Abstract
Since 1997, in order for a new drug to obtain its price and reimbursement in Italy, the negotiation between authorities and the pharmaceutical industry must include an economic evaluation. The economic evaluation study leads to price and reimbursement negotiations together with such other requirements as the price of the new drug in other countries, the impact on the domestic market in terms of public pharmaceutical expenditure, and the effects on the national economy (employment and investments). In response to the need to set methodological standards for the economic evaluation of drugs a group of about 40 experts (the Italian Group for Pharmacoeconomic Studies) made up of representatives of the regulatory authorities and ministries, academia, and the industry prepared recommendations concerning the methodology and the presentation of pharmacoeconomic studies. The principles were intensively reviewed and discussed during a number of workshops and meetings throughout one year, and then finally and officially presented to the regulatory authorities. The elements which must be contained in each study submitted to the authorities are briefly described in this paper, considering the main theoretical and regulatory contributions found in the literature. In particular, the economic analyses suggested are cost-effectiveness and cost-utility, and they must be applied from the points of view of both society and the Italian National Health Service. Even though pragmatic economic-clinical trials are preferred, given the difficulties in releasing these kinds of studies for drugs which have just been authorized, the use of models is suggested when satisfying a series of requirements (the reproducibility of the results by the regulatory commission, detailed description of the methodology and the intermediate results, etc.). Preference is given to microcosting, that is, cost measurement performed at the health care provider level (eg. hospitals), from which representative data at the national level can be obtained. In terms of the presentation of an economic evaluation, a synthesis of the study must be prepared on the basis of a detailed list of issues in order to facilitate evaluation of the study by the regulatory authorities. The approach followed by the Italian Group for Pharmacoeconomic Studies is based on the belief that only the recommendations prepared with the active contributions of all subjects interested in the economic evaluation of drugs are likely to be efficiently applied and disseminated.