Authors' objectives: Cardiovascular disease has declined but remains a major disease burden across developed countries. To assess the effectiveness and cost-effectiveness of statin therapy across United Kingdom population categories. Despite substantial declines in cardiovascular disease (CVD) morbidity and mortality across high-income countries in recent decades, CVD remains a major disease burden. Across randomised trials, statin therapy has been reliably shown to reduce rates of CVD irrespective of age, sex, CVD risk and comorbidities, with more potent statin regimens achieving larger reductions in low-density lipoprotein cholesterol (LDL-C), demonstrating larger CVD risk reductions. While generally safe, statin therapy has been linked to small excesses in muscle events and incident diabetes. To develop a reliable evaluative framework, informed by large UK individual participant data (IPD), and to assess the long-term net health effects and cost-effectiveness of statin therapy across a wide range of UK population categories.

Authors' results and conclusions: Across categories of participants 40–70 years old, lifetime use of standard statin therapy resulted in undiscounted 0.20–1.09 quality-adjusted life-years gained per person, and higher-intensity statin therapy added a further 0.03–0.20 quality-adjusted life-years per person. Among participants aged ≥ 70 years, lifetime standard statin was estimated to increase quality-adjusted life-years by 0.24–0.70 and higher-intensity statin by a further 0.04–0.13 quality-adjusted life-years per person. Benefits were larger among participants at higher cardiovascular disease risk or with higher low-density lipoprotein cholesterol. Standard statin therapy was cost-effective across all categories of people 40–70 years old, with incremental costs per quality-adjusted life-year gained from £280 to £8530. Higher-intensity statin therapy was cost-effective at higher cardiovascular disease risk or higher low-density lipoprotein cholesterol. Both standard and higher-intensity statin therapies appeared to be cost-effective for people aged ≥ 70 years, with an incremental cost per quality-adjusted life-year gained of under £3500 for standard and under £11,780 for higher-intensity statin. Standard or higher-intensity statin therapy was certain to be cost effective in the base-case analysis at a threshold of £20,000 per quality-adjusted life-year. Statins remained cost-effective in sensitivity analyses. Based on the current evidence of the effects of statin therapy and modelled contemporary disease risks, low-cost statin therapy is cost-effective across all categories of men and women aged ≥ 40 years in the United Kingdom, with higher-intensity statin therapy cost-effective at higher cardiovascular disease risk or higher low-density lipoprotein cholesterol. A total of 117,896 participants in 16 statin versus control trials in the CTTC, 501,854 UKB participants and 6761 Whitehall II participants informed the analyses. Age, sex, socioeconomic deprivation, smoking, hypertension, diabetes, MI and stroke events were key determinants of CVD risk. Model-predicted event rates corresponded well to observed rates across participant categories in UKB and Whitehall II studies. Modelled CVD and nonvascular disease events were associated with reductions in HRQoL and increases in hospital admission and primary care costs. Across categories of participants 40–70 years old, there were estimated gains in undiscounted QALYs of 0.20–1.09 per person with lifetime use of standard statin therapy, and higher-intensity statin therapy added a further 0.03–0.20 QALYs per person. Among participants aged ≥ 70 years, lifetime use of standard statin increased quality of life-adjusted life expectancy by 0.24–0.70 QALYs and higher-intensity statin by further 0.04–0.13 QALYs per person. Health benefits with statin therapy were larger among participants at higher CVD risk and with higher LDL-C levels. Standard-intensity statin therapy was cost-effective across all population categories 40–70 years old with an incremental cost per QALY gained ranging from £280 to £8530. Higher-intensity statin therapy was cost-effective at higher CVD risk and higher LDL-C levels. Both standard and higher-intensity statin therapies appeared to be cost-effective for people aged ≥ 70 years with an incremental cost per QALY gained below £3500 for standard statin versus no statin and below £11,780 for higher-intensity versus standard statin. Statin therapy, either standard or higher intensity, was found certain to be cost effective at a willingness-to-pay threshold of £20,000 per QALY, with higher-intensity statin therapy preferred at higher CVD risk or higher LDL-C level. The probability of statin therapy being cost-effective remained above 80% across all participant categories at £10,000-per-QALY threshold, albeit with a shift towards a preference for standard statin therapy across some categories of people. Statin therapy remained cost-effective in sensitivity analyses. Based on current evidence of effects of statin therapy and modelled analyses of contemporary disease risks, low-cost statin therapy is likely to be highly cost-effective across categories of men and women aged ≥ 40 years in the UK, with higher-intensity regimens cost-effective at higher CVD risk or higher LDL-C levels.

Authors' methods: The cardiovascular disease microsimulation model, developed using Cholesterol Treatment Trialists’ Collaboration data and the United Kingdom Biobank cohort, projected cardiovascular events, mortality, quality of life and healthcare costs using participant characteristics. United Kingdom primary health care. A total of 117,896 participants in 16 statin trials in the Cholesterol Treatment Trialists’ Collaboration; 501,854 United Kingdom Biobank participants by previous cardiovascular disease status, sex, age (40–49, 50–59 and 60–70 years), 10-year cardiovascular disease risk [QRISK®3 (%):

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/17/140/02

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/KDAP7034

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/KDAP7034

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk