Months Of Continuous Enrollment Research Articles

P048 Herpes Zoster Incidence in Patients with Systemic Lupus Erythematosus: A Retrospective Cohort Study

Abstract Background/Aims Herpes zoster (HZ) results from reactivation of the varicella-zoster virus and is characterized by a painful dermatomal rash. HZ is associated with increased healthcare costs and reduced patient quality of life. Objectives: To estimate HZ incidence in patients with systemic lupus erythematosus (SLE) and in a general immunocompetent adult population in the United States. Methods This retrospective cohort study used administrative claims data (Optum Research Database) to identify adults (≥18 years) between October 2015 and May 2022 who were assigned to one of two cohorts based on ICD-10-CM diagnosis codes: SLE cohort and immunocompetent cohort. Patients with diagnosis codes for other immunocompromising conditions (ICC) were excluded from the immunocompetent cohort and from the main SLE cohort to create a sub-cohort (SLE without other ICC). The immunocompetent cohort represented a random sample of one million individuals meeting the cohort criteria. Indexing occurred at the later of 12 months of continuous enrollment (CE) or the first SLE diagnosis for the SLE cohorts, and after 12 months of CE for the immunocompetent cohort. Patients with HZ vaccination prior to index or a HZ diagnosis in the 12-month baseline period were excluded. Patients were followed for a variable period from index until the earlier of an incident HZ diagnosis or censoring event (HZ vaccination, disenrollment, death, or the end of the study period). Overall incidence rates of HZ were estimated in each cohort and stratified by age at index, and by baseline disease severity for the SLE cohorts using a published algorithm. Results The SLE cohort included 60,430 patients, among which 21,206 comprised the SLE without other ICC cohort. The immunocompetent cohort included 1,000,000 patients. Mean (standard deviation) age and percent female for the SLE (55 [15] years; 89% female) and for the SLE without other ICC (53 [16] years; 89% female) cohorts were higher compared to the immunocompetent (46 [18] years; 50% female) cohort (p < 0.001). For the SLE cohort, HZ incidence (95% confidence interval [CI]) per 1,000 person-years was 19.72 (18.93-20.55) overall and 16.27 (15.04-17.58) and 21.50 (20.48-22.56) per 1,000 person-years for patients aged 18-49 and ≥50 years, respectively. HZ incidence (95% CI) for the SLE without other ICC cohort was 14.03 (12.83-15.32) per 1,000 person-years overall (18-49 years: 11.24 [9.61-13.07]; ≥50 years: 16.08 [14.39-17.91]). HZ incidence (95% CI) for the immunocompetent cohort was 5.64 (5.53-5.74) per 1,000 person-years (18-49 years: 3.46 [3.35-3.57]; ≥50 years: 8.57 [8.37-8.77]). HZ incidence rates in the SLE cohorts increased with baseline disease severity. Conclusion HZ incidence was high among patients with SLE. HZ prevention strategies in this population may be warranted. Disclosure N. Stempniewicz: Corporate appointments; N.S. is an employee of GSK. Shareholder/stock ownership; N.S. is a shareholder of GSK. A. Steffens: Consultancies; A.S. is a consultant of GSK. K. Kim: Corporate appointments; K.K. is an employee of GSK. A. Jorga: Corporate appointments; A.J. is an employee of GSK. Shareholder/stock ownership; A.J. is a shareholder of GSK. C.F. Bell: Corporate appointments; C.F.B. is an employee of GSK. Shareholder/stock ownership; C.F.B. is a shareholder of GSK. M. DuCharme: Consultancies; M.D. is a consultant of GSK. H. Trenz: Consultancies; H.T. is a consultant of GSK. D. Singer: Corporate appointments; D.S. is an employee of GSK. Shareholder/stock ownership; D.S. is a shareholder of GSK. H. Odedra: Corporate appointments; H.O. is an employee of GSK. Other; H.O. is the presenter on behalf of the authors.

759 Revisiting the ETV Success Score Using Machine Learning Can We Do Better?

INTRODUCTION: The endoscopic third ventriculostomy (ETV) success score (ETVSS) is a useful decision-making heuristic when considering the probability of surgical success, defined as no repeat CSF diversion surgery needed within six months. Nonetheless, the original dataset published in 2009 was relatively small (n = 618) and logistic regression (LR) model performance modest. METHODS: We queried the MarketScan national database for the years 2005-2020 to identify patients <18 years of age who underwent a first-time ETV and subsequently had at least 6 months of continuous enrollment in the database. We collected data on predictors matching the original ETVSS—age, etiology of hydrocephalus, and history of any previous shunt placement. Next, we used six ML algorithms—LR, support vector classifier, random forest, k-nearest neighbors, XGBoost, and Naive Bayes—to develop predictive models. Finally, we used nested cross-validation to assess models’ comparative performances on unseen data. RESULTS: We identified 1698 patients that met inclusion criteria, and 1139 (67%) had successful ETVs. Performance of all models exceeded that of the original ETVSS, with the LR model still performing best with area under the receiver operating characteristic curve (AUROC) 0.90 (95% confidence interval, 0.86-0.94), sensitivity 0.79 (0.70-0.88), and specificity 0.91 (0.87-0.95) at Youden’s index. The random forest was the second-best ML algorithm following closely behind. This compares favorably to the original ETVSS with AUROC 0.80 (0.76-0.84, p < 0.01), sensitivity 0.65 (0.47-0.85, p < 0.01), and specificity 0.71 (0.65-0.75, p < 0.01). CONCLUSIONS: Our predictions for ETV success outperform the current gold standard. Logistic regression may still be the most interpretable and predictive algorithm; further work is underway to externally validate these models.

Comparison of Healthcare Costs for Women with Treated Versus Untreated Vasomotor Symptoms Due to Menopause.

The study objective was to estimate all-cause healthcare resource utilization (HCRU) and medical and pharmacy costs for women with treated versus untreated vasomotor symptoms (VMS) due to menopause. A retrospective study was conducted using US claims data from Optum Research Database (study period: January 1, 2012-February 29, 2020). Women aged 40-63years with a VMS diagnosis claim and ≥ 12 and ≥ 18months of continuous enrollment during baseline and follow-up periods, respectively, were included. Women treated for VMS were propensity score matched 1:1 to untreated controls with VMS. Standardized differences (SDIFF) ≥ 10% were considered meaningful. A generalized linear model (gamma distribution, log link, robust standard errors) estimated the total cost of care ratio. Subgroup analyses of on- and off-label treatment costs were conducted. Of 117,582 women diagnosed with VMS, 20.5% initiated VMS treatment and 79.5% had no treatment. Treated women (n = 24,057) were matched to untreated VMS controls. There were no differences in HCRU at follow-up (SDIFF < 10%). Pharmacy ($487 vs $320, SDIFF 28.4%) and total ($1803 vs $1536, SDIFF 12.6%) costs were higher in the treated cohort. Total costs were 7% higher in the treated cohort (total cost ratio 1.07, 95% CI 1.05-1.10, P < 0.001). The on-label treatment pharmacy costs ($546 versus $315, SDIFF 38.6%) were higher in the treated cohort. Off-label treatment had higher medical costs ($1393 versus $1201, SDIFF 10.4%). Most women with VMS due to menopause were not treated within 6months following diagnosis. While both on- and off-label treatment increased the total cost of care compared with untreated controls, those increases were modest in magnitude and should not impede treatment for women who report symptom improvement as a result of treatment.

Impact of COVID-19 Infection on Health-Related Quality of Life in the Japanese Population: A Large Health-Insurance-Based Database Study.

Evidence for acute or long-term coronavirus disease 2019 (COVID-19) infection is relatively limited. We aimed to evaluate the impact of COVID-19 infection on health-related quality of life (HRQoL) in the Japanese population. Eligible study participants were 13,365 employees and their dependents who answered questionnaires at baseline and 18 months later and who had at least 6 months of continuous enrolment before and after baseline. Of the 711 study participants who developed COVID-19 infection, 29.0% reported a decline in HRQoL, whereas 25.2% of uninfected participants reported a decline. The adjusted odds ratios (95% confidence intervals) for the association between COVID-19 infection and declines in HRQoL in the age categories of less than 30 years, 30s, 40s, 50s, and 60 years or higher were 0.54 (0.15-1.92), 1.70 (1.03-2.81), 1.14 (0.82-1.57), 1.05 (0.77-1.42), and 0.87 (0.46-1.64), respectively. This study demonstrates a differential association between COVID-19 infection and declines in HRQoL by age group. A 1.7-fold increase in the odds of negative changes in HRQoL was observed in only those in their 30s. Further studies are needed to elucidate differences in the impact of COVID-19 infection on HRQoL between younger people such as those in their 30s and the older population.

Diagnosis patterns among diverse populations with mild cognitive impairment and Alzheimer’s disease: A large nationwide electronic health record cohort study

AbstractBackgroundWith recent advances and emerging research on diagnostic biomarkers and evolving diagnostic criteria, practitioners managing patients with cognitive complaints operate within a complex, changing environment. Although some evidence is available on the importance of prompt diagnosis, little information exists on the diagnostic process used in real‐world settings among diverse populations. This study’s objective was to characterize diagnosis patterns among adults with mild cognitive impairment (MCI), Alzheimer’s disease (AD), and/or dementia in the United States, and stratify by gender, age and race/ethnicity.MethodThis retrospective observational cohort study utilized the Optum® Market Clarity database from January 1, 2017–September 30, 2021. Eligible individuals had ≥1 diagnosis of MCI, AD, and/or dementia in their electronic health records or ≥2 diagnosis codes separated by ≥30 days in claims data, had ≥12 months of continuous enrollment before the cohort entry date, and had ≥1 day of continuous healthcare plan enrollment after the index date. Demographic information and the occurrence of diagnostic tests were also obtained from electronic medical records and insurance claims. Descriptive statistics were calculated and stratified by demographic factors.ResultA total of 179,419 newly diagnosed MCI cases, 81,267 AD cases, and 338,739 dementia cases were identified. The mean age at MCI, AD, or dementia diagnosis was similar overall for males and females. Among Caucasians, the mean age of MCI diagnosis was 70.5±14.8 for females and 69.8±14.5 for males. Among African Americans, the mean age at MCI diagnosis was 66.3±15.4 for females and 63.6±16.1 for males. PET scans and CSF biomarker screening occurred less often than MRI and CT (MCI: PET 0.6%, CSF 1.6%, MRI 16.6%, CT 17.5%; AD: PET 0.5%; CSF 0.9%; MRI 9.0%; CT 18.4%; dementia: PET 0.2%; CSF 1.6%; MRI 9.5%; CT 25.9%).ConclusionThe mean age at MCI, AD, and dementia diagnosis varied by demographic groups. The diagnosis of MCI, AD, and dementia remains largely clinical, with low use of brain imaging or CSF biomarkers. This knowledge of the patient populations and diagnostic experiences in a real‐world setting allows for greater understanding and growth to improve diagnosis across diverse groups and lead to faster support.

Anemia and Transfusion Dependency Are Important Prognostic Factors for Overall Survival in Patients with Myelofibrosis: Results of a Real-World Analysis of Medicare Patients

Introduction: Anemia is a hallmark feature of myelofibrosis (MF) and causes many patients (pts) to require red blood cell transfusions. Both anemia and transfusion dependency have been associated with decreased survival in pts with MF. The purpose of this study was to assess the relationship between anemia severity and transfusion dependency on overall survival (OS) among pts with MF in the Medicare population. Methods: This retrospective cohort study used the Medicare fee-for-service database to identify pts with a diagnosis of MF between January 1, 2012, and December 31, 2020. Study inclusion criteria were as follows: (1) ≥1 inpatient or ≥2 outpatient claims for MF (on separate dates &amp;lt;90 days apart; the earliest appearance of MF was set as the MF diagnostic index date [MFDID]); (2) 12 months of continuous enrollment preceding (baseline) and 6 months of continuous enrollment following (follow-up) the MFDID; (3) absence of Janus kinase inhibitor therapy during the 12-month baseline period; (4) absence of polycythemia vera, essential thrombocythemia, or another primary cancer other than basal and squamous cell skin carcinoma during the baseline period; and (5) absence of participation in a clinical trial. Transfusions were assessed over a 180-day landmark period following anemia index date (AID; set to the earliest evidence of anemia, unless it occurred during the 100 days prior to the MFDID, in which the AID was set to the MFDID), and pts were stratified into 3 subcohorts: transfusion independent (TI; no transfusions), transfusion dependent (TD; ≥6 transfusion claims on 6 separate days over any 12-week window), or transfusion requiring (TR; received transfusion claims but did not meet TD criteria). A subset of pts were identified as having anemia based on medical claims from the Medicare fee-for-service database or laboratory test results from the Prognos Biomarker and Laboratory Database ≤100 days before and any time after the MFDID, with severity subcohorts graded based on hemoglobin levels: mild (10 to &amp;lt;12 g/dL), moderate (8 to &amp;lt;10 g/dL), or severe (&amp;lt;8 g/dL) disease. OS from the MFDID was assessed for all pts using Kaplan-Meier analyses, with log-rank tests used to determine statistically significant differences among the transfusion dependency and anemia severity subcohorts. Results: A total of 1749 pts qualified for the transfusion cohorts: 980 were TI, 559 were TR, and 210 were TD. Mean age was 74.8 years, 47.9% were male, and 81.7% were White. Results of Kaplan-Meier analyses showed a median OS of 44.1 months (95% CI, 39.8-48.5 months) for the overall transfusion sample and 62.6 months (95% CI, 57.8-68.2 months) for the TI cohort, 29.0 months (95% CI, 25.9-32.9 months) for the TR cohort, and 22.6 months (95% CI, 20.1-28.1 months) for the TD cohort ( P&amp;lt;.001) (Figure A). A total of 265 pts with corresponding laboratory testing data qualified for the anemia cohorts: 128 were mild, 99 were moderate, and 38 were severe. Mean age was 73.6 years, 47.5% were male, and 79.6% were White. Results of Kaplan-Meier analyses showed a median OS of 64.3 months (95% CI, 56.5-76.9 months) for the overall anemia sample and 89.8 months (95% CI, 72.9 months-not calculable) for the mild cohort, 58.9 months (95% CI, 40.8-69.1 months) for the moderate cohort, and 20.6 months (95% CI, 15.9-49.4 months) for the severe cohort ( P&amp;lt;.001) (Figure B). Conclusions: These results demonstrate that dependency on transfusions, increasing transfusion requirements, and greater anemia severity are each negative prognostic factors for OS among Medicare fee-for-service pts with diagnosed MF. Therapies that reduce transfusion dependency and anemia severity may aid in improving health outcomes and prolong survival in pts with MF. Figure. Kaplan-Meier Curves of Overall Survival in Transfusion (A) and Anemia (B) Subcohorts, Calculated from the Myelofibrosis Diagnostic Index Date

Real-World Effectiveness and Safety Outcomes of Acalabrutinib Treatment By Line of Therapy in Patients with Chronic Lymphocytic Leukemia and/or Small Lymphocytic Lymphoma

Background: Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor (BTKi) approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Data from phase 3, randomized, controlled trials of acalabrutinib, as monotherapy or in combination with obinutuzumab, in patients with treatment-naive (TN) and relapsed/refractory (R/R) CLL with long-term follow-up, including ELEVATE-TN, ELEVATE-RR, and ASCEND, have demonstrated sustained improvement vs comparators in progression-free survival and overall survival (OS) with cardiovascular (CV) and bleeding events consistent with previous reports (Sharman et al. J Clin Oncol. 2021; Byrd et al. J Clin Oncol. 2021; Ghia et al. Blood. 2022). As real-world evidence of the acalabrutinib effectiveness and safety profile is limited in CLL/SLL patients, this study aimed to describe time to next treatment (TTNT), OS, and CV and bleeding events in patients receiving first-line (1L) and later-line (2L+) acalabrutinib for the treatment of CLL/SLL in the real-world setting. Methods: A retrospective, observational analysis was conducted utilizing the Optum Clinformatics © Data Mart claims and electronic medical record database to identify patients aged ≥18 years with TN or R/R CLL/SLL who initiated acalabrutinib in any line of therapy (LoT) on or after November 21, 2019 (FDA approval date for acalabrutinib). Patients with CLL/SLL were required to have ≥6 months of continuous enrollment in the Optum database system prior to acalabrutinib treatment initiation. Patients were followed until the earliest of last day of data availability, death, or end of study period (September 30, 2022). Treatment effectiveness was described as TTNT (time from acalabrutinib initiation to next LoT or death of any cause) and OS (time from acalabrutinib initiation to date of death from any cause or end of study period). The Kaplan-Meier (KM) method was used to estimate TTNT and OS. Patients who continued treatment at the last follow-up were censored. CV and bleeding events were assessed in all patients who initiated acalabrutinib. All outcomes were evaluated in patients who received 1L or 2L+ acalabrutinib therapy. Results: A total of 530 patients were identified and included in the analysis. Of these patients, 63% (n=334) received 1L acalabrutinib and 37% (n=196) received 2L+ acalabrutinib. At acalabrutinib initiation, the mean age was 72.8 years in the 1L cohort and 74.2 years in the 2L+ cohort; 61.7% (121/196) of patients treated with 2L+ acalabrutinib had prior BTKi therapy prior to acalabrutinib initiation (ibrutinib, n=120; zanubrutinib, n=1). Distributions of gender and race were similar between the cohorts. At baseline, 18.1%, 75.3%, and 16.0% of patients had atrial fibrillation/flutter, hypertension, and bleeding episodes, respectively. With a median follow-up of 8.9 months in the 1L cohort and 12.4 months in the 2L+ cohort, the median TTNT and OS were not reached in either cohort. At 18 months, the proportion of patients remaining on treatment was 82% in the 1L cohort and 78% in the 2L+ cohort ( Figure 1). Of the patients that progressed, the median TTNT was 4.0 months in the 1L cohort (n=33) and 4.2 months in the 2L cohort (n=31). The 18-month OS rate was 90% and 85% for the 1L and 2L+ cohorts, respectively ( Figure 2). After initiation of acalabrutinib treatment, the incidence rates of atrial fibrillation/flutter, hypertension, and bleeding events were 2.7%, 8.9%, and 2.7% of patients in the 1L cohort and 7.4%, 2.4%, and 3.3% of patients in the 2L+ cohort, respectively, who had no history of these events prior to treatment with acalabrutinib. Conclusions: This is the first study demonstrating real-world effectiveness (OS and TTNT) and safety data of acalabrutinib treatment in first-line and later-line therapy. While clinical trial and clinical practice settings may differ, overall, the survival findings in this study were similar to those of acalabrutinib trials. The observed incidence rates of CV and bleeding events were not inconsistent with those observed in published acalabrutinib trials.

Cardiovascular Outcomes of α-Blockers vs 5-α Reductase Inhibitors for Benign Prostatic Hyperplasia

The most prescribed class of medications for benign prostatic hyperplasia (BPH) is α-blockers (ABs). However, the cardiovascular safety profile of these medications among patients with BPH is not well understood. To compare the safety of ABs vs 5-α reductase inhibitors (5-ARIs) for risk of adverse cardiovascular outcomes. This active comparator, new-user cohort study was conducted using insurance claims data from a 20% random sample of Medicare beneficiaries from 2007 to 2019 to evaluate the 1-year risk of adverse cardiovascular outcomes. Males aged 66 to 90 years were indexed into the cohort at new use of an AB or 5-ARI. Twelve months of continuous enrollment and at least 1 diagnosis code for BPH within 12 months prior to initiation were required. Data were analyzed from January 2007 through December 2019. Exposure was defined by a qualifying prescription fill for an AB or 5-ARI after at least 12 months without a prescription for these drug classes. Follow-up began at a qualified refill for the study drug. Primary study outcomes were hospitalization for heart failure (HF), composite major adverse cardiovascular events (MACE; hospitalization for stroke, myocardial infarction, or death), composite MACE or hospitalization for HF, and death. Inverse probability of treatment and censoring-weighted 1-year risks, risk ratios (RRs), and risk differences (RDs) were estimated for each outcome. Among 189 868 older adult males, there were 163 829 patients initiating ABs (mean [SD] age, 74.6 [6.2] years; 579 American Indian or Alaska Native [0.4%], 5890 Asian or Pacific Islander [3.6%], 9179 Black [5.6%], 10 610 Hispanic [6.5%], and 133 510 non-Hispanic White [81.5%]) and 26 039 patients initiating 5-ARIs (mean [SD] age, 75.3 [6.4] years; 76 American Indian or Alaska Native [0.3%], 827 Asian or Pacific Islander [3.2%], 1339 Black [5.1%], 1656 Hispanic [6.4%], and 21 605 non-Hispanic White [83.0%]). ABs compared with 5-ARIs were associated with an increased 1-year risk of MACE (8.95% [95% CI, 8.81%-9.09%] vs 8.32% [95% CI, 7.92%-8.72%]; RR = 1.08 [95% CI, 1.02-1.13]; RD per 1000 individuals = 6.26 [95% CI, 2.15-10.37]), composite MACE and HF (RR = 1.07; [95% CI, 1.03-1.12]; RD per 1000 individuals = 7.40 [95% CI, 2.88-11.93 ]), and death (RR = 1.07; [95% CI, 1.01-1.14]; RD per 1000 individuals = 3.85 [95% CI, 0.40-7.29]). There was no difference in risk for HF hospitalization alone. These results suggest that ABs may be associated with an increased risk of adverse cardiovascular outcomes compared with 5-ARIs. If replicated with more detailed confounder data, these results may have important public health implications given these medications' widespread use.

The OSA patient journey: pathways for diagnosis and treatment among commercially insured individuals in the United States.

The aims of this study were to characterize obstructive sleep apnea (OSA) care pathways among commercially insured individuals in the United States and to investigate between-groups differences in population, care delivery, and economic aspects. We identified adults with OSA using a large, national administrative claims database (January 1, 2016-February 28, 2020). Inclusion criteria included a diagnostic sleep test on or within ≤ 12 months of OSA diagnosis (index date) and 12 months of continuous enrollment before and after the index date. Exclusion criteria included prior OSA treatment or central sleep apnea. OSA care pathways were identified using sleep testing health care procedural health care common procedure coding system/current procedural terminology codes then selected for analysis if they were experienced by ≥ 3% of the population and assessed for baseline demographic/clinical characteristics that were also used for model adjustment. Primary outcome was positive airway pressure initiation rate; secondary outcomes were time from first sleep test to initiation of positive airway pressure, sleep test costs, and health care resource utilization. Associations between pathway type and time to treatment initiation were assessed using generalized linear models. Of 86,827 adults with OSA, 92.1% received care in 1 of 5 care pathways that met criteria: home sleep apnea testing (HSAT; 30.8%), polysomnography (PSG; 23.6%), PSG-Titration (19.8%), Split-night (14.8%), and HSAT-Titration (3.2%). Pathways had significantly different demographic and clinical characteristics. HSAT-Titration had the highest positive airway pressure initiation rate (84.6%) and PSG the lowest (34.4%). After adjustments, time to treatment initiation was significantly associated with pathway (P < .0001); Split-night had shortest duration (median, 28 days), followed by HSAT (36), PSG (37), PSG-Titration (58), and HSAT-Titration (75). HSAT had the lowest sleep test costs and health care resource utilization. Distinct OSA care pathways exist and are associated with differences in population, care delivery, and economic aspects. Wickwire EM, Zhang X, Munson SH, etal. The OSA patient journey: pathways for diagnosis and treatment among commercially insured individuals in the United States. J Clin Sleep Med. 2024;20(4):505-514.

Comparative effectiveness and safety of apixaban and low-molecular weight heparin among patients with venous thromboembolism and active cancer in an extended treatment setting

Abstract Background The 2020 European Society of Cardiology guidelines recommend extended anticoagulant (AC) treatment among patients with VTE and with progressive or persistent risk factors (such as cancer) as they are at a high risk of a recurrent VTE episode. Purpose The study evaluated the risk of recurrent VTE and major bleeding (MB) among patients with VTE and active cancer prescribed apixaban or LMWH (reference) for ≥3 months. Methods This retrospective study included patients ≥18 years with VTE who initiated apixaban or LMWH within 30 days following the first VTE event using a large administrative claims database, representing ≥140 million patients enrolled in US health plans. Data from July 1, 2016, through April 30, 2022, was used. Patients were required to have ≥3 months of continuous enrollment (CE) and ≥3 months of continuous primary AC treatment following the date of apixaban/LMWH initiation. The end of 3 months of primary treatment was designated as index date. The follow-up period was from the day after the index date until the earliest of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or the end of the study period. The MB and recurrent VTE outcomes were evaluated and compared in the follow-up period. Inverse-probability treatment weighting (IPTW) was used to balance the treatment cohorts on relevant demographic and clinical characteristics including VTE and cancer-related variables. Incidence rate for the outcomes were calculated per 100 person-years. Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE and MB reported as hazard ratios (HR) along with 95% confidence interval (CI). Results After the eligibility criteria was met, the study included 13,527 apixaban and 2,914 LMWH treated patients with VTE and active cancer. Post IPTW, the treatment cohorts were balanced on baseline patient characteristics (Figure 1). In the follow-up period, the incidence rates (IR) per 100 person-years for recurrent VTE and MB were lower for apixaban than LMWH among patients with VTE and active cancer (Figure 2). Apixaban patients had a lower risk of recurrent VTE (HR: 0.42; 95% CI: 0.34–0.53) and MB (HR: 0.50; 95% CI: 0.41–0.61) when compared to LMWH (Figure 2). Conclusion In this observational cohort analysis of patients with VTE and active cancer, extended anticoagulation treatment of ≥3 months with apixaban was associated with a lower risk of recurrent VTE and MB compared with LMWH. Additional research is required to confirm these findings.Figure 1Figure 2

Abstract 12766: Assessing the Economic and Clinical Impact of Surgical Aortic Valve Replacement on Patients With Symptomatic Aortic Valve Regurgitation

Hypothesis: The purpose of this study was to estimate the differences in mortality, healthcare utilization, and annualized cost among patients with symptomatic aortic regurgitation (sAR) who underwent surgical valve replacement (SAVR) compared with those that were managed non-operatively within 12 months of their diagnosis. Methods: Using the Optum® United Health Care Database, we identified 132,317 patients from 2016 to 2021 with a diagnosis of clinically symptomatic aortic regurgitation (sAR) who had a minimum of 6 months of continuous enrollment prior to sAR and at least 12 months of continuous enrollment following sAR and no record of aortic stenosis or transcatheter aortic valve replacement. sAR was defined as ≥ 2 visits for either heart failure, angina, dyspnea, or syncope in the presence of aortic regurgitation. Outcomes were all-cause mortality, healthcare utilization, and annualized cost. Inverse propensity score weighting (IPW) was employed to adjust for baseline differences and included patient demographics and comorbidities measured by the Elixhauser Comorbidity Index. Cox proportional hazards were used to model survival and general linear models were estimated for annualized healthcare utilization and total costs. Results: Among 132,317 patients identified with sAR, only 400 (0.3%) underwent SAVR within the first 12 months of their sAR diagnosis. They were younger on average 65 vs. 75 years (p&lt;0.0001), more often male (71 vs 48%, p&lt;0.0001), and had a slightly higher Comorbidity Index (5.1 vs. 4.8, p=0.0527). After IPW, sAR patients who had SAVR had lower mortality (HR 0.384; 95% CI 0.375-0.394; P&lt;.0001), estimated annualized inpatient visits (0.33 versus 0.43; P=0.0039) and emergency department visits (0.54 versus 0.70; P=0.0002), hospital days (2.70 versus 3.14; P&lt;.0001), and annualized cost ($33,744 versus $41,399; P&lt;.0001). Conclusion: In this retrospective study, SAVR performed within 12 months of the diagnosis of symptomatic aortic regurgitation is associated with improved mortality and lower annualized healthcare utilization and costs. The clinical and economic benefits related to timely surgical management of aortic regurgitation should be considered when managing patients with symptomatic aortic regurgitation.

Abstract 12945: Six-Month Adherence Among Early Inclisiran Initiators vs. Anti-PCSK9 mAbs Users: A Retrospective Analysis of US Claims Databases

Introduction: Poor adherence with statins is an obstacle in achieving LDL-C targets for patients with atherosclerotic cardiovascular disease (ASCVD). Inclisiran is a first-in-class, long-acting, small-interfering RNA approved as an adjunct to diet and maximally tolerated statin for adults with ASCVD or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. It is initially administered subcutaneously by an HCP, again at 3 months and then twice yearly. Real-world studies assessing adherence of inclisiran are limited. Hypothesis: This study evaluated treatment adherence at 6 months for patients who newly initiated inclisiran, alirocumab (every 2 weeks or 1/month) or evolocumab (every 2 weeks or 1/month) since 2022. Methods: This retrospective, observational study utilized the US Komodo Health database from 1/1/21 - 2/8/23. Komodo Health is a nationally representative longitudinal database that captures 330 million patients in the US from open and closed administrative databases. Patients were aged ≥18 years, had 12 months of continuous enrollment (CE) before the index date, 6 months CE after the index date and a first claim for inclisiran, alirocumab, or evolocumab in the identification period (1/1/22 - 10/31/22). Adherence was defined as the proportion of days covered (PDC): the number of days covered by the drug divided by the observational period (6 months after index date). Poor adherence was defined as PDC &lt;80%. Results: A total of 981 patients had ≥6 months of CE after the index date and were in the inclisiran cohort;11,330 patients were in the alirocumab cohort and 30,515 in the evolocumab cohort. Mean (SD) 6-month adherence was highest for inclisiran at 0.85 (0.22) followed by 0.72 (0.30) for alirocumab and 0.70 (0.30) for evolocumab. The proportion of patients with high adherence (PDC ≥0.8) was 69.9% for inclisiran, followed by 51.0% for alirocumab and 48.6% for evolocumab. Of patients in the inclisiran cohort (n=981), 70.9% received a second dose with a mean time of 90.9 (32.0) days between doses. Conclusions: Early evidence post launch shows patients initiating inclisiran had higher adherence vs anti-PCSK9 mAbs. Inclisiran is a new option for patients with ASCVD who may have difficulty reaching their LDL-C target.

Impact of the COVID-19 pandemic on administration of systemic therapy in the Medicare population.

158 Background: The treatment of cancer was profoundly disrupted by COVID-19. Although there were well-documented impacts on cancer screening and surgery, the precise effect on treatment patterns with systemic therapy in the Medicare population has not been described. Methods: This study analyzed the 100% Medicare Research Identifiable Files (2017-2022) for patients with breast cancer, colorectal cancer, lung cancer, prostate cancer, and lymphoma who received antineoplastic therapy under either the Part B or Part D benefit setting. We examined patient demographics, patient diagnoses, treatment regimens, and Total Cost of Care (TCOC) (per month on treatment). Patients were selected for analysis if they had 12 months of continuous enrollment in Medicare Parts A, B, and D within the calendar year, and at least 2 claims of the same therapy within 60 days. Demographic information was attributed from the Master Beneficiary Summary File (MBSF). Results: Prior to the pandemic, 14% of breast cancer patients, 16% of colorectal cancer patients, 34% of lung cancer patients, 25% of lymphoma patients and 12% of prostate cancer patients received systemic therapy. During the pandemic, the number of Medicare beneficiaries with a cancer diagnosis decreased in all diagnosis groups. In addition, during the peak year of the COVID pandemic (2020), the proportion of beneficiaries receiving therapy decreased as well, ranging from -3% (lymphoma) to -9% (colorectal). This decrease was uniform across race and socio-economic indicators (LIS beneficiary or dually enrolled in Medicare/Medicaid). For four of the cancer types (breast, colorectal, lung, and prostate), the average number of months on therapy in 2020 slightly increased for chemotherapy. Across all cancer types and treatment types, the average per month TCOC increased during in 2020. Conclusions: Treatment of cancer was disrupted by COVID-19. A smaller number of Medicare beneficiaries were diagnosed with cancer and of these, a smaller percent received systemic treatment. Of those treated, time on treatment was slightly longer and TCOC was slightly higher. These effects were seen to the same extent in all examined sociodemographic groups. The pandemic certainly impacted the systemic treatment of cancer but to a modest degree.

Racial disparities in utilization of first-generation versus second-generation long-acting injectable antipsychotics in Medicaid beneficiaries with schizophrenia.

Multiple studies report racial disparities in antipsychotic prescription patterns. This study assessed demographic and clinical factors associated with the utilization of first-generation (FG) versus second-generation (SG) long-acting injectable (LAI) antipsychotics. This retrospective, observational cohort analysis used claims data from the IBM MarketScan® Multi-State Medicaid database. The study included adults with an LAI claim between 01-January-2009 and 31-December-2018, an ICD-9-CM or ICD-10-CM diagnosis of schizophrenia, race recorded as Black or White, and ≥12months of continuous enrollment before the index LAI. Descriptive analysis detailed the relationship between race and FG or SG LAI initiation. Multivariate logistic regression was used to assess potential associations with FG vs. SG LAI initiation, including clinical and demographic factors, comorbidities, and index year. A total of 10,773 patients were included: 6659 (62%) Black and 4114 (38%) White. Black patients had a higher utilization of FG LAIs than White patients (46.8% vs. 38.9%) over the 10years analyzed. Black patients were more likely to utilize FG LAIs than White patients (odds ratio: 1.47; 95% CI: 1.34, 1.62) after controlling for index year and covariates (race, age, gender, insurance plan type, Quan-Charlson Comorbidity index score, comorbidities, prior medications). Significant predictors of FG LAI utilization were older age, type of baseline oral antipsychotic (FG vs SG), type of coverage (managed care vs fee for service), and greater comorbidity burden. The utilization of FG LAIs was greater in Black compared to White Medicaid beneficiaries with schizophrenia over a 10-year period. These findings suggest that racial disparities exist in LAI initiation, with implications for differential quality of schizophrenia treatment.

Treatment Patterns for Plantar Fibromatosis in the United States: A Retrospective Observational Study

Category: Midfoot/Forefoot; Other Introduction/Purpose: Plantar fibromatosis (PF) is a rare disease affecting the plantar aponeurosis, characterized by disordered fibrous tissue and subsequent formation of subcutaneous nodules on the foot/feet. There are no established clinical guidelines for management of PF symptoms, and real-world evidence on treatment patterns among PF patients in the United States (US) is scarce. This retrospective observational study used a comprehensive approach to identify newly diagnosed PF patients and describe subsequent conservative (non-surgical) and surgical treatment patterns. Methods: Patients with evidence of PF from ICD-9/10 diagnosis codes in IQVIA’s PharMetrics® Plus were identified between January 2015-March 2020 and linked to IQVIA’s Ambulatory Electronic Medical Records (AEMR) to confirm diagnosis, using PF- specific SNOMED diagnosis codes or problem name; the earliest evidence of PF was the diagnosis date. Further, eligible patients were required to have continuous enrollment (CE) in a health plan for 12 months before diagnosis (baseline), 24 months of CE after diagnosis (follow-up), evidence of PF ≥30 days after first diagnosis, and age ≥18 years on diagnosis date. Patients with prior diagnosis of PF (through 2014) or other select lower limb conditions during baseline were excluded. Baseline demographic/clinical characteristics and conservative treatment utilization prior to PF diagnosis were assessed. Proportion of patients receiving PF- related conservative and surgical treatment, frequency of use, and time from diagnosis to initiation of first treatment were reported during follow-up. Results: The incident PF cohort (N=620) had mean (SD) age of 52.2(9.9) years and 63.2% were women. Most common baseline comorbidities were thyroid diseases (14.2%), diabetes without complications (12.3%), and smoking (12.3%); 19.0% had evidence of foot or ankle pain/stiffness. During baseline, 53.5% of patients received prescribed analgesic medications (30.6% received opioids). Most patients (91.1%) received conservative treatment after PF diagnosis, including analgesics and physical/occupational therapy (Figure 1A). Among all treatment modalities, time to initiation (months) was shortest for orthotics (median:0.5; IQR:5.5), injectable corticosteroids (median:2.0; IQR:9.2) and prescribed NSAID (median:2.5; IQR:9.1; Figure 1B). Among 42 patients (6.8%) receiving PF-related surgery, conservative treatments were common both before surgery (83.3%; median time from diagnosis to surgery:6.0 months) and after surgery (92.9%). Conclusion: Most newly diagnosed PF patients received conservative treatments within the first 3 months after diagnosis. Analgesic use was high during baseline as well as follow-up. During the 24 months after diagnosis, few patients received surgery and conservative treatment modalities often continued after surgery. Overall, continued and widespread conservative management among PF patients indicates lack of treatment options for PF. Further studies on treatment patterns in US patients aged ≥65 years are needed.

Skin Cancer and Hydrochlorothiazide: Novel Population-Based Analyses Considering Personal Risk Factors Including Race/Ethnicity.

Hydrochlorothiazide, a common antihypertensive, has photosensitive properties, potentially increasing skin cancer risk. We evaluated melanoma and nonmelanoma skin cancer among hydrochlorothiazide users with 3 different cohorts as each allows assessment of different potential cofounders/effect modifiers, including race/ethnicity. We built 3 cohorts using IBM MarketScan Research Databases: Commercial and Encounters (>3.5 million individuals, 2010-2018), a subcohort with health risk assessment respondents (415, 330), and Medicaid (509, 767, 2011-2017). Adults (aged 18+ years) entered the respective cohort with a first-filled prescription (cohort entry) for hydrochlorothiazide (the exposure of interest) or angiotensin-converting enzyme (ACE) inhibitors (the active comparator), with ≥12 months of continuous enrollment with medical/pharmacy coverage at baseline. We excluded those who used hydrochlorothiazide/ACE inhibitor (including fixed-dose combination products) 12 months before cohort entry and those with prior skin cancer, HIV, or organ transplant. We compared the risk for hydrochlorothiazide versus ACE inhibitor using multivariate proportional hazards regression. Baseline characteristics were similar, aside from more Black individuals among hydrochlorothiazide users (43.3% [95% CI, 43.0%-43.6%]) than ACE inhibitor users (28.1% [95% CI, 27.9%-28.3%]). The hazard ratio (95% CI) for nonmelanoma skin cancer related to hydrochlorothiazide (versus ACE inhibitor) was 0.96 (0.91-1.00) in the Commercial cohort, 1.01 (0.77-1.32) for the health risk assessment subcohort, and 1.33 (0.77-2.29) for Medicaid. For melanoma, the respective hazard ratios were 1.07 (0.95-1.20), 0.85 (0.43-1.67), and 0.93 (0.51-1.67), respectively. Our evaluation using 3 different approaches, including adjustment for race/ethnicity, did not establish a clear difference between hydrochlorothiazide and ACE inhibitor in terms of skin cancer risk.

Racial and Ethnic Disparities in Treatment Initiation Among Patients with Newly Diagnosed Psoriatic Arthritis: A Retrospective Medicaid Claims Database Study.

In patients with psoriatic arthritis (PsA), potential differences in care by race/ethnicity have not been well studied. This retrospective, observational cohort analysis utilized the IBM MarketScan® Multi-State Medicaid database. Patients aged ≥ 18years with two or more PsA-related claims between January 1, 2010 and December 31, 2019, and ≥ 12months of continuous enrollment before the first diagnosis of PsA (index date) were included. Outcomes evaluated were the use of disease-modifying antirheumatic drugs (DMARDs) overall and by type (conventional synthetic, biologic, targeted synthetic) within 12months following initial PsA diagnosis, as well as the time to DMARD initiation after initial PsA diagnosis, stratified by race/ethnicity. Multivariate Cox proportional hazards models were used to assess potential associations between patient baseline characteristics and time to DMARD initiation. Among patients with newly diagnosed PsA (N = 3432), the mean age was 44.4years, 69.9% were female, 77.4% were White, and 10.1% were Black. Of the 2993 patients with at least 12months of follow-up, fewer Black patients received any DMARD therapy compared with White patients (68.4 vs. 76.4%, respectively, p = 0.002), and, specifically, a lower percentage of Black patients received biologic DMARDs compared with White patients (33.6 vs. 42.6%, respectively, p = 0.003). After adjusting for baseline characteristics, Black patients had significantly longer time to initiation of any DMARD (HR [95% CI] 0.82 [0.71-0.94]) and biologic DMARD (0.84 [0.71-0.99]) compared with White patients. Other baseline variables such as older age, anxiety, and hepatitis C were also significantly associated with longer time to any DMARD initiation after initial PsA diagnosis. Time to treatment initiation was significantly longer in Black patients compared with White patients with newly diagnosed PsA. These findings suggest care delivery disparities in patients with PsA and highlight the need for future studies to understand factors that drive the observed differences in drug therapy by race/ethnicity.

Association of Hospital Incentive Care Management Partnerships for Uninsured Patients With Emergency Department Utilization

The South Carolina (SC) Healthy Outcomes Plan (HOP) program aimed to expand access to health care to individuals without insurance; it remains unknown whether there is an association between the SC HOP program and emergency department (ED) use among patients with high health care costs and needs. To determine whether participation in the SC HOP was associated with reduced ED utilization among uninsured participants. This retrospective cohort study included 11 684 HOP participants (ages 18-64 years) with at least 18 months of continuous enrollment. Generalized estimating equations and segmented regression of interrupted time-series analyses of ED visits and charges were conducted from October 1, 2012, to March 31, 2020. Time intervals related to the HOP were 1 year before and 3 years after participation. ED visits per 100 participants per month and ED charges per participant per month overall and by subcategory. The mean (SD) age of the 11 684 participants in the study was 45.2 (10.9) years; 6293 (54.5%) were women; 5028 (48.4%) were Black participants and 5189 (50.0%) were White participants. Over the study period, the mean (SE) number of ED visits decreased by 44.1%, from 48.1 (5.2) to 26.9 (2.8) per 100 participants per month. The mean (SE) ED charges were reduced to $858 ($46) per participant per month, a decrease from a mean (SE) of $1583 ($88) per participant per month 1 year before HOP implementation. There was an immediate level decrease of 40% (relative risk [RR], 0.61; 99.5% CI, 0.48-0.76; P < .001) from the preenrollment period, with a sustained reduction trend of 8% (RR 0.92; 99.5% CI, 0.89-0.95; P < .001) during the postenrollment period. A level change for ED charges was detected, at a decrease of 40% (RR 0.60; 99.5% CI, 0.47-0.77; P < .001) directly after HOP enrollment with a subsequent downward trend of 10% (RR 0.90; 99.5% CI, 0.86-0.93; P < .001) for the postenrollment period. In this retrospective cohort study, proportions and charges of ED visits by uninsured patients saw immediate and sustained decreases after HOP enrollment. Reducing ED charges may have been driven by decreasing the ED as the primary point of patient care, especially for high-frequency users. These findings have implications for other nonexpansion states seeking to maximize uninsured compensation for low-income populations through improved outcomes.

Home versus outpatient hospital intravenous immunoglobulin infusion and health care resource utilization

BackgroundHome health care delivery is projected to increase. Intravenous immunoglobulin (IVIG) therapy has high potential to move from the outpatient hospital (OPH) setting to home delivery. ObjectiveThis study examined the relationship between home and OPH IVIG infusions and health care utilization. MethodsWe used a retrospective cohort study design and the Humana Research Database to identify patients with 1 or more medical or pharmacy claims for an IVIG infusion agent from January 1, 2017, to December 31, 2018. Eligible patients were enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan, with at least 12 months of continuous enrollment before and after their first infusion (i.e., index date) received in the home or OPH setting. We measured the odds of experiencing an inpatient (IP) stay or emergency department (ED) visit, adjusted for baseline differences in age, sex, race, region, population density, low-income, and dual eligibility status, MAPD or commercial health plan, plan type, treatment-naïve status, home health use, RxRisk-V comorbidity burden score, and indications for IVIG use. ResultsA total of 208 and 1079 patients received IVIG infusions in the home and OPH setting, respectively. The odds for an IP stay (odds ratio [OR] 0.56 [95% CI 0.38–0.82]) and ED visit (OR 0.62 [95% CI 0.41–0.93]) were significantly lower in patients who received IVIG infusion in the home than patients receiving infusion in the OPH setting. ConclusionsOur findings suggest there may be value to increasing referrals for IVIG home infusion. Decreased health care utilization provides value to the system in cost savings and to patients and families owing to less disruption and improved clinical outcomes. Further study can help inform health policy designed to maximize the benefits of IVIG home infusion while minimizing potential risks.

943-P: Improved Glycemic Outcomes after One Year among Level 2 Members

Background: Level2’s virtual specialty clinic, offered across the United States to people with type 2 diabetes on participating insurance plans, combines providers, coaches, continuous glucose monitors (CGM), and fitness trackers to help members gain insight, and focus on long-term behavior change. We retrospectively assessed differences in glycemic outcomes following one year of participation in Level2. Methods: People joining Level2 between 01/01/21 and 07/31/21 with 15 months of Level2 participation and 3 prior months of continuous enrollment in a participating commercial health plan were included in the analysis. We used CGM-derived GMI and A1c values available from a database of de-identified administrative claims to determine baseline and 12-month follow-up glycemic outcomes. Wilcoxon signed-rank tests were used to test for pair-wise improvements in glycemic measures between baseline and follow-up overall and stratified by baseline A1c. Results: Of the 3,440 people identified for the analysis, a subset (N = 200) had both baseline A1c and valid GMIs during follow-up. This subset was 53% (N = 106) male with mean age of 55.4 (SD = 8.5) years and had mean baseline A1c of 7.97% (SD = 1.02). The median difference between baseline A1c and follow-up GMI was -0.83% (p &amp;lt; 0.001) overall, with significant differences of -0.82% (p &amp;lt; 0.001) and -2.41% (p &amp;lt; 0.001) in those with baseline 7% &amp;lt; A1c &amp;lt; 9% and A1c &amp;gt; 9%, respectively. Over 50% of people had a decrease in glycemic outcome of more than 0.5%, with 67% and 95% of people improving by more than 0.5% in the 7-9% and &amp;gt; 9% groups respectively. There were 87 people that also had an A1c at 12-month follow-up; the median difference in A1c was -0.65% (p &amp;lt; 0.001), 50% had a decrease of more than 0.5%, and median difference between GMI/A1c follow up values was 0.13 (p = 0.11). Conclusion: Level2 members with baseline A1c and follow-up GMI saw significant improvements in glycemic control over one year of engagement. These improvements were observed for measures of both follow-up A1c and GMI. Disclosure S.Bacon: Employee; Optum Labs, Research Support; Level2. N.Thompson: Employee; Level2, Stock/Shareholder; UnitedHealth Group. D.Ferrell: Stock/Shareholder; Level2, Medexpress Urgent Care. J.Fung: Employee; Level2.