|An economic evaluation of rosuvastatin treatment in systolic heart failure: evidence from the CORONA trial
|Lorgelly PK, Briggs AH, Wedel H, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wikstrand J, Janosi A, van Veldhuisen DJ, Barrios V, Fonseca C, McMurray JJ, the Controlled Rosuvastatin Multinational Study in Heart Failure Study Group
This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn.
This study examined the cost-effectiveness of rosuvastatin in patients aged 60 years or older, with systolic heart failure, of ischaemic aetiology, and with an ejection fraction of 0.40 or less. The authors concluded that rosuvastatin produced fewer major cardiovascular events, which resulted in significantly lower costs for cardiovascular hospitalisations and procedures, which partly offset the additional cost of the drug. The study was generally well carried out and the authors’ conclusions appear to be robust.
Type of economic evaluation
This study examined the cost-effectiveness of rosuvastatin in patients aged 60 years or older, with systolic heart failure, of ischaemic aetiology, and with an ejection fraction of 0.40 or less.
Rosuvastatin 10mg daily was compared against placebo.
The analysis was based on a single study. The time horizon was approximately three years. The authors stated that the analysis was carried out from the perspective of the health care sector, which was the UK National Health Service (NHS).
The clinical data came from the Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA), which was a large-scale, prospective, placebo, randomised controlled trial (RCT) that was carried out at 378 centres in 21 countries (Kjekshus, et al. 2005, see ‘Other Publications of Related Interest’ below for bibliographic details). The trial included a sample of 5,011 patients, with 2,514 in the rosuvastatin group and 2,497 in the placebo group. The mean age was 72.7 years for both groups. The mean follow-up time was 910 days in the rosuvastatin group and 907 days in the placebo group. The composite endpoint of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke was the key clinical outcome.
Monetary benefit and utility valuations:
Measure of benefit:
The summary benefit measure was the rate of major cardiovascular events. Both fatal and non-fatal events were considered and these included cardiovascular hospitalisations, additional cardiovascular events occurring while in hospital, cardiovascular events that did not require hospitalisation, and cardiovascular deaths. The benefits were discounted at an annual rate of 3.5%.
The economic analysis included the costs of hospitalisations, procedures, and rosuvastatin. The resource use data were mainly derived from the clinical trial. The costs were from NHS reference costs, with some data provided by experts. The unit costs per event and not per day were used for hospitalisations, as there were potential differences in the length of stay between the countries included in the clinical trial. These costs were in UK pounds sterling (£), for the price year 2005 to 2006, and a 3.5% annual discount rate was applied.
Analysis of uncertainty:
Confidence intervals around the incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were generated. The cost of statin monitoring was varied in a univariate sensitivity analysis.
In comparison with placebo, rosuvastatin avoided 0.164 major cardiovascular events at an additional cost of £303 (£289 including non-cardiovascular hospitalisations; £343 including monitoring visits; and £328 excluding heart transplants). The additional cost of rosuvastatin was only partly offset (44%) by a reduction in the cardiovascular hospitalisations.
The incremental cost per major cardiovascular event avoided with rosuvastatin was £1,840 (£1,759 including non-cardiovascular hospitalisations; £2,090 including monitoring visits; and £1,987 excluding heart transplants).
The analysis of uncertainty showed that these results were very stable and the probability of rosuvastatin being cost-effective approached 100% at a willingness-to-pay of £5,000 or more to avoid a major cardiovascular event.
The authors concluded that rosuvastatin led to a reduction in major cardiovascular events, which resulted in significantly lower costs for cardiovascular hospitalisations and procedures, which partly offset the additional cost of the drug.
The selection of the comparators was based on the interventions in the clinical trial (treatment versus no-treatment). The dosage of rosuvastatin was reported. Comparisons with other statins were beyond the scope of this analysis.
The evidence was from an international RCT, which is a rigorous design and it had a large sample of patients, who were from several nations. The two groups were comparable at baseline in their clinical and demographic characteristics. The full details of this trial were published elsewhere. The benefit measure was disease specific and might not be comparable with the benefits of other health care interventions.
The economic analysis was consistent with the perspective. A breakdown of the cost items was given, with both the unit costs and the resource quantities. The price year and data sources were reported. The authors stated that the costs of other medications were not included as their use was similar between groups. The authors reported the costs of hospitalisations per event and not per day, due to differences in the length of stay among countries included in the clinical trial.
Analysis and results:
The costs and benefits were appropriately synthesised and both the total and incremental results were reported. Few details of the analysis of uncertainty were presented. For instance, the results of the cost-effectiveness acceptability curves were only presented in a graph. The authors acknowledged some limitations of their analysis, such as the use of major cardiovascular events instead of quality-adjusted life-years as the benefit measure. This was due to a lack of utility values from the clinical trial and the need for assumptions for a long-term analysis.
The study was generally well carried out and the authors’ conclusions appear to be robust.
Supported by a grant from AstraZeneca.
Lorgelly PK, Briggs AH, Wedel H, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wikstrand J, Janosi A, van Veldhuisen DJ, Barrios V, Fonseca C, McMurray JJ, the Controlled Rosuvastatin Multinational Study in Heart Failure Study Group. An economic evaluation of rosuvastatin treatment in systolic heart failure: evidence from the CORONA trial. European Journal of Heart Failure 2010; 12(1): 66-74
Other publications of related interest
Kjekshus J, Dunselman P, Blideskog M, Eskilson C, Hjalmarson A, McMurray JV, Waagstein F, Wedel H, Wessman P, Wikstrand J. A statin in the treatment of heart failure? Controlled rosuvastatin multinational study in heart failure (CORONA): study design and baseline characteristics. European Journal of Heart Failure 2005; 7: 1059-1069.
Subject indexing assigned by NLM
Aged; Cardiopulmonary Bypass /utilization; Cost-Benefit Analysis; Costs and Cost Analysis; Female; Fluorobenzenes /economics /therapeutic use; Heart Failure /drug therapy /economics; Heart Transplantation /utilization; Hospital Mortality; Hospitalization /economics /statistics & Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors /economics /therapeutic use; Male; Middle Aged; Prospective Studies; Pyrimidines /economics /therapeutic use; Rosuvastatin Calcium; Sulfonamides /economics /therapeutic use; numerical data
Date bibliographic record published
Date abstract record published