In a complicated P&R environment, the ATU program provides rapid access opportunities for manufacturers, growing its strategic importance. This article provides insights into the changes the French Social Security Law (LFSS) implemented for the nominative ATU (nATU) program in 2020.
Over the years, the ATU program in France has become one of the key considerations for a manufacturer’s EU P&R strategy. In an evolving P&R environment, where the path to market access can be long and complicated, ATU status granted by the French National Agency for Medicines and Health Products Safety (ANSM) provides rapid access opportunities for drugs without a marketing authorization or those undergoing P&R negotiations. Only drugs that target serious or rare indications without available appropriate treatment alternatives and presumed efficacy and safety data can benefit from the ATU program. Besides obtaining a rapid market access, the ATU program also enables a manufacturer to set the drug price freely. This generates substantial strategic appeal for manufacturers, considering the international price referencing implications across EU and the potential for early revenue.
Typically, two types of ATU can be granted: nominative ATU (nATU) or cohort ATU (cATU). While nATU is patient-specific and granted at the request of individual physicians, cATU is designated for a group of patients at the request of the drug manufacturer. The requirements and eligibility criteria differ slightly between the two, with cATU being somewhat more restrictive.
With the growing strategic importance of ATU status, both the number of drugs granted ATU and their prices have risen, leading to a significant budget impact with costs exceeding >€1B per year for the French healthcare system. In an effort to offset the burden and continue this program sustainably, the French authorities have been slowly introducing initiatives to reform the program. In its most recent iteration, French Social Security Law (LFSS) for 2020 implemented two new changes for the nATU program:
- Additional monitoring mechanisms / conditions: Stricter eligibility criteria have been rolled out for nATU, mirroring requirements for cATU status. For example, nATU will now require drug safety and efficacy to be “strongly presumed” (instead of “presumed to be favorable”) and the clinical trial to be “ongoing” in France (instead of “ongoing or submitted”). Additionally, the number of nATUs authorized per product will now be capped.
- Repeal of “free pricing” for nATU: The Ministry of Health will now determine the compensation rates for nATU drugs rather than the manufacturer, but this price is not expected to be published. Manufacturers should still be able to freely set the price charged to hospitals, but will have to pay back the difference versus the compensation amount set by the MoH (free pricing will still apply for drugs with cATU status).
The nATU program serves more than 2.5 times the patients in cATU program. The high prices set by the recent nATU drugs propelled the above changes, which may now impact P&R negotiations in France. It remains to be seen if the French ATU program can preserve its strategic appeal. A second article provides you with an in-depth overview of recent ATU changes and its implications.
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