Continuous Health Plan Enrollment Research Articles

Real-World HbA1c Changes Among Type 2 Diabetes Mellitus Patients Initiating Treatment With a 1.0 Mg Weekly Dose of Semaglutide for Diabetes.

Background: Medical management of patients with type 2 diabetes mellitus (T2DM) is complex because of the chronic nature of the disease and its associated comorbidities. Injectable once-weekly semaglutide for diabetes (OW sema T2D) is a type of glucagon-like peptide-1 receptor agonist approved for the treatment of patients with T2DM. Objectives: To describe patient characteristics and HbA1c changes for patients prescribed 1.0 mg maintenance dose OW sema T2D. Methods: This retrospective study included adult patients with T2DM with a pre-index glycated hemoglobin (HbA1c) of at least 7%, initiating treatment with OW sema T2D between January 1, 2018, and December 31, 2019, and prescribed a 1.0 mg maintenance dose. Patients were identified in the Optum Research Database and were included if they had continuous health plan enrollment for at least 12 months prior to (pre-index) and at least 12 months following (post-index) the date of the first OW sema T2D claim (index). Dose at initiation and prescriber specialty were captured. Change in HbA1c between the latest post-index and pre-index HbA1c measurement was calculated among all patients and among those with at least 90 days of continuous treatment (persistent patients). Results: A total of 2168 patients were included in this study. On average, patients were taking 13.5 different classes of medications. The majority of patients had lipid metabolism disorder (90.8%), hypertension (86.6%), diabetes with complications (86.8%), or other nutritional/endocrine/metabolic disorders (72.5%). The mean HbA1c reduction was 1.2% (P < .001). Patients persistent with OW sema T2D (n =1280) had a mean HbA1c reduction of 1.4% (P < .001). The mean (SD) days covered with a 1.0 mg maintenance dose was 236.1 (94.1) days. Discussion: Despite being medically complex, the patients in this real-world study experienced significant reductions in HbA1c following initiation of OW sema T2D. Conclusions: A 1.0 mg maintenance dose of OW sema T2D is an effective treatment for T2DM in the real world.

Comparison of two modeling approaches for the identification of predictors of complications in children with cerebral palsy following spine surgery

BackgroundChildren with non-ambulatory cerebral palsy (CP) frequently develop progressive neuromuscular scoliosis and require surgical intervention. Due to their comorbidities, they are at high risk for developing peri- and post-operative complications. The objectives of this study were to compare stepwise and LASSO variable selection techniques for consistency in identifying predictors when modelling these post-operative complications and to identify potential predictors of respiratory complications and infections following spine surgery among children with CP.MethodsIn this retrospective cohort study, a large administrative claims database was queried to identify children who met the following criteria: 1) ≤ 25 years old, 2) diagnosis of CP, 3) underwent surgery during the study period, 4) had ≥ 12-months pre-operative, and 5) ≥ 3-months post-operative continuous health plan enrollment. Outcome measures included the development of a post-operative respiratory complication (e.g., pneumonia, aspiration pneumonia, atelectasis, pleural effusion, pneumothorax, pulmonary edema) or an infection (e.g., surgical site infection, urinary tract infection, meningitis, peritonitis, sepsis, or septicemia) within 3 months of surgery. Codes were used to identify CP, surgical procedures, medical comorbidities and the development of post-operative respiratory complications and infections. Two approaches to variable selection, stepwise and LASSO, were compared to determine which potential predictors of respiratory complications and infection development would be identified using each approach.ResultsThe sample included 220 children. During the 3-month follow-up, 21.8% (n = 48) developed a respiratory complication and 12.7% (n = 28) developed an infection. The prevalence of 11 variables including age, sex and 9 comorbidities were initially considered to be potential predictors based on the intended outcome of interest. Model discrimination utilizing LASSO for variable selection was slightly improved over the stepwise regression approach. LASSO resulted in retention of additional comorbidities that may have meaningful associations to consider for future studies, including gastrointestinal issues, bladder dysfunction, epilepsy, anemia and coagulation deficiency.ConclusionsPotential predictors of the development of post-operative complications were identified in this study and while identified predictors were similar using stepwise and LASSO regression approaches, model discrimination was slightly improved with LASSO. Findings will be used to inform future research processes determining which variables to consider for developing risk prediction models.

Incidence of lymphedema among adults with cerebral palsy.

Lymphedema is a chronic and progressive condition but is understudied among adults with cerebral palsy (CP). To compare the 2-year incidence of lymphedema between adults with versus without CP before and after accounting for multimorbidity, cancer diagnosis/treatment, and lymph node/channel surgery. Retrospective cohort study. Nationwide commercial claims data from January 1, 2011 to December 31, 2017. Adults ≥18 years old with and without CP with at least 12 months of continuous health plan enrollment, defined as the baseline period, were included for analysis. The 12-month baseline period was used to establish information on preexisting lymphedema (for exclusion), presence of cancer, including radiation treatment and lymph node surgery, and the Whitney Comorbidity Index (WCI). Not applicable. The 2-year incidence rate (IR) and IR ratio (IRR) of lymphedema were evaluated. Cox regression estimated the hazard ratio (HR) of 2-year lymphedema after adjusting for age, gender, WCI, cancer diagnosis/treatment, and lymph node/channel surgery. The 2-year IR of lymphedema was 5.73 (95% confidence interval [CI] = 4.59-6.88) for adults with CP (n = 9922) and 1.81 (95% CI = 1.79-1.83) for adults without CP (n = 12,932,288); the IRR was 3.17 (95% CI = 2.59-3.87) and the adjusted HR was 2.43 (95% CI = 1.98-2.98). There was evidence of effect modification by gender, age, and WCI score. All HRs were elevated, but men with versus without CP had higher HRs than women with versus without CP; HRs for adults with versus without CP were higher for younger participants and those with lower WCI scores. Adults with CP had a higher 2-year rate of lymphedema compared with those without CP. Men with CP had a disproportionately higher rate than women with CP when compared with their gender-based reference cohorts without CP.

Abstract B007: Racial/ethnic and socioeconomic disparities in over- and under-screening of cervical cancer among a national sample of commercially insured individuals

Abstract In the United States (US), disparities in cervical cancer screening uptake persist by race/ethnicity and socioeconomic status (SES). However, few have examined how race/ethnicity and SES contribute to specific guideline adherence patterns, which can exacerbate existing disparities. We investigated the impact of race/ethnicity and SES (education and household net worth [HHN]) on the probability of over- and under-screening. Optum Clinformatics Data Mart from 2012-2021 was used to identify average-risk females aged 30-64 and ≥1 cervical cancer screening with continuous health plan enrollment and no history of hysterectomy/cervical cancer. Over- and under-screening were defined as intervals between the index and subsequent screening which were shorter and longer than the interval recommended by the 2012 US Preventive Services Task Force guideline, respectively. Multivariate logistic regression was used to evaluate the association of race/ethnicity (Non-Hispanic [NH]-White, NH-Asian, Hispanic, NH-Black) and SES including HHN (&amp;lt;$250,000, $250,000-$500,000, &amp;gt;$500,000) and education level (&amp;lt;Bachelor’s Degree, &amp;gt;Bachelor’s Degree) with over- and under-screening. We tested for interactions between race/ethnicity and SES. Of the 686,884 eligible patients, 72.8% were NH-White, 71.4% had &amp;lt;Bachelor's Degree and 43.3% had HHN &amp;lt;$250,000. Only 7.2% were guideline adherent, 30.7% were under-screened, and 62.1% were over-screened. After regression adjustment, the odds of under-screening were higher among NH-Asian (OR, 1.2; 95%CI, 1.1- 1.2), NH-Black (OR, 1.1; 95%CI, 1.0-1.1), and Hispanic (OR, 1.2; 95%CI, 1.1-1.2) vs NH-White, &amp;lt;Bachelor’s degree (OR, 1.1; 95%CI, 1.0-1.1) vs &amp;gt;Bachelor’s degree, and HHN &amp;lt;$250,000 (OR, 1.3 95%CI, 1.2-1.3) and $250,000-$499,000 (OR, 1.1; 95%CI, 1.0-1.1) vs &amp;gt;$500,000. Odds of over-screening were higher among NH-Black (OR, 1.3; 95%CI, 1.2-1.3), and Hispanic (OR, 1.2; 95%CI, 1.1-1.2) vs NH-White, and lower among &amp;lt;Bachelor’s degree (OR, 0.9; 95%CI, 0.8-0.9) vs &amp;gt;Bachelor’s degree, and HHN &amp;lt;$250,000 (OR, 0.9; 95%CI, 0.9-1.0) and $250,000-$499,000 (OR, 0.9; 95%CI, 0.9-1.0) vs &amp;gt;$500,000. For under-screening, the interaction between race/ethnicity and HHN was significant, and the predicted probability (PP) increased with higher HHN among Hispanic but not in other groups (p&amp;lt;0.01). For over-screening, the interaction between race/ethnicity and HHN was significant and the PP increased with higher HHN among Hispanic and NH-White but decreased for NH-Black and NH-Asian. The interaction between race/ethnicity and education was significant and the PP increased with higher education among Hispanic and NH-White but decreased among NH-Black and NH-Asian. Even within a commercially insured population, we observed that the majority of patients received non-guideline adherent screening and SES contributed to disparities differently among racial/ethnic groups. Findings indicate the need to tailor interventions and policies for subpopulations experiencing over- and under-screening to address the overall screening quality and disparities in outcomes. Citation Format: Michelle B. Shin, Sarah Axeen, Jennifer Tsui. Racial/ethnic and socioeconomic disparities in over- and under-screening of cervical cancer among a national sample of commercially insured individuals [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B007.

Real-World Treatment Patterns Among Patients with Type 2 Diabetes Mellitus Initiating Treatment with Oral Semaglutide.

The treatment landscape for type 2 diabetes mellitus (T2DM) is complex and constantly evolving, and real-world evidence of prescribing patterns is limited. The objectives of this study were to characterize lines of therapy (LOTs), calculate the length of time spent on each LOT, and identify the reasons for the LOT end among patients who initiated oral semaglutide for T2DM. This retrospective, claims-based study included commercial and Medicare Advantage adults with T2DM. Data from November 1, 2019, and June 30, 2020, were obtained from Optum Research Database. Patients with ≥ 1 claim for oral semaglutide and continuous health plan enrollment for ≥ 12months prior to (baseline period) and ≥ 6months following (follow-up period) the date of the first oral semaglutide claim were included. LOT 1 began on the date of the first oral semaglutide claim. The start date of any subsequent LOTs was the date of the first claim for an additional non-insulin anti-diabetic drug class or a reduction in drug class with use of commitment medications. The LOT ended at the first instance of medication class discontinuation, change in regimen or end of follow-up. Of the 1937 patients who initiated oral semaglutide, 950 (49.0%) remained on their initial regimen over the 6-month follow-up period, 844 (43.6%) had at least one subsequent LOT, and 89 (4.6%) had at least two subsequent LOTs. Among patients with more than one LOT, approximately 20%-25% used oral semaglutide as monotherapy or combination therapy during LOTs 2 and 3. Metformin was frequently used during treatment across all LOTs. This study provides insight for physicians and payers into the real-world prescribing practices within the first 6months following oral semaglutide initiation and fills the gap in understanding the frequency of regimen changes in the constantly evolving and complex environment of T2DM care.

Reduction in Diabetes-Related Hospitalizations and Medical Costs After Dexcom G6 Continuous Glucose Monitor Initiation in People with Type 2 Diabetes Using Intensive Insulin Therapy.

Some people with type 2 diabetes (T2D) require intensive insulin therapy to manage their diabetes. This can increase the risk of diabetes-related hospitalizations. We hypothesize that initiation of real-time continuous glucose monitoring (RT-CGM), which continuously measures a user's glucose values and provides threshold- and trend-based alerts, will reduce diabetes-related emergency department (ED) and inpatient hospitalizations and concomitant costs. A retrospective analysis of US healthcare claims data using Optum's de-identified Clinformatics® Data Mart database was performed. The cohort consisted of commercially insured, CGM-naïve individuals with T2D who initiated Dexcom G6 RT-CGM system between August 1, 2018, and March 31, 2021. Twelve months of continuous health plan enrollment before and after RT-CGM initiation was required to capture baseline and follow-up rates of diabetes-related hospitalizations and associated healthcare resource utilization (HCRU) costs. Analyses were performed for claims with a diabetes-related diagnosis code in either (1) any position or (2) first or second position on the claim. A total of 790 individuals met the inclusion criteria. The average age was 52.8 (10.5) [mean (SD)], 53.3% were male, and 76.3% were white. For claims with a diabetes-related diagnosis code in any position, the number of individuals with ≥ 1 ED visit decreased by 30.0% (p = 0.01) and with ≥ 1 inpatient visit decreased by 41.5% (p < 0.0001). The number of diabetes-related visits and average number of visits per person similarly decreased by at least 31.4%. Larger relative decreases were observed for claims with a diabetes-related diagnosis code in the first or second position on the claim. Total diabetes-related costs expressed as per-person-per-month (PPPM) decreased by $341 PPPM for any position and $330 PPPM for first or second position. Initiation of Dexcom G6 among people with T2D using intensive insulin therapy was associated with a significant reduction in diabetes-related ED and inpatient visits and related HCRU costs. Expanded use of RT-CGM could augment these benefits and result in further cost reductions.

Real-world glycated haemoglobin changes among type 2 diabetes mellitus patients treated with a maintenance dose of 7 mg or 14 mg of oral semaglutide.

To describe the change in glycated haemoglobin (HbA1c) among patients with type 2 diabetes following treatment with a 7 or 14 mg maintenance dose of oral semaglutide. This retrospective, claims-based study included adult patients with type 2 diabetes with a pre-index HbA1c of ≥7%, initiating treatment with oral semaglutide between 1 November 2019 and 30 June 2020; the patients had continuous health plan enrolment for ≥12 months before (pre-index) and ≥6 months following (post-index) the date of the first oral semaglutide claim (index). Patients were required to have a maintenance dose of 7 or 14 mg. Pre-index demographic and clinical characteristics were captured, as were doses at initiation and prescriber specialty. The change in HbA1c between the latest post-index and pre-index HbA1c measurements was calculated among all patients and among those with ≥90 days of continuous treatment (persistent patients). This study included 520 patients, most of whom had a complex medical history, experienced a range of comorbidities and received an average of 11.5 different classes of medications during the pre-index period. The mean HbA1c reduction during the 6-month post-initiation period was 1.2% (p < .001) for all patients and 1.4% (p < .001) for persistent patients. In this real-world study, patients with a pre-index HbA1c ≥7% who initiated treatment with oral semaglutide with a 7 or 14 mg maintenance dose had significantly lower HbA1c levels following treatment.

Health care costs and utilization of progressive fibrosing lung disease by underlying interstitial lung disease type.

Fibrosing interstitial lung disease (ILD) encompasses more than 200 diverse pulmonary disorders, of which up to 40% become progressive. The 4 underlying ILD types most likely to result in progression are unclassified ILD/idiopathic interstitial pneumonia (IIP), autoimmune ILDs, exposure-related ILD/hypersensitivity pneumonitis, and sarcoidosis. To compare health care resource utilization (HCRU) and costs among patients with fibrosing ILD that has progressed ("progressive" fibrosing cohort) vs patients whose fibrosis did not meet criteria set for progression ("not yet progressed" cohort). This was a noninterventional study of commercial enrollees and Medicare Advantage with Part D beneficiaries, which used administrative claims data for the period from October 1, 2015, through May 31, 2021. Adult patients (aged ≥18 years) with fibrosing ILD and 12 months of continuous health plan enrollment were included. Patients with idiopathic pulmonary fibrosis, baseline ILD diagnoses, or missing demographic data were excluded. Patients were first classified according to the underlying type of fibrosing ILD. For statistical analyses of outcomes, 2 cohorts were compared within each subtype: progressive fibrosing ILD vs not yet progressed ILD. The final study population included propensity score-matched (PSM) patients (1:1) based on pre-ILD baseline demographic and clinical characteristics. HCRU categories included inpatient hospitalization counts and the number of inpatient days and total costs (in 2021 US dollars), analyzed descriptively and weighted by the per-patient-per-month cost. Lin's regression was used to predict 12-month total cost estimates for comparison by cohort. The distribution by underlying conditions was as follows: autoimmune ILD (n = 4,156), HP (n = 8,181), sarcoidosis (n = 775), and unclassified ILD/IIP (n = 18,635). After PSM, pre-ILD baseline variables were generally well balanced between the progressive and not yet progressed fibrosing ILD cohorts. For all underlying subtypes of ILD, patients in the progressive cohort had significantly more utilization and higher costs compared with patients in the not yet progressed cohort. Progressive cohorts had significantly higher adjusted rates of inpatient days among patients with at least 1 inpatient stay compared with the not yet progressed cohorts (all P < 0.01). In addition, the progressive cohorts had significantly higher adjusted 12-month total costs, with the differences ranging from $24,493 to $55,072 (all comparisons P < 0.001). Irrespective of underlying ILD type, patients with progressive fibrosing ILD had significantly increased HCRU and cost relative to those whose fibrosing ILD had not yet progressed.

Liver, renal, genitourinary and diabetic ketoacidosis risks among new users of empagliflozin versus dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: Post-authorization safety study based on multinational cohorts.

To estimate risks of diabetic ketoacidosis (DKA), acute liver injury (ALI), acute kidney injury (AKI), chronic kidney disease (CKD), severe complications of urinary tract infection (UTI) and genital infection (GI) among patients with type 2 diabetes initiating empagliflozin versus those initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor. In this large multinational, observational, new-user cohort study in UK, Danish and US healthcare data sources, patients initiated empagliflozin or a DPP-4 inhibitor between August 2014 and August 2019, were aged ≥18 years, and had ≥12 months' continuous health plan enrolment. Incidence rates by exposure and incidence rate ratios, adjusted for propensity-score deciles, were calculated. In total, 64 599 empagliflozin initiators and 203 315 DPP-4 inhibitor initiators were included. There was an increased risk [pooled adjusted incidence rate ratios (95% confidence interval)] of DKA [2.19 (1.74-2.76)] and decreased risks of ALI [0.77 (0.50-1.19) in patients without predisposing conditions of liver disease; 0.70 (0.56-0.88) in all patients] and AKI [0.54 (0.41-0.73)]. In the UK data, there was an increased risk of GI [males: 4.04 (3.46-4.71); females: 3.24 (2.81-3.74)] and decreased risks of CKD [0.53 (0.43-0.65)] and severe complications of UTI [0.51 (0.37-0.72)]. The results were generally consistent in subgroup and sensitivity analyses. Compared with DDP-4 inhibitor use, empagliflozin use was associated with increased risks of DKA and GI and decreased risks of ALI, AKI, CKD and severe complications of UTI. These associations are consistent with previous studies and known class effects of sodium-glucose cotransporter 2 inhibitors, including renoprotective effects and beneficial effects on alanine aminotransferase levels.

Real-World HbA1c Changes Among Type 2 Diabetes Mellitus Patients Initiating Treatment With a 1.0 Mg Weekly Dose of Semaglutide for Diabetes

Background: Medical management of patients with type 2 diabetes mellitus (T2DM) is complex because of the chronic nature of the disease and its associated comorbidities. Injectable once-weekly semaglutide for diabetes (OW sema T2D) is a type of glucagon-like peptide–1 receptor agonist approved for the treatment of patients with T2DM. Objectives: To describe patient characteristics and HbA1c changes for patients prescribed 1.0 mg maintenance dose OW sema T2D. Methods: This retrospective study included adult patients with T2DM with a pre-index glycated hemoglobin (HbA1c) of at least 7%, initiating treatment with OW sema T2D between January 1, 2018, and December 31, 2019, and prescribed a 1.0 mg maintenance dose. Patients were identified in the Optum Research Database and were included if they had continuous health plan enrollment for at least 12 months prior to (pre-index) and at least 12 months following (post-index) the date of the first OW sema T2D claim (index). Dose at initiation and prescriber specialty were captured. Change in HbA1c between the latest post-index and pre-index HbA1c measurement was calculated among all patients and among those with at least 90 days of continuous treatment (persistent patients). Results: A total of 2168 patients were included in this study. On average, patients were taking 13.5 different classes of medications. The majority of patients had lipid metabolism disorder (90.8%), hypertension (86.6%), diabetes with complications (86.8%), or other nutritional/endocrine/metabolic disorders (72.5%). The mean HbA1c reduction was 1.2% (P &lt; .001). Patients persistent with OW sema T2D (n =1280) had a mean HbA1c reduction of 1.4% (P &lt; .001). The mean (SD) days covered with a 1.0 mg maintenance dose was 236.1 (94.1) days. Discussion: Despite being medically complex, the patients in this real-world study experienced significant reductions in HbA1c following initiation of OW sema T2D. Conclusions: A 1.0 mg maintenance dose of OW sema T2D is an effective treatment for T2DM in the real world.

Common teratogenic medication exposures—a population-based study of pregnancies in the United States

BackgroundRisk mitigation for most teratogenic medications relies on risk communication via drug label, and prenatal exposures remain common. Information on the types of and risk factors for prenatal exposures to medications with teratogenic risk can guide strategies to reduce exposures. ObjectivesTo identify medications with known or potential teratogenic risk commonly used during pregnancy among privately insured persons. Study DesignWe used MarketScan® Commercial Claims and Encounters Data to identify pregnancy episodes with live or non-live (ectopic pregnancies, spontaneous and elective abortions, stillbirths) outcomes among persons aged 12 to 55 years during 2011-2018. Start/end dates of medication exposure and pregnancy outcomes were identified via an adapted algorithm based on validation studies. We required continuous health plan enrollment from 90 days before conception until 30 days after pregnancy end date. Medications with known or potential teratogenic risk were selected from the Teratogen Information System (TERIS) and drug monographs based on the level of risk and quality of evidence (138 with known and 60 with potential risk). We defined prenatal exposure based on ≥1 outpatient pharmacy claim or medical encounter for drug administration during target pregnancy periods considering drug risk profiles (e.g., risk only in the first trimester or at a certain dose threshold). Sex hormones and hormone analogs, abortion and post-partum/abortion hemorrhage treatments were not considered as teratogenic medications because of challenges to separate pregnancy-related indications, nor were opioids (due to complex risk-benefit) or anti-obesity drugs if their only teratogenic mechanism was weight loss. ResultsAmong all pregnancies, the 10 medications with known teratogenic risk and with the highest prenatal exposures were sulfamethoxazole/trimethoprim (SMX/TMP) (1,988 per 100,000 pregnancy years), high-dose fluconazole (1248), topiramate (351), lisinopril (144), warfarin (57), losartan (56), carbamazepine (50), valproate (49), vedolizumab (28 since 2015), and valsartan (25). Exposure prevalence to SMX/TMP decreased from 2,346 to 1,453 per 100,000 pregnancy years during 2011 – 2018, but exposure prevalence to vedolizumab increased sixfold since its approval in 2015. Prenatal exposures in the first trimester among non-live pregnancies were higher compared to live-birth pregnancies, with the largest difference for warfarin (non-live 370 vs. live-birth 78), followed by valproate (258 vs. 86) and topiramate (1,728 vs. 674). Prenatal exposures to medications with potential teratogenic risk were most prevalent for low-dose fluconazole (6,495), metoprolol (1,325) and atenolol (448). The largest first-trimester exposure differences between non-live and live-birth pregnancies were for lithum (242 vs. 89), gabapentin (1,639 vs. 653), and duloxetine (1,914 vs. 860). Steady increases in hydralazine and gabapentin exposures were seen during study years, while atenolol exposures decreased (561 to 280). ConclusionsSeveral medications with teratogenic risk for which there are potentially safer alternatives continue to be used during pregnancy. The fluctuating rates of prenatal exposure observed in select teratogenic medications suggest regular reevaluation of risk mitigation strategies is needed. Future research focusing on understanding the clinical context of medication use is necessary to develop effective strategies for reducing exposures to medications with teratogenic risk during pregnancy.

Anticoagulant therapy beyond primary treatment among active cancer and non-cancer patients with venous thromboembolism in the United States

Abstract Background European Society of Cardiology (ESC) and American Society of Hematology (ASH) guidelines recommend anticoagulant (AC) therapy for ≥3 months among patients with major persistent risk factors such as cancer to prevent recurrent venous thromboembolism (VTE). Purpose To describe AC use beyond the primary treatment period (3 months) among Active Cancer and non-Cancer patients with VTE. Demographics and clinical profiles were also evaluated for these patients. Methods This retrospective observational study included VTE patients ≥18 years from a US large administrative claims database (01/01/2017 – 04/30/2022). Patients who initiated AC treatment (apixaban, dabigatran, rivaroxaban, warfarin, or low molecular weight heparin [LMWH]) within 30 days of index VTE event were selected and the treatment start date was defined as the AC initiation date. Active Cancer and non-Cancer cohorts were created based on the presence or absence of cancer diagnosis or cancer treatment 6 months before or 30 days after the index VTE event. Patients were required to have continuous health plan enrollment (CE) 6 months prior and ≥3 months after the AC initiation date. The end of 3 months after the AC initiation was defined as index date. Patients with evidence of recurrent VTE and switch to a new AC during the primary treatment period were excluded. Continuous use of initial AC treatment for ≥3 months and baseline patient characteristics were assessed. The primary AC treatment duration was expanded to ≥6 months in a scenario analysis. Results The initial study population included 434,523 patients who initiated primary AC treatment within 30 days of index VTE; 19% (n=83,050) in the Active Cancer and 81% (n=351,473) in the non-Cancer cohorts. After the selection criteria were met, the Active Cancer cohort included 52,409 patients; of these, overall, 49.1% of patients received continuous primary AC treatment for ≥3 months (apixaban = 55.6%, dabigatran = 41.7%, rivaroxaban = 55.9%, LMWH = 26.9%, warfarin = 46.7%). Among patients in non-Cancer cohort (n=254,913), overall, 56.7% received continuous primary AC treatment for ≥3 months (apixaban = 59.0%, dabigatran = 49.2%, rivaroxaban = 57.7%, LMWH =20.1%, warfarin = 54.2%). For primary AC treatment duration of ≥6 months, type of AC use was consistent; however, the treatment rates were lower, for both Active Cancer (29.8%) and non-Cancer (34.8%) cohorts. (Figure 1). Patients in the Active Cancer cohort were older, had a higher comorbidity burden and higher % of patients with a history of bleeding compared to the non-Cancer cohort. (Figure 2). Conclusion About one-half (49.1%) of VTE patients with Active Cancer received ≥3 months of primary AC treatment; this proportion was higher (56.7%) in the non-Cancer cohort. Apixaban and rivaroxaban were the most prescribed anticoagulants. The study highlights potential gaps in guideline-recommended anticoagulation treatment among VTE patients in an extended treatment setting.Figure 1Figure 2

Abstract 12480: Characterization of Symptoms and Diagnostic Procedures Prior to Diagnosis Among Patients With Pulmonary Arterial Hypertension in the United States

Introduction: Pulmonary arterial hypertension (PAH) is a progressive, fatal disease associated with non-specific symptoms, which may lead to diagnosis delays and poor outcomes. Research Question: Which symptoms and diagnostic procedures occur prior to PAH diagnosis and do they vary based on diagnosis delay? Aim: To describe PAH symptoms and diagnostic procedures among patients newly diagnosed with PAH. Methods: Adults with PAH were identified from Optum’s de-identified Clinformatics ® Data Mart Database (2016-2021). Eligible patients had continuous health plan enrollment ≥12 months (mo) before the first recorded PAH-related symptoms (i.e., index date ) and from the index date until the first recorded PAH diagnosis on a medical claim (i.e., study period ). Patients also had ≥1 fill for a PAH treatment and ≥1 right heart catheterization at any time post-index. PAH symptoms and diagnostic procedures were described during the study period, overall, and stratified by time between the index date and first PAH diagnosis (i.e., diagnosis delay ; ≤12 mo, 12–24 mo, and &gt;24 mo). Results: The sample included 538 patients (≤12 mo: N=327; 12–24 mo: N=126; &gt;24 mo: N=85). Mean age was 66 years, 60.6% were female, and mean (range) diagnosis delay was 11.8 (0.0–50.2) mo. During the study period, most patients had ≥2 unique symptoms recorded, but those with longer delay had more fatigue (≤12 mo: 26.6%; 12–24 mo: 55.6%; &gt;24 mo: 54.1%), edema (29.1%; 42.9%; 51.8%), and dizziness (10.1%; 23.0%; 18.8%), among others. Mean delay was shorter when the first symptoms were ascites (4.2 mo) and syncope (6.4 mo) and longer for fatigue (14.2 mo) and dizziness (14.0 mo). On average, patients with longer delay had more diagnostic procedures pre-diagnosis (≤12 mo: 4.3; 12–24 mo: 8.2; &gt;24 mo: 8.7), driven by more electrocardiograms (ECG; 1.9; 4.2; 4.5). Overall, 85.5% of patients had an ECG and 83.5% had a transthoracic echocardiography pre-diagnosis. Conclusions: Symptoms such as fatigue, edema, and dizziness were more common in patients with longer time to diagnosis and these patients had more diagnostic procedures. Greater physician awareness and new screening tools (e.g., predictive algorithms using ECG data) could accelerate PAH diagnosis and treatment aiming at improving patient outcomes.

Abstract 12861: Steroidal Mineralocorticoid Receptor Antagonist Treatment Patterns and Predictors of Discontinuation

Introduction: Steroidal mineralocorticoid receptor antagonists (sMRA), spironolactone and eplerenone, are indicated for several cardiovascular (CV) conditions, including heart failure and hypertension. However, adverse drug reactions may lead to discontinuation. This study aimed to explore sMRA treatment patterns and predictors of discontinuation. Methods: This retrospective observational study used administrative claims from the Healthcare Integrated Research Database® to identify naïve adult users of sMRAs between 01 Jan 2016 and 31 May 2021 with at least 12 months of continuous health plan enrollment before initiation. Five subgroups were identified based on comorbidities before sMRA initiation - heart failure with preserved or reduced ejection fraction (HFpEF/HFrEF), undetermined heart failure (undHF), chronic kidney disease (CKD) and type 2 diabetes (T2D), and nondiabetic-CKD (ndCKD). sMRA treatment patterns and discontinuation (i.e., no refill within two prescription cycles) were described. Multivariate logistic regression modeling was used to explore predictors (i.e., demographics, comorbidity burden, specialist prescribing, CV disease, and medications) of discontinuation in all sMRA users and subgroups separately. Results: We identified 224,100 sMRAs users (99% spironolactone), including 8,553 HFpEF, 19,636 HFrEF, 20,336 undHF, 11,336 CKD and T2D, and 10,134 ndCKD, patients. Over a median of 655 days, a dose change was observed in 23% of patients. A dose increase was more common than a decrease (16% vs. 7%), a trend that was observed across all subgroups. Overall, 73% of sMRA users discontinued treatment after a median of 90 days. Discontinuation in subgroups was lower; 62% in HFpEF, 58% in HFrEF, 61% in undHF, and 66% in both CKD subgroups. No specific factors were consistently associated with increased odds of sMRA discontinuation. However, increased comorbidity burden, use of other CV medications, and cardiologist prescribers significantly decreased the odds of discontinuation across most subgroups. Conclusions: Most naïve sMRA users discontinue therapy within six months of initiation. No demographic or clinical factors were consistently associated with increased odds of sMRA discontinuation.

Treatment Patterns and Modifications of Tyrosine Kinase Inhibitors (TKI) Therapy in Early Lines in Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Real-World Analysis from a Large Commercial Claims Database in the United States (US)

Introduction: Although current TKI options are often successful in managing CML-CP in early lines of therapy, patients may experience issues related to tolerability or resistance to TKIs. Physicians often have to proceed with treatment modifications including discontinuation, switching, temporary interruptions, or dose modifications when the patient's current treatment is not working as expected. This retrospective cohort study assessed these TKI therapy management patterns in patients with CML in first-line (1L) or second-line (2L) treatment in the US. Methods: A large administrative claims database of commercially insured patients, the OptumInsight Clinformatics database (January 2007-June 2022), was used to select adult patients with CML who received 1L TKI therapy (imatinib, dasatinib, nilotinib, or bosutinib; 1L cohort) and those who received 2L TKI therapy (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib; 2L cohort), with treatment initiation (index date) on or after 2012. Patients were required to have ≥6 months of continuous health plan enrollment pre-index, with no hematopoietic stem cell transplantation (HSCT) or CML-related chemotherapy treatments for accelerated phase (AP) or blast crisis (BC) pre-index. Treatment modifications assessed post-index included 1) treatment discontinuation, defined as the earliest of HSCT/treatment switch (defined below)/initiation of a CML-related chemotherapy for AP or BC, 2) treatment switch defined as initiation of another TKI/omacetaxine mepesuccinate, 3) temporary treatment interruption defined as gap of ≥ 14 days followed by resuming the index TKI, and 4) dose reduction (as compared to the initial dose) were assessed. Time to first event post-index were conducted using Kaplan Meier analyses for each of these treatment modifications, in 1L and 2L cohorts, separately. Results: A total of 2,043 patients were included in the 1L cohort with 47.8% of them receiving imatinib, 31.0% dasatinib, 19.2% nilotinib, and 2.0% bosutinib (median age: 64 years; 44.9% female; 69.7% White; 49.5% with Medicare advantage plan operated by commercial insurance [Part C]). Patients in the 1L cohort were observed for a mean (SD) period of 29.1 (27.3) months from index date to earliest of loss of follow-up/end of data. Overall, more than a quarter of patients (27.3%) experienced treatment discontinuation, with rates of discontinuation of 16.1% at 6 months, 25.0% at 12 months, and 33.5% at 24 months post-index ( Figure 1). Treatment switch was observed in 26.0% of the patients, with rates of 15.5% at 6 months and 24.4% at 12 months post-index. The proportion of patients with temporary treatment interruption was 18.6%, with rates of 20.6% at 6 months and 22.2% at 12 months post-index. Dose reduction (as compared to initial dose) occurred in 21.9% of patients, with rates of 18.8% at 6 months and 23.3% at 12 months post-index. A total of 586 patients were included in the 2L cohort with 23.0% of them receiving imatinib, 36.9% dasatinib, 26.6% nilotinib, 10.9% bosutinib and 2.6% ponatinib (median age: 65 years; 47.3% female; 72.5% White; 48.3% with Medicare advantage plan operated by commercial insurance [Part C]). Patients in the 2L cohort were observed for a mean (SD) period of 28.4 (25.4) months from index date to earliest of loss of follow-up/end of data. Almost a third of patients (32.8%) experienced treatment discontinuation, with rates of discontinuation of 22.1% at 6 months, 29.9% at 12 months, and 43.1% at 24 months post-index ( Figure 1). Treatment switch was observed in 30.5% of patients, with rates of 20.5% at 6 months and 28.3% at 12 months post-index. The proportion of patients with temporary treatment interruption was 21.3%, with rates of 24.8% at 6 months and 25.4% at 12 months post-index. Dose reduction as compared to initial dose occurred in 20.6% of patients, with rates of 17.5% at 6 months and 27.2% at 12 months post-index. Conclusions: Findings from this real-world study demonstrate that almost a quarter of patients with CML treated with current TKI treatment options in 1L or 2L experienced treatment discontinuation/switch in the first year from TKI initiation suggesting lack of optimal response/tolerability to currently available TKIs, with more pronounced rates in 2L. This suggests that unmet clinical needs still persist in this population, warranting optimal 1L and 2L treatment options with better tolerability profile for CML management.

Antiretroviral therapy among people with HIV with comorbidities in the United States: a retrospective cohort study

Objectives To describe patterns of antiretroviral medications among people with HIV (PWH) who also have common comorbid conditions in a United States cohort. Methods This retrospective cohort study used Optum Research Database claims data from 01/01/2017 through 01/31/2019 to identify adult PWH (≥18 years) based on pharmacy claims for ART during 2018. The index date was defined as the first date of an ART claim. Study inclusion required ≥1 HIV/AIDS diagnosis code during the study period, and continuous health plan enrollment 12 months prior to and at least 30 days after the index date. Descriptive statistics were used to report study results. Results The study population consisted of 17,694 PWH; mean (SD) age 52.2 (12.8) years; 62.0% were ≥ 50 years old. About 50.6% of the study sample had ≥2 comorbidities at baseline. The most prevalent comorbid conditions were hypertension (33.2%), hyperlipidemia (29.7%), neuropsychiatric conditions (26.9%), and cardiovascular disease (11.5%). Most (93.5%) of PWH received a nucleotide reverse transcriptase inhibitor (NRTI) backbone regimen, including tenofovir alafenamide (41.6%), tenofovir disoproxil fumarate (28.1%), and abacavir (22.0%). The most commonly used anchor agents, 62.6%, were integrase strand transfer inhibitors (INSTIs): dolutegravir (30.4%), elvitegravir (24.2%), and raltegravir (7.3%). The proportion of PWH using specific ARTs did not vary significantly with the presence and type of comorbidities. Conclusion From our analyses, ART prescribing did not appear to vary with the presence of comorbidities and potential medication contraindications. ART regimens may have comparable efficacy profiles; however, selection should be guided by each patient’s comorbidities to prevent potential comedication drug toxicities.

Patient and physician perspectives and experiences of basal insulin titration in type 2 diabetes in the United States: Cross-sectional surveys.

Patient- and physician-associated barriers impact the effectiveness of basal insulin (BI) titration in the management of type 2 diabetes (T2D). We evaluated the experiences of patients with T2D and physicians with BI titration education. In this observational, cross-sectional study, patients with T2D and physicians treating patients with T2D were identified by claims in the Optum Research Database and were invited to complete a survey. Eligible patients had 12 months of continuous health-plan enrolment with medical and pharmacy benefits during the baseline period, and recent initiation of BI therapy. Eligible physicians had initiated BI for ≥1 eligible patient with T2D during the past 6 months. In total, 416 patients and 386 physicians completed the survey. Ninety per cent of physicians reported treating ≥50 patients with T2D; 66% treated ≥25% of patients with BI. Whereas 74% of patients reported that BI titration was explained to them by a physician, 96% of physicians reported doing so. Furthermore, 20% of patients stated they were offered educational materials whereas 56% of physicians reported having provided materials. Physicians had higher expectations of glycaemic target achievement than were seen in the patient survey; their main concern was the patients' ability to titrate accurately (79%). There is a marked difference in patients' and physicians' experiences of BI titration education. Novel tools and strategies are required to enable effective BI titration, with more educational resources at the outset, and ongoing access to tools that provide clear, simple direction for self-titration with less reliance on physicians/health care providers.

Real-World Hemoglobin A1c Changes, Prescribing Provider Types, and Medication Dose Among Patients with Type 2 Diabetes Mellitus Initiating Treatment with Oral Semaglutide.

Given the lack of real-world data on oral semaglutide use outside clinical trials, the purpose of this study was to describe dose, prescriber specialty, and change in hemoglobin A1c (HbA1c) after 6months of oral semaglutide treatment for patients with type 2 diabetes mellitus (T2DM). This was a retrospective study among adult patients with T2DM with ≥ 1 claim for oral semaglutide between November 1, 2019`1-June 30, 2020. Patients had continuous health plan enrollment ≥ 12months prior to (pre-index) and ≥ 6months following (post-index) the date of the first oral semaglutide claim (index). Dose at initiation and specialty of the prescribing provider were captured. Change in HbA1c between the last post- and pre-index HbA1c measurement was calculated. Patients were stratified by pre-index HbA1c ≥ 9% (poorly controlled) and HbA1c < 9%. A total of 744 HbA1c < 9% and 268 poorly controlled patients were included in the study. Most patients had an initial oral semaglutide dose of 7mg (49.3%) or 3mg (42.9%), prescribed most frequently by a primary care provider (27.8%). Mean HbA1c reduction was 0.8% (p < 0.001). Patients with poorly controlled T2DM had greater HbA1c reductions than patients with HbA1c < 9% (2.0% versus 0.4%, p < 0.001). Patients persistent with oral semaglutide (≥ 90days continuous treatment) had a mean HbA1c reduction of 0.9% (p < 0.001); persistent patients with poorly controlled T2DM had a mean reduction of 2.5%. Patients with T2DM in this study experienced significant reductions in HbA1c within 6months following initiation of oral semaglutide. Patients with a higher starting HbA1c experienced greater HbA1c reductions. The initial dose of oral semaglutide was higher than prescribing instructions indicated for more than half of the study patients.

Retrospective Analysis of the Burden of Illness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Versus Asthma in Commercially Insured US Patients.

Background andaim Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder associated with the presence of blood and tissue eosinophilia, extravascular granulomas, and asthma. Currently, the burden of EGPA on the patient and the healthcare system is not well characterized. This study aimed to assess the real-world clinical and economic burden of disease in adult patients with EGPA compared with matched patients with asthma without EGPA. Methods This retrospective cohort study used medical, pharmacy, enrolment, and demographic data from a US administrative claims database (PharMetrics Plus). Patients ≥18 years old, with ≥six months of continuous health plan enrolment in the baseline period, and ≥12 months of continuous health plan enrolment in the follow-up period were eligible for this analysis. Patients with EGPA and patients with asthma without EGPA were identified using diagnosis codes and were subsequently matched 1:5 (e.g., one patient with EGPAmatched with five patients with asthma, without EGPA) based on baseline characteristics. The primary outcome measure was all-cause healthcare costs; secondary outcomes included healthcare resource utilization, medication usage, and clinical characteristics. Results In the final matched cohorts, there were 7183 patients with EGPA and 35,915 patients with asthma without EGPA. During the follow-up period, mean total all-cause healthcare costs were significantly higher in patients with EGPA than in those with asthma without EGPA (mean {standard deviation}: $44,405 {$82,060} vs $24,487 {$54,691}; p<0.0001). Patients with EGPA had mean total all-cause healthcare costs that were 73.9% greater than those in patients with asthma without EGPA, even after applying a multivariable analysis to adjust for differences in demographic and clinical characteristics. Medication usage was consistently higher in the EGPA population than in the asthma population (excepting short-acting β2-agonists). The majority of patients in the EGPA population (83.1%) also experienced ≥one relapse during the study period, with 26.3% of patients in the EGPA population experiencing a major relapse. Conclusions There is a significantly greater economic and clinical burden associated with EGPA compared with asthma without EGPA in adults. These results underscore the unmet need in this patient population for improved disease control strategies that will reduce the burden of EGPA on patients and the healthcare system.

Characteristics associated with receipt of treatment among patients diagnosed with chronic hepatitis C virus.

Although current guidelines recommend that nearly all patients with chronic hepatitis C virus (HCV) infection receive treatment, a substantial proportion remain untreated. We conducted an administrative claims analysis to provide real-world data on treatment patterns and characteristics of treated versus untreated patients among individuals with HCV in the United States. Adults with an HCV diagnosis from 01 July 2016 through 30 September 2020 and continuous health plan enrolment for 12 months before and ≥1 month after the diagnosis date were identified in the Optum Research Database. Descriptive and multivariable analyses were conducted to evaluate the association between patient characteristics and the rate of treatment. Of 24,374 patients identified with HCV, only 30% initiated treatment during follow-up. Factors associated with increased rate of treatment included younger age versus age 75+ (hazard ratio [HR] 1.50-1.83 depending on age group), commercial versus Medicare insurance (HR 1.32), and diagnosis by a specialist versus a primary care physician (HR 2.56 and 2.62 for gastroenterology and infectious disease or hepatology, respectively) (p < .01 for all). Several baseline comorbidities were associated with decreased rate of treatment, including psychiatric disorders (HR 0.87), drug use disorders (HR 0.85) and cirrhosis (HR 0.42) (p < .01 for all). These findings highlight existing HCV treatment inequities, particularly among older patients and those with psychiatric disorders, substance use disorders or chronic comorbidities. Targeted efforts to increase treatment uptake in these populations could mitigate a considerable future burden of HCV-related morbidity, mortality and healthcare costs.