Transparency, first of all. At the same time, however, innovation evaluated on the basis of efficacy, but also safety, and comparison with existing standard treatments in a dynamic process that takes into account the continuous evolution of scientific knowledge. These are the criteria around which the AIFA experts are working for the development of the new innovation algorithm that will be applied in the evaluation of drugs, with operation expected by the end of 2013. The guidelines were presented during the IV Paa - Public affairs association national conference held yesterday in Rome, Paul Siviero, coordinator of the Aifa drug strategies and policies area. «We are faced with the challenge of how to guarantee access to new treatments and their appropriate use in contexts with reduced budgets» underlines Siviero. «In the new evaluation model of innovativeness we started from the assumption that this must take into account the effects on the quality of care in terms of reduction of morbidity and mortality, pain relief, benefits in terms of quality of life for the patient. Furthermore, the effects on the cost of care, i.e. on the resources used for development and dispensing to the patient, are fundamental and, finally, those on the value of the treatment, i.e. the improvement in quality in relation to costs. There are 5 parameters on which we are developing a points evaluation model that we will make available to members of the technical-scientific Commission: pathology, drug, safety, clinical efficacy, cost effectiveness. Everyone will have a traceable decision-making path and will determine a final score. Each Cts member will be able to evaluate the overall work of his colleagues and any disputes can be resolved by majority vote. Always in the name of transparency, the final dossier will be available to the Regions which, in their decision-making autonomy, will be able to know the evaluation criteria used by AIFA. As regards implementation times, it is announced that it will become fully operational by 2013. «First of all, we will present the complete algorithm to the newly established Aifa Commissions» says Siviero. «There will then be a moment of sharing and public consultation with scientific societies, academia and stakeholders. It will then be the turn of a pilot phase with reduced functionality to then move on to the final stage with the production of an electronic dossier for each product, hopefully by the end of next year" (N.M.).
source: www.doctornews July 4, 2012
