Carbapenem-resistant gram-negative bacteria in Germany: incidence and distribution among specific infections and mortality: an epidemiological analysis using real-world data.

PURPOSE: Infections with carbapenem-resistant gram-negative bacteria (in Germany classified as 4MRGN) are a growing threat in clinical care. This study was undertaken to understand the overall burden of 4MRGN infections in Germany in the context of a Health Technology Appraisal (HTA) for Ceftazidime/Avibactam (CAZ/AVI). Besides, the incidences mortality was an endpoint of interest. METHODS: To assess infections with carbapenem-resistant gram-negative bacteria and related mortality, three different data sources have been used. From the German statistics office (DESTATIS) data have been retrieved to obtain the overall frequency these pathogens. Via two other databases, the German analysis database (DADB) and a Benchmarking of > 200 hospitals in a representative sample (BM-DB), the distribution of the infections and the mortality have been analyzed. RESULTS: DESTATIS data showed a total of 11,863 carbapenem-resistant gram-negative bacteria codings, of which 10,348 represent infections and 1515 carriers. The most frequent infections were complicated urinary tract infections (cUTI) (n = 2,337), followed by pneumonia (n = 1006) and intra-abdominal infections (n = 730). A considerable amount of patients had multiple infections in one hospital episode (n = 1258). In-hospital mortality was 18.6% in DADB and 14.3% in the BM-DB population, respectively. In cases with additional bloodstream infections, DADB mortality was correspondingly higher at 33.0%. DADB data showed an incremental mortality increase of 5.7% after 30 days and 10.0% after 90 days resulting in a cumulative 90 day mortality of 34.3%. CONCLUSIONS: Infections with carbapenem-resistant gram-negative bacteria are still rare (6.8-12.4 per 100,000) but show a significant increase in mortality compared to infections with more sensitive pathogens. Using different data sources allowed obtaining a realistic picture.

Costs of dose escalation among ulcerative colitis patients treated with adalimumab in Germany.

AIMS: We determined adalimumab utilisation and associated drug costs in patients with ulcerative colitis (UC), focusing on patients requiring dose escalation. METHODS: The retrospective cohort study analysed the de-identified prescription data of the Arvato Health Analytics (Munich, Germany) database (2010-2015) in adult UC patients undergoing adalimumab therapy. RESULTS: A total of 154 patients were newly treated with adalimumab (average 39.6 years, 53% females), with a mean dose of 2.93 mg/day. Within 12 months, 69 patients (45%) received a dose increase of > 50% (doubled dose in 48 patients; 32%), with the escalation reported at 169.3 ± 99.3 days. A subsequent dose de-escalation to the standard dose occurred in 50 (32%) of patients that initially had a dose increase of > 50% (after 94.7 ± 49.6 days). Direct drug costs were 28,846 € in the overall study population, 24,934 € in patients on standard dose, 36,094 € in patients with dose increase, and 32,742 € in patients with increase and subsequent decrease. CONCLUSION: Dose escalation occurred frequently, and in one third of patients the dose was at least doubled. Dose escalations were associated with substantial increases in direct drug costs. Dose escalation of adalimumab can severely affect both the health care system and the drug budget of the physician. It needs to be considered that other biologic medications may constitute a more cost-effective alternative.

Incidence, Treatment Patterns, and Health Care Costs of Infantile Hemangioma: Results of a Retrospective German Database Analysis.

OBJECTIVES: To determine the incidence, effect (defined according to treatment rate), and health care costs of infantile hemangiomas (IHs) in Germany from 2007 to 2012 by analyzing patient data of German statutory health insurances. METHODS: A retrospective analysis using data from a database matched with the overall population covered by German statutory health insurance was performed. To describe the treatment rate and costs of IHs, a search algorithm was developed dividing the study population into three groups (patients with IHs, patients with IHs possibly requiring treatment, and patients with IHs receiving treatment). RESULTS: The incidence of IHs was 2.0% to 3.2%, with a slight increase during the later years of the study period and a female:male ratio of 1.4:1. IH incidence was lower and girls were less likely to present with IHs than in previous reports. The mean treatment rate of IHs was 11.3%. Mean health care costs during first year of life for infants diagnosed with IHs in 2012 were slightly lower (€2,396) than for all infants (€2,649), whereas costs for infants diagnosed and treated for IHs were considerably higher (€10,550). The majority of these costs were due to hospitalization (€8,658). CONCLUSION: This retrospective study is the first to analyze the incidence and sex ratio of IHs based on German claims data. The treatment rate of IHs was consistent with previous reports. The mean health care costs for treated patients with IHs were substantially higher than those for all newborns. Limitations of this study are coding bias, a limited sample size, and claims perspective (nonclinical approach).