519 Background: Upper gastrointestinal bleeding associated with esophagogastric varices (EGV) is a morbid and potentially deadly complication of advanced hepatocellular carcinoma (aHCC). However, the presence of EGV among the aHCC population receiving esophagogastroduodenoscopy (EGD) in the US is not well understood, nor are the predictors of EGV- or bleeding-related ER or hospitalization (the outcome) among those who are newly initiated on systemic treatment. Methods: A retrospective cohort analysis was conducted utilizing IQVIA’s PharMetrics Plus Health Plans Claims database (January 1, 2016, to July 31, 2021). Patients ≥18 years of age with ≥1 prescription for an aHCC systemic treatment were included; the date of the first prescription was the index date. At least 12 months of continuous enrollment pre-index and 6 months post-index (unless patients were deceased) were required. Patients with pre-index diagnosis codes for renal cell carcinoma, differentiated thyroid carcinoma, colorectal cancer, gastric cancer, non-small cell lung carcinoma, and liver transplant were excluded. Logistic regression was conducted to identify associations between baseline characteristics and the outcome. Results: A total of 904 patients with aHCC were included (mean age: 61.3 years; 75.3% male); 39.4% of patients died within 6 months following the index date. During the pre-index period, 688 (76.1%) patients had portal hypertension-related comorbidity, 327 (36.2%) had EGD, 122 (13.5%) had EGV, and 63 (7.0%) had bleeding. During the observational period, 458 (50.7%) patients received EGD, among whom 209 (45.6%) also had EGV. 141 (15.6%) patients had ≥1 outcome event during the post-index period. In the adjusted analysis, patients with pre-index bleeding and with EGV but no bleeding had 4.5- and 3.1-times higher odds of having post-index outcome, respectively, as compared with those lacking pre-index bleeding and EGV. Moreover, the pre-index presence of portal hypertension-related comorbidities was associated with 3.1 times greater odds of having a post-index outcome. Conclusions: EGV and bleeding events are common in patients with aHCC receiving systemic therapies. The EGV prevalence of 45.6% among those receiving EGD is consistent with prior similar studies outside of the US (Giannini EG, et al. Clin Gastroenterol and Hepatol. 2006; Iavarone M, et al. United European Gastroenterol J. 2016; Hsieh WY, et al. Sci Rep. 2017). The presence of bleeding, EGV, and portal hypertension-related comorbidities prior to treatment initiation were associated with the increased post-treatment risk of EGV- or bleeding-related ER or hospitalization in these patients. To our knowledge, this is the first study to assess and report the presence of EGV among those receiving EGD in a US aHCC population.
The study objective was to provide current patient-level paid cost estimates for complications among adult patients with Type 2 diabetes. Patients ages ≥18 with ≥1 claim for a diabetes-related complication were selected from the PharMetrics Health Plan Claims Database, a large U.S. claims database including medical and pharmacy claims for >75 million patients from 80 health plans, during 2009-2010. Patients were continuously-enrolled in the same health plan ≥12 months before and ≥24 months after the first complication claim and had a diagnosis of Type-2 DM prior to their first complication. Patients with gestational diabetes, missing cost, or Medicare Reimbursement or SCHIP coverage were excluded. Diabetes-related complications included cardiovascular events, gangrene, amputation, foot ulcer, renal disease, chronic kidney disease, eye disease and neuropathy. All direct costs in the 2-years following complications were inflated to 2011 dollars. There were 113,222 adult Type-2 DM patients identified with a mean age of 58 years and 53% male. The most frequent complications included neuropathy (27%), non-proliferative retinopathy (22%), renal disease (21%) and heart failure (14%). The most frequent treatments were oral antidiabetics (69%), antihyperlipidemics (62%), ACE-inhibitors (44%), insulins (34%) and antidepressants (29%). The mean (SD) total cost per patient was $38,849 ($71,253) [inpatient $14,086 ($45,290), outpatient $17,319 ($40,887), and pharmacy $7,443 ($12,152)]. Renal disease cost among those with renal disease averaged $20,908 ($80,294), foot ulcers costs among those with amputation/foot ulcers averaged $6,358 ($18,017) and heart failure costs among those with cardiovascular/cerebrovascular disease averaged $5,764 ($24,384). Patients with Type 2 DM exhibited substantial health care costs associated with medical complications. The most costly conditions are renal disease, foot ulcers/amputations and cardiovascular/cerebrovascular diseases.
BACKGROUND: Despite their long-term risks, corticosteroids are often used in the management of ulcerative colitis (UC) to help patients achieve and maintain disease remission. The aim of this study was to describe the frequency of high-level corticosteroid exposure and the association between this exposure and both clinical and economic outcomes. METHODS: This retrospective analysis used the IQVIA Real-World Data Adjudicated Claims—US database from January 1, 2006 to June 30, 2017. Patients aged ≥18 years with ≥2 medical claims for UC (ICD9:556.* or ICD10 K51.*) who initiated their first UC therapy (considered the “index” date) between July 1, 2006 and June 30, 2013 and had continuous enrollment 6 months prior to (pre-index) and 4 years after (post-index) this therapy were included. The first 3 years of the post-index window was the corticosteroid exposure observation period; the fourth (and last) year was the outcomes assessment period. Patients were categorized into one of 2 corticosteroid use cohorts: “frequent” (>30 days of continuous corticosteroid exposure in at least 2 of the 3 observation years) versus “infrequent” (all others). Cohorts were compared with respect to the incidence of clinical outcomes (known disease and corticosteroid-related sequelae including infections, osteoporosis etc.), healthcare resource utilization, and costs in the outcomes assessment period. Analyses included chi-square tests and 2-sample t tests. RESULTS: A total of 22,841 patients with UC were included (53.1% female; mean age = 45.2 years [SD = 11.5]). Among them, 4,098 (17.9%) patients met criteria for frequent corticosteroid use. Compared with patients in the infrequent cohort, patients in the frequent cohort were significantly more likely to be younger (28.0% vs 22.7% were 18–39 years), male (48.9% vs 46.5%), and had greater total pre-index costs ($17,294 vs $8,257) (all P < 0.05). Patients in the frequent cohort were significantly more likely to develop gastrointestinal conditions (e.g., ulcers, gastrointestinal bleeding; 87.5% vs 74.0%), infections (e.g., herpes zoster; 53.5% vs 44.3%), musculoskeletal conditions (e.g., osteoporosis; 59.7% vs 51.5%), and dermatologic conditions (e.g., acne, abdominal striae; 34.9% vs 29.8%) (all P < 0.05) during the subsequent outcomes assessment period compared with patients in the infrequent cohort. Patients in the frequent cohort were also more likely to experience a future emergency room visit (24.8% vs 17.9%), an inpatient hospitalization (16.9% vs 8.2%), longer average length of hospital stays (5.9 vs 5.4 days), and higher costs (pharmacy: $17,243 vs $7,939; outpatient: $9,998 vs $6,363; inpatient: $7,299 vs $2,769) compared with patients in the infrequent cohort (all P < 0.05). CONCLUSION(S): Frequent corticosteroid exposure was common among patients with UC and subsequently associated with an increased likelihood of adverse clinical outcomes and greater healthcare resource utilization, and costs.
e20544 Background: Multiple Myeloma (MM) is a hematologic malignancy with an estimated 5-year survival rate of just over 50%. Evolving paradigms arising from numerous FDA approvals continue to shape the treatment landscape for relapsed and refractory MM (RRMM) patients. As the number of approved drugs/regimens increases, the efficacy as well as toxicity profiles for the more heavily refractory patient change. The objective of this study was to evaluate adverse event rates and associated outcome patterns among RRMM patients treated with pomalidomide (poma) or daratumumab (dara). Methods: Adult patients with ≥1 claim of poma or dara (index) were identified between Jan 1, 2012 and Feb 28, 2018 using IQVIA’s Real-World Adjudicated US claims database. Patients were required to be continuously enrolled in the health plan ≥180 days prior and ≥360 days post index date, have a diagnosis or treatment claim for MM and a claim of any immunomodulatory drugs and proteasome inhibitors before index date. Mean time to new therapy and mean time to readmission were evaluated over the 1-year post-index period among RRMM patients. Overall survival (OS) was measured using Kaplan-Meier curves. Occurrences of adverse events (AEs) and mean length of stay for AE-related hospitalization were also reported. Results: There were 289 patients in the RRMM cohort with 67.8% of patients treated with combination therapy in the baseline period. Of index therapies, 81% of patients used poma and 40% used dara in post-index period. Overall, 42% of patients had a Charlson Comorbidity Score of ≥3. Among 258 patients with a new treatment post-index, mean (SD) time to a new treatment was 4.7(5.3) months. Median OS was 14.6 months. Post-index hematological AE were frequent such as anemia (72.0%), febrile neutropenia (52.6%), neutropenia (30.1%) and thrombocytopenia (36.0%, Table). Mean length of stay for AE-related hospitalizations was 10.1 days and mean time to readmission was 63.3 days. Conclusions: Low OS, high frequency of AEs and longer LOS for AE-related hospitalizations suggest that outcomes of these patients remain poor despite availability of newer treatment options. Further study is warranted to better manage the individual and system-wide toxicity in this clinical setting. [Table: see text]
Treatment adherence and persistence are essential to achieving therapeutic goals in diabetes and may be improved by patient support programs (PSPs). The COACH Program was launched in 2015 with the goal of supporting patients with diabetes who are prescribed insulin glargine 300 U/mL (Gla-300). The study objective was to assess the program's impact on persistence and adherence with therapy among patients with type 2 diabetes.A retrospective 12-month analysis was conducted to compare treatment adherence and persistence in patients treated with Gla-300 who actively participated in the COACH PSP versus those who did not enroll using COACH engagement and claims data for the identification period from February 1, 2016 to July 31, 2016. COACH (n=544) and non-COACH (n=544) participants were matched on selected baseline characteristics.COACH participants were more likely to be adherent to (68.0% vs 61.4%, p= 0.0201; OR: 1.81, p=0.0002) and persistent (48.5% vs 42.1%, p= 0.0309; discontinuation HR: 0.60, p<0.0001) with Gla-300 than non-COACH patients during the 12-month follow-up after controlling for clinical confounders. Additionally, both insulin-naive and basal insulin switcher COACH participants, respectively, were more likely to be adherent (OR: 2.25, p=0.0082 and OR: 1.662, p=0.0364) and persistent (discontinuation HR: 0.53, p=0.0054 and HR: 0.67, p=0.0492) than non-COACH patients. Finally, COACH participants with greater level of engagement showed better persistence.These data demonstrate that participation and engagement with COACH PSPs are associated with improved persistence and adherence to Gla-300 among patients with type 2 diabetes.
Abstract Introduction We sought to examine real-world treatment patterns and healthcare resource utilization (HCRU) for patients receiving an antipsychotic (AP) and subsequently prescribed benztropine. Methods A retrospective analysis was conducted among patients with evidence of benztropine initiation using claims data from IQVIA’s New Data Warehouse from January 2017–March 2020. Patients were indexed on the date of first pharmacy claim for benztropine and had continuous enrollment in the 6 months prior (pre-index) and minimum 12 months post-index date, up to 24 months. Patients also had ≥1 pharmacy claim for an AP either pre-index or on the index date. Results A total of 112,542 patients were included; 59% were female with mean age of 46 years. The most common comorbidities were bipolar disorder (BD; 28.3%), schizophrenia (SCZ; 28.3%), and depression (26.3%). Over half of the cohort (54.1%) had ≥2 comorbid conditions. Nearly 20% of patients had ≥20 medications (median 10–14) and medications with anticholinergic (AC) properties were used by 87.9%. Approximately 80% of patients had mild AC burden at baseline (using AC burden calculator). The median number of benztropine prescription fills was 5 with treatment duration <3 months in 44.3% of patients and <6 months in 61.7%. All-cause mean healthcare costs in the 12-month cohort (24-month cohort) were $11,755 ($23,128), mean costs for pharmacy were $9,229 ($18,148), and mean costs for inpatient stays were $34,669 ($41,280). Emergency room (ER) visits occurred in 47.3% and physician office visits in 78.9% of the cohort. In patients with available inpatient 12-month data (n=33,717), inpatient stays occurred in 4.0% (13.3% when extrapolated to total cohort). In patients with 24-month data (n=73,836), ER visits occurred in 61% of the cohort and inpatient stays in 6.6% (21.9% when extrapolated to the total cohort). Multivariate analyses showed baseline SCZ was associated with a significantly increased risk of ER visit of 30% and inpatient stay of 50%. Similarly, substance abuse was associated with an increased risk of ER visit of 85% and inpatient stay of about 40%. Other significant associations with ER visits included falls/accidents at baseline (148% increased risk), abnormal movement disorders (38% increased risk), and orthostatic hypotension (38% increased risk). Conclusions In this real-world analysis of patients initiating benztropine, polypharmacy and AC burden were frequently observed. BD, SCZ, and depression were the most common comorbidities. Healthcare costs and HCRU were high for the entire cohort; inpatient stays contributed to high costs. Baseline SCZ, falls/accidents (ER only), and substance abuse were significantly associated with ER and inpatient admissions. The comorbidity and medication profiles of this cohort may have influenced the high healthcare costs and HCRU observed in the study. Funding Neurocrine Biosciences, Inc.
People with diabetes are at a higher risk of developing a variety of medical conditions relative to those without diabetes, resulting in increased healthcare costs. Self-monitoring of blood glucose (SMBG) is accepted as a recommended element of effective diabetes self-management. However, little is known about the real-world frequency and actual expenditures associated with SMBG, as well as the impact of SMBG costs relative to the cost of diabetes treatments. The primary objective is to evaluate the real-world utilization and costs of SMBG tests in Canada among insulin-treated diabetes patients during a 12-month follow-up period. A retrospective cohort study was conducted using the IMS Brogan Inc. Drug Plan database from July 1, 2006 through June 30, 2010. Total costs during the 12-month follow-up period were assessed, focusing on blood glucose (BG) testing strip costs, insulin therapy costs, and costs associated with oral antidiabetics medications. All prevalent patients with two or more prescriptions for insulin between January 1, 2007 and December 31, 2009 were initially included in the analysis, the first prescription serving as their index date. Depending on the insulin type(s) used, patients were subcategorized into one of four insulin regimen groups (basal, bolus, premix, or basal–bolus). Among an initial sample of patients with two or more claims for insulin between January 1, 2007 and December 31, 2009, 142,551 met the aforementioned inclusion and exclusion criteria. An overall mean utilization of pharmacy-based blood glucose testing of approximately 1,094 strips per person per year was observed, with an average cost per testing strip of Canadian $0.79. SMBG treatment costs for insulin users ($860), specifically those associated with prescription testing strips, totaled 41.6% of the average annual pharmacy costs of diabetes-related prescriptions ($2,068). This study shows that SMBG accounts for approximately 40% of the total diabetes-related pharmacy costs for insulin users.
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