OBJECTIVES

The aim of this research was to update the analysis previously published about comparison of the distribution of the added medical benefit levels (ASMR) issued by the HAS transparency committee (TC) depending on the early access status (ATU or not) in France.

METHODS

The TC opinions concerning a first application for reimbursement inscription adopted between January 2016 and March 18th, 2020 were analyzed. Medicines assessed through simplified procedures and applications resubmitted after a previous withdrawal or a previous negative opinion were excluded.

RESULTS

228 TC opinions on 225 medicines met the inclusion criteria: of them, 72 medicines available through ATU (vs 64 previously) were assessed for the “Added Medical benefit” (81 ASMR, one per indication vs 73 previously) vs 124 medicines (98 previously) that were not available through early access program (127 ASMR vs 100 previously).

Fifteen (20.8%) medicines available through ATU (vs 22% previously) were granted an ASMR considered as innovative (0 ASMR I (major), 3 ASMR II (important), 12 ASMR III(moderate)) vs 6 (4.8% vs 4.1% previously) medicines without early access (1 ASMR I, 1 ASMR II and 4 ASMR III). Twenty-six (36.1% vs 34% previously) drugs received a unique minor ASMR IV for medicines available in early access vs 20 (16.1% vs 15% previously) in the group without early access. Twenty-four (33.3% vs 33% previously) drugs received no ASMR in the group of medicines in ATU vs 98 (79.0% vs 80.6% previously) in the group without early access. Twelve drugs (vs 11 previously) were granted with two ASMR.

CONCLUSIONS

This extended analysis confirms the trend already observed last year. Medicines which have been the subject of an early access program were indeed more likely to obtain an ASMR considered as innovative and a better “rating” for ASMR than the medicines which were not in early access.