Total All-cause Healthcare Costs Research Articles

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

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

Incidence and Costs of Clinically Significant Events with Systemic Therapy in Patients with Unresectable Hepatocellular Carcinoma: A Retrospective Cohort Study.

Systemic therapies have been associated with clinically significant events (CSEs) in patients with unresectable hepatocellular carcinoma (uHCC). We evaluated the incidence of CSEs (bleeding, clotting, encephalopathy, and portal hypertension), and their impact on healthcare resource utilization (HCRU) and costs, in patients with uHCC treated with first-line (1L) atezolizumab plus bevacizumab (A + B), lenvatinib (LEN), or sorafenib (SOR) in the USA. A retrospective cohort study was performed using medical/pharmacy claims from Optum® Clinformatics® Data Mart. Patients diagnosed with HCC who initiated 1L A + B between June 01, 2020 and December 31, 2020 or LEN/SOR between January 01, 2016 and May31, 2020 were included. Outcomes included incidence rates of CSEs, HCRU, and costs. Subgroup analysis was performed in patients with no CSEs or ≥ 1 CSE. In total, 1379 patients were selected (A + B, n = 271; LEN, n = 217; SOR, n = 891). Clotting (incidence rate per 100 patient-years [PY] 94.9) and bleeding (88.1 per 100 PY) were the most common CSEs in the A + B cohort. The most common CSEs in the LEN cohort were clotting (78.6per 100 PY) and encephalopathy (66.3 per 100 PY). Encephalopathy (73.0per 100 PY) and portal hypertension (72.3 per 100 PY) were the most common CSEs in the SOR cohort. Mean total all-cause healthcare costs per patient per month (PPPM) were $32,742, $35,623, and $29,173 in the A + B, LEN, and SOR cohorts, respectively. Mean total all-cause healthcare costs PPPM were higher in patients who had ≥ 1 CSE versus those who did not (A + B $34,304 versus $30,889; LEN $39,591 versus $30,621; SOR $31,022 versus $27,003). Despite improved efficacy of 1L systemic therapies, CSEs remain a concern for patients with uHCC, as well as an economic burden to the healthcare system. Newer treatments that reduce the risk of CSEs, while improving long-term survival in patients with uHCC, are warranted.

Epidemiology, treatment patterns, and humanistic and economic burden of biliary tract carcinoma: A systematic and targeted literature review.

443 Background: Patients with biliary tract cancers (BTC) are typically diagnosed at late stage, with limited treatment options. As such, BTC is associated with poor prognosis, high economic burden and reduced health-related quality of life (HRQoL). As the treatment paradigm is evolving, with multiple immunotherapies showing promise, this study aimed to assess the current disease and treatment landscape. Methods: Systematic literature reviews (Embase, MEDLINE, Cochrane, NHS-EED; database inception to Feb 10, 2023) were conducted for HRQoL and economic burden. Targeted literature reviews (Embase, MEDLINE) were conducted for epidemiology (Jan 01 2017–Feb 06 2023) and treatment guidelines/patterns (Jan 01 2012–Feb 06 2023). Conference abstracts were also searched (2019–2022). Eligibility criteria included global studies (English language) in adults with metastatic and/or unresectable BTC. Results: Overall, 264 studies were included (epidemiology=170, treatment guidelines=14, treatment patterns=50, HRQoL=12, economic burden=18). In the US, Europe and Asia, age-standardized incidence rates were 5.04, 8.39–8.78 and 9.1–10.1 (per 100,000 person-years) and prevalence rates were 0.01%, 0.02–0.34% and 0.02–2.61%, respectively. Treatment pattern studies were mainly from Asia, Europe (n=19 each) and North America (n=10). Gemcitabine [gem]-based chemotherapy was most common in 1L BTC (24–100%) and fluorouracil-based regimens were common in 2L+ BTC (12.3–74.3%). Median overall survival (mOS) for gem-based and fluorouracil-based 1L regimens were 7.7–14.8 months and 7–16.7 months, respectively. Disease progression/toxicity frequently led to treatment discontinuation/dose modifications. In the US, use of non-guideline-based regimens increased by line of therapy (LOT). Among the clinical studies (n=5) reporting HRQoL in 1L, n=4 assessed gem-based combinations. BTC impaired HRQoL domains for anxiety, tiredness (EORTC QLQ-BIL21), work productivity, activity impairment (WPAI scale) and depression (PHQ-9). BTC was associated with substantial economic burden. Mean total all-cause healthcare costs per patient per month (PPPM) increased by LOT (US; 1L: $19,589–25,517, 2L: $22,617–29,721, 3L: $23,256–33,534). US healthcare resource utilization in 1L was driven by outpatient visits (98%), emergency department visits (33–80%) and hospitalization (70–80%). Mean hospital stay ranged from 0.6–7 days PPPM. Conclusions: Epidemiology data varied between Western and Asian populations, but gem-based chemotherapy was identified as the standard of care across regions. There is high unmet need in advanced BTC, as existing options are characterized by poor survival outcomes and considerable economic burden. These findings indicate a need for novel approaches for the management of BTC.

A real-world assessment of healthcare costs associated with agitation in Alzheimer’s dementia

Aims To describe and compare clinical characteristics, healthcare costs, and institutionalization/mortality outcomes among patients with and without agitation associated with Alzheimer’s dementia (AAD). Methods Data from the Reliant Medical Group database (01/01/2016-03/31/2020) were used, including claims, electronic medical records, and clinical information/physician notes abstracted from medical charts. Patients aged ≥55 years with Alzheimer’s dementia (AD) were observed during a randomly selected 12-month study period after AD diagnosis. Using information recorded in medical charts, patients were classified into cohorts based on experiencing (agitation cohort) and not experiencing (no agitation cohort) agitated behaviours during the study period. Entropy balancing was used to create reweighted cohorts with similar characteristics. Study outcomes (patient demographic and clinical characteristics, treatments received, healthcare costs, institutionalization and death events) were compared between cohorts; agitation characteristics were described for the agitation cohort only. Results Among 711 patients included in the study, 240 were classified in the agitation cohort and 471 in the no agitation cohort. After reweighting, several comorbidities were more frequently observed in the agitation versus no agitation cohort, including infection, depression, and altered mental status. Use of antidepressants, anticonvulsants, antipsychotics, and antianxiety medications was more common in the agitation versus no agitation cohort. Common agitated behaviours included hitting (20.8%), pacing/aimless wandering (17.5%), and cursing/verbal aggression (15.0%). Total all-cause healthcare costs were $4287 per-patient-per-year higher in the agitation cohort versus no agitation cohort (p = 0.04), driven by higher inpatient costs. Death was more common and time to death and institutionalization were shorter in the agitation versus no agitation cohort. Limitations Results may not be generalizable to the US population with AD. Conclusions Among patients with AD, agitation was associated with shorter time to death/institutionalization and increased comorbidities, medication use, and healthcare costs, highlighting the additional clinical and economic burden that agitation poses to patients and the healthcare system.

Treatment patterns and economic burden of bacterial vaginosis among commercially insured women in the USA.

Aim: Bacterial vaginosis (BV) is a common vaginal dysbiosis associated with adverse clinical sequelae, most notably, increased risk of sexually transmitted infections (STIs). The aims of this study were to estimate the frequency of BV recurrence, treatment patterns, other gynecological (GYN) conditions, and the associated healthcare resource utilization (HCRU) and costs among commercially insured patients in the USA. Patients & methods: Female patients aged 12-49years with an incident vaginitis diagnosis and ≥1 pharmacy claim for a BV medication (fungal treatment only excluded) were selected from the Merative™ MarketScan commercial database (2017-2020). During a minimum 12-month follow-up, additional treatment courses, treatment patterns, frequency of other GYN conditions, and HCRU and costs were assessed. Generalized linear models were used to identify baseline predictors of total all-cause healthcare costs and number of treatment courses. Results: The study population included 140,826 patients (mean age: 31.5years) with an incident vaginitis diagnosis and ≥1 BV medication claim. During the follow-up, 64.2% had 1 treatment course, 22.0% had 2, 8.1% had 3, and 5.8% had ≥4; 35.8% had a BV recurrence (≥2 BV medication claims). The most commonly prescribed BV medication was oral metronidazole (73.6%). Approximately 12% (n=16,619) of patients had a new diagnosis of another GYN condition in the follow-up; 8.2% had a new STI, which were more common among patients with ≥4 treatment courses (12.9%). During follow-up, total all-cause healthcare costs averaged $8987 per patient per year (PPPY) of which $470 was BV-related. BV-related healthcare costs increased from $403 PPPY among those with 1 treatment course to $806 PPPY among those with ≥4 with nearly half the costs attributed to outpatient office visits. Conclusion: BV recurrence among this population represented a substantial clinical and healthcare economic burden warranting improvements in women's healthcare.

Iron Deficiency Anemia: The Impact of Intravenous Iron Replacement Treatment on Health Care Costs

INTRODUCTION: An estimated 5 million patients in the United States have iron deficiency anemia (IDA). Although most patients with IDA initiate treatment with oral iron therapy, IV iron replacement therapy is often required in patients with chronic inflammatory diseases such as cancer, heart failure (HF) or chronic kidney disease (CKD). The 2022 AHA/ACC/HFSA recommends IV iron as a treatment option for patients with HF with reduced ejection fraction and iron deficiency with or without anemia. There is limited real-world data on the economic value of IV iron treatment. This study examined health care costs for patients treated with ferric carboxymaltose (FCM) and patients treated with low-dose IV iron therapy in the populations with cancer, HF or CKD. METHODS: This study included commercial and Medicare Advantage patients from the Optum Research Database, a large, national United States administrative claims database. Patients were included if they were treated with IV iron therapy from 2017 to 2019; the first treatment date was the index date. Patient were required to have cancer, HF, or CKD in addition to an IDA diagnosis. Continuous enrollment was required for a 6-month baseline and 12-month follow-up period (with patients retained if they had &amp;lt;12 months due to death). Cohorts were classified based on index date treatment: FCM patients received ferric carboxymaltose; low-dose IV iron patients were treated with iron sucrose, iron dextran, or sodium ferric gluconate complex in sucrose. Follow-up all-cause total costs were compared using generalized linear models, and inpatient costs estimated with 2-part models to account for patients with no hospitalizations. Models adjusted for age, gender, geographic region, plan type, index year, comorbidity score, and baseline health care cost. Sensitivity analyses compared FCM with the subgroup treated with iron sucrose. RESULTS: Cancer population: Of 10,763 cancer patients meeting eligibility criteria, 5,892 patients received FCM, and 4,871 patients received low-dose IV iron. Within the low-dose IV iron cohort, 3,040 patients (62%) received iron sucrose. The meanadjusted all-cause total cost was similar between FCM and low-dose IV iron (cost ratio 0.97; p=0.182) and significantly lower for FCM vs. iron sucrose (cost ratio 0.92; p=0.001). Adjusted all-cause inpatient costs for FCM were lower compared to low-dose IV iron due to lower risk of hospitalization (odds ratio 0.79, p&amp;lt;0.001) and reduced inpatient costs if hospitalized (cost ratio 0.88; p&amp;lt;0.001); results were similar versus iron sucrose (p&amp;lt;0.001). HF population: Of 8,337 HF patients, 3,364 patients received FCM, and 4,973 patients received low-dose IV iron therapy. Within the low-dose IV iron cohort, 3,471 patients (70%) received iron sucrose. All-cause total cost for FCM was similar to low-dose IV iron (cost ratio 0.97, p=0.198) but significantly lower for iron sucrose (0.95, p=0.024) during follow-up period. All-cause inpatient cost was also lower for FCM compared to lose-dose IV iron (odds ratio 0.76; cost ratio 0.88; p&amp;lt;0.001) and iron sucrose (odds ratio 0.79; cost ratio 0.85; p&amp;lt;0.001). CKD population: Of 10,617 CKD patients, 4,377 patients received FCM, and 6,240 patients received low-dose IV iron. Within the low-dose IV iron cohort, 4,584 patients (73%) received iron sucrose. During the follow-up period, the mean adjusted all cause total cost was significantly lower for FCM compared to low-dose IV iron (cost ratio 0.94; p=0.006) and iron sucrose (cost ratio 0.93; p=0.004). All-cause inpatient cost was also lower for FCM compared to low-dose IV iron (odds ratio 0.75; cost ratio 0.84; p&amp;lt;0.001) and iron sucrose (odds ratio 0.75; cost ratio 0.89; p&amp;lt;0.001). CONCLUSIONS: Despitethe higher drug acquisition cost ofFCM relative to low-dose IV iron, the drug price differential was offset by lower inpatient cost incurred in the FCM group. This resulted in similar all-cause total health care costs between FCM and low-dose IV iron in cancer and heart failure patients and lower total cost for FCM compared to low-dose IV iron in CKD patients. These results were more pronounced when comparing FCM with iron sucrose; the FCM group consistently had statistically lower total costs than iron sucrose in patients with cancer, HF and CKD. These findings suggest FCM's potential economic benefit in reducing in inpatient utilization and associated costs to patients and health plans than the low-dose IV iron products.

Economic burden and healthcare resource utilization (HRU) associated with cystectomy (CYS) in US patients with muscle invasive bladder cancer (MIBC).

17 Background: CYS is strongly recommended for surgically eligible patients with MIBC following cisplatin-based neoadjuvant chemotherapy and is associated with significant surgery-related complications as well as meaningful health-related quality of life impacts. This study described real-world HRU and costs for patients with MIBC, overall and among those who had a CYS. Methods: Adults with MIBC were selected from de-identified IBM MarketScan Commercial and Medicare Supplemental Databases (1/1/2010-2/28/2021) and Multi-State Medicaid Database (1/1/2010-12/31/2019). The index date was defined as the date of initiation of treatment with systemic therapy, radiotherapy, or CYS (used as proxies to identify MIBC) following the first observed bladder cancer (BC) diagnosis. HRU and costs (in 2021 US dollars) were reported per-patient-per-year (PPPY) from the index date to the earliest of metastatic BC, end of continuous insurance eligibility, or end of data. Results: Among 2,249 patients with MIBC (71% male, mean age 65 years, mean [median] follow up = 21 [13] months), 20.3% (N=456) had a CYS (75% male, mean age 63 years, mean [median] follow up = 24 [17] months). In the overall MIBC population, median all-cause total healthcare costs PPPY were $10,524 in the 12-month pre-index period, and $40,980 in the post-index period (Table) with 32% of total healthcare costs PPPY attributable to BC ($13,284). Post-index median all-cause total healthcare costs PPPY were 2.4 times higher among those with CYS ($97,824) relative to the overall MIBC population, with 67% of costs attributable to BC. Patients with CYS had higher all-cause and BC-related HRU PPPY in both inpatient and outpatient settings than the overall MIBC population (TABLE). In addition to the removal of the bladder, CYS surgeries frequently required alteration of other organ systems including prostate and seminal vesical for male; uterus, ovaries, fallopian tubes, and anterior vaginal wall for female patients. Conclusions: This study demonstrates the significant cost and healthcare resource burden associated with CYS in patients with MIBC and further illustrates the need for effective therapies that leave the bladder intact and avoid surgical removal or alteration of otherwise functional organ systems. [Table: see text]

Characteristics and Disease Burden of Patients With Eosinophilic Granulomatosis With Polyangiitis Initiating Mepolizumab in the United States.

Although the high disease burden associated with eosinophilic granulomatosis with polyangiitis (EGPA) has been established, the disease burden in patients initiating mepolizumab in real-world practice is poorly understood. This study aimed to assess characteristics and burden of real-world patients with EGPA initiating mepolizumab. This was a database study (GSK study ID: 214156) of US patients (≥12 years old) with EGPA and ≥1 mepolizumab claim (index date) identified from the Merative MarketScan Commercial and Medicare Supplemental Databases (November 1, 2015, to March 31, 2020). Outcomes assessed in the 12-month baseline period before index (inclusive) included patient characteristics, treatment use, EGPA relapses, asthma exacerbations, health care resource utilization, and costs. In the 103 patients included (mean age, 51.1 years; 63.1% female), the most common manifestations were asthma (89.3%), chronic sinusitis (57.3%), and allergic rhinitis (43.7%). In total, 91.3% of patients had ≥1 oral corticosteroid (OCS) claim (median dose, 7.4 mg/d prednisone-equivalent), 45.6% were chronic OCS users (≥10 mg/d during the 90 days preindex), 99.0% had ≥1 EGPA-related relapse, and 62.1% ≥1 asthma exacerbation. During the baseline period, 26.2% and 97.1% of patients had EGPA-related inpatient admissions and office visits, respectively. Median all-cause total health care costs per patient were $33,298, with total outpatient costs ($16,452) representing the largest driver. Before initiating mepolizumab, a substantial real-world EGPA disease burden is evident for patients, with resulting impact on health care systems, and indicative of unmet medical needs. Mepolizumab treatment, with a demonstrated positive clinical benefit-risk profile may represent a useful treatment option for reducing EGPA disease burden.

Bacterial Vaginosis Treatment Patterns, Associated Complications, and Health Care Economic Burden of Women With Medicaid Coverage in the United States.

Bacterial vaginosis (BV) is a highly prevalent vaginal infection. Primary objectives of this study were to examine treatment patterns among female patients with Medicaid coverage who were diagnosed with incident BV, the frequency of BV-associated complications, and health care resource utilization (HCRU) and associated costs of incident BV and its recurrence. Secondary objectives were to identify predictors of total all-cause health care costs and number of treatment courses. Female patients aged 12-49 years with an incident vaginitis diagnosis and ≥1 pharmacy claim for a BV medication were selected from the Merative MarketScan Medicaid database (2017-2020). Additional treatment courses were evaluated during a ≥12-month follow-up period, in which new cases of BV-associated complications and HCRU and the associated costs were also measured. Generalized linear models were used to identify baseline predictors of total all-cause health care costs and number of treatment courses. An incident vaginitis diagnosis and ≥1 BV medication claim were present in 114 313 patients (mean age: 28.4 years; 48.6% black). During the follow-up, 56.6% had 1 treatment course, 24.9% had 2, 10.2% had 3, and 8.3% had ≥4; 43.4% had BV recurrence. Oral metronidazole (88.5%) was the most frequently prescribed medication. Nearly 1 in 5 had a new occurrence of a BV-associated complication; most (76.6%) were sexually transmitted infections (STIs). Total all-cause and BV-related costs averaged $5794 and $300, respectively, per patient; both increased among those with more treatment courses. Older age, pregnancy, comorbidity, any STIs, postprocedural gynecological infection (PGI), and infertility were predictive of higher total all-cause health care costs, while race/ethnicity other than white was predictive of lower costs. Older age, black race, any STIs, pelvic inflammatory disease, and PGI were predictive of >1 treatment courses. The high recurrence of BV represents an unmet need in women's health care and better treatments are necessary.

Health care resource utilization and costs among patients with multiple myeloma with exposure to double-class or triple-class multiple myeloma treatments: A retrospective US claims database analysis.

BACKGROUND: Despite recent advancements in the therapeutic landscape, multiple myeloma (MM) remains incurable. There are multiple treatment options available with a novel mechanism of action, but there is limited evidence describing the economic burden among patients with MM exposed to different drug classes and combinations and across different health care settings. OBJECTIVE: To describe all-cause and MM-related health care resource utilization (HCRU) and costs among patients with MM exposed to different drug classes and combinations (ie, double-class and triple-class-exposed) and characterize the economic burden in different health care settings among these patients with MM. METHODS: We conducted a retrospective cohort study using the IBM MarketScan databases. The study included adult patients (aged ≥18 years) diagnosed with MM between December 1, 2015, and December 31, 2019. The study sample comprised double-class-exposed (DCE) and triple-class-exposed (TCE) cohorts, categorized based on their earliest exposure to different combinations of immunomodulatory drugs, proteasome inhibitors, or targeted monoclonal antibody. Patients with at least 1 subsequent line of therapy following the categorization were included, and the start date of the first subsequent line of therapy was the index date. The primary outcomes were all-cause and MM-related HCRU and costs during the follow-up period. Costs were stratified across 8 care settings defined by place of service. The Kaplan-Meier sample average technique was used to estimate the cumulative mean outcomes, accounting for differential follow-up periods. The outcomes were reported as per patient per month (PPPM). 18 years) diagnosed with MM between December 1, 2015, and December 31, 2019. The study sample comprised double-class-exposed (DCE) and triple-class-exposed (TCE) cohorts, categorized based on their earliest exposure to different combinations of immunomodulatory drugs, proteasome inhibitors, or targeted monoclonal antibody. Patients with at least 1 subsequent line of therapy following the categorization were included, and the start date of the first subsequent line of therapy was the index date. The primary outcomes were all-cause and MM-related HCRU and costs during the follow-up period. Costs were stratified across 8 care settings defined by place of service. The Kaplan-Meier sample average technique was used to estimate the cumulative mean outcomes, accounting for differential follow-up periods. The outcomes were reported as per patient per month (PPPM). RESULTS: The study included 1,521 patients with MM, of whom 1,016 (66.8%) were DCE and 505 (33.2%) were TCE. The mean total all-cause health care costs were $20,338 PPPM, and approximately 85% of the total all-cause costs were MM-related. The mean all-cause and MM-related total costs were driven by overall drug costs primarily attributed to MM treatment and administration costs. The TCE cohort was associated with more HCRU and incurred higher costs than the DCE cohort across all categories. The hospital-based ambulatory setting had the highest all-cause and MM-related costs during the follow-up period: $7,302 (95% CI = $6,801-$7,784) PPPM and $6,695 (95% CI = $6,239-$7,136) PPPM, respectively. CONCLUSIONS: The study findings suggest that the economic burden following exposure to multiple drug classes and combinations is substantial, especially among the TCE cohort and in the ambulatory setting. These findings highlight the need for more effective treatments that can mitigate the economic burden of patients with MM. Future research on the HCRU and costs related to recently approved MM treatments with novel mechanisms is warranted. DISCLOSURES: At the time of this study, Dr Yang was a postdoctoral fellow and the fellowship was supported by GSK. Dr Boytsov is a full-time employee of GSK. Dr Carlson discloses consulting fees from Pfizer, AbbVie, and Genentech. Dr Barthold reports no disclosures.

Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens.

Dolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen for HIV-1 treatment with long-term efficacy and good tolerability comparable to 3- or 4-drug regimens. This study evaluated DTG/3TC cost versus other standard single-tablet regimens during its first year of approval. This retrospective study analyzed US claims data from adults with HIV-1. Eligibility criteria included≥1 dispensing of DTG/3TC, DTG/abacavir (ABC)/3TC, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF, and darunavir (DRV)/COBI/FTC/TAF (index date was first dispensing) and≥6months of continuous eligibility before index date (baseline period). All-cause and HIV-related healthcare costs were evaluated during the observation period (index date until earliest of end of continuous eligibility or data availability). Adjusted cost differences and adjusted cost ratios were estimated using multivariable regression models controlling for differences in baseline characteristics between cohorts. Overall, 22,061 individuals with HIV-1 and dispensed treatment with DTG/3TC (n=590), DTG/ABC/3TC (n=4355), BIC/FTC/TAF (n=9068), EVG/COBI/FTC/TAF (n=7081), or DRV/COBI/FTC/TAF (n=967) were included. Most claims data were from men (mean age~46years). Mean unadjusted all-cause total healthcare costs per patient per month were significantly lower for DTG/3TC versus BIC/FTC/TAF and DRV/COBI/FTC/TAF, and mean unadjusted HIV-related healthcare costs per patient per month were significantly lower for DTG/3TC versus DRV/COBI/FTC/TAF. Cost differences were primarily driven by significantly lower pharmacy costs for DTG/3TC versus other regimens (P<0.001), while medical costs were similar across cohorts. Results were similar among treatment-naive and treatment-experienced individuals. After adjusting for baseline covariates, significant adjusted cost differences were generally consistent with unadjusted findings. Adjusted cost ratios generally favored DTG/3TC for all-cause healthcare and HIV-related costs, with all pharmacy cost ratios favoring DTG/3TC (P<0.001). Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.

The burden of ovarian cancer in the USA from 2007 to 2018: evidence from the Medical Expenditure Panel Survey.

Aim: To evaluate the economic and humanistic burden of ovarian cancer in the USA. Methods: Medical Expenditure Panel Survey data (2007-2018) were used to estimate all-cause healthcare resource useand costs for economic burden and examine the activities of daily living and quality-of-life (QoL) measures for humanistic burden between ovarian cancer patients and a non-cancer population. Results: Compared with controls, patients with ovarian cancer had more comorbidities and worse QoL. Their predicted number of annual hospitalizations and office-based visits was significantly higher, as were their estimated annual all-cause total healthcare costs. Total costs were driven by hospitalization costs. Conclusion: The study identified the burden of ovarian cancer and demonstrated that patients with ovarian cancer have greater healthcare resource use, higher costs and worse QoL than the non-cancer population. Future research is needed to develop strategies for managing ovarian cancers and inform decision-making to reduce disease burden.

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

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

Incremental cost burden among patients with severe uncontrolled asthma in the United States.

BACKGROUND: The economic burden of severe asthma and severe uncontrolled asthma (SUA) is significant. Updated assessments of health care resource utilization (HCRU) and cost are needed given the increase in treatment options and updates to guidelines in recent years. OBJECTIVE: To describe all-cause and asthma-related HCRU and costs among patients with SUA vs patients with nonsevere asthma in the United States using real-world data. METHODS: MarketScan administrative claims databases were used to select adults with persistent asthma for this retrospective analysis between January 1, 2013, and December 31, 2019. Asthma severity status was defined using the Global Initiative for Asthma step 4/5 criteria (index is the earliest date qualifying patients as severe or randomly assigned for nonsevere patients). Patients with SUA were a subset of the severe cohort meeting the following criteria: those who were hospitalized with asthma as the primary diagnosis or had at least 2 emergency department or outpatient visits with an asthma diagnosis and a steroid burst within 7 days. HCRU, costs (allcause and asthma-related defined as medical claims with an asthma diagnosis and pharmacy claims for asthma treatment), work loss, and indirect costs due to absenteeism and short-term disability (STD) were compared between patients with SUA, severe, and nonsevere asthma. Outcomes were reported during a fixed 12-month post-index period using chi-square and t-tests where appropriate. RESULTS: 533,172 patients with persistent asthma were identified (41.9% [223,610]) severe and 58.1% [309,562] nonsevere). Of the severe patients, 17.6% (39,380) had SUA. The mean (SD) all-cause total health care costs were significantly higher in patients with SUA ($23,353 [$40,817]) and severe asthma ($18,554 [$36,147]) compared with those with nonsevere asthma ($16,177 [$37,897], P < 0.001 vs nonsevere asthma). The results were consistent for asthma-related costs. In addition, although patients with severe asthma made up 41.9% of the total study population, they contributed disproportionately higher costs (60.5%) to the total asthma-related direct costs, with the effect more evident among patients with SUA (7.4% of study population contributed 17.7% of the total asthma-related costs). For the subset of patients with asthma with workplace absenteeism, patients with SUA lost more time from work (259.3 vs 236.2 hours lost, P = 0.002; 7.8 vs 5.3 STD days, P < 0.001), and had higher corresponding indirect costs ($5,944 vs $5,415, P = 0.002 for absenteeism related; $856 vs $582, P < 0.001 for STD related) compared with patients with nonsevere asthma. CONCLUSIONS: Patients with SUA have significantly higher asthma-related economic burden compared with patients with nonsevere asthma and contribute a disproportionally higher percentage of asthma-related costs. DISCLOSURES: This study was funded by Amgen and AstraZeneca. The design and analysis for this study was conducted primarily by Merative. Amgen and AstraZeneca provided funding to support protocol development, data analysis, and manuscript development activities associated with this study. Dr Burnette is on the advisory board and a consultant for GSK, a consultant and member of the advisory boards and speakers' bureaus of Sanofi, Genzyme, Regeneron, AstraZeneca, and Amgen Inc. Dr Wang, Dr Rane, Dr Lindsley, and Dr Llanos are employees and shareholders of Amgen Inc. Dr Chung and Dr Ambrose are employees and shareholders of AstraZeneca. Ms Princic and Ms Park are employees of Merative, which received funding from Amgen to conduct this study.

Economic and Clinical Burden of Herpes Zoster Among Patients With Inflammatory Bowel Disease in the United States.

Patients with ulcerative colitis (UC) or Crohn's disease (CD) are at increased risk of herpes zoster (HZ); however, relevant cost and healthcare resource utilization (HCRU) data are limited. We estimated HCRU (hospitalization, emergency department [ED], and outpatient visits) and costs in patients with UC or CD, with and without HZ, using administrative claims data (October 2015-February 2020). HCRU and costs (2020 US dollars) were compared at 1 month, 1 quarter, and 1 year after the index date, using propensity score adjustment and generalized linear models. In total, 20 948 patients were included: UC+/HZ+ (n = 431), UC+/HZ- (n = 10 285), CD+/HZ+ (n = 435), and CD+/HZ- (n = 9797). Patients with HZ had higher all-cause HCRU rates and all-cause total healthcare costs relative to those without HZ. In the first month, adjusted incidence rate ratios (aIRRs) for hospitalizations and ED visits for patients with UC and HZ compared with UC alone were 2.87 (95% confidence interval [CI], 1.93-4.27) and 2.66 (95% CI,1.74-4.05), respectively; for those with CD and HZ, aIRRs were 3.34 (95% CI, 2.38-4.70) and 3.31 (95% CI, 2.32-4.71), respectively, compared with CD alone (all P < .001). Adjusted cost differences in UC and CD cohorts with HZ over the first month were $2189 and $3774, respectively, chiefly driven by higher inpatient costs. The incremental impact on HCRU and costs in cohorts with HZ predominantly occurred during the first quarter following diagnosis. HZ is associated with increased HCRU and costs in patients with UC and CD, especially shortly after diagnosis.

Patient Perspectives on the Burden of Heart Failure with Preserved Ejection Fraction in a US Commercially Insured and Medicare Advantage Population: A Survey Study.

Patient-reported health related quality of life (HRQOL) is not routinely assessed in clinical practice. Little is known about health status outcomes reported by patients with heart failure with preserved ejection fraction (HFpEF) in non-clinical trial settings. To better understand patient burden of HFpEF in terms of HF-specific functional and symptom status, HRQOL, healthcare resource utilization (HCRU) and costs in a US-based commercial and Medicare Advantage insured population. We conducted a cross-sectional survey of patients with HFpEF and linked their survey and administrative claims data. Consenting, eligible patients completed a survey that included the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and the PROMIS Global Health-10 (GH-10) questionnaire, as well as clinical and demographic questions. HF medication use, HCRU and costs during the 12-month baseline period before the survey were determined from claims data. Generalized linear regression was used to assess the associations between baseline characteristics and the KCCQ-23 overall summary score. Of 598 survey respondents with survey and claims data, 54.7% were female with mean age 74.0 years. The KCCQ-23 overall summary and clinical summary scores were 64.8 and 63.0, respectively, and the GH-10 physical and mental health summary scores were 39.9 and 45.5. Factors related to lower KCCQ-23 overall summary scores were HF treatment and symptom changes during the past 4-weeks before the survey, hospital admission during the past year, low household income, high comorbidity index, and morbid obesity (BMI>40). Total all-cause healthcare costs were $38,243 during the year prior to the survey, of which 42% were HF-related. Patient-reported outcome measure scores indicated impairment due to HF symptoms and physical limitations in this real-world sample of patients with HFpEF, highlighting a need to assess patient-reported outcomes as well as the clinical and economic outcomes traditionally assessed by clinicians, health systems and payers.

Economic Burden of Fatigue in Inflammatory Bowel Disease.

This retrospective study gathered medical/pharmacy claims data on patients with inflammatory bowel disease (IBD) between January 01, 2000 and March 31, 2019 from the IBM MarketScan commercial claims database to assess the real-world impact of fatigue on healthcare costs in patients newly diagnosed with IBD. Eligible participants were ≥18 years, newly diagnosed with IBD (≥2 separate claims), and had ≥12 months of continuous database enrollment before and after fatigue diagnosis. The date of fatigue diagnosis was the index date; participants were followed for 12 months post-index. Patients with (cases) or without (controls) fatigue were matched 1:1 by propensity score matching. Patients with evidence of prior IBD diagnosis/treatment, or those with a chronic disease other than IBD wherein fatigue is the primary symptom, were excluded. Healthcare resource utilization (HCRU), including hospitalizations, inpatient and outpatient visits, and associated costs were compared between cases and controls. Matched IBD cohorts (21 321 cases/21 321 controls) were identified (42% Crohn's disease [CD] and 58% ulcerative colitis [UC]) with similar baseline characteristics (average age: 46 years; 60% female). Cases versus controls had significantly more all-cause outpatient visits (incidence rate ratio [IRR], 95% confidence intervals [95% CI]: 1.64 [1.61, 1.67], P < .001) and all-cause hospitalizations (IRR [95% CI]: 1.92 [1.81, 2.04], P < .001); as well as significantly higher all-cause total direct healthcare costs (mean: $24 620 vs. $15 324; P < .001). Similar findings were observed for IBD-related outcomes, as well as in CD- and UC-specific subgroups. Presence of fatigue is associated with an increase in HCRU and total medical costs among patients newly diagnosed with IBD.

Comparing the burden of illness in patients with alopecia areata vs atopic dermatitis in the US population from a payer perspective.

BACKGROUND: Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. AA frequently co-occurs with other inflammatory autoimmune conditions, presenting a significant clinical burden. OBJECTIVE: To compare the burden of illness, direct and indirect costs in adult patients with AA vs atopic dermatitis (AD). METHODS: This retrospective cohort study used US administrative claims data from the Merative MarketScan Commercial Claims and Encounters Database to compare commercially insured adults with AA to those with AD. Patients with an AA diagnosis between January 2017 and September 2019 were propensity score matched to patients with AD. Comorbidity burden, medication use, health care resource utilization, health care costs, and indirect costs during a 12-month follow-up period were compared between cohorts. RESULTS: Overall, 25,446 adult patients with AA were selected for the matched analysis with the AD cohort. Patients with AA generally had lower comorbidity burden than patients with AD; mean Deyo-Charlson Comorbidity Index scores were 0.36 (SD = 0.99) and 0.39 (SD = 0.92), for AA and AD, respectively (P = 0.007). Patients with AA had significantly lower proportions of allergic rhinitis, asthma, pruritus, skin infections, and urticaria, but higher proportions of thyroid disease, when compared with patients with AD (all P < 0.001). A smaller proportion of patients with AA had prescriptions for topical (45.3% vs 64.8%; P < 0.001) and oral (20.3% vs 29.6%; P < 0.001) corticosteroids and antianxiety and/or antidepressants (24.7% vs 29.7%; P < 0.001), but a significantly larger proportion for intralesional corticosteroids (triamcinolone) (49.6% vs 21.7%; P < 0.001), compared with patients with AD. Despite a lower comorbidity burden and generally less medication usage in patients with AA, total all-cause health care costs did not significantly differ between the AA and AD cohorts ($10,705 vs $10,816; P = 0.712), and outpatient costs were higher in patients with AA ($6,297 vs $5,859; P = 0.014). Female patients with AA had significantly greater costs for both outpatient and outpatient pharmacy when compared with female patients with AD. Patients with AA were more likely to have a claim for long-term disability (0.6% vs 0.3%; P = 0.001) and higher long-term disability-associated indirect costs ($73 [SD = $1,442] vs $25 [SD = $774]; P = 0.004) compared with patients with AD. CONCLUSIONS: We found similar total health care costs in patients with AA and AD, despite a lower proportion of comorbidities and prescription use in patients with AA. Outpatient costs were also significantly higher overall in patients with AA. Although often dismissed as a cosmetic condition, AA, an autoimmune disease, has a similar level of medical expenditure as AD. DISCLOSURES: This study was funded by Eli Lilly and Company. Mr Fenske and Drs Ding, Morrow, and Smith are employed by Eli Lilly and Company. Drs Manjelievskaia, Moynihan, and Silver are employed by Merative. Drs Manjelievskaia, Moynihan, and Silver were employed by IBM Watson Health at the time of study completion. IBM Watson Health received funding from Eli Lilly and Company to conduct this study.

Work Loss and Direct and Indirect Costs Associated with Parkinson's Disease.

To examine work loss and indirect costs during the three-year periods prior to and following initial diagnosis of Parkinson's disease (PD) in patients and in spouses of PD patients, as well as direct costs of healthcare. This is a retrospective, observational cohort study using the MarketScan Commercial and Health and Productivity Management databases. A total of 286 employed PD patients and 153 employed spouses met all diagnostic and enrollment criteria for short-term disability (STD) analysis (PD Patient cohort and Caregiving Spouse cohort). The proportion of PD patients having a STD claim increased from roughly 5% and plateaued at around 12-14% starting in the year prior to first diagnosis of PD. The mean number of days lost from work due to STD per year increased from 1.4 days in the 3rd year prior to diagnosis to 8.6 days in the 3rd year after diagnosis (corresponding to an increase in indirect costs from $174 to $1104). STD use for spouses of patients with PD was lowest in the year after their spouses were diagnosed and then rose dramatically in the 2nd and 3rd years after the spouse's diagnosis. Total all-cause direct health-care costs increased during the years leading up to PD diagnosis and were highest in the years following diagnosis, with PD-related costs contributing ~20-30% of the total. PD has both a significant direct and indirect financial burden on patients and their spouses when analyzed for 3 years before and after diagnosis.

Clinical and Economic Burden of Systemic Lupus Erythematosus in the Years Preceding End-Stage Kidney Disease Diagnosis: A Retrospective Observational Study.

This study aimed to describe the clinical burden, healthcare resource utilisation (HCRU) and healthcare costs for patients with systemic lupus erythematosus (SLE) in the 12-60months preceding an end-stage kidney disease (ESKD) diagnosis in the USA. This retrospective observational study identified adult patients with SLE with newly diagnosed ESKD between 1March 2012 and 31December 2018 using administrative claims data. Clinical characteristics, mean all-cause HCRU (i.e. any HCRU visit and pharmacy fill) and total all-cause healthcare costs (comprising medical and pharmacy costs in 2019 US dollars) were assessed during the 12months pre-ESKD diagnosis and yearly during the 5years pre-ESKD diagnosis among patients with ≥ 5years of continuous health plan enrolment. Of the 1356 patients included, 51.2% had severe SLE, 71.2% had lupus nephritis (LN) and 20.6% underwent kidney biopsy during the 12months pre-ESKD. The mean (standard deviation [SD]) number of HCRU visits during the 12months pre-ESKD was 78.0 (64.1) per patient. The mean (SD) total healthcare costs per patient in the 12months pre-ESKD diagnosis was $64,887 (106,822), driven by medical costs $51,764 (96,458). The proportions of patients with severe SLE, LN and those undergoing biopsy increased from year5 to year1 pre-ESKD diagnosis. The mean (SD) number of HCRU visits increased from year5 (61.6 [54.0]) to year1 (83.2 [62.1]) pre-ESKD. Mean (SD)total healthcare costs rose year on year from year5 ($34,890 [74,346]) to year1 ($73,236 [114,584]) pre-ESKD. There were substantial clinical burden and healthcare costs among patients with SLE in the 12months pre-ESKD diagnosis. The clinical burden and healthcare costs generally increased with each year approaching ESKD diagnosis. Early interventions for patients with SLE could prevent the development of ESKD, mitigating the burden of the disease.