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Bridging the gap: Translating expedited regulatory approval into optimal reimbursement

Related topics: Pharmaceutical/Biotech, Market Access & HEOR, Regulations & Ethics

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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.

Janice Haigh
VP Pricing & Market Access
Parexel Access Consulting

Richard Macaulay
Principal Consultant

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This is the presenters’ personal opinion and does not necessarily represent true facts, the official views or policy of their organisation, nor the views of Evidence Life Science.