A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care

There is a well-validated association between <i>SLCO1B1</i> (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive <i>SLCO1B1</i> pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before stat...

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Autores principales: Charles A. Brunette, Olivia M. Dong, Jason L. Vassy, Morgan E. Danowski, Nicholas Alexander, Ashley A. Antwi, Kurt D. Christensen
Formato: article
Lenguaje:EN
Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/bce280f5a3324b0bba6cd0a0da6a1f6f
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Sumario:There is a well-validated association between <i>SLCO1B1</i> (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive <i>SLCO1B1</i> pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before statin initiation. Despite its potential clinical application, the cost implications of <i>SLCO1B1</i> testing are largely unknown. We conducted a cost–consequence analysis of preemptive <i>SLCO1B1</i> testing (PGx+) versus usual care (PGx−) among Veteran patients enrolled in the Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. The assessment was conducted using a health system perspective and 12-month time horizon. Incremental costs of <i>SLCO1B1</i> testing and downstream medical care were estimated using data from the U.S. Department of Veterans Affairs’ Managerial Cost Accounting System. A decision analytic model was also developed to model 1-month cost and SAMS-related outcomes in a hypothetical cohort of 10,000 Veteran patients, where all patients were initiated on simvastatin. Over 12 months, 13.5% of PGx+ (26/193) and 11.2% of PGx− (24/215) participants in the I-PICC Study were prescribed Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline-concordant statins (Δ2.9%, 95% CI −4.0% to 10.0%). Differences in mean per-patient costs for lipid therapy prescriptions, including statins, for PGx+ compared to PGx− participants were not statistically significant (Δ USD 9.53, 95% CI −0.86 to 22.80 USD). Differences in per-patient costs attributable to the intervention, including PGx testing, lipid-lowering prescriptions, SAMS, laboratory and imaging expenses, and primary care and cardiology services, were also non-significant (Δ− USD 1004, 95% CI −2684 to 1009 USD). In the hypothetical cohort, <i>SLCO1B1</i>-informed statin therapy averted 109 myalgias and 3 myopathies at 1-month follow up. Fewer statin discontinuations (78 vs. 109) were also observed, but the <i>SLCO1B1</i> testing strategy was 96 USD more costly per patient compared to no testing (124 vs. 28 USD). The implementation of <i>SLCO1B1</i> testing resulted in small, non-significant increases in the proportion of patients receiving CPIC-concordant statin prescriptions within a real-world primary care context, diminished the incidence of SAMS, and reduced statin discontinuations in a hypothetical cohort of 10,000 patients. Despite these effects, <i>SLCO1B1</i> testing administered as a standalone test did not result in lower per-patient health care costs at 1 month or over 1 year of treatment. The inclusion of <i>SLCO1B1</i>, among other well-validated pharmacogenes, into preemptive panel-based testing strategies may provide a better balance of clinical benefit and cost.