First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure — CardioBBEAT

Background: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Methods: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva$^{®}$). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. Results: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. Conclusions: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System

Cost-Effectiveness Analysis of Direct-Acting Antiviral Agents for Occupational Hepatitis C Infections in Germany

Around 1% of the world’s population is infected with hepatitis C. The introduction of new direct-acting antiviral agents (DAAs) in 2014 has substantially improved hepatitis C treatment outcomes. Our objective was to evaluate the long-term cost effectiveness of DAAs in health care personnel (HP) with confirmed occupational diseases in Germany. A standardised database from a German statutory accident insurance was used to analyse the cost-effectiveness ratio for the DAA regimen in comparison with interferon-based triple therapies. Taking account of the clinical progression of the disease, a Markov model was applied to perform a base case analysis for a period of 20 years. The robustness of the results was determined using a univariate deterministic sensitivity analysis. The results show that treatment with DAAs is more expensive, but also more effective than triple therapies. The model also revealed that the loss of 3.23 life years can be averted per patient over the 20 years. Compared to triple therapies, DAA treatment leads to a higher sustained virologic response (SVR). Although this results in a decrease of costs in the long term, e.g., pension payments, DAA therapy will cause greater expense in the future due to the high costs of the drugs

Cost-Effectiveness Analysis of Direct-Acting Antiviral Agents for Occupational Hepatitis C Infections in Germany

Around 1% of the world’s population is infected with hepatitis C. The introduction of new direct-acting antiviral agents (DAAs) in 2014 has substantially improved hepatitis C treatment outcomes. Our objective was to evaluate the long-term cost effectiveness of DAAs in health care personnel (HP) with confirmed occupational diseases in Germany. A standardised database from a German statutory accident insurance was used to analyse the cost-effectiveness ratio for the DAA regimen in comparison with interferon-based triple therapies. Taking account of the clinical progression of the disease, a Markov model was applied to perform a base case analysis for a period of 20 years. The robustness of the results was determined using a univariate deterministic sensitivity analysis. The results show that treatment with DAAs is more expensive, but also more effective than triple therapies. The model also revealed that the loss of 3.23 life years can be averted per patient over the 20 years. Compared to triple therapies, DAA treatment leads to a higher sustained virologic response (SVR). Although this results in a decrease of costs in the long term, e.g., pension payments, DAA therapy will cause greater expense in the future due to the high costs of the drugs.</jats:p

The first year of noninvasive remote telemonitoring in chronic heart failure is not cost saving but improves quality of life: the randomized controlled cardiobbeat trial

Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva(R)) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany.Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 +/- 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in keuro) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life.Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 +/- 59 days, SoC 346 +/- 45 days; p = 0.298) associated with increased total costs (RTM 18.5 +/- 39.5 keuro, SoC 12.8 +/- 22.0 keuro; p = 0.046). This yielded an ICER of -1.15 keuro/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01).Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective.ClinTrials.gov (NCT02293252)

Remote telemonitoring in chronic heart failure does not reduce healthcare cost but improves quality of life

Background: Evidence that home telemonitoring (HTM) for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Therefore the CardioBBEAT trial was designed to prospectively assess the health economic impact of a dedicated home monitoring system for patients with CHF based on actual costs directly obtained from patients’ health care providers. Methods: Between January 2010 and June 2013, 621 patients (mean age 63,0 ± 11,5 years, 88 % male) with a confirmed diagnosis of CHF (LVEF ≤ 40 %) were enrolled and randomly assigned to two study groups comprising usual care with and without an interactive bi-directional HTM (Motiva®). The primary endpoint was the Incremental Cost-Effectiveness Ratio (ICER) established by the groups’ difference in total cost and in the combined clinical endpoint “days alive and not in hospital nor inpatient care per potential days in study” within the follow up of 12 months. Secondary outcome measures were total mortality and health related quality of life (SF-36, WHO-5 and KCCQ). Results: In the intention-to-treat analysis, total mortality (HR 0.81; 95% CI 0.45 – 1.45) and days alive and not in hospital (343.3 ± 55.4 vs. 347.2 ± 43.9; p = 0.909) were not significantly different between HTM and usual care. While the resulting primary endpoint ICER was not positive (-181.9; 95% CI −1626.2 ± 1628.9), quality of life assessed by SF-36, WHO-5 and KCCQ as a secondary endpoint was significantly higher in the HTW group at 6 and 12 months of follow-up. Conclusions: The first simultaneous assessment of clinical and economic outcome of HTM in patients with CHF did not demonstrate superior incremental cost effectiveness compared to usual care. On the other hand, quality of life was improved. It remains open whether the tested HTM solution represents a useful innovative approach in the recent health care setting