OBJECTIVES: According to the framework agreement signed between the French pharmaceutical companies association and the French economic committee, the drug price negotiation must last 180 days. However, negotiation is much longer, attaining 271 days on average in 2015. The main objective of this study was to identify factors influencing the duration of negotiations in France.

METHODS: Our retrospective analysis included new indications and new registrations of drugs evaluated between January 2015 and November 2017. The price negotiation period was the time between Transparency Committee (TC) assessment and publication of the price by the Health Ministry. Eight factors potentially influencing duration were tested such as: clinical added value (ASMR), audition by TC, long-lasting disease, target population size, therapeutic area, orphan status. As some negotiations were still ongoing (negotiation time censored), we used a Kaplan-Meyer method, with a date point on 14^th April 2018. Univariate analyses were conducted using a two tailed test with a 5% alpha risk.

RESULTS: We included 269 drugs evaluated by the TC. There were 24 ASMR 1-2-3, 72 ASMR 4 and 173 ASMR 5. There were 88 drugs in the hemato-oncology field. At date point, 193 (71.7%) drugs obtained a price. Univariate analysis showed that the most influencing criteria were a TC audition (283 days versus 202 days, p=0.005), a long-lasting condition indication (253 days versus 172 days, p=0.01), a target population size > 5000 patients (301 days versus 210 days, p=0.17), the orphan status (282 days versus 218 days, p=0.18) and the ASMR level (330 days for ASMR 1-2-3 versus 217 for ASMR 4-5, p=0.18).

CONCLUSIONS: These results are a first insight on how some factors influence price negotiation delays in France. It seems that drugs with a TC audition, a long-lasting condition indication or an ASMR 1-2-3 can expect a much longer negotiation time. Multivariate analyses are under process.