A modification of the French “SMR / ASMR” system is necessary, but is not urgent …

This is one of the conclusions of a report written in October 2013 but (surprisingly...) only made publically available these days on the IGAS (Social Affairs General Inspection) website.


The situation is currently the following : when the Transparency Committee (TC) assesses a drug aiming at being reimbursed, a SMR ("Service Médical Rendu" = Medical benefit) and an ASMR ("Amélioration du Service Médical Rendu" = Improvement of the medical benefit) are assigned to the concerned drug.
There are different levels of SMR ranging from "Insufficient" to "Important" (or "Major" in some situations) and conditioning the level of reimbursement by the Social Security (0% for an "insufficient" SMR to 65% for an "Important" SMR). Thus, the SMR level determines if a drug can be reimbursed and if the answer is positive, the associated level of reimbursement.
Then the ASMR is related to the level of improvement of the clinical benefit brought by the drug to the patient. It ranges from 5 (no improvement) to 1 (Major improvement). This ASMR level is a very important driver of the price negotiation with the CEPS (Economic Committee for Health Products).


If this system is well understood by pharma companies and payers, it is poorly understood by prescribers and patients (for instance, there is much confusion made between "SMR" and "ASMR", two very similar acronyms). Moreover, whereas the clinical performances of the drug should be the main driver of the SMR level determination it appears that, very frequently, it is in fact driven by the severity of the treated disease.


That is why, in 2012, the HAS proposed to replace SMR and ASMR by a single index called the ITR (Relative Therapeutic Index), a new assessment tool which was to be more focused on the methodological aspects of the drug assessment with more attention to be paid to the relevance of the selected drug comparators, the relevance of the selected clinical endpoints as well as to the methodological quality of the clinical trials presented. But, it is not necessary to describe in more details what the determination process of ITR should have been as today it seems like it is "dead"... In fact the author of the IGAS report considers that the ITR determination process, as it is described through HAS recommendation, is a "technocratic" one, lacking of flexibility and which, consequently, shouldn't be applied as such.


Nevertheless the author of the report acknowledges that an evolution of the SMR/ASMR system is still needed even if it has to be very progressive. According to the author of the report, this evolution should be presented in the next PLFSS (Law Project for Social Security Funding) for 2016 and should be implemented during a 2 years transition period.
In the meantime, the French Ministry of Health has recently set up a working group in charge of reviewing current modalities of drugs and devices assessment. Thus, precisions about possible evolutions in the French reimbursement process should be disclosed in the next months.


To be continued...


B.FRANCE