PDG57 LEVEL of Innovation According to Therapeutic Areas As per TC Opinions

Abstract

The aim of this analysis was to identify the levels of innovations according to therapeutic areas as per to the Transparency Committee (TC) opinions. The new drugs evaluated on initial registration between January 2017 and March 2020 were selected and sorted by major therapeutic areas (neurology, oncology, infectiology, cardiology, endocrinology & metabolism). The classification in therapeutic areas was made from ATC codes to the exception of Radiopharmaceuticals for diagnostic use (ATC code: V09) which were classified based on the indications (some were classified in oncology and others in endocrinology and metabolism). Then the attributed “medical benefit” (SMR) and “added medical benefit” (ASMR) levels in each of the therapeutic areas was counted. The sample contained 178 drugs evaluated for 204 indications. Most of the SMRs granted by the TC were important (65%), mainly in oncology (35%) and infectiology (25%). Only 8 moderated SMR were granted in neurology and oncology and 16 low SMR in cardiology (31%), oncology (50%) and endocrinology & metabolism (19%). On the other hand, 24% of the indications evaluated obtained an insufficient SMR leading to only 156 levels of ASMR being granted. According to the TC, 10% of the indications were innovative (ASMR I to III) and these innovations are more prevalent in oncology (14% of the indications evaluated in oncology) and equivalent in other therapeutic areas (5 to 8%). The TC recognized an added value in innovative therapeutic areas, mainly in oncology (8/14 of ASMR III and 15/39 of ASMR IV). On the contrary, it seems more difficult to be innovative in the other therapeutic areas.