Predictors of flare-related inpatient or emergency department stay in systemic lupus erythematosus: A real-world analysis of Medicaid claims in the United States.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by multisystem inflammation. Medical management of SLE is based on reducing inflammation and tissue damage in the affected organs; however, medications used to treat SLE have been found to contribute to additional organ damage. Therefore, finding new ways to predict and prevent flares that require an inpatient (IP) stay or emergency department (ED) visit is critical for reducing the clinical and economic burden in patients with SLE. OBJECTIVE: To identify risk factors of SLE flares requiring an IP/ED visit among a Medicaid-insured population with SLE. METHODS: This retrospective study included patients from the Merative MarketScan Medicaid database (2013-2019). To capture patients at all stages of their SLE journey, all SLE claims for a patient were captured, and the index date was randomly selected among those claims that were at least 12 months after the first evidence of SLE. Patients were required to be continuously enrolled 1-year pre-index (year 1) and post-index (year 2). Demographics, clinical characteristics, and health care use and costs were measured in year 1, and flares requiring an IP/ED visit were identified in year 2 using the Garris algorithm. Multivariable logistic regression and classification and regression tree (CART) modeling were used to identify year 1 predictors and combination of factors, respectively, associated with flares-related IP/ED visits. RESULTS: Of the 8,083 patients included in the study, 37.6% of patients (n = 3,039) had a flare. Logistic regression identified ED visits in year 1 as one of the strongest predictors of flares-related IP/ED visits in year 2 (odds ratio = 2.19 [95% CI = 1.93-2.49]). SLE treatment progression to biologics (0.54 [0.42-0.70]) was the strongest predictor of decreased odds. Other strong predictors included other neurological disorders (1.63 [1.43-1.87]), Black race (1.49 [1.32-1.68]), chronic kidney disease/renal failure (1.35 [1.10-1.66]), and opioid use (1.30 [1.17-1.45]). CART modeling identified patients with an ED visit, an IP admission, and a diagnosis of Elixhauser Comorbidity Index-defined other neurological disorders in year 1 as having the highest probability of a flare-related IP/ED visit in year 2 (probability = 0.708), whereas patients without an ED visit had the lowest probability (probability = 0.185). CONCLUSIONS: Patients with the highest risk of a flare that required an IP/ED visit were those with a prior ED visit, IP admission, and other neurological disorders. Modeling also identified patients with prior opioid use, Black patients, and patients without SLE medications as subgroups with a high risk of a flare requiring an IP/ED visit.

Utilization and disparities in medication treatment for opioid use disorder among patients with comorbid opioid use disorder and chronic pain during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic's impact on utilization of medications for opioid use disorder (MOUD) among patients with opioid use disorder (OUD) and chronic pain is unclear. METHODS: We analyzed New York State (NYS) Medicaid claims from pre-pandemic (August 2019-February 2020) and pandemic (March 2020-December 2020) periods for beneficiaries with and without chronic pain. We calculated monthly proportions of patients with OUD diagnoses in 6-month-lookback windows utilizing MOUD and proportions of treatment-naïve patients initiating MOUD. We used interrupted time series to assess changes in MOUD utilization and initiation rates by medication type and by race/ethnicity. RESULTS: Among 20,785 patients with OUD and chronic pain, 49.3% utilized MOUD (versus 60.3% without chronic pain). The pandemic did not affect utilization in either group but briefly disrupted initiation among patients with chronic pain (ß=-0.009; 95% CI [-0.015, -0.002]). Overall MOUD utilization was not affected by the pandemic for any race/ethnicity but opioid treatment program (OTP) utilization was briefly disrupted for non-Hispanic Black individuals (ß=-0.007 [-0.013, -0.001]). The pandemic disrupted overall MOUD initiation in non-Hispanic Black (ß=-0.007 [-0.012, -0.002]) and Hispanic individuals (ß=-0.010 [-0.019, -0.001]). CONCLUSIONS: Adults with chronic pain who were enrolled in NYS Medicaid before the COVID-19 pandemic had lower MOUD utilization than those without chronic pain. MOUD initiation was briefly disrupted, with disparities especially in racial/ethnic minority groups. Flexible MOUD policy initiatives may have maintained overall treatment utilization, but disparities in initiation and care continuity remain for patients with chronic pain, and particularly for racial/ethnic minoritized subgroups.

Risks of opioid overdose among New York State Medicaid recipients with chronic pain before and during the COVID-19 pandemic.

OBJECTIVE: The COVID-19 pandemic contributed to healthcare disruptions for patients with chronic pain. Following initial disruptions, national policies were enacted to expand access to long-term opioid therapy (LTOT) for chronic pain and opioid use disorder (OUD) treatment services, which may have modified risk of opioid overdose. We examined associations between LTOT and/or OUD with fatal and non-fatal opioid overdoses, and whether the pandemic moderated overdose risk in these groups. METHODS: We analyzed New York State Medicaid claims data (3/1/2019-12/31/20) of patients with chronic pain (N = 236,391). We used generalized estimating equations models to assess associations between LTOT and/or OUD (neither LTOT or OUD [ref], LTOT only, OUD only, and LTOT and OUD) and the pandemic (03/2020-12/2020) with opioid overdose. RESULTS: The pandemic did not significantly (ns) affect opioid overdose among patients with LTOT and/or OUD. While patients with LTOT (vs. no LTOT) had a slight increase in opioid overdose during the pandemic (pre-pandemic: aOR:1.65, 95% CI:1.05, 2.57; pandemic: aOR:2.43, CI:1.75,3.37, ns), patients with OUD had a slightly attenuated odds of overdose during the pandemic (pre-pandemic: aOR:5.65, CI:4.73, 6.75; pandemic: aOR:5.16, CI:4.33, 6.14, ns). Patients with both LTOT and OUD also experienced a slightly reduced odds of opioid overdose during the pandemic (pre-pandemic: aOR:5.82, CI:3.58, 9.44; pandemic: aOR:3.70, CI:2.11, 6.50, ns). CONCLUSIONS: Findings demonstrated no significant effect of the pandemic on opioid overdose among people with chronic pain and LTOT and/or OUD, suggesting pandemic policies expanding access to chronic pain and OUD treatment services may have mitigated the risk of opioid overdose.

Clinical and economic characterization of mild, moderate, and severe systemic lupus erythematosus: Real-world observation across payer channels in the United States.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting as many as 322,000 people in the United States. Because of heterogeneity in both disease course and clinical manifestations, it is critical to identify a prevalent SLE population that includes patients with moderate or severe disease. Additionally, differences in the clinical and economic burden of SLE may exist across payer channels, yet to date this has not been reported in any previous studies. OBJECTIVE: To characterize the clinical and economic burden of SLE across disease severity and payer channels. METHODS: This retrospective study included patients from Merative MarketScan Commercial, Medicare Supplemental, and Medicaid databases from 2013 to 2020 (Commercial/Medicare) or 2013 to 2019 (Medicaid), with at least 1 inpatient or at least 2 outpatient SLE claims and no invalid steroid claims. The index date was a random SLE claim with at least 12 months of disease history. Patients were continuously enrolled 1 year pre-index (baseline) and 1 year post-index and classified with mild, moderate, or severe disease using a published algorithm. Baseline demographics, clinical characteristics, flares, and utilization/costs were compared across disease severity. RESULTS: 22,385 Commercial, 2,035 Medicare, and 8,083 Medicaid patients had SLE. Most Medicaid patients (51.1%) had severe disease. Comorbidity scores increased with disease severity (P < 0.001). 30.7% of Commercial, 34.1% Medicare, and 51.3% Medicaid patients had opioids, which increased with disease severity (P < 0.001). All-cause costs ranged from 1.8- to 2.3-fold for moderate vs mild and 4.2- to 6.5-fold for severe vs mild. Outpatient medical costs accounted for the highest proportion of all-cause costs, except Medicaid patients with severe disease, for whom inpatient costs were highest. Mean (SD) SLE-related annual costs were $23,030 (43,304) vs $1,738 (4,427) in severe vs mild for Commercial, $12,264 (31,896) vs $2,024 (4,998) for Medicare, and $7,572 (27,719) vs $787 (3,797) for Medicaid (P < 0.001). For patients with severe disease in Medicaid, 16.5% and 60.1% had inpatient and emergency department (ED) visits, respectively, vs 10.3% and 26.5% Commercial vs 10.6% and 24.6% Medicare. Mean [SD] flares per year in the baseline period increased from 2.5 [1.7] in mild to 4.6 [1.9] in severe for Commercial, 3.2 [1.9] to 5.0 [2.1] for Medicare, and 2.0 [1.6] to 4.5 [2.0] for Medicaid. CONCLUSIONS: Patients with severe SLE experienced more comorbidities, flares, and utilization/costs. Outpatient costs were the largest driver of all-cause costs for Commercial and Medicare (and Medicaid for mild to moderate SLE). Medicaid beneficiaries had the highest rate of severe SLE, highest use of ED and inpatient services, and highest oral corticosteroid and opioid use but the lowest utilization of disease-modifying treatments. Results demonstrate an unmet need in SLE treatment, especially among patients with moderate to severe disease or Medicaid coverage. DISCLOSURES: This study was funded by AstraZeneca. Drs Wu and Bryant are current employees of AstraZeneca and may own stock and/or options. At the time of the study, Ms Perry and Mr Tkacz were employed by IBM Watson Health, which received funding from AstraZeneca to conduct this study.

Evaluating chronic pain as a risk factor for COVID-19 complications among New York State Medicaid beneficiaries: a retrospective claims analysis.

OBJECTIVE: To assess whether chronic pain increases the risk of COVID-19 complications and whether opioid use disorder (OUD) differentiates this risk among New York State Medicaid beneficiaries. DESIGN, SETTING, AND SUBJECTS: This was a retrospective cohort study of New York State Medicaid claims data. We evaluated Medicaid claims from March 2019 through December 2020 to determine whether chronic pain increased the risk of COVID-19 emergency department (ED) visits, hospitalizations, and complications and whether this relationship differed by OUD status. We included beneficiaries 18-64 years of age with 10 months of prior enrollment. Patients with chronic pain were propensity score-matched to those without chronic pain on demographics, utilization, and comorbidities to control for confounders and were stratified by OUD. Complementary log-log regressions estimated hazard ratios (HRs) of COVID-19 ED visits and hospitalizations; logistic regressions estimated odds ratios (ORs) of hospital complications and readmissions within 0-30, 31-60, and 61-90 days. RESULTS: Among 773 880 adults, chronic pain was associated with greater hazards of COVID-related ED visits (HR = 1.22 [95% CI: 1.16-1.29]) and hospitalizations (HR = 1.19 [95% CI: 1.12-1.27]). Patients with chronic pain and OUD had even greater hazards of hospitalization (HR = 1.25 [95% CI: 1.07-1.47]) and increased odds of hepatic- and cardiac-related events (OR = 1.74 [95% CI: 1.10-2.74]). CONCLUSIONS: Chronic pain increased the risk of COVID-19 ED visits and hospitalizations. Presence of OUD further increased the risk of COVID-19 hospitalizations and the odds of hepatic- and cardiac-related events. Results highlight intersecting risks among a vulnerable population and can inform tailored COVID-19 management.

Health care resource utilization and costs associated with treatment among patients initiating calcitonin gene-related peptide inhibitors vs other preventive migraine treatments in the United States.

BACKGROUND: Limited data are available on health care resource utilization (HCRU) and health care costs of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) for preventive treatment of migraine. OBJECTIVE: To compare all-cause and migraine-related HCRU and direct health care costs in patients with migraine initiating CGRP mAbs, galcanezumab (GMB), vs standard-of-care (SOC) preventive treatments in the United States. METHODS: This retrospective observational study used insurance claims data collected from IBM MarketScan Research Databases. Adults (aged ≥ 18 years) with 1 or more claims for CGRP mAb (GMB, erenumab, or fremanezumab) or SOC preventive treatment between May 1, 2018, and June 30, 2019, were included. The date of earliest migraine treatment claim during this period was the index date. Annual all-cause and migraine-related HCRU included inpatient visits, emergency department visits, and acute and preventive migraine medication fills. After matching, HCRU and costs at 6- and 12-month follow-up in CGRP mAb, specifically GMB, vs SOC cohorts were analyzed using paired t-test and chi-square test. RESULTS: In the 12-month follow-up study, 4,528 patients using CGRP mAb (GMB, n = 426) and 10,897 patients using SOC were included. After matching, 3,082 pairs were identified in the CGRP mAb and SOC cohorts and 421 pairs in the GMB and SOC cohorts. After matching, all variables were well balanced across cohorts. At 12-month follow-up, the percentage decrease in acute and preventive migraine medication fills was significantly greater in the CGRP mAb (acute: -1.5% vs -0.2%, P < 0.001; preventive: -1.1% vs 3.8, P < 0.001) and GMB cohorts (acute: -1.5% vs -0.2%, P = 0.002; preventive: -1.8 vs 3.0, P < 0.001) compared with the SOC cohort. At follow-up, compared with the SOC cohort, the mean change of annual all-cause total costs was significantly higher in both the CGRP mAb ($6,043 vs $1,323, P < 0.001) and GMB cohorts ($8,398 vs $68, P < 0.001), and the mean change of annual migraine-related total costs was significantly higher in both the CGRP mAb ($3,416 vs $976, P < 0.001) and GMB cohorts ($4,334 vs $1,245, P < 0.001). Significant cost savings in mean acute and preventive migraine prescription costs occurred in both the CGRP mAb (acute: -$358 vs -$80, P < 0.001; preventive: -$298 vs $1,376, P < 0.001) and GMB cohorts (acute: -$280 vs -$36, P = 0.034; preventive: -$374 vs $1,537, P < 0.001) compared with the SOC cohort. CONCLUSIONS: Although treatment with CGRP mAbs and GMB increase total costs, they may lead to significantly greater cost savings in outpatient acute and preventive migraine medication costs vs SOC. Further studies assessing indirect health care costs are important to understand additional cost savings with CGRP mAbs. DISCLOSURES: Drs Varnado, Ye, and Schuh are employees and stockholders of Eli Lilly and Company. Dr Wenzel is a former employee of Eli Lilly and Company. Dr Manjelievskaia is an employee of IBM Watson Health. Ms Perry is a former employee of IBM Watson Health. This study was sponsored by Eli Lilly and Company. IBM Watson Health received funding for this study from Eli Lilly and Company. Independent analyses were conducted by IBM Watson Health. Eli Lilly and Company and IBM Watson Health collaborated on designing the study and interpreting results.

Effect of the US National HIV/AIDS Strategy targets for improved HIV care engagement: a modelling study.

BACKGROUND: The recently updated White House National HIV/AIDS Strategy (NHAS) includes specific progress indicators to improve the HIV care continuum in the USA, but the economic and epidemiological effect of achieving those indicators remains unclear. We aimed to project the impact of achieving NHAS goals on HIV incidence, prevalence, mortality, and costs among adults in the USA over 10 years. METHODS: We constructed a dynamic transmission model of HIV progression and care engagement based on literature sources and the most recent published US Centers for Disease Control and Prevention data. We specifically considered achievement of the 2020 targets set forth in NHAS progress indicator 1 (90% awareness of serostatus), indicator 4 (85% linkage within 1 month), and indicator 5 (90% of diagnosed individuals in care). FINDINGS: At current rates of engagement in the HIV care continuum, we project 524,000 (95% uncertainty range 442,000-712,000) new HIV infections and 375,000 deaths (364,000-578,000) between 2016 and 2025. Achievement of NHAS progress indicators 1 and 4 has modest epidemiological effect (new infections reduced by 2·0% and 3·9%, respectively). By contrast, increasing the proportion of diagnosed individuals in care (NHAS indicator 5) averts 52% (95% UR 47-56) of new infections. Achievement of all NHAS targets resulted in a 58% reduction (95% UR 52-61) in new infections and 128 000 lives saved (106,000-223,000) at an incremental health system cost of US$105 billion. INTERPRETATION: Achievement of NHAS progress indicators for screening, linkage, and particularly improving retention in care, can substantially reduce the burden of HIV in the USA, but continued and increased financial investment will be required. FUNDING: The National Institutes of Health, the B Frank and Kathleen Polk Assistant Professorship in Epidemiology, Emory University CFAR, Johns Hopkins University CFAR, and CDC/NCHHSTP Epidemiological and Economic Modeling Agreement (5U38PS004646).