HOW DO US MANUFACTURERS BENEFIT FROM EUROPEAN SCIENTIFIC ADVICE? A CASE STUDY
Author(s)
Schuurman S1, Delaitre-Bonnin C2
1ICON plc., Stockholm, AB, Sweden, 2ICON plc, Nanterre, France
Introduction The reimbursement processes differ between the US and Europe (EU). Manufacturers would ideally adjust their clinical development plan (CDP) strategy to the EU health technology assessment (HTA) requirements, and obtain integrated scientific advice (ISA) to inform their CDPs. ISA, gained through parallel consultations with regulatory (European Medicines Agency [EMA]) and HTA agencies, can provide valuable insights to inform the generation of relevant evidence for patients, clinicians, regulators, HTA bodies and payers. The aim of this study was to explore how US manufacturers could benefit from EU ISA. Methods We reviewed internal case studies of ISA focusing on processes and results. The goal was to assess the advantages and potential barriers for US companies in engaging ISA based on our experience. Results Disease and market access landscape assessments identified the current treatment pathway, unmet needs, competitor CDPs and evidence gaps in the disease area. Alignment was achieved on EMA and HTA, and HTA-only questions on the CDP and economic analysis for a briefing book (BB). The key ISA areas of value were identified: de-risking the CDP and addressing uncertainty, managing internal expectations and eliminating the ‘silo-ing’ of teams by promoting early cross-functional collaboration and understanding of payer value drivers. Potential barriers identified were: the lack of HTA agencies able to provide advice within the set timelines, change in the treatment landscape between the time of seeking advice and the actual submission, and most agencies expecting to receive the BB before the start of Phase 2/3 studies. Finally, the ISA is not binding and could be considered both as a barrier and an advantage to the manufacturer. Conclusion In the context of a complex and challenging regulatory and HTA environment, the results of EU ISA includes internal buy-in, an aligned company strategy, timely advice and project management with long-term optimisation for US manufacturers.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PNS129
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy, Systems & Structure
Disease
No Specific Disease