Months Of Continuous Enrollment Research Articles

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Health Care Costs With Sustained Oral Corticosteroid Use in Systemic Lupus Erythematosus

The goal of this study was to compare health care costs, health care resource utilization, and adverse events associated with sustained oral corticosteroid (OCS) use versus no OCS use in systemic lupus erythematosus. This retrospective cohort study used claims data (January 1, 2006-July 31, 2019) from patients with systemic lupus erythematosus aged ≥5 years with ≥24 months of continuous enrollment. Health care costs, health care resource utilization, and OCS-related adverse events were assessed. The sustained OCS cohort (defined as ≥12 months of continuous OCS use) was divided into exposure categories based on the number of 6-month classification periods with >5 mg/d OCS (0, 1-2, or 3-4). Of the 6234 patients in the sustained OCS use cohort, there were 1587 (25.5%) patients with 0 periods of >5 mg/d OCS use, 2087 (33.5%) patients with 1 to 2 periods of >5 mg/d OCS use, and 2560 (41.1%) patients with 3 to 4 periods of >5 mg/d OCS use; the no OCS use cohort included 7828 patients. Adjusted health care cost differences (95% CIs) were significantly greater for patients with 0, 1 to 2, and 3 to 4 periods of OCS use >5 mg/d versus the no OCS use cohort ($7774 [5426-10,223], $21,738 [18,898-25,321], and $30,119 [26,492-33,774], respectively). A higher proportion of patients in all OCS exposure categories required health care resource utilization (≥99.7% vs 93.4%) and experienced OCS-related adverse events (94.3%-96.8% vs 82.6%) versus the no OCS use cohort, with more periods of OCS use >5 mg/d associated with increased health care resource utilization and adverse events. Sustained OCS use in systemic lupus erythematosus was associated with high economic burden, health care resource utilization, and OCS-related adverse events. These data highlight the need for health care providers to carefully consider OCS use in systemic lupus erythematosus.

Hypnotic prescription trends and patterns for the treatment of insomnia in Japan: analysis of a nationwide Japanese claims database

BackgroundThere is limited consensus regarding the optimal treatment of insomnia. The recent introduction of orexin receptor antagonists (ORA) has increased the available treatment options. However, the prescribing patterns of hypnotics in Japan have not been comprehensively assessed. We performed analyses of a claims database to investigate the real-world use of hypnotics for treating insomnia in Japan.MethodsData were retrieved for outpatients (aged ≥ 20 to < 75 years old) prescribed ≥ 1 hypnotic for a diagnosis of insomnia between April 1st, 2009 and March 31st, 2020, with ≥ 12 months of continuous enrolment in the JMDC Claims Database. Patients were classified as new or long-term users of hypnotics. Long-term use was defined as prescription of the same mechanism of action (MOA) for ≥ 180 days. We analyzed the trends (2010–2019) and patterns (2018–2019) in hypnotics prescriptions.ResultsWe analyzed data for 130,177 new and 91,215 long-term users (2010–2019). Most new users were prescribed one MOA per year (97.1%–97.9%). In 2010, GABAA-receptor agonists (benzodiazepines [BZD] or z-drugs) were prescribed to 94.0% of new users. Prescriptions for BZD declined from 54.8% of patients in 2010 to 30.5% in 2019, whereas z-drug prescriptions remained stable (~ 40%). Prescriptions for melatonin receptor agonist increased slightly (3.2% to 6.3%). Prescriptions for ORA increased over this time from 0% to 20.2%. Prescriptions for BZD alone among long-term users decreased steadily from 68.3% in 2010 to 49.7% in 2019. Prescriptions for ORA were lower among long-term users (0% in 2010, 4.3% in 2019) relative to new users. Using data from 2018–2019, multiple (≥ 2) MOAs were prescribed to a higher proportion of long-term (18.2%) than new (2.8%) users. The distribution of MOAs according to psychiatric comorbidities, segmented by age or sex, revealed higher proportions of BZD prescriptions in elderly (new and long-term users) and male (new users) patients in all comorbidity segments.ConclusionPrescriptions for hypnotics among new and long-term users in Japan showed distinct patterns and trends. Further understanding of the treatment options for insomnia with accumulating evidence for the risk–benefit balance might be beneficial for physicians prescribing hypnotics in real-world settings.

Value of Surgical and Nonsurgical Treatment for Sleep Apnea: A Closer Look at Health Care Utilization.

To determine how surgery, continuous positive airway pressure (CPAP), and no treatment impact health care utilization in patients who have obstructive sleep apnea (OSA). This is a retrospective cohort study of patients between the ages of 18 and 65 that were diagnosed with OSA (9thInternational Classification of Diseases) from January 2007 to December 2015. Data were collected over 2 years, and prediction modelswere generated to evaluate trends over time. A population-based study using real-world data and insurance databases. A total of 4,978,649 participants were identified, all with at least 25 months of continuous enrollment. Patients with previous soft tissue procedures not approved for OSA (nasal surgery), or without continuous insurance coverage were excluded. A total of 18,050 patients underwent surgery, 1,054,578 were untreated, and 799,370 received CPAP. IBM Marketscan Research database was utilized to describe patient-specific clinical utilization, and expenditures, across outpatient, and inpatient services, and medication prescriptions. When the cost of the interventionwas eliminated in the 2-year follow-up, the monthly payments of group 1 (surgery) were significantly less than group 3 (CPAP) in overall, inpatient, outpatient, and pharmaceutical payments (p < .001). The surgery group was associated with less cumulative payments compared to the other 2 groups when the cost of the intervention (CPAP or surgery) was eliminated in all comorbidities and age groups. Treating OSA with surgery can lessen overall health care utilization compared to no treatment and CPAP.

Prompt initiation of triple therapy following hospitalization for a chronic obstructive pulmonary disease exacerbation in the United States: An analysis of the PRIMUS study.

BACKGROUND: Severe exacerbations requiring hospitalization contribute a substantial portion of the morbidity and costs of chronic obstructive pulmonary disease (COPD). Triple therapy (inhaled corticosteroid + long-acting β-agonist + long-acting muscarinic antagonist) is a recommended option for patients who experience recurrent COPD exacerbations or persistent symptoms. Few real-world studies have specifically examined the effect of prompt initiation of triple therapy, specifically among patients hospitalized for a COPD exacerbation. OBJECTIVE: To assess whether prompt initiation of triple therapy following a severe COPD exacerbation was associated with lower risk of subsequent exacerbations and lower health care use and costs and the effects of each 30-day delay of initiation. METHODS: Adults aged 40 years or older with COPD were identified in the Merative MarketScan Databases between January 1, 2010, and December 31, 2019, and were required to meet the following criteria: open or closed triple therapy (date of first closed prescription or last component of open=index treatment date), more than 1 inpatient admission with a primary COPD diagnosis (ie, severe exacerbation) in the prior 12 months (index exacerbation), 12 months of continuous enrollment before (baseline) and after (follow-up) index exacerbation, and absence of select respiratory diseases and cancer. Patients were stratified based on timing of open or closed triple therapy after the index exacerbation: prompt (≤30 days), delayed (31-180 days), or very delayed (181-365 days). Multivariable regression controlled for baseline characteristics (age, sex, insurance type, index year, comorbidities, prior treatment, and prior exacerbations) and estimated the odds of subsequent exacerbations, change in the number of exacerbations, and change in health care costs during 12-month follow-up associated with each 30-day delay of triple therapy initiation. RESULTS: A total of 6,772 patients met inclusion criteria (2,968 [43.8%] prompt, 1,998 [29.5%] delayed, and 1,806 [26.7%] very delayed). The adjusted odds of any exacerbation and a severe exacerbation during 12-month follow-up increased by 13% (odds ratio [95% CI]: 1.13 [1.11-1.15]) and 10% (1.10 [1.08-1.12]), respectively, for each 30-day delay in triple therapy initiation, and the mean number of exacerbations increased by 5.4% (95% CI = 4.7%-6.1%). There was a 3.0% increase (95% CI = 2.2%-3.8%) in mean all-cause costs and a 3.7% increase (95% CI = 2.9%-4.6%) in total COPD-related costs for each 30-day delay of triple therapy initiation. CONCLUSIONS: Longer delays in triple therapy initiation after a COPD hospitalization result in greater risk of subsequent exacerbations and higher health care resource use and costs. Adequate post-discharge follow-up care and earlier consideration of triple therapy may improve clinical and economic outcomes among patients with COPD. DISCLOSURES: This study was funded by AstraZeneca. Dr Evans is employed by Merative, formerly IBM Watson Health, and Mr Tkacz was employed by IBM Watson Health at the time of this study; Merative/IBM Watson Health received funding from AstraZeneca to conduct this study. Mr Pollack, Dr Staresinic, Dr Feigler, and Dr Patel are employed by AstraZeneca. Dr Touchette, Dr Portillo, and Dr Strange are paid consultants to AstraZeneca. Dr Strange also participates in research grants paid to the Medical University of South Carolina by AstraZeneca, CSA Medical, and Nuvaira, and is a consultant to GlaxoSmithKline, Morair, and PulManage regarding COPD.

Cost to Treat Newly Diagnosed Patients with Paroxysmal Nocturnal Hemoglobinuria: A Retrospective Analysis

Background Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hematologic disorder that renders affected patients’ red blood cells susceptible to premature destruction (i.e., hemolysis) and can lead to excess morbidity. Current pharmacological treatments for PNH include not only eculizumab, launched in 2007, but more recently approved treatments such as ravulizumab and pegcetacoplan. Even among patients treated with currently available therapies, suboptimal C5 inhibition or exacerbating factors such as infections may result in breakthrough hemolysis or other PNH-related complications. Given the evolving treatment landscape and challenges in treatment and diagnosis, it is unclear what the total and setting-specific costs and health care utilization are among patients newly diagnosed with PNH. Objectives To determine healthcare resource utilization and costs for newly diagnosed patients with PNH. Methods United States (US) adults with a new ICD-10 diagnosis of PNH (D59.5) from April 2016 to December 2020 identified in the OptumLabs claims data were included. The date of the first claim with a PNH diagnosis was defined as the index diagnosis date. Patients were required to have at least 6 months of continuous enrollment before the index diagnosis date to identify newly diagnosed patients and at least 6 months of continuous enrollment after the index diagnosis date for analysis. Comorbidity was measured with the National Cancer Institute (NCI) comorbidity index. All-cause healthcare resource utilization (HCRU), all-cause costs, PNH-related HCRU (defined as claims with an ICD-10 code of D59.5 in any position), and PNH-related costs were measured on a per-patient per-month (PPPM) basis for inpatient admissions, emergency department (ED) visits, office visits, and other outpatient visits for the 6-month follow-up period. The PPPM frequency of blood transfusions and utilization of bone marrow transplant were also assessed. The cost and HCRU results were age-weighted to be representative of the US population. Results Of the 749 patients with an ICD-10 diagnosis of PNH (D59.5) during the selected timeframe, 381 were newly diagnosed patients who met all inclusion criteria. In the unweighted sample, approximately half of the patients (50.9%) were female, with an average age of 61.3 (SD = 17.8), and the average NCI Comorbidity Index was 0.57 (SD = 0.65). Of the 381 patients in the weighted sample, 149 (39.1%) had an inpatient admission. Of these inpatient admissions, 86 (57.7%) were PNH-related. For patients with at least one inpatient admission, the mean length of stay (LOS) was 2.2 days (SD = 3.0) and the median LOS was 1.0 days. One hundred twenty-three (32.3%) PNH patients had an emergency department (ED) visit in the first 6 months after the index diagnosis, 12 of which (9.8%) were PNH-related. Nearly all patients had office visits (97.9%) or other outpatient visits (96.6%) in the 6-month follow up period. Blood transfusions occurred in 18.6% of the PNH population, while bone marrow transplant was relatively rare (result suppressed due to small cell size). (Table 1) The PPPM total cost for newly diagnosed patients was $10,480, or $125,758 per patient per year. Of these costs, 39.0% ($4,090 PPPM) were for pharmacy costs (including infusion costs), 33.9% ($3,551 PPPM) were for inpatient costs, 6.4% ($672 PPPM) were for office visits, 0.9% ($94 PPPM) were for ED visits, and 19.8% ($2,073 PPPM) were for other outpatient visits. The total PNH-related cost was $4,763 PPPM, accounting for 45% of the total cost. PNH-related pharmacy costs for eculizumab and ravulizumab, including administration, accounted for 60.2% ($2,868) of PNH-related costs (no pegcetacoplan use was observed since it was approved in 2021). PNH-related inpatient costs accounted for 28.0% ($1,333), office visits accounted for 3.6% ($172), and other outpatient visits accounted for 8.1% ($386) of total PNH-related costs. ED visits were rarely flagged with the PNH ICD-10 code, with less than 0.1% of PNH-related costs coming from the ED. (Figure 1) Conclusions Despite new treatment options available for PNH, HCRU and associated costs remain high with 39.1% of PNH patients having an inpatient visit in the first 6 months after diagnosis. Nearly one in five newly diagnosed PNH patients still require at least one blood transfusion in the follow-up period, signaling further unmet medical need in PNH. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Clinical and Economic Outcomes in Patients with Transfusion-Dependent β-Thalassemia and Patients with Sickle Cell Disease with Recurrent Vaso-Occlusive Crises Receiving Hematopoietic Stem Cell Transplants in the United States

Background: Transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD) are inherited blood disorders caused by mutations in the β-globin gene, resulting in abnormal, reduced, or absent expression of hemoglobin. TDT is characterized by ineffective red blood cell production that leads to chronic anemia, need for regular red blood cell transfusions (RBCTs), and organ complications. SCD is characterized by sickle-shaped red blood cells that cause vaso-occlusive crises (VOCs), hemolysis, and end-organ damage. Hematopoietic stem cell transplant (HSCT) is currently the only curative option for patients with TDT and patients with SCD. There is limited research on the frequency and outcomes of HSCT in these two patient populations. This study describes the economic and clinical outcomes for a combined population of patients with TDT and patients with SCD with recurrent VOCs who received HSCTs in the United States. Methods: This retrospective cohort study used administrative claims from the MerativeTM Commercial, Medicare, and Multi-State Medicaid Databases to identify patients with ≥1 inpatient or ≥2 outpatient claims for β-thalassemia or SCD between March 1, 2010, and March 1, 2019. Eligible patients with TDT were required to have ≥8 discrete RBCTs in any 12-month period on or after the date of the earliest qualifying β-thalassemia claim. At least 3 days between service dates of RBCT claims were required to be considered discrete RBCTs. Patients with TDT were required to have 1 year of continuous enrollment after their first transfusion to be included. Eligible patients with SCD with recurrent VOCs were required to have ≥2 diagnosed VOCs per year in any 2 consecutive years after and including the first qualifying SCD claim. A VOC was defined as inpatient or outpatient claim of acute chest syndrome, priapism, SCD crisis, or splenic sequestration; at least 3 days between VOC claims were required to be considered discrete VOCs. Eligible patients with SCD with recurrent VOCs were required to have 24 months of continuous enrollment before the second VOC in the second consecutive year and 12 months of continuous enrollment after. Patients with TDT and patients with SCD who met the above criteria and received an HSCT were included in the analysis set. Patients receiving HSCT were identified utilizing relevant procedure codes. The index date was the date of transplant. Patients were followed from the index date to the earliest of end of enrollment, death, or end of study period (March 1, 2020). Demographics were assessed at the index date, and clinical complications, healthcare resource utilization, and costs were descriptively summarized in the post-index period. Costs were based on paid amounts of adjudicated claims and patient cost-sharing and included costs in the 10 days before the index date to account for pre-transplant healthcare services associated with the transplant. Results: Two hundred thirty-four and 3500 patients met the criteria for TDT and SCD with recurrent VOCs, respectively, for a total of 3734 patients. Of that total, 62 patients (1.66%) underwent a transplant and were therefore included in the analysis cohort. Mean patient age at the index date was 12.6 years, and 46.8% were female. A proportion of transplant patients experienced graft versus host disease (GvHD) (37/62; 59.7%), unspecified HSCT complications (33/62; 53.2%), or bone marrow transplant rejection or failure (6/62; 9.7%) post-transplant. Average length of stay for the index HSCT admission was 42 days; in the first year post-transplant, patients averaged 58.3 days in the hospital. Total costs in the first 100 days and 1 year post-transplant were $442,752 and $623,301, respectively. Inpatient costs accounted for 93.7% and 88.7% of costs at 100 days and 1 year, respectively. Conclusions: This retrospective cohort study suggests that only a small proportion of patients with TDT and patients with SCD with recurrent VOCs receive HSCTs. Many patients who undergo transplants experience clinical complications, including graft failure and GvHD, and substantial economic burden. Given the limited utilization and potential safety risks of HSCT, additional curative treatment approaches are needed for patients with TDT and patients with SCD with recurrent VOCs.

Clinical Burden of Alpha- and Beta-Thalassemia Compared to Matched Controls in the Real-World Setting

Introduction Thalassemia is an inherited anemia caused by diminished globin chain synthesis. More severe forms lead to ineffective erythropoiesis and chronic hemolytic anemia (HA) with subsequent clinical complications. Two types of thalassemia, alpha (α) and beta (β), result from defective synthesis of α- or β-globin, respectively. Limited research has been conducted in the US regarding burden of comorbidities, including both non-transfusion dependent thalassemia (NTDT) and transfusion dependent thalassemia (TDT), especially α-thalassemia. Methods Claims data for patients and controls were selected from the MarketScan® Commercial and Medicare and Multi-State Medicaid claims databases. Patients were those with ≥1 inpatient or ≥2 claims in any setting for α- or β-thalassemia international classification of diseases (ICD)-9/ICD-10 codes from 1/1/2013 to 6/30/2021 (Table 1). Due to limitations in billing claims, some patients with thalassemia trait and minor may have been coded incorrectly by physicians and included in the NTDT group. The index date was defined as the first date of α- or β-thalassemia diagnosis code. Adults (≥18 years) with 12 months of continuous enrollment following index were included. TDT was defined as ≥8 transfusions within 12 months of follow-up, each within 42 days of each other. Controls with no history of thalassemia or other HAs were matched at 5:1 to thalassemia cases on age, sex, payer, and follow-up time. Medicaid patients were also matched on race. Thalassemia-related clinical outcomes, including pulmonary hypertension, cardiovascular disease, cerebrovascular disease, osteoporosis, and other comorbidities were measured during 12 months of follow-up and compared to matched controls. Chi-square (categorical variables) and t-tests (continuous variables) were used for outcome comparisons with a significance level of 0.05. Results In the commercial and Medicare population, a total of 4,183 patients with thalassemia and 20,915 matched controls were analyzed. Of patients with thalassemia, 1,675 (40.0%) had α-thalassemia and 2,508 (60.0%) had β-thalassemia. In the 12 months following index, 2 (0.1%) α-thalassemia and 84 (3.3%) β-thalassemia had TDT; 1,673 (99.9%) α-thalassemia and 2,424 (96.7%) β-thalassemia had NTDT (Table 1). Sensitivity analysis without the 42-day requirement between transfusions had a minimal impact on TDT numbers. The average age for NTDT was 46.3 (SD 14.8) years and 29.4% were male. Compared to matched controls, α-NTDT and β-NTDT were more likely to have cardiovascular disease (α-NTDT: 7.2% vs. 4.7%; β-NTDT: 7.3% vs. 4.9%), cerebrovascular disease (α-NTDT: 3.8% vs. 1.9%; β-NTDT: 3.5% vs. 2.3%), pulmonary hypertension (α-NTDT: 1.1% vs. 0.3%; β-NTDT: 1.2% vs. 0.3%), jaundice (α-NTDT: 1.0% vs. 0.2%%; β-NTDT: 1.7% vs. 0.1%) and liver disease (α-NTDT: 1.2% vs 0.4%, β-NTDT: 2.2% vs. 0.5%) (all p<0.001) (Table 2). Osteoporosis (α-NTDT: 3.9% vs. 2.6% and β-NTDT: 4.5% vs. 2.5%; both p<0.005) and hypogonadism (α-NTDT: 1.8% vs. 1.0%, p=0.005; β-NTDT: 1.6% vs. 1.1%, p=0.045) were also more frequent among NTDT than matched controls. α-NTDT (1.7 [SD 1.5] vs. 1.1 [SD 1.2]) and β-NTDT (1.8 [SD 1.5] vs. 1.1 [SD 1.3]) had a higher mean number of comorbidities than their respective controls (both p<0.001; Table 1). β-TDT also had higher comorbidities compared to matched controls; there were too few patients with α-TDT to report. The Medicaid analysis of thalassemia compared to controls showed similar results to the Commercial/Medicare analysis, with a larger difference in the number of comorbidities observed (α-NTDT (2.3 [SD 1.8] vs. 1.1 [SD 1.4]) and β-NTDT (2.7[SD 1.8] vs. 1.3 [SD 1.5]; both p<0.001). Conclusions Serious comorbidities and unmet needs persist for patients with thalassemia, even in thalassemia types that have historically been considered less severe such as NTDT. Both α-NTDT and β-NTDT had significantly higher clinical burden than matched controls including endocrinopathies, cardiovascular disease, liver disease and pulmonary hypertension - conditions associated with considerable morbidity and mortality. Some individuals with thalassemia minor or trait may have been included, suggesting that NTDT estimates in this study provide a lower boundary for the impact of NTDT. Additional therapies are needed to address the underlying cause of the disease, and for prevention of these serious complications. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Economic Burden of Hematopoietic Cell Transplantation (HCT) Among Commercially Insured Patients with Hematological Malignancies in the United States (US)

INTRODUCTION: HCT is a potentially curative treatment option for high-risk hematologic malignancies. Approximately 20,000 HCTs are performed in the US annually. A wide range of costs for both autologous HCT (auto-HCT) and allogeneic HCT (allo-HCT) are reported. For commercially insured patients with hematologic malignancies, the economic burden of an auto-HCT was estimated at $390,159 and allo-HCT at $745,341 in 2011-2014 over a 6-month pre- and 12-month post-HCT period (Bonafede 2017), indirect and caregiver costs may further increase burden (Applebaum 2017; Denzen 2017). We characterize all-cause healthcare resource utilization (HRU) and costs among commercially insured patients with hematologic malignancies who received an auto- or allo-HCT in a more contemporary era. METHODS: Adults with hematologic malignancies and ≥1 inpatient admission for an auto- or allo-HCT (Jan 2015-Mar 2020) were identified from the MarketScan Commercial and Medicare Supplemental Databases. Patients were indexed on the date of first HCT inpatient admission. Included patients had 12 months of continuous enrollment before and after the index date and ≥2 medical claims with a diagnosis code for an eligible hematologic malignancy (acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis, myeloproliferative disease, acute lymphoblastic leukemia, chronic myeloid leukemia, multiple myeloma, Hodgkin disease, or lymphoma) with ≥1 claim occurring on or before the index date. Patients with an HCT prior to the index date were excluded. Controls were selected from patients meeting study criteria with the exception of an HCT claim requirement. The index date for patients in the control group was randomly assigned based on the time between diagnosis and HCT for the HCT cohorts. Controls and HCT recipients were matched 3:1 based on age, sex, insurance type, Deyo-Charlson Comorbidity Index categories, and hematologic malignancy. Total all-cause HRU and inpatient, outpatient (ie, ED [emergency department], physician office, other visits), and pharmacy costs were compared between the HCT cohorts and controls over the 6-month pre- and 12-month post-index periods. Healthcare costs (2021 US$) were based on paid amounts of adjudicated claims, including insurer/health plan payments and patient cost-sharing (copayment, deductible, and coinsurance). RESULTS: A total of 1653 auto-HCT recipients were matched to 4959 controls and 411 allo-HCT recipients matched to 1233 controls. After matching, HCT cohorts and controls were similar in age, sex, insurance type (Table 1), Deyo-Charlson Comorbidity Index categories, and hematologic malignancy. Pre-index comorbidities differed among the HCT and control cohorts, with psychiatric disturbances, infections, and heart valve disease significantly more common in both the auto- and allo-HCT recipients vs matched controls (P<0.001 for all). Multiple myeloma was the most common eligible indication for auto-HCT whereas acute myeloid leukemia/myelodysplastic syndrome/myelofibrosis/myeloproliferative disease were the most common indications for allo-HCT. Over the 18-month observation period, total all-cause costs were significantly higher for auto-HCT recipients vs matched controls ($540,194 vs $182,846; P<0.001; Figure 1), with auto-HCT recipients having significantly higher costs than controls for all categories evaluated except ED visits during the post-index period ($817 vs $879; P<0.4). Auto-HCT costs were driven by inpatient and outpatient costs. For allo-HCT recipients vs matched controls, total all-cause costs were significantly higher ($929,799 vs $190,776; P<0.001) during the 18-month observation period, with allo-HCT recipients having significantly higher costs than controls for all categories evaluated except ED visits during the pre- and post-index periods ($568 vs $533; P=0.11, $824 vs $862; P>0.9). Inpatient costs were the primary cost driver for allo-HCT recipients. CONCLUSIONS: The use of HCT, a potentially curative treatment for some patients with hematologic malignancies, is associated with considerable HRU and economic burden. This analysis did not include indirect costs, caregiver burden, or donor costs, and therefore likely underestimates the true burden of HCT for patients with hematologic malignancies. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Hormonal Contraceptive Use and Association with Thromboembolism in Women with Sickle Cell Disease

Introduction Women with sickle cell disease (SCD) require broad access to highly effective contraceptive methods due to high rates of unplanned pregnancy and adverse maternal and fetal outcomes. Combined (estrogen-containing) hormonal contraception carries a known risk of thromboembolism (TE) in the general population, and women with SCD have higher baseline risk of TE, thus use of these agents in women with SCD may further increase that risk. The paucity of safety data on hormonal contraceptive use in women with SCD limits the ability of providers and patients to make informed decisions. Objectives This study aims to use population-level administrative claims data of publicly insured women with SCD in the United States (US) to assess patterns of hormonal contraception use and evaluate risk of TE during the first year of use. We hypothesized that TE rates are higher in women prescribed combined hormonal contraceptives (CHC) as compared to women prescribed progestin-only contraceptives (POC). Methods We obtained data using the Centers for Medicare and Medicaid Services Analytic eXtract (CMS MAX) from 2006-2018. Study population included females of reproductive age (12-44 years) with >3 ICD-9 or ICD-10 codes consistent with SCD. Women had to have ≥12 months of continuous enrollment with at least 6 months of data as 'washout period' prior to enrollment period. A new prescription for hormonal contraception was identified using national drug codes in pharmaceutical claims or ICD-9 or 10 procedure codes. CHC included the combined oral contraceptive pill (OCP), transdermal patch, and vaginal ring. POC included the progestin-only pill, depot medroxyprogesterone acetate (DMPA) injection, intrauterine device (IUD) and subdermal implant. TE was defined as the presence of ≥2 ICD-9 or ICD-10 codes for venous TE (deep vein thrombosis (DVT) or pulmonary embolism (PE)) or arterial TE (stroke or myocardial infarction (MI)). Arterial TE was also required to have an associated inpatient admission. Women were included in the analysis for 12 months after contraception initiation, or censored in the event of either contraceptive switch, pregnancy or abortion, or TE occurrence. Data were summarized descriptively and TE incidence rates were calculated as events per 1,000 person-years. Results We identified a total of 41,012 reproductive-aged women with SCD enrolled in CMS MAX, of whom 22.6% (n=9,261) had received ≥1 new prescription for hormonal contraception. Among women with new contraceptive use, 58.5% (n=5,420) initiated CHC and 41.5% (n=3,841) initiated POC. Median age at the start of contraception was 22.3 years (range: 12.0-43.9) and median age at the start of CHC and POC were 22.1 and 22.7 years respectively. Among CHC users, 84.6% (n=4,584) of women were prescribed the combined OCP, 7.7% (n=419) the transdermal patch, and 7.7% (n=417) the vaginal ring. For POC users, DMPA was prescribed to 72.3% (n=2,777), progestin-only pills to 21.2% (n=816), IUD to 4.2% (n=163) and subdermal implant to 2.2% (n=85) of women. A total of 141 (1.5%) new contraceptive users with SCD were identified to have a TE during the follow-up period. The median time from contraception initiation to TE diagnosis was 183 days (IQR: 82-244). The most common TE event was PE (46.1%) followed by DVT (41.8%), stroke (6.4%), and MI (2.1%); 3.5% of women had multiple TE events. TE rate was 16.4 events per 1,000 person-years in CHC users, and the TE event rate was 17.0 events per 1,000 person-years in POC users (p=0.84). Rates of TE did not differ between the two most commonly used methods in each group, the combined OCP (15.5 events per 1,000 person-years ) and DMPA (17.7 events per 1,000 person-years) (p=0.48). Conclusion Our work provides population-level data regarding contraceptive practices for women with SCD in the US. We found that CHC was more frequently prescribed than POC, and identified low rates of long-acting reversible contraception use. The most frequently prescribed agents were the combined OCP and the DMPA injection. TE rates after initiation of the combined OCP and DMPA did not differ. Although limited by the retrospective study design and use of administrative claims data, this study suggests a similar safety profile for CHC and POC in women with SCD with respect to risk of TE.

Use of the Postacute Sequelae of COVID-19 Diagnosis Code in Routine Clinical Practice in the US

A new International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code (U09.9 Post COVID-19 condition, unspecified) was introduced by the Centers for Disease Control and Prevention on October 1, 2021. To examine the use of the U09.9 code and describe concurrently diagnosed conditions to understand physician use of this code in clinical practice. This cohort study of US patients with an ICD-10-CM code for post-COVID-19 condition used deidentified patient-level claims data aggregated by HealthVerity. Children and adolescents (aged 0-17 years) and adults (aged 18-64 and ≥65 years) with a post-COVID-19 condition code were identified between October 1, 2021, and January 31, 2022. To identify a prior COVID-19 diagnosis, 3 months of continuous enrollment (CE) before the post-COVID-19 diagnosis date was required. Presence of the ICD-10-CM U09.9 code. There were 56 143 patients (7723 female patients [61.2%]; mean [SD] age, 47.6 [19.2] years) with a post-COVID-19 diagnosis code, with cases increasing in mid-December 2021 following the trajectory of the Omicron case wave by 3 to 4 weeks. The analysis cohort included 12 622 patients after the 3-month preindex CE criteria was applied. Among this cohort, the median (IQR) age was 49 (35-61) years; however, 1080 (8.6%) were pediatric patients. The U09.9 code was used most often in the outpatient setting, although 305 older adults (14.0%) were inpatients. Only 698 patients (5.5%) had at least 1 of the 5 codes listed as possible concurrent conditions in the coding guidance. Only 8879 patients (70.4%) had a documented acute COVID-19 diagnosis code (569 [52.7%] among children), and the median (IQR) time between acute COVID-19 and post-COVID-19 diagnosis codes was 56 (21-200) days. The most common concurrently coded conditions varied by age; children experienced COVID-19-like symptoms (eg, 207 [19.2%] had cough and 115 [10.6%] had breathing abnormalities), while 459 older adults aged 65 years or older (21.1%) experienced respiratory failure and 189 (8.7%) experienced viral pneumonia. This retrospective cohort study found patients with a post-COVID-19 ICD-10-CM diagnosis code following the acute phase of COVID-19 disease among patients of all ages in clinical practice in the US. The use of the U09.9 code encompassed a wide range of conditions. It will be important to monitor how the use of this code changes as the pandemic continues to evolve.

Comparison of clinical and economic burden of pulmonary arterial hypertension patients with and without connective tissue disease treated with macitentan

Abstract Introduction Patients with pulmonary arterial hypertension (PAH) and connective tissue disease (CTD) have a poorer prognosis than those diagnosed with other PAH etiologies. Purpose To compare the clinical and economic burden among PAH patients with and without CTD (PAH-CTD/PAH non-CTD) treated with macitentan. Methods This retrospective study used the Optum Clinformatics DataMart to identify PAH-CTD and PAH non-CTD patients aged ≥18 years and prescribed macitentan from 01JAN2015–30JUN2019. The index date was the date of the first macitentan claim. Patients had to have ≥12 months of continuous enrollment before index and were followed until earliest of macitentan discontinuation, health plan disenrollment, death, or study end. Patients in the PAH-CTD cohort had to have a claim for a CTD condition at any time during the 12-month baseline period. Patients with a baseline claim for any PAH medication, chronic thromboembolic pulmonary hypertension, prior atrial septostomy or lung transplant were excluded. Descriptive analysis comprised means, standard deviations, medians, and interquartile ranges for continuous variables and frequencies and percentages for categorical variables. Multivariable analyses (Cox proportional hazards and generalized linear models) adjusting for baseline characteristics were used to compare time to PAH-related and all-cause hospitalization, disease progression (death, lung transplant, atrial septostomy or addition of intravenous/subcutaneous prostanoids), and PAH- and all-cause related medical (inpatient and outpatient) costs between the two cohorts with PAH non-CTD as reference. Results The analysis included 203 PAH-CTD and 750 PAH non-CTD patients treated with macitentan. Versus PAH non-CTD, PAH-CTD patients were younger, had proportionately more females, and lower Charlson Comorbidity Index (CCI) scores (Table). The proportion of patients with a baseline hospitalization, length of stay and inpatient costs were similar across groups. There were no significant differences observed in time to PAH-related hospitalization (hazard ratio [HR]=0.99; p=0.910), all-cause hospitalization (HR=1.13; p=0.195), or disease progression (HR=1.00; p-value=0.973) for the PAH-CTD cohort (PAH non-CTD as reference). All-cause medical costs were similar between the cohorts ($3,836 per patient per month [PPPM] for PAH CTD vs $3,521 PPPM for PAH non-CTD, p=0.362). PAH-CTD patients incurred higher mean PAH-related medical costs vs PAH non-CTD ($2,806 PPPM vs $1,961 PPPM, p=0.047). Conclusion The study suggests that risk of all-cause and PAH-related hospitalization and disease progression did not differ for PAH-CTD and PAH non-CTD patients. Treatment with macitentan in the real world appears to confer similar clinical benefits in both PAH-CTD and PAH non-CTD groups. All-cause costs did not differ between the two cohorts but PAH-related costs were significantly higher in PAH-CTD patients suggesting an incremental burden associated with CTD. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Janssen Scientific Affairs, LLC

Social Needs Identified by Diagnostic Codes in Privately Insured U.S. Adults

The relationships between healthcare use and social needs are not fully understood. In 2015, International Classification of Diseases, Tenth Revision coding introduced voluntary Z codes for social needs‒related healthcare encounters. This study evaluated early national patterns of Z codes in privately insured adults. In 2021, the authors conducted a case-control analysis of national commercial health payer claims from 2016 to 2019. Among adults with ≥6 months of continuous enrollment and ≥1 medical claims, patients with any assigned Z codes were defined as cases. Controls were selected through stratified random sampling. Z codes were organized under 3 categories: socioeconomic, community/social, and environmental. Of 29.5 million adults, 521,334 patients (1.8%) had any assigned Z codes. Among all the Z codes, 53.5% identified community/social issues, 30.3% identified environmental issues, and 16.2% identified socioeconomic issues. Among socioeconomic Z codes, housing needs were frequently identified, but needs for food, utility bills, and transportation were very rarely identified. In multivariable regression analysis, females had higher odds of Z code assignment than males. Depression and chronic pulmonary disease were the 2 common comorbidities (≥5% prevalence in cases and controls) that were highly associated with Z code assignment. Less common comorbidities strongly associated with Z code assignment were drug abuse, alcohol abuse, psychoses, and AIDS/HIV. In this national study of privately insured patients, many Z codes identified healthcare encounters caused by social stressors, whereas few identified food- or transportation-related causes. Depression and chronic pulmonary disease were highly associated with Z code assignment.