OBJECTIVES:

The aim of this research was to analyse the distribution of innovation over the last 6 years, based on the therapeutic areas and the added medical benefit (ASMR) issued by the HAS transparency committee (TC).

METHODS:

All the TC opinions concerning a first registration for reimbursement adopted between January 1^st, 2016, and December 31^st, 2021, were analyzed. Opinions with insufficient medical benefit (insufficient SMR) or without details regarding the level of added medical benefit (ASMR) have been excluded, and opinions including several presentations of the specialties were counted only once.

RESULTS:

A total of 1,211 TC opinions were evaluated for the “Added Medical Benefit” between 2016 and 2021. There has been a decrease of ASMR V in favour of ASMR I-IV (ASMR I-IV: 13% in 2016 vs 21% in 2021). More specifically, when analysing the number of ASMR I-IV, there has been an increase in ASMR I-III compared to ASMR IV since 2016, until a crossover in 2021 with a higher proportion of ASMR I-III than ASMR IV (ASMR IV: 74% in 2016 and 48% in 2021; ASMR I-III: 26% in 2016 and 52% in 2021). Furthermore, while oncology was the therapeutic area the most represented in the proportion of ASMR I-III, a recognition of the most innovative drugs, a decrease in the TC opinions since 2016 can be noted (57% in 2016 vs 25% in 2021). Conversely, for the last two years, there has been a better distribution of innovation in terms of share, notably with an increase in two therapeutic areas: the digestive and respiratory systems, with around 20% of total TC opinions dealing with ASMR I-III respectively.

CONCLUSIONS:

In recent years, there has been a trend towards a greater recognition of innovation in France, as well as a greater distribution across different therapeutic areas, especially since 2020.