Specialty drug coverage varies between health plans' medical and pharmacy benefit policies.

In an effort to control drug spending, health plans are increasingly shifting specialty drugs from their medical benefit to the pharmacy benefit. One consequence of this trend is that some health plans have both a medical and a pharmacy coverage policy for the same drug. To examine how frequently health plans issue medical and pharmacy benefit policies for the same specialty drug and to evaluate the concordance between plans' medical and pharmacy policies when plans issue both policy types.

Inhibitor clinical burden of disease: a comparative analysis of the CHESS data.

Background: Patients with hemophilia and inhibitors generally face greater disease burden compared to patients without inhibitors. While raising awareness of relative burden may improve the standard of care for patients with inhibitors, comparative data are sparse. Analyzing data drawn from the Cost of Haemophilia across Europe - a Socioeconomic Survey (CHESS) study, the aim of this study was to compare the clinical burden of disease in patients with severe hemophilia with and without inhibitors.

Cost-effectiveness of ceftolozane/tazobactam compared with piperacillin/tazobactam as empiric therapy based on the in-vitro surveillance of bacterial isolates in the United States for the treatment of complicated urinary tract infections.

Background: A challenge in the empiric treatment of complicated urinary tract infection (cUTI) is identifying the initial appropriate antibiotic therapy (IAAT), which is associated with reduced length of stay and mortality compared with initial inappropriate antibiotic therapy (IIAT). We evaluated the cost-effectiveness of ceftolozane/tazobactam compared with piperacillin/tazobactam (one of the standard of care antibiotics), for the treatment of hospitalized patients with cUTI.

Methods: A decision-analytic Monte Carlo simulation model was developed to compare the costs and effectiveness of empiric treatment with either ceftolozane/tazobactam or piperacillin/tazobactam in hospitalized adult patients with cUTI infected with Gram-negative pathogens in the US.

Systematic review and network meta-analysis of tedizolid for the treatment of acute bacterial skin and skin structure infections caused by MRSA.

Background: Tedizolid, the active moiety of tedizolid phosphate, is approved in the United States, the European Union, Canada and a number of other countries for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). This network meta-analysis (NMA) evaluates the comparative effectiveness of tedizolid and other antibacterials indicated for the treatment of ABSSSI caused by MRSA.

Methods: Systematic review of 10 databases was undertaken to inform an NMA to estimate the relative effectiveness of tedizolid and established monotherapy comparators (ceftaroline, daptomycin, linezolid, teicoplanin, tigecycline, vancomycin) for treating MRSA-associated ABSSSI.

An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.

Background: Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.

Methods: The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection.

Economic Impact of Alvimopan Considering Varying Definitions of Postoperative Ileus.

Background: Prolonged postoperative ileus (POI) is the predominant cause of extended hospitalization after bowel resection surgery. Alvimopan accelerates gastrointestinal recovery, potentially reducing health care costs. We examined the value of alvimopan in reducing prolonged POI and length of stay for patients undergoing abdominal surgery using different definitions of POI.

Psoriasis patients' willingness to accept side-effect risks for improved treatment efficacy.

Background: Previous studies suggest that efficacy is more important than side-effect risks to psoriasis patients. However, those studies did not consider potentially fatal risks of biologic treatments.

Objective: To quantify the risks patients are willing to accept for improvements in psoriasis symptoms.

Alvimopan, a peripherally acting μ-opioid receptor antagonist, is associated with reduced costs after radical cystectomy: economic analysis of a phase 4 randomized, controlled trial.

Purpose: We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized, phase 4 clinical trial.

Materials And Methods: Resource utilization data were prospectively collected and evaluated by cost consequence analysis. Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs.

Influence of explanatory and confounding variables on HRQoL after controlling for measurement bias and response shift in measurement.

The purpose of this study was to examine the influence of explanatory and confounding variables on health-related quality of life after accounting for response shift, measurement bias and response shift in measurement using structural equation modeling. Hypertensive patients with coronary artery disease randomized to anti-hypertensive treatment, completed the ShortForm-36 questionnaire at both baseline and 1 year (n = 788). Three measurement biases were found and all three were considered as response shift in measurement.

Patients' willingness to accept the risks and benefits of new treatments for chronic hepatitis C virus infection.

Background: Some patients with chronic hepatitis C virus (HCV) infection forego treatment due to concerns about treatment efficacy, treatment duration, and side effects.

Objective: The purpose of this study was to quantify patient preferences among possible outcomes associated with new, direct-acting antiviral agents (DAAs) for the treatment of HCV infection and determine which treatment features are most important to patients in making treatment decisions.

Methods: Adult participants with a self-reported physician diagnosis of HCV infection in five countries completed a web-enabled, choice-format conjoint analysis survey.

Assessment of response shift using two structural equation modeling techniques.

Objective: To identify response shift using two structural equation modeling (SEM) techniques.

Study Design And Setting: Hypertensive patients (n = 909) with coronary artery disease (CAD) completed SF-36 surveys at both baseline and 1-year follow-up. Response shift was identified using Oort and Schmitt SEM techniques.

Trends in the prevalence of thrombocytopenia among individuals infected with hepatitis C virus in the United States, 1999-2008.

Background: Thrombocytopenia is associated with the natural history of hepatitis C virus (HCV) infection and anti-viral therapy. Recent, national estimates of the clinical burden of thrombocytopenia among HCV-infected individuals in the United States are unavailable. Bi-yearly data from the 1999-2000 to 2007-2008 National Health and Nutrition Examination Surveys (NHANES) were used to examine the prevalence of thrombocytopenia among HCV-infected individuals in the United States.

Spillover adherence effects of fixed-dose combination HIV therapy.

The impact of fixed-dose combination (FDC) products on adherence to other, non-fixed regimen components has not been examined. We compared adherence to a third antiretroviral (ART) component among patients receiving a nucleoside reverse transcriptase inhibitor (NRTI) backbone consisting of the FDC Epzicom(®), GlaxoSmithKline Inc, Research Triangle Park, NC (abacavir sulfate 600 mg + lamivudine 300 mg; FDC group) versus NRTI combinations taken as two separate pills (NRTI Combo group) using data from a national sample of 30 health plans covering approximately 38 million lives from 1997 to 2005. Adherence was measured as the medication possession ratio (MPR).

Cost-effectiveness of respiratory syncytial virus prophylaxis in various indications.

Objectives: To evaluate the cost-effectiveness of immunoprophylaxis against respiratory syncytial virus (RSV) infections with palivizumab based on actual cost and observed incidence rates in various pediatric risk groups.

Design: Decision tree analysis comparing children with various combinations of the following indications: chronic lung disease, congenital heart disease, or prematurity (≤32 weeks gestation), and children with none of these indications. One-way sensitivity analyses and Monte Carlo simulations were used to quantify parameter uncertainty.

Economic efficiency of genetic screening to inform the use of abacavir sulfate in the treatment of HIV.

Background: Abacavir sulfate (abacavir) is associated with a hypersensitivity reaction (HSR) that affects 5-8% of patients. While serious complications are rare, failure to identify it, or abacavir re-challenge following HSR, can be fatal. Genetic screening for HLA-B*5701 can identify patients who are likely to experience an HSR and reduces the incidence of the reaction.

Methodological concerns with economic evaluations of meningococcal vaccines.

The evolution of meningococcal vaccines illustrates nicely the incremental technological process that is common to much medical innovation and particularly appropriate to economic analysis. However, the economic evaluation of vaccines is complicated by several features unique to vaccines, including the possibility of indirect (herd immunity) benefits and the shear breadth of vaccination strategies available to decision makers. As with the vaccines themselves, the modelling approaches applied to the economic evaluation of meningococcal vaccines have evolved to become increasingly complex.

A model of patient choice with mid-therapy information.

For many treatments, a patient's prognosis may be refined by conducting a mid-therapy assessment (MTA). When therapy lasts some time, an MTA predicts a patient's ultimate outcome based on early signs of response. The availability and timing of such assessments also serve as a mechanism by which policy makers can influence patients' treatment-initiation decisions.

The cost of health care for children and adults with sickle cell disease.

Although sickle cell disease (SCD) is marked by high utilization of medical resources, the full cost of care for patients with SCD, including care not directly related to SCD, is unknown. The purpose of this study was to estimate the total cost of medical care for a population of children and adults with SCD. We used data from individuals diagnosed with SCD enrolled in the Florida Medicaid program during 2001-2005 to estimate total, SCD-related, and non-SCD-related cost per patient-month based on patient age at the time of health care use.

Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

Background: Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.

Methods: We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research.

A predictive model of health state utilities for HIV patients in the modern era of highly active antiretroviral therapy.

Objective: Existing estimates of human immunodeficiency virus (HIV)-related health state utilities are inadequate for comparing alternative treatments on the basis of regimen-specific attributes such as dosing requirements or tolerability. The objective of this study was to examine the marginal impact of dosing, adverse events (AEs), and other factors on patients' health state utilities.

Methods: Treatment naive and experienced HIV patients participating in five open-label trials of highly active antiretroviral therapy (HAART) completed the 36-Item Short Form Health Survey (SF-36) instrument at various time points.

Cost-utility analysis of rimonabant in the treatment of obesity.

Objective: To estimate the incremental cost-utility ratio (ICUR) of rimonabant 20 mg/day in the treatment of obesity from a third-party payer's perspective.

Methods: Pooled data from three randomized clinical trials were used to develop a decision tree with five treatment alternatives: 1- and 2-year treatment with rimonabant, 2-year placebo, 1-year rimonabant followed by 1-year placebo, and no treatment. All alternatives, except no treatment, were accompanied by lifestyle interventions.