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Early stage Healthcare Technology Assessment

Pecchia, Leandro; Castaldo, Rossano; Melillo, Paolo; Bracale, Umberto; Craven, Michael P.; Bracale, Marcello


Leandro Pecchia

Rossano Castaldo

Paolo Melillo

Umberto Bracale

Marcello Bracale


Roberto Miniati

Ernesto Iadenza

Fabrizio Dori


This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.

Acceptance Date Oct 1, 2015
Publication Date Jan 5, 2016
Deposit Date Jul 18, 2017
Peer Reviewed Peer Reviewed
Book Title Clinical engineering: from devices to systems
ISBN 9780128037676
Keywords Early stage HTA; pre-market HTA; HTA of medical devices; Headroom; Markov Models; analytic hierarchy process (HTA)
Public URL
Publisher URL\:%20from%20devices%20to%20systems