Patient-Reported Racial and Ethnic Disparities in Patients With Ulcerative Colitis: Results From the National Health and Wellness Survey.

Background: Ulcerative colitis (UC) is an inflammatory condition characterized by chronic, disabling gastrointestinal symptoms that can have detrimental effects on psychological, social, and professional quality of life. Few studies have examined patient-reported outcomes (PROs) and economic outcomes among individuals with varying UC severity and across different racial/ethnic groups. Methods: This cross-sectional study assessed sociodemographic data, PROs, and economic outcomes for participants from the National Health and Wellness Survey (2018, 2019, and 2020) with UC. Multivariable analyses were used to assess the association of self-reported UC severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HCRU), and medical costs. Results: This study included 1500 participants with UC (1150 non-Hispanic White, 99 non-Hispanic Black, and 251 Hispanic). Moderate/severe disease was associated with significantly worse HRQoL and WPAI, greater HCRU, and higher direct medical costs than mild UC. Compared with non-Hispanic White participants, non-Hispanic Black participants reported better HRQoL, whereas Hispanic participants reported more HCRU and higher medical costs. Race/ethnicity significantly interacted with UC severity level in predicting labor force participation. Conclusions: Participants with moderate/severe disease had worse outcomes than those with mild UC. Additionally, racial/ethnic differences were found in HRQoL, employment, WPAI, HCRU, and direct medical costs. Notably, Hispanic participants showed distinct patterns, particularly in how disease severity influenced employment outcomes. Further research is needed to better understand the differential burden among patients across racial/ethnic groups.

COPD treatment ratio: a measure for improving COPD population health.

OBJECTIVES: Despite chronic obstructive pulmonary disease (COPD) being a leading cause of death in the US, there are few COPD measures in current quality programs. The objective of this study was to assess the validity and applicability of the COPD treatment ratio (CTR) as a surrogate marker of COPD exacerbation risk for use in quality measurement. CTR is defined as the ratio of COPD maintenance medications to all COPD medications (maintenance and rescue). STUDY DESIGN: This retrospective cohort study used 2016-2019 administrative claims from Optum Clinformatics Data Mart to evaluate CTR values over a 12-month baseline period, with exacerbations measured the following year. Patients 40 years or older with Medicare Advantage or commercial insurance and with a COPD diagnosis were included. METHODS: Logistic regression models were used to examine relationships between CTR values and COPD exacerbations. Prediction model performance was evaluated using C statistics, and receiver operating characteristics were used to determine the optimal cut point for CTR. RESULTS: Of 132,960 patients included in the analysis, 79.5% were Medicare Advantage beneficiaries, and the mean age was 69.6 years. Higher CTR values were significantly associated with reduced risk of any, moderate, and severe exacerbations in the total population and when stratified by insurance type. CTR performed fairly to moderately well in predicting COPD exacerbations. The optimal cut point for COPD exacerbation prediction was 0.7. CONCLUSIONS: Study results substantiated CTR as a valid measure of COPD exacerbation risk and support the use of CTR in quality improvement to drive evidence-based care for individuals with COPD.

Real-World Treatment Persistence Among Advanced Therapy-Naïve or -Experienced Patients with Ulcerative Colitis Initiated on Ustekinumab or Adalimumab.

INTRODUCTION: Persistence on advanced therapies in ulcerative colitis (UC) is a useful real-world treatment performance measure. This study compared real-world persistence during the maintenance phase among advanced therapy-naïve and -experienced patients with UC initiated on ustekinumab or adalimumab. METHODS: Claims data from the IQVIA PharMetrics® Plus de-identified database (01/01/2015-06/30/2022) were used to select adult patients with UC treated with ustekinumab or adalimumab based on the agent first initiated (index date) after 10/21/2019. Inverse probability of treatment weighting was used to balance cohorts on baseline characteristics. Persistence on the index agent (no gaps in days of supply of > 120 days for ustekinumab or > 60 days for adalimumab), persistence while corticosteroid-free, while on monotherapy, and persistence on the US labeled dose were described and compared during the 12-month period post-index using Kaplan-Meier analysis and Cox proportional hazards models. Outcomes were analyzed separately among advanced therapy-naïve and advanced therapy-experienced patients. RESULTS: At 12 months post-index, advanced therapy-naïve patients receiving ustekinumab (n = 371) had higher persistence on the index agent [83.8% vs. 57.6%, hazard ratio (95% confidence interval) = 3.09 (2.29-4.16); p < 0.001), persistence while corticosteroid-free [2.00 (1.63-2.45); p < 0.001], persistence while on monotherapy [2.67 (2.07-3.44); p < 0.001], and persistence on the labeled dose [4.21 (2.76-6.44); p < 0.001] versus those receiving adalimumab (n = 1726). At 12 months post-index, advanced therapy-experienced patients receiving ustekinumab (n = 693) had higher persistence on the index agent [78.1% vs. 59.2%, 2.44 (1.82-3.26); p < 0.001], persistence while corticosteroid-free [1.24 (1.01-1.54); p = 0.0447], persistence while on monotherapy [2.53 (2.00-3.21); p < 0.001], and persistence on the labeled dose [4.77 (3.09-7.35); p < 0.001] versus those receiving adalimumab (n = 254). CONCLUSION: This claims-based analysis demonstrated significantly higher treatment persistence, including persistence while corticosteroid-free, persistence while on monotherapy, and persistence on the labeled dose, among both advanced therapy-naïve and advanced therapy-experienced patients with UC initiated on ustekinumab compared to adalimumab.

Real-World Long-Term Persistence and Surgical Procedure-Free Period Among Bio-naïve Patients with Crohn's Disease and Fistula Initiated on Ustekinumab.

INTRODUCTION: Fistula is a common complication of Crohn's disease (CD). Treatment with biologics has been associated with fistula healing. Long-term persistence is an important factor for a chronic inflammatory process such as fistula. This study described 24-month persistence and time-to-surgery endpoints among bio-naïve patients with CD and intestinal fistula who were initiated on ustekinumab. METHODS: Adults with CD and any enteric or perianal fistula initiated on ustekinumab (index date) between September 23, 2016, and March 2, 2022, were selected from the IQVIA PharMetrics® Plus database and followed up to 24 months. Persistence on ustekinumab (no gaps in days of supply of > 120 days) and composite endpoints of being persistent while on monotherapy and persistent while corticosteroid free were also assessed. The date of surgery was defined as the date of first claim for any CD-related surgeries. Persistence and time-to-surgery endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or other biologic use (event), corticosteroid use (event), date of surgery (event), 24-month follow-up or data end (censoring) using Kaplan-Meier analyses. RESULTS: The sample included 445 patients (mean age: 42.8 years; 56.6% female). The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI] 55.8-71.4). Furthermore, 53.3% of patients were persistent while on monotherapy (95% CI 45.1-60.7), and 45.6% of patients were persistent while being corticosteroid free (95% CI 36.9-53.8). At 24 months, 22.8% (95% CI 17.0-30.3) of patients underwent any CD-related surgery. CONCLUSION: This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after initiation. Time-to-surgery estimate was comparable to existing evidence. These findings support ustekinumab as a treatment option for long-term management of CD with fistula.

Comparison of real-world healthcare resource utilization among advanced therapy-naïve and advanced therapy-experienced patients with ulcerative colitis initiated on ustekinumab or vedolizumab.

OBJECTIVES: To describe and compare healthcare resource utilization (HRU) among advanced therapy-naïve and advanced therapy-experienced patients with ulcerative colitis (UC) initiating ustekinumab or vedolizumab in the United States. METHODS: Claims data from IQVIA PharMetrics Plus de-identified database (01/01/2015-06/30/2022) were used to identify adult patients with UC initiating ustekinumab or vedolizumab (index date) after 10/21/2019. Baseline characteristics were balanced using inverse probability of treatment weighting. All-cause and UC-related HRU (number of inpatient admissions, inpatient days, emergency department visits, and outpatient visits) were described during the post-index period, and Poisson regression models were used to evaluate associations between index therapy and HRU outcomes. Analyses were performed separately among advanced therapy-naïve or advanced therapy-experienced patients. RESULTS: A total of 444 (ustekinumab) and 1,917 (vedolizumab) advanced therapy-naïve patients, and 647 (ustekinumab) and 1,152 (vedolizumab) advanced therapy-experienced patients were identified. In advanced therapy-naïve patients, higher rates of UC-related inpatient days (rate ratio [95% confidence interval] = 1.84 [1.15, 3.58]; p = 0.004), emergency department visits (1.39 [1.01, 2.17]; p = 0.044), and outpatient visits (1.81 [1.61, 2.04]; p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. In advanced therapy-experienced patients, higher rates of UC-related inpatient admissions (1.47 [1.06, 2.12]; p = 0.012), inpatient days (2.18 (1.44, 3.71); p < 0.001), and outpatient visits (1.50 (1.19, 1.82); p < 0.001) were observed among patients initiating vedolizumab relative to ustekinumab. Results were similar when all-cause HRU was examined. CONCLUSIONS: Among patients with UC with and without advanced therapy experience, higher rates of all-cause and UC-related HRU were observed among those treated with vedolizumab relative to ustekinumab.

Racial and Ethnic Disparities in Health-Related Outcomes in Crohn's Disease: Results From the National Health and Wellness Survey.

Background: Crohn's disease (CD) is a chronic inflammatory condition affecting the entire gastrointestinal tract that is associated with significant humanistic, clinical, and economic burdens. Few studies have assessed the association between CD severity and patient-reported outcomes (PROs), healthcare resource utilization (HCRU), and medical costs; even fewer have examined differences in disease outcomes among patients of various racial/ethnic groups. Methods: In this cross-sectional study, sociodemographic data, PROs, and economic outcomes for participants with self-reported CD were collected from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of CD severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), HCRU, and medical costs. Results: Analyses included 1077 participants with CD (818 non-Hispanic White, 109 non-Hispanic Black, and 150 Hispanic). Participants with self-reported moderate/severe CD reported significantly worse HRQoL and WPAI, greater HCRU, and higher medical costs than those with self-reported mild CD. Non-Hispanic Black participants reported better HRQoL and fewer healthcare provider visits than non-Hispanic White participants. There were no significant differences in PROs between non-Hispanic White and Hispanic groups. Interactions between race/ethnicity and CD severity emerged for some, but not all groups: Specifically, non-Hispanic Black participants with moderate/severe CD reported greater absenteeism and more gastroenterologist visits than non-Hispanic Black participants with mild CD. Conclusions: Participants with moderate/severe CD reported worse PROs, greater HCRU, and higher medical costs than those with mild CD. Additionally, racial/ethnic differences were found across several HCRU and economic outcomes. Further research is needed to better understand factors contributing to burden among patients with varying CD severity across racial/ethnic groups.

Associations between pharmacy choice and influenza vaccination: Mail order vs community pharmacy users.

BACKGROUND: Despite the effectiveness of vaccines, US adult vaccination rates remain low. This is especially true for the influenza vaccine, which is recommended annually and widely available. The accessibility of community pharmacies as convenient places to receive influenza vaccines has been shown to increase uptake. However, use of mail order pharmacies may reduce in-person pharmacist encounters and reduce the likelihood that users receive annual influenza vaccines. OBJECTIVE: To determine the association between the type of pharmacy a patient uses and their likelihood of receiving an influenza vaccine. METHODS: This cross-sectional cohort study used the 2018 Medical Expenditure Panel Survey to observe noninstitutionalized US adult pharmacy users. Pharmacy type was dichotomized into community use only vs any mail order pharmacy use. Multivariable weighted logistic regression was used to identify associations between the type of pharmacy used and influenza vaccination, adjusting for sociodemographic, health status, and health care access and utilization confounders. All analyses were stratified by age (< 65 and ≥ 65 years). RESULTS: The aged younger than 65 years and aged 65 years and older samples had 8,074 and 4,037 respondents who represented 95,930,349 and 40,163,276 weighted observations, respectively. Compared with community pharmacy users, mail order users were more likely to be aged 65 and older, be White, have high income, and have a usual source of care (P < 0.0001). Adjusted odds ratios (AORs) for influenza vaccination were significantly lower among community pharmacy users than mail order users among individuals aged younger than 65 years (AOR=0.71; 95% CI = 0.580.87) but was not significant among those aged 65 years and older (AOR = 0.87; 95% CI = 0.69-1.09). CONCLUSIONS: Community pharmacy users aged younger than 65 years are less likely to receive the influenza vaccine than their mail order pharmacy user counterparts. These counterintuitive results could be caused by residual confounding due to differences in factors that influence pharmacy use type and vaccination likelihood. Further exploration is needed to account for differences between these populations that independently drive vaccination choice. DISCLOSURES: Dr Burbage was a fellow in the Real World Evidence, Population Health and Quality Research Postdoctoral Fellowship Program in collaboration with University of North Carolina Eshelman School of Pharmacy and Pharmacy Quality Alliance, and supported by Janssen Scientific Affairs at the time of this study. She is now employed by Janssen Scientific Affairs. Dr Parikh is an employee of Pharmacy Quality Alliance. Dr Campbell was employed by Pharmacy Quality Alliance at the time of the study. He is now employed by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Ramachandran has received an unrelated research contract with Pharmacy Quality Alliance. Dr Gatwood has received vaccine-related research grants from Merck & Co. and GlaxoSmithKline unrelated to this project and consulting fees for a vaccine-related expert panel with Merck & Co. unrelated to this manuscript and is an advisory board member with Janssen Scientific Affairs. Dr. Urick was employed by the UNC Eshelman School of Pharmacy at the time of this writing and is currently employed by Prime Therapeutics. He has received community pharmacy-related consulting fees from Cardinal Health and Pharmacy Quality Solutions unrelated to this work. Dr Ozawa has a research grant from Merck & Co. unrelated to this project. This project did not receive funding from any agency in the public, commercial, or not-for-profit sectors.

Pharmacists as accessible health care providers: quantifying the opportunity.

BACKGROUND: Community pharmacists are well positioned to improve patient access to care, which may assist value-based care programs in reaching patients. While pharmacy accessibility is broadly acknowledged, much of the research supporting accessibility claims is poor quality. OBJECTIVE: To quantify the accessibility of pharmacists in comparison with physicians or qualified health care professionals (QHP) in a commercially insured population. METHODS: IBM MarketScan claims data from 2018 were used for this cross-sectional study. Beneficiaries included in the primary analysis were aged 18-64 years, enrolled with pharmacy benefits in 2018 for 12 months, and had at least 1 valid prescription drug claim or evaluation and management (E&M) code in 2018. Unique pharmacy visits were defined using a 6-day fill window for prescription fill dates, while visits to physicians or other QHP were defined as unique service dates tied to an E&M code. We assessed differences in visit frequency for the full sample, those with multiple chronic conditions (MCC), and "superutilizers" (top 5% based on total cost of care). Our statistical approach included descriptive statistics and the Wilcoxon sign rank test. RESULTS: After applying the inclusion criteria, 11,720,958 beneficiaries were included in the full sample. The MCC cohort contained 13.8% of the total sample (mean [SD] age: 50.8 [10.8]; 908,880 [56.1%] female). Finally, the superutilizers were 57.3% female with an average age of 48.4 years and comprised 5.3% of the total sample. The median number of pharmacy and physician or QHP visits for the full sample were 5 and 3 (P < 0.0001), yielding a pharmacy to physician or QHP visit ratio of 1.7:1. The MCC cohort had a median of 13 pharmacy visits and 7 physician or QHP visits (ratio 1.9:1; P < 0.0001), and the superutilizers had a median of 14 pharmacy visits and 9 physician or QHP visits (ratio 1.6:1; P < 0.0001). CONCLUSIONS: This study found that patients visit their community pharmacies almost twice as often as they visit their physicians or other QHP. Study findings emphasize the accessibility of community pharmacists and highlight the role of community pharmacists in improving patient engagement in all care programs, including value-based care programs. DISCLOSURES: The database infrastructure used for this project was funded by the Department of Epidemiology, University of North Carolina (UNC) Gillings School of Global Public Health; the Cecil G. Sheps Center for Health Services Research, UNC; the CER Strategic Initiative of UNC's Clinical Translational Science Award (UL1TR001111); and the UNC School of Medicine. All authors are employed by the UNC School of Pharmacy. Urick declares consulting fees from Cardinal Health. The other authors have no conflicts of interest to disclose. Portions of this work were previously presented at the AMCP 2021 Virtual, April 12-16, 2021.