No Claim Left Behind: Viability of Assessing Early Real-World Vaccine Effectiveness in Open and Closed Administrative Healthcare Claims
Author(s)
Neloufar Rahai, MPH, PhD1, Rohan Shah, BS1, Elisha Beebe, BS1, Brian Conroy, PhD1, Michelle Skornicki, MPH1, Katherine E Mues, PhD, MPH1, Amanda Wilson, PhD, MPH2, Andre B. Araujo, PhD2.
1Aetion, Inc., New York, NY, USA, 2Moderna, Inc., Cambridge, MA, USA.
1Aetion, Inc., New York, NY, USA, 2Moderna, Inc., Cambridge, MA, USA.
OBJECTIVES: Adjudicated closed administrative healthcare claims data are commonly used in real-world analyses with a data lag, whereas using open claims data may support real-time (RT) analyses to allow for earlier estimates of vaccine effectiveness (VE).
METHODS: Using HealthVerity claims, US adults ≥18 years, vaccinated with mRNA-1273.815 (12 September 2023-31 December 2023) were matched on calendar date, demographics, bivalent vaccine receipt, and prior medical claims frequency, to individuals who did not receive mRNA-1273.815. Cox models estimated hazard ratios and VE (1-HR*100) among inverse probability weighted cohorts. RT analyses used a datacut available 2 February 2024, while and closed claims analyses used a datacut available 30 April 2024. Both analyses had identical study and follow-up periods through 26 January 2024.
RESULTS: In RT and closed claims analyses, 1,134,585 and 1,272,161 individuals were identified that received mRNA-1273.815. Demographic and comorbidity profiles were similar; weighted baseline characteristics were balanced.
In RT, incidence rate was 87.0 (95% CI 75.1-100.3) and 196.6 (177.4-217.2) per 100,000 person-years (PY), among exposed and unexposed patients, respectively; weighted VE was 54% (95% CI 46%-62%). In closed claims analysis, incidence rate was 516.5 (490.7-543.3) and 1,050.0 (1,009.9-1,091.3) per 100,000 PY, among exposed and unexposed, weighted VE was 51% (95% CI 48%-54%).
CONCLUSIONS: Real-time analysis of open and closed claims resulted in substantially lower rates of COVID-19 hospitalizations compared with the closed claims analysis, indicating a sizable proportion of outcome claims were not available. Nevertheless, outcome distribution between the vaccinated and unvaccinated groups was similar, resulting in similar VE. Findings suggest a real-time analysis could be appropriate for early evaluation of VE, but additional data are needed.
METHODS: Using HealthVerity claims, US adults ≥18 years, vaccinated with mRNA-1273.815 (12 September 2023-31 December 2023) were matched on calendar date, demographics, bivalent vaccine receipt, and prior medical claims frequency, to individuals who did not receive mRNA-1273.815. Cox models estimated hazard ratios and VE (1-HR*100) among inverse probability weighted cohorts. RT analyses used a datacut available 2 February 2024, while and closed claims analyses used a datacut available 30 April 2024. Both analyses had identical study and follow-up periods through 26 January 2024.
RESULTS: In RT and closed claims analyses, 1,134,585 and 1,272,161 individuals were identified that received mRNA-1273.815. Demographic and comorbidity profiles were similar; weighted baseline characteristics were balanced.
In RT, incidence rate was 87.0 (95% CI 75.1-100.3) and 196.6 (177.4-217.2) per 100,000 person-years (PY), among exposed and unexposed patients, respectively; weighted VE was 54% (95% CI 46%-62%). In closed claims analysis, incidence rate was 516.5 (490.7-543.3) and 1,050.0 (1,009.9-1,091.3) per 100,000 PY, among exposed and unexposed, weighted VE was 51% (95% CI 48%-54%).
CONCLUSIONS: Real-time analysis of open and closed claims resulted in substantially lower rates of COVID-19 hospitalizations compared with the closed claims analysis, indicating a sizable proportion of outcome claims were not available. Nevertheless, outcome distribution between the vaccinated and unvaccinated groups was similar, resulting in similar VE. Findings suggest a real-time analysis could be appropriate for early evaluation of VE, but additional data are needed.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
SA60
Topic
Study Approaches
Disease
STA: Vaccines