OBJECTIVES:

The aim of this research was to compare the distribution of the positive added medical benefit levels (ASMR I-IV) issued by the HAS transparency committee (TC) depending on the early access status (ATU or not) and the potential public health interest (ISP or not).

METHODS:

All the TC opinions concerning a first registration to the reimbursement adopted between January 1^st, 2016, and December 31^st, 2021, were analyzed. Opinions with insufficient medical benefit (insufficient SMR) and no added medical benefit (ASMR V) have been excluded from this analysis, and opinions including several presentations of the specialties were counted only once.

RESULTS:

A total of 120 TC opinions met the inclusion criteria. Among the drugs which have benefited from an ATU, the proportion that obtained an ASMR I-III was lower than those that obtained an ASMR IV (respectively 43% versus 57%). Among the drugs which have no ATU, the proportion that obtained an ASMR I-III was lower than those that obtained an ASMR IV (respectively 25% versus 75%).

Among the drugs which have benefited from an ISP, the proportion that obtained an ASMR I-III was similar to those that obtained an ASMR IV (50% for both). Among the drugs which have no ISP, the proportion that obtained an ASMR I-III was lower than those that obtained an ASMR IV (respectively 28% versus 72%).

Among the drugs with neither ATU nor ISP, the proportion which obtained an ASMR I-III was significantly lower than those that obtained an ASMR IV (respectively 18% versus 82%).

CONCLUSIONS:

Having benefited from an ATU or ISP does not lead to a positive impact to obtain an ASMR I to III versus an ASMR IV. On the other hand, not having benefited from an ATU or ISP reduces the chances of obtaining an ASMR I to III.