NEWSLETTER 1. Cost-effectiveness assessment of European influenza human pandemic alert and response strategies

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1 FLURESP was launched on April 1 st, 2011 The FLURESP consortium is a multidisciplinary team composed by European experts in influenza and public health response to influenza outbreaks, health economics, computerized sciences, legal and ethical aspects of public health, epidemiology and statistics. Cost-effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 1 Sep 30 th 2011 Main Objective The main objective of the FLURESP project is to assess performance, costs and cost-effectiveness of key response strategies, taking into account lessons from the 2009 pandemic situation in Europe. In particular sequential response strategies will be investigated (first line, second line, third line) in order to improve European public authorities ability to better respond to various categories of threats through better preparedness planning. Work plan First phase: Describing and assessing human pandemic scenarios in Europe. After an extensive literature review, the FLURESP consortium will define pandemic scenarios in Europe Second phase: Assessing response strategies using a set of selected criteria with pilot data collection in four European countries: France, Italy, Poland and Romania Third phase: Multi-criteria modelling will compare response strategies using various advanced methodological approaches including cluster, outranking and multi-dimensional analyses. Fourth phase: Development of sequential costeffectiveness simulation models comparing the response stragegies with extensive sensitivity analyses using Monte-Carlo simulations Fifth phase: Guidelines for Policy Decision making will be proposed taking into account the deliverables of the four previous phases.

2 EVENTS FLURESP Kick Off meeting Luxemburg, April 1 st 2011 A large part of the kick off meeting was dedicated to present the project strategy, scientific key issues and all beneficiaries institutions. The representatives were also informed about the expectations from EAHC and DG Sanco regarding the Fluresp project. Synergies with the activity of WHO and ECDC have been discussed in the frame of presentations from collaborating partners WHO and ECDC. FLURESP Working meeting Paris, June 20 st 2011 FLURESP beneficiary institutions Université Claude Bernard Lyon 1, (main beneficiary) France Université Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario, Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania Collaborating partners After the introduction to WP4 objectives and strategy held by Ariel Beresniak, Caterina Rizzo went thought the planning and methods on how to proceed with the WP4 s activities The first part of the meeting was dedicated to list the scientific sources for pandemic scenarios. Four main sources were defined and discussed: Literature review National technical reports International bodies technical reports Other EC projects The second part of the meeting focused on Candidate parameters to define flu pandemic scenarios. After a large discussion, participants agreed in using a selection of criteria Virus related and Health systems related Relevant parameters could be selected considering information collected within influenza surveillance systems available and on the basis of their use for risk assessment using mathematical modelling. Key pandemic scenarios should be defined in the frame of a simple matrix. World Health Organisation, Headquarter European Centre for Disease Prevention and Control University of Crete, Greece Ministry for Health, Elderley and Community Care, Malta Project leader: Dr. Ariel Beresniak Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

3 Typology of human influenza pandemic scenarios in Europe (WP4) Cost-effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 2 Oct 31 st 2011 Workpackage 4 was dedicated to develop a typology of various scenarios of human pandemic. In order to define a set of possible pandemic scenarios, the following tasks have been carried out: literature review, review of technical national and international reports, review of available information from other EC founded projects. 8 virus related parameters were selected as candidates to be relevant in the pandemic scenario description. At the same purpose, a comparison among the main European national and international technical reports allowed the identification of 5 health system related parameters. Severity profile of possible scenarios derived from the literature review and from the data collected in previous pandemics have been reported. This severity profile do not takes into account any mitigation or control measure and is similar to what already appears in technical reports dealing with pandemic fixed scenarios. What has been suggested is to consider a set of more flexible scenarios that is far from the classic scenarios structure used to date. Since the scenario severity profile could differ by each parameter, it has been considered also the severity profile by each parameter defined (e.g. low severity profile of transmission and with an high severity profile of virulence and medical resource utilization). Moreover since these scenarios do not take into account the age profile of the population and the proportion of chronic medical conditions, it has been consider eda reasonable solution to retain the worst case scenario for at risk groups. The final WP4 deliverable led to a comprehensive and original matrix of scenarios typology taking into account pandemic severity and capacity to respond. A scientific manuscript synthesizing this original approach is in preparation to be submitted in an international peer reviewed Journal. Scientific communications FLURESP communications have been presented in the following congresses : 4th ESWI Influenza Conference, Malta Sep 11-14, 2011 European Health Forum, International health security, Gastein Oct 5 th, 2011

4 EVENTS FLURESP Working meeting Rome, November 3 srt 2011 Organized at the Instituto Superiore di Sanita, this working meeting was dedicated to validate the assumptions and preliminary results of WP4. A number of potential criteria has been screened and discussed in the frame of their relevance in Public Health in general, and of the FLURESP objectives in particular. A candidate pandemic scenarios matriy has been discussed and enriched. FLURESP Working meeting Lyon, March 6th st 2012 FLURESP beneficiary institutions Université Claude Bernard Lyon 1, (main beneficiary) France Université Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario, Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania Collaborating partners A publication reference list related to the WP5 topic has been presented and discussed. A large part of this working meeting was dedicated to discuss the list of response and measures against human influenza pandemic. The following public health interventions have been selected: Interventions related to individual disease transmission : Individual measures (hand washing, mask, etc.) Societal interventions: - Border control (quarantine, fever screening, border closure, etc.) - Community infection control measures (school closure, class dismissal, staggering, Mask in public area, social distancing, limitation of public transports, etc.) Interventions in health care facilities: - infection control (mask N95, limitation of aerosols, etc.) Vaccination programs Antiviral distribution programs (preventive or curative) Interventions related to level of care - mechanical ventilation - supportive care Screening interventions World Health Organisation, Headquarter European Centre for Disease Prevention and Control University of Crete, Greece Ministry for Health, Elderley and Community Care, Malta Project leader: Dr. Ariel Beresniak Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

5 Description of response strategies according to various scenarios of influenza human pandemic (WP5) Cost effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 3 Apr 27 th The objective of the core Workpackage 5 was to describe regional and national response strategies according to various scenarios of influenza human pandemic in Europe, according to existing preparedness plans. Because of the complex and zoonotic nature of the disease, the aim of WP5 was to assess relevant responses and measures strategies, taking into account performance of interventions, costs, legal and ethical aspects and intersectoral aspects. The WP5 team reviewed the actions taken by member states during the 2009 pandemic and assessed the decision processes in EU countries. The team selected 18 response strategies categorized in 7 groups: - Individual disease transmission - Societal interventions - Immunization programs - Antiviral distribution programs - Reduction of secondary infections - Interventions related to level of care - Screening interventions A set of standard criteria was defined including social disturbance, ethical impact, legal impact, feasibility level, direct and communication costs, work losses. In addition 5 performance indicators have been defined, and expressed in success rates: -Success rate 1: reduction of mortality due to influenza 40% -Success rate 2: reduction of work loss days 30% -Success rate 3: reduction of morbidity due to influenza 30% -Success rate 4: reduction of the max weekly incidence rate -Success rate 5: delay epidemic peak 2 weeks Finally 16 sequential strategies were defined composed by various combinations of the response strategies over the 3 quarters of a standard pandemic period. An extensive pilot data collection was carried out in France. Italy, Poland and Romania. WP5 is critical for the overall FLURESP project as it will not only focus on describing response strategies but also on proposing indicators and relevant criteria to assess most efficient sequential strategies in the frame of WP6 and WP7.

6 Scientific communications FLURESP communications have been presented in the following events: - XIV International Symposium of Respiratory Viral Infections (Macrae Foundation), Istanbul, 23-26th Mar European Commission Press conference: Why is it important to be vaccinated, Luxembourg, Oct 2012 FLURESP Working meeting Madrid, Oct th 2012 FLURESP beneficiary institutions Université ité Claude Bernard Lyon 1, (main beneficiary) France Université Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario, Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania A large part of this working meeting was dedicated to validate the pilot data collected in France, Italy, Poland and Romania in the frame of WP6. In addition, WP2 Dissemination and WP3 Evaluation Workpackages were discussed. FLURESP Working meeting Paris, 14 th Feb Collaborating partners World Health Organisation, Headquarter European Centre for Disease Prevention and Control University of Crete, Greece Ministry for Health, Elderley and Community Care, Malta Preliminary results from WP6 (multi-criteria analyses) were presented and discussed.: -Some response strategies seem to have a negligible effect - Other response strategies seem effective (immunization programs and antiviral distribution programs) - Effect of response strategies appear similar from one country to another Project leader: Dr. Ariel Beresniak Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

7 Multi-criteria analyses comparing human pandemic response strategies The objective of WorkPackage 6 (WP6) aims to perform multi-criteria analyses for decision-making purpose on the set of response strategies defined in the frame of WP5. This would allow to propose new tools for decision making during influenza pandemics taking into account the complexity raised by multiple parameters. Cost effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 4 May 30 th 2013 Led by partner UCBL (Claude Bernard University), the WP6 team took into account 18 response strategies, which have been investigated in the frame of WP5. The WP6 team: -set up 10 criteria for evaluating each response strategy - defined aggregation procedures of the 10 criteria using statistical methods, such as Principal Component Analyses and Multiple Correspondence Analyses - designed a priorization tool, available online, for generating a rating as an output according to one set of criteria - performed multi-criteria analyses for decisionmaking purposes according to two main objectives: ranking and cluster response strategies for each of the 4 target countries (France, Italy, Poland and Romania) plus all countries together. Finally, an overview of the pandemic preparedness plans at national level was carried out using data from Preparedness plans of EU member states, in order to perform multicriteria analyses and cluster EU countries by multi-component.profiles of preparedness plans. For this purpose, quality indicators of preparedness plans were used to cluster MS according to their preparedness plans quality profiles, such as timelines, monitoring and evaluation strategies, legal framework, financial resources, surveillance sites, animal surveillance, vaccine storage, etc.

8 Online priorization tool A software development tool has been specifically developed to propose a priorization rating of each response strategy. An easy to use application of the tool will be integrated as an online interactive tool in the FLURESP website for Public Health authorities. This would not only propose an easy to use priorization tool, but would also contribute to train decision makers about multi-cirteria approaches. Users would be able to enter their own data and generate original results based on optimization and aggregation techniques. This figure shows a spider graph as one possible output to represent the importance of strategies according to relative areas: FLURESP beneficiary institutions Université ité Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario, Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania Université Claude Bernard Lyon 1, (main beneficiary) France Collaborating partners This figure shows a preference graph linking different response strategies: World Health Organisation, Headquarter European Centre for Disease Prevention and dcontrol University of Crete, Greece Ministry for Health, Elderly and Community Care, Malta This priorization tool will be available online to health decision makers and the public health community on the Fluresp web site by Q4-2013: Project leader: Dr. Ariel Beresniak Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

9 Cost-Effectiveness analyses of Public health responses against human influenza Cost effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 5 Jan 30 th 2014 FLURESP PUBLIC CONFERENCE How to prioritize i i Public Health Interventions against Human Influenza? European Commission DG Sanco Luxemburg March 28 th 2014 Presentation of FLURESP results Recommendations and Guidelines Discussion with European Stakeholders Information and invitations: conference@fluresp.eu Despite that human influenza epidemic scenarios and their main related responses have been well documented and investigated by international organizations and few European Commission projects, they have never been assessed and ranked using cost-effectiveness advanced modelling techniques. The objectives of the WorkPackage 7 (WP7) of the FLURESP European project is to perform costeffectiveness analyses of public health interventions against human influenza, according to six epidemic scenarios. This novel approach to integrated decision-making proposed by the FLURESP consortium constitutes a premiere at the European and global levels for enabling EU member states to select the most appropriate and efficient public health response strategies to various scenarios of human influenza epidemic. A total of 18 public health interventions against human influenza have been selected in the frame of WP5. In order to assess and compare the costeffectiveness of the 18 interventions relevant to 6 human influenza epidemic scenarios (A-F) in 4 EU countries (France, Italy, Poland and Romania), this would have required to develop 432 original costeffectiveness models (4 countries x 6 pandemic scenarios x 18 interventions) according to one single effectiveness criterion. Hence, the development of so many models would have been totally impractical and outside of the scope and feasibility of the FLURESP project. Nonetheless, 108 models havebeenprogrammed for France (18 interventions x 6 pandemic scenarios), including the selection of 6 models for Italy, 6 for Romania and 6 for Poland. In addition, 8 pilot "sequential" models have been developed representing a sequence of 3 successive sets of combined interventions ti along the 3 quarters of a standard 9-month pandemic duration. The possibility of assessing costs and overall effectiveness of a set of combined public health interventions (in parallel and in sequence) is a very important feature of the FLURESP project and represents a significant added value compared to existing research in human influenza. In total, 134 cost-effectiveness models have been developed in the frame of the FLURESP project so far by January 2014.

10 Effectiveness criteria In order to conduct the FLURESP costeffectiveness assessments, particular attention has been paid to select a relevant effectiveness criteria, which is public-health meaningful, reproducible and with a robust metric. QALYs (Quality Adjusted Life Years) and DALYs (Disability Adjusted Life Years) were unable to meet these requirements, and not recommended for decision making by a recent validation study conducted in the frame of the ECHOUTCOME-FP7 European project. Five public-health meaningful effectiveness criteria were considered, wich can be expressed in probability of "Success/no Success" with Success rates defined according to the distributions of probabilities. Success criteria 1: probability to achieve a reduction of mortality due to influenza 40% Success criteria 2: probability to achieve a reduction of morbidity due to influenza 30% Success criteria 3: probability to achieve a reduction odf work days lost 30% Success criteria 4: probability of reducing the maximum weekly incidence rate Success criteria 5: probability of delaying the epidemic peak by 2 weeks or more To date, only Success criteria 1 has been used for practical reasons (explosive number of models). Additional success criteria will be programmed subsequently according to potential additional ressources. Costs criteria The direct costs for each response strategy (public health interventions and communications) were estimated during WP5 according to a uniform distribution between a minimum and maximum value for each of the 18 single public health measures, in each of the four target countries, for each of the 6 pandemic scenarios. The direct costs include direct intervention costs and program communication costs. Detailed cost values have been assessed in the frame of WP5. Cost-Effectiveness results Cost-Effectiveness results are under embargo until the final FLURESP public conference, which will be organized on March 28th in the premises of the DG Sanco in Luxemburg. Invitations are proposed to European stakeholders under request to conference@fluresp.eu FLURESP beneficiary institutions UniversitéU i ité Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario, Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita,, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania Université Claude Bernard Lyon 1, (main beneficiary) France Collaborating partners World Health Organisation (WHO), Headquarter European Centre for Disease Prevention and Control (ECDC) University of Crete, Greece Ministry for Health, Elderly and Community Care, Malta Project leader: Ariel Beresniak, MD, MPH, PhD Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

11 Fluresp European Cost-Effectiveness Guidelines Cost effectiveness assessment of European influenza human pandemic alert and response strategies NEWSLETTER 6 Sep 30 th 2014 The FLURESP innovative approach provides a transparent and robust scientific approach to assess and compare 18 response strategies according to six human influenza pandemic scenarios for assisting healthcare decision making. Such approach constitutes a premiere for assessing and managing different alerts of influenza human pandemic, at the local, national and global levels. In a context of multiple public health threats, and scarce resources, using clinically relevant outcomes and advanced simulation modelling, the FLURESP project represents a breakthrough method to optimize pandemic influenza preparedness framework, and to assist decisions during a given outbreak. By guiding public health measures and resource allocation decisions to reduce the spread of pandemic influenza, the FLURESP project establishes a new benchmark for improving decision-making in healthcare, towards optimizing health outcomes of populations. The FLURESP innovative approaches enable to assess, select, and deploy the best most efficient public health strategies in response to various levels of alerts of influenza human pandemic, contributing to establishing best practices in pandemic influenza readiness in Europe, and beyond. Importantly, this approach can also be exploited to guide decisions relevant to other major public health treats, across disease areas and geographies. The eight following recommendations are based on original scientific evidence derived from the cost-effectiveness analyses

12 1. An appropriate data collection should be organized through a robust information system to better assess interventions against different levels of human influenza epidemics 2. Cost-Effectiveness of public health interventions should be expressed using meaningful criteria such as costs per success 3. Vaccination programs should be implemented using existing vaccination centers and primary care services 4. Whatever the level of severity of the human influenza outbreak (seasonal flu or severe pandemic), vaccination programs should target the general population 5. Curative distribution of antivirals should be encouraged and facilitated 6. Guidelines for antibiotic therapy should be developed d and assessed 7. Priority should be given to the development of referral centres with extracorporeal membrane oxygenation (ECMO) capability 8. Screening interventions and individual prevention measures of disease transmission should be implemented in addition to other measures FLURESP beneficiary institutions UniversitéU i ité Paris Descartes, France Instituto Vasco de Investigacion y Desarrollo Agrario (NEIKER), Spain Retroscreen Virology Ltd, UK Istituto Superiore di Sanita,, Italy Open Rome, France Laurent Niddam Europai Közössegi Jogasz Iroda, Hungary National Institute of Public Health, Poland Institutul National de Sanatate Publica, Romania Université Claude Bernard Lyon 1, (main beneficiary) France Collaborating partners World Health Organisation (WHO), Headquarter European Centre for Disease Prevention and Control (ECDC) University of Crete, Greece Ministry for Health, Elderly and Community Care, Malta Project leader: Ariel Beresniak, MD, MPH, PhD Université Paris-Descartes ariel.beresniak@parisdescartes.fr This project has received funding from the European Union in the framework of the Health Program through the Directorate-General for Health and Consumers of the European Commission under grant agreement

13 The Fourth ESWI Conference Team GCO (Global Conference Organisers) B.V. Parabool DH Sliedrecht The Netherlands Tel: +31 (0) Fax: +31 (0) Title : FLURESP : a new European Commission project assessing cost-effectiveness of European influenza human pandemic response strategies Co-Authors: A. Beresniak1, M. Barral2, S. Briand3, J.M. Cohen4, C. Gaucu5, P. Gorynski6, C. Lionis7, L. Niddam8, J. Oxford9, F. Popovici10, C. Rizzo11, D.A. Zighed12. 1Paris Descartes University, Liraes, Paris, France. 2Neiker Tecnalia, Animal Health Department, Derio, Spain. 3WHO, Epidemic and Pandemic Alert and response, Geneva, Switzerland. 4OPENROME, Epidemiology, Paris, France. 5Ministry of Health, Public Health Regulation Division, Msida, Malta. 6National Institute of Hygiene, Medical Statistics, Warsaw, Poland. 7University of Crete, Public Health, Crete, Greece. 8Niddam European Community Lawyer, Legal, Budapest, Hungary. 9Retroscreen Virology ltd, Virology, London, United Kingdom. 10National Institute of Public Health, Bureau for Health Events Rapid Alert, Bucharest, Romania. 11National Center for Epidemiology Surveillance and Health Promotion, Research, Roma, Italy. 12Claude Bernard University, Eric, Lyon, France. 1

14 Background : The constant threat of emerging subtipes influenza viruses with pandemic potential imposes to European countries to prepare efficient responses adapted to pandemic planning. Most of the European countries had pandemic preparedness plans in place when the Pandemic H1N1 ( 2009) strain emerged in april These plans need to be revised to take into account the lessons learned form the 2009 pandemic. The objective of the FLURESP project is to assess performance and socioeconomical impact of response strategies in order to improve European public authorities ability to better respond to various categories of threats thru better preparedness plannings. Method : The FLURESP consortium is a multidisciplinary team composed by European experts in influenza and public health response to influenza outbreaks, Health Economics, Public Health, Computarized Sciences, Legal, Epidemiology and Statistics. The objective of the FLURESP project is support decision making process regarding the revision of national pandemic preparedness plans. The activities carried out by FLURESP will help to define main pandemic scenarios at the European level, describe and cluster response strategies and assess these response strategies in the frame of multicriteria and cost-effectiveness analyses, taking into account lessons from the 2009 pandemic situation in Europe. Expected Results : The first phase will be dedicated to the description of possible pandemic scenarios by criteria, such as severity or spread types. The second phase will focus on listing potential response strategies per flu pandemic scenario. During the third phase, Multi-criteria analyses will be carried out on each response strategy in order to assess their performance and efficiency. The fourth phase will perform cost-effectiveness assessments of the response strategies, which will be ranked by level of cost-effectiveness. The fifth phase will propose guidelines and recommendations for policy decision makers. Conclusion : If flu pandemic scenarios and main related responses are well documented and investigated, they have never been assessed and ranked using both multi-criteria and costeffectiveness approaches. The integrated approach of Decision Making proposed by the FLURESP consortium would constitute a premiere at the European and global level, which would support European member states to select the most appropriate and efficient public response to various scenarios of human pandemic. The outcome of the FLURESP project will provide an extensive assessment of Influenza pandemic response strategies at European level, based on cost-effective analysis of the possible response strategies for each pandemic scenario. 2