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Willingness to Pay to Prevent Chemotherapy Induced Nausea and Vomiting Among Patients with Breast, Lung, or Colorectal Cancer.
Abstract
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.
... Within the investigated timeframe of this review (January 2010-April 2016), most studies were published in 2012 (25%) [31][32][33][34][35][36][37]. The majority of studies were conducted in North America (n = 13) [33,34,[38][39][40][41][42][43][44][45][46][47] with at least one study each year since 2010; 2014 was a peak year, with five published studies. Europe has the second most publications (n = 11) [31,35,[48][49][50][51][52][53][54][55][56], while Asia and Australia, with two published studies each, make less common use of DCEs in cancer treatment [32,36,57,58]. ...
... A total of 93% of the studies reported methods for attribute identification [31,32,[34][35][36][37][38][39][40][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58]; only two studies (7%) did not [33,41]. Findings regarding current practice in attribute and level generation are summarised in Electronic Supplementary Material Appendix B. To identify attributes, most studies relied on a literature review of existing studies or package inserts (79%) [31, 32, 35-40, 42, 44, 46-52, 54-56, 58], followed by the use of qualitative research. ...
... Cost 'Out-of-pocket cost' was included in nine studies [35,37,39,40,42,44,47,53,57]. No other attributes regarding cost were included. ...
Introduction:
As several studies have been conducted to elicit patients' preferences for cancer treatment, it is important to provide an overview and synthesis of these studies. This study aimed to systematically review discrete choice experiments (DCEs) about patients' preferences for cancer treatment and assessed the relative importance of outcome, process and cost attributes.
Methods:
A systematic literature review was conducted using PubMed and EMBASE to identify all DCEs investigating patients' preferences for cancer treatment between January 2010 and April 2016. Data were extracted using a predefined extraction sheet, and a reporting quality assessment was applied to all studies. Attributes were classified into outcome, process and cost attributes, and their relative importance was assessed.
Results:
A total of 28 DCEs were identified. More than half of the studies (56%) received an aggregate score lower than 4 on the PREFS (Purpose, Respondents, Explanation, Findings, Significance) 5-point scale. Most attributes were related to outcome (70%), followed by process (25%) and cost (5%). Outcome attributes were most often significant (81%), followed by process (73%) and cost (67%). The relative importance of outcome attributes was ranked highest in 82% of the cases where it was included, followed by cost (43%) and process (12%).
Conclusion:
This systematic review suggests that attributes related to cancer treatment outcomes are the most important for patients. Process and cost attributes were less often included in studies but were still (but less) important to patients in most studies. Clinicians and decision makers should be aware that attribute importance might be influenced by level selection for that attribute.
... The included studies investigated WTP to reduce various treatment side effects, namely nausea and vomiting (N&V) [53,61,[72][73][74], febrile neutropenia [43,75,76], hair loss [72,77], fatigue [53,72], diarrhoea [72], infection that led to hospitalisation [72], tingling in extremities [72], pain [72], cardiac toxicity [39], anaemia [52], bacterial or fungal infection [78], skin toxicity [51], rash [53], and general reduction in side effects [38,57]. The WTP for side effect reduction ranged from $253 (to avoid treatment of febrile neutropenia in hospital) [76] to $33,110 (for 20% improvement in vomiting) [73]. ...
... DCE studies generally performed better than CV in quality assessment, with only 1/17 (5.9%) [82] graded as low quality. Majority of the studies (10/17, 58.8%) [48,51,57,69,75,78,[83][84][85][86] were of high quality while 6/17 (35.3%) [49,50,53,65,72,74] were of moderate quality. The least reported item was qualifying questions to the tasks, with an average score of 17.6%, followed by evaluation of experimental design (32.4%) and sampling strategy justification (41.2%) (Detailed results for quality assessment can be found in Supplementary Tables S2 and S3). ...
Background
Understanding patient preferences in cancer management is essential for shared decision-making. Patient or societal willingness-to-pay (WTP) for desired outcomes in cancer management represents their preferences and values of these outcomes.
Objective
The aim of this systematic review is to critically evaluate how current literature has addressed WTP in relation to cancer treatment and achievement of outcomes.
Methods
Seven databases were searched from inception until 2 March 2021 to include studies with primary data of WTP values for cancer treatments or achievement of outcomes that were elicited using stated preference methods.
Results
Fifty-four studies were included in this review. All studies were published after year 2000 and more than 90% of the studies were conducted in high-income countries. Sample size of the studies ranged from 35 to 2040, with patient being the most studied population. There was a near even distribution between studies using contingent valuation and discrete choice experiment. Based on the included studies, the highest WTP values were for a quality-adjusted life year (QALY) ($11,498–$589,822), followed by 1-year survival ($3–$198,576), quality of life (QoL) improvement ($5531–$139,499), and pain reduction ($79–$94,662). Current empirical evidence suggested that improvement in QoL and pain reduction had comparable weights to survival in cancer management.
Conclusion
This systematic review provides a summary on stated preference studies that elicited patient preferences via WTP and summarised their respective values. Respondents in this review had comparable WTP for 1-year survival and QoL, suggesting that improvement in QoL should be emphasised together with survival in cancer management.
... Age, income, gender, education level, cancer staging, and time since diagnosis were investigated as they have been reported in other studies to affect patients' preferences. 14,15,[37][38][39][40] The following subgroups were introduced as interaction terms with all the attribute levels in the baseline data of the conditional logit model: age (below 40 vs 40-60 vs above 60 years), gender (male vs female), income (low income (bottom 40% of Malaysian income strata) vs middle income (middle 40%) vs high income (top 20%)), education level (with vs without tertiary education), and cancer staging (stage III vs IV). Association is confirmed if the interaction term is statistically significant. ...
Objectives
This study aims to quantify advanced cancer patients' preferences for quality of life (QoL) outcomes versus survival extension in Malaysia. The secondary aim is to explore the change in preferences over time.
Methods
A discrete choice experiment was developed to include seven attributes valued in cancer management: physical, psychological, and social functioning, pain control, survival, place of death and cost. Patients were recruited via convenience sampling from two Malaysian public hospitals. The survey questionnaire was administered to patients within six months of their cancer diagnosis with a follow-up three months later. Conditional logit regression was used to estimate the preference weight, relative attribute importance and willingness-to-pay.
Results
One hundred valid responses were collected at baseline and 45 at follow-up. Respondents placed higher values on QoL improvements from severe to moderate or mild levels and to achieve home death over survival extension from 6 to 18 months. However, additional improvements (from moderate to mild) in some of the QoL outcomes were not valued as highly as life extension from 12 to 18 months, showing that it was vital for patients to avoid being in severe health dysfunction. Improving physical dysfunction from severe to mild yielded three times as much value as additional one-year survival. After three months, the respondents’ preferences changed significantly, with increased relative attribute importance of physical functioning, pain control, and cost.
Conclusions
As QoL outcomes are valued more than survival, palliative care should be introduced as early as possible to alleviate suffering related to advanced cancer.
... Other important attributes included specific side-effects, such as nausea and vomiting, and adverse outcomes on aspects such as physical capacity and personal appearance. Cost of treatment was an attribute included in the United States based study by Miller et al. and was found to be the most important factor in the decision process [19]. ...
Aim:
The global burden of colorectal cancer (CRC) is set to increase by 60% by 2030. An aging population and increasing treatment complexity add difficulties for patients and clinicians in CRC management. Patient preferences can be investigated using attribute-based stated preference (AbSP) techniques to explore trade-offs between different treatments. These techniques include discrete-choice experiments (DCEs), conjoint analysis and time-trade off (TTO) methods. This systematic review with a narrative synthesis aimed to determine the use and design of AbSP studies in CRC treatment and to identify patient choice themes.
Method:
The searches were performed using MEDLINE, Embase, PsycInfo and Cochrane Library in March 2021. All manuscripts featuring the use of AbSP techniques in CRC treatment were included. Data synthesis was performed using a narrative approach.
Results:
The search strategy returned 271 articles. Eighteen AbSP studies were included featuring 1890 patients and 296 clinicians. AbSP techniques compromised DCE (38.9%, n = 7), TTO (38.9%, n = 7) and conjoint analysis (22.2%, n = 4). Eleven studies (61.1%) involved piloting of tasks and the average task completion rate was 75%. CRC treatments included chemotherapy (33%, n = 6), combined treatments (33%, n = 6), surgery (17%, n =3), targeted therapy (11%, n =2) and radiotherapy (6%, n =1). The most examined domain was physical health, investigated with 49 (59.8%) attributes.
Conclusions:
Life expectancy was the main attribute in chemotherapy treatment. With surgery, patients were willing to trade life-expectancy to avoid adverse outcomes or a permanent stoma. Communication skills, treatment cost, and clinicians' views were important attributes for patients in cancer services. Further research in the elderly population, and other quality of life domains, are needed to deliver patient-centred CRC care.
... More than 70% of cancer among children are currently curable with modern and intensive therapeutic modalities, including high-dose chemotherapy with or without allogeneic stem cell transplantation. However, only a few reports have presented high-level evidence regarding antiemetic treatment among pediatric patients from Western populations [69][70][71]. Accordingly, such patients receive modified dosages based on the results of clinical trials among adult patients. Proper antiemetic treatments may allow pediatric patients to receive cancer chemotherapy without a decline in QOL. ...
Patients with cancer should appropriately receive antiemetic therapies against chemotherapy-induced nausea and vomiting (CINV). Antiemetic guidelines play an important role in managing CINV. Accordingly, the first Japanese antiemetic guideline published in 2010 by the Japan Society of Clinical Oncology (JSCO) has considerably aided Japanese medical staff in providing antiemetic therapies across chemotherapy clinics. With the yearly advancements in antiemetic therapies, the Japanese antiemetic guidelines require revisions according to published evidence regarding antiemetic management worldwide. A revised version of the first antiemetic guideline that considered several upcoming evidences had been published online in 2014 (version 1.2), in which several updated descriptions were included. The 2015 JSCO clinical practice guideline for antiemesis (version 2.0) (in Japanese) has addressed clinical antiemetic concerns and includes four major revisions regarding (1) changes in emetogenic risk categorization for anti-cancer agents, (2) olanzapine usage as an antiemetic drug, (3) the steroid-sparing method, and (4) adverse drug reactions of antiemetic agents. We herein present an English update summary for the 2015 JSCO clinical practice guideline for antiemesis (version 2.0).
... Nauseas and vomiting are common in Ca patients due to the disease and therapy. The underutilization of antiemetics due to cost and nonadherence to guidelines might contribute to the prevalence of nauseas and vomiting [17]. Furthermore, fatigue was found to be the second most disabling symptom among Ca patients. ...
Background
Neoplasm, AKA cancer (Ca), is associated with major morbidity and mortality.
Aim
Measurement of health related quality of life (HRQoL) of Ca patients is uncommon in Ethiopia. The present study determined the HRQoL and its determinants among people living with Ca in north Ethiopia.
Methods
A prospective hospital based study was conducted from 1 January 2017 to 30 August 2017 on Ca patients attending cancer treatment center of University of Gondar Teaching Hospital. The European Organization for Research and Treatment of Cancer Questionnaire version 3 was utilized to collect the data. The rate of QoL was presented using means with standard deviation (±SD). Binary logistic regression was employed to determine factors associated with HRQoL.
Result
The present study is based on the findings from 150 subjects. The rate of QoL was 52.7 (20.1) (mean ± SD). The highest functional status was emotional functioning 61 (25.5). Patients with no disease metastasis, 92.1 (5.1), had high QoL as compared to metastasis, 22.1 (18.9) (p = 0.03). Patients with affected physical functioning have a 20% reduction in QoL and Adjusted Odds Ratio (AOR) of 0.794 [0.299–891]. Patients with low satisfaction level with the provided care, 0.82 [0.76–0.93], and those with unmet needs, 0.85 [0.80–0.95], experienced reduced level of HRQoL.
Conclusion
Health related quality of life of cancer patients was found to be low in Ethiopia. Patients with limited rate of disease metastasis had improved HRQoL. Further, the unmet needs of Ca patients and the level of satisfaction with the overall care were found to influence the extent of HRQoL. Therefore, early detection of neoplasm to arrest metastasis is warranted in order to achieve better QoL. In addition, addressing the unmet needs of these patients and ensuring higher satisfaction rate are recommended to maintain adequate HRQoL.
... First, we restricted our cohort to fee-for-service Medicare beneficiaries with part D coverage. It is unknown whether our findings generalize to younger women, Medicare beneficiaries enrolled in an HMO, or women without prescription drug coverage through part D. In particular, disparities may be even larger in samples that are more diverse with respect to insurance coverage [43]. Second, we focused on NK1 receptor antagonist use as an indicator of CINV prophylaxis. ...
Purpose:
Racial minority cancer patients may experience underuse of antiemetic medications to prevent chemotherapy-induced nausea and vomiting (CINV). In addition to its adverse implications for quality of life, antiemetic underuse may contribute to observed disparities in acute illness during chemotherapy. To understand the potential contribution of CINV prophylaxis to breast cancer disparities, we assessed racial variation in potent antiemetic use and post-chemotherapy utilization related to CINV and the relationship between the two.
Methods:
We used SEER-Medicare data to evaluate the health care utilization in the 14 days following chemotherapy initiation among black and white women receiving highly emetogenic chemotherapy for breast cancer. We used modified Poisson regression to assess the relationship between (1) race and CINV-related utilization and (2) NK1 use and CINV-related utilization, overall and stratified by race. We report adjusted risk ratios (aRR) and 95 % confidence intervals (CI).
Results:
The study included 1130 women. Black women were 11 % less likely than white women to use neurokinin-1 receptor antagonists (NK1s) for CINV prophylaxis (p = 0.02); however, they experienced fewer CINV-related encounters following chemotherapy (unadjusted RR = 0.63, 95 %CI = 0.40-0.99; p = 0.05). After adjustment for clinical covariates, estimates were similar but no longer statistically significant (p = 0.07). Among white women, NK1 use was associated with increased CINV-related utilization (aRR NK1 users vs. non-users: 1.35, 95 % CI = 1.07-1.69, p = 0.01), likely resulting from unmeasured confounders.
Conclusion:
Black women were less likely to use NK1s- and CINV-related services. Racial variation in CINV-related services use may be partly explained by differential symptom reporting or access to care.
... However, NICE only recommends the use of Oncoptype DX in clinical practice for patients at intermediate risk according to traditional tools. In terms of subjective valuation by the patients, there are some studies on willingness to pay for avoiding chemotherapy side effects in breast cancer treatments (Lalla et al., 2014;Miller et al., 2013) obtaining WTP above $3,000. ...
... [18][19][20][21][22][23][24][25][26] Furthermore, patients with cancer are willing to pay increasing amounts to avoid chemotherapy side effects. 51 Health policymakers require evidence that demonstrates the value of GEP to support policy decisions regarding funding and reimbursement, and are increasingly incorporating public values into these decisions. 32 We found that GEP is highly valued and strongly influences chemotherapy treatment decisions in a sample of women from the general population but varies depending on clinical risk. ...
Objectives Gene expression profiling (GEP) of tumours informs baseline risk prediction, potentially affecting adjuvant chemotherapy decisions for women with early-stage breast cancer. Since only 15% will experience a recurrence, concerns have been raised about potential harms from overtreatment and high GEP costs in publicly funded healthcare systems. We aimed to estimate preferences and personal utility of GEP testing information and benefit–risk trade-offs in chemotherapy treatment decisions.
Design, setting and intervention Based on literature review and findings from our qualitative research (focus groups, interviews with patients with breast cancer and medical oncologists), we developed a discrete choice experiment (DCE) survey and administered it via an internet panel. The DCE included 12 choice tasks with 5 attributes and 3 alternatives considering orthogonality, D-efficiency and level balance.
Participants The DCE survey was administered to 1004 Canadian women from the general population.
Main outcome measures Preferences were analysed using conditional logit and hierarchical Bayes and evaluated for goodness of fit. We conducted simulation analyses for alternative scenarios.
Results GEP test score indicating likely benefit from chemotherapy was the most important attribute. Doctor's clinical estimate of the risk of cancer returning, trust in your cancer doctor and side effects of chemotherapy (temporary and permanent) were relatively less important but showed significant differences among levels. In the scenario analyses, 78% were likely to choose chemotherapy in a high-risk scenario, 55% in a moderate-risk scenario and 33% in a low-risk scenario, with the other attributes held constant. A high GEP score was more important in influencing the choice of chemotherapy for those at intermediate clinical risk.
Conclusions GEP testing information influences chemotherapy treatment decisions in early-stage breast cancer and varies depending on clinical risk. Clinicians should be aware of these differences and tailor the use of GEP testing accordingly.
... 5,[12][13][14][15] Moreover, current intravenous treatment has severe side effects, which in many situations increase the cost to the health care system because of additional days of hospitalization. [16][17][18][19] Therefore, novel local treatments are required in order to control the disease with less side effects. Several local modalities have been administered, either in the form of aerosol, gene therapy, intratumoral therapy, or ablation. ...
Lung cancer remains the leading cause of death in cancer patients. Severe treatment side effects and late stage of disease at diagnosis continue to be an issue. We investigated whether local treatment using 2-diethylaminoethyl-dextran methyl methacrylate copolymer with p53 (DDMC-p53) with or without cisplatin and/or microwave ablation enhances disease control in BALBC mice. We used a Lewis lung carcinoma cell line to inoculate 140 BALBC mice, which were divided into the following seven groups; control, cisplatin, microwave ablation, DDMC-p53, DDMC-p53 plus cisplatin, DDMC-p53 plus microwave, and DDMC-p53 plus cisplatin plus microwave. Microwave ablation energy was administered at 20 W for 10 minutes. Cisplatin was administered as 1 mL/mg and the DDMC-p53 complex delivered was 0.5 mL. Increased toxicity was observed in the group receiving DDMC-p53 plus cisplatin plus microwave followed by the group receiving DDMC-p53 plus cisplatin. Infection after repeated treatment administration was a major issue. We conclude that a combination of gene therapy using DDMC-p53 with or without cisplatin and microwave is an alternative method for local disease control. However, more experiments are required in a larger model to identify the appropriate dosage profile.
... 5,[12][13][14][15] Moreover, current intravenous treatment has severe side effects, which in many situations increase the cost to the health care system because of additional days of hospitalization. [16][17][18][19] Therefore, novel local treatments are required in order to control the disease with less side effects. Several local modalities have been administered, either in the form of aerosol, gene therapy, intratumoral therapy, or ablation. ...
Lung cancer remains the leading cause of death in cancer patients. Severe treatment side effects and late stage of disease at diagnosis continue to be an issue. We investigated whether local treatment using 2-diethylaminoethyl-dextran methyl methacrylate copolymer with p53 (DDMC-p53) with or without cisplatin and/or microwave ablation enhances disease control in BALBC mice. We used a Lewis lung carcinoma cell line to inoculate 140 BALBC mice, which were divided into the following seven groups; control, cisplatin, microwave ablation, DDMC-p53, DDMC-p53 plus cisplatin, DDMC-p53 plus microwave, and DDMC-p53 plus cisplatin plus microwave. Microwave ablation energy was administered at 20 W for 10 minutes. Cisplatin was administered as 1 mL/mg and the DDMC-p53 complex delivered was 0.5 mL. Increased toxicity was observed in the group receiving DDMC-p53 plus cisplatin plus microwave followed by the group receiving DDMC-p53 plus cisplatin. Infection after repeated treatment administration was a major issue. We conclude that a combination of gene therapy using DDMC-p53 with or without cisplatin and microwave is an alternative method for local disease control. However, more experiments are required in a larger model to identify the appropriate dosage profile.
ABSTRACT
Background: Cancer is a challenge for majority of population’s health-related quality of life (HRQoL),
This study aimed to analyze the impact of clinical characteristics and social determinants of health on
the QoL of a cohort of persons diagnosed and/or treated for cancer.
Methods: We performed a cross-sectional study in a cohort of 155 with various stages of cancer at different stages of their disease. Data were obtained using questionnaires QLQ-C30 from the European Organization for Research and Treatment of Cancer (EORTC), which include a set of functional and symptomatic scales.
Results: Out of 155 subjects, large proportion were diagnosed with Oral cancer 67(43.2%) and Breast
cancer 23(14.8%). The mean of global health status/QoL was 52.34 (SD= 23.34). Quality of life was significantly associated with some functional scales as role functioning (P≤0.001), social function, (P=0.00),
and symptom scales as pain (P=0.00), loss of appetite (P=0.004) and financial impact (P=0.02) as well as
associations were noted in relation to socio demographic characteristics. The highest functional status
was cognitive functioning (54.58±27.68).
Conclusions: The cancer diagnosis has become more prevalent and carries significant changes to the
method of living with physical and emotional changes in term of quality of life (QoL) because of inconvenience, torment, disfigurement, reliance and loss of confidence.
Keywords: Cancer Patients, Quality of Life, EORTC QLQ-30 Scale, cognitive functions, HRQoL
Fighting cancer is an economically expensive challenge for both health care payers, and the patients and their families and the median costs for cancer care are rapidly increasing in the last decade. Although both direct and indirect costs of medical assistance have been a frequent source of distress and contention, however analysis of the non-medical expenses incurred directly by cancer patients has not received adequate attention. Developing a deeper understanding of so-called "out-of-pocket" costs may be necessary. Out-of-pocket costs for medical care range from 7 % to 11 % of medical costs for all payers. However, the range of out-of-pocket costs shows considerable variability in different studies. In this review, we reviewed available data concerning direct and indirect medical costs, including psychosocial ones.
Background
Regulatory agencies as well as private organizations pursue programs that advocate patient centricity and emphasize the importance of dialog with patients. Various methods are applied to elicit the preferences of patients regarding the aspects of treatment they lend more importance to. Decisions on treatment choices are critical to patients with lung cancer because of their poor prognosis and the serious trade-off between safety and efficacy in traditional cytotoxic chemotherapy.Methods
We conducted a systematic literature review of quantitative patient preference studies of patients with lung cancer. Our exhaustive search of MEDLINE, CINAHL, EMBASE, PLOS, and SpringerLink identified 15 relevant studies published from January 2000 to April 2020 that enabled us to assess the relative importance of treatment attributes according to lung cancer patients’ perspective.ResultsThe literature review revealed that patients with lung cancer tend to place a higher weight on efficacy and quality of life (QoL) attributes than on other attributes. Overall survival was found to be the most important among the efficacy attributes. The consequences of adverse events seemed less important than the possible efficacy from therapies. The clinical utility of treatment, such as the route of administration, was generally not considered important. It remains inconclusive whether sociodemographic factors and/or medical history affect the relative importance of a patient’s preference.Conclusion
Our systematic review clarified that patients generally prefer a better efficacy profile to a better safety profile, which underscores the importance of improved benefits in anti-lung cancer drug development.
Antiemetic drug development can follow the same logical path as antineoplastic drug development from appropriate preclinical models through Phase I, Phase II, and Phase III testing. However, due to the marked success of antiemetic therapy over the last 25 years, placebo antiemetic treatment against highly or moderately emetogenic chemotherapy is not acceptable. Promising antiemetic agents therefore rapidly reach Phase III testing, where they are substituted into or added to effective and accepted regimens. One challenge of antiemetic drug development is determining whether substitution is indeed acceptable or whether prior regimens must be maintained intact as a basis for further antiemetic drug development. An additional challenge is the classification of emetogenic level of new antineoplastic agents. Accurate reporting of emetogenicity of such antineoplastic agents in the absence of preventive antiemetic treatment may not be available. However, at the 2009 Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Consensus Conference, an expert panel used best available data to establish rankings of emetogenicity. Oral chemotherapeutic agents are ranked separately from intravenous agents, recognizing intrinsic differences in emetogenicity as well as differing schedules of administration. Since oral chemotherapeutic agents are often administered in extended regimens, the distinction between acute and delayed emesis is less clear, and cumulative emesis must be considered. As control of vomiting has improved, attention has shifted to control of nausea, a related but distinct and equally important problem. Additional efforts will be necessary to understand mechanisms of nausea and to identify optimal remedies.
The objective of this work is to perform a systematic review and meta-analysis of all randomized controlled trials comparing a single intravenous dose of palonosetron (PAL) 0.25 mg with other 5-HT(3)R in patients receiving moderately or highly emetogenic (MoHE) chemotherapy.
Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoints were the incidence of acute and delayed nausea and vomiting. The side effects of each treatment were analyzed. A subgroup analysis was performed to evaluate the influence of the use of corticosteroids. The results are expressed as risk ratio (RR) and the correspondent 95% confidence interval (CI).
Five studies were included, with 2057 patients. PAL was compared with ondansetron, granisetron, and dolasetron. Patients in PAL group had less nausea, both acute (RR = 0.86; CI 95% = 0.76 to 0.96; p = 0.007) and delayed (RR = 0.82; CI95% = 0.75 to 0.89; p < 0.00001). They also had less acute vomiting (RR = 0.76; CI 95% = 0.66 to 0.88; p = 0.0002) and delayed vomiting (RR = 0.76; CI95% = 0.68 to 0.85; p < 0.00001). There were no statistical differences in side effects like headache (RR = 0.84; CI 95% = 0.61 to 1.17; p = 0.30), dizziness (RR = 0.40; CI 95% = 0.13 to 1.27; p = 0.12), constipation (RR = 1.29; CI 95% = 0.77 to 2.17; p = 0.33) or diarrhea (RR = 0.67; CI 95% = 0.24 to 1.85; p = 0.44). Patients receiving PAL presented less nausea and vomiting regardless of the use of corticoids. We found no statistical heterogeneity in the global analysis.
PAL was more effective than the other 5-HT(3)R in preventing acute and delayed CINV in patients receiving MoHE treatments, regardless of the use of concomitant corticosteroids.
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).
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.
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 $176.
CINV visits in the first HEC or MEC cycle were common and costly, especially inpatient hospitalizations in the delayed phase. Strategies to reduce CINV in the delayed phase could reduce healthcare utilization and costs.
The neurokinin-1 (NK1) receptor antagonists are a new class of agents designed to reduce the risk of emesis following chemotherapy, particularly with cisplatin. Early data from double-blind randomised trials suggest that an orally administered NK1 antagonist can reduce the absolute risk of acute and delayed emesis following cisplatin by 20 and 30%, respectively.
To measure the value that patients with cancer place on improved emesis control and quality of life.
Willingness-to-pay analysis.
Five study sites in Canada, Italy, Spain and Greece.
245 patients with cancer either receiving chemotherapy with cisplatin or who had received cisplatin-based chemotherapy within the previous 6 months.
After background information had been presented, patients were asked to define the maximum that they would pay per day for a drug that reduced their risk of acute and delayed (days 2 to 5) emesis by 20 and 30%, respectively. Costs were converted to US dollars ($US) using year 2000 exchange rates.
For a 20% improvement in acute emesis, Canadian, Italian and Spanish patients with cancer were willing to pay $US46, $US34 and $US63 per day, respectively, compared with $US8 for patients from Greece (p < 0.001). For a 30% improvement in delayed emesis, Canadian, Italian and Spanish patients with cancer were also willing to pay more than their Greek counterparts (SUS41, $US31, $US50 and $US9 daily for 4 days, respectively; p < 0.001). These significant differences in patient value between countries remained, even after adjusting for socioeconomic variables and previous history of emesis.
There are substantial cultural differences in how patients with cancer value benefit and improved quality of life. Since the majority of the world's population resides outside North America and Western Europe, there may be a need to re-evaluate perceived levels of patient benefit and measures of quality of life.
Over $6 billion per year is spent on prescription medication for gastroesophageal reflux disease (GERD). This study is an economic analysis of patients' willingness to pay for a prescription medication that offers complete relief of GERD symptoms.
The study was a cross-sectional, nonrandomized design recruiting patients from 5 clinical sites. A computer-administered discrete-choice questionnaire was used to explore patients' willingness to pay for various attributes (time to relief, amount of relief, side effects, and out-of-pocket cost) associated with GERD treatment. Patients chose between 2 different combinations of attributes by indicating which scenario they preferred. Data were gathered on health status, health-related quality of life, and sociodemographic characteristics.
Two hundred five patients completed the discrete-choice questionnaire with a consistency rate of 99.5%. All attributes were relevant to patient decision making. Respondents were willing to pay up to $182 to obtain complete relief in a short period of time without side effects. Patients with less severe GERD symptoms were willing to pay more to avoid side effects ($58.25 vs $38.43). Older patients were less willing to pay for better relief than younger patients.
Results demonstrate that patients are willing to pay more per month for a medication that provides more complete and faster relief from GERD symptoms. This information can guide clinicians and formulary committees in evaluating optimal treatment for GERD.
In this study, we estimated the proportion of patients who experience chemotherapy-induced nausea and vomiting (CINV) in current practice and evaluated the impact of CINV on quality of life and cost in Canada. Patients receiving highly emetogenic chemotherapy were recruited from 4 Canadian oncology centers. Patients used diaries to record information on their activities, incidence of nausea and vomiting, and health resources consumed each day for 5 days following chemotherapy. They also completed the Functional Living Index-Emesis (FLIE) questionnaire and a health utility instrument before chemotherapy and 5 days later. Of the 323 patients recruited, 266 (82%) completed their diary. On day 1, 26% of patients reported nausea or vomiting (acute emesis). From day 2 to day 5 after chemotherapy, 44% reported nausea or vomiting (delayed emesis). Patients who experienced nausea or vomiting during the study period had a decrease in FLIE score of 22% and a decrease in health utility of 15%. Patients with nausea or vomiting reported an average of 19 hours per cycle during which they were unable to perform their normal activities. Also, friends or relatives spent an average of 10 hours helping these patients. Incremental medical costs per patient experiencing CINV were $61 Canadian. Including productivity losses, total incremental costs were $592 Canadian per patient. Despite use of antiemetics, CINV remains problematic, impacting the quality of life of patients with cancer and increasing costs.
Physicians and nurses often underestimate the incidence of chemotherapy-induced nausea and vomiting (CINV) after both highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). This study assesses physicians' and nurses' perceptions of CINV in their own practices after the introduction of aprepitant.
A prospective observational study of patients receiving the first cycle of HEC regimens with CDDP and without CDDP or MEC was performed. Eligible patients completed a 6-day diary recording emetic episodes, nausea assessment, and antiemetic medication use. Physicians and nurses estimated the incidence of acute and delayed CINV after the first administration of HEC and MEC. The observed incidence rates of CINV were compared with the rates predicted by healthcare providers. Aprepitant was given to patients receiving HEC regimes with CDDP.
Twenty-nine physicians and nurses and 95 patients (87% receiving HEC and 14% MEC) were recruited. The global control of CINV was 66.67% for all patients and 73.33%, 47.06%, and 55.56% for patients receiving HEC regimens with CDDP, HEC regimens without CDDP and MEC, respectively. Physicians and nurses underestimated the control of acute CINV in patients receiving HEC regimens with CDDP, but they accurately predicted the control of delayed CINV. All physicians and nurses predicted the control of acute CINV after HEC regiments without CDDP and after MEC quite accurately, whereas they overestimated the control of delayed CINV after both regimens.
Aprepitant allows for better control of CINV in HEC regimens with CDDP, and this control is accurately perceived by physicians and nurses. However, physicians and nurses overestimate the control of delayed CINV after HEC regimens without CDDP and after MEC. CINV is still an important target for improved therapeutic intervention and the healthcare providers must be aware of its actual incidence.
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.
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.
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.
CINV remains a significant problem among US patients, suggesting a need for more effective prophylaxis use in clinical practice.
To provide a systematic analysis of how adverse symptoms of disease and side effects of cancer therapy relate to patient noncompliance with treatment, we interviewed 107 patients with hematologic malignancies at the initiation of therapy and 6 months later to collect information on the type, frequency, and difficulty of unpleasant physical effects experienced. Level of compliance was monitored (biochemically and with self-report) on a monthly basis for oral self administration of allopurinol and prednisone. Appointment-keeping to receive infused chemotherapy was also monitored. Nausea was the most frequent side effect experienced. Nausea, fever, and pain were the most difficult physical effects to tolerate when they occurred. Complex treatment regimens and severe diseases related to reports of more physical effects. Younger patients had a more difficult time dealing with these effects than did older patients. Neither the occurrence, frequency, or difficulty dealing with any of the effects related to noncompliance with either of the two self-administered medications. Difficulty with particular effects did relate to noncompliance with clinic appointments to receive infused chemotherapy.
The goals of this study were to: (1) systematically evaluate patient preferences regarding side effects of high-dose chemotherapy with stem cell support for treatment of advanced ovarian cancer; and (2) assess whether patients' preferences changed over time.
Forty patients with stage III or IV disease were enrolled in this study. Patients' preferences regarding 12 health states (side effects) were assessed using visual analogue scale (VAS) and time trade-off (TTO) methods during mobilization chemotherapy (T(1)) and 6-7 weeks later after high-dose chemotherapy and stem cell transplant (T(2)). Each assessment involved a 45-min interview conducted at the patient's bedside.
The three most preferred health states were no evidence of disease (NED), a chemotherapy with few or no side effects, and alopecia, while the least preferred health states were chemotherapy with multiple severe side effects, hepatotoxicity, and nausea and vomiting. These results were observed at both T(1) and T(2) using both preference assessment methods. Pancytopenia scores significantly increased from T(1) to T(2) using the VAS method (P < 0.05), but decreased using the TTO method.
Chemotherapy-experienced women with ovarian cancer have consistent preferences for the best and worst health states associated with the side effects of chemotherapy. Patients are more averse to nausea and vomiting than many other symptoms. Women's perceptions of pancytopenia may be dependent upon the number of prior cycles of chemotherapy and site of care for anemia, thrombocytopenia, and febrile neutropenia.
To examine preferences for HIV test methods using conjoint analysis, a method used to measure economic preferences (utilities).
Self-administered surveys at four publicly funded HIV testing locations in San Francisco, California, between November 1999 and February 2000 (n = 365, 96 percent response rate).
We defined six important attributes of HIV tests and their levels (location, price, ease of collection, timeliness/accuracy, privacy/anonymity, and counseling). A fractional factorial design was used to develop scenarios that consisted of combinations of attribute levels. Respondents were asked 11 questions about whether they would choose "Test A or B" based on these scenarios.
We used random effects probit models to estimate utilities for testing attributes. Since price was included as an attribute, we were able to estimate willingness to pay, which provides a standardized measure for use in economic evaluations. We used extensive analyses to examine the reliability and validity of the results, including analyses of: (1) preference consistency, (2) willingness to trade among attributes, and (3) consistency with theoretical predictions.
Respondents most preferred tests that were accurate/timely and private/anonymous, whereas they had relatively lower preferences for in-person counseling. Respondents were willing to pay an additional $35 for immediate, highly accurate results; however, they had a strong disutility for receiving immediate but less accurate results. By using conjoint analysis to analyze new combinations of attributes, we found that respondents would most prefer instant, highly accurate home tests, even though they are not currently available in the U.S. Respondents were willing to pay $39 for a highly accurate, instant home test.
The method of conjoint analysis enabled us to estimate utilities for specific attributes of HIV tests as well as the overall utility obtained from various HIV tests, including tests that are under consideration but not yet available. Conjoint analysis offers an approach that can be useful for measuring and understanding the value of other health care goods, services, and interventions.
The authors determined the incidence of acute and delayed chemotherapy-induced nausea and emesis (vomiting) (CINV) among patients receiving highly (HEC) or moderately (MEC) emetogenic chemotherapy. They also assessed whether physicians and nurses accurately recognized the incidence of acute and delayed CINV in their own practices.
A prospective, observational study of adult patients receiving HEC or MEC for the first time was performed. Before patient enrollment, medical oncologists and oncology nurses estimated the incidence of acute (Day 1) and delayed (Days 2-5) CINV after first administration of HEC and MEC in their own practices. Eligible patients from their practices then completed a 6-day diary including emetic episodes, nausea assessment, and antiemetic medication use. Observed incidence rates of acute and delayed CINV were compared with physician/nurse predictions.
Twenty-four physicians and nurses and 298 eligible patients (67 receiving HEC and 231 receiving MEC) were recruited from 14 oncology practices in 6 countries. Greater than 35% of patients overall experienced acute nausea, whereas 13% experienced acute emesis. Delayed nausea and emesis were observed in 60% and 50% of HEC patients, respectively, and in 52% and 28% of MEC patients, respectively. Delayed symptoms appeared without acute symptoms after HEC (emesis, 38%; nausea, 33%) and MEC (emesis, 19%; nausea, 21%). Physicians and nurses accurately predicted the incidence of acute CINV but underestimated the incidence of delayed nausea and emesis after HEC by 21 and 28 percentage points, respectively, and delayed nausea after MEC by 28 percentage points. Greater than 75% of physicians and nurses underestimated the incidence of delayed CINV after both HEC and MEC.
Physicians and nurses markedly underestimated the incidence of delayed nausea and emesis after both HEC and MEC. Delayed nausea and emesis, which may appear even in the absence of acute nausea and emesis, remain important targets for improved therapeutic intervention.
To assess preference and willingness-to-pay (WTP) for the insulin mixture Humalog Mix25 relative to Humulin 30/70, from the patients' perspective, the relative importance of individual treatment attributes was also determined. Differences among five European countries were investigated.
Two hundred and ninety patients with type 2 diabetes were recruited from five European countries. Of these, 235 were suitable for inclusion in the analysis. Their mean age was 51.3 years and, on average, patients had had diabetes for 11 years. A discrete-choice conjoint analysis was conducted using face-to-face interviews. Treatment attributes, such as timing of injections around meals, 2-hour postprandial control, effect of prandial dosing, frequency of nocturnal hypoglycemia, and cost, and levels were derived after a systematic review of all published comparative clinical trial data. Meta-analyses were undertaken where appropriate.
Ninety percent (95% CI 86-93%) of patients would choose Humalog Mix25 over Humulin 30/70, at the same cost. On average, European subjects were willing to pay 111 euros per month more for Humalog Mix25 (95% CI 86.71-156.91 euros). The primary driver was the reduced risk of nocturnal hypoglycemic events, contributing 49% of WTP. The convenience of dosing immediately before the meal contributed 37%. Preference results were similar in all five countries, although WTP and sensitivity to increasing cost both varied.
Patients in all countries showed a preference and WTP for Humalog Mix25 over Humulin 30/70. The main drivers of patient WTP may be of interest to pharmaceutical prescribers, manufacturers, and reimbursement agencies.
Clinical reports suggest that nausea remains a side effect of chemotherapy despite widespread use of serotonin receptor antagonists. This study summarized the frequency, timing, and intensity of postchemotherapy nausea for patients receiving doxorubicin, cisplatin, or carboplatin.
Three hundred sixty chemotherapy-naïve patients (73% female) were enrolled in a study testing the ability of an information intervention to reduce nausea. Of these, 322 subjects completed the Morrow Assessment of Nausea and Emesis (MANE), as well as a 5-day self-report diary, at Cycle 1 (300 subjects completed the MANE and self-report diary at Cycle 2). All patients received a 5-hydroxytryptamine-3 receptor antagonist (ondansetron) with dexamethasone on the day of treatment.
Seventy-six percent of the patients developed nausea during the 5-day period, beginning with the Cycle 1 infusion, and 73% of patients reported delayed nausea (DN) during Days 2-5. The proportions were similar during Cycle 2. Fifty-five percent of patients described their DN as being of moderate or greater intensity compared with 28% of patients who described acute nausea. Carboplatin was less likely to cause DN than either of the other agents (56% of 106 patients compared with 75% of 47 receiving cisplatin and 83% of 169 taking doxorubicin). The mean peak DN severity was 4.34 (range, 1-7) for doxorubicin, which was significantly higher than the mean peak value for carboplatin (3.66) but was not significantly different from the mean peak value for cisplatin (4.26). Eighteen percent of patients did not experience nausea until Day 3 or later.
Despite prophylaxis with ondansetron, the majority of patients receiving one of these common chemotherapy agents experienced nausea. The frequency of DN was nearly twice that of acute nausea. Results show the need for continued development of antiemetics that are effective against DN.
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.
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.
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.
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.
Palonosetron (Aloxi(®), Onicit(®), Paloxi(®)) is a second-generation 5-HT(3) receptor antagonist (RA) with an extended half-life of ~40 hours and high binding affinity for the 5-HT₃ receptor that is markedly different from other 5-HT(3) RAs. Phase III trials demonstrate that a single dose of palonosetron compared with traditional 5-HT₃ RAs is more effective in preventing chemotherapy-induced nausea and vomiting (CINV) during the first 24 hours following chemotherapy (acute CINV), and also exhibits prolonged efficacy to provide significantly better protection from CINV in the delayed and overall phases. This superior and extended protection from CINV conferred by palonosetron following a single intravenous dose before chemotherapy simplifies dosing schedules. Recent research has focused on optimization of palonosetron-based antiemetic regimens, particularly in combination with steroids and neurokinin-1 RAs. The available clinical data indicate high control rates for palonosetron, suggesting a synergistic potential for protection in patients scheduled to receive emetogenic drug regimens.
Software for Web Interviewing and Conjoint Analysis
- B Orme