Abstract
Background
The 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.
Methods
IHSP 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.
Results
Since 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.
Conclusions
Horizon Scanning is a useful tool to support policy-makers in allocating resources more efficiently.
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Ringraziamenti
Gli autori ringraziano i componenti del Comitato Scientifico (Fabio Benedetti, Vittorio Bertelè, Luigi Bozzini, Emanuele Carbonieri, Claudio Graiff, Anna Maria Grion, Roberta Joppi, Luigi Mezzalira, Vittorio Pengo, Anna Maria Stanzial) per il costante apporto critico di valutazione dell’innovazione e dell’impatto delle nuove tecnologie e la Segreteria Scientifica (Laura Agnoletto, Elisa Cinconze, Luca Demattè, Marisa De Rosa, Daniela Pase, Chiara Poggiani, Elisa Rossi) per il supporto nella raccolta ed elaborazione dei dati.
Disclosure Il lavoro non ha beneficiato di alcun finanziamento esterno.
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Joppi, R., Pase, D. & Poggiani, C. Italian Horizon Scanning Project. G Ital Health Technol Assess 6, 11–21 (2013). https://doi.org/10.1007/s40269-013-0003-3
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DOI: https://doi.org/10.1007/s40269-013-0003-3