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. 2016 Sep 15;11(9):e0162441.
doi: 10.1371/journal.pone.0162441. eCollection 2016.

The Health Economic Value of Changes in Glycaemic Control, Weight and Rates of Hypoglycaemia in Type 1 Diabetes Mellitus

Phil McEwan  1 , Hayley Bennett  1 , Jonathan Fellows  1 , Jennifer Priaulx  2 , Klas Bergenheim  3
Affiliations

The Health Economic Value of Changes in Glycaemic Control, Weight and Rates of Hypoglycaemia in Type 1 Diabetes Mellitus

Phil McEwan et al. PLoS One. .

Abstract

Aims: Therapy-related consequences of treatment for type 1 diabetes mellitus (T1DM), such as weight gain and hypoglycaemia, act as a barrier to attaining optimal glycaemic control, indirectly influencing the incidence of vascular complications and associated morbidity and mortality. This study quantifies the individual and combined contribution of changes in hypoglycaemia frequency, weight and HbA1c to predicted quality-adjusted life-years (QALYs) within a T1DM population.

Materials and methods: We describe the Cardiff Type 1 Diabetes (CT1DM) Model, originally informed by the Diabetes Control and Complications Trial (DCCT) and updated with the Epidemiology of Diabetes Interventions and Complications (EDIC) study and Swedish National Diabetes Registry for microvascular and cardiovascular complications respectively. We report model validation results and the QALY impact of HbA1c, weight and hypoglycaemia changes.

Results: Validation results demonstrated coefficients of determination for clinical endpoints of R2 = 0.863 (internal R2 = 0.999; external R2 = 0.823), costs R2 = 0.980 and QALYs R2 = 0.951. Achieving and maintaining a 1% HbA1c reduction was estimated to provide 0.61 additional discounted QALYs. Weight changes of ±1kg, ±2kg or ±3kg led to discounted QALY changes of ±0.03, ±0.07 and ±0.10 respectively, while modifying hypoglycaemia frequency by -10%, -20% or -30% resulted in changes of -0.05, -0.11 and -0.17. The differences in discounted costs, life-years and QALYs associated with HbA1c 6% versus 10% were -£19,037, 2.49 and 2.35 respectively.

Conclusions: Using a model updated with contemporary epidemiological data, this study presents an outcome-focused perspective to assessing the health economic consequences of differing levels of glycaemic control in T1DM with and without weight and hypoglycaemia effects.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: PM, HB and JF are employed by HEOR Ltd., which received funding support in the form of a grant from AstraZeneca plc. The funding agreement ensured PM, HB and JF's independence in designing the study, interpreting the data, writing, and publishing the report. Authors JP and KB are employed by AstraZeneca. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow diagram of the Cardiff Type 1 Diabetes Model simulation process.
Fig 2
Fig 2. Model validation.
Observed versus predicted validation endpoints (internal and external) and validation to published T1DM model output (costs and quality adjusted life years). Overall validation coefficient of determination for clinical endpoints, R2 = 0.863; internal R2 = 0.999; external R2 = 0.823; total costs R2 = 0.979; total QALYs R2 = 0.951.
Fig 3
Fig 3. Weight and hypoglycaemia QALY plot.
Assessing the impact of changes in weight and rates of hypoglycaemia events on per-patient lifetime quality-adjusted life year (QALY) difference. The reference point relates to a 1% reduction in HbA1c (%) with no associated changes in weight or hypoglycaemia, which was associated with a predicted QALY gains of 0.99. This figure illustrates the relative impact of weight change ±3 kg and hypoglycaemia changes ±30% on the QALY gained, beyond those already seen with the reference point.
Fig 4
Fig 4. Health economic value associated with various levels of glucose control.
Assessing the impact of unit (%) changes in HbA1c on per-patient cost savings, QALY gains and health economic value (defined as the amount of additional spend (£) justified to obtain the additional QALY gain predicted for each unit reduction in HbA1c at a willingness-to-pay threshold of £20, 000.
See this image and copyright information in PMC

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