The long-awaited decree expanding the scope of medicinal products eligible for the  list “en sus” has finally been published!  

It should be remembered that, in principle, medicinal products are paid for by the health insurance system within health care institutions as part of homogeneous groups of stays (GHS). In practice, the GHS envelopes are insufficient to cover the cost of expensive medicinal products. In such cases, these medicinal products can be reimbursed “in addition to” the GHS if they meet certain criteria defined by decree.

The article R. 162-37-2 of the French Social Security Code conditions the inclusion of a medicinal product on the list “en sus” to four cumulative criteria, including the level of improvement in medical service rendered (“ASMR“).

Until now, inclusion on the “extra” list was reserved for medicinal products with an ASMR of level I to III in the indication considered. As an exception, medicinal products with an ASMR IV could also be included in the list “en sus”:

  • if the indication in question is of public health interest and there is no relevant comparator; 
  • or if the relevant comparators are already included in the list “en sus”.

Decree no. 2021-1614 of December 9, 2021, modifying the criteria for listing pharmaceutical specialties on the list “en sus”, published in Saturday’s Journal Official, broadens the scope of eligible medicinal products to all those that provide an improvement in medical service rendered (ASMR I to IV).

Medicinal products providing no ASMR (ASMR V) also remain eligible if the relevant comparators are already listed “en sus” (on the question of the relevant comparator, see our article of November 29, 2019).

Which applications are concerned? 

  1. Obviously, all applications for inclusion on the list “en sus” submitted as of today ; 
  2. But also all applications for inclusion on the list “en sus” that have been submitted since July 5, 2021 and are still being processed.

It is specified that, for these applications, registration on the “in addition to” list will not be effective until January 1, 2022, at the earliest.