Unintended Consequences in Cancer Care Delivery Created by the Medicare Part B Proposal: Is the Clinical Rationale for the Experiment Flawed?

Purpose: Medicare currently enrolls ≥ 45 million adults, and by 2030 this is projected to increase to ≥ 80 million beneficiaries. With this growth, the Centers for Medicare & Medicaid Services (CMS) issued a proposal, the Medicare Part B Drug Payment Model, to shrink drug expenditures, a major contributor to overall health care costs. For this to not adversely affect patient outcomes, lower-cost alternative medications with equivalent efficacy and no increased toxicity must be available.

Antipsychotics, glycemic disorders, and life-threatening diabetic events: a Bayesian data-mining analysis of the FDA adverse event reporting system (1968-2004).

Background: This analysis compared diabetes-related adverse events associated with use of different antipsychotic agents. A disproportionality analysis of the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) was performed.

Methods: Data from the FDA postmarketing AERS database (1968 through first quarter 2004) were evaluated.

Part 2: Examining pediatric vesicoureteral reflux: a real-world evaluation of treatment patterns and outcomes.

Objective: Vesicoureteral reflux (VUR) occurs in 1% of infants and children. Upon diagnosis, patients are often placed on prophylactic antibiotics to prevent urinary tract infections (UTIs) and potential renal damage. The objective of this study was to assess current diagnosis and treatment patterns for patients diagnosed with VUR, focusing on compliance with antibiotic therapy and the occurrence of UTIs.

Part 1: Vesicoureteral reflux treatment: the past, present, and future.

The purpose of this manuscript is to provide clinicians with highlights of key findings pertaining to our current understanding and treatment of the condition of vesicoureteral reflux (VUR). This includes a review of the disease, patient characteristics, current treatment options, challenges for managed care and patients, and opportunities for improvements in care. This is not intended as a comprehensive review of VUR.

A large retrospective analysis of acute urinary retention and prostate-related surgery in BPH patients treated with 5-alpha reductase inhibitors: dutasteride versus finasteride.

Objective: The purpose of this study was to examine the rates of acute urinary retention (AUR) and surgery after initiating 5-alpha reductase inhibitor (5ARI) therapy and to compare the 2 currently available 5ARIs, dutasteride and finasteride, in a real-world, managed care setting. This study constitutes the first direct comparison of therapeutic outcome between a mono 5ARI (finasteride) and a dual 5ARI (dutasteride).

Methods: This is a retrospective descriptive and comparative analysis of the rates of AUR and prostate surgery in patients with benign prostatic hyperplasia (BPH) treated with 5ARI therapy, either dutasteride or finasteride.

An assessment of the diagnosed prevalence of diseases in men 50 years of age or older.

Objective: A lack of focus on certain men's health problems has led to significant morbidity and mortality in aging men. Managed care must begin to focus on the conditions that are most prevalent in this fast-growing population in an effort to improve the quality of care. To assist in achieving this goal, a naturalistic retrospective study assessing the prevalence of the 10 leading disorders in men older than the age of 50 was conducted, with an additional focus on men eligible for Medicare.

A comparative pharmacoeconomic assessment of two surfactants for the prevention of respiratory distress syndrome.

Objective: The use of exogenous surfactants among preterm infants for the prevention and treatment of respiratory distress syndrome (RDS) has led to economic and cost-effectiveness evaluations of these products. Lucinactant (Surfaxin), a novel, peptide-based, synthetic surfactant, has been shown to significantly reduce RDS-related mortality, compared with the most commonly prescribed animal-derived surfactant, beractant (Survanta). Infants who survive expend significant healthcare resources; therefore, the impact of improved survival through 1-year corrected age was evaluated in a prospectively defined pharmacoeconomic analysis.

An economic comparison of risperidone and olanzapine use within an integrated managed mental health program.

This study assessed differences in total mental health care costs for 1 year following initiation of risperidone or olanzapine in individuals within NorthSTAR, an integrated managed mental health pilot project. A retrospective database analysis of individuals with schizophrenia or schizoaffective disorder and newly started on either agent was conducted. Antipsychotic medication costs were significantly lower for individuals prescribed risperidone than olanzapine (1763 dollars versus 2582 dollars; p<0.

Assessment of compliance with antipsychotic treatment and resource utilization in a Medicaid population.

Background: Partial compliance with mental health medications has been associated with an increased risk of clinical worsening, relapse, and repeat hospitalization.

Objective: The purpose of this study was to evaluate the effect of partial compliance of patients (diagnosed as having schizophrenia or bipolar disorder) with prescribed oral atypical and conventional antipsychotic agents and the corresponding impact on resource utilization.

Methods: Patients receiving antipsychotic agents ina large Southeastern Medicaid program were grouped according to their level of compliance.

Pharmacy cost evaluation of risperidone, olanzapine, and quetiapine for the treatment of schizophrenia in acute care inpatient settings.

Objective: This study examines total pharmacy cost and usage patterns of schizophrenic patients in acute mental health inpatient settings for three atypical antipsychotics -- risperidone, olanzapine, and quetiapine. Despite the readily available unit cost information for drugs, actual pharmacy costs may deviate significantly from 'labeled costs'. Recent research findings indicate the need for more robust evaluation of such pharmacy costs.

Outcomes and costs of risperidone versus olanzapine in patients with chronic schizophrenia or schizoaffective disorders: a Markov model.

Objective: To compare expected outcomes and costs of care in patients with chronic schizophrenia or schizoaffective disorders who are treated with risperidone versus olanzapine.

Methods: A Markov model was developed to examine outcomes and costs of care in patients with chronic schizophrenia or schizoaffective disorders receiving risperidone or olanzapine. The time frame of interest was 1 year.

Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia.

Objective: The objective of this study was to evaluate the relationship between compliance with an antipsychotic medication regimen and risk of hospitalization in a cohort of California Medicaid patients with schizophrenia.

Methods: Compliance behavior was estimated by using a retrospective review of California Medicaid pharmacy refill and medical claims for 4,325 outpatients for whom antipsychotics were prescribed for treatment of schizophrenia from 1999 to 2001. Compliance behavior was estimated by using four different definitions: gaps in medication therapy, medication consistency and persistence, and a medication possession ratio.

Comparative study of the development of diabetes mellitus in patients taking risperidone and olanzapine.

Objectives: A growing body of literature suggests that certain atypical antipsychotics, especially olanzapine and clozapine, may induce glucoregulatory dysfunction. We assessed the differences in risk of developing diabetes mellitus during treatment with olanzapine and risperidone by using patients treated with haloperidol and fluphenazine as control subjects in whom we would not expect to see an increased risk.

Methods: We conducted a retrospective analysis of the Veteran's Integrated Service Network 10 Veterans Affairs (VA) database.

Differential effects of antipsychotic agents on the risk of development of type 2 diabetes mellitus in patients with mood disorders.

Background: Atypical antipsychotics are being used increasingly in the management of mood disorders.

Objective: The objective of this study was to investigate the association between exposure to antipsychotic therapy and newly reported type 2 diabetes mellitus in patients with mood disorders.

Methods: Claims data for the period January 1996 through December 1997 were analyzed for patients with mood disorders in 2 large US health plans.

Differential effects of risperidone, olanzapine, clozapine, and conventional antipsychotics on type 2 diabetes: findings from a large health plan database.

Background: Case series suggest that some antipsychotics may induce or exacerbate type 2 diabetes. This study measured the association of antipsychotic treatments with diabetes at a population level.

Method: Claims data for psychosis patients (ICD-CM-9 290.

Identifying patients with gastroesophageal reflux disease: validation of a practical screening tool.

A reliable, accurate noninvasive method for identifying patients with gastroesophageal reflux disease (GERD) in the primary care setting is needed. A population-based case-finding instrument may assist managed care organizations in identifying candidates for disease management or quality improvement programs. Our aim was to develop and validate a GERD case-finding instrument.