The Impact of Introducing Successive Biosimilars on Changes in Prices of Adalimumab, Infliximab, and Trastuzumab-Polish Experiences.

Biosimilars are cheaper than original drugs and are thus of interest to the public. The aim of this article is to assess the benefits of introducing more than one biosimilar for the same substance (active pharmaceutical ingredient, API). The hypothesis is that the introduction of successive biosimilars of a specific original drug reduces the price of the selected API. The study focuses on drug prices varying with the successive arrival of new biosimilars. Three drugs that have at least three reimbursed biosimilars on the market were selected, two from the same therapeutic group (adalimumab and infliximab) and one (trastuzumab) representing another class of drugs. The following data were analyzed: price variation after the introduction of the first, second, and third biosimilar, and the average price reduction for all three biosimilars. Additionally, a literature review was conducted. The reimbursement of each new biosimilar is beneficial since it is associated with a price reduction in percentage terms. However, the first biosimilar brought about the greatest savings due to the higher initial prices of the original drugs and to Polish reimbursement rules. This article is helpful for when taking healthcare decisions regarding the pricing of and reimbursement for new biosimilars.

An evaluation of the usefulness of extracorporeal liver support techniques in patients with severe liver dysfunction.

INTRODUCTION: The mortality rate in patients with severe liver dysfunction with no option of transplantation is unacceptably high. The main aim of this study was to evaluate the usefulness of applying extracorporeal liver support (ECLS) techniques in this group of patients. MATERIAL AND METHODS: Data from hospital admissions of 101 patients with severe liver dysfunction who were admitted to the department of Anaesthesiology and intensive therapy between 2006 and 2015 were retrospectively analysed. The study group was divided into two subgroups. Standard Medical therapy (SMT) was a subgroup of patients receiving standard Medical therapy, and SMT + ECLS was a subgroup containing patients receiving standard medical therapy complemented by at least one extracorporeal liver support procedure. RESULTS: Significantly lower intensive care unit (ICU) mortality and 30-day mortality rates were found in the SMT + ECLS subgroup (p = 0.0138 and p = 0.0238 respectively). No difference in 3-month mortality was identified between the two groups. In a multivariate model, independent risk factors for ICU mortality proved to be the SOFA score and prothrombin time. The highest discriminatory power for ICU mortality was demonstrated for the SOFA score, followed by APACHE II, SAPS II, MELD UNOS and GCS scores. For 30-day mortality, however, the best discriminatory power was shown for the SAPS II score, followed by SOFA, APACHE II, MELD UNOS and GCS scores. CONCLUSIONS: Further studies are needed to assess the contribution of non-biological extracorporeal liver support procedures to a decrease in mortality rates in the population of patients with severe liver dysfunction.

An Evaluation of the Usefulness of Extracorporeal Liver Support Techniques in Patients Hospitalized in the ICU for Severe Liver Dysfunction Secondary to Alcoholic Liver Disease.

BACKGROUND: The mortality rate in patients with severe liver dysfunction secondary to alcoholic liver disease (ALD) who do not respond to the standard treatment is exceptionally high. OBJECTIVES: The main aim of this study was to evaluate the usefulness of applying extracorporeal liver support techniques to treat this group of patients. PATIENTS AND METHODS: The data from 23 hospital admissions of 21 patients with ALD who were admitted to the department of anesthesiology and intensive therapy (A&IT) at the Dr Wl. Bieganski Regional Specialist Hospital in Lódz between March 2013 and July 2015 were retrospectively analyzed. RESULTS: A total of 111 liver dialysis procedures were performed during the 23 hospitalizations, including 13 dialyses using fractionated plasma separation and adsorption (FPSA) with the Prometheus® system, and 98 procedures using the single pass albumin dialysis (SPAD) system. Upon admission to the intensive care unit (ICU), the median (interquartile range [IQR]) Glasgow coma scale (GCS), sequential organ failure assessment (SOFA), acute physiology and chronic health evaluation (APACHE) II, and simplified acute physiology score (SAPS) II scores were 15 (14 - 15), 9 (7 - 13), 17 (14 - 24), and 32 (22 - 50), respectively. The ICU, 30-day, and three-month mortality rates were 43.48%, 39.13%, and 73.91%, respectively. As determined by the receiver operative characteristic (ROC) analysis for single-factor models, the significant predictors of death in the ICU included the patients' SOFA, APACHE II, SAPS II, and model of end-stage liver disease modified by the united network for organ sharing (MELD UNOS Modification) scores; the duration of stay (in days) in the A&IT Department; and bile acid, creatinine and albumin levels upon ICU admission. The ROC analysis indicated the significant discriminating power of the SOFA, APACHE II, SAPS II, and MELD UNOS modification scores on the three-month mortality rate. CONCLUSIONS: The application of extracorporeal liver support techniques in patients with severe liver dysfunction secondary to ALD appears justified in the subset of patients with MELD UNOS Modification scores of 18 - 30.

Predictive value of the APACHE II, SAPS II, SOFA and GCS scoring systems in patients with severe purulent bacterial meningitis.

BACKGROUND: Scoring systems in critical care patients are essential for predicting of the patient outcome and evaluating the therapy. In this study, we determined the value of the Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score II (SAPS II), Sequential Organ Failure Assessment (SOFA) and Glasgow Coma Scale (GCS) scoring systems in the prediction of mortality in adult patients admitted to the intensive care unit (ICU) with severe purulent bacterial meningitis. METHODS: We retrospectively analysed data from 98 adult patients with severe purulent bacterial meningitis who were admitted to the single ICU between March 2006 and September 2015. RESULTS: Univariate logistic regression identified the following risk factors of death in patients with severe purulent bacterial meningitis: APACHE II, SAPS II, SOFA, and GCS scores, and the lengths of ICU stay and hospital stay. The independent risk factors of patient death in multivariate analysis were the SAPS II score, the length of ICU stay and the length of hospital stay. In the prediction of mortality according to the area under the curve, the SAPS II score had the highest accuracy followed by the APACHE II, GCS and SOFA scores. CONCLUSIONS: For the prediction of mortality in a patient with severe purulent bacterial meningitis, SAPS II had the highest accuracy.

Adult intensive therapy services contracted by the National Health Fund in 2012.

BACKGROUND: Limited financial resources of the National Health Fund (NHF) affect the extent of funding allocated for intensive therapy services. The objective of the study was to analyse the levels of funding the departments of anaesthesiology and intensive therapy are provided with by NHF regional branches in 2012. METHODS: Websites of NHF regional branches were surveyed to obtain the data about the therapeutic entities containing departments of anaesthesiology and intensive therapy, whose services were contracted by NHF in 2012. The contract value, number of contracted points and price of a point were determined for each department. Moreover, based on preliminary survey of the National Official Register of Economic Entities (REGON), the number of intensive therapy beds in the departments in question was calculated. RESULTS: The highest expenditure on adult intensive therapy per one citizen was found in the West Pomeranian, Podlasie and Lesser Poland provinces whereas the lowest one in Swietokrzyskie, Pomeranian and Lublin provinces. CONCLUSION: Funds allocated by NHF for services of departments of anaesthesiology and intensive therapy are insufficient.

Paediatric intensive therapy services contracted by the National Health Fund in 2012.

BACKGROUND: Departments of paediatric anaesthesiology and intensive therapy are relevant elements of the healthcare system in Poland. The aim of the present study was to analyse the level of funding of departments of paediatric anaesthesiology and intensive therapy provided by regional branches of the National Health Fund (NHF) in 2012. METHODS: The survey of websites of regional branches of NHF provided data about therapeutic entities with departments of paediatric anaesthesiology and intensive therapy, whose services were contracted by NHF in 2012. The contract value for 2012, number of contracted points and price of a point were defined for each department. Moreover, using the Register of Therapeutic Entities, the number of intensive therapy beds in the departments of paediatric anaesthesiology and intensive therapy in these entities was determined. RESULTS: The highest expenditure for intensive therapy of children and teenagers under 17 years of age per one citizen was found in the Silesian, Opole and Lodz provinces; the lowest expenditure was observed in the Lubusz (no contracted departments), Swietokrzyskie and Podkarpacie provinces. CONCLUSION: The level of funding of departments of paediatric anaesthesiology and intensive therapy provided by NHF appears to be sufficient; however, the staff and equipment potential of many such departments is not fully exploited.