Administrative Claims Data Research Articles

Mortality and Morbidity of Heart Failure Hospitalization in Adult Patients With Congenital Heart Disease.

Little is known about outcomes following heart failure (HF) hospitalization among adults with congenital heart disease (CHD) in the United States. We aim to compare the outcomes of HF versus non-HF hospitalizations in adults with CHD. Using a national deidentified administrative claims data set, patients with adult congenital heart disease (ACHD) hospitalized with and without HF (ACHDHF+, ACHDHF-) were characterized to determine the predictors of 90-day and 1-year mortality and quantify the risk of mortality, major adverse cardiac and cerebrovascular events, and health resource use. Cox proportional hazard regression was used to compare ACHDHF+ versus ACHDHF- for risk of events and health resource use. Of 26 454 unique ACHD admissions between January 1, 2010 and December 31, 2020, 5826 (22%) were ACHDHF+ and 20 628 (78%) were ACHDHF-. The ACHD HF+ hospitalizations increased from 6.6% to 14.0% (P<0.0001). Over a mean follow-up period of 2.23 ± 2.19 years, patients with ACHDHF+ had a higher risk of mortality (hazard ratio [HR], 1.86 [95% CI, 1.67-2.07], P<0.001), major adverse cardiac and cerebrovascular events (HR, 1.73 [95% CI, 1.63-1.83], P<0.001) and health resource use including rehospitalization (HR, 1.09 [95% CI, 1.05-1.14], P<0.001) and increased postacute care service use (HR, 1.56 [95% CI, 1.32-1.85], P<0.001). Cardiology clinic visits within 30 days of hospital admission were associated with lower 90-day and 1-year all-cause mortality (odds ratio [OR], 0.62 [95% CI, 0.49-0.78], P<0.001; OR, 0.69 [95% CI, 0.58-0.83], P<0.001, respectively). HF hospitalization is associated with increased risk of mortality and morbidity with high health resource use in patients with ACHD. Recent cardiology clinic attendance appears to mitigate these risks.

Prevalence, Epidemiology, Mortality and Morbidity of Thrombotic Events in SLE: A Nationwide Study in the United States

CONCLUSION Thrombotic events (TE) are a major cause of morbidity and mortality in patients with Systemic Lupus Erythematosus (SLE). Data is scant, however, on the prevalence, epidemiological characteristics, in hospital morbidity and mortality of TEs in this population. To perform a comprehensive epidemiological study on patients with SLE and DVT, PE or atypical thrombosis and their variation by gender, geographic region and hospital status. We also aimed to explore the associated morbidity and mortality for each TE and potential associations with other risk factors such as obesity and smoking. We conducted a retrospective cohort study, using the 2003-2018 Nationwide Inpatient Sample (NIS) database. All adult patients with a diagnosis of SLE using ICD-9 and 10 codes were included. The ICD 9 and 10 codes were also used to find other TE variables including DVT, PE, Cerebral venous sinus thrombosis (CVST), Splanchnic thrombosis (ST)and Arterial thrombosis (AT). Of the 513,904 SLE patients included, PE, DVT, ST, CVST and AT were identified in 1.38%, 3.07%, 1.34%, 0.04% and 0.35% patients respectively. Each TE (except CVST) had a statistically significant increase in length of hospital stay, cost of hospitalization and all-cause in-hospital mortality. Higher prevalence of PE, DVT, ST and AT were reported in males with SLE, and higher prevalence of obesity was seen in SLE patients with TEs, except AT, which interestingly was associated with a lower prevalence of obesity. Despite comprising only one third of the cohort, African Americans (AAs) faced the highest burden of PEs and DVTs. No significant differences were seen between geographic regions. This study is limited by administrative claims data, lack of antiphospholipid antibody status, and only includes inpatient encounters. Additionally, this is an observational retrospective study, and the assessment is limited to association of these thrombotic events in the SLE population. Arterial, venous and atypical thrombosis exert significant morbidity and mortality in patients with SLE. Racial and gender variations exist in each category of thrombosis, and identifying these differences is crucial while taking management decisions for patients with SLE. Particular attention should be directed to AAs with SLE, who appear to be particularly vulnerable.

Psychiatric and Substance Use Disorders Are Independent Predictors of Treatment Response and Outcomes in United States Veterans with Newly Diagnosed Acute Myeloid Leukemia Treated with Venetoclax Combinations

BACKGROUND: Venetoclax (VEN) combinations have become the standard frontline therapy for patients with newly diagnosed acute myeloid leukemia (AML) who are deemed unable to tolerate intensive induction chemotherapy, either due to age or comorbidities. However, outcomes in the real-world setting have been inferior to those observed in clinical trials. Preexisting psychiatric diagnoses and substance use disorders (SUDs) have previously been associated with increased mortality in patients with cancer, but their prognostic influence in veterans with AML is unclear. The aim of this study was to measure the prevalence of psychiatric and SUDs in veterans with AML treated with VEN combinations, determining the impact of these conditions on treatment response and outcomes. METHODS: This was a retrospective cohort study of veterans with newly diagnosed AML who received frontline therapy with VEN combinations within the national Veterans Affairs (VA) Healthcare System. To measure the prevalence of psychiatric and SUDs, we used the Centers for Medicare and Medicaid Services (CMS) Chronic Conditions Data Warehouse algorithm, which tracks health conditions by administrative claims data with International Classification of Diseases (ICD) diagnostic and procedural codes. Our endpoints were rates of complete remission or complete remission with incomplete marrow recovery (CR/CRi), early mortality (EM, or death within 60 days of treatment initiation), intensive care unit (ICU) admissions, and overall survival (OS). We evaluated the relationship between comorbid medical conditions and outcomes using Kaplan-Meier analysis and Cox proportional hazards regression models, first unadjusted, and then adjusted for all covariates. Patients who underwent allogeneic stem cell transplantation (HSCT) were excluded from statistical analyses. RESULTS: We identified 452 veterans treated with VEN up to April 1, 2022 (Table 1). In combination with VEN, 60% (n=270) received azacitadine, 37% (n=168) received decitabine, and 3% (n=14) received low-dose cytarabine. Median age was 74.3 years (IQR: 71.2-78.5) with 52% ≥75 years. By European LeukemiaNet (ELN) 2017 risk classification, 61% (n=274) were classified as adverse risk. Forty-six percent (n=206) of veterans had a preexisting psychiatric diagnosis, and 19% (n=84) had SUDs; 11% (n=49) had both comorbidities. Psychiatric disorders were significantly more prevalent in younger veterans (68% in &amp;lt;65 years vs 50% in 65-74 years vs 39% in ≥75 years, p&amp;lt;0.003); same was true for SUDs (38% in &amp;lt;65 years vs 26% in 65-74 years vs 9% in ≥75 years, p&amp;lt;0.001). For the entire cohort, CR/CRi was achieved by 57% (n=257), and only 3% (n=12) received HSCT. Zero veterans with SUDs and 8 with psychiatric diagnoses were transplanted. At the end of study period, 69% (n=310) had died. Median OS was 216 days (95% CI: 195-254). The 60-day mortality rate was 20% (n=87), of which 8 veterans had primary refractory AML. ICU admissions after treatment initiation was significantly higher in veterans with SUDs compared to those without history of SUDs (5.0 versus 2.2 per 5 person-years, p&amp;lt;0.001). On multivariable analyses (Table 2), both psychiatric and SUDs were independently associated with decreased odds of CR/CRi. Veterans with psychiatric disturbances had a 1.97 times higher hazard of EM (95% CI: 1.16-3.39, p=0.01) and a 1.28 times higher hazard of death (95% CI: 1.00-1.64, p=0.05) compared to veterans without concurrent psychiatric disorders. CONCLUSION: Psychiatric diagnoses and SUDs were not only prevalent among veterans with AML, but they also negatively impacted treatment response, EM, and OS-independently of age, sociodemographic variables, markers of disease risk, and VEN combination. Veterans with SUDs also had significantly higher ICU admissions after treatment initiation for AML. Compared to published clinical trials data, veterans experienced inferior outcomes. Veterans with psychiatric and SUDs may have difficulty adhering to regimens, reemergence of their mental instability and illness that is triggered by AML diagnosis and its treatment, or biologic mechanisms associated with these comorbidities. Better understanding of these factors contributing to health disparities and targeting these comorbidities with supportive care interventions alongside AML-specific therapy may improve outcomes and warrant further study.

Emergency Admissions and the Prescribing of Buprenorphine, Methadone, and Psychotropic Medications in People with Sickle Cell Disease: An Analysis of National Insurance Claims

Background Although there have been efforts to address overdose risks and treatment gaps in general populations receiving opioids, there is has been little research examining potential drug-related poisoning risks in some of the highest-need and complex populations, including those with sickle cell disease (SCD). Chronic opioid medications are necessary and well-tolerated for the treatment of chronic pain, diffuse inflammation, chronic organ damage, and vaso-occlusive pain crises for people with SCD. Previous studies have found that patients with SCD are not more likely to develop addiction to opioids than the general population. However, amid the ongoing endemic of drug-related poisonings in the U.S., epidemiological data is scarce regarding the clinical characteristics of people who have SCD and physiologic opioid tolerance and dependence. There has been particularly limited work on the intersection of sociodemographic characteristics, substance use, and other mental health conditions in the SCD population. Concern has also been raised about the ongoing opioid epidemic contributing to increased stigma, and greater barriers to the management of acute and chronic pain in SCD. Studies have shown that preoccupation with opioid prescription monitoring hindered the ability of physicians to provide comprehensive SCD care. People with SCD often face more restrictive utilization management policies for opioids than peers with other forms of chronic pain (i.e., cancer-related pain). In order for us to develop better interventions for people with SCD, real-world data is urgently needed to describe the current treatment landscape and identify gaps in care for people with SCD and physiologic opioid dependence or tolerance. Using administrative claims data in the US, we aim to: 1) quantify the burden of hospitalization and emergency room admission for medication-related poisoning events, 2) describe the prevalence of opioid prescriptions, such as buprenorphine and methadone, in people with SCD and physiologic opioid dependence or misuse. Methods In this retrospective cohort study of people with physiologic opioid dependence or opioid use disorder (OUD), we analyzed ten years (1/2006-12/2016) of data from the Merative™ MarketScan® Commercial and Multi-State Medicaid Databases. The predictor variable was SCD (versus a comparator group of people with chronic pain) with diagnoses identified using ICD-9/10 codes. The outcome variables were 1) emergency admissions or hospitalization for non-fatal drug/medication-related poisoning events during enrollment, and 2) prescriptions for buprenorphine, methadone, and other opioids, identified via procedure codes and linked pharmacy records respectively. We used multivariable cox regression to estimate the relationship between SCD diagnosis and time until poisoning events. Multivariable poisson regression models were used to assess the relationship between SCD and buprenorphine, methadone, and other opioid prescriptions. Results Our overall cohort consisted of 25,448 people with ICD9-10 opioid dependence or misuse, including 313 with SCD and 25,135 with non-SCD chronic pain. In the SCD cohort, the median age was 30.8 years, and 82% were enrolled in Medicaid. Compared to the non-SCD chronic pain cohort, the SCD cohort had more hospitalizations or emergency admission for iatrogenic events (37.4% vs 9.8%, aHR=2.21[2.12-2.31]). With regards to medication receipt compared to peers with non-SCD chronic pain, the SCD cohort had a lower prevalence of buprenorphine prescriptions (8% vs 30.1%, aRR=0.20[0.18-0.21]) and a higher prevalence of methadone prescriptions for chronic pain (63.6% vs 6.8%, aRR=5.36[5.21-5.51]) and non-methadone/non-buprenorphine opioid prescriptions (80.5% vs 33.7%, aRR=2.20[2.15-2.25]). Conclusions We observed an elevated rate of emergency admission and/or hospitalization for drug/medication-related poisoning, as well as a significant burden of psychiatric comorbidity in a cohort of people with SCD and physiologic opioid dependence or OUD. The prescribing of potentially safer opioids, such as buprenorphine, was uncommon in the cohort. Further research is urgently needed to optimize opioid treatment strategies, combat stigma, and improve the comprehensive management of pain and co-occurring disorders in the SCD population.

Prevalence and Incidence of Primary Autoimmune Hemolytic Anemia and Cold Agglutinin Disease in the United States, 2016-2022: A Retrospective Study in Administrative Claims

Background Autoimmune hemolytic anemia (AIHA) is a decompensated acquired hemolysis caused by autoantibodies that act against red blood cells leading to anemia. Cold agglutinin disease (CAD) is a rare subtype of AIHA mediated by classical complement pathway activation, characterized by chronic hemolysis, severe anemia, fatigue, weakness, dizziness, and circulatory problems. The aim of this study was to update the epidemiology of AIHA and CAD in the United States using administrative claims data that includes commercially insured patients, as well as those with Medicare Advantage, Medicare Fee for Service (FFS) and Managed Medicaid plans. Methods Administrative closed claims from Optum CDM database (commercially insured single-payer and Medicare Advantage), Inovalon MORE 2 Registry (commercially insured multi-payer, Medicare Advantage, and Managed Medicaid), and 100% Medicare FFS (Part A/B services) data were used for this analysis. AIHA cases were defined as patients with at least 2 claims with ICD-9/10 diagnosis codes for AIHA (283.0, D59.1, D59.10, D59.11, D59.12, D59.13, D59.19) at least 30 days apart. CAD cases were defined as patients with at least 2 claims with ICD-10 diagnosis codes for CAD (D59.12) or at least 1 claim with diagnosis code for AIHA followed by 1 claim with diagnosis code for CAD (D59.12) at least 30 days apart. Index date was assigned to the first observed claims with the AIHA/CAD diagnosis. Analyses included patients 18 years of age and above with at least 180 days of continuous enrollment in their health plan prior to index for the assessment of the exclusion criteria. Patients with secondary causes of AIHA/CAD (e.g., lymphoma, leukemia, myeloma, cytomegalovirus, or Epstein-Barr virus) were excluded. US census data from years 2016-2021 was used to standardize the incidence and prevalence estimates by age and sex. Point prevalence was calculated as of January 1 st of each year using an all-data lookback. Period prevalence was calculated using a one calendar year assessment period. Incidence estimated new cases in a given year among patients with no prior evidence of AIHA in all data lookback. For CAD, estimates were presented for years 2022/23 due to the recency of the ICD-10 code specific to CAD (active as of 1 October 2020). Results Age and sex standardized point prevalence of AIHA per 1,000,000 persons was approximately 210 in the Medicare FFS across years 2016-2021, 160 in the Optum claims across years 2016-2022, and 50 in the MORE 2 database across years 2016-2022. One-year prevalence per 1,000,000 persons was approximately 190 in the Medicare FFS, 70 in the Optum claims, and 50 in the MORE 2 database across study years. Incidence per 1,000,000 was 50-60 in the Medicare FFS, 20-30 in the Optum claims, and 15 in the MORE 2 database. While overall standardized estimates differed across databases, incidence and prevalence estimates were similar when stratified by age group, indicating that standardization did not fully account for the underlying differences in the composition and representativeness of the overall US population in the three databases. Incidence and prevalence were higher among females than males and increased with age as expected. Incidence per 1,000,000 for year 2021 ranged from roughly 10-80 among those under the age of 45 years to 30-80 among those over the age of 65 years across the three databases. Point prevalence per 1,000,000 for year 2021 had a broader range from 30 to 220 among those under the age of 45 years and from 120 to 360 among those over the age of 65 years. The standardized point prevalence per 1,000,000 for CAD was 31 in Optum claims (year 2023), 33 in Medicare FFS (year 2021), and 14 in MORE 2 (year 2021). Prevalence of CAD was higher among females and increased with age. Conclusion This multi-database analysis provides updated epidemiology estimates for AIHA and CAD in the US. Age and sex standardized point prevalence for AIHA ranged from 60 to 210 per 1,000,000 across the 3 databases, with higher prevalence in the Medicare FFS database which primarily captures population over the age of 65 and was lower in the two databases that capture younger age groups, such as Managed Medicaid and commercially insured populations. Similarly, incidence of AIHA ranged from 15 to 60 per 1,000,000. Point prevalence of CAD ranged from 14 to 33 per 1,000,000. These estimates are in line with those previously reported for North America and Western Europe.

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.

Factors Associated with Treatment Receipt in Medicare Beneficiaries Diagnosed with Acute Myeloid Leukemia

Background: The treatment a patient with AML receives may be influenced by where the patient is diagnosed and the physician making the initial diagnosis. Such factors could be targeted for intervention to help ensure patients receive optimal treatment; however, data constraints have previously limited a complete examination of patient, physician and hospital factors associated with treatment for AML. This study aimed to investigate the association of patient, hospital, and physician factors with treatment receipt for patients diagnosed with AML. Treatment receipt included allogeneic hematopoietic cell transplant (alloHCT) or chemotherapy without alloHCT among patients who received a National Marrow Donor Program (NMDP) donor search (search). Methods: Centers for Medicare and Medicaid (CMS) Medicare administrative claims data from 2010 to 2018 were linked to NMDP Donor Search data and to publicly available CMS and National Provider Identifier physician and hospital datasets. Patients aged 65-74 diagnosed with AML between 2010 and 2017 and enrolled in fee-for-service (Part A and B) Medicare for at least one year after diagnosis or until death, were included. The treatment groups (alloHCT and search) were identified using diagnosis and procedure codes. A multivariable hierarchical logistic regression procedure was performed to determine factors associated with treatment receipt, with hospital as a random effect. Models were adjusted for patient, hospital and physician characteristics identified at the time of diagnosis. Patients missing physician and hospital characteristics were excluded. Individuals with a racial/ethnic background of Black/African-American, Asian/Pacific Islander, Hispanic, American Indian/Alaska Native, and Other were grouped due to small numbers. All analyses were performed using Statistical Analysis Software (SAS ®) Enterprise Guide 7.1. Results: A total of 916 patients met eligibility criteria: 554 (60%) received alloHCT; 362 (40%) received search. The majority of patients in both groups were Non-Hispanic White and were age 65-69 years. A multivariable model demonstrated the variables associated with receipt of alloHCT (Figure 1). Characteristics significantly associated with decreased odds of receiving alloHCT were sex (male compared to female), race/ethnicity (a combined category of Black/African-American, Asian/Pacific Islander, Hispanic, American Indian/Alaska Native, and Other compared to Non-Hispanic White), living in an area with a lower percentage of population with a college education, age (71-75 compared to 65-69 years), and chemotherapy provision (chemotherapy not compared to provided by staff). Conclusion: This study used novel linked datasets to identify the association of patient, hospital, and physician characteristics at time of diagnosis with receipt of alloHCT, compared to patients who received a search but not an alloHCT. Notably, patient characteristics, and the hospital characteristic of provision of chemotherapy by hospital staff were associated with alloHCT receipt. Donor availability may contribute to the decreased odds of alloHCT by race/ethnicity, but studies to increase HLA-mismatched unrelated alloHCT are helping to decrease this barrier. Neighborhood education attainment was used as a proxy for socioeconomic status (SES), and SES has been associated with access to care. Ensuring treatment information is accessible and available in plain language may help patients considering different treatment options. Claims data is not collected for research, and has some inherent limitations, including the lack of disease severity, cytogenetics, patient preferences, and an algorithm was used to identify diagnosing physician and hospital. Additionally, this analysis includes patients who were able to access a transplant center to receive a search or alloHCT. Next steps will compare characteristics of those who received chemotherapy but did not receive a search to those who received a search and those who received an alloHCT. Study results will be used to help inform strategies aimed at improving access to treatment for patients diagnosed with AML.

Distribution of a Remote Medical Exam Device Associated with an Increase in Telehealth Use.

Background: The COVID-19 pandemic accelerated telehealth adoption, but its effects on care quality and costs remain unclear. This study evaluates a remote patient monitoring device's impact on utilization and spending. Methods: A large insurer launched a pilot program involving 2,880 households, representing 6,731 members in three states. Administrative claims data compared participant households to a matched group lacking necessary contact information for participation. Results: Participants had a 0.19 per member (p = 0.03) increase in telehealth visits and a 0.19 per member (p = 0.08) decrease in outpatient in-person visits relative to nonparticipants during the post 6-month period. No significant differences were observed in total outpatient and emergency department visits or total spending. Subgroup analyses revealed a significant reduction in telehealth visits followed by in-person outpatient visits in households with younger children (-9.1%; p < 0.05). Conclusion: This evaluation suggests that remote devices may boost telehealth utilization without increasing costs.

Real-World Outcomes of Medicare Fee-for-Service Beneficiaries Meeting the Eligibility Criteria for the DREAMM-7 and DREAMM-8 Clinical Trials

Introduction: Belantamab mafodotin (belamaf), an investigational first-in-class B-cell maturation antigen-binding antibody-drug conjugate, has demonstrated deep and durable responses as a monotherapy in patients with relapsed/refractory multiple myeloma (RRMM) in the DREAMM-2 and DREAMM-3 trials. Two randomized controlled trials (RCTs) exploring the use of belamaf in combination therapy are ongoing in patients with RRMM treated with at least 1 prior line of therapy (2L+). DREAMM-7 is evaluating the efficacy and safety of belamaf in combination with bortezomib and dexamethasone versus daratumumab in combination with bortezomib and dexamethasone. DREAMM-8 is evaluating the efficacy and safety of belamaf in combination with pomalidomide and dexamethasone versus pomalidomide in combination with bortezomib and dexamethasone. The present study aimed to provide real-world context for DREAMM-7 and DREAMM-8 trial results by reporting treatment outcomes of Medicare Fee-for-Service (FFS) patients with characteristics that meet the inclusion/exclusion criteria for each trial. Methods: A retrospective database analysis was conducted to develop trial-like cohorts (one per trial) using the 100% sample from Medicare FFS administrative claims data spanning 2016-2020. Inclusion/exclusion criteria from each RCT protocol included the presence of an MM diagnosis (based on an ICD-9-CM or ICD-10-CM diagnosis code for MM), ≥1 prior line of therapy (prior lenalidomide treatment required for the DREAMM-8 cohort), and other exclusion criteria related to renal, liver, and cardiovascular function. These criteria were used to identify patients in the Medicare FFS database who would be eligible for trial enrollment. Both RCT protocols restricted the overall study populations to ≤50% of patients with at least 2 prior lines of therapy (3L+). Accordingly, random sampling without replacement was applied across eligible Medicare patient lines of therapy to generate cohorts composed of 50% 2L RRMM patients and 50% 3L+ RRMM patients. Index date was the date the randomized line of therapy was initiated. Overall survival (OS) for each cohort was estimated using time from index date until death. Real-world progression-free survival (rwPFS) for each cohort was estimated as the time from index date until next treatment or death. Results: Overall, 1,911 and 1,280 patients met the DREAMM-7 and DREAMM-8 eligibility criteria, respectively. Following random sampling, the analysis cohorts were composed of 1,232 patients (DREAMM-7) and 1,066 patients (DREAMM-8). For the DREAMM-7 trial-like cohort, median rwPFS was 13.6 months and median OS was 29.6 months(Figure). The most commonly used regimens in this cohort were lenalidomide +/- steroids (21.3%), bortezomib +/- steroids (14.4%), and bortezomib + lenalidomide +/- steroids (8.9%). In the DREAMM-8 trial-like cohort, median rwPFS was 13.2 months and median OS was 30.8 months (Figure). In this cohort, the most common regimens were lenalidomide +/- steroids (21.1%), bortezomib +/- steroids (12.9%), and pomalidomide +/- steroids (8.3%). Over a third of patients in the DREAMM-8 trial-like cohort were retreated with lenalidomide. Conclusions: Real-world outcomes of Medicare FFS patients with RRMM eligible for DREAMM-7 and DREAMM-8 were suboptimal: 57% and 56% died within 3 years of entry into their trial-like cohort, respectively, and median rwPFS was around 1 year for both cohorts. Lenalidomide +/- steroids and bortezomib +/- steroids were most commonly used in each cohort. Retreatment with lenalidomide was common in the DREAMM-8 trial-like cohort. These suboptimal outcomes and frequent retreatment demonstrate a substantial need for new effective treatment modalities to improve patient outcomes and provide further treatment choice in the 2L+ RRMM setting. Funding: GSK (Study 209838). Drug linker technology licensed from Seagen Inc.; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa.

1631. Background Incidence Rates of Health Outcomes Relevant to Vaccine Monitoring in Lyme Disease Endemic and Non-endemic US Regions using Administrative Claims Data

Abstract Background A 6-valent vaccine (VLA15) is being tested in clinical trials for the prevention of Lyme disease caused by Borrelia burgdorferi sensu lato strains expressing OspA serotypes 1-6. Background incidence rates (IRs) of health outcomes in Lyme disease endemic and non-endemic regions of the US may help to contextualize whether the frequencies of events reported during vaccine clinical trials or post-marketing are consistent with expected population level rates. The objective of this study was to estimate and compare IRs of health outcomes in Lyme disease endemic vs. non-endemic regions using US administrative claims data. Methods IQVIA PharMetrics® Plus commercial claims database was used to estimate IRs of 63 outcomes relevant to vaccine safety monitoring in the US during 01/01/2017-12/31/2019. Endemic regions were classified using 3-digit zip codes that overlapped with Lyme disease high incidence counties (10 cases/100,000 persons) according to the CDC. Analyses included all individuals aged ≥ 2 years with ≥ 1 year of enrollment. Outcomes were defined by ICD-10-CM diagnosis codes according to the literature or expert input and required ≥ 1 inpatient or ≥ 2 outpatient claims/codes. Crude IRs and 95% confidence intervals (CIs) were calculated for each outcome and compared between endemic vs. non-endemic regions using IR ratios (IRR). Results The study population included 8.7M in endemic and 27.8M in non-endemic regions. Mean age was slightly higher in endemic (37.7 yrs [SD=18.9]) vs. non-endemic (36.8 yrs [SD=19.5]) cohorts, and 51% in both cohorts were female. Table 1 provides a summary of the IRs and IRRs for the 10 highest and 10 lowest ranking IRRs for health conditions by endemic region status. IRRs (95% CI) ranged from a low of 0.74 (0.71, 0.78) for systemic lupus erythematosus to a high of 2.14 (1.93, 2.37) for meningoencephalitis. Conclusion This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions in vaccine safety monitoring. Differences in background IRs between endemic and non-endemic regions should be considered when contextualizing possible safety signals in clinical trials and post-marketing. Disclosures Jill Dreyfus, PhD, MPH, Pfizer, Inc.: Employment|Pfizer, Inc.: Stocks/Bonds Swapna Munnangi, PhD, IQVIA: Employment Camilla Bengtsson, PhD, IQVIA: Employment|Pfizer, Inc: Advisor/Consultant Barbara Correia, PhD, IQVIA: Employee|Pfizer, Inc.: Advisor/Consultant Rejane Figueiredo, PhD, IQVIA: Biostatistician Sarah Galvin, BS, Pfizer, Inc.: Employment James H. Stark, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Michele Zawora, MD, FAAFP, Pfizer: Employment|Pfizer: Stocks/Bonds Mark Riddle, MD, DrPH, Pfizer: Employee salary Jason Maguire, MD, Pfizer, Inc.: Employee|Pfizer, Inc.: Stocks/Bonds Qin Jiang, PhD, Pfizer: Employee|Pfizer: Employee|Pfizer: Stocks/Bonds|Pfizer: Stocks/Bonds Juan Naredo Turrado, MS, IQVIA: Employee Steven Bailey, MD, MPH, MBA, Pfizer, Inc.: Employment

510. Real-world Effectiveness of Sotrovimab for COVID-19: Evidence from United States (US) Administrative Claims Data

Abstract Background This study compared outcomes among COVID-19 patients (pts) treated with the monoclonal antibody (mAb) sotrovimab matched to untreated pts. Methods Administrative claims (Komodo Health) were used to identify pts (≥ 12 years) diagnosed with COVID-19 (ICD-10: U0.7.1) in an ambulatory setting in the US (26 May 2021–5 April 2022). The sotrovimab cohort included pts meeting sotrovimab’s Emergency Use Authorization (EUA) criteria and receiving sotrovimab ≤ 10 days from diagnosis (index date = day of infusion). The untreated cohort included pts with no evidence of early/prophylaxis mAb or antiviral treatments (index date imputed based on the time distribution between diagnosis and sotrovimab infusion for their matched counterpart from the sotrovimab cohort). Pts were required to be continuously enrolled for ≥ 12 months pre-index and ≥ 29 days post-index (excluding death). Exact matching and propensity-score matching (EM/PSM) methods were used to construct 1:2 matched cohorts of sotrovimab-treated and untreated patients (EM; age [≤ 5 years], diagnosis date [≤ 14 days], state: PSM; gender, payor, region, Quan-Charlson score, EUA criteria, index date, baseline healthcare utilization). Outcomes evaluated in the 29-day post-index period were all-cause hospitalization, all-cause hospitalization and/or mortality, all-cause mortality, intensive care unit (ICU) admission, and maximum level of respiratory support. Results A total of 34,160 sotrovimab pts were matched to 68,320 untreated pts (characteristics well balanced: 54 years of age, approximately 40% male, 42% had commercial payor, and approximately 50% indexed in January 2022). The 29-day hospitalization and/or mortality rates were 4.0% (n=1,380 / 34,160) and 5.2% (n=3,566 / 68,320) in the sotrovimab and untreated cohorts, respectively (p &amp;lt; 0.0001). Patients in the sotrovimab cohort had statistically significantly lower rates of all-cause hospitalization, all-cause mortality, ICU admission, and respiratory support as compared with patients in the untreated cohort (Table). *Obtained from conditional logistic regression models (binary outcomes). All models adjusted for malignancy. ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit Conclusion Sotrovimab demonstrated effectiveness in preventing severe outcomes (hospitalization, mortality and respiratory support) as compared with untreated pts during the period in which Delta and early Omicron variants were predominant. Disclosures Christopher F. Bell, MS, GSK: Employee|GSK: Stocks/Bonds Tasneem Lokhandwala, PhD, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Daniel C. Gibbons, PhD, GSK: Employee|GSK: Stocks/Bonds Myriam Drysdale, PhD, GSK: Employee|GSK: Stocks/Bonds Jane Wang, MS, GSK: Funding to conduct study|Vir Biotechnology, Inc: Funding to conduct study Emily Lloyd, MSc, GSK: Employee|GSK: Stocks/Bonds

Use of Disease-Modifying Treatments in Patients With Sickle Cell Disease

Despite hydroxyurea being an established treatment for sickle cell disease (SCD), it remains underused. The recent approval of the disease-modifying treatments (DMTs) l-glutamine, crizanlizumab, and voxelotor underscores the need to understand the uptake of DMTs in the current treatment landscape. To explore characteristics that may be associated with DMT use and to describe observed patterns of yearly DMT use from 2014 to 2021. This cross-sectional study used administrative claims data from Optum's deidentified Clinformatics Data Mart Database from January 1, 2014, to September 30, 2021, to identify adults and children with SCD. Data were analyzed from August 1, 2022, to August 28, 2023. Use of DMTs. Patient characteristics across groups with varying patterns of DMT use and yearly patterns of prescription fills for hydroxyurea, crizanlizumab, voxelotor, and l-glutamine. A total of 5022 beneficiaries with SCD (2081 [41.4%] aged 18-45 years; 2929 [58.3%] female) were included in sample A (144 [2.9%] inconsistent users, 274 [5.5%] incident users, 892 [17.8%] consistent users, and 3712 [73.9%] non-DMT users). Inconsistent users had a higher prevalence of vaso-occlusive crises (mean [SD], 3.7 [4.7]), splenic complications (6 of 144 [4.2%]), pulmonary complications (36 of 144 [25.0%]), kidney disease (21 of 144 [14.6%]), acute chest syndrome (18 of 144 [12.5%]), and health care visits (eg, mean [SD] inpatient visits, 7.0 [10.7]) compared with the other use groups. Non-DMT users had the lowest prevalence of vaso-occlusive crises (mean [SD], 0.8 [2.4]), acute chest syndrome (109 of 3712 [2.9%]), and inpatient (mean [SD], 2.0 [6.6]) and emergency department (mean [SD], 0.7 [3.1]) visits and the highest proportion of adults 65 years and older (593 of 3712 [16.0%]). In sample B (6387 beneficiaries with SCD), hydroxyurea use modestly increased from 428 of 2188 participants (19.6%) in 2014 to 701 of 2880 (24.3%) in 2021. Use of l-glutamine increased briefly but gradually decreased throughout the study period. In 2021, out of 2880 participants, 102 (3.5%) had at least 1 fill for crizanlizumab and 131 (4.6%) had at least 1 fill for voxelotor. Overall, total DMT use increased from 428 of 2188 participants (19.6%) in 2014 to 815 of 2880 patients (28.3%) in 2021. In this cross-sectional analysis of adults and children with SCD, uptake of DMTs remained low from 2014 to 2021, despite the approval of newer therapies. Notable differences in patient characteristics across varied DMT exposure types necessitate further exploration into factors that facilitate DMT use and the creation of strategies to enhance DMT uptake.

Association of Depression and Adherence to Oral Anticoagulation in Patients With Atrial Fibrillation.

Adherence to oral anticoagulation is essential for stroke prevention in atrial fibrillation (AF). Depression has been associated with decreased adherence to medications in multiple disease states and in AF is further associated with increased risk of stroke. We hypothesized that individuals with depression and AF have decreased adherence to anticoagulation than those without depression. We used administrative claims data to identify individuals with AF initiating anticoagulation with direct-acting oral anticoagulants (DOACs) or warfarin between 2013 and 2019. We quantified adherence using proportion of days covered, categorized as limited (proportion of days covered, <80%), adequate (proportion of days covered, ≥80% to <90%), or optimal (proportion of days covered, ≥90%). We related depression to 12-month adherence to anticoagulation in logistic regression models, adjusting for demographics, medical and psychiatric comorbidities, household income, educational attainment, and insurance type. As a secondary analysis, we determined the association of depression to adherence for each DOAC agent. We identified 101 041 individuals (aged 74.5±8.9 years; 50.6% women; 29.5% race or ethnicity other than White, including Asian or Black race and Hispanic ethnicity) who initiated either DOACs or warfarin. The odds of adequate adherence to DOACs was 11% (95% CI, 0.85-0.93), and the odds of optimal adherence was 12% (95% CI, 0.83-0.91) less in individuals with depression than those without. Depression was not associated with adherence to warfarin. We identified an association between depression and decreased adherence to DOACs but not warfarin in individuals with AF. Recognizing depression in AF may guide interventions to improve anticoagulation adherence and reduce stroke risk.

Trends in mechanical circulatory support use and outcomes of patients with cardiogenic shock in Japan, 2010-2020: a nationwide inpatient database study

Abstract Background/Introduction Little is known about the impact of the downgrade of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella in Japan, where IABPs have been enthusiastically used. Purpose This study aimed to describe the annual trends in the mechanical circulatory support (MCS) use and outcomes in patients with cardiogenic shock (CS) requiring MCS. Methods This was a retrospective cohort study using the Japanese Diagnosis Procedure Combination database, which contained administrative claims data and discharge abstracts from more than 1,500 acute care hospitals and covered approximately 90% of all tertiary emergency hospitals in Japan. Using the data from July 2010 to March 2021, we identified inpatients with CS requiring MCS. The primary outcome was in-hospital mortality. The secondary outcomes were the length of MCS, length of hospital stay, total hospitalization cost, major bleeding, ischemic stroke, continuous renal replacement therapy, and total blood transfusion volume during the hospitalization. The patients were stratified into three groups: (i) IABP alone, (ii) Impella alone, and (iii) extracorporeal membrane oxygenation (ECMO) regardless of IABP or Impella use. The patient characteristics and outcomes were reported by the fiscal year. Results Of the 160,559 eligible patients, 117,599 (73.2%) were identified as the IABP alone group, 1,465 (0.9%) as the Impella alone group, and the remaining 41,495 (25.8%) as the ECMO group. Of the overall 1,107 hospitals, IABP alone was used in 1,096 (99.0%), Impella alone in 120 (10.8%), and ECMO in 831 (75.1%). In-hospital mortality was 17.4%, 38.0%, and 68.3% in the IABP alone, Impella alone, and ECMO groups, respectively. The length of hospital stay was 32.6, 36.6, and 29.4 days and the total hospitalization cost was 4,522, 9,098, and 5,840 thousand yen in the IABP alone, Impella alone, and ECMO groups, respectively. All of major bleeding, ischemic stroke, and continuous renal replacement therapy were most prevalent in the Impella alone group and least prevalent in the IABP alone group. The prevalence of an IABP alone significantly decreased from 80.5% in 2010 to 65.3% in 2020 (P for trend &amp;lt;0.001). In contrast, the prevalence of an Impella alone significantly increased from 0.0% in 2010 to 5.0% in 2020, and the prevalence of ECMO significantly increased from 19.5% in 2010 to 29.6% in 2020. In-hospital mortality significantly increased from 29.3% in 2010 to 32.6% in 2020 in the overall patients with CS requiring MCS, but significantly decreased in those requiring ECMO from 73.7% in 2010 to 64.1% in 2020 (P for trend &amp;lt;0.001 for both). Conclusions There were significant annual changes in the patterns of MCS use and clinical outcomes in patients with CS requiring MCS.

Does a digitally enabled telerehabilitation program reduce hospital admissions and length of stay for private health insurance patients in Australia?

Abstract Introduction Traditional cardiac rehabilitation (CR) programs are associated with reduced cardiovascular morbidity, hospital admissions and mortality. However, participation continues to be poor. Novel digital health models of care have emerged, providing a new frontier in healthcare delivery, but evidence for their impact on healthcare utilization is limited. We implemented and investigated a telehealth program complemented by a CR mobile app for patients following a hospitalization for coronary heart disease (CHD). Purpose To assess whether a digitally enabled CR program is equivalent to traditionally delivered CR (F2F-CR) and whether it reduces rehospitalizations and total hospital days compared to patients who did not undertake CR (no-CR). Methods Privately insured patients, following a hospitalization for CHD, were recruited nationally, across Australia, between October 2019 - 2020. Participants received weekly telehealth consultations for 8 weeks, supplemented by a CR mobile app. Using administrative private health insurance claims data, we assessed differences in 90-day and 12-month rehospitalizations and total hospital days for the digital-CR group (n=138) compared with a) F2F-CR (n=115) and b) no-CR (n=266). Results Among the cohort, 27% lived in regional/rural areas, 71% were male and the majority were aged over 60 years (83%). The digital-CR group had lower total hospital days relative to the no-CR group in the 12 months post index event (4.5 vs 7.2 days; mean difference 2.8 days; p=0.019; 95% CI: 5.1-0.5). Readmission rates were lower at 90 days and similar at 12 months post discharge in the digital-CR group compared with the no-CR group, although not statistically significant. There were 0.17 and 0.21 (p=0.43) readmissions per patient at 90 days post discharge and 1.08 and 1.07 (p=0.94) readmissions per patient within 12 months in the digital-CR group and no-CR group respectively. There were no significant differences for digital-CR relative to F2F-CR on any measures. Conclusion Rehospitalization rates were similar between the groups, whilst the digital-CR group had significantly fewer days in hospital than the no-CR group. Digital-CR may reduce the severity of rehospitalizations highlighted by fewer days in hospital. The digital-CR and F2F-CR outcomes were similar, confirming that digitally enabled CR programs provide similar benefits regarding reduced days in hospital, whilst providing additional benefits of improved access and choice. Digital-CR should be made widely available for cardiac patients post hospital discharge.Mean hospital days Digital-CR vs No-CRMean hospital days Digital-CR vs F2F-CR

Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries.

Evaluation of Medicare-Medicaid integration models' effects on patient-centered outcomes and costs requires multiple data sources and validated processes for linkage and reconciliation. To describe the opportunities and limitations of linking state-specific Medicaid and Centers for Medicare & Medicaid Services administrative claims data to measure patient-centered outcomes for North Carolina dual-eligible beneficiaries. We developed systematic processes to (1) validate the beneficiary ID linkage using sex and date of birth in a beneficiary ID crosswalk, (2) verify dates of dual enrollment, and (3) reconcile Medicare-Medicaid claims data to support the development and use of patient-centered outcomes in linked data. North Carolina Medicaid beneficiaries with full Medicaid benefits and concurrent Medicare enrollment (FBDE) between 2014 and 2017. We identified need-based subgroups based on service use and eligibility program requirements. We calculated utilization and costs for Medicaid and Medicare, matched Medicaid claims to Medicare service categories where possible, and reported outcomes by the payer. Some services were covered only by Medicaid or Medicare, including Medicaid-only covered home and community-based services (HCBS). Of 498,030 potential dual enrollees, we verified the linkage and FBDE eligibility of 425,664 (85.5%) beneficiaries, including 281,174 adults enrolled in Medicaid and Medicare fee-for-service. The most common need-based subgroups were intensive behavioral health service users (26.2%) and HCBS users (10.8%) for adults under age 65, and HCBS users (20.6%) and nursing home residents (12.4%) for adults age 65 and over. Medicaid funded 42% and 49% of spending for adults under 65 and adults 65 and older, respectively. Adults under 65 had greater behavioral health service utilization but less skilled nursing facility, HCBS, and home health utilization compared with adults 65 and older. Linkage of Medicare-Medicaid data improves understanding of patient-centered outcomes among FBDE by combining Medicare-funded acute and ambulatory services with Medicaid-funded HCBS. Using linked Medicare-Medicaid data illustrates the diverse patient experience within FBDE beneficiaries, which is key to informing patient-centered outcomes, developing and evaluating integrated Medicare and Medicaid programs, and promoting health equity.

Abstract 11771: Validity of an Administrative Claims-Based Measure of Low-Value Carotid Revascularization

Introduction: Low value care is defined as care where harms or costs outweigh benefits. Researchers, payers, and policymakers commonly use administrative claims data to identify low-value care, but the validity of many claims-based algorithms has not been assessed. Research Question: What is the validity of a commonly-used claims-based algorithm to identify low-value carotid artery revascularization (CAR) procedures, compared to a reference standard of chart review? Methods: This was a retrospective cohort study of Medicare fee-for-service beneficiaries attributed to a large accountable care organization. We used administrative claims data linked to electronic health record data and identified all CAR procedures (endarterectomy or stenting) from 01/01/2020-12/31/2021. We excluded patients without claims history in the year prior to CAR. Using methods previously described by policymakers and researchers, we classified CAR as low-value by claims if patients did not have diagnosis codes for stroke, transient ischemic attack, or other neurologic symptoms such as vision changes or hemiplegia in the year prior to CAR. We then reviewed linked electronic health records to determine if cases were misclassified by the claims-based measure. Per recent guidelines, we classified CAR as low-value by chart review if it was performed in patients with less than 50% symptomatic stenosis or greater than 80% asymptomatic stenosis. Results: A total of 127 CAR cases (mean age 77 years; 63% men; 87% white) with complete electronic health record data were identified, and 48 (38%) were classified as low-value by the claims-based algorithm. Only 11 of the 48 cases classified as low-value by claims were confirmed to be low-value by chart review. The positive predictive value of the claims-based algorithm was 23%. Conclusions: A commonly-used claims-based measure to identify low-value CAR procedures had poor accuracy with a positive predictive value of 23%. Using administrative claims to identify low-value CAR procedures might overestimate the number of procedures considered to be low-value. This has implications for the current system of quality reporting, particularly when quality is tied to financial incentives.

Abstract 14471: Can Administrative Claims Data Accurately Identify Low-Value Pre-Operative Cardiovascular Testing?

Background: Low-value care is defined as care where harms or costs outweigh the benefits. Low-value care services are often identified using administrative claims data, but the validity of claims-based measures may be limited due to the lack of clinical details. One example of a commonly-used claims-based measure of low-value care is pre-operative stress testing prior to low-risk surgery. Clinical practice guidelines recommend against routine testing since it provides no benefit, but testing may be clinically appropriate in patients with symptoms that warrant further investigation such as chest pain. AIM: To test the validity of a claims-based measure of low-value pre-operative stress testing against a gold standard of chart review. Methods: In this retrospective cohort study, we analyzed Medicare claims data linked to electronic health record data from a large accountable care organization. We applied a currently-used claims-based algorithm to identify patients who received a stress test within 60 days prior to a low-risk surgery (e.g., cataract surgery) in 2021. We then reviewed linked electronic health record data to assess the proportion of tests that were actually low-value or were misclassified (i.e., were clinically appropriate based on patient symptoms). Results: We identified 120 patients (median age 74, 50% female, 78% white) who underwent low-risk surgery and received a pre-operative stress test considered low-value by the claims algorithm. We excluded 35 patients who had insufficient data for chart review. Of the remaining 85patients, we found that 36 (42%) were confirmed low-value while 49 (58%) were actually clinically appropriate due to symptoms that prompted testing. The claims-based algorithm hada positive predictive value (PPV) of 42%. Conclusions: A commonly used claims-based measure for identifying low-value pre-operative CV testing misclassifies a substantial proportion of tests as low-value when they are clinically appropriate. This has significant implications for policy and practice, as it can erode trust in quality reporting systems and discourage clinically appropriate testing.

Abstract 12926: Characteristics of Tafamidis-Treated Patients With Mixed Phenotype Transthyretin Amyloidosis: A Real-World Study in the Medicare Fee-for-Service Population

Introduction: Transthyretin amyloidosis (ATTR amyloidosis) is highly heterogeneous, characterized by predominantly cardiac, predominantly neurologic or mixed phenotypes. Diagnosis of mixed phenotype is often delayed, due in part to fragmented care. Research based on administrative claims data has improved knowledge of the disease, but investigation of the mixed phenotype has been limited by deficiencies in ICD diagnosis codes. Hypothesis: Proxy algorithms can be used to identify and characterize mixed phenotype ATTR amyloidosis in Medicare patients. Methods: This noninterventional, retrospective, observational cohort study was conducted using de-identified patient data from the US Medicare database (Jan 1, 2016-Dec 31, 2021). Based on literature review and clinician consultation, 3 distinct proxy algorithms were developed to select 3 cohorts of tafamidis-treated patients with possible mixed phenotype ATTR amyloidosis ( Figure ). Baseline patient characteristics were analyzed descriptively. Results: In 1,243 patients, mean (SD) age ranged from 76.0 (6.3)-79.5 (6.5) y, and 68-83% were men. Comorbidity burden was similar across cohorts (Charlson comorbidity indices: 1.6 [0.9]-1.7 [1.0]). The most common cardiovascular comorbidities were hypertensive diseases, arrhythmia, conduction disorders and LVH; the most common noncardiovascular comorbidities were cataracts, chronic and acute kidney disease, constipation and diabetes ( Table ). Conclusions: In this real-world study, proxy algorithms helped identify and characterize mixed phenotype ATTR amyloidosis in Medicare patients. Additional research is needed to further validate these algorithms.

Abstract 14482: Low Utilization of Guideline-Recommended Genetic and Pharmacogenetic Testing Among Patients With Cardiovascular Conditions in the United States (US)

Introduction: Cardiovascular disease (CVD) continues to be the leading cause of death in the US and globally. Clinical practice guidelines recommend genetic testing for the diagnosis of select CVDs to improve disease management, reduce incidence of cardiac events, and positively impact major cardiac adverse events. Professional guidelines also recommend pharmacogenomic (PGx) testing for patients being prescribed certain medications. Research Question: What is the utilization of genetic diagnosis and PGx testing in patients with CVD in the US? Methods: This study used data from the Optum Labs Data Warehouse, composed of de-identified administrative claims data for both commercially insured and Medicare Advantage enrollees to assess rates of genetic testing among adult patients diagnosed with 4 major types of CVD conditions (arrhythmias (N=518,316), familial hypercholesterolemia (FH) (N=38,068), cardiomyopathies (CM) (N=74,597), and aortopathies (N=58,316)) and PGx testing rates in patients prescribed CVD medications with PGx test recommendations (per CPIC guidelines) between January 1, 2017 to December 31, 2021. Patients were required to have ≥12 months of continuous enrollment prior (baseline) to diagnosis (index date) and ≥12 months post-index period unless they died (follow-up). Genetic and PGx testing was captured using Current Procedural Terminology (CPT®) codes in both baseline and follow-up periods. Results: Low genetic testing utilization was found across the 4 major types of CVD conditions. Genetic testing rates were 1.3% in the arrythmia cohort, 1.9% in the CM cohort, 2.0% in the aortopathy cohort and 1.9% in the FH cohort. PGx testing rates in patients prescribed with CVD relevant medications were 0.6% (N=2,094/377,111) in the arrhythmia cohort, 0.8% (N=501/60,632) in the CM cohort, 0.7% (N=247/37,344) in the aortopathy cohort, and 1.3% (N=329/25,835) in FH cohort. Conclusions: Despite clinical practice guidelines, genetic and PGx testing in patients with CVD conditions remains underutilized. Future work will help us understand the barriers to guideline adherence both for genetic diagnosis and PGx testing that could impact clinical management and patient outcomes.