INNOVATIVE CLINICAL TRIAL DESIGNS- WELCOMED BY REGULATORS BUT WHAT ABOUT THE PAYERS?
Author(s)
Leanne Larson, MHA, PAREXEL International, Waltham, USA; Richard Macaulay, PhD, PAREXEL International, London, UK; Detlev Parow, MD, MBA, D A K - Gesundheit, Hamburg, Germany; Andrew Walker, PhD, Salus Alba Consulting, Glasgow, UK
Presentation Documents
ISSUE: There is an increasing trend to utilize innovative new designs for clinical trials. This panel will explore payer perspectives on the benefits and challenges posed by conducting reimbursement assessments on data coming from these trial designs. Leanne Larson will present an overview of different innovative approaches (focusing on adaptive and umbrella trials) and the opportunities that these offer for the development of new medicines. Detlev Parow and Andrew Walker will present an overview of conducting pricing and reimbursement assessments on drugs utilizing these new clinical trial designs from a German and United Kingdom reimbursement perspective, respectively. Each panelist will speak for 10 minutes and this will be followed by a 15-minute panel discussion, and 15 minutes of Q&A from the audience.
OVERVIEW: There is a well-recognized long-standing decline in R&D productivity in the pharmaceutical industry which has driven exploration of new approaches to the clinical development of pharmaceuticals. These include innovative randomized controlled trial designs, including adaptive, umbrella, basket, hybrid and pragmatic studies. Adaptive trials, perhaps the best established of these, have already been the subject of guidance documents by both the EMA and FDA. However, the reimbursement hurdle is becoming increasingly difficult for companies to clear and thus the perspective of payers is key. Payers may welcome such innovative approaches if they enable the development of new treatments for diseases of high unmet needs, alongside the prospect of better defined biomarkers and more relevant comparators. However, there may be payer concerns in terms of their acceptability due to the potential for perceived bias alongside their complex Bayesian statistics that may be difficult to independently verify.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Code
IP25
Topic
Health Policy & Regulatory, Study Approaches