Adaptive Pathways – panellist contribution in Milan

Professor Yvonne-Beatrice Boehler MD, MBA presented as panellist in an Issue Panel on the 18th ISPOR Annual European Congress (International Society for Pharmacoeconomics and Outcomes Research) in November in Milan. Her topic: Earlier market approval / access schemes for new drugs (namely: Adaptive Pathways) and a German pricing / reimbursement perspective.

The Issue Panel with contributions from 4 international experts in the field highlighted the topic “Adaptive Pathways” (AP) – a concept initiated by the European Medicines Agency concerning earlier market approval / access for innovative drugs including a flexible life-span approach, e.g. regarding evidence generation.

In her talk, Boehler was to give a German payers perspective. Namely: What is needed to justify reimbursement from national public pharmaceutical budgets currently and how may assessment / price-setting be changing in an AP environment?

In summary, she derived benchmarks from current German reimbursement processes and assessment data indicating some promising but also challenging aspects for a possible AP scenario: While a promising database for drugs on more targeted patient populations may be likely also in an AP setting, the situation for drugs with conditional marketing authorization based on more limited data may be more challenging. However, she also delineated movements in the system for aspects like surrogate endpoints and Real World Data.

Boehler’s presentation slides – including detailed references and data appendices – are available online at Adaptive Pathways – a German perspective

Information on the Issue Panel and the other presenters are available at ISPOR 18th Annual European Congress (IP3)