To evaluate the economic impact of the 2009 routine US childhood immunization schedule, including diphtheria and tetanus toxoids and acellular pertussis, Haemophilus influenzae type b conjugate, inactivated poliovirus, measles/mumps/rubella, hepatitis B, varicella, 7-valent pneumococcal conjugate, hepatitis A, and rotavirus vaccines; influenza vaccine was not included.
Decision analysis was conducted using population-based vaccination coverage, published vaccine efficacies, historical data on disease incidence before vaccination, and disease incidence reported during 2005 to 2009. Costs were estimated using the direct cost and societal (direct and indirect costs) perspectives. Program costs included vaccine, administration, vaccine-associated adverse events, and parent travel and work time lost. All costs were inflated to 2009 dollars, and all costs and benefits in the future were discounted at a 3% annual rate. A hypothetical 2009 US birth cohort of 4 261 494 infants over their lifetime was followed up from birth through death. Net present value (net savings) and benefit-cost ratios of routine childhood immunization were calculated.
Analyses showed that routine childhood immunization among members of the 2009 US birth cohort will prevent ∼42 000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively. The direct and societal benefit-cost ratios for routine childhood vaccination with these 9 vaccines were 3.0 and 10.1.
From both direct cost and societal perspectives, vaccinating children as recommended with these vaccines results in substantial cost savings.
Comments
Re:Comment on Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009.
To the editors - Drs. Newall and Beutels express a concern that evaluations like ours can lead to specific vaccines 'freeriding' (e.g. recommending new vaccines into a routine immunization program based at least partly on an assessment of the overall benefits of the entire program) on the savings of more cost-effective vaccines. This would represent an unintended use of the results of economic evaluations such as ours. However, we do not believe that this is a risk for the United States immunization program. In the United States, new vaccines are included in the routine immunization schedule only after careful consideration of the vaccine's benefits, risks, and costs.1 Evidence for vaccine recommendations is considered by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) after being evaluated using the GRADE system for determining evidence quality.2 All economic analyses considered as evidence must meet or exceed standardized, publicly-available, methodological criteria, and must be approved by CDC prior to admission as evidence to ACIP.3 By law, all new ACIP recommendations are included in the U.S. immunization program and covered by all future health insurance plans, private and public. Contracts for federally-purchased vaccines are negotiated annually, vaccine by vaccine. We do not believe that our study will have much influence in determining individual vaccine prices.
The purpose of our analysis was to understand the economic and health benefits and costs of the routine immunization schedule in the way that is administered - as a coherent, integrated program. Our analysis addresses the value of the U.S. immunization program, which is authorized by law and financed by government and private sources. Program funders should have information on the value of their investment in the health of children and our study was intended to provide this information.
Drs. Newall and Beutels point out that "the cost of each program is not presented." Although we do not consider that each vaccine is an individual program, Drs. Newall and Beutels are correct that our paper does not describe vaccine-by-vaccine costs to the U.S. immunization program. Since we consider the immunization program as a whole, the costs of an additional vaccine in the routine schedule are incremental costs, as the immunization program is already established and functioning. Drs. Newall and Beutels also note that there is insufficient detail for someone to replicate our findings. This is a fair point. We chose to limit details because of the limitations of journal article space. We will provide detailed data and methods upon request.
It is our impression that immunization programs around the world would benefit from a whole-program to no-program health and economic evaluation. It is a way for programs to describe their value to society and to the funders of immunization programs. We believe that other countries' overall immunization programs will also be shown to save money while preventing suffering and death.
References
1. Smith JC. The structure, role, and procedures of the U.S. Advisory Committee on Immunization Practices (ACIP). Vaccine 28S (2010) A68-A75.
2. Ahmed F, Temte JL,Campos-Outcalt D, Sch?nemann HJ, for the ACIP Evidence Based Recommendations Work Group. Methods for developing evidence -based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 2011; 29(49):9171-9176.
3. ACIP: Guidance for Health Economics Studies. Available at www.cdc.gov/vaccines/acip/committee/guidance/economic-studies.html, accessed June 14, 2014.
Conflict of Interest:
None declared
Comment on Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009.
Zhou et al. examine the economic impact of the routine US childhood immunization schedule in 2009 [1]. This article was an update to a (highly cited) analysis, which assessed the previous US schedule in 2001 [2]. During this time the schedule has been expanded to include several new relatively expensive vaccines, including rotavirus, hepatitis A and pneumococcal conjugate vaccine.
The analysis of the existing US schedule was of particular interest to our group as we have recently published an article which specifically reviews the methodological challenges in assessing the value for money of implemented vaccination programs [3]. Retrospective economic analyses are a neglected area within vaccine research, as the focus of economic modelling has primarily been to conduct predictive analyses (before implementation) to inform funding decisions.
Zhou et al.'s key message is that the 2009 routine childhood immunizations as a group are highly cost saving when compared to no vaccination at all [1]. While this straightforward message may be appealing to those sympathetic to vaccination and the health benefits it provides, it may produce complacency in the need for careful and ongoing economic assessment of individual vaccines [3]. The focus on the combined benefits of childhood programs conflates vaccination programs that have clearly established that they offer excellent value for money (e.g., measles, pertussis) with those for which the empirical cost-effectiveness evidence is less clear-cut (e.g., rotavirus, hepatitis A).
While Zhou et al. does present some details for each program, such as the savings from each individual vaccination program (Table 3 [1]), the cost of each program is not presented. Furthermore, the methods are insufficiently detailed and transparent to replicate the analyses presented. The discussion of rotavirus and hepatitis A vaccination is potentially confused by the author's assertion that, while they are not cost-saving these vaccines are "still cost-effective". They justify this point not by showing specific cost-effectiveness results of their own analyses, but by referring to other predictive model-based cost- effectiveness analyses.
In short, the approach may potentially lead to vaccines 'freeriding' on the savings of more cost-effective programs. This is problematic both because of the need to ensure we are gaining value for money in health spending decisions and because economic evaluations can be a powerful tool in drug price negotiations [4]. Indeed, one of the ways that economic analyses of implemented programs may be useful is in assessing whether vaccine prices may need to be re-negotiated if, for example, the benefits of a vaccine program are less than was anticipated [3].
It is important that we do not use economic evaluations as a way of highlighting the success of immunisation as a whole, but to carefully assess the value for money of each component (e.g., combination or monovalent vaccine) in the schedule.
Acknowledgements
ATN holds National Health and Medical Research Council (NHMRC) Training Fellowship 630724
References
[1] Zhou F, Shefer A, Wenger J, Messonnier M, Wang LY, Lopez A, et al. Economic evaluation of the routine childhood immunization program in the united states, 2009. Pediatrics 2014;133(4):577-85.
[2] Zhou F, Santoli J, Messonnier ML, Yusuf HR, Shefer A, Chu SY, et al. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001. Archives of Pediatrics and Adolescent Medicine 2005;159(12):1136-44.
[3] Newall AT, Reyes JF, Wood JG, McIntyre P, Menzies R, Beutels P. Economic evaluations of implemented vaccination programmes: Key methodological challenges in retrospective analyses. Vaccine 2014;32(7):759-65.
[4] Harris AH, Hill SR, Chin G, Jing Jing L, Walkom E. The role of value for money in public insurance coverage decisions for drugs in australia: A retrospective analysis 1994-2004. Medical Decision Making 2008;28(5):713-22.
Conflict of Interest:
None declared