[From the therapeutic utility to the added therapeutic value and the incremental cost-effectiveness ratio]

From the social perspective, the concepts of therapeutic utility and degree of innovation of new drugs should be referred to their social added value in relation to the available treatment alternatives and the added costs that they imply; that is, to their incremental cost-effectiveness ratio. The analytic elements highlighting this approach are: 1) the dimensions of the social value of the medication that should go beyond the conventional outcomes measures to also incorporate measures of health related quality of life, patient and family comfort and convenience, healthcare consumption avoided and productive losses avoided; 2) the relative or incremental character of this value that should be quantified in front of previous alternatives -not versus placebo- and under conditions of real use; and 3) the incremental costs that bears the administration of the new medication. The incremental cost-effectiveness ratio is the appropriate approach for decisions about coverage of a treatment by the public insurer, the price that he is willing to pay for the drug, and the clinical situations and patient groups in which it is recommended. The incremental cost-effectiveness analysis and the use of an indicative threshold of the maximum cost that the society is willing to pay for one additional "quality adjusted life year" are the essential elements of this approach, which doesn't require to fix the price of the new medications at the threshold of the willingness to pay.