Racial disparities in chronic lymphocytic leukemia/small lymphocytic lymphoma accounting for small molecule inhibitors: A real-world cohort analysis.

Kaplan-Meier curve depicting overall survival from CLL treatment start by race. For patients with CLL, no overall survival difference was observed between races in this real-world US database.

Temporal Changes in Cholangiocarcinoma Incidence and Mortality in the United States from 2001 to 2017.

BACKGROUND: Previous studies report increasing cholangiocarcinoma (CCA) incidence up to 2015. This contemporary retrospective analysis of CCA incidence and mortality in the US from 2001-2017 assessed whether CCA incidence continued to increase beyond 2015. PATIENTS AND METHODS: Patients (≥18 years) with CCA were identified in the National Cancer Institute Surveillance, Epidemiology, and End Results 18 cancer registry (International Classification of Disease for Oncology [ICD-O]-3 codes: intrahepatic [iCCA], C221; extrahepatic [eCCA], C240, C241, C249). Cancer of unknown primary (CUP) cases were identified (ICD-O-3: C809; 8140/2, 8140/3, 8141/3, 8143/3, 8147/3) because of potential misclassification as iCCA. RESULTS: Forty-thousand-and-thirty CCA cases (iCCA, n=13,174; eCCA, n=26,821; iCCA and eCCA, n=35) and 32,980 CUP cases were analyzed. From 2001-2017, CCA, iCCA, and eCCA incidence (per 100 000 person-years) increased 43.8% (3.08 to 4.43), 148.8% (0.80 to 1.99), and 7.5% (2.28 to 2.45), respectively. In contrast, CUP incidence decreased 54.4% (4.65 to 2.12). CCA incidence increased with age, with greatest increase among younger patients (18-44 years, 81.0%). Median overall survival from diagnosis was 8, 6, 9, and 2 months for CCA, iCCA, eCCA, and CUP. From 2001-2016, annual mortality rate declined for iCCA (57.1% to 41.2%) and generally remained stable for eCCA (40.9% to 37.0%) and for CUP (64.3% to 68.6%). CONCLUSIONS: CCA incidence continued to increase from 2001-2017, with greater increase in iCCA versus eCCA, whereas CUP incidence decreased. The divergent CUP versus iCCA incidence trends, with overall greater absolute change in iCCA incidence, provide evidence for a true increase in iCCA incidence that may not be wholly attributable to CUP reclassification.

Productivity loss outcomes and costs among patients with cholangiocarcinoma in the United States: an economic evaluation.

BACKGROUND: Cholangiocarcinoma (CCA) is associated with poor prognosis. Healthcare-related management likely presents a substantial economic burden associated with time away from work in patients with CCA. OBJECTIVES: To assess productivity loss, associated indirect costs, and all-cause healthcare resource utilization and costs owing to workplace absenteeism, short-term disability, and long-term disability in CCA patients with work absence and disability benefits eligibility in the United States. METHODS: US retrospective claims data from Merative MarketScan Commercial and Health and Productivity Management Databases. Eligible patients were adults with ≥1 non-diagnostic medical claim for CCA in the index period (1 January 2011-31 December 2019) and had ≥6 months of continuous medical and pharmacy benefit enrolment before and ≥1 month of follow-up and full-time employee work absence and disability benefits eligibility after the index date. Outcomes were assessed in patients with CCA, intrahepatic CCA (iCCA), and extrahepatic CCA (eCCA) in absenteeism, short-term disability, and long-term disability cohorts (measured per patient per month [PPPM] for a month of 21 workdays), with costs standardized to 2019 USD. RESULTS: One thousand and sixty-five patients with CCA were included (iCCA: n = 624 [58.6%]; eCCA: n = 380 [35.7%]). The mean age was 51.9-53.9 years across cohorts. In patients with iCCA and eCCA, respectively, the number of mean all-cause days absent PPPM for illness was 6.0 and 4.3, and 12.9 and 6.6% had ≥1 CCA-related short-term disability claim. Median indirect costs PPPM owing to absenteeism, short-term disability, and long-term disability, respectively, in patients with iCCA were $622, $635, and $690, and $304, $589, and $465 in patients with eCCA. Patients with iCCA vs. eCCA had higher inpatient, outpatient medical, outpatient pharmacy, and all-cause healthcare costs PPPM. CONCLUSIONS: Patients with CCA had high productivity losses, indirect costs, and medical costs. Outpatient services costs contributed greatly to the higher healthcare expenditure observed in patients with iCCA vs. eCCA.

Cholangiocarcinoma (CCA) changes patients' health, lives, finances, and work. We wanted to understand the effect of CCA on work, costs of lost workdays, and costs of healthcare for patients in the US. We looked at health insurance claims for 1,065 adults which included payments requested to insurance providers for covered healthcare from 2011 to 2019. We grouped people in three ways. The "absence group" included 107 people whose work absences we could track. The "short-term leave" (STL) group included 617 people whose jobs allowed short-term medical leave benefits. The "long-term leave" (LTL) group included 549 people whose jobs allowed long-term medical leave benefits. People could belong to more than one group, i.e. a person who had an absence could also take STL or LTL. About two thirds of the employees with CCA in the absence group missed at least 1 day of work because of illness and lost more than 5 workdays per month on average. Work lost for all absences generally costs employers almost $1000 per month. About half of the STL group took short-term leaves. On average, they lost 6­7 workdays per month, costing about $860. About one-tenth of the LTL group took long-term leaves. On average, they lost just over 6 workdays per month, costing about $800. Average total healthcare costs for all groups were about $10,300­$11,200 per month. Overall, people with CCA inside the liver missed more days from work because of illness and had higher total healthcare costs compared to those with CCA outside the liver.

Off-label prescribing patterns of antidepressants in children and adolescents.

PURPOSE: To understand the extent of off-label prescribing among pediatrics, the study assesses the prescribing patterns of antidepressants in ambulatory settings. METHODS: A cross-sectional analysis was conducted using the National Ambulatory Medical Care Survey from 2000 to 2006. The prevalence of off-label prescribing of antidepressants was estimated, and predictive factors were evaluated. PARTICIPANTS: Children and adolescents aged 6-18 years to private physicians' offices. MAIN OUTCOME MEASURES: Prevalence of antidepressant prescriptions including FDA and non-FDA-approved indications, types of antidepressants prescribed, and factors associated with off-label prescribing. RESULTS: Our study population made 18 646 visits to private physicians' offices, representing about 667 million weighted visits during the study period. The mean age of the patients was 12.2 years (SD = 3.7), and majority of the visits were made by White people (73.1%). Of all visits, 3.7% (95%CI: 3.2%-4.2%) were associated with antidepressants. The most prevalent form of antidepressants prescribed were selective serotonin reuptake inhibitors (63.7%). Only 9.2% of the visits were associated with FDA-approved indications. Visits made to pediatricians (adjusted OR = 2.4; 95%CI: 1.1-5.1), family physicians, and other offices (adjusted OR = 1.9; 95%CI: 1.2-3.1) were more likely to be associated with off-label prescribing as compared with visits to a psychiatrist's office. CONCLUSIONS: The study observed a very high prevalence of off-label antidepressant prescribing patterns among children and adolescents in US ambulatory care settings. Coordinated efforts should be placed to evaluate the potential reasons and ramifications of antidepressant off-label prescribing to guard patients' safety.

Osteoporosis pharmacotherapy and counseling services in US ambulatory care clinics: opportunities for multidisciplinary interventions.

OBJECTIVE: This study was conducted to assess rates and predictors of osteoporosis management with medication or nonmedication therapy, and to compare rates of medication and nonmedication therapy in office-based and hospital-based ambulatory care settings in the United States. METHODS: This cross-sectional study included data on all ambulatory office visits made by patients aged >or=60 years in 2000-2005 in 2 national survey databases representing US ambulatory clinics. Visits with and without a record of anti-osteoporosis medication were identified, and bivariate and multivariate analyses were performed to determine predictive factors for receipt of medication or nonmedication therapy for the prevention and treatment of osteoporosis. RESULTS: During 2000-2005, visits by patients with a diagnosis of osteoporosis or fragility fracture represented <2% of all visits in office- and hospital-based ambulatory care settings. Medication therapy for osteoporosis was documented in 53.2% of these visits, and nonmedication therapy was documented in 31.5%. The most frequently prescribed drug class was bisphosphonates (36.0%), followed by calcium and vitamin D supplementation (23.9%). The most commonly used nonmedication therapies were exercise (16.7%) and diet/nutrition counseling (19.4%). Rates of medication therapy did not differ significantly by ambulatory care setting. However, visits to hospital-based clinics were significantly less likely than visits to office-based clinics to involve nonmedication therapy (adjusted odds ratio [OR] = 0.6; 95% CI, 0.5-0.9; P = 0.004). Compared with visits by women, visits by men were significantly less likely to involve medication therapy (adjusted OR = 0.6; 95% CI, 0.4-0.9; P = 0.013), nonmedication therapy (adjusted OR = 0.3; 95% CI, 0.2-0.6; P < 0.001), or any therapy (adjusted OR = 0.4; 95% CI, 0.3-0.6; P<0.001). Patients aged >or=80 years were significantly less likely to receive nonmedication therapy than were those aged 60 to 69 years (adjusted OR = 0.6; 95% CI, 0.4-0.9; P = 0.023). Visits by patients with public insurance were significantly less likely to involve medication therapy than visits by patients with other sources of payment (adjusted OR = 0.7; 95% CI, 0.5-1.0; P = 0.040). No difference in the prevalence of any type of therapy was observed in relation to race. CONCLUSIONS: Based on the prevalence of medication and nonmedication therapies, levels of osteoporosis care did not differ by ambulatory care setting. However, patterns of care varied by certain visit characteristics, including insurance type, age, and sex.

Cost-Effectiveness Analysis of Canagliflozin 300 mg Versus Dapagliflozin 10 mg Added to Metformin in Patients with Type 2 Diabetes in the United States.

INTRODUCTION: Agents that inhibit sodium glucose co-transporter 2 (SGLT2), including canagliflozin and dapagliflozin, are approved in the United States for the treatment of adults with type 2 diabetes mellitus (T2DM). SGLT2 inhibition lowers blood glucose by increasing urinary glucose excretion, which leads to a mild osmotic diuresis and a net loss of calories that are associated with reductions in body weight and blood pressure. This analysis evaluated the cost-effectiveness of canagliflozin 300 mg versus dapagliflozin 10 mg in patients with T2DM inadequately controlled with metformin in the United States. METHODS: A 30-year cost-effectiveness analysis was performed using the validated Economic and Health Outcomes Model of T2DM (ECHO-T2DM) from the perspective of the third-party health care system in the United States. Patient demographics, biomarker values, and treatment effects for the ECHO-T2DM model were sourced primarily from a network meta-analysis (NMA) that included studies of canagliflozin and dapagliflozin in patients with T2DM on background metformin. Costs were derived from sources specific to the United States. Outcomes and costs were discounted at 3%. Sensitivity analyses that varied key model parameters were conducted. RESULTS: Canagliflozin 300 mg dominated dapagliflozin 10 mg as an add-on to metformin over 30 years, with an estimated cost offset of $13,991 and a quality-adjusted life-year gain of 0.08 versus dapagliflozin 10 mg. Results were driven by the better HbA1c lowering achieved with canagliflozin, which translated to less need for insulin rescue therapy. Findings from sensitivity analyses were consistent with the base case. CONCLUSION: These results suggest that canagliflozin 300 mg is likely to provide better health outcomes at a lower overall cost than dapagliflozin 10 mg in patients with T2DM inadequately controlled with metformin from the perspective of the United States health care system. FUNDING: Janssen Scientific Affairs, LLC and Janssen Global Services, LLC.

Cost-effectiveness of Canagliflozin versus Sitagliptin When Added to Metformin and Sulfonylurea in Type 2 Diabetes in Canada.

BackgroundCanagliflozin, an agent that inhibits sodium glucose co-transporter 2, is approved as add-on to metformin plus sulfonylurea for the treatment of type 2 diabetes in Canada. Canagliflozin offers greater glycemic control, as well as important additional benefits such as weight loss and blood pressure reductions, versus dipeptidyl peptidase-4 inhibitors such as sitagliptin.  ObjectiveThis analysis evaluated the cost-effectiveness of canagliflozin 300 mg and canagliflozin 100 mg versus sitagliptin 100 mg in patients with type 2 diabetes inadequately controlled on metformin plus sulfonylurea from the perspective of the Canadian Agency for Drugs and Technologies in Health. MethodsA 40-year cost-effectiveness analysis was performed using the validated Economic and Health Outcomes Model of Type 2 Diabetes Mellitus (ECHO-T2DM). Patient characteristics, treatment effects, and rates of hypoglycemia and adverse events were sourced from the canagliflozin clinical program. Canada-specific costs and utilities were applied. Sensitivity analyses were conducted using alternative values for key model inputs. ResultsBoth canagliflozin 300 and 100 mg dominated sitagliptin 100 mg over 40 years, providing quality-adjusted life-year gains of 0.31 and 0.28, and cost offsets of $2,217 and $2,560, respectively. Both canagliflozin doses dominated sitagliptin in each of the sensitivity analyses. ConclusionsSimulation results suggested that canagliflozin 300 and 100 mg provided better health outcomes and lower costs than sitagliptin 100 mg as a third-line therapy added-on to metformin and sulfonylurea in patients with type 2 diabetes in Canada.

Cost-Effectiveness of Canagliflozin versus Sitagliptin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus in Mexico.

OBJECTIVE: To assess the cost-effectiveness of canagliflozin versus sitagliptin for the treatment of type 2 diabetes mellitus (T2DM) as an add-on to metformin in Mexico. METHODS: A validated model (Economic and Health Outcomes [ECHO]-T2DM) was used to estimate the cost-effectiveness of canagliflozin 300 or 100 mg versus sitagliptin 100 mg in patients with T2DM inadequately controlled on metformin monotherapy. Data from a head-to-head, phase III clinical trial, including patients' baseline demographic characteristics, biomarker values, and treatment effects, were used to simulate outcomes and resource use over 20 years from the perspective of the Mexican health care system. Costs of complications and adverse events were tailored to the Mexican setting and discounted at 5%. Cost-effectiveness was assessed using willingness-to-pay thresholds equivalent to 1 times the gross domestic product per capita (locally perceived to be "very cost-effective") and 3 times the gross domestic product per capita (locally perceived to be "cost-effective") on the basis of recommendations of the Mexican government and the World Health Organization. RESULTS: Owing primarily to better glycated hemoglobin (HbA1c), body weight, and systolic blood pressure values, canagliflozin 300 and 100 mg were associated with an incremental benefit of 0.16 and 0.06 quality-adjusted life-years (QALYs) versus sitagliptin 100 mg, respectively, over 20 years. The mean differences in cost for canagliflozin 300 and 100 mg versus sitagliptin 100 mg were Mexican pesos (MXP) 1797 (US $134) and MXP 7262 (US $540), respectively, resulting in a cost per QALY gained of MXP 11,210 (US $834) and MXP 128,883 (US $9590), respectively. Both of these cost-effectiveness ratios are below the very cost-effective willingness-to-pay threshold in Mexico. The general finding that canagliflozin is cost-effective versus sitagliptin in Mexico was supported by sensitivity analyses. CONCLUSION: In Mexico, both doses of canagliflozin are likely to be cost-effective versus sitagliptin in patients with T2DM who have inadequate glucose control on metformin, primarily because of better biomarker control and higher QALYs.