OBJECTIVES: The price and time to market for a new drug are two major issues for the pharmaceutical industries in France.

This study assessed the correlation between the added medical value (ASMR, a criterion assessed and rated from I to V by the HAS and used to determine the price) and the price and its negotiation time for drugs having entered the French Early Access Program (ATUc).

METHODS: For this study, we selected the drugs from the ATUc program as of January 1, 2014.

For each product, we compared when possible, its price in the ATUc program with the one obtained when it entered the French market. Moreover, we recorded the time between the granting of the ASMR and the awarding of the price.

Finally, we sorted the data by ASMR level and calculated the average price reductions and negotiation times for each group.

There was no drug with an ASMR I level and only one drug with an ASMR II level, so we did not consider them.

RESULTS: A correlation was found between the ASRM level, the price and its trading time.

The higher the level of ASMR, the less the delta between its price in ATUc and its negotiated price is important and the longer the negotiation time.

For ASMR III, IV and V, the price deltas were respectively -8.5%, -17% and -20.2% and the negotiation times were respectively 581.6 days, 558 days and 306.5 days.

CONCLUSIONS: This study allows us to anticipate the average time required to negotiate prices with the authorities and the price decrease to be expected compared to the price set in the ATUc.