1479. Incidence of Acute Otitis Media in Children in the United States before and after the introduction of Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018

Abstract

Background Acute otitis media (AOM) leads to considerable healthcare resource utilization in children. Streptococcus pneumoniae is an important cause of AOM. Merck is developing V114, an investigational 15-valent PCV that contains PCV13 serotypes as well as 22F and 33F. To demonstrate the potential value of V114, it is important to estimate the remaining clinical burden associated with AOM. This study estimated AOM incidence rates (IRs) before and after the introduction of 7-valent and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) in the US. Methods This was a retrospective observational study using IBM MarketScan® Commercial Claims and Encounters (CCAE) (1998-2018) and Multi-State Medicaid databases (2001-2018). AOM claims in children < 18 years old were identified using ICD9 codes 382.x and ICD10 codes H66.x and H67.x. An episode could comprise one or more AOM-related claims. A gap of at least 14 days between two AOM-related claims was required to define the start of a new episode. IRs were defined as the numbers of episodes per 1,000 person-years (PY). Annual IRs were stratified by age groups (< 2, 2-4, and 5-17), and reported separately for CCAE and Medicaid databases. Results AOM IRs declined over time among commercially and Medicaid-insured children in all age groups < 18 years old. In particular, among children < 2 years, AOM IRs declined from 1,111 in 1998 to 727/1,000 PY in 2018 in commercially plans and from 895 in 2001 to 656/1,000 PY in 2018 in Medicaid (Figure 1). In children 2-4 years, AOM IRs declined from 517 in 1998 to 400/1,000 PY in 2018 in commercial plans and from 385 in 2001 to 329/1,000 PY in 2018 in Medicaid (Figure 2). In children 5-17 years, AOM IRs declined from 112 in 1998 to 87/1,000 PY in 2018 in commercial plans and from 98 in 2001 to 87/1,000 in 2018 in Medicaid (Figure 3). Figure 1. AOM incidence in commercially and Medicaid-insured children ages 0 - 1 years, episodes per 100,000 patient-years (1998 - 2018) Figure 2. AOM incidence in commercially and Medicaid-insured children ages 2 - 4 years, episodes per 100,000 patient-years (1998 - 2018) Figure 3. AOM incidence in commercially and Medicaid-insured children ages 5 - 17 years, episodes per 100,000 patient-years (1998 - 2018) Conclusion AOM IRs declined following the introduction of PCV7 and PCV13; however, disease burden remains substantial in younger children. The impact of future PCVs on AOM will depend on the proportion of AOM caused by S. pneumoniae and vaccine-type serotypes. Disclosures Tianyan Hu, PhD, Merck (Employee, Shareholder) Yan Song, PhD, Merck (Consultant) Nicolae Done, PhD, Merck & Co., Inc. (Consultant) Eli Orvis, BA, Merck (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant) Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder)

Estimating population-based incidence of community-acquired pneumonia and acute otitis media in children and adults in Ontario and British Columbia using health administrative data, 2005–2018: a Canadian Immunisation Research Network (CIRN) study

“… 4 36 The incidence of paediatric AOM has also been estimated using administrative billing codes in the USA. 44 As such, it is unlikely that our burden estimates are substantially overestimated because of false positive cases. Diagnostic and laboratory practices to identify a patient with CAP or AOM may vary among physicians in Ontario and BC.…”

“…However, a small reduction in AOM could also have resulted from influenza vaccination in children 43. The incidence of AOM in US children also declined from 1998 to 2018 using claims data from commercial plans (1111–727/1000 person-years in children aged <2 years, 517–400/1000 person-years in children aged 2–4 years, and 112–87/1000 person-years in children aged 5–17 years) and Medicaid (895–656/1000 person-years in children aged <2 years, 385–329/1000 person-years in children aged 2–4 years, and 98–87/1000 person-years in children aged 5–17 years) 44. A lack of contemporaneous data on the burden of AOM in adults precluded comparison of our rates.…”

“…Diagnostic codes similar to ours have been used to estimate the incidence of all-cause CAP hospitalisation in Canada previously 4 36. The incidence of paediatric AOM has also been estimated using administrative billing codes in the USA 44. As such, it is unlikely that our burden estimates are substantially overestimated because of false positive cases.…”

Cost-Effectiveness Analysis of Routine Use of 15-Valent Pneumococcal Conjugate Vaccine in the US Pediatric Population

“…Before the introduction of pneumococcal vaccines in routine immunization schedules, the incidence of IPD was about 95 cases per 100,000 in children <5 years old in 1998 in the United States (US) [ 13 ]. The disease burdens of pneumococcal pneumonia and AOM, for which pneumococcus was the most common cause, were also high at that time [ 14 , 15 ]. In 2000, the Centers for Disease Control and Prevention (CDC) Advisory Committee for Immunization Practices (ACIP) recommended the 7-valent pneumococcal conjugate vaccine (PCV7) be administered at 2, 4, 6 and 12–15 months for all children aged 2–23 months.…”