Cost effectiveness of endovascular ultrasound renal denervation in patients with resistant hypertension

Background Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system. Methods Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP (‘control’ patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs). Results A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463–£5739 [€6341–€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000–£30,000 (€23,214–€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks. Conclusions Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication

Is adding HCV screening to the antenatal national screening program in Amsterdam, the Netherlands, cost-effective?

INTRODUCTION: Hepatitis C virus (HCV) infection can lead to severe liver disease. Pregnant women are already routinely screened for several infectious diseases, but not yet for HCV infection. Here we examine whether adding HCV screening to routine screening is cost-effective. METHODS: To estimate the cost-effectiveness of implementing HCV screening of all pregnant women and HCV screening of first-generation non-Western pregnant women as compared to no screening, we developed a Markov model. For the parameters of the model, we used prevalence data from pregnant women retrospectively tested for HCV in Amsterdam, the Netherlands, and from literature sources. In addition, we estimated the effect of possible treatment improvement in the future. RESULTS: The incremental costs per woman screened was €41 and 0.0008 life-years were gained. The incremental cost-effectiveness ratio (ICER) was €52,473 which is above the cost-effectiveness threshold of €50,000. For screening first-generation non-Western migrants, the ICER was €47,113. Best-case analysis for both scenarios showed ICERs of respectively €19,505 and €17,533. We estimated that if costs per treatment were to decline to €3,750 (a reduction in price of €31,000), screening all pregnant women would be cost-effective. CONCLUSIONS: Currently, adding HCV screening to the already existing screening program for pregnant women is not cost-effective for women in general. However, adding HCV screening for first-generation non-Western women shows a modest cost-effective outcome. Yet, best case analysis shows potentials for an ICER below €20,000 per life-year gained. Treatment options will improve further in the coming years, enhancing cost-effectiveness even more

Tornado diagrams of the sensitivity analyses.

<p>Diagram A) describes scenario 1a and diagram B) scenario describes scenario 1b. Both diagrams show the change in ICER when reducing or increasing each parameter with 25%.</p

Schematic description of the Markov model.

<p>Annually, women move between health stages according to defined transition rates given in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0070319#pone-0070319-t001" target="_blank">Table 1</a>. The natural history of HCV infection (hepatitis C virus) is modelled through the stages of chronic infection, cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), liver transplantation, and the years after transplantation. The dotted arrows indicate competing mortality. In <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0070319#pone-0070319-g001" target="_blank">Figure 1A</a> the model is presented for the women who are not routinely screened for HCV during their pregnancy and are diagnosed in a later stage of infection, in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0070319#pone-0070319-g001" target="_blank">Figure 1b</a> the model is presented for women who are routinely screened during their pregnancy.</p

Best-case scenarios for screening all pregnant women (scenario 1a) and first-generation non-Western women (scenario 1b).

<p>With parameter optimization ±25% and incremental cost-effectiveness ratio calculated with reference to the “no routine screening” strategy.</p><p>LYG:life years gained.</p><p>ICER: incremental cost-effectiveness ratio.</p

Cost-effectiveness outcomes for all pregnant women and first-generation non-Western women (scenarios 1a and 1b), based on probabilistic uncertainty analysis (10000 simulations).

<p>The incremental cost-effectiveness ratio (ICER) is calculated with reference to the “no routine screening” strategy.</p><p>LYG:life years gained.</p><p>ICER: incremental cost-effectiveness ratio.</p

Overview of annual transition probabilities and cost variables used in the Markov model.

<p>HCV: hepatitis C virus.</p><p>HCC: hepatocellular carcinoma.</p>#<p>In the prevalence a clearance rate of 42% <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0070319#pone.0070319-Rozenbaum1" target="_blank">[14]</a> was included. The prevalence used in the model for all pregnant women is 0.2% (9/4563; 95% CI: 0.10–0.37) and for first generation non-Western women 0.43% (7/1612; 95% CI 0.21–0.89).</p>$<p>Transition rate is age-dependent.</p>*<p>same distribution was used for first-generation non-Western women.</p>**<p>new protease inhibitors are added to the standard of care regimen (peginterferon alfa and ribavirine).</p