Fda Breakthrough Medicines; Have They Caused Breakthrough Headaches for Hta Agencies?

Abstract

would seem most relevant to different stakeholders. Methods: A landscape review was performed in Medline and EMBASE. Initial search retrieved over 2000 articles. After a selection based on reference to healthcare, policy issues, or social justice, 64 papers were included. Data were extracted and a full table was made, including all arguments found; next, identical or largely overlapping criteria were excluded and a reduced set was compiled. Results: The final set included 26 arguments, categorized by type (clinical, social justice, ethical, and policy). Examples of arguments included in the final set are: Longevity, need, dignity and public health value. For each argument, relevance to stakeholders was scored on three levels (not, partly, and completely relevant). ConClusions: Many arguments play a role in making decisions about patient treatments, but not all are relevant to all interventions. Moreover, they may interact with each other. Therefore, systematic and analytical approaches such as multi-criteria decision analysis may be not suitable. As such, a viable way to deal with interacting and possibly conflicting arguments might be to arrange public discussions that would evoke different stakeholders' perspectives. PHP209 Fda BreaktHrougH Medicines; Have tHey caused BreaktHrougHHeadacHes For Hta agencies?