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Value of a Hypothetical Pharmacogenomic Test for the Diagnosis of Statin-Induced Myopathy in Patients at High Cardiovascular Risk

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Abstract

We recently conducted two economic evaluations of a hypothetical pharmacogenomic test for statin-induced myopathy (SIM) in patients at high cardiovascular risk. Although the models differed in modeling technique and data inputs, both yielded similar results. We believe our approach to assessing the economic value of a diagnostic test was highly advantageous as it characterized the complete range of false-negative and false-positive test outcomes. We used a broad interpretation of test parameters that reflected physician and patient behavioral responses to the test results and accounted for patient adherence to treatment. Both economic evaluations indicated that a highly accurate pharmacogenomic test for SIM would provide a positive incremental net monetary benefit (INMB) for a provincial payer in Canada. However, the value of the test would depend on its ability to accurately diagnose patients when they experience musculoskeletal pain symptoms and guide patients with a test result indicating no SIM to adhere to treatment. Interestingly, our results indicated that a highly inaccurate test would still yield a positive INMB. We found this surprising result was driven by the imbalance of the risk of cardiovascular events outweighing the risk of rhabdomyolysis in patients at high cardiovascular risk. A highly accurate pharmacogenomic test for SIM in patients at high cardiovascular risk would provide economic value for payers. However, the economic and clinical value of the test would depend on the credibility of the test results and their success in influencing patients without SIM to adhere to therapy.

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Notes

  1. The Supplemental Appendix from Mitchell et al. [29] provides detailed methodological information on the estimated time-to-event functions and the formula used to adjust time-to-event for statin interruption.

  2. The first modelled CVE corresponded to patients’ second CVE, as patients entered the model initiating a statin after their first-ever CVE.

  3. With modern technology, it is straightforward to design computer programs to assess the complete matrix of results across all test parameters. In most cases, the results will indicate the minimal combinations of test parameters required to be cost effective.

  4. The INMB measure expresses the excess value for the payer when the WTP for a QALY is known. The INMB is expressed as INMB = ∆QALYs × WTP − ∆costs. A positive INMB value represents a monetary gain for the payer considering how much it is willing to pay for an additional QALY. Similarly, a negative INMB value represents a monetary loss.

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Authors and Affiliations

  1. Faculté de Médecine, Université de Montréal, Montréal, Canada

    Dominic Mitchell & Jacques LeLorier

  2. Centre de Recherche du Centre Hospitalier de l’Université de Montréal, Montréal, Québec, Canada

    Dominic Mitchell & Jacques LeLorier

  3. Département de Médecine Sociale et Préventive, Faculté de Médecine, Université Laval, Québec, Canada

    Jason R. Guertin

  4. Centre de recherche du CHU de Québec, Université Laval, Québec, Canada

    Jason R. Guertin

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DM contributed to the conception and design of the study, data acquisition, analysis and interpretation of data, drafting the article, and final approval. JRG and JL contributed to the conception and design of the study, analysis and interpretation of data, drafting the article, and final approval.

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Correspondence to Jacques LeLorier.

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Funding

This research was supported by Genome Canada and Genome Québec. Jason R. Guertin is a recipient of an establishment fund from the Centre de recherche du CHU de Québec - Université Laval and from the Fondation du CHU de Québec.

Conflict of interest

Dominic Mitchell, Jason R. Guertin, and Jacques LeLorier have no conflicts of interest that are directly relevant to the content of this review.

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Mitchell, D., Guertin, J.R. & LeLorier, J. Value of a Hypothetical Pharmacogenomic Test for the Diagnosis of Statin-Induced Myopathy in Patients at High Cardiovascular Risk. Mol Diagn Ther 22, 641–652 (2018). https://doi.org/10.1007/s40291-018-0356-6

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