How to Anticipate the Assessment of the Public Health Benefit of New Medicines?

As a conclusion, the possibilities to estimate the expected benefit of a new medicine on the health status of a specific population are currently limited. These limitations are regrettable because such an estimate is feasible without disrupting the development plans. The authors' general recommendations to update the development plans seem especially appropriate as the additions should not only be beneficial to France but to all the health authorities who would wish to assess the expected benefit of a new medicine on their territories. Anticipating the lack of clinical and epidemiological data and the lack of data that enable to evaluate the transposability of the trials results to real clinical practice is a sine qua none condition to improve the PHB assessment. The anticipation of these needs should be planned early enough by the pharmaceutical companies which could in this purpose meet the health authorities and the heads of the French public health policy in a consultation. Finally, because of the PHB's universal dimension, it is suggested that the necessary actions and publications be initiated so that the PHB can be acknowledged at the European level.