title: Protocolisation, Use and Development of Anti-Cancer Drugs in the Context of T2A (Case-Mix Based Payment System) Set-Up.
abstract: Drugs used in oncology represent more than half of the innovative and costly drugs which are not covered by a Group Homogène de Soins (DRG type classification) within the context of the case-mix based payment system (termed T2A). For these drugs, good practice reference guidelines have been drawn up by scientific societies and registration agencies. Recognised indications, relevant indications and situations where the treatment should not be prescribed are defined by the National Institute of Cancer. The reference guidelines should lead towards the good use of these drugs and allow the sick funds to control prescriptions. They should evolve with time, which means that bibliographic monitoring and independent expert opinion is necessary to update them as science provides new data. Manufacturers are involved in this process which in no case should undermine developmental efforts leading to registration. The objective of this protocolisation is to allow all patients early and legitimate access to drugs representing real therapeutic progress. These reference guidelines should be integrated into the life-cycle of a drug and should give rise to new developments allowing the good use of cancer products in situations which have been properly validated.
authors.affiliation: Novartis Pharma SAS, Rueil Malmaison, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Mathieu-Boué
authors.affiliation: Afssaps, Saint Denis, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Demolis
authors.affiliation: Hôpital Lariboisière, Paris, France. Electronic address: jf.bergmann@lrb.aphp.fr.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bergmann
keywords: case-mix based payment system; good practice; oncology; reference guidelines; therapeutic protocol