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  1. Article: 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.

    Lodise, Thomas / LaPensee, Kenneth

    American health & drug benefits

    2019  Volume 12, Issue 4, Page(s) 168–176

    Abstract: 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 ... ...

    Abstract 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.
    Language English
    Publishing date 2019-07-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2853721-X
    ISSN 1942-2970 ; 1942-2962
    ISSN (online) 1942-2970
    ISSN 1942-2962
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Correction to: Decision Analysis: Omadacycline Relative to Moxifoxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difcile Infection.

    Lodise, Thomas P / Mistry, Rohit / Young, Kate / LaPensee, Kenneth

    Clinical drug investigation

    2021  Volume 41, Issue 6, Page(s) 593

    Language English
    Publishing date 2021-04-28
    Publishing country New Zealand
    Document type Published Erratum
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-021-01039-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Lodise, Thomas P / Mistry, Rohit / Young, Kate / LaPensee, Kenneth

    Clinical drug investigation

    2021  Volume 41, Issue 3, Page(s) 269–275

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Administration, Intravenous ; Adult ; Anti-Bacterial Agents/therapeutic use ; Clostridium Infections/epidemiology ; Community-Acquired Infections/drug therapy ; Hospitalization ; Humans ; Moxifloxacin/therapeutic use ; Pneumonia, Bacterial/drug therapy ; Pneumonia, Bacterial/microbiology ; Tetracyclines/therapeutic use
    Chemical Substances Anti-Bacterial Agents ; Tetracyclines ; omadacycline (090IP5RV8F) ; Moxifloxacin (U188XYD42P)
    Language English
    Publishing date 2021-02-19
    Publishing country New Zealand
    Document type Comparative Study ; Journal Article
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-021-01005-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Lodise, Thomas P / Van Le, Hoa / LaPensee, Kenneth

    Antibiotics (Basel, Switzerland)

    2020  Volume 9, Issue 9

    Abstract: 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 ...

    Abstract (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
    Language English
    Publishing date 2020-09-04
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2681345-2
    ISSN 2079-6382
    ISSN 2079-6382
    DOI 10.3390/antibiotics9090577
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    LaPensee, Kenneth / Mistry, Rohit / Lodise, Thomas

    American health & drug benefits

    2019  Volume 12, Issue 1-Supplement 1, Page(s) S1–S12

    Abstract: 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 ...

    Abstract 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
    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.
    Language English
    Publishing date 2019-04-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2853721-X
    ISSN 1942-2970 ; 1942-2962
    ISSN (online) 1942-2970
    ISSN 1942-2962
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: 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.

    LaPensee, Kenneth / Mistry, Rohit / Lodise, Thomas

    American health & drug benefits

    2019  Volume 12, Issue 1-Supplement 2, Page(s) S13–S24

    Abstract: 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 ... ...

    Abstract 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
    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.
    Language English
    Publishing date 2019-04-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2853721-X
    ISSN 1942-2970 ; 1942-2962
    ISSN (online) 1942-2970
    ISSN 1942-2962
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: 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.

    Chitra, Surya / Hinahara, Jordan / Goss, Thomas F / Gunter, Kyle / LaPensee, Kenneth

    Open forum infectious diseases

    2021  Volume 8, Issue 10, Page(s) ofab459

    Abstract: 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 ... ...

    Abstract 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.
    Language English
    Publishing date 2021-09-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofab459
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    LaPensee, Kenneth T

    Journal of managed care pharmacy : JMCP

    2003  Volume 9, Issue 1, Page(s) 36–44

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Fees, Pharmaceutical/statistics & numerical data ; Female ; Health Maintenance Organizations/economics ; Humans ; Infant ; Male ; Medicaid/economics ; Middle Aged ; United States
    Language English
    Publishing date 2003-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2022394-8
    ISSN 1944-706X ; 1083-4087
    ISSN (online) 1944-706X
    ISSN 1083-4087
    DOI 10.18553/jmcp.2003.9.1.36
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  9. Article ; Online: Hedgehog signaling and steroidogenesis.

    Finco, Isabella / LaPensee, Christopher R / Krill, Kenneth T / Hammer, Gary D

    Annual review of physiology

    2015  Volume 77, Page(s) 105–129

    Abstract: Since its discovery nearly 30 years ago, the Hedgehog (Hh) signaling pathway has been shown to be pivotal in many developmental and pathophysiological processes in several steroidogenic tissues, including the testis, ovary, adrenal cortex, and placenta. ... ...

    Abstract Since its discovery nearly 30 years ago, the Hedgehog (Hh) signaling pathway has been shown to be pivotal in many developmental and pathophysiological processes in several steroidogenic tissues, including the testis, ovary, adrenal cortex, and placenta. New evidence links the evolutionarily conserved Hh pathway to the steroidogenic organs, demonstrating how Hh signaling can influence their development and homeostasis and can act in concert with steroids to mediate physiological functions. In this review, we highlight the role of the components of the Hh signaling pathway in steroidogenesis of endocrine tissues.
    MeSH term(s) Adrenal Glands/metabolism ; Animals ; Female ; Hedgehog Proteins/physiology ; Humans ; Male ; Ovary/metabolism ; Placenta/metabolism ; Pregnancy ; Signal Transduction/physiology ; Steroids/metabolism ; Testis/metabolism
    Chemical Substances Hedgehog Proteins ; Steroids
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 207933-1
    ISSN 1545-1585 ; 0066-4278
    ISSN (online) 1545-1585
    ISSN 0066-4278
    DOI 10.1146/annurev-physiol-061214-111754
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  10. Article ; Online: Modeling economic implications of alternative treatment strategies for acute bacterial skin and skin structure infections.

    Revankar, Nikhil / Ward, Alexandra J / Pelligra, Christopher G / Kongnakorn, Thitima / Fan, Weihong / LaPensee, Kenneth T

    Journal of medical economics

    2014  Volume 17, Issue 10, Page(s) 730–740

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Acetamides/economics ; Acetamides/therapeutic use ; Acute Disease ; Administration, Intravenous ; Anti-Bacterial Agents/economics ; Anti-Bacterial Agents/therapeutic use ; Daptomycin/economics ; Daptomycin/therapeutic use ; Health Expenditures/statistics & numerical data ; Humans ; Linezolid ; Oxazolidinones/economics ; Oxazolidinones/therapeutic use ; Patient Discharge/statistics & numerical data ; Skin Diseases, Bacterial/drug therapy ; Soft Tissue Infections/drug therapy ; United States ; Vancomycin/economics ; Vancomycin/therapeutic use
    Chemical Substances Acetamides ; Anti-Bacterial Agents ; Oxazolidinones ; Vancomycin (6Q205EH1VU) ; Linezolid (ISQ9I6J12J) ; Daptomycin (NWQ5N31VKK)
    Language English
    Publishing date 2014-10
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.3111/13696998.2014.941065
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