Who benefits from integrative biomedical research? The socio-economic assessment method of VPHOP Dr. rer. pol. Rainer Thiel, empirica with Karl Stroetman, Veli Stroetmann, Marco Viceconti

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Outline 1.Background VPHOP project 2.Methodological challenges to assess integrative biomedical research 3.Three steps of the technology assessment framework 4.Results and future potentials

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, “Osteoporotic Virtual Physiological Human Project” ●EU funded, to create a patient-specific hypermodel for predicting with ICT-based tools for modelling and simulation of human physiology the absolute risk of bone fracture ●P2 medicine for osteoporosis; directly interrelated with improved clinical outcomes as well as the transformation of diagnosis and treatment of a chronic disease ●Results will be validated not only technically -- impact assessed on organisational, economic and societal issues including clinical practice ●Virtual Physiological Human (VPH) initiative, framework of methods and technologies to investigate the human body as a whole

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Organ-level model Cell-level model Constituent-level model Tissue-level model The VPHOP Hypermodel Body-level model Boundary Conditions Bone Remodelling Failure Criterion Constitutive Equation

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Assessing the value of VPH health technology Conventional methods (Health Technology Assessment) of limited use, because: ●Very early, experimental phase of technology diffusion ●Radical departure from current type of medical technology ●Likely to transform clinical practice and replace standard of care ●Complex technology integrating a multitude of health technologies

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Methodological challenges impact assessment extends into the future – ex-post evaluation methods insufficient two analytically distinct objects of analysis: 1.clinical management of the osteoporotic patient and the hospital change management; 2.disease states and improved health of the patient (fractures avoided and prevention)

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Multi-disciplinary, multi-method approach

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, VPHOP technology impact assessment framework To estimate socio-economic benefits, costs, and related risks, three working steps will be performed: 1.Comparing current and potential new standard of care; prepare detailed clinical pathway and work flows 2. Disease modelling (e.g. Markov cycles) to assess consequences of fractures avoided = tool-box for extracting and generating data (clinical and non-clinical; tangible and non- tangible) 3.Integration and evaluation of data through a scenario- oriented cost benefit analysis

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Overview concept and components

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Step 1: Comparing current and new standard of care clinical care pathway a tool for (1) collecting basic clinical and economic data (2) estimating the expected impact of the new clinical technology for routine clinical management human and instrumental resources, duration, and costs associated will be attached allows comparison between cost incurred and performance of –(1) current standard of care for osteoporosis –(2) new clinical care with VPHOP services

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Step 1: Example of algorithm care pathway for osteoporosis

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Step 2: Disease modelling to assess health impact of VPHOP to estimate long term costs and outcomes associated with osteoporosis and benefits of VPHOP services as healthcare intervention improved diagnostics and treatment from the increased predictive power captured as benefits from improved prevention, i.e. associated reduction in costs due to avoided fractures translating expected changes in the patients’ health states into estimates of socio-economic benefits, costs, and related risks

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Step 2: Illustration Markov health states osteoporosis

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Final step 3: Evaluation through cost benefit analysis results and data from the clinical pathway analysis and disease modelling will be applied into a single CBA identifies and measures total cost and benefits, incl. social costs and benefits, in monetary values discounted costs and benefits can be presented as a cost-benefit ratio options are being evaluated and can be compared in order to identify the most profitable option

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Results – Why Impact Assessment? ●Technology development & selection guided by socio-economic ex ante assessment ●Exploitation scenarios, business plans and industrial exploitation derive from socio-economic impact analysis, identifying relevant costs and benefits for all stakeholders ●From the onset configured to permit transfer of the methodology to a broader range of diverse future biomedical integrative research

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Acknowledgements We thank the European Commission for their financial and non-financial support! VPHOP is a project co-funded by the European Commission Seventh FRAMEWORK PROGRAMME. The research reported upon in this presentation has either directly or indirectly been supported by the European Commission, Directorate General Information Society and Media, Brussels. The results, analyses and conclusions derived there from reflect solely the views of its authors and of the presenter. The EC is not liable for any use that may be made of the information contained therein.

IV International Conference on Computational Bioengineering, Bertinoro, September 16-18, Further information: Communication & Technology Research Oxfordstr. 2, Bonn, Germany Tel: +49 (2 28) Fax: +49 (2 28)