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Are patients willing to incur out-of-pocket costs for pharmacogenomic testing?

The Pharmacogenomics Journal volume 17, pages 1–3 (2017)Cite this article

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Genetic modulation of drug response can cause serious, potentially life-threatening adverse drug reactions, can increase susceptibility to drug–drug interactions and can diminish or enhance therapeutic efficacy. As a result, the clinical implementation of pharmacogenomics at the bedside could make it possible to avoid adverse drug reactions and maximize drug efficacy. Ideally, selection of medications based on the genetic profile of individual patients will produce optimal effects for specific indications. Over the past decade, a large number of pharmacogenomic variants with demonstrated clinical utility have been identified and incorporated into drug labels by the US Food and Drug Administration.1 Recognizing that pharmacogenomics has the potential to immediately impact the care of patients in a clinically meaningful manner, President Obama highlighted the importance of ‘delivering the right treatments, at the right time, every time to the right person’ in his Precision Medicine Initiative Remarks.2 However, the incorporation of pharmacogenomics into clinical practice has proved slow and challenging. Some of those challenges include (1) delay in the initiation of therapy due to the use of traditional reactive, as opposed to preemptive, ordering of pharmacogenomic testing, (2) lack of support for commercial electronic health record systems to integrate genomic data and enable automated clinical decision support at the point of care, (3) limited evidence of the benefit for preemptive testing for efficacy, as opposed to testing to avoid rare toxicities, (4) complexity of interpretation of the genotype data and (5) limited coverage and reimbursement of pharmacogenomic testing by health insurance companies.3 Given these challenges, early implementation of large-scale preemptive pharmacogenomics has been restricted to large medical centers with substantial institutional support to cover the costs.4, 5, 6 Expansion of these efforts to patient populations willing to pay out of pocket to defray costs could facilitate wider adoption. However, the types of patients willing to pay out of pocket and the amount these patients would be willing to pay for pharmacogenomic testing are unknown.

Direct-to-consumer genetic testing companies provide some clues as to what patients might be willing to pay for pharmacogenomic testing. 23andMe is the most widely used direct-to-consumer genetic testing company that provides health-related information as well as ancestry information to over 1 000 000 customers.7 Cost of testing was initially $999 in 2007, was lowered to $99 in 2012 and was raised to $199 in 2015 with the introduction of a new Food and Drug Administration compliant report (www.23andMe.com). Customers have access to their raw genetic data, but the health-related portion of the interpreted report includes only a small set of results for rare disease carrier status. Further limiting the utility of these results is the lack of integration with individual patient’s electronic health record for use in current and future medical care. Clearly, large numbers of consumers are willing to pay for direct-to-consumer genetic testing; however, it remains to be determined what types of patients would be willing to incur out-of-pocket costs to have their health-care provider order genetic testing, and what amount would these patients be willing to pay out of pocket. It may be that in the actual health-care context, patients have the expectation that the costs of genetic testing should be covered by their health insurance plan. To address these questions, we surveyed patients participating in the Mayo Clinic Right Drug, Right Dose, Right Time Protocol (RIGHT Protocol) study.4 The RIGHT Protocol is tasked with extending pharmacogenomics implementation beyond ‘reactive genotyping,’ to include ‘preemptive sequencing,’ with integration of clinically actionable pharmacogenomic variants into the electronic health record in the Mayo Clinic and Mayo Clinic Health Systems. The RIGHT Protocol recruited 1013 patients and identified variants in CYP2C19, CYP2C9, VKORC1, SLCO1B1 and CYP2D6 that could cause drug–gene interactions with warfarin, clopidogrel, simvastatin, tamoxifen, opioid analgesics and selective serotonin reuptake inhibitors. Variant information was added to the electronic health record for each patient, and parallel point-of-care clinical decision support for drug–gene interactions was implemented. This study was conducted according to the principles of the Declaration of Helsinki, and informed consent was obtained from all participants. The Mayo Clinic institutional review board approved the study.

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Acknowledgements

This work was supported in part by Mayo Clinic Center for Individualized Medicine, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, National Institutes of Health grants U19 GM61388 (The Pharmacogenomics Research Network), R01 GM28157, U01 HG005137, R01 CA138461, R01 AG034676 (The Rochester Epidemiology Project), U01 HG06379 and U01 HG06379 Supplement (The Electronic Medical Record and Genomics (eMERGE) Network).

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Authors and Affiliations

  1. Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    S J Bielinski, J L St Sauver, J E Olson, E J Bell & V L Roger

  2. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

    J L St Sauver, M E Mc Gree, D J Jacobson, T J Beebe & V L Roger

  3. Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA

    M L Wieland & P Y Takahashi

  4. Center for Individualized Medicine, Mayo Clinic, Rochester, MN, USA

    C R Vitek

  5. Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    M E Mc Gree & D J Jacobson

  6. Department of Health Sciences Research, Biomedical Ethics Program, Mayo Clinic, Rochester, MN, USA

    J B McCormick & R R Sharp

  7. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA

    J L Black

  8. Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA

    P J Caraballo

  9. Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA

    R R Sharp & T J Beebe

  10. Division of Clinical Pharmacology, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, MN, USA

    R M Weinshilboum & L Wang

  11. Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN, USA

    V L Roger

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Correspondence to S J Bielinski.

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Bielinski, S., St Sauver, J., Olson, J. et al. Are patients willing to incur out-of-pocket costs for pharmacogenomic testing?. Pharmacogenomics J 17, 1–3 (2017). https://doi.org/10.1038/tpj.2016.72

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