Pharmaco-economic issues for diabetes therapy

doi:10.1016/j.beem.2007.08.002

Best Practice & Research Clinical Endocrinology & Metabolism

Volume 21, Issue 4, December 2007, Pages 657-685

https://doi.org/10.1016/j.beem.2007.08.002 Get rights and content

A systematic review was undertaken to analyse pharmaco-economic issues in diabetes, with evidence selected on the basis of relevance and immediacy. Pharmaco-economics in diabetes primarily relates to making choices about antidiabetic pharmaceuticals, and this is being influenced by global trends. Trends include increasing numbers of patients with diabetes, with increasing costs of caring for people with diabetes, and an ever-present focus on the costs of pharmaceuticals which are predicted to increase as the pace of development of new medications parallels the increasing incidence of the condition. These developments have influenced the demand for health care in diabetes in the last decade, and will continue to determine this in the coming decade. Recent national experiences are cited to illustrate current issues and to focus specifically upon the challenges facing a raft of new diabetes treatment options now hitting the marketplace, although supported by fewer completed long-term trials. It can be anticipated that these newer agents will be appraised for their cost-effectiveness or value for money. Economic analyses for some of the new technologies are summarized; in general, the peer-reviewed publications using well-accepted and validated models have reported that these technologies are cost-effective. Endorsement of any technology in a national setting is not awarded simply because the incremental cost-effectiveness ratio (ICER) falls below the threshold regarded as value for money. In most national observations the reviewers expressed concerns about assumptions used in economic modelling which resulted in the ICERs being deemed optimistic at best, generally highly uncertain, and resulting in the cost-effectiveness appearing better than it really would be in clinical practice. This has often led to the authorities concluding that the price advantage of new technologies over comparators could not be justified, essentially leading to restrictions in use compared to their licence. In general, a paucity of robust evidence on longer-term outcome data together with a lack of health-related quality of life (HRQOL) data collected in a reliable manner in appropriate patients and amenable to utility (and hence quality adjusted life year or QALY) estimation have resulted in problems for these new drugs at the so-called fourth (cost-effectiveness) hurdle. In the light of these findings, the implications for generating credible fit-for-purpose cost-effectiveness analyses of new technologies in diabetes are discussed. Throughout this chapter, the interested reader is referred to a number of excellent review articles for further details.

Section snippets

Increasing numbers of people with diabetes and ‘pre-diabetes’

The last decade has seen a meteoric rise in the incidence and prevalence of diabetes worldwide.⁴ In the USA, from 1995 through 2005 the numbers diagnosed with diabetes increased from 8 to 15.8 million⁵; including undiagnosed cases, this is estimated to exceed 20 million people or 7% of the population⁶, and this trend is set to continue. Type-2 diabetes accounts for over 90% of cases of diagnosed diabetes, and is associated with older age, obesity, physical inactivity and race/ethnicity.⁷ The

Increasing societal burden of diabetes and ‘pre-diabetes’

The socioeconomic consequences of diabetes and ‘pre-diabetes’ are huge.9, *12 People with type-2 diabetes can anticipate a life expectancy shortened by 10 years compared with the general population, due mainly to an increased risk of cardiovascular (CV) death, myocardial infarction (MI) or stroke.13, 14 Type-2 diabetes has been defined as a state at risk of premature CV death associated with hyperglycaemia and microvascular disease¹⁵, because more than 65% of deaths are from CV causes.¹⁶ The

Impact of treatment options on complications and cost

The aim of treating type-2 diabetes is to delay or prevent the complications, and it is well known that improving glycaemic control and associated CV risk factors substantially reduces the risk39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 and associated costs51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 of long-term complications. Importantly, treatment of risk factors has been associated with a positive impact on HRQOL in newly diagnosed patients19, 66 as well as people with more

Pharmaco-economics and type-2 diabetes

The growing interest in the optimal allocation of health-care funding in prevention of type-2 diabetes and its complications is reflected in four reviews of economic evaluations in diabetes. The first three had different perspectives and inclusion criteria and spanned different periods.*27, *84, *85 The latest systematic review⁸⁶ focused on studies concerning the more costly macrovascular complications and drew a number of conclusions in terms of efficient use of health-are expenditure (see

Increased choice: new treatment options in diabetes

Metformin and sulphonylurea as monotherapy or combination therapy have tended to be the mainstay of first- and second-line therapy in type-2 diabetes, although some clinicians are increasingly advocating use of at least two drugs to obviate the monotherapy failure that accompanies long-term metformin in most patients. Stringent glycaemic control is important to the management of type-2 diabetes; reducing HbA_1c levels down to the normal range is considered the Holy Grail of diabetes treatment.*7

Cost-effectiveness of newer technologies for diabetes

This chapter concentrates on the newer (more expensive) classes of drugs with economic analyses in type-1 and type-2 diabetes, summarized in Table 2, Table 3, respectively. We have identified recent evidence relating to long-acting insulin analogues, inhaled insulins (Exubera^®), incretins (exenatide, Byetta^®) and rimonabant (Acomplia^®). The appearance of these newer medicines is not yet supported with longer-term clinical trials, and the published economic literature to support these

Increasing scrutiny of the cost-effectiveness of diabetes treatments

There are increasing demands by decision-makers in different countries, particularly in the Health Technology Assessment (HTA) arena, to justify the cost-effectiveness of new and existing technologies in health care in real-world settings (Figure 1). In order to make funding or reimbursement decisions, payers or national agencies such as the National Institute for Health and Clinical Excellence (NICE) require robust and relevant outcome data, including HRQOL and costs to address patient

Clinical guidelines in type-2 diabetes will increase medication use

Over the coming decade, cost containment pressures will increase (Figure 1), and emerging evidence will continue to influence the pharmaco-economics of diabetes. In relation to cost-effective prescribing, the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guideline recommended⁷: (1) lipid-lowering treatment provides a cost-effective way of preventing complications; and (2) tight control of hypertension is cost-effective. These findings resonate with

Significant increasing spend on medicines to treat diabetes predicted

US spending on diabetes treatments could soar by 70% from 2007 through 2009 due to rising obesity, an aging population, increasing prevalence of diabetes, more aggressive treatment of diabetes, and a pipeline of new (and more costly) treatment options.¹³⁶ During 2006, diabetes treatments were the second largest contributor to prescription drug spends, trailing only cholesterol-reducing drugs. Increased usage was largely driven by expansion of the treatment population rather than intensive

Pharmaco-economic issues to address in future appraisals

Endorsement of any technology is not awarded simply because the ICER falls below the threshold for cost-effectiveness. Common problems identified in the pharmaco-economic literature for diabetes (and other disease areas) and HTA experiences are summarized in Table 4.

A paucity of robust evidence on relevant longer-term outcomes measures, together with a lack of HRQOL data collected in a reliable manner in appropriate patients and amenable to utility (and hence QALY) estimation, have resulted in

Generating and interpreting the right clinical evidence?

To be fit for purpose, relevant RCTs available in a timely fashion and reflecting clinical practice must include HRQOL tools such as the EQ-5D which translate into utility and QALY gain associated with the technology in question. The RCT is the gold standard source of quality clinical evidence¹³⁷ and recommended to populate models.¹³⁸ However, the relevance of the RCT as a source of clinical efficacy has been challenged¹³⁹, largely because the question posed is not the goal of the economic

Geographical and ethnic generalizability of cost-effectiveness data

Decision-takers are aware of national variations in terms of medical resource utilization and clinical outcomes, and are increasingly enquiring of the implications of this.145, 146, 147 Trial-wide cost-effectiveness results may not be directly applicable to any of the countries collaborating in a multinational study. In addition, study variability may arise from differences in baseline event rates, costs and utility.¹⁴⁸ The importance of accounting for between-country differences in tailoring

Summary

The last decade has witnessed a markedly increased prevalence of diabetes with increased associated costs. Many trials with different endpoints complicate comparisons between therapies. Pharmaco-economics is now at the leading edge in terms of securing the most efficient use of precious health-care resources in diabetes. Recent relevant trends report rapid growth of national drugs expenditure, an environment in which the cost control mechanisms are anticipated to intensify, and where scrutiny

Acknowledgements

The authors thank Beata Kloska BSc (Hons) MSc, MCLIP, Information Specialist, Library Services, Royal Society of Medicine, London, W1G 0AE, UK for her assistance with literature searches.

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Cited by (27)

Effects of low-carbohydrate diet and ketogenic diet on glucose and lipid metabolism in type 2 diabetic mice
2021, Nutrition
Citation Excerpt :
In all, 90% of diabetes is type 2 diabetes mellitus (T2DM), which is characterized by hyperglycemia and insulin resistance (IR). T2DM brings many complications in the long term, so it's no exaggeration to say that diabetes shortens people's life span by ≥10 years [3]. With the significant health and economic burdens, it is clear that prevention and intervention of T2DM are urgently needed.
With the prevalence of diabetes worldwide, it is urgent to find a suitable treatment. Recently, the ketogenic diet has shown beneficial effects in reducing blood glucose, but some concerns have been raised about its probable side effects, such as hyperlipidemia and hepatic steatosis. Because a low-carbohydrate diet replaces part of the fat with carbohydrates on the basis of the ketogenic diet, we would like to know whether it does better in treating type 2 diabetes. The aim of this study was to explore the possibility of a low-carbohydrate diet as a substitute for a ketogenic diet intervention in mice with type 2 diabetes.
C57 BL/6 J mice with type 2 diabetes, constructed by a high-fat diet combined with streptozotocin, were fed a standard diet, a high-fat diet, a low-carbohydrate diet, or a ketogenic diet for 14 wk, respectively. Then glucose and insulin tolerance tests were conducted. At the end of the study, blood and liver samples were collected and analyzed for serum biochemical indicators, histopathologic evaluation, hepatic lipid and glycogen content, and expression levels of mRNA and protein.
Reduced blood glucose could be observed in both low-carbohydrate and ketogenic diets, as well as improvement in glucose tolerance and insulin sensitivity. However, the ketogenic diet decreased liver glycogen content and promoted gluconeogenesis. Mechanistically, this effect was due to inhibition of phosphorylated AMP-activated protein kinase, which could be improved by a low-carbohydrate diet. Regarding lipid metabolism, the ketogenic diet increased lipid oxidation and reduced de novo lipogenesis, but the hepatic lipid content still inevitably increased. On the contrary, the low-carbohydrate diet reduced triacylglycerols and markers of liver damage.
Collectively, these findings suggest that both diets are effective in lowering blood glucose, improving glucose tolerance, and raising insulin sensitivity. Moreover, the low-carbohydrate diet plays a role in inhibiting hepatic gluconeogenesis and improving lipid metabolism. The results suggest that the two diets have different effects on glucose and lipid metabolism, and that the low-carbohydrate diet might have more benefits in the treatment of type 2 diabetes mellitus.
Direct health care costs in patients with type 2 diabetes mellitus six months after starting insulin treatment in Spain: The INSTIGATE Study
2011, Endocrinologia y Nutricion
El estudio INSTIGATE tuvo como objetivo evaluar los costes directos sanitarios incurridos por pacientes con diabetes mellitus tipo-2 (DM2) que inician insulinoterapia en España. Es un estudio observacional, no intervencionista, prospectivo y multicéntrico.
Se valoraron los costes directos por paciente, según la práctica clínica habitual, durante un período de 6 meses antes y después del inicio de la insulinoterapia. En total se evaluaron 188 pacientes (42,6% mujeres) con una edad media de 65,3 años, un índice de masa corporal medio de 29,7 kg/m² y una duración media de la enfermedad de 10,7 años.
Antes de iniciar la insulinoterapia, la media (desviación estándar) de las variables clínicas fueron: % de hemoglobina-A_1c 9,22 (1,58); glucosa plasmática en ayunas (mmol/L) 12,03 (3,62), y colesterol total (mmol/L) 4,90 (1,1). La media del total de los costes directos sanitarios por paciente 6 meses antes y después de iniciar el tratamiento con insulina fue de 639€ y 1.110€ respectivamente. Los costes medios totales a los 6 meses del inicio de la insulinoterapia comprendieron: costes de ingresos hospitalarios (30,5%; 339€), insulina (16,2%; 180€), asistencia en servicios de atención primaria (14,3%; 159€), monitorización de glucosa en sangre (13,8%; 153€), asistencia por parte de especialistas (13,3%; 148€), antidiabéticos orales (7,8%; 87€) y otros tratamientos relacionados con la diabetes (3,9%; 43€).
Los resultados clínicos de este grupo de pacientes con DM2 mejoraron tras iniciar terapia con insulina. Esta mejoría se acompañó de aumentos en la utilización de recursos y de costes directos sanitarios durante los 6 primeros meses de insulinoterapia.
The INSTIGATE study was designed to assess direct health care costs incurred by patients with type 2 diabetes mellitus (T2DM) who start insulin therapy in Spain. It was a multicenter, observational, non-interventional, prospective study.
Direct costs per patient in standard clinical practice were assessed for 6 months before and after the start of insulin therapy from the perspective of the Spanish health care system perspective. A total of 188 patients (42.6% women) with a mean age of 65.3 years, a mean body mass index of 29.7 kg/m², and a mean disease duration of 10.7 years were assessed.
Before insulin therapy was started, mean (standard deviation) values of various clinical parameters were: hemoglobin A_1c (%), 9.22 (1.58); fasting plasma glucose (mmol/L), 12.03 (3.62); and total cholesterol (mmol/L), 4.90 (1.1). These values decreased after insulin therapy was started. Mean total direct health care costs per patient 6 months before and after insulin start were €639 and €1,110, respectively. Mean total costs 6 months after insulin was started included costs of hospitalization (30.5%, €339), insulin (16.2%, €180), primary care (14.3%, €159), blood glucose monitoring (13.8%, €153), specialized care (13.3%, €148), oral antidiabetics (7.8%, €87), and other diabetes-related treatments (3.9%, €43).
The clinical outcomes of T2DM patients improved after insulin therapy was started. This improvement was associated to increases in resource utilization and direct health care costs in the first 6 months of insulin therapy.
The Direct Economic Cost of Pharmacologically-Treated Diabetes in Italy-2006. The ARNO Observatory
2011, Nutrition, Metabolism and Cardiovascular Diseases
To estimate the prevalence and the direct cost of pharmacologically-treated diabetes in Italy.
The ARNO observatory database, containing the 20-year medical prescriptions of over 10 million Italian people, was used. Ten-year longitudinal data were available in 22 Local Health Districts (LHD). Subjects were classified as having diabetes when prescribed glucose-lowering drugs (oral agents or insulin) (311,979 individuals in 2006). The direct cost was calculated as the sum of drug use, financial compensation by LHD for the inpatient (hospital DRG) and outpatient activities (consultations, laboratory tests, radiology, etc.), all regulated by government contracts. Individuals with diabetes were compared with pharmacologically-treated subjects without diabetes, pair-matched for age, sex and general practitioner.
In the 10-year period, the prevalence of pharmacologically-treated diabetes increased from 3.08% to 4.45% (P for trend, <0.001). The average pro capita cost totaled €2,589 in 2006 (95% confidence interval (CI), 2,584–2,594), corresponding to a rate ratio vs. no-diabetes of 1.54 (95% CI, 1.50–1.56). The cost of drugs was € 827 (rate ratio, 1.80 vs. no-diabetes; 95% CI, 1.79–1.82), that of service use, € 488 (rate ratio, 1.07 (0.93–1.25). Only 20% of the pharmaceutical cost was due to glucose-lowering drugs, a percentage stable through the years. The cost of any hospital admission, as defined by DRGs, was independent of diabetes, but the overall cost was much higher in diabetes due to much higher admission rates. Cardiovascular complications and renal failure accounted for the large majority of excess hospital cost.
The direct economic burden of pharmacologically-treated diabetes on the National Health System is very high, due to the growing prevalence of disease and the cost of complications.
Managing diabetes-related costs and quality of life issues: Value of insulin analogs and pens for inpatient use
2010, Health Policy
Diabetes mellitus is a serious disease that is growing at an epidemic rate, yet it can be managed and controlled with appropriate individualized therapy. In the hospital, costs can be reduced and health-related quality of life (HRQOL) improved by optimal glycemic and blood pressure control, minimal or no hypoglycemia, minimal glucose fluctuations, fewer or no complications, and a shorter length of stay. Insulin analogs and pens are tools that have been used successfully to manage hyperglycemia in the inpatient and outpatient settings. Limited evidence suggests that these advances in insulin therapy may increase HRQOL and improve cost-effectiveness in hospitalized patients compared with regular and NPH insulin and vial/syringe administration of insulin, although additional data are needed to confirm these findings. Most insulin algorithms used in hospitals rely on analogs for basal and prandial glucose control; however, analogs have not been extensively evaluated in clinical trials in this patient population. More studies are needed to evaluate the impact of insulin pen and analog use on HRQOL and costs in hospitalized patients.
Conducting cost-effectiveness analyses of type 2 diabetes in low- and middle-income countries: Can locally generated observational study data overcome methodological limitations?
2010, Diabetes Research and Clinical Practice
In low- and middle-income countries, the high personal and economic burden of type 2 diabetes is further compounded by inadequate resources for diabetes care when compared with high-income countries. Health technology assessments (HTAs) aim to inform policy decision makers in their efforts to achieve more effective allocation of resources by providing evidence-based input on new technologies. Within the hierarchy of evidence, randomized controlled trials (RCTs) remain the ‘gold standard’ used to inform HTAs, but are limited by poor external validity (ie, generalizability to real-world populations). Unlike RCTs, observational studies are able to enrol broader patient populations, but their design renders such studies vulnerable to confounding factors and selection bias. However, it is increasingly recognized that observational studies can complement RCTs by supporting and extending efficacy findings from RCTs to real-world clinical practice, particularly across geographical populations. They can also provide locally relevant baseline and disease natural history data to populate health economic models. Thus, observational data are likely to be of considerable informative value to policy makers in developing countries reaching decisions on diabetes care within an environment of scarce resources.
Hypoglycemic and antihyperglycemic effect of Begonia malabarica Lam. in normal and streptozotocin induced diabetic rats
2009, Journal of Ethnopharmacology
Citation Excerpt :
The number of adults with diabetes in the world will rise to 300 million by the year 2025 and the major part of this numerical increase will occur in developing countries (King et al., 1998). Trends in the last 10 years are influencing the supply and demand for healthcare in diabetes (Bottomely and Raymond, 2007). The UK perspective diabetic study (UKPDS) had indicated that the intensive glycemic control reduced the disease complications and mortality (Adler et al., 2000; Stratton et al., 2000).
The stem of Begonia malabarica was used traditionally by the Malasar tribe to treat diabetes. To validate the hypoglycemic and antihyperglycemic effects of the hexane, ethylacetate and methanol extracts obtained from an ethnomedicinal plant, Begonia malabarica.
The doses for the study were fixed based on Irwin test. The hypoglycemic effect of hexane, ethylacetate and methanol extracts of Begonia malabarica stems were studied in normal animals. The antihyperglycemic effect of the methanol extract was studied in streptozotocin induced diabetic rats.
In normal rats the treatment with the methanol extract of Begonia malabarica had shown a highly significant reduction (16.54 and 34.47%) in plasma glucose levels from the 0 h values at the dose of 100 and 200 mg/kg respectively. In streptozotocin induced diabetic rats the body weight of the Begonia malabarica methanol extract treated animals had shown a significant increase (13.38% at 200 mg/kg) after 4 weeks treatment. The plasma glucose levels were reduced significantly by 46.57 and 50.20% after 4 weeks treatment at 100 and 200 mg/kg respectively. Likewise the absolute kidney weight was also reduced in a significant manner. After 25 days treatment the Begonia malabarica methanol extract treated animals had shown low fasting plasma glucose levels (54.29, 61.34% in 100 and 200 mg/kg) and reduced postprandial plasma glucose levels (54.23, 65.96% in 100 and 200 mg/kg) when compared with diabetic control values. Serum insulin levels and liver glycogen levels were increased to 40.04 and 42.18% in 200 mg/kg Begonia malabarica methanol extract treated animals respectively. The treatment with Begonia malabarica methanol extract did not change the triglycerides and total cholesterol levels. The urea and creatinine levels were also reduced significantly by this treatment. The reduction in SGPT levels indicated the absence of toxicity of Begonia malabarica extract at this dose level.
This study supports the use of Begonia malabarica by the Malasar tribe for the treatment of diabetes. Fractionation of this extract may yield novel prototypes to manage diabetes mellitus.

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10Pharmaco-economic issues for diabetes therapy

Section snippets

Increasing numbers of people with diabetes and ‘pre-diabetes’

Increasing societal burden of diabetes and ‘pre-diabetes’

Impact of treatment options on complications and cost

Pharmaco-economics and type-2 diabetes

Increased choice: new treatment options in diabetes

Cost-effectiveness of newer technologies for diabetes

Increasing scrutiny of the cost-effectiveness of diabetes treatments

Clinical guidelines in type-2 diabetes will increase medication use

Significant increasing spend on medicines to treat diabetes predicted

Pharmaco-economic issues to address in future appraisals

Generating and interpreting the right clinical evidence?

Geographical and ethnic generalizability of cost-effectiveness data

Summary

Acknowledgements

Value in Health

Value in Health

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Value in Health

Health Policy

Value in Health

Lancet

Lancet

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Lancet

Clinical Therapeutics

Clinical Therapy

Endocrinology and Metabolism Clinics of North America

Guidelines for computer modeling of diabetes and its complications. American Diabetes Association Consensus Panel

Diabetes Care

Global prevalence of diabetes estimates for the year 2000 and projections for 2030

Diabetes Care

National Diabetes Fact Sheet: general information and national estimates on diabetes in the United States, 2005

Diabetes Atlas

Obesity and type-2 diabetes in children, 1996-7 to 2003-4

BMJ

Excess mortality in a population with diabetes and the impact of material deprivation: longitudinal, population based study

BMJ

The independent effect of type-2 diabetes mellitus on ischaemic heart disease, stroke and death: a population-based study of 13,000 men and women with 20 years of follow-up

Archives of Internal Medicine

Diabetes: a state of premature cardiovascular death

Practical Diabetes International

Coping with type-II diabetes: the patient's perspective

Diabetologia

Modelling EuroQol health-related utility values for diabetic complications from CODE-2 data

Health Economics

Estimating utility values for health states of type-2 diabetic patients using the EQ-5D UKPDS 62

Medical Decision Making

Valuing health-related quality of life in diabetes

Diabetes Care

Revealing the cost of Type-II diabetes in Europe

Diabetologia

CODE-2*UK: Our contribution to a European Study of the costs of Type-2 diabetes

Practical Diabetes International

Patterns and costs of hospital care for coronary heart disease related and not related to diabetes

Heart

An economic model of the long-term health care burden of Type-II diabetes

Diabetologia

The projected health care burden of Type-2 diabetes in the UK from 2000 to 2060

Diabetic Medicine

Lifetime costs of complications resulting from type-2 diabetes in the US

Diabetes Care

The economics of screening and treatment in type-2 diabetes mellitus

Pharmaco-economics

Diabetes in America

Assessing the impact of complications on the costs of type-II diabetes

Diabetologia

Managing care of type-2 diabetes. Learnings from T2ARDIS

British Journal of Diabetes and Vascular Disease

Impact of type-1 and type-2 diabetes on patterns and costs of drug prescribing: a population-based study

Diabetes Care

Diabetes. A new world order?

British Journal of Diabetes and Vascular Disease

Economic costs of diabetes in the US in 2002. American Diabetes Association

Diabetes Care

The cost of insulin-dependent diabetes mellitus (IDDM) in England and Wales

Diabet Medicine

Diabetes: the cost of illness in Sweden

Journal of Internal Medicine

10
Pharmaco-economic issues for diabetes therapy

Managing care of type-2 diabetes. Learnings from T²ARDIS