1. Critical assessment of uncertainty in economic evaluations on influenza vaccines for the elderly population in Spain.
- Author
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Ortiz-de-Lejarazu Leonardo R, Díez Domingo J, de Miguel ÁG, Martinón Torres F, Margüello ER, López-Belmonte Claver JL, Palomo-Jiménez PI, Farré Avellà JM, and Abellán Perpiñán JM
- Subjects
- Humans, Spain epidemiology, Aged, Uncertainty, Vaccination economics, Vaccination statistics & numerical data, Aged, 80 and over, Influenza Vaccines economics, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Influenza, Human economics, Cost-Benefit Analysis
- Abstract
Background: Influenza is a seasonal infection with a huge impact on morbidity and mortality in older adults, for whom vaccination is recommended. New influenza vaccines for this population have been introduced in Spain in the past 5 years, and a number of cost-effectiveness analyses (CEA) have been published to aid healthcare decision-making. The objective of this study was to assess possible sources of uncertainty in the CEAs of influenza vaccines for the older adults in Spain., Methods: A systematic review was performed to identify Spanish CEAs published since 2016. Potential sources of structural, methodologic and parametric uncertainty in CEA results were systematically analysed using the TRansparent Uncertainty ASsessmenT (TRUST) Tool, quality assessment checklists, and the WHO guidance on economic evaluations of influenza vaccine strategies. The primary sources of efficacy/effectiveness were analysed in depth to ascertain whether they could support the conclusions of the respective CEAs., Results: Seven CEAs were included. Overall, they were designed and performed in accordance with the applicable guidelines; however, some critical sources of uncertainty were detected, mainly: (1) the choice and use of efficacy/effectiveness data (real-world single season studies, meta-analyses including studies with high risk of bias and/or high heterogeneity with biased interpretation); (2) use of fewer than 5 seasons to estimate influenza burden; (3) generalized use of influenza-like illness data to estimate effectiveness and burden, among others., Conclusions: Seemingly well-designed studies may conceal important sources of uncertainty that affect the results. This must be taken into account when interpreting results to support decision-making., Competing Interests: Declarations. Ethics approval and consent to participate: Ethics approval does not apply to this study because there are no patients involved. Consent for publication: Not applicable, no personal data have been included in the publication. Competing interests: ROLL has received fees for academic services and grants to attend international meetings from Abbot, CSL, GSK, Moderna, MSD, Novavax, Pfizer, Roche and Sanofi. JDD reports personal fees/grants from GSK, Sanofi Pasteur and MSD and nonfinancial support from Sanofi Pasteur and MSD. AGM has received grants paid to his institutions by Sanofi, GSK, and Pfizer. He has also received personal consulting fees from Sanofi, MSD, and Moderna, as well as for lectures and congress presentations from GKS, HIPRA, Astra-Zeneca, Novavax, Pfizer and Jannsen. He has received support for attending meetigs/travel by Pfizer, MSD, GSK, and Sanofi. Finally, he declares having participated in safety monitory boards for Pfizer, Hipra and Novavax. ERM has participated in advisory boards, conferences, courses and lectures organized by Glaxo SmithKline, Sanofi Pasteur, MSD, GSK, Seqirus, Pfizer, Moderna, Takeda, and AstraZeneca. She has also participated in data safety or advisory boards from Pfizer, Sanofi, MSD, Moderna, Takeda and GSK. FMT has received honoraria and/or reimbursement for participation fees/travel expenses from GSK, Pfizer Inc, Sanofi Pasteur, MSD, Seqirus, Biofabri, and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. He has also acted as principal investigator in randomized controlled trials sponsored by the above-mentioned companies as well as by Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. JMAP declares having received consulting fees from Sanofi. JLLBC, PIPJ and JMFA are employees of Sanofi and may hold shares and/or stock options in the company., (© 2025. The Author(s).)
- Published
- 2025
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