Clinical and economic burden of intravenous paclitaxel or nab-paclitaxel for metastatic breast cancer.

BACKGROUND: Intravenous (IV) taxane therapy for metastatic breast cancer (mBC) has been associated with toxicities and demanding dosing schedules, which can limit treatment effectiveness. OBJECTIVES: To assess treatment patterns, toxicities, and costs in women with mBC initiating IV paclitaxel or IV nab-paclitaxel. METHODS: Adult women diagnosed with BC from January 1, 2014, to September 30, 2018, were identified in the MarketScan Commercial and MarketScan Medicare Supplemental databases. Women had a metastatic disease diagnosis and newly initiated treatment with IV paclitaxel/nab-paclitaxel (first administration date was considered the index date), and continuous enrollment for at least 12 months prior to and at least 3 months following the index date. Treatment discontinuation, dose reductions, toxicities, and health care utilization and costs per patient per month (PPPM) were assessed over the full follow-up and the index line of IV paclitaxel/nab-paclitaxel therapy (Index LOT). RESULTS: The sample included 8890 women aged 54.6 (±10.9) years, followed for 18.9 (±13.5) months. Most (82.0%) initiated IV paclitaxel/nab-paclitaxel monotherapy; 83.1% had early discontinuation (<18 weeks of treatment) of the Index LOT. Among the 6943 women eligible for the dose-change analysis, 42.4% evidenced an IV paclitaxel/nab-paclitaxel dose reduction ≥10% during the Index LOT. The most common toxicities during the Index LOT were gastrointestinal upset (30.5%), myelotoxicity (27.0%), infection (26.2%), general symptoms (25.9%), and chemotherapy-induced peripheral neuropathy (22.7%). Over follow-up, 39.7% of women had an inpatient admission and 43.0% had an emergency department visit. The mean of all-cause total costs was $11,991 PPPM, while BC-related total costs were $5320 PPPM. CONCLUSIONS: Many mBC patients initiating IV paclitaxel/nab-paclitaxel experienced dose reductions, toxicities, and/or early discontinuation of the Index LOT, which may limit treatment effectiveness. More tolerable treatments with reduced dosing complexity could improve mBC treatment and help contain costs.

Chemotherapy-induced peripheral neuropathy in metastatic breast cancer patients initiating intravenous paclitaxel/nab-paclitaxel.

BACKGROUND: Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes. OBJECTIVE: To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel. METHODS: Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score-matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up. RESULTS: Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC-related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01). CONCLUSIONS: CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

Cost of home vs clinic administration of paclitaxel in metastatic breast cancer.

OBJECTIVES: To estimate the costs associated with home administration of oral paclitaxel and encequidar (novel P-glycoprotein pump inhibitor allowing oral paclitaxel bioavailability) compared with clinic/office administration of intravenous (IV) paclitaxel (175 mg/m2) and protein-bound paclitaxel in US patients with metastatic breast cancer. STUDY DESIGN: Economic analysis. METHODS: A cost calculator was constructed from a payer's perspective including all costs related to administration of the chemotherapies, including drug administration, premedications and concomitant medications, oncologist office visits, laboratory testing, and administration-related adverse events. Total administration cost per patient per month (PPPM) and 6-month costs per patient were estimated for oral paclitaxel and encequidar, 175 mg/m2 IV paclitaxel, and protein-bound paclitaxel. Three scenarios for oral paclitaxel and encequidar, a weekly IV paclitaxel scenario (80-100 mg/m2), and univariate sensitivity analyses were conducted. RESULTS: Home administration of oral paclitaxel and encequidar was associated with a total administration cost of $523 PPPM, 64.4% lower than once-every-3-weeks IV paclitaxel (175 mg/m2; $1469 PPPM) and 63.8% lower than protein-bound paclitaxel (260 mg/m2; $1445 PPPM). Difference in costs was driven largely by higher administration and premedication costs associated with IV therapies. Scenario analyses showed that increased clinical experience with home administration of oral paclitaxel and encequidar was associated with reduction in cost of care associated with its administration over time. For the weekly IV (80-100 mg/m2) paclitaxel scenario, the total administration cost was $2510 PPPM (4.8 times higher than for oral paclitaxel and encequidar). Univariate sensitivity analysis demonstrated that the model findings were robust. CONCLUSIONS: Home administration of oral paclitaxel and encequidar was associated with lower administration costs compared with once-every-3-weeks IV paclitaxel (175 mg/m2) and protein-bound paclitaxel, resulting in potential cost savings for payers.

Survey of hospitals for guidelines, policies, and protocols for anticoagulants.

PURPOSE: A survey of community hospitals that are part of a national group purchasing organization (GPO) was conducted to assess the formulary status of currently available anticoagulants, assess the current status of anticoagulant prescribing guidelines and the existing scope of such guidelines, and identify perceptions about the appropriateness of the use of anticoagulants in community hospitals in the United States. METHODS: A Web-based survey of acute care hospitals that were members of a leading health care resource management and GPO was conducted. The survey was sent to 224 hospitals. RESULTS: Of 224 hospitals, 127 participated in the survey, a response rate of 59.6%. Warfarin, unfractionated heparin (UFH), and enoxaparin were the anticoagulants most commonly included (>80%) on the hospitals' drug formularies. Guidelines relating to the use of UFH and low-molecular-weight heparins (LMWHs) existed in approximately 87.4% and 55.1% of responding hospitals, respectively, followed by warfarin and direct thrombin inhibitors (DTIs) (approximately 44.1% and 30.7%, respectively). Among hospitals without guidelines, 78.2%, 72.1%, 65.4%, 50.0%, and 41.4% reported that such guidelines would be useful if they included LMWHs, warfarin, DTIs, UFH, and fondaparinux, respectively. Guidelines for prophylaxis of venous thromboembolism (VTE), appropriate drug selection, and dosing for VTE prophylaxis and treatment existed in 59.8%, 53.5%, and 43.3% of the hospitals, respectively. CONCLUSION: The study found that a sizable percentage of the responding community hospitals did not have guidelines, protocols, or policies related to the use of anticoagulants. Further, those hospitals without such guidelines commonly reported a need for clinical practice guidelines.

Association between hospital size and pharmacy department productivity.

PURPOSE: The purposes of this study were to characterize and quantify workload and productivity in hospitals according to their size, to establish comparative statistics useful for pharmacy administrators as a means to contrast their efficiency to that of other hospitals of similar sizes, and to provide data to enable policymakers to better assess staffing and resource needs. METHODS: A 50-item Web-based survey designed to illicit information about pharmacy department staffing, workload, and productivity was sent electronically to 242 members of Consorta, Inc., a group-purchasing organization. Responses were received from 110 organizations, a response rate of 45.5%. The responses were categorized into three groups according to the number of staffed beds and were profiled and compared using descriptive and inferential statistics. RESULTS: Pharmacy department workload and expenditures were primarily a function of hospital size: Hospital volume statistics, pharmacy expenditures, hours of operation, pharmacy full-time equivalents (FTEs), and dispensing workload all are highly dependent on the size of the facility. The range of clinical services provided by small, medium, and large hospitals did not differ with the exception of a few services provided more often in larger hospitals. Overall productivity ratios demonstrated greater efficiency among larger hospitals. In terms of costs, pharmacy and hospital expenditures per occupied bed and per admission generally decreased as hospital size increased. CONCLUSION: Results of a survey suggested consistency in clinical services provided by hospitals of varying size and increased productivity with increasing hospital size. Respondents employed fewer FTEs than those in other national surveys.

Hospital policies for treatment of acute decompensated heart failure.

BACKGROUND: It is unclear to what extent hospitals use guidelines or protocols in treating acute decompensated heart failure (ADHF) and whether nesiritide is included in these guidelines or protocols. OBJECTIVE: To assess the formulary status of currently used drugs, therapeutic guidelines, and perceptions about the appropriateness of treatment of ADHF in community hospitals. METHODS: A Web-based survey of pharmacy directors at community hospitals that were part of a national group purchasing organization was conducted. RESULTS: One hundred seven hospitals participated in the survey (response rate 47.1%). Diuretics such as furosemide and bumetanide were more commonly included (100% and 94.4%, respectively) on hospital formularies than was torsemide (69.2%). Dopamine and dobutamine were more common (94.4% each) on the formulary than was milrinone (68.2%). Nitroprusside and nitroglycerin were listed on the formularies of more than 90% of participating institutions, while nesiritide was listed on the formularies in only 48.6% of hospitals and was placed on restricted status in 36.4% of hospitals. Guidelines for care of patients with ADHF were used in the emergency department (ED), inpatient care units, and outpatient clinics in 18.6%, 43.0%, and 8.5% of hospitals, respectively. Overall, ADHF care, including general treatment as well as specific use of nesiritide, was deemed appropriate in the majority of patients, but nearly twice as many respondents perceived the management of ADHF and specific use of nesiritide as inappropriate in the ED compared with inpatient treatment. Only 41.1% of the respondents reported following Braunwald recommendations for the use of nesiritide. CONCLUSIONS: A sizable percentage of responding community hospitals do not have guidelines for treatment of ADHF despite the existence of such guidelines in the literature. There are opportunities for improvement in the general treatment of ADHF as well as for the use of nesiritide in ADHF, especially in the ED or observation unit versus inpatient units.

Monitoring of pharmacy staffing, workload, and productivity in community hospitals.

PURPOSE: The purpose of this survey was to identify and characterize pharmacy productivity monitoring systems used in community hospitals that were part of a national group purchasing organization (GPO). METHODS: A 50-item questionnaire was developed, pretested, and sent electronically to the directors of pharmacy at 242 member hospitals of Consorta, Inc., a national GPO. The questionnaire was designed to elicit information on (1) hospital pharmacy demographics, (2) systems used to measure hospital pharmacy productivity, and (3) staffing levels and workload. Hospital demographic data were also obtained for respondent and nonrespondent hospitals from the American Hospital Association's AHA Guide. Descriptive statistics, Student's t tests, and chi-square tests were used to characterize the data and compare respondents with nonrespondents. RESULTS: Responses were received from 110 hospitals (45.5%). No clinically significant differences were found when respondent and nonrespondent hospitals were compared based on AHA Guide data. The productivity workload ratios monitored most often by respondent hospitals were full-time equivalents (FTEs) per adjusted patient day, FTEs per dose dispensed, and FTEs per dose billed. Respondents reported a mean +/- S.D. of 21.90 +/- 18.83 actual FTEs and total doses dispensed, billed, or administered per year of 111,391.4 +/- 111,538.0. A major limitation of the productivity systems used in the hospitals was the inability of the systems to account for clinical services performed by the pharmacy staff. CONCLUSION: A survey of community hospitals indicated that although most engaged in productivity monitoring, systems for such measurement often failed to capture all relevant clinical workload data.