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.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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.
Retrospective claims database analysis.
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.
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.
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.
Introduction: Recentreal-world data for multiple myeloma (MM) treatment patterns and outcomes are limited, particularly for patients with refractory or relapsed MM. As the MM treatment landscape ...evolves, it is important to understand how new treatments are integrated into patient treatment patterns. The aim of this study was to examine patient demographics, clinical characteristics, treatment patterns, and survival among Medicare patients with MM following exposure to daratumumab (DAR), an immunomodulatory agent, and a proteasome inhibitor (PI).
Methods: This was a retrospective database analysis utilizing the Centers for Medicare and Medicaid Services claims data during the study period of January 1, 2016, through December 31, 2018. The start of the study period was chosen to align with DAR market entry in the United States (FDA approval November 2015). Medicare patients, diagnosed with MM, and with existing claims for DAR, an immunomodulatory agent, and a PI (tri-exposure) were eligible for inclusion. Index tri-exposure was achieved once a patient had been exposed to all 3 MM treatments, regardless of their sequence. The index date was the first observed claim for any MM regimen (index line of therapy LOT) following tri-exposure. Patients were required to have ≥6 months of continuous enrollment prior to the index date (baseline period). Therapies given after the index LOT were defined as post-index therapy. Patient data were assessed until health plan disenrollment, death, or end of study period, whichever occurred first.
Results: There were 1336 Medicare patients with MM who met the inclusion criteria. Of these patients, the mean age (standard deviation SD) at the index date was 71 (8.5) years and 705 (52.8%) were male. The Southern United States showed the largest representation of patients in this population (n=471, 35.3%). The top baseline comorbidities included respiratory infections (98.3%), osteoarthritis (86.8%), anemia (86.9%), hypertension (78.1%), dyslipidemia (66.5%), chronic pain/fibromyalgia (51.9%), acute or chronic kidney disease (44.5%), cardiac arrhythmia (45.81%), and neutropenia (47.98%).
The mean (SD) number of days from the index date until the end of index LOT was 48.7 days (12.0). Among 949 patients (71.0%) who had post-index therapy, the mean (SD) time from the last observed claim for index LOT to the beginning of the post-index therapy and duration of post-index therapy was 51.8 (44.2) days and 57.8 (16.0) days, respectively. The median (range) duration of follow-up time from the index date was 223 (3─886) days. During the study follow-up period, 571 patients (42.7%) died, and the median (range) number of days from the index date until death was 173 (3─873) days.
While there was variation in treatment sequencing leading to tri-exposure, the most frequent tri-exposure sequence was an immunomodulatory agent < PI < DAR (33.2% See Table for overview of treatment sequencing). Among patients who received index LOT following tri-exposure, 49.4% had triplet therapy and 29.8% had doublet therapy. The most common index LOT regimens were triplet: DAR/pomalidomide/dexamethasone (DEX; 7.6%), elotuzumab/lenalidomide/DEX (5.2%), and DAR/bortezomib/DEX (4.9%). The most common post-index LOT regimens were triplet (39.9%): DAR/pomalidomide (6.1%), carfilzomib/cyclophosphamide/DEX (3.7%), DAR/bortezomib/DEX (3.5%), and DAR/lenalidomide/DEX (3.5%). During follow-up, 52.8% of patients were retreated with DAR, 79% with PI, and 77.3% with immunomodulatory drugs.
Conclusions: This study suggests wide variation in treatment sequencing and regimens after tri-exposure to DAR, an immunomodulatory agent, and a PI. Triplet regimens were predominant treatment after the tri-exposure and following the index LOT. Retreatment with the same agents was common. Among those who died, survival was often less than 1 year following tri-exposure. These results highlight the need for new treatment options in triple-class refractory MM settings.
Funding: GSK (Study 213462)
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Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.
Introduction: Although multiple myeloma (MM) is currently incurable, the survival rate has improved over the past decade. Despite advances in treatment, most patients will become refractory to ...treatment. Lenalidomide and proteasome inhibitors (PI) are frequently used in early MM treatment regimens; however, there is a need to further understand how follow-up treatments affect patient outcomes. The aim of this retrospective database analysis was to examine the demographics, clinical characteristics, treatment sequencing, and overall survival in US Medicare patients with MM who initiated any MM treatment after observed treatment with lenalidomide and a PI.
Methods: Claims data from the Centers for Medicare and Medicaid Services (CMS) were assessed during the study period of January 1, 2016, through December 31, 2018. Medicare patients who were diagnosed with MM and had any MM therapy at least 28 days following treatment with lenalidomide and PI were eligible. The index date (ID) was the date of the first observed claim for any MM therapy as a next line of therapy (LOT) following treatment with lenalidomide and a PI. Patients were required to have ≥6 months of continuous enrollment prior to ID (baseline period). Patient data were assessed until health plan disenrollment, death, or end of study period (whichever occurred first).
Results: This study identified a cohort of 6590 eligible Medicare patients with MM exposed to lenalidomide and a PI. The mean age (standard deviation) was 72 (8.0) years, and 53.0% of patients were male. The Southern United States showed the largest representation of patients in this population (37.0%). The top baseline comorbidities included osteoarthritis (83.0%), hypertension (76.9%), anemia (76.7%), and respiratory infections (75.7%). PIs used in the lenalidomide/PI combination in the baseline period included bortezomib (67%), carfilzomib (30%), and ixazomib (29%). A patient could have received one or more of these PIs.
Of the 6590 patients who received index therapy, 51% had triplet therapy, 35% had doublet therapy, 10% had monotherapy, 3% had quad therapy, and <1% had another combination.
Among the 78% patients with a post-index LOT, 37% had triplet therapy, 37% had doublet therapy, 22% had monotherapy, 4% had quad therapy, and <1% had another combination. The most common therapies during the follow-up were dexamethasone (88%), lenalidomide (73%), bortezomib (45%), pomalidomide (31%), and daratumumab (31%). Patients could have received one or more of these therapies in the follow-up period. Overall, 4,788 (73%) patients were retreated with lenalidomide and 5,613 (85%) patients were retreated with a PI during the follow-up period.
Between the ID and the end of study period, 24.4% of patients died. The median (range) time to death was 211 (1─890) days from ID.
Conclusions: This study showed there was wide variation in subsequent treatment strategies following lenalidomide/PI exposure. After exposure, patients were most often treated with triplet therapies, and there was frequent re-treatment with previously used agents and/or classes. These results highlight the need for novel treatments/classes of therapy and sequencing strategies that may improve outcomes in patients with MM.
Funding: GSK (Study 213462)
Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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