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Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents |
Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M |
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Record Status 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. CRD summary This study assessed the cost-effectiveness of once-daily liraglutide versus exenatide twice daily in patients with type 2 diabetes who had failed to improve with metformin, sulphonylurea, or both. The authors concluded that liraglutide improved clinical benefits and provided value-for-money from the perspective of the health care payer in Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria. The cost-effectiveness framework was conventional and the clinical sources were valid. The authors’ conclusions appear to be robust. Type of economic evaluation Study objective This study assessed the cost-effectiveness of once-daily liraglutide versus exenatide twice daily in patients with type 2 diabetes who had failed to improve with metformin, sulphonylurea, or both. Interventions The two treatments were liraglutide (1.8mg once daily) and exenatide (10 micrograms twice daily). Each treatment was given in addition to the usual care, and was assumed to last for a maximum of five years. Location/setting Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria/primary care. Methods Analytical approach:The analysis was based on a published Markov model, the Center for Outcomes Research (CORE) Diabetes Model, with a lifetime horizon. The authors stated that the analysis was carried out from the perspective of the third-party payer. Effectiveness data:Most of the clinical data and patients’ characteristics were from the published Liraglutide Effect and Action in Diabetes (LEAD) 6 trial (Buse, et al. 2009, see 'Other Publications of Related Interest' below for bibliographic details). This was a head-to-head open-label parallel-group multinational clinical trial, with 233 patients in the liraglutide group and 231 in the exenatide group. The length of follow-up was 26 weeks and the main clinical endpoint was the change in glycated haemoglobin (HbA1c). This trial provided data on the short-term effect and the tolerability of the two groups. The long-term projections were based on validated estimates used in the CORE Diabetes Model. Monetary benefit and utility valuations:The utility values were from published sources, the main one being the UK Prospective Diabetes Study. Measure of benefit:Quality-adjusted life-years (QALYs) were the summary benefit measure. The discount rates were 3% for Switzerland, Denmark, and Finland, 4% for Norway, 1.5% for the Netherlands, and 3.5% for Austria. Cost data:The economic analysis included the costs of drugs and the treatment of diabetes complications. Resource consumption was from the clinical trial, for each country, and the unit costs were from country-specific published sources. The costs were reported in local currency and in Euros (EUR), converted using official purchase power parity indices. The price year was 2008 and the discount rates were 3% for Switzerland, Denmark, and Finland, 4% for Norway and the Netherlands, and 3.5% for Austria. Analysis of uncertainty:Nonparametric bootstrapping was used to assess uncertainty, with cost-effectiveness acceptability curves calculated up to a willingness-to-pay threshold of EUR 60,000 per QALY gained. One-way sensitivity analyses were carried out varying the time horizon, discount rate, measures of drug efficacy, utility values, and unit costs. The ranges of values were from published sources or authors’ opinions. In an alternative scenario, a societal perspective was adopted, including patient co-payments and lost productivity due to complications. Results The expected additional costs with liraglutide over exenatide were EUR 1,023 in Switzerland, EUR 1,364 in Denmark, EUR 1,866 in Norway, EUR 1,368 in Finland, EUR 1,395 in the Netherlands, and EUR 1,207 in Austria. The gain in QALYs was 0.15 in Switzerland, 0.12 in Denmark, 0.14 in Norway, 0.16 in Finland, 0.17 in the Netherlands, and 0.14 in Austria. The incremental cost per QALY gained with liraglutide over exenatide was EUR 6,902 in Switzerland, EUR 11,805 in Denmark, EUR 13,546 in Norway, EUR 8,459 in Finland, EUR 8,119 in the Netherlands, and EUR 8,516 in Austria. At a threshold of EUR 40,000 per QALY gained, liraglutide was cost-effective in 80% of simulations in Switzerland, 71% in Denmark, 75% in Norway, 79% in Finland, 77% in the Netherlands, and 78% in Austria. One-way sensitivity analyses showed that the time horizon and the exclusion of clinical benefits for liraglutide were the most influential parameters. For example, in Switzerland with a five-year time horizon, the cost-effectiveness of liraglutide rose to EUR 45,880 per QALY gained and without benefits it rose to EUR 27,341 per QALY gained. The inclusion of indirect costs (societal perspective) made liraglutide dominant, as it was more effective and less expensive than exenatide. Authors' conclusions The authors concluded that liraglutide improved clinical benefits and provided value-for-money from the perspective of the health care payer in all six European countries. CRD commentary Interventions:The rationale for the selection of the comparators was clear as the two available glucagon-like peptide 1 drugs were compared with each other. These are likely to be valid comparators in other settings. Effectiveness/benefits:The clinical inputs were from a randomised trial, and this design is generally considered to provide valid evidence. The trial had been published elsewhere and limited information on its methods and results was reported. Its head-to-head design and International basis enhance its reliability. Long-term projections were based on a well-known diabetes model that was validated in many countries. Extensive sensitivity analysis was conducted assess the uncertainty in these projections. QALYs were an appropriate benefit measure given the impact of diabetes on survival and quality of life. Unadjusted survival was also reported. Valid sources appear to have been used for the utility values, as published data were not available for every country. Costs:The cost categories appear to be consistent with the perspective of the third-party payer. The costs were based on official rates for each country, but the unit costs, resource quantities, and data sources were not reported. This limits the transparency of the analysis. The resource use was country-specific data from the clinical trial, rather than a pooled estimate. This appears to have been appropriate, but the number of patients supplying data for each country was not stated and a small sample might have reduced the accuracy of these estimates. The price year was reported, and reflation exercises will be possible. The impact of alternative assumptions for the costs was investigated in the sensitivity analyses. Analysis and results:The results were extensively presented for each country. An incremental approach was used to synthesise the costs and benefits of the two treatments. Conventional discounting for each country was applied to the model outcomes. The CORE Diabetes Model was appropriate for simulating disease progression and its management; this model had been validated in numerous studies. The uncertainty was satisfactorily investigated in deterministic and probabilistic analyses, and the results were clearly discussed. The analysis was conducted in six European countries with similar findings, and the results should be transferable to other developed countries. Concluding remarks:The cost-effectiveness framework was conventional and the clinical sources were valid. The authors’ conclusions appear to be robust. Funding Funded by Novo Nordisk Pharma AG, Switzerland, manufacturer of liraglutide. Bibliographic details Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clinical Therapeutics 2011; 33(11): 1698-1712 Other publications of related interest Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009; 374: 39–47. Indexing Status Subject indexing assigned by NLM MeSH Administration, Oral; Cohort Studies; Cost-Benefit Analysis; Diabetes Mellitus, Type 2 /drug therapy; Drug Administration Schedule; Glucagon-Like Peptide 1 /administration & Humans; Hypoglycemic Agents /administration & Liraglutide; Middle Aged; Peptides /administration & Quality-Adjusted Life Years; Venoms /administration & derivatives /therapeutic use; dosage /analogs & dosage /therapeutic use; dosage /therapeutic use; dosage /therapeutic use AccessionNumber 22012000058 Date bibliographic record published 09/03/2012 Date abstract record published 23/04/2012 |
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