Treatment Patterns and Economic Burden in ModeratetoSevere Chronic Hand Eczema in the USA: A Real-World Retrospective Claims Analysis.

Validation of an ovarian cancer line of therapy algorithm for real- world outcomes research in insurance claims (375)

Background:Randomized clinical trials have shown long-acting mono bronchodilator therapy to be efficacious in improving lung function and dyspnea, while reducing exacerbations; however, less is known regarding the effectiveness in routine clinical practice. This study examined treatment patterns, rescue medication use, healthcare resource utilization and costs, and exacerbations in patients with chronic obstructive pulmonary disease (COPD) who initiated long-acting mono bronchodilator therapy in real-world settings.Methods:This retrospective study used US claims data from adult patients with COPD initiating long-acting mono bronchodilator therapy between 1 January 2008 and 31 January 2015. Patients were required to have continuous health plan enrollment 12 months prior to (baseline period) and 12 months following therapy initiation (follow-up period). Outcomes, including treatment patterns, rescue medication use, exacerbations, and healthcare utilization and costs, were measured until the earliest of treatment augmentation or discontinuation, death, health plan disenrollment, or the end of the study period. Results were analyzed descriptively for all measures. Baseline and follow-up measures of all-cause and COPD-related healthcare costs and exacerbations [per patient per month (PPPM)] were compared using paired t tests.Results:Among 27,394 patients with a mean follow up of 6.3 months, 18.2% augmented, 74.2% discontinued, and 7.6% continued long-acting mono bronchodilator therapy. Rescue medication use was prevalent during the follow-up period, with an average of 1.0 short-acting β agonist (SABA) fills/month and 0.8 short-acting muscarinic antagonist (SAMA) fills/month, among patients with at least one fill for the medication of interest. PPPM mean number of exacerbations was more than triple (0.17 versus 0.05, p < 0.001) and PPPM exacerbation-related costs were more than double over the follow-up period compared with baseline ($1070 versus $485). COPD-related costs accounted for 50% of all-cause costs during the follow-up period and were significantly higher compared with baseline ($1206 versus $592, p < 0.001).Conclusions:Patients initiating long-acting mono bronchodilator therapy had high rates of medication discontinuation or augmentation. Patients used more rescue medications and experienced significantly more COPD exacerbations with higher healthcare costs compared with baseline. Further research is warranted to determine whether more aggressive initial therapy would result in symptom improvement.

BackgroundThis study evaluated the impact of atherosclerotic cardiovascular disease (ASCVD) on healthcare resource utilization and costs in patients with type 2 diabetes mellitus (T2DM).MethodsThis study was a retrospective, cross-sectional study using US claims data. Adult patients with T2DM were stratified by presence or absence of ASCVD and compared regarding annual (2015) healthcare resource utilization and associated costs. Subgroup analyses were conducted for three age groups (18–44, 45–64, and ≥ 65 years).ResultsAmong 1,202,596 eligible patients with T2DM, 45.2% had documented ASCVD. The proportions of patients with inpatient and ER-based resource utilization during 2015 were three-to-four times greater in the ASCVD cohort as compared to the non-ASCVD cohort for the categories of inpatient visits (15.6% vs 4.4% of patients), outpatient ER visits (18.4% vs 5.2% of patients), and inpatient ER visits (4.3% vs 0.9% of patients). Outpatient utilization also was higher among patients with ASCVD as compared to those without ASCVD (mean number of annual office visits per patient, 9.1 vs 5.6), and more than twice as many patients with ASCVD had ≥ 9 office visits (43.5% vs 19.8%). Average per-patient total healthcare cost was $22,977 for ASCVD vs $9735 for non-ASCVD, with medical costs primarily driving the difference ($17,849 vs $6079); the difference in pharmacy costs was smaller ($5128 vs $3656). In the 18–44, 45–64, and ≥ 65 age subgroups respectively, total annual healthcare costs were 143, 127, and 114% higher in ASCVD vs non-ASCVD patients.ConclusionsThese findings indicate significantly higher healthcare resource utilization and associated costs in patients having T2DM with ASCVD compared to T2DM without ASCVD.

AimTo evaluate the impact of timing of aripiprazole once-monthly (AOM) initiation on healthcare resource utilization (HCRU), risk of hospitalization, and healthcare costs in patients with schizophrenia.MethodsA retrospective cohort study was conducted using data from the Merative MarketScan database (01/01/2013–12/31/2019). Adults aged ≥18 years with a new episode of care for schizophrenia and an AOM claim were included. Patients were classified into two cohorts based on the time between the first schizophrenia diagnosis and the first AOM claim (early cohort: ≤1 year; late cohort: >1 year). All-cause and psychiatric-specific HCRU, risk of hospitalization, and healthcare costs were evaluated over 1-year post-AOM initiation. The relationship between the timing of AOM initiation and HCRU was evaluated using negative binomial regression, and healthcare costs using generalized linear models (log-link with gamma distribution). Logistic regression was used to estimate the likelihood of hospitalization during the follow up period for both all-cause and psychiatric-specific hospitalization.ResultsA total of 945 patients were included (early cohort: n = 525; late cohort: n = 420). At baseline, the early cohort had lower mean age, a greater proportion of males, and a lower mean Charlson Comorbidity Index score than the late cohort (all p < .05). After adjusting for baseline demographic and clinical characteristics, all-cause and psychiatric-specific hospitalization during the 1-year follow-up period were statistically significantly higher for the late cohort versus the early cohort (all-cause: incident rate ratio [IRR] = 1.63, 95% confidence interval [CI]: 1.28–2.07, p < .01; psychiatric-specific: IRR = 1.93, 95% CI: 1.46–2.55, p < .01). The early cohort had statistically significantly lower adjusted all-cause ($21,686 versus $29,033; p = .0002) and psychiatric-specific ($24,414 versus $32,461; p = .0002) healthcare costs versus the late cohort.LimitationsThis study utilized claims data, which are intended for administrative purposes rather than for research.ConclusionsThis analysis extends previous evidence for the benefits of AOM in patients with new episodes of schizophrenia, by demonstrating lower HCRU, risk of hospitalization, and healthcare costs with early AOM initiation compared with later initiation.

A wake-up call for corporate America.

Myasthenia gravis (MG) is a rare neuromuscular disorder with an estimated prevalence of 37 per 100,000 individuals in the United States. Despite patients with MG using a wide range of health care services, there is a lack of information regarding health care costs and health care resource utilization (HCRU). To gain insight into the health care cost and HCRU associated with an MG diagnosis from the US payer perspective. Patients with MG, defined by at least 2 claims for MG diagnoses, were identified from a commercial and Medicare claims database between 2016 and 2021. Controls who were never diagnosed with MG were matched at a 10:1 ratio with each patient with MG based on baseline demographic and clinical characteristics. The primary outcomes were 1-year total health care costs associated with MG diagnosis, and the secondary outcomes were 1-year HCRU associated with MG diagnosis. Difference-in-difference estimates from a multivariable linear regression model were used to report adjusted health care costs and HCRU. The final analytic cohort included 3,700 patients with MG and 37,000 controls. On average, patients were aged 54years, with 60% being female. The difference-in-difference estimates of the total health care cost for MG diagnosis in commercial and Medicare patients were $25,799 and $4,927, respectively (P < 0.01). MG diagnosis had significant impacts on HCRU across all health care settings. We quantified a significant increase in health care costs and HCRU in the first year following diagnosis of MG compared with the matched cohort. Future studies can further investigate long-term health care costs associated with patients with MG.

ABSTRACTIntroductionAlthough covalent Bruton's tyrosine kinase inhibitors (cBTKis) have transformed treatment of chronic lymphocytic leukemia and small lymphocytic leukemia (CLL/SLL), cBTKi‐related cardiotoxicity is a known side effect. This real‐world study evaluated incident cardiovascular adverse events (CVAE), healthcare resource utilization (HCRU), and costs among patients with CLL/SLL receiving cBTKis.MethodsAdult patients with CLL/SLL who initiated ibrutinib or acalabrutinib treatment (index date) between 2020 and 2023 were identified using US claims data and followed up to 36 months post‐index. Incident CVAEs (not present pre‐index) were assessed during cBTKi treatment and patients were stratified by CVAE status. HCRU and costs were evaluated per 1000 patient‐months (PPPM).ResultsOverall, 2069 patients were identified (mean age of 73.7 ± 9.1 years, 40.4% female) with a mean treatment‐specific observation period of 11.4 ± 9.5 months. At least one incident CVAE was observed in 442 (21.4%) patients. The incidence rate was 21.6 PPPM for hypertension, 8.9 PPPM for atrial fibrillation, 8.6 PPPM for ventricular arrhythmias, and 8.3 PPPM for atrial flutter. Patients with incident CVAEs had significantly more total medical service days PPPM (4334 vs. 3138, p < 0.001), primarily driven by increased inpatient (690 vs. 230), outpatient (2798 vs. 2425), other visit (662 vs. 375), and ER days (184 vs. 109) than those without CVAEs. Total healthcare costs (PPPM) were substantially higher for patients with incident CVAEs ($20,250,560 vs. $17,413,460, p < 0.001) mainly due to higher inpatient ($3,417,948 vs. $915,839, p < 0.001), outpatient ($2,415,060 vs. $1,769,628, p < 0.01), and ER costs ($186,820 vs. $87,585, p < 0.001).ConclusionsThe observed class‐effect of high CVAEs with cBTKis underscores the unmet need for safer, more selective agents for CLL/SLL treatment. The HCRU and economic burden remain high for CLL/SLL, especially among patients experiencing CVAEs during cBTKi treatment. These findings emphasize the importance of optimizing clinical management to reduce CVAE risk and downstream impacts on HCRU and costs.

Bipolar I disorder (BP-I) is a chronic and recurrent mental health disorder, broadly characterized by patients who alternate between the extremes of the mood spectrum: mania or hypomania; and depression. In 2015, the total estimated annual cost of BP-I in the United States reached more than $200 billion, approximately 2.5 times higher than the general population, largely driven by the increased use of acute health care services. Long-acting injectable antipsychotics such as aripiprazole were developed to significantly reduce patient burden for treatment adherence compared with oral formulations, to allow consistent dosing and improved outcomes. Previous real-world evidence studies have shown the benefits of starting aripiprazole once-monthly injection (AOM) at an early stage in patients diagnosed with schizophrenia; however, the effect of early initiation in the BP-I population remains unknown. To evaluate the impact of initiating AOM 400mg (AOM 400) in adults at an early stage (<180 days) following a diagnosis of BP-I compared with late initiation (>365 days) in a real-world setting, via a retrospective analysis using claims data from the MarketScan Medicaid database. Study outcomes included the numbers of emergency department, hospitalization, outpatient, and pharmacy visits, together with the associated costs over a 1-year time horizon. A generalized linear model was used to compare the annualized costs associated with early, intermediate, and late initiators of treatment, using late initiators as the main reference group. Among 866 patients diagnosed with BP-I (median age, 36years), 161 early initiators had significantly lower risks of emergency department visits (incidence rate ratio = 0.76; 95% CI, 0.61-0.94) and outpatient pharmacy visits (incidence rate ratio = 0.82; 95% CI, 0.73-0.93) compared with 591 late initiators. Early initiators also incurred lower pharmacy visit costs ($18,787 vs $23,503; P = 0.03) and lower medical costs ($13,898 vs $18,277; P = 0.01). Overall, early initiators incurred much lower total health care costs than late initiators during the follow-up ($31,086 vs $40,599, respectively; P < 0.001). Early initiators also incurred significantly lower total health care costs than intermediate initiators ($31,086 vs $40,892; P = 0.01). This real-world study demonstrates that early initiation of AOM 400 among patients living with BP-I may offer a significant advantage of lower health care resource utilization and associated costs when compared with late initiation.

IntroductionDolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen for HIV-1 treatment with long-term efficacy and good tolerability comparable to 3- or 4-drug regimens. This study evaluated DTG/3TC cost versus other standard single-tablet regimens during its first year of approval.MethodsThis retrospective study analyzed US claims data from adults with HIV-1. Eligibility criteria included ≥ 1 dispensing of DTG/3TC, DTG/abacavir (ABC)/3TC, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF, and darunavir (DRV)/COBI/FTC/TAF (index date was first dispensing) and ≥ 6 months of continuous eligibility before index date (baseline period). All-cause and HIV-related healthcare costs were evaluated during the observation period (index date until earliest of end of continuous eligibility or data availability). Adjusted cost differences and adjusted cost ratios were estimated using multivariable regression models controlling for differences in baseline characteristics between cohorts.ResultsOverall, 22,061 individuals with HIV-1 and dispensed treatment with DTG/3TC (n = 590), DTG/ABC/3TC (n = 4355), BIC/FTC/TAF (n = 9068), EVG/COBI/FTC/TAF (n = 7081), or DRV/COBI/FTC/TAF (n = 967) were included. Most claims data were from men (mean age ~ 46 years). Mean unadjusted all-cause total healthcare costs per patient per month were significantly lower for DTG/3TC versus BIC/FTC/TAF and DRV/COBI/FTC/TAF, and mean unadjusted HIV-related healthcare costs per patient per month were significantly lower for DTG/3TC versus DRV/COBI/FTC/TAF. Cost differences were primarily driven by significantly lower pharmacy costs for DTG/3TC versus other regimens (P < 0.001), while medical costs were similar across cohorts. Results were similar among treatment-naive and treatment-experienced individuals. After adjusting for baseline covariates, significant adjusted cost differences were generally consistent with unadjusted findings. Adjusted cost ratios generally favored DTG/3TC for all-cause healthcare and HIV-related costs, with all pharmacy cost ratios favoring DTG/3TC (P < 0.001).ConclusionDolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-023-00848-4.

Objective: To describe patient characteristics, treatment patterns, and health care costs among patients diagnosed with major headache disorders overall and by type (tension-type headache [TTH], migraine, cluster headache [CH], or &gt;1 primary headache type), and secondarily to evaluate drug treatment patterns among triptan initiators with a major headache diagnosis. Methods: Using US claims data from January 2012 through December 2017, we identified adults with evidence of a major headache disorder: TTH, migraine, or CH; the first diagnosis date was deemed the index date. To evaluate triptan use specifically, patients who initiated triptans were identified; the first triptan claim date was deemed the index date. Patient characteristics, treatment patterns (concomitant treatments, adherence, number of fills), and annual health care costs data were obtained. Results: Of the 418,779 patients diagnosed with major headache disorders, the following 4 cohorts were created: TTH (8%), migraine (87%), CH (1%), and &gt;1 primary headache type (4%). The majority used analgesic (54–73%) and psychotropic (57–81%) drugs, primarily opioids (36–53%). Headache-related costs accounted for one-fifth of all-cause costs. Of the 229,946 patients who initiated triptans, the following 7 study cohorts were analyzed: sumatriptan (68%), rizatriptan (21%), eletriptan (5%), zolmitriptan (3%), naratriptan (2%), frovatriptan (1%), and almotriptan (&lt;1%). The major concomitant analgesic medication classes were opioids (41%) and nonsteroidal anti-inflammatory drugs (34%). Conclusion: The primary headache disorder treatment paradigm is complex, with significant variability. Predominant concomitant use of opioids and switching to opioids is of concern, necessitating solutions to minimize opioid use. Switching to non-oral/fast-acting or targeted preventive therapies should be considered.

<b>Introduction:</b> Omalizumab (OMA) is an add-on therapy used to treat moderate to severe allergic asthma patients uncontrolled on inhaled corticosteroids. Understanding characteristics of patients prescribed OMA is relevant for its cost-effective use. <b>Aims:</b> To investigate the socio-demographic, clinical and healthcare resource factors associated with the likelihood of receiving OMA treatment. <b>Methods:</b> We conducted a nested case-control study of patients (age ≥ 12) with moderate to severe allergic asthma from 2006–2012 in a US claims database. Cases (each OMA-recipient) were matched to controls (4 non-OMA-recipients) with equivalent time since cohort index date. Potential determinants for OMA prescription included: demographics, comorbidities, different measures of severity, resource utilization and costs. <b>Results:</b> From 22,952 moderate to severe allergic asthma patients, we identified 356 OMA cases then selected 1,424 controls. Patients were more likely to receive OMA 12 months pre-case/control date if they: were severe vs. moderate (OR_adj=1.60, 1.05-2.46); were persistently severe (over prior 12 months) (OR_adj=2.21, 1.30-3.77) or oscillating severe (OR_adj=3.52, 2.47-5.04) vs persistently moderate; had ≥1 episode of poor asthma control (OR_adj=2.85, 2.06-3.93);pre-case date had 1 unit increase in Charlson index (OR_adj=1.25, 1.12-1.39), or had $1000 increase in healthcare costs (OR_adj=1.16, 1.10-1.22). <b>Conclusions:</b> Disease severity was the strongest determinant of receiving OMA. However, patients that oscillate between moderate and severe disease appear to receive OMA more frequently than those that are persistently severe.

To estimate healthcare utilization and costs in amyloid light-chain (AL) amyloidosis. AL amyloidosis patients were identified in 2007-2015 claims databases if they had ≥1 inpatient/≥2 outpatient claims consistent with AL amyloidosis and received ≥1 AL-specific treatment. Descriptive statistics were reported. 50.1% (n=3670) were admitted ≥1 time during the year, 11.3% (n=827) ≥3times. From 2007 to2015, bortezomib use increased from 4.6to 25.3%; melphalan use decreased from 18.9to 2.0%; costs increased from 92,866 to $114,030. Among incident patients with at least 2years of follow-up, healthcare utilization and costs decreased from first to second year post-diagnosis. AL chemotherapy-based prescribing practices changed. Total annual healthcare costs increased over time among AL amyloidosis patients.

Costs Associated With Changes in Antidepressant Treatment in a Managed Care Population With Major Depressive Disorder

Objective:To compare changes in healthcare resource utilization and costs among members with painful diabetic peripheral neuropathy (pDPN), postherpetic neuralgia (PHN), or fibromyalgia (FM) in a commercial health plan implementing pregabalin step-therapy with members in unrestricted plans.Methods:Retrospective study of outcomes associated with implementation of a pregabalin step-therapy protocol using claims data from Humana (‘restricted’ cohort) and Thomson Reuters MarketScan (‘unrestricted’ cohort). Members aged 18–65 years receiving treatment for pDPN, PHN, or FM during 2008 or 2009 were identified; cohorts were matched on diagnosis and geographic region. Baseline to follow-up changes in healthcare resource utilization and costs were determined using difference-in-differences (DID) analysis. Statistical models adjusting for covariates explored relationships between restricted access and outcomes.Results:A total of 3876 restricted cohort members were identified and matched to 3876 unrestricted cohort members. FM was the predominant diagnosis (84.7%). The unrestricted cohort was older (mean = 49.0 (SD = 10.4) years vs 47.6 (SD = 10.5) years; p < 0.001), and had greater comorbidity (RxRisk-V score = 5.4 (SD = 3.2) vs 4.4 (SD = 2.9), p < 0.001) than the restricted cohort. Compared with the unrestricted cohort, the restricted cohort demonstrated a greater year-over-year decrease in pregabalin utilization (−2.6%, p = 0.008), and greater increases in physical therapy and disease-related outpatient utilization (3.7%, p = 0.010 and 3.6%, p = 0.022, respectively). There were no statistically significant net differences in all-cause or disease-related total healthcare, medical, or pharmacy costs between cohorts. After adjusting for baseline compositional differences between cohorts, restricted plan membership was associated with a net increase in all-cause medical ($1222; p = 0.016) and disease-related healthcare costs ($859; p = 0.002). Limitations include use of a combined analysis for pDPN, PHN, and FM, especially since the observed results were likely driven by FM; an inability to link the prescribing of a medication with the condition of interest, which is common to claims analyses; and lack of pain severity information.Conclusions:Implementation of a pregabalin step-therapy protocol resulted in lower pregabalin utilization, but this restriction was not associated with reductions in total healthcare costs, medical costs, or pharmacy costs.

Health Care Resource Utilization and Costs of CAR T Therapy in Patients with Large B-Cell Lymphoma: A Retrospective US Claims Database Analysis