Patient preferences for treatment attributes in moderate-to-severe atopic dermatitis: a discrete choice experiment.

Purpose: Evidence on treatment preferences of patients with moderate-to-severe atopic dermatitis (AD) in the United States (US) is limited and an assessment of treatment preferences in this group is warranted.Materials and methods: An online discrete choice experiment survey was conducted (June 2023) among US adults with self-reported moderate-to-severe AD or experience with systemic therapy who had inadequate response to topical treatments. Preference weights estimated from conditional logistic regression models were used to calculate willingness to trade off and attributes' relative importance (RI).Results: Participants (N = 300; mean age: 45 years; 70% females; 52% systemic therapy experienced) preferred treatments with higher efficacy, lower risk of adverse events (AEs), and less frequent blood tests (p < .05). Treatment attributes, from high to low RI, were itch control (38%), risk of cancer (23%), risk of respiratory infections (18%), risk of heart problems (11%), sustained improvement in skin appearance (5%), blood test frequency (3%), and frequency and mode of administration (2%); together, AE attributes accounted for more than half of the RI.Conclusions: Participants preferred AD treatments that maximize itch control while minimizing AE risks, whereas mode of administration had little impact on preferences. Understanding patients' preferences may help improve shared decision-making, potentially leading to enhanced patient satisfaction with treatment, increased engagement, and better clinical outcomes.

Comparison of healthcare resource utilization and costs of patients with HR+/HER2- advanced breast cancer treated with ribociclib versus other CDK4/6 inhibitors.

AIMS: To assess healthcare resource utilization (HRU) and healthcare costs among women with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- aBC) treated with cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors. METHODS: Women with HR+/HER2- aBC, initiating CDK4/6 inhibitor treatment were identified using IBM MarketScan Commercial and Medicare Supplemental databases (Q1/2000-Q3/2018). Based on the first CDK4/6 inhibitor patients received (index therapy), three cohorts were identified: abemaciclib, palbociclib, and ribociclib. The baseline period (six months preceding treatment initiation) was used to describe patient characteristics. All-cause HRU and direct total healthcare costs (medical and pharmacy) from treatment initiation until the earliest of the end of index therapy, continuous health plan enrollment, or data availability, were compared for the ribociclib cohort versus the abemaciclib and palbociclib cohorts, separately, using weighted regression analyses balanced on baseline covariates. RESULTS: Average age at treatment initiation was ∼60 years and the majority of patients were postmenopausal (abemaciclib: 92%; palbociclib: 92%; ribociclib: 79%). Average follow-up duration was 3.9, 8.8, and 5.9 months for the abemaciclib, palbociclib, and ribociclib cohorts, respectively. After reweighting, HRU was not statistically different between the ribociclib and abemaciclib cohorts, however, the ribociclib cohort incurred significantly lower total healthcare costs (-$5,452; 95% CI: -$8,726; -$1,139, p = .01). Medical costs (driven by outpatient costs) and pharmacy costs (driven by CDK4/6 inhibitor costs) were significantly lower for the ribociclib cohort. Among the reweighted ribociclib and palbociclib cohorts, HRU and total healthcare costs were not statistically different, although the ribociclib cohort had lower outpatient costs per-patient-per-month (-$1,245, 95% CI: -$2,349; -$37, p = .04). LIMITATIONS: Due to the retrospective, observational design, treatment cohorts were not randomly assigned. CONCLUSIONS: During CDK4/6 inhibitor therapy, ribociclib patients tended to incur lower medical and pharmacy costs than abemaciclib patients. Among ribociclib and palbociclib patients, HRU and healthcare costs were similar.

Evaluation of access to care issues in patients with breast cancer.

AIMS: System-level efforts have been deployed to improve oncology care and access while reducing utilization and costs. Understanding the nature of access to care from the perspective of patients themselves is an unmet need. This study examined access to care in a population of women with breast cancer and its relationship to overall patient satisfaction. MATERIALS AND METHODS: Patients with breast cancer from six oncology clinics in five states completed a survey during routine office visits. Access to care (higher scores indicated increasing access barriers), overall patient satisfaction, and patient demographic/clinical characteristics were measured. The relationships between access (composite and factor scores) and satisfaction were assessed using multivariable analyses controlling for age (the only significant characteristic from bivariate analyses). RESULTS: A total of 180 patients completed the survey. Factor analysis of access to care items revealed an 8-factor measure - Insurance, Health System, Emotional, Holistic Treatment, Family Support, Knowledge/Understanding, Information Quality, and Financial Support - with high reliability (Composite: Cronbach alpha = 0.93; Factors: Cronbach alpha range = 0.85-0.91). Access composite score was moderately low (mean = 1.90), indicating an overall low level of access barriers, and overall patient satisfaction was high (mean = 4.59). The composite score (p < .001) and the Health System and Knowledge/Understanding factors (p < .01) were significant and negative predictors of overall satisfaction. LIMITATIONS: Study sites were high functioning clinics and all, but one, are Oncology Care Model practices. Thus, the scope of access to care issues for patients of under-resourced clinics might not be well addressed. CONCLUSIONS: Access to care overall and by factor was significantly predictive of patient satisfaction with care. In addition, access to care factors varied across several demographic and clinical characteristics. Future strategies that address access to care challenges should consider these modifiable, patient-centric, and system-based issues.

Economic modeling for the US of the cost-efficiency and associated expanded treatment access of conversion to biosimilar pegfilgrastim-bmez from reference pegfilgrastim.

Aims: For this economic analysis, we aimed to model: (1) the cost-efficiency of prophylaxis with biosimilar pegfilgrastim-bmez for chemotherapy-induced (febrile) neutropenia (CIN/FN) compared to reference pegfilgrastim, and (2) the expanded access to CIN/FN prophylaxis and anti-neoplastic treatment that could be achieved with biosimilar cost-savings on a budget-neutral basis.Methods: In a hypothetical panel of 20,000 cancer patients receiving CIN/FN prophylaxis and using the average sales price (ASP) for the second quarter of 2019 for reference pegfilgrastim, we: conducted an ex ante simulation from the payer perspective of the cost-savings of 10-100% conversion from reference to biosimilar pegfilgrastim-bmez using drug price discounting ranging from 10-35%; estimated the budget-neutral expanded access to biosimilar pegfilgrastim-bmez enabled by these cost-savings; and estimated the budget-neutral expanded access to anti-neoplastic treatment with pembrolizumab. The simulations were replicated using fourth quarter 2019 wholesale acquisition cost (WAC) for reference pegfilgrastim and biosimilar pegfilgrastim-bmez in a post facto analysis.Results: In ASP simulations, cost-savings of using pegfilgrastim-bmez over reference pegfilgrastim in a 20,000 patient panel range from $1.3 M (at 15% price discount) to $3 M (35%) at 10% conversion rate and from $6.4 M to $14.9 M, respectively, at 50% conversion. These savings could provide prophylaxis with pegfilgrastim-bmez to an additional 352 (15% discount) to 1,076 patients (35%) at 10% conversion or 1,764-5,384, respectively, at 50% conversion. Alternatively, savings could be reallocated for anti-neoplastic treatment with pembrolizumab to 3 (15% discount) to 9 (35%) patients at 10% conversion or 19-45, respectively, at 50% conversion. When utilizing WAC, cost-savings range from $4.6 M (10% conversion) to $23.1 M (50%) which could provide pegfilgrastim-bmez to an additional 1,174 (10% conversion) to 5,873 patients (50%).Conclusions: Prophylaxis with biosimilar pegfilgrastim-bmez increases the value of cancer care by generating significant cost-savings that could be reallocated to provide expanded access to CIN/FN prevention and anti-neoplastic therapy on a budget-neutral basis.

Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma.

Background: Guidelines recommend febrile neutropenia (FN) prophylaxis following myelotoxic chemotherapy with either daily injections of filgrastim (Neupogen®) or biosimilar filgrastim-sndz (Zarzio/Zarxio®), single-injection pegfilgrastim (Neulasta®), or pegfilgrastim administered through an on-body injector (PEG-OBI; Neulasta® Onpro®). PEG-OBI failure rates up to 6.9% have been reported, putting patients at incremental risk for FN and FN-related hospitalization. Our objective was to estimate, from a US payer perspective, the incremental costs of FN hospitalizations and the total incremental costs associated with PEG-OBI prophylaxis at varying device failure rates over assured FN prophylaxis with daily injections of filgrastim or filgrastim-sndz or a single injection of pegfilgrastim.Methods: Cost simulations comparing prophylaxis with PEG-OBI at failure rates of 1-10% versus assured prophylaxis in cycle 1 of chemotherapy were performed for panels of 10,000 patients with lung cancer treated with cyclophosphamide, doxorubicin, and etoposide (1 analysis) or non-Hodgkin lymphoma (NHL) treated with CHOP or CNOP (2 analyses). Daily injection scenarios were 4.3, 5, and 11 injections for lung cancer and 5, 6.5, and 11 for NHL. The analyses are from the US payer perspective.Results: For lung cancer, the total incremental cost of PEG-OBI prophylaxis at varying failure rates and durations ranged from $6,691,969‒$31,765,299 over filgrastim and $18,901,969‒$36,538,299 over filgrastim-sndz. For NHL, in scenario 1, the total incremental costs ranged from $6,794,984‒$30,361,345 over filgrastim and $19,004,984‒$35,911,345 over filgrastim-sndz; in scenario 2, the incremental costs ranged from $7,003,657‒$32,448,067 over filgrastim and $19,213,657‒$37,998,067 over filgrastim-sndz.Conclusions: In this simulation, the incremental costs of FN-related hospitalization due to PEG-OBI failure in cycle 1 compared to assured prophylaxis with reference pegfilgrastim, reference filgrastim, and biosimilar filgrastim-sndz varied depending upon the PEG-OBI failure rate and the alternative G-CSF prophylaxis option. Biosimilar filgrastim-sndz offers the greatest cost-efficiency.

Incidence of febrile neutropenia during chemotherapy among patients with nonmyeloid cancer receiving filgrastim vs a filgrastim biosimilar.

BACKGROUND: Filgrastim and other granulocyte colony-stimulating factors are recommended to decrease febrile neutropenia (FN) incidence among patients with nonmyeloid cancers undergoing chemotherapy. Data comparing biosimilar filgrastim-sndz with reference filgrastim (filgrastim-ref) are limited outside of clinical trials in the US. OBJECTIVE: To compare the incidence of FN across chemotherapy cycles 1-6 between patients treated with filgrastim-sndz vs filgrastim-ref. MATERIALS AND METHODS: This was a retrospective claims analysis of patients with nonmyeloid cancer enrolled in commercial or Medicare Advantage plans from March 2015 to June 2016 and receiving filgrastim-sndz or filgrastim-ref during ≥1 completed chemotherapy cycle. Patients undergoing hematopoietic stem cell transplantation, pregnant patients, and those with missing data were excluded. FN was identified using the diagnosis codes for neutropenia + fever, neutropenia + bacterial/fungal infection, and neutropenia + infection + fever. Equivalence testing for FN incidence at the cycle level across chemotherapy cycles 1-6 was conducted for filgrastim-sndz vs filgrastim-ref after adjusting for baseline characteristics using inverse probability of treatment weighting. Results were considered equivalent if the 90% CIs for between-cohort differences were within ±6.0%. RESULTS: The analysis included 3,459 patients (162 filgrastim-sndz and 3,297 filgrastim-ref). Before weighting, the filgrastim-sndz cohort was younger than filgrastim-ref and had a higher proportion of men, a higher proportion with commercial insurance, and lower proportions with granulocyte colony-stimulating factor prophylaxis or metastatic cancer. After weighting, baseline characteristics were similar between cohorts. Adjusted FN incidence was equivalent for filgrastim-sndz vs filgrastim-ref, respectively: neutropenia + fever, 0.81% vs 0.61% (difference [90% CI]=0.20 [-0.57 to 1.56]); neutropenia + infection, 1.21% vs 1.33% (difference [90% CI]=-0.12 [-1.17 to 2.28]); neutropenia + infection + fever, 0.0% vs 0.14% (difference=-0.14; CI not calculated because filgrastim-sndz had 0 events). CONCLUSION: Filgrastim-sndz and filgrastim-ref are statistically equivalent for preventing FN across chemotherapy cycles 1-6 among patients with nonmyeloid cancer.

Clinical Outcomes of Treatment with Filgrastim Versus a Filgrastim Biosimilar and Febrile Neutropenia-Associated Costs Among Patients with Nonmyeloid Cancer Undergoing Chemotherapy.

BACKGROUND: Granulocyte colony-stimulating factors such as filgrastim are used to decrease the incidence of febrile neutropenia (FN) among patients with nonmyeloid cancers undergoing chemotherapy treatment. Although the biosimilar filgrastim-sndz has been approved in the United States since 2015, limited real-world comparisons of filgrastim-sndz versus reference filgrastim (filgrastim-ref) have been conducted. OBJECTIVE: To compare FN incidence and assess overall FN-related health care resource utilization and medical costs among U.S. patients with non-myeloid cancer who received filgrastim-sndz or filgrastim-ref during their first chemotherapy cycle. METHODS: This was a retrospective claims analysis of patients with non-myeloid cancer who were enrolled in commercial or Medicare Advantage insurance plans from March 2015 through June 2016 and received filgrastim-sndz or filgrastim-ref during their first observed chemotherapy cycle. Patients with evidence of hematopoietic stem cell transplantation or pregnancy and those with missing demographic information were excluded. FN was defined on the basis of diagnosis codes for neutropenia and fever (N/F); neutropenia and infection (N/I); and neutropenia, infection, and fever (N/I/F). Cohorts were adjusted for differences in baseline patient characteristics using the inverse probability of treatment weighting (IPTW) method, and equivalence testing was used to compare the proportion of patients who developed FN between weighted cohorts. On the basis of the range of neutropenic fever incidence found in the PIONEER clinical trial, FN incidence was considered equivalent if 90% CIs for between-cohort differences were within ± 6%. Mean FN-related health care resource utilization and total FN-related medical costs were calculated for the overall study population. RESULTS: A total of 3,542 patients were included in the study (172 filgrastim-sndz; 3,370 filgrastim-ref; mean ages 62.1 years and 64.7 years, respectively). After IPTW, there were 162 patients in the filgrastim-sndz cohort and 3,297 in the filgrastim-ref cohort (mean age 64.5 years for both). FN incidence in the weighted filgrastim-sndz versus filgrastim-ref cohorts, respectively, was 1.4% versus 0.9% for N/F, 2.3% versus 1.7% for N/I, and 0.0% versus 0.3% for N/I/F; FN incidence was statistically equivalent between treatment cohorts. Among patients in either treatment cohort who developed FN, the proportion with FN-related inpatient stays during the first chemotherapy cycle ranged from 35.0% for N/I to 70.0% for N/I/F. Mean (SD) FN-related total medical costs across all patients who developed FN were $11,977 ($18,383) for N/F, $8,040 ($14,809) for N/I, and $21,733 ($30,003) for N/I/F, in 2015 U.S. dollars. For all 3 definitions of FN, the largest proportions (73.5%-93.4%) of medical costs were inpatient related. CONCLUSIONS: In this real-world study of patients with nonmyeloid cancers undergoing chemotherapy, the incidence of FN was statistically equivalent between individuals treated with filgrastim-sndz versus filgrastim-ref during their first chemotherapy cycle. FN-related health care resource utilization and medical costs among patients who developed FN were substantial. DISCLOSURES: This work was funded by Sandoz, which participated in the study design, data interpretation, writing and revision of the manuscript, and decision to submit the manuscript for publication. Balu and Campbell are employees of Sandoz, which is the manufacturer of the filgrastim biosimilars Zarzio and Zarxio. DeLeon was an employee of Sandoz at the time this study was conducted. Lal, Brekke, Elliott, and Korrer are employees of Optum, which was contracted by Sandoz to conduct this study.

Expanded access to cancer treatments from conversion to neutropenia prophylaxis with biosimilar filgrastim-sndz.

AIM: Biosimilar medicines offer significant cost-savings potential over their reference products, which can be re-allocated to provide access to other cancer treatments on a budget-neutral basis. METHODS: Simulation study using cost data for the USA under consideration of several prophylaxis patterns. RESULTS: Potential savings from conversion from reference filgrastim to biosimilar filgrastim-sndz are significant. These savings expand budget-neutral access to novel immunotherapies (obinutuzumab; pembrolizumab) or supportive care (filgrastim-sndz). CONCLUSION: The combination of biosimilar savings and expanded access increases the value of cancer care as the same supportive care is provided at lower cost, additional cancer care is enabled at no additional cost, and more patients will have access to cancer care.

Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia.

AIMS: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis. METHODS: A cost-efficiency analysis of the prophylaxis of one patient during one chemotherapy cycle under 1-14 days' time horizon was conducted using the unit dose average selling price (ASP) and Current Procedural Terminology (CPT) codes for subcutaneous prophylactic injection under four scenarios: cost of medication only (COSTMED), patient self-administration (SELFADMIN), healthcare provider (HCP) initiating administration followed by self-administration (HCPSTART), and HCP providing full administration (HCPALL). Two case studies were created to illustrate real-world clinical implications. The analyses were replicated using wholesale acquisition cost (WAC). RESULTS: Using ASP + CPT, cost savings achieved with filgrastim-sndz relative to reference filgrastim ranged from $65 (1 day) to $916 (14 days) across all scenarios. Relative to pegfilgrastim, savings with filgrastim-sndz ranged from $834 (14 days) up to $3,666 (1 day) under the COSTMED, SELFADMIN, and HPOSTART scenarios; and from $284 (14 days) up to $3,666 (1 day) under the HPOALL scenario. Similar to the cost-savings compared to pegfilgrastim, filgrastim-sndz achieved savings relative to pegfilgrastim-injector: from $834 (14 days) to $3,666 (1 day) under the COSTMED scenario, from $859 (14 days) to $3,692 (1 day) under SELFADMIN, from $817 (14 days) to $3,649 (1 day) under HPOSTART, and from $267 (14 days) to $3,649 (1 day) under HPOALL. Cost savings of filgrastim-sndz using WAC + CPT were even greater under all scenarios. CONCLUSIONS: Prophylaxis with filgrastim-sndz, a biosimilar filgrastim, was associated consistently with significant cost-savings over prophylaxis with reference filgrastim, pegfilgrastim, and pegfilgrastim-injector, and this across various administration scenarios.

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

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

Impact of 5-HT3 receptor antagonists on chemotherapy-induced nausea and vomiting: a retrospective cohort study.

BACKGROUND: 1st generation 5-hydroxytryptamine receptor antagonists (5-HT3 RAs), and palonosetron, a 2nd generation 5-HT3 RA, are indicated for the prevention of chemotherapy (CT)-induced nausea and vomiting (CINV) associated with moderately (MEC) and highly emetogenic CT agents (HEC). This study explores the impact of step therapy policies requiring use of an older 5-HT3 RA before palonosetron on risk of CINV associated with hospital or emergency department (ED) admissions. METHODS: Patients who received cyclophosphamide post breast cancer (BC) surgery or who were diagnosed with lung cancer on carboplatin (LC-carboplatin) or cisplatin (LC-cisplatin) were selected from PharMetrics' (IMS LifeLink) claims dataset (2005-2008). Patients were followed for 6 months from initial CT administration for CINV events identified through ICD-9-CM codes. Patients were grouped into those initiated with older, generic 5-HT3 RAs (ondansetron, granisetron, and dolasetron) and those initiated and maintained on palonosetron throughout study follow-up. CINV events and CINV days were analyzed using multivariate regressions controlling for demographic and clinical variables. RESULTS: Eligible patients numbered 3,606 in BC, 4,497 in LC-carboplatin and 1,154 in LC-cisplatin cohorts, with 52%, 40%, and 34% in the palonosetron group, respectively. There was no significant difference between the two 5-HT3 RA groups in age or Charlson Comorbidity Index among the two MEC cohorts (BC and LC-carboplatin). Among the LC-cisplatin cohort, palonosetron users were older with more males than the older 5-HT3 RA group (age: 60.1 vs. 61.3; males, 66.9% vs. 56.9%). Compared to the older 5-HT3 RAs, the palonosetron groups incurred 22%-51% fewer 5-HT3 RA pharmacy claims, had fewer patients with CINV events (3.5% vs. 5.5% in BC, 9.5% vs. 12.8% in LC-carboplatin, 16.4% vs. 21.7% in LC-cisplatin), and had lower risk for CINV events (odds ratios 0.62, 0.71, or 0.71, respectively; p<0.05). The BC and LC-carboplatin palonosetron groups experienced 50% and 30% fewer CINV days than the generic 5-HT3 RA group (p<0.05). CONCLUSIONS: Patients with breast or lung cancer initiated and maintained on palonosetron were at significantly lower risk for potentially costly CINV versus those on older 5-HT3 RAs. Further studies on impact of step therapy policy are warranted in order to minimize the clinical and economic burden of CINV.

Impact of initiating antiemetic prophylaxis with palonosetron versus ondansetron on risk of uncontrolled chemotherapy-induced nausea and vomiting in patients with lung cancer receiving multi-day chemotherapy.

PURPOSE: The purpose of this study is to examine the risk of uncontrolled chemotherapy-induced nausea/vomiting (CINV) among lung cancer patients receiving multi-day chemotherapy and ondansetron- or palonosetron-initiated prophylactic antiemetic regimens in a community oncology setting. METHODS: The Georgia Cancer Specialists electronic medical records database was used to retrospectively identify lung cancer patients who received multi-day cisplatin or carboplatin regimens with ondansetron or palonosetron on day 1 between April 1, 2006 and July 31, 2009. Uncontrolled CINV events were identified through ICD-9-CM codes (nausea/vomiting), CPT codes (dehydration), rescue medications, nausea/vomiting hospitalizations, and/or antiemetic therapy after last chemotherapy administration of the cycle. Risk for uncontrolled CINV, up to 7 days after last chemotherapy administration, was analyzed at cycle level using logistic regression with regressors of gender, age, number of chemotherapy administration days, Charlson comorbidity index, cancer type, multicancer diagnoses, and chemotherapy regimen. RESULTS: A total of 209 palonosetron and 153 ondansetron patients (702 and 515 cycles, respectively) met the inclusion criteria. Palonosetron patients were significantly older (mean 67.9 versus 63.9 years; P < 0.0001), with no significant difference in gender, baseline comorbidity score, or multicancer diagnosis. Palonosetron cycles had 63% lower risk for uncontrolled CINV events versus ondansetron cycles [odds ratio (OR) 0.37; 95% confidence interval (CI) 0.25-0.54; P < 0.0001]. Sub-analysis by chemotherapy supported overall analysis (cisplatin OR 0.09; 95% CI 0.04-0.25; P < 0.0001; carboplatin OR 0.46; 95% CI 0.30-0.70; P = 0.0003). CONCLUSION: In this retrospective analysis of lung cancer patients, multi-day chemotherapy cycles administered with palonosetron on day 1 were associated with a significantly lower risk for uncontrolled CINV events versus ondansetron-initiated chemotherapy cycles.

Impact of 5-HT(3) RA selection within triple antiemetic regimens on uncontrolled highly emetogenic chemotherapy-induced nausea/vomiting.

BACKGROUND: It is recommended that patients initiate triple antiemetic therapy with one of the 5-hydroxytryptamine receptor antagonists (5-HT(3) RAs), aprepitant (or its intravenous prodrug fosaprepitant) and dexamethasone prior to the start of highly emetogenic chemotherapy (HEC). However, the impact of 5-HT(3) RA selection within triple antiemetic regimens on the risk of uncontrolled chemotherapy-induced nausea and vomiting (CINV) with HEC has not been well studied. AIM: To assess the likelihood of an uncontrolled CINV event following antiemetic prophylaxis with the 5-HT(3) RA palonosetron + aprepitant/fosaprepitant + dexamethasone (palonosetron cohort) versus any of the other 5-HT(3) RAs + aprepitant/fosaprepitant + dexamethasone (other 5-HT(3) RA cohort) among single-day HEC cycles. METHODS: Single-day HEC cycles (a gap of at least 5 days between two administrations) among patients with a cancer diagnosis and receiving antiemetic prophylaxis with the aforementioned regimens between 1/1/2006 and 6/30/2010 were identified from the IMS LifeLink claims database. Uncontrolled CINV events were identified through ICD-9-CM codes (nausea and vomiting), Current Procedural Terminology codes (hydration), rescue medications and/or use of antiemetic therapy from days 2-5 following HEC administration. Risks for an uncontrolled CINV event among all patients, and within breast cancer and multiple cancer subpopulations, were analyzed at cycle level using logistic multivariate regression models. RESULTS: A total of 8018 cycles for the palonosetron cohort and 1926 cycles for the other 5-HT(3) RA cohort (3574 and 978 patients, respectively) were analyzed. Single-day HEC cycles received by the palonosetron cohort had a significantly lower unadjusted risk of an uncontrolled CINV event (17.5 vs 20.7% for the other 5-HT(3) RA cohort; p = 0.0010), with a 17% lower adjusted risk for palonosetron-administered cycles (odds ratio: 0.83; 95% CI: 0.73-0.94; p = 0.0042). Results in the breast cancer and multiple cancer subgroups were consistent with those for the overall population. CONCLUSION: In this retrospective claims data analysis, single-day HEC cycles administered with palonosetron + aprepitant/fosaprepitant + dexamethasone had a lower risk for an uncontrolled CINV event versus other 5-HT(3) RAs + aprepitant/fosaprepitant + dexamethasone.

Chemotherapy-induced nausea and vomiting and antiemetic prophylaxis with palonosetron versus other 5-HT3 receptor antagonists in patients with cancer treated with low emetogenic chemotherapy in a hospital outpatient setting in the United States.

BACKGROUND: The incidence of overall (acute and delayed) chemotherapy-induced nausea and vomiting (CINV) events among patients treated with single- and multi-day low emetogenic chemotherapy (LEC) is not well established. We studied a cohort of patients receiving LEC and antiemetic prophylaxis with palonosetron (Group 1) versus other 5-HT(3) receptor antagonists (5-HT(3)-RAs) (Group 2), to determine the overall rate of CINV and the proportion of patients experiencing delayed CINV (days 2-7 of a CT cycle) in a hospital outpatient setting. METHODS: Patients aged ≥18 years with cancer diagnosis initiating single-day and multi-day LEC for the first time between 4/1/2007 and 3/31/2009 were identified from the Premier Perspective database. CINV events (ICD-9-CM codes for nausea, vomiting, or volume depletion or CINV-related rescue medications) were assessed descriptively. A generalized linear multivariate regression model was developed, estimating the overall CINV event rate among Group 1 and 2 patients in the follow-up period (first of eight chemotherapy [CT] cycles or 6 months). RESULTS: In the follow-up period, out of a total of 10,137 overall CINV events (single-day and multi-day LEC), 8783 events (86.6%) were identified in single-day LEC treated patients. Within single-day LEC treated events, in the first cycle, of 3184 events, 2996 (94.1%) events were delayed. Average number of delayed events per patient remained consistent throughout the eight cycles (3.1 [1st cycle] vs. 2.9 [8th cycle]; P = 0.842]). Among 2439 patients on antiemetic prophylaxis with a 5-HT(3)-RA, 10.1% (n = 247) initiated palonosetron. Regression analysis indicated that Group 1 patients (versus Group 2) had a 15.2% reduction in CINV event rate per CT cycle; P = 0.0403. Study limitations include potential lack of generalizability, absence of data on certain confounders including alcohol consumption and prior history of motion sickness, potential underestimation of incidence of uncontrolled CINV, and inability to draw conclusions pertaining to cause and effect relationship. CONCLUSION: In this retrospective analysis, delayed CINV comprised a major proportion of overall CINV among cancer diagnosed patients on single-day LEC. Additionally, palonosetron prophylaxis was associated with a significantly lower overall CINV event rate versus other 5-HT(3)-RA prophylaxis in single- and multi-day LEC treatment.

Palonosetron versus other 5-HT(3) receptor antagonists for prevention of chemotherapy-induced nausea and vomiting in patients with cancer on chemotherapy in a hospital outpatient setting.

BACKGROUND: Despite favorable evidence from clinical trials for single-dose palonosetron versus other commercially available 5-HT(3)-receptor antagonists for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV), clinical comparative data are scarce from hospital outpatient settings, where these antiemetic agents are used in patients diagnosed with cancer who are receiving chemotherapy (CTH). OBJECTIVE: The purpose of our retrospective study was to assess the hospital claims to evaluate the rate of uncontrolled CINV with antiemetic prophylaxis using palonosetron versus other 5-HT(3)-receptor antagonists in patients diagnosed with cancer who are receiving CTH (highly emetogenic CTH, moderately emetogenic CTH, low-emetogenic CTH, or minimally emetogenic CTH) treatment in a hospital outpatient setting. METHODS: Patients aged ≥18 years who had cancer and were being treated with CTH and antiemetic prophylaxis with palonosetron (Group 1) and other 5-HT(3) receptor antagonists (Group 2) for the first time between April 1, 2007, and March 31, 2009, were identified using a hospital-service database. Within each CTH cycle, CINV events were identified through International Classification of Diseases (ICD)-9 codes for nausea, vomiting, and/or volume depletion (from Day 1 of each CTH administration until the end of the CTH cycle) or for use of rescue medications (Day 2 until the end of the CTH cycle). A multivariate regression model was developed to predict uncontrolled CINV event rates per CTH cycle between Groups 1 and 2 matched on CTH emetogenicity distribution in the study follow-up period (first of 8 cycles or 6 months). A subgroup analysis of patients on CTH with the highest risk of nausea and vomiting (highly emetogenic CTH or moderately emetogenic CTH) was also conducted. RESULTS: Of 9144 identified patients, 1775 were prescribed palonosetron (Group 1). Group 1 patients were statistically younger (61.2 vs 62.8 years; P < 0.001), composed of more females (57.1% vs 51.9%; P < 0.001) and more whites (72.8% vs 71.4%; all races P < 0.001), received more highly emetogenic CTH treatments (43.3% vs 28.5%; all CTH P < 0.001), and had more lung (26.1% vs 22.4%) and breast cancer patients (19.3% vs 15.3%; all cancer P < 0.001). The regression model predicted a 13.7% decrease in CINV event rate per CTH cycle for Group 1 versus Group 2. For Subgroup 1, the model predicted a 12.5% decrease in the CINV event rate per cycle in Group 1 patients versus those in Group 2. CONCLUSIONS: In this study, patients with cancer who were treated with CTH and on antiemetic prophylaxis using palonosetron were found to have significantly lower CINV event rates than those receiving other 5-HT(3) receptor antagonists.

Palonosetron versus other 5-HT3 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies treated with emetogenic chemotherapy in a hospital outpatient setting in the United States.

OBJECTIVE: This study evaluated the rate of uncontrolled chemotherapy-induced nausea and vomiting (CINV) after initiating antiemetic prophylaxis with palonosetron versus other 5-HT3 receptor antagonists (RAs) in patients diagnosed with hematologic malignancies (lymphoma and leukemia) and receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in a hospital outpatient setting. METHODS: Patients aged ≥ 18 years and diagnosed with hematologic malignancies initiating HEC or MEC and antiemetic prophylaxis with palonosetron (Group 1) and other 5-HT3 RAs (Group 2) for the first time in a hospital outpatient setting between 4/1/2007 and 3/31/2009 were identified from the Premier Perspective Database. Within each cycle, CINV events were identified (in the hospital outpatient, inpatient, and emergency room settings) through ICD-9 codes for nausea, vomiting, and/or volume depletion (from each CT administration day 1 until the end of the CT cycle), or use of rescue medications (day 2 until the end of the CT cycle). Negative binomial distribution generalized linear multivariate regression model estimating the CINV event rate on CT, specific CT cycles, and cancer diagnosis (leukemia/lymphoma)-matched groups in the follow-up period (first of 8 cycles or 6 months) was developed. RESULTS: Of 971 identified patients, 211 initiated palonosetron (Group 1). Group 1 patients comprised of more females [50.2 vs. 41.4%; p = 0.0226], Whites [74.4 vs. 70.4%, and Hispanics [7.6 vs. 6.3%; all races p = 0.0105], received more HEC treatments [89.6 vs. 84.2%; all CT types p = 0.0129], and had more lymphoma diagnosed patients [89.6 vs. 76.3%; all cancer types p = 0.0033] at baseline. After controlling for differences in several demographic and clinical variables, the regression model predicted a 20.4% decrease in CINV event rate per CT cycle for Group 1 versus Group 2 patients. Study limitations include potential lack of generalizability, absence of data on certain confounders including alcohol consumption and prior history of motion sickness, potential underestimation of incidence of uncontrolled CINV, and inability to draw conclusions pertaining to cause and effect relationship. CONCLUSION: In this retrospective hospital study, patients with hematologic malignancies treated with HEC or MEC and initiated on antiemetic prophylaxis with palonosetron in the hospital outpatient setting were more likely to experience significantly lower CINV event rates (in the hospital outpatient, inpatient, and emergency room settings) versus patients initiated on other 5-HT3 RAs.

Likelihood of a subsequent chemotherapy-induced nausea and vomiting (CINV) event in patients receiving low, moderately or highly emetogenic chemotherapy (LEC/MEC/HEC).

OBJECTIVE: To assess the likelihood of subsequent chemotherapy-induced nausea and vomiting (CINV) events following a first chemotherapy administration CINV event in patients receiving single-day low, moderately, or highly emetogenic chemotherapy (LEC, MEC, or HEC). METHODS: A retrospective analysis was conducted utilizing Georgia Cancer Specialists, Florida Cancer Specialists, and ACORN electronic medical records databases (April 2006 through July 2009). Patients were included who received more than one single-day LEC, MEC, or HEC administration (oral or intravenous) with no chemotherapy 3 months prior to the first LEC, MEC, or HEC administration. Two cohorts, patients with a first administration CINV and no first administration CINV, were created and followed for 6 months. A multivariate logistic regression assessed the likelihood of subsequent CINV, controlling for age, gender, Charlson comorbidity index, cancer type, number of chemotherapy administrations, gap between LEC, MEC, or HEC administrations, and number of different LEC, MEC, or HEC agents administered. RESULTS: A total of 10,586 patients met the inclusion criteria (LEC = 3099; MEC = 5172; HEC = 2315). Of those patients, 4.4% (n = 136), 7.8% (n = 402), and 13.8% (n = 320) experienced a CINV event with their initial single-day LEC, MEC, or HEC administration, respectively. The unadjusted subsequent CINV rate was higher in the cohorts with first LEC, MEC, or HEC administration CINV for all groups receiving LEC (33.1% vs. 16.0%; p < 0.0001), MEC (46.5% vs. 18.9%; p < 0.0001), or HEC (59.1% vs. 26.9%; p < 0.0001). After controlling for covariates, patients with first LEC, MEC, or HEC administration CINV were 3.1, 3.8, and 3.7 times more likely to have a subsequent CINV compared to patients without a first LEC, MEC, or HEC administration CINV (Odds Ratio: 3.05 [95% CI: 2.08-4.48, p < 0.0001]; 3.77 [95% CI: 3.04-4.68, p < 0.0001]; and 3.70 [95% CI: 2.88-4.74, p < 0.0001], respectively). CONCLUSION: In this retrospective analysis, patients receiving single-day LEC, MEC, or HEC who had a prior CINV were at increased risk of subsequent CINV. Further studies assessing increased risk of a subsequent CINV events are warranted given this study represents an assessment of electronic medical record data within select community-based populations under usual care.

Clinical and economic burden of chemotherapy-induced nausea and vomiting among patients with cancer in a hospital outpatient setting in the United States.

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.

Impact of fixed-dose and multi-pill combination dyslipidemia therapies on medication adherence and the economic burden of sub-optimal adherence.

OBJECTIVE: To compare medication adherence between patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies and assess the association between optimal adherence (MPR > or = 80%) and cardiovascular disease (CVD)-associated total healthcare resource utilization (THR) and costs (THC). RESEARCH DESIGN AND METHODS: The HealthCore Integrated Research Database was used to identify patients > or =18 years newly initiating fixed-dose combination [niacin extended-release (NER) and lovastatin (NERL)] or multi-pill combination therapies [NER and simvastatin (NER/S) or lovastatin (NER/L)] between 1/1/2000 and 6/30/2006 (index date), with minimum 18 months of follow-up. Adherence was measured using medication possession ratio (MPR). Three multivariate models were developed controlling for demographic and clinical characteristics. A logistic model evaluated the association between study cohorts and optimal adherence, while negative binomial and gamma models estimated the association between optimal adherence and CVD-associated THR and THC, respectively. RESULTS: In all, 6638 NERL, 1687 NER/S, and 663 NER/L patients were identified. Fixed-dose combination patients were younger [mean (SD) ages of 51.9 (10.5) vs. 56.0 (9.4) [NER/S] and 56.1 (10.6) [NER/L]; p < 0.01], had lower comorbidity (Deyo-Charlson Index 0.50 +/- 0.9 vs. 0.7 +/- 1.1 and 0.6 +/- 1.1, p < 0.01 and p < 0.05) and comprised fewer males (73.1 vs. 83.0% and 77.7%; p < 0.01 and p = 0.1). Fixed-dose combination patients had higher average 1-year MPR versus NER/S and NER/L patients (0.54 +/- 0.35 vs. 0.50 +/- 0.35 and 0.47 +/- 0.34, p < 0.01). NER/S and NER/L patients were 31.3% (95% CI: 22.9-39.5%) and 39.1% (95% CI: 26.7-49.4%) less likely to be optimally adherent than fixed-dose combination patients (p < 0.01). Additionally, optimally adherent patients had 8% and 40% decreases in annual CVD-attributable THR [0.920 (95% CI: 0.857-0.989); p = 0.023] and THC [0.601 (95% CI: 0.427-0.845); p = 0.003] versus sub-optimally adherent patients. Key limitations of the study include the limited ability of MPR to analyze the continuity of medication usage, inability to capture data on other key variables including race, income, and clinical characteristics such as smoking history, absence of laboratory values on all study patients, inability to capture over-the-counter fills of niacin, and inability to show causality of results obtained. CONCLUSIONS: Adherence was significantly higher among patients initiating fixed-dose combination versus multi-pill combination dyslipidemia therapies in this managed-care population. Additionally, patients with optimal adherence had a significantly lower CVD-associated THR and THC versus patients with sub-optimal adherence.