infectious-recovered (SEIR) transmission model linked to an economic influenza outcomes model to assess the economic value of introducing the MNP into the current influenza vaccine market in the United States from the third-party payer and societal perspectives. We also explored the impact of different vaccination settings, self-administration, the MNP price, vaccine efficacy, compliance, and MNP market share. Outcomes included costs, quality-adjusted life years (QALYs), cases, and incremental cost-effectiveness ratios (ICERs; cost/QALY).
  
  
  RESULTS
  With healthcare provider administration, MNP introduction would be cost-effective (ICERs ≤$23,347/QALY) at all MNP price points ($9.50-$30) and market shares (10-60%) assessed, except when compliance and efficacy were assumed to be the same as existing vaccines and the MNP occupied a 10% market share. If MNP self-administration were available (assuming the same efficacy as current technologies), MNP compliance or its efficacy would need to increase by ≥3% in order to be cost-effective (ICERs ≤$1401/QALY), assuming a 2% reduction in administration success with unsupervised self-administration. Under these conditions, MNP introduction would be cost-effective for all price points and market shares assessed.
  
  
  CONCLUSIONS
  When healthcare providers administered the MNP, its introduction would be cost-effective or dominant (i.e., less costly and more effective) in the majority of scenarios assessed. If self-administration were available, MNP introduction would be cost-effective if it increased compliance enough to overcome any decrease in self-administration success or if the MNP presentation afforded an increase in efficacy over current delivery methods for influenza vaccines.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, United States. Electronic address: brucelee@jhu.edu.
authors.forename: Bruce Y
authors.initials: BY
authors.lastname: Lee
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, United States.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Bartsch
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Mercy
authors.initials: M
authors.lastname: Mvundura
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Courtney
authors.initials: C
authors.lastname: Jarrahian
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, United States.
authors.forename: Kristina M
authors.initials: KM
authors.lastname: Zapf
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, United States.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Marinan
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 855 N Wolfe Street, Suite 600, Baltimore, MD 21205, United States.
authors.forename: Angela R
authors.initials: AR
authors.lastname: Wateska
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Bill
authors.initials: B
authors.lastname: Snyder
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Savitha
authors.initials: S
authors.lastname: Swaminathan
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Erica
authors.initials: E
authors.lastname: Jacoby
authors.affiliation: School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA 30332, United States.
authors.forename: James J
authors.initials: JJ
authors.lastname: Norman
authors.affiliation: School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA 30332, United States.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Prausnitz
authors.affiliation: PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, United States.
authors.forename: Darin
authors.initials: D
authors.lastname: Zehrung
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D016503:Drug Delivery Systems / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007252:Influenza Vaccines / Q000008:administration & dosage*; D007271:Injections, Intradermal / Q000191:economics / Q000379:methods; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D014481:United States; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines
keywords: Cost-effectiveness; Economics; Influenza; Influenza vaccination; Microneedle patch