FIRST EMA-EUNETHTA PARALLEL CONSULTATION FOR VACCINES
Author(s)
Laigle V1, Sinha A2, Preuveneers G3, Russel K4
1MSD Vaccins, Lyon, France, 2Merck & Co., Inc., Kenilworth, NJ, USA, 3MSD Belgium, Brussels, Belgium, 4Merck & Co., Inc., Upper Gwynned, NJ, USA
Presentation Documents
Background Health Technology Assessment bodies (HTAb) early advice procedures were initiated in 2013 to improve the quality and adequacy of initial evidence generation to facilitate the HTA process and support funding decision. A platform was created in 2017 to provide companies with coordinated parallel regulatory and HTA advice under EUnetHTA coordination. Until 2018, no vaccine had undergone this process. National Immunization Technical Advisory Groups (NITAGs) are established by national authorities to provide independent, objective, and evidence-based advice on vaccines included in immunization programs. NITAGs provide equivalent HTA for vaccines, with various degrees of coordination with HTAb. Despite their critical role, NITAGs are not part of the parallel consultation platform for pipeline vaccines. This gap stands in contrast to the importance of multi-stakeholder advice including NITAGs to inform vaccine development. MSD decided to pilot the practice of early advice procedure for a novel vaccine, adapting the procedure to include NITAGs. Discussion Several NITAGs engaged positively in the procedure with variable levels of engagement. Most of them were not familiar with early advice processes and needed to acquire different approval internally as current procedures often did not accommodate involvement with vaccines still in development. Stakeholders agreed to flexibility with timelines, to allow NITAGs to join the procedure at various stages and to participate to the degree they deemed appropriate. Bringing external stakeholders involved important challenges in terms of confidentiality, timelines and heterogeneity in the advices provided. Overall it required 18 months to coordinate. This pilot demonstrated that early advice with NITAGs can be achieved. In the process, it highlighted the lack of a framework to overcome challenges in engaging NITAGs. Conclusion Vaccines companies face a challenging environment when seeking multi-disciplinary early advice. The first parallel-NITAGs consultation for a vaccine was performed and highlighted the need for developing a more robust framework.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PIN13
Disease
Vaccines