Cost effectiveness of using trastuzumab biosimilars compared to trastuzumab original drugs to treat breast cancer in a hospital setting.

INTRODUCTION: Subcutaneous (SC) drug administration, such as the Herceptin® in an oncology day hospital reduces the administration time of trastuzumab. In the context of combination therapy administration, this time-saving may be called into question. The challenge posed by the deployment of much less expensive IV biosimilar forms raises questions about the cost-effectiveness of SC administration. METHODS: Using data from a french Diagnostic Related Groups regarding prescriptions of intravenous Herceptin® (HIV), Herceptin® biosimilar IV (BSIV), and Herceptin® subcutaneous (HSC), we conducted two simulations. This simulation involved replacing all HSC with BSIV in combination therapy administration (Simulation 1) and subsequently substituting IV forms with SC forms only when prescribed as monotherapy (Simulation 2). A cost-benefit analysis was conducted based on these two simulations, from the hospital's perspective, for Normandy's population over a 1-year timeframe. RESULTS: In Simulation 1, there was an average cost-saving of €12 per patient per year, but it resulted in a loss of 10140 min, equivalent to 10 min per patient per year when compared to the current situation. Simulation 2 yielded average cost-savings for the hospital amounting to €51 per patient per year, along with a time-saving of 67 min per patient per year compared to the current situation. CONCLUSIONS: The development of a program aimed at optimizing the prescription of Trastuzumab holds the potential to deliver significant cost-savings to hospitals while enhancing the quality of service provided to the patients. This optimization involves using H SC in monotherapy and BS IV in combination therapy administration.

Introduction of biosimilar pegfilgrastim in France: Economic analysis of switching from originator.

OBJECTIVES: To assess the economic impact of introducing biosimilar pegfilgrastim compared to the current standard granulocyte colony-stimulating factor (G-CSF) practice in France. METHODS: A budget impact model was developed to investigate the impact of introducing pegfilgrastim biosimilar over 5 years. The model analysed drug acquisition costs, ambulatory costs, as well as costs associated with poor outcomes, and compared the current standard practice of long-acting and short-acting G-CSF to a revised practice including pegfilgrastim biosimilar in addition to standard practice treatments. The cost of switching to pegfilgrastim biosimilar, within a pharmacy setting, was analysed within the model using data from a survey of French pharmacists. RESULTS: The budget impact model calculated a cost saving of €51,007,531 over 5 years switching from the current standard practice to pegfilgrastim biosimilar. A sensitivity analysis accounting for variation in pegfilgrastim biosimilar uptake of 1) 15% in year 1 and 1% in years 2-5 and 2) 15% in years 1-5, estimated savings ranging between €29,377,784 and €79,847,194, respectively. A further analysis predicted cost savings of €287,344,835 over 5 years with the extension of pegfilgrastim biosimilar, at an uptake of 15% in year 1 and 7% in years 2-4, to both long-acting and short-acting G-CSF groups compared to unchanged current practice. CONCLUSIONS: The introduction of pegfilgrastim biosimilar will help to reduce cost and alleviate some of the financial pressure on the French healthcare system.

Management and cost analysis of cancer patients treated with G-CSF: a cohort study based on the French national healthcare insurance database.

OBJECTIVES: To describe the management and costs associated with G-CSF therapy in cancer patients in France. METHODS: This study analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer. Then the costs and characteristics of patients associated with the use of different G-CSF products were analyzed in the sub-set of breast cancer patients. RESULTS: The most frequent malignancies in the database population were breast cancer (23.3%), hematological malignancies (22.2%), and lung cancer (12.4%). The reimbursed G-CSF was pegfilgrastim in 34.1% of cases, lenograstim in 26.7%, and filgrastim in 17.9%. More than one G-CSF product was reimbursed to 21.3% of patients. The total annual reimbursed health expenses per patient, according to the type of G-CSF, were €27,001, €24,511, and €20,802 for patients treated with filgrastim, lenograstim, and pegfilgrastim, respectively. Ambulatory care accounted for, respectively, 35%, 38%, and 41% of those costs. In patients with breast cancer, ambulatory care cost was €7,915 with filgrastim, €7,750 with lenograstim, and €6,989 with pegfilgrastim, and the respective cost of G-CSF was €1,733, €1,559, and €3,668. CONCLUSION: All available G-CSF products have been shown to be effective in cancer patients, and both daily G-CSFs and pegylated G-CSF are recommended in international guidelines. Nevertheless, this analysis of G-CSF reimbursement indicates that the choice of product can markedly affect the total cost of ambulatory care.

Cost-effectiveness analysis on the use of fidaxomicin and vancomycin to treat Clostridium difficile infection in France.

BACKGROUND: Fidaxomicin is a macrocyclic antibiotic with proven efficacy against Clostridium difficile infection (CDI) in adults. It was licensed in France in 2012, but, due to higher acquisition costs compared with existing treatments, healthcare providers require information on its cost/benefit profile. OBJECTIVE: To compare healthcare costs and health outcomes of fidaxomicin and vancomycin, as reference treatment for CDI. METHODS: A Markov model was used to simulate the treatment pathway, over 1 year, of adult patients with CDI receiving fidaxomicin or vancomycin. Several patient sub-groups (severe CDI; recurrent CDI; concomitant antibiotics; cancer; renal failure; elderly) were evaluated. Cost-effectiveness was analyzed based on cure and recurrence rates derived from published randomized clinical trials comparing fidaxomicin and vancomycin, and costs calculated from the payer perspective using French hospitalization data and drug cost databases. Model outputs included costs in euros (reference year 2014) and health outcomes (recurrence; sustained cure rates). Alternative scenario and sensitivity analyses were performed using data from other clinical trials in CDI, including one conducted in real-life clinical practice in France. RESULTS: Drug acquisition costs were €1,692 higher in fidaxomicin-treated patients, but this was offset by the lower hospitalization costs with fidaxomicin, which were reduced by €1,722. The reduction in the cost of hospitalization was driven by the significantly lower number of recurrences in fidaxomicin-treated patients, offsetting the acquisition cost of fidaxomicin in all sub-groups except recurrent CDI and concomitant antibiotics. CONCLUSION: This study demonstrated that, despite higher acquisition costs, the lower recurrence rate with fidaxomicin resulted in cost savings or low incremental costs compared with vancomycin.

Cost of managing anemia in end-stage renal disease: the experience of five French dialysis centers.

OBJECTIVE: The aim of this retrospective study was to evaluate the direct cost of anemia treatment in hemodialysis patients and to evidence factors predictive of 1-year cost. METHODS: Retrospective study which included hemodialyzed patients during year 2009 in five centers. Patients were evaluable if they had at least one hemoglobin (Hb) assay per month and were monitored for at least 4 months. Patients were classified in different "annual Hb category" according to their monthly mean Hb [Hb categories: Ideal (10 ≤ Hb ≤ 12 g/dL); High (Hb > 12 g/dL) and Low (Hb < 10 g/dL) if >75% of time in respective category, otherwise classified in the Fluctuating category]. RESULTS: We analyzed 636 patients (male, 59.4%) with a mean age of 67 years who underwent 144 hemodialysis sessions (median number per patient) in 2009. The cost of anemia treatment was largely driven by erythropoiesis-stimulating agents (ESA) (68% of total cost for Low Hb category and approximately 90% for the other Hb categories). Adjusted predictive factors for 1-year direct cost of anemia treatment (p < 0.0001) were dialysis center (2,518-5,617), death (6,091 vs. 4,911), age (4,911 for ≤55 years and 5,378 for 65-75 years), female gender (4,911 vs. 4,398 for male), Low Hb category (13,005 vs. 5,034 for Ideal, 4,911 for Fluctuating and 2,418 for High), serum ferritin level (5,102 for 200-500 µg/mL and 4,646 for ≥500 µg/mL) and duration of dialysis (4,911 if ≤2 years and 2,952 if 4-6 years). LIMITATIONS: Retrospective study, and low number of patients in the Low Hb category. CONCLUSIONS: The main factors that were predictive of 1-year cost of anemia treatment in hemodialysis patients were centers, patients in the Low Hb category, and dialysis duration of less than 2 years.

Estimated annual costs of prophylaxis and treatment of venous thromboembolic events associated with major orthopedic surgery in France.

Venous Thromboembolism (VTE) remains a major complication following orthopedic surgery despite heparin prophylaxis. Clinical consequences associated with this complication are deep vein thrombosis (DVT), pulmonary embolism, and long-term consequences of DVT, especially Postthrombotic syndrome (PTS). The purpose of the present study was to estimate the annual direct costs of VTE following major orthopedic surgery of the lower limb in France. This cost of illness study was performed by using available information from health system databases (1999) and literature and specific surveys (2002). Direct costs were calculated by using estimates of the number of patients with major orthopedic surgery in France during one year. Patients presenting with VTE were identified from the national disease-related group inpatient database. Additional resource consumption was identified by comparison with disease-related groups without the VTE complications. Ambulatory care costs after hospitalization, for recurrences and PTS, were estimated from specific surveys of general practitioners and venous disease specialists. Total annual costs of VTE associated with major orthopedic surgery for the French Sickness Fund were estimated to be approximately 60 million euros over 1 year with 28 million euros for inpatient care and 30 million euros for recurrences and PTS.

[Medico economic analysis in first line chemotherapy in advanced lung cancer]. / Analyse economique de deux chimiothérapies en première ligne du cancer pulmonaire a un stade avancé.

Our objective was to analyse economic consequences modifying first line chemotherapy in treatment non small cell lung cancer IIIB-IV. Therefore a cost minimisation has been performed. Resources consumption were collected in a Pneumology department for 21 patients receiving previously mitomycine-ifosfamide-platin and for the 21 first patients receiving vinorelbine-platin, new patients diagnosed during year 2001. Costs were derived from hospital accounting system, economic analysis performed from the hospital and from the health French system points of view. Activity Synthetic Index point decrease of 2.9% per patient in vinorelbine-platin versus mitomycine-ifosfamide-platin, as an increase of 64.6% of hospital drug spending is registered (1,893 Euro versus 1,150 Euro) and an over cost of 15.7% for health French system (14179 Euro versus 12,257 Euro). Whatever the perspective of economic analysis, vinorelbine-platin arm is dominated by the mitomycine-ifosfamide-platin arm.

Routine once-weekly darbepoetin alfa administration is cost-effective in lung cancer patients with chemotherapy-induced anemia: a Markov analysis.

BACKGROUND: Despite the clinical efficacy of recombinant human erythropoietin (RHE) on chemotherapy-induced anemia, most cost-effectiveness studies have given unfavorable results. OBJECTIVE: To determine the cost of managing anemia in unselected patients receiving chemotherapy for lung cancer, and the efficacy and cost-effectiveness of RHE. METHOD: We constructed Markov models of two cohorts of patients who received (n=94) or did not receive (n=89) darbepoetin (one weekly injection when the hemoglobin level fell below 11 g/dl), focusing on changes in hemoglobin levels, transfusion requirements, anemia management costs, and the cost-effectiveness ratios of the two management strategies. RESULTS: The use of RHE significantly reduced the proportion of patients needing transfusions (from 33.6% to 19.1%, p<0.05) and the number of red cell units used by transfusion (from 2.97+/-1.47 to 2.11+/-0.47, p<0.01). Markov modeling showed that the RHE strategy significantly increased the mean Hb level (13+/-0.5 g/dl versus 11.9+/-1g/dl, p<0.001), at the price of an increase in the main cost (respectively, US$ 1732+/-897 and 996+/-643; p<0.01). The cost-effectiveness ratio favored the RHE strategy (7.02 versus 9.04). Sensitivity analysis showed that the RHE strategy remained dominant in most situations. CONCLUSION: Routine use of RHE appears to be cost-effective in patients receiving chemotherapy for lung cancer.

Cost-effectiveness of propofol anesthesia using target-controlled infusion compared with a standard regimen using desflurane.

The cost-effectiveness of propofol anesthesia using target-controlled infusion (TCI) versus a standard regimen using desflurane for anesthesia maintenance was analyzed. This observational study consisted of 100 inpatients 18 to 75 years old with an American Society of Anesthesiologists physical status of I or II who were scheduled for otological surgery lasting less than four hours. Patients received one of two treatments. The desflurane-maintenance group received propofol 2-4 mg/kg and sufentanil 0.15-0.30 microg (as the citrate)/kg. A constant fresh gas flow of 1 L/min was used during maintenance of anesthesia. The propofol-maintenance group received TCI propofol and an additional infusion of sufentanil. Anesthesia was induced with 0.15-0.30 microg/kg. One blinded evaluator assessed the postoperative recovery from anesthesia for all patients. The cost of drugs and medical devices used during the intraoperative and postoperative periods was calculated. Effectiveness was defined as the absence of postoperative nausea and vomiting (PONV), while the cost-effectiveness of each procedure was the cost per PONV-free episode. The efficiency of each procedure represented the production of effectiveness per dollar invested. Chi-square and t tests, sensitivity analysis, and logistic regression were also performed. The only intergroup difference detected was the frequency of PONV occurring in the early recovery phase (11 in the desflurane group versus 2 in the propofol group). Of those patients requiring antiemetic rescue, 9 were in the desflurane group and only 2 were in the propofol group (p < 0.05). The TCI propofol regimen was more expensive than the desflurane regimen ($45 versus $28 per patient, respectively) (p < 0.001). The differential cost-effectiveness ratio was $94.7 per PONV-free episode. PONV 24 hours after surgery and patient satisfaction were similar between groups. A standard regimen of desflurane was more cost-effective than TCI propofol for anesthesia maintenance in achieving PONV-free episodes.

Desflurane improves the throughput of patients in the PACU. A cost-effectiveness comparison with isoflurane.

PURPOSE: In a pharmacoeconomic approach of anesthesia, postanesthesia care unit (PACU) occupancy can be chosen as a criteria of effectiveness to compare two anesthetic drugs with different rates of elimination and different costs of administration. Our objective was to develop a cost-effectiveness approach for the comparison of isoflurane (I) and desflurane (D). METHOD: In this prospective observational study, 68 patients aged 18-70 received either D or I for maintenance of anesthesia for inpatient abdominal procedures. Length of stay (LOS) in PACU was collected by a blinded observer. After the relationship between duration of surgery and LOS in PACU had been established in the 68 observed patients, we estimated the PACU occupancy according to duration of surgery and time of admission in PACU using a computer model of 204 consecutive patients, based on the hypothesis of an exclusive use of either D or I. Outcome measures were direct costs of the anesthesia procedure and occupancy of the PACU. RESULTS: The direct cost of the anesthetic was significantly higher with D than with I. This represents an increase of CAN$ 2 708 for the 204 patients. PACU occupancy was reduced by at least one patient (out of five beds) during 26.1% of the time with D (P <0.01). DISCUSSION: Improving the throughput of patients in PACU by using new halogenated anesthetic agents with faster rates of elimination may outweigh the incremental cost of this strategy. This becomes particularly meaningful in operating theatres experiencing frequent overcrowded periods.