LASER ANALYTICA scientific contribution @ ISPOR 17th Annual European Congress8-12 November 2014 – RAI center – Amsterdam , The Netherlands

Educational Symposium
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

Issue Panel

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

Poster Presentations Session I – Monday, 10 November 2014
Restless Leg Syndrome Detection In Hemodialysis. Castejón N, Arenas MD, Rebollo P, Sellés Galiana F, Delgado Conde P, Gil González MT, Gutierrez Rivas P, Reichert GarcÍa J
Poster Presentations Session II – Monday, 10 November 2014
Rapid Relative Effectiveness Assessment Of Pharmaceuticals: Transferability And Completeness Of Information Derived From Global Value Dossiers To Complete A EUnetHTA Submission. Neeser K, Lister J, Stanisic S, Stengel C, Mueller E
A Cost-Effectiveness Analysis Of Onabotulinumtoxina Versus Best Supportive Care (Bsc) For The Treatment Of Anticholinergic Treatment-Refractory Neurogenic Detrusor Overactivity (NDO). Hamid R, Loveman C, Millen J, Colayco D, Stanisic S, Gultyaev D
Cost-Effectiveness Comparison Of Botulinum Toxin Type A Plus Best Supportive Care Versus Best Supportive Care Alone In The Treatment Of Idiopathic Overactive Bladder With Urinary Incontinence Among Patients Not Adequately Managed By Anticholinergic Therapy In France. Ruffion A, Velard M, Loveman C, Khalaf K, Roze S, Pignata M, Stanisic S, Lister J
Poster Presentations Session III – Tuesday, 11 November 2014
Management Of Chronic Thromboembolic Pulmonary Hypertension: Clinical And Reported Outcomes From A Referral Hospital In Spain. Escribano P, Del Pozo R, Cuervo J, Rebollo P, Alvarez MP, Espinós B, Vieta A, López-Gude MJ, Cortina J
Pain Incidence And Analgesic Consumption During Haemodialysis Sessions: Impact On Health-Related Quality Of Life. Rebollo P, Arenas MD, Castejón N, Reichert García J, Delgado Conde P, Gutierrez Rivas P, Gil González MT
Misoprostol Vaginal Insert Pharmacoeconomic Model For 5 European Countries. Walczak J, Bierut A, Dowgiallo J, Pacocha K, Pieniazek I, Stelmachowski J, Opala T, Sobkowski M, Baev O
Poster Presentations Session IV – Tuesday, 11 November 2014
Predictive Modelling For Optimal Target Population And Real-World Study Design: An Example In Mother-To-Child Transmission Of HIV. Amzal B
Patient Driven Questionnaire Development, Item Feedback From Users Of A Patient Network. Castejón N, Harrington M, Campillo-Álvarez Á, Rebollo P
Efficacy, Effectiveness And The “Efficacy-To-Effectiveness Gap”: Review Of The Current State Of Play And Perspectives. First Results From The IMI GETREAL Consortium. Nordon C, Karcher H, Pichler F, Abenhaim L
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