Outpatient Medical Claims Research Articles

Effect of an oncology care management program on ED visits in a rural Medicaid population.

175 Background: Optum’s Cancer Support Program (CSP) provides care management to members with cancer diagnoses facing healthcare barriers. CSP nurses educate members on symptom management, palliative care and advance care planning, address psychosocial needs and close gaps in care. Improving health equity and outcomes is a program priority. In 2023, Optum analyzed outpatient claims for 24,221 Medicaid members with cancer and found that rural members visit emergency departments (ED) 31% more than urban members. As part of a CSP quality and outcomes assessment, we aimed to understand CSP’s impact on ED utilization within a high-risk rural Medicaid population. Methods: Beginning 1/1/23, Medicaid members in rural zip codes with an active cancer diagnosis were stratified as high- or low-risk based on diagnosis and clinical factors. High-risk members were invited to participate in CSP and receive individualized telephonic care management. 2023 outpatient medical claims were evaluated, and rural ED visit rates were compared for high-risk CSP participants and non-participants for approximately 4 months (average CSP engagement) after CSP enrollment or identification (non-participants). Population demographics were tested via a Mood's median test; ED visits per thousand members per year (PTMPY)—engaged, non-engaged, and difference in means—was tested via a 10,000-iteration bootstrap. Results: The study population included 421 members stratified as high-risk. Of those, 38% (161) enrolled in CSP. Reasons for non-enrollment included inability to reach the member (61%) and member refused (39%). There were no statistically significant differences between the groups’ demographic composition (all variables had p ≥ 0.05). Under a 10,000-iteration bootstrap, there were 2,696 ED visits PTMPY, 80% CI [2,258, 3,150] in the participant group and 3,427 ED visits PTMPY, 80% CI [2,904, 3,974] in the non-participant group. The difference in means between the groups was 730 ED visits PTMPY, 80% CI [52, 1,421]. Conclusions: Rural Medicaid members enrolled in CSP experienced lower ED visit rates, suggesting that care management may be effective at reducing ED utilization within rural populations that lack access to wraparound oncology services. Limitations of this study include small sample size and potential enrollment bias. Further analysis is underway to increase the study sample size and identify other factors that may be impacted by care management, thereby improving healthcare equity.

#1133 Kidney characteristics of belimumab-treated patients with SLE pre-lupus nephritis indication: identifying data for future comparative research

Abstract Background and Aims Lupus nephritis (LN) is a severe, renal manifestation occurring in approximately 40% of patients with the chronic autoimmune disease systemic lupus erythematosus (SLE) [1]. Belimumab (BEL), a human immunoglobulin G1λ monoclonal antibody that binds to and inhibits soluble B-lymphocyte stimulator, was indicated for SLE in 2011 and LN in 2020 by the US Food and Drug Administration [2]. BEL has proven efficacy for SLE and LN [2], but there are limited data regarding the effectiveness of BEL to delay LN onset due to lack of sufficient follow-up time. Evaluating the demographic, clinical and kidney characteristics of patients treated with BEL before its regulatory approval for LN allows for a longer follow-up period. This study describes the kidney characteristics of patients with SLE treated with BEL and/or standard therapy (ST) pre-LN indication. The objective was to evaluate whether there are sufficient data from BEL-treated patients with kidney impairment and available laboratory measurements for use in future comparative research regarding effectiveness of BEL to delay LN onset. Method This retrospective, real-world study (GSK Study 217532) used electronic health record (EHR) data to assess adult patients with SLE. Eligible patients received BEL with or without ST (BEL cohort) or ST only (ST cohort) during the study identification period (1 January 2017 to 31 December 2020) and had activity in the EHR 12 months pre-index (baseline period); the index date was the first prescription of BEL or ST. A diagnosis of SLE was defined as presence of International Classification of Diseases, 10th Revision, Clinical Modification codes (M32.1x, M32.8, M32.9) based on either ≥ 2 outpatient medical claims or ≥ 1 inpatient/emergency department claim during the baseline period (or index date). Patients were excluded if they received BEL during the baseline period. LN- and kidney-related characteristics were measured during the baseline period and after 36 months of follow-up. Results This study identified 32 017 patients with SLE: 1318 in the BEL cohort and 30 699 in the ST cohort. The mean (standard deviation) age of the BEL and ST cohorts was 43.9 (12.7) and 51.9 (15.2) years, respectively. Most patients were White (BEL: n = 804 [61.0%]; ST: n = 19,812 [64.5%]) and female (BEL: n = 1247 [94.6%], ST: n = 27 826 [90.6%]). At baseline, 13.1% of the BEL cohort and 10.0% of the ST cohort had an LN diagnosis; chronic kidney disease (CKD) was reported in 22.1% of the BEL cohort and 27.7% of the ST cohort (Table 1). End-stage kidney disease (ESKD) was observed at baseline in 1.0% of the BEL cohort and 4.0% of the ST cohort. Dialysis rate at baseline was 0.7% in the BEL cohort and 3.5% in the ST cohort. A smaller proportion of the BEL cohort had kidney impairment than the ST cohort. Overall, 32.1% of the BEL cohort (n = 423) and 46.1% of the ST cohort (n = 14,162) had 36 months of valid follow-up. The proportion of patients with available kidney laboratory characteristics was generally similar between baseline and 36 months follow-up, and between BEL and ST cohorts (Table 2). However, the proportion of the BEL cohort at baseline and at 36 months’ follow-up with a proteinuria laboratory measurement was >2-fold that of the ST cohort (baseline: BEL = 30.5%, ST = 12.9%; follow-up: BEL = 42.1%, ST = 20.2%). Conclusion This study demonstrates that there are adequate kidney value measurements for BEL and ST patients available to assess kidney outcomes over time in patients with SLE pre-LN indication of BEL. Observationally, the ST cohort displayed more impairment than the BEL cohort, which could indicate more advanced disease in this slightly older cohort. However, future studies should account for baseline differences between ST and BEL cohorts to assess kidney impairment–related outcome measures, by using matching and weighting procedures. Funding GSK.

Healthcare resource utilization and costs among patients with alpha-1 antitrypsin deficiency with liver and/or lung disease: a longitudinal retrospective study in the USA.

Aim: To evaluate all-cause and liver-associated healthcare resource utilization (HCRU) and costs among patients with alpha-1 antitrypsin deficiency (AATD) with liver disease (LD) and/or lung disease (LgD). Materials & methods: This was a retrospective analysis of linked administrative claims data from the IQVIA PharMetrics® Plus and the IQVIA Ambulatory Electronic Medical Records (AEMR) databases from 1July2021 to 31January 2022. Patients with AATD in the IQVIA PharMetrics Plus database were included with ≥1 inpatient or ≥2 outpatient medical claims ≥90days apart with a diagnosis of AATD, or with records indicating a protease inhibitor (Pi)*ZZ/Pi*MZ genotype in the IQVIA AEMR database with linkage to IQVIA PharMetrics Plus. For a patient's identified continuous enrollment period, patient time was assigned to health states based on the initial encounter with an LD/LgD diagnosis. A unique index date was defined for each health state, and HCRU and costs were calculated per person-year (PPY). Results: Overall, 5136 adult and pediatric patients from the IQVIA PharMetrics Plus and IQVIA AEMR databases were analyzed. All-cause and liver-associated HCRU and costs were substantially higher following onset of LD/LgD. All-cause cost PPY ranged from US $11,877 in the absence of either LD/LgD to US $74,015 in the presence of both LD and LgD. Among liver transplant recipients in the AATD with LD health state, liver-associated total costs PPY were US $87,329 1-year pre-transplantation and US $461,752 1-year post-transplantation. In the AATD with LgD and AATD with LD and LgD health states, patients who received augmentation therapy were associated with higher all-cause total costs PPY and lower liver-associated total costs PPY than their counterparts who did not receive augmentation therapy. Conclusion: Patients with AATD had increased HCRU and healthcare costs in the presence of LD and/or LgD. HCRU and healthcare costs were highest in the AATD with LD and LgD health state.

Assessment of Unmet Health-Related Social Needs Among Patients With Mental Illness Enrolled in Medicare Advantage

A large body of literature has found associations between unmet health-related social needs (HRSNs) and adverse mental health outcomes. A comparative analysis of the risks associated with HRSNs among patients with varying severity of mental illness and an assessment of how these risks compare with those of individuals without mental illness are needed. To examine the prevalence and risks of HRSNs among patients with serious and persistent mental illness (SPMI), patients with mental health diagnoses but no serious and persistent mental illness (non-SPMI), and patients with both SPMI and non-SPMI compared with individuals without mental illness. This retrospective cohort study used data from the Accountable Health Communities HRSN Screening Tool surveys, which target a nationally representative sample of Medicare Advantage members of a large payer (Humana Inc). The surveys were conducted between October 16, 2019, and February 29, 2020. Of the initial 329 008 eligible Medicare Advantage enrollees, 70 273 responded to the survey (21.4% response rate). Of those, 56 081 respondents (79.8%) had complete survey responses and were included in the final analytic sample. Outcomes of interest included 7 HRSNs (financial strain, food insecurity, housing instability, housing quality, severe loneliness, transportation problems, and utility affordability) based on responses to the survey. The major independent variable was the presence of mental illness up to 12 months preceding the date of survey completion. Codes indicating mental illness listed as the primary, principal, or secondary diagnoses of a patient's inpatient or outpatient medical claims data were identified, and participants were grouped into 4 cohorts: SPMI, non-SPMI, SPMI plus non-SPMI, and no mental illness. Among 56 081 older adults, the mean (SD) age was 71.31 (8.59) years; 32 717 participants (58.3%) were female, and 43 498 (77.6%) were White. A total of 21 644 participants (38.6%) had at least 1 mental illness diagnosis in the past year, 30 262 (54.0%) had an HRSN, and 14 163 (25.3%) had both mental illness and an HRSN. Across all specific HRSNs, the odds of experiencing the respective HRSN was most substantial for those with SPMI plus non-SPMI vs those with only non-SPMI or SPMI. The HRSN with the largest risk differences among the study cohorts was severe loneliness; compared with the cohort without mental illness, the non-SPMI cohort had 2.07 times higher odds (95% CI, 1.84-2.32; P < .001), the SPMI cohort had 3.35 times higher odds (95% CI, 3.03-3.71; P < .001), and the SPMI plus non-SPMI cohort had 5.13 times higher odds (95% CI, 4.68-5.61; P < .001) of severe loneliness. In this study, the increased risk of having HRSNs associated with SPMI, alone or in combination with non-SPMI, emphasizes the need for more targeted interventions to address social needs in this vulnerable population.

INITIAL TREATMENT STRATEGY IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION USING TWO LARGE US ADMINISTRATIVE CLAIMS DATABASES

INITIAL TREATMENT STRATEGY IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION USING TWO LARGE US ADMINISTRATIVE CLAIMS DATABASES

The risk of COVID-19 in patients with psoriasis: A retrospective cohort study

To the Editor: Clinical trials and real-world data generally suggest that biologics do not increase susceptibility to COVID-19.1 However, it remains unknown whether these therapies may confer a protective effect against contracting COVID-19. Therefore, we sought to assess the risk of COVID-19 infection in patients with psoriasis compared with the general population and in patients receiving systemic and topical therapies. This study used the Symphony Health dataset, a large repository of pharmacy data, inpatient and outpatient medical claims, and remittance data (over 300 million patients, 7 million COVID-19 cases, and payer information: Medicaid/Medicare/commercial/cash).

Incidence and Risk Factors of Pulmonary Hypertension After Venous Thromboembolism: An Analysis of a Large Health Care Database.

Background Pulmonary hypertension (PH) is a devastating potential complication of pulmonary embolism, a manifestation of venous thromboembolism (VTE). The incidence of and risk factors for PH in those with prior VTE are poorly characterized. Methods and Results International Classification of Diseases (ICD) codes from inpatient and outpatient medical claims from MarketScan administrative databases for years 2011 to 2018 were used to identify cases of VTE, comorbidities before the VTE event, and PH occurring subsequent to the VTE event. Cumulative incidence and hazard ratios (HR), and their 95% CI, were calculated. The 170021 VTE cases included in the analysis were on average (±SD) 57.5±15.8years old and 50.5% were female. A total of 5943 PH cases accrued over an average follow-up of 1.94years. Two years after incident VTE, the cumulative incidence (95% CI) of PH was 3.5% (3.4%-3.7%) overall. It was higher among older individuals, among women (3.9% [3.8%-4.1%]) than men (3.2% [3.0%-3.3%]), and among patients presenting with pulmonary embolism (6.2% [6.0%-6.5%]) than those presenting with deep vein thrombosis only (1.1% [1.0%-1.2%]). Adjusting for age and sex, risk of PH was higher among patients with VTE with underlying comorbidities. Using the Charlson comorbidity index, there was a dose-response relationship, whereby greater scores were associated with increased PH risk (score ≥5 versus 0: HR, (2.50 [2.30-2.71])). When evaluating individual comorbidities, the strongest associations were observed with concomitant heart failure (HR, 2.17 [2.04-2.31]), chronic pulmonary disease (2.01 [1.90-2.14]), and alcohol abuse (1.66 [1.29-2.13]). Conclusions In this large, real-world population of insured people with VTE, 3.5% developed PH in the 2years following their initial VTE event. Risk was higher among women, with increasing age, and in those with additional comorbidities at the time of the VTE event. These data provide insights into the burden of PH and risk factors for PH among patients with VTE.

Age-related healthcare services utilization for the management of sickle cell disease among treated Texas Medicaid patients

Abstract Objectives To determine if there are age-related differences in sickle cell disease (SCD)-related healthcare utilization and to describe temporal healthcare utilization following an emergency department (ED) visit or hospitalization in treated SCD patient population. Methods Texas Medicaid prescription and medical claims from 1 September 2011 to 31 August 2016 were used. Patients aged 2–63 years with at least one inpatient or outpatient SCD medical claim and receiving one or more SCD-related medications (hydroxyurea, opioid or non-opioid analgesics) were included. The primary outcomes were utilization of SCD-related ED, inpatient and outpatient visits, all-cause prescription medications and type of SCD-related service at index and subsequent healthcare services. Age group was the primary independent variable. Key findings Overall (N = 2339), healthcare service utilization was relatively higher among age groups 2–12, 18–25 and 26–40. Proportions of patients having ≥1 ED and ≥1 inpatient visits, respectively, were significantly higher among age groups 2–12 (33.2%; 23.0%), 18–25 (29.3%; 25.1%) and 26–40 (32.3%; 22.4%) as compared with age group 13–17 (21.3%; 12.9%). The number of outpatient visits was highest among children aged 2–12 (4.5 ± 7.6, P &amp;lt; 0.0001), while mean number of all-cause medications was the highest for older adults aged 41–63 (22.4 ± 16.3; P &amp;lt; 0.0001). After an index ED visit (N = 598), outpatient visits were the most prevalent healthcare services. After an index hospitalization (N = 203), a subsequent hospitalization was the most prevalent healthcare service. Conclusions Texas Medicaid SCD patients receiving treatment have a high use of healthcare services, especially among children and young adults who are transitioning from childhood to adulthood. Age-specific interventions should be developed to promote optimal care transitions among young adults.

Increase in Achilles Tendon Rupture Surgery in Japan: Results From a Nationwide Health Care Database.

Background:Nationwide epidemiologic studies in Scandinavian countries have shown that the incidence of Achilles tendon ruptures (ATRs) has increased, and the rate of surgical treatment has declined markedly in the past decade. However, there is a lack of national-level data on the trend of ATRs and surgical procedures in other regions.Purpose:To clarify the trend in the incidence of ATRs and the proportion of surgery using the nationwide health care database in Japan.Study Design:Descriptive epidemiology study.Methods:Age- and sex-stratified data on the annual number of ATRs and surgical procedures between 2010 and 2017 were obtained from the Japanese national health care database, which includes almost all inpatient and outpatient medical claims nationwide. The Japanese population data were also obtained from the population census. The change in the annual incidence of ATRs per 100,000 people was assessed using a Poisson regression analysis. The trend in the annual proportion of surgeries relative to the occurrence of tendon ruptures was determined using a linear regression analysis.Results:A total of 112,601 ATRs, with men accounting for 67%, were identified over 8 years. Patients aged ≥60 years accounted for 27,106 (24%), while those aged 20 to 39 years and 40 to 59 years accounted for 36,164 (32%) and 49,331 (44%), respectively. The annual incidence of ATR ranged from 12.8/100,000 to 13.9/100,000 (women, 8.2-8.9/100,000; men, 17.2-19.5/100,000), which did not change over the study period (P = .82). Moreover, the annual incidences did not change across sexes and age categories. The annual proportion of surgery increased significantly, from 67% in 2010 to 72% in 2017 (P = .003). The annual proportions increased across sexes and age categories except for women aged 40 to 59 years.Conclusion:The incidence of ATR did not change between 2010 and 2017, according to the Japanese nationwide health care database. Furthermore, the proportion of surgical treatment increased during the study period. Overall, 70% of patients underwent surgical treatment. This study suggested that the trend in ATR and surgery differed across regions.

HEALTH OUTCOMES AND COSTS ASSOCIATED WITH ORAL TREPROSTINIL AND SELEXIPAG ONE YEAR INTO TREATMENT: A UNITED STATES CLAIMS DATABASE ANALYSIS IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION

TOPIC: Pulmonary Vascular Disease TYPE: Original Investigations PURPOSE: Previous comparisons of oral treprostinil (TRE) and selexipag (SLX) using real-world data have been limited to short duration follow-up periods or have used models to estimate healthcare costs. This analysis aims to characterize various outcomes and direct healthcare costs for pulmonary arterial hypertension (PAH) patients being treated with TRE or SLX 1-year into treatment. METHODS: A retrospective analysis was completed using the IBM® MarketScan® Research Databases from January 2014 to June 2019. Patients were required to have a pulmonary hypertension inpatient or outpatient medical claim identified by International Classification of Disease Codes (ICD-9-CM: 416.0, 416.8, 416.9; ICD-10-CM: I27.0, I27.20, I27.21, I27.29, I27.81, I27.83, I27.89, I27.9) plus a prescription claim for TRE or SLX. The index date was defined as the day of the first claim for TRE or SLX. Patients were ≥18 years old and required to have a PH medical claim in the 6-month pre-index, continuous health insurance enrollment 6 months pre-index and 12 months post-index. Adherence was defined as having a medication possession ratio (MPR) ≥80% and persistence was defined by continuous therapy in the 1-year follow-up period without a medication gap of ≥60 days. RESULTS: 120 patients in the TRE cohort and 155 patients in the SLX cohort met inclusion criteria. Patients were of similar age (TRE: mean [SD] = 57.0 [16.1] vs. SLX: 57.2 [13.5]), similar sex (TRE: 70% female vs. SLX: 77.4%) and had a similar Charlson Comorbidity Index (CCI) score (TRE: mean [SD] 3.5 [2.6] vs. SLX: 3.1 [2.0]). Concomitant PAH therapies received during the pre-index period were generally similar between cohorts, however, more patients on TRE compared to SLX (11.7% vs. 2.6%, p=0.003) transitioned from parenteral PAH treatment. In the 1-year following treatment, adherence and persistence were comparable: adherence was 83% for TRE and 81% for SLX (p=0.567) and persistence was 53% for TRE and 59% for SLX (p=0.373). Among the patients persistent on therapy at 1-year, median (IQR) annual pharmacy costs were $232,071 ($211,039-$256,402) for SLX compared with $107,511 ($45,647-$186,622) for TRE (p<0.01) representing 116% higher median annual pharmacy costs for SLX. A similar proportion within each group switched to parenteral prostacyclin therapy (TRE: 6.7% vs SLX: 5.2%, p=0.794) or inhaled prostacyclin therapy (TRE: 3.3% vs SLX: 3.2%, p=1.0) in the 1-year follow-up period. After adjusting for baseline differences between cohorts, total mean PAH-related healthcare costs (pharmacy + medical) in the 1-year follow-up period were $350,782 ($307,873-$394,849) for SLX compared to $229,564 ($198,791-$264,944) for TRE (p<0.05). CONCLUSIONS: Real-world claims data show similar utilization and outcomes for TRE and SLX in patients with PAH with notable differences in costs in the 1-year following treatment initiation. CLINICAL IMPLICATIONS: Cost differences between TRE and SLX should be considered when selecting oral prostacyclin therapies given the broader economic impact on the U.S. healthcare system as well as potential costs specific to health insurers, pharmacy-benefit managers, employers, and patients. DISCLOSURES: Employee relationship with United Therapeutics Please note: >$100000 by Peter Classi, source=Web Response, value=Salary Consultant relationship with United Therapeutics Please note: 2020-current Added 04/27/2021 by Bonnie Dean, source=Web Response, value=Grant/Research Support Employee relationship with United Therapeutics Please note: 2017 to Present Added 04/27/2021 by Alex DeRuiter, source=Web Response, value=Salary Employee relationship with Xcenda, LLC Please note: 01/04/2020 Added 04/30/2021 by Henry Lee, source=Web Response, value=Salary Employee relationship with United Therapeutics Corporation Please note: >$100000 by Kellie Morland, source=Web Response, value=Salary Employee relationship with Xcenda LLC Please note: Jan 1, 2020 Added 04/27/2021 by Dana Stafkey-Mailey, source=Web Response, value=UT provided Xcenda Fin Support Employee relationship with United Therapeutics Corporation Please note: 11 Months Added 04/27/2021 by Benjamin Wu, source=Web Response, value=Salary

HEALTHCARE RESOURCE UTILIZATION AND TREATMENT PATTERNS BEFORE AND AFTER INITIATION OF INHALED TREPROSTINIL

TOPIC: Pulmonary Vascular Disease TYPE: Original Investigations PURPOSE: Inhaled treprostinil (i-TRE) has been shown in large scale clinical trials to improve exercise capacity and quality of life in patients with pulmonary arterial hypertension. However, real-world evidence is limited for initial i-TRE and particularly in patients on prior dual background PAH therapy with an endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) or soluble guanylate cyclase (SGC). METHODS: A retrospective cohort study of patients initiating i-TRE was conducted using the Optum® De-identified Clinformatics® Data Mart. Patients were identified having a pharmacy or medical claim for i-TRE between 01-JAN-2011 through 30-SEP-2019 and indexed on date of first claim. Patients were required to be ≥18 years of age at index, have ≥1 inpatient or ≥2 outpatient medical claims separated by at least 30 days with a diagnosis of pulmonary hypertension (International Classification of Diseases, 9th/10th Edition, Clinical Modification: 416.0, 416.8, 416.9, I27.0, I27.2, I27.20, I27.21, I27.81, I27.89, I27.9) in the 12-months pre-index, continuous enrollment from the 12-months pre-index through 12-months post-index, and no claim for i-TRE in the pre-index. Dual background therapy was classified as having an ERA and PDE5i or SGC in the 3-months prior to index. Outcomes were compared in the pre-index period to the post-index period. Continuous variables were compared using Wilcoxon signed rank sum test and dichotomous variables were compared using McNemar’s test. RESULTS: 332 patients initiating i-TRE met full selection criteria and a subgroup of 76 were categorized as having dual background therapy. Baseline characteristics were fairly similar with a mean (standard deviation[SD]) age at index of 65.1(13.0) and 60.9(14.6), percent female 65.7% and 64.5%, and mean(SD) Quan-Charlson Comorbidity Index of 3.44(1.8) and 3.43(1.8) for all initiators and dual background therapy patients, respectively. The percent of all initiators experiencing an all-cause hospitalization significantly decreased from 170 (51.2%) in the pre-index to 130 (39.2%) in the post-index period (p=0.0007). A larger significant decrease in hospitalizations was seen in dual background therapy initiators with 40 (52.6%) experiencing any hospitalization in the pre-index versus 23 (30.3%) in the post-index (p=0.0011). For all initiators and dual background therapy, no changes were observed for utilization of emergency department visits, physician office visits, or other outpatient visits. CONCLUSIONS: In this analysis of real-world data, inhaled treprostinil was effective in reducing hospitalization, a known risk factor for poor outcomes. The benefit remained substantial even in patients on prior dual background therapy with an ERA and PDE5i or SGC. CLINICAL IMPLICATIONS: This claims analysis suggest the use of inhaled treprostinil is an effective treatment modality to reduce hospitalizations for pulmonary hypertension. DISCLOSURES: No relevant relationships by Charles Burger, source=Web Response Employee relationship with United Therapeutics Please note: >$100000 by Peter Classi, source=Web Response, value=Salary Employee relationship with United Therapeutics Please note: >$100000 by Andrew Nelsen, source=Web Response, value=Salary Employee relationship with United Therapeutics Please note: 07/2019 - present Added 04/20/2021 by Christine Park, source=Web Response, value=Salary Employee relationship with United Therapeutics Corporation Please note: Present Added 04/01/2021 by Benjamin Wu, source=Web Response, value=Salary

Treatment Patterns and Costs of Transfusion and Chelation in Commercially-Insured and Medicaid Patients with Transfusion-Dependent β-Thalassemia

BACKGROUND: β-thalassemia is a potentially life-threatening, hereditary blood disorder characterized by ineffective erythropoiesis and peripheral hemolysis, leading to profound anemia and iron avidity. It is estimated to affect approximately 15,000 people in the U.S. and European Union. Patients with the most severe form of the disease, transfusion-dependent β-thalassemia (TDT), must adhere to a lifelong regimen of frequent red blood cell (RBC) transfusions for survival. While regular transfusions effectively manage the symptoms of TDT, they also substantially accelerate iron overload. As a result, patients with TDT must also adhere to lifelong chelation therapy regimens to reduce iron-associated morbidity and mortality. A variety of chelation therapies are available in the U.S., and treatment regimens should be optimized for the specific needs of individual patients. While the burden of chronic treatment on patients is clear, there are limited data available on economic costs of RBC transfusions and chelation therapy in the treatment of TDT in the U.S.OBJECTIVES: Objectives of this study were to: 1) develop an algorithm to identify patients with TDT in a U.S. administrative claims database; 2) evaluate demographic characteristics of these patients; 3) examine treatment patterns with RBC transfusions and chelation therapy; and 4) estimate the annual reimbursed costs associated with the use of RBC transfusions and chelation therapy in these patients.METHODS: This retrospective analysis used the U.S. MarketScan Commercial and Medicaid Multi-State Database, which together represent the administrative inpatient and outpatient medical, and outpatient pharmacy experience of approximately 30 million (in 2016) commercially-insured employees and their dependents, and Medicaid beneficiaries. These individuals are covered under a variety of fee-for-service and managed care health plans.Patients with TDT included in this study were required to have ≥ 8 RBC transfusions in a given 12-month period (first transfusion date = index date) between October 1, 2011 and September 30, 2016, one or more non-diagnostic inpatient or outpatient medical claims with a β-thalassemia or hemoglobin E β-thalassemia diagnosis between 3 months before and 15 months after the index date, and no evidence of allogeneic stem cell transplantation between the first and eighth transfusions. Demographic characteristics of the TDT patients were summarized. The annual number of RBC transfusions and prescriptions for chelation therapy were summarized on a per-patient basis, as well as the annual costs (i.e. reimbursed amounts) for these therapies. Additional costs associated with management of patients with TDT (e.g. ongoing monitoring of iron overload with cardiac T2* MRI and liver iron tests) are being estimated in the study but are not included in this abstract.RESULTS: A total of 8,480 patients with a diagnosis of β-thalassemia were identified, of which 253 patients (3.0%) met the selection criteria for inclusion in this analysis. Mean patient age was 22.8 years (median 21 years) and 53.4% were female; 33.2% lived in the Northeast, 25.7% in the Midwest, 24.9% in the South, and 16.2% in the West. Patients with TDT in this analysis had a median of 14 blood transfusions annually (range 8-56), with an average cost of $1,478 per transfusion. The mean annual cost of transfusions per patient was $22,478. The majority of patients (84.1%) had ≥ 1 prescription for chelation therapy, with 73.8% receiving an oral chelation therapy regimen only, 7.8% IV only, and 18.4% combination therapy. On average, chelation therapy cost $52,718 per patient, per year.CONCLUSION: In the U.S., the average annual economic cost of TDT conventional chronic symptom management with RBC transfusions and iron chelation therapy is approximately $75,000. Treatment with both transfusion and chelation are life-long requirements for most patients with TDT; thus the cumulative economic burden for basic management of TDT is substantial. Furthermore, these costs represent only a portion of the total economic burden of TDT, which also includes the costs of ongoing monitoring of cardiac and other organ iron overload, costs associated with morbidities related to TDT and iron overload, and the significant time burden for patients (e.g. to meet multi-disciplinary clinical teams including endocrinologists, cardiologists, etc.; and transfusion appointments). DisclosuresParamore:bluebird bio: Employment, Equity Ownership. Vlahiotis:Truven Health Analytics, an IBM Watson Health company: Employment. Moynihan:Truven Health Analytics, an IBM Watson Health company: Employment. Cappell:Truven Health Analytics, an IBM Watson Health company: Employment. Ramirez-Santiago:bluebird bio: Employment, Equity Ownership.

Hypercoagulability Testing and Hypercoagulable Disorders in Young Central Retinal Vein Occlusion Patients

To determine frequency of hypercoagulability testing and hypercoagulable states in patients with central retinal vein occlusion (CRVO) younger than 50 years. Retrospective cohort study. Deidentified patients younger than 50 years with newly diagnosed CRVO from a national insurance claims database. The de-identified Clinformatics Data Mart Database (Optum) containing medical claims from a commercial and Medicare Advantage insurance database was used. All outpatient medical claims (office visits, associated diagnoses, and laboratory testing) and demographic data for each beneficiary during their enrollment were accessible. Prevalence of (1) laboratory hypercoagulable workup within 90 days of CRVO diagnosis, (2) new diagnosis of a hypercoagulable state within 1 year of CRVO diagnosis, and (3) diagnosis of hypertension, diabetes mellitus (DM), and hyperlipidemia. One thousand one hundred eighty-one patients met inclusion criteria. Six hundred seventy-one patients (56.8%) were men, 450 patients (38.1%) had undergone hypercoagulable testing within 90 days, and 136 patients (11.5%) were diagnosed with a hypercoagulable state within 1 year after CRVO diagnosis. This proportion was similar between those patients with DM, hypertension, or hyperlipidemia (10.5% [65/620]) and those without (12.7% [71/561]; P= 0.28). Of the 136 patients diagnosed with a hypercoagulability state, 68.4% (93/136) had undergone testing within 90 days of CRVO diagnosis and 31.6% (43/136) did not. Of those who had not undergone hypercoagulability testing, 5.9% (43/731) were diagnosed with a hypercoagulable state within 1 year compared with 20.7% (93/450) in those who were tested (P < 0.001). The prevalence of a hypercoagulable state within 1 year of CRVO diagnosis in patients younger than 50 years was 11.5%, and the prevalence was similar between patients with atherosclerotic risk factors and those without. Rate of testing was only 38.1%. Future research should examine the usefulness of uniform hypercoagulable testing in young CRVO patients.

Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis.

BACKGROUND: Clostridioides difficile infection (CDI) affected an estimated 365,000 persons in the United States in 2017. Despite a nationally decreasing trend of CDI cases, the population incidence of recurrent CDI (rCDI) has not improved. Elderly individuals (aged ≥ 65 years) are at higher risk of CDI, rCDI, and complicated CDI compared with younger individuals. OBJECTIVE: To analyze Medicare fee-for-service data for 12 months after an initial CDI episode, in order to obtain real-world data on health care resource utilization (HRU) and costs for elderly patients with CDI and rCDI. METHODS: A retrospective cohort study of patients who were aged ≥ 65 years and had a first (index) CDI diagnosis from January 1, 2010, to December 31, 2016, and continuous enrollment in Medicare Parts A, B, and D during the 12-month pre-index and 12-month post-index periods was conducted. A CDI episode was identified by either an inpatient stay with CDI diagnosis code or an outpatient medical claim with a CDI diagnosis code plus a CDI treatment. Each CDI episode was followed by a 14-day CDI claim-free period after the last CDI claim or end of CDI treatment. rCDI was a second or subsequent episode of CDI that occurred within an 8-week window after the 14-day CDI claim-free period. The number of CDI and rCDI episodes, HRU, time to recurrence, and total all-cause direct medical costs were calculated over the 12-month pre-index (baseline) and 12-month follow-up periods and stratified by number of rCDI episodes (No rCDI, 1 rCDI, 2 rCDI, 3+ rCDI). RESULTS: A total of 268,762 patients with an index CDI were included. Mean age was 78.3 years, and 69.0% were female. HRU was higher during the 6 months immediately pre-index versus 7-12 months pre-index, including a higher proportion of patients with a hospital admission (55.1% vs. 27.5%) or emergency department visit (41.3% vs. 27.4%), respectively. Moreover, 34.7% of the study population experienced rCDI. Of those who experienced 1 recurrence, 59.1% had a second recurrence, and of those who had 2 recurrences, 58.4% had a third. During the 12-month follow-up, postacute care was used by at least 70% of each rCDI cohort. The proportion of patients with ≥ 4 hospital admissions during follow-up was highest for the 3+ rCDI cohort (24.9% of patients). During the 12-month follow-up, mean total all-cause direct costs were $76,024, $99,348, $96,148, and $96,517 for the No rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI cohorts, respectively, largely driven by inpatient costs. Adjusted all-cause total costs were significantly higher for all 3 rCDI cohorts compared with the No rCDI cohort. CONCLUSIONS: Elderly individuals experienced high rates of recurrence after their first CDI episode, and especially after a prior recurrence. The intensity of HRU during follow-up was higher for patients who suffered recurrences. Patients with rCDI had the burden of higher costs of care, including the patient out-of-pocket responsibility, versus patients with a single CDI episode. DISCLOSURES: Funding for this study was provided by Ferring Pharmaceuticals. Nelson is an employee of Ferring Pharmaceuticals, and Scott, Boules, and Unni were employees of Ferring Pharmaceuticals at the time of this study. Teigland and Parente are employees of Avalere Health and provided consulting services to Ferring Pharmaceuticals. Feuerstadt has served as a consultant to and on the speakers bureau for Merck and Co. and has served as a consultant for Ferring Pharmaceuticals and Roche Pharmaceuticals. Portions of the data contained in this study appeared as an abstract/ePoster for the AMCP Annual Meeting 2020, April 2020.

Changes in outpatient antibiotic prescribing for acute respiratory illnesses, 2011 to 2018.

Objectives:To describe acute respiratory illnesses (ARI) visits and antibiotic prescriptions in 2011 and 2018 across outpatient settings to evaluate progress in reducing unnecessary antibiotic prescribing for ARIs.Design:Cross-sectional study.Setting and patients:Outpatient medical and pharmacy claims captured in the IBM MarketScan commercial database, a national convenience sample of privately insured individuals aged <65 years.Methods:We calculated the annual number of ARI visits and visits with oral antibiotic prescriptions per 1,000 enrollees overall and by age category, sex, and setting in 2011 and 2018. We compared these and calculated prevalence rate ratios (PRRs). We adapted existing tiered-diagnosis methodology for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.Results:In our study population, there were 829 ARI visits per 1,000 enrollees in 2011 compared with 760 ARI visits per 1,000 enrollees in 2018. In 2011, 39.3% of ARI visits were associated with ≥1 oral antibiotic prescription versus 36.2% in 2018. In 2018 compared with 2011, overall ARI visits decreased 8% (PRR, 0.92; 99.99% confidence interval [CI], 0.92–0.92), whereas visits with antibiotic prescriptions decreased 16% (PRR, 0.84; 99.99% CI, 0.84–0.85). Visits for antibiotic-inappropriate ARIs decreased by 9% (PRR, 0.91; 99.99% CI, 0.91–0.92), and visits with antibiotic prescriptions for these conditions decreased by 32% (PRR, 0.68; 99.99% CI, 0.67–0.68) from 2011 to 2018.Conclusions:Both the rate of antibiotic prescriptions per 1,000 enrollees and the percentage of visits with antibiotic prescriptions decreased modestly from 2011 to 2018 in our study population. These decreases were greatest for antibiotic-inappropriate ARIs; however, additional reductions in inappropriate antibiotic prescribing are needed.

1359. Utilization of West Virginia Pediatric Medicaid Claims Data to Guide Outpatient Antimicrobial Stewardship Interventions

BackgroundAntimicrobial resistance is a significant public health risk with overuse and misuse of antibiotics as primary drivers. West Virginia (WV) leads the nation in per capita prescribing in the outpatient setting, where the majority of antibiotic use occurs.MethodsWe analyzed outpatient pharmacy and medical claims for WV Medicaid recipients age < 20 years from 1/1/2018 – 12/31/2019. Dental claims were excluded. Oral antibiotics were identified using National Drug Codes (NDCs). Key demographic variables extracted from the claims include patient age (as of December 31st of that calendar year [CY]), sex, race, ethnicity, Medicaid region, place of medical service, provider, and cost. Rates of prescribing were calculated as the number of prescriptions per 1,000 children and stratified by age, race/ethnicity, sex, and WV Medicaid region. We used geographic information system (GIS) mapping to depict geographic variation in prescribing by county. Oral antibiotic prescriptions were compared across CY 2018 and 2019 including spectrum of antibiotic coverage.ResultsIn CY 2018, 204,576 pediatric patients received 237,759 antibiotics (1,162 prescriptions/1,000 children). In 2019, 201,520 pediatric patients received 227,440 antibiotics (1,129 prescriptions/1,000 children). Prescription rates were higher among females, Caucasians and a younger (0-2) age group (Table 1). Antibiotics were more commonly prescribed by non-physician (e.g. nurse practitioner, etc.), non-pediatric specialty providers. Amoxicillin, cefdinir, and azithromycin were the most commonly prescribed antibiotics across CYs. Table 2 summarizes commonly prescribed antibiotics and their associated cost. Medicaid region 4 encompassed the highest prescription rates. Figure 1 is a GIS map of prescription rates by WV county.Table 1. West Virginia pediatric (0 – 19 years*) Medicaid patient population demographic summary by calendar year (CY). Table 2. Oral antibiotic prescription review including cost, CY 2018-2019. Figure 1. Geographic information system (GIS) mapping of prescriptions per 1,000 children by WV county. ConclusionThere is significant variation in antibiotic prescribing across WV. Potential areas of stewardship intervention should focus on non-physician, non-pediatric providers in Medicaid Region 4, the southern and arguably most rural portion of the state. Secondary analysis revealed an alarmingly high total number of broad-spectrum antibiotic use compared to narrow-spectrum. Further data analysis will examine diagnosis-specific prescription practices within this population.DisclosuresMichael J. Smith, MD, MSC.E, Kentucky Medicaid (Grant/Research Support)Merck (Grant/Research Support)

Update on respiratory syncytial virus hospitalizations among U.S. preterm and term infants before and after the 2014 American Academy of Pediatrics policy on immunoprophylaxis: 2011-2017

ABSTRACT Palivizumab is the only licensed respiratory syncytial virus (RSV) immunoprophylaxis (IP) available to prevent severe RSV disease in high-risk pediatric populations, including infants born at 29–34 weeks’ gestational age (wGA). In 2014, the American Academy of Pediatrics (AAP) stopped recommending RSV IP use for otherwise healthy 29–34 wGA infants and stated that 29–34 wGA infants and term infants have similar RSV hospitalization (RSVH) rates. This study aimed to compare RSV IP use and RSVH rates in 29–34 wGA infants and term infants during the 3 RSV seasons before and after the 2014 AAP policy change. RSV IP use in otherwise healthy infants 29–30, 31–32, and 33–34 wGA was estimated from pharmacy or outpatient medical claims for palivizumab. RSVH rates in the first 6 months of life were calculated per 100 infant-seasons. RSVH rate ratios were used to compare preterm infants and term infants before and after the policy change. Across infant cohorts (29–34 wGA) and chronologic age groups (<3 months and 3-<6 months), absolute decreases in RSV IP use between the combined 2011–2014 seasons and 2014–2017 seasons ranged from 7% to 38% and from 68% to 97%, respectively. Compared with 2011–2014, the RSVH risk increased 2.09-fold (P< .001) and 1.76-fold (P< .001) in 2014–2017 for infants born at 29–34 wGA and aged <6 months with commercial and Medicaid insurance, respectively. Overall, RSV IP use declined in the RSV seasons following the 2014 RSV IP policy change, and RSVH increased among 29–34 wGA infants aged <6 months.

Health status of Medicare-enrolled autistic older adults with and without co-occurring intellectual disability: An analysis of inpatient and institutional outpatient medical claims.

Little is known about the extent to which the healthcare needs of autistic older adults with intellectual disability differ from autistic older adults without intellectual disability. Our study is the first, to our knowledge, to use US national data to compare physical and mental health conditions among autistic older adults with and without intellectual disability. The data analyzed in this study consisted of records from inpatient hospitalizations as well as "institutional outpatient" healthcare visits, which include visits to hospital outpatient departments, rural health clinics, renal dialysis facilities, outpatient rehabilitation facilities, Federally Qualified Health Centers, and community mental health centers. Autistic older adults with intellectual disability were significantly more likely to have thyroid disorders, epilepsy, respiratory infections, gastrointestinal conditions, osteoporosis, cognitive disorders, and schizophrenia/psychotic disorders. In contrast, autistic older adults without intellectual disability were significantly more likely to have obesity, diabetes, high blood pressure, cerebrovascular disease, chronic obstructive pulmonary disease, arthritis, back conditions, attention deficit disorders, substance use disorders, and suicidal ideation or intentional self-injury. These findings highlight the importance of developing distinct, tailored health management strategies for the autistic older adults with and without intellectual disability.

Economic Burden of Metastatic Ovarian Cancer in a Commercially Insured Population: A Retrospective Cohort Analysis.

Ovarian cancer is the tenth most common type of cancer and the fifth leading cause of cancer death among females in the United States. The majority of incident ovarian cancer cases are diagnosed in individuals aged < 65 years, but limited evidence exists regarding the economic burden of ovarian cancer in this age group. To (a) estimate the annual all-cause direct total cost of metastatic ovarian cancer and (b) compare it to the cost of individuals without cancer in the working age commercially insured U.S. We conducted a retrospective cohort analysis using the IBM MarketScan Commercial Database. Patients were included if they met the following criteria: ≥ 1 medical claim with a secondary malignancy diagnosis in the primary position between January 1, 2011, and December 31, 2015 (earliest date of diagnosis defined as the index date); aged ≥ 18 years on the index date; ≥ 12 months of continuous enrollment before the index date; ≥ 1 month of continuous enrollment after the index date; and ≥ 1 inpatient medical claim or ≥ 2 outpatient medical claims ≥ 30 days apart, with an ovarian cancer diagnosis in any claim position within 60 days before or 30 days after the index date. Patients were excluded if they had ≥ 1 medical claim with a cancer diagnosis except for ovarian cancer in any claim position during the 12-month pre-index period. Controls were randomly selected and matched to metastatic ovarian cancer patients based on age, region, index date, number of months of continuous enrollment after the index date, and propensity score. Annual all-cause direct total costs and ovarian cancer-related direct total costs were estimated and compared for each cohort by using the Kaplan-Meier sample average technique to account for censoring after the index date. 2,991 metastatic ovarian cancer patients and 2,991 matched controls were included in this study. Patients in the metastatic ovarian cancer cohort had a mean (SD) age of 54.4 (8.5) years, and controls had a mean (SD) age of 54.2 (8.4) years. The mean (95% CI) annual all-cause total costs in the 12-month post-index period were $140,124 ($134,025-$146,267) for metastatic ovarian cancer patients and $35,161 ($31,338-$39,529) for controls; the resulting mean (95% CI) difference in annual all-cause total costs was $104,964 ($99,732-$110,042). In comparison with the annual all-cause total costs, the mean (95% CI) annual ovarian cancer-related total costs in the 12-month post-index period were $86,971 ($82,349-$91,508) for metastatic ovarian cancer patients and $0 ($0-$0) for controls. Working age patients with metastatic ovarian cancer have significantly higher costs compared with those without cancer. These findings contribute to the understanding of the burden of illness in a patient population where limited evidence currently exists on the economic consequences of the disease. No outside funding supported this study. The authors have nothing to disclose. This study was presented at the 2019 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; May 18-22, 2019; New Orleans, LA.

Comparison of infection-related hospitalization risk and costs in tumor necrosis factor inhibitor-experienced patients with rheumatoid arthritis (RA) treated with abatacept or other targeted disease-modifying anti-rheumatic drugs (tDMARDs)

Background: Evidence on the cost and risk of infection-related hospitalizations associated with targeted disease-modifying anti-rheumatic drugs (tDMARDs) in patients with RA previously treated with a tumor necrosis factor inhibitor (TNFi) is limited. This study compared the risk and cost of infection-related hospitalizations in commercially insured TNFi-experienced RA patients receiving abatacept, TNFi, or another non-TNFi.Methods: A retrospective observational study was conducted using 2 large insurance claims databases (1 January 2009–30 June 2017). Adult TNFi-experienced RA patients initiating a subsequent tDMARD (initiation date of tDMARD = index date) with 12 months of continuous enrollment pre-index date, and who had ≥1 inpatient or ≥2 outpatient medical RA claims on 2 different dates were included. Abatacept was compared to TNFis (adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab) and other non-TNFis (tocilizumab, rituximab, and tofacitinib). Cox proportional hazards models estimated the adjusted risk for infection-related hospitalization; costs were calculated on a per-member-per-month (PMPM) and per-patient-per-month (PPPM) basis using generalized linear models.Results: More patients in the abatacept cohort had an infection-related hospitalization at baseline (4.5%) vs TNFis (2.0%, p < .0001) and other non-TNFis (3.6%, p = .2619). However, during follow-up abatacept patients had fewer infection-related hospitalizations (abatacept: 2.8%, TNFi: 3.7% and other non-TNFis: 5.2%; p < .05). Regression results indicated that compared to patients on abatacept, patients receiving a TNFi [HR: 1.6 (95% CI: 1.1, 2.2)] and other non-TNFis [HR: 1.9 (95% CI: 1.3, 2.8)] had a significantly higher risk of infection-related hospitalization. Abatacept PMPM costs were lowest ($0.25 vs $0.39 and $0.43 for TNFi and other non-TNFi respectively). Mean PPPM (95% CI) cost in the follow-up was lower for abatacept compared to TNFi ($73 vs. $115; p = .042), and other non-TNFi ($73 vs. $125; p = .039).Conclusions: There were significantly lower infection-related hospitalizations and associated costs in TNF-experienced RA patients treated with abatacept than TNFis and other non-TNFis.