The Role of Delafloxacin in Patients with Community-Acquired Bacterial Pneumonia in the Outpatient Setting: A Budget Impact Model.

BACKGROUND AND OBJECTIVE: Community-acquired bacterial pneumonia (CABP) affects millions of people each year in the USA. The majority of patients with CABP are treated in the community setting with empirical antimicrobial therapy. Delafloxacin is an anionic fluoroquinolone approved for the treatment of adult patients with CABP. This de novo analysis sought to estimate the budget impact of delafloxacin in the treatment of adult patients with CABP in the outpatient setting from the payer's perspective. METHODS: A budget impact model (BIM) was developed from the perspective of a US third-party payer to estimate the cost of introducing delafloxacin for the outpatient treatment of CABP over a 1-year time horizon. Population, clinical, and cost inputs were based on the available literature, clinical trial data, and real-world evidence studies. Scenario analyses were conducted to evaluate the potential budget impact among COPD/asthma patients based on the findings from the phase III trial of delafloxacin for CABP, which indicated that patients with COPD or asthma may experience improved effectiveness with delafloxacin compared to moxifloxacin. RESULTS: In the base-case analysis, with a hypothetical plan of 1,000,000 members, the model estimated that adding delafloxacin to the formulary resulted in a total budget impact of $58,987. This increase was mainly attributed to treatment acquisition costs. In the scenario analysis that was restricted to COPD/asthma patients, adding delafloxacin to the formulary was estimated to result in a total budget impact of $5,042. CONCLUSION: The results of the budget impact analyses provide conservative estimates of the impact of adding delafloxacin to outpatient formularies in substitution of moxifloxacin.

Efficacy of Intracameral Moxifloxacin Endophthalmitis Prophylaxis at Aravind Eye Hospital.

PURPOSE: To compare the rate of postoperative endophthalmitis before and after initiation of intracameral (IC) moxifloxacin for endophthalmitis prophylaxis in patients undergoing cataract surgery. DESIGN: Retrospective, clinical registry. PARTICIPANTS: All charity and private patients (116 714 eyes) who underwent cataract surgery between February 15, 2014, and April 15, 2015, at the Madurai Aravind Eye Hospital were included. Group 1 consisted of 37 777 eyes of charity patients who did not receive IC moxifloxacin, group 2 consisted of 38 160 eyes of charity patients who received IC moxifloxacin prophylaxis, and group 3 consisted of 40 777 eyes of private patients who did not receive IC moxifloxacin. METHODS: The electronic health record data for each of the 3 groups were analyzed, and the postoperative endophthalmitis rates were statistically compared. The cost of endophthalmitis treatment (groups 1 and 2) and the cost of IC moxifloxacin prophylaxis (group 2) were calculated. MAIN OUTCOME MEASURES: Postoperative endophthalmitis rate before and after initiation of IC moxifloxacin endophthalmitis treatment cost. RESULTS: Manual, sutureless, small incision cataract surgery (M-SICS) accounted for approximately all of the 75 937 cataract surgeries in the charity population (97%), but only a minority of the 40 777 private surgeries (21% M-SICS; 79% phacoemulsification). Thirty eyes in group 1 (0.08%) and 6 eyes in group 2 (0.02%) were diagnosed with postoperative endophthalmitis (P < 0.0001). The group 3 endophthalmitis rate was 0.07% (29 eyes), which was also higher than the second group's rate (P < 0.0001). There were no adverse events attributed to IC moxifloxacin in group 2. The total cost of treating the 30 patients with endophthalmitis in group 1 was virtually identical to the total combined cost in group 2 of routine IC moxifloxacin prophylaxis and treatment of the 6 endophthalmitis cases. CONCLUSIONS: Routine IC moxifloxacin prophylaxis achieved a highly significant, 4-fold reduction in postoperative endophthalmitis in patients undergoing M-SICS. Compared with previous studies, having such a high volume of patients undergoing surgery during a relatively short 14-month time period strengthens the conclusion. This study provides further evidence that moxifloxacin is an effective IC prophylactic antibiotic and suggests that IC antibiotics should be considered for M-SICS and phacoemulsification.

Comparison of enrofloxacin and ceftiofur sodium for the treatment of relapse of undifferentiated fever/bovine respiratory disease in feedlot cattle.

This commercial field trial compared the efficacy of enrofloxacin and ceftiofur sodium in beef cattle at high risk of developing undifferentiated fever (UF), also known as bovine respiratory disease (BRD) that received tilmicosin at feedlot arrival, were diagnosed and initially treated for UF with tilmicosin, and subsequently required a second UF treatment (first relapse). Feedlot cattle (n = 463) were randomly assigned to 2 experimental groups: ENRO or CEF. Second UF relapse, 3rd UF relapse, overall case fatality and BRD case fatality rates were lower in the ENRO group than in the CEF group (P < 0.05). There were no differences in average daily gain (allocation to re-implant date), chronicity, histophilosis case fatality or miscellaneous case fatality rates between the groups (P ≥ 0.05). A per-animal economic advantage of Can$57.08 was calculated for the ENRO group versus the CEF group. In feedlot cattle in western Canada at high risk of developing UF, it was more cost effective to administer enrofloxacin than ceftiofur sodium for treatment of UF relapse.

Gemifloxacin use in the treatment of acute bacterial exacerbation of chronic bronchitis.

The newest generation of fluoroquinolones have proven efficacy against bacterial organisms associated with acute exacerbation of chronic bronchitis (AECB). Gemifloxacin, as one of the quinolones in this class, exhibits many of the pharmacokinetic and pharmacodynamic characteristics of the class with a few notable differences. Against Streptococccus pneumoniae it has a lower minimal inhibitory concentration (MIC) than the other respiratory fluoroquinolones and it has activity against both bacterial DNA gyrase and topoisomerase IV. The increased activity of gemifloxacin against both enzymes may be associated with decreased rates of resistance. Clinically, gemifloxacin has been shown to have positive effects on length of hospitalization and increased success at long-term follow-up in AECB patients. These associations were observed in noninferiority comparison studies. Although an advantage with the use of gemifloxacin in AECB is suggested, there are no comparison data is available to conclude that gemifloxacin is superior to the other respiratory fluoroquinolones. Gemifloxacin is generally well tolerated, but is associated with a characteristic rash and gastrointestinal upset as its most common observed side effects.

Topical ophthalmic fourth-generation fluoroquinolones: Appropriate use and cost considerations.

PURPOSE: The utilization and refill rates of topical ophthalmic fourth-generation fluoroquinolones among physicians, as well as the associated costs, were studied. METHODS: A large data set of retrospective pharmacy prescription claims was obtained from multiple plans, including commercial managed care organizations, Medicaid, and Medicare. The data included the number and cost of all new and refill prescriptions for six months for gatifloxacin 0.3% and moxifloxacin 0.5% by physician specialty. New prescription and refill data were also analyzed from a state Medicaid plan to determine if similar trends existed. RESULTS: Primary care physicians wrote approximately 7,000 (7.7%) gatifloxacin and 84,000 (92.3%) moxifloxacin prescriptions, with pediatricians accounting for 4,000 (5.1%) gatifloxacin and 75,000 (94.9%) moxifloxacin prescriptions. Eye care physicians accounted for a similar amount of prescriptions for each antibiotic during the same period. The total cost of prescriptions for all primary care practitioners was approximately $170,000 for gatifloxacin and $2.5 million for moxifloxacin; prescriptions written by pediatricians accounted for $110,000 for gatifloxacin and $2.2 million for moxifloxacin. CONCLUSION: Prescription drug claims from payers using pharmacy benefit management companies during a six-month period indicated that the numbers of prescriptions written for gatifloxacin and moxifloxacin were similar among eye care physicians, but primary care physicians wrote a greater number of prescriptions for moxifloxacin. Analysis of claims to a Medicaid database revealed an increase in the prescriptions written by primary care physicians for moxifloxacin after its addition to the drug formulary.

Respiratory tract infections: at-risk patients, who are they? Implications for their management with levofloxacin.

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.

The evolution of ototopical therapy: from cumin to quinolones.

A radical change has occurred in the management of otorrhea over the past decade. Multiple studies have supported the efficacy of topical quinolones in the management of acute otitis media, acute otitis externa, and CSOM. For the first time, otolaryngologists have a scientific foundation on which to base our treatment protocols for these conditions. We no longer must rely solely on our clinical experience and prejudices. The quinolone drops have a superior safety profile and a broad antimicrobial spectrum, their overall cost is lower than the alternatives, and their convenient dosing schedule is tolerated well by most patients. When one takes all these factors into consideration, it becomes clear that topical quinolone therapy, with or without a steroid additive, is the treatment of choice for otorrhea in patients with a tympanic membrane perforation or ventilating tube. The development of ototopical medications has followed along the lines of Darwinian evolution, and the quinolone drops have clearly demonstrated the concept of "survival of the fittest."

A novel method of estimating cost of therapy by using patient population characteristics: analysis of fluoroquinolones in various populations with different distributions of renal function.

INTRODUCTION: Formulary decisions regarding a given drug class are often made in the absence of patient outcome and/or sophisticated pharmacoeconomic data. Analyses that consider factors beyond simple acquisition costs may be useful in such situations. For example, the cost implications of using manufacturers' recommendations for dosing in patients with renal dysfunction may be important, depending on the distribution of various levels of renal function within a patient population. METHODS: Using four 1000-patient populations representing different renal function distributions and a fifth population of our medical center's distribution, we determined the costs of therapy for intravenous and oral levofloxacin, gatifloxacin, and moxifloxacin for a 10-day course of therapy for community-acquired pneumonia. Costs considered were average wholesale prices (AWPs), 50% of AWP, or same daily price, plus intravenous dose preparation and administration costs when applicable. Costs for each renal function distribution were examined for significant differences with an analysis-of-variance test. Also, costs of failing to adjust dosing regimens for decreased renal function were determined. RESULTS: Differences in fluoroquinolone costs (AWP, 50% AWP, or when matched as the same daily price) among the populations were found. When considering same daily prices, differences among populations ranged from about 35,000 dollars with intravenous gatifloxacin to more than 51,000 dollars for intravenous levofloxacin (all fluoroquinolones, p>0.05). Within a population, differences in costs among the intravenous fluoroquinolones ranged from 47,000-99,000 dollars. Rank orders of the drugs and population costs of therapy were affected by the pricing structure used and varied by the specific population and drug. Differences among the fluoroquinolones or populations were much smaller (<2100 dollars) when considering oral regimens. Costs potentially incurred by failing to adjust dosing for renal function were substantial. CONCLUSION: Formulary decisions can be facilitated by considering factors such as patient characteristics and related dosing in addition to simple acquisition costs. In our example, consideration of the distribution of renal function within a given patient population and related dosing for these fluoroquinolones revealed potentially important differences within the class.