Assessment of the innovative quality of agomelatine through the Innovation Assessment Algorithm

Authors

  • Liliana Civalleri SIFEIT – Società Italiana per Studi di Economia ed Etica sul Farmaco e sugli Interventi Terapeutici [Italian Association for Research on the Economics and Ethics of Medications and Therapeutic Procedures], Rome
  • Sabrina Licata SIFEIT – Società Italiana per Studi di Economia ed Etica sul Farmaco e sugli Interventi Terapeutici [Italian Association for Research on the Economics and Ethics of Medications and Therapeutic Procedures], Rome

DOI:

https://doi.org/10.7175/fe.v13i3.279

Keywords:

Agomelatine, IAA, Innovation, Efficacy, Effectiveness

Abstract

Aim: the aim of this study was to assess the innovative quality of a medicine based on agomelatine, authorized by the European Commission through a centralized procedure on 19th February 2009 and distributed in Italy under the brands Valdoxan® and Thymanax®.

Methodology: the degree of innovation of agomelatine was determined through the Innovation Assessment Algorithm (IAA), which considers the innovative quality of a medicine as a combination of multiple properties. The algorithm may be represented as a decision tree, with each branch corresponding to a property connected with innovation and having a fixed numerical value. The sum of these values establishes the degree of innovation of the medicine. The IAA is articulated in two phases: the first assesses the efficacy of the drug based on the clinical trials presented in support of the registration application (IAA-efficacy); the second reconsiders the degree of innovation on the basis of the efficacy and safety data resulting from clinical practice once the drug has been placed on the market (IAA-effectiveness).

Results and conclusions: the score obtained for agomelatine was 592.73 in the efficacy phase and 291.3 in the effectiveness phase. The total score for the two phases was 884, which is equivalent to a good degree of innovation for the molecule

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Published

2012-09-21

Issue

Section

Original Research

How to Cite

1.
Civalleri L, Licata S. Assessment of the innovative quality of agomelatine through the Innovation Assessment Algorithm. Farmeconomia. Health Economics and Therapeutic Pathways. 2012;13(3):141-152. https://doi.org/10.7175/fe.v13i3.279

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