Search

Objectives: Olanzapine has been shown to be effective in preventing chemotherapy-induced nausea and vomiting (CINV) after highly emetogenic chemotherapy (HEC); however, there is limited work on the impact of CINV on health-related quality of life (HRQoL) and the comparative cost-effectiveness of CINV prophylaxis in the Malaysian context. Therefore, this study was conducted to determine the HRQoL using EQ-5D-5L and the cost-effectiveness of olanzapine compared with aprepitant for CINV prophylaxis in Malaysia using data from a local study., Methods: Fifty-nine chemo-naive patients receiving either olanzapine or aprepitant were randomly recruited and completed the EQ-5D-5L before and day 5 after HEC. HRQoL utility scores were analyzed according to the Malaysian valuation set. The economic evaluation was conducted from a healthcare payer perspective with a 5-day time horizon. Quality-adjusted life days (QALD) and the rate of successfully treated patients were used to measure health effects. The incremental cost-effectiveness ratio is assessed as the mean difference between groups' costs per mean difference in health effects. A one-way sensitivity analysis was performed to assess variations that might affect outcomes., Results: Aprepitant and olanzapine arms' patients had comparable baseline mean HRQoL utility scores of 0.920 (SD = 0.097) and 0.930 (SD = 0.117), respectively; however, on day 5, a significant difference (P value = .006) was observed with mean score of 0.778 (SD = 0.168) for aprepitant and 0.889 (SD = 0.133) for olanzapine. The cost per successfully treated patient in the aprepitant arm was 60 times greater than in the olanzapine arm (Malaysian Ringgit [MYR] 927 vs MYR 14.83). Likewise, the cost per QALD gain in the aprepitant arm was 36 times higher than in the olanzapine arm (MYR 57.05 vs MYR 1.57). Incremental cost-effectiveness ratio of MYR -937.00 (USD -200.98) per successfully treated patient and MYR -391.84 (USD -85.43) per QALD gained for olanzapine compared with the aprepitant-based regimen., Conclusions: An olanzapine-based regimen is a cost-effective therapeutic substitution in patients receiving HEC in Malaysia., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to assess the productivity loss and cost due to maternal ill-health conditions and its associated factors throughout pregnancy in rural Sri Lanka., Design: A follow-up study of women registered in the Rajarata Pregnancy Cohort (RaPCo)., Setting: Anuradhapura district, Sri Lanka., Participants: 1573 pregnant women who were followed up from pregnancy identification to termination., Primary and Secondary Outcome Measures: The primary outcome measures of this study are productivity loss due to maternal ill-health conditions expressed by days/month and productivity cost due to maternal ill-health conditions expressed in monetary terms (US$)/month. Data were collected monthly, and all pregnant women were asked to report the leading cause of maternal ill-health condition and the associated loss due to absenteeism and presenteeism., Results: During the pregnancy follow-up, 3595 (81.5%) months had at least one episode of maternal ill-health condition. Of these, only 1729 (48.1%) episodes sought medical care. Assistance for lost routine work was reported in 1281 (35.6%) episodes. The absenteeism, presenteeism and gross and net productivity loss per month were 3.6, 4.5, 8.1 and 5.5 days/month, respectively. The corresponding productivity cost was US$15.26/month. Nausea and vomiting (NVP) reported the highest prevalence (n=1599, 44.5%) until the second month of the third trimester, presenteeism (5.5 days/month) and gross productivity loss (9.5 days/month). Pregnant women with vaginal bleeding reported the highest absenteeism (6.2 days/month) and net productivity loss (6.8 days/month). Pregnant women diagnosed with anaemia reported the highest productivity cost (US$26.98/month). Monthly household expenditure, poverty and receiving assistance were the associated factors of productivity loss (p<0.05)., Conclusion: Maternal ill-health conditions during pregnancy lead to productivity loss in rural Sri Lanka. NVP, vaginal bleeding and anaemia are the leading causes of productivity loss. Hence, controlling and preventing the leading causes are the recommended priorities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Chronic nausea and vomiting syndromes (CNVS), gastroparesis and functional dyspepsia (FD) are complex disorders. Body Surface Gastric Mapping (BSGM), a new test of gastric function, using Gastric Alimetry® (Alimetry, New Zealand) may be useful for de-escalating healthcare utilisation. This study aimed to define healthcare costs and estimate health economic impacts of implementing this test in patients with chronic gastroduodenal symptoms., Methods: Consecutive patients at a tertiary referral centre evaluated with Gastric Alimetry were included. Frequency and cost data relating to medical investigations, hospital and outpatient presentations were evaluated. Costs of healthcare utilisation were calculated, and the potential cost savings of implementing Gastric Alimetry within a diagnostic decision-tree model were estimated., Results: Overall, 31 consecutive patients (mean age 36.1 years; 83.9% female; predominant symptoms: nausea [83.9%], pain [61.3%], vomiting [67.7%] and bloating [35.5%]) completed Gastric Alimetry testing. Repeat gastroscopy and abdominal CT rates were 29% (8/28) and 85% (11/13), respectively. Gastric Alimetry testing identified spectral abnormalities in 45.2% of patients, and symptom profiling classified a further 29.1% of patients. Median annualised cost difference after test introduction was NZ$-12,032. Estimated reductions in investigation-related costs when incorporating Gastric Alimetry into the diagnostic workflow model were approximately NZ$1,300 per patient., Conclusions: Healthcare utilisation and confirmatory testing rates remain high in nausea and vomiting syndromes. This study presents real-world data, together with a decision-tree analysis, showing Gastric Alimetry can streamline clinical care pathways, resulting in reduced healthcare utilisation and cost., (© 2024. The Author(s).)

Purpose of Review: To investigate the cost of netupitant and palonosetron (NEPA) in the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in adults receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) for cancer treatment in real life., Recent Findings: A retrospective analysis of all consecutives patients with advanced lung cancer treated in platinum-based (carboplatin or cisplatin) chemotherapy and with breast cancer treated with anthracycline and cyclophosphamide -based chemotherapy at our Medical Oncology Unit during 4 years was performed. The costs of drugs are at the Pharmacy of our Hospital (&OV0556;)., Summary: We evaluated 110 patients with lung cancer and 55 patients with breast cancer. Concerning lung cancer, we have obtained an advantage of 133 &OV0556; in monthly medical costs of NEPA and dexamethasone (DEX) vs. the combination of palonosetron (PALO) and DEX for each patient. Concerning breast cancer, we have obtained an advantage of 78 &OV0556; in monthly medical costs of NEPA and DEX vs. the combination of PALO and DEX for each patient. Combining the medical costs of antiemetic therapy with the measure of efficacy represented by the complete response, the combination of NEPA and DEX is cost-effective for preventing CINV in HEC and MEC cancer treatment.

Purpose: To evaluate the impact on cost, time, resource use, and clinic workflow of converting the route of drug administration from a neurokinin-1 receptor antagonist (NK-1 RA) 30-min intravenous (IV) infusion to aprepitant IV, and more specifically to IV push, within a multicenter community oncology practice., Methods: This was a retrospective, multicenter time, motion, and resource/cost evaluation study. Conversion to aprepitant IV was determined by calculating number of doses of aprepitant IV versus fosaprepitant administered in patients receiving moderately or highly emetogenic chemotherapy regimens. Operational advantages (i.e., supply costs, time saved) of switching from fosaprepitant IV infusion to aprepitant administered as a 2-min IV push were assessed., Results: A total of 12,908 doses of aprepitant IV 130 mg were administered at 13 Rocky Mountain Cancer Centers clinics over an 18-month period. Conversion from fosaprepitant to aprepitant IV reached 90% after 9 months of aprepitant IV initiation. Supply costs per administration were reduced ($2.51 to $0.52) when aprepitant was prepared as an IV push versus an NK-1 RA infusion. The overall time savings per administration of aprepitant was reduced by 90% (from 36.5 to 3.5 min, 33 min saved) as an IV push rather than an infusion. Most of the time saved per administration (30 min) pertained to the infusion nurse, and 3 min was saved by the pharmacy technician., Conclusion: Successful conversion to aprepitant, and specifically to a 2-min IV push, provides time, cost, and resource savings, improves operational efficiency, and avoids the negative impact of potential future IV fluid shortages.

Introduction: The analysis was conducted to assess a cost-efficacy analysis of new antiemetic drugs (netupitant plus palonosetron (NEPA)) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in highly and moderately emetogenic chemotherapy for cancer treatment. Areas covered: The present evaluation was restricted to pivotal phase III randomized controlled trials (RCTs) of NEPA versus (vs.) palonosetron for the prophylaxis of CINV. We calculated the pharmacological costs necessary to get the benefit in complete response (CR), for each trial. Our analysis evaluated 2 RCTs, including 1720 patients. Referring to both highly and moderately emetogenic chemotherapy, NEPA plus DEX was economic superior to palonosetron (PALO) plus DEX, with 13 312 € and 7885 € gain in medical costs every 100 patients treated, respectively. The cost-effectiveness ratios (CERs) (€/CR) in highly emetoge nic risk were 1.24 and 13.23 for the NEPA and PALO group, respectively and 1.49 and 15.20 for the same groups in moderately emetogenic risk. The incremental cost-effectiveness ratio (ICER) between the groups was 1016.18 €/CR and 1024.03 €/CR in highly and moderately emetogenic risk, respectively. Expert opinion: The combination of NEPA plus DEX is cost-effective for preventing CINV in highly and moderately (AC-based) emetogenic cancer treatment.

Background: Nausea and vomiting of pregnancy (NVP) is the most prevalent medical condition associated with pregnancy. The Royal College of Obstetricians and Gynaecologists published its first guidelines for management of NVP in 2016, although many current treatments are off label, with only one recently licensed treatment for NVP in the UK., Aim: To identify the current practices for NVP management across the patient pathway, and estimate the economic burden to NHS services., Design and Setting: This was an observational, retrospective research study conducted in the Newcastle Gateshead Clinical Commissioning Group (CCG) health economy area in England., Method: Data were collected from GP practices, local hospital datasets, ambulance services (April 2013-March 2016), and the Hospital Episode Statistics dataset (2006-2016)., Results: Eight GP practices participated in the study. In all, 15.2% of the total pregnant population presented with NVP. Treatment varied significantly between GP practices, and 33.6% of women re-presented to their GP. There was an annual increase in women admitted to hospital for NVP symptoms, with increasing length of stay per admission. Almost half (44.6%) of the calls to 999/111 from women experiencing NVP symptoms resulted in an ambulance dispatch. The annual cost of NVP to this health economy was estimated to be £199 804, which crudely extrapolates to £25 758 731 at UK level. Due to underestimations of costs, the impact to the UK NHS could be up to £62 373 961., Conclusion: There is considerable variation in current management practices for NVP outside of recently published guidelines, and this may result in substantial resource use and avoidable financial impact to the NHS., (© British Journal of General Practice 2019.)

Background and Aims: Chronic cannabis use is associated with nausea and vomiting that may lead to emergency department (ED) visits, multiple diagnostic tests, and procedures. The aim of this study was to analyze recent trends in ED visits for vomiting associated with cannabis use disorder between 2006 and 2013., Methods: Data were obtained from the National Emergency Department Sample records in which vomiting (ICD-9-CM codes 787.01, 787.03, and 536.2) was a primary diagnosis in combination with cannabis abuse or dependence (304.3, 304.30, 304.31, 304.32, 304.33, 305.2, 305.20, 305.21, 305.22, and 305.23) and were seen in the ED between 2006 and 2013. The National Emergency Department Sample collects data from more than 25 million visits in over 950 EDs and is weighted to provide national estimates., Results: The rate of ED visits for vomiting with cannabis use disorder from 2006 compared with 2013 increased from 2.3 to 13.3 per 100,000 ED visits, while the mean inflation-adjusted costs increased 68.5% from $2758.43 to $4647.62, respectively. Men between the ages of 20 and 29 were the most common group to present to the ED for vomiting with cannabis use disorder. The Midwest and West had the higher rates of ED visits for vomiting with cannabis use disorder compared with the Northeast and South., Conclusions: ED visits for vomiting associated with cannabis use disorder is common and is associated with significant medical costs. Further research on the role of cannabis use in nausea and vomiting is warranted.

Background: Data on cyclic vomiting syndrome (CVS) are limited to studies from tertiary care centers. There is a paucity of information about CVS on a national scale., Aim: To study the clinical characteristics, comorbidities, and hospital outcomes in patients hospitalized with CVS using a nationwide database., Methods: We identified all hospitalizations associated with a primary diagnosis of CVS in 2010 and 2011 using the Nationwide Inpatient Sample with an age category of 18-55 years. A 1:2 random sample of non-CVS hospitalizations with the same age category was obtained, and comparisons between groups were made. Multivariate logistic regression analysis was used to determine comorbidities independently associated with CVS., Results: Our study included 20,952 CVS and 44,262 non-CVS patients. CVS patients tended to be younger, male, and white compared to non-CVS patients. On multivariate analysis, CVS was significantly associated with comorbidities including dysautonomia, migraine, anxiety, marijuana use, irritable bowel syndrome, gastroparesis, gastroesophageal reflux disease, asthma, cigarette smoking, and hypertension. CVS patients underwent esophagogastroduodenoscopy, colonoscopy, and gastric emptying tests more frequently. They had more favorable hospital outcomes like more routine discharges (discharge to home/self-care), lower mortality, and shorter length of stay but tended to leave against medical advice more frequently. CVS patients incurred total hospital charges of about $400 million over the 2 years., Conclusions: Our study showed that CVS is associated with several comorbidities and incurred substantial health care costs despite benign outcomes. Efforts to optimize therapy of CVS, manage comorbid conditions and reduce healthcare utilization are warranted.

In Sweden, acute gastrointestinal illness (AGI) incidence, severity, impact on productivity, related healthcare usage and associated costs are not ascertained. We measured these in 2013-2014 using a population-based cohort reporting weekly. We defined AGI as ⩾3 episodes of loose stools or vomiting/24 h; or loose stools or vomiting with ⩾2 other gastrointestinal symptoms. After each AGI episode, we collected information about perceived severity, healthcare use and absenteeism. We calculated incidence rates, AGI absenteeism and costs comprising direct healthcare costs and productivity loss due to work/school absenteeism. A total of 3241 participants reported 1696 AGI episodes [incidence 360/1000 person-years, 95% confidence interval (CI) 326-395; highest in the <5 years age group]. In the <5 years age group, 31% of episodes were perceived as mild, 61% as moderate and 8% as severe; 9·4% led to primary-care consultations, and 1·4% to hospital admissions. In the ⩾5 years age group, 18% of episodes were perceived as mild, 64% as moderate and 18% as severe; 6·4% led to primary-care consultations, and 1·9% to hospital admissions. AGI caused 8 891 000 days of absenteeism (95% CI 6 009 000-12 780 000). AGI cost €1 005 885 000 (95% CI 754 309 000-1 257 195 000) nationally for the year. In Sweden, a minority of cases perceive AGI as a mild illness. AGI is a burden on the healthcare system and causes productivity loss, with high costs. Countries may consider these estimates when prioritizing health interventions.

Background: Chemotherapy-induced nausea and vomiting (CINV) is a particularly distressing event for oncology patients. This review aims at analyzing the impact of CINV on Health-Related Quality of Life (QoL) and on the use of healthcare resources., Methods: A systematic search was conducted according to the PRISMA statement on MEDLINE, EMBASE and NHS EED., Results: Sixty-seven studies were included in the final selection. Despite the availability of numerous treatment options, CINV was found to have a strong impact on HRQoL of patients. Direct costs are particularly affected, but this result could be due to scarcity of studies assessing indirect costs., Conclusions: Evidence supports the notion that CINV continues to have a negative impact on HRQoL of patients, even for those receiving moderately emetic chemotherapy. Further studies need also to collect data on the cost of CINV, particularly indirect costs, to ensure that decisions on use of healthcare resources are better supported., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: To assess the comparative cost effectiveness of day care over inpatient management of nausea and vomiting of pregnancy (NVP)., Study Design: A cost utility analysis was performed using a decision analytical model in which a Markov model was constructed. The Markov model was primarily populated with data from a recently published randomised controlled trial. Which included pregnant women presenting to Cork University Maternity Hospital, a tertiary referral maternity hospital, seeking treatment for NVP. Costs and outcomes were estimated from the perspective of the Irish health service (HSE) and patients. A probabilistic sensitivity analysis, using a Monte Carlo simulation, was also performed. A Bayesian Value of Information analysis was used to estimate the value of collecting additional information., Results: When both the healthcare provider and patient's perspective was considered, day care management of NVP remained less costly (mean €985; 95% C.I. 705-1456 vs. €3837 (2124-8466)) and more effective (9.42; 4.19-12.25 vs. 9.49; 4.32-12.39 quality adjusted life years) compared with inpatient management. The Cost Effectiveness Acceptability Curve indicates the probability that day care management is 70% more cost effective compared to inpatient management at a ceiling ratio of €45,000 per QALY, indicating little decision uncertainty. The Bayesian Value of Information analysis indicates there is value in collecting further information; the Expected Value of Perfect Information (EVPI) is estimated to be €5.4 million., Conclusion: Day care management of NVP is cost effective compared to inpatient management., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Chemotherapy-induced nausea and vomiting (CINV) is a troubling side effect of cancer treatment and is often poorly controlled. As a consequence, CINV is associated with substantially increased costs of care and significant interference with patients' lives. Inadequate control over CINV results from factors that include failure to provide guideline-adherent prophylactic medication and limitations in available therapies. Newer serotonin receptor antagonists, such as palonosetron, and addition of neurokinin-1 (NK-1) receptor antagonists to treatment have significantly decreased both acute and delayed CINV. A fixed-dose combination of palonosetron and a new NK-1 receptor, netupitant, is significantly superior to palonosetron alone and has small, but consistent, numerical advantages over aprepitant plus palonosetron for prevention of CINV. The combination of a serotonin receptor antagonist plus an NK-1 receptor antagonist has been shown to be cost-effective for prevention of CINV and the availability of a fixed-dose combination of netupitant and palonosetron may enhance this benefit.

Objective: Nausea and/or vomiting (N/V) are frequent side effects of opioid drugs. These are of major concerns to patients and caregivers and only few studies have focused on their economical costs., Design: This is a prospective, nonproduct-related, activity-based evaluation of personnel and material costs of opioid-related N/V among inpatients., Setting: Data were obtained from surgical, general medicine, and palliative care wards at 16 German hospitals of different size, healthcare mandate, and ownership., Patients, Participants: According to predefined criteria, of 462 documented N/V events, 340 were diagnosed as opioid related., Interventions: Elicited activities and pharmacological interventions for N/V episodes followed local standards., Main Outcome Measure: Both materials used and the time engaged to treat patients with N/V were documented on an "ad hoc" activity recording form. The total cost of an opioid-related N/V episode was calculated based on standard wages of the involved personnel and standard costs of the inherent materials used., Results: Mean staff tenure time for handling an episode of N/V was 26.2 ± 19.8 minutes (nausea 16.9 ± 28.7 minutes; nausea + vomiting: 33.4 ± 26.8 minutes). In the German context, this corresponds to average personnel costs of €18.06 ± 13.64. Material cost contributes to another €13.49 ±13.38 of costs mainly depending on acquisition costs of antiemetic drugs., Conclusions: N/V showed to have impact on workload of nurses and (to lesser extent) physicians and economic burden of €31 ± 22 for each N/V episode. In view of these results, the potential costs of strategies to minimize the incidence of N/V (use of antiemetics and/or the use of new analgesics) should be outweighed against the incurred costs of N/V.

Opioids are the cornerstone of pain management; however, their use is associated with a variety of adverse drug events (ADEs) ranging from nausea and vomiting to urinary retention and respiratory depression. The purpose of this review is to describe the frequency and cost associated with different types of opioid-related ADEs to better understand their economic impact. A search of studies published in journals from 1946 to December, 2013, was conducted using MEDLINE and EMBASE. A total of 20 articles were reviewed. Data reflect a substantial economic burden of opioid-related ADEs resulting in high hospital costs, prolonged hospital stays, and substantial health care resource usage. Nausea, vomiting, and constipation are frequent and increased costs occur in all types of pain (surgical, nonsurgical, cancer, noncancer) in both inpatients and outpatients. Given the large economic burden of opioid-related ADEs, prevention rather than treatment may be the most effective strategy.

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.

Side effects or toxicities are frequent, undesirable companions of almost all forms of non-surgical cancer therapy. It is unusual for patients to complete treatment with radiation or chemotherapy without experiencing at least one form of therapy-associated tissue injury or systemic side effect. Often, toxicities do not occur as solitary events; rather, they result in clusters of symptoms that share a common biological aetiology. Like any disease, cancer treatment-related toxicities (CTRTs) vary in their severity. But, in contrast to most diseases in which incidence is described as being present or absent, the current approach to CTRT typically limits reporting to severe cases only. Not only does this dilute the frequency with which CTRTs occur, but it also undermines our ability to determine the full burden of their impact and to accurately assess the cost effectiveness of potential toxicity interventions. In this article, we report the results of a directed literature review for the years 2000-2012, in which we studied and compared three tissue-based toxicities (nausea and vomiting, diarrhoea, and oral mucositis) and one systemic toxicity (fatigue). Our results confirm the heavy burden of resource use and cost associated with CTRTs. The inclusion of fatigue in our analysis provided an opportunity to compare and contrast a toxicity in which there are both acute and chronic consequences. Our findings also demonstrate a number of challenges to, and opportunities for, future study. Among the most obvious are the lack of provider consistency in diagnosis and grading, especially when there is no global agreement on severity scales. Compounding this inconsistency is the disconnect between healthcare providers and patients that exists when describing toxicity severity and impact. In many cases, cancer can be thought of as a chronic disease that requires prolonged but episodic treatment once the acute disease is eradicated. This change reflects increasing treatment successes, but it also implies that the burden of CTRTs will be expanded and prolonged. Creation of hierarchical attribution of costs in the presence of simultaneous CTRTs, accurate coding, and consistent tracking tools for toxicities will be imperative for effective appraisal of the costs associated with cancer treatment regimen toxicities.

Background: Chemotherapy-induced nausea and vomiting remain difficult symptoms to manage in clinical practice. As standard antiemetic drugs do not fully eliminate these symptoms, it is important to explore the adjuvant role of non-pharmacological and complementary therapies in antiemetic management approaches. Acupressure is one such treatment showing highly suggestive evidence so far of a positive effect, meriting further investigation., Objectives: The primary objective was to assess the effectiveness and cost-effectiveness of self-acupressure using wristbands compared with sham acupressure wristbands and standard care alone in the management of chemotherapy-induced nausea. Secondary objectives included assessment of the effectiveness and cost-effectiveness of the wristbands in relation to vomiting and quality of life and exploration of any age, gender and emetogenic risk effects., Design: Randomised three-arm sham-controlled trial (Assessment of Nausea in Chemotherapy Research or ANCHoR) with an economic evaluation. Arms include the wristband arm, the sham wristband arm and the standard care only arm. Randomisation consisted of minimisation with a random element balancing for gender, age (16-24, > 24-50, >50 years) and three levels of emetogenic chemotherapy (low, moderate and high). Qualitative interviews were incorporated to shed more light on the quantitative findings., Setting: Outpatient chemotherapy clinics in three regions in the UK involving 14 different cancer units/centres., Participants: Chemotherapy-naive cancer patients receiving chemotherapy of low, moderate and high emetogenic risk., Intervention: The intervention was acupressure wristbands pressing the P6 point (anterior surface of the forearm)., Main Outcome Measures: The Rhodes Index for Nausea/Vomiting, the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool and the Functional Assessment of Cancer Therapy - General (FACT-G). At baseline participants completed measures of anxiety/depression, nausea/vomiting expectation and expectations from using the wristbands., Results: In total, 500 patients were randomised in the study arms (166 standard care, 166 sham acupressure and 168 acupressure) and data were available for 361 participants for the primary outcome. The primary outcome analysis (nausea in cycle 1) revealed no statistically significant differences between the three arms, although the median nausea experience in patients using wristbands (both real and sham ones) was somewhat lower than that in the antiemetics only group (median nausea experience scores for the four cycles: standard care arm 1.43, 1.71, 1.14, 1.14; sham acupressure arm 0.57, 0.71, 0.71, 0.43; acupressure arm 1.00, 0.93, 0.43, 0). A gender effect was evident (p= 0.002), with women responding more favourably to the use of sham acupressure wristbands than men (odds ratio 0.35 for men and 2.02 for women in the sham acupressure group; 1.27 for men and 1.17 for women in the acupressure group). This suggests a placebo effect. No significant differences were detected in relation to vomiting outcomes, anxiety and quality of life. Some transient adverse effects were reported, including tightness in the area of the wristbands, feeling uncomfortable when wearing them and minor swelling in the wristband area (n= 6).There were no statistically significant cost differences associated with the use of real acupressure bands (£70.66 for the acupressure group, £111.13 for the standard care group and £161.92 for the sham acupressure group). In total, 26 subjects took part in qualitative interviews. The qualitative data suggested that participants perceived the wristbands (both real and sham) as effective and helpful in managing their nausea during chemotherapy., Conclusions: There were no statistically significant differences between the three arms in terms of nausea, vomiting and quality of life, although apparent resource use was less in both the real acupressure arm and the sham acupressure arm compared with standard care only; therefore; no clear conclusions can be drawn about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting. However, the study provided encouraging evidence in relation to an improved nausea experience and some indications of possible cost savings to warrant further consideration of acupressure both in practice and in further clinical trials., Trial Registration: ISRCTN87604299., Source of Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 26. See the HTA programme website for further project information.

Background: In a prospective cohort study of antiemetic therapy conducted in Malaysia, a total of 94 patients received low emetogenic chemotherapy (LEC) with or without granisetron injections as the primary prophylaxis for chemotherapy-induced nausea and vomiting (CINV). This study is a retrospective cost analysis of two antiemetic regimens from the payer perspective., Materials and Methods: This cost evaluation refers to 2011, the year in which the observation was conducted. Direct costs incurred by hospitals including the drug acquisition, materials and time spent for clinical activities from prescribing to dispensing of home medications were evaluated (MYR 1=$0.32 USD). As reported to be significantly different between two regimens (96.1% vs 81.0%; p=0.017), the complete response rate of acute emesis which was defined as a patient successfully treated without any emesis episode within 24 hours after LEC was used as the main indicator for effectiveness., Results: Antiemetic drug acquisition cost per patient was 40.7 times higher for the granisetron-based regimen than for the standard regimen (MYR 64.3 vs 1.58). When both the costs for materials and clinical activities were included, the total cost per patient was 8.68 times higher for the granisetron-based regimen (MYR 73.5 vs 8.47). Considering the complete response rates, the mean cost per successfully treated patient in granisetron group was 7.31 times higher (MYR 76.5 vs 10.5). The incremental cost-effectiveness ratio (ICER) with granisetron-based regimen, relative to the standard regimen, was MYR 430.7. It was found to be most sensitive to the change of antiemetic effects of granisetron-based regimen., Conclusions: While providing a better efficacy in acute emesis control, the low incidence of acute emesis and high ICER makes use of granisetron as primary prophylaxis in LEC controversial.

Background: Despite its high incidence among children under the age of five, little is known about the burden of pediatric gastroenteritis outside the medical setting. The objective of this study was to describe the burden of acute gastroenteritis among children residing in the United Arab Emirates, including those not receiving medical care., Methods: A quantitative cross-sectional survey of 500 parents of children under 5 years of age who had suffered from acute gastroenteritis the preceding three months was conducted in the cities of Abu Dhabi and Al Ain. Data collected included respondent characteristics, disease symptoms, medical care sought, and parental expenditures and work loss. Data were analyzed using parametric and non-parametric statistical methods., Results: Vomiting and diarrhea episodes lasted on average between 3 and 4 days. Overall, 87% of parents sought medical care for their children; 10% of these cases required hospitalization with an average length of stay of 2.6 days. When medical care was sought, the average parental cost per gastroenteritis episode was US$64, 4.5 times higher than with home care only (US$14). Nearly 60% of this difference was attributable to co-payments and medication use: 69% of children used oral rehydration solution, 68% antiemetics, 65% antibiotics and 64% antidiarrheals. Overall, 38 parents missed work per 100 gastroenteritis episodes for an average of 1.4 days., Conclusions: Given its high incidence, pediatric gastroenteritis has an important financial and productivity impact on parents in the United Arab Emirates. To reduce this impact, efforts should be made both to prevent acute gastroenteritis and to optimize its treatment.

Purpose: The objective of this study was to estimate the cost of antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in daily practice in Japan., Methods: This was a retrospective observational study using medical records. Eligible patients were those with bladder or testicular cancer receiving platinum-containing highly emetogenic chemotherapy. The incidence of CINV on days 1-5 in single-day chemotherapy and on days 1-9 in multiple-day chemotherapy, and the costs of antiemetic therapy directly associated with the administration of antiemetics were estimated. The analysis of costs was performed from a hospital perspective., Results: A total of 54 patients or 169 chemotherapy courses were included. In all chemotherapy courses 5-HT(3) receptor antagonists were used on the day(s) that platinum-containing agents were administered and frequently used on subsequent days. In contrast, the use of corticosteroids was infrequent. Acute CINV in single-day chemotherapy was well controlled, but the incidences of delayed CINV in single-day chemotherapy and CINV in multiple-day chemotherapy were relatively high. The costs for antiemetic therapy were $484.65 in courses with CINV and $318.56 in courses without CINV, and the difference was approximately $170 per chemotherapy course, which was considered to be mainly imputable to the prevalence of CINV., Conclusions: The cost of antiemetic therapy for CINV is substantial in Japan as well as in other countries, and it is suggested that the onset of CINV is a possible cost driver. The improvements in antiemetic therapy may contribute not only to improved patient well-being but also to a reduction of economic burden.

Despite recent progress, chemotherapy-induced nausea and vomiting (CINV), especially delayed CINV, continues to be a problem. Delayed CINV is underestimated and perceived differently by providers and patients. Communication between providers and patients about this side effect may help improve outcomes. This study identifies patients' and providers' perceptions of management and barriers to quality CINV care. Provider and patient versions of a Nausea and Vomiting Management Barriers Questionnaire were developed to address potential barriers. Providers and patients were given opportunities to add detail in open-ended questions. Providers were recruited through the NCCN and the Oncology Nursing Society mailing lists. Patients who received at least 2 cycles of chemotherapy and experienced CINV were recruited through a consortium of advocacy groups. Both providers (n = 141) and patients (n = 299) completed the survey. Providers (41%) and patients (42%) agreed medication side effects were a concern, but more patients (63%) than providers (36%) tried to limit the number of medications taken (P < .0001). Many providers (67%) spontaneously reported barriers to managing CINV, with financial and patient-related factors among the most common. Few patients (10%) reported cost as a barrier, but 37% endorsed the desire "to be strong by not complaining." Barriers to communication and quality care of CINV differ between caregivers and patients. Addressing misconceptions and establishing mutually consistent goals will lead to more effective overall care.

Objective: Involuntary tobacco smoke exposure causes substantial morbidity in children. We hypothesized that children exposed to tobacco smoke in the home would have increased school absenteeism with associated costs due to lost caregiver wages/time., Methods: We analyzed data on health and absenteeism among schoolchildren aged 6 to 11 years identified in the 2005 National Health Interview Survey (NHIS). We used multivariate models to assess the relationships between adult-reported household smoking and child health and school absenteeism. Analyses were adjusted for children's and parents' demographic and socioeconomic characteristics. The value of lost caregiver time was estimated by using self-reported employment and earnings data in the NHIS and publicly available time-use data., Results: Children living with 1 or ≥ 2 adults who smoked in the home had 1.06 (95% confidence interval [CI]: 0.54-1.55) and 1.54 (95% CI: 0.95-2.12) more days absent from school per year, respectively, than children living with 0 smokers in the home. Living with ≥ 2 adults who smoked in the home was associated with increased reports of having ≥ 3 ear infections in the previous 12 months (adjusted odds ratio [aOR]: 2.65 [95% CI: 1.36-5.16]) and having a chest cold in the 2 weeks before interview (aOR: 1.77 [95% CI: 1.03-3.03]) but not with having vomiting/diarrhea in the previous 2 weeks (aOR: 0.93 [95% CI: 0.45-1.89]). Caregivers' time tending children absent from school was valued at $227 million per year., Conclusions: Tobacco smoke exposure has significant consequences for children and families above and beyond child morbidity, including academic disadvantage and financial burden.

Objectives: Hospitalized patients often experience adverse events of the gastrointestinal tract due to analgesic treatment. The objectives of this study were to estimate use of medications for treatment of nausea, vomiting, or constipation (NVC medications) after initiation of analgesic treatment, and to compare differences in length of stay and treatment costs between patients who received NVC medications and those who did not., Methods: This retrospective cohort study used the Premier Perspective data from January 1, 2005 to December 31, 2007 and stratified inpatients into 4 groups based on the first analgesic agent they were given. Patients were observed for 14 days after the first analgesic use until a regimen change, first use of NVC medication, or hospital discharge, whichever occurred first. Data were analyzed using a Cox proportional hazards model and a generalized linear model., Results: This study found that 239,183 (55.1%) of 434,304 patients received NVC medications after analgesic administration. Compared with oral nonopioid analgesics, the risk of using NVC medication was 4.8 times higher for injectable opioid analgesics after controlling for confounders. Patients who received NVC medications were hospitalized 0.26 days longer (P < 0.0001) at an additional cost of $756 per patient compared with patients who did not receive NVC medications (P < 0.0001)., Discussion: Use of an analgesic with improved gastrointestinal tolerability may potentially reduce use of NVC medications and hospital resources.

Purpose: Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of chemotherapy, but it may be prevented or mitigated with medications. Uncontrolled CINV can lead to reduced quality of life and can result in increased costs (due to health care utilization and missed work). We prospectively assessed the prevalence and burden of CINV in a US population., Methods: Final analysis was performed on 178 patients, beginning chemotherapy during 2007-2008 at oncology specialty settings. Patients kept a diary recording use of antiemetic medications just before the start of chemotherapy and use of antiemetic medications, health care resources, and episodes of nausea and vomiting during the 5 days following. In addition, they completed a Functional Living Index-Emesis (FLIE) questionnaire and a Work Productivity and Assessment Inventory-Nausea and Vomiting assessment, to determine the impact of CINV on daily functioning and on work productivity, respectively. Physicians independently recorded prescribed medications and health care utilization., Results: Of the patients, 61.2% reported experiencing CINV (34.3% with acute CINV and 58.4% with delayed CINV). Based on the FLIE assessment, 37.2% of all patients reported reduced daily functioning, and of those with poorly managed CINV, about 90% reported a significant impact on daily functioning. Total costs due to CINV were on average $778.58 per patient from the day of administration through the 5 days following the first cycle of chemotherapy; patients with more severe CINV typically had higher costs., Conclusions: CINV remains a significant problem among US patients, suggesting a need for more effective prophylaxis use in clinical practice.

Objective: This study evaluated the overall burden of illness of chemotherapy-induced nausea and vomiting (CINV) and associated all-cause costs from a hospital's perspective (costs to the hospital) in patients with cancer treated with chemotherapy (CT) in the US hospital outpatient setting., Methods: Patients with a cancer diagnosis aged ≥18 years initiating CT in a hospital outpatient setting for the first time between April 1 2007 and March 31 2009 were extracted from the Premier Perspective Database. Patients were followed through eight CT cycles or 6 months post-index date, whichever occurred first. Within each CT cycle, the follow-up time for CINV event estimation was from day 1 (except rescue medication use that was identified from day 2) to cycle end. A multivariate regression model was developed to predict the CINV event rate per CT cycle in the study follow-up period. Associated total all-cause costs of managing CINV from a hospital's perspective were analyzed descriptively. Event rate and associated costs were estimated in the entire hospital setting (outpatient, inpatient, and emergency room). All-cause costs included inpatient, hospital outpatient, and ER visit costs (identified through a primary or secondary diagnosis code for nausea, vomiting, and/or volume depletion) and pharmacy cost (rescue medications for CINV treatment). All physician costs and non CINV-related treatment (pharmacy) costs were excluded from the analyses., Results: Among 11,495 study patients, 8,806 patients (76.6%) received prophylaxis for all cycles in the follow-up period. The overall base population had an average age of 63.3 years, was 51.0% female, and 72.7% White. The distribution of emetogenicity for cycle 1 CT cycle was 26.0% HEC, 46.1% MEC, and 26.4% LEC/MinEC combined. In the follow-up period, a total of 47,988 CINV events with an associated total all-cause treatment cost of $89 million were observed. Average daily treatment cost for all care settings was $1854.7. The regression model predicted a 20% CINV event rate per CT cycle in the follow-up period. Study limitations include potential lack of generalizibility, absence of data on certain confounders including alcohol consumption and prior history of motion sickness, lack of a control analysis group to estimate incremental use of resource utilization and associated costs, and a potential for cost under-estimation., Conclusion: In the current study analysis, a 20% CINV event rate per CT cycle per patient was predicted with an associated all-cause average daily total cost of approximately $1850. Further studies on early and appropriate antiemetic prophylaxis on CINV rates and economic outcomes are warranted.

Purpose: Chemotherapy-induced nausea and vomiting (CINV), common adverse events of chemotherapy, may be associated with considerable healthcare resource utilization. This study was conducted to describe CINV-associated healthcare visits and costs following a first cycle of highly or moderately emetogenic chemotherapy (HEC or MEC)., Methods: This retrospective cohort study used the Premier Perspective™ Database to identify adult patients who received their first HEC or MEC and at least one antiemetic agent from 2003 to 2007 at US hospital-based outpatient facilities. Hospital visits with a CINV-related ICD-9 diagnosis were included from the chemotherapy administration date to 30 days later or 1 day before the second chemotherapy, whichever was first. CINV costs were hospital-reported costs., Results: Of 19,139 patients (HEC, 16%; MEC, 84%), mean (SD) age was 59 (14) years; 59% were female; 66% were white. CINV prophylaxis included 5-HT₃ antagonists (85%), dexamethasone (76%), and NK-1 antagonists (2%). Overall, 13.8% of patients had a CINV-associated visit (HEC, 18%; MEC, 13%): 0.2% for acute CINV (day of chemotherapy, excluding chemotherapy administration visit) and 13.7% for delayed CINV. CINV-associated visits included inpatient (IP, 64%), outpatient (OP, 26%), and emergency room (ER, 10%) visits. Mean (SD) costs of CINV visits were $5,299 ($6,639); for IP, $7,448 ($7,271); OP, $1,494 ($2,172); and ER, $918 ($1,071). Mean per-patient CINV-associated costs across all patients were $731 ($3,069). Sensitivity analysis excluding visits where CINV was a secondary diagnosis code resulted in a CINV incidence of 4.4%, a mean CINV visit cost of $4,043, and a mean per-patient CINV-associated cost across all patients of $176., Conclusions: CINV visits in the first HEC or MEC cycle were common and costly, especially inpatient hospitalizations in the delayed phase. Strategies to reduce CINV in the delayed phase could reduce healthcare utilization and costs.

Background: The use of antiemetics for children with vomiting is one of the most controversial decisions in the treatment of gastroenteritis in developed countries. Ondansetron, a selective serotonin receptor antagonist, has been found to be effective in improving the success of oral rehydration therapy. However, North American and European clinical practice guidelines continue to recommend against its use, stating that evidence of cost savings would be required to support ondansetron administration. Thus, an economic analysis of the emergency department administration of ondansetron was conducted. The primary objective was to conduct a cost analysis of the routine administration of ondansetron in both the United States and Canada., Methods and Findings: A cost analysis evaluated oral ondansetron administration to children presenting to emergency departments with vomiting and dehydration secondary to gastroenteritis from a societal and health care payer's perspective in both the US and Canada. A decision tree was developed that incorporated the frequency of vomiting, intravenous insertion, hospitalization, and emergency department revisits. Estimates of the monetary costs associated with ondansetron use, intravenous rehydration, and hospitalization were derived from administrative databases or emergency department use. The economic burden in children administered ondansetron plus oral rehydration therapy was compared to those not administered ondansetron employing deterministic and probabilistic simulations. We estimated the costs or savings to society and health care payers associated with the routine administration of ondansetron. Sensitivity analyses considered variations in costs, treatment effects, and exchange rates. In the US the administration of ondansetron to eligible children would prevent approximately 29,246 intravenous insertions and 7,220 hospitalizations annually. At the current average wholesale price, its routine administration to eligible children would annually save society US$65.6 million (US$49.1-US$81.1) and health care payers US$61.1 million (US$46.2-US$76.3). In Canada the administration of ondansetron to eligible children would prevent 4,065 intravenous insertions and 1,003 hospitalizations annually. Its routine administration would annually save society CDN$1.72 million (CDN$1.15-CDN$1.89) and the health care system CDN$1.18 million (CDN$0.88-CDN$1.41)., Conclusions: In countries where intravenous rehydration is often employed, the emergency department administration of oral ondansetron to children with dehydration and vomiting secondary to gastroenteritis results in significant monetary savings compared to a no-ondansetron policy. Please see later in the article for the Editors' Summary.

Background: Gastrointestinal (GI) adverse effects are common with oral opioid treatment., Objective: To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective., Methods: Medical and pharmacy claims from the PharMetrics' Patient-Centric Database were used to identify opioid-naïve patients who received a new prescription for oxycodone- or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases-9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities., Results: Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits (0.36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001)., Conclusions: The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system.

Objectives: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer chemotherapy which may increase morbidity, reduce quality of life and threaten the success of cancer therapy. Aprepitant is effective in preventing CINV, achieving higher complete response (no emesis and no rescue therapy) compared to standard prevention, in patients receiving either highly (HEC) or moderately emetogenic chemotherapy (MEC; absolute reduction = 11 and 13%, respectively). We assessed the cost effectiveness of aprepitant-based vs standard prevention in these indications in Belgium., Materials and Methods: A decision analytical model was developed in MS Excel (Fig. 1). To estimate resource use, two approaches were used. The first is based on the preventive regimens applied in randomized controlled trials comparing aprepitant-based CINV prevention (for HEC: aprepitant days 1-3, ondansetron 32 mg i.v. day 1, oral placebo twice daily days 2-4, oral dexamethasone days 1-4; for MEC: aprepitant days 1-3, ondansetron 16 mg p.o. day 1, placebo on days 2-3, oral dexamethasone day 1), vs a standard regimen (for HEC: oral placebo days 1-3, ondansetron 32 mg i.v. day 1 and 16 mg p.o. days 2-4, oral dexamethasone days 1-4; for MEC: oral placebo, ondansetron 16 mg p.o. days 1-3, dexamethasone day 1) The second analysis is based on current real-world resource use in the Belgian setting in the prevention of CINV using a longitudinal Hospital Database. CINV-specific utility values were used to calculate quality-adjusted life years (QALYs). Drug costs were obtained from official reimbursement listings. Treatment costs for CINV were obtained from a German study and adapted to Belgium., Results: The aprepitant-based regimen is associated with 0.003 and 0.014 more QALYs in HEC and MEC, respectively and with per patient savings of 66.84 (trial based) and 74.62 (real-life based) for HEC and 17.95 (trial based) and 21.70 (real-life based) for MEC. Hence, aprepitant is both more effective and less expensive (=dominant). One-way sensitivity analyses were performed on treatment cost of emesis, the clinical benefit of aprepitant and the cost of ondansetron and showed that the results were robust on the first two parameters but sensitive on the decrease in cost of ondansetron for the moderately emetogenic chemotherapy regimens., Conclusions: In both approaches, the aprepitant-based strategy is more effective and less expensive compared to standard care.

Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most feared side effects of cancer treatment. Poorly controlled CINV may lead to additional office visits or emergency room admissions, thus increasing the overall costs of cancer care. The objective of the project was to estimate the societal costs of uncontrolled CINV among working-age cancer patients., Methods: The 1997-2002 Health and Productivity Management database, a proprietary database linking medical claims to work loss information, was used. The study population consisted of employees or their spouses who were cancer patients treated with highly or moderately emetogenic chemotherapy regimens. Costs of uncontrolled CINV were estimated by comparing the direct medical costs and indirect costs between those with and without uncontrolled CINV; all costs were normalized as monthly costs and updated to 2006 US dollars. The Wilcoxon Mann-Whitney test was used to compare the costs differences in univariate analyses, followed by multivariate analyses., Results: In all, 2,018 patients were identified; 1,771 (88%) received 5-HT(3) receptor antagonists, and uncontrolled CINV was found in 563 (28%). The estimated monthly medical costs associated with uncontrolled CINV were approximately 1,300 dollars higher for cancer patients at working ages. Subgroup analysis concluded that indirect costs per patient per month were 433 dollars higher for those in the uncontrolled CINV group., Conclusions: Despite a prevalent use of the 5-HT(3) receptor antagonists, uncontrolled CINV remained a common and costly problem among cancer patients treated with highly or moderately emetogenic chemotherapy., ((c) 2007 American Cancer Society.)

Background: Tropisetron, ondansetron, and granisetron are considered equally efficacious, supported by several international studies. However, there are interindividual variations in their metabolism that could affect efficacy. The clustering of such variations may change from one to another nation. Therefore, their equality must be validated in Turkish patients. The aim of this study was to compare their efficacies, side-effect profiles, and costs in the prophylaxis of emesis induced by moderate to high emetogenic chemotherapies., Methods: A total of 158 patients with a median age of 48 years, 115 (72.8 percent) female and 43 (27.2 percent) male, were included, respectively. Fifty-one, 61, and 46 patients were allocated to tropisetron (5 mg), ondansetron (8 mg), and granisetron (3 mg IV) in combination with 8 mg dexamethasone, which were continued 5 mg once a day, 8 mg b.i.d. and 1 mg b.i.d. PO for 5 days, respectively., Results: The complete response (CR) rates in the control of acute emesis were 80.4 percent with tropisetron, 72.1 percent with ondansetron, and 71.7 percent granisetron (p = 0.877). CR rates in delayed emesis (Days 2-5) were 68.6 percent, 68.9 percent, and 76.1 percent, respectively (p = 0.527). Rates of freedom from nausea in the same period were 37.3 percent, 35.9 percent, and 33.9 percent (p = 0.949). Nausea control rates, side-effect profile did not differ. However, headache seemed to be encountered higher (45.6 percent) in Turkish patients than others (3.9-9 percent). Tropisetron is the least expensive one ($95.3 per cycle) according to current prices in Turkey., Conclusions: There were no differences among the 3 serotonin antagonists with respect to efficacy and frequency of side-effects in our patients. Tropisetron is the least expensive at current prices. The choice may be based on other parameters, such as ease of administration and patient preference.

Goals of Work: The aim of this paper is to analyze the costs of chemotherapy-induced nausea and vomiting (CINV) in Italy., Materials and Methods: In this prospective observational study at seven public oncology centers, incidence and intensity of CINV daily for 8 days after chemotherapy in consecutive patients receiving cisplatin-containing chemotherapy were recorded. All costs related to CINV (direct medical, direct nonmedical, and indirect) were recorded (in 2003 euros)., Main Results: A total of 172 patients were enrolled; cost data were available for 168 patients. Thirty-seven percent of patients experienced acute CINV, and 57% experienced delayed CINV; 39% achieved total control, defined as no nausea, vomiting, or rescue therapy. Mean per-patient costs of acute and delayed CINV were 30.03 euro from the hospital perspective, 4.9 euro from the patient perspective, and 26.85 euro from the National Health Service (NHS) perspective. Costs of CINV were highly variable among oncology centers, largely because of differences in procedures for preventing delayed CINV. These costs were four times higher when antiemetic drugs were prescribed and paid for by the NHS than when antiemetic prophylaxis was provided directly from hospital pharmacies. Moreover, in the delayed phase, the NHS incurred a 94% increase in costs for patients without total control. Overall costs for patients who did not experience total control of CINV were 35.57 euro higher than for those who did (85% increase)., Conclusions: Costs of CINV for the Italian NHS could be reduced if hospitals furnished antiemetic prophylaxis directly to patients. Better control of both acute and delayed CINV would improve patient well-being as well as reduce the budgetary impact of CINV in Italy.

Background: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer therapy. We aimed to determine outcomes associated with use of aprepitant in outpatients undergoing highly emetogenic chemotherapy in Germany from a patient's and payer's perspective., Methods: A decision-analytic model compared an aprepitant regimen (aprepitant/ondansetron/dexamethasone) to a control regimen (ondansetron/dexamethasone) over a five days period. Clinical results and resource utilisation observed in aprepitant phase III clinical trials were assigned German unit cost data., Results: Complete response over one chemotherapy cycle was observed in 68% of patients in the aprepitant group (N=514) compared to 48% of patients in the control group (N=518). Patients were estimated to have gained an equivalent of 15 additional hours of perfect health per cycle (0.63 quality-adjusted life days) with aprepitant-based regimen compared to control regimen. Cost per quality-adjusted life year gained with aprepitant was estimated at euro28,891., Conclusions: Aprepitant substantially improved CINV-related health outcomes in patients undergoing highly emetogenic chemotherapy. Incremental benefits materialised in a cost-effective fashion.

Objective: Chemotherapy-induced nausea and vomiting (CINV) is a significant problem for cancer patients. Aprepitant, a novel NK-1 receptor antagonist, is approved for use with 5-HT3 antagonists and corticosteroids to prevent CINV associated with highly emetogenic chemotherapy. Nevertheless, the cost-effectiveness of standard aprepitant use has not been established., Methods: We developed a Markov model to compare three strategies for CINV: conventional treatment with a 5-HT3 antagonist and a corticosteroid, conventional treatment plus aprepitant, and conventional treatment with aprepitant added after the onset of CINV. Data from published clinical trials provided probabilities and utilities for the model. Data from the Centers for Medicare and Medicaid Services and the Federal Supply Scale provided costs for medical resources and medications utilized. Resource use data were based on a randomized clinical trial and routine clinical practice. The incremental cost-effectiveness ratio (ICER) for each aprepitant strategy was calculated in US$ per healthy day equivalent (HDE) and converted to dollars per quality-adjusted life-year (QALY). Univariate and probabilistic sensitivity analyses addressed uncertainty in model parameters., Results: Adding aprepitant after CINV occurred cost $264 per HDE ($96,333/QALY). The three-drug strategy cost $267/HDE with a 95% confidence range of $248-$305/HDE ($97,429/QALY; $90,396-$111,239/QALY). In univariate analyses, the most influential factors on the ICER were: the cost of aprepitant, the likelihood of delayed CINV without aprepitant, the likelihood of acute CINV with/without aprepitant, and the increase in HDE from avoiding CINV., Conclusions: Aprepitant provides modest incremental benefits compared with conventional management of CINV. Routine aprepitant use appears most cost-effective when the likelihood of delayed CINV or the cost of rescue medications is high.

Objective: It is a current hypothesis that chemotherapy-induced nausea and vomiting (CINV) may ultimately impede the clinical success of cancer treatments by hindering patients' adherence to the optimal treatment schedule. The aim of this study is to examine clinical trial data retrospectively for possible evidence of such a detrimental impact of CINV., Patients and Methods: Data from three recent European Organization for Research and Treatment of Cancer (EORTC) trials of highly emetogenic cisplatin-based chemotherapy in diverse patient populations were analyzed retrospectively for incidence and possible impact of CINV. Data on the incidence of emesis are presented as simple descriptive analyses, while the hypothetical impact of CINV on clinical outcomes and on the patients' length of hospital stays is analyzed by means of multivariate regression analysis techniques to control for confounding variables., Main Results: Between 42 and 59% of the patients in the trials experienced at least one episode of nausea of NCIC grade 2 or worse, while the incidence of vomiting of similar grade was between 31 and 58%. Only in one of the trials could the determinants of the adherence to protocol therapy be assessed, statistically significant variables were the severity of emesis (p < 0.0001) and other toxicities combined (p < 0.019). In turn, a Cox regression showed adherence to protocol therapy and other toxicities as the only statistically significant determinants of overall survival., Conclusions: This study has shown a discernible detrimental impact of CINV on patients' adherence to protocol therapy and, indirectly, on survival in one of the three trials examined. Further studies are required to substantiate this finding.

Objective: We investigated the relationship between quality-adjusted life years (QALYs) and willingness to pay (WTP) in acute and chronic conditions., Study Design and Setting: Face-to-face interviews were used to collect data in a convenience sample of women. Participants completed one interview evaluating preferences for an acute condition, post-chemotherapy nausea and vomiting (PCNV), and the other interview for a chronic condition (breast cancer). Preferences were elicited for QALYs using visual analogue scale (VAS), and standard gamble in addition to WTP. Because QALYs and WTP are purportedly based on the same underlying theoretical foundations, WTP was regressed onto change in QALYs, age, income, and health status., Results: Regression analysis reported statistically significant models for all breast cancer (P < .001) and PCNV (P < .05) conditions tested. However, QALY was not a significant predictor of WTP., Conclusion: The results of this study indicate QALYs was a poor predictor of WTP for the conditions tested. Linear combinations of change in QALYs, age, income, and health status were a better predictor of WTP for chronic than acute conditions. This can be attributed to violations of underlying assumptions in measurement of QALYs with acute conditions and to problems with the use of WTP with chronic conditions.

Background: Delayed chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer chemotherapy. We assessed, under current practice patterns, the occurrence and impact on healthcare resource utilization of CINV in patients receiving emetogenic chemotherapy. An additional aim of this study was to estimate costs imputable to CINV in the German healthcare environment., Materials and Methods: This prospective, multi-center, cross-sectional cost-of-illness study was conducted in three hospitals and in three office-based facilities in Germany. Consecutive patients undergoing emetogenic chemotherapy (levels 4 or 5 according to Hesketh classification of emetogenicity) were enrolled. Data were obtained from preplanned chart reviews and from self-administered patient questionnaires. Analysis of direct costs was performed from the perspectives of third party payer (statutory sick fund), provider (hospital) and patients. Indirect costs were assessed on the basis of paid workdays lost., Results: During the 5-day observation period, 134 of 208 chemotherapy cycles observed (64.4%) were associated with at least one episode of nausea or vomiting. More patients experienced delayed than acute CINV (60.7% versus 32.8%), and more patients reported nausea than vomiting (62.5% versus 26.0%). A total of 68 patients (32.6%) utilized healthcare resources due to CINV. The most frequently used resources were rescue medications and outpatient hospital and office physician visits. Only one patient required hospitalization and only three patients lost workdays due to CINV. Average costs imputable to CINV per patient (with or without CINV) per treatment cycle incurred by third party payers and hospital providers were Euro 49 and Euro 48, respectively. Patient or treatment characteristics that were associated with high costs imputable to CINV were as follows: cisplatin-containing regimen; experience of emesis; and presence of delayed CINV., Conclusions: A substantial proportion of patients continue to experience CINV. This entails not only clinical but also economic consequences, and highlights a continuing need for improved utilization of existing antiemetic agents and for new, more efficacious treatments. The greatest improvements in patient care and potential for cost offset may be realized by preventing delayed CINV.

Background: Neither droperidol nor ondansetron has been proven completely effective, and there are conflicting data comparing the efficacy of the two agents. The purpose of this study was to compare the efficacy, safety and cost of a combination of ondansetron administered intravenously in the operating room followed by oral ondansetron treatment at home with the more commonly used treatment of intravenous droperidol therapy and oral dimenhydrinate therapy, for the prevention and treatment of postoperative nausea and vomiting in children undergoing strabismus surgery., Methods: Double-blind randomized clinical trial with parallel comparison groups. All patients aged 6 months to 18 years who underwent strabismus surgery at a pediatric hospital in Montreal between Nov. 13, 2000, and June 12, 2001, were included. The exclusion criteria were nausea or vomiting, or use of antiemetics or narcotics in the 24 hours preceding surgery, and past history of hepatic, gastric or renal disease. The outcome measures were frequency of nausea and vomiting, severity of nausea and adverse effects in hospital, during transportation home and during the first 24 hours at home. Data were obtained through nursing notes and through a telephone interview conducted 24 to 48 hours after discharge., Results: Of the 208 eligible patients, 172 were randomly assigned to the study groups (88 to the ondansetron group and 84 to the droperidol/dimenhydrinate group). We found no statistically significant difference in the incidence of nausea and vomiting in hospital or at home between the two groups (25.3% vs. 31.6%, p = 0.371). There was a significant difference between the two groups in the rate of vomiting during transportation home (3.6% vs. 12.6%, p = 0.044). The incidence of severe nausea was 14.4% with ondansetron and 15.4% with droperidol, a nonsignificant difference (p = 1.00). No significant difference was observed between the two groups in the incidence of any nausea (p = 0.434) or adverse effects (p = 0.220). We calculated that the combination of droperidol and dimenhydrinate was seven times less costly than the ondansetron regimen., Interpretation: In this study, the efficacy and safety of intravenous administration of droperidol followed by oral use of dimenhydrinate did not differ from that of intravenous followed by oral use of ondansetron in children undergoing strabismus surgery. Since treatment with ondansetron is much more costly than the combination of droperidol and dimenhydrinate, at this time the use of ondansetron in the prevention and treatment of vomiting and nausea in this population may not be beneficial on a cost basis if all other variables are considered.

Because patients with cyclic vomiting often (82%) have a family history of migraines and often (60%) respond to antimigraine therapy, we investigated whether an initial therapeutic trial could precede diagnostic testing. We used a decision analysis program to compare the cost and benefit of three initial treatment strategies. The costs of the three strategies were extensive diagnostic evaluation, $3020; empiric treatment alone, $1830, and upper GI series with small-bowel follow-through (UGI-SBFT) plus empiric treatment, $1600, respectively. When compared with the extensive evaluation strategy, initial antimigraine treatment avoided 65% of the esophagogastroduodenoscopys. On the basis of this decision analysis, a UGI-SBFT plus empiric migraine therapy was the most cost-effective initial strategy to treat cyclic vomiting syndrome. The cost of complications of a missed malrotation with volvulus was higher than that of adding a UGI-SBFT to each evaluation.

Objectives: To review the evidence-based management of nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum., Evidence: MEDLINE and Cochrane database searches were performed using the medical subject headings (MeSH) of treatment, nausea, vomiting, pregnancy, and hyperemesis gravidarum. The quality of evidence reported in these guidelines has been described using the Evaluation of Evidence criteria outlined in the Report of the Canadian Task Force on the Periodic Health Exam., Benefits: NVP has a profound effect on women's health and quality of life during pregnancy, as well as a financial impact on the health care system, and its early recognition and management are recommended. (III-B) COST: Costs, including hospitalizations, additional office visits, and time lost from work, may be reduced if NVP is treated early.

The serotonin 5-HT3 receptor antagonists or 'setrons' have become the standard of care for the prevention of chemotherapy-induced emesis (CIE) and are first-line therapy for acute CIE in healthcare organisations worldwide. However, their superior efficacy versus standard antiemetics comes at a significant cost. Currently, 3 agents are available in the US: ondansetron, granisetron and dolasetron. The most important treatment-related factor contributing to CIE is the emetogenicity of chemotherapy. The ability to customise, or stratify, the setron dose to match the emetogenic challenge of the chemotherapy administered has potential benefits, both clinically and economically. In adults, there is an appreciable amount of clinical literature addressing stratified administration; however, the amount of 'hard' economic data is rather limited. Intuitively, if clinical outcomes are equivalent, then stratified administration should be associated with economic benefits, as it generally promotes the use of doses lower than those recommended by the manufacturer. The literature strongly substantiates this for ondansetron, but is not as favourable for granisetron or dolasetron. As the rationale and justification for dose stratification is contained in the clinical literature, the authors have reviewed the pertinent literature supporting the clinical and economic benefits of dose stratification in both adult and paediatric patients. The authors also provide a discussion of various additional strategies that can be employed to ensure the appropriate and cost-effective use of setrons in real-world practice settings. These strategies include the use of lower doses than recommended by manufacturers, use for acute versus delayed phase emesis, enhancing the antiemetic efficacy by the addition of a corticosteroid, use of oral versus injectable formulations (when appropriate) and the implementation and use of local, national and international drug use guidelines.

Objective: To introduce a computerized data collection system used for an outcomes-based approach to antiemetic therapy in children, and to present data collected with this system in support of a new antiemetic dosing regimen., Methods: A validated nausea/vomiting survey was used to collect data on nausea severity (NSEV), vomiting severity (VSEV), daily activity interference (DAI), and the number of vomiting episodes. NSEV, VSEV, and DAI were rated as 0 = none to 3 = severe. All children and/or their parents were surveyed following the completion of each highly emetogenic chemotherapy regimen. This survey was computerized and transferred to a handheld data entry unit. Time and motion studies were performed to compare the time required to collect nausea/vomiting data and transfer the data to a computerized database with the hand-held system versus traditional paper (manual) surveys. The hand-held technology was used to collect survey data for children receiving a new antiemetic regimen (daily ondansetron and dexamethasone [OD]), which was then compared with data obtained with a previously employed regimen (thrice-daily ondansetron and daily methylprednisolone [OM]). Statistical analysis and a cost-effectiveness analysis (CEA) were performed to compare the two antiemetic regimens., Results: The mean time required for total data entry with the manual system was 5.2 minutes per survey versus 2.4 minutes with the hand-held technology (p = 0.0026). A total of 376 nausea/vomiting surveys in 78 children receiving the OM antiemetic regimen were compared with 153 surveys in 38 children treated with the OD regimen. The mean survey scores were as follows: NSEV (1.2 vs. 0.8), VSEV (1.0 vs. 0.7), DAI (1.0 vs. 0.7), and number of vomiting episodes (4.3 vs. 2.1) for OM and OD, respectively; all were significantly lower with the OD regimen (p < 0.05). The percentage of patients with complete control of nausea and vomiting (19.2% vs. 39.2%) and good control (55.6% vs. 65.4%) were significantly greater with the OD regimen (p < 0.05). The CEA revealed that the OD resulted in a reduction of approximately $31 per patient for good protection and a $258 reduction for complete protection from nausea and vomiting., Conclusions: A computerized outcomes-based system aided by handheld technology allowed for more prompt and efficient collection of nausea/vomiting data. The OD antiemetic regimen was shown to be a more cost-effective alternative for children receiving severely emetogenic chemotherapy.

The goals of this work were to compare the relative efficacy of ondansetron, granisetron and tropisetron in a randomised double blind crossover trial, evaluating objective, subjective and pharmacoeconomic parameters. To this end, 136 patients were enrolled, 120 of whom were eligible and evaluable. Each patient received three identical chemotherapy cycles with an antiemetic protocol which consisted in dexamethasone 20 mg i.v. and a tapering dose schedule for 4 days, and a single i.v. dose of an antiserotoninergic drug in each cycle. Arm A patients received tropisetron 5 mg; arm B patients, granisetron 3 mg; and arm C patients, ondansetron 24 mg. Numbers of patients and days with emetic episodes, grade of nausea, patient preference, headaches, need for metoclopramide, nursing or medical consultation, or admission to emergency room or ward were evaluated. There was no difference in the percentage incidence of acute or delayed nausea and vomiting. Twenty-five per cent of patients preferred tropisetron, 30% preferred granisetron, and 45% preferred ondansetron (P<0.01). Toxicity was mild in less than 10% of patients. Direct and indirect costs of treatment varied from 19.74 to 28.53 euros for tropisetron, 31.07-46.51 euros for granisetron and 22.76-62.61 euros for ondansetron. There was no difference in objective activity. In the schedules studied, patients preferred ondansetron. Indirect costs amount to less than 10% of the total antiemetic cost. Direct costs varied widely and should be considered whenever an antiemetic drug is selected.

The use and application of techniques for modeling data obtained from various data sources are discussed. Modeling with internal and external data has become a popular way for health care organizations to apply pharmacoeconomics to pharmacy practice. Modeling studies use existing clinical and epidemiologic data to project the effect of a clinical, policy, or medication decision on a patient, population, or organization. Although several modeling techniques have been used in health care, the most common approaches are to modify and adapt existing models or to develop a unique model to answer questions of interest in a specific practice setting. Typically, an economic model developed by adapting an existing one will use either the clinical decision-analysis or Markov modeling technique. Regardless of the technique used, external data must be carefully evaluated to ensure that the data are appropriate for use in making decisions at a specific organization. For example, cost data must be analyzed to ensure that the calculations are reproducible. Also, it must be acknowledged that this strategy may not always be appropriate. The use of modeling techniques can assist decision-makers in making more informed clinical, policy, and medication decisions in real-world settings. Caution is required when adapting and interpreting existing models to ensure appropriate application in a specific organization.

Purpose: To evaluate the effect of ondansetron availability on the costs of managing nausea and vomiting., Methods: We retrospectively assessed antiemetic costs (drug costs, nursing time, pharmacy time, physician's time, supplies, and facility "hotel" costs, in 1991 Canadian dollars) for all patients who received moderately or highly emetogenic chemotherapy from 6 months before to 6 months after ondansetron became commercially available in September 1991. We compared the costs for treating patients who received ondansetron versus those who received other antiemetic regimens, the costs for treating patients in the 6 months before versus the 6 months after ondansetron commercial availability, and the costs for treating patients in the first 4 months versus the last 4 months of the study period., Results: We found no cost differences for patients treated with ondansetron versus other antiemetic regimens. However, there was a significant reduction in emesis management costs for patients treated after versus before the availability of ondansetron: for patients treated in the last third versus first third of the study period, there was a decrease in cost per patient per month of treatment of $374 (95% confidence interval, $243 to $505). These savings were achieved through a reduction in hospital bed days and other costs associated with the prevention and more effective management of nausea and vomiting. At the same time, the number of patients who received emetogenic chemotherapy and their average age increased, presumably because of the better control of gastrointestinal toxicity., Conclusion: Ondansetron availability has been associated with changes in the clinical management of cancer patients receiving chemotherapy and with overall cost savings compared with previously available antiemetic therapy.