Costs and outcomes of treating chronic hepatitis C patients in routine care - results from a nationwide multicenter trial.

Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly.

[Costs of a guideline-based treatment of patients with chronic hepatitis C in the era of interferon-free treatment]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-C-Patienten im Zeitalter Interferon-freier Therapien.

The treatment of chronic hepatitis C has considerably changed with the introduction of recent direct acting antivirals. These antivirals have sustained virologic response (SVR) rates above 90 % as well as reduced toxicity and treatment duration. Therefore, current German guidelines recommend these interferon-free regimens as first-choice treatment. Nevertheless, recent developments were accompanied by a significant increase in treatment costs, which led to extensive discussions on reasonable pharmaceutical prices. The aim of the current study was to analyze the average treatment costs and costs per patient cured for guideline treatment recommendations. Analyses were stratified according to genotype, treatment status (naive/experienced), and presence/absence of cirrhosis. Costs were separated in (1.) basic diagnostic procedures, (2.) monitoring, and (3.) pharmaceuticals. The calculation is based on a remuneration scheme in the statutory health insurance system. In treatment-naïve non-cirrhotic patients, the average cost is 41 766 €/SVR for the treatment with SOF/LDV calculated (PTV/r/OMV+DSV: 53 129 €/SVR). In treatment-naive cirrhotic patients, costs were 60 323 €/SVR (SOF/LDV+RBV) and 80 604 €/SVR (PTV/r/OMV+DSV+RBV). Treatment-experienced genotype 1 patients had average costs of 60 366 €/SVR for SOF/LDV treatment as well as 53 134 €/SVR for PTV/r/OMV+DSV±RBV treatment (cirrhotic patients: 62 208 €/SVR for SOF/LDV+RBV; 80 824 €/SVR for PTV/r/OMV+DSV+RBV). The average treatment costs per SVR in treatment-naive genotype 1 patients are comparable to previous standard of care treatments and lower in treatment-experienced patients. In other genotypes, treatment costs and costs per cure are significantly higher compared to previous standard of care. However, long-term modelling studies show that new regimens are cost-effective.

[Costs of a guideline-based treatment of patients with chronic hepatitis C in Germany]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-C-Patienten in Deutschland.

The costs of a guideline-based treatment in chronic hepatitis C infected people are unknown. The goal of HCV therapy is to achieve a sustained viral response and thereby to reduce morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma. This study analyses the costs of a guideline-based treatment based on the German guideline on the management of HCV infection. In addition, costs of newly introduced protease inhibitors were calculated. Costs for baseline diagnostics, monitoring and medical treatment were calculated according to the stage of the disease, the HCV genotype and viral response. Costs for baseline diagnostics account for €â€Š302.75 and monitoring accounts for €â€Š596 to €â€Š1173. Dual therapy with pegylated interferon and ribavirin results in average costs of €â€Š7709 to €â€Š34 692. Total costs of a guideline-based treatment range between €â€Š8,608 and €â€Š36 167 depending on HCV genotype and length of therapy. With the introduction of protease inhibitors for HCV genotype 1 patients, costs of pharmaceuticals have increased further. Triple-therapy with telaprevir accounts for €â€Š43 280 respectively €â€Š54 844. Costs for Boceprevir treatment range from €â€Š34 143 to €â€Š60 990. Due to increasing costs, health-economic evaluations gain significant relevance and should be considered when implementing new treatment strategies.

[Costs of guideline-based treatment of hepatitis B patients in Germany]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-B-Patienten in Deutschland.

The costs of guideline-based treatment are unknown for most diseases. This also applies for economically significant infectious diseases like viral hepatitis and HIV. On the basis of the "German Guidelines for the Management of HBV Infection" from 2011 patients were grouped into HBsAg-positive, immuntolerant and chronic hepatitis patients with and without cirrhosis. Costs were divided in baseline diagnostics, monitoring and medical treatment according to the guideline. The calculation was modelled for a period of five years. Costs for virological diagnostics and imaging account for a large proportion of diagnostic costs. The main cost factors are expenses for pharmaceutical treatment with interferon or HBV polymerase inhibitors. On the assumption that only 25 % of the infected patients are diagnosed, 5-year total costs in Germany account for more than 2.5 billion Euros. Therefore, chronic hepatitis B is a disease with a very high economic burden. The aim of a guideline treatment is to prevent the development of cirrhosis with all its complications as well as the development of liver-cell carcinoma. Prophylactic vaccination against hepatitis B should be advised also considering the potential economic impact.

Estimating trends in working life expectancy based on health insurance data from Germany - Challenges and advantages.

Against the backdrop of population aging and growing strain on pension systems, monitoring the development of Working Life Expectancy (WLE) is vital to assess whether the policies taken are effective. This is the first study investigating time trends and educational inequalities in WLE based on German health insurance data. The analyses are based on the data of the AOK Lower Saxony (N = 3,347,912) covering three time periods (2006-08, 2011-13, and 2016-18). WLE is defined as years spent in the labor force (i.e. in employment and unemployment) and was calculated for each age between 18 and 69 years for the three periods to depict changes over time using multistate life table analysis. Educational inequalities in 2011-13 are reported for two educational levels (8-11 years and 12-13 years of schooling). WLE increased in both sexes with increases being stronger among women. This holds irrespective of whether WLE at age 18 (35.8-38.3 years in men, 27.5-34.0 years in women) or the older working-age (e.g. at age 50 10.2-11.7 years in men, 7.8-10.5 years in men) is considered. Among women at all ages and men from their mid-20s onwards, WLE was higher among higher-educated individuals. Inequalities were most pronounced among women (e.g. Δ3.1 years in women, Δ1.3 years in men at age 50). The study supports previous research indicating that measures to extend working life are effective, but that noticeable inequalities in WLE exist. Health insurance data represent a valuable source for such research that has so far remained untapped. The data provide a suitable basis to investigate trends and inequalities in WLE. Future research should build on the strengths of the data by broadening the research towards a more comprehensive analysis of the development of WLE from a health perspective.

Hand hygiene in intensive care units: a matter of time?

BACKGROUND: Healthcare-associated infections are a frequent threat to patient safety and cause significant disease burden. The most important single preventive measure is hand hygiene (HH). Barriers to adherence with HH recommendations include structural aspects, knowledge gaps, and organizational issues, especially a lack of time in daily routine. AIM: To determine the number of hand hygiene opportunities (HHOs), compliance rates, and time spent on hand hygiene in intensive care units (ICUs). METHODS: We conducted an observational study in two ICUs to determine the average number of HHOs per patient. Documentation was based on the World Health Organization concept of 'five moments for hand hygiene'. HHOs were collected in 12 patient rooms for 12h each. FINDINGS: On average, 134 (internal ICU) and 182 (surgical ICU) HHOs per patient were observed during the 12h observation period. Overall HH compliance was 42.6%. Considering additional HHOs during the night shift, we estimated 218 (internal ICU) and 271 (surgical ICU) HHOs per patient-day. The average duration of hand disinfection was 7.6s. The time spent on HH was 8.3 (internal ICU) and 11.1 (surgical ICU) min during the day shift for each patient for all healthcare workers (nurses: 6.9min in the internal ICU and 8.3min in the surgical ICU). If nurses fully complied with guidelines, 58.2 (internal ICU) and 69.8 (surgical ICU) min would be spent on HH for each patient during the day shift. CONCLUSION: Complying with guidelines is time-consuming. Sufficient time for HH should be considered in staff planning.