CONFERENCE "EQUIVALENCE AND COMPARATIVE EFFECTIVENESS: REGULATORY ASPECTS AND ECONOMIC SUSTAINABILITY"
Fedaisf editorial staff
Rome, 29 October 2014
The theme of therapeutic equivalence between pharmaceutical products having different active ingredients is increasingly attracting the attention of the scientific and institutional community, also with reference to the pressing governance needs of pharmaceutical expenditure.
AIFA with the determines 204 of 03.06.2014 has adopted "Guidelines" according to which regional tenders based on "therapeutic equivalence between medicinal products containing different active ingredients" remain subject to a prior ruling by the Medicines Agency, against a documented request for technical-scientific evaluation.
The "Pact for Health 2014-2016” (art. 23, paragraph 5), recently approved by the State-Regions Conference, reaffirmed that the AIFA decisions in this area are valid and applicable throughout the national territory, prefiguring the establishment of a coordination information network including the regional centers of purchase.
Furthermore, the "Health Pact 2014-2016" (art. 27, paragraph 3) has highlighted that national HTA evaluations on medicinal products have the objective of providing reliable, transparent and transferable information to regional and local contexts, on comparative efficacy of medicines and on the subsequent effects in terms of cost-effectiveness in clinical practice, both at marketing, as well as during marketing and the entire life cycle of the medicine.
The Conference therefore aims to analyze the issues of equivalence and comparative effectiveness, allowing a comparison between all the players in the system and also proposing technical-scientific evaluation methodologies that respond to current regulatory processes and can thus contribute to the economic sustainability of the National Health Service.
