[Identification, during development, of a methodology targeted at determining the positioning of new drugs for therapeutic strategies: examples of rheumatoid arthritis and cardiac insufficiency].
The Marketing Authorization (MA) granted to a new molecular entity does not allow for proper anticipation of its future positioning within the therapeutic strategy. A specific methodology should be devised as early as during the pre-MA development phase that could result in an initial positioning that should be subjected to further reappraisal with regard to scientific advances, the arrival of new treatments and further developments with this molecule. A methodology is thus proposed, based on early optimisation of the development plan, the granting of subsequent MAs, and reappraisal of the positioning within the strategy, based on analysis of all available data. It should be possible to take into account the economic context, within an agreed system with pre-defined medico-economic criteria. This may in turn raise the issue of the role of the various parties involved in this assessment, as well as how to understand the respective opinions of stakeholders: authorities, sponsors, prescribers and patients, each of whom has a specific view of the definition of the strategic objective that should apply to the disease concerned.
Le Jeunne
C
C
Hôpital Européen Georges Pompidou, Paris, France.
Plétan
Y
Y
Boissel
J P
JP
D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004345:Drug Industry / Q000639:trends*; D006331:Heart Diseases / Q000188:drug therapy*; D006801:Humans; D010601:Pharmacology, Clinical / Q000379:methods*; D012107:Research Design