Pharmaceutical/Biotech, Market Access & HEOR, Regulations & Ethics
Regulatory approval has traditionally been the main hurdle for developers trying to bring needed new drugs to patients. However, today, expedited regulatory pathways enable drugs for severe diseases to receive approval with less data whilst payers, in the face of budgetary pressures, are demanding more data. Thus, the gap has widened between what evidence regulators require and what payers desire.
Strategies to bridge this gap and translate regulatory approval into optimal reimbursement are becoming increasingly key to ensure the commercial success of innovative new products, which will be the focus of this presentation and will include:
- Making RCTs more payer relevant.
- Real world evidence utilization.
- Innovative pricing models.
- Early scientific advice.