Italian Horizon Scanning Project

Abstract

BackgroundThe often modest therapeutic value, the uncertain level of innovation, and the high costs of new drugs suggest a pressing need for early evaluation of emerging pharmaceuticals. The Italian Horizon Scanning Project (IHSP) critically reports on emerging drugs in order to timely assess their potential impact on the National Health System.MethodsIHSP identifies, filters and prioritizes emerging drugs for which a European Marketing Authorization (MA) is expected within 12–36 months. The final New Product Information Report, issued 12 months before the MA, critically reports on efficacy and safety of selected drugs, on their possible level of innovation, place in therapy and social and economic impact.ResultsSince 2008, 39 new drugs were prioritized (corresponding to 44 indications) due to (i) their potential high epidemiological and economic impact; (ii) the limited availability or the complete lack of treatments; (iii) the uncertainty of the possible place in therapy of the emerging drug; (iv) the possible better efficacy and/or safety profile or possible better compliance of the new medicine versus the available therapies. Among the 39 drugs, 14 active principles were indicated in cancer patients, eight for cardiovascular diseases, and four for multiple sclerosis.ConclusionsHorizon Scanning is a useful tool to support policy-makers in allocating resources more efficiently.