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Overhauling the reimbursement system for molecular diagnostics

Nature Biotechnology volume 29, pages 390–391 (2011)Cite this article

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To the Editor:

The commentary by Schulman and Tunis1 published last November highlights the lack of clinical utility data (that is, clinical evidence obtained using scientifically robust methods, ideally controlled studies, that shows an improvement in health outcomes in patients) for molecular diagnostic tests as a major barrier to securing coverage for such tests from US healthcare payers. This argument is well supported by recent studies2,3 that demonstrate that the robustness of clinical data available for biomarker tests is the strongest predictor of gaining coverage. The dilemma is that companies developing molecular diagnostics are deterred from conducting studies to assess clinical utility because such trials are complicated, expensive and time consuming to run and are, moreover, not directly required by the US Food and Drug Administration (FDA) in approving tests. Healthcare insurers, on the other hand, are reluctant to reimburse biomarker tests without evidence of clinical utility as these may prove ineffective in improving patient outcomes and thus be financially wasteful at a time when it has become critical to control rising healthcare costs.

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  1. Institute of Biotechnology, University of Cambridge, Cambridge, UK

    Nafees N Malik

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  1. Nafees N Malik
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Correspondence to Nafees N Malik.

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Competing interests

N.N.M. presently works for GlaxoSmithKline, but the correspondence is based on work done at the University of Cambridge.

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Malik, N. Overhauling the reimbursement system for molecular diagnostics. Nat Biotechnol 29, 390–391 (2011). https://doi.org/10.1038/nbt.1869

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