CASE STUDY: Changing a US-oriented evidence generation program for European success
A US-headquartered biotech was developing a novel molecule in a pain indication.
Placebo-controlled pivotal studies met primary endpoints, consistent with FDA expectations, and the product was on track for NDA submission.
However, European payers expect evidence of value versus currently used therapies, so our client needed AESARA’s European access experts to inform their European access strategy.
The key activities to provide guidance on the optimal access strategy were:
- Conduct EU5 landscape assessment based on desk research, European access experience & expertise
- Use digital market access decision tool to characterize risks and opportunities of each option
- Lay out the strategic options with cross-functional stakeholders for access in Europe
- Use our direct industry experience to shape recommendations to inform executive decisions on access investments for Europe
- US-based client brand team and executive stakeholders educated on price, access and reimbursement in key European markets
- Strengths and risks of evidence program objectively identified in terms of European price, access and reimbursement
- Strategic options intelligently compared for likelihood of success and return on investment
- Executive business decision enabled through well-presented report