France : the CEPS opens the door to “price-performance” agreements

Things are definitively changing in the field of pricing and reimbursement modalities in France...
As reported at the beginning of this month in the French economic newspaper "Les Echos", Celgene and the CEPS have signed a "price- performance" agreement for Imnovid, a drug indicated in multiple myeloma.



According to this agreement, the drug (which obtained an ASMR 3), is to be reimbursed on the basis of 8,900.00 euros for a 21 days treatment period but, if this treatment appears to be not effective, then the company will have to pay back the French Social Security, on a per patient basis.



To comply with this agreement Celgene set up a registry gathering, for each patient, efficacy and safety data. The aim of this registry is to demonstrate that the drug is effective not only when used in the "perfect" environment of a clinical trial but also in the real life.



This is something relatively new in France as, to date, only 2 other agreements of that kind have been disclosed, each of them related to drugs with an ASMR 5.



This kind of agreement, applied to innovative and expensive drugs, might become something rather attractive to French Health Authorities, which are dealing with more and more constrained budgets.



Nevertheless, one of the main challenges associated to that kind of agreement will be for both parts to agree on the criteria to be measured (and on the way to measure them) in order to determine the "performance" of the treatment.


 



Bruno FRANCE