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Background: Recent real-world studies revealed high proportions of patients with metastatic urothelial cancer (mUC) do not receive any systemic therapy. This study describes the demographics, clinical characteristics, treatment rate and related predictive factors, healthcare resource utilization, and direct medical costs of patients with mUC receiving systemic therapy (or not) in the inpatient setting in Italy. Methods: This retrospective observational study used the national hospital discharge database (Scheda di Dimissione Ospedaliera) to describe incident adult (≥ 18 years) patients with a first hospitalization for mUC (index) from 2017-2018, identified by a combination of ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification), medical procedure, and diagnosis-related group codes. A model was fitted to identify factors associated with receiving inpatient chemotherapy and/or radiotherapy. Results: Of 3674 patients with mUC identified, 1014 (27.6%) were treated with inpatient chemotherapy and/or radiotherapy and 2660 (72.4%) were not treated. The median age at index was 71 and 78 years for treated and untreated patients, and the mean (SD) Charlson Comorbidity Index (CCI) score was 0.3 (0.8) and 0.6 (1.1), respectively. Primary tumor location was the bladder in 87.2% of patients. Cardiovascular disease and renal function impairment were more prevalent in untreated (22.6% and 13.2%) vs treated (16.7% and 7.8%) patients. Older age (odds ratio [p-value]) (0.94 [< 0.001]), female sex (0.82 [0.035]), and higher CCI score (0.82 [< 0.001]) were all associated with a lower likelihood of receiving inpatient systemic treatment. The first year was the costliest: estimated national projected costs during the 36-month follow-up from first hospitalization for mUC were €34.3 million (95% CI, €30.3-€60.0 million) and €31.8 million (95% CI, €28.1-€56.0 million) when estimated after 1 year. Conclusions: Our findings indicate a low rate of inpatient systemic therapy for patients with mUC in Italy (driven by older age, female sex, and high comorbidity burden), with a large economic burden despite a high nontreatment rate. Although this study provides a partial capture of the treatment pathway in Italy, the results are consistent with other European studies with similar designs and highlight the need to better identify the reasons for not administering inpatient systemic chemotherapy and/or radiotherapy. [ABSTRACT FROM AUTHOR]

While PTSD is commonly associated with multiple comorbidities, studies have yet to quantify the impact of these comorbidities on key clinical outcomes and HCRU. This study explored risks of emergency room (ER) visits, inpatient admissions (IA), suicidal ideation (SI), and treatment follow-up duration (FU), amongst PTSD patients with comorbid MDD and/or SUD. Using real-world data (RWD) generated by electronic health records accessed from the NeuroBlu database, a cohort of adolescent patients (12-17 yrs) was examined over a one-year study period following PTSD diagnosis. 5794 patients were included in the cohort. Compared to patients with only PTSD (n = 3061), those with comorbid MDD (n = 1820) had greater odds of ER (4.5 times), IA (1.6 times), and FU (4.3 times). Those with comorbid SUD (n = 653) had greater odds of IA (4.5 times), shorter FU (34 days), and lower odds of ER (0.5 times). Both comorbidities (n = 260) had greater odds of ER (3.8 times), IA (2.6 times), SI (3.6 times), and shorter FU (12 days). These RWD had a high proportion of missingness. Health records of patients who changed service providers could not be accounted for in this study. Both MDD and SUD substantially elevated the risk of HCRU and suicidal ideation for PTSD patients. • Limited literature studying the cumulative effects of major depressive disorder (MDD) and substance use disorder (SUD) on adolescents diagnosed with PTSD. • Comorbid MDD and SUD was respectively present in 31 % and 11 % of the 5794 adolescents diagnosed with PTSD. • Minimally, the odds of inpatient admission is at least 40 % higher in patients with comorbid MDD or SUD present, with the odds of patients with comorbid SUD being admitted to the hospital being 4.5 times higher than those with PTSD only. • Patients with both MDD and SUD were not observed to develop worse outcomes. • Screening for comorbid MDD and SUD may substantially improve prognosis of PTSD in adolescents. [ABSTRACT FROM AUTHOR]

Background: Moderate to severe (M2S) atopic dermatitis (AD) is a chronic condition impacting individuals, society, and healthcare systems. Considering the changing M2S-AD treatment landscape, this study assesses the M2S-AD burden in patients reaching referral centers in Greece. Methods: This was a multicenter, cross-sectional study. Patients aged 12 years or older with clinically diagnosed M2S-AD were enrolled. Data collected included clinical practice assessments and the following validated patient-reported instruments: Dermatology Life Quality Index (DLQI); EuroQol-5 Dimensions-3 Level scale (EQ-5D-3L); Patient Oriented Eczema Measure (POEM); Peak Pruritus Numerical Rating Scale (PP-NRS); and Work Productivity and Activity Impairment: General Health (WPAI:GH). A pain frequency/intensity/cause questionnaire and a sleep disturbance scale were also used. Results: Outcomes of 184 adults (51.1% female) with M2S-AD based on the Eczema Area and Severity Index (EASI) are presented (n = 117 moderate; n = 67 severe). Among the patients, 14.8% were obese, 59.2% had allergic comorbidities, and 88.0% were receiving AD-specific therapy (systemic: 38.6%). The median age, disease duration, body surface area, and total EASI scores were 38.8 years, 11.8 years, 30.0%, and 16.9, respectively. The median DLQI score was 12.0, with 'symptoms/feelings' being the most affected domain. EQ-5D dimensions 'anxiety/depression' and 'pain/discomfort' were also affected (65.2% and 64.1% reporting problems, respectively). The median POEM score was 17.0. Pain, severe pruritus (PP-NRS ≥ 7), and sleep disturbance were reported by 80.4%, 62.0%, and 88.5%, respectively. The median WPAI:GH 'work productivity loss' and 'activity impairment' scores were 23.8% and 30.0%, respectively. Conclusions: Both moderate and severe AD patients reaching Greek specialized centers experience significant symptom burden and impairments in quality of life, sleep, work, and daily activities. [ABSTRACT FROM AUTHOR]

Abstract Background Recent real-world studies revealed high proportions of patients with metastatic urothelial cancer (mUC) do not receive any systemic therapy. This study describes the demographics, clinical characteristics, treatment rate and related predictive factors, healthcare resource utilization, and direct medical costs of patients with mUC receiving systemic therapy (or not) in the inpatient setting in Italy. Methods This retrospective observational study used the national hospital discharge database (Scheda di Dimissione Ospedaliera) to describe incident adult (≥ 18 years) patients with a first hospitalization for mUC (index) from 2017-2018, identified by a combination of ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification), medical procedure, and diagnosis-related group codes. A model was fitted to identify factors associated with receiving inpatient chemotherapy and/or radiotherapy. Results Of 3674 patients with mUC identified, 1014 (27.6%) were treated with inpatient chemotherapy and/or radiotherapy and 2660 (72.4%) were not treated. The median age at index was 71 and 78 years for treated and untreated patients, and the mean (SD) Charlson Comorbidity Index (CCI) score was 0.3 (0.8) and 0.6 (1.1), respectively. Primary tumor location was the bladder in 87.2% of patients. Cardiovascular disease and renal function impairment were more prevalent in untreated (22.6% and 13.2%) vs treated (16.7% and 7.8%) patients. Older age (odds ratio [p-value]) (0.94 [

Jennifer H Lofland,1 Samyuktha Darbha,2 Ahmad B Naim,1 David Rosmarin3 1US Medical Affairs, Incyte Corporation, Wilmington, DE, USA; 2Health Economics and Outcomes Research, Datawave Solutions Corp, Cranbury, NJ, USA; 3Department of Dermatology, Indiana University School of Medicine, Indianapolis, IN, USACorrespondence: Jennifer H Lofland, US Medical Affairs, Incyte Corporation, 1801 Augustine Cut-Off, Wilmington, DE, 19803, USA, Tel +1 302 498 5861, Email jlofland@incyte.comPurpose: This study aimed to describe healthcare resource utilization and costs among individuals with vitiligo who were diagnosed with ≥ 1 psychosocial comorbidity, using data from US claims databases.Patients and Methods: A retrospective, observational cohort analysis of the IBM MarketScan Commercial and Medicare supplemental claims databases for US individuals with vitiligo aged ≥ 12 years and a first vitiligo claim between January 1 and December 31, 2018, was undertaken to assess psychosocial burden, including mental and behavioral health comorbidities.Results: Of the 12,427 individuals included in the analysis, nearly 1 in 4 (23.5%) who had vitiligo were also diagnosed with ≥ 1 psychosocial comorbidity. A greater percentage of these individuals versus those who were not diagnosed with a psychosocial comorbidity had a vitiligo-related prescription claim (50.2% vs 45.4%; P< 0.0001), especially for oral corticosteroids (25.4% vs 16.6%; P< 0.0001) and low-potency topical corticosteroids (9.0% vs 7.6%; P< 0.05). Total vitiligo-related healthcare resource utilization and costs were consistent among individuals with and without psychosocial comorbidity despite significantly (P< 0.05) higher vitiligo-related ER visit utilization and expenditure among those with psychosocial comorbidity. Furthermore, individuals diagnosed with vitiligo and ≥ 1 psychosocial comorbidity had significantly (P< 0.0001) greater utilization of all-cause mean prescription claims (25.0 vs 12.8), outpatient services (other than physician and ER visits: 19.5 vs 11.3), outpatient physician visits (10.1 vs 6.4), inpatient stays (0.6 vs 0.1), and ER visits (0.4 vs 0.2) and incurred significantly higher mean (SD) direct medical expenditures (&dollar;18,804 [&dollar;46,621] vs &dollar;9833 [&dollar;29,094] per patient per year; P< 0.0001).Conclusion: Individuals with vitiligo who were diagnosed with ≥ 1 psychosocial comorbidity incurred greater total all-cause but not vitiligo-related healthcare resource utilization and expenditures than those without diagnosis of psychosocial comorbidities. Identification of psychosocial comorbidities in individuals with vitiligo may be important for multidisciplinary management of vitiligo to reduce overall burden for individuals with vitiligo.Keywords: vitiligo, mental health, behavioral health, healthcare resource utilization, HCRU, healthcare costs

Introduction: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed. Methods: Data for this US, retrospective claims analysis were obtained from the Merative® MarketScan® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had ≥ 12 months of continuous enrollment prior to initiation (preindex period) and ≥ 6 months of data following initiation (postindex period; variable follow-up after 6 months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex. Results: In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P < 0.001) and 0.94 (0.74) to 0.81 (0.75) (P < 0.001). Migraine-related outpatient and neurologist office visits, emergency department visits, and other outpatient services PPPM decreased pre- versus postindex (P < 0.001 for all), resulting in a reduction in mean (SD) total health care costs PPPM from US$541 (US$858) to US$490 (US$974) (P = 0.003). Patients showed high adherence and persistence rates, with mean (SD) proportion of days covered of 0.71 (0.29), medication possession ratio of 0.74 (0.31), and persistence duration of 160.3 (33.2) days 6 months postindex. Conclusions: Patients with certain migraine comorbidities, potential AMO, and/or UPMPR in a real-world setting had reduced migraine-related medication use, HCRU, and costs following initiation of fremanezumab. Graphical abstract available for this article. [ABSTRACT FROM AUTHOR]

Introduction: The study objective was to estimate all-cause healthcare resource utilization (HCRU) and medical and pharmacy costs for women with treated versus untreated vasomotor symptoms (VMS) due to menopause. Methods: A retrospective study was conducted using US claims data from Optum Research Database (study period: January 1, 2012–February 29, 2020). Women aged 40–63 years with a VMS diagnosis claim and ≥ 12 and ≥ 18 months of continuous enrollment during baseline and follow-up periods, respectively, were included. Women treated for VMS were propensity score matched 1:1 to untreated controls with VMS. Standardized differences (SDIFF) ≥ 10% were considered meaningful. A generalized linear model (gamma distribution, log link, robust standard errors) estimated the total cost of care ratio. Subgroup analyses of on- and off-label treatment costs were conducted. Results: Of 117,582 women diagnosed with VMS, 20.5% initiated VMS treatment and 79.5% had no treatment. Treated women (n = 24,057) were matched to untreated VMS controls. There were no differences in HCRU at follow-up (SDIFF < 10%). Pharmacy ($487 vs $320, SDIFF 28.4%) and total ($1803 vs $1536, SDIFF 12.6%) costs were higher in the treated cohort. Total costs were 7% higher in the treated cohort (total cost ratio 1.07, 95% CI 1.05–1.10, P < 0.001). The on-label treatment pharmacy costs ($546 versus $315, SDIFF 38.6%) were higher in the treated cohort. Off-label treatment had higher medical costs ($1393 versus $1201, SDIFF 10.4%). Conclusions: Most women with VMS due to menopause were not treated within 6 months following diagnosis. While both on- and off-label treatment increased the total cost of care compared with untreated controls, those increases were modest in magnitude and should not impede treatment for women who report symptom improvement as a result of treatment. [ABSTRACT FROM AUTHOR]

Abstract Introduction Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed. Methods Data for this US, retrospective claims analysis were obtained from the Merative® MarketScan® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had ≥ 12 months of continuous enrollment prior to initiation (preindex period) and ≥ 6 months of data following initiation (postindex period; variable follow-up after 6 months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex. Results In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P

Emmeline Igboekwe,1 Sumit Verma,2 Rosirene Paczkowski3 1US Medical Affairs, R&D Global Medical, GSK, Durham, NC, USA; 2STATinMED, LLC, Dallas, TX, USA; 3Value Evidence and Outcomes, R&D Global Medical, GSK, Collegeville, PA, USACorrespondence: Rosirene Paczkowski, GSK, Upper Providence UP4410, 1250 South Collegeville Road, Collegeville, PA 19426, USA, Tel +1 904.832.7934, Email rosirene.x.paczkowski@gsk.comPurpose: Chronic obstructive pulmonary disease (COPD) and asthma are associated with chronic inflammation of the respiratory tract; despite some overlap of symptoms, they are considered separate disorders. Triple therapy is recommended for patients with COPD and asthma whose symptoms remain uncontrolled despite dual therapy. There are limited real-world studies evaluating outcomes among patients with COPD and asthma who are receiving inhaled triple therapy. This United States (US)-based real-world study aimed to evaluate clinical and economic outcomes among patients with COPD and asthma receiving single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI]).Patients and Methods: Retrospective pre-post study using claims data from the Optum Clinformatics® database. Patients with COPD and asthma were indexed on the first date of FF/UMEC/VI prescription (1 October 2017– 31 March 2019). Each patient acted as their own control. Patients were required to have continuous health plan enrollment for 12 months prior to (pre-treatment) and following (post-treatment) index. Exacerbations, all-cause and COPD-related healthcare resource utilization, and costs were compared before and after FF/UMEC/VI initiation.Results: Overall, 2743 patients were included (mean age: 71 years; 64% female). Cardiovascular disease was the most prevalent comorbidity during both the pre- and post-treatment periods (90% for both periods). There was a lower proportion of patients with ≥ 1 COPD exacerbation or ≥ 1 asthma exacerbation post-treatment versus pre-treatment (51% vs 57%, p< 0.0001, and 22% vs 32%, p< 0.0001, respectively). Fewer patients had ≥ 1 all-cause office visit post-treatment versus pre-treatment (99.3% vs 99.7%, p=0.0329); more patients had ≥ 1 COPD-related office visit post-treatment versus pre-treatment (89.6% vs 87.5%, p=0.0035). Total all-cause healthcare costs were significantly higher post-treatment versus pre-treatment (&dollar;72,809 vs &dollar;63,734, p< 0.0001). The driver of increased costs appeared to be primarily non-COPD-related (COPD-related costs: post-treatment &dollar;27,779 vs pre-treatment &dollar;25,081, p=0.0062).Conclusion: FF/UMEC/VI reduced exacerbations among patients with COPD and asthma in a real-world setting in the US.Plain Language Summary: Chronic obstructive pulmonary disease (COPD) and asthma are different respiratory conditions that have similar symptoms. Patients can be diagnosed with both conditions at the same time. A flare-up of COPD or asthma symptoms can lead to a lung attack, which can result in hospitalization and a considerable decline in patient health as well as being associated with high healthcare resource use and costs.An inhaler with three different medicines (fluticasone furoate, umeclidinium, and vilanterol; shortened to FF/UMEC/VI) can be prescribed for patients with COPD or asthma. This study was done to assess how FF/UMEC/VI (taken using a single inhaler) affected lung attacks as well as healthcare resource use and costs among patients who have been diagnosed with both COPD and asthma.This study found that fewer patients experienced a lung attack in the first 12 months after starting FF/UMEC/VI compared with the 12 months before starting FF/UMEC/VI. A lower proportion of patients had ≥ 1 medical office visit, ≥ 1 hospital admission, or ≥ 1 emergency room visit after starting FF/UMEC/VI compared with before FF/UMEC/VI. Many patients in this study had other medical conditions such as heart and kidney disease as well as their asthma and COPD. Although total healthcare costs were higher for patients after they had started FF/UMEC/VI compared with before, this appeared to be mainly due to patients’ other medical conditions, besides from COPD.FF/UMEC/VI may be able to reduce future symptom flare-ups and lung attacks in patients who have been diagnosed with both COPD and asthma.Keywords: asthma, chronic obstructive pulmonary disease, exacerbation, HCRU, real-world, triple therapy

Introduction: Triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) has been shown to improve symptoms and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. This real-world study compared exacerbation rates and healthcare resource utilization (HCRU) before and after initiation of FF/UMEC/VI in patients with COPD previously treated with inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). Methods: This retrospective cohort study included commercial and Medicare Advantage with Part D administrative claims data from September 01, 2016, to March 31, 2020, of patients diagnosed with COPD. The index date was the date of the first FF/UMEC/VI claim (September 2017–March 2019). The 12 months prior to index (baseline) were used to assess patient characteristics and outcomes; the 12 months following index (follow-up) were used to assess study outcomes. All patients had ≥ 30 consecutive days' supply of any ICS/LABA dual therapy during the 12 months prior to FF/UMEC/VI initiation. Subgroup analyses included patients with ≥ 30 consecutive days' supply of budesonide/formoterol (BUD/FORM) during baseline. Analyses of patients with ≥ 1 COPD exacerbation during baseline were reported as well. Results: The overall population included 1449 patients (mean age 70.75 years; 54.18% female), of whom 540 were patients in the BUD/FORM subgroup. Significantly fewer patients experienced any exacerbation during follow-up versus baseline (overall population 53.49% vs 62.59%; p < 0.001; BUD/FORM subgroup 55.00% vs 62.41%; p = 0.004). Effects on exacerbation reduction were more pronounced among patients with ≥ 1 exacerbation during baseline. Lower COPD-related HCRU was observed during the follow-up compared with baseline for both the overall population and the BUD/FORM subgroup. Conclusion: Patients with COPD treated with ICS/LABA during baseline, including patients specifically treated with BUD/FORM and those with a history of ≥ 1 exacerbation, had fewer COPD exacerbations and lower COPD-related HCRU after initiating FF/UMEC/VI. [ABSTRACT FROM AUTHOR]

Objective: Describe the economic burden of COVID-19 on employers and employees in the United States (US). Methods: A targeted literature review was conducted to evaluate the impact of COVID-19 on US-based employers and employees in terms of healthcare resource utilization (HCRU), medical costs, and costs associated with work-loss. Searches were conducted in MEDLINE, Embase, and EconLit using a combination of disease terms, populations, and outcomes to identify articles published from January 2021 to November 4, 2022. As data from the employer perspective were lacking, additional literature related to influenza were included to contextualize the impact of COVID-19, as it shifts into an endemic state, within the existing respiratory illness landscape. Results: A total of 41 articles were included in the literature review. Employer and employee perspectives were not well represented in the literature, and very few articles overlapped on any given outcome. HCRU, costs, and work impairment vary by community transmission levels, industry type, population demographics, telework ability, mitigation implementation measures, and company policies. Work-loss among COVID-19 cases were higher among the unvaccinated and in the week following diagnosis and for some, these continued for 6 months. HCRU is increased in those with COVID-19 and COVID-19-related HCRU can also continue for 6 months. Conclusions: COVID-19 continues to be a considerable burden to employers. The majority of COVID-19 cases impact working age adults. HCRU is mainly driven by outpatient visits, while direct costs are driven by hospitalization. Productivity loss is higher for unvaccinated individuals. An increased focus to support mitigation measures may minimize hospitalizations and work-loss. A data-driven approach to implementation of workplace policies, targeted communications, and access to timely and appropriate therapies for prevention and treatment may reduce health-related work-loss and associated cost burden. PLAIN LANGUAGE SUMMARY: In January 2020, the US government declared COVID-19 a public health emergency. This lasted until May 2023. To fight this health emergency, the US government provided free testing, vaccination, and treatment. Although the US government has declared the emergency over, COVID-19 continues to infect people. For people with private health insurance, costs associated with COVID-19 patient healthcare have now been transferred from the government to employers. In this study, we collected information from published scientific articles about the costs of COVID-19 for employers and workers in the US. We found that people who were not vaccinated against COVID-19 required more medical care and cost more than people who were vaccinated. In some cases, this trend lasted for as long as 6 months. This was mostly because of workers missing work, not working effectively while sick, and needing to be hospitalized. People who could work from home, whose companies had policies to prevent infections, and who took steps to avoid getting infected needed less medical care and missed work less often. This information may be used to help develop policies, communications, and guidance to prevent COVID-19 and limit its impact on employers and workers. [ABSTRACT FROM AUTHOR]

Aim: The objectives were to investigate the differences in per patient per month (PPPM) healthcare resource utilization (HCRU) and costs among commercially insured and Medicare Advantage patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (mBC) who experience disease progression in 12 months compared with those who don’t investigate the impact of progression timing on cumulative healthcare costs. Patients & methods: This claims-based study included patients diagnosed with mBC between 1 January 2013 and 30 April 2020 and received HER2-targeted therapy. Patients were categorized as progressed or nonprogressed. For objective one, monthly HCRU and costs were assessed for up to two lines of therapy (LOTs). Data were summarized descriptively and compared using a generalized linear model (GLM). For objective two, patients with at least 6 months of follow-up were assessed and cumulative healthcare costs were estimated in the 3 years following the start of LOT1 or LOT2 using a GLM and Kaplan–Meier weighting. Results: Among the 4113 patients in the study sample, 3406 had at least 12 months of follow-up (or less if due to death). Compared with nonprogressed patients, progressed patients had higher mean PPPM healthcare costs (LOT1: $22,014 vs $18,372, p < 0.001; LOT2: $19,643 vs $16,863, p = 0.001), and HCRU, including number of emergency room visits and inpatient stays (both p < 0.001) in the 12 months following LOT start. Progressed patients had higher 3-year mean cumulative healthcare costs than nonprogressed patients following LOT1 and LOT2 and this difference was greater for patients who progressed earlier. Conclusion: Disease progression was associated with significant increases in HCRU and costs. Delays in progression were associated with lower cumulative healthcare costs. Earlier use of more clinically effective treatments to delay progression may reduce the economic burden among these patients.

Abstract Introduction Cystic fibrosis (CF) is a life-limiting genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a CFTR modulator (CFTRm) that targets the underlying cause of CF. Based on safety and efficacy demonstrated in clinical trials, ELX/TEZ/IVA is approved in the US for the treatment of CF in people aged ≥ 2 years who have ≥ 1 F508del-CFTR mutation or a CFTR mutation that is responsive to ELX/TEZ/IVA based on in vitro data. While ELX/TEZ/IVA demonstrated unprecedented improvements in lung function and dramatic reductions in pulmonary exacerbations (PEx) and associated hospitalizations in clinical trials, a limited number of studies have examined the impact of ELX/TEZ/IVA on healthcare resource utilization (HCRU) and associated costs in a real-world setting. The aim of this retrospective study was to evaluate changes in PEx, HCRU, and associated non-CFTRm healthcare costs following initiation of ELX/TEZ/IVA among people with CF aged ≥ 12 years in the US. Methods We evaluated the rates of PEx, HCRU, and associated costs before and after initiation of ELX/TEZ/IVA in people with CF aged ≥ 12 years using data from the Merative MarketScan® Commercial Claims and Encounters Database and the Merative Multi-State Medicaid Database from April 21, 2019 to December 31, 2020. Because the study period included time following the onset of the COVID-19 pandemic, we limited our primary analysis to the period prior to the pandemic (October 21, 2019 to March 12, 2020). Outcomes following the onset of the pandemic (March 13 to December 31, 2020) were examined in an exploratory analysis. Results In both commercially insured and Medicaid-insured people with CF, ELX/TEZ/IVA was associated with reductions in PEx, hospitalizations, and associated costs prior to the COVID-19 pandemic, and these reductions were maintained following the onset of the pandemic. Conclusions These findings suggest that ELX/TEZ/IVA reduces the burden and costs associated with PEx and hospitalizations in people with CF.

Abstract Background Management of paediatric atopic dermatitis (AD) remains challenging, and presents a considerable healthcare resource utilisation (HCRU) burden. Objectives To describe secondary HCRU for children and adolescents with moderate‐to‐severe AD in Ireland. Methods This was a single‐centre chart review of children (age 6–11 years) and adolescents (age 12–17 years) with clinician‐confirmed moderate‐to‐severe AD. Eligible patients were selected consecutively, starting with the most recently consulting patient, and working backwards until patient identification for the study was complete. From first secondary care appointment post 1 January 2014, at least 12 months' medical record data were abstracted, including patient demographics/clinical characteristics, treatments, HCRU, and patient‐reported outcomes. Results Data were abstracted for 31 patients (22 children). Mean (SD) duration of observation was 4.4 (1.9) years. Most patients (74.2%) had severe AD at first referral, a mean (SD) of 2.7 (1.5) comorbid conditions, 2.2 (1.1) patient‐reported flare episodes/patient/year‐of‐observation, and 18.5 (12.2) tests/scans/procedures/patient/year‐of‐observation. Patients had tried a mean (SD) of 7.9 (5.3) treatments/patient/year‐of‐observation. Topical corticosteroids (TCS; 48.5% of prescriptions) were most frequently prescribed. Mean (SD) use (duration) of TCS, nonsteroidal topicals (tacrolimus, 4.1% of prescriptions), systemic corticosteroids (prednisolone, 2.2%), and systemic immunosuppressants (10.7%, of which methotrexate was 68.2%) was 38.6 (41.1), 54.4 (41.1), 2.0 (3.1), and 27.6 (21.1) months. Mean (SD) consultations/patient/year‐of‐observation was 15.3 (6.3); 28 (5.9%) for flare. Eight (25.8%) patients were hospitalised (including six children). There were 0.03 hospitalisations/patient/year‐of‐observation, and 4.4 nights spent in hospital, mostly for flare. Earliest mean (SD) Children's Dermatology Life Quality Index score was 9.7 (6.2); latest was 6.6 (5.5). Conclusion This is the first study examining paediatric AD HCRU in an Irish healthcare setting. Moderate‐to‐severe paediatric AD results in complex treatment, with high healthcare burden in hospital outpatient care. Despite treatment and a low hospitalisation rate, patients experience flare, lengthy hospital stays, and minor changes in quality of life.

Introduction: Cystic fibrosis (CF) is a life-limiting genetic disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a CFTR modulator (CFTRm) that targets the underlying cause of CF. Based on safety and efficacy demonstrated in clinical trials, ELX/TEZ/IVA is approved in the US for the treatment of CF in people aged ≥ 2 years who have ≥ 1 F508del-CFTR mutation or a CFTR mutation that is responsive to ELX/TEZ/IVA based on in vitro data. While ELX/TEZ/IVA demonstrated unprecedented improvements in lung function and dramatic reductions in pulmonary exacerbations (PEx) and associated hospitalizations in clinical trials, a limited number of studies have examined the impact of ELX/TEZ/IVA on healthcare resource utilization (HCRU) and associated costs in a real-world setting. The aim of this retrospective study was to evaluate changes in PEx, HCRU, and associated non-CFTRm healthcare costs following initiation of ELX/TEZ/IVA among people with CF aged ≥ 12 years in the US. Methods: We evaluated the rates of PEx, HCRU, and associated costs before and after initiation of ELX/TEZ/IVA in people with CF aged ≥ 12 years using data from the Merative MarketScan® Commercial Claims and Encounters Database and the Merative Multi-State Medicaid Database from April 21, 2019 to December 31, 2020. Because the study period included time following the onset of the COVID-19 pandemic, we limited our primary analysis to the period prior to the pandemic (October 21, 2019 to March 12, 2020). Outcomes following the onset of the pandemic (March 13 to December 31, 2020) were examined in an exploratory analysis. Results: In both commercially insured and Medicaid-insured people with CF, ELX/TEZ/IVA was associated with reductions in PEx, hospitalizations, and associated costs prior to the COVID-19 pandemic, and these reductions were maintained following the onset of the pandemic. Conclusions: These findings suggest that ELX/TEZ/IVA reduces the burden and costs associated with PEx and hospitalizations in people with CF. [ABSTRACT FROM AUTHOR]

Introduction: Adults aged 18–64 years comprise most of the working population, meaning that influenza infection can be disruptive, causing prolonged absence from the workplace, and reduced productivity and the ability to care for dependents. Influenza vaccine uptake is relatively low, even among the older adults in this population (i.e., aged 50–64 years), reflecting a lack of perceived need for vaccination. This systematic literature review (SLR) aimed to characterize the global burden of influenza in the 18–64 years population. Methods: An electronic database search was conducted and supplemented with conference and gray literature searches. Eligible studies described at least one of clinical, humanistic, or economic outcomes in adults aged 18–64 years and conducted across several global regions. Included studies were published in English, between January 1, 2012, and September 20, 2022. Results: A total of 40 publications were included, with clinical, humanistic, and economic outcomes reported in 39, 5, and 15, respectively. Risk of influenza-associated clinical outcomes were reported to increase with age among the 18–64 years population, including hospitalizations (Yamana et al. in Intern Med 60:3401–3408, 2021; Derqui et al. in Influenza Other Respir Viruses 16:862–872, 2022; Fuller et al. in Influenza Other Respir Viruses 16:265–275, 2022; Ortiz et al. in Crit Care Med 42:2325–2332, 2014; Yandrapalli et al. in Ann Transl Med 6:318, 2018; Zimmerman et al. in Influenza Other Respir Viruses 16:1133–1140, 2022). ICU admissions, mortality, ER/outpatient visits, and use of mechanical ventilation were recorded. Adults aged 18–64 years with underlying comorbidities were at higher risk of influenza-related hospitalizations, ICU admission, and mortality than otherwise healthy individuals. Length of hospital stay increased with age, although a lack of stratification across other economic outcomes prevented identification of further trends across age groups. Conclusions: High levels of hospitalization and outpatient visits demonstrated a clinical influenza-associated burden on patients and healthcare systems, which is exacerbated by comorbidities. Considering the size and breadth of the general population aged 18–64 years, the limited humanistic and economic findings of this SLR likely reflect an underreported burden. Greater investigation into indirect costs and prolonged absenteeism associated with influenza infection is required to fully understand the economic burden in this population. [ABSTRACT FROM AUTHOR]

Abstract Background Myasthenia gravis (MG) is a rare, chronic, debilitating, unpredictable, and potentially life-threatening neuromuscular disease. There is a lack of real-world data on disease management that could be used to further understand and address unmet patient needs and burden. We aimed to provide comprehensive real-world insights in the management of MG in five European countries. Methods Data were collected using the Adelphi Real World Disease Specific Programme™ in MG, a point-in-time survey of physicians and their patients with MG in France, Germany, Italy, Spain, and the United Kingdom (UK). Physician- and patient-reported clinical data were collected, including demographics, comorbidities, symptoms, disease history, treatments, healthcare resource utilization (HCRU), and quality of life outcomes. Results In total, 144 physicians completed 778 patient record forms from March to July 2020 in the UK, and from June to September 2020 in France, Germany, Italy and Spain. Mean patient age at symptom onset was 47.7 years, with a mean time from symptom onset to diagnosis of 332.4 days (10.97 months). At diagnosis, 65.3% of patients were classified as Myasthenia Gravis Foundation of America Class II or above. Mean number of symptoms reported at diagnosis per patient was five, with ocular myasthenia reported in at least 50% of patients. At time of survey completion, the mean number of symptoms reported per patient was five and ocular myasthenia and ptosis were each still present in more than 50% of patients. Acetylcholinesterase inhibitors were the most commonly prescribed chronic treatments in all countries. Of 657 patients treated with chronic treatment at the time of the survey, 62% continued to experience moderate-to-severe symptoms. On average, 3.1 healthcare professionals (HCPs) were involved in patient management, 6.2 consultations were made per patient with any HCP over the last 12 months, and 178 (22.9%) patients were hospitalized in the last 12 months. Overall, HCRU and disease management were similar across all countries. Conclusions Our findings demonstrated the high burden of MG despite current treatment options for patients with MG.

Background: Myasthenia gravis (MG) is a rare, chronic, debilitating, unpredictable, and potentially life-threatening neuromuscular disease. There is a lack of real-world data on disease management that could be used to further understand and address unmet patient needs and burden. We aimed to provide comprehensive real-world insights in the management of MG in five European countries. Methods: Data were collected using the Adelphi Real World Disease Specific Programme™ in MG, a point-in-time survey of physicians and their patients with MG in France, Germany, Italy, Spain, and the United Kingdom (UK). Physician- and patient-reported clinical data were collected, including demographics, comorbidities, symptoms, disease history, treatments, healthcare resource utilization (HCRU), and quality of life outcomes. Results: In total, 144 physicians completed 778 patient record forms from March to July 2020 in the UK, and from June to September 2020 in France, Germany, Italy and Spain. Mean patient age at symptom onset was 47.7 years, with a mean time from symptom onset to diagnosis of 332.4 days (10.97 months). At diagnosis, 65.3% of patients were classified as Myasthenia Gravis Foundation of America Class II or above. Mean number of symptoms reported at diagnosis per patient was five, with ocular myasthenia reported in at least 50% of patients. At time of survey completion, the mean number of symptoms reported per patient was five and ocular myasthenia and ptosis were each still present in more than 50% of patients. Acetylcholinesterase inhibitors were the most commonly prescribed chronic treatments in all countries. Of 657 patients treated with chronic treatment at the time of the survey, 62% continued to experience moderate-to-severe symptoms. On average, 3.1 healthcare professionals (HCPs) were involved in patient management, 6.2 consultations were made per patient with any HCP over the last 12 months, and 178 (22.9%) patients were hospitalized in the last 12 months. Overall, HCRU and disease management were similar across all countries. Conclusions: Our findings demonstrated the high burden of MG despite current treatment options for patients with MG. [ABSTRACT FROM AUTHOR]

Background: Real-world data on health care resource utilisation (HCRU) and costs for French patients with multiple myeloma (MM) are limited due to the quickly evolving MM treatment landscape. This retrospective, national-level study quantified the MM economic burden in France. Methods: The study included patients with newly diagnosed MM from the Système National des Données de Santé coverage claims database between 2013 and 2018 who received active treatment within 30 days of diagnosis. HCRU included hospitalisations, drugs, consultations, procedures, tests, devices, transport, and sick leave. Costs were annualized to 2019 prices. Drug treatments, reported by line of therapy (LOT), were algorithmically defined using drug regimen, duration of therapy, and gaps between treatments. Analyses were stratified by stem cell transplantation status and LOT. Results: Among 6413 eligible patients, 6229 (97.1%) received ≥ 1 identifiable LOT; most received 1 (39.8%) or 2 LOT (27.5%) during follow-up. Average annual hospitalisation was 6.3 episodes/patient/year (median duration: 11.6 days). The average annual cost/patient was €58.3 K. Key cost drivers were treatment (€28.2 K; 39.5% of total HCRU within one year of MM diagnosis) and hospitalisations (€22.2 K; 48.6% of total HCRU costs in first year). Monthly treatment-related costs increased from LOT1 (€2.447 K) and LOT5 + (€7.026 K); only 9% of patients received LOT5 +. At LOT4 + , 37 distinct regimens were identified. Hospitalisation costs were higher in patients with stem cell transplantation than total population, particularly in the first year. Conclusions: This study showed a high economic burden of MM in France (€72.37 K/patient/year in the first year) and the diversity of regimens used in late-line treatments. [ABSTRACT FROM AUTHOR]

Background: Understanding patient-specific trends in costs and healthcare resource utilization (HCRU) surrounding lumbar spine surgery is critically needed to better inform surgical decision making and the development of targeted interventions.Purpose: 1) Identify subgroups of patients following distinct patterns in direct healthcare payments pre- and postoperatively, 2) determine whether these patterns are associated with patient and surgical factors, and 3) examine whether preoperative payment patterns are related to postoperative payments, healthcare resource utilization (HCRU), and adverse events.Study Design/setting: Retrospective analysis of an administrative claims database (IBM Marketscan Research Databases 2007-2015).Patient Sample: Adults undergoing primary single-level decompression surgery for lumbar stenosis (n=12,394).Outcome Measures: Direct healthcare payments, HCRU payments (15 categories), 90-day complications and all-cause readmission, 2-year reoperation METHODS: Group-based trajectory modeling is an application of finite mixture modeling that is able to identify meaningful subgroups within a population that follow distinct developmental trajectories over time. We used this technique to identify subgroups of patients following distinct profiles in preoperative direct healthcare payments. A separate analysis was performed to identify distinct profiles in payments postoperatively. Patient and surgical factors associated with these payment profiles were assessed with multinomial logistic regression, and associations with adverse events were assessed with risk-adjusted multivariable logistic regression.Results: We identified 4 preoperative patient payment subgroups following distinct profiles in payments: Pre-Low (5.8% of patients), Pre-Early-Rising (4.8%), Pre-Medium (26.1%), and Pre-High (63.3%). Postoperatively, 3 patient subgroups were identified: Post-Low (8.9%), Post-Medium (29.6%), and Post-High (61.4%). Patients following the higher-cost pre- and postoperative payment profiles were older, more likely female, and had a greater physical and mental comorbidity burden. With each successively higher preoperative payment profile, patients were increasingly likely to have high postoperative payments, use more HCRU (particularly high-cost services such as inpatient admissions, ER, and SNF/IRF care), and experience postoperative adverse events. Following risk adjustment for patient and surgical factors, patients following the Pre-High payment profile had 209.5 (95% CI: 144.2, 309.7; p<.001) fold greater odds for following the Post-High payment profile, 1.8 (1.3, 2.5; p=.003) fold greater odds for 90-day complications, and 1.7 (1.2, 2.6; p=.035) fold greater odds for 2-year reoperation relative to patients following the Pre-Low payment profile.Conclusions: There are identifiable subgroups of patients who follow distinct profiles in direct healthcare payments surrounding lumbar decompression surgery. These payment profiles are related to patient age, sex, and physical and mental comorbidities. Notably, preoperative payment profiles may provide prognostic value, as they are associated with postoperative costs, HCRU, and adverse events.Level Of Evidence: III. [ABSTRACT FROM AUTHOR]

Purpose: To describe secondary care health care resource utilization (HCRU) for children and adolescents with atopic dermatitis (AD). Patients and Methods: This UK chart review of patients with moderate‐to‐severe AD was conducted in four National Health Service hospitals. Cohorts were defined by age (children 6–11 years, adolescents 12–17) at first consultation. Eligible patients were selected consecutively, starting with the most recently consulting patient. At least 12 months' data were abstracted from medical records. Data were collected on HCRU, demographics/clinical characteristics, treatment, and patient‐reported outcomes. Results: Data were abstracted for 55 patients. Most patients (80%) had severe AD at first referral, a mean (SD) of 3.2 (10.7) patient‐reported flare episodes/patient/year‐of‐observation, and 18.5 (16.7) tests/scans/procedures/patient/year. Mean (SD) observation duration was 3.6 (1.8) years. Patients had tried mean (SD) 7.9 (5.3) treatments/patient/year of observation. Topical corticosteroids (TCS; 24.5% of prescriptions) were most frequently prescribed. Mean (SD) use of emollients/moisturizers, TCS, systemic corticosteroids, and systemic immunosuppressants was 30.9 (21.3), 21.1 (23.4), 1.7 (8.3), and 7.8 (8.2) months. There was a mean (SD) of 5.3 (2.9) consultations/patient/year‐of‐observation; 116 (10.7%) for flare. Most hospitalizations (87.5%) were for children; the 8/55 (15%) hospitalized patients (mean 2.0 hospitalizations/patient during observation period) spent 6.2 (SD: 5.1) nights in hospital/hospitalization. Earliest mean (SD) Children's Dermatology Life Quality Index score was 15.3 (7.2); latest was 12.9 (7.5). Conclusion: Children and adolescents with moderate‐to‐severe AD had a high HCRU burden and small changes in quality of life, indicating that current treatments may provide suboptimal AD control in most cases. [ABSTRACT FROM AUTHOR]

Pimavanserin (PIM) is the only FDA approved atypical antipsychotic (AAP) for the treatment of Parkinson's Disease Psychosis (PDP) while other off-label AAPs like quetiapine (QUE) are also used. Real-world comparative effects of PIM and QUE on health resource utilization (HCRU) may provide insights about their relative benefits. To examine annual HCRU among newly initiated PIM or QUE monotherapy among patients with PDP. Retrospective analysis of 100% Medicare (Parts A, B, and D) claims of patients with PDP during 1 January 2013 to 31 December 2019 was conducted. Treatment-naive patients with first prescription for PIM or QUE from 1 January 2014 to 31 December 2018 were selected if they had ≥12-months continuous monotherapy and had no prior AAP use for ≥12-month pre-index. Post-index 12-month HCRU was compared between 1:1 propensity score matched (PSM) PIM or QUE cohorts. HCRU outcomes included: rates of all-cause and psychiatric-related inpatient hospitalizations by stay-type [i.e., long-term stays (LT-stays), short-term stays (ST-stays), skilled nursing facility stays (SNF-stays)], outpatient hospitalizations, emergency room (ER) visits, and office visits. Relative risk and 95% confidence intervals are reported [RR (95% CI)]. A total of 842 and 7,116 were treated with PIM and QUE, respectively. Mean age and gender distribution were similar among both groups. After PSM, those on PIM (n=842) had significantly lower RR for all-cause: inpatient hospitalizations [RR=0.78 (0.70–0.87)], ST-stays [RR=0.75 (0.66–0.84)], SNF-stays [RR=0.64 (0.54–0.76)], and ER visits [RR=0.91 (0.84–0.97)] vs. QUE (n=842). PIM patients had slightly higher RR for all-cause office visits [RR=1.03 (1.01–1.05)] vs. QUE. Psychiatric-related inpatient hospitalizations were also lower for PIM vs. QUE: [RR=0.63 (0.48–0.82)] ST-stays [RR=0.61 (0.43–0.86)], SNF-stay [RR=0.69 (0.47–1.02)], and ER visits [RR=0.53 (0.37–0.76)]. In this analysis of PDP patients, PIM monotherapy resulted in nearly 22% and 37% lower all-cause hospitalizations and psychiatric-related inpatient hospitalizations compared to QUE. [ABSTRACT FROM AUTHOR]

Pimavanserin (PIM) is the only FDA-approved atypical antipsychotic (AAP) for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Comparative real-world analyses demonstrating its benefits are needed. To evaluate health care resource utilization (HCRU) outcomes among PDP patients treated with PIM vs. other-AAPs. Retrospective cohort analysis of Parts A, B, and D claims from 100% Medicare sample from 01 January 2013–31 December 2019 was conducted. PDP Patients initiating (i.e. index date) continuous monotherapy (PIM vs. other-AAPs) for ≥12-months during 01 January 2014–31 December 2018 without 12-months pre-index AAP use were selected after 1:1 propensity score matching (PSM) on 31 variables (sex, race, region, age, and 27 Elixhauser comorbidities). HCRU outcomes included: annual all-cause and psychiatric hospitalization (short-term stay, long-term stay, and SNF-stay [skilled nursing facility]) rates, annual all-cause and psychiatric-ER visit rates, mean per-patient-per-year (PPPY) hospitalizations, and average length of stay (ALOS). PIM and other-AAPs were compared using generalized linear models (GLM) controlled for demographic characteristics, comorbidities, coexisting-dementia, and coexisting insomnia. Of 12,164 PDP patients, 48.41% (n = 5,889) were female, and mean age was 77 (±8.14) years. Among 1:1 matched patients (n = 842 in each), 37.8% (n = 319) on PIM vs. 49.8% (n = 420) on other-AAPs (p <.05) reported ≥1 all-cause hospitalizations, respectively. Specifically, short-term and SNF-stay among PIM patients vs. other-AAPs were: 34% (n = 286) vs. 46.2% (n = 389) and 20.2% (n = 170) vs. 31.8% (n = 267) (p <.05), respectively. Similarly, 9.6% (n = 81) of PIM vs. 14.6% (n = 123) of other-AAPs patients had ≥1 psychiatric hospitalization (p <.05). Furthermore, ≥1 all-cause and psychiatric ER visit among PIM vs. other-AAPs were 61.6% (n = 519) vs. 69.4% (n = 584) and 5.2% (n = 43) vs. 10.2% (n = 86) (p <.05), respectively. PIM also had significantly lower ALOS, and mean PPPY short-term hospitalization and SNF-stays. In this analysis of PDP patients, PIM monotherapy resulted in nearly 12% and 7% lower all-cause hospitalizations and ER visits vs. other-AAPs. [ABSTRACT FROM AUTHOR]

Background: This study examined the clinical characteristics, genetic basis, healthcare utilisation and costs of catecholaminergic ventricular tachycardia (CPVT) patients from a Chinese city. Methods: This was a territory-wide retrospective cohort study of consecutive CPVT patients at public hospitals or clinics in Hong Kong. Healthcare resource utilisation for accident and emergency (A&E), inpatient and outpatient attendances were analysed over 19 years (2001-2019) followed by calculations of annualised costs (in USD). Results: Sixteen patients with a median presentation age (interquartile range (IQR) of 11 (9-14) years old) were included. Fifteen patients (93.8%) were initially symptomatic. Ten patients had both premature ventricular complexes (PVCs) and ventricular tachycardia/fibrillation (VT/VF). One patient had PVCs without VT/VF. Genetic tests were performed on 14 patients (87.5%). Eight (57.1%) tested positive for the ryanodine receptor 2 (RyR2) gene. Seven variants have been described elsewhere (c.14848G>A, c.12475C>A, c.7420A>G, c.11836G>A, c.14159T>C, c.10046C>T and c.7202G>A). c.14861C>G is a novel RyR2 variant not been reported outside this cohort. Patients were treated with beta-blockers (n = 16), amiodarone (n = 3) and verapamil (n = 2). Sympathectomy (n = 8) and implantable-cardioverter defibrillator implantation (n = 3) were performed. Over a median follow-up of 13.3 years (IQR: 8.4-18.1) years, six patients exhibited incident VT/VF. At the patient level, the median (IQR) annualised costs for A&E, inpatient and outpatient attendances were $66 (40-95), $10521 (5240-66887) and $791 (546-1105), respectively. Conclusions: All patients presented before the age of 19. The yield of genetic testing was 57%. The most expensive attendance type was inpatient stays, followed by outpatients and A&E attendances. [ABSTRACT FROM AUTHOR]

A retrospective, observational cohort study was conducted to generate realworld evidence in adult patients diagnosed with sarcoidosis-associated pulmonary hypertension (SAPH) at a referral center in England between 2012 and 2019. Data from the referral center electronic medical record database were linked to the National Health Service Hospital Episode Statistics database to collect and analyze patient demographics, clinical characteristics, comorbidities, treatment patterns, health-related quality of life (HRQoL; assessed using the EmPHasis-10 questionnaire), healthcare resource utilization (HCRU), costs, and survival. Sixty-two patients with SAPH were identified. At diagnosis, 84% were in WHO functional class III and presented with significant pulmonary hemodynamic impairment. Cardiovascular and respiratory comorbidities were commonly reported prediagnosis. Median EmPHasis-10 score at diagnosis was 34, indicative of poor HRQoL. In the 1st year after diagnosis, median (Q1, Q3) per-patient HCRU was 1 (0, 2) all-cause inpatient hospitalizations; 3 (2, 4) same-day hospitalizations; and 9 (6, 11) outpatient consultations. In 24 patients who were hospitalized longer than 1 day in the 1st year after diagnosis, the median duration of hospitalization was 4 days. With a median follow-up of 1.8 years, the median overall survival was 2.9 years. In this cohort of patients with SAPH, poor HRQoL and high HCRU were observed following diagnosis. To our knowledge, this is the first study to report on HRQoL and HCRU in patients with SAPH. More research is needed on treatment options for this population with high unmet needs. [ABSTRACT FROM AUTHOR]

Amidst the multifaceted challenges posed by COVID-19, interest in complementary and alternative medicine (CAM) has risen. Chyawanprash (CP), an Ayurvedic formulation, is recognized for its multifunctional properties. This systematic review aims to evaluate its safety and effectiveness as a COVID-19 prophylactic. A literature search was conducted for articles published within the past three years from databases such as Cochrane Library, PubMed, and Google Scholar. A total of 1008 articles were identified, and 34 were included for full-text screening, resulting in five randomized controlled trials (RCTs) meeting the eligibility criteria. Meta-analysis was performed using a random effects model, with results represented in odds ratio (95% confidence intervals (CIs)), and publication bias presented through funnel plots. The five clinical trials conducted in India analyzed 153,343 participants. In the meta-analysis, the odds ratios for COVID-19-positive patients, COVID-19-positive in symptomatic patients, healthcare resource utilization (HCRU), and adverse events were 0.45 (95% CI 0.06-3.08, p = 0.41), 0.37 (95% CI 0.01-12.86, p = 0.58), 0.95 (95% CI 0.18-5.04, p = 0.95), and 0.94 (95% CI 0.63-1.40, p = 0.75) respectively. Notably, significant heterogeneity was observed among studies including both COVID-19-positive cases (I 2  = 80%, p = 0.007) and symptomatic COVID-19 cases (I 2  = 83%, p = 0.01), whereas non-significant zero heterogeneity was observed in HCRU (I 2  = 0%, p = 0.74) and adverse events (I 2  = 0%, p = 1.00). The meta-analysis reveals a trend in the efficacy of CP as prophylaxis for COVID-19 treatments. However, owing to high heterogeneity and bias, further research is recommended., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Sharma et al.)

Abstract A retrospective, observational cohort study was conducted to generate real‐world evidence in adult patients diagnosed with sarcoidosis‐associated pulmonary hypertension (SAPH) at a referral center in England between 2012 and 2019. Data from the referral center electronic medical record database were linked to the National Health Service Hospital Episode Statistics database to collect and analyze patient demographics, clinical characteristics, comorbidities, treatment patterns, health‐related quality of life (HRQoL; assessed using the EmPHasis‐10 questionnaire), healthcare resource utilization (HCRU), costs, and survival. Sixty‐two patients with SAPH were identified. At diagnosis, 84% were in WHO functional class III and presented with significant pulmonary hemodynamic impairment. Cardiovascular and respiratory comorbidities were commonly reported prediagnosis. Median EmPHasis‐10 score at diagnosis was 34, indicative of poor HRQoL. In the 1st year after diagnosis, median (Q1, Q3) per‐patient HCRU was 1 (0, 2) all‐cause inpatient hospitalizations; 3 (2, 4) same‐day hospitalizations; and 9 (6, 11) outpatient consultations. In 24 patients who were hospitalized longer than 1 day in the 1st year after diagnosis, the median duration of hospitalization was 4 days. With a median follow‐up of 1.8 years, the median overall survival was 2.9 years. In this cohort of patients with SAPH, poor HRQoL and high HCRU were observed following diagnosis. To our knowledge, this is the first study to report on HRQoL and HCRU in patients with SAPH. More research is needed on treatment options for this population with high unmet needs.

Background Context: Improved understanding of the pre- and postoperative trends in costs and healthcare resource utilization (HCRU) is needed to better inform patient expectations and aid in the development of strategies to minimize the significant healthcare burden associated with lumbar spine surgery.Purpose: Examine the time course of costs and HCRU in the 2 years preceding and following elective lumbar spine surgery for stenosis in a large national claims cohort.Study Design/setting: Retrospective analysis of an administrative claims database (IBM® Marketscan® Research Databases 2007-2015).Patient Sample: Adult patients undergoing elective primary single-level lumbar surgery for stenosis with at least 2 years of continuous health plan enrollment pre- and postoperatively.Outcome Measures: Functional measures, including monthly rates of HCRU (15 categories), monthly gross covered payments (including payments made by the health plan and deductibles and coinsurance paid by the patient) overall, by HCRU category, and by spine versus non-spine-related.Methods: All available patients were utilized for analysis of HCRU. For analysis of payments, only patients on noncapitated health plans providing accurate financial information were analyzed. Payments were converted to 2015 United States dollars using the medical care component of the consumer price index. Trends in payments and HCRU were plotted on a monthly basis pre- and post-surgery and assessed with regression models. Relationships with demographics, surgical factors, and comorbidities were assessed with multivariable repeated measures generalized estimating equations.Results: Median monthly healthcare payments 2 years prior to surgery were $275 ($22, $868). Baseline HCRU at 2 years preoperatively was stable or only gradually rising (office visits, prescription drug use), but began an increasingly steep rise in many categories 6 to 12 months prior to surgery. Monthly payments began an increasingly steep rise 6 months prior to surgery, reaching a peak of $1,402 ($634, $2,827) in the month prior to surgery. This was driven by an increase in radiology, office visits, PT, injections, prescription medications, ER encounters, and inpatient admissions. Payments dropped dramatically immediately following surgery. Over the remainder of the 2 years, the median total payments declined only slightly, as a continued decline in spine-related payments was offset by gradually increased non-spine related payments as patients aged. By 2 years postoperatively, the percentage of patients using PT and injections returned to within 1% of the baseline levels observed 2 years preoperatively; however, spine-related prescription medication use remained elevated, as did other categories of HCRU (radiology, office visits, lab/diagnostic services, and also rare events such as inpatient admissions, ER encounters, and SNF/IRF). Patients with a fusion component to their surgeries had higher payments and HCRU preoperatively, and this did not resolve postoperatively. Variations in payments and HCRU were also evident among plan types, with patients on comprehensive medical plans-predominantly employer-sponsored supplemental Medicare coverage-utilizing more inpatient, ER, and inpatient rehabilitation & skilled nursing facilities. Patients on high-deductible plans had fewer payments and HCRU across all categories; however, we are unable to distinguish whether this is because they used fewer of these services or if they were paying for these services out of pocket without submitting to the payer. By 2 years postoperatively, 51% of patients had no spine-related monthly payments, while 33% had higher and 16% had lower monthly payments relative to 2 years preoperatively.Conclusions: This is the first study to characterize time trends in direct healthcare payments and HCRU over an extended period preceding and following spine surgery. Differences among plan types potentially highlight disparities in access to care and plan-related financial mediators of patients' healthcare resource utilization. [ABSTRACT FROM AUTHOR]

This retrospective analysis of the Optum Clinformatics Data Mart database evaluated US patient characteristics, healthcare resource utilization (HCRU), costs, and treatment patterns among unvaccinated adults with outpatient-diagnosed COVID-19 to quantify US economic burden. The index event was the earliest outpatient diagnosis of confirmed COVID-19 from May 1 to December 10, 2020. Patients had 12 months' continuous enrollment before and were followed for ≥60 days after index date until insurance dis-enrollment or study end. 236,589 patients had outpatient-diagnosed COVID-19 (7,692 with and 228,897 without subsequent COVID-19-related inpatient admission >48 h post-diagnosis). The median age was 51 years (≥65 years, 30.0%); 72.4% had ≥1 risk factor. Patients with versus without subsequent inpatient admission were more often male, older, Black/Hispanic, and had comorbidities/risk factors. With a median follow-up of 162 days, patients had a median of 1 COVID-19-related outpatient visit (with inpatient admission, 5 outpatient visits). Those with inpatient admission had a median of 1 COVID-19-related inpatient visit (median length of stay [LOS], 6 days), 33.3% were admitted to intensive care (median LOS, 8 days), 8.4%, 7.1%, and 13.3% received invasive mechanical ventilation, noninvasive mechanical ventilation, and supplemental oxygen, respectively; 13.5% experienced readmission. Inpatient mortality was 6.0% (0.3% for nonhospitalized patients). Antithrombotic therapy, antibiotics, corticosteroids, and remdesivir use increased among patients with inpatient admission versus without. Median total COVID-19-related non-zero medical costs were $208 for patients without inpatient admission (with inpatient admission, $39,187). Results reflect the circulating SARS-CoV-2 and treatment landscape during the study period. Requirements for continuous enrollment could have biased the population. Cost measurements may have included allowed (typically higher) and charge amounts. Given the numbers of the US population who are still not fully vaccinated and the evolving epidemiology of the pandemic, this study provides relevant insights on real-world treatment patterns, HCRU, and the cost burden of outpatient-diagnosed COVID-19. [ABSTRACT FROM AUTHOR]

Kaname Ueda,1 Tomoyuki Takura,2 Shinji Fujikoshi,1 Juliana Meyers,3 Saurabh P Nagar,3 Hiroyuki Enomoto1 1Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2Department of Healthcare Economics and Health Policy, University of Tokyo, Tokyo, Japan; 3RTI Health Solutions, Research Triangle Park, NC, USACorrespondence: Kaname UedaMedicines Development Unit Japan, Eli Lilly Japan K.K., 5-1-28 Isogamidori, Chuo-ku, Kobe 651-0086, JapanTel +81-78-242-9519Fax +81-78-242-9939Email ueda_kaname@lilly.comPurpose: To assess comorbidity burden and pain-management patterns among working-aged patients with knee osteoarthritis only (KOA/O) and patients with knee osteoarthritis plus osteoarthritis at another site (KOA/+) in Japan.Patients and Methods: Retrospective claims data analysis was conducted using the Japan Medical Data Center database. Working-aged adults (aged 40 to 71 years) with 5 years of follow-up and diagnosed with knee osteoarthritis (KOA) between January 1, 2011, and December 31, 2012, were evaluated. The first claim with a KOA diagnosis defined the index date. Patients were divided into two mutually exclusive cohorts: KOA/O and KOA/+. Longitudinal pain-management patterns during each year of follow-up were analyzed.Results: A total of 2542 patients met study criteria: 1575 KOA/O and 967 KOA/+. Mean age and number of comorbidities were higher among the KOA/+ versus KOA/O cohort. Pharmaceutical treatment was received by 91.5% of patients in the KOA/+ compared with 85.1% of patients in the KOA/O cohort during the first year of follow-up. The most common pharmacological treatment received during the first year of follow-up was either topical or oral nonsteroidal anti-inflammatory drugs for both cohorts. During each year of follow-up, the KOA/+ cohort had greater proportion of patients with at least one health-care encounter (ie, hospital admissions, outpatient and pharmacy visits) and higher direct medical costs compared with the KOA/O cohort.Conclusion: This study demonstrates that a greater proportion of the working population with KOA/+ received pain-related treatment compared with patients with KOA/O. Further studies are necessary to evaluate appropriate pain management for both KOA only and KOA with other sites.Keywords: knee osteoarthritis, pain management, Japan, working-aged, HCRU

Background: Treatment approach for metastatic non-small cell lung cancer (mNSCLC) has revolutionized in the recent decade with the introduction of immunotherapy and targeted medications in first-line (1L) therapy. We present real-world data on clinical outcomes and direct healthcare resource utilization (HCRU) and cost in a 2.7-million-member Israeli health provider., Patients and Methods: Newly diagnosed mNSCLC patients between January 2017 and December 2020 were categorized by 1L treatment: platinum-based chemotherapy, targeted therapy, or immunotherapy. HCRU and costs were calculated based on the Ministry of Health Prices and were assessed at a minimum of 6 months' follow-up (cutoff: 30 June 2021)., Results: A total of 886 patients were included in the study: 40.6% female, median age 68 years (IQR 61-74), 24.3% never smokers, 80.6% with adenocarcinoma, and 54% with a 0-1 performance status. The median follow-up was 27.12 months (95% CI, 24.7-29.6) and the median duration of first-line (1L) treatment was 2.3 months for platinum-based chemotherapy (n = 177), 12.3 months for targeted therapy (n = 255), and 4.8 months for immunotherapy (n = 463). The median overall survival was 9.09, 27.68, and 12.46 months, respectively. Total 1L costs were driven by radiotherapy for platinum-based chemotherapy and medication for targeted therapy or immunotherapy. Total costs for deceased patients over the entire follow-up were €121 155, €129 458, and €110 716, respectively., Conclusion: The treatment of mNSCLC carries a high economic burden, primarily driven by first-line therapy, especially with targeted and immune therapies. Further studies are needed to evaluate the impact of innovative treatments on the disease management costs of mNSCLC., (© The Author(s) 2024. Published by Oxford University Press.)

Objective Assess long-term comorbidity burden and pain management patterns among working-age patients with knee osteoarthritis (KOA) only without low back pain (LBP) (KOA-noLBP) and patients with KOA plus LBP (KOA+LBP) in Japan. Methods Retrospective claims data analyses were conducted on data from the Japan Medical Data Center (JMDC) database. Adult patients (≥40 years) with a diagnosis of knee osteoarthritis (KOA) (January 1, 2011–December 31, 2012) and 5 years of follow-up were evaluated. The first claim with a KOA diagnosis defined the index date. Longitudinal pain management patterns were assessed in both cohorts. Results Overall, 1,828 patients met study criteria (717 with KOA-noLBP; 1,111 with KOA+LBP). The mean age of patients with KOA-noLBP was 52.1 years, and that of patients with KOA+LBP was 53.1 years, with more females in the KOA+LBP cohort (49.4% vs. 55.0%). Regardless of cohort, >90% of patients received pharmacological intervention during the 5-year follow-up period. The most common regimen first received was either topical or oral nonsteroidal anti-inflammatory drugs. A higher mean number of pharmaceutical treatments were received by patients in the KOA+LBP cohort (3.6) than by patients in the KOA-noLBP cohort (2.7) during the follow-up period. Regardless of cohort, most of the direct medical cost was derived from medication. Conclusion This study demonstrates that a greater proportion of the JMDC population of working individuals with KOA were comorbid with LBP and received pain-related treatment in the long-term perspective relative to patients with KOA without LBP. Appropriate pain management for both KOA and LBP would be key for effective resource utilization in an aging society facing socioeconomic burdens [ABSTRACT FROM AUTHOR]

Aims: Peripheral artery disease (PAD), often treated with lower extremity revascularization, is associated with risk of major atherothrombotic vascular events (acute limb ischemia [ALI], major non-traumatic lower-limb amputation, myocardial infarction [MI], ischemic stroke, cardiovascular death). This study aims to assess healthcare resource utilization and costs of such events among patients with PAD after revascularization. Materials and methods: Patients aged ≥50 years with PAD who were treated with lower-extremity revascularization were identified from Optum Clinformatics Data Mart claims database (01/2014-06/2019). The first lower extremity revascularization after PAD diagnosis was defined as the index date. Patients had ≥6months of health plan enrollment before the index date. Patients were followed until the earliest of 1) end of enrollment or data; 2) diagnosis of atrial fibrillation or venous thromboembolism; or 3) oral anticoagulant use. All-cause healthcare resource use per-patient-year was compared before and after a major atherothrombotic vascular event post-revascularization among those with an event. Additionally, event-related healthcare costs per-patient-year were reported for each event type. Results: Of the 38,439 PAD patients meeting the study criteria, 6,675 (17.4%) had a major atherothrombotic vascular event. On average, patients were observed for 7.3months before an event and 6.2months after an event. Patients with an event had significantly higher all-cause healthcare resource use versus similar metrics pre-event (e.g. inpatient visits among those with ALI: 3.5 ± 5.8 post-event vs. 2.0 ± 8.1 pre-event, p<.05). Event-related costs ranged from $57,825±$131,810 per-patient-year for ischemic stroke to $108,302±$150,168 for major non-traumatic lower-limb amputation. Limitations: Data do not contain clinical information. Additionally, results are limited to commercially insured and Medicare Advantage beneficiaries. Conclusion: Patients with PAD who experience major atherothrombotic vascular events post-revascularization have considerably higher healthcare resource use and costs compared with similar metrics pre-event. Therefore, reducing the rate of such events could reduce overall healthcare costs for this population. [ABSTRACT FROM AUTHOR]

Purpose: Osteoarthritis (OA) is one of the most common causes of chronic pain and a leading cause of disability in the US. The objective of this study was to examine the clinical and economic burden of OA by pain severity. Patients and Methods: We used nationally representative survey data. Adults ≥ 18 years with self-reported physician-diagnosed OA and experiencing OA pain were included in the study. OA pain severity was measured using the Short Form McGill Pain Questionnaire Visual Analog Scale (SF-MPQ-VAS). Data were collected for demographics, clinical characteristics, health-related quality of life (HRQoL), productivity, OA treatment, adherence to pain medication, and healthcare resource utilization. Univariate analysis was performed to examine differences between respondents with moderate-to-severe OA pain vs those with mild OA pain. Results: Higher proportions of respondents with moderate-to-severe OA pain (n=3798) compared with mild OA pain (n=2038) were female (69.4% vs 57.3%), < 65 years of age (54.8% vs 43.4%), and not employed (70.6% vs 64.5%). Respondents with moderate-to-severe OA pain experienced OA pain daily (80.8% vs 48.8%), were obese (53.0% vs 40.5%), had more comorbidities (sleep disturbance, insomnia, depression, and anxiety), and reported significantly poorer health status and HRQoL, and greater productivity and activity impairment (all P< 0.05). Moderate-to-severe OA pain respondents were prescribed significantly more pain medications than mild OA pain respondents (41.0% vs 17.0%) and had higher adherence (75.9% vs 64.1%) yet were less satisfied with their pain medications (all P< 0.001). Outpatient and emergency room visits, and hospitalizations in the 6 months prior to the survey were significantly higher in moderate-to-severe OA pain respondents vs those with mild OA pain (all P< 0.05). Conclusion: Patient and clinical burden was significantly greater in moderate-to-severe OA pain respondents vs mild OA pain respondents and may inform decision-making for appropriate resource allocation and effective management strategies that target specific subgroups. [ABSTRACT FROM AUTHOR]

Abstract Introduction The aim of this study was to describe the real-word treatment and associated healthcare resource use (HCRU) of multiple sclerosis (MS) patients, as stratified by different MS subtypes. Methods All patients with MS continuously insured by two German statutory healthcare insurance funds from 2011 to 2015 were enrolled. These patients were categorized into four subgroups according to their MS type as follows: clinically isolated syndrome (CIS); relapsing remittent MS (RRMS); primary progressive MS (PPMS); and secondary progressive MS (SPMS). Sociodemographic characteristics, treatments, and HCRU for 2015 were analyzed. Treatment cascades for treatment-naïve patients were also determined. Results A total of 13,333 patients with MS were identified. The largest proportion of patients had RRMS (41.9%), followed by PPMS (17.1%). Mean age of the enrolled patients was 50.2 years, and 70.7% were female. Among all patients, 38.3% of those with CIS, 22.4% with PPMS, 69.6% with RRMS, and 33.9% with SPMS received a prescription of a disease-modifying immunomodulatory agent, with interferon beta-1a being the most frequently prescribed agent. Likewise, 14.5, 18.5, 19.9, and 21.5% of patients with CIS, PPMS, RRMS, and SPMS, respectively, received a flare-up treatment with glucocorticoids. MS-associated overall costs, including indirect costs for MS-associated days absent from work, were € 16,433, with costs related to MS medication (€ 8770; 53.4%) being the main driver of costs in all subgroups. MS-associated costs according to MS subtypes were € 12,427 for CIS patients, € 14,459 for PPMS patients, € 20,583 for RRMS patients, and € 17,554 for SPMS patients. Conclusion Among the four MS subtypes, RRMS patients most often received a disease-modifying immunomodulatory treatment. Consequently, healthcare costs were highest for patients with this MS subtype. Contrary to the treatment guideline, a substantial percentage of patients with CIS, RRMS, and SPMS did not receive any disease-modifying immunomodulatory treatment.

Abstract Aims The aims of this study were to describe patient characteristics of the adult chronic heart failure (HF) population and to estimate the prevalence, incidence, healthcare resource utilization (HCRU), and mortality associated with HF in Southwest Finland. Methods and results This was a retrospective biobank and clinical registry study. Adult patients with an HF diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD) code I50) during 2004–2013 in secondary care were included in the study and compared with age‐matched and gender‐matched control patients without an I50 diagnosis. HF patients were stratified in groups by left ventricular ejection fraction (LVEF) as follows: LVEF

Objectives: To report healthcare resource utilization (HCRU) and safety outcomes in systemic light chain (AL) amyloidosis from the EMN23 study., Materials and Methods: The retrospective, observational, multinational EMN23 study included 4,480 patients initiating first-line treatment for AL amyloidosis in 2004-2018 and assessed, among other objectives, HCRU and safety outcomes. HCRU included hospitalizations, examinations, and dialysis; safety included serious adverse events (SAEs) and adverse events of special interest (AESIs). Data were descriptively analyzed by select prognostic factors (e.g., cardiac staging by Mayo2004/European) for 2004-2010 and 2011-2018. A cost-of-illness analysis was conducted for the UK and Spain., Results: HCRU/safety and dialysis data were extracted for 674 and 774 patients, respectively. Of patients with assessed cardiac stage (2004-2010: 159; 2011-2018: 387), 67.9% and 61.0% had ≥ 1 hospitalization, 56.0% and 51.4% had ≥ 1 SAE, and 31.4% and 28.9% had ≥ 1 AESI across all cardiac stages in 2004-2010 and 2011-2018, respectively. The per-patient-per-year length of hospitalization increased with disease severity (cardiac stage). Of patients with dialysis data (2004-2010: 176; 2011-2018: 453), 23.9% and 14.8% had ≥ 1 dialysis session across all cardiac stages in 2004-2010 and 2011-2018, respectively. The annual cost-of-illness was estimated at €40,961,066 and €31,904,386 for the UK and Spain, respectively; dialysis accounted for ∼28% (UK) and ∼35% (Spain) of the total AL amyloidosis costs., Conclusions: EMN23 showed that the burden of AL amyloidosis is substantial, highlighting the need for early disease diagnosis and effective treatments targeting the underlying pathology., Competing Interests: Disclosure Arnaud Jaccard, honoraria from Servier, Amgen, Abbvie, and Pfizer; participating in advisory committees for Janssen; research funding from Sanofi and Janssen; Frank Bridoux, lecture fees from Janssen, Astra Zeneca, GSK, and Novartis; consultancy for Janssen, Attralus and Astra Zeneca; Wilfried Roeloffzen, honoraria/advisory board from Janssen, MSD, Amgen, and Sanofi; Monique C. Minnema, honoraria from BMS; consultancy for Janssen-Cilag, GSK, CDR life and Gilead; speaker's bureau for Medscape. Research support from Beigene; Rui Bergantim, honoraria/advisory board from Janssen, BMS, Amgen, Takeda and Pfizer; research funding from BMS and Amgen; Roman Hájek, consultancy/advisory relationship with Janssen, Amgen, Celgene, Abbvie, BMS, Novartis, PharmaMar, and Takeda; honoraria from Janssen, Amgen, Celgene, BMS, PharmaMar, and Takeda; research funding from Janssen, Amgen, Celgene, BMS, Novartis, and Takeda; Cristina João, scientific advisory for Takeda, BMS, Janssen, GSK, and Amgen, Abbvie, Pfizer; M. Teresa Cibeira, honoraria for lectures/advisory board for Janssen, Amgen, Akcea, and Sanofi; Giovanni Palladini; participating in advisory boards for Alexion, Argobio, Janssen, and Protego; honoraria from Alexion, Argobio, Janssen, Protego, The Binding Site, Pfizer, Prothena, Sebia, and Siemens; research funding from Gate bioscience and The Binding Site; Stefan Schönland, research support from Janssen, Prothena, and Sanofi; participating in advisory boards for Janssen, Telix, and Prothena; honoraria from Janssen, Takeda, Pfizer, and Prothena; travel and congress participation grants from Janssen, Prothena, Celgene, Binding Site, and Jazz; Paolo Milani, speaker honoraria from Janssen and Pfizer; participating in advisory board for Janssen; Meletios A. Dimopoulos, honoraria from participation in advisory boards from Abbvie, Amgen, Bristol Myers Squibb, Beigene Inc, GSK, Janssen, Karyopharm, Pfizer, Regeneron, Sanofi and Takeda; Ute Hegenbart, travel grants from Janssen, Prothena, and Pfizer; participating in advisory boards for Pfizer, Janssen, and Prothena; honoraria from Janssen, Pfizer, Alnylam, and Akcea; research funding from Janssen and Prothena; Blanca Gros, current employment with Janssen; Aisha Asra, current employment with Janssen; Valeria Magarotto, current employment with Janssen; Giorgos Cheliotis, current employment with Health Data Specialists; Giorgos Psarros, current employment with Health Data Specialists; Pieter Sonneveld, research support from Janssen, BMS, Sanofi, and Amgen, all for EMN trials; participating in advisory boards for Janssen, BMS, Sanofi, Amgen, Cargen, and Pfizer; Ashutosh Wechalekar, honoraria/advisory board from Janssen, Alexion, Attralus, Celgene/BMS, Takeda, and GSK; Efstathios Kastritis, honoraria/advisory board from Genesis Pharma, Janssen, GSK, and Pfizer; research support from Amgen, Janssen, and Pfizer., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Aim: The objectives were to investigate the differences in per patient per month (PPPM) healthcare resource utilization (HCRU) and costs among commercially insured and Medicare Advantage patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (mBC) who experience disease progression in 12 months compared with those who don't investigate the impact of progression timing on cumulative healthcare costs. Patients & methods: This claims-based study included patients diagnosed with mBC between 1 January 2013 and 30 April 2020 and received HER2-targeted therapy. Patients were categorized as progressed or nonprogressed. For objective one, monthly HCRU and costs were assessed for up to two lines of therapy (LOTs). Data were summarized descriptively and compared using a generalized linear model (GLM). For objective two, patients with at least 6 months of follow-up were assessed and cumulative healthcare costs were estimated in the 3 years following the start of LOT1 or LOT2 using a GLM and Kaplan-Meier weighting. Results: Among the 4113 patients in the study sample, 3406 had at least 12 months of follow-up (or less if due to death). Compared with nonprogressed patients, progressed patients had higher mean PPPM healthcare costs (LOT1: $22,014 vs $18,372, p < 0.001; LOT2: $19,643 vs $16,863, p = 0.001), and HCRU, including number of emergency room visits and inpatient stays (both p < 0.001) in the 12 months following LOT start. Progressed patients had higher 3-year mean cumulative healthcare costs than nonprogressed patients following LOT1 and LOT2 and this difference was greater for patients who progressed earlier. Conclusion: Disease progression was associated with significant increases in HCRU and costs. Delays in progression were associated with lower cumulative healthcare costs. Earlier use of more clinically effective treatments to delay progression may reduce the economic burden among these patients.

Background and Aims: Nonalcoholic steatohepatitis (NASH) may progress to advanced liver disease (AdvLD). This study characterized comorbidities, healthcare resource utilization (HCRU) and associated costs among hospitalized patients with AdvLD due to NASH in Italy.Methods and Results: Adult nonalcoholic fatty liver disease (NAFLD)/NASH patients from 2011 to 2017 were identified from administrative databases of Italian local health units using ICD-9-CM codes. Development of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), or liver transplant (LT) was identified using first diagnosis date for each severity cohort (index-date). Patients progressing to multiple disease stages were included in >1 cohort. Patients were followed from index-date until the earliest of disease progression, end of coverage, death, or end of study. Within each cohort, per member per month values were annualized to calculate all-cause HCRU or costs(€) in 2017. Of the 9,729 hospitalized NAFLD/NASH patients identified, 97% were without AdvLD, 1.3% had CC, 3.1% DCC, 0.8% HCC, 0.1% LT. Comorbidity burden was high across all cohorts. Mean annual number of inpatient services was greater in patients with AdvLD than without AdvLD. Similar trends were observed in outpatient visits and pharmacy fills. Mean total annual costs increased with disease severity, driven primarily by inpatient services costs.Conclusion: NAFLD/NASH patients in Italy have high comorbidity burden. AdvLD patients had significantly higher costs. The higher prevalence of DCC compared to CC in this population may suggest challenges of effectively screening and identifying NAFLD/NASH patients. Early identification and effective management are needed to reduce risk of disease progression and subsequent HCRU and costs. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to describe the real-word treatment and associated healthcare resource use (HCRU) of multiple sclerosis (MS) patients, as stratified by different MS subtypes. Methods: All patients with MS continuously insured by two German statutory healthcare insurance funds from 2011 to 2015 were enrolled. These patients were categorized into four subgroups according to their MS type as follows: clinically isolated syndrome (CIS); relapsing remittent MS (RRMS); primary progressive MS (PPMS); and secondary progressive MS (SPMS). Sociodemographic characteristics, treatments, and HCRU for 2015 were analyzed. Treatment cascades for treatment-naïve patients were also determined. Results: A total of 13,333 patients with MS were identified. The largest proportion of patients had RRMS (41.9%), followed by PPMS (17.1%). Mean age of the enrolled patients was 50.2 years, and 70.7% were female. Among all patients, 38.3% of those with CIS, 22.4% with PPMS, 69.6% with RRMS, and 33.9% with SPMS received a prescription of a disease-modifying immunomodulatory agent, with interferon beta-1a being the most frequently prescribed agent. Likewise, 14.5, 18.5, 19.9, and 21.5% of patients with CIS, PPMS, RRMS, and SPMS, respectively, received a flare-up treatment with glucocorticoids. MS-associated overall costs, including indirect costs for MS-associated days absent from work, were € 16,433, with costs related to MS medication (€ 8770; 53.4%) being the main driver of costs in all subgroups. MS-associated costs according to MS subtypes were € 12,427 for CIS patients, € 14,459 for PPMS patients, € 20,583 for RRMS patients, and € 17,554 for SPMS patients. Conclusion: Among the four MS subtypes, RRMS patients most often received a disease-modifying immunomodulatory treatment. Consequently, healthcare costs were highest for patients with this MS subtype. Contrary to the treatment guideline, a substantial percentage of patients with CIS, RRMS, and SPMS did not receive any disease-modifying immunomodulatory treatment. [ABSTRACT FROM AUTHOR]

BACKGROUND: Significant public health concerns exist regarding the misuse and abuse of prescription opioids. Abuse-deterrent formulation (ADF) opioids may be leveraged as an important tool for combating the current opioid crisis. OBJECTIVES: To evaluate the relationships between ADF opioid formulary coverage and the ADF utilization rate, the risk for opioid abuse or overdose, opioid abuse or overdose-related healthcare resource utilization, and medical costs within a calendar year. METHODS: This cross-sectional multiyear panel study included adults prescribed an opioid medication in 2015 or 2016. We analyzed the medical and pharmacy claims linked to health plan benefit design data. An ADF opioid--including reformulated oxycodone hydrochloride (HCl) controlled-release (CR; reformulated OxyContin), morphine sulfate and naltrexone HCl extended-release (ER; Embeda), and hydrocodone bitartrate ER (Hysingla ER)--was considered covered if it was listed on the health plan's formulary. Generalized linear models were used to assess the association between ADF opioid formulary coverage and the study outcomes. RESULTS: Of 1,350,607 eligible patients, those enrolled in health plans with coverage of ADF opioids were more likely to fill a prescription for an ADF opioid than those enrolled in plans that did not cover ADF opioids. The risk for opioid abuse or overdose was significantly lower among patients enrolled in plans with broader ADF coverage (adjusted odds ratio [OR], 0.91; 95% confidence interval [CI], 0.86-0.95 for oxycodone HCl CR only vs no ADF coverage; adjusted OR, 0.70; 95% CI, 0.67-0.73 for oxycodone HCl CR plus ≥1 ADF opiods vs no ADF; adjusted OR, 0.77; 95% CI, 0.73-0.81 for oxycodone HCl CR plus ≥1 ADF opiods vs oxycodone HCl CR only; all P <.0001). Approximately 15% and 25% reductions in the opioid abuse or overdose-related hospitalization rate and medical costs were observed for those in the oxycodone HCl CR plus ≥1 ADF opioids coverage group versus those without ADF opioid coverage. CONCLUSIONS: Broad formulary coverage of ADF opioids is associated with reduced rates of opioid abuse or overdose in real-world managed care populations. Health plan administrators and policymakers may consider improving the formulary coverage of ADF opioids as a strategy to ensure appropriate patient access to necessary pain medications while mitigating risk for opioid abuse or overdose. [ABSTRACT FROM AUTHOR]

More oncology biologics are becoming available for subcutaneous (sc.) administration and are expected to provide useful therapeutic options. We evaluated evidence published in the past 5 years to assess the humanistic and economic impact of sc. versus intravenous administration of approved cancer therapies and identify outcomes favoring either administration route. These publications focused predominantly on healthcare resource utilization and economic outcomes, demonstrating resource and cost savings with sc. administration. Patients reported a better health-related quality of life and preference for sc. formulations. Time-and-motion study analyses confirmed the convenience of sc. administration. These findings suggest that future availability of sc. oncology biologics, especially anti-PD-1/PD-ligand 1 antibodies due to their increased utility in various malignancies, may be beneficial for patients, healthcare providers and payers. [ABSTRACT FROM AUTHOR]

Aims: The aims of this study were to describe patient characteristics of the adult chronic heart failure (HF) population and to estimate the prevalence, incidence, healthcare resource utilization (HCRU), and mortality associated with HF in Southwest Finland. Methods and results: This was a retrospective biobank and clinical registry study. Adult patients with an HF diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD) code I50) during 2004–2013 in secondary care were included in the study and compared with age‐matched and gender‐matched control patients without an I50 diagnosis. HF patients were stratified in groups by left ventricular ejection fraction (LVEF) as follows: LVEF < 40% [HF with reduced ejection fraction (HFrEF)]; LVEF ≥ 40% [HF with preserved ejection fraction (HFpEF)]; or unknown (LVEF unknown). HCRU was stratified by inpatient, outpatient, and emergency room visits. In 2013, the incidence of HF was 3.2/1000, and the prevalence was 13.9/1000 inhabitants (n = 15 594). In the stratified analysis of HF patients (n = 8833, average ± SD age 77.1 ± 11.2), 1115 (12.6%) patients had HFrEF (female 31.3%), 1449 (16.4%) had HFpEF (female 50.9%), and 6269 (71%) had unknown LVEF (female 52.1%). The most common co‐morbidities were essential hypertension (58%), chronic elevated serum creatinine (57.3%), atrial fibrillation and flutter (55.1%), and chronic ischaemic heart disease (46.4%). Patients with HF diagnosis had higher HCRU compared with that of age‐matched and gender‐matched controls (3.7 more days per year at the hospital for HF patients compared with the controls). The total 5 year mortality was 62.6% for HF patients and 28.3% for controls, with higher age being the strongest predictor of mortality. Moreover, multivariable Cox regression analysis showed that patients with HFrEF had a 13% (95% confidence interval 2.7–25%) increased risk of mortality compared with HFpEF patients. Conclusions: The high mortality rate and HCRU among the studied HF patients highlight the severity of the disease and the economic and social burden on both patients and society. This calls for improved methods of care for this large patient population. [ABSTRACT FROM AUTHOR]

Despite recommended routine vaccination with meningococcal conjugate vaccine (MenACWY) at ages 11–12 years with a booster at age 16 years, national estimates indicate MenACWY uptake is lower in older adolescents than younger adolescents. This study aimed to identify factors associated with MenACWY uptake among adolescents. Commercial Claims and Encounters (CCAE) and Medicaid MarketScan Databases from 2011 to 2016 were retrospectively analyzed (2017) to determine receipt of ≥1 dose of MenACWY during early (10.5 through 13 years) and late (15.5 through 18 years) adolescence. Multivariable logistic regression and nonlinear decomposition analyses were used to identify factors associated with MenACWY vaccination, potential missed opportunities, and differences between age groups. A larger proportion of younger adolescents than older adolescents received MenACWY: CCAE, 71.7% versus 48.9% (p <.001); Medicaid, 59.3% versus 31.8% (p <.001), respectively. In multivariable models (CCAE), older adolescents were less likely than younger ones to receive MenACWY (adjusted odds ratios [95% confidence intervals]:.68 [.67,.69]) and more likely to have a potential missed opportunity (1.27 [1.25, 1.28]). Decomposition results showed lower MenACWY uptake in older adolescents is largely attributed to fewer non-MenACWY vaccines received, fewer preventive care visits, and interaction with nonpediatric healthcare providers. Missed opportunities and infrequent preventive care encounters contribute to lack of vaccination in younger and older adolescents. However, the disparity in uptake between the two age groups was largely attributable to differences in healthcare utilization, suggesting a need for unique strategies to increase uptake among older adolescents, such as solidifying a vaccination platform for ages 16–18 years through encouragement of annual preventive care visits. [ABSTRACT FROM AUTHOR]

Background: Effects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.Methods: Patients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient's last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period.Results: At Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: -5.1 for galcanezumab 120 mg/240 mg; p<0.001).Conclusion: Results from this long-term, open-label study suggest that treatment with galcanezumab is likely to lead to high patient satisfaction with treatment as well as meaningful reductions in migraine-specific HCRU and acute headache medication use in people with migraine. [ABSTRACT FROM AUTHOR]

Aim: To determine the economic burden associated with anticholinergic medication use in adults with overactive bladder (OAB) in the USA. Methods: A systematic literature review was conducted to identify articles assessing healthcare resource utilization (HCRU) and costs associated with anticholinergic use in adults with OAB. Results: From the 34 articles identified, increased anticholinergic burden, switching anticholinergic treatments and potentially inappropriate anticholinergic use were associated with increased HCRU and/or costs. However, studies comparing patients with OAB receiving anticholinergics to individuals with untreated OAB or without OAB reported a mix of increases and decreases in HCRU and costs. Conclusion: Additional controlled studies assessing the economic impact of anticholinergics in OAB are needed and may enable optimization of economic and potentially patient outcomes.