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The use of the ‘linked evidence approach’ to guide policy on the reimbursement of personalized medicines

Published Online:18 Aug 2014https://doi.org/10.2217/pme.14.28

Abstract

It is uncommon to find published clinical trials that measure the health benefits of medical testing. As a consequence, policy makers often have to decide whether access to, or public funding of, medical tests is warranted without knowing the clinical impact of testing on the patient. In the situation where a policy maker is considering a companion genetic test and tailored drug therapy, deficiencies in the evidence base are exacerbated because two technologies need to be assessed and the proposed genetic biomarker needs to be validated. The Linked Evidence Approach (LEA) is a methodology that was developed in 2005 to cope with inadequacies in the evidence supporting medical test evaluations. In 2010 the approach was adapted to the evaluation of pharmacogenetic interventions. This article describes how LEA and similar analytic frameworks are used internationally, highlights particular challenges with the approach, and proposes ways that LEA might be applied to pharmacogenomic interventions.

Keywords:

Papers of special note have been highlighted as: ▪ of interest; ▪▪ of considerable interest

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Published online 18 August 2014

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This work is licensed under the Creative Commons Attribution-NonCommercial 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/

Financial & competing interests disclosure

The author is regularly contracted by the Australian Government Department of Health to undertake evaluations of genetic tests and personalized medicines to inform reimbursement decisions. The author worked with Government to develop the co-dependent technology evaluation framework. With thanks to Claude Farah, David Tamblyn and Skye Newton for their comments on the manuscript. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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