Comparing survival outcomes between neoadjuvant and adjuvant chemotherapy within breast cancer subtypes and stages among older women: a SEER-Medicare analysis.

BACKGROUND: This study aimed to compare survival outcomes of neoadjuvant (NAC) and adjuvant chemotherapy (AdC) within each breast cancer subtype and stage among older women. METHODS: Older (≥ 66 years) women newly diagnosed with stage I-III invasive ductal breast cancer during 2010-2017 and treated with both chemotherapy and surgery within one year were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Analyses were performed within each of six groups, jointly defined based on subtype (hormone receptor [HR]-positive/human epidermal growth factor receptor 2 [HER2]-negative, HER2 + , and triple-negative) and stage (I-II and III). Kaplan-Meier curves and multivariable Cox models were used to compare overall and recurrence-free survival between NAC and AdC, with optimal full matching performed for confounding adjustment. RESULTS: Among 8,495 included patients, 8,329 (20.6% received NAC) remained after matching. Before multiple testing adjustment, Cox models showed that NAC was associated with a lower hazard for death among stage III HER2 + patients (hazard ratio = 0.347, 95% confidence interval CI 0.161-0.745) but a higher hazard for death among triple-negative patients (stage I-II: hazard ratio = 1.558, 95% CI 1.024-2.370; stage III: hazard ratio = 2.453; 95% CI 1.254-4.797). A higher hazard for death/recurrence was associated with NAC among stage I-II HR + /HER2- patients (hazard ratio = 1.305, 95% CI 1.007-1.693). No significant difference remained after multiple testing adjustment. CONCLUSIONS: The opposite trends (before multiple testing adjustment) of survival comparisons for advanced HER2 + and triple-negative disease warrant further research. Caution is needed due to study limitations such as cancer stage validity.

Real-world opioid use among patients with migraine enrolled in US commercial insurance and risk factors associated with migraine progression.

BACKGROUND: Migraineurs may be categorized as having episodic migraine (EM: < 15 headache days/month) or chronic migraine (CM: ≥ 15 days/month for > 3 months with ≥ 8 days/month having features of migraine). Opioid use has been linked to progression from EM to CM. OBJECTIVE: To describe the utilization of opioid prescriptions among patients with migraine, to determine the association between opioid use and migraine progression, and to explore demographic and clinical risk factors for migraine progression. METHODS: This retrospective cohort study used Optum's deidentified Clinformatics Data Mart Database from January 2015 to December 2018. Adult patients with a migraine diagnosis and continuous health plan enrollment were included. Opioid use was measured by average daily morphine equivalent dose, also known as morphine milligram equivalent (MME). Descriptive statistics were used to summarize the opioid use by patient demographic and clinical characteristics. A Cox proportional hazards model with stepwise selection was used to determine the risk factors of new-onset CM. RESULTS: Overall, 35% of patients with migraine (27,331 of 78,134) received prescription opioids (> 0 MME/day) during the 12-month follow-up period. Higher opioid dosage was found in patients who had CM and comorbidities of interest. Compared with patients with EM, patients with CM were twice as likely to receive at least 20 MME/day (CM 3.8% vs EM 1.9%) and had a higher median opioid day supply (CM 20 vs EM 10) during follow-up. About 7% of patients with CM with at least 1 opioid prescription had at least 50 MME/day in any 90-day period during follow-up. A significant association was found between MME level and the likelihood of new-onset CM. Additional significant risk factors of migraine progression included younger age, female sex, South and West regions, and having a diagnosis of medication overuse headache, depression, back pain, or fibromyalgia (all P < 0.05). CONCLUSIONS: Despite guidelines and the availability of more migraine-specific treatments, opioids are still commonly prescribed to patients with migraines in real-world practice, especially for those with CM. In this study population, a higher risk of new-onset CM was associated with receiving higher opioid doses.

Neoadjuvant chemotherapy use trends among older women with breast cancer: 2010-2017.

PURPOSE: This study assessed chemotherapy use trends before (neoadjuvant chemotherapy [NAC]) or after surgery (adjuvant chemotherapy [AdC]) among older women with breast cancer and examined factors related to NAC receipt. METHODS: Women (> 65 years) diagnosed with stage I-III breast cancer during 2010-2017 who received NAC or AdC were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. All patients were stratified into six strata based on subtype (hormone receptor-positive/human epidermal growth factor receptor 2-negative [HR + /HER2-], HER2 + , and triple-negative breast cancer [TNBC]) and stage (I-II and III). Cochran-Armitage tests were performed to test temporal trends of NAC use in each stratum. Multivariable logistic regression analyses were performed to identify factors (sociodemographic and clinical) related to NAC use. RESULTS: Among included older (mean ± standard deviation: 72.3 ± 5.2 years) women (N = 8,495) with stage I-III breast cancer, NAC use increased from 11.7% (2010) to 32.6% (2017). Significant increases in NAC were found in all strata (p < .0001) with more substantial increases in HER2 + disease and TNBC compared to HR + /HER2- disease. Multivariable logistic regressions identified the youngest age category (66-69 years) and later stage as significant (p < 0.05) predictors of NAC receipt in most strata, in addition to diagnosis year. CONCLUSION: Similar to the overall breast cancer population, NAC use increased among a population of older women. NAC was received by most patients with stage III HER2 + disease or TNBC in more recent years and was more common among younger elderly women and those in stage III.

Economic Burden of Chronic Comorbidities Among Community-Dwelling Older Adults With Dementia: A Propensity Score Matched National-Level Study.

OBJECTIVE: This study examined the extent to which chronic comorbidities contribute to excess health care expenditures between older adults with dementia and propensity score (PS)-matched nondementia controls. METHODS: This was a retrospective, cross-sectional, PS-matched case (dementia): control (nondementia) study of older adults (65 y or above) using alternative years data from pooled 2005 to 2015 Medical Expenditure Panel Surveys (MEPS). Chronic comorbidities were identified based on Clinical Classifications System or ICD-9-CM codes. Ordinary least squares regression was utilized to quantify the impact of chronic comorbidities on the excess expenditures with logarithmic transformation. Expenditures were expressed as 2019 US dollars. All analyses accounted for the complex survey design of MEPS. RESULTS: The mean yearly home health care expenditures were particularly higher among older adults with dementia and co-occurring anemia, eye disorders, hyperlipidemia, and hypertension compared with PS-matched controls. Ordinary least squares regression models revealed that home health care expenditures were 131% higher (ß=0.837, P <0.001) among older adults with dementia compared with matched nondementia controls before adjusting for chronic comorbidities. When additionally adjusting for chronic comorbidities, the percentage increase, while still significant ( P <0.001) decreased from 131% to 102%. CONCLUSIONS: The excess home health care expenditures were partially explained by chronic comorbidities among community-dwelling older adults with dementia.

Healthcare utilization and costs among patients with chronic migraine, episodic migraine, and tension-type headache enrolled in commercial insurance plans.

OBJECTIVE: To quantify and compare healthcare utilization and costs for patients with chronic migraine (CM), episodic migraine (EM), and tension-type headache (TTH) enrolled in US commercial health plans. METHODS: This retrospective cohort study used the Optum Clinformatics® Data Mart database from January 2015 to December 2018. Adult patients with a diagnosis of EM, CM or TTH and at least 12 months of continuous enrollment before and after diagnosis were included. Inverse probability of treatment weighting was used to adjust for baseline differences among the three groups. Patient demographic and clinical characteristics at baseline, and healthcare utilization and costs during follow-up, were described and compared between the three groups. RESULTS: A total of 45,849 patients were included: 8955 with CM, 31,961 with EM, and 4933 with TTH. The total all-cause annual direct medical costs of patients with CM ($17,878) were 1.38 times higher (95% CI: 1.31-1.44) than those with EM ($12,986), and 2.26 times higher (95% CI: 2.08-2.47) than those with TTH ($7902). The annual migraine/TTH-related costs of patients with CM ($1869) were 4.19 times higher (95% CI: 3.92-4.48) than those with EM ($446), and 11.90 times (95% CI: 10.59-13.52) higher than those with TTH ($157). In the adjusted analyses, for all service categories (emergency department, inpatient, outpatient, and prescriptions), the expected costs in the migraine groups were higher than in the TTH group (all p < 0.001), while controlling for covariates. Main findings were consistent in both weighted and unweighted samples, and with both unadjusted and adjusted analyses. CONCLUSION: This study provides an updated assessment of healthcare utilization and expenditures for adult patients with primary headache disorders. Compared to TTH, migraine is associated with higher resource use and direct medical costs, especially for those with a chronic condition. Future studies are needed to understand the indirect medical costs (productivity loss) and humanistic burden (quality of life) between migraine and TTH.

Healthcare Utilization, Costs, and Adverse Events of Real-Time Continuous Glucose Monitoring versus Traditional Blood Glucose Monitoring Among US Adults with Type 1 Diabetes.

OBJECTIVE: To compare healthcare utilization, costs, and incidence of diabetes-specific adverse events (ie, hyperglycemia, diabetic ketoacidosis, and hypoglycemia) in type 1 diabetes adult patients using real-time continuous glucose monitoring (rtCGM) versus traditional blood glucose monitoring (BG). METHODS: Adult patients (≥18 years old) with type 1 diabetes in a large national administrative claims database between 2013 and 2015 were identified. rtCGM patients with 6-month continuous health plan enrollment and ≥1 pharmacy claim for insulin during pre-index and post-index periods were propensity-score matched with BG patients. Healthcare utilization associated with diabetic adverse events were examined. A difference-in-difference (DID) method was used to compare the change in costs between rtCGM and BG cohorts. RESULTS: Six-month medical costs for rtCGM patients (N = 153) increased from pre- to post-index period, while they decreased for matched BG patients (N = 153). DID analysis indicated a $2,807 (P = .062) higher post-index difference in total medical costs for rtCGM patients. Pharmacy costs for both cohorts increased. DID analysis indicated a $1,775 (P < .001) higher post-index difference in pharmacy costs for rtCGM patients. The incidence of hyperglycemia for both cohorts increased minimally from pre- to post-index period. The incidence of hypoglycemia for rtCGM patients decreased, while it increased marginally for BG patients. Inpatient hospitalizations for rtCGM and BG patients increased and decreased marginally, respectively. CONCLUSIONS: rtCGM users had non-significantly higher pre-post differences in medical costs but significantly higher pre-post differences in pharmacy costs (mostly due to the rtCGM costs themselves) compared to BG users. Changes in adverse events were minimal.

Age-related prescription medication utilization for the -management of sickle cell disease among Texas Medicaid patients.

INTRODUCTION: Sickle cell disease (SCD) is associated with recurrent complications and healthcare burden. Although SCD management guidelines differ based on age groups, little is known regarding actual utilization of preventative (hydroxyurea) and palliative therapies (opioid and nonopioid analgesics) to manage complications. This study assessed whether there were agerelated differences in SCD index therapy type and SCD-related medication utilization. DESIGN AND PATIENTS: Texas Medicaid prescription claims from September 1, 2011 to August 31, 2016 were retrospectively analyzed for SCD patients aged 2-63 years who received one or more SCD-related medications (hydroxyurea, opioid, or nonopioid analgesics). OUTCOME MEASURES: The primary outcomes were SCD index drug type and medication utilization: hydroxyurea adherence, and days' supply of opioid, and nonopioid analgesics. Chi-square, analysis of variance, and Kruskal-Wallis tests were used. RESULTS: Index therapy percentages for included patients (N = 2,339) were the following: opioids (45.7 percent), nonopioids (36.6 percent), dual therapy-opioids and nonopioids (11.2 percent), and hydroxyurea (6.5 percent), and they differed by age-groups (χ2 = 243.0, p < 0.0001). Hydroxyurea as index therapy was higher among children (2-12:9.1 percent) compared to adults (26-40:3.7 percent; 41-63:2.9 percent). Opioids as index therapy were higher among adults (18-25:48.0 percent; 26-40:54.9 percent; 41-63:65.2 percent) compared to children (2-12:36.6 percent). Mean hydroxyurea adherence was higher (p < 0.0001) for younger ages, and opioid days' supply was higher for older ages. CONCLUSIONS: Texas Medicaid SCD patients had low hydroxyurea utilization and adherence across all age groups. Interventions to increase the use of hydroxyurea and newer preventative therapies could result in better management of SCD-related complications and reduce the frequency of pain crises, which may reduce the need for opioid use.

Prevalence of and Factors Associated with Gabapentinoid Use and Misuse Among Texas Medicaid Recipients.

BACKGROUND AND OBJECTIVES: Gabapentin and pregabalin have been considered relatively safe opioid-sparing adjuncts for pain management. However, rising prescribing trends, presence of gabapentinoids in opioid-related overdoses, and the growing body of evidence regarding gabapentinoid misuse and abuse, have caused gabapentinoids to emerge as a drug class of public health concern. This study aimed to assess the prevalence of, and factors associated with gabapentinoid use and misuse. METHODS: This retrospective study of Texas Medicaid data from 1/1/2012 to 30/8/2016 included patients aged 18-63 years at index date, with ≥ 1 gabapentinoid prescription, and continuously enrolled 6 months pre-index and 12 months post-index. Gabapentinoid misuse was defined as ≥ 3 claims exceeding daily doses of 3600 mg for gabapentin and 600 mg for pregabalin. Age, gender, concurrent opioid use, neuropathic pain diagnoses and gabapentinoid type were independent variables. Descriptive and inferential statistics were used. RESULTS: Of included subjects (N = 39,000), 0.2% (N = 81) met study criteria for gabapentinoid misuse. Overall, the majority (76.4%) of gabapentinoid users were aged 41-63 years with a mean ± SD age of 48.2 ± 10.7 years. Those patients meeting the study criteria for gabapentinoid misuse were significantly younger (45.1 ± 11.0 vs 48.2 ± 10.7, p = 0.0084). Majority of the study sample was female (68.1%). However, a significantly higher proportion of males met the study criteria for gabapentinoid misuse compared to females (0.3% vs 0.2%, p = 0.0079). Approximately one-half (51.9%) of the study sample had neuropathic pain, and gabapentinoid misuse was significantly higher in neuropathic pain patients compared to those without neuropathic pain (0.3% vs 0.1%, p = 0.0078). Over three-quarters (77.4%) of patients were using gabapentin; however, gabapentinoid misuse was significantly higher among pregabalin users (0.4% vs 0.2%, p = 0.0003). Approximately 20% (17.3%) of gabapentinoid users had ≥ 90 days of concurrent opioid use. However, there was no significant difference in gabapentinoid misuse among patients with concurrent opioid use compared to patients without (0.3% vs 0.2%, p = 0.1440). Factors significantly associated with misuse included: male sex (odds ratio [OR] 0.486; 95% confidence interval [CI] 0.313-0.756; p = 0.0013); neuropathic pain (OR 2.065; 95% CI 1.289-3.308; p = 0.0026); and pregabalin versus gabapentin use (OR 2.337, 95% CI 1.492-3.661; p = 0.0002). Concurrent opioid use was not significantly associated with gabapentinoid misuse (OR 1.542, 95% CI 0.920-2.586; p = 0.1006). CONCLUSION: Prevalence of gabapentinoid misuse was low (0.2%) among Texas Medicaid recipients. Younger age, male gender, neuropathic pain diagnosis and pregabalin use were significantly associated with higher levels of gabapentinoid misuse.

Use of a claims-based algorithm to estimate disease severity in the multiple sclerosis Medicare population.

BACKGROUND/OBJECTIVE: To compare algorithm determined disease severity, risk of multiple sclerosis (MS) relapse, and MS-related hospitalization between the age-eligible and disability-eligible MS Medicare populations. METHODS: Using the Humana claims dataset (2013 - 2015), patients were divided into Medicare age-eligible and disability-eligible groups. A previously developed algorithm, which used MS symptoms and healthcare utilization to categorize MS disease severity into three groups (low, moderate, high) at baseline was employed. Flexible parametric and Cox proportional hazard models were used to estimate the risk for MS relapses and MS-related hospitalizations among the MS disease severity groups and the two eligibility cohorts in the follow-up period. RESULTS: Of the overall sample (N = 6,559), the majority (N = 4,813, 73.4%) were disability-eligible and in the low disease severity group (N = 4,468, 68.1%). In 10 of 16 disease severity algorithm predictors, the prevalence of these predictors was significantly (p<0.001) higher in the disability-eligible group compared to the age-eligible group. Survival analyses revealed that the disability-eligible group had a significantly higher risk for follow-up MS relapses and follow-up MS-related hospitalizations (HR = 1.79 [CI 1.54 - 2.08] and HR = 1.38 [CI 1.11-1.72], respectively) compared to those in the age-eligible group. When both eligibility and disease severity were considered in the model increases in hazard ratios corresponded generally to increases in disease severity. However, the type of Medicare eligibility does not appear to have a clear pattern across MS disease severity groups for either MS relapse or hospitalizations, CONCLUSION: The disability-eligible Medicare population had a significantly higher prevalence of MS comorbidities and higher MS severity scores at baseline. In addition, they had a higher risk for MS-related relapses and MS-related hospitalizations in the follow-up period. It is important to account for disability status when assessing disease severity and healthcare utilization.

Assessment of basal insulin adherence using 2 methodologies among Texas Medicaid enrollees with type 2 diabetes.

BACKGROUND: Basal insulin is often recommended as the initial therapy for patients with type 2 diabetes who require insulin treatment. Adequate adherence is critical to diabetes management, yet suboptimal insulin adherence has been reported. Second-generation long-acting (SGLA) insulin has higher dosing flexibility and lower hypoglycemia risk and may improve adherence. However, little is known regarding adherence to SGLA insulin and how adherence to SGLA insulin compares with intermediate-acting neutral protamine Hagedorn (NPH) and first-generation long-acting (FGLA) insulin. Measurement of insulin adherence is challenging because of the inaccuracies of recorded days supply of insulin, and traditional medication possession ratio (MPR) may be negatively affected. Adjusted MPR (aMPR) has been developed in an effort to address this issue. OBJECTIVE: To examine the unadjusted and adjusted associations between basal insulin type and adherence to basal insulin using MPR and aMPR. METHODS: This retrospective database study used Texas Medicaid prescription claims from January 1, 2014, through June 30, 2017. The index date was the date of the first basal insulin prescription without the same prescription 6 months before (pre-index), and all patients were followed for 12 months (post-index). Patients aged 18-63 years with ≥ 1 pre-index prescription of an oral hypoglycemia agent (OHA) or a glucagon-like peptide-1 receptor agonist (GLP-1 RA), without any post-index prescription of premixed insulin or a basal insulin different from index insulin, and with continuous enrollment throughout the pre- and post-index periods, were included. The dependent variable was basal insulin adherence over 12 months, measured using MPR and aMPR. Unadjusted and adjusted adherence comparisons were conducted by basal (background) insulin type (NPH, FGLA, and SGLA). Covariates included age, gender, baseline use of basal insulins and comorbid medications, total number of medications, OHA adherence, post-index number of OHAs, and use of bolus insulins and GLP-1 RAs. Analysis of variance, chi-square tests, and multiple logistic regression analyses were performed. RESULTS: Of the 5,034 patients included, NPH, FGLA, and SGLA insulin users accounted for 3.7%, 89.8%, and 6.5%, respectively. The overall mean (SD) age was 50.9 (9.9) years, and 65.9% were female. In the unadjusted bivariate analyses, SGLA insulin users had significantly higher adherence, using either MPR (SGLA 0.68 [0.25] vs. FGLA 0.59 [0.27] vs. NPH 0.55 [0.27]; P < 0.0001) or aMPR (0.83 [0.23] vs. 0.78 [0.26] vs. 0.73 [0.28]; P = 0.0001). After controlling for covariates, insulin type was not significantly associated with the likelihood of being adherent (MPR or aMPR ≥ 0.8) using either measure. CONCLUSIONS: Adherence to SGLA insulin was not different from adherence to other basal insulins after controlling for patient characteristics. Yet, MPR and aMPR have limitations and warrant further confirmation of the study findings. Before new adherence measures for insulin therapy are developed, MPR and aMPR should be used with caution. DISCLOSURES: No specific funding was received for this manuscript. The authors report no potential conflicts of interest. Part of the data from this study was presented as posters at the American Pharmacists Association 2020 Annual Meeting & Exposition, March 20-23, 2020, in National Harbor, MD, and at the International Society for Pharmacoeconomics and Outcomes Research 2020 Conference, May 16-20, 2020, in Orlando, FL.

Predictors of Annual Base Salary for Health Economics, Outcomes Research, and Market Access Professionals in the Biopharmaceutical Industry.

BACKGROUND: Analysis of salary data for health economics, outcomes research, and market access professionals in biopharmaceutical space plays an important role in hiring talent, benchmarking remuneration, and evaluating income discrepancies. OBJECTIVES: To (a) identify predictors of annual base salary (ABS) for health economics, outcomes research, and market access professionals who participated in the 2017 Global Salary Survey by HealthEconomics.Com and (b) evaluate salary-related gender disparity among survey respondents. METHODS: 501 professionals from the HealthEconomics.Com global subscriber list participated in a survey that assessed salary, bonus, benefits, and job satisfaction in June 2017. Two multivariable regression models identified significant predictors of ABS for U.S. and non-U.S. regions separately. Analysis of variance determined interaction effects between gender, organizational size, job title, and people management responsibilities separately. RESULTS: Of the 501 respondents, 385 were included in the analysis because they reported ABS. Median ABS for male (n = 117) and female (n = 111) U.S.-based respondents was $172,500 and $162,500, respectively. For male (n = 75) and female (n = 65) non-U.S.-based respondents, the median was identical at $92,500. Mean (SD) ABS between male ($180,534 [$77,755]) and female ($165,113 [$64,604]; t [226] = 1.62; P = 0.106) U.S. respondents was not significantly different. Mean (SD) ABS for male ($110,900 [$65,898]) and female ($98,039 [$48,639]; t [138] = 1.30; P = 0.196) non-U.S. respondents was not significantly different, as well. Multivariable regression models for U.S. and non-U.S. respondents accounted for 62.7% and 63.9% of variance in ABS (P < 0.001), respectively. In both models, significantly higher salaries were associated with professionals aged > 40 years; biopharmaceutical employment; having a PhD, PharmD, or MD; and having a job title of president or director (all P < 0.05). CONCLUSIONS: After controlling for covariates, gender was not statistically significantly associated with ABS. Age, organization type, terminal degree, and job title were significant predictors of higher salaries inside and outside of the United States. Additional research should be conducted to increase generalizability of results, which were based on a convenience sample. DISCLOSURES: No funding supported this research. Shah and Peeples are employed by HealthEconomics.Com, which administered the survey used in this study. The authors report no other potential conflicts of interest.

Comparison of Prostaglandin Analog Treatment Patterns in Glaucoma and Ocular Hypertension.

BACKGROUND: Prostaglandin analogs (PGAs) are considered an initial therapy to manage increased intraocular pressure (IOP) for patients with glaucoma. When the initial PGA treatment fails to lower IOP adequately, the patient may add or change medications or have surgery/laser treatment. OBJECTIVE: To compare medication adherence, duration of therapy, and treatment patterns among 3 PGAs-latanoprost, travoprost, and bimatoprost-as initial therapies for patients with glaucoma or ocular hypertension. METHODS: This was a retrospective cohort study using administrative claims data. The cohort consisted of patients newly diagnosed with glaucoma or ocular hypertension with at least 1 prescription claim for latanoprost, travoprost, or bimatoprost and enrolled in a Medicare Advantage plan between 2007 and 2012. The 24-month medication possession ratio (MPR) was used to measure medication adherence. Discontinuation of first-line PGA therapy was defined as nonpersistence (90-day gap allowance) of the index PGA or a change in therapy during the 24-month follow-up period. Types of second-line therapy (i.e., switch, addition, and surgery) were identified. The 1:1:1 propensity score matching was used. RESULTS: Patients who met the inclusion criteria were propensity score matched, resulting in 1,296 patients per PGA group. Latanoprost users showed higher adherence (50.1%) than travoprost (48.8%) and bimatoprost (43.0%) users. The latanoprost and travoprost groups had significantly higher MPRs than bimatoprost (P < 0.0001). The latanoprost group showed significantly longer duration of first-line therapy (372 days) than the bimatoprost group (343 days; P = 0.003) but not the travoprost group (361 days). After controlling for demographic and clinical characteristics, a Cox proportional hazards model showed that the travoprost and bimatoprost groups had a higher risk of discontinuation of first-line therapy than the latanoprost group (P < 0.0001). The percentage of patients continuing on the index PGA without treatment pattern change (i.e., switches, additions, and surgery) was higher for latanoprost users (52.9%) compared with travoprost (39.0%) or bimatoprost users (42.1%; P < 0.001). CONCLUSIONS: Patients who used latanoprost as their initial therapy were more likely to adhere and persist to the index PGA compared with bimatoprost users. The latanoprost group demonstrated a lower risk of discontinuing first-line therapy than the travoprost and bimatoprost groups. The results may assist ophthalmologists in determining the optimal management of this patient population with respect to treatment patterns. DISCLOSURES: No outside funding supported this study. All authors except Heo and Nair are employed by The University of Texas at Austin College of Pharmacy. Heo was with the Health Outcomes Division, The University of Texas at Austin College of Pharmacy during a portion of this study and is employed by Genesis Research. Nair is employed by Humana. The authors have no financial relationships relevant to this article to disclose. This study was presented as a poster at the 2016 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting, May 2016, Washington, DC.

Patterns of antiepileptic drug use in patients with potential refractory epilepsy in Texas Medicaid.

OBJECTIVES: Antiepileptic drug (AED) monotherapy is usually effective in 60% of the patients with epilepsy while the remaining patients have refractory epilepsy. This study compared treatment patterns (adherence, persistence, addition, and switching) associated with refractory and nonrefractory epilepsy. METHODS: Texas Medicaid claims from 09/01/07-12/31/13 were analyzed, and patients eligible for the study 1) were between 18 and 62 years of age, 2) had a prescription claim for an AED during the identification period (03/01/08-12/31/11) with no prior baseline AED use (6-month), and 3) had evidence of epilepsy diagnosis within 6 months of AED use. Based on AED use in the identification period, patients were categorized into "refractory" (≥3AEDs) and "nonrefractory" (<3AEDs) cohorts. The index date was the date of the first AED claim. Patients in both cohorts were matched 1:1 using propensity scoring and compared for adherence (proportion of days covered (PDC) ≥80% vs. <80%), persistence, addition (yes/no), and switching (yes/no) using multivariate conditional regression models. Conditional logistic regression and Cox proportional hazard models were used to address the study objectives. RESULTS: Of the 10,599 eligible patients, 2798 (26.5%) patients in the refractory cohort were matched to patients in the nonrefractory cohort. Patients in the refractory cohort had significantly higher (p < 0.005) mean (±Standard deviation (SD)) adherence (88.6% (±19.1%) vs. 77.0% ±â€¯(25.8%)) and persistence (328.0 (±87.3) days vs. 294.9 ±â€¯(113.4) days) as compared with patients in the nonrefractory cohort. Compared with patients with nonrefractory epilepsy, patients with refractory epilepsy were 3.6 times (odds ratio (OR) = 3.553; 95% confidence interval (CI) = 3.060-4.125; p < 0.0001) more likely to adhere to AEDs and had a 34.7% (hazard ratio (HR) = 0.653; 95% CI = 0.608-0.702; p < 0.0001) lower hazard rate of discontinuation of AEDs. Also, patients with refractory epilepsy were 3.7 times (OR = 3.723; 95% CI = 2.902-4.776; p < 0.0001) more likely to add an alternative AED and 3.6 times (OR = 3.591; 95% CI = 3.010-4.284; p < 0.0001) more likely to switch to an alternative AED. CONCLUSION: Patients with refractory epilepsy were significantly more likely to adhere and persist to AED regimen and were significantly more likely to add and switch to an alternative AED than patients with nonrefractory epilepsy.

Determinants of health-related quality of life in international graduate students.

INTRODUCTION: International graduate students often experience additional levels of stress due to acculturation. Given the impact of stress on health outcomes (both physical and mental), this study examined the health-related quality of life (HRQoL) in international graduate students to determine its association with acculturative stress, perceived stress, and use of coping mechanisms. METHODS: A cross-sectional, self-administered survey was designed and sent to 38 student chapters within the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) student network. HRQoL [physical component summary (PCS) and mental component summary (MCS)] was measured using the 12-item Short Form (SF-12) while coping mechanisms were assessed using the Brief COPE Scale. Acculturative and perceived stress were assessed using the Acculturative Stress Scale for International students [ASSIS] and Graduate Stress Inventory-Revised (GSI-R), respectively. Demographic and personal information (e.g. age, religion) were also collected. Descriptive statistics (mean ± SD and frequency) and hierarchical multiple regression analysis were conducted. RESULTS: The average PCS and MCS were 60 ± 9 and 44 ± 13, respectively, indicating that while the physical health was above the United States (US) general population norm (50), mental health scores were lower. Findings from the hierarchical multiple regression showed that perceived and acculturative stress significantly predicted mental health. Acculturative stress was also a significant predictor of physical health. CONCLUSION: The results from this study support the hypothesis that international students in the US experience both perceived and acculturative stress that significantly impacts their HRQoL. Universities should consider providing education on stress reduction techniques to improve the health of international graduate students.

Prediction of Change in Prescription Ingredient Costs and Co-payment Rates under a Reference Pricing System in South Korea.

BACKGROUND: The reference pricing system (RPS) establishes reference prices within interchangeable reference groupings. For drugs priced higher than the reference point, patients pay the difference between the reference price and the total price. OBJECTIVES: To predict potential changes in prescription ingredient costs and co-payment rates after implementation of an RPS in South Korea. METHODS: Korean National Health Insurance claims data were used as a baseline to develop possible RPS models. Five components of a potential RPS policy were varied: reference groupings, reference pricing methods, co-pay reduction programs, manufacturer price reductions, and increased drug substitutions. The potential changes for prescription ingredient costs and co-payment rates were predicted for the various scenarios. RESULTS: It was predicted that transferring the difference (total price minus reference price) from the insurer to patients would reduce ingredient costs from 1.4% to 22.8% for the third-party payer (government), but patient co-payment rates would increase from a baseline of 20.4% to 22.0% using chemical groupings and to 25.0% using therapeutic groupings. Savings rates in prescription ingredient costs (government and patient combined) were predicted to range from 1.6% to 13.7% depending on various scenarios. Although the co-payment rate would increase, a 15% price reduction by manufacturers coupled with a substitution rate of 30% would result in a decrease in the co-payment amount (change in absolute dollars vs. change in rates). CONCLUSIONS: Our models predicted that the implementation of RPS in South Korea would lead to savings in ingredient costs for the third-party payer and co-payments for patients with potential scenarios.

Integration of pharmacists into patient-centered medical homes in federally qualified health centers in Texas.

OBJECTIVES: To describe the integration and implementation of pharmacy services in patient-centered medical homes (PCMHs) as adopted by federally qualified health centers (FQHCs) and compare them with usual care (UC). SETTING: Four FQHCs (3 PCMHs, 1 UC) in Austin, TX, that provide care to the underserved populations. PRACTICE DESCRIPTION: Pharmacists have worked under a collaborative practice agreement with internal medicine physicians since 2005. All 4 FQHCs have pharmacists as an integral part of the health care team. Pharmacists have prescriptive authority to initiate and adjust diabetes medications. PRACTICE INNOVATION: The PCMH FQHCs instituted co-visits, where patients see both the physician and the pharmacist on the same day. PCMH pharmacists are routinely proactive in collaborating with physicians regarding medication management, compared with UC in which pharmacists see patients only when referred by a physician. EVALUATION: Four face-to-face, one-on-one semistructured interviews were conducted with pharmacists working in 3 PCMH FQHCs and 1 UC FQHC to compare the implementation of PCMH with emphasis on 1) structure and workflow, 2) pharmacists' roles, and 3) benefits and challenges. RESULTS: On co-visit days, the pharmacist may see the patient before or after physician consultation. Pharmacists in 2 of the PCMH facilities proactively screen to identify diabetes patients who may benefit from pharmacist services, although the UC clinic pharmacists see only referred patients. Strengths of the co-visit model include more collaboration with physicians and more patient convenience. Payment that recognizes the value of PCMH is one PCMH principle that is not fully implemented. CONCLUSION: PCMH pharmacists in FQHCs were integrated into the workflow to address specific patient needs. Specifically, full-time in-house pharmacists, flexible referral criteria, proactive screening, well defined collaborative practice agreement, and open scheduling were successful strategies for the underserved populations in this study. However, reimbursement plans and provider status for pharmacists should be established to sustain this model of care.

Adherence, Persistence, and Health Care Costs for Patients Receiving Dipeptidyl Peptidase-4 Inhibitors.

BACKGROUND: The dipeptidyl peptidase-4 (DPP-4) inhibitors are among the newer, yet more established, classes of diabetes medications. OBJECTIVE: To compare adherence, persistence, and health care costs among patients taking DPP-4 inhibitors. METHODS: Claims were extracted from Humana Medicare Advantage Prescription Drug (MAPD) or commercial plans for patients aged > 18 years with ≥ 1 prescription filled for a DPP-4 inhibitor between July 1, 2011, and March 31, 2013. The first prescription claim for a DPP-4 inhibitor established the index date and index medication; 12-month pre-index and post-index data were analyzed. The Diabetes Complications Severity Index (DCSI) was used to assess a level of baseline diabetes-related comorbidities. Adherence (proportion of days covered [PDC] ≥ 80%) and persistence (< 31-day gap) measures were compared before and after, adjusting for DCSI, pre-index insulin, age, and gender. Post-index costs (in 2013 U.S. dollars) were compared using general linear modeling (GLM) to adjust for pre-index costs, DCSI, pre-index insulin, age, and gender. RESULTS: Based on study criteria, 22,860 patients with MAPD coverage (17,292 sitagliptin, 4,282 saxagliptin, and 1,286 linagliptin) and 3,229 patients with commercial coverage (2,368 sitagliptin, 643 saxagliptin, and 218 linagliptin) were included. For MAPD patients, the mean age was 70-72 years, and females represented 50%-52% of patients. For commercial patients, mean age was 55-56 years, and females represented 44% of patients. Clinical indicators for patients on linagliptin showed a higher comorbidity level than sitagliptin or saxagliptin cohorts (MAPD DCSI 3.0 vs 2.4 and 2.2, P < 0.001; commercial DCSI 1.2 vs. 0.9 and 0.9, P < 0.001); a higher use of pre-index insulin (MAPD 22% vs. 15% and 14%, P < 0.001; commercial 18% vs. 11% and 10%, P = 0.003); and higher mean pre-index costs (MAPD $14,448 vs. $11,818 and $10,399, P < 0.001; commercial $13,868 vs. $9,357 and $8,223, P = 0.016). For the MAPD cohort, the unadjusted PDC was lower for linagliptin patients (67%) compared with saxagliptin (72%) or sitagliptin (72%) patients (P < 0.001). Significant differences were still seen when adjusted for covariates. Linagliptin patients were more likely to be nonpersistent (73%) than those on saxagliptin (65%) or sitagliptin (67%; P < 0.01 for adjusted and unadjusted comparisons). For the commercial population, there were no significant differences in mean PDC between the 3 groups (linagliptin 70%, saxagliptin 72%, and sitagliptin 74%; P = 0.096). Dichotomized comparisons of nonpersistence were significantly different (linagliptin 65%, saxagliptin 62%, and sitagliptin 57%; P = 0.010), although upon adjustment using a Cox proportional hazard model, no significant differences were found. When controlling for other factors, post-index adjusted health care costs were similar between the medication cohorts (MAPD: sitagliptin = $13,913, saxagliptin = $13,651, and linagliptin = $13,859; commercial: sitagliptin = $11,677, saxagliptin = $12,059, and linagliptin = $11,163; all P > 0.25). CONCLUSIONS: For MAPD and commercial populations, baseline patient demographics were similar between the 3 DPP-4 inhibitor groups, but the linagliptin group may have had more complex patients (higher pre-index costs, higher DCSI, and more use of insulin). For the MAPD population, patients on linagliptin were less adherent and persistent than patients taking sitagliptin or saxagliptin for all unadjusted and adjusted comparisons. For the commercial population, which was notably smaller, these differences were in the same direction, but not all were statistically significant. When controlling for baseline factors, 12-month post-index direct medical health care costs were similar between index DPP-4 inhibitors. DISCLOSURES: No external funding was provided for this research. The project was done as part of internal work by Humana employees. Rascati received no compensation. None of the authors have any financial disclosures or conflicts of interests to report. Worley and Everhart are employees of Comprehensive Health Insights, a subsidiary of Humana, and Meah is an employee of Humana. Discussion of the adherence and persistence data was presented as a poster at the Academy of Managed Care Pharmacy Nexus Conference, October 2015. Cost data were presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research 18th Annual European Congress, November 2015. Study concept and design were contributed by Rascati, Worley, and Meah, along with Everhart. Rascati took the lead in data collection, assisted by Meah, and data interpretation was performed by all the authors. The manuscript was written primarily by Rascati, along with Worley, Everhart, and Meah, and revised by Rascati, Everhart, and Worley, with assistance from Meah.

Direct and indirect costs among patients with binge-eating disorder in the United States.

OBJECTIVE: To quantify the economic burden of binge-eating disorder (BED) in terms of work productivity loss, healthcare resource utilization, and healthcare costs. METHODS: Respondents of the US National Health and Wellness Survey 2013 were invited to participate in a follow-up internet survey to identify adults with BED using DSM-5 criteria. Work productivity loss, healthcare resource utilization, and direct and indirect costs were assessed for BED respondents and matched non-BED respondents using generalized linear models or two-part models as appropriate. RESULTS: A total of 1,720 people were included in our analysis (N = 344 with BED; N= 1,376 without BED). BED respondents had higher levels of activity impairment than non-BED respondents (41.29% vs. 23.18%, p < .001). Employed BED respondents (N = 178) had a greater level of work impairment than employed non-BED respondents (N = 686) (36.83% vs. 14.41%, p = .009). Higher healthcare resource utilization in the past 6 months among BED respondents was reported than matched non-BED respondents: numbers of surgeries (0.23 vs. 0.13, p = .021), ER visits (0.26 vs. 0.15, p = .016), and physician visits (6.09 vs. 4.56, p = .002). BED respondents reported higher total direct costs than matched non-BED respondents ($20,194 vs. $14,465, p = .005). The indirect costs among employed BED respondents were also higher than those without BED ($19,327 vs. $9,032, p < .001). DISCUSSION: Individuals with BED reported significantly greater economic burden with respect to work productivity loss, level of healthcare resource utilization, and costs compared to non-BED respondents. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:523-532).

Predictors of Appropriate Pharmacotherapy Management of COPD Exacerbations and Impact on 6-Month Readmission.

BACKGROUND: Suboptimal treatment of exacerbations is a major concern in management of chronic obstructive pulmonary disease (COPD). The Pharmacotherapy Management of COPD Exacerbation (PCE) Healthcare Effectiveness Data and Information Set (HEDIS) measure is a quality measure included by the National Committee for Quality Assurance that focuses on appropriate use of steroids and bronchodilators during an acute COPD exacerbation. There is limited evidence evaluating predictors of this quality measure, as well as its association with hospital readmission and cost outcomes. OBJECTIVES: To (a) describe characteristics of patients hospitalized for COPD, (b) evaluate factors associated with appropriate receipt of pharmacotherapy upon discharge, and (c) evaluate factors associated with the rate of readmission. METHODS: In this retrospective, observational, event-based study of COPD-related hospital and ED visits, events were identified between 2007 and 2013 from a Central Texas health plan using administrative claims data. The index date was defined as the date of admission. Subjects were included if they were aged ≥ 40 years and had a medical claim with a primary diagnosis for COPD or a pharmacy claim for a COPD maintenance medication during the 1-year pre-index period. Study groups were identified based on the receipt of PCE within the time frame specified by HEDIS: (a) a systemic corticosteroid within 14 days of discharge (PCE-C) or (b) a bronchodilator within 30 days of discharge (PCE-D). Bivariate analyses of potential factors associated with the receipt of PCE were performed using t-tests for continuous data and chi-square tests for categorical data. Generalized estimating equations, including significant predictors from the bivariate analyses, were used to determine factors associated with receipt of PCE-C and/or PCE-D, as well association with COPD-related and all-cause readmission within 6 months of discharge. RESULTS: Of 375 identified index admissions, 254 (68%) patients received PCE-C; 299 (80%) received PCE-D; and 229 (61%) received both. Patients were more likely to receive PCE with an index inpatient visit as compared with an ED visit (PCE-C: RR = 2.25, 95% CI = 1.21-4.17, P = 0.010; PCE-D: RR = 1.90, 95% CI = 1.01-3.58, P = 0.048). Those with previous use of rescue medication were also more likely to receive PCE (PCE-C: RR = 1.88, 95% CI = 1.12-3.17, P = 0.018; PCE-D: RR = 2.11, 95% CI = 1.16-3.83, P = 0.014). Patients with greater adherence (proportion of days covered [PDC] ≥ 75%) to COPD maintenance medication before admission (RR = 8.67, 95% CI = 1.60-46.78, P = 0.012) were also more likely to receive PCE-D. Older patients were more likely to have a COPD-related readmission (RR = 1.07, 95% CI = 1.01-1.13, P = 0.028), while use of maintenance medication before admission was associated with lower risk of an all-cause readmission (RR = 0.49, 95% CI = 0.30-0.79, P = 0.004). In addition, patients with higher medical and pharmacy costs before the index event were more likely to have all-cause readmission (RR = 1.01, 95% CI = 1.00-1.02, P = 0.013). Receipt of PCE was not shown to be a significant predictor of all-cause or COPD-related readmission. CONCLUSIONS: The use of bronchodilators and systemic corticosteroids after a COPD-related inpatient or ED visit may be related to the severity of the index COPD exacerbation or patients' previous pattern of bronchodilator use. However, the use of maintenance medication before the index event was associated with a significant reduction in all-cause readmission, so proper treatment of the underlying disease may be an effective strategy in reducing readmission. DISCLOSURES: Funding for this study was provided by GlaxoSmithKline (HO-14-15081). Tran was a Fellow at Scott & White Health Plan (SWHP) during year 1 of this study and a Fellow at Novartis during year 2 of this study. Novartis did not have any input in this study nor did it contribute any funding or support for this research. Tran, Xiang, Godley, and Stock were employed by SWHP at the time of this study. Rascati is employed by the University of Texas at Austin and also by the Journal of Managed Care & Specialty Pharmacy and has received consulting fees from GlaxoSmithKline. Coleman, Bogart, and Stanford are GlaxoSmithKline employees and shareholders. Study design was created by Rascati, Tran, and Godley, with assistance from Stock, Coleman, Bogart, and Stanford. Tran and Xiang collected the data, with data analysis and interpretation performed by Stock and Rascati. The manuscript was written by Tran, Rascati, and Xiang and revised by Godley, Stock, Coleman, Bogart, and Stanford.

Medication Adherence and Persistence in Patients with Severe Major Depressive Disorder with Psychotic Features: Antidepressant and Second-Generation Antipsychotic Therapy Versus Antidepressant Monotherapy.

BACKGROUND: Major depressive disorder with psychotic features, or psychotic depression, is a severe mental health disorder often associated with a worse depression-related symptom profile when compared with major depressive disorder without psychotic features. While combination pharmacotherapy with an antidepressant and an antipsychotic is recommended as first-line therapy, antidepressant monotherapy has been found to be useful and efficacious in psychotic depression. OBJECTIVE: To assess the rates of antidepressant adherence and antidepressant persistence in Texas Medicaid patients with psychotic depression who used antidepressant plus second-generation antipsychotic (AD/SGA) therapy or antidepressant (AD) monotherapy. METHODS: Using Texas Medicaid prescription and medical claims data from September 2007 to December 2012, adult patients aged 18-63 years were included if they had no confounding psychiatric disorders, no antidepressant claims during a 6-month pre-index period, and at least 1 diagnosis for severe major depressive disorder with psychotic features (ICD-9-CM codes 296.24 and 296.34). The first claim date for an antidepressant served as the index date. All patients were required to have at least 2 antidepressant claims, and those in the AD/SGA cohort were required to have 2 or more claims for an SGA. Study covariates included age, gender, race/ethnicity, residence, Charlson Comorbidity Index (CCI) score, and tobacco use/dependence. Statistical analyses included descriptive statistics, univariate analyses, logistic regression, and Cox proportional hazards regression. RESULTS: A total of 926 patients met study criteria (AD cohort = 510; AD/SGA cohort = 416). The overall sample had a mean [±SD] age of 40.5 [±13.2] years and was primarily female (66.8%) and non-Caucasian (74.8%). When compared with the AD cohort, patients in the AD/SGA cohort had a 52.3% higher likelihood of being adherent to antidepressant therapy based on proportion of days covered (PDC; OR = 1.523; 95% CI = 1.129-2.053; P = 0.006). Similarly, antidepressant adherence was 42.0% higher for the AD/SGA cohort based on medication possession ratio (MPR; OR = 1.420; 95% CI = 1.062-1.898; P = 0.018). Younger patients, African Americans, and tobacco users/dependents had significantly worse likelihoods of antidepressant medication adherence based on PDC and MPR. The risk of antidepressant nonpersistence was 23.2% lower for patients in the AD/SGA cohort (HR = 0.768; 95% CI = 0.659-0.896; P = 0.001), compared with those in the AD cohort. Antidepressant nonpersistence was significantly higher in younger patients, African Americans, Hispanics, and tobacco users/dependents. CONCLUSIONS: Better antidepressant adherence and persistence outcomes were associated with combination pharmacotherapy with an AD and an SGA antipsychotic. This study provides real-world estimates that support the current first-line treatment recommendations for psychotic depression; however, it should be noted that the majority of study patients used AD therapy only. Future research in psychotic depression is needed. DISCLOSURES: Kim-Romo received funding to conduct this study from the PhRMA Foundation Pre-Doctoral Fellowship in Health Outcomes. Rascati, Richards, Ford, Wilson, and Beretvas declare no conflict of interest in relation to this manuscript. Kim-Romo and Rascati collaborated on the study design, data analysis, study interpretation, and writing of this manuscript. Richards, Ford, Wilson, and Beretvas provided critical evaluation of the study design, analysis, and interpretation, as well as edited this manuscript.