Health-Related Quality of Life as Measured by the 36-Item Short Form Survey Among Adults With Acute Bacterial Skin and Skin Structure Infections who Received Either Omadacycline or Linezolid in a Phase 3 Double-Blind, Double-Dummy Clinical Trial.

This analysis of data from a Phase 3 study of adults with acute bacterial skin and skin structure infections showed that successful oral treatment with omadacycline (n = 368) or linezolid (n = 367) was associated with improvement in health-related quality of life.

Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection.

BACKGROUND AND OBJECTIVE: Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities. METHODS: A conceptual healthcare-decision analytic model was created to estimate incremental costs associated with treating 100 hospitalized CABP patients with an initial 5-day inpatient regimen of omadacycline instead of moxifloxacin. The underlying model assumption was that treatment with omadacycline has the potential to reduce CDI events relative to moxifloxacin. The model included excess costs associated with each treatment group from admission through discharge. Attributable CDI cost per case in the moxifloxacin group varied from $15,000 to $45,000 (US$). Omadacycline acquisition cost was $300-600/day for 5 days. RESULTS: At a CDI attributable cost per case of $30,000 (base-case analyses), the incremental treatment cost (US$) per 100 patients ranged from $300,000 to $- 120,000 (cost savings). The excess CDI incidence in moxifloxacin-treated patients would need to be 5-10% for omadacycline to be cost-saving, assuming the attributable CDI cost is approximately $30,000. CONCLUSION: Targeted omadacycline use may reduce economic burden associated with hospitalized CABP patients treated with moxifloxacin if it can reduce excess cases of moxifloxacin-associated CDI.

Hospital Admission Patterns in Adult Patients with Community-Acquired Pneumonia Who Received Ceftriaxone and a Macrolide by Disease Severity across United States Hospitals.

(1) Objective: There are limited data regarding community-acquired pneumonia (CAP) admissions patterns in US hospitals. Current expert CAP guidelines advocate for outpatient treatment or an abbreviated hospital stay for CAP patients in pneumonia severity index (PSI) risk classes I-III (low risk); however, the extent of compliance with this recommendation is unclear. This study sought to estimate the proportion of admissions among CAP patients who received ceftriaxone and macrolide therapy, one of the most commonly prescribed guideline-concordant CAP regimens, by PSI risk class and Charlson comorbidity index (CCI) score. (2) Methods: A retrospective cross-sectional study of patients in the Vizient® (MedAssets, Irving, Texas) database between 2012 and 2015 was performed. Patients were included if they were aged ≥ 18 years, had a primary diagnosis for CAP, and received ceftriaxone and a macrolide on hospital day 1 or 2. Baseline demographics and admitting diagnoses were used to calculate the PSI score. Patients in the final study population were grouped into categories by their PSI risk class and CCI score. Hospital length of stay, 30-day mortality rates, and 30-day CAP-related readmissions were calculated across resulting PSI-CCI strata. (3) Results: Overall, 32,917 patients met the study criteria. Approximately 70% patients were in PSI risk classes I-III and length of stay ranged between 4.9 and 6.2 days, based on CCI score. The 30-day mortality rate was <0.5% and <1.4% in patients with PSI risk classes I and II, respectively. (4) Conclusions: Over two-thirds of hospitalized patients with CAP who received ceftriaxone and a macrolide were in PSI risk classes I-III. Although the findings should be interpreted with caution, they suggest that there is a potential opportunity to improve the efficiency of healthcare delivery for CAP patients by shifting inpatient care to the outpatient setting in appropriate patients.

Cost-Saving Opportunities with an Oral and Intravenous Once-Daily Aminomethylcycline Antibiotic for Hospitalized Patients with Community-Acquired Bacterial Pneumonia: Findings from Decision-Analytic Models.

BACKGROUND: The most frequently prescribed regimens for the treatment of hospitalized adults with suspected or documented community-acquired bacterial pneumonia (CABP), an acute bacterial infection of the pulmonary parenchyma, are ceftriaxone plus a macrolide, or a respiratory fluoroquinolone. Although these regimens are consistent with expert guidelines, there are growing concerns regarding their safety and efficacy. Omadacycline is a once-daily antibiotic with oral and intravenous (IV) formulations; it was recently approved in the United States for the treatment of adults with CABP. OBJECTIVE: To estimate the cost impact of shortening hospital stay or avoiding hospitalization when using a treatment with an IV and an oral formulation, such as omadacycline, versus an IV-only drug regimen, such as ceftriaxone plus a macrolide, in adults with CABP who are not candidates for respiratory fluoroquinolone therapy. METHODS: We developed 2 conceptual healthcare decision models to identify potential cost-saving opportunities in hospitalized adults with CABP who receive omadacycline versus ceftriaxone plus a macrolide. The early hospital discharge model examined the cost impact of shifting patients with CABP from inpatient treatment with ceftriaxone plus a macrolide to inpatient IV omadacycline treatment and early hospital discharge with oral omadacycline. The hospital-avoidance model examined the cost impact of omadacycline treatment in the outpatient setting in patients with CABP who have low disease severity. The models defined the upper range of the daily acquisition cost for omadacycline that conferred cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide. RESULTS: In the early hospital discharge model, omadacycline showed cost-savings with a 2-day hospital stay reduction if the daily cost of omadacycline was ≤$836, almost twice its wholesale acquisition cost. In the hospital-avoidance model, the daily omadacycline thresholds that still conferred cost-savings relative to inpatient ceftriaxone plus a macrolide ranged from $1302 to $1334, based on a daily wholesale acquisition cost of $450 for omadacycline, depending on the potential use of the emergency department and an observation unit. CONCLUSION: The study findings show that the targeted use of omadacycline for the treatment of select patient populations with CABP could result in cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide.

Budget Impact Model of Omadacycline on Replacing a Proportion of Existing Treatment Options Among Patients Who Present to the Emergency Department with Acute Bacterial Skin and Skin Structure Infections.

BACKGROUND: Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant Staphylococcus aureus. Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI. OBJECTIVES: To estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned. METHODS: The base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates. RESULTS: The annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively. CONCLUSION: This hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.

Budget Impact of Omadacycline for the Treatment of Patients with Community-Acquired Bacterial Pneumonia in the United States from the Hospital Perspective.

BACKGROUND: Community-acquired bacterial pneumonia (CABP) is an acute, lower respiratory bacterial infection. Despite advances in medical care, CABP remains associated with considerable morbidity, mortality, and healthcare costs; early empiric treatment is recommended by the Infectious Diseases Society of America and by the American Thoracic Society. Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adult patients with CABP. OBJECTIVE: To estimate the budget impact of introducing omadacycline as a treatment option among patients with suspected or documented CABP from a US hospital perspective. METHODS: A budget impact model was developed in Microsoft Excel® 2010. Population, clinical, and cost inputs were based on the available literature, clinical trial data, and real-world evidence databases. Emergency departments and observation units were assumed to be hospital-owned as part of the analyses. Sensitivity analyses assessed the impact of key parameters on the model results, and scenario analyses were explored to analyze the budget impact of reducing length of hospital stay and avoiding hospitalization. RESULTS: The introduction of omadacycline as a treatment resulted in a total budget increase of $20,643 over 3 years. This increase was mainly attributed to treatment acquisition costs. In a scenario where the length of hospital stay was reduced by 1 day (under the assumption that an antibiotic with IV and oral formulations can facilitate earlier discharge from inpatient care), the 3-year total budget decreased to $2384; reducing the hospital stay by 2 days resulted in 3-year cost-savings of $15,875. Shifting inpatient care to the outpatient setting with omadacycline resulted in 3-year cumulative cost-savings of $112,843. CONCLUSION: This is the first omadacycline budget impact model developed for adult patients with suspected or documented CABP. The model projected a modest budget increase with the introduction of omadacycline, mainly due to treatment acquisition costs.

Analysis of a prescription drug prior authorization program in a Medicaid health maintenance organization.

OBJECTIVE: To determine the factors important in approving prescription reimbursement under prior authorization (PA) in a Medicaid managed care organization (MCO). METHODS: A cross-sectional statistical analysis was performed using administrative data for one month of PA requests to an MCO with more than 250,000 Medicaid recipients in the northeast United States. RESULTS: More than 95% of PA reviews resulted in payment for the originally prescribed products. The most common treatments involved were atypical antipsychotics, antacids, antidepressants, antihypertensives, anticonvulsants, and Cox-2 inhibitors. The rejection rate for nonformulary products was 7.1% while that for formulary products was 3.7%. Nevertheless, most drugs requiring PA were formulary- listed, with protocols to reinforce prescription guidelines. Rejection of reimbursement was inversely related to patient age. Most likely to be authorized were drugs for smoking cessation, pain, and nausea, while those least likely to be approved were multivitamins, sleep aids, and high-cost antidepressants. CONCLUSION: Although nonformulary products are more frequently subject to PA, 78.6% of PA procedures are performed in response to requests for formulary-listed products. The PA rejection rate for this Medicaid MCO was small; 4.4% overall and 7.1% for nonformulary versus 3.7% for formulary drugs.

Modeling economic implications of alternative treatment strategies for acute bacterial skin and skin structure infections.

OBJECTIVE: The economic implications from the US Medicare perspective of adopting alternative treatment strategies for acute bacterial skin and skin structure infections (ABSSSIs) are substantial. The objective of this study is to describe a modeling framework that explores the impact of decisions related to both the location of care and switching to different antibiotics at discharge. METHODS: A discrete event simulation (DES) was developed to model the treatment pathway of each patient through various locations (emergency department [ED], inpatient, and outpatient) and the treatments prescribed (empiric antibiotic, switching to a different antibiotic at discharge, or a second antibiotic). Costs are reported in 2012 USD. RESULTS: The mean number of days on antibiotic in a cohort assigned to a full course of vancomycin was 11.2 days, with 64% of the treatment course being administered in the outpatient setting. Mean total costs per patient were $8671, with inpatient care accounting for 58% of the costs accrued. The majority of outpatient costs were associated with parenteral administration rather than drug acquisition or monitoring. Scenarios modifying the treatment pathway to increase the proportion of patients receiving the first dose in the ED, and then managing them in the outpatient setting or prescribing an oral antibiotic at discharge to avoid the cost associated with administering parenteral therapy, therefore have a major impact and lower the typical cost per patient by 11-20%. Since vancomycin is commonly used as empiric therapy in clinical practice, based on these analyses, a shift in treatment practice could result in substantial savings from the Medicare perspective. CONCLUSIONS: The choice of antibiotic and location of care influence the costs and resource use associated with the management of ABSSSIs. The DES framework presented here can provide insight into the potential economic implications of decisions that modify the treatment pathway.