Review of the Cost Effectiveness of Pharmacogenetic-Guided Treatment of Hypercholesterolaemia

Abstract

Hypercholesterolaemia is a highly prevalent condition that has major health and cost implications for society. Pharmacotherapy is an important and effective treatment modality for hypercholesterolaemia, with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ('statins') the most commonly used class of drugs. Over the past decade, there has been intensive research to identify pharmacogenetic markers to guide treatment of hypercholesterolaemia. This study aimed to review the evidence of incremental cost, effect and cost effectiveness of pharmacogenetic-guided treatment of hypercholesterolaemia. Three cost-effectiveness analyses (CEAs) were identified that studied the value of screening for genotypes of angiotensin I converting enzyme (ACE), cholesteryl ester transfer protein (CETP), and kinesin family member 6 (KIF6) prior to initiating statin therapy. For all three CEAs, a major limitation identified was the reproducibility of the evidence supporting the clinical effect of screening for the pharmacogenetic marker. Associated issues included the uncertain value of pharmacogenetic markers over or in addition to existing approaches for monitoring lipid levels, and the lack of evidence to assess the effectiveness of alternative therapeutic options for individuals identified as poor responders to statin therapy. Finally, the economic context of the market for diagnostic tests (is it competitive or is there market power?) and the practicality of large-scale screening programmes to inform prescribing in a complex and varied market may limit the generalizability of the results of the specific CEAs to policy outcomes. The genotype of solute carrier organic anion transporter family member 1B1 (SLCO1B1) has recently been associated with increased risk of muscle toxicity with statin therapy and the review identified that exploration of cost effectiveness of this pharmacogenetic marker is likely warranted.

Pharmacogenomic and pharmacogenetic-guided therapy as a tool in precision medicine: current state and factors impacting acceptance by stakeholders

“…Routine PGx testing for statin therapy is not recommended by current guidelines (Ramsey et al , 2014; Talameh & Kitzmiller, 2014) nor covered by most payers. Additional studies are needed to determine clinical utility and cost-effectiveness of PGx testing in patient populations given factors including the type of statin (as pharmacokinetic profiles for each statin are unique), the dose and concomitant use of other drugs (Sorich et al , 2013; Talameh & Kitzmiller, 2014).…”

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity

“…Six publications discussed effects from a perspective of clinical utility such as the NNTG (Sorich et al, 2013 ):…”

Indirect Estimation of the Comparative Treatment Effect in Pharmacogenomic Subgroups

“…Also, the method is a useful addition to the toolbox of methods available to assist in assessing the possible cost-effectiveness of a pharmacogenomic marker (e.g. [23]–[25]). In that context it provides a clear mathematical structure for synthesising the available evidence and transparency about the underlying assumption (i.e., exchangeability).…”