Showing papers by "Lorenzo G. Mantovani published in 2001"

Guidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies

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.

Cost-Benefit Analysis of Amtolmetin-Guacil

Abstract: To assess the economic profile of amtolmetin-guacil (AMG). The analytical framework of this study was a cost-benefit analysis. Using published trials focusing on the gastrointestinal tolerability of AMG versus other nonsteroidal anti-inflammatory drugs (NSAIDs), we assessed the economic profile of AMG in comparison with tolmetin, indomethacin, diclofenac and piroxicam. NSAID users from published randomised controlled trials (RCTs) and meta-analyses used for the present evaluation. AMG vs piroxicam, AMG vs diclofenac, AMG vs indomethacin, AMG vs tolmetin. The cost of NSAIDs in managing gastrointestinal lesions was considered. According to the cost-benefit analysis design, the effect was expressed as net cost or benefit consequent to the use of AMG vs other NSAIDs. The cost of managing gastrointestinal lesions has been estimated to range between L879 400 (EUR454) and L9 176 600 (EUR4740) [year of costing 2000], depending on the grade of severity considered. Compared with tolmetin, the net benefit of using AMG ranged (over 90 days) from a maximum of L4 243 530 (EUR2190) to a minimum of L793 246 (EUR410). With indomethacin, benefits ranged after 30 days from L6 064 058 (EU3132) to L2 026 644 (EUR1046). Similarly, compared with diclofenac, the savings were (over 28 to 30 days) between L3 301 962 (EUR1705) and L736 938 (EUR380). When compared with piroxicam, after 14 days savings reached a minimum of L290 229 (EUR150) and a maximum of L2 178 944 (EUR1077) [year of costing 2000]. Although further research is needed, from this study AMG appears to have a desirable economic profile compared with the other NSAIDs investigated in this study.