Abstract
Objectives: To assess the costs of severe hypoglycaemic events (SHEs) in diabetes patients in Germany, Spain and the UK.
Methods: Healthcare resource use was measured by surveying 639 patients aged ≥16 years, receiving insulin for type 1 (n=319) or type 2 diabetes (n=320), who experienced ≥1 SHE in the preceding year. Patients were grouped by location of SHE treatment: group 1, community (family/domestic); group 2, community (healthcare professional); group 3, hospital. Costs were calculated from published unit costs applied to estimated resource use. Costs per SHE were derived from patient numbers per subgroup. Weighted average costs were derived using a prevalence database.
Results: Hospital treatment was a major cost in all countries. In Germany and Spain, costs per SHE for type 1 patients differed from those for type 2 patients in each group. Average SHE treatment costs were higher for patients with type 2 diabetes (Germany, €533; Spain, €691; UK, €537) than type 1 diabetes patients (€441, €577 and €236, respectively). Telephone calls, visits to doctors, blood glucose monitoring and patient education contributed substantially to costs for non-hospitalised patients.
Conclusions: Treatment of SHEs adds significantly to healthcare costs. Average costs were lower for type 1 than for insulin-treated type 2 diabetes, in all three countries.
Introduction
Severe hypoglycaemia, also called major hypoglycaemia, is usually defined as an event which the patient cannot treat without external assistance. These events are invariably characterised by neuroglycopenia (deprivation of glucose to the neurones in the brain) with impairment of cognitive function, and approximately 30% of episodes of severe hypoglycaemia result in coma and seizuresCitation1. People with type 1 diabetes typically experience between 1.0 and 1.7 severe hypoglycaemic events (SHEs) per patient per yearCitation2, but whereas these events occur less frequently in people with insulin-treated type 2 diabetes, they are more common than is often appreciatedCitation3. This was demonstrated by the UK Hypoglycaemia Group Study, in which the frequency of hypoglycaemia was documented in patients with type 1 and type 2 diabetes, who had differing durations of insulin therapy. Although the annual frequency of severe hypoglycaemia was only 0.1 episodes per patient in those with insulin-treated type 2 diabetes of <2 years’ duration, it increased to 0.7 episodes per patient for those who had been on insulin for >5 years; for patients with type 1 diabetes, the corresponding annual rates were 1.1 episodes per patient in those with shorter disease duration (<5 years) and 3.2 episodes per patient in those who had had the disease for >15 yearsCitation4.
The external assistance required by a patient who experiences a SHE may be provided by a family member or friend, but in a substantial number of cases, help from emergency healthcare professionals (HCPs) is requested, and many patients need treatment in hospital. It is well accepted that the economic burden of diabetes is substantial, but studies that have examined the impact of SHEs on healthcare costs are limited in their scope. In the UK, the annual cost of hospitalisation and ambulances to treat people with severe hypoglycaemia was recently estimated to be £15 millionCitation5, which is broadly consistent with an earlier estimate based on incidence and cost burden of SHEs treated by the emergency medical services in people with type 1 and type 2 diabetes in ScotlandCitation6. In Sweden, the estimated direct and indirect costs of hypoglycaemic events in type 2 diabetes patients was €4.25 million per yearCitation7. Hypoglycaemia has been reported to account for 65.4% and 35.6% of the total direct and indirect costs of diabetes in Spain, respectivelyCitation8. The average cost of treatment of a hypoglycaemia episode is higher than or similar to the costs incurred by common diabetes-related complications such as eye disease, hyperlipidaemia, or gangreneCitation8. However, many cases of hypoglycaemia are not recorded, which makes estimation of the cost of hypoglycaemia episodes relative to overall costs of diabetes very difficult.
A survey of people with insulin-treated diabetes (types 1 and 2) in three European countries was recently reported, which examined the characteristics of patients who experienced SHEs and the resources used in the treatment of these events and their follow-up. The quantitative results of that study have been published separatelyCitation9,10. Much of the limited data available on the economic impact of SHEs presents direct costs derived from retrospective chart reviews, or assesses the costs of emergency treatment in hospitals. Few studies have incorporated the costs of home- and community-treatment relating to acute and post-SHE management (including follow-up training). Therefore, the other main objective of this survey was to gain a broader perspective of the costs incurred in managing SHEs in the three countries and how differences in their healthcare systems might influence the cost of providing acute treatment and post-event follow-up. This paper presents the results of an economic analysis of the direct (healthcare resource use) and indirect (work productivity) costs of SHE management to the society in UK, Germany, and Spain based on the resource use data from the patient survey, which have been previously presented in abstract formCitation11.
Patients and methods
Study design
The cost analysis presented in this article was based on data from a survey of 639 people with diabetes in Germany (n=214), Spain (n=224) and the UK (n=201) who were recruited predominantly by HCPs using a non-random selection process. The survey participants were aged ≥16 years, receiving insulin for type 1 diabetes (n=319) or insulin (alone or in combination with oral antidiabetic agents) for type 2 diabetes (n=320), and had experienced at least one SHE in the preceding 12 months.
Information on healthcare resources employed throughout the treatment of the SHE and in follow-up activities after the patient had fully recovered was collected by a questionnaire completed at patient interviews carried out in February and March 2007. The survey method and questionnaire are described in greater detail elsewhereCitation9,10.
In each country, patients were grouped by diabetes type (1 or 2) and further categorised according to the setting in which the SHE was managed and treated. Patients in treatment group 1 (‘Family/domestic’) were treated by a family member or friend, and had no contact with a HCP. Patients treated by a HCP were categorised either as treatment group 2 (‘Community HCP’), who received emergency treatment from a paramedic or a medical practitioner without requiring treatment in a hospital, or treatment group 3 (‘Hospital HCP’), who were treated in a hospital.
Resource utilisation and cost analysis
Both direct and indirect costs were measured in this study. Most of the resources measured were direct costs, i.e. relating both to the acute treatment (outside and inside hospital) of the patient at the time of the SHE, and to follow-up activities after the SHE had been treated, such as additional visits and calls to the patient's doctor, increased frequency of blood glucose measurements and further education in diabetes self-management to avoid future events. The indirect cost of absence from work caused by the SHE was also measured.
The consumption of healthcare resources by each patient measured in the survey was for a single SHE experienced by each patient – if a patient had experienced more than one SHE in the 12-month period, the resource consumption was measured for the most recent event.
Cost estimation
For each unit of resource consumption estimated from the survey, a cost was derived by applying unit costs (shown in ) obtained from published (including online) sources and official statistics. Costs of hospital stay, community HCPs, and use of ambulances were obtained from the appropriate local health service tariffs, the cost of drugs from national compendia or formularies, and average salary costs from national statistics offices. In some cases, extra calculations or averaging of values in the published sources was required to produce a more appropriate estimate. Where necessary, unit costs have been corrected to 2007 values to account for inflation, using the German Consumer Price Index, Spanish General Consumer Price Index, and the UK Hospital & Community Health Services Pay and Prices Index.
Table 1. Costs of all resources included in analysis in local currency. Where necessary, unit costs have been inflated to 2007 values using the German Consumer Price Index, Spanish General Price Index, and the UK Hospital & Community Health Services Pay and Prices Index.
The cost of hospital treatment in the analysis was calculated differently for the German sample and the Spanish and UK samples. In Spain and the UK, each hospital department (emergency room, intensive care unit, etc.) is charged at a separate rate, as well as a hospitalisation tariff in the UK. In Germany, a single hospitalisation tariff is charged for any treatment, regardless of which department provides it or the length of stay, and an extra €140 per patient is charged for any treatment in an accident and emergency department. The cost of blood glucose tests and other procedures and assessments carried out in hospital in all three countries is included in the tariff or the department cost.
The estimated costs for each country were calculated in local currency (euros or pounds sterling). For inter-country comparison, UK costs were converted to euros at £1.00 = €1.473. This was the average rate that applied during the 12 months before survey data were collected, i.e. the period during which the SHE was treated (Feb 2006 to March 2007).
For each country, cost data were sub-grouped by diabetes type and treatment group for analysis. The cost per SHE was calculated by dividing the total costs in each subgroup by the number of patients in the subgroup, as each patient was asked to describe resource use for only one SHE, as described above.
Derivation of average costs
To estimate the average cost per SHE for a typical person with type 1 and insulin-treated type 2 diabetes, the individual cost-per-SHE values in each treatment group were factored (weighted) according to the prevalence of the three treatment groups in the general population of diabetes patients, which was expected to vary by country and diabetes type. The actual prevalence of patients in the survey could not be used for this purpose, as the selection method used did not produce a random distribution across treatment groups. It was not possible to conduct an additional large survey and therefore frequency distributions from syndicated market research data in the 2006 RoperASW database were used for the analysis.
The RoperASW survey is performed every 2 years on diabetes patients in six European countries (Germany, France, Italy, the Netherlands, Spain and the UK). Patients screened from households selected at random complete a face-to-face questionnaire. The information collected includes whether a patient experienced a SHE in the previous 12 months, and whether or not it was treated by a healthcare professional. The final sample size in 2006 was approximately 600 patients per country.
shows how type 1 and insulin-treated type 2 diabetes patients in the RoperASW database are distributed between two categories, family/domestic treatment (corresponding to treatment group 1 of the current survey) and any HCP treatment (groups 2 and 3 of the current survey sample, combined). These prevalence values were used to perform the first factoring step. The estimated individual prevalence of patients in group 2 (community HCP) and group 3 (hospital HCP) was based on prevalence data from a survey performed in Germany specifically for that purpose [Novo Nordisk, data on file]. Data from the German survey were used as the base-case assumption for all three countries in the current analysis; for type 1 diabetes patients, the assumed base-case prevalence split for groups 2 and 3, respectively, was 50%:50%, and for type 2 diabetes patients, 35%:65%. To validate our analyses in the RoperASW database, we also performed sensitivity analyses to test the effect on the average cost per SHE of higher and lower assumed prevalence (±25 percentage points) for groups 2 and 3: for type 1 diabetes patients, 25%:75% and 75%:25% ratios were tested, and for type 2 diabetes patients, 10%:90% and 60%:40%, respectively.
Table 2. Estimates of prevalence of severe hypoglycaemic events in insulin-dependent diabetes from Roper ASW survey data.
Results
Comparison of costs by country and treatment group
All of the results described in this section relate to costs in each of the actual subgroups in the survey sample, without any weighting of data.
The direct and indirect costs (in local currency) of treating and managing SHEs in each of the three countries are shown in –, grouped by diabetes type and treatment group. shows a comparison of costs per SHE in the three countries, with UK values converted to euros for consistency. In the UK, the cost per SHE in any given treatment group was similar for type 1 and type 2 diabetes patients; in Germany and Spain, however, some differences were observed between type 1 and type 2 diabetes patients, particularly in treatment groups 1 and 2 (treatment outside hospital). The hierarchy of costs across treatment groups was also consistent from country to country (): the total cost per SHE in group 3 (hospital HCP) was between 3.5 and 8.4 times higher than in group 2 (community HCP), and between 24 and 101 times higher than in group 1 (domestic/family), depending on country and type of diabetes.
Figure 1. Treatment cost per severe hypoglycaemic event (SHE) in type 1 and type 2 diabetes patients in Germany (A), Spain (B) and the UK (C). Values are shown in euros (and in pounds sterling for the UK).
Table 3. Cost (in euros) of treatment of severe hypoglycaemic events (SHEs) in Germany, showing breakdown by treatment group and type of diabetes. Figures in parentheses are proportions (%) of the treatment group total.
Table 4. Cost (in euros) of treatment of severe hypoglycaemic events (SHEs) in Spain, showing breakdown by treatment group and type of diabetes. Figures in parentheses are proportions (%) of the treatment group total.
Table 5. Cost (in pounds sterling) of treatment of severe hypoglycaemic events (SHEs) in the UK, showing breakdown by treatment group and type of diabetes. Figures in parentheses are proportions (%) of the treatment group total.
Table 6. Comparison of total, direct and indirect costs per severe hypoglycaemic event (SHE) in each country by treatment group and type of diabetes. All values shown in euros (values for UK converted from those in at £1.00 = €1.473).
For patients in treatment group 1, who were treated without the help of a HCP, the actual costs of treating the SHE were minimal. The largest contributor to costs (54–96% depending on country and type of diabetes) being follow-up activities after the event, i.e. calls and visits to primary care physician (PCP), increased frequency of glucose testing, and further education about managing diabetes. For patients in group 2 (community HCP), the main cost item was HCP attendance (with or without ambulance attendance), which accounted for 58–77% of costs (data not shown); however, post-event follow-up activities also contributed substantially (24–34%) to overall costs in this treatment group in Spain and the UK. In treatment group 3 (hospital HCP), the costs of hospital treatment far outweighed all other costs, but it was notable that direct treatment costs outside hospital incurred by patients in the hospital HCP group were fairly similar to those incurred by patients in the community HCP group. Hospital costs per patient were higher in Germany than in Spain or the UK, resulting in a large disparity between these countries in the cost per SHE in treatment group 3; the values in Germany (€3,298 and €3,023 for types 1 and 2 diabetes, respectively) were more than twice those in Spain and the UK (see –). The costs of dextrose, glucagon and other agents used to reverse hypoglycaemia contributed very little to total costs, even in patients who are treated without any assistance from HCPs (data not shown).
Indirect costs (absence from work) accounted for only 2–5% of the total cost of those patients treated in hospital in all countries (treatment group 3; see –). However, as total costs for SHEs treated outside hospital were much less than in group 3, absence from work costs made a larger relative contribution. This was particularly notable in Germany, where absence from work costs represented 41% of total costs for type 1 and type 2 diabetes patients in treatment group 1, and 31% of total costs for type 1 diabetes patients in treatment group 2.
As shown in –, some disparity was observed between countries in the cost per SHE for patients who were not treated in hospital (treatment groups 1 and 2). This was particularly marked for type 1 diabetes patients, for whom the estimated costs per SHE in Germany (€52 and €489 in groups 1 and 2, respectively) were substantially higher than those in Spain (€32 and €274). In type 2 diabetes patients, close similarities in cost per SHE were documented across all three countries for treatment group 2.
Estimation of the average treatment cost per severe hypoglycaemic event
Cost values described in this section were weighted according to assumptions about the prevalence of patients in each treatment group, as described previously (see Methods). The average cost per SHE for a typical patient with type 1 or insulin-treated type 2 diabetes are shown in . Estimated average treatment costs per SHE for a type 2 diabetes patient were higher than those for a type 1 diabetes patient in all three countries. The difference between type 1 and type 2 diabetes patients was particularly large in the UK (€236 and €537, respectively), because the weighting factors from the RoperASW prevalence data show a greater bias towards HCP treatment (i.e., treatment groups 2 or 3) in patients with type 2 diabetes than in patients with type 1 diabetes (see ). This contrasts with Germany and Spain, where the probability of needing HCP treatment is very similar for type 1 and type 2 diabetes patients (see prevalence assumptions in ), resulting in a less marked difference in treatment costs (respectively: Germany, €441 and €533; Spain, €577 and €691).
Table 7. Estimated average cost per severe hypoglycaemic event (SHE) in each country (all values in euros). Estimates for an average type 1 and type 2 diabetes patient were derived by weighting the cost for each treatment group using prevalence data from other surveys. Scenarios A and B show the effect on estimate of altering the prevalence split in treatment groups 2 and 3 from the base case (see text). Values for UK converted from those in at £1.00 = €1.473.
Because of the large differences in the cost per SHE between patients needing community HCP treatment (group 2) and those needing hospital treatment (group 3), the average cost per SHE changed considerably when calculated using different prevalence values, as shown in . For example, in the most pessimistic scenario for type 2 diabetes patients, in which 90% of HCP-treated patients are treated in hospital, the cost per SHE ranged from €664 to €857.
Discussion
In all three of the countries in our survey, the estimated cost of treatment and follow-up for a SHE affecting a patient with insulin-treated type 2 diabetes was greater than that for a patient with type 1 diabetes, with values ranging from €533 (Germany) to €691 (Spain) for the average patient with type 2 diabetes, and from €236 (UK) to €577 (Spain) for the average patient with type 1 diabetes. The wider cost range for type 1 diabetes patients results from the difference in treatment patterns for type 1 and insulin-treated type 2 diabetes patients in the UK, where the prevalence data that were used to derive average costs for the general population of people with type 1 or type 2 diabetes showed that the probability of SHEs being treated by a HCP is much greater for a patient with type 2 diabetes (53%) than for one with type 1 diabetes (23%). Thus, we can hypothesise that patients with type 1 diabetes have a higher annual utilisation of resources due to more frequent SHEs, but at a lower cost per event. This, we speculate, may reflect greater experience of patients with type 1 diabetes in dealing with a SHE and, being of younger age, may also be attributed to a lower likelihood of the requirement for multi-drug treatment regimes and the presence of fewer comorbidities or complication that would be likely to increase hospital resource use. The differences in prevalence data also account for Spain having the highest average cost per SHE for type 1 and type 2 diabetes patients despite hospital costs per SHE being less than half those in Germany. Our estimated average cost per SHE for type 1 diabetes patients in Spain is substantially higher than the value of €366 reported in a recent studyCitation8. This is surprising given that the indirect costs per SHE in that study were much higher than in our study, viz. €127 (35% of the total), and a higher proportion of patients received hospital treatment. Their data were highly skewed, however, with 88% of the sample having lower costs than the meanCitation8.
For SHEs that required hospitalisation, the estimated cost per event was €3,023–3,298 in Germany, but only about €1,400 in Spain and roughly €1,300 in the UK. The higher hospitalisation costs in Germany may reflect differences in national healthcare systems. Unlike Spain and the UK, Germany operates a statutory healthcare insurance scheme in which all hospitalisation costs are reimbursed by insurance plans. This may mean that there is less incentive to discharge patients quickly after a SHE in Germany than there is in Spain and the UK. Longer hospital stay could potentially have benefits; giving time to adjust therapy and improve education, but such evaluations were beyond the scope of this study. The German estimate is a little lower than that found in a study of type 2 diabetes patients in Sweden, which reported total costs of €3,918 per severe event treated in hospital, comprising direct costs of €2,807 and indirect costs (lost productivity) of €1,111Citation7.
For the groups of patients who receive treatment for SHEs outside hospital, ambulance use and on-the-spot treatment are the major contributors to cost; however, the cost of follow-up treatment for these patients is also substantial. Although the cost of medical follow-up in the days and weeks after a hypoglycaemic event is not normally included in calculations of treatment costs, our analysis shows it to be the dominant cost element for patients treated in the family/domestic setting, and in Spain and the UK, it accounts for between a quarter and a third of the total cost in patients treated by a community HCP.
For patients experiencing SHEs that require hospital treatment, hospital costs far outweigh all other costs. Although the RoperASW survey data indicate that the majority of patients in the three countries surveyed are treated in the community, hospital treatment is much more expensive than other sites of treatment and adds significantly to the average cost in all countries. In our analysis, each SHE treated in hospital cost up to 8.4 times more than one treated by HCPs in the community, and as much as 100 times the cost of a SHE treated with no HCP help at all. These findings agree closely with those of a Swedish study in type 2 diabetes patients, which found that hypoglycaemic events treated in hospitals cost roughly 10 times more than those treated in the communityCitation7. In an earlier study in Tayside, UK, roughly 54% of the emergency treatment costs for severe hypoglycaemia were on hospital careCitation6. The quantitative analysis originally performed on the surveyCitation9,10 showed that the prevalence of impaired hypoglycaemia awareness was higher in patients requiring HCP treatment than in those in the family/domestic group. This suggests that training patients to recognise and treat the early symptoms of hypoglycaemia could help to reduce the average cost of treating SHEs by avoiding the need for more expensive treatment interventions.
The indirect cost that was measured in the analysis (absence from work) was only a significant contributor to total costs in patients for whom direct costs of treatment were small, e.g. those treated in the family/domestic setting (treatment group 1). Even so, differences were evident between the three countries. In treatment group 1, absence from work in Germany was more than four times as expensive (relative to total costs) as in Spain, and also more expensive than in the UK; this results from a higher absence rate in Germany, since the hourly German salary rate used in our model (€20.74) was only twice that in Spain (€10.67) and not much higher than in the UK (€17.56). Absence from work was measured only for patients – no financial value was applied to the time taken by family or friends to assist and treat patients in the domestic setting, or to the negative effects on health utility, mainly for the patient but also for family members, associated with fear of future SHEs. The fear of future SHEs in patients with previous experience of severe hypoglycaemia has a detrimental effect on their quality of life, as well as reducing productivityCitation12–14, and also influenced patients’ self-management and quality of metabolic controlCitation15.
Although the present cost analysis was performed using relatively small numbers of patients, comparison of data from three countries with different health and cultural systems added extra value to the findings. The use of prevalence data from other surveys allowed us to estimate a weighted average cost for each country, facilitating comparison between countries and giving a broader illustration of the impact of SHEs on typical treatment costs for patients with type 1 and type 2 diabetes. Moreover, our average cost estimate included patients who had been treated in the family/domestic setting, where a lower estimate would be expected than analyses that consider only events that are treated by HCPs. However, there is uncertainty about the accuracy of the prevalence estimates that we used in the present study, and as shown in the limited sensitivity analysis we performed, the variance in the number of patients who require hospital HCP treatment has a notable effect on the average treatment cost per event in all countries.
As mentioned previously, the selection method used to enrol patients into the survey did not produce a random distribution across treatment groups. This might have biased selection in favour of patients with a more organised approach to disease management, therefore underestimating the true cost of treating SHEs in these countries. Because patients who have had SHEs (particularly events treated in hospitals) were very difficult to find using randomised telephone screening, a targeted search for these patients through primary care centres was necessary. This enabled us to recruit sufficient patients in each treatment group to make a meaningful comparison, but also meant that we had to adjust our results using Roper survey data to produce an estimate of average costs for type 1 and type 2 diabetes patients in everyday practice.
Conclusion
In conclusion, SHEs experienced by people with type 1 or type 2 diabetes impose considerable demands on healthcare budgets, particularly SHEs that are sufficiently severe as to require hospitalisation. Patient training and treatment of the early symptoms of hypoglycaemia may reduce the higher costs incurred by the use of more expensive treatments to manage SHEs and also prevent the occurrence of further SHEs. Although differences exist between healthcare systems in the three countries surveyed in this analysis, there were clear similarities in the cost of treating a SHE in the average type 2 diabetes patient. Average costs were lower for type 1 than for insulin-treated type 2 diabetes, but for the average patient with type 1 diabetes, the treatment cost in Germany and Spain was approximately double that of the UK. Further studies are warranted to examine the factors determining differences in the cost of SHEs in patients with type 1 and 2 diabetes.
Acknowledgements
Declarations of interest: Financial support for this study was provided by Novo Nordisk A/S (Denmark). M.L. and M.H. are employees of, and shareholders in, Novo Nordisk. B.M.F. and W.K. have served as members of medical advisory boards for Novo Nordisk. The publication was supported by Novo Nordisk A/S (Denmark) with editorial assistance from ESP Bioscience (Sandhurst, UK). The authors are wholly responsible for the study design, analysis and scientific evaluation.
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