The Impact Of Regulatory Accelerated Approval Schemes And Htas On Access To New Oncology Medicines: Evidence From 11 Countries

Abstract

S43abstraction was done to capture deidentified patient characteristics, treatment decisions, and clinical events. ReSultS: Our research found that prior to 2014 only 14% of mCRPC patients received newer treatment options (abiraterone, enzalutamide, sipuleucel-T) as first-line treatment. Between 2015 and 2016, 37% of the patients received newer treatment options, and by 2016 and later this number rose to 77% of the patients. ConCluSionS: Though these results demonstrated the rapid adoption of newer treatment options in areas of high unmet needs like mCRPC, they also highlighted the need for continued physician education as nearly 25% of patients did not receive recommended newer options as their first-line treatment since 2016. +Cancer Facts & Figures 2017. American Cancer Society.

Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis

“…Although regulatory agencies such as the FDA are increasingly aware of the economic dimension of regulatory standards, global alignment with other regulatory agencies as well as with (mainly European) HTA bodies is necessary to fully reap the economic benefits. For instance, findings suggest that accelerated regulatory approval does not necessarily guarantee early market access because HTA bodies are not aligned with regulatory agencies [32]. Even now, pharmaceutical firms with a higher market presence in Europe invest less in R&D which can be lead to the conclusion that the highly regulated European drug markets reduce the companies' incentives to invest in R&D [33,34].…”