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

INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen for HIV-1 treatment with long-term efficacy and good tolerability comparable to 3- or 4-drug regimens. This study evaluated DTG/3TC cost versus other standard single-tablet regimens during its first year of approval. METHODS: This retrospective study analyzed US claims data from adults with HIV-1. Eligibility criteria included ≥ 1 dispensing of DTG/3TC, DTG/abacavir (ABC)/3TC, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF, and darunavir (DRV)/COBI/FTC/TAF (index date was first dispensing) and ≥ 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. RESULTS: Overall, 22,061 individuals with HIV-1 and dispensed treatment with DTG/3TC (n = 590), DTG/ABC/3TC (n = 4355), BIC/FTC/TAF (n = 9068), EVG/COBI/FTC/TAF (n = 7081), or DRV/COBI/FTC/TAF (n = 967) were included. Most claims data were from men (mean age ~ 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). CONCLUSION: Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.

Treatment patterns, health care resource utilization, and costs associated with use of atypical antipsychotics as first vs subsequent adjunctive treatment in major depressive disorder.

BACKGROUND: Major depressive disorder (MDD) is a highly prevalent mental health condition associated with substantial economic burden. Inadequate response to first-line antidepressant monotherapy is common, with most patients requiring 1 or more changes in their treatment regimen. Adjunctive treatment with atypical antipsychotics (AAs) is a guideline-recommended treatment option in patients with inadequate response. However, patients often cycle through multiple treatments before receiving adjunctive AAs, and the economic impact of this delay is unknown. OBJECTIVE: To describe adjunctive treatment patterns among patients with MDD and compare health care resource utilization (HCRU) and costs between patients whose first adjunctive therapy included an AA and those who received an AA after other adjunctive treatments. METHODS: The Merative MarketScan Commercial Database (January 1, 2014, to June 30, 2019) was used to identify patients with administrative claims meeting the following inclusion criteria: adults with newly diagnosed MDD (first observed MDD diagnosis = index diagnosis date); continuous health insurance for at least 6 months pre-index and at least 3 months post-index; and initiation of MDD treatment within 60 days post-index. Lines of therapy (LOTs), HCRU, and costs were analyzed in patients who received AA adjunctive therapy, including those who initiated AAs as the first adjunctive treatment and those who initiated AAs as subsequent adjunctive treatment. RESULTS: Of 508,830 patients meeting inclusion criteria, 121,060 (24%) received adjunctive treatment and 20,797 (4%) received an AA as adjunctive therapy. Mean time to adjunctive therapy initiation was approximately 7.3 months for AA adjunctive therapy. Patients who initiated an AA as their first adjunctive therapy compared with patients who initiated an AA as their subsequent adjunctive therapy had fewer LOTs on average (0.9 LOTs vs 3.9 LOTs) and shorter time between index diagnosis date and initiation of an AA (5 months vs 12 months). Subsequent AA initiators had significantly greater HCRU than first AA initiators (driven primarily by outpatient visits) and incurred significantly higher total health care costs, with mean all-cause and mental health-related health care cost differences per patient per year of $2,441 and $1,762, respectively (both P < 0.05). CONCLUSIONS: Less than 5% of patients in this study received an adjunctive AA as part of their MDD treatment regimen, suggesting underutilization of this recommended therapeutic approach. Patients who received an AA as their first adjunctive treatment regimen had lower HCRU and health care costs than subsequent AA initiators. Along with published evidence of clinical benefits, this potential impact on economic burden should be considered when making treatment choices for patients with inadequate response to antidepressants.

Real-World Treatment Patterns and Switching Following Moderate/Severe Chronic Obstructive Pulmonary Disease Exacerbation in Patients with Commercial or Medicare Insurance in the United States.

Purpose: There is limited literature regarding real-world treatment patterns of patients with COPD, particularly since the introduction of once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in 2017. Here, we evaluated treatment patterns of patients with COPD before and after a COPD exacerbation. Patients and Methods: Retrospective, descriptive study using medical and pharmacy claims data and enrollment information from the Optum® Clinformatics® Data Mart database. Patients aged ≥40 years with ≥1 COPD exacerbation on or after September 18, 2017 were included. The index date was the last day of the first COPD exacerbation (ie day of visit for a moderate exacerbation or discharge date for a severe exacerbation). The baseline period was 12 months prior to index and the follow-up period (≥3 months) spanned from index until the earliest of health plan disenrollment, end of data availability (September 30, 2020), or death. Treatment patterns were evaluated during baseline and follow-up, with a focus on medication switching in the 90 days pre- and post-index. Results: COPD exacerbations were identified in 307,727 patients (125,942 severe; 181,785 moderate). Mean age at index was 72.8 years; 56.3% were female. Before and after first exacerbation, 37.7% and 48.2% of patients used ≥1 controller medication, respectively. In the 90 days pre-index, ICS, LABA, and LAMA medications were used by 27.5% of patients. Of these users, 64.3% remained on the same medication class, 21.7% discontinued, and 14.1% switched medication in the 90 days post-index. Among switchers, 44.0% switched to triple therapy. Most common switches were ICS/LABA to ICS/LABA/LAMA (20.7%) and LAMA to ICS/LABA/LAMA (16.4%). Conclusion: Many COPD exacerbations occur among patients not on controller medications. Although the percentage of patients receiving a controller medication increased following a first exacerbation, it remained below 50%. Of patients receiving controller medications pre-exacerbation, only a small proportion escalated to triple therapy post-exacerbation.

Healthcare Resource Utilization and Costs of Rivaroxaban Versus Warfarin Among Non-valvular Atrial Fibrillation (NVAF) Patients with Diabetes in a US Population.

INTRODUCTION: The healthcare resource utilization (HRU) and costs of oral anticoagulant-naïve patients with non-valvular atrial fibrillation (NVAF) and diabetes initiated on rivaroxaban or warfarin in the United States (US) has not been previously evaluated. METHODS: This retrospective study used data from the Optum's de-identified Clinformatics® Data Mart Database (1 January, 2012 to 30 September, 2021) to evaluate the HRU and costs of adult patients with NVAF and diabetes newly initiated on rivaroxaban or warfarin (on or after January 2013). Inverse probability of treatment weighting (IPTW) was used to adjust for confounding between cohorts. HRU and costs (USD 2021) were assessed per patient-year (PPY) post-treatment initiation. Weighted cohorts were compared using rate ratios (RR) from Poisson regression models, odds ratios (OR) from logistic regression models, and cost differences; 95% confidence intervals (CI) and p values were generated using non-parametric bootstrap procedures. RESULTS: After IPTW, 17,881 and 19,274 patients initiated on rivaroxaban and warfarin were included, respectively (mean age: 73 years; 40% female). During 12 months of follow-up, the rivaroxaban cohort had lower all-cause HRU PPY across all components, including lower rates of inpatient stays (RR: 0.84, 95% CI 0.81, 0.88), outpatient visits (RR: 0.67, 95% CI 0.66, 0.68), and 30 day hospital readmission (OR: 0.75, 95% CI 0.66, 0.83; all p < 0.001) compared to the warfarin cohort. Moreover, rivaroxaban was associated with medical cost savings PPY (mean cost difference: - $9306, 95% CI - $11,769, - $6607), which compensated for higher pharmacy costs relative to warfarin (mean cost difference: $5518, 95% CI $5193, $5839), resulting in significantly lower all-cause total healthcare costs for rivaroxaban versus warfarin (mean cost difference: - $3788, 95% CI - $6258, - $1035; all p < 0.001). CONCLUSION: Among NVAF patients with diabetes in a real-world US setting, rivaroxaban was associated with lower healthcare costs compared to warfarin.

The real-world health resource use and costs of misdiagnosing bipolar I disorder.

BACKGROUND: Misdiagnosis of bipolar I disorder (BP-I) as major depressive disorder (MDD) is common. This study evaluated healthcare resource utilization (HRU) and costs among BP-I patients who were initially misdiagnosed with MDD (misdiagnosed BP-I cohort) versus patients diagnosed with BP-I without a known prior MDD diagnosis (BP-I only cohort). METHODS: Data from IBM® MarketScan® Research Databases were used. The index date was the first MDD diagnosis for misdiagnosed patients or first BP-I diagnosis for BP-I only patients. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. All-cause and mental health (MH)-related HRU and costs were compared between weighted cohorts using rate ratios (RRs) and mean cost differences, respectively. Outcomes were reported per patient-year (PPY). Confidence intervals and P-values were calculated using non-parametric bootstrap procedures. RESULTS: Overall, 14,729 misdiagnosed BP-I and 16,072 BP-I only patients met criteria. Baseline characteristics were balanced across weighted cohorts. Misdiagnosed BP-I patients had significantly higher rates of hospitalizations, emergency room visits, and outpatient visits than BP-I only patients during follow-up (all-cause RRs: 1.94, 1.33, and 1.38, respectively, all P < .001; MH-related RRs: 2.19, 1.77, and 1.77, respectively, all P < .001). Similarly, misdiagnosed BP-I patients incurred significantly higher total healthcare costs PPY over follow-up (all-cause: $21,202 vs $14,661, cost difference = $6541; MH-related: $12,901 vs $6749, cost difference = $6152; both P < .001). Cost differences were even higher during the first year (all-cause = $7146; MH-related = $6619; both P < .001). LIMITATIONS: Claims database (e.g., coding inaccuracies); generalizability to uninsured patients. CONCLUSIONS: The prompt and correct diagnosis of BP-I may significantly reduce HRU and costs.

Disease burden and treatment adherence among children and adolescent patients with asthma.

OBJECTIVE: To assess asthma burden and medication adherence in a US de-identified patient level claims database. METHODS: This retrospective observational study used the IQVIA PHARMETRICS PLUS database to identify patients aged 5-17 years, diagnosed with asthma between 01/01/2012-09/30/2017 (asthma cohort), and those initiating treatment with twice-daily inhaled corticosteroids (ICS) or twice-daily ICS/long-acting beta2 agonists (LABA) (treatment cohorts; index date = first dispensing). Patient characteristics, asthma medication, and healthcare resource utilization were assessed over a 12-month baseline period. Treatment cohort endpoints were assessed in a 12-month follow-up period, including: adherence using proportion of days covered (PDC); persistence (no gap >45 days between dispensings). RESULTS: The asthma cohort included 186,868 patients (112,689 children, mean age 7.9 years; 74,179 adolescents, mean age 14.3 years). During baseline, 34.5% used ICS or ICS/LABA, 24% used oral corticosteroids, 11.1% had ≥1 asthma-related emergency department visit, 2.2% had ≥1 asthma-related hospitalization. Among treatment cohorts, 47,276 and 10,247 patients initiated twice-daily ICS and ICS/LABA, respectively (mean ages: 9.9; 12.5 years). Mean PDC adherence to twice-daily ICS and ICS/LABA was 30% and 34% at 6 months (PDC ≥0.8: 4.3%; 6.1%); 21% and 24% at 12 months (PDC ≥0.8: 1.8%; 2.8%). Persistence with twice-daily ICS and ICS/LABA was 10.1% and 14.2% at 6 months; 5.6% and 8.0% at 12 months. CONCLUSIONS: A large disease burden and unmet need exist among US children/adolescent asthma patients, evidenced by low use of, and poor adherence to, ICS-containing medication, the notable proportion of oral corticosteroid users, and higher-than-expected asthma-related emergency department and hospitalization rates.

Time-to-first exacerbation, adherence, and medical costs among US patients receiving umeclidinium/vilanterol or tiotropium as initial maintenance therapy for chronic obstructive pulmonary disease: a retrospective cohort study.

BACKGROUND: Adherence to chronic obstructive pulmonary disease (COPD) maintenance medication is important for managing symptoms and exacerbation risk, and is associated with reduced mortality, hospitalizations, and costs. This study compared on-treatment exacerbations, medical costs, and medication adherence in patients with COPD initiating treatment with umeclidinium/vilanterol (UMEC/VI) or tiotropium (TIO). METHODS: This retrospective matched cohort study selected patients from Optum's de-identified Clinformatics Data Mart database who initiated maintenance treatment with UMEC/VI or TIO between 01/01/2014 and 12/31/2017 (index date defined as the first dispensing). Eligible patients were ≥ 40 years of age and had ≥ 12 months continuous health plan coverage pre- and post-index; ≥ 1 medical claim for COPD pre-index or on the index date; no moderate/severe COPD-related exacerbations on the index date; no asthma diagnosis pre- or post-index; no maintenance medication fills containing inhaled corticosteroids, long-acting ß2-agonists, or long-acting muscarinic antagonists pre-index or on the index date; and no fills for both UMEC/VI and TIO on the index date. Outcomes included time-to-first (Kaplan-Meier analysis) and rates of on-treatment COPD-related moderate/severe exacerbations, medication adherence (proportion of days covered [PDC] and proportion of adherent patients [PDC ≥ 0.8]), and COPD-related medical costs per patient per month (PPPM). Propensity score matching was used to adjust for potential confounders. RESULTS: Each cohort included 3929 matched patients. Kaplan-Meier rates of on-treatment COPD-related exacerbations were similar between cohorts (hazard ratio at 12 months; overall: 0.93, moderate: 0.92, severe: 1.07; all p > 0.05). UMEC/VI versus TIO initiators had significantly higher adherence (mean PDC: 0.44 vs 0.37; p < 0.001; proportion with PDC ≥ 0.8: 22.0% vs 16.4%; p< 0.001) and significantly lower mean on-treatment COPD-related total medical costs ($867 vs $1095 PPPM; p = 0.028), driven by lower outpatient visit costs. CONCLUSIONS: These findings provide valuable information for physicians considering UMEC/VI or TIO as initial maintenance therapy options for patients with COPD.

Healthcare costs of patients with cancer stratified by Khorana score risk levels.

AIMS: Patients with cancer are at high risk of venous thromboembolism (VTE), which entails a high economic burden. The risk of cancer-associated VTE can be assessed using the Khorana score (KS), a validated VTE risk prediction algorithm. This study compared healthcare costs associated with different KS in a population of patients newly diagnosed with cancer. METHODS: The Optum Clinformatics DataMart database (01/01/2012-09/30/2017) was used to select adult patients with ≥1 hospitalization or ≥2 outpatient claims with a cancer diagnosis (index date) initiated on systemic therapy or radiation therapy. Patients were classified in mutually exclusive cohorts based on KS (i.e. KS = 0, 1, 2 or ≥3). The observation period spanned from index to the earliest among the end of data availability, death, end of insurance coverage, or 12 months. RESULTS: In total 6,194 patients (KS = 0: 2,488; KS = 1: 2,125; KS = 2: 1,074; KS ≥ 3: 507) were included. On average, patients were aged 68 years, 48-52% were female, and the Quan-Charlson comorbidity index ranged between 1.1 and 1.4. Over the observation period, all-cause total healthcare costs per patient per month (PPPM) were $8,826 (KS = 0), $11,598 (KS = 1), $14,028 (KS = 2), and $16,211 (KS ≥ 3). Using the KS = 0 cohort as a reference, adjusted PPPM costs were $2,506, $4,775, and $6,452 higher in the KS = 1, KS = 2, and KS ≥ 3 cohorts, respectively. Hospitalization and outpatient costs were the main drivers of these differences. Similar results were found for VTE-related costs, which represented 4-11% of the total all-cause cost difference between KS cohorts. LIMITATIONS: Residual confounders; results may not be generalized to patients with other insurance plans or those who received treatments other than systemic therapy or radiation therapy. CONCLUSIONS: This real-world analysis found that cancer patients at higher risk of VTE (based on KS) incurred significantly greater all-cause and VTE-related healthcare costs compared with cancer patients at lower risk of VTE.

Umeclidinium/Vilanterol Compared with Fluticasone Propionate/Salmeterol, Budesonide/Formoterol, and Tiotropium as Initial Maintenance Therapy in Patients with COPD Who Have High Costs and Comorbidities.

BACKGROUND: Comorbidities in patients with chronic obstructive pulmonary disease (COPD) are associated with increased medical costs and risk of exacerbations. This study compared COPD-related medical costs and exacerbations in high-cost, high-comorbidity patients with COPD receiving initial maintenance treatment (IMT) with umeclidinium/vilanterol (UMEC/VI) versus fluticasone propionate/salmeterol (FP/SAL), budesonide/formoterol (B/F), or tiotropium (TIO). METHODS: This retrospective, matched cohort study identified patients from Optum's de-identified Clinformatics Data Mart database who initiated UMEC/VI, FP/SAL, B/F, or TIO between January 1, 2014 and December 31, 2018 (index date defined as date of the first fill). Eligibility criteria included age ≥40 years at index, ≥1 pre-index COPD diagnosis, no pre-index asthma diagnosis, 12 months of continuous insurance coverage pre-index, and high pre-index costs (≥80th percentile of IMT population) and comorbidities (Quan-Charlson comorbidity index ≥3). Propensity score matching was used to control for potential confounders. On-treatment COPD-related medical costs (primary endpoint) and exacerbations were evaluated. RESULTS: Matched cohorts were well balanced on baseline characteristics (UMEC/VI vs FP/SAL: n=1194 each; UMEC/VI vs B/F: n=1441 each; UMEC/VI vs TIO: n=1277 each). Patients receiving UMEC/VI had significantly lower COPD-related medical costs versus FP/SAL (difference: $6587 per patient per year; P=0.048), and numerically lower costs versus B/F and TIO. Patients initiating UMEC/VI had significantly lower risk of COPD-related severe exacerbation versus FP/SAL (hazard ratio [95% CI]: 0.78 [0.62, 0.98]; P=0.032), B/F (0.77 [0.63, 0.95]; P=0.016), and TIO (0.79 [0.64, 0.98]; P=0.028). The rate of COPD-related severe exacerbations was significantly lower with UMEC/VI versus FP/SAL (rate ratio [95% CI]: 0.73 [0.59, 0.91]; P=0.008) and B/F (0.73 [0.59, 0.93]; P=0.012), and numerically lower versus TIO (0.83 [0.68, 1.04]; P=0.080). CONCLUSION: These findings suggest that high-cost, high-comorbidity patients with COPD receiving UMEC/VI compared with FP/SAL, B/F, and TIO as IMT may have lower medical costs and exacerbation risk.

Treatment patterns, healthcare resource utilization, and costs of patients diagnosed with primary mediastinal B-cell lymphoma in the United States.

AIMS: With the advent of ICD-10-CM codes for PMBCL on 10/01/2015, assessment of treatment patterns and healthcare burden among US patients is possible. This study sought to describe the real-world treatment patterns and economic outcomes of patients with PMBCL. METHODS: Data from the Optum Clinformatics DataMart database was used (January 2013-March 2018). Patients with a first PMBCL ICD-10-CM diagnosis (with or without an antecedent ICD-10-CM diagnosis of DLBCL/other lymphoma, which may have been assigned before PMBCL confirmation) after 10/01/2015 (index date) and no ICD-9-CM diagnosis code for unspecified PMBCL/DLBCL were identified as incident patients. Those with PMBCL ICD-10-CM and unspecified ICD-9-CM diagnosis for PMBCL/DLBCL before 10/01/2015 (index date) were identified as prevalent patients. Patients were observed from the index date up to the earliest among death, end of data availability, or end of continuous health plan enrollment. An adapted algorithm was used to identify lines of therapy (LOT). RESULTS: Among 118 incident and 30 prevalent PMBCL patients, 14% and 20% of patients received ≥2 LOTs, respectively. In incident patients, 48% received ≥1 LOT, 14% ≥2, and 4% ≥3 LOTs. Among prevalent patients, 63% received ≥1 LOT and 20% ≥2 LOTs. The most frequently recorded 1 L therapy was R-CHOP both among incident and prevalent patients. Mean total healthcare costs for incident and prevalent patients were $149,340 and $92,799 per patient per year, respectively, with higher costs ≤12 months ($187,241 and $167,553). Outpatient costs were the main driver (accounting for 60.5% and 64.6% for incident and prevalent patients, respectively). LIMITATIONS: Potential underuse of ICD-10-CM codes shortly after discontinuation of ICD-9-CM codes in 01/2015; regimens identified for each LOT using the claims-based algorithm may not reflect the regimen administered. CONCLUSION: The multiple LOTs necessary for a sizeable minority of patients and the high costs of care highlight the significant unmet needs of PMBCL patients.

Real-World Characteristics, Treatment Patterns, Health Care Resource Use, and Costs of Patients with Diffuse Large B-Cell Lymphoma in the U.S.

BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) represents the most common subtype of non-Hodgkin lymphoma in the U.S., but current real-world data are limited. This study was conducted to describe real-world characteristics, treatment patterns, health care resource utilization (HRU), and health care costs of patients with treated DLBCL in the U.S. MATERIALS AND METHODS: A retrospective study was conducted using the Optum Clinformatics Data Mart database (January 2013 to March 2018). Patients with an International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis for DLBCL after October 2015 and no prior International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis for unspecified DLBCL or primary mediastinal large B-cell lymphoma were classified as incident; those with such codes were classified as prevalent. An adapted algorithm identified lines of therapy (e.g., first line [1L]). All-cause HRU and costs were calculated per-patient-per-year (PPPY) among patients with a ≥1L. RESULTS: Among 1,877 incident and 651 prevalent patients with ≥1L, median age was 72 years and 46% were female. Among incident patients, 22.6% had at least two lines (2L), whereas 38.4% of prevalent patients had ≥2L. The most frequent 1L therapy was rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Incident patients had 1.3 inpatient and 42.0 outpatient (OP) visits PPPY, whereas prevalent patients had 0.8 and 31.3 visits PPPY, respectively. Total costs were $137,156 and $81,669 PPPY for incident and prevalent patients, respectively. OP costs were the main driver of total costs at $88,202 PPPY, which were higher within the first year. CONCLUSION: This study showed that a large portion of patients require additional therapy after 1L treatment to manage DLBCL and highlighted the substantial economic burden of patients with DLBCL, particularly within the first year following diagnosis. IMPLICATIONS FOR PRACTICE: Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) carry a substantial clinical and economic burden. A large portion of these patients require additional therapy beyond first-line treatment. There is significant unmet need among patients with DLBCL who require additional therapy beyond first-line treatment. Patients who do not respond to first-line therapy and are not eligible for transplants have very high health care resource utilization and costs, especially in the first 12 months following initiation of treatment.

Healthcare costs of NVAF patients treated with rivaroxaban and apixaban in the US.

OBJECTIVES: To provide the most current assessment of real-world healthcare resource utilization (HRU) and costs among patients with non-valvular atrial fibrillation (NVAF) who newly initiated rivaroxaban and apixaban using a large US database. MATERIAL AND METHODS: A retrospective weighted cohort design was used with healthcare insurance claims from the Optum Clinformatics Data Mart databases (January 2012-December 2018). The index date was defined as the first dispensing of rivaroxaban or apixaban. Adult NVAF patients with an index date on or after 1 January 2016, ≥ 12 months of continuous eligibility before the index date and ≥ 1 month after, and without prior use of oral anticoagulant were included. The observation period spanned from the index date to the earliest of the end of data availability, end of insurance coverage, or death. Inverse probability of treatment weighting (IPTW) was used to adjust for differences in baseline characteristics between cohorts. All-cause healthcare resource utilization (HRU), including hospitalization, emergency room, and outpatient visits, and healthcare costs, including medical and pharmacy costs, were evaluated from the payer's perspective during the observation period up to 18 and 24 months, separately. RESULTS: In total, 23,822 rivaroxaban and 53,666 apixaban users were included. After weighting, all baseline characteristics were well balanced between cohorts (mean age: 73.8 years, female: 46.6% in both cohorts). Up to 18 months of follow-up, rivaroxaban users incurred significantly lower total healthcare costs compared to apixaban users (cost difference = -$1,121; p = 0.020), driven by significantly lower rates of outpatient hospital visits and associated costs (cost difference = -$1,579; p < 0.001). Similar results were found in the analysis conducted for up to 24 months of follow-up (total cost difference = ‒$1,111; p = 0.020). CONCLUSIONS: In this large retrospective analysis, patients with NVAF initiated on rivaroxaban incurred significantly lower healthcare costs compared to those initiated on apixaban, which were primarily driven by significantly lower outpatient visits and costs during the 18- and 24-month follow-up periods.

Healthcare costs of stroke and major bleeding in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants.

Objective: To assess long-term healthcare costs related to ischemic stroke and systemic embolism (stroke/SE) and major bleeding (MB) events in patients with non-valvular atrial fibrillation (NVAF) treated with non-vitamin K antagonist oral anticoagulants (NOACs). Materials and methods: Optum's Clinformatics Data Mart database from 1/2009-12/2016 was analyzed. Adult patients with ≥1 stroke/SE hospitalization (index date) were matched 1:1 to patients without stroke/SE (random index date), based on propensity scores. Patients with an MB event were matched to patients without MB. All patients had an NOAC dispensing overlapping index date, ≥12 months of eligibility pre-index date, and ≥1 NVAF diagnosis. The observation period spanned from the index date until the earliest date of death, switch to warfarin, end of insurance coverage, or end of data availability. Mean costs were evaluated: (1) per-patient-per-year (PPPY) and (2) at 1, 2, 3, and 4 years using Lin's method. Results: The cost differences were, respectively, $48,807 and $28,298 PPPY for NOAC users with stroke/SE (n = 1,340) and those with MB (n = 3,774) events compared to controls. Cost differences of patients with vs without stroke/SE were $49,876, $51,627, $57,822, and $60,691 at 1, 2, 3, and 4 years post-index, respectively (p < 0.001). These cost differences were $31,292, $35,658, $44,069, and $47,022 for patients with vs without MB after 1, 2, 3, and 4 years post-index, respectively (p < 0.001). Limitations: Limitations include unobserved confounders, coding and/or billing inaccuracies, limited sample sizes over longer follow-up, and the under-reporting of mortality for deaths occurring after 2011. Conclusions: The incremental healthcare costs incurred by patients with vs without stroke/SE was nearly twice as high as those of patients with vs without MB. Moreover, each additional year up to 4 years after the first event was associated with an incremental cost for patients with a stroke/SE or MB event compared to those without an event.

Medication adherence and persistence in chronic obstructive pulmonary disease patients receiving triple therapy in a USA commercially insured population.

INTRODUCTION: This longitudinal, retrospective cohort study of patients with COPD describes baseline characteristics, adherence, and persistence following initiation of inhaled corticosteroids (ICS)/long-acting ß2-agonists (LABA)/long-acting muscarinic antagonists (LAMA) from multiple inhaler triple therapy (MITT). METHODS: Patients aged ≥40 years receiving MITT between January 2012 and September 2015 were identified from the IQVIA™ Real-world Data Adjudicated Claims-USA database. MITT was defined as subjects with ≥1 overlapping days' supply of three COPD medications (ICS, LABA, and LAMA). Adherence (proportion of days covered, PDC) and discontinuation (defined as a gap of 1, 30, 60, or 90 days of supply in any of the three components of the triple therapy) were calculated for each patient over 12 months of follow-up. In addition, analyses were stratified by number of inhalers. RESULTS: In total, 14,635 MITT users were identified (mean age, 62 years). Mean PDC for MITT at 12 months was 0.37%. Mean PDC for the ICS/LABA and LAMA component at 12 months was 49% (0.49±0.31; median, 0.47) and 54% (0.54±0.33; 0.56), respectively. The proportion of adherent patients (PDC ≥0.8) at 12 months was 14% for MITT. Allowing for a 30-day gap from last day of therapy, 86% of MITT users discontinued therapy during follow-up. CONCLUSION: Patients with COPD had low adherence to and persistence with MITT in a real-world setting. Mean PDC for each single inhaler component was higher than the mean PDC observed with MITT. Reducing the number of inhalers may improve overall adherence to intended triple therapy.

Treatment persistence and hospitalization rates among patients with schizophrenia: a quasi-experiment to evaluate a patient information program.

OBJECTIVE: The effective treatment of schizophrenia requires continuous antipsychotic maintenance therapy. However, poor persistence with treatment is common among patients with schizophrenia. The objective of this study was to compare persistence and hospitalization rates among patients with schizophrenia treated with long-acting injectable (LAI) antipsychotics (i.e. paliperidone palmitate and risperidone) and enrolled in a patient information program (program cohort) with patients treated with oral antipsychotics (OAs) who were not enrolled in a patient information program (nonprogram cohort). RESEARCH DESIGN AND METHODS: Using a quasi-experimental design, data from chart reviews (for program patients) and Medicaid claims (for nonprogram patients) was analyzed. Patients were eligible if they had ≥12 months of pre-index data, ≥6 months of post-index data, and no hospitalization at index. MAIN OUTCOME MEASURES: Persistence and hospitalization rates were assessed at 6 months post-index. Propensity score matching was used to control for observed differences in demographics and baseline clinical characteristics. Odds ratios (ORs) were calculated using generalized estimating equation models and adjusted for matched pairs and propensity score. RESULTS: A total of 102 program patients were matched to 408 nonprogram patients with similar baseline characteristics. Adjusted ORs indicated that the persistence rate at 6 months was significantly higher for the program cohort (88.2%) versus the nonprogram cohort (43.9%; OR: 9.70; P < .0001). The 6 month post-index hospitalization rate for the program cohort (14.7%) was significantly lower versus the nonprogram cohort after adjustments (22.5%; OR: 0.55; P = 0.0321). LIMITATIONS: The data for the program and nonprogram patients were from two different and independent data sources (healthcare claims and chart reviews, respectively). Results were based on a relatively small number of program LAI patients. CONCLUSION: Program patients treated with LAI antipsychotics had higher persistence rates and significantly lower adjusted hospitalization rates compared with nonprogram patients treated with OAs.

Hospitalizations and Other Health Care Resource Utilization Among Patients with Deep Vein Thrombosis Treated with Rivaroxaban Versus Low-molecular-weight Heparin and Warfarin in the Outpatient Setting.

PURPOSE: Compared with low-molecular-weight heparin (LMWH) and warfarin, the oral anticoagulant rivaroxaban has advantages, such as simplified care, that may lead to less health care resource utilization. METHODS: A retrospective, matched-cohort analysis was conducted using claims dated between January 2011 and December 2013 from the Truven Health Analytics MarketScan databases. Adult patients who had a primary diagnosis of deep vein thrombosis (DVT) during an outpatient or emergency room (ER) visit after November 2, 2012, and who were treated with rivaroxaban or LMWH/warfarin on the same day, were identified. Patients were observed over 1, 2, 3, and 4 weeks after the DVT diagnosis. The mean numbers of hospitalizations for all causes and for venous thromboembolism (VTE) (which included those for DVT or pulmonary embolism), as well as other health care resource utilization (ER, outpatient, and other visits), and the associated health care costs and pharmacy costs, were evaluated and compared between cohorts using the Lin method. FINDINGS: All of the 512 rivaroxaban-treated patients were well matched with the LMWH/warfarin-treated patients. The mean numbers of all-cause hospitalizations were significantly lower in the rivaroxaban users compared with those in the LMWH/warfarin users over 1 week (0.012 vs 0.032; P = 0.044) and 2 weeks (0.022 vs 0.048; P = 0.040). The corresponding mean numbers of VTE-related hospitalizations were significantly lower with rivaroxaban over 1 week (0.008 vs 0.028; P = 0.020), 2 weeks (0.016 vs 0.042; P = 0.020), and 4 weeks (0.034 vs 0.068; P = 0.036). The mean numbers of all-cause and VTE-related outpatient visits were also significantly lower in rivaroxaban users compared with those in LMWH/warfarin users over 1, 2, 3, and 4 weeks (all, P < 0.001). In terms of all-cause and VTE-related ER and other visits, no statistically significant differences were found between cohorts over the first 4 weeks. The associated mean all-cause total health care costs were significantly lower in the rivaroxaban users compared with those in the LMWH/warfarin users over 1 week (US $2332 vs $3428; P < 0.001) and 2 weeks ($3108 vs $4524; P < 0.001); moreover, significantly lower mean costs related to all-cause hospitalizations (weeks 1 and 2) and pharmacy (weeks 1-4) were observed in patients treated with rivaroxaban, while no differences were found in costs related to ER visits (weeks 1-4), outpatient visits (weeks 1-4), or other visits (with the exception of week 1). IMPLICATIONS: Patients with DVT treated with rivaroxaban after an outpatient/ER visit had significantly lower mean numbers of hospitalizations and outpatient visits, as well as lower mean total, hospitalization, and pharmacy costs during the first 2 weeks of treatment compared with those in matched LMWH/warfarin users.

Predictors of high healthcare resource utilization and liver disease progression among patients with chronic hepatitis C.

BACKGROUND: Since hepatitis C virus therapy is typically prioritized for patients with more advanced disease, predicting which patients will progress could help direct scarce resources to those likely to benefit most. This study aims to identify demographics and clinical characteristics associated with high healthcare resource utilization (HRU) and liver disease progression among CHC patients. METHODS: Using health insurance claims (January 2001-March 2013), adult patients with ≥2 CHC claims (ICD-9-CM: 070.44 or 070.54), and ≥6 months of continuous insurance coverage before and ≥36 months after the first CHC diagnosis were included. Patients with human immunodeficiency virus were excluded. Generalized estimating equations were used to identify the demographic and clinical characteristics of being in the 20% of patients with the highest HRU. Factors predicting liver disease progression were also identified. RESULTS: In the study population (n = 4898), liver disease severity and both CHC- and non-CHC-related comorbidities and conditions were strong predictors of high healthcare costs, with odds ratios (ORs; 95% confidence interval [CI]) for ≥2 CHC-related and ≥2 non-CHC-related comorbidities/conditions of 2.78 (2.48-3.12) and 2.19 (1.76-2.72), respectively. CHC- and non-CHC-related comorbidities and conditions were also strong predictors of liver disease progression with ORs (95% CI) for ≥2 CHC-related and ≥2 non-CHC-related comorbidities and conditions of 2.18 (1.83-2.60) and 1.50 (1.14-1.97), respectively. LIMITATIONS: Potential inaccuracies in claims data, information or classification bias, and findings based on a privately insured population. CONCLUSION: This study suggests that CHC patients with high healthcare resource utilization have a high level of comorbidity at baseline and also that non-CHC comorbidities and conditions are strong predictors of high HRU. Non-cirrhotic CHC patients with one or more comorbidities are at high risk of progressing to cirrhosis or end-stage liver disease.

Costs of hospital visits among patients with deep vein thrombosis treated with rivaroxaban and LMWH/warfarin.

BACKGROUND: For many years, the standard of care for patients diagnosed with deep vein thrombosis (DVT) has been low-molecular-weight heparin (LMWH) bridging to an oral Vitamin-K antagonist (VKA). The availability of new non-VKA oral anticoagulants (NOAC) agents as monotherapy may reduce the likelihood of hospitalization for DVT patients. OBJECTIVE: To compare hospital visit costs of DVT patients treated with rivaroxaban and LMWH/warfarin. METHODS: A retrospective claim analysis was conducted using the MarketScan Hospital Drug Database for care provided between January 2011 and December 2013. Adult patients using rivaroxaban or LMWH/warfarin with a primary diagnosis of DVT during the first day of a hospital visit were identified (i.e., index hospital visit). Based on propensity-score methods, historical LMWH/warfarin patients (i.e., patients who received LMWH/warfarin before the approval of rivaroxaban) were matched 4:1 to rivaroxaban patients. The hospital-visit cost difference between these groups was evaluated for the index hospital visit, as well as for total hospital-visit costs (i.e., including index and subsequent hospital visit costs). RESULTS: All rivaroxaban users (n = 134) in the database were well-matched with four LMWH/warfarin users (n = 536). The mean hospital-visit costs were $5257 for the rivaroxaban cohort and $6764 in the matched-cohort of patients using LMWH/warfarin. The $1508 cost difference was statistically significant between cohorts (95% CI = [-$2296; -$580]; p-value = 0.002). Total hospital-visit costs were lower for rivaroxaban compared to LMWH/warfarin users within 1, 2, 3, and 6 months after index visit (significantly lower within 1 and 3 months, p-values <0.05) LIMITATIONS: Limitations were inherent to administrative-claims data, completeness of baseline characteristics, adjustments restricted to observational factors, and lastly the sample size of the rivaroxaban cohort. CONCLUSION: The availability of rivaroxaban significantly reduced the costs of hospital visits in patients with DVT treated with rivaroxaban compared to LMWH/warfarin.

Economic outcomes with prasugrel versus clopidogrel in acute coronary syndrome patients: observations from prasugrel users and matched clopidogrel users.

OBJECTIVE: To compare healthcare costs between clopidogrel and prasugrel over 30-day and 365-day periods after discharge from the hospital or emergency room (ER) in patients treated with prasugrel who were hospitalized or had an ER visit for an acute coronary syndrome (ACS) event. METHODS: This retrospective observational study was based on claims from January 2009-July 2012 in the Truven Health Analytics MarketScan database. Clopidogrel patients were propensity-score matched 1:1 to prasugrel-treated patients. Lin's frequentist cost history method for censored data and Bayesian zero-inflated gamma regression models were used to analyze healthcare costs. RESULTS: The clopidogrel/prasugrel matched-cohort included 10,963 well-matched pairs of patients. Lin's frequentist analysis showed that outpatient visit costs were significantly lower for clopidogrel than prasugrel after 30 days of follow-up. At 30 days, Bayesian data analysis showed strong evidence that clopidogrel was superior to prasugrel for all-cause and ACS-related hospitalization costs and showed very strong evidence that clopidogrel was superior to prasugrel for all-cause and ACS-related outpatient visit costs. At 365 days, Bayesian data analysis showed strong evidence that clopidogrel was superior to prasugrel for all-cause outpatient visit costs and very strong evidence that clopidogrel was superior to prasugrel for ACS-related outpatient visit costs. Point estimates of the all-cause and ACS-related ER visit costs at 30 days and 365 days were similar, but statistical results were inconclusive because of the large variability in this outcome variable. CONCLUSION: Based on retrospective observational data in a real-world setting, all-cause and ACS-related hospitalization and outpatient visit costs were lower for clopidogrel than prasugrel over 30 days after discharge from a hospitalization or ER visit associated with ACS in patients treated with prasugrel. At 365 days the difference in all-cause and ACS-related outpatient costs remained, but there was little evidence of a difference in either all-cause or ACS-related hospitalization costs.

Daily costs of hospitalization in non-valvular atrial fibrillation patients treated with anticoagulant therapy.

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in the US, with an estimated prevalence of 2.7-6.1 million persons in 2010. OBJECTIVE: This study evaluates the progression of daily hospitalization costs among non-valvular atrial fibrillation (NVAF) patients treated with anticoagulant therapy. METHODS: A claims analysis was conducted with Premier Perspective Comparative Hospital Database records from January 2009-March 2013. Patients of 18 years or older who were diagnosed with NVAF and used anticoagulant therapy were studied. Treatment patterns and mean daily costs of hospitalization per patient as well as total costs of hospitalization were reported. Comparisons of mean daily costs with those of the previous day were presented to identify statistical cost differences between hospitalization days. RESULTS: A total of 375,560 patients were identified; 67,017 with AF as admitting/primary diagnosis, and 308,543 with AF as a secondary diagnosis. The mean age of the overall population, primary AF diagnosis cohort, and secondary AF diagnosis cohort was 73.8, 67.9, and 75.0 years, while their proportion of females was 46.3%, 45.6%, and 46.5%, respectively. The mean length of stay was 6.8 days, 3.7 days, and 7.5 days for the overall population, the primary AF diagnosis cohort, and the secondary AF diagnosis cohort, respectively. For all cohorts, mean daily costs stabilized on the third day (overall population: $2103; primary AF diagnosis cohort: $1505; secondary AF diagnosis cohort: $2208). LIMITATIONS: Claims data may have contained inaccuracies or omissions in coded procedures, diagnoses, or pharmacy claims. CONCLUSION: The study showed that daily hospitalization costs for NVAF patients stabilized on the third day of hospitalization and that any reduction or prolongation in hospital length of stay could have a significant impact on the cost burden associated with AF.