Real-world clinical outcomes and healthcare costs in patients with Crohn's disease treated with vedolizumab versus ustekinumab in the United States.

OBJECTIVE: To compare real-world treatment persistence, dose escalation, rates of opportunistic or serious infections, and healthcare costs in patients with Crohn's disease (CD) receiving vedolizumab (VDZ) vs ustekinumab (UST) in the United States. METHODS: A retrospective observational study in adults with CD initiated on VDZ or UST on/after 26 September 2016, was performed using the IBM Truven Health MarketScan databases (1 January 2009-30 September 2018). Rates of treatment persistence, dose escalation, opportunistic or serious infection-related encounters, and healthcare costs per patient per month (PPPM) were evaluated. Entropy balancing was used to balance patient characteristics between cohorts. Event rates were assessed using weighted Kaplan-Meier analyses and compared between cohorts using log-rank tests. Healthcare costs were compared between cohorts using weighted 2-part models. RESULTS: 589 VDZ and 599 UST patients were included (172 [29.2%] and 117 [19.5%] were bio-naïve, respectively). After weighting, baseline characteristics were comparable between cohorts. No significant difference in rates of treatment persistence (12-month: VDZ, 76.5%; UST, 82.1%; p = .17), dose escalation (12-month: VDZ, 29.3%; UST, 32.7%; p = .97), or opportunistic or serious infection-related encounters were observed between VDZ and UST. Total mean healthcare costs were significantly lower for patients treated with VDZ vs UST (mean cost difference = -$5051 PPPM; p < .01). Findings were consistent in bio-naïve patients. CONCLUSIONS: In this real-world study, similar treatment persistence, dose escalation, and rates of opportunistic or serious infections were observed with VDZ- and UST-treated patients with CD. However, VDZ was associated with a significantly lower cost outlay for healthcare systems.

Crohn's disease (CD) causes inflammation in the digestive system. Vedolizumab (VDZ) and ustekinumab (UST) are therapies for patients with CD. Little is known about the clinical outcomes and healthcare costs of VDZ versus UST in the real world in the United States. We used health claims data and found that VDZ and UST had comparable real-world clinical outcomes. After 12 months of treatment, the proportions of patients with CD who stayed on treatment and those who needed to increase therapy dose were similar with VDZ and UST. The rate of infection was also similar between the two groups of patients. However, the monthly healthcare costs were $5051 less for patients treated with VDZ than with UST. This was mainly due to the lower cost of VDZ, which was almost half of that of UST. The lower treatment costs with VDZ may provide substantial savings for the healthcare system and patients specifically. Future cost-effectiveness studies on VDZ and UST are needed to aid treatment selection for patients with CD.

Clinical and cost outcomes of pre-emptive plerixafor administration in patients with multiple myeloma undergoing stem cell mobilization.

PURPOSE: The stem cell mobilization agent plerixafor significantly improves CD34+ stem cell procurement in patients with multiple myeloma undergoing autologous stem cell transplant. We compared mobilization success rates and costs of two regimens of plerixafor administration: pre-emptive (P-PL, initiated the evening prior to the first day of stem cell collection) and standard (S-PL, initiated the evening prior to the second day of stem cell collection in the event of inadequate collection on the first day). METHODS: Patients with multiple myeloma undergoing mobilization were categorized as either P-PL or S-PL. Stem cell collection success was evaluated using logistic regression models. Associated costs were aggregated in terms of average collections per patient in each mobilization option (patient level), and escalated to a panel of 5000 patients (population level). RESULTS: 299 patients were evaluable; 241 received P-PL and 58 received S-PL. Patients receiving P-PL had higher median CD34+ count pre-collection and higher median total CD34+ cell harvest on the first collection (6.75 × 106/kg for P-PL, 1.96 × 106/kg for S-PL; P<0.01). In multivariable analyses, P-PL remained significantly associated with the ability to collect ≥2 × 106/kg CD34+ on the first day (OR = 4.05, 95% CI, 1.19-13.83, P = 0.03) and ≥5 × 106/kg CD34+ in total (OR = 3.09, 95% CI, 1.04-9.23, P = 0.04). P-PL saved $11,248 (46%) per patient compared with S-PL. CONCLUSION: P-PL significantly enhanced collection efficiency, with most patients completing collection in 1 day, resulting in substantial cost savings.

Preparation of smart and reversible wettability cellulose fabrics for oil/water separation using a facile and economical method.

Successful fabrication of smart membrane based on cellulose fabric for controllable oil/water separation was reported. Sheet hexagonal ZnO was in situ synthesized on surface of cellulose fibers using NaOH/urea and ZnCl2 aqueous solution which were also exploited to fix ZnO steadily due to their swelling and dissolving effects on cellulose. Reversible wettability transition between superhydrophobicity/superoleophilicity and superhydrophilicity/superoleophobicity underwater was manipulated easily by dipping into a lauric acid ethanol solution and NaOH/ethanol water solution in turn for 2min. In detail, the as-prepared functionalized membranes can separate weight or light oil/water mixtures with separation efficiency higher than 98% of water removing and 96.5% of oil removing and high oil flux of 2900-3200 L h-2 m-2 and water flux of 3100-3400 L h-2 m-2. Simultaneously, the modified fabrics exhibited good stability and excellent recyclability via 20 times cycle operations of wettability transition and separation.

COMPARING CLINICAL OUTCOMES AND COSTS FOR DIFFERENT TREATMENT INTENSIFICATION APPROACHES IN PATIENTS WITH TYPE 2 DIABETES UNCONTROLLED ON BASAL INSULIN: ADDING GLUCAGON-LIKE PEPTIDE 1 RECEPTOR AGONISTS VERSUS ADDING RAPID-ACTING INSULIN OR INCREASING BASAL INSULIN DOSE.

OBJECTIVE: Not all patients with type 2 diabetes achieve recommended glycated hemoglobin A1c (A1C) levels after adequate titration of basal insulin (BI). Current intensification approaches include addition of rapid-acting insulin (RAI) or a glucagon-like peptide 1 receptor agonist (GLP-1 RA), but it is not clear which strategy results in better long-term outcomes. METHODS: This retrospective analysis of health insurance claims data in the U.S. MarketScan database compared glycemic control and healthcare resource utilization and costs 12 months after adding a GLP-1 RA to BI versus adding a RAI or increasing BI doses. Propensity score matching was used in the comparative effectiveness analysis. RESULTS: A total of 8,034 patients underwent treatment intensification within 6 months of showing poor glycemic control; 4,134 patients had their BI dose adjusted, and 2,076 and 331 received RAI and GLP-1 RA, respectively. A1C changes were similar for the GLP-1 RA and RAI cohorts but higher for the GLP-1 RA versus the dose-adjustment group. The hypoglycemia rate was lower after adding GLP-1 RA versus RAI or increasing BI dose. No overall changes in utilization of healthcare resources or diabetes-related costs were observed between intensification strategies, although prescription costs were higher for the GLP-1 RA cohort. CONCLUSION: BI in combination with GLP-1 RAs appears to be an effective intensification strategy, further reducing A1C levels and hypoglycemia frequency compared to increasing BI doses. GLP-1 RA addition also decreases hypoglycemia frequency versus BI dose increases and RAI addition, without raising overall healthcare costs. ABBREVIATIONS: A1C = hemoglobin A1c; BI = basal insulin; CAD = coronary artery disease; ED = emergency department; FPG = fasting plasma glucose; GLP-1 RA = glucagon-like peptide 1 receptor agonist; ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification; NPH = neutral protamine Hagedorn; OAD = oral antidiabetes drug; PSM = propensity score matching; RAI = rapid-acting insulin; T2D = type 2 diabetes.

Persistence with rapid-acting insulin and its association with A1C level and severe hypoglycemia among elderly patients with type 2 diabetes.

OBJECTIVE: To examine the persistence with rapid-acting insulin (RAI) and its association with clinical outcomes among elderly patients with type 2 diabetes (T2D). METHODS: This observational, retrospective cohort study analyzed RAI persistence and its association with change in glycated hemoglobin A1c and risk of severe hypoglycemia among elderly (≥65 years) Medicare beneficiaries with T2D who added RAI to their basal insulin regimen. RESULTS: Among T2D patients with >1 RAI prescriptions (n = 3927), only 21% were persistent. Baseline factors positively associated with RAI persistence (adjusted odds ratio [95% CI]) were: age ≥75 vs. 65-74 years: 1.20 (1.01-1.43); use of ≥3 oral antidiabetes drugs: 1.63 (1.16-2.28); cognitive impairment: 1.34 (1.03-1.73); and A1C >9.0%: 1.58 (1.15-2.17). Elderly T2D patients having emergency department visits (0.73 [0.59-0.91]) and higher RAI out-of-pocket costs (≥$75 vs. $0 - <$6.40: 0.56 [0.44-0.70]) were less likely to be persistent. Persistent RAI users had a significantly higher reduction in A1C (beta coefficient [standard error]): -0.24 (0.10) and lower odds of severe hypoglycemia (adjusted odds ratio [95% CI]): 0.73 (0.53-0.99). CONCLUSION: Among elderly T2D patients, persistence with RAI added to basal insulin was associated with improved glycemic control and lower risk of severe hypoglycemia. Despite treatment effectiveness, RAI persistence was poor and might be improved by reducing RAI out-of-pocket costs.

Rapid Acting Insulin Use and Persistence among Elderly Type 2 Diabetes Patients Adding RAI to Oral Antidiabetes Drug Regimens.

We examined the real-world utilization and persistence of rapid acting insulin (RAI) in elderly patients with type 2 diabetes who added RAI to their drug (OAD) regimen. Insulin-naïve patients aged ≥65 years, with ≥1 OAD prescription during the baseline period, who were continuously enrolled in the US Humana Medicare Advantage insurance plan for 18 months and initiated RAI were included. Among patients with ≥2 RAI prescriptions (RAIp), persistence during the 12-month follow-up was assessed. Multivariate logistic regression analyses identified factors affecting RAI use and persistence. Of 3734 patients adding RAI to their OAD regimen, 2334 (62.5%) had a RAIp during follow-up. Factors associated with RAIp included using ≤2 OADs; cognitive impairment, basal insulin use during follow-up; and higher RAI out-of-pocket costs ($36 to <$56 versus $0 to $6.30). Patients were less likely to persist with RAI when on ≤2 OADs versus ≥3 OADs and when having higher RAI out-of-pocket costs ($36 to <$56 versus $0 to $6.30) and more likely to persist when they had cognitive impairment and basal insulin use during follow-up. Real-world persistence of RAI in insulin-naïve elderly patients with type 2 diabetes was very poor when RAI was added to an OAD regimen.

Relationship between disease severity and quality of life and assessment of health care utilization and cost for ulcerative colitis in Australia: a cross-sectional, observational study.

BACKGROUND & AIMS: The burden of ulcerative colitis (UC) in relation to disease severity is not well documented. This study quantitatively evaluated the relationship between disease activity and quality of life (QoL), as well as health care utilization, cost, and work-related impairment associated with UC in an Australian population. METHODS: A cross-sectional, noninterventional, observational study was performed in patients with a wide range of disease severity recruited during routine specialist consultations. Evaluations included the Assessment of Quality of Life-8-dimension (AQoL-8D), EuroQol 5-dimension, 5-level (EQ-5D-5L), the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ), and the Work Productivity and Activity Impairment (WPAI) instrument. The 3-item Partial Mayo Score was used to assess disease severity. Health care resource utilization was assessed by chart review and patient questionnaires. RESULTS: In 175 patients, mean (SD) AQoL-8D and EQ-5D-5L scores were greater for patients in remission (0.80 [0.19] and 0.81 [0.18], respectively) than for patients with active disease (0.70 [0.20] and 0.72 [0.19], respectively, both Ps<0.001). IBDQ correlated with both AQoL-8D (r=0.73; P<0.0001) and EQ-5D-5L (0.69; P<0.0001). Mean 3-month UC-related health care cost per patient was AUD $2914 (SD=$3447 [mean for patients in remission=$1970; mild disease=$3736; moderate/severe disease=$4162]). Patients in remission had the least work and activity impairment. CONCLUSIONS: More severe UC disease was associated with poorer QoL. Substantial health care utilization, costs, and work productivity impairments were found in this sample of patients with UC. Moreover, greater disease activity was associated with greater health care costs and impairment in work productivity and daily activities.

Cost-Effectiveness of Infliximab for the Treatment of Acute Exacerbations of Ulcerative Colitis in the Netherlands.

INTRODUCTION: Infliximab is registered for the treatment of moderate-to-severe active ulcerative colitis (UC) adult patients who have had an inadequate response, or are intolerant, or have medical contraindications to therapy including corticosteroids and 5-aminosalicylates or thiopurines (6-mercaptopurine [6-MP] or azathioprine [AZA]). The authors estimate the costs and effects and evaluate the cost-effectiveness of infliximab at the licensed dose of 5 mg/kg versus cyclosporine or surgery for the treatment of adult Dutch patients hospitalized with acute exacerbations of UC, refractory to intravenous steroids. METHOD: An existing decision analytical model was updated to simulate disease progression of hospitalized UC patients in the Netherlands, refractory to intravenous corticosteroids, and to estimate the costs and benefits associated with infliximab compared to cyclosporine and surgery over a 1-year time horizon. Colectomy rates were derived from infliximab and cyclosporine randomized trials and synthesized using multiple treatment comparison methods. The utility estimates associated with health states of ulcerative colitis patients were obtained from the literature. Resource use and drug use frequencies as well as unit costs were obtained from Dutch sources. The primary effectiveness measure used in the analysis was quality-adjusted life years (QALYs). RESULTS: For a typical UC patient with body weight of 70 kg, the costs of treatment with infliximab, cyclosporine, and surgery over a 1-year treatment period were €17,062, €14,784, €13,979, respectively. The associated numbers of QALYs were 0.80, 0.70, and 0.58 for infliximab, cyclosporine, and surgery respectively. The incremental cost-effectiveness ratio for infliximab was €24,277 per QALY gained compared to cyclosporine, and €14,639 per QALY gained compared to surgery. CONCLUSIONS: Infliximab induction regimen appears to be a cost-effective treatment option in comparison to cyclosporine and surgery for hospitalized patients with acute exacerbations of UC, refractory to intravenous corticosteroids in the Netherlands.

Patient characteristics and prescription fill patterns for allergic rhinitis medications, with a focus on montelukast, in a commercially insured population.

BACKGROUND: Allergic rhinitis (AR), also known as hay fever, is caused by an overreaction of the immune system to airborne allergens. AR is a substantial cause of widespread morbidity, medical treatment costs, and reduced productivity at work and school. OBJECTIVE: The goal of this research was to describe patient characteristics and prescription fill patterns for patients with AR and to determine those factors associated with the use of montelukast in a large population of commercially insured patients who sought medical treatment for AR. METHODS: This was a retrospective cohort study using administrative claims data from a commercially available database. Patients, aged 4 to 64 years, with >or=3 years' continuous enrollment and >or=1 medical claim for AR between January 1, 2004, and December 31, 2006, were included. Patients with a concomitant asthma diagnosis were excluded. Patients' demographic and clinical characteristics, comorbidities, health care resource utilization, AR-related medication use, and AR-related physician office visits were assessed for 12 months before the first AR medication fill (index) in 2006. Stepwise logistic regression was used to identify factors predicting the initiation of montelukast therapy for the treatment of AR in 2006. RESULTS: The study population consisted of 75,140 children (mean [SD] age, 10.6 [4.0] years) and 226,236 adults (mean age, 43.8 [11.8] years). Slightly more than half (52.4%) of the pediatric population was male compared with 44.7% of the adult population. Fifty percent of patients had no pharmacy fills for an AR medication in 2006. Among patients with AR pharmacy fills (n = 150,751), 78.1% had a single index medication fill (montelukast represented 4.5%) and 21.9% were prescribed multiple index medications. Children with AR were more likely to fill a prescription for montelukast (n = 7513) if they were 4 to 11 years of age; male; diagnosed with cough/wheeze; and had 1 or 2 oral corticosteroid fills, >or=3 antibiotic fills, and AR-related physician office visits in the prior 12 months (all, P < 0.001). Prescription fills for montelukast among adult patients with AR were significantly (P < 0.001) associated with other respiratory/atopic conditions; prior fills for antihistamines, oral corticosteroids, or intranasal corticosteroids; and AR-related physician office visits in the prior 12 months. Children and adults with health plans based in the midwestern or southern region of the United States had greater odds of initiating montelukast than those with plans based in the western region (P < 0.001). CONCLUSIONS: Half of the patients identified with AR did not fill a prescription for an AR medication. Among those patients with AR-related prescription drug fills, most were prescribed a single index pharmacotherapy and did not receive additional AR medications within 30 days of the index date. The use of montelukast was limited and was more commonly prescribed to children and adults with AR whose condition was not controlled with other AR medications.

Estimation of resource utilization associated with osteoporotic hip fracture and level of post-acute care in China.

OBJECTIVE: Research suggests that the incidence and cost of treating osteoporotic hip fracture (OHF) in China is rising. The purpose of this study was to estimate resource utilization associated with OHF, including hospital length of stay (LOS) and inpatient costs, and to examine the level of post-acute care for osteoporosis among patients hospitalized for OHF in Shanghai, China. METHODS: This was a retrospective study of 2855 patients aged 50 years and older who were hospitalized for bone fragility hip fractures in 13 districts of Shanghai in the 2000. One hundred and one patients were randomly selected and interviewed to determine the treatments and associated costs for the 6-month period following hospitalization. Log linear regressions with bootstrapping resampling were conducted for LOS and hospital cost data to estimate the average LOS and associated costs after adjusting for demographic and comorbid characteristics. RESULTS: Hospital records of 2855 patients (mean age, 73.6 +/- 9.9 years) were reviewed. For women, mean LOS (35 days) was longer for those greater than 60 years of age; however, mean cost of hospital stay (15 082 RMB) increased to a peak at age 65-74 years (18 932 RMB). For men, mean LOS (34 days) and mean cost of hospitalization (13 149 RMB) both increased with age. Only 14% of patients hospitalized for OHF received treatment for osteoporosis. Due to the small number of patients and sampling that was taken largely for geographical convenience, care should be taken when generalizing these data into other areas of China. CONCLUSIONS: OHF is associated with substantial resource utilization in Shanghai, China. Although patients hospitalized with OHF should be considered for osteoporosis therapy to alleviate economic and patient burden, most patients with OHF received no such treatment.