LASER ANALYTICA scientific contribution @ ISPOR 17th Annual European Congress8-12 November 2014 – RAI center – Amsterdam , The Netherlands
REAL-WORLD EFFECTIVENESS STUDIES: why now & now what?
Sunday, 9 November 2014 – 18:45 – 19:45 Room: Forum (ground floor)There is a growing request for real-world effectiveness studies as policy makers, payers, and health care providers are increasingly looking into pragmatic measures of the health impact of drugs, using data collected from real-life practice. This symposium will focus on post-authorization effectiveness studies (PAES), beyond regulation to post-reimbursement success and effectiveness studies as opportunities for product lifecycle.
Methods and challenges for relative effectiveness studies in practice notably, the objective of studies and the type of real world data necessary (routine collected and specifically generated for that purpose) will be emphasized.
Speakers will present how effectiveness studies can successfully address regulatory commitments throughout the product life-cycle, discussing the challenges of early/ongoing real-world studies for benefit-risk management plans.
Representatives from HTA agencies and Industry will address real-world studies as payer-relevant evidence to address HTA hurdles, such as price/risk-sharing agreements, as well as the challenges presented by different country-specific requirements that often imply country-specific data.
Discussion will also touch on methodological and strategic concerns for industry, elaborating on how best to ensure smooth and integrated real-world data generation, and introducing the concept of real-world data platforms.
Moderator: Lucien Abenhaim, MD, PhD Chairman, LASER Analytica, London, UKSpeaker: Billy Amzal, X-Eng, MSc, MPA, PhD Global Scientific Vice President, Consulting & Analytics, LASER Analytica, London, UK & Paris, France
Speaker: Jens Grueger, PhD Vice President & Head of Global Pricing & Market Access, ROCHE Pharma AG, Basel, Switzerland
MULTICRITERIA FOR REAL LIFE DECISION MAKING?
Perspectives and experience from the field
Wednesday, 12 November 2014 10:00 – 11:00 SESSION IV – IP16 Room: G106-107 (1st Floor)Pragmatic multicriteria approaches provide processes to bridge systematic consideration of criteria contributing to the value of interventions, as well as the evidence (scientific and colloquial) needed to consider these criteria. Although still in its infancy in healthcare and raising many questions for their implementation, by furthering identification of values often influencing decisions in real life across stakeholders, multicriteria approaches may help promote interventions that are most beneficial to patient and population health, while shaping more efficient, sustainable and equitable healthcare systems.
Multicriteria approaches are proposed as innovative methods to support health care decision making processes in several regions of the world. However, their implementation and benefit remain subject of debate. Whilst there is agreement about the need to define criteria, a number of questions remain in particular regarding criteria selection and weighting, and whose preferences should be used. In this panel, current reflection, controversies and perspectives from several standpoints will be presented.
Moderator: Mireille Goetghebeur, PhD, MEng, Global Scientist, LASER Analytica, MontrealCanadaPanelists:
François Meyer, MD, Advisor to the President, International Affairs, Haute Autorité de Santé (HAS), Paris, France
Sarah Garner, PhD, BPharm, Associate Director, Research and Development, National Institute for Health and Care Excellence (NICE), London, UK
Michele Tringali, MD, Deputy Officer, HTA Program, Direzione Generale Salute, Regione Lombardia, Milan, Italy