As costs continue to rise and downward reimbursement price pressure increases, the industry is exploring new drug development approaches, including innovative randomized controlled trial designs such as adaptive, umbrella, and basket studies.
Adaptive trials, the most established of these, have already been the subject of guidance documents by both the European Medicines Agency (EMA) and Food and Drug Administration (FDA).
Further, in 2017 the FDA provided its first site-agnostic approval of a drug (pembrolizumab) based on data from a basket trial. However, in many markets it is the reimbursement hurdle, rather than the regulatory hurdle, that is proving the major barrier to overcome in order to enable patient access.
Therefore, payer perceptions on such innovative trial designs will be key to informing pharmaceutical company utilization of such approaches.
This webinar will cover:
- The different innovative approaches and the opportunities that these offer for the development of new medicines.
- How to conduct price and reimbursement assessments on drugs utilizing these new clinical trial designs from a German and United Kingdom reimbursement perspective, respectively.