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Inclusion of Safety-Related Issues in Economic Evaluations for Seasonal Influenza Vaccines: A Systematic Review.

ABSTRACT: (1) Background: Vaccines for seasonal influenza are a good preventive and cost-effective strategy. However, it is unknown if and how these economic evaluations include the adverse events following immunization (AEFI), and what the impact of such inclusion is on the health economic outcomes. (2) Methods: We searched the literature, up to January 2020, to identify economic evaluations of seasonal influenza vaccines that considered AEFIs. The review protocol was published in PROSPERO (CDR42017058523). (3) Results: A total of 52 economic evaluations considered AEFI-related parameters in their analyses, reflecting 16% of the economic evaluations on seasonal influenza vaccines in the initial study selection. Most studies used the societal perspective (64%) and evaluated vaccination of children (37%). Where considered, studies included direct medical costs of AEFIs (90%), indirect costs (27%), and disutilities/quality-adjusted life years loss due to AEFIs (37%). The majority of these studies accounted for the effects of the costs of AEFI on cost-effectiveness for Guillain-Barré syndrome. In those papers allowing cost share estimation, direct medical cost of AFEIs was less than 2% of total direct costs. (4) Conclusions: Although the overall impact of AEFIs on the cost-effectiveness outcomes was found to be low, we urge their inclusion in economic evaluations of seasonal influenza vaccines to reflect comprehensive reports for the decision makers and end-users of the vaccination strategies.

SUBMITTER: Fens T

PROVIDER: S-EPMC7913116 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Inclusion of Safety-Related Issues in Economic Evaluations for Seasonal Influenza Vaccines: A Systematic Review.

Fens Tanja T Boer Pieter T de PT Puijenbroek Eugène P van EPV Postma Maarten J MJ

Vaccines 20210202 2

(1) Background: Vaccines for seasonal influenza are a good preventive and cost-effective strategy. However, it is unknown <i>if</i> and <i>how</i> these economic evaluations include the adverse events following immunization (AEFI), and what the impact of such inclusion is on the health economic outcomes. (2) Methods: We searched the literature, up to January 2020, to identify economic evaluations of seasonal influenza vaccines that considered AEFIs. The review protocol was published in PROSPERO ...[more]

PMID: 33540633

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Project description:BackgroundAlthough public health guidelines have implications for resource allocation, these issues were not explicitly considered in previous WHO pandemic preparedness and response guidance. In order to ensure a thorough and informed revision of this guidance following the H1N1 2009 pandemic, a systematic review of published and unpublished economic evaluations of preparedness strategies and interventions against influenza pandemics was conducted.MethodsThe search was performed in September 2011 using 10 electronic databases, 2 internet search engines, reference list screening, cited reference searching, and direct communication with relevant authors. Full and partial economic evaluations considering both costs and outcomes were included. Conversely, reviews, editorials, and studies on economic impact or complications were excluded. Studies were selected by 2 independent reviewers.Results44 studies were included. Although most complied with the cost effectiveness guidelines, the quality of evidence was limited. However, the data sources used were of higher quality in economic evaluations conducted after the 2009 H1N1 pandemic. Vaccination and drug regimens were varied. Pharmaceutical plus non-pharmaceutical interventions are relatively cost effective in comparison to vaccines and/or antivirals alone. Pharmaceutical interventions vary from cost saving to high cost effectiveness ratios. According to ceiling thresholds (Gross National Income per capita), the reduction of non-essential contacts and the use of pharmaceutical prophylaxis plus the closure of schools are amongst the cost effective strategies for all countries. However, quarantine for household contacts is not cost effective even for low and middle income countries.ConclusionThe available evidence is generally inconclusive regarding the cost effectiveness of preparedness strategies and interventions against influenza pandemics. Studies on their effectiveness and cost effectiveness should be readily implemented in forthcoming events that also involve the developing world. Guidelines for assessing the impact of disease and interventions should be drawn up to facilitate these studies.

Project description:BackgroundWe aimed to provide a comprehensive overview of methodological challenges in economic evaluations of disease prevention and health promotion (DPHP)-measures.MethodsWe conducted an overview of reviews searching MEDLINE, EMBASE, NHS Economic Evaluation Database, Database of Promoting Health Effectiveness Reviews, Cochrane Database of Systematic Reviews (CDSR) and Database of Promoting Health Effectiveness Reviews (DOPHER) (from their inception to October 2021). We included both systematic and scoping reviews of economic evaluations in DPHP addressing following methodological aspects: (i) attribution of effects, (ii) outcomes, (iii) inter-sectoral (accruing to non-health sectors of society) costs and consequences and (iv) equity. Data were extracted according to the associated sub-criteria of the four methodological aspects including study design economic evaluation (e.g. model-based), type/scope of the outcomes (e.g. outcomes beyond health), perspective, cost categories related to non-health sectors of society, and consideration of equity (method of inclusion). Two reviewers independently screened all citations, full-text articles, and extracted data. A narrative synthesis without a meta-analysis or other statistical synthesis methods was conducted.ResultsThe reviewing process resulted in ten systematic and one scoping review summarizing 494 health economic evaluations. A lifelong time horizon was adopted in about 23% of DPHP evaluations, while 64% of trial-based evaluations had a time horizon up to 2 years. Preference-based outcomes (36%) and non-health outcomes (8%) were only applied in a minority of studies. Although the inclusion of inter-sectoral costs (i.e. costs accruing to non-health sectors of society) has increased in recent years, these were often neglected (between 6 and 23% depending on the cost category). Consideration to equity was barely given in economic evaluations, and only addressed in six of the eleven reviews.ConclusionsEconomic evaluations of DPHP measures give only little attention to the specific methodological challenges related to this area. For future economic DPHP evaluations a tool with structured guidance should be developed. This overview of reviews was not registered and a published protocol does not exist.

Project description:ObjectivesThis study aims to conduct a systematic review of economic evaluations of COVID-19 interventions and to examine whether and how these studies incorporate non-health impacts and distributional concerns.MethodsWe searched the National Institutes of Health's COVID-19 Portfolio as of May 20, 2021, and supplemented our search with additional sources. We included original articles, including preprints, evaluating both the health and economic effects of a COVID-19-related intervention. Using a pre-specified data collection form, 2 reviewers independently screened, reviewed, and extracted information about the study characteristics, intervention types, and incremental cost-effectiveness ratios (ICERs). We used an Impact Inventory to catalog the types of non-health impacts considered.ResultsWe included 70 articles, almost half of which were preprints. Most articles (56%) included at least one non-health impact, but fewer (21%) incorporated non-economic consequences. Few articles (17%) examined subgroups of interest. After excluding negative ICERs, the median ICER for the entire sample (n = 243 ratios) was $67,000/quality-adjusted life-year (QALY) (interquartile range [IQR] $9000-$893,000/QALY). Interventions including a pharmaceutical component yielded a median ICER of $93,000/QALY (IQR $4000-$7,809,000/QALY), whereas interventions including a non-pharmaceutical component were slightly more cost-effective overall with a median ICER of $81,000/QALY (IQR $12,000-$1,034,000/QALY). Interventions reported to be highly cost-effective were treatment, public information campaigns, quarantining identified contacts/cases, canceling public events, and social distancing.ConclusionsOur review highlights the lack of consideration of non-health and distributional impacts among COVID-19-related economic evaluations. Accounting for non-health impacts and distributional effects is essential for comprehensive assessment of interventions' value and imperative for generating cost-effectiveness evidence for both current and future pandemics.

Project description:IntroductionThe European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance.MethodsAEIs were collected within 7 days of vaccination from ten general practices predominantly administering inactivated quadrivalent influenza vaccine (IIV4, Fluarix Tetra, GSK). Vaccinees completed an adverse drug reaction (ADR) card. ADR card and medically attended AEIs data were recorded in practice electronic health records. We report the outcome of the first 5 weeks of safety surveillance (September 12, 2016-October 16, 2016); in an exploratory analysis, rates of AEI for IIV4 are compared to those passively reported through a sentinel network.ResultsPractices vaccinated 13.1% (12,864/98,091) of their registered population; 5.6% (95% CI 5.20-6.00) of them reported AEIs, none serious. The most frequent were respiratory 2.60% (95% CI 2.33-2.88), musculoskeletal 1.82% (95% CI 1.59-2.05) and neurological 1.05% (95% CI 0.88-1.23). AEIs were more frequently reported for adults than for children; 5.91% (95% CI 5.49-6.34) compared to 1.49% (95% CI 0.69-2.29); 47.18% of the adults reported AEI using the ADR card, none were returned for subjects < 18 years old. The frequency of AEIs reporting was higher, 6.88% (95% CI 6.35-7.42) vs. 3.30% (95% CI 2.68-3.96, 100/3028, p < 0.000), through ESS than passive surveillance.ConclusionThe ESS did not reveal any safety signal and we demonstrated the feasibility of conducting ESS following EMA recommendations. The use of a customised ADR card led to a doubling of AEIs reports over passive surveillance in adults.FundingGlaxoSmithKline Biologicals SA, Wavre, Belgium.

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Inclusion of Safety-Related Issues in Economic Evaluations for Seasonal Influenza Vaccines: A Systematic Review.

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Inclusion of Safety-Related Issues in Economic Evaluations for Seasonal Influenza Vaccines: A Systematic Review.

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