OBJECTIVES

The aim of this research was to compare the mean time spent during P&R process in France including HAS evaluation by Transparency committee (TC) and price negotiation between medicines with or without an early access program named (ATU).

METHODS

All the TC opinions concerning a first inscription for reimbursement published between January 2016 and April 2019 and with a delay between MA and TC opinion less than 2 years were analysed. Simplified procedures and new applications following a previous withdrawal of application or a previous negative opinion were excluded. Only the medicines with an available public price were taken in this analysis.

RESULTS

In the selected time period, 180 TC opinions met the inclusion criteria, concerning 177 drugs: 70 products available through ATU vs 107 medicines without early access. The time between the MA and the TC opinion were collected for 177 medicines (tisagenlecleucel, midostaurine and atezolizumab had 2 opinions on 2 indications realized at 2 distinct dates), 67 of which had an ATU and 110 did not. The average time between MA and TC opinion after MA was 216 days for medicines with ATU versus 295 days for those without ATU. To study the time between TC opinion and price publication, 70 medicines were collected, 25 with ATU and 45 without ATU. The average time spent for price negotiation and publication was 344 days for medicines with ATU versus 234 days for those without ATU. But the global average time spent in P&R processes was 528 days for the medicines with ATU versus 494 days for those without ATU.

CONCLUSIONS

The time for TC evaluation is shorter for medicines with ATU but the price negotiation takes longer and impacts the global delay of P&R.