Inpatient Admissions and Re-Admissions in Medicare Beneficiaries Initiating Umeclidinium/Vilanterol or Tiotropium Therapy.

Purpose: Patients with chronic obstructive pulmonary disease (COPD) who are hospitalized are more likely to die from their illness and have increased likelihood of re-admission than those who are not. Subsequent re-admissions further increase the burden on healthcare systems. This study compared inpatient admission rates and time-to-first COPD-related inpatient admission among Medicare beneficiaries with COPD indexed on umeclidinium/vilanterol (UMEC/VI) versus tiotropium (TIO). Patients and Methods: This retrospective study used the All-Payer Claims Database to investigate hospital admission and re-admission outcomes in Medicare beneficiaries with COPD with an initial pharmacy claim for UMEC/VI or TIO from 1 January 2015 to 28 February 2020. Inpatient admissions, baseline, and follow-up variables were assessed in patients indexed on UMEC/VI and TIO after propensity score matching (PSM), with time-to-first on-treatment COPD-related inpatient admission as the primary endpoint. Re-admissions were assessed among patients with a COPD-related inpatient admission in the 30- and 90-days post-discharge. Results: Post-PSM, 7152 patients indexed on UMEC/VI and 7069 on TIO were eligible for admissions analysis. The mean (standard deviation [SD]) time-to-first COPD-related inpatient admission was 46.71 (87.99) days for patients indexed on UMEC/VI and 44.96 (85.90) days for those on TIO (p=0.06). The mean (SD) number of inpatient admissions per patient was 1.24 (2.92) for patients indexed on UMEC/VI and 1.26 (3.05) for those on TIO (p=0.49). Proportion of patients undergoing re-admissions was similar between treatments over both 30 and 90 days, excluding a significantly lower proportion of patients indexed on UMEC/VI than those indexed on TIO for COPD-related re-admissions for hospital stays of 4-7 days and 7-14 days, and all-cause re-admissions for stays of 4-7 days. Conclusion: Patients with COPD using Medicare in the US and receiving UMEC/VI or TIO reported similar time-to-first inpatient admission and similar proportion of re-admissions.

Prevalence and characteristics of hepatitis delta virus infection in patients with hepatitis B in the United States: An analysis of the All-Payer Claims Database.

BACKGROUND AND AIMS: HDV leads to the most severe form of viral hepatitis; however, the prevalence of HDV is not well understood. Using real-world data from the All-Payer Claims Database, this study estimates the prevalence of HBV/HDV infection among the chronic HBV population and describes patient/clinical characteristics for adults with HBV/HDV infection in the United States. APPROACH AND RESULTS: Adults (≥18 years) with ≥1 inpatient claim or ≥2 outpatient claims for HDV infection or HBV in the All-Payer Claims Database from January 1, 2014, to December 31, 2020, were identified. HDV prevalence was calculated as the proportion of patients with HBV/HDV infection among total patients with HBV infection. Patient characteristics, socioeconomic status, advanced liver complications (eg, cirrhosis, HCC), and comorbidities were assessed. A total of 6719 patients were diagnosed with HBV/HDV among 144,975 with HBV and 12 months of continuous data, for a prevalence of 4.6%. At diagnosis, 31.7% of patients with HBV/HDV had advanced liver complications, including compensated cirrhosis (16.3%) and decompensated cirrhosis (10.4%). Diabetes (50.5%), hypertension (49.8%), and HIV infection (30.9%) were the top 3 comorbidities. CONCLUSIONS: In a large database capturing approximately 80% of the US-insured population, HBV/HDV infection prevalence was 4.6% among adults infected with HBV. Patients infected with HDV had high rates of baseline liver complications and other comorbidities at the time of diagnosis, suggesting potentially delayed diagnosis and/or treatment. Earlier identification of HBV/HDV infection among the population with HBV may provide opportunities to improve linkage to care and treatment, thereby reducing the risk of liver-related morbidity and mortality.

The cost of flares among patients with systemic lupus erythematosus with and without lupus nephritis in the United States.

OBJECTIVE: Assess healthcare costs associated with systemic lupus erythematosus (SLE) flares among patients with and without lupus nephritis (LN). METHODS: This retrospective cohort study used medical and pharmacy claims data from the United States-based Optum Clinformatics database to identify adults with SLE between 1 January 2016, and 31 December 2018. Index was the date of a patient's earliest SLE diagnosis claim during the identification period. Patients were categorized based on ICD-9/-10 diagnosis codes into one of two cohorts: SLE with LN (LN) and SLE without LN (non-LN). Baseline characteristics were assessed in the 12 months preceding index (baseline period). The presence, severity, and healthcare costs (in 2019 US dollars) of flares were determined in the 12 months following index (follow-up period). RESULTS: Overall, 11,663 patients with SLE were included (LN, n = 2916; non-LN, n = 8747). During the baseline period, a greater proportion of patients in the LN cohort versus non-LN cohort had a Charlson Comorbidity Index score ≥4 (72.5% vs 13.7%) and inpatient stays (41.0% vs 17.0%). A total of 12,190 flares were identified during the follow-up period (LN, 3494; non-LN, 8696). A greater proportion of flares experienced by patients with LN versus those without LN were moderate (61.2% vs 53.6%) and severe (10.6% vs 5.4%). The mean (standard deviation [SD]) number of moderate and severe flares per patient was greater among the LN cohort than the non-LN cohort (moderate: LN, 1.8 [1.2] and non-LN, 1.4 [1.2]; severe: LN, 0.2 [0.6] and non-LN, 0.1 [0.3]). The mean (SD) total healthcare costs associated with SLE flares of any severity were greater for patients with LN (LN, $5842 [9604]; non-LN, $2600 [4249]). The mean (SD) cost per flare increased with severity (mild: LN, $2753 [4640] and non-LN, $1606 [2710]; moderate: LN, $4561 [7156] and non-LN, $2587 [3720]; severe: LN, $29,148 [27,273] and non-LN, $14,829 [19,533]). CONCLUSIONS: Patients with SLE with LN have greater healthcare costs than those without LN. Flares among patients with LN were more frequent, severe, and costly than among patients without LN. This highlights the need for treatments that prevent or reduce flares among patients with SLE, both with and without LN.

Impact of Mepolizumab on Exacerbations in the US Medicare Population.

BACKGROUND: Asthma is a common chronic respiratory disorder associated with significant disease and economic burden. Mepolizumab is an anti-IL-5 mAb approved for use as an add-on treatment in patients with severe eosinophilic asthma. OBJECTIVE: To assess the impact of mepolizumab initiation on asthma exacerbation frequency, oral corticosteroid (OCS) use, and asthma exacerbation-related costs in a US Medicare population. METHODS: This was a retrospective cohort study of mepolizumab claims from patients with asthma in the Centers for Medicare and Medicaid Services Medicare database carried out between January 2016 and December 2018. The index date (first claim for mepolizumab) was required to occur between January and December 2017. The baseline and follow-up periods were the 12 months before and 12 months after the index, respectively. Outcomes included changes in the proportion of patients experiencing exacerbations (primary), OCS use (secondary), and asthma exacerbation-related costs during the baseline and follow-up periods. RESULTS: The study identified 1,278 patients (mean age, 67.9 years; 65% female) with one or more prescription or administration claim for mepolizumab who were eligible for study inclusion. There was a significant relative reduction in the proportion of patients with an asthma exacerbation (27%; P < .0001) in the follow-up versus baseline period. Similarly, a lower proportion of patients received OCS for asthma (16% relative reduction; P < .0001), fewer patients were chronic OCS users (5 mg/day or more; 48% relative reduction; P < .0001), and there was a significant decrease in asthma exacerbation-related costs (total reduction, $888; P = .0002) during the follow-up versus the baseline period. CONCLUSION: Mepolizumab reduced exacerbations, OCS use, and exacerbation-related healthcare costs in a US Medicare population, confirming its benefits in this specific population with severe asthma.

Clinical and economic burden of HPV-related cancers in the US veteran population.

BACKGROUND: Human papillomavirus (HPV) is one of the most common sexually transmitted infection in the United States and can lead to cervical, vulvovaginal, anal, penile, and oropharyngeal cancers. Compared with the general population, US military members are at a higher risk of HPV-related conditions, yet vaccination rates are relatively low in this population. As many service members may not be diagnosed with HPV-related cancers until after they leave active service, the objective of this study was to determine the incidence, prevalence, and economic burden of HPV-related cancers among US veterans. METHODS: The study used the 2014-2018 Veterans Health Administration (VHA) database to identify newly diagnosed adult patients (cases) with HPV-related cancers, including cervical, vulvovaginal, anal, penile, and oropharyngeal cancers. Cases were matched by age, race, and sex to patients without HPV related cancer (controls). Outcome measures included annual incidence, prevalence, health care resource utilization (HCRU), and costs. These outcomes were calculated from the index date (first cancer diagnosis) through the earliest of 24 months, death, or end of study period. Adjusted results were examined using generalized linear models. RESULTS: The annual prevalence and incidence rates of HPV-related cancers ranged from 43 (anal) to 790 (oropharyngeal) cases per million (CPM), and four (anal) to 131 (cervical) CPM, respectively. Compared with controls, cases had significantly higher annual HCRU. Mean numbers of annual inpatient hospitalizations were several times higher compared to controls (cervical: 6.7-times (×); vulvovaginal: 2.7×; penile: 6.6×; oropharyngeal: 10.2×; and anal: 14.9×; all p < 0.01). Similarly, cases had significantly higher all-cause healthcare costs vs. matched controls across all cancer types: cervical ($24,252 vs. $10,402), vulvovaginal ($34,801 vs. $10,913), penile ($42,772 vs. $9,139), oropharyngeal ($82,763 vs. $10,017), and anal ($98,146 vs. $8,339); (all p < 0.01). CONCLUSIONS: HPV-related cancers may cause significant clinical and economic burden within the VHA system. Given the consequences of HPV-related cancers among veterans who did not have access to the vaccine, HPV vaccination of active military and eligible veterans should be considered a healthcare priority.

Identification of patients with congenital hemophilia in a large electronic health record database.

BACKGROUND: Electronic health records (EHRs) are an important source of information with regard to diagnosis and treatment of rare health conditions, such as congenital hemophilia, a bleeding disorder characterized by deficiency of factor VIII (FVIII) or factor IX (FIX). OBJECTIVE: To identify patients with congenital hemophilia using EHRs. DESIGN: An EHR database study. SETTING: EHRs were accessed from Humedica between January 1, 2007, and July 31, 2013. PATIENTS: Selection criteria were applied for an initial ICD-9-CM diagnosis of 286.0 (hemophilia A) or 286.1 (hemophilia B), and confirmation of records 6 months before and 12 months after the first diagnosis. Additional selection criteria included mention of "hemophilia" and "blood" or "bleed" within physician notes identified via natural language processing. RESULTS: A total of 129 males and 35 females were identified as the analysis population. Of those patients for whom both prothrombin time and activated partial thromboplastin time test results were available, only 56% of males and 7% of females exhibited a pattern of test results consistent with congenital hemophilia (normal prothrombin time and prolonged activated partial thromboplastin time). Few patients had a prescription for a hemophilia treatment; males most commonly received Amicar (10.8%) or FVIII (9.0%), whereas females most commonly received DDAVP (11.0%). The most identifiable sites of pain were the chest and the abdomen; 41% of males and 37% of females had joint pain. To evaluate whether patients had been correctly identified with congenital hemophilia, EHRs of 6 patients were reviewed; detailed assessment of their data was found to be inconsistent with a conclusive diagnosis of congenital hemophilia. LIMITATIONS: Inconsistent coding practices may affect data integrity. CONCLUSION: A potentially high number of false positive identifications, particularly among female patients, suggests that ICD-9-CM coding alone may be insufficient to identify patient cohorts. In-depth reviews and multimodal analysis of chart notes may improve data integrity.

Identification of people with acquired hemophilia in a large electronic health record database.

BACKGROUND: Electronic health records (EHRs) can provide insights into diagnoses, treatment patterns, and clinical outcomes. Acquired hemophilia (AH) is an ultrarare bleeding disorder characterized by factor VIII inhibiting autoantibodies. AIM: To identify patients with AH using an EHR database. METHODS: Records were accessed from a large EHR database (Humedica) between January 1, 2007 and July 31, 2013. Broad selection criteria were applied using the International Classification of Diseases, Ninth Revision, clinical modification (ICD-9-CM) code for intrinsic circulating anticoagulants (286.5 and all subcodes) and confirmation of records 6 months before and 12 months after the first diagnosis. Additional selection criteria included mention of "bleeding" within physician notes identified via natural language processing output and a normal prothrombin time and prolonged activated partial thromboplastin time. RESULTS: Of 6,348 patients with a diagnosis code of 286.5 or any subcodes, 16 males and 15 females met the selection criteria. The most common bleeding locations reported was gastrointestinal (23%), vaginal (16%), and endocrine (13%). A wide range of comorbidities was reported. Natural language processing identified chart note mention of "hemophilia" in 3 patients (10%), "bruise" in 15 patients (48%), and "pain" in all 31 patients. No patients received a prescription for approved/recommended AH treatments. Four patient cases were reviewed to validate whether the identified cohort had AH; each patient had bleeding symptoms and a normal prothrombin time and prolonged activated partial thromboplastin time, although none received hemostatic treatments. CONCLUSION: In ultrarare disorders, ICD-9-CM coding alone may be insufficient to identify patient cohorts; multimodal analysis combined with in-depth reviews of physician notes may be more effective.

Longitudinal adherence to colorectal cancer screening guidelines.

OBJECTIVES: To describe adherence with United States Preventive Services Task Force (USPSTF) colorectal cancer (CRC) screening recommendations over a 10-year period in a large, continuously insured screening population at average risk for CRC. STUDY DESIGN: Retrospective claims database analysis. METHODS: Insured members (N = 151,638) who turned 50 years old between January 1, 2000, and December 31, 2004, and were at average risk for CRC were included in the analysis. Subjects were categorized as adherent, inadequately screened, or screening-naïve based on their level of adherence with USPSTF CRC screening guidelines. Outcomes considered were age at initial CRC screening and CRC screening tests received over the 10-year period. RESULTS: Of the 151,638 subjects in the cohort, only 97,518 (64%) were adherent with current CRC screening recommendations. An additional 18,050 (12%) were considered inadequately screened and 36,070 (24%) were screening-naïve. In those subjects who received some form of CRC screening, the average age at screening initiation was 53 years--3 years past the age recommended by current guidelines. Of those subjects who were inadequately screened, nearly half (46%) received only 1 fecal occult blood or fecal immunochemical test over the 10-year period. CONCLUSIONS: In a sample of continuously insured average-risk individuals aged 50 to 54 years, CRC screening was initiated later and performed less frequently than recommended in USPSTF guidelines.

Comparison of health care costs and hospital readmission rates associated with negative pressure wound therapies.

OBJECTIVE: A retrospective national claims database analysis evaluated total and wound-related costs (eg, hospital readmission rates) for patients with chronic wounds treated with negative pressure wound therapy (NPWT), comparing NPWT-V (V.A.C. Therapy, KCI, an Acelity company, San Antonio, TX) and NPWT-O (other non-KCI models of NPWT, the brands of which were not known to the researchers). METHODS: Patients with ≥ 1 NPWT claim from January 2009-June 2012 in outpatient settings in the United States were included, if they had continuous medical and pharmacy benefits for 12 months before the initial index date of their NPWT claim and at least 3 months post index. Mean total health care costs were assessed at 3 months and 12 months; wound-related hospital readmission rates were assessed at 3 months and 6 months. Cost differences between cohorts were analyzed by t test and readmission rates were analyzed by chi-square test. RESULTS: At 3 months, the cohort of NPWT-V patients was significantly younger (59.2 vs 63.6 years, P < 0.01). The same patients were followed at 3, 6, and 12 months, although some fell out as time progressed. At the 3-month assessment, mean comorbidity scores did not differ between the NPWT-V group and the NPWT-O groups (3.38 vs 3.66). Total costs were lower for NPWT-V vs NPWT-O at 3 months ($35,498 vs $39,722, respectively; P = 0.08) and 12 months ($80,768 vs $111,212; P = 0.03). Significantly lower inpatient (P = 0.01), emergency room (P < 0.01), and home (P = 0.05) costs, despite higher (P = 0.04) NPWT costs, accounted for lower 12-month NPWT-V total costs. Wound-related readmission rates were significantly lower for NPWT-V at 3 months (5% vs 8%; P ≤ 0.01) and 6 months (6% vs 11%; P ≤ 0.01). For all wound types, NPWT-O patients had a 17-fold higher rate of switching to alternate NPWT models compared with NPWT-V patients. CONCLUSION: In this retrospective analysis, NPWT-V patients had lower total costs, lower wound-related costs, and lower hospital readmission rates than NPWT-O patients at all time points assessed.

Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.

BACKGROUND: Long-term persistence to treatment for chronic disease is difficult for patients to achieve, regardless of the disease or medication being used. The objective of this investigation was to examine treatment persistence with glatiramer acetate (GA) relative to available disease-modifying therapies (DMT) for multiple sclerosis (MS) over 12-, 24- and 36-month periods. METHODS: Data from Clinformatics™ for DataMart affiliated with OptumInsight was used to identify patients using DMT between 2001 and 2010. Patients with 12, 24, and 36 months of follow-up were included. Persistence was defined as continuous use of the same DMT for the duration of follow-up regardless of treatment gaps. Regimen changes including re-initiation of therapy following gaps of 15 days or more, switching therapy, and DMT discontinuation were investigated. Descriptive statistics were used to summarize the results. RESULTS: Cohorts of GA users with 12 months (n = 12,144), 24 months (n = 7,386) and 36 months (n = 4,693) of follow-up were identified. Persistence rates with GA were 80% for all time periods; discontinuation rates declined over time while switching increased modestly. In contrast, the full DMT-treated cohorts showed persistent rates of 68.3% at 12 months (n = 35,312), 53.9% at 24 months (n = 21,927), and 70.1% at 36 months (n = 14,343). As with these full DMT-treated cohorts, the proportion of GA users remaining on their initial therapy without a gap of 15 days or more decreased with length of follow-up. However, the proportion of GA users with a gap in treatment who re-initiated GA increased over time (64.4% at 12 months; 75.1% at 24 months, and 80.1% at 36 months) while those in the full DMT-treated cohorts re-initiated therapy at rates of only 50-60%. CONCLUSIONS: Persistence rates for GA were 80% for the 12-, 24- and 36-month time periods in contrast with the full DMT-treated cohorts whose persistence rates never exceeded 70.0%. Although there were more gaps in therapy of 15 days or more with all DMT over time, the proportion of GA users re-initiating therapy increased with follow-up contributing to the steady persistence. Therapy persistence is essential to achieve the desired outcomes in MS.

Treatment patterns in multiple sclerosis: administrative claims analysis over 10 years.

OBJECTIVE: Treatment patterns for the MS disease-modifying therapies (DMT) have changed over time. The objective of this study was to examine and describe treatment patterns in MS over a 10-year period. METHODS: MS patients who filled a DMT prescription between January 1, 2001 and December 31, 2010 were identified from Clinformatics for DataMart affiliated with OptumInsight. Two cohorts were identified: those with a DMT prescription in 2003 and those with a DMT prescription in 2008. Treatment patterns were examined 2 years before and after the anchor prescriptions for each cohort. RESULTS: Comparing treatment patterns prior to the two anchor prescriptions, interferon-beta (IFNß)-1a IM (Avonex) and IFNß-1b (Betaseron) gained the most users in 2001-2003, while IFNß-1a IM and IFNß-1a SC (Rebif) gained the most users from 2006-2008. In the 2 years following the two anchor prescriptions, treatment patterns changed. From 2003-2005, 21.2% of IFNß-1a SC users and more than 15.0% of IFNß-1a IM and IFNß-1b users changed to another interferon or glatiramer acetate (GA; Copaxone), while 12.5% of GA users changed to an interferon, most often IFNß-1a SC. From 2008-2010 the largest proportion of changes from each of the interferons and natalizumab (NZ; Tysabri) were to GA, while those switching from GA were most often changed to IFNß-1a SC. Those with a 2008 anchor prescription for NZ were most often changed (57%) to GA. LIMITATIONS: In retrospective database analyses the presence of a claim for a filled prescription does not indicate that the drug was consumed, and reasons for changes in therapy are not available. The study design looking forward and backward from the anchor prescriptions may have contributed to differences in the proportion of patients seen with no observable change in DMT. Claims-based data are also constrained by coverage limitations that determine the data available and limit the generalizability of results to managed care patients. CONCLUSIONS: Changes in treatment patterns in the first half of the observation period were reflective of the addition of IFNß-1a SC to the market in 2002. Following the 2003 and 2008 anchor prescriptions there were differences in treatment patterns, with more IFNß-1a IM users being changed to IFNß-1a SC after the 2003 anchor DMT, and more of each of the interferons and NZ being changed to GA following the 2008 anchor DMT. With the introduction of oral therapies for MS, treatment patterns will again be impacted.