health care economic information
(2) (A) For purposes of this paragraph, the term “health care economic information” means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention. (B) Such term does not include any analysis that relates only to an indication that is not approved under section 355 , 360(k) , 360c(f)(2) , or 360e of this title or section 262 of title 42 for such drug.