27
Better health, better futures RESCEU study: RSV disease burden and economic impact Prof Harish Nair MBBS, PhD, FRCPE, FFPH Chair of Paediatric Infectious Diseases and Global Health
Better health, better futuresBetter health, better futuresBetter health, better futures
RESCEU study: RSV disease burden and economic impact
Prof Harish Nair MBBS, PhD, FRCPE, FFPH
Chair of Paediatric Infectious Diseases and Global Health
• Funding from Bill and Melinda Gates Foundation and Innovative Medicines Initiative for RSV-related work
• Funding from Sanofi Pasteur for RSV and non-RSV related work
• Funding from National Institute of Health Research, UK for RSV and non-RSV related work
• Honorarium from Sanofi, Abbvie and Janssen for participating in SAB meeting
• Grants, consultancies and travel support from WHO• Travel support from ERS
Disclosure
• RESCEU – who are we?– scope of our work
• Results ØARI burden attributable to RSVØGlobal burden of RSV in adults >65 yearsØEconomic burden due to RSV-ALRI in children <5
yearsØGlobal seasonality of RSV
Outline
RESCEU - introduction € 29M (2017-2021) Innovative Medicines Initiative (IMI) Project to build evidence base on RSV disease burden and associated economic impact in Europe to§ inform vaccine policy and improve clinical management of RSV
cases§ build pan European stakeholder community for RSV; actively
engage stakeholders to improve strategic planning and decision making
§ create a powerful new bio-repository for future research using existing and prospectively collecting clinically annotated biological specimens
§ collaborate with regulatory authorities (EMA and FDA) to ensure required regulatory input for clinical platform development and to conduct clinical trials
§ establish an ethics/governance framework that will allow wide stakeholder engagement including national and international public health agencies, pharmaceutical industry and regulators.
www.resc-eu.org
Consortium structure
§ Consortium formed with ReSViNETas nucleus
§ RESCEU partners – Academic, Public Health Agencies and EFPIA
§ RESCEU Affiliate partners – Inner and outer circle (all stakeholders)
§ Linkages to existing consortia§ International Scientific
Advisory Group § RESCEU Ethics Advisory Committee
www.resc-eu.org
Affiliated Partners
www.resc-eu.org
Academic (Inner Circle) Public Health Institutions (Inner Circle)Barcelona Institute for Global Health (ES) National Institute for Health and Welfare THL (FI)Queen's University Belfast (UK) Norwegian Institute of Public Health (NO)Emma Children’s Hospital, Academic Medical Centre (NL) Public Health Institute Slovenia (SL)Erasmus Medical Centre (NL) National Centre For Epidemiology Department of Respiratory Viruses (HU)Institut Pasteur (FR) Center for Health Policies and Services (RO)London School of Hygiene & Tropical Medicine (UK) Netherland Institute for Health Services Research (NL)Ospedale Bambino Gesù di Roma (IT) Xunta de Galicia, Consellería de Sanidade (ES)Royal Manchester Children's Hospital (UK) Patient Societies (Inner Circle)U. Valencia / Global Influenza Hospital Surveillance Network (ES) ReSViNET Patient Advisory Board (UK)Université de Versailles Saint-Quentin (FR) Clinical Societies (Inner Circle)University of Cambridge (UK) RCGP Research & Surveillance Centre (UK)University of Groningen (NL) Royal College of Physicians of Edinburgh (UK) University of Leuven (BE) World Association of Perinatal Medicine (WAPM) (INT)University of Lille (FR) Academic Institutions (Outer Circle)Instituto de Medicina Molecular (PT) Nationwide Children's Hospital in Columbus (USA)University of Liverpool (UK) Fundación INFANT (ARG)University of Perugia (IT) Pontifícia Universidade Católica do Rio Grande do Sul (BRA)University of Surrey (UK) Telethon Kids Institute (AUS)Utrecht University (NL) Public Health Institutions (Outer Circle)University Children's Hospital Sant Joan de Deu (ES) Canada Immunization Research Network (CAN)Université Libre de Bruxelles (BE) PATH - Center for Vaccine Innovation and Access (USA)Medical Faculty of the Martin-Luther University Halle-Wittenberg (DE)
Assessing RSV burden in at least 6 European countries
Italy (Veneto Region)
Netherlands
DenmarkEngland
Scotland
Norway
Finland
Hospital admissions dataIntensive care admissions data
Mortality data
Maternal and perinatal data
Primary care data
Laboratory data
Disease registry data
Financial data
Primary Outputs
• National estimates of weekly number and annual rates of RSV-associated:
• Hospital admissions• ICU admissions• GP consultations• Deaths• (and all associated healthcare costs)
• Risk factors for severe RSV-associated disease (including maternal and perinatal characteristics)
• Generate new evidence of the association between RSV and asthma/wheeze
• Recruitment for clinical studies• Linkage of health records from EU countries• Publications of systematic review
Progress
Publications of systematic reviews
OR meta-estimates and attributable fractions in exposed in ARI cases vs asymptomatic controls
Virus #studies OR (95%CI) AFE% (95%CI)
RSV 10 8.5 (3.9 - 18.5) 88 (74 - 95)
Influenza 10 8.3 (4.4 - 15.9) 88 (77 - 94)
Influenza A 8 8.4 (3.9 - 17.8) 88 (75 - 94)
Influenza B 5 NA ~100
PIV 8 NA ~100
hMPV 7 9.8 (2.3 - 41.0) 90 (57 – 98)
AdV 8 NA ~100
RV 11 7.1 (3.7 - 13.6) 86 (73 -93)
RSV-ARI burden in adults ≥65 years
Economic burden due to RSV-ALRI in children
• Systematic review of review of published literature (Global Health, Medline and EMBASE) and assembly of unpublished data reporting costs related to RSV-ALRI in children <5y
• Inclusion criteria• published between 1 Jan 2000 and 30th September 2017• reporting cost data on RSV management in children < 60
months• Total costs per patient / episode were extracted from the
studies and adjusted to reflect 2017 USD and then converted all costs to € 2017.
• Meta-analyses of cost per episode and LOS was quantified using sample size weighted, random effects model in Stata V.12
• Global costs of RSV management modelled using RSV estimates for 2015 at global and regional levels
Economic burden due to RSV-ALRI in children
Manuscript under review, J Infect Dis
• 41 studies reporting data from 365,828 RSV disease episodes identified.
• 78% of studies based Europe, North Americas and Australia. No studies from Africa
• Average cost per episode Ø€ 299 (95% CI: 295 – 303) for outpatient management
without follow-upØ€ 2,191 (2,190 – 2,192) for outpatient with follow-up for 2
yearsØ€ 3,452 (3,265 - 3,639) for inpatients without follow-upØ€ 8,591 (8,489 – 8,692) for inpatient with follow-up for 2
years
Economic burden due to RSV-ALRI in children
Manuscript under review, J Infect Dis
Patient Group Developed countries
Developing countries Total Costs
(Billions, Euro€ 2017, 95% CI)Inpatient 1.15 (0.97-1.46) 1.53 (1.29 – 1.82) 2.65( 2.26 – 3.28)
Outpatient 0.58 (0.23-1.33) 1.60( 0.97 – 3.31) 2.17 (1.20– 4.65)
Total 1.69 (1.20 – 2.79) 3.13 (2.27- 5.13) 4.82 (3.47 – 7.93)
• 65% of global costs in developing countries • 55% of global costs accounted for by
hospitalization
Economic burden due to RSV-ALRI in children
Manuscript under review, J Infect Dis
• Method• Monthly viral activity data from systematic literature
review, online dataset and RSV GEN• Annual average percentage (AAP) reported as the measure
of viral activity on a monthly basis• Duration of epidemic defined as minimum number of
months that account for ≥75% of annual positives, with each month being an epidemic month
• Modelling of flu and RSV activity using temperature and relative humidity; online prediction tool developed
Global seasonality of RSV
Equator
Tropics
InfluenzaN = 246 sites
Tropic of Cancer
Tropic of Capricorn
Equator
Tropics
RSVN = 183 sites
Tropic of Cancer
Tropic of Capricorn
Seasonality: RSV vs flu
• Online prediction tool for flu and RSV seasonal epidemics• http://resceu.ecdf.ed.ac.uk/shiny/ShinyPred/
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
19.4 8.5 3.6 1.2 0.5 0.3 0.4 0.4 0.8 5.3 21.9 37.7
Predicted:England
Observed: England
Global seasonality of RSV
Gridded temperature and relative humidity data from HadISDH dataset.Willett et al. Clim. Past 2014; Smith et al. Bull. Amer. Meteor. Soc 2011
Global seasonality of RSV
• RESCEU has made substantial progress in the last 34 months
• Reported first global burden estimates for RSV in adults ≥65 years; economic burden in children <5 years; and a model to predict RSV seasonality worldwide
• In the next 24 months several FIRST AND EXCITING RESULTS expected
• Global RSV burden in pre-term infants• RSV Burden in young children, adults ≥65 years and
adults with COPD in Europe (from prospective cohort studies) and data-linkage studies
• Biomarkers for severe RSV
Summary
Acknowledgements
