European Health Economic Trial on Home ICD Monitoring
European Health Economic Trial on Home ICD Monitoring
Aim Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated.
Methods and results A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169–238) vs. €213 (182–243); range for difference (€−36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327–489) vs. €400 (345–455); range for difference (€−104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different.
Conclusion For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.
Over the last years remote monitoring of implanted devices like implantable defibrillators (ICD) has been introduced. All stakeholders see potential benefits: physicians and hospitals (the 'providers') may optimize performance by reducing the number of in-hospital visits, while specialist nurses and/or technicians can filter alerts from the remote system, hence possibly saving physician time. For patients, the technology provides a more continuous follow-up (FU) and saves time for visits to outpatient clinics that often do not result in specific actions. Many studies have shown that remote technology results in patient care that is non-inferior to classical FU with in-office visits. Especially daily remote monitoring results in earlier detection of device and patient-related problems which translate into earlier clinical decision-making, less inappropriate shocks and improved device longevity. The CONNECT trial also showed a significant reduction in the length of cardiovascular hospitalizations and the IN-TIME trial even showed a mortality benefit in ICD patients with heart failure. Some trials have looked as secondary end-points at the cost impact from the perspective of the healthcare payer. There is data indicating that healthcare payers may have a dominant strategy option with remote ICD monitoring, since costs may be reduced and outcomes improved with remote FU.
While investigators have evaluated the time needed from physicians and nurses/technicians for remote monitoring, a formal cost analysis from the provider viewpoint has never been performed. Nevertheless, the net financial impact on providers will influence their willingness to change care models from reimbursed in-hospital visits to remote evaluation, especially when the latter is not reimbursed and given the investments needed to train nurses and employ those for the FU activities. Industry has to provide additional hardware (transmitters), set up infrastructure (servers) and take care of communication costs, which are not covered separately from the device price. If all stakeholders want to stimulate a reorganization of FU for ICD patients towards remote monitoring, they need to know its cost structure to ensure proper financing for the future. Therefore, the primary objective of this EuroEco trial was to evaluate the impact on the cost for providers when relying on Home Monitoring (HM)-based FU compared with classical FU with only in-office visits. Since reimbursement systems are very heterogeneous in different European countries, secondary objectives were to study the impact on the providers' net clinical income for FU, and the costs for ICD FU with or without remote monitoring from a healthcare payer perspective. Further secondary end-points were the rate of in-office FU visits with relevant findings and patient-reported quality-of-life assessed by the SF-36 questionnaire.
Abstract and Introduction
Abstract
Aim Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated.
Methods and results A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169–238) vs. €213 (182–243); range for difference (€−36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327–489) vs. €400 (345–455); range for difference (€−104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different.
Conclusion For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.
Introduction
Over the last years remote monitoring of implanted devices like implantable defibrillators (ICD) has been introduced. All stakeholders see potential benefits: physicians and hospitals (the 'providers') may optimize performance by reducing the number of in-hospital visits, while specialist nurses and/or technicians can filter alerts from the remote system, hence possibly saving physician time. For patients, the technology provides a more continuous follow-up (FU) and saves time for visits to outpatient clinics that often do not result in specific actions. Many studies have shown that remote technology results in patient care that is non-inferior to classical FU with in-office visits. Especially daily remote monitoring results in earlier detection of device and patient-related problems which translate into earlier clinical decision-making, less inappropriate shocks and improved device longevity. The CONNECT trial also showed a significant reduction in the length of cardiovascular hospitalizations and the IN-TIME trial even showed a mortality benefit in ICD patients with heart failure. Some trials have looked as secondary end-points at the cost impact from the perspective of the healthcare payer. There is data indicating that healthcare payers may have a dominant strategy option with remote ICD monitoring, since costs may be reduced and outcomes improved with remote FU.
While investigators have evaluated the time needed from physicians and nurses/technicians for remote monitoring, a formal cost analysis from the provider viewpoint has never been performed. Nevertheless, the net financial impact on providers will influence their willingness to change care models from reimbursed in-hospital visits to remote evaluation, especially when the latter is not reimbursed and given the investments needed to train nurses and employ those for the FU activities. Industry has to provide additional hardware (transmitters), set up infrastructure (servers) and take care of communication costs, which are not covered separately from the device price. If all stakeholders want to stimulate a reorganization of FU for ICD patients towards remote monitoring, they need to know its cost structure to ensure proper financing for the future. Therefore, the primary objective of this EuroEco trial was to evaluate the impact on the cost for providers when relying on Home Monitoring (HM)-based FU compared with classical FU with only in-office visits. Since reimbursement systems are very heterogeneous in different European countries, secondary objectives were to study the impact on the providers' net clinical income for FU, and the costs for ICD FU with or without remote monitoring from a healthcare payer perspective. Further secondary end-points were the rate of in-office FU visits with relevant findings and patient-reported quality-of-life assessed by the SF-36 questionnaire.
