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CPT 81328 SLCO1B1 (solute carrier organic anion transporter family, member 1B1) gene analysis, common variant(s)Last reviewed at VbBS in November 2017. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction), gene analysis, common variant(s) (eg, *5) (CPT 81328)Background: genetic variations in this gene are associated with response to simvastatin. Clinical guidelines exist that can guide dosing of simvastatin based on SLCO1B1 gene variant using genotyping or whole exome sequencing. EvidenceNelson 2016, effects of genetics on drug efficacySLCO1B1 effect size on statin metabolism: 0.15% Carr 2013, proof of concept study on SLCO1B1 genetic variants on prediction of statin myelopathySLCO1B1 c.521T>C single-nucleotide polymorphism to be a significant risk factor (P = 0.009), with an odds ratio (OR) per variant allele of 2.06 (1.32-3.15) for all myopathy and 4.09 (2.06-8.16) for severe myopathy (CPK > 10x ULN, and/or rhabdomyolysis; n = 23). Meta-analysis showed an association between c.521C>T and simvastatin-induced myopathy, although power for other statins was limitedGAP discussion: no commentsPreliminary HERC staff recommendation:Add CPT 81328 to line 660 Conditions for which certain treatments have no clinically important benefit or have harms that outweigh benefits No proven clinical benefit ................
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