A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

AIMS/HYPOTHESIS: Long-term follow-up of the Steno-2 study demonstrated that intensified multifactorial intervention increased median lifespan by 7.9 years and delayed incident cardiovascular disease by a median of 8.1 years compared with conventional multifactorial intervention during 21.2 years of follow-up. In this post hoc analysis of data from the Steno-2 study, we aimed to study the difference in direct medical costs associated with conventional vs intensified treatment. METHODS: In 1993, 160 Danish individuals with type 2 diabetes and microalbuminuria were randomised to conventional or intensified multifactorial target-driven intervention for 7.8 years. Information on direct healthcare costs was retrieved from health registries, and the costs in the two groups of participants were compared by bootstrap t test analysis. RESULTS: Over 21.2 years of follow-up, there was no difference in total direct medical costs between the intensified treatment group, €12,126,900, and the conventional treatment group, €11,181,700 (p = 0.48). The mean cost per person-year during 1996-2014 was significantly lower in the intensified treatment group (€8725 in the intensive group and €10,091 in the conventional group, p = 0.045). The main driver of this difference was reduced costs associated with inpatient admissions related to cardiovascular disease (p = 0.0024). CONCLUSIONS/INTERPRETATION: Over a follow-up period of 21.2 years, we found no difference in total costs and reduced cost per person-year associated with intensified multifactorial treatment for 7.8 years compared with conventional multifactorial treatment. Considering the substantial gain in life-years and health benefits achieved with intensified treatment, we conclude that intensified multifaceted intervention in high-risk individuals with type 2 diabetes seems to be highly feasible when balancing healthcare costs and treatment benefits in a Danish healthcare setting.

INCORPORATING ENVIRONMENTAL OUTCOMES INTO A HEALTH ECONOMIC MODEL.

OBJECTIVES: Traditional economic evaluations for most health technology assessments (HTAs) have previously not included environmental outcomes. With the growing interest in reducing the environmental impact of human activities, the need to consider how to include environmental outcomes into HTAs has increased. We present a simple method of doing so. METHODS: We adapted an existing clinical-economic model to include environmental outcomes (carbon dioxide [CO2] emissions) to predict the consequences of adding insulin to an oral antidiabetic (OAD) regimen for patients with type 2 diabetes mellitus (T2DM) over 30 years, from the United Kingdom payer perspective. Epidemiological, efficacy, healthcare costs, utility, and carbon emissions data were derived from published literature. A scenario analysis was performed to explore the impact of parameter uncertainty. RESULTS: The addition of insulin to an OAD regimen increases costs by 2,668 British pounds per patient and is associated with 0.36 additional quality-adjusted life-years per patient. The insulin-OAD combination regimen generates more treatment and disease management-related CO2 emissions per patient (1,686 kg) than the OAD-only regimen (310 kg), but generates fewer emissions associated with treating complications (3,019 kg versus 3,337 kg). Overall, adding insulin to OAD therapy generates an extra 1,057 kg of CO2 emissions per patient over 30 years. CONCLUSIONS: The model offers a simple approach for incorporating environmental outcomes into health economic analyses, to support a decision-maker's objective of reducing the environmental impact of health care. Further work is required to improve the accuracy of the approach; in particular, the generation of resource-specific environmental impacts.

Real-World Clinical Effectiveness of Liraglutide 3.0 mg for Weight Management in Canada.

OBJECTIVE: Real-world clinical effectiveness of liraglutide 3.0 mg, in combination with diet and exercise, was investigated 4 and 6 months post initiation. Changes in absolute and percent body weight were examined from baseline. METHODS: A cohort of liraglutide 3.0 mg initiators in 2015 and 2016 was identified from six Canadian weight-management clinics. Post initiation values at 4 and 6 months were compared with baseline values using a paired t test. RESULTS: The full cohort consisted of 311 participants, with 210 in the ≥ 4-month persistence group and 167 in the ≥ 6-month persistence group. Average baseline BMI was 40.7 kg/m2 , and weight was 114.8 kg. There was a significant change in body weight 6 and 4 months after initiation of treatment in persistent subjects (≥ 6-month: -8.0 kg, P < 0.001; ≥ 4-month: -7.0 kg, P < 0.001) and All Subjects, regardless of persistence (-7.3 kg; P < 0.001). Percentage change in body weight from baseline was -7.1% in the ≥ 6-month group and -6.3% in the ≥ 4-month group, and All Subjects lost 6.5% body weight. Of participants in the ≥ 6-month group, 64.10% and 34.5% lost ≥ 5% and > 10% body weight, respectively. CONCLUSIONS: In a real-world setting, liraglutide 3.0 mg, when combined with diet and exercise, was associated with clinically meaningful weight loss.

The association between body mass index and health and economic outcomes in Brazil.

BACKGROUND: Obesity is associated with significant physical, psychosocial and economic burden globally. In Brazil, almost 50% of the population is either overweight or obese. The prevalence of morbid obesity increased by 255% between 1975 and 2003. The current study sought to quantify the relationship between weight status and health outcomes. METHODS: Data from three waves (2011, 2012, and 2015) of the Brazil National Health and Wellness Survey, an Internet-based survey administered to a demographically diverse sample of Brazilian adults, were used. Body mass index category was calculated based on self-reported height and weight and respondents were categorized into five groups (normal, overweight, obese class I, obese class II, obese class III; n = 34,254). Multivariable analyses, controlling for sociodemographic variables and health history, tested the association with body mass index group and outcomes including health status (Medical Outcomes Study Short Form 12-Item Health Survey version 2/Medical Outcomes Study Short Form 36-Item Health Survey version 2), work productivity (Work Productivity and Activity Impairment-General Health Questionnaire), and costs associated with work impairment (indirect costs), self-reported healthcare resource use and associated direct costs. RESULTS: Overall, 53.6% of the surveyed Brazilian population reported being overweight or obese. In virtually all the analyses, increasing body mass index group was associated with significant and progressively worse outcomes. Most notable was the finding that hospitalization costs were over twice as high (R$3141.84 vs. R$1349.60) and indirect costs were nearly double (R$1656.80 vs. R$884.15) for obesity class III than for normal body mass index respondents. CONCLUSIONS: Obesity rates in Brazil are considerable and, from a patient and societal perspective, increasingly burdensome, thereby highlighting the need for stakeholders to prioritize strategies for weight management interventions.

The cost of diabetes and obesity in Australia.

AIMS: To assess and compare the direct healthcare and non-healthcare costs and government subsidies by body weight and diabetes status. METHODS: The Australian Diabetes, Obesity and Lifestyle study collected health service utilization and health-related expenditure data at the 2011-2012 follow-up surveys. Costing data were available for 4,409 participants. Unit costs for 2016-2017 were used where available or were otherwise inflated to 2016-2017 dollars. Age- and sex-adjusted costs per person were estimated using generalized linear models. RESULTS: The annual total direct cost ranged from $1,998 per person with normal weight to $2,501 per person with obesity in participants without diabetes. For those with diabetes, total direct costs were $2,353 per person with normal weight, $3,263 per person with overweight, and $3,131 per person with obesity. Additional expenditure as government subsidies ranged from $5,649 per person with normal weight and no diabetes to $8,085 per person with overweight and diabetes. In general, direct costs and government subsidies were higher for overweight and obesity compared to normal weight, regardless of diabetes status, but were more noticeable in the diabetes sub-group. The annual total excess cost compared with normal weight people without diabetes was 26% for obesity alone and 46% for those with obesity and diabetes. LIMITATIONS: Participants included in this study represented a healthier cohort than the Australian population. The relatively small sample of people with both obesity and diabetes prevented a more detailed analysis by obesity class. CONCLUSION: Overweight and obesity are associated with increased costs, which are further increased in individuals who also have diabetes. Interventions to prevent overweight and obesity or reduce weight in people who are overweight or obese, and prevent diabetes, should reduce the financial burden.

Insulin Degludec in Clinical Practice: A Review of Japanese Real-World Data.

INTRODUCTION: In this literature review we evaluated the real-world clinical effectiveness of switching Japanese diabetic patients from their current insulin regimen to insulin degludec (IDeg). METHODS: Studies were identified from Japanese Diabetes Society (JDS) abstracts (2014-2015) and PubMed (2012 onwards). Inclusion criteria were: Japanese population, >15 participants, and studies switching patients from basal or basal-bolus insulin regimens to IDeg. Randomized controlled trials and case reports were excluded. Weighted mean changes in safety and effectiveness endpoints were calculated using the number of patients in each study. RESULTS: In total, 81 JDS abstracts and seven manuscripts met the search criteria, representing 4238 patients [1028 with type 1 diabetes (T1D), 602 with type 2 diabetes (T2D), 2608 with unspecified or mixed diabetes]. Glycated hemoglobin (HbA1c) was reported in 93% of studies, with an improvement in 84% of these (51% significant, 33% numerical), no change in 12%, and worsening in 4% (3% numerical, 1% significant). Across all studies, the weighted mean absolute change in HbA1c was -0.3% (-2.7 mmol/mol). Basal insulin dose was reported in 58% of studies and was lower in 60% of these (30% significant, 30% numerical), numerically unchanged in 26%, and higher in 14% (2% significant, 12% numerical). The weighted mean change in basal insulin dose was -4.8% and -3.0% for all studies and for studies with only significant results, respectively. The weighted mean change in basal dose based on all studies was -8.9, -5.5, and -2.9% for the T1D, T2D, and unspecified patient populations, respectively. Hypoglycemia was recorded in 31% of the studies. After switching treatment to IDeg, 55% of studies reported decreased hypoglycemia, 29% no change, and 16% an increase. Quality of life (QoL) was measured in 11% of studies, of which 82% reported improved QoL after switching, and 18% reported no change in QoL. CONCLUSION: Switching from a conventional basal insulin to IDeg has the potential to improve HbA1c with a lower insulin dose. Switching to IDeg may also provide a reduced risk of hypoglycemia and improvement in QoL. FUNDING: Novo Nordisk.