Michelle Hill

Aim: The use of automated insulin delivery systems, including the MiniMed™ 780G advanced hybrid closed‐loop system, has been shown to improve glycemic management in people with type 1 diabetes (T1D). The aim was to assess the cost‐effectiveness of the MiniMed 780G system versus multiple daily injections (MDI) of insulin in combination with continuous glucose monitoring (CGM) in the management of people with T1D with elevated HbA1c levels in Japan. Methods: Modeling was performed using the IQVIA Core Diabetes Model and clinical input data were sourced from a randomized controlled trial. A time horizon of 55 years, a discount rate of 2.0% per annum, and a payer perspective were used. Sensitivity analyses were used to examine the robustness of base‐case results. Results: In the base‐case, an incremental cost‐effectiveness ratio (ICER) of JPY 4,723,991 per quality‐adjusted life year (QALY) gained was found, with an incremental benefit of 2.83 quality‐adjusted life years with the MiniMed 780G system versus MDI + CGM. The MiniMed 780G system was therefore cost‐effective, assuming a willingness‐to‐pay threshold of JPY 5,000,000 per QALY. Although treatment costs were found to be JPY 16,226,167 higher for the MiniMed 780G, costs associated with managing long‐term complications were lower. A probabilistic sensitivity analysis found the intervention to have a 76.9% probability of being cost‐effective in Japan. Conclusion: The MiniMed 780G system was projected to be cost‐effective in the management of people with T1D in Japan with HbA1c above target levels. Its use was also predicted to improve clinical outcomes when compared with MDI + CGM.

Background: The Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP‐IT) demonstrated a 40% reduction of major cardiac implantable electronic device (CIED) infection with the use of an absorbable antibacterial envelope in patients at high risk of infection. The objective of this analysis was to determine the cost‐effectiveness of this envelope in a high‐risk patient population treated in the Australian public healthcare system. Methods: A decision tree model compared the use of an antibacterial envelope versus no envelope over the lifetime of a patient with a high risk of infection as defined in WRAP‐IT. Detailed clinical outcomes were based on 12‐month data from WRAP‐IT and other local inputs derived from local sources including linked‐administrative data in New South Wales (NSW). Results: The use of an antibacterial envelope results in a cost saving of A$157 at 12 months and an incremental cost of A$62 over a lifetime. Incremental quality‐adjusted life‐years (QALYs) with the envelope were 0.00144 at 12 months and 0.00872 over a lifetime. Both the 12 month and the lifetime cost/QALY gained resulted in an ICER that was “dominant.” That is, the envelope did not result in a significant increased cost over a lifetime; however, it resulted in increased QALYs. Conclusions: An antibacterial envelope is a dominant strategy in patients at high risk of infection. Use of the envelope was essentially cost neutral to the Australian public healthcare system, and increases the quality and length of life of the patient.

Background: Cardiac implantable electronic device (CIED) infections are a serious complication that occurs in ~1%–3% of device recipients. However, data on total healthcare costs associated with CIED infections in Australia are scant. This study aims to comprehensively estimate the total healthcare costs of CIED infections in Australia. Methods: This retrospective cohort study included patients 18+ years diagnosed with CIED infections between July 2017 and September 2022 in New South Wales. Using linked administrative data, costs were estimated for in‐hospital care, emergency department visits, outpatient services, Medicare claims, ambulance transport, and dispensed medications in the period from 28 days before to 42 days after CIED infection‐related hospitalizations. Results: We identified 726 patients with CIED infections, of whom 233 (32.1%) died during a mean follow‐up of 35.6 months. The average treatment costs of $77 746, predominantly driven by hospital expenses (88.3%). Key hospital cost drivers included device type, mechanical ventilation, intensive care unit (ICU) stays, temporary pacing, lengths of stay, high‐risk patients, and multiple comorbidities. Patients undergoing complete system removal with reimplantation (31.7% of patients) had the highest costs ($120 792), followed by patients with complete system removal only (15.7%; $98 453), and without system removal (52.6%; $45 649). For patients undergoing complete system removal and/or reimplantation procedures, the cost varied by device type ($90 089 for pacemaker patients, $111 677 for cardiac resynchronization therapy (CRT)‐pacemaker, $128 864 for implantable cardiac defibrillators, and $148 888 for CRT‐defibrillator patients). Conclusions: Our findings highlight the substantial health care costs associated with CIED infections, with wide variations across patient factors and clinical care pathways.

Background: Cardiac implantable electronic devices (CIED) with reactive atrial‐based anti‐tachycardia pacing (rATP) have been developed to stop the progression of atrial fibrillation (AF), a frequently occurring arrhythmia. This study assessed the value of rATP from the Australian private healthcare payer perspective. Methods: A Markov state‐transition model, including bradycardia, stroke, heart failure (HF), and death, was used to evaluate the value of rATP in conjunction with either pacemakers (PM), implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT‐P), or CRT defibrillators (CRT‐D). It was assumed that PM patients have bradycardia with no AF, and other patients have mild HF at insertion. Efficacy inputs, battery life, and device costs varied between devices. Conservatively, outpatient/follow‐up costs of stroke and HF were excluded. All analyses were conducted using a cost‐effectiveness threshold of 50 000 Australian dollars (A$) per quality‐adjusted life year (QALY) gained, and deterministic sensitivity analysis was performed on key inputs. Results: Using a 30‐year horizon and a 5% discount rate, rATP was cost‐effective up to a value of A$5609 (PM), A$11 628 (CRT‐D), A$14 142 (CRT‐P), and A$17 858 (ICD). In sensitivity analysis, varying patient age, rATP efficacy, HF and stroke mortality, stroke recurrence risk, utility values, time horizon, battery life, and the discount rate, the value of rATP ranged from A$3122 to A$11 375 (PM), A$1455 to A$26 409 (ICD), A$1171 to A$20 674 (CRT‐P), and A$973 to A$16 907 (CRT‐D). Conclusion: Reactive ATP provides clinical benefits to patients who require a CIED. These benefits justify a value premium for devices with rATP functionality.

Background: Micra™ VR Transcatheter Pacing System (Micra VR) is a single‐chamber transcatheter leadless pacemaker. Absence of leads and subcutaneous pocket reduces or completely eliminates the risk of complications associated with the conventional transvenous pacemakers (TVPM). When compared with TVPM, the leadless technology provides a quicker postimplantation recovery and causes less cosmetic concerns/discomfort providing better patient experiences in the long run. We performed a modeled cost‐utility analysis of Micra VR versus TVPM for the management of patients with bradycardia.Methods: We developed a Markov model comparing Micra VR to TVPM over the device battery life of 17 years. Key data inputs were drawn from the MICRA Coverage with Evidence Development (CED) study. Costs were obtained from Australian sources. The analysis is from the perspective of the Australian healthcare system.Results: The risks of complications, including device‐related events, in real‐world clinical practice were relatively low for TVPM. The magnitude of cost savings arising from risk reductions provided by Micra VR was however sizable, offsetting roughly a quarter of its additional device cost. Over the 17‐year model period, Micra VR was associated with an estimated incremental cost of A$4277 and an incremental quality‐adjusted life years (QALYs) of 0.09 when compared with TVPM, yielding an incremental cost‐effectiveness ratio of A$47 379 per QALY gain.Conclusions: Micra VR is likely to offer a cost‐effective alternative to the conventional TVPM technology for the management of patients with bradycardia.

Aims: An infection following cardiac implantable electronic device (CIED) procedure is a serious complication, but its association with all-cause mortality is inconsistent across observational studies. To quantify the association between CIED infection and all-cause mortality in a large, contemporary cohort from New South Wales, Australia. Methods and results: This retrospective cohort study used linked hospital and mortality data and included all patients aged >18 years who underwent a CIED procedure between July 2017 and September 2022. Cardiac implantable electronic device infection was defined by the presence of relevant diagnosis codes. Cox regression to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the association of CIED infection with mortality, at 1-year, and at the end of follow-up, with CIED infection included as a time-dependent variable, and other potential risk factors for mortality included as fixed covariates. We followed 37,750 patients with CIED procedures {36% female, mean age [standard deviation (SD)] 75.8 [12.7] years}, and 487 (1.3%) CIED infections were identified. We observed 5771 (15.3%) deaths during an average follow-up of 25.2 (SD 16.8) months. Compared with no infection group, patients with CIED infection had a higher Kaplan-Meier mortality rate (19.4 vs. 6.8%) and adjusted hazard of mortality (aHR 2.73, 95% CI 2.10−3.54) at 12 months post-procedure. These differences were attenuated but still remained significant at the end of follow-up (aHR 1.83, 95% CI 1.52−2.19). Conclusion: In a complete, state–wide cohort of CIED patients, infection was associated with higher risks of both short–term and long–term mortality.