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Published online May 26, 2009
PEDIATRICS Vol. 123 No. 6 June 2009, pp. 1452-1463 (doi:10.1542/peds.2008-1482)
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ARTICLE

New Vaccines Against Otitis Media: Projected Benefits and Cost-effectiveness

Megan A. O'Brien, MPHa, Lisa A. Prosser, PhDb, Jack L. Paradise, MDc,d, G. Thomas Ray, MBAe, Martin Kulldorff, PhDb, Marcia Kurs-Lasky, MSf, Virginia L. Hinrichsen, MPHb, Jyotsna Mehta, MSb, D. Kathleen Colborn, BSc, Tracy A. Lieu, MD, MPHb,g

a Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
b Department of Ambulatory Care and Prevention, Center for Child Health Care Studies, Harvard Medical School and Harvard Pilgrim Health Care, Boston, Massachusetts
c Division of General Academic Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
d Department of Pediatrics, School of Medicine
f Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
e Division of Research, Kaiser Permanente, Oakland, California
g Division of General Pediatrics, Children's Hospital Boston, Boston, Massachusetts

OBJECTIVE. New vaccines that offer protection against otitis media caused by nontypeable Haemophilus influenzae and by Moraxella catarrhalis are under development. However, the potential health benefits and economic effects of such candidate vaccines have not been systematically assessed.

METHODS. We created a computerized model to compare the projected benefits and costs of (1) the currently available 7-valent pneumococcal conjugate vaccine, (2) a candidate pneumococcal–nontypeable H influenzae vaccine that has been tested in Europe, (3) a hypothetical pneumococcal-nontypeable H influenzae–Moraxella vaccine, and (4) no vaccination. The clinical probabilities of acute otitis media and of otitis media with effusion were generated from multivariate analyses of data from 2 large health maintenance organizations and from the Pittsburgh Child Development/Otitis Media Study cohort. Other probabilities, costs, and quality-of-life values were derived from published and unpublished sources. The base-case analysis assumed vaccine dose costs of $65 for the 7-valent pneumococcal conjugate vaccine, $100 for the pneumococcal-nontypeable H influenzae vaccine, and $125 for the pneumococcal-nontypeable H influenzae–Moraxella vaccine.

RESULTS. With no vaccination, we projected that 13.7 million episodes of acute otitis media would occur annually in US children aged 0 to 4 years, at an annual cost of $3.8 billion. The 7-valent pneumococcal conjugate vaccine was projected to prevent 878000 acute otitis media episodes, or 6.4% of those that would occur with no vaccination; the corresponding value for the pneumococcal–nontypeable H influenzae vaccine was 3.7 million (27%) and for the pneumococcal–nontypeable H influenzae–Moraxella vaccine was 4.2 million (31%).

Using the base-case vaccine costs, pneumococcal–nontypeable H influenzae vaccine use would result in net savings compared with nontypeable 7-valent pneumococcal conjugate use. Conversely, pneumococcal–nontypeable H influenzae–Moraxella vaccine use would not result in savings compared with pneumococcal–nontypeable H influenzae vaccine use, but would cost $48 000 more per quality-adjusted life-year saved. The results were sensitive to variations in assumptions on vaccine effectiveness and vaccine dose costs but not to variations in other assumptions.

CONCLUSIONS. New candidate vaccines against otitis media have the potential to prevent millions of disease episodes in the United States annually. If priced comparably with other recently introduced vaccines, these new otitis vaccines could achieve cost-effectiveness comparable with or more favorable than that of the 7-valent pneumococcal conjugate vaccine.

Key Words: otitis media • vaccines • cost-effectiveness

Abbreviations: PCV7—7-valent pneumococcal conjugate vaccine • NTH—nontypeable Haemophilus influenzae • pneumo—pneumococcal • AOM—acute otitis media • OME—otitis media with effusion • QALY—quality-adjusted life-year • HVMA—Harvard Vanguard Medical Associates

Accepted Sep 26, 2008.


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