OBJECTIVES: Managing glucose levels presents the greatest challenge in patients with type 1 diabetes mellitus (T1D). Continuous subcutaneous insulin infusion and sensor augmented pumps (SAP) have been introduced to counter these challenges. Hybrid closed-loop system (HCL), approved in 2016, is an advancement over existing SAPs and eliminates the necessity of constant blood glucose monitoring. The study aimed to estimate the cost-effectiveness of HCL compared to SAP for patients 16 years and older using a payer perspective.

METHODS: A Markov model consisting of two health states “well” and “dead”, was constructed based on Scuffham and Carr model (permission taken). The model also transitioned into hypoglycemia and ketoacidosis adverse event states including deaths related to these adverse events. Monte Carlo simulations was conducted using 10,000 hypothetical T1D patients over a 1-year time horizon. Direct costs included device costs, adverse event costs; and were estimated from published literature and 2017 Red Book. Utilities were derived from clinical trials and published literature. The primary outcome was quality-adjusted life years (QALYs).

RESULTS: Cost of HCL was assumed to be $8,000, as the company had not fixed the price and the cost of SAP was $6,200. An annual cost of $1,000 for the sensor was also attached with HCL. Other costs associated with the two devices such as test strips ($31.10), lancet ($8.60), and insulin ($275.58) were similar. Over a 1-year period, the cost of SAP was $12,220 and HCL was $14,472. However, the gain in QALY from HCL over SAP remained marginally better (14.71 vs. 14.70). The cost of SAP was less than HCL mainly because of its one-time purchase cost.

CONCLUSIONS : HCL is a better, yet, expensive option compared to SAPs. Future economic studies based on real world utilizations are needed to understand the true cost-effectiveness of this new device.