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Educational Symposia during the ISPOR 15TH Annual European Congress, Berlin, Germany
Symposia are free and open to all ISPOR delegates, no pre-registration required
SUNDAY, 4 NOVEMBER 2012

17:15-18:15

CLINICAL PRACTICE DATA IN EUROPE: CURRENT AND FUTURE OPPORTUNITIES FOR RESEARCH AND TECHNOLOGY ASSESSMENT
 

Data on care delivery and health outcomes in actual clinical practice is of key importance for informing reimbursement decisions and monitoring consequences of these decisions. Such data is routinely produced and stored by health care providers or health insurers in electronic medical records and administrative systems; however, this data is not always made available for research or health technology assessments. Investments are made in retrospective chart reviews, prospective observational studies and registries to meet requirements by reimbursement agencies and other decision makers. Improved utilization of existing data could potentially contribute towards optimizing health care decision making, improving health outcomes and reducing costs of care and drug development. This symposium will describe the current situation on availability and usage of retrospective patient-level data for outcomes research and health technology assessment (HTA) across Europe. Presentations will focus on Germany and France, countries currently adopting increasing requirements on HTA, as well as examples of opportunities brought by developments in infrastructure of health care informatics. The role of the pharmaceutical industry in relation to the analysis of retrospective patient-level data for evaluation of health care technologies will be emphasized.

Moderator: Linus Jönsson, MD, PhD, Executive Vice President & Senior Scientist
OptumInsight, Stockholm, Sweden

THE CASE OF FRANCE: ALL THE DATA YOU NEED BUT CANNOT GET
Speaker: Gérard de Pouvourville, PhD, Professor, Healthcare Management, ESSEC Business School, Cergy-Pontoise, France

DANCERS IN THE DARK - EPIDEMIOLOGICAL AND CLINICAL RESEARCH BASED ON ROUTINELY COLLECTED GERMAN HEALTH INSURANCE DATA
Speaker: Maria Trottmann, PhD, Project Manager, Gesundheitsforen Leipzig GmbH, Leipzig, Germany

THE PHARMACEUTICAL INDUSTRY PERSPECTIVE
Speaker: Thomas Paulsson, PhD, Executive Director Europe, Global Health Economics and Outcomes Research, Bristol-Myers Squibb, Brussels, Belgium

 
Sponsored by OptumInsight

18:30-19:30

DO WE NEED INNOVATIVE MEASURES TO MEASURE INNOVATION?

 

Rapid and sustained patient access is integral to a successful life of any new medicine, including new immunological treatments with novel mechanisms of action and very different patterns of response. It is important to encourage new ways of thinking to ensure that innovative, new medicines, which deliver value, are made available to the patients who will benefit from its use. Therefore, current practices needs to be challenged and the evaluation of innovative new treatments needs to capture their true value. This symposium will examine current methods of determining value and whether they are fit for purpose. Different types of innovative health economics and outcomes measures will be discussed. The panel will address the question of likely future developments in the use of methods to assess innovation, the impact of these methods on pricing & reimbursement decisions. Future industry requirements to deliver the required measures to fully reflect and illustrate the degree of innovation and incremental value provided by new medicines will be presented.

WHAT IS INNOVATION IN MEDICINES – ESPECIALLY WITH REGARD TO TODAY'S HI TECH IMMUNOLOGICAL TREATMENTS?
Speaker: Colin Wight, Chief Executive, GalbraithWight, Polegate, UK

HOW ARE EXISTING MEASURES OF VALUE SHAPING UP? WHAT'S GOOD AND WHAT NEEDS IMPROVEMENT?
Speaker: Nic Brereton, BSc., Health Economist & Managing Director, BresMed Health Solutions LTD, Sheffield, UK

INCORPORATING INNOVATION MEASURES - A REAL LIFE EXAMPLE IN IMMUNO-ONCOLOGY
Speaker: Michael Lees, MCom, Director of HEOR, Oncology, Europe Bristol-Myers Squibb, Paris, France

NEW OPTIONS TO CONSIDER FOR DELIVERING AND VALUING INNOVATION
Speaker: Colin Wight, Chief Executive, GalbraithWight, Polegate, UK

HOW DO THESE IDEAS COMPARE WITH WHAT WE DO NOW & COULD WE ACCOMMODATE THESE INNOVATION CONCEPTS?
Speaker: Ailsa Brown, Lead Health Economist, Scottish Medicines Consortium, Glasgow, UK

 
Sponsored by GalbraithWight Market Access
MONDAY, 5 NOVEMBER 2012

7:30-8:30

OUTCOMES RESEARCH - A TOTAL HEALTH CARE SYSTEM APPROACH

 

This educational symposium will explain how an integrated approach to clinical care and research creates large implications for all types of outcomes research and improves outcomes for patients, by better and more appropriate use of existing medications and by the earlier adoption of new medicines or devices. Furthermore, it will discuss gaining access to all important real- world data and suggest methods by which risk/benefit analysis using both relative rate data from phase 3 clinical trials modeled together with real-world data, can provide input to help with value based pricing. Speakers from academia, government and the commercial sector will provide a wide perspective on many of today's key "HTA" and "outcomes" issues.

Moderator: John Parkinson, PhD, Director CPRD, London, UK

THE NEEDS OF HTA TO SUPPORT HEALTH SYSTEM DECISION MAKING IN RESOURCE ALLOCATION, PARTICULARLY RELATING TO NEW MEDICAL TECHNOLOGIES
Speaker: Mark J. Sculpher, MSc, PhD, Professor of Health Economics, Centre for Health Economics, University of York, York, UK

OBSERVATIONAL AND INTERVENTIONAL PERSPECTIVES AROUND RISK/BENEFIT AND VALUE-BASED PRICING
Speaker:Tjeerd van Staa, MD, PhD, MSc, MA, Director of Research, CPRD, London, UK

INTEGRATING CLINICAL CARE AND RESEARCH IN THE NHS
Speaker: Peter Knight, BA, Deputy Director, Head of Research Information and Intelligence Research & Development Directorate, Department of Health, London, UK

THE NICE PERSPECTIVE
Speaker: Sarah Garner, PhD, Associate Director, Research & Development, NICE, London, UK

LIFE CYCLE APPROACH AND EUROPEAN IMPLICATIONS
Speaker: Robert Thwaites, MA, Vice President, Health Economics, United BioSource Corporation, London, UK

 

Breakfast available prior to the presentation for symposium attendees


Sponsored by CPRD


12:15-13:15

New research for future approaches to measuring and valuing health

 

Recent advances in developing the EQ-5D-5L and the valuation of health states described by the EQ-5D-5L will be presented. A number of new future areas of methodological research will be highlighted, particularly experimental work regarding the development and potential use of 'bolt on' dimensions. The rationale for exploring bolt-ons will be considered and the conceptual and empirical challenges discussed. Results from current research and plans for further research in this area will be provided.

Moderator: Nancy Devlin, PhD, Director of Research, Office of Health Economics, London, UK

RESEARCH IN WHICH THE EUROQOL GROUP HAS ENGAGED
Speaker: Nancy Devlin, PhD, Director of Research, Office of Health Economics, London, UK

DOES THE EQ-5D ALWAYS CAPTURE TRUE CHANGES IN HEALTH AND WHAT CAN WE DO?
Speaker: Ben van Hout, PhD, Professor, Department of Health Economics, University of Sheffield, Sheffield, UK

AN EXPERIMENT: DEVELOPING AND VALUING AN EQ-5D-5L BOLT-ON FOR PSORIASIS
Speaker: Andrew Lloyd, PhD, Vice President, Patient Reported Outcomes, Oxford Outcomes, Oxford, UK

THE VALUATION OF HEALTH STATES RESULTING FROM AN EQ-5D-5L WITH BOLT-ON(S)
Speaker: John Brazier, PhD, Professor, HEDS, ScHARR, University of Sheffield, Sheffield, UK

 
Sponsored by EuroQol Group
TUESDAY, 6 NOVEMBER 2012

7:30-8:30

The Impact of European Collaboration on National Relative Effectiveness Assessment

 

The European collaboration on HTA is due to start conducting European relative effectiveness assessment of pharmaceuticals. To prepare for these pilots, HTA agencies, which are members of EUnetHTA have been discussing methodologies for rapid relative effectiveness assessment (REA) of pharmaceuticals at the time of launch. The purpose of these decisions is to explore the possibility of providing internationally agreeable recommendations in identified methodological areas, such as, inter alia, the choice of the most appropriate comparator, or acceptability of surrogate endpoints. At the same time, national health care decision-making is still driven by local politics, as demonstrated by some major debates during 2012. This symposium will discuss the impact of European collaboration on relative effectiveness assessment in national health care decision making.

Moderator: Edith Frénoy, MS, Director Market Access, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium

CAN EUROPE AGREE ON COMMON RELATIVE EFFECTIVENESS ASSESSMENT METHODOLOGIES?
Speaker: François Meyer, MD, Advisor to the President, International Affairs, Haute Autorité de Santé, Saint-Denis La Plaine, France

WILL LOCAL DECISION-MAKERS TAKE EUROPEAN METHODOLOGIES ON BOARD?
Speaker: Alric Ruether, MD, PhD, Head of Department of Health Care Quality International Affairs, Institute of Quality and Efficiency in Health Care (IQWiG), Cologne, Germany

HOW TO FACTOR EUROPEAN GUIDELINES INTO DRUG DEVELOPMENT?
Speaker: Ansgar Hebborn, PhD, Head, Global Market Access Policy, F. Hoffmann-La Roche AG, Basel, Switzerland

PANEL DISCUSSION
Additional Panelists:
Finn Børlum Kristensen, PhD, EUnetHTA Secretariat Director, Danish Health and Medicines Authority, Copenhagen, Denmark; Anders Lamark Tysse, MS, Policy Officer and National Expert, EU Commission, DG Health and Consumers, Brussels, Belgium

 
Sponsored by EFPIA

11:45-12:45

EFFECTIVE COMMUNICATION WITH FEDERAL AUTHORITIES FOR SCIENTIFIC ADVICE EARLY IN PRODUCT DEVELOPMENT

 

In recent years, the decision process for the assessment of new technologies for pricing and reimbursement by the responsible authoritative body has changed dramatically in some European countries. Examples include introduction of the “AMNOG” dossier through the Federal Joint Commission (G-BA) in Germany, technology appraisals through the National Institute for Health and Clinical Excellence (NICE) in the UK, and the Dental and Pharmaceutical Benefits Board (TLV) in Sweden. To facilitate this process and assist the manufacturers applying for pricing and reimbursement, early scientific advice is offered by the reimbursement authorities on issues including appropriate patient population, comparators, trial design, endpoints, outcomes, economic modelling, etc. In this symposium, representatives from the G-BA, NICE and TLV will briefly present the process for providing early scientific advice to technology developers. The following topics will be discussed: 1) what questions are appropriate to ask the agency; 2) how detailed should the briefing document be and what topics should be its primary focus; 3) will the agency provide very specific advice about trial design and supplementary studies; 4) will there be any procedure to resolve conflicting advice from different agencies, e.g. different recommended comparators. The symposium will discuss the process for providing early scientific advice to technology developers. Furthermore, it will facilitate open communication between manufacturers and HTA agencies, leading to more efficient processes and enhanced outcomes of these early scientific advice meetings for both parties.

Moderator: Anne Heyes, MBA, Head, Market Access and Outcomes Strategy - Europe, RTI Health Solutions, Manchester, UK

Speakers:
Michael Kulig, MD, PhD, MPH, Scientific Advisor, Medical Consultancy Department, Federal Joint Committee, Berlin, Germany

Leeza Osipenko, PhD, Senior Scientific Adviser, Scientific Advice Programme, Centre for Health Technology Evaluation, NICE, London, UK

Fredrik Nilsson, PhD, Senior Health Economist, Dental and Pharmaceutical Benefits Agency, Reimbursement Applications Unit, Stockholm, Sweden

Doreen McBride, PhD, Senior Director, Health Economics - Germany, RTI Health Solutions,
Berlin, Germany

 
Sponsored by RTI
WEDNESDAY, 7 NOVEMBER 2012

7:30-8:30

INFORMATION TECHNOLOGY: POWERING THE NEXT GENERATION OF OUTCOMES RESEARCH AND HEALTH CARE DELIVERY

 

During the last 5 years there has been a fundamental change in the use of information technologies to facilitate the use of real-world patient-level data for increasingly sophisticated purposes. Moving away from single datasets, which are often initiated as administrative tools (e.g. insurance claims databases, general practice records) towards interoperable data & analysis platforms integrating and linking data from multiple sources and coupling this to interactive data interrogation and reporting tools has multiple benefits for high quality pharmaco-epidemiological and health outcomes research. However, this vision requires not only sophisticated information management and processing technologies but also broader health care collaborations and a willingness to share data, which to date has been limited. Achieving international interoperability is critical to the progress of outcomes research and health care delivery as it enables creation of a clearer, more comprehensive and granular longitudinal patient journey across disease and treatment pathways of interest. This symposium will discuss approaches to harness technology in health care delivery and provide a perspective on the tangible value this is bringing to various health care stakeholders.

THE IMPORTANCE OF ACHIEVING DATA INTEROPERABILITY ON THE PROGRESS OF OUTCOMES RESEARCH AND HEALTH CARE
Moderator: Jacco Keja, PhD, Senior Principal, Health Economics & Outcomes Research, IMS
Health, London, UK and Lecturer, Erasmus University, Rotterdam, The Netherlands

MAKING CONNECTIONS: NEW MEDICINE DEVELOPMENT IN AN INTEROPERABLE WORLD
Speaker: Andrew Gaughan, MSc, Global Director, Payer and Real-World Evidence Informatics, AstraZeneca, Macclesfield, UK

ACADEMIC AND GOVERNMENT INITIATIVES ON DATA HARMONISATION AND LINKAGE
Speaker: Isabel Fortier, PhD, Researcher, Research Institute, McGill University Health Centre and Director of Research and Development, P3G Consortium, Montreal, Canada

DATALINKAGE: WHAT IS NEXT? OVERCOMING THE HURDLES
Speaker: Ian Bonzani, PhD, Clinical Project Director, Real-World Evidence Solutions, IMS Health, London, UK

Questions & Answers
 


Sponsored by IMS Health

Breakfast available prior to the presentation for symposium attendees


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