BACKGROUND: Oseltamivir is usually not often prescribed (or reimbursed) for non-high-risk patients consulting for influenza-like-illness (ILI) in primary care in Europe. We aimed to evaluate the cost-effectiveness of adding oseltamivir to usual primary care in adults/adolescents (13 years +) and children with ILI during seasonal influenza epidemics, using data collected in an open-label, multi-season, randomised controlled trial of oseltamivir in 15 European countries. METHODS: Direct and indirect cost estimates were based on patient reported resource use and official country-specific unit costs. Health-Related Quality of Life was assessed by EQ-5D questionnaires. Costs and quality adjusted life-years (QALY) were bootstrapped (N = 10,000) to estimate incremental cost-effectiveness ratios (ICER), from both the healthcare payers' and the societal perspectives, with uncertainty expressed through probabilistic sensitivity analysis and expected value for perfect information (EVPI) analysis. Additionally, scenario (self-reported spending), comorbidities subgroup and country-specific analyses were performed. RESULTS: The healthcare payers' expected ICERs of oseltamivir were €22,459 per QALY gained in adults/adolescents and €13,001 in children. From the societal perspective, oseltamivir was cost-saving in adults/adolescents, but the ICER is €8,344 in children. Large uncertainties were observed in subgroups with comorbidities, especially for children. The expected ICERs and extent of decision uncertainty varied between countries (EVPI ranged €1-€35 per patient). CONCLUSION: Adding oseltamivir to primary usual care in Europe is likely to be cost-effective for treating adults/adolescents and children with ILI from the healthcare payers' perspective (if willingness-to-pay per QALY gained > €22,459) and cost-saving in adults/adolescents from a societal perspective.

Centre for Family and Community Medicine Medical University of Lodz Lodz Poland

Centre for Health Economics Research and Modelling Infectious Diseases University of Antwerp Campus Drie Eiken room D S 221 Universiteitsplein 1 2610 Antwerp Belgium

Département de Santé Publique Hôpital de l'Archet Nice France

Department of Clinical Research Basel Institute for Clinical Epidemiology and Biostatistics University Hospital Basel Basel Switzerland

Department of Family Medicine and Population Health University of Antwerp Antwerp Belgium

Department of Family Medicine Medical University of Bialystok Białystok Poland

Department of General Practice Antibiotic Center for Primary Care Institute of Health and Society University of Oslo Oslo Norway

Department of Public Health and Primary Care Gent University Gent Belgium

Division of Infectious Diseases and Hospital Hygiene Basel Institute for Clinical Epidemiology and Biostatistics University Hospital Basel Basel Switzerland

DRC Drug Research Center LLC Balatonfüred Hungary

Family Doctors' Clinic Lodz Poland

FDC Mano šeimos gydytojas Klaipeda Lithuania

General Practice and Primary Health Care at the School of Medicine University of Crete Crete Greece

General Practice Family Medicine School of Public Health and Community Medicine Institute of Medicine Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Institute of General Practice 1st Faculty of Medicine Charles University Prague Prague Czech Republic

Interuniversity Institute for Biostatistics and Statistical Bioinformatics Hasselt University Hasselt Belgium

Julius Center for Health Sciences and Primary Care University Medical Center Utrecht The Netherlands

Laboratory of Medical Microbiology Vaccine and Infectious Disease Institute University of Antwerp Antwerp Belgium

Malia Surgery Kastelli HC Heraklio Greece

RCSI Department of General Practice 123 St Stephens Green Dublin 2 Ireland

Research Education Development and Innovation Primary Health Care Region Västra Götaland Sandared Sweden

Research Leader Antibiotic Centre for Primary Care Department of General Practice University of Oslo Oslo Norway

Research Unit for General Practice Department of Public Health University of Copenhagen Copenhagen Denmark

School of Primary Care Population Sciences and Medical Education Faculty of Medicine University of Southampton Southampton UK

Section and Research Unit of General Practice Department of Public Health University of Copenhagen Copenhagen Denmark

The Nuffield Department of Primary Care Health Sciences University of Oxford Oxford UK

University Institute in Primary Care Research Jordi Gol Via Roma Health Centre Barcelona Spain

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