original article
original article
Diabetes, Obesity and Metabolism 16: 366–375, 2014. © 2014 John Wiley & Sons Ltd
Cost-effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin – from the UK health care cost perspective M. Evans1 , M. Wolden2 , J. Gundgaard3 , B. Chubb4 & T. Christensen2 1 University Hospital Llandough, Cardiff, UK 2 Value Communication & Global Marketing, Novo Nordisk A/S, Søborg, Denmark 3 Health Economics & HTA, Novo Nordisk A/S, Søborg, Denmark 4 Health Economics & Outcomes Research - EU, Novo Nordisk Ltd, Crawley, UK
Aims: The aim of this analysis was to evaluate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine (IGlar) in adults with type 2 diabetes mellitus (T2DM) who are considered appropriate for treatment with a basal insulin analogue, using a short-term economic model. Methods: Meta-analysis data from three phase III clinical studies were used to populate a simple and transparent short-term model. The costs and effects of treatment with IDeg versus IGlar were calculated over a 12-month period. The analysis was conducted from the perspective of the UK National Health Service. Sensitivity analyses were conducted to assess the degree of uncertainty surrounding the results. Results: IDeg is a cost-effective treatment option versus IGlar in patients with T2DM using basal insulin. Base case incremental costeffectiveness ratios (ICERs) were estimated at £15 795 per quality-adjusted life-year (QALY) and £13 078 per QALY, which are below commonly accepted thresholds for cost-effectiveness. Sensitivity analyses demonstrated that hypoglycaemia event rates had an important effect on the results. With higher event rates for non-severe hypoglycaemia IDeg was less costly and more effective than IGlar (dominant). Conversely, using lower event rates for severe hypoglycaemia generated higher ICERs. Using hypoglycaemia rates from a subgroup of patients who experienced ≥1 hypoglycaemic event per year IDeg was highly cost-effective versus IGlar; with estimated ICERS of £4887 and £2625 per QALY. Conclusions: This short-term modelling approach allows the economic evaluation of newer insulin analogues when advanced long-term modelling based on HbA1c differences is inappropriate. For patients with T2DM who are considered appropriate for treatment with a basal insulin analogue, IDeg is a cost-effective treatment option compared with IGlar and offers additional benefits to subgroups of patients, such as those suffering from recurrent hypoglycaemia. Keywords: cost-effectiveness, insulin analogues, insulin therapy, pharmaco-economics, type 2 diabetes Date submitted 5 July 2013; date of first decision 27 August 2013; date of final acceptance 12 December 2013
Introduction The prevalence of type 2 diabetes mellitus (T2DM) and associated diabetes-related health problems continue to rise, posing a significant economic burden to the health care system [1]. For patients with T2DM the consequences of failing to maintain glycaemic control are substantial, with an increased risk of diabetes-related complications and a reduction in health-related quality of life (HRQoL) [2,3]. Good glycaemic control through timely and intensive diabetes therapy delays or prevents microvascular complications, and reduces cardiovascular and all-cause mortality [4,5]. T2DM is a progressive disease, requiring therapy intensification in association with disease progression [6]. In an era of increasing therapy choice and reducing health care resources, treatment choice based on optimum value for money is increasingly important. Correspondence to: Dr Marc Evans, University Hospital Llandough, Cardiff, UK. E-mail: [email protected]
Ultimately many patients with T2DM require insulin to maintain adequate haemoglobin A1c (HbA1c) levels [7]. Fear of hypoglycaemia, weight gain and inflexible timing of insulin doses are, however, recognized barriers to the initiation and intensification of insulin therapy [8,9]. Hypoglycaemia has a major impact on a patient’s life in terms of physical, mental and social functioning. It also poses a substantial cost burden to the community through increased treatment costs and reduced productivity [10–12]. Current basal insulin analogues such as insulin glargine (IGlar) have an improved time action profile compared with neutral protamine Hagedorn (NPH) insulin, resulting in a reduced potential for hypoglycaemia [13]. Thus, long-acting insulin analogues are recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of patients with T2DM whose lifestyle is restricted by recurrent hypoglycaemic episodes [14]. However, there remains an unmet need for further refinements in insulin pharmacology, with the goal of reducing hypoglycaemia risk.
original article
DIABETES, OBESITY AND METABOLISM
Insulin degludec (IDeg) is a basal insulin analogue with an ultra-long duration of action and a distinct, slow absorption mechanism which results in a flat and stable action profile. Upon subcutaneous injection IDeg forms multi-hexamers, resulting in a soluble depot from which it is slowly and continuously absorbed into the circulation, contributing to significantly lower blood glucose variations compared with IGlar [15–17]. The efficacy and safety of IDeg versus IGlar in adults with T2DM starting insulin therapy were investigated in three phase III, open label, treat-to-target trials [18–20]. Data from the three trials were pooled in a series of meta-analyses, which demonstrated that similar glycaemic control (non-inferior) was achieved with IDeg with a significantly lower rate of both severe hypoglycaemia (86% lower) and non-severe nocturnal hypoglycaemia (36% lower) [21] and a 10% lower daily insulin dose (dose ratio 0.9), compared with IGlar. Severe hypoglycaemic events are defined as those requiring third party assistance, and non-severe events are events with a plasma glucose reading of
original article
Diabetes, Obesity and Metabolism 16: 366–375, 2014. © 2014 John Wiley & Sons Ltd
Cost-effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin – from the UK health care cost perspective M. Evans1 , M. Wolden2 , J. Gundgaard3 , B. Chubb4 & T. Christensen2 1 University Hospital Llandough, Cardiff, UK 2 Value Communication & Global Marketing, Novo Nordisk A/S, Søborg, Denmark 3 Health Economics & HTA, Novo Nordisk A/S, Søborg, Denmark 4 Health Economics & Outcomes Research - EU, Novo Nordisk Ltd, Crawley, UK
Aims: The aim of this analysis was to evaluate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine (IGlar) in adults with type 2 diabetes mellitus (T2DM) who are considered appropriate for treatment with a basal insulin analogue, using a short-term economic model. Methods: Meta-analysis data from three phase III clinical studies were used to populate a simple and transparent short-term model. The costs and effects of treatment with IDeg versus IGlar were calculated over a 12-month period. The analysis was conducted from the perspective of the UK National Health Service. Sensitivity analyses were conducted to assess the degree of uncertainty surrounding the results. Results: IDeg is a cost-effective treatment option versus IGlar in patients with T2DM using basal insulin. Base case incremental costeffectiveness ratios (ICERs) were estimated at £15 795 per quality-adjusted life-year (QALY) and £13 078 per QALY, which are below commonly accepted thresholds for cost-effectiveness. Sensitivity analyses demonstrated that hypoglycaemia event rates had an important effect on the results. With higher event rates for non-severe hypoglycaemia IDeg was less costly and more effective than IGlar (dominant). Conversely, using lower event rates for severe hypoglycaemia generated higher ICERs. Using hypoglycaemia rates from a subgroup of patients who experienced ≥1 hypoglycaemic event per year IDeg was highly cost-effective versus IGlar; with estimated ICERS of £4887 and £2625 per QALY. Conclusions: This short-term modelling approach allows the economic evaluation of newer insulin analogues when advanced long-term modelling based on HbA1c differences is inappropriate. For patients with T2DM who are considered appropriate for treatment with a basal insulin analogue, IDeg is a cost-effective treatment option compared with IGlar and offers additional benefits to subgroups of patients, such as those suffering from recurrent hypoglycaemia. Keywords: cost-effectiveness, insulin analogues, insulin therapy, pharmaco-economics, type 2 diabetes Date submitted 5 July 2013; date of first decision 27 August 2013; date of final acceptance 12 December 2013
Introduction The prevalence of type 2 diabetes mellitus (T2DM) and associated diabetes-related health problems continue to rise, posing a significant economic burden to the health care system [1]. For patients with T2DM the consequences of failing to maintain glycaemic control are substantial, with an increased risk of diabetes-related complications and a reduction in health-related quality of life (HRQoL) [2,3]. Good glycaemic control through timely and intensive diabetes therapy delays or prevents microvascular complications, and reduces cardiovascular and all-cause mortality [4,5]. T2DM is a progressive disease, requiring therapy intensification in association with disease progression [6]. In an era of increasing therapy choice and reducing health care resources, treatment choice based on optimum value for money is increasingly important. Correspondence to: Dr Marc Evans, University Hospital Llandough, Cardiff, UK. E-mail: [email protected]
Ultimately many patients with T2DM require insulin to maintain adequate haemoglobin A1c (HbA1c) levels [7]. Fear of hypoglycaemia, weight gain and inflexible timing of insulin doses are, however, recognized barriers to the initiation and intensification of insulin therapy [8,9]. Hypoglycaemia has a major impact on a patient’s life in terms of physical, mental and social functioning. It also poses a substantial cost burden to the community through increased treatment costs and reduced productivity [10–12]. Current basal insulin analogues such as insulin glargine (IGlar) have an improved time action profile compared with neutral protamine Hagedorn (NPH) insulin, resulting in a reduced potential for hypoglycaemia [13]. Thus, long-acting insulin analogues are recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of patients with T2DM whose lifestyle is restricted by recurrent hypoglycaemic episodes [14]. However, there remains an unmet need for further refinements in insulin pharmacology, with the goal of reducing hypoglycaemia risk.
original article
DIABETES, OBESITY AND METABOLISM
Insulin degludec (IDeg) is a basal insulin analogue with an ultra-long duration of action and a distinct, slow absorption mechanism which results in a flat and stable action profile. Upon subcutaneous injection IDeg forms multi-hexamers, resulting in a soluble depot from which it is slowly and continuously absorbed into the circulation, contributing to significantly lower blood glucose variations compared with IGlar [15–17]. The efficacy and safety of IDeg versus IGlar in adults with T2DM starting insulin therapy were investigated in three phase III, open label, treat-to-target trials [18–20]. Data from the three trials were pooled in a series of meta-analyses, which demonstrated that similar glycaemic control (non-inferior) was achieved with IDeg with a significantly lower rate of both severe hypoglycaemia (86% lower) and non-severe nocturnal hypoglycaemia (36% lower) [21] and a 10% lower daily insulin dose (dose ratio 0.9), compared with IGlar. Severe hypoglycaemic events are defined as those requiring third party assistance, and non-severe events are events with a plasma glucose reading of
