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Abstract
A systematic review identified studies eliciting utility decrements from myocardial infarction (MI) and stroke in patients with Type 2 diabetes mellitus (T2DM) and examined their use in economic models of new diabetes treatments. In 16 utility studies in patients with T2DM, utility decrements in the first year ranged from 0.017 to 0.226 for MI and from 0.034 to 0.590 for stroke. Sixteen of 19 economic evaluations of new treatments for T2DM included utility decrements for an MI and/or stroke from one of the 16 utility studies. Decrements for MI ranged from 0.012 to 0.180 in the first year. Decrements for stroke ranged from 0.044 to 0.690 in the first year. Utility studies in patients with T2DM provide little information about changes in utility decrements by time since the event and by disease severity. Cost–effectiveness studies do not always indicate how these values were used in the analysis.
Financial & competing interests disclosure
This study was funded by Boehringer Ingelheim GmbH. R Palencia is an employee of Boehringer Ingelheim GmbH. At the time this research was conducted, at the time this research was conducted, V Brennan was an employee of RTI Health Solutions and B Hass was an employee of Boehringer Ingelheim GmbH. A Colosia, C Copley-Merriman and J Mauskopf are employees of RTI Health Solutions. This study was conducted by RTI Health Solutions in collaboration with Boehringer Ingelheim GmbH. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
VK Brennan and AD Colosia undertook the review. VK Brennan led the manuscript writing. J Mauskopf and C Copley-Merriman assisted with the interpretation of the studies and revised the manuscript. R Palencia and B Hass helped conceptualize, review and interpret the manuscript. All authors provided approval of the final manuscript for submission.
In 16 primary utility studies in patients with Type 2 diabetes mellitus (T2DM), utility decrements in the first year associated with myocardial infarction (MI) ranged from 0.017 to 0.226, and those associated with a stroke ranged from 0.034 to 0.590.
Only one study provided different utility decrements for stroke with and without residual effects, though three other studies included utility decrements for transient ischemic attack.
Three studies provided different regression coefficients for utility decrements in the year that the event occurred and in subsequent years, but they reached different conclusions as to the statistical significance of these changes.
Nineteen economic evaluations of new treatments included utility decrements for an MI and/or stroke in patients with T2DM.
Decrements included in the economic evaluations ranged from 0.012 to 0.180 during the year of an MI event and, where specified, from 0.000 to 0.078 in subsequent years.
Decrements included in the economic evaluations for stroke ranged from 0.044 to 0.690 in the year of the event and, where specified, from 0.000 to 0.269 in subsequent years.
Of the 19 economic evaluations, 16 used values from one of the 16 included utility-elicitation studies, but two of these 16 studies incorrectly used the regression coefficients from one of the utility-elicitation studies as marginal disutilities; three used disutilities from the US studies in patients with any type of diabetes and two used the US general population disutilities.
Observed variability in the estimated utility loss for patients experiencing a stroke or an MI may impact the estimated cost–effectiveness ratios for a treatment that reduces the rates of these events.
Economic models for patients with T2DM should include estimates of the utility associated with MI and stroke taken from high-quality studies, and should test the impact of alternative estimates of utility decrements in sensitivity analyses.