PREDICTING FUTURE EVIDENCE- RISK-SHARING AGREEMENTS, MANAGED ENTRY SCHEMES, OR SOMETHING ELSE?
Author(s)
Rosalie Viney, PhD, University of Technology Sydney, Sydney, Australia
Presentation Documents
ISSUE: Predicting future evidence in drug reimbursement
OVERVIEW: Accelerated regulatory approval of medicines is becoming more and more common when clinical trials stop prematurely due to improved efficacy in areas of high unmet need such as cancer. This leads to a very complex situation in terms of uncertainty when predicting future clinical treatment algorithms and when extrapolating the evidence beyond the duration of the clinical trial for both efficacy, toxicity and quality of life, as well as when crystal-balling the potential budget impact. Both decision makers and manufacturers face substantial challenges as they try to balance the opportunity against clinical need and the risk of a less than anticipated health gain. This panel will explore the value of various options that have been suggested and implemented in Australia, ranging from risk share agreements to managed entry schemes with the promise of future evidence. The panel will present different perspectives on the topic with representatives from the payer and industry.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Code
IP9
Topic
Health Policy & Regulatory, Organizational Practices