OBJECTIVES: In 1994, in French health care system, a supplement status for ambulatory reimbursement drugs, called “exception drugs”, was established. This status enables to reimburse only specified indications of particularly costly drugs. In this study we  analyze what characteristics a drug should possess in order to be considered as an "exception drug". METHODS: Included in the study, were drugs that had status of “exception drugs” as of April 2011. The clinical (actual benefit, improvement of actual benefit) and economic (amount reimbursed by National Health Insurance) characteristics were collected from official and publicly available websources, as well as supplement restrictions for prescription (any prescription or only the first one must be accomplished by a hospital practitioner; prescription must be accomplished by a specialist; or prescription requires specific following during the treatment). RESULTS: As of April 2011, there were 56 “exception drugs” in trade name and 30 in generic name. The drugs from 9 ATC classes level I were presented; the most numerous were A16 (Other alimentary tract and metabolism), H01 (Pituitary and hypothalamic hormones and analogues), B03 (Antianemic preparations). Supplement restrictions for prescription was applied to 33 drugs. Some “exception drugs” (10) had also the status of drugs financed out of DRG payment system. Most of the drugs, 91.07% (51/56) had high level of actual benefit. Around half of the “exception drugs”, 42.86% (24/56) had level of improvement in actual benefit from I to III. In 2009, part of reimbursed amount of “exception drugs” was 7.73% from all reimbursed drugs, whereas in 2004 it was 2.85%. Interestingly, in 2009 four "exception drugs" constituted about 1% of the reimbursed amount each, and 40 – less than 0.1%. CONCLUSIONS: The analyzed types of characteristics, both economic and clinical, can be used as criteria for establishing the status of "exception drug".