Optum's De-identified Clinformatics Research Articles

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.

Comparing the outcomes and costs of cardiac monitoring with implantable loop recorders and mobile cardiac outpatient telemetry following stroke using real-world evidence.

Aim: Patients with ischemic stroke (IS) commonly undergo monitoring to identify atrial fibrillation with mobile cardiac outpatient telemetry (MCOT) or implantable loop recorders (ILRs). The authors compared readmission, healthcare cost and survival in patients monitored post-stroke with either MCOT or ILR. Materials & methods: The authors used claims data from Optum's de-identified Clinformatics® Data Mart Database to identify patients with IS hospitalized from January 2017 to December 2020 who were prescribed ambulatory cardiac monitoring via MCOT or ILR. They compared the costs associated with the initial inpatient visit as well as the rate and causes of readmission, survival and healthcare costs over the following 18months. Datasets were balanced using patient baseline and hospitalization characteristics. Multivariable generalized linear gamma regression was used for cost comparisons. Cox proportional hazard regression was used for survival and readmission analysis. Sub-cohorts were analyzed based on the severity of the index IS. Results: In 2244 patients, readmissions were significantly lower in the MCOT monitored group (30.2%) compared with the ILR group (35.4%) (hazard ratio [HR] 1.23; 95% CI: 1.04-1.46). Average cost over 18months starting with the index IS was $27,429 (USD) lower in the MCOT group (95% CI: $22,353-$32,633). Survival difference bordered on statistical significance and trended to lower mortality in MCOT (8.9%) versus ILR (11.3%) (HR 1.30; 95% CI: 1:00-1.69), led by significance in patients with complications or comorbidities with the index event (MCOT 7.5%, ILR 11.5%; HR 1.62; 95% CI: 1.11-2.36). Conclusion: The use of MCOT versus ILR as the primary monitor following IS was associated with significant decreases in readmission, lower costs for the initial IS and total care over the next 18months, significantly lower mortality for patients with complications and comorbidities at the index stroke, and a trend toward improved survival across all patients.

Patterns of Comorbidities and Prescribing and Dispensing of Non-steroidal Anti-inflammatory Drugs (NSAIDs) Among Patients with Osteoarthritis in the USA: Real-World Study.

Osteoarthritis (OA) is a major cause of chronic pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are analgesics commonly used for musculoskeletal pain; however, NSAIDs can increase the risk of certain adverse events, such as gastrointestinal bleeding, edema, heart failure, and hypertension. The objective of this study was to characterize existing comorbidities among patients with OA. For patients with OA with and without a coexisting medical condition of interest (CMCOI), we estimated the prevalence of prescribing and dispensing NSAIDs pre-OA and post-OA diagnosis. Data from three large administrative claims databases were used to construct an OA retrospective cohort. Databases leveraged were IBM MarketScan Medicare Supplemental Database (MDCR), IBM MarketScan Commercial Database (CCAE), and Optum's de-identified Clinformatics® Data Mart Database (Optum CDM). The OA study population was defined to be those patients who had an OA diagnosis from an inpatient or outpatient visit with at least 365 days of prior observation time in the database during January 2000 through May 2021. Asthma, cardiovascular disorders, renal impairment, and gastrointestinal bleeding risks were the CMCOI of interest. Patients with OA were then classified as having or not having evidence of a CMCOI. For both groups, NSAID dispensing patterns pre-OA and post-OA diagnosis were identified. Descriptive analysis was performed within the Observational Health Data Sciences and Informatics framework. In each database, the proportion of the OA population with at least one CMCOI was nearly 50% or more (48.0% CCAE; 74.4% MDCR; 68.6% Optum CDM). Cardiovascular disease was the most commonly observed CMCOI in each database, and in two databases, nearly one in four patients with OA had two or more CMCOI (23.2% MDCR; 22.6% Optum CDM). Among the OA population with CMCOI, NSAID utilization post-OA diagnosis ranged from 33.0 to 46.2%. Following diagnosis of OA, an increase in the prescribing and dispensing of NSAIDs was observed in all databases, regardless of patient CMCOI presence. This study provides real-world evidence of the pattern of prescribing and dispensing of NSAIDs among patients with OA with and without CMCOI, which indicates that at least half of patients with OA in the USA have a coexisting condition. These conditions may increase the risk of side effects commonly associated with NSAIDs. Yet, at least 32% of these patients were prescribed and dispensed NSAIDs. These data support the importance of shared decision making between healthcare professionals and patients when considering NSAIDs for the treatment of OA in patients with NSAID-relevant coexisting medical conditions.

Effects of the valsartan recall on heart failure patients: A nationwide analysis.

Valsartan is commonly used for cardiac conditions. In 2018, the Food and Drug Administration recalled generic valsartan due to the detection of impurities. Our objective was to determine if heart failure patients receiving valsartan at the recall date had a greater likelihood of unfavorable outcomes than patients using comparable antihypertensives. We conducted a cohort study of Optum's de-identified Clinformatics® Datamart (July 2017-January 2019). Heart failure patients with commercial or Medicare Advantage insurance who received valsartan were compared to persons who received non-recalled angiotensin receptor blockers (ARBs) and angiotensin converting enzyme-inhibitors (ACE-Is) for 1 year prior and including the recall date. Outcomes included a composite for all-cause hospitalization, emergency department (ED), and urgent care (UC) use and a measure of cardiac events which included hospitalizations for acute myocardial infarction and hospitalizations/ED/UC visits for stroke/transient ischemic attack, heart failure or hypertension at 6-months post-recall. Cox proportional hazard models with propensity score weighting compared the risk of outcomes between groups. Of the 87 130 adherent patients, 15% were valsartan users and 85% were users of non-recalled ARBs/ACE-Is. Valsartan use was not associated with an increased risk of all-cause hospitalization/ED/UC use six-months post-recall (HR 1.00; 95% CI 0.96-1.03), compared with individuals taking non-recalled ARBs/ACE-Is. Similarly, cardiac events 6-months post-recall did not differ between individuals on valsartan and non-recalled ARBs/ACE-Is (HR 1.04; 95% CI 0.97-1.12). The valsartan recall did not affect short-term outcomes of heart failure patients. However, the recall potentially disrupted the medication regimens of patients, possibly straining the healthcare system.

Healthcare Costs of Irritable Bowel Syndrome (IBS) and IBS Subtypes in the United States.

Contemporaneous data on healthcare costs of irritable bowel syndrome (IBS) in the United States (U.S.) are lacking. We aimed to estimate all-cause and IBS-specific costs in patients with and without IBS and to compare costs across IBS subtypes. Using Optum's de-identified Clinformatics® Data Mart Database (CDM), we performed a retrospective cohort analysis of patients with and without IBS using data spanning 2016-2021. IBS patients were identified by ICD-10 codes. Controls were randomly selected from CDM participants. Primary outcomes were total all-cause and IBS-specific healthcare costs. Secondary outcomes were costs of individual services associated with any claim. Costs were compared between IBS and control groups and across IBS subtypes using propensity score weighting. Comorbidities were measured with the Elixhauser Comorbidity Index. Comparison of 102,887 patients with IBS (77.9% female; mean ± standard deviation age 60.3±18.4 years; 75.8% white) and 102,887 controls demonstrated higher median (interquartile range [IQR]) total costs per year (p<0.001) for patients with IBS ($13,288 [5,307-37,071]) than controls ($5,999 [1,800-19,426]). IBS was associated with increased healthcare utilization and higher median annual costs per-patient for all services. Median (IQR) annual IBS-specific spending was $1127 (370-5,544) per patient. Propensity score-weighted analysis across IBS subtypes revealed differences in total all-cause and IBS-specific costs and in costs of individual services. Highest spending was observed in IBS-C (all-cause $16,005[6,384-43,972]; IBS-specific $2,222 [511-7887]). Individuals with IBS exhibit higher healthcare utilization and incur substantially higher all-cause costs than those without. Care costs differ by IBS subtype.

Association between social vulnerability index and admission urgency for transcatheter aortic valve replacement

BackgroundTranscatheter aortic valve replacement (TAVR) are not offered equitably to vulnerable population groups. Adequate levels of insurance may narrow gaps among patients with higher social vulnerability index (SVI). Among a national population of individuals with commercial or Medicare insurance, we sought to determine whether SVI was associated with urgency of receipt of TAVR for aortic stenosis. Methods and resultsUsing Optum's de-identified Clinformatics Data Mart Database (CDM), we identified admissions for TAVR with aortic stenosis between January 2018 and March 2022. Admission urgency was identified by CDM claims codes. SVI was cross-referenced to patient zip codes and grouped into quintiles. Generalized linear mixed effects models were used to predict the probability of a TAVR admission being urgent based on SVI quintiles, adjusting for patient and hospital-level covariates. ResultsAmong 6680 admissions for TAVR [median age 80 years (interquartile range 75–85), 43.9 % female], 8.5 % (n = 567) were classified as urgent. After adjusting for patient and hospital-level variables, there were no significant differences in the odds of urgent admission for TAVR according to SVI quintiles [OR 5th (greatest social vulnerability) vs 1st quintile (least social vulnerability): 1.29 (95 % CI: 0.90–1.85)]. ConclusionsAmong commercial or Medicare beneficiaries with aortic stenosis, SVI was not associated with admission urgency for TAVR. To clarify whether cardiovascular care delivery is improved across SVI with higher paying beneficiaries, future investigation should identify whether relationships between SVI and TAVR urgency vary for Medicaid beneficiaries compared to commercial beneficiaries.

Dynamic Prognosis Prediction for Patients on DAPT After Drug-Eluting Stent Implantation: Model Development and Validation.

The rapid evolution of artificial intelligence (AI) in conjunction with recent updates in dual antiplatelet therapy (DAPT) management guidelines emphasizes the necessity for innovative models to predict ischemic or bleeding events after drug-eluting stent implantation. Leveraging AI for dynamic prediction has the potential to revolutionize risk stratification and provide personalized decision support for DAPT management. We developed and validated a new AI-based pipeline using retrospective data of drug-eluting stent-treated patients, sourced from the Cerner Health Facts data set (n=98 236) and Optum's de-identified Clinformatics Data Mart Database (n=9978). The 36 months following drug-eluting stent implantation were designated as our primary forecasting interval, further segmented into 6 sequential prediction windows. We evaluated 5 distinct AI algorithms for their precision in predicting ischemic and bleeding risks. Model discriminative accuracy was assessed using the area under the receiver operating characteristic curve, among other metrics. The weighted light gradient boosting machine stood out as the preeminent model, thus earning its place as our AI-DAPT model. The AI-DAPT demonstrated peak accuracy in the 30 to 36 months window, charting an area under the receiver operating characteristic curve of 90% [95% CI, 88%-92%] for ischemia and 84% [95% CI, 82%-87%] for bleeding predictions. Our AI-DAPT excels in formulating iterative, refined dynamic predictions by assimilating ongoing updates from patients' clinical profiles, holding value as a novel smart clinical tool to facilitate optimal DAPT duration management with high accuracy and adaptability.

Prevalence of pediatric lower urinary tract symptoms in a national claims database of privately insured patients, 2003-2014.

We conducted this study to estimate the prevalence of pediatric lower urinary tract symptoms (pLUTS) in a US privately insured pediatric population who are 6-20 years old by age, sex, race/ethnicity from 2003-2014. This has not been previously described in the literature. We retrospectively reviewed Optum's de-identified Clinformatics® Data Mart Database between 2003-2014. A pLUTS patient was defined by the presence of ≥ 1 pLUTS-related ICD-9 diagnosis code between the age of 6-20 years. Neurogenic bladder, renal transplant and structural urologic disease diagnoses were excluded. Prevalence by year was calculated as a proportion of pLUTS patients among the total population at risk. Variables reviewed included age, sex, race, geographic region, household factors and clinical comorbidities including attention-deficit/hyperactivity disorder (ADHD), constipation, and sleep apnea. Point of service (POS) was calculated as a proportion of pLUTS-related claims associated with a POS compared to the total claims at all POS in the time period. We identified 282,427 unique patients with ≥ 1 claim for pLUTS between the ages of 6-20 years from 2003 to 2014. Average prevalence during this period was 0.92%, increasing from 0.63% in 2003 to 1.13% in 2014. The median age group of patients was 6-10 years. More patients were female (59.80%), white (65.97%), between 6 and 10 years old (52.18%) and resided in the Southern US (44.97%). Within a single household, 81.71% reported ≤ 2 children, and 65.53% reported ≥ 3 adults. 16.88% had a diagnosis of ADHD, 19.49% had a diagnosis of constipation and 3.04% had a diagnosis of sleep apnea. 75% of pLUTS-related claims were recorded in an outpatient setting. Families consistently seek medical care in the outpatient setting for pLUTS. The demographic and clinical characteristics of our cohort reflect prior literature. Future studies can help define temporal relationships between household factors and onset of disease as well as characterize pLUTS-related healthcare resource utilization. Additional work is required in publicly insured populations.

Utilization of Biologic Disease-Modifying Antirheumatic Therapy in Patients With Rheumatoid Arthritis and Recently Diagnosed Breast Cancer.

Biologic disease-modifying antirheumatic drugs (bDMARDs) are immunosuppressants, and there have been concerns that they might impact tumor immunity in patients with cancer with rheumatoid arthritis (RA). The purpose of this study was to describe the utilization trends of bDMARD in patients with RA after breast cancer (BC) diagnosis. We performed a retrospective cohort study of adults with RA and BC (2008 onward) from Optum's de-identified Clinformatics® Data Mart Database (CDM); the Surveillance, Epidemiology, and End Results Program (SEER) Medicare; and the Texas Cancer Registry (TCR) Medicare databases. We evaluated bDMARD utilization trends during the first three years after BC. We conducted multivariable logistic regression to evaluate the association of utilizationwith patient characteristics. A total 1,412 patients were identified in CDM and 1,439 patients in SEER/TCR-Medicare. During the three months before BC diagnosis, 28.2% (CDM) and 26.9% (SEER/TCR-Medicare) patients had received bDMARDs. Within the first three years after diagnosis, 24.1% (CDM) and 26.4% (SEER/TCR-Medicare) were receiving bDMARDs. About 70% of the patients in the two cohorts received glucocorticoids with no significant time trend increases. The largest predictor of bDMARD utilization was prior use before BC (CDM: odds ratio [OR] 27.15, 95% confidence interval [CI] 19.29-38.19; SEER/TCR: OR 18.98, 95% CI 13.72-26.26). Regional and distant BC compared to in situ or localized were also associated with lower bDMARDs utilization in SEER/TCR-Medicare (OR 0.54, 95% CI 0.36-0.82; OR 0.31, 95% CI 0.13-0.77, respectively). The utilization of tumor necrosis factor inhibitors and other bDMARDs in patients with RA and recent BC has not increased since 2008. Glucocorticoids utilization remained high. The largest predictor of bDMARD utilization was prior use before BC.

Financial Viability of the No Surprises Act Independent Dispute Resolution Process: Radiology and Other Hospital-Based Specialties.

Background: The federal No Surprises Act (NSA), designed to eliminate surprise medical billing for out-of-network (OON) care for circumstances beyond patients' control, established the independent dispute resolution (IDR) process to settle clinician-payer payment disputes for OON care. Objective: To assess the fraction of OON claims for which radiologists and other hospital-based specialists can expect to at least break even when challenging payer-determined payments through the NSA IDR process, as a measure of the process's financial viability. Methods: This retrospective study extracted claims from a national commercial database (Optum's de-identified Clinformatics Data Mart Database) for hospital-based specialties occurring on the same day as in-network ED visits or inpatient stays from January 2017 to December 2021. OON claims were identified. OON claims batching was simulated using IDR rules. Maximum potential recovered payments from the IDR process was estimated as the difference between charges and allowed amount. The percentage of claims for which the maximum potential payment, and one-quarter of this amount (a more realistic payment recovery estimate), would exceed IDR fees was determined, using $150 and $450 fee thresholds to approximate the range of final 2024 IDR fees. These values represented the percentage of OON claims that would be financially viable candidates for IDR submission. Results: Among 76,221,264 claims for hospital-based specialties associated with in-network ED visits or inpatient stays, 1,482,973 (1.9%) were OON. Maximum potential payment exceeded fee thresholds of $150 and $450 for 55.0% and 32.1%, respectively, of batched OON claims for radiologists, and 76.8% and 61.3%, respectively, of batched OON claims for all other hospital-based specialties combined. At payment of one-quarter of that amount, these values were 26.9% and 10.6%, respectively, for radiologists, and 56.6% and 38.4%, respectively, for all other hospital-based specialties combined. Conclusions: The IDR process would be financially unviable for a substantial fraction of OON claims for hospital-based specialists (more so for radiology than for other such specialties). Clinical Impact: Although the NSA enacted important patient protections, IDR fees limit clinicians' opportunities to dispute payer-determined payments and potentially undermine their bargaining power in contract negotiations. Therefore, IDR rulemaking may negatively impact patient access to in-network care.

Large-scale epidemiological analysis of common skin diseases to identify shared and unique comorbidities and demographic factors.

The utilization of large-scale claims databases has greatly improved the management, accessibility, and integration of extensive medical data. However, its potential for systematically identifying comorbidities in the context of skin diseases remains unexplored. This study aims to assess the capability of a comprehensive claims database in identifying comorbidities linked to 14 specific skin and skin-related conditions and examining temporal changes in their association patterns. This study employed a retrospective case-control cohort design utilizing 13 million skin/skin-related patients and 2 million randomly sampled controls from Optum's de-identified Clinformatics® Data Mart Database spanning the period from 2001 to 2018.A broad spectrum of comorbidities encompassing cancer, diabetes, respiratory, mental, immunity, gastrointestinal, and cardiovascular conditions were examined for each of the 14 skin and skin-related disorders in the study. Using the established type-2 diabetes (T2D) and psoriasis comorbidity as example, we demonstrated the association is significant (P-values<1x10-15) and stable across years (OR=1.15-1.31). Analysis of the 2014-2018 data reveals that celiac disease, Crohn's disease, and ulcerative colitis exhibit the strongest associations with the 14 skin/skin-related conditions. Systemic lupus erythematosus (SLE), leprosy, and hidradenitis suppurativa show the strongest associations with 30 different comorbidities. Particularly notable associations include Crohn's disease with leprosy (odds ratio [OR]=6.60, 95% confidence interval [CI]: 3.09-14.08), primary biliary cirrhosis with SLE (OR=6.07, 95% CI: 4.93-7.46), and celiac disease with SLE (OR=6.06, 95% CI: 5.49-6.69). In addition, changes in associations were observed over time. For instance, the association between atopic dermatitis and lung cancer demonstrates a marked decrease over the past decade, with the odds ratio decreasing from 1.75 (95% CI: 1.47-2.07) to 1.02 (95% CI: 0.97-1.07). The identification of skin-associated comorbidities contributes to individualized healthcare and improved clinical management, while also enhancing our understanding of shared pathophysiology. Moreover, tracking these associations over time aids in evaluating the progression of clinical diagnosis and treatment. The findings highlight the potential of utilizing comprehensive claims databases in advancing research and improving patient care in dermatology.

Identifying neonatal intensive care (NICU) admissions using administrative claims data.

To define a method for identifying neonatal intensive care unit (NICU) admissions using administrative claims data. This was a retrospective cohort study using claims from Optum's de-identified Clinformatics® Data Mart Database (CDM) from 2016 -2020. We developed a definition to identify NICU admissions using a list of codes from the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), Current Procedural Terminology (CPT), and revenue codes frequently associated with NICU admissions. We compared agreement between codes using Kappa statistics and calculated positive predictive values (PPV) and 95% confidence intervals (CI). On average, revenue codes (3.3%) alone identified more NICU hospitalizations compared to CPT codes alone (1.5%), whereas the use of CPT and revenue (8.9%) and CPT or revenue codes (13.7%) captured the most NICU hospitalizations, which aligns with rates of preterm birth. Gestational age alone (4.2%) and birthweight codes alone (2.0%) identified the least number of potential NICU hospitalizations. Setting CPT codes as the standard and revenue codes as the "test,", revenue codes resulted in identifying 86% of NICU admissions (sensitivity) and 97% of non-NICU admissions (specificity). Using administrative data, we developed a robust definition for identifying neonatal admissions. The identified definition of NICU codes is easily adaptable, repeatable, and flexible for use in other datasets.

Updates in Characteristics and Survival Rates of Hepatocellular Carcinoma in a Nationwide Cohort of Real-World US Patients, 2003-2021.

Causes of hepatocellular carcinoma (HCC) may change as treatments become available for some liver diseases. We examined the distribution of HCC cause and survival of a nationwide cohort of insured patients. Optum's de-identified Clinformatics® Data Mart Database (CDM), 2003-2021. A total of 34707 patients with HCC were included: mean age: 68.3±11.6 years, 61% male, 62% Caucasian, 74% cirrhosis. Non-alcoholic fatty liver disease (NAFLD) was the most common etiology (38.9%), then hepatitis C virus (HCV) (25.3%), cryptogenic (18.0%), alcohol-associated liver disease (9.4%), other liver diseases (5.8%) and hepatitis B virus (HBV) at 2.6%. NAFLD patients were the oldest (mean age 71.1±11.2) and had the highest Charlson Comorbidity Index (CCI) (mean 10.5±3.9), while HCV were the youngest (mean age 64.2±9.2 years) and HBV had the lowest CCI (mean 7.2±4.4) (both P<0.0001). The overall 5-year survival was 18.8% (95% CI 18.2-19.3) but was lower in the recent 2014-2021 period vs 2003-2013 (18.1% vs 19.5%, P=0.003). The 2014-2021 cohort (inclusive of HCV treatment advances) was significantly older, with more females, fewer Caucasians, more African Americans, more Hispanics, fewer Asians, more cirrhosis, more NAFLD, and higher CCI (all P<0.001). On multivariable analysis, males (aHR: 1.13), Caucasians (aHR: 1.46), African Americans (aHR: 1.53) and Hispanics (aHR: 1.28) vs Asians, 2014-2021 (vs 2003-2013) cohort (aHR: 1.12), NAFLD (aHR: 1.14) or cryptogenic liver disease (aHR: 1.45) were associated with increased mortality (all P<0.001). HCC patients in more recent time 2014-2021 were more likely to be older, more likely to have nonviral etiology, and had worse survival compared to those from 2003 to 2013.

Clinical and Economic Burden of Illness in Patients with Persistent or Chronic Primary Immune Thrombocytopenia Treated with TPO-Ras and Rituximab

Background Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by reduced platelet counts. Patients with ITP lasting for ≥3 months (persistent or chronic primary ITP), and who do not respond adequately or maintain a response to initial therapy, are usually treated with advanced therapies such as thrombopoietin receptor agonists (TPO-RAs [avatrombopag/romiplostim/eltrombopag]), rituximab, and fostamatinib. The economic and clinical outcomes among patients on advanced therapies for ITP are not well described in real-world data. Objective This study aimed to evaluate the clinical and economic burden among ITP patients (lasting ≥3 months) treated with TPO-RAs, or rituximab, or fostamatinib by therapy type. Methods This retrospective cohort study used the US administrative health insurance claims data from the Optum's de-identified Clinformatics ® Data Mart Database. Patients with ITP lasting ≥3 months (aged ≥18 years), treated with TPO-RAs, or rituximab, or fostamatinib (index) between October 1, 2015, to August 31, 2020, after a 180-days washout period were included. Patient characteristics were evaluated 180 days prior to index (baseline). Follow-up for clinical outcomes started one-day after the index date and on the index date for economic outcomes. Patients were censored on switch to another ITP therapy different from index, death, end of data, or end of enrollment. Clinical outcomes (bleeding events [overall and type of bleeding], thromboembolic events [TEs], and clinical events identified as potential drug related adverse reactions) were reported as rate of events per 1000 person-years (PY). Health care resource use included number of hospitalizations, hospital days, emergency room visits, number of intensive care unit (ICU) admissions (both reported as rate of events per 1000 PY), and length of ICU stay. All analyses were stratified by treatment type on index date, however formal adjusted comparisons were not performed. Outcomes for fostamatinib users are not presented due to low sample size. Results A total of 404 patients treated with TPO-RAs, 333 with rituximab, and 14 with fostamatinib were eligible for the analysis. The average age of patients across the three cohorts was 60 years; 57.0% were females. The most common comorbidities across the three cohorts were diabetes (26.8%), coronary artery disease (14.4%), chronic heart failure (9.3%), and any TE (10.5%). At baseline, 29.0% of TPO-RA users, 30.6% of rituximab users, and 28.6% of fostamatinib users had experienced bleeding events. At baseline, bacterial infections occurred in 2% to 4% of patients treated with TPO-RAs and rituximab. At baseline, 36.1% TPO-RA users, 52.9% rituximab users, and 42.9% fostamatinib users had required any rescue therapy (IV anti-D, IV immunoglobulins, IV steroids, and platelet transfusion). Patients initiating TPO-RAs and rituximab were observed for a median (interquartile range, IQR) duration of 629 (286-1077) days and 398 (75-991) days, respectively. TPO-RA users and rituximab users stayed on the therapy for a mean (SD) duration of 305 (356) days and 31 (20) days, respectively. Among rituximab users, 60.7% completed a 4-week treatment course at index. During follow-up, the rate of bleeding events among TPO-RA and rituximab users was 284 and 254 per 1000 PY, respectively. The most common bleeding events were gastrointestinal bleeding, hematuria, and epistaxis. The rate of bacterial infections was 71 per 1000 PY in patients treated with TPO-RAs and 58 per 1000 PY in those treated with rituximab. The rate of TEs among TPO-RA and rituximab users was 153 and 110 per 1000 PY, respectively (Table 1). During follow-up, 38.4% of TPO-RA users and 55.9% of rituximab users required rescue therapy. The rate of hospitalizations among patients treated with TPO-RAs and rituximab was 573 and 400 per 1000 PY, respectively. The rate of ICU stays in patients treated with TPO-RAs was 176 per 1000 person-years, and 143 per 1000 person-years for those treated with rituximab (Table 2). Conclusion ITP patients (lasting ≥ 3 months) treated with TPO-RAs and rituximab continue to experience substantial rates of infections, TEs and bleeding (often requiring rescue therapies). All-cause hospitalization was high in this population. Further studies are needed to understand long-term clinical and economic outcomes among ITP patients.

First-Time Users of Advanced Therapies Among Adult Patients with Persistent or Chronic Primary Immune Thrombocytopenia: Patient Characteristics, Treatment Switching Patterns, and Clinical Outcomes

Background Primary immune thrombocytopenia (ITP) is a rare acquired autoimmune disorder characterized by low platelet count, with an overall age/sex-standardized annual incidence of 6.1 per 100,000 persons in the US in 2016. Patients who fail to respond or maintain a response to initial therapy (e.g., corticosteroids, intravenous immunoglobulins), move to advanced therapies with robust evidence such as thrombopoietin receptor agonists (TPO-RAs [eltrombopag/ romiplostim/ avatrombopag]), rituximab, and fostamatinib, as per the international consensus guidelines. Among patients with primary ITP lasting ≥3 months who are first-time users of advanced therapies, there is limited real-world evidence on patient characteristics, treatment patterns, and clinical outcomes. Objectives The key objectives were to assess patient characteristics, treatment patterns, and clinical outcomes of first-time users of advanced therapy in patients with primary ITP lasting ≥3 months. Methods This retrospective, cohort study included patients identified from Optum de-identified Clinformatics ® Data Mart database, aged ≥18 years with primary ITP lasting 3 months or more, who initiated advanced therapy for the first time between October 1, 2015, and August 31, 2020. Patients were required to have ≥365 days of available data prior to index date, without evidence of conditions associated with secondary ITP. Patients were indexed on the date of initiation of advanced therapies. Baseline characteristics, including demographics, comorbidities, use of medication, and bleeding events requiring medical attention (e.g., intracranial bleeding, gastrointestinal bleeding, hematuria) were assessed 365 days prior to index and reported using descriptive statistics. Treatment patterns and rates of bleeding events, thromboembolic events (TEs), bacterial infections, and hospitalizations were assessed during follow-up, which began one-day after index date and until discontinuation of the index therapy. Patients were censored on death, end of data accrual, disenrollment, or switch to another advanced therapy. Outcomes were reported as the number of events per 1000 person-years and time to first event. Results Total 375 patients with primary ITP lasting ≥3 months, who were first-time users of advanced therapies were included, with 51% (n=192) initiating TPO-RAs, 49% (n=182) initiating rituximab, and &amp;lt;1% (n=2) initiating fostamatinib. Mean (SD) age of overall population was 62 (19) years, and 55.7% were female. About 9% of patients were Black, 4% Asian, and 11% Hispanic ( Table 1). In year prior to index date, previous bleeding events were most common clinical symptoms in patients with ITP initiating advanced therapies (any bleeding, 39.7%). Other frequently reported comorbidities were diabetes (28.5%), coronary artery disease (18.9%), and asthma (17.3%); 13.1% of patients had a TE. About 5% patients reported bacterial infections ( Table 1). Patients initiating TPO-RA and those starting rituximab were observed for a median (interquartile range, IQR) duration of 22.2 (14.5-34.9) months and 27.1 (13.5-43.2) months, respectively. Almost 9% of TPO-RAs initiators switched to rituximab (median [IQR] time to switch: 3.2 [1.7-6.9] months), while 23.6% of rituximab initiators switched to TPO-RAs (median [IQR] time to switch: 3.1 [1.7-7.6] months) during follow-up. After initiating advanced therapies, the rates of any bleeding event and TEs were 288 per 1000 person-years (95% CI: 240-336) and 129 per 1000 person-years (95% CI: 99-158), respectively. Mean (SD) time to first bleeding event was 299 (351) days and that of TE was 257 (325) days. Infection rate was 70 per 1000 person-years ( Table 2). In follow-up, 31% of patients had ≥1 ITP-related hospitalization and 38% had an all-cause hospitalization, resulting in rates of 215 [95% CI: 176-255] and 299 [95% CI: 250-349] per 1000 person-years, respectively. Approximately 5% of patients underwent splenectomy (incidence rate: 27 per 1000 person-years [95% CI: 15-40]) with mean (SD) time of 245 (186) days post initiation of advanced ITP therapy ( Table 2). Conclusion This study demonstrated high clinical burden and need for subsequent additional therapies among patients with primary ITP lasting ≥3 months, which is evident from high rates of switching between advanced therapies, bleeding events requiring medical attention, TEs, and ITP-related hospitalizations.

Economic Burden of Delayed Diagnosis in Patients with Pulmonary Arterial Hypertension (PAH).

The aim of this study was to assess health care resource utilization (HRU) and costs associated with delayed pulmonary arterial hypertension (PAH) diagnosis in the United States. Eligible adults with newly diagnosed PAH from Optum's de-identified Clinformatics® Data Mart Database (2016-2021) were assigned to mutually exclusive cohorts based on time between first PAH-related symptom and first PAH diagnosis (i.e., ≤12 months' delay, >12 to ≤24 months' delay, >24 months' delay). All-cause HRU and health care costs per patient per month (PPPM) were assessed during the first year following diagnosis and compared across cohorts using regression analysis adjusted for baseline covariates. Sensitivity analyses were conducted to assess outcomes during all available follow-up post-diagnosis. Among 538 patients (mean age: 65.6 years; 60.6% female), 60.8% had ≤12 months' delay, 23.4% had a delay of >12 to ≤24 months, and 15.8% had >24 months' delay. Compared with ≤12 months, delays of >12 to ≤24 months and >24 months were associated with increased hospitalizations (incidence rate ratio [95% confidence interval]: 1.40 [1.11-1.71] vs 1.71 [1.29-2.12]) and outpatient visits (1.17[1.06-1.30] vs 1.26 [1.08-1.41]). Longer delays were also associated with more intensive care unit (ICU) stays and 30-day readmissions. Diagnosis delays translated into excess costs PPPM of US$3986 [1439-6436] for >12 to ≤24 months and US$5366 [2107-8524] for >24 months compared with ≤12months' delay; increased hospitalization costs (US$3248 [1108-5135] and US$4048 [1401-6342], respectively) being the driver. Sensitivity analyses yielded similar trends. Delayed PAH diagnosis is associated with significant incremental economic burden post-diagnosis, driven by hospitalizations including ICU stays and 30-day readmissions, highlighting the need for increased awareness and a potential benefit of earlier screening.

Evaluation of longer- vs short-term use of patiromer on health care resource utilization in the patiromer longer-term use evaluation (VALUE) study.

Studies suggest that continuous long-term use of patiromer by patients with hyperkalemia is associated with less health care resource utilization compared with not using potassium binders. To retrospectively evaluate health care resource utilization and costs with longer-term adherent vs short-term use of patiromer. Time-restricted extracts from Optum's de-identified Clinformatics® Data Mart Database (CDM; January 2016-May 2019) and Symphony Health (SHA; January 2016-September 2018) deidentified databases were analyzed. Both include participants enrolled in commercial and privatized public insurance programs (SHA includes some government programs). Both integrate health care claims data from medical and pharmacy claims. Patients aged 18 years or older with hyperkalemia and an index patiromer prescription were selected. Patiromer use was identified as short-term (<2 months) and any fill quantity or adherent longer-term with claims for at least 2 consecutive months and fill quantities of at least 80% of the total days. Groups were matched on multiple categorical covariates to control for demographic variables, baseline characteristics, and markers of disease severity. Random sampling without replacement was performed 50 times to identify 50 sets of patients matched from the short-term cohort to the longer-term cohort. Health care costs/charges and encounters were compared for a 6-month post-index period using t-tests. Of the CDM patients, 1,267 (40.2%) vs 1,887 (59.8%) and of the SHA patients, 2,234 (35.1%) vs 4,132 (64.9%) experienced longer-term vs short-term patiromer use, respectively. Patient sampling selected 242 and 485 patient-matched pairs from CDM and SHA databases, respectively. At 6 months post-index in longer-term vs short-term patiromer groups (P < 0.0001 for all differences shown), respective mean medical and prescription costs/charges were $42,000 vs $54,311 (-$12,311) and $6,816 vs $4,786 (+$2,030), respectively, for CDM patients and $75,147 vs $84,414 (-$9,267) and $4,689 vs $3,736 (+$953) for SHA patients. In the CDM database, medical costs were lower for longer-term vs short-term cohorts for end-stage renal disease services charges ($10,342 vs $14,976 [-$4,634]), inpatient charges ($15,789 vs $21,473 [-$5,684]), and office visit charges ($10,152 vs $13,152 [-$3,000]). Patient out-of-pocket costs ($658 vs $420 [+$238]) and total prescription charges ($6,158 vs $4,366 [+$1,792]) were higher for the longer-term cohort of CDM patients, with similar findings in the SHA dataset. Adherent, longer-term use of patiromer is associated with significantly lower medical costs offsetting higher prescription costs, driven by the largest changes in inpatient and clinic services at CDM and SHA, respectively. This illustrates an economic value of longer-term adherence to patiromer.

Association Between Race, Cardiology Care, and the Receipt of Guideline-Directed Medical Therapy in Peripartum Cardiomyopathy.

Black patients with peripartum cardiomyopathy (PPCM) have disproportionately worse outcomes than White patients, possibly related to variable involvement of cardiovascular specialists in their clinical care. We sought to determine whether race was associated with cardiology involvement in clinical care during inpatient admission and whether cardiology involvement in care was associated with higher claims of guideline-directed medical therapy (GDMT) a week after hospital discharge. Using Optum's de-identified Clinformatics® Data Mart (CDM), we included Black and White patients' first hospital admission for PPCM from 2008 to 2021. Cardiology involvement in clinical care was defined as the receipt of attending care from a cardiovascular specialist during admission. GDMT included beta-blockers (BB) for all patients and triple therapy (BB, angiotensin-responsive medications, and mineralocorticoid receptor antagonists) for non-pregnant patients. Logistic regression was used to determine the associations between cardiology involvement in clinical care during admission and (1) patient race and (2) GDMT prescription, adjusting for age and comorbidities. Among 668 patients (32.6% Black, 67.4% White, 93.3% commercially insured), there was no significant difference in the odds of cardiology involvement in clinical care by race (aOR: 1.41; 95%CI: 0.87-2.33, P=0.17). Inpatient cardiology care was associated with 2.75 times increased odds of having a prescription claim for GDMT (BB) for White patients (aOR: 2.75; 95%CI 1.50-5.06, P=0.001), and the estimated effect size was similar but not statistically significant for Black patients (aOR: 2.20, 95% CI, 0.84-5.71, P=0.11). The interaction between race and cardiology involvement in clinical care was not statistically significant for the receipt of BB prescription. Among 274 non-pregnant patients with PPCM (37.2% Black, 62.8% White), 5.8% received triple GDMT. Of these, none of the Black patients lacking cardiology care had triple GDMT. However, cardiology involvement in care was not significantly associated with triple GDMT for either race. Among a commercially insured population within PPCM, race was not associated with cardiology involvement in clinical care during hospitalization. However, cardiology involvement in care was associated with significantly higher odds of prescription claims for BB for only White patients. Additional strategies are needed to support equitable GDMT prescription.

Indirect impact of the COVID-19 pandemic on the care and outcomes of people with MS: A combined survey and insurance claims study

BackgroundIn the context of the COVID-19 pandemic, people with multiple sclerosis (pwMS) have been particularly vulnerable to adverse outcomes due to increased risk of severe infection and/or widespread disruptions in care. The CopeMS study led by The University of Texas at Austin and the MS Association of America investigates the long-term impact of the COVID-19 pandemic on healthcare access, disease modifying therapy (DMT) utilization and outcomes of pwMS. MethodsThis retrospective cohort analysis used Optum's de-identified Clinformatics® Data Mart Database (CDM), a large de-identified administrative healthcare claims database to identify pwMS who were continuously enrolled from 01/01/2019 to 12/31/2020 and assessed changes in the utilization of DMTs and healthcare services during the COVID-19 pandemic compared to the year prior. Additionally, a national survey of pwMS and healthcare providers (HCPs) was conducted to further understand the indirect impact of the pandemic on healthcare resource utilization (HCRU), outcomes and prescription patterns. ResultsOut of 529 pwMS in our national survey, over 47 % reported that their overall health and neurologic symptoms had deteriorated during the COVID-19 pandemic, with increased anxiety, and inability to maintain exercise habits as leading perceived causes for worsening. Survey respondents reported widespread disruption of MS-related services during the pandemic. In the Optum database, we identified 39,209 pwMS validating inclusion criteria. We observed a decrease in the utilization of MS-related services in 2020 compared to 2019. Significantly fewer pwMS had visits with their neurologist, primary care provider, physical or occupational therapist despite an increased utilization of telemedicine services. Fewer pwMS had magnetic resonance imaging (MRI) studies of the brain or spinal cord during the pandemic. Only 22.2 % of HCPs surveyed agreed that the perceived risk of more severe COVID-19 infection on a specific DMT influenced their therapeutic decisions. In the Optum database, individuals with an established diagnosis of MS prior to 2019 saw decreases in utilization of platform and moderate efficacy DMTs. In this group, those over the age of 55 saw a decrease in utilization of B-cell therapies (rate ratio 0.79, CI 0.75–0.83), whereas individuals under the age of 55 saw an increase in utilization of B-cell therapies (rate ratio 1.10, CI 1.03–1.17). We did not see any difference in rates of starting DMTs in persons diagnosed in 2019 prior to the pandemic and those diagnosed in 2020. Compared to 2019, B-cell therapies were prescribed more frequently in pwMS diagnosed in 2020 who were younger than 55 or commercially insured (rate ratio 1.35, CI 1.11–1.63). ConclusionThe COVID-19 pandemic was associated with perceived worsening of neurological symptoms in pwMS. Despite the expansion of telemedicine, we observed decreased access to healthcare services important to the comprehensive care of pwMS. Additionally, we observed changes in DMT utilization in pwMS during the pandemic, particularly in older adults with an established diagnosis of MS.

Impact of selexipag use within 12 months of pulmonary arterial hypertension diagnosis on hospitalizations and medical costs: A retrospective cohort study.

Oral selexipag, a prostacyclin pathway agent (PPA), is effective in patients with pulmonary arterial hypertension (PAH). The objective of this study is to assess the impact of initiating oral selexipag within 12 months of diagnosis on health outcomes. This retrospective cohort study used data from Optum's de-identified Clinformatics® Data Mart Database. PAH patients between 1 October 2015 and 30 September 2019 were included. Patients were also required to have received PAH medication within 12 months of their initial diagnosis. Study groups included patients who initiated selexipag within 12 months of PAH diagnosis (SEL ≤ 12) and those who did not initiate any PPA within 12 months of PAH diagnosis (No PPA ≤ 12). Inverse probability of treatment weighting was used to remove potential confounding between groups. Cox and Poisson regression models were used to compare hospitalization and disease progression. Generalized linear model with gamma distribution and log link was used to compare costs. SEL ≤ 12 had lower rate of all-cause hospitalizations (rate ratio: 0.76, 95% confidence interval [CI]: 0.60, 0.96) versus no PPA ≤ 12, but no differences in PAH-related hospitalization rate (rate ratio: 1.03, 95% CI: 0.79, 1.33) or risk of disease progression (hazard ratio: 1.01, 95% CI: 0.71, 1.44). SEL ≤ 12 incurred lower all-cause (mean difference: -$23 623; 95% CI: -35 537, -8512) and PAH-related total medical costs (mean difference: -$12 927; 95% CI: -19 559, -5679) versus no PPA ≤ 12. Selexipag initiation within 12 months of PAH diagnosis demonstrated reductions in all-cause hospitalization rate and medical costs.