The global community of market access professionals met in France on 2 October 2023 at the Market Access Day Paris 2023 – the first post-pandemic event of the Market Access Society (MAS). This meeting was also a great opportunity to discuss the latest developments of the benefit assessment under AMNOG in Germany, Europe’s largest pharmaceutical market. Thus, Dr. Meriem Bouslouk-Marx, MBM Future Health, was invited as an expert speaker to contribute to the programme. Her speech aimed to give an overview of the future challenges companies will have to address for their launch in Germany.
Dr. Bouslouk-Marx presented a paper with the title ‘Case Study – Zolgensma® in Germany’. Onasemnogene abeparvovec (Zolgensma®), an advanced therapy medicinal product (ATMP) to treat the rare disease spinal muscular atrophy (SMA), served as example for the latest benefit assessment decisions in Germany. Dr. Bouslouk-Marx showed the increasing complexity of the resolutions published by the G-BA – the decision-making Health Technology Assessment (HTA) body in Germany – on the orphan drug Zolgensma® .
Moreover, Dr. Bouslouk-Marx highlighted the strict requirements for real-world evidence set by the G-BA. The upcoming EU Joint Clinical Assessment will certainly not reduce the complexity of the benefit assessment in Germany.
Ready for MAS at the Salle Louis Liard at the Sorbonne
Meriem Bouslouk-Marx presenting at the Market Access Day