Cost-Effectiveness of Lenvatinib Compared with Sorafenib for the First-Line Treatment of Advanced Hepatocellular Carcinoma in Australia.

BACKGROUND AND OBJECTIVE: In the REFLECT trial, lenvatinib showed superior clinical benefits to sorafenib in terms of progression-free survival and was non-inferior for overall survival in the treatment of advanced hepatocellular carcinoma (HCC). We assessed the cost-effectiveness of lenvatinib compared with sorafenib for patients with advanced HCC in Australia. METHOD: A partitioned-survival model was built to perform a cost-effectiveness analysis comparing lenvatinib and sorafenib from an Australian health-system perspective. Survival curves were obtained from the REFLECT trial and fitted with parametric survival functions for extrapolation purposes beyond the trial follow-up. Cost and quality-adjusted life-years (QALYs) were accrued over the 10-year time horizon of the model. Deterministic and probability sensitivity analysis (PSA) were carried out to verify the validity of the model. RESULTS: Lenvatinib incurred higher costs (A$96,325) and superior health outcomes (QALYs: 1.205), while sorafenib had lower costs (A$92,394) and inferior health outcomes (QALYs: 1.086). Thus, lenvatinib yielded an incremental cost-utility ratio of A$33,028/QALY gained. Further, the results of the PSA found that the probability of lenvatinib being cost-effective at a willingness-to-pay threshold of A$50,000/QALY was 64%. CONCLUSION: Our study found that, at current prices, lenvatinib is a cost-effective treatment option compared with sorafenib for the first-line treatment of patients with advanced HCC.

Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.

Aim: To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China. Materials & methods: Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population. Results: Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. Conclusion: According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.

Cost-effectiveness analysis of lenvatinib treatment for patients with unresectable hepatocellular carcinoma (uHCC) compared with sorafenib in Japan.

BACKGROUND: Lenvatinib demonstrated a treatment effect on overall survival by the statistical confirmation of non-inferiority to sorafenib for the first-line treatment of uHCC. The objective of this study was to evaluate the cost-effectiveness of lenvatinib compared with sorafenib for patients with uHCC in Japan. METHODS: A partitioned-survival model was developed to estimate the cost-effectiveness of lenvatinib versus sorafenib when treating uHCC patients over a lifetime horizon and considering total public healthcare expenditure. Efficacy and safety data were extracted from the REFLECT trial. Utility values were derived from the European Quality-of-Life 5-Dimension Questionnaire, conducted with patients enrolled in the REFLECT trial. Direct medical costs, such as primary drug therapy, outpatient visits, diagnostic tests, hospitalization, post-progression therapy, and adverse-event treatments, were included. Cost parameters unavailable in the clinical trial or publications were obtained based on the consolidated clinical standards from a Delphi panel of four Japanese medical experts. RESULTS: For lenvatinib versus sorafenib, the incremental cost was - 406,307 Japanese Yen (JPY), and the incremental life years and quality-adjusted life years (QALYs) were 0.27 and 0.23, respectively. Thus, lenvatinib dominated sorafenib, due to the mean incremental cost-effectiveness ratio falling in the fourth quadrant, conferring more benefit at lower costs compared with sorafenib. The probabilistic sensitivity analysis showed that 81.3% of the simulations were favorable to lenvatinib compared with sorafenib, with a payer's willingness-to-pay-per-QALY of 5 million JPY. CONCLUSIONS: Lenvatinib was cost-effective compared with sorafenib for the first-line treatment of uHCC in Japan.

[The patients' cost of the montelukast therapy due to the generic substitution]. / A montelukasztterápia betegterheinek változása a generikus árverseny hatására.

INTRODUCTION AND AIM: The aim of our study was to analyse the public price of the montelukast sodium therapy in Hungary. METHOD: Data derived from the nationwide pharmaceutical database of the Hungarian National Health Insurance Fund Administration. We observed the turnover and price of the medicaments containing the active substance montelukast sodium from 2007 to 2015. Accordingly, our indicators were: consumer price, DCT (daily cost of therapy), co-payment, quasi co-payment, DOT (days of treatment). RESULTS: Due to the increasing DOT, the total amount of the public price paid by the patients increased until 2011, reaching the amount of 1 million USD; then, due to the generic competition and the blind bid methods, it decreased to 490 000 USD. The total amount of the public price of the brand-name Singulair moved to the generics during 3 years (2011-2014). The DCT of the originator Singulair 10 mg tablets decreased from 1.1 USD to 0.34 USD; the DCT of the generic product Montelukast TEVA decreased from 0.67 USD to 0.16 USD in the period under review. CONCLUSION: Due to the generic competition, the patients' access to drugs containing montelukast sodium increased significantly: the DOT increased, the co-payment decreased. Orv Hetil. 2018; 159(17): 682-687.

Cost Effectiveness of Lenvatinib, Sorafenib and Placebo in Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer.

BACKGROUND: Lenvatinib (Lenvima®) and sorafenib (Nexavar®) are the two most recently Food and Drug Administration-approved drugs for treating radioiodine-refractory differentiated thyroid cancer (RR-DTC). Both demonstrated superior progression-free survival over placebo in their respective Phase III clinical trials. This study compared the cost-effectiveness of the two treatments with placebo from a limited societal perspective. METHODS: A Markov model was developed to estimate the costs and health benefits for treatment of RR-DTC. The probabilities and survival rates were obtained from two Phase III trials: the SELECT trial comparing lenvatinib to placebo, and the DECISION trial comparing sorafenib to placebo. A bimonthly cycle length and half-cycle correction were used for a lifetime time horizon. Medical costs and utility data were obtained from RedBook, Healthcare Cost and Utilization Project, and the published literature. All costs were adjusted to US$2015, discounted at 3% annually. Then second-order Monte Carlo simulation with distributions was conducted to obtain the acceptability curve to address the uncertainty around model inputs. RESULTS: In the base case, lenvatinib was the most cost-effective treatment compared to sorafenib (incremental cost-effectiveness ratio [ICER] = $25,275/quality-adjusted life year [QALY]) and placebo (ICER = $40,869). Sorafenib is also cost-effective compared to placebo (ICER = $64,067/QALY). The treatment decisions were found to be sensitive to the treatment costs and the health utility associated with lenvatinib and its side effects. The acceptability curve showed lenvatinib optimal 80% of time at WTP of $100,000/QALY. CONCLUSIONS: This study suggests that lenvatinib is the optimally cost-effective treatment for RR-DTC, although both lenvatinib and sorafenib are cost-effective compared to placebo.

[The effect of generic price competition on drug consumption and health insurance pharmaceutical expenditures in Hungary]. / A generikus árverseny hatása a gyógyszerforgalomra es a társadalombiztosítási támogatás kiáramláisra Magyarországon.

AIM: The aim of our study was to analyze the Hungarian montelukast sodium drug market. We examined the effect of the appearance of generic drugs on the price and turnover of the brand-name drug, Singulair. DATA AND METHODS: Data derived from the nationwide pharmaceutical database of Hungarian National Health Insurance Fund Administration (2007-2014). We analized the turnover and price of the medicaments containing the active substance montelukast sodium. Accordingly our indicators were: consumer price, social insurance subsidy, patients' co-payment and days of treatment (DOT). RESULTS: First the generics started from a significantly lower price of 18 USD which was lower than the price of brand-name Singulair (32 USD). Then the prices of the generics started to diminish. While in 2007 the DOT was below 2 million, it increased over 10 million days by 2014. The increase of DOT was followed by the increase of health insurance subsidy until 2011. Then the amount of health insurance subsidy decreased from 10,5 million USD to 7 million USD in 2012. In 2013 and 2014 there was a further reduction, the amount of the health insurance subsidy decreased to 4,1 million USD in 2013, and in 2014 it was reduced to 2.2 million USD. CONCLUSIONS: Following the introduction of generic drugs, the price of the medicaments containing montelukast sodium was significantly reduced, while the days on treatment (DOT) increased. The patients' access to drugs containing montelukast sodium increased significantly. The annual health insurance subsidy was significantly reduced as well.

Single daily dose of moxifloxacin versus ofloxacin plus metronidazole as a new treatment approach to uncomplicated pelvic inflammatory disease: a multicentre prospective randomized trial.

OBJECTIVES: To evaluate the efficacy and safety of moxifloxacin versus ofloxacin plus metronidazole in patients with uncomplicated pelvic inflammatory disease (uPID; defined as PID symptoms and signs, but no complications such as septicemia, perihepatitis, and tubo-ovarian abscess) in Turkey. STUDY DESIGN: This was a multicenter, prospective, randomized, parallel-group study conducted between June 2010 and March 2013 in four hospitals in Turkey. Women received a 14-day course of either oral moxifloxacin at 400mg once daily (n = 560) or oral ofloxacin at 400mg twice daily plus oral metronidazole at 500 mg twice daily (n = 543). RESULTS: A total of 1156 women were randomized to the study. Total compliance was achieved in 1103 patients. For the primary measure of efficacy (clinical cure), moxifloxacin showed no difference compared with ofloxacin plus metronidazole (445/560 [79.5%] vs. 449/543 [82.7%]; p = 0.172). Bacteriological cure rates were high and comparable between treatment arms (99/119 [83.2%] vs. 93/110 [84.5%]; p = 0.781). Drug-related adverse events occurred less frequently with moxifloxacin than with ofloxacin plus metronidazole (210/560 [37.5%] vs. 252/543 [46.4%]; p = 0.003). Furthermore, moxifloxacin treatment was lower in cost and achieved higher patient compliance compared with ofloxacin plus metronidazole (31.4 Euros vs. 23.4 Euros and 7/578 (1.2%) vs. 22/578 (3.8%), respectively; p = 0.005). CONCLUSIONS: In patients with uPID, once-daily moxifloxacin monotherapy was clinically and microbiologically as efficacious as twice-daily ofloxacin plus metronidazole therapy and was associated with fewer drug-related adverse events, lower patient non-compliance, and a lower treatment cost.

Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease.

BACKGROUND: Exacerbations are a major cause of disability, hospital admissions, and increased healthcare costs in patients with chronic obstructive pulmonary disease (COPD). This study investigated the clinical outcomes of outpatients with moderate to severe exacerbated COPD and their related costs. METHODS: An observational study on the outcomes of ambulatory exacerbations of COPD was conducted. The course of the exacerbation was evaluated at a follow-up visit at 4 weeks. A cost analysis that encompassed the use of healthcare resources for treatment of the exacerbation was performed. RESULTS: A total of 260 patients were included, with a mean age of 68.3 years and a mean FEV1 (% predicted) of 58.9 %. Twenty-two percent of patients had significant cardiovascular comorbidity. The most frequently prescribed antibiotics were moxifloxacin in 137 cases and amoxicillin-clavulanate in 50 cases. The rate of failure at 4 weeks was 12.5 %, with no differences between the two most prescribed antibiotics; however, patients treated with moxifloxacin had symptoms for 1.9 fewer days (P = 0.01). The mean cost of the exacerbation was 344.96 (95 % CI: 48.55-641.78), with 9.6 % of the costs for drugs and 72.9 % for hospital care of patients for whom treatment had failed. CONCLUSIONS: Antibiotic treatment of our population was in compliance with local guidelines. The rate of failure observed in our study was lower than that reported in previous studies; however, the small percentage of patients that required hospital attention generated almost two-thirds of the total costs of the exacerbations.

[Cost effectiveness of treatment with salmeterol/fluticasone compared to montelukast for the control of persistent asthma in children]. / Costo-efectividad del tratamiento de salmeterol/fluticasona en comparación con leucotrieno montelukast para el control del asma infantil.

OBJECTIVE: To assess the incremental cost-effectiveness of SFC compared with MON for the control of persistent asthma in children. METHODS: We conducted an economic evaluation on a 12-week prospective randomized open-label parallel-group comparison of SFC versus MON in children with symptomatic asthma receiving inhaled corticosteroids and short-acting ß2-agonists. Asthma-related medication, unscheduled physician contacts and hospitalizations were collected prospectively. The main effectiveness measure was percentage of asthma-controlled week with no short-acting ß2-agonist use during the study period. The analysis was conducted from the Mexican healthcare perspective using 2010 unit cost prices, and only direct costs were considered, all costs are reported in US dollar. . The model was made fully probabilistic to reflect the joint uncertainty in the model parameters. RESULTS: Over the whole treatment period, the median percentages of asthma-controlled weeks were 83.3% in the SFC group and 66.7% in the MON group (SFC-MON difference, 16.7%; 95% CI, 8.3-16.7; P < 0.001 in favor of SFC). The mean total cost of the SFC regimen was $ 2,323 compared with $ 3,230 for the MON regimen. The SFC was the dominant strategy (both more effective and less expensive) using the SFC was associated with an incremental cost per additional asthma-controlled of $ (5,467). Probabilistic sensitivity analysis tested numerous assumptions about the model cost and efficacy parameters and found that the results were robust to most changes. CONCLUSIONS: This analysis demonstrates that, compared with MON, SFC may be cost saving from the Mexican health care perspective for the treatment of pediatric patients with asthma. SFC provided a reduction in the number of severe exacerbations, frequent asthma symptoms and rescue medication use. Incremental cost-effectiveness analysis indicated the dominance of SFC because of both lower costs and greater efficacy.

Hospital visits and costs following outpatient treatment of CAP with levofloxacin or moxifloxacin.

BACKGROUND: Hospital admissions (inpatient and emergency room) are a major source of medical costs for community-acquired pneumonia (CAP) initially treated in the outpatient setting. Current CAP treatment guidelines do not differentiate between outpatient treatment with levofloxacin and moxifloxacin. OBJECTIVE: Compare health care resource use and medical costs to payers for CAP outpatients initiating treatment with levofloxacin or moxifloxacin. RESEARCH DESIGN AND METHODS: CAP episodes were identified in the PharMetrics database between 2Q04 and 2Q07 based on: pneumonia diagnosis, chest X-ray and treatment with levofloxacin or moxifloxacin. Subsequent 30-day risk of pneumonia-related hospital visits and 30-day health care costs to payers for levofloxacin vs. moxifloxacin treatment were estimated after adjusting for pre-treatment demographics, health care resource use and pneumonia-specific risk factors using propensity score and exact factor matching. RESULTS: A total of 15,472 levofloxacin- and 6474 moxifloxacin-initiated CAP patients were identified. Among 6352 matched pairs, levofloxacin treatment was associated with a 35% reduction in the odds of pneumonia-related hospital visits (odds ratio = 0.65, P = 0.004), lower per-patient costs for pneumonia-related hospital visits (102 dollars vs. 210 dollars, P = 0.001), lower pneumonia-related total costs (medical services and prescription drugs, 363 dollars vs. 491 dollars, P < 0.001) and lower total costs (1308 dollars vs. 1446 dollars, P < 0.001) vs. moxifloxacin over the 30-day observation period. LIMITATIONS: Although observational analyses of claims data provide large sample sizes and reflect routine care, they do have several inherent limitations. Since randomization of subjects is not possible, adequate statistical techniques must be used to ensure that patient characteristics are well-balanced between treatment groups. In addition, data may be missing or miscoded. CONCLUSIONS: CAP outpatients initiated with levofloxacin generated substantially lower costs to payers compared to matched patients initiated with moxifloxacin. The cost savings for patients initiated with levofloxacin were largely attributable to reduced rates of pneumonia-related hospitalization or ER visits.

Comparative analysis of length of stay, total costs, and treatment success between intravenous moxifloxacin 400 mg and levofloxacin 750 mg among hospitalized patients with community-acquired pneumonia.

OBJECTIVE: This study aimed to evaluate the length of stay (LOS), costs, and treatment consistency among patients hospitalized with community-acquired pneumonia (CAP) initially treated with intravenous (IV) moxifloxacin 400 mg or IV levofloxacin 750 mg. METHODS: Adults with CAP receiving IV moxifloxacin or IV levofloxacin for > or =3 days were identified in the Premier Perspective comparative database. Primary outcomes were LOS and costs. Secondary outcomes included treatment consistency, which was defined as 1) no additional IV moxifloxacin or levofloxacin after > or =1 day off study drug; 2) no switch to another IV antibiotic; and 3) no addition of another IV antibiotic. RESULTS: A total of 7720 patients met inclusion criteria (6040 receiving moxifloxacin; 1680 receiving levofloxacin). Propensity matching created two cohorts (1300 patients each) well matched for demographic, clinical, hospital, and payor characteristics. Before the patients were matched, mean LOS (5.87 vs. 5.46 days; P = 0.0004) and total costs per patient ($7302 vs. $6362; P < 0.0001) were significantly greater with moxifloxacin. After the patients were matched, mean LOS (5.63 vs. 5.51 days; P = 0.462) and total costs ($6624 vs. $6473; P = 0.476) were comparable in both cohorts. Treatment consistency was higher for moxifloxacin before (81.0% vs. 78.9%; P = 0.048) and after matching (82.8% vs. 78.0%; P = 0.002). CONCLUSIONS: In-hospital treatment of CAP with IV moxifloxacin 400 mg or IV levofloxacin 750 mg was associated with similar hospital LOS and costs in propensity-matched cohorts.

A comparison of levofloxacin and moxifloxacin use in hospitalized community-acquired pneumonia (CAP) patients in the US: focus on length of stay.

OBJECTIVE: Length of stay (LOS) and hospitalization costs were compared among patients admitted for community-acquired pneumonia (CAP) and initially treated with either levofloxacin 750 mg intravenous (IV) or with moxifloxacin 400 mg IV. Hospital-related complications and relationship of LOS and comorbidities were descriptively examined. METHODS: A retrospective database study was conducted of adult patients admitted for CAP and given levofloxacin 750 mg IV or moxifloxacin 400 mg IV through the first 3 days of hospitalization, using the Premier Perspective comparative database. Cohorts were matched 1:1 by hospital geographic location, by coarse caliper propensity scores using all baseline covariates, and by Mahalanobis metric matching based on age and severity (All Patient Refined-Diagnosis-related Groups Severity of Illness (APR-DRG SOI) index). Comparisons between groups were further adjusted for characteristics that remained imbalanced after matching using generalized estimating equation methodology. RESULTS: The initial sample of 3868 patients (levofloxacin = 827; moxifloxacin = 3041) was reduced to 1594 (797 patients per treatment group) after matching. Analyses of matched cohorts showed that the mean hospital LOS was significantly shorter for patients treated with levofloxacin 750 mg IV than for those patients treated with moxifloxacin 400 mg IV (5.8 vs. 6.4 days, respectively; least squares mean difference = 0.54 days; p = 0.020). Hospitalization costs were also lower for the levofloxacin 750 mg IV-treated patients (least squares mean difference = US$129; p = 0.753). There were no significant differences in the percentage of patients experiencing complications. LIMITATIONS: Although claims databases provide large sample sizes and reflect routine care, they do have several inherent limitations. Since randomization of subjects is not possible, adequate statistical techniques must be used to ensure treatment groups are balanced with respect to patient and clinical characteristics. In addition, data may be missing or miscoded. CONCLUSIONS: This retrospective study suggests that among patients hospitalized with CAP, initial treatment with levofloxacin 750 mg IV is associated with a significantly shorter mean hospital LOS compared with treatment with moxifloxacin 400 mg IV. The clinical implications of a shorter hospital LOS include improved patient and economic outcomes.

A cost-minimisation analysis comparing moxifloxacin with levofloxacin plus ceftriaxone for the treatment of patients with community-acquired pneumonia in Germany: results from the MOTIV trial.

OBJECTIVE: This study presents a cost-minimisation analysis of moxifloxacin compared to combination treatment with levofloxacin and ceftriaxone in patients hospitalised with community-acquired pneumonia (CAP) in Germany. RESEARCH DESIGN AND METHODS: In the MOTIV study, 738 adult patients with CAP requiring hospitalisation and initial parenteral antibiotic therapy were randomised to sequential IV/oral therapy with either moxifloxacin (n = 368), or levofloxacin and ceftriaxone (n = 365). The primary effectiveness endpoint was the proportion of patients demonstrating clinical improvement 5-7 days after the completion of study treatment. Subgroup analysis considered patients with severe CAP according to pneumonia severity index (PSI) risk class IV and V, microbiologically proven infection, a history of chronic obstructive pulmonary disease, and a history of cardiovascular disease. The analysis included the cost of study medication, hospital stay, readmission and inpatient procedures and diagnostics. Event frequency in the study was multiplied by German unit costs to estimate per-patient expenditure. The analysis was conducted from a hospital perspective. Sensitivity analysis investigated the effect of costing from an insurer perspective. RESULTS: No significant difference was found in the percentage of successfully treated patients. Average per patient cost was euro 2190 for the moxifloxacin group, and euro 2619 for the levofloxacin + ceftriaxone group (difference -euro 430, 95% CI: -euro 138, -euro 740; p < 0.05). Variability in total costs was wide, with some patients accruing up to euro 18,000. Medication cost was significantly lower with moxifloxacin than levofloxacin + ceftriaxone (-euro 470, 95% CI: -euro 522, -euro 421), and accounted for between 15 and 30% of total costs. CONCLUSIONS: In this analysis of patients hospitalised with CAP in Germany, treatment with moxifloxacin was significantly less costly than treatment with levofloxacin and ceftriaxone.

A cost-effectiveness analysis of antimicrobial treatment of community-acquired pneumonia taking into account resistance in Belgium.

OBJECTIVE: This article assesses the cost-effectiveness of outpatient antimicrobial treatment of community-acquired pneumonia (CAP) taking into account resistance in Belgium. RESEARCH DESIGN AND METHODS: Our decision analytic model focused on mild to moderate CAP, but did not consider severe CAP. Treatment pathways reflected empirical treatment initiated in the absence of data on CAP aetiology. First-line treatment consisted of moxifloxacin, co-amoxiclav, cefuroxime or clarithromycin. If first-line treatment was unsuccessful, patients were either hospitalised or second-line treatment with a different antimicrobial was initiated. Clinical failure rates were obtained from the published literature or expert opinion. Costs were calculated using published sources from the third-party payer perspective. MAIN OUTCOME MEASURES: Effectiveness measures included first-line clinical failure avoided, second-line treatment avoided, hospitalisation avoided and death avoided. Healthcare costs were included, but costs of productivity loss were not considered. RESULTS: Costs of treating a CAP episode amounted to 144E with moxifloxacin/co-amoxiclav; 222E with co-amoxiclav/clarithromycin; 211E with cefuroxime/moxifloxacin; and 193E with clarithromycin/moxifloxacin. The rate of first-line failure was 5%, 16%, 19% and 18% for these four treatment strategies, respectively. The rate of second-line treatment amounted to 4%, 13%, 16% and 15%, respectively. The hospitalisation rate was 1%, 4%, 4% and 4%, respectively. The death rate was 0.01%, 0.04%, 0.03% and 0.03%, respectively. Sensitivity analyses supported the dominance of moxifloxacin/co-amoxiclav in nearly all scenarios. CONCLUSIONS: First-line treatment of CAP patients with moxifloxacin followed by co-amoxiclav or hospitalisation if required was more effective and less costly as compared with first-line treatment with co-amoxiclav, cefuroxime or clarithromycin.

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.

Moxifloxacin versus levofloxacin for treatment of acute rhinosinusitis: a retrospective database analysis of treatment duration, outcomes, and charges.

OBJECTIVE: Antibiotics are clinically indicated for acute bacterial rhinosinusitis, but they may be prescribed inappropriately. This retrospective study examined how labeled recommendations for duration of moxifloxacin and levofloxacin treatment of acute bacterial rhinosinusitis compare with real-world practice, and compared the failure and recurrence rates, and associated charges. METHODS AND MAIN OUTCOME MEASURES: The PharMetrics Patient-Centric claims database was searched over a 3-year period for episodes of acute rhinosinusitis treated within 5 days with moxifloxacin or levofloxacin. The duration of antibiotic treatment prescribed was compared with the labeled recommendation. Failure rates (a second antibiotic claim to treat acute rhinosinusitis within 30 days of the first claim), recurrence rates (subsequent antibiotic claims to treat any rhinosinusitis more than 30 days after the original or second [in the case of failure] claim), and treatment charges from the perspective of the payer (health insurer) were also compared using multivariate analysis. RESULTS: The initial duration prescribed of moxifloxacin was shorter than for levofloxacin (-1.65 days, p < 0.0001), reflecting the shorter labeled recommendation (10 days versus 10-14 days). The durations of monotherapy (-2.06 days, p < 0.0001) and of all antibiotic treatment (-1.97 days, p < 0.0001) were also significantly shorter for episodes treated initially with moxifloxacin. The odds ratio for treatment failure (0.718; 95% confidence interval = 0.598-0.863; p = 0.0004) and the hazard ratio for recurrence (0.652; p = 0.0005) were both significantly lower for moxifloxacin than for levofloxacin, and resulted in lower total treatment charges (-$37.94 +/- 13.65; p = 0.0055). CONCLUSION: The shorter treatment durations seen for moxifloxacin in this database of real-world care reflect the label-recommended duration for acute rhinosinusitis. Despite this shorter duration of therapy, moxifloxacin resulted in better outcomes than levofloxacin in terms of the risk of treatment failure and recurrence. In addition, the total charges were lower for patients treated with moxifloxacin.

Economic evaluation of the antibiotic treatment of exacerbations of chronic bronchitis and COPD in primary care.

This was an observational and economic survey performed in primary care practices throughout Spain to assess the effectiveness and direct medical costs derived from antibiotic treatment of exacerbations of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) in primary care. A total of 252 physicians included 1456 valid patients, 80% were male and the mean age was 68.2 years (SD = 9.8). The antibiotic treatment administered was moxifloxacin in 575 (39.5%), amoxicillin/clavulanate in 460 (31.6%) and clarithromycin in 421 (28.9%). No significant differences were found in clinical and demographic characteristics between treatment arms. The 30-days follow-up visit was completed by 1097 (75%) patients, who were therefore valid for economic evaluation. During follow-up, 440 new medical visits were generated, 69 patients required attendance in emergency wards (6.3%) and 22 were hospitalised (2%). The overall mean cost of exacerbation was Euro 118.58 [95% confidence interval (CI) = Euro 92.2-144.9] and Euro 52.44 (44.2%) were due to therapeutical failure. The mean cost of exacerbation was Euro 111.46 (95% CI = Euro 73.4-149.5) for patients treated with moxifloxacin, Euro 109.45 (95% CI = Euro 68.2-150.7) for those treated with amoxicillin/clavulanic acid and Euro 138.95 (95% CI = Euro 89.4-188.5) for patients receiving clarithromycin. In conclusion, a significant number of patients require new medical interventions after ambulatory treatment of exacerbations of CB or COPD. The mean cost of an exacerbation was Euro 118.58 and failure was responsible for 44.2% of the total cost of exacerbation.

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.