Identifying Drivers of Cost Savings with Insulin Administration Devices in Type 2 Diabetes in the United States Richard F. Pollock, 1 Bradley H. Curtis, 2 Kristina S. Boye, 2 Louise Timlin, 3 William J. Valentine 1 1 Ossian Health Economics and Communications, GmbH Basel, Switzerland 2 Eli Lilly and Company, Indianapolis, Indiana, USA 3 Eli Lilly and Company Ltd., Windlesham, Surrey, UK METHODS A model was constructed using Microsoft Excel ® to evaluate the budget impact of a new reusable IAD capable of reducing hypoglycemic event rates and insulin wastage whilst improving compliance in patients with type 2 diabetes. A hypothetical cohort of type 2 diabetes patients was created for the analysis. The population was defined as a 1 million member healthcare plan with a type 2 diabetes prevalence of 7.8% and annual incidence of 0.52%. The present analysis focused specifically on patients currently on a basal insulin regimen, but ready to initiate basal-bolus regimen. The model reported budget impact outcomes over one and five-year time horizons. A 3% annual discount rate was applied to all future costs, which were accounted from a US healthcare payer perspective. A series of univariate sensitivity analyses was performed. With the exception of minor and major hypoglycemia, the cumulative incidence of diabetes complications was projected using equations from the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model, which capture changes in risk factors including age, HbA1c, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) cholesterol ratio. 1 The base case analysis assumed that both the new IAD and previous devices used the same insulin, which effected a mean HbA1c decrease of 1.4%, based on recent study of patients initiating a prandial insulin regimen. 2 Costs of diabetes complications in the year of onset and in subsequent years were taken primarily from a 2008 US costing study by Pelletier et al. (Table 1). 3 The model also captured costs associated with basal and bolus insulin at a cost of USD 0.04 per IU, needle costs (at USD 0.09 per needle) and costs associated with self-monitoring of blood glucose (SMBG), which was assumed to comprise 2 test strips per day at USD 0.74 per strip. A series of budget impact analyses were performed, each comprising two scenarios, the first of which estimated the costs in a cohort using their current IAD (i.e. a pen). The second scenario evaluated the same costs, but with all patients using a new hypothetical IAD effecting reduced hypoglycemia rates (through double-dosing alerts), improved compliance (through dose reminders) and decreased insulin wastage (through a reduction in the priming volume required before each injection). In each of these analyses, a range of benefits were investigated (2% to 10% reductions in hypoglycemia rates, 2% to 10% improvements in compliance and 0.4 IU to 2.0 IU reductions in insulin wastage per injection). An analysis in which all benefits were applied simultaneously was also performed. RESULTS • In the base case analysis (over a five year time horizon), the target population comprised 4,251 patients and discounted healthcare expenditure was USD 34.35 million (USD 1,616 per patient per year) in the scenario prior to the introduction of the new IAD (Table 2). • Reductions in minor or major hypoglycemia rates were accompanied Complication Cost in year of event, USD Cost in subsequent years, USD Myocardial infarction 15,889 1,458 Stroke 6,773 518 End-stage renal disease (ESRD), weighted mean 11,644 8,560 Hemodialysis (91.6% of ESRD patients) 11,344 8,255 Peritoneal dialysis (5.9% of ESRD patients) 17,004 14,652 Transplant (2.4% of ESRD patients) 10,581 5,776 Blindness 1,066 75 Amputation, weighted average 7,157 1,956 Toe amputation (49.2% of diabetes amputees) 2,510 322 Foot amputation (15.5% of diabetes amputees) 2,222 313 Leg amputation (35.4% of diabetes amputees) 15,779 4,942 Major hypoglycemic event 369 0 Minor hypoglycemic event 0.74 0 Table 1 Diabetes complication costs used in the analysis by reductions in healthcare expenditure, with overall savings of between USD 1,400 (with a 2% reduction in minor hypoglycemia) and USD 65,700 (with a 10% reduction in major hypoglycemia) over one year. • The scenario in which the new IAD improved compliance by 10% (relative to the previous IAD) resulted in a total increase in expenditure of USD 1.06m over five years, driven primarily by an increase in needle and insulin costs. • Insulin wastage analyses yielded cost decreases ranging from USD 150,500 to USD 752,500 in the case of 0.4 IU and 2.0 IU reductions in the priming volume per injection, respectively. • The analysis in which all benefits were applied simultaneously (a 10% reduction in minor and major hypoglycemia rates, a 2 IU per injection reduction in insulin wastage and a 10% improvement in compliance) resulted in a cost saving of USD 213,000 over five years, a reduction of 0.62% (Figure 1). The cost saving comprised decreased insulin costs (USD -301,000), decreased costs of diabetes complications (USD 5,400) and decreased minor and major hypoglycemia costs (USD -31,300 and USD -287,800, respectively), although this was partly offset by an increase in needle costs of USD 412,300. LIMITATIONS • The study omitted a small number of potential drivers of the budget impact of reusable IADs, notably dosing accuracy, needlestick injuries and the cost of training to use the new IAD. • The use of equations derived from UKPDS may have led to an underestimation of complication rates in US patients with more advanced disease than the newly-diagnosed UKPDS cohort. CONCLUSIONS • In conclusion, a new IAD capable of conferring all the modeled benefits of improved compliance, reduced hypoglycemia rates and reduced (or eliminated) needle priming would represent cost savings of around USD 213,000 in a typical million member plan in the US over five years. • This saving would represent a 0.62% reduction in total healthcare expenditure, whilst conferring benefits in terms of reduced diabetes complications, improved patient survival and increased treatment satisfaction. • A notable strength of the present study was the ability of the model to capture changes in clinical parameters. REFERENCES 1. Clarke PM et al. A model to estimate the lifetime health outcomes of patients with type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model (UKPDS no. 68). Diabetologia. 2004 Oct;47(10):1747-59. 2. Holman RR et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736–47. 3. Pelletier EM et al. Direct medical costs for type 2 diabetes mellitus complications in the US commercial payer setting: a resource for economic research. Appl Health Econ Health Policy. 2008;6(2-3):103-12. Figure 1 Changes in healthcare expenditure over five years BACKGROUND AND OBJECTIVES As the prevalence of type 2 diabetes and the costs associated with the condition continue to increase worldwide, healthcare payers are under increasing pressure to utilize budgets more efficiently. The aim of the present study was to investigate potential drivers of costs and cost savings when assessing the budget impact of insulin administration devices (IADs) in patients with type 2 diabetes. Analysis Cost over 5 years (‘000 USD) Incremental cost (‘000 USD) Current insulin administration device 34,349 ̶ 10% reduction in minor hypoglycemia 34,313 -36 10% reduction in major hypoglycemia 34,018 -331 10% improvement in compliance to bolus insulin regimen 35,411 +1,062 2.0 IU reduction in insulin wastage per bolus injection 33,597 -753 All benefits 34,136 -213 Table 2 Changes in diabetes healthcare expenditure ESRD, end-stage renal disease; USD, 2009 US dollars PMD11 International Society for Pharmacoeconomics and Outcomes Research 16th Annual International Meeting; Baltimore, MD; May 21 – 25, 2011 Sponsored by Eli Lilly and Company USD, 2009 US dollars -0.10% -0.96% -2.19% +3.09% -0.62% -3.0% -2.0% -1.0% 0.0% 1.0% 2.0% 3.0% 4.0% Minor hypoglycemia rate down 10% Major hypoglycemia rate down 10% Insulin wastage down 2 IUs per injection Adherence up 10% All benefits Percentage change in healthcare expenditure with new IAD (%)