Compounded glycopyrrolate is a compelling choice for drooling children: five years of facility experience

Background Describe the efficacy of a galenic glycopyrrolate formulation and its impact on patients with sialorrhea Quality of Life (QoL), including costs analysis. Methods We performed a retrospective observational study on 21 patients who received a custom-formulated galenic glycopyrrolate syrup for sialorrhea for an average period of 14.3 months. We analyzed the telephone interviews with elaborated and validated questionnaires and the therapy costs comparing the brand marketed drug with the galenic formulation. Results Overall, 16 out of 21 patients (76.2%) reported a significant improvement in sialorrhea and QoL. In 14 subjects (66.7%), there was a remarkable decrease in the drooling severity; 10 individuals (47.6%) reported a reduction in drooling frequency. Nine patients experienced at least one adverse effect of glycopyrrolate therapy, and three of them stopped the treatment. No severe side effects were observed. The galenic drug significantly reduced costs for patients. Conclusions An oral glycopyrrolate solution easily administered to children with brain injuries is not commercially available in many European countries. This study demonstrates the efficacy of a compounded glycopyrrolate syrup on drooling severity, frequency and ensures a better QoL in patients and their caregivers.

Impact of ABCDE Bundle Implementation in the Intensive Care Unit on Specific Patient Costs

Objectives: To measure the impact of full versus partial ABCDE bundle implementation on specific cost centers and related resource utilization. Design: Retrospective cohort study. Setting: Two medical ICUs within Montefiore Health System (Bronx, NY). Patients: Four hundred and seventy-two mechanically ventilated patients admitted to the medical ICUs during a hospitalization which began and ended between January 1, 2013 and December 31, 2013. Interventions: The full (A)wakening, (B)reathing, (C)oordination, (D)elirium Monitoring/Management and (E)arly Mobilization bundle was implemented in the intervention ICU while a portion of the bundle (A, B, and D components) was implemented in the comparison ICU. Measurements and Main Results: Relative to the comparison ICU, implementation of the entire bundle in the intervention ICU was associated with a 27.3% (95% CI: 9.9%, 41.3%; P = 0.004) decrease in total hospital laboratory costs and a 2,888.6% (95% CI: 77.9%, 50,113.2%; P = 0.018) increase in total hospital physical therapy costs. Cost of total hospital medications, diagnostic radiology and respiratory therapy were unchanged. Relative to the comparison ICU, total hospital resource use decreased in the intervention ICU (incidence rate ratio [95% CI], laboratory: 0.68 [0.54, 0.87], P = 0.002; diagnostic radiology: 0.75 [0.59, 0.96], P = 0.020). Conclusions: Full ABCDE bundle implementation resulted in a decrease in total hospital laboratory costs and total hospital laboratory and diagnostic resource utilization while leading to an increase in physical therapy costs.

The Role of Streptococcus spp. in Bovine Mastitis

The Streptococcus genus belongs to one of the major pathogen groups inducing bovine mastitis. In the dairy industry, mastitis is the most common and costly disease. It not only negatively impacts economic profit due to milk losses and therapy costs, but it is an important animal health and welfare issue as well. This review describes a classification, reservoirs, and frequencies of the most relevant Streptococcus species inducing bovine mastitis (S. agalactiae, S. dysgalactiae and S. uberis). Host and environmental factors influencing mastitis susceptibility and infection rates will be discussed, because it has been indicated that Streptococcus herd prevalence is much higher than mastitis rates. After infection, we report the sequence of cow immune reactions and differences in virulence factors of the main Streptococcus species. Different mastitis detection techniques together with possible conventional and alternative therapies are described. The standard approach treating streptococcal mastitis is the application of ß-lactam antibiotics. In streptococci, increased antimicrobial resistance rates were identified against enrofloxacin, tetracycline, and erythromycin. At the end, control and prevention measures will be considered, including vaccination, hygiene plan, and further interventions. It is the aim of this review to estimate the contribution and to provide detailed knowledge about the role of the Streptococcus genus in bovine mastitis.

Increasing Number of Individuals Receiving Hepatitis B nucleos(t)ide Analogs Therapy in Germany, 2008–2019

Background: Germany is a low prevalence country for hepatitis B virus (HBV) infection with higher prevalence in vulnerable groups. The number of treated chronic hepatitis B (CHB) patients is unknown. We aimed to determine the number of CHB patients treated with nucleos(t)ide analogs (NUCs), the treatment costs within the statutory health insurance (SHI) in Germany and per patient per month.Methods: Data on pharmacy bills of NUCs to patients with SHI between 2008 and 2019 were purchased from Insight Health™ and described. Negative binomial regression was used for trend analysis.Results: Number of patients increased between 2008 and 2019 (4.9% per year) with little changes in treatment options. Overall prescription costs were increasing (6.7% per year on average) until the introduction of tenofovir and entecavir generics in 2017 after which costs decreased by 31% in 2019. Average therapy costs peaked at 498 Euro per patient per month in 2016 and decreased to 214 Euro in 2019. Prescriptions changed from 30 to 90 pills per pack over time. HBV therapy was prescribed to 97% by three medical specialist groups, mainly specialists in internal medicine (63%), followed by hospital-based outpatient clinics (20%) and general practitioners (15%). Contrary to guideline recommendation, adefovir was still prescribed after 2011 for 1–5% of patients albeit with decreasing tendency. Prescriptions per 100,000 inhabitants were highest in Berlin and Hamburg.Conclusion: Our data shows, that the number of treated CHB patients increased steadily, while NUC therapy costs decreased. We recommend continued testing and treatment for those eligible to prevent advanced liver disease and possibly decrease further transmission of HBV.

Cost-Effectiveness Analysis of 68Ga DOTA-TATE PET/CT, 111In-Pentetreotide SPECT/CT and CT for Diagnostic Workup of Neuroendocrine Tumors

Neuroendocrine tumors (NETs) are relatively rare neoplasms arising from the hormone-producing neuroendocrine system that can occur in various organs such as pancreas, small bowel, stomach and lung. As the majority of these tumors express somatostatin receptors (SSR) on their cell membrane, utilization of SSR analogs in nuclear medicine is a promising, but relatively costly approach for detection and localization. The aim of this study was to analyze the cost-effectiveness of 68Ga-DOTA-TATE PET/CT (Gallium-68 DOTA-TATE Positron emission tomography/computed tomography) compared to 111In-pentetreotide SPECT/CT (Indium-111 pentetreotide Single Photon emission computed tomography/computed tomography) and to CT (computed tomography) alone in detection of NETs. A decision model on the basis of Markov simulations evaluated lifetime costs and quality-adjusted life years (QALYs) related to either a CT, SPECT/CT or PET/CT. Model input parameters were obtained from publicized research projects. The analysis is grounded on the US healthcare system. Deterministic sensitivity analysis of diagnostic parameters and probabilistic sensitivity analysis predicated on a Monte Carlo simulation with 30,000 reiterations was executed. The willingness-to-pay (WTP) was determined to be $ 100,000/QALY. In the base-case investigation, PET/CT ended up with total costs of $88,003.07 with an efficacy of 4.179, whereas CT ended up with total costs of $88,894.71 with an efficacy of 4.165. SPECT/CT ended up with total costs of $89,973.34 with an efficacy of 4.158. Therefore, the strategies CT and SPECT/CT were dominated by PET/CT in the base-case scenario. In the sensitivity analyses, PET/CT remained a cost-effective strategy. This result was due to reduced therapy costs of timely detection. The additional costs of 68Ga-DOTA-TATE PET/CT when compared to CT alone are justified in the light of potential savings in therapy costs and better outcomes.

The cost-effectiveness of azithromycin in reducing exacerbations in uncontrolled asthma

Add-on azithromycin (AZM) results in a significant reduction in exacerbations among adults with persistent uncontrolled asthma. The aim of this study was to assess the cost-effectiveness of add-on AZM in terms of healthcare and societal costs.The AMAZES trial randomly assigned 420 participants to AZM or placebo. Healthcare use and asthma exacerbations were measured during the treatment period. Healthcare use included all prescribed medicine and healthcare contacts. Costs of antimicrobial resistance (AMR) were estimated based on overall consumption and published estimates of costs. The value of an avoided exacerbation was based on published references. Differences in cost between the two groups were related to differences in exacerbations in a series of net monetary benefit estimates. Societal costs included lost productivity, over the counter medicines, steroid induced morbidity and AMR costs.Add-on AZM resulted in a reduction in healthcare costs (mean (95% CI)) including nights in hospital (AUD$433.70 ($48.59–$818.81) or €260.22(€29.15–€491.29)), unplanned healthcare visits (AUD$20.25 ($5.23–$35.27) or €12.15 (€3.14–€21.16)), antibiotic costs (AUD$14.88 ($7.55–$22.21) or €8.93(€4.53–€13.33)) and oral corticosteroid costs (AUD$4.73 ($0.82–$8.64) or €2.84(€0.49–€5.18)), all p<0.05. Overall healthcare and societal costs were lower (AUD$77.30 (€46.38) and AUD$256.22 (€153.73) respectively) albeit not statistically significant. The net monetary benefit of add-on AZM was estimated to be AUD$2072.30 (95% CI $1348.55–$2805.23) or (€1243.38 (€809.13–€1683.14) assuming a willingness to pay per exacerbation avoided of AUD$2651 (€1590.60). Irrespective of the sensitivity analysis applied, the net monetary benefit for total, moderate and severe exacerbations remained positive and significant.Add-on AZM therapy in poorly controlled asthma was a cost-effective therapy. Costs associated with AMR did not influence estimated cost-effectiveness.

Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: the experience of the Hellenic Cooperative Oncology Group

BackgroundWe evaluated real-world clinical outcomes and toxicity data and assessed treatment-related costs in patients with advanced breast cancer who received treatment with cyclin-dependent kinase inhibitors (CDKi).Patients and methodsWe conducted a prospective–retrospective analysis of patients with advanced hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who received a CDKi, in combination with endocrine therapy, at any line of treatment. The primary endpoint was progression-free survival (PFS). Cost analysis was conducted from a public third-payer (National Organization for Healthcare Services Provision (EOPYY)) perspective, assessing only costs related to direct medical care, including drug therapy costs and adverse drug reaction (ADR)-related costs.ResultsFrom July 2015 to October 2019, 365 women received endocrine therapy combined with CDKi; median age was 61 years, postmenopausal 290 (80.6%) patients. CDKi were administered as first-line treatment in 149 (40.9%) patients, second-line treatment in 96 (26.4%) and third-line treatment and beyond in 119 (32.7%) patients. The most common adverse events were neutropenia, anaemia, thrombocytopenia and fatigue. Grade 3–4 adverse events occurred in 86 (23.6%) patients, whereas 8 (2.2%) patients permanently discontinued treatment due to toxicity. The median PFS for patients who received CDKi as first-line, second-line and third-line treatment and beyond was 18.7, 12 and 7.4 months, respectively. The median overall survival since the initiation of CDKi treatment was 29.9 months (95% CI: 23.0–not yet reached (NR)). The mean pharmaceutical therapy cost estimated per cycle was 2 724.12 € for each patient, whereas the main driver of the ADR-related costs was haematological adverse events.ConclusionsTreatment with CDKi was well tolerated, with a low drug discontinuation rate. Patients who received CDKi as first-line treatment had improved PFS and OS compared with second-line treatment and beyond. The main component of direct medical costs assessed in the cost analysis comprises CDKi pharmaceutical therapy costs.Trial registration numberNCT04133207

Second Opinions before Surgery Have the Potential to Reduce Costs – An Exploratory Analysis

Aim In this study cost data of patientʼs first and second opinion of a German second opinion program of patients with orthopedic indications are raised and compared. Methods Anonymized patient data were used from a second opinion program gathered in the period from 2013 to 2015. Costs of the first and second opinion were raised using DRG, the EBM catalog, the remuneration agreement on physical therapy and the price of drugs. In order to increase transferability, initial therapy recommendation and second opinion were compared in a cost analysis to determine a theoretical savings potential. Results A total of 170 consecutive patients with orthopedic indication and first and second opinion were analyzed in this study. Only one out of three initial therapy recommendations was confirmed by the second opinion. In the second opinion, physiotherapy and pain therapy were often suggested for indications which received a surgery referral by the initial therapy recommendation. In scenario 1 (average resource use), the costs of the first therapy recommendation in median was 5020.96 € (IQR = 961.71 – 7342.66), the second opinion was 322.07 € (IQR = 146.39 – 1341.32). In median, the operation costs of the initial therapy recommendation were equal to 156.12 physiotherapeutic sessions and 26.02 N3 packs Ibuprofen 800. Conclusion Therapy costs for the initial therapy recommendation are clearly exceeding the therapy costs of the second opinion. This assumes a potential to reduce therapy costs with the use of a second opinion. This study lays the foundation to carry out further conclusive analyses concerning this matter.