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Original Research ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pharmacol. | doi: 10.3389/fphar.2019.00830

Economic evaluation as a means to assess feasibility for reimbursement of personalized medicine interventions

 Stavros Symeonidis1,  Stefania Koutsilieri1,  Athanassios Vozikis2, David N. Cooper3, Christina Mitropoulou4 and  George P. Patrinos5*
  • 1University of Patras, Greece
  • 2University of Piraeus, Greece
  • 3Cardiff University, United Kingdom
  • 4The Golden Helix Foundation, United Kingdom
  • 5Department of Pharmacy, University of Patras, Greece

Background: The incorporation of genomic testing into clinical practice constitutes an opportunity to improve patients’ lives, as it makes possible the implementation of innovative, individualized clinical interventions that maximize efficacy and/or minimize the risk of adverse drug reactions. In order to ensure equal access to genomic testing for all patients, the costs associated with these tests should be reimbursed by their respective national healthcare systems. Given that funding for the public health sector is decreasing in real terms, it is of paramount importance that the emerging interventions are thoroughly evaluated both in terms of their clinical effectiveness and their full economic cost.
Objective: The aim of this study was to identify those genome-guided interventions that could be adopted and reimbursed by national healthcare systems. Further, we recorded the underlying factors determining the broad adoption of genome-guided interventions in clinical practice, in order to identify potential reimbursement criteria.
Methods: We performed a systematic review of published (PubMed-listed) scientific articles on the economic evaluation of those individualized clinical interventions that include genomic tests. Information on genomic tests reimbursed by the US Medicare program was also included. Subsequently, we correlated the regulatory guidance given for the interventions collated in our systematic review with the corresponding economic evaluation results and policies of the Medicare program. Regulatory guidance information was collected from the PharmGKB online knowledgebase and the Clinical Pharmacogenetics Implementation Consortium (CPIC).
Results: Most of the included studies constitute cost-utility analyses, in which the outcome of the interventions has been measured in quality adjusted life years (QALYs) where as an estimate of the total cost has been based upon direct medical cost data. Favorable economic evaluation results, as well as concrete evidence demonstrating the clinical utility of pre-emptive genotyping, are considered as prerequisites for the broad adoption and reimbursement of the costs incurred during genomic testing.
Conclusions: Our findings further underline the need for further cost-utility analyses within different national healthcare systems, in order to promote the reimbursement of the cost of innovative genome-guided therapeutic interventions.

Keywords: economic evaluation, Pricing, reimbursement, Personalised medicine, Quality of Life, willingness to pay (WTP), Genomics

Received: 07 May 2019; Accepted: 27 Jun 2019.

Edited by:

Vita Dolzan, University of Ljubljana, Slovenia

Reviewed by:

Alessio Squassina, University of Cagliari, Italy
Ioannis S. Vizirianakis, Aristotle University of Thessaloniki, Greece  

Copyright: © 2019 Symeonidis, Koutsilieri, Vozikis, Cooper, Mitropoulou and Patrinos. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. George P. Patrinos, University of Patras, Department of Pharmacy, Patras, GR-26504, Greece,