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Mobilization and collection of peripheral blood stem cells is part of the standard treatment procedure for non-Hodgkin’s lymphoma patients eligible for high-dose chemotherapy with autologous stem cell transplantation. Mobilization is usually achieved with chemotherapy and/or cytokines, but plerixafor might be added in case of poor mobilization. Due to the high cost several institutions have developed their own management pathway to optimize use of plerixafor. Such models are however rarely generalizable; in a multi-center, European, non-interventional study, evaluating the impact of plerixafor in poor mobilizers, country specific differences in patient treatment and cost structure were obvious. For German centers, there was a non-significant reduction in the number of apheresis sessions carried out and in apheresis costs. In contrast to other European countries the majority of German Plerixafor patients were very poor mobilizing patients with initial CD34+ cell count ≤ 10/µl (40/51). In this group the number of apheresis sessions decreased from 2.1 to 1.6 sessions per patient (p = 0.01) and costs decreased from €6246 to €4758 (p = 0.01). Our results show that preemptive plerixafor use has a strong effect in poor mobilizers with an initial CD34+ cell count ≤ 10 cells/µl. CA extern

High-dose chemotherapy alongside peripheral blood stem cell (PBSC) infusion has become the standard of care in different hematologic malignancies. The goal of PBSC mobilization is to allow collection of sufficient CD34+ cells to proceed to transplantation. The current mobilization regimen with granulocyte colony-stimulating factor (G-CSF), alone or in combination with chemotherapy, still fails in 10-25% of patients. Plerixafor is able to rescue most of these patients from mobilization failure. In this study, we investigated the impact of plerixafor on the cost and time spent on apheresis in patients who were considered poor mobilizers, with

Background: Autologous hematopoietic stem cell transplantation (ASCT) is the current standard of care in patients with multiple myeloma (MM) to support reconstitution of the bone marrow after myeloablative chemotherapy. Mobilization of blood progenitor cells to the peripheral circulation is stimulated via administration of granulocyte colony-stimulating factor (G-CSF) with or without chemotherapy. The addition of chemotherapy, typically cyclophosphamide, increases the yield of peripheral blood stem cells (also known as CD34+ cells) at the expense of additional toxicity. The unpredictability of harvest yield and the potential need for weekend apheresis sessions complicates mobilization planning when using chemotherapy. Plerixafor, a CXCR4 antagonist, in combination with G-CSF has been shown to be superior to G-CSF alone, leading to higher CD34+ yields in fewer apheresis sessions [Giralt et al, 2014]. However, the advantage of the combination of plerixafor with G-CSF is less well described in the context of new treatment options that can impair stem cell harvest yields when using G-CSF as the sole mobilization agent. Objective: The primary objective of this study was to determine clinical outcomes associated with G-CSF alone vs G-CSF + chemomobilization vs G-CSF + plerixafor from initiation of mobilization until 6 to 12 months after ASCT. Method: This is a retrospective study in patients with MM, carried out at 10 centers in the US. Patients were eligible if ≥ 18 years and undergoing first ASCT (≤ 12 months from initial diagnosis and no disease progression). Eligible patients were identified through a database query of hospital records of oncology patients diagnosed with MM and eligible for ASCT before June 2016. Patients fulfilling inclusion and exclusion criteria were attributed to three treatment arms depending on the mobilization regimen received:Arm 1: G-CSF + plerixaforArm 2: G-CSF + chemomobilizationArm 3: G-CSF Patients will be selected until 170 patients are assigned to each treatment arm or patient records are exhausted. Demographics, induction regimen, mobilization regimens and outcomes, apheresis, transplantation outcomes and survival status were extracted from medical charts and entered in the electronic case report form. Here, we present interim results from data collected at three centers as of June 24, 2019. Results: At the interim analysis cut-off date, 130 patients were included in the database (G-CSF: 52; G-CSF + plerixafor: 78; G-CSF + chemomobilization: 0). Demographic and baseline characteristics were comparable between the two treatment arms. More male patients were included (male: 63%, female: 37%) and the mean age was 58 and 59 years in the G-CSF and G-CSF + plerixafor groups, respectively (Table 1). Disease stage and the proportion of patients with poor-, intermediate- and high-cytogenetic risk status were similar in the two treatment groups. Few patients had a complete response (CR) after chemotherapy, but response rate (CR + partial response) was 91% in both treatment arms. The burden of apheresis in terms of number of sessions and blood volume processed was lower in patients receiving G-CSF + plerixafor compared with patients receiving G-CSF only (Table 2). CD34+ yield was higher in the G-CSF + plerixafor treatment arm, especially after the first apheresis session (Table 2). There was no difference in ASCT outcome between the two treatment groups. All patients had neutrophil engraftment except for one patient in the G-CSF only group, and all patients had platelet engraftment except one patient in each treatment group. There was no significant difference in the proportion of patients experiencing relapse between the two treatment groups at 6 and 12 months of follow-up. Overall, ≥ 90% of patients avoided relapse at 12 months. 96% and 93% of patients were still alive at 12 months in the G-CSF only and G-CSF + plerixafor treatment groups, respectively (Table 3). For the purpose of this study, safety data was not reviewed [Mozobil PI, 2019]. Conclusions: Per interim results, plerixafor reduced the burden of apheresis and increased CD34+ yields. Transplantation outcomes, relapse and overall survival at 6 and 12 months were not significantly different between the two treatment arms. Therefore, plerixafor could increase apheresis efficiency without compromising ASCT success in the context of currently used chemotherapy regimens. Disclosures Mark: Amgen: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Takeda: Honoraria. Bubalo:Sanofi: Other: Research and writing support. Barnes:Sanofi: Employment. Drea:Sanofi-Genzyme: Employment. Fausel:Sanofi-Genzyme: Other: Grant to cover costs of data collection.

A health economic analysis was undertaken based on the one-year database from a randomized study of rabbit anti-human thymocyte immunoglobulin (rATG) versus basiliximab, in kidney transplantation using resource utilization data and cost estimates from three German hospitals. A three-state Markov model was applied to estimate cost effectiveness to 10 years post-transplant. Total mean treatment cost per patient to year 1 post-transplant was €62,075 versus €59,767 for rATG versus basiliximab (p

To evaluate the time to symptom resolution and i.v.-to-p.o. transition in community-acquired pneumonia (CAP) patients treated with 750 mg or 500 mg levofloxacin.A retrospective, subset analysis of a multicenter, randomized, double-blind, controlled trial comparing 750 mg levofloxacin for 5 days to 500 mg levofloxacin for 10 days for the treatment of CAP.A total of 528 CAP patients were included. Baseline symptoms were re-evaluated on Day 3 of therapy, and time to i.v.-to-p.o. transition was recorded for inpatients.For the overall population, 67.4% of patients receiving 750 mg levofloxacin had resolution of fever by Day 3 of therapy, compared to 54.6% of 500 mg treated patients (P = 0.006). Patients who started on 750 mg levofloxacin i.v. (N = 108) transitioned to p.o. in an average of 2.68 days while those starting on 500 mg i.v. (N = 124) transitioned in 2.95 days (P = 0.144). The median time for i.v.-to-p.o. switch was 2.35 days and 2.75 days for patients receiving 750 mg and 500 mg levofloxacin, respectively (P = 0.098, log rank test). By Day 3 of therapy, 68% of patients receiving the 750 mg dose had transitioned from i.v. to p.o. levofloxacin, compared with 61% of the 500 mg group (P = 0.280). The safety profiles were comparable for the two regimens.The 750 mg levofloxacin dose resulted in a greater proportion of patients with resolution of CAP symptoms by Day 3 when compared with 500 mg therapy. Consequently, the 750 mg regimen trended toward more rapid transition to p.o., potentially resulting in lower overall drug costs. Time to switch from i.v. to p.o. was determined by the investigators' discretion rather than a set protocol. Additionally, length of stay data was not collected in this study, which can significantly impact overall healthcare costs. Further research is required to fully understand the economic impact of the 750 mg, 5-day levofloxacin regimen.

Objective. To quantify time expended, patient satisfaction, and econometrics associated with short-acting (sargramostim, epoetin alfa) and long-acting (darbepoetin alfa, pegfilgrastim) growth factors. Design. Retrospective resource utilization and prospective two-phase observational study. Methods. During week 1, time-motion measurements related to patient treatment and drug preparation were collected for scheduling; check-in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey. Results. Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p

The abilities of therapeutic interchange (TI) and standard educational tools (SET) to change prescribing habits were compared. We evaluated the replacement of ciprofloxacin with levofloxacin in a four-hospital health system during a 14-month study period. Two hospitals used TI and two SET. The demographics, sites of infection, and severity of illness were analyzed for 554 patients treated at SET hospitals and 1323 patients treated at TI hospitals during a total of 2040 hospitalizations over a 14-month period. In TI hospitals, 97% of patients received levofloxacin, whereas 43% received levofloxacin in SET hospitals (p < 0.001). Clinical outcomes were not significantly different for the two groups, although more patients in the SET hospitals received combination antimicrobial therapy. Differences in savings per patient were significant between TI hospitals ($60) and SET hospitals ($37) (p < 0.001). The total annualized savings for all four hospitals was $156,444. TI was more effective than SET in facilitating changes in prescribing patterns in a health care system and resulted in significant cost savings to hospitals and payers.

Study Objective. To compare rates of adverse events with filgrastim versus sargramostim when given prophylactically to patients receiving myelosuppressive chemotherapy. Design. Retrospective review with center crossover. Setting. Ten United States outpatient chemotherapy centers. Patients. Four hundred ninety patients treated for lung, breast, lymphatic system, or ovarian tumors. Intervention. Prophylactic use of filgrastim or sargramostim, with dosages at investigator discretion. Measurements and Main Results. The frequency and severity of adverse events and the frequency of switching to the alternative CSF were assessed. There was no difference in infectious fever. Fever unexplained by infection was more common with sargramostim (7% vs 1%, p

Two of the most serious respiratory tract infections are community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB). The most common pathogens found in patients with these infections are Haemophilus influenzae and Streptococcus pneumoniae. Pseudomonas aeruginosa is also relatively common, particularly in elderly patients with AECB. S. pneumoniae and P. aeruginosa are also of concern in relation to the development of resistance to antimicrobial drugs. The administration of antibiotics at doses that result in concentrations exceeding the mutant prevention concentration at the site of infection is one strategy to prevent the development of drug-resistant pathogens. AECB is associated with a high risk of in-hospital mortality, particularly in patients treated in the intensive care unit. CAP is also associated with significant risks and often requires treatment under hospital supervision. Several patient-related factors help identify those patients who are most at risk of mortality and morbidity. Treatment should be tailored towards the severity of the disease. The fluoroquinolones, such as levofloxacin, are an effective treatment option for AECB and CAP. Compared with many other antibiotics, resistance to levofloxacin remains low for most infecting pathogens. The oral bioavailability of levofloxacin is over 99%, enabling simple switching from intravenous to oral therapy during treatment. It is also preferentially distributed to compartments in the lung, thus achieving high concentrations at the site of respiratory tract infections. Combined with cover of the major infecting pathogens found in patients with AECB and CAP, and a cost-effective treatment compared with many alternative therapies, levofloxacin is an attractive option for the treatment of at-risk patients with these respiratory tract infections.

Economic pressures on the delivery of health care have necessitated a focus on reducing costs and resource utilization while maintaining or improving the quality of care. A growing consensus holds that switching from intravenous to oral therapy is a cost-effective and clinically sound approach for a significantly large group of patients with community-acquired pneumonia (CAP). Drug utilization studies within the INOVA Health System revealed that levofloxacin is a cost-effective alternative to ciprofloxacin in infectious disease and that use of risk prediction criteria can reduce inappropriate hospitalizations for CAP, thereby reducing costs. In addition, the INOVA experience demonstrates that the strategy used to implement new antibiotic regimens such as switch-therapy regimens is an important factor in cost reduction: a therapeutic interchange mandate is more successful than standard educational techniques in changing treatment patterns.

With the implementation of prospective payment (e.g. diagnosis-related groups [DRGs] and cost containment efforts, physicians and pharmacists have had to reevaluate current drug delivery systems in the search for the least costly means of administering parenteral products. The following describes a three-phase approach to fully assess relative antibiotic cost and to assess economic efficiencies of intramuscular and intravenous administration of antibiotics. Relative costs of therapy consist of acquisition cost, administration cost and total cost of self-administration. Various intravenous administration systems are described, as are considerations for intramuscular administration. Comparisons are made using intravenous and intramuscular administrations of cefazolin, gentamicin, penicillin and imipenem. Using a 'best case' scenario, the intramuscular route was found to be up to one tenth the expense of the intravenous route in certain instances. Also, the intramuscular route may facilitate early discharge and self-administration in the home. Antibiotics available for intramuscular injection should therefore be considered as an economically efficient alternative to intravenous injections, in appropriate patients.