Economic Evaluations of Pharmacogenetic and Pharmacogenomic Screening Tests: A Systematic Review. Second Update of the Literature

Elizabeth J J Berm, Margot de Looff, Bob Wilffert, Cornelis Boersma, Lieven Annemans, Stefan Vegter, Job F M van Boven, Maarten J Postma, Elizabeth J J Berm, Margot de Looff, Bob Wilffert, Cornelis Boersma, Lieven Annemans, Stefan Vegter, Job F M van Boven, Maarten J Postma

Abstract

Objective: Due to extended application of pharmacogenetic and pharmacogenomic screening (PGx) tests it is important to assess whether they provide good value for money. This review provides an update of the literature.

Methods: A literature search was performed in PubMed and papers published between August 2010 and September 2014, investigating the cost-effectiveness of PGx screening tests, were included. Papers from 2000 until July 2010 were included via two previous systematic reviews. Studies' overall quality was assessed with the Quality of Health Economic Studies (QHES) instrument.

Results: We found 38 studies, which combined with the previous 42 studies resulted in a total of 80 included studies. An average QHES score of 76 was found. Since 2010, more studies were funded by pharmaceutical companies. Most recent studies performed cost-utility analysis, univariate and probabilistic sensitivity analyses, and discussed limitations of their economic evaluations. Most studies indicated favorable cost-effectiveness. Majority of evaluations did not provide information regarding the intrinsic value of the PGx test. There were considerable differences in the costs for PGx testing. Reporting of the direction and magnitude of bias on the cost-effectiveness estimates as well as motivation for the chosen economic model and perspective were frequently missing.

Conclusions: Application of PGx tests was mostly found to be a cost-effective or cost-saving strategy. We found that only the minority of recent pharmacoeconomic evaluations assessed the intrinsic value of the PGx tests. There was an increase in the number of studies and in the reporting of quality associated characteristics. To improve future evaluations, scenario analysis including a broad range of PGx tests costs and equal costs of comparator drugs to assess the intrinsic value of the PGx tests, are recommended. In addition, robust clinical evidence regarding PGx tests' efficacy remains of utmost importance.

Conflict of interest statement

Competing Interests: The authors have the following interests: Stefan Vegter and Cornelis Boersma are employees of GSK, besides their part-time academic positions. Their contribution to this manuscript was from their visiting researcher positions they hold at the University of Groningen. Maarten J. Postma and Lieven Annemans have received grants, honoraria and speaking fees from several pharmaceutical companies (Abbott Diagnostics, Bayer, Biomarin, Boehringer, Bresmed, Forest labs, Genzyme, Gmasol, GSK, GSK bio, Ingress Health, Mundipharma, Novartis, PerkinElmer, Pfizer, Pharmerit, Roche, Sandoz, Sanofi, Shire, SPMSD, Vertex). No other potential conflict of interest related to this study was reported. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. PRISMA flow chart of the…
Fig 1. PRISMA flow chart of the literature search.
Fig 2. Type of outcome analysis (A)…
Fig 2. Type of outcome analysis (A) and sensitivity analysis (B) of PGx studies from 2000- September 2014.
Fig 3. Genes analysed (A) and study…
Fig 3. Genes analysed (A) and study outcomes (B) of papers published between August 2010 and September 2014.

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