LDL-P across LDL density phenotype adjusted for potentially confounding covariates.

<p>LDL-P across LDL density phenotype adjusted for potentially confounding covariates.</p

Receiver Operating Characteristic Curve analysis of TC/HDL-C for achieving LDL-P<1000 nmol/L target value (solid line) with 95% CI (broken lines).

<p>The diagonal broken line indicates the line of random chance or no discrimination. • Indicates optimized cutpoint for TC/HDL-C (2.96); Sensitivity 0.82; Specificity 0.81.</p

Mean LDL-P vs. LDL density phenotypes with covariate adjustments.

<p>Note that the effect of LDL modal density phenotype on LDL-P is rendered insignificant by HDL-C, ApoB and TC/HDL-C ratio.</p

Receiver operating characteristic curve analysis of selected predictors of achieving LDL-P<1000 nmol/L target value.

<p>HDL-C results in classification significantly differ from chance, p = 0.049; all others, p<0.0001.</p

Differences in utility elicitation methods in cardiovascular disease: a systematic review

<p><b>Aims:</b> Utility values inform estimates of the cost-effectiveness of treatment for cardiovascular disease (CVD), but values can vary depending on the method used. The aim of this systematic literature review (SLR) was to explore how methods of elicitation impact utility values for CVD.</p> <p><b>Materials and methods:</b> This review identified English-language articles in Embase, MEDLINE, and the gray literature published between September 1992 and August 2015 using keywords for “utilities” and “stroke”, “heart failure”, “myocardial infarction”, or “angina”. Variability in utility values based on the method of elicitation, tariff, or type of respondent was then reported.</p> <p><b>Results:</b> This review screened 4,341 citations; 290 of these articles qualified for inclusion in the SLR because they reported utility values for one or more of the cardiovascular conditions of interest listed above. Of these 290, the 41 articles that provided head-to-head comparisons of utility methods for CVD were reviewed. In this sub-set, it was found that methodological differences contributed to variation in utility values. Direct methods often yielded higher scores than did indirect methods. Within direct methods, there were no clear trends in head-to-head studies (standard gamble [SG] vs time trade-off); but general population respondents often provided lower scores than did patients with the disease when evaluating the same health states with SG methods. When comparing indirect methods, the EQ-5D typically yielded higher values than the SF-6D, but also showed more sensitivity to differences in health states.</p> <p><b>Conclusions:</b> When selecting CVD utility values for an economic model, consideration of the utility elicitation method is important, as this review demonstrates that methodology of choice impacts utility values in CVD.</p

Univariate Discrimination of LDL-P and Performance by Lipid Criteria.

<p>Univariate Discrimination of LDL-P and Performance by Lipid Criteria.</p

Receiver operating characteristic curve analysis of LDL-P as a predictor of achieving composite LDL-C, non-HDL-C, and triglyceride composite targets, ATP-III very high risk (ATP-III Composite) or composite of univariate ROC optimized LDL-P cutpoints, nmol/L, for the same parameters (table A, ROC Optimized).

<p>Classifications significantly differ from chance, p<0.0001.</p

Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context

<p><b>Aim:</b> To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population.</p> <p><b>Materials and methods:</b> Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into four cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (<i>n</i> = 1448), acute coronary syndrome (ACS) (<i>n</i> = 602), ischemic stroke (IS) (<i>n</i> = 151), and heart failure (HF) (<i>n</i> = 291) incident cohorts. The value-based price range for evolocumab was assessed using a previously published economic model. The model incorporated CPRD CV event rates and considered CV event reduction rate ratios per 1 mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C) from a meta-analysis of statin trials by the Cholesterol Treatment Trialists Collaboration (CTTC), i.e. CTTC relationship.</p> <p><b>Results:</b> Multiple-event rates of composite CV events (ACS, IS, or coronary revascularization) per 100 patient-years were 12.3 for the high-risk prevalent ASCVD cohort, and 25.7, 13.3, and 23.3, respectively, for incident ACS, IS, and HF cohorts. Approximately one-half (42%) of the high-risk ASCVD patients with a new CV event during follow-up had a subsequent CV event. Combining these real-world event rates and the CTTC relationship in the economic model, the value-based price range (credible interval) under a willingness-to-pay threshold of $150,000/quality-adjusted life-year gained for evolocumab was$11,990 ($9,341–$14,833) to $16,856 ($12,903–$20,678) in ASCVD patients with baseline LDL-C levels ≥70 mg/dL and ≥100 mg/dL, respectively.</p> <p><b>Conclusion:</b> Real-world CVD burden is substantial. Using the observed CVD burden in CPRD and the CTTC relationship, the cost-effectiveness analysis showed that, accounting for uncertainties, the expected value-based price for evolocumab is higher than its current annual cost, as long as the payer discount off list price is greater than 20%.</p