Mark Pearson. Peteris Zilgavis
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1 Elizabeth Kuiper Director European Affairs, EFPIA Mark Pearson Deputy Director, Employment Labour and Social Affairs, OECD Peteris Zilgavis Head of Unit Health and Well- Being DG CONNECT, European Commission Zoltán Kaló Professor of Health Economics e- mail:
2 } Compared to higher income Western European countries - worse health status - even more limited health care resources } Pricing of new health care technologies is adjusted to large WE markets, and due to the external price referencing system (and risk of parallel trade) CEE and WE prices are not significantly different } Inefficient health care financing system: - low public budget and priority for health technology assessment inappropriate pricing and reimbursement decisions - limited polifcal interest to monitor the impact of decisions
3 Necessary public health care budget based on needs Available public budget Consequences: 1. Delayed access of pafents to high cost technologies 2. PaFent routes are blocked by volume limits and waifng lists 3. PotenFal difference between efficacy and effecfveness of new medicines 4. Poor performance and health outcomes
4 } (differenfal pricing of new technologies in EU) } BeQer use of big data to support health care financing decisions - ex ante: health technology assessment - ex post: monitor the impact of decisions + pay for performance } PotenFal data sources: - payers databases - pafent registries - pafent reported outcomes
5 Elizabeth Kuiper Director European Affairs, EFPIA Mark Pearson Deputy Director, Employment Labour and Social Affairs, OECD Peteris Zilgavis Head of Unit Health and Well- Being DG CONNECT, European Commission Zoltán Kaló Professor of Health Economics e- mail:
6 TITLE OF THE POWERPOINT 6
7 Example of a project TITLE OF THE POWERPOINT 7
8 ROADS aims to address current unmet needs in Alzheimer's disease and in particular the lack of integrated data standards Pre-clinical AD Available data sources to inform the real world trajectory and impact of AD are very limited Ø Lack of consensus around appropriate study designs and endpoints in real world data sets Ø Lack of clarity on how best to model the natural history of the disease using real world data sources MCI due to AD Mild AD Moderate AD Severe AD Positive Amyloid PET Imaging Scan and/or Aβ CSF/Tau changes Asymptomatic Slight memory deficit Memory impairment Multi-domain impairment Severe cognitive impairment No functional impairment Some impairment of complex function (iadls) Functional impairment Behaviour symptoms Some assistance Nursing home IMIBD4BO_IMIStakeholdersForum_ROADS.pptx 8
9 The end goal of ROADS is improved assessment & treatments of AD patients Build an understanding of how to measure outcomes in AD In collaboration with National Health Authorities, Health Technology Assessment Bodies (HTAs), regulatory agencies, providers, patients, etc. Define a data strategy plan for a second phase in 2019 to collect real world outcomes IMIBD4BO_IMIStakeholdersForum_ROADS.pptx 9
10 Expected impact of ROADS is better patient care from early stages of disease Better understanding of evolution of disease and data to enable giving the right treatment to the right patient at the right time Better data from early stages of disease, enabling for earlier diagnosis and better treatment selection from the start Faster access to innovation through alignment on outcomes that matter and that will therefore be measured and evaluated IMIBD4BO_IMIStakeholdersForum_ROADS.pptx 10
11 Elizabeth Kuiper Director European Affairs, EFPIA Mark Pearson Deputy Director, Employment Labour and Social Affairs, OECD Peteris Zilgavis Head of Unit Health and Well- Being DG CONNECT, European Commission Zoltán Kaló Professor of Health Economics e- mail:
12 Big data for what? Better clinical decision making KP: risk stratification for sepsis in premature births KP: risk-prediction of adherence to therapies leading to better 5-year survival for colon cancer patients. FDA: mini-sentinel for drug interactions Governance and managing care-co-ordination Carolinas: predict readmission risk and identify patients at risk of various future complications Clalit: predict readmission among elderly ER patients Waste reduction CMS monitors 4.5m transactions a day: save $115m in improper payments Research Euro/Canadian pooling of data on over 50s to monitor dementia IBM: Cognitive computing to predict CHF
13 Little linkage and quality monitoring beyond hospital data & cancer registries Hospital in- pafent data Cancer registry data Mortality data 22 Countries Emergency health care data Mental hospital in- pafent CVD registry data NaFonal personal health data available PrescripFon medicines data PopulaFon census/registry Unique ID included and used consistently PopulaFon health survey data Formal long- term care data Primary care data PaFent reported outcomes Record linkage to regularly monitor health care quality and system performance Diabetes registry PaFent experiences survey Source: OECD HCQI Country Survey, 2013/14 13
14 Preparing a big data strategy 1. Strategic planning: Leadership and change-management and identify key stakeholders 2. Assessment: Assess existing data silos and content taxonomies, data management practices, analytical uses and interoperability 3. Building data governance and public trust: Regulations and policies to protect data privacy and security and promote trust, transparency 4. Technological infrastructure and capabilities: Build information architecture, content standards and interoperability 5. Financial Sustainability: Ensure resources and incentives for public and private sectors to innovate and invest 14
15 Elizabeth Kuiper Director European Affairs, EFPIA Mark Pearson Deputy Director, Employment Labour and Social Affairs, OECD Peteris Zilgavis Head of Unit Health and Well- Being DG CONNECT, European Commission Zoltán Kaló Professor of Health Economics e- mail:
16 Next steps following the Green Paper on mhealth (I) Code of Conduct on Privacy and Security Stakeholder meeting on the quality and reliability of mhealth and wellbeing apps Pro- Innovation Regulatory Framework for Non- Embedded Software
17 Next steps following the Green Paper on mhealth (II) Ø Follow-up actions to support mhealth deployment under Horizon 2020: digital health literacy big data digital security evidence-gathering and exchange of best practices Ø Possible extension of the EU ehealth Interoperability Framework to cover mhealth
18 Citizen-centric healthcare Patient empowerment Digital health literacy Access to health data Co-production of health
19 ehealth Action Plan Ø Electronic Health Records Ø Telemedicine (incl. mobile health) Ø Citizen generated health data Ø Big Data Ø Trust and security
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