Cost effectiveness analysis of elementary school-located vaccination against influenza-Results from a randomized controlled trial

Department of Public Health Sciences, University of California Davis School of Medicine, Davis, CA, USA. Electronic address: .
Vaccine (Impact Factor: 3.62). 03/2013; 31(17). DOI: 10.1016/j.vaccine.2013.02.052
Source: PubMed

ABSTRACT School-located vaccination against influenza (SLV-I) has been suggested to help meet the need for annual vaccination of large numbers of school-aged children with seasonal influenza vaccine. However, little is known about the cost and cost-effectiveness of SLV-I. We conducted a cost-analysis and a cost-effectiveness analysis based on a randomized controlled trial (RCT) of an SLV-I program implemented in Monroe County, New York during the 2009-2010 vaccination season. We hypothesized that SLV-I is more cost effective, or less-costly, compared to a conventional, office-located influenza vaccination delivery. First and second SLV-I clinics were offered in 21 intervention elementary schools (n=9027 children) with standard of care (no SLV-I) in 11 control schools (n=4534 children). The direct costs, to purchase and administer vaccines, were estimated from our RCT. The effectiveness measure, receipt of ≥1 dose of influenza vaccine, was 13.2 percentage points higher in SLV-I schools than control schools. The school costs ($9.16/dose in 2009 dollars) plus project costs ($23.00/dose) plus vendor costs excluding vaccine purchase ($19.89/dose) was higher in direct costs ($52.05/dose) than the previously reported mean/median cost [$38.23/$21.44 per dose] for providing influenza vaccination in pediatric practices. However SLV-I averted parent costs to visit medical practices ($35.08 per vaccine). Combining direct and averted costs through Monte Carlo Simulation, SLV-I costs were $19.26/dose in net costs, which is below practice-based influenza vaccination costs. The incremental cost-effectiveness ratio (ICER) was estimated to be $92.50 or $38.59 (also including averted parent costs). When additionally accounting for the costs averted by disease prevention (i.e., both reduced disease transmission to household members and reduced loss of productivity from caring for a sick child), the SLV-I model appears to be cost-saving to society, compared to "no vaccination". Our findings support the expanded implementation of SLV-I, but also the need to focus on efficient delivery to reduce direct costs.

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    ABSTRACT: Influenza vaccination coverage for U.S. school-aged children is below the 80% national goal. Primary care practices may not have the capacity to vaccinate all children during influenza vaccination season. No real-world models of school-located seasonal influenza (SLV-I) programs have been tested. Determine the feasibility, sustainability, and impact of an SLV-I program providing influenza vaccination to elementary school children during the school day. In this pragmatic randomized controlled trial of SLV-I during two vaccination seasons, schools were randomly assigned to SLV-I versus standard of care. Seasonal influenza vaccine receipt, as recorded in the state immunization information system (IIS), was measured. Intervention and control schools were located in a single western New York county. Participation (intervention or control) included the sole urban school district and suburban districts (five in Year 1, four in Year 2). After gathering parental consent and insurance information, live attenuated and inactivated seasonal influenza vaccines were offered in elementary schools during the school day. Data on receipt of ≥1 seasonal influenza vaccination in Year 1 (2009-2010) and Year 2 (2010-2011) were collected on all student grades K through 5 at intervention and control schools from the IIS in the Spring of 2010 and 2011, respectively. Additionally, coverage achieved through SLV-I was compared to coverage of children vaccinated elsewhere. Preliminary data analysis for Year 1 occurred in Spring 2010; final quantitative analysis for both years was completed in late Fall 2012. Results are shown for 2009-2010 and 2010-2011, respectively: Children enrolled in suburban SLV-I versus control schools had vaccination coverage of 47% vs 36%, and 52% vs 36% (p<0.0001 both years). In urban areas, coverage was 36% vs 26%, and 31% vs 25% (p<0.001 both years). On multilevel logistic analysis with three nested levels (student, school, school district) during both vaccination seasons, children were more likely to be vaccinated in SLV-I versus control schools; ORs were 1.6 (95% CI=1.4, 1.9; p<0.001) and 1.5 (95% CI=1.3, 1.8; p<0.001). Delivering influenza vaccine during school is a promising approach to improving pediatric influenza vaccination coverage. ClinicalTrials.govNCT01224301.
    American journal of preventive medicine 01/2014; 46(1):1-9. DOI:10.1016/j.amepre.2013.08.021 · 4.53 Impact Factor
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    ABSTRACT: Background There continues to be a need for increases in adult vaccination rates, especially among those working in environments which may easily become communicable disease outbreak centers, such as school employees in the school environment. The purpose of this study was to evaluate why rural Utah school employees were non-compliant with the influenza and measles, mumps, and rubella (MMR) vaccines, as well as to identify their views on mandatory vaccination policies. Methods A questionnaire was distributed to all school employees in a rural Utah school district. Data analysis included frequencies and measures of central tendency and dispersion for quantitative items and theme identification for qualitative items. Results Only 51% of school employees were adequately vaccinated for influenza. Reasons for noncompliance with the influenza vaccine included inconvenience, lack of perceived need, and questionable vaccine efficacy. There were 39.3% school employees who had not received an MMR during adulthood, which was commonly attributed to lack of knowledge regarding the need for this vaccine. Almost half (45.7%) of school employees believed a mandatory vaccination policy should be instituted, although 24.2% of school employees were opposed to mandatory adult vaccination policies. Reasons for opposing vaccination mandates included violation of personal choice, lack of perceived vaccination safety and efficacy, lack of perceived need for adult vaccines, and vaccine cost. Conclusions Suboptimal vaccination rates of school employees may negatively affect the health and well-being of individuals in the school environment. School employees report a variety of beliefs regarding the influenza and MMR vaccines. While over half of school employees support mandatory vaccination policies for adults working in the school environment, those opposing such a policy report concerns regarding violation of personal choice. Public health officials and school administrators should coordinate efforts to increase vaccination rates among adults in the school environment.
    Vaccine 08/2014; 32(37). DOI:10.1016/j.vaccine.2014.06.029 · 3.62 Impact Factor
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    ABSTRACT: Background: Influenza is a worldwide prevalent infectious disease of the respiratory tract annually causing high morbidity and mortality in Germany. Influenza is preventable by vaccination and this vaccination is so far recommended by the The German Standing Committee on Vaccination (STIKO) as a standard vaccination for people from the age of 60 onwards. Up to date a parenterally administered trivalent inactivated vaccine (TIV) has been in use almost exclusively. Since 2011 however a live-attenuated vaccine (LAIV) has been approved additionally. Consecutively, since 2013 the STIKO recommends LAIV (besides TIV) for children from 2 to 17 years of age, within the scope of vaccination by specified indications. LAIV should be preferred administered in children from 2 to 6 of age. The objective of this Health Technology Assessment (HTA) is to address various research issues regarding the vaccination of children with LAIV. The analysis was performed from a medical, epidemiological and health economic perspective, as well as from an ethical, social and legal point of view. Method: An extensive systematic database research was performed to obtain relevant information. In addition a supplementary research by hand was done. Identified literature was screened in two passes by two independent reviewers using predefined inclusion and exclusion criteria. Included literature was evaluated in full-text using acknowledged standards. Studies were graded with the highest level of evidence (1++), if they met the criteria of European Medicines Agency (EMA)-Guidance: Points to consider on applications with 1. meta-analyses; 2. one pivotal study. Results: For the medical section, the age of the study participants ranges from 6 months to 17 years. Regarding study efficacy, in children aged 6 months to ≤7 years, LAIV is superior to placebo as well as to a vac-cination with TIV (Relative Risk Reduction - RRR - of laboratory confirmed influenza infection approx. 80% and 50%, respectively). In children aged >7 to 17 years (= 18th year of their lives), LAIV is superior to a vaccination with TIV (RRR 32%). For this age group, no studies that compared LAIV with placebo were identified. It can be concluded that there is high evidence for superior efficacy of LAIV (compared to placebo or TIV) among children aged 6 months to ≤7 years. For children from >7 to 17 years, there is moderate evidence for superiority of LAIV for children with asthma, while direct evidence for children from the general population is lacking for this age group. Due to the efficacy of LAIV in children aged 6 months to ≤7 years (high evidence) and the efficacy of LAIV in children with asthma aged >7 to 17 years (moderate evidence), LAIV is also very likely to be efficacious among children in the general population aged >7 to 17 years (indirect evidence). In the included studies with children aged 2 to 17 years, LAIV was safe and well-tolerated; while in younger children LAIV may increase the risk of obstruction of the airways (e.g. wheezing). In the majority of the evaluated epidemiological studies, LAIV proved to be effective in the prevention of influenza among children aged 2-17 years under everyday conditions (effectiveness). The trend appears to indicate that LAIV is more effective than TIV, although this can only be based on limited evidence for methodological reasons (observational studies). In addition to a direct protective effect for vaccinated children themselves, indirect protective ("herd protection") effects were reported among non-vaccinated elderly population groups, even at relatively low vaccination coverage of children. With regard to safety, LAIV generally can be considered equivalent to TIV. This also applies to the use among children with mild chronically obstructive conditions, from whom LAIV therefore does not have to be withheld. In all included epidemiological studies, there was some risk of bias identified, e.g. due to residual confounding or other methodology-related sources of error. In the evaluated studies, both the vaccination of children with previous illnesses and the routine vaccination of (healthy) children frequently involve cost savings. This is especially the case if one includes indirect costs from a societal perspective. From a payer perspective, a routine vaccination of children is often regarded as a highly cost-effective intervention. However, not all of the studies arrive at consistent results. In isolated cases, relatively high levels of cost-effectiveness are reported that make it difficult to perform a conclusive assessment from an economic perspective. Based on the included studies, it is not possible to make a clear statement about the budget impact of using LAIV. None of the evaluated studies provides results for the context of the German healthcare setting. The efficacy of the vaccine, physicians' recommendations, and a potential reduction in influenza symptoms appear to play a role in the vaccination decision taken by parents/custodians on behalf of their children. Major barriers to the utilization of influenza vaccination services are a low level of perception and an underestimation of the disease risk, reservations concerning the safety and efficacy of the vaccine, and potential side effects of the vaccine. For some of the parents surveyed, the question as to whether the vaccine is administered as an injection or nasal spray might also be important. Conclusion: In children aged 2 to 17 years, the use of LAIV can lead to a reduction of the number of influenza cases and the associated burden of disease. In addition, indirect preventive effects may be expected, especially among elderly age groups. Currently there are no data available for the German healthcare setting. Long-term direct and indirect effectiveness and safety should be supported by surveillance programs with a broader use of LAIV. Since there is no general model available for the German healthcare setting, statements concerning the cost-effectiveness can be made only with precaution. Beside this there is a need to conduct health eco-nomic studies to show the impact of influenza vaccination for children in Germany. Such studies should be based on a dynamic transmission model. Only these models are able to include the indirect protective effects of vaccination correctly. With regard to ethical, social and legal aspects, physicians should discuss with parents the motivations for vaccinating their children and upcoming barriers in order to achieve broader vaccination coverage. The present HTA provides an extensive basis for further scientific approaches and pending decisions relating to health policy.
    11/2014; 10:Doc03. DOI:10.3205/hta000119
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