The French HAS Commission for Economic Evaluation and Public Health » (CEESP), has made 15 efficiency decisions last year, amongst which 3 (for Kadcyla®, Sovaldi® and Tivicay®) have been recently published.
Just as a reminder : it is mandatory to submit such an efficiency dossier, when a reimbursement dossier is submitted for a new drug (or for a device) for which an ASMR of level 3 to 1 is requested, and for which the impact on public health is expected to be a significant one (that is, for instance, an annual scheduled turnover superior to 20 millions of euros, the first year of full commercialization).
Regarding these decisions, a first technical point to be noted is that they have been published in December 2014 whereas they were already available for publication several months ago. This delay between the availability of the decisions and their publication is due to the fact that a CEESP decision can only be published once the price negotiation with the CEPS is ended.
Everybody was impatient to see what these decisions would look like. And the thing is, that there is no specific conclusion (just like: "the cost per QALY is acceptable...") associated to these decisions. Moreover, it has also to be noted that if these decisions are very detailed ones (with for instance a detailed critical analysis of the presented economic model), the price initially requested by the manufacturer is hidden...
So, these "medico-economic" decisions are just made to assist the CEPS (Economic Committee for Health products) in the tariff negotiation with the manufacturer, what finally makes CEESP decisions different of what NICE decisions are, for example.
The question is: will, on a long-term perspective, the CEESP be satisfied to be only a "consultative" commission, only here to assist the CEPS... ?
Apparently, the HAS doesn't consider to be its role and responsibility to determine acceptable levels of cost per QALY (more precisely, doesn't consider it has to be the only organization in charge of determining it), and calls for a national public discussion on the topic.
To be continued...