Willingness to pay to prevent chemotherapy induced nausea and vomiting among patients with breast, lung, or colorectal cancer.

OBJECTIVE: Understanding the value patients place on avoiding various aspects of chemotherapy induced nausea and vomiting (CINV) can help medical professionals assess whether current and emerging treatments are acceptable based on their costs and expected effects. Little is known, however, about the value patients place on avoiding various aspects of CINV. The current study helps fill this gap in the literature. METHODS: 301 patients completed a discrete-choice conjoint survey. Patients viewed 25 conjoint tasks, each containing two descriptions of CINV, and indicated which they preferred. The descriptions combined levels from eight CINV attributes (likelihood of nausea, duration of nausea, severity of nausea, likelihood of vomiting, duration of vomiting, severity of vomiting, need to seek treatment for dehydration, and out-of-pocket treatment costs). RESULTS: Cost contributed more to patient choices than any other single attribute. The combined effect of the likelihood, duration, and severity attributes for nausea, however, was a stronger driver of patient choices than cost, as was the combined effect of the likelihood, duration, and severity attributes for vomiting. The nausea attributes also were a stronger driver of patient choices than the vomiting attributes. Patients were willing to pay to avoid increases in all attributes, except likelihood of vomiting, where the result was not statistically different from zero. Willingness-to-pay varied by income, disease stage, Eastern Cooperative Oncology Group performance status, chemotherapy status, and whether patients worked while on chemotherapy. LIMITATIONS: Although the study used a convenience sample, data were collected from several geographically dispersed U.S. oncology clinics. CONCLUSIONS: Several antiemetics are now available at different price points. This study assesses the value patients place on their benefits and may be used to inform decisions about the management of CINV.

Hematologic outcomes and blood utilization in cancer patients with chemotherapy-induced anemia (CIA) pre- and post-national coverage determination (NCD): results from a multicenter chart review.

PURPOSE: In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. METHODS: Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. RESULTS: Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05-1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15-2.04, p = 0.0034). CONCLUSIONS: Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.

A retrospective study of quality of life in a community sample of patients with early stage breast cancer.

Few studies have examined the pattern of change in quality of life (QoL) over time among patients with breast cancer, or the impact of disease recurrence on QoL. This retrospective study examined QoL among patients with stage I-IIIB breast cancer. Individual, disease and treatment characteristics were abstracted from the medical record, and linked with QoL data collected as a routine part of patient care. The sample included patients with nonrecurrent (N = 100) and recurrent (N = 19) disease, who completed 1,449 QoL assessments. Linear mixed model analysis showed that disease recurrence significantly and adversely affected QoL across all domains. QoL did not appear to deteriorate before recurrence. The pattern of adjustment after recurrence varied across QoL domains in theoretically consistent ways. Study findings suggest that patients show improvement in some areas after recurrence, but generally do not recover previous levels of QoL.

Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study.

GOALS OF WORK: Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux) and rituximab (Rituxan). PATIENTS AND METHODS: A prospective multicenter study involving time and motion and activity sampling methods was conducted among patients with cancer receiving their first outpatient infusion of cetuximab or rituximab. Patients were observed from initiation of MoAb infusion to the end of the clinic visit. IRs were classified as absent, mild/moderate, and severe/life threatening. Staff time and costs were estimated for preparation and administration of MoAb, other chemotherapy agents, and for management of IRs. Resource costs were compared across IR groups within each MoAb. MAIN RESULTS: Among 161 patients enrolled, 32% of 71 patients on cetuximab and 39% of 90 patients on rituximab experienced IRs. Treatment of patients who experienced IRs required more staff time (31-80% more time) and resulted in higher human resource costs (increase of 17-65 US dollars) than patients who did not experience IRs. CONCLUSIONS: IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.

Retrospective chart review of severe infusion reactions with rituximab, cetuximab, and bevacizumab in community oncology practices: assessment of clinical consequences.

GOALS OF WORK: Monoclonal antibody (MoAb) treatments can result in severe infusion reactions. Managing infusion reactions in the outpatient setting introduces clinical and resource challenges for patients and providers, but there is little information regarding prevention, management, or outcomes of severe infusion reactions. This study represents one of the first attempts to describe the clinical consequences of severe infusion reactions associated with MoAb treatment. MATERIALS AND METHODS: Clinic staff identified adults treated with rituximab, cetuximab, or bevacizumab who experienced a grade 3 or higher (severe) infusion reaction. Chart reviews from 19 oncology practice sites across the USA captured patient demographics, infusion reaction management procedures, and clinical outcomes. MAIN RESULTS: With an average age of 62 years, the sample comprised of 76 patients who experienced a severe infusion reaction while receiving rituximab (n = 47), cetuximab (n = 24), and bevacizumab (n = 5). The most common pretreatment medications were acetaminophen and antihistamine in the rituximab group and corticosteroids (42%) in the cetuximab group. All cetuximab and the majority of rituximab severe infusion reactions occurred during the first cycle of therapy. Postinfusion reaction management typically included corticosteroids, oxygen, and intravenous fluids. Overall, 22% were hospitalized for a mean of 4 days (range = 2.0 to 6.0 days). Permanent discontinuation of MoAb therapy occurred after the majority of cetuximab (79 to 100%) related severe infusion reactions. CONCLUSIONS: Severe infusion reactions are intensive events that present a serious challenge to patients and oncology practices. Efforts to prevent or reduce such reactions could be of great benefit.

Recent developments in the classification, evaluation, and treatment of insomnia.

Sleep/wake complaints, and specifically insomnia, are some of the more common problems encountered in the outpatient setting. Despite its prevalence, few clinicians are experts at diagnosing and treating this entity. Additionally, diagnosis and treatment of insomnia is a time-intensive process (often the initial interview takes at least 1 h, depending on the complexity of the insomnia). With a conservative estimate of the annual cost of insomnia between dollar 92.5 and dollar 107.5 billion dollars, it is becoming clear that insomnia has significant medical and public health implications. A problem that has hampered insomnia research is the lack of a standard definition of insomnia for use in research, as well as guidelines for assessment. In recent years, there have been important advances in the classification, evaluation, and treatment of insomnia with efforts to establish greater consensus in how to define and measure insomnia. Cognitive behavioral and pharmacologic therapies have been shown to be effective treatment approaches. Insomnia is a complex entity, often multifactorial in its etiology; and as research and clinical guidelines are established and validated (leading to better data interpretation), continued enhancement of our understanding of this disorder is expected.

Hypnotics should not be considered for the initial treatment of chronic insomnia. Con.

Analysis of the use of hypnotic medication versus CBT for insomnia using an established model for ethical medical decision making leads to the conclusion that hypnotics are not appropriate as the initial treatment in cases of chronic insomnia. Instead, CBT should be considered as the initial treatment for chronic insomnia. This decision is based on empirical data demonstrating that CBT is equally effective in the short-term treatment of insomnia and is superior to pharmacologic treatment in the long-term management of insomnia. Long-term management is a critically important concern, since 'chronic' insomnia requires a long-term solution. Using CBT as the initial treatment is also supported by empirical data showing that combining hypnotic use with CBT leads to worse outcomes compared with CBT alone. In addition to the efficacy data described above, patients have been shown to prefer nondrug therapy for insomnia when given the choice. QoL issues support the use of CBT because of the avoidance of side effects associated with use of hypnotic medication, such as residual sedation, psychomotor and cognitive impairment, and perhaps, most importantly, psychologic dependence. The greatest challenge to endorsement of use of CBT arises from contextual issues, such as the out-of-pocket cost to the patient and availability of the treatment. In some instances, these factors may be significant barriers to the use of CBT for insomnia. These barriers can be addressed with improved insurance reimbursement for CBT, in addition to training more providers.