Pharmacy & Therapeutics - October 2008 - (Page PP3)

PRODUCT PROFILER: Granisetron Transdermal Delivery System patients left the hospital. (The 24% reduction occurred at Day 6, and was compared with good compliance on Days 1 to 3.)8 In addition to the poor outcomes that can result from treatment interruptions or discontinuation, uncontrolled nausea and vomiting can lead to problems such as anorexia, weight loss, and nutritional imbalances, thus complicating disease management and increasing overall health care costs.9 Effect on Quality of Life and Costs Uncontrolled nausea and vomiting can also have a significant effect on a patient’s quality of life. In addition to the potential for experiencing any of the complications already mentioned, patients might not be able to maintain activities of daily living or work, eat meals, take other prescribed medications, or even complete household tasks.5 Additional expenses associated with poorly controlled CINV include medical costs for unscheduled office visits, the need for hydration, and emergency department admissions.1 Shih et al. and controlled CINV was 6.23 and 3.61 days per month, respectively, and the average indirect costs of uncontrolled CINV were $433 high per month than those of controlled CINV.1 Vanscoy et al. Shih et al. examined the economic impact of poorly controlled CINV among working-age cancer patients treated with highly or moderately emetogenic chemotherapy.1 The study population included patients with uncontrolled and those with controlled CINV. Patients with uncontrolled CINV had made at least one office visit or emergency room visit or had been hospitalized with a diagnosis of nausea and/or vomiting or dehydration during the study period, according to the International Classification of Diseases (ICD-9).1 Direct medical costs were divided into three categories: costs of chemotherapy, costs of treatments for chemotherapy-related adverse events (AEs) (e.g., neutropenia), and costs associated with uncontrolled CINV only.1 An exploratory subgroup analysis evaluated indirect costs, which the researchers estimated by comparing work-loss days for employees in uncontrolled CINV and in controlled CINV groups.1 The hours lost from work were multiplied by the average hourly wage rate, obtained from the Bureau of Labor Statistics, and were stratified by census regions to account for geographic variations in wages.1 The results showed that the total direct medical costs per patient per month in the uncontrolled CINV group (excluding the costs of chemotherapy and its related AEs) were $1,383 higher than those costs incurred by the controlled CINV group (P < 0.0001).1 After the researchers controlled for confounders, the cost difference between the groups was $1,280 higher per month in the uncontrolled CINV group.1 Although the sample size was underpowered to detect statistical significance in the exploratory subgroup for which total indirect costs were evaluated, the average number of work-loss days for uncontrolled Vanscoy et al. conducted an analysis of 1,149 cancer patients who were treated with a first-generation serotonin type-3 (5-HT3) receptor antagonist (ondansetron, granisetron [Kytril], or dolasetron) in the U.S. from 1999 through 2003.10 Patients were followed for the first five days after receiving moderately emetogenic chemotherapy for documentation in the electronic medical record of unscheduled visits or calls to the oncology practice for management of failed CINV prophylaxis, defined as an “extreme CINV event.”10 Patients who were considered to have had these events were those with (1) severe nausea and more than two emetic episodes on any day and severe nausea the following day or (2) more than five emetic episodes on any day and moderate or severe nausea the following day.10 The study found that one in nine patients (11.1%) had poorly controlled CINV and consumed further health care resources.10 The investigators also examined the impact of these extreme CINV events on operational efficiency and potential revenue of an outpatient oncology practice.10 Based on data from 20 community oncology practices, the estimated average labor time to manage an extreme CINV event was 255 minutes, which translated into approximately $175 in labor costs (in 2005 dollars). Using only Medicare G-codes for hydration, they found that the typical laboratory tests ordered as part of the evaluation and management of a patient with cancer who has CINV with dehydration and a level III office visit lead to an average reimbursement of approximately $198, or a net revenue of just $23.10 For a typical patient with breast cancer receiving dose-dense doxorubicin/cyclophosphamide (AC) chemotherapy, the estimated labor time was 258 minutes, or $163 in labor costs. However, the reimbursement under Centers for Medicare and Medicaid Services (CMS) in 2005 for a patient receiving dose-dense AC was approximately $508, a net revenue of $345.10 The disparity in revenues in these two situations and with these different types of therapies demonstrates that managing extreme CINV events not only has significant clinical and economic consequences for the patient but also can have important financial consequences for the oncology practice.10 It is important to note that these net revenue figures just cited do not take into consideration other costs (such as rent, utilities, non-medical care items necessary to operate a medical oncology practice, and the revenue or loss from drug margins) in either of the scenarios described.10 3

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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