The French government plans in its draft social security budget for 2017, (presented last Friday), to review with the pharmaceutical industry on the pricing mechanism of innovative medicines with temporary authorisation for use (ATU). The ATU can deliver in a very short time, (even before the granting of the marketing authorisation (MA)) potentially innovative drugs to patients suffering from serious or rare conditions when previous treatments have not worked. If the marketing authorisation is obtained, it is called post-ATU.
During these two periods, these drugs are sold at free prices set by the manufacturer. When they leave the device, discounts are negotiated by the Economic Committee for Health Products (CEPS), (who are responsible for setting drug prices), on the basis of free starting price.
But this freedom of prices allows the industry to benefit, during and post-ATU, from an “integral” reimbursement of Social Security, which does not take into account discounts (later) and therefore provides no incentive to exit the drug. 100 million per year until 2013, the overall cost of treatment exceeds €600 million since 2014.
The PLFSS maintains the principle of freedom of prices under an ATU or post-ATU but guarantees the retroactive repayment of any differential between the free rate and the price (net of conventional discounts) negotiated between the laboratory and CEPS . According to Marisol Touraine, MoH, the idea is “that there is not too long a period during which prices would be totally free without supervision.”