Comment on: Real-world quality of life and healthcare resource utilization in patients with metabolic dysfunction-associated steatohepatitis - Circular definition of CVRM comorbidities undermines the validity of core subgroup comparisons.

ABSTRACTObjective: To understand the impact of anemia on health-related quality of life (HRQOL) and healthcare resource utilization (HRU) in patients with HIV/AIDS.Methods: In 2003, adults with HIV/AIDS were recruited through 114 US STD/HIV clinics to complete self-administered questionnaires. Adults reporting anemia as a side-effect of antiretroviral therapy (ART) during the past month were considered anemic. HRU was evaluated by emergency room (ER) visits, days of hospitalization, and healthcare provider visits in the past 6 months. The SF‑8 was used to measure HRQOL. Linear regression was used to evaluate independent effects of anemia on HRQOL and HRU controlling for demographics, years since HIV diagnosis, HIV viral load, CD4+ count, and ART use.Results: 2044 patients were enrolled, with 498 (24%) experiencing anemia. Anemic patients had lower SF‑8 summary scores (mental: 38.2 ± 11.6 vs. 42.9 ± 11.9, p < 0.001; physical: 40.1 ± 10.0 vs. 45.5 ± 10.4, p < 0.001) than nonanemic patients. HRU in the anemic group was significantly higher ( p < 0.05), with respect to percentage of patients visiting ER, mean number of ER visits, mean number of days hospitalized, and mean number of total visits to providers. In linear regression models, anemic patients had mental and physical HRQOL scores more than 4 points lower than nonanemic patients ( p < 0.001 for both). Additionally, anemic patients had 2.7 more visits to healthcare providers ( p < 0.001).Limitations: Data were cross-sectional, self-reported by patients, and did not include clinical measures of anemia.Conclusion: Based on this survey, self-reported anemia appears to be associated with worsened HRQOL and greater HRU among HIV/AIDS patients using ART.

The primary objective of this study is to explore the potential link between the utilization of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) and its impact on mortality, disease severity, and healthcare resource utilization in individuals diagnosed with COVID-19. We aim to establish a solid theoretical foundation for safe and effective clinical medications. We conducted a comprehensive search of various databases, including CNKI, PubMed, Science, Cell, Springer, Nature, Web of Science, and Embase. We also traced the literature of the included studies to ensure a thorough analysis of the available evidence. After applying a set of inclusion and exclusion criteria, we ultimately included a total of 41 articles in our analysis. To determine the overall effect size for dichotomous variables, we used the Mantel-Haenszel odds ratio in random effect models. For continuous variables, we calculated the inverse variance SMD using random effect models. To assess the outcomes and heterogeneity, we considered p-values (p < 0.05) and I2 values for all outcomes. We performed multivariate and univariate meta-regression analyses using the maximum likelihood approach with the CMA 3.0 software. The results of our analysis indicated that the use of ACEIs or ARBs did not significantly influence mortality (OR = 1.10, 95% CI 0.83-1.46, p = 0.43, I2 = 84%), severity (OR = 0.99, 95% CI 0.68-1.45, p = 0.98, I2 = 84%), or healthcare resource utilization (SMD = 0.03, 95% CI 0.06-0.12, p = 0.54, I2 = 37%) in patients with COVID-19 compared to those not taking ACEIs or ARBs. The multivariate meta-regression analysis model explained 63%, 31%, and 100% of the sources of heterogeneity for the three outcome indicators. The use of ACEIs and ARBs is not significantly correlated with mortality, severity, or healthcare resource utilization in patients with COVID-19, indicating safe clinical use of the medications.

Diastolic dysfunction (DD) is often linked to the development and persistence of atrial fibrillation (AF), but its impact on healthcare resource utilization (HCRU) in patients with or without AF is unclear. Patients who received a transthoracic echocardiogram at our institution between 2010 and 2022 were included. DD was derived from the echocardiogram reports. HCRU included cardiac interventional, structural, surgical, and electrophysiology procedures, as well as diagnostic monitoring and imaging tests. A cohort of 157,043 patients (mean age 58±18years, 55% women, 88% White, 9% with AF, 23% with DD, LVEF 56±8%, BMI 30±8kg/m2) was retrospectively analyzed. The presence and severity of DD is associated with a proportional increase in HCRU, calculated as the mean annual number of cardiac procedures per year. For patients with no AF, the HRCU was 0.60±1.02 in patients with no DD versus 0.93±1.39 in those with any grade of DD (p<0.001). Similar findings were seen in patients with AF (HCRU 1.08±1.40 vs. 1.27±1.64, in patients without versus with DD, p<0.001). At lower grades of DD, the presence of AF is associated with higher HCRU, but this difference dissipates in patients with grade III DD (1.77±2.37 vs. 1.67±2.15, p=0.42). DD is associated with higher HCRU in patients with or without AF. DD significantly increases HCRU which is higher in the presence of AF. These data emphasize the real-world impact of DD on HCRU and highlight the need to prioritize DD diagnosis and treatment to improve patients' health and reduce cost.

FRI0359 Treatment Patterns and Healthcare Resource Utilization Among Patients with Psoriatic Disease in a Large National Claims Database

Aims: Muscle weakness (MW)-attributable healthcare resource utilization (HCRU) and costs in patients with chronic obstructive pulmonary disease (COPD) have not been well-characterized in US insurance claims databases. The primary objective of this study was to estimate HCRU in patients with evidence of COPD with and without MW diagnosis codes.Materials and methods: This retrospective analysis used the MarketScan® Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. Between January 2007 and March 2016, we identified patients aged ≥40 years with diagnosis codes for COPD (≥1 emergency department or inpatient claim or ≥2 outpatient claims within 1 year). The cohort was divided into patients with and without ≥1 MW diagnosis code. Propensity score matching was used to generate pairs of patients with and without MW (1:1). Multivariable regression analyses were used to estimate adjusted incremental costs and utilization attributable to the presence of MW diagnosis codes among patients with COPD.Results: Of 427,131 patients who met the study inclusion criteria, 14% had evidence of MW. After matching, 107,420 unique patients remained equally distributed across MW status. Patients with MW diagnosis codes had greater predicted annual HCRU, $2,465 greater total predicted annual COPD-related costs, and $15,179 greater total all-cause costs than those without MW diagnosis codes. Overall, <1% of patients received COPD-related pulmonary rehabilitation services.Limitations: Study limitations include the potential for undercoding of MW and lack of information on severity of MW in claims data.Conclusion: The presence of MW diagnosis codes yielded higher HCRU in this COPD population and suggests that the burden of MW affects both all-cause and COPD-related care. However, utilization of pulmonary rehabilitation, a known effective treatment for MW, remains low. Future research should expand on our results by assessing data sources that allow for clinical confirmation of MW among patients with COPD.

Aim: To compare oral corticosteroid (OCS) burden and healthcare resource utilization (HCRU) in patients with chronic rhinosinusitis with nasal polyps undergoing functional endoscopic sinus surgery (FESS; intervention) versus not undergoing FESS. Materials & methods: Retrospective cohort study using US claims data (Optum's de-identified Clinformatics® Data Mart Database; 2011-2021). Groups were propensity score (PS) matched to adjust for confounding. OCS burden (cumulative dose in mg prednisone equivalents) and HCRU were assessed during baseline (365days pre-index), intervention (days 0-44), and follow-up (days 45-365); costs during intervention and follow-up. Results: Before PS-matching, both groups had substantial comorbidity burden (>50% allergic rhinitis; >25% asthma) and over half of patients had used OCS (65% [FESS] vs 52% [non-FESS]; p<0.01). After PS-matching (n=8909 per group), OCS cumulative dose during follow-up was 18% lower among FESS versus non-FESS patients (mean difference: -40mg per patient [95% CI: -57, -23; p<0.01]). Similar proportions of patients filled OCS prescriptions during follow-up (35% [FESS], 36% [non-FESS]) and in these patients, OCS burden remained high (mean [SD] cumulative dose 521 [786] vs 612 [906] mg, respectively). Mean total healthcare costs per patient during the intervention period were $28,832 (FESS) and $2537 (non-FESS), but similar during follow-up ($15,659 and $15,926, respectively). HCRU was similar in follow-up, except more FESS patients visited an otolaryngologist (57% vs 32%, p<0.01). Conclusion: In US clinical practice, OCS burden in patients with chronic rhinosinusitis with nasal polyps was significantly lower but remained substantial following FESS, and HCRU and costs during follow-up were similar to matched patients without FESS.

Real-world evidence on the effectiveness of mepolizumab at reducing healthcare resource utilization (HCRU) and clinical symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) is limited. This real-world study used linked electronic medical record and claims data from the OM1 Real-World Data Cloud of clinician networks in the US, including an ear, nose and throat physician registry. CRSwNP-related HCRU, procedures, concomitant medications, and sign and symptom outcomes were assessed in adult patients with CRSwNP who initiated mepolizumab on/after July 29, 2021 (index date), with ≥1 mepolizumab record, data available for ≥12 months pre- and ≥6 months post-index (follow-up/post-mepolizumab period). There was a significant difference in CRSwNP-related HCRU 6-months post- versus pre-mepolizumab initiation (N = 245), mean difference in outpatient visits (95% confidence interval): -0.82(-1.10, -0.53), p < 0.0001; otolaryngologist visits: -0.35(-0.54, -0.16), p = 0.0004; allergist visits: -0.28(-0.43, -0.14), p = 0.0001. Similar reductions were observed for all-cause HCRU. At 6-months post-mepolizumab, proportion of patients with oral corticosteroid and oral antibiotic prescriptions substantially reduced (36% pre- vs. 27% post-; and 38% pre- vs. 23% post-, respectively). There were clinically meaningful improvements in symptoms recorded 6-months post- versus pre-mepolizumab, with fewer patients experiencing anosmia (-53%), facial pain/pressure (-35%), nasal discharge (-32%) and nasal obstruction (-29%). In real-world practice, mepolizumab is associated with reduced HCRU and improved clinical symptoms, potentially alleviating medication burden in patients with CRSwNP. These results indicate, beyond improvements shown in randomized controlled trials, mepolizumab may reduce HCRU disease burden as early as 6-months post-initiation. This study offers real-world insight that may support clinical decision-making with mepolizumab.

Aims: Treatment of acute myeloid leukemia (AML) requires significant healthcare resource utilization (HRU), including lengthy hospitalizations. In a phase 3 study (NCT01696084), CPX-351 (Vyxeos) showed significant benefits to overall survival and complete remission versus conventional 7 + 3 cytarabine/daunorubicin. This analysis evaluated HRU in patients aged 60–75 years with newly diagnosed high-risk/secondary AML treated with CPX-351 versus 7 + 3 in the phase 3 study.Materials and methods: Patients were randomized to receive up to two induction cycles with CPX-351 or 7 + 3. Responders could receive up to two cycles of consolidation. To normalize HRU to length of treatment, patients were assessed on a per patient-year (PPY) basis. HRU analyses included hospital and intensive care unit (ICU) stays, anti-infective use, transfusions, and white blood cell colony-stimulating factor (CSF).Results: The median (range) total duration of hospitalization was 39 (3–110) days with CPX-351 (n = 153) and 32 (2–83) days with 7 + 3 (n = 151); the estimated durations of hospitalization PPY were 198.4 and 240.5 days, respectively. The median (range) total duration of ICU stays was 0 (0–45) days with CPX-351 and 0 (0–17) days with 7 + 3; the estimated durations of ICU stays PPY were 6.7 and 10.5 days, respectively. When comparing supportive care use during CPX-351 and 7 + 3 treatment, the estimated number PPY of bags of platelets used (24.6 vs 26.9, respectively), bags of packed red blood cells used (13.0 vs 13.9), days of anti-infectives (162.0 vs 159.2), and days of CSF (4.0 vs 2.4) were not notably different.Limitations: This clinical study analysis may not represent real-world HRU patterns or be generalizable to a broader AML population.Conclusions: These PPY data, showing shorter durations of hospitalization and similar use of supportive care with CPX-351 versus 7 + 3, suggest CPX-351 is not associated with increased HRU in older patients with newly diagnosed high-risk/secondary AML.

Few studies have assessed healthcare resource utilization (HRU) in patients with Philadelphia‐negative myeloproliferative neoplasms (MPN) using a matched cohort design. Further, no detailed assessment of HRU in the years preceding an MPN diagnosis exists. We conducted a registry‐based nationwide Danish cohort study, including patients with essential thrombocythemia, polycythemia vera, myelofibrosis, and unclassifiable MPN diagnosed between January 2010 and December 2016. HRU data were summarized annually from 2 years before MPN diagnosis until emigration, death, or end of study (December 2017). We included 3342 MPN patients and 32 737 comparisons without an MPN diagnosis, matched on sex, age, region of residence, and level of education. During the study period, the difference in HRU (rate ratio) between patients and matched comparisons ranged from 1.0 to 1.5 for general practitioner contacts, 0.9 to 2.2 for hospitalizations, 0.9 to 3.8 for inpatient days, 1.0 to 4.0 for outpatient visits, 1.3 to 2.1 for emergency department visits, and 1.0 to 4.1 for treatments/examinations. In conclusion, MPN patients had overall higher HRU than the matched comparisons throughout the follow‐up period (maximum 8 years). Further, MPN patients had substantially increased HRU in both the primary and secondary healthcare sector in the 2 years preceding the diagnosis.

Hypophosphatasia (HPP) is a rare, inherited, systemic disease characterized by skeletal and systemic manifestations. Asfotase alfa (AA) is the only US Food and Drug Administration-approved treatment for perinatal/infantile- and juvenile-onset HPP. Real-world data are scarce on fracture rates and healthcare resource utilization (HCRU) in patients treated with AA. This retrospective, observational study evaluated fracture-related outcomes and HCRU in patients with HPP treated with AA from January 2016 to December 2022 using the US Medicare Fee-for-Service and Inovalon Medical Outcomes Research for Effectiveness and Economics closed claims databases. Patients (≥2 yr of age) treated with AA (≥1 pharmacy claim for AA between January 2017 and December 2021 [identification period]) and ≥12 mo of continuous enrollment with medical and pharmacy coverage pre- and post-AA initiation were included. Clinical outcomes (change in fractures, types of fractures, and fracture event rates) and HCRU were assessed. Statistical analyses were performed to compare outcomes before and after initiation of AA. One hundred forty-nine patients (65.1% females, 69.1% adults; mean age, 39.6 yr) met the inclusion criteria. The proportion of patients experiencing fractures in the 12 mo following AA initiation significantly decreased compared to the 12 mo prior to treatment (18.1% vs 8.1%; p = .004). The mean fracture rate per patient per year nominally decreased post-AA initiation (0.24 vs 0.14; p = .096). The decrease was significant in fragility fracture rates (0.08 vs 0.02; p = .019). Most prescribed concomitant drugs at baseline were opioid analgesics (36.9%), nonopioid analgesics (34.2%), and antidepressants (34.9%). At baseline, 38.2% of patients were continuously using opioids and 21.8% were using high-dose opioids. Asfotase alfa initiation was associated with a statistically significant reduction in the proportion of patients experiencing fractures and fragility fracture rates, underscoring its potential therapeutic benefits.

Aims To analyze secondary objectives of the REGAIN study related to acute headache medication use and healthcare resource utilization (HCRU) in patients with chronic migraine treated with galcanezumab, a monoclonal antibody to calcitonin gene-related peptide. Methods Adults with chronic migraine (N = 1,113) were randomized (2:1:1) and treated with double-blind monthly injections of placebo, galcanezumab-120 mg, or galcanenzumab-240 mg for 3 months, followed by a 9-month open-label extension with 120 or 240 mg/month galcanezumab. Headache and medication information was collected by daily eDiary. HCRU was reported for the 6 months before randomization, monthly thereafter, and converted to rate per 100-patient-years. Results At baseline, 63–64% of patients met criteria for acute headache medication overuse. At Month 3, incidence of headache medication overuse in the galcanezumab groups (33% and 33%) was significantly lower than in the placebo group (46%, both p < .001) and was 16% and 23% in the previous-galcanezumab groups at Month 12. From a baseline of 14.5 to 15.5, reduction in mean number of monthly migraine headache days with acute headache medication use was also significantly greater in the galcanezumab groups at Month 3 (−4.2 and −4.9) than in placebo (−2.6, both p < .001), with reductions of −6.8 and −7.6 in the previous-galcanezumab groups at Month 12. Migraine-specific HCRU rates decreased for all groups, with no significant between-group differences at Month 3. At Month 12, in the two previous-galcanezumab groups, emergency room visits decreased by 58% and 75%, hospital admissions by 100%, and healthcare professional visits by 54% and 67%. Limitations Only 3 months of double-blind, placebo-controlled data, a longer HCRU recall period for baseline than postbaseline, and patients receiving care in the clinical trial itself, may limit generalizability. Conclusions Treatment with galcanezumab resulted in significant reductions in headache medication overuse and migraine headache days requiring acute medication use, with notable reductions in migraine-specific HCRU.

Refractory chronic cough (RCC) significantly impairs patient quality of life and poses a major challenge in clinical management. However, little is known about the healthcare resource utilization (HRU) of patients with RCC. The goal of our study is to describe the HRU and associated costs of RCC patients and those with non-refractory chronic cough (non-RCC). Patients with chronic cough were prospectively recruited from 6 centers in France. At 6months, the patients were classified as having RCC or no RCC. A retrospective analysis was made using the French National Health Insurance Database (SNDS) in order to determine healthcare utilization for the one-year period preceding inclusion at the site and for the one-year period thereafter. Sixty-eight patients were included. Among them, 32 (47%) patients had RCC. There was no difference between groups regarding clinical data apart from cough duration (56.8 ± 59.5months in the no RCC group vs. 139.3 ± 123.8months in the RCC group, p = 0.002). Within 1year prior to inclusion, there was no difference in terms of drug dispensations between the 2 groups. During the 1-year post-inclusion period, a significantly higher proportion of patients with RCC received at least one dispensation of opioids and amitriptyline compared to those with no RCC (8 (25%) vs. 2 (6%) for opioids, p = 0.038 and 14 (44%) vs. 3 (8%) for amitriptyline, p = 0.0015, respectively). Within 1year after inclusion, more patients with RCC had attended speech pathologist visits in comparison to patients with no RCC (14 (44%) patients vs. 10 (28%) patients, p = 0.21, respectively). Total costs within 12months prior to inclusion were 3,878€ [2,498 - 5,755€] for patients with no RCC and 5,159€ [3,426 - 7,138€] with RCC, but the difference was not significant. No change occurred in the 1-year period following inclusion. RCC has a high healthcare utilization with substantial costs.

e16046 Background: Advanced prostate cancer often leads to the development of BM and as a result SREs. Treatment and management of SREs, as well as the underlying disease, influences the patient’s HRQoL and HRU. We evaluated the impact of SREs on HRQoL (FACT-P) and HRU in patients with BM. Methods: Data were extracted from the Adelphi Prostate Cancer Disease-Specific Programme (DSP), a cross-sectional survey of 150 urologists and oncologists and their prostate cancer patients conducted from March to June 2012 in the US. Each specialist completed comprehensive record forms on 12 of their patients being treated for prostate cancer. Patients were invited to complete a questionnaire, which included the FACT-P HRQoL instrument. Patients were stratified by SRE experience to assess the impact of SRE on patients with BM. SRE was defined as an event of bone radiation, bone surgery, fracture, or spinal cord compression. Results: Data were collected from 1,749 prostate cancer patients, of which 941 were identified with BM; SRE status was recorded in 499 BM patients (Table). HRQoL was significantly lower in patients experiencing SREs, while the rate of consultations and likelihood of being hospitalized was significantly higher. Conclusions: SREs result in a significant economic burden on the healthcare system and negative impact on HRQoL in prostate cancer patients with BM. [Table: see text]

Objectives To summarize healthcare resource utilization (HCRU) in patients with newly diagnosed (incident) paroxysmal or persistent atrial fibrillation (AF). Methods This retrospective, observational cohort study assessed HCRU among patients with incident paroxysmal or persistent AF using data from 1 January 2015 to 30 September 2019 in the IBM MarketScan® Research Databases. Results A total of 50,796 patients were identified in the overall incident AF cohort. Rates of all-cause inpatient hospital stays, all-cause emergency room visits, and all-cause outpatient visits in the overall incident cohort were 46.8, 114.7, and 2,752.7 events per 100 patient-years (PY), respectively. Rates of cardiovascular-related inpatient stays for the overall population were 11.3 events per 100 PY. During follow-up, 50.4% of the overall cohort filled prescriptions for direct-acting oral anticoagulants and 5.0% had catheter ablation. Conclusions Advances in anticoagulation and ablation have been realized since previously published HCRU analyses of patients with atrial fibrillation. This update suggests that HCRU among patients with incident AF in the US remains high with some subgroups of patients receiving more specialized care.

Objective This study compared the healthcare resource utilization (HRU) of patients with lower-risk myelodysplastic syndromes (LR-MDS) treated with luspatercept versus erythropoiesis-stimulating agents (ESAs). Methods This real-world retrospective cohort study used claims data from the Symphony Health Integrated Dataverse, a large nationally representative United States database, to identify patients with LR-MDS who initiated luspatercept or ESA between May 1, 2020, and June 30, 2022. Index date was defined as the date of the first claim for luspatercept or ESA. The follow-up period was from the index date to the earliest of the end of clinical activity or end of data availability. All-cause and MDS-related HRU were evaluated for both treatment cohorts and compared using generalized estimating equations with Poisson distribution and robust variance estimator. Results Overall, 243 and 3,515 patients were included in the luspatercept and ESA cohorts, respectively. Patients in both cohorts had a similar median (interquartile range [IQR]) age at index (luspatercept: 77.0 [70.0–79.0] years; ESA: 78.0 [72.0–79.0] years) and median (IQR) follow-up duration (luspatercept: 14.6 [10.4–22.6] months; ESA: 14.4 [9.5–20.9] months). Compared with patients treated with ESA, patients treated with luspatercept had a 26% lower rate of all-cause inpatient visits (adjusted incidence rate ratio [aIRR], 0.74; 95% confidence interval [CI], 0.58–0.93; p < .05) and a 31% lower rate of all-cause outpatient visits (aIRR, 0.69; 95% CI, 0.61–0.79; p < .001). The rate of MDS-related inpatient visits was also 25% lower among the patients treated with luspatercept versus ESA (aIRR, 0.75; 95% CI, 0.56–0.99; p < .05). Conclusion This study showed that patients with LR-MDS treated with luspatercept required significantly less HRU than patients treated with ESA. Further research is warranted to evaluate the financial impact of this lower HRU burden.