Cost of genetic testing, delayed care, and suboptimal treatment associated with polymerase chain reaction versus next-generation sequencing biomarker testing for genomic alterations in metastatic non-small cell lung cancer.

AIMS: To assess US payers' per-patient cost of testing associated with next-generation sequencing (NGS) versus polymerase chain reaction (PCR) biomarker testing strategies among patients with metastatic non-small cell lung cancer (mNSCLC), including costs of testing, delayed care, and suboptimal treatment initiation. METHODS: A decision tree model considered biomarker testing for genomic alterations using either NGS, sequential PCR testing, or hotspot panel PCR testing. Literature-based model inputs included time-to-test results, costs for testing/medical care, costs of delaying care, costs of immunotherapy [IO]/chemotherapy [CTX] initiation prior to receiving test results, and costs of suboptimal treatment initiation after test results (i.e. costs of first-line IO/CTX in patients with actionable mutations that were undetected by PCR that would have been identified with NGS). The proportion of patients testing positive for a targetable alteration, time to appropriate therapy initiation, and per-patient costs were estimated for NGS and PCR strategies combined. RESULTS: In a modeled cohort of 1,000,000 members (25% Medicare, 75% commercial), an estimated 1,119 had mNSCLC and received testing. The proportion of patients testing positive for a targetable alteration was 45.9% for NGS and 40.0% for PCR testing. Mean per-patient costs were lowest for NGS ($8,866) compared to PCR ($18,246), with lower delayed care costs of $1,301 for NGS compared to $3,228 for PCR, and lower costs of IO/CTX initiation prior to receiving test results (NGS: $2,298; PCR:$5,991). Cost savings, reaching $10,496,220 at the 1,000,000-member plan level, were driven by more rapid treatment with appropriate therapy for patients tested with NGS (2.1 weeks) compared to PCR strategies (5.2 weeks). LIMITATIONS: Model inputs/assumptions were based on published literature or expert opinion. CONCLUSIONS: NGS testing was associated with greater cost savings versus PCR, driven by more rapid results, shorter time to appropriate therapy initiation, and minimized use of inappropriate therapies while awaiting and after test results.

Real world treatment patterns, healthcare resource use and costs in patients with advanced or metastatic non-small cell lung cancer by EGFR mutation type.

AIMS: This study described treatment patterns, healthcare resource utilization (HRU) and costs among advanced or metastatic non-small cell lung cancer (a/mNSCLC) patients with different epidermal growth factor receptor (EGFR) mutation types. MATERIALS AND METHODS: This retrospective study leveraged NeoGenomics NeoNucleus linked with IQVIA PharMetrics Plus between 01 January 2016 to 30 April 2021 (study period). Patients with evidence of a/mNSCLC between 01 July 2016 to 31 March 2021 (selection window) with EGFR test results indicating exon 19 deletion (exon19del), exon 21 L858R (L858R), or exon 20 insertion (exon20i) mutations were included; date of first observed evidence of a/mNSCLC was the index date. Treatment patterns, all-cause HRU and costs during ≥1 month follow-up were reported for each cohort (exon19del, L858R, and exon20i). RESULTS: A total of 106 exon19del, 75 L858R, and 13 exon20i patients met the study criteria. The prevalence of hospitalization was highest in the exon20i cohort (76.9%), followed by L858R (62.7%) and exon19del (55.7%) cohorts. A higher proportion of patients had evidence of hospice/end-of-life care in the exon20i (30.8%) and L858R (29.3%) cohorts relative to the exon19del cohort (22.6%). The exon20i cohort had higher median total healthcare costs per patient per month ($27,069) relative to exon19del ($17,482) and L858R ($17,763). EGFR tyrosine kinase inhibitors (TKI) were the most frequently observed treatment type for exon19del and L858R cohorts, while chemotherapy was the most observed treatment in exon20i cohort. LIMITATIONS: The sample size for the study cohorts was small, thus no statistical comparisons were conducted. CONCLUSIONS: This is one of the first real-world studies to describe HRU and costs among a/mNSCLC patients by specific EGFR mutation type. HRU and costs varied between EGFR mutation types and were highest among exon20i cohort, potentially reflecting higher disease burden and unmet need among patients with this mutation.

Patients with non-small cell lung cancer (NSCLC) in an advanced or metastatic stage (a/mNSCLC) where cancer has spread to other parts of the body have high chance of dying within five years. Treatment and management of a/mNSCLC also incurs significant healthcare resource utilization (HRU) and costs. Patients with a/mNSCLC may have their epidermal growth factor receptor (EGFR) gene mutated with different variations. Our study described what a/mNSCLC patients were treated with, their HRU and healthcare costs separately for the following three types of EGFR mutations: exon 19 deletion (exon19del), exon 21 L858R (L858R), or exon 20 insertion (exon20i). Our study found that patients with exon19del or L858R mutation were commonly treated with EGFR tyrosine kinase inhibitors (TKIs), while exon20i patients were mostly treated with chemotherapy due to lack of targeted treatment for exon20i during the time when the study was conducted. HRU and healthcare costs were highest for patients with exon20i, which shows that patients with exon20i face high burden and have a need for new treatment options.

Disparities in Lung Cancer: A Targeted Literature Review Examining Lung Cancer Screening, Diagnosis, Treatment, and Survival Outcomes in the United States.

BACKGROUND: Although incidence and mortality of lung cancer have been decreasing, health disparities persist among historically marginalized Black, Hispanic, and Asian populations. A targeted literature review was performed to collate the evidence of health disparities among these historically marginalized patients with lung cancer in the U.S. METHODS: Articles eligible for review included 1) indexed in PubMed®, 2) English language, 3) U.S. patients only, 4) real-world evidence studies, and 5) publications between January 1, 2018, and November 8, 2021. RESULTS: Of 94 articles meeting selection criteria, 49 publications were selected, encompassing patient data predominantly between 2004 and 2016. Black patients were shown to develop lung cancer at an earlier age and were more likely to present with advanced-stage disease compared to White patients. Black patients were less likely to be eligible for/receive lung cancer screening, genetic testing for mutations, high-cost and systemic treatments, and surgical intervention compared to White patients. Disparities were also detected in survival, where Hispanic and Asian patients had lower mortality risks compared to White patients. Literature on survival outcomes between Black and White patients was inconclusive. Disparities related to sex, rurality, social support, socioeconomic status, education level, and insurance type were observed. CONCLUSIONS: Health disparities within the lung cancer population begin with initial screening and continue through survival outcomes, with reports persisting well into the latter portion of the past decade. These findings should serve as a call to action, raising awareness of persistent and ongoing inequities, particularly for marginalized populations.

Healthcare Resource Utilization and Costs in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer Receiving First-Line Treatment in the United States: An Insurance Claims-Based Descriptive Analysis.

BACKGROUND: An estimated 10-15% of non-small cell lung cancer (NSCLC) cases present with epidermal growth factor receptor mutation (EGFRm). While EGFR tyrosine kinase inhibitors (EGFR-TKIs) such as osimertinib have become first-line (1L) standard of care for these patients, limited chemotherapy use still occurs in real-world practice. Studies of healthcare resource use (HRU) and cost of care provide a means by which the value of various treatment regimens, healthcare efficiency, and disease burden can be assessed. These studies are important for population health decision makers and health systems that prioritize value-based care to drive population health. OBJECTIVE: The aim of this study was to descriptively assess HRU and costs among patients with EGFRm advanced NSCLC initiating 1L therapy in the United States. METHODS: IBM MarketScan Research Databases (January 1, 2017 to April 30, 2020) were used to identify adult patients with advanced NSCLC, based on a diagnosis for lung cancer (LC) and initiation of 1L therapy or diagnosis of metastases within 30 days of the first LC diagnosis. All patients had ≥ 12 months of continuous insurance eligibility prior to the first LC diagnosis and initiated (in 2018 or after) an EGFR-TKI during any line of therapy to proxy EGFRm status. Per-patient-per-month all-cause HRU and costs were described during 1L for patients initiating 1L osimertinib or chemotherapy. RESULTS: A total of 213 patients with advanced EGFRm NSCLC were identified (mean age at 1L initiation: 60.9 years; 69.0% female). In 1L, 66.2% initiated osimertinib, 21.1% chemotherapy, and 12.7% another regimen. Mean 1L therapy duration was 8.8 months (osimertinib) and 7.6 months (chemotherapy), respectively. Among osimertinib recipients, 28% had an inpatient admission, 40% an emergency room (ER) visit, and 99% an outpatient visit. Among chemotherapy recipients, these proportions were 22%, 31%, and 100%. Mean monthly all-cause healthcare costs among osimertinib and chemotherapy patients were US$27,174 and US$23,343, respectively. Among osimertinib recipients, drug-related costs (including pharmacy and outpatient antineoplastic drug and administration costs) made up 61% (US$16,673) of total costs, inpatient costs 20% (US$5462), and other outpatient costs 16% (US$4432). In chemotherapy recipients, 59% (US$13,883) of total costs were drug-related, 5% (US$1166) were inpatient costs, and 33% (US$7734) other outpatient costs. CONCLUSIONS: Higher mean total cost of care was observed among patients receiving 1L TKI (osimertinib) than 1L chemotherapy in EGFRm advanced NSCLC. However, descriptive differences in type of spending and HRU were identified: higher inpatient costs and inpatient days for osimertinib versus higher outpatient costs for chemotherapy. Findings suggest that significant unmet needs may remain for 1L treatment of EGFRm NSCLC, and despite significant advances in targeted care, further individualized therapies are needed to balance benefits, risks, and total cost of care. Furthermore, observed descriptive differences in inpatient admissions may have implications for quality of care and patient quality of life, for which additional research is warranted.

Real-World Patient Characteristics, Treatment Patterns, and Mutation Testing Patterns Among US Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutations.

INTRODUCTION: Approximately 15% of patients with non-small cell lung cancer (NSCLC) harbor an epidermal growth factor receptor mutation (EGFRm). Mutation testing (including EGFRm) is recommended for patients with advanced NSCLC (aNSCLC) prior to initiating first-line therapy (L1) or after progression on targeted therapy. To elucidate current and future unmet needs, the present study characterized real-world EGFR testing patterns and treatment patterns in patients with aNSCLC. METHODS: This retrospective observational cohort study evaluated newly diagnosed adult patients with aNSCLC (stage IIIB or higher) from the Flatiron Health database. Eligible patients received at least L1 during 2015-2020 (testing cohorts) or 2011-2020 (treatment cohorts). Eligible patients for the treatment cohorts had an EGFR mutation. RESULTS: The testing cohort included 22,726 patients, 75.5% had at least one EGFR test and 15.2% of those tested were positive for EGFR mutation. From 2015 to 2020, the median time from sample collection to test results decreased substantially while the proportion of NGS EGFR tests and use of plasma samples increased. The treatment cohort included 3701 patients (95% common mutations [cEGFR], 5.0% exon 20 insertions [ex20ins]). Three or more lines of therapy (LOTs) were observed in approximately 30% of patients. For L1, most cEGFR patients received EGFR tyrosine kinase inhibitors (EGFR-TKI, 68.1%) or platinum-based chemotherapy (PBC, 24.8%); most ex20ins patients received PBC (66.1%) or EGFR-TKI (17.5%). The most common L2 was EGFR-TKI (54.1%) or PBC (22.8%) for cEGFR and immunotherapy (25.9%) or PBC (25.9%) for ex20ins. No predominant L3 was evident in either group. CONCLUSION: This real-world study, among the largest analyses of testing patterns for patients with aNSCLC, demonstrates a comprehensive view of treatment patterns for patients with EGFR mutations, including ex20ins. Despite recent improvement, increased use of EGFR testing, including advanced methods, is needed to optimize treatment pathways and outcomes. Additionally, the lack of a predominant therapy in later lines indicates a need for new therapies.

Total cost of testing for genomic alterations associated with next-generation sequencing versus polymerase chain reaction testing strategies among patients with metastatic non-small cell lung cancer.

BACKGROUND: To assess the total cost of testing associated with next-generation sequencing (NGS) versus polymerase chain reaction (PCR) testing strategies among patients with metastatic non-small cell lung cancer (mNSCLC) from a Medicare and US commercial payer's perspective. MATERIALS AND METHODS: A decision tree model considered testing for genomic alterations in EGFR, ALK, ROS1, BRAF, KRAS, MET, HER2, RET, NTRK1 among patients with newly diagnosed mNSCLC using (1) liquid or tissue biopsy NGS tests, (2) exclusionary mutation (KRAS) test followed by sequential PCR tests, (3) sequential PCR tests, or (4) hotspot panel PCR tests. The alteration test sequence followed clinical guideline recommendations. Inputs based on literature, expert opinion, or assumptions included prevalence of mNSCLC, proportion of patients using each testing strategy (50% NGS [90% tissue, 10% liquid], 10% exclusionary, 10% sequential, 30% hotspot), proportion testing positive for each genomic mutation, rebiopsy rates, and costs for testing and associated medical care. Time to appropriate targeted therapy initiation and total costs were calculated for NGS, each PCR testing strategy, and all PCR strategies combined. RESULTS: Among a hypothetical plan of 1,000,000 members (75% commercial, 25% Medicare), 1,119 patients were estimated to have mNSCLC and be eligible for testing. Estimated mean time to appropriate targeted therapy was 2 weeks for NGS and 6 weeks for PCR (sequential: 9 weeks, exclusionary: 8 weeks, hotspot: 3 weeks). Mean per patient costs were $4,932 for NGS and $6,605 for PCR (exclusionary: $5,563, sequential: $6,263, hotspot: $7,066). Per patient costs were higher from a commercial perspective (NGS: $6,225; PCR: $8,430) relative to Medicare (NGS: $2,099; PCR: $2,646); nevertheless, NGS was the least costly testing strategy across plan types. CONCLUSION: NGS was associated with the fastest time to appropriate targeted therapy initiation and lowest total cost of testing compared to PCR testing strategies for newly diagnosed patients with mNSCLC.

Health Care Resource Utilization and Costs Associated With Switching Biologics in Rheumatoid Arthritis.

PURPOSE: Although biologics are effective in managing rheumatoid arthritis (RA), many patients experience at least one biologic switch during treatment. A switch in biologic treatment can occur for medical or nonmedical reasons. Changes to treatment regimens, even in patients previously stable on therapy, can have clinical and cost implications. This study examined health care resource use and costs incurred with switching from an anti-tumor necrosis factor (TNF) medication in a population of patients with RA. METHODS: A retrospective analysis of patients with RA identified in Truven Commercial Claims and Encounters database (January 1, 2009, to December 13, 2013) was conducted. Patients were required to show evidence of new initiation of treatment with a biologic medication (index date) and continuous eligibility from 6 months before to 12 months after index. Patients were segmented into a continuous biologic group and a biologic switch group, the latter being further divided into switch from anti-TNF to anti-TNF (A-A subgroup) and switch from anti-TNF to a treatment with other mechanism of action (A-O subgroup). Means (SD) and medians of resource use and cost outcomes were calculated over the 12-month postindex period; multivariate models controlling for demographics, biologic switch, and preindex health, resource use, and costs were constructed. FINDINGS: The total sample comprised 18,070 patients, with 16,643 qualifying for the continuous group and 1427 qualifying for the overall switch group. The overall switch group was more likely to utilize physician office, emergency department, and pharmacy services compared to the continuous group. Consequently, the overall switch group incurred greater total health care costs compared to the continuous group ($41,482 vs $36,557 per patient per annum; p < 0.05). Within the switch group, the A-O subgroup had significantly greater outpatient, medical, and total health care expenditures compared to those in the A-A subgroup. Regression analyses revealed that increased baseline utilization and costs, worse health, and older age were associated with increased utilization and costs over the follow-up period. Switching of biologics was associated with an approximate increase of US $4000 per patient per annum in total health care costs. IMPLICATIONS: These findings suggest that switching biologic agents in patients with RA may be accompanied by increased total health care costs. Efforts to optimize patient response to initial biologic therapy and to reduce unnecessary switching, such as for nonmedical reasons, may help to mitigate these costs.

Effect of rivaroxaban versus warfarin on health care costs among nonvalvular atrial fibrillation patients: observations from rivaroxaban users and matched warfarin users.

INTRODUCTION: New target-specific oral anticoagulants may have benefits, such as shorter hospital length of stay, compared to warfarin in patients with nonvalvular atrial fibrillation (NVAF). This study aimed to assess, among patients with NVAF, the effect of rivaroxaban versus warfarin on health care costs in a cohort of rivaroxaban users and matched warfarin users. METHODS: Health care claims from the Humana database from 5/2011 to 12/2012 were analyzed. Adult patients newly initiated on rivaroxaban or warfarin with ≥2 atrial fibrillation (AF) diagnoses (The International Classification of Diseases, Ninth Revision, Clinical Modification: 427.31) and without valvular AF were identified. Based on propensity score methods, warfarin patients were matched 1:1 to rivaroxaban patients. Patients were observed up to end of data, end of insurance coverage, death, a switch to another anticoagulant, or treatment nonpersistence. Health care costs [hospitalization, emergency room (ER), outpatient, and pharmacy costs] were evaluated using Lin's method. RESULTS: Matches were found for all rivaroxaban patients, and characteristics of the matched groups (n = 2253 per group) were well balanced. Estimated mean all-cause and AF-related hospitalization costs were significantly lower for rivaroxaban versus warfarin patients (all-cause: $5411 vs. $7427, P = 0.047; AF-related: $2872 vs. $4147, P = 0.020). Corresponding estimated mean all-cause outpatient visit costs were also significantly lower, but estimated mean pharmacy costs were significantly higher for rivaroxaban patients ($5316 vs. $2620, P < 0.001). Although estimated mean costs of ER visits were higher for rivaroxaban users compared to those of warfarin users, differences were not statistically significant. Including anticoagulant costs, mean overall total all-cause costs were comparable for rivaroxaban versus warfarin users due to cost offset from a reduction in the number and length of hospitalizations and number of outpatient visits ($17,590 vs. $18,676, P = 0.542). CONCLUSION: Despite higher anticoagulant cost, mean overall total all-cause and AF-related cost remains comparable for patients with NVAF treated with rivaroxaban versus warfarin due to the cost offset from reduced health care resource utilization.

Effects of rivaroxaban versus warfarin on hospitalization days and other health care resource utilization in patients with nonvalvular atrial fibrillation: an observational study from a cohort of matched users.

PURPOSE: Compared with warfarin, the new target-specific oral anticoagulant agents may have advantages, such as shorter hospital length of stay, in patients with nonvalvular atrial fibrillation (NVAF). The objective of the present study was to assess, among patients with NVAF, the effects of rivaroxaban versus warfarin on the number of hospitalization days and other health care resource utilization in a cohort of rivaroxaban users and matched warfarin users. METHODS: Data from health care claims dated from May 2011 to December 2012 from the Humana database were analyzed. Adult patients newly initiated on treatment with rivaroxaban or warfarin, with ≥2 diagnoses of AF (ICD-9-CM code 427.31), and without valvular AF were identified. Based on propensity score methods, warfarin recipients were matched 1:1 to rivaroxaban recipients. The end of the observation period was defined as the end of data availability, the end of insurance coverage, death, the date of a switch to another anticoagulant agent, or day 14 of treatment nonpersistence. The total number of hospitalization days and other health care resource utilization parameters (numbers of hospitalizations, emergency department [ED] visits, and outpatient visits) were evaluated using the method by Lin et al. FINDINGS: Matches for all rivaroxaban recipients were found, and the characteristics of the matched groups (n = 2253 per group) were well balanced. The mean age of both cohorts was 74 years; 46% were female. The estimated mean total numbers of hospitalization days were significantly less in rivaroxaban users compared with those in warfarin users (all-cause, 2.71 vs 3.87 days [P = 0.032]; AF-related, 2.11 vs 3.02 days [P = 0.014]). The numbers of outpatient visits were also significantly less (all-cause, 25.26 vs 35.79 visits [P < 0.001]; AF-related, 5.48 vs 9.06 visits [P < 0.001]). Rivaroxaban users had a lesser estimated mean number of all-cause hospitalizations compared with warfarin users (0.55 vs 0.73; P = 0.084), and a significantly lesser estimated mean number of AF-related hospitalizations (0.40 vs 0.57; P = 0.022). The difference in the estimated mean numbers of all-cause ED visits was not statistically significant between the rivaroxaban and warfarin users. IMPLICATIONS: In this study conducted in clinical practice, the estimated mean numbers of hospitalization days, outpatient visits, and AF-related hospitalizations associated with rivaroxaban were significantly less than were those associated with warfarin in these patients with NVAF. The corresponding estimated difference in all-cause ED visits was not statistically significant.

Infliximab dosing patterns in a sample of patients with Crohn's disease: results from a medical chart review.

BACKGROUND: Infliximab, a monoclonal antibody tumor necrosis factor-alpha inhibitor, is an effective therapy that is indicated for the treatment of patients with Crohn's disease. Although dose escalation from 5 mg/kg to 10 mg/kg is allowed according to the prescribing label of infliximab, conflicting results exist regarding the rate at which this escalation may occur, which may affect payers and providers. OBJECTIVE: The goal of this exploratory study was to characterize and quantify the rate of infliximab dose escalation in a sample of patients with Crohn's disease. METHODS: Administrative claims data from patients with Crohn's disease in a large mid-Atlantic managed care organization were collected and used to target and recruit providers into a chart review study of infliximab dosing. Data from the charts of 161 patients with Crohn's disease who were receiving infliximab between 2006 and 2010 were extracted. Patients were grouped into an infliximab dose-escalation group or a dose-stable group based on these data. The evidence of any infliximab dose ≥7.5 mg/kg or evidence of a mean maintenance interval of 42 days or less resulted in the placement of a patient in the dose-escalation group, with the balance of patients comprising the stable-dose group. RESULTS: A total of 925 infliximab infusions were captured from 161 patients. Of the 161 patients identified, 110 had at least 4 infusions, and 4 had missing data; therefore, only 106 (66%) patients were qualified for the final infliximab dosing analysis. A total of 18 (17%) of these patients had evidence of infliximab dose escalation (dose-escalation group), and the remaining 88 (83%) patients had a consistent 5-mg/kg dose and schedule (stable-dose group). Of the 18 patients in the dose-escalation group, 9 (50%) had a decrease in maintenance interval, whereas 12 (66.7%) patients had an increase in their dosage. A total of 3 (16.7%) patients had both an increase in dose and a reduction in maintenance interval. CONCLUSIONS: Infliximab has been shown to be a cost-effective treatment for patients with Crohn's disease. The rate of infliximab dose escalation in this study was within the lower range of published estimates for this medication. Studies using larger sample sizes are needed to validate the findings of the current study. In addition, studies that are focused on quantifying and describing the nature of infliximab dose escalation may be useful in the development of successful patient-treatment matching algorithms.

Impact of co-morbidities and patient characteristics on international normalized ratio control over time in patients with nonvalvular atrial fibrillation.

This study determined the association between co-morbidities, including heart failure (HF) and time in therapeutic range (TTR), in patients with nonvalvular atrial fibrillation. Longitudinal patient-level anticoagulation management records collected from 2006 to 2010 were analyzed. Adult patients with nonvalvular atrial fibrillation who used warfarin for a 12-month period with no gap of >60 days between visits were identified. TTR <55% was defined as "lower" TTR. CHADS2 score of ≥2 was defined as "higher" CHADS2. Logistic regression analyses were conducted to determine the association between co-morbidities and TTR. A total of 23,425 patients met the study criteria. The mean age ± SD was 74.8 ± 9.7 years, with 84.8% aged ≥65 years. The most common co-morbidities were hypertension (41.7%), diabetes (24.1%), HF (11.7%), and previous stroke (11.1%). The mean TTR ± SD was 67.3 ± 14.4%, with 18.6% of patients in the lower TTR range. In multivariate analyses using age, gender, hypertension, diabetes, stroke, and region as covariates, HF (adjusted odds ratio [OR] 1.41, 95% confidence interval [CI] 1.28 to 1.56; p <0.001), diabetes (OR 1.28, 95% CI 1.19 to 1.38; p <0.001), and previous stroke (OR 1.15, 95% CI 1.04 to 1.27; p <0.001) were associated with lower TTR. In a second set of multivariate analyses using gender and region as covariates, a higher CHADS2 score was associated with lower TTR (OR 1.11, 95% CI 1.04 to 1.18; p <0.001). In conclusion, HF was associated with the greatest likelihood of a lower TTR, followed by diabetes, then stroke. Anticoagulation control may be more challenging for patients with these conditions.

Patient satisfaction with warfarin- and non-warfarin-containing thromboprophylaxis regimens for atrial fibrillation.

OBJECTIVE: To compare patient-reported limitations, concerns, and burdens in those receiving and not receiving warfarin for thromboprophylaxis in atrial fibrillation (AF). METHODS: We conducted a cross-sectional survey study of patients with AF receiving thromboprophylaxis for stroke prevention. Patients were administered the validated Anti-Clot Treatment Scale (ACTS). Mean scores of patients receiving and not receiving warfarin were compared for each ACTS item, and for the Burden and Benefit subscales. RESULTS: From July 2010 to August 2011, 80 patients with AF were administered the survey, with 65 patients receiving a regimen containing warfarin and 15 patients not receiving a regimen containing warfarin. Six of the 17 individual questions depicting patient- perceived limitations in physical activity due to bleeding, limitations on diet, feelings of inconvenience of occasional aspects of thromboprophylaxis therapy, and frustration, and burden had less favorable scores in the warfarin-managed patients compared with the patients not receiving warfarin (P < 0.05 for all). Mean ACTS Burden scores were more favorable in the no-warfarin group (44.5 ± 6.4) compared with the warfarin group (39.8 ± 8.0; P = 0.003). No difference was seen between the 2 groups on the ACTS Benefits score (11.1 ± 3.4 vs 10.4 ± 3.7; P = 0.38). CONCLUSION: Patients with AF receiving warfarin may have less favorable feelings regarding thromboprophylaxis versus those receiving non-warfarin thromboprophylaxis. Patients report having more limitations and having greater feelings of burden on warfarin.

Caregiver assistance among Medicare beneficiaries with atrial fibrillation and factors associated with anticoagulant treatment.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and disproportionately affects the elderly. OBJECTIVE: This study describes patient characteristics and caregiver assistance among Medicare beneficiaries with AF and examines factors associated with receiving anticoagulant treatment. METHODS: Patients with AF and age/gender-matched controls were identified from Medicare Current Beneficiary Survey data from 2001 to 2006. A logistic regression model was used to assess factors associated with receiving anticoagulants in a subgroup of patients with AF whose treatment pattern was established for 2 consecutive years. Sample weights were applied to obtain nationally representative estimates. RESULTS: A total of 2990 patients with AF and 5980 control patients were included in the burden of disease analysis, and 1481 patients with AF were included in the anticoagulant predictor analysis. Patients with AF had a higher level of comorbidity (Charlson Comorbidity Index: 3.3 vs 1.5; P < 0.05), worse self-perceived health status (P < 0.001), and greater level of disability (P < 0.001) than their matched counterparts. A greater proportion of patients with AF required caregiver assistance (62.8% vs 51.5%; P < 0.001). Logistic regression found that higher Charlson Comorbidity Index scores, difficulty in obtaining necessary health care, older age, being widowed, a history of psychiatric disorders, and being underweight decreased the likelihood of receiving anticoagulant therapy. CONCLUSIONS: In a Medicare population, a greater need for caregiver assistance was observed in patients with AF. Subgroups characterized by frailty or inability for self-care were identified as being less likely to receive anticoagulant therapy. The need for caregiver assistance among patients with AF, as well as the patient subgroups identified as less likely to receive anticoagulant therapy, should be considered when making treatment decisions.

Resource utilization before and during infliximab therapy in patients with inflammatory bowel disease.

OBJECTIVE: Although Remicade (infliximab) is costly relative to non-biologic therapy, its impact on healthcare resource utilization and mucosal healing may make it a cost-effective option. This study aimed to compare gastrointestinal (GI)-related healthcare resource utilization and severity of mucosal damage before and during infliximab therapy in Crohn's disease (CD) or ulcerative colitis (UC) patients. METHODS: A retrospective chart review was conducted at 14 gastroenterology practices from across the country, which varied in practice sizes and types. Patients were aged ≥18 years, diagnosed with CD or UC, and had an infliximab index date between January 1, 2005 and September 30, 2007. GI-related utilization 12 months before and 12 months after the index date was compared. Endoscopic disease severity was categorized based on blinded review of abstracted reports. RESULTS: Results from 268 patients indicated significantly lower rates of surgery (29.7% to 9.9%, p < 0.0001, CD; 24.4% to 12.8%, p = 0.042, UC) and colonoscopy (54.4% to 17.6%, p < 0.0001, CD; 50.0% to 22.1%, p = 0.0007, UC) during infliximab therapy. The rates of hospitalizations in UC (15.1% to 3.5%, p = 0.0124) and radiology assessments in CD (23.1% to 10.4%, p = 0.006) also decreased. Based on severity data from 183 procedures, greater proportions of patients had normal or mild ratings during infliximab treatment compared with pre-treatment. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 gastroenterology clinics during the first year of infliximab treatment. In addition, the number of patients with pre-treatment and post-treatment disease severity information was too small to make comparisons among disease severity groups. Further information about the severity of disease and the extent of mucosal healing could be helpful in determining the effect of therapy on resource utilization in future research. CONCLUSIONS: GI-related resource utilization was significantly lower and attenuation of mucosal damage severity was observed during infliximab treatment compared with the pre-treatment period.

Stability of infliximab dosing in inflammatory bowel disease: results from a multicenter US chart review.

OBJECTIVE: Infliximab dosing for inflammatory bowel disease (IBD) is based on patient weight and treatment response. Understanding dosing patterns may provide insight into treatment response and predictability of treatment cost. The purpose of this medical record review was to assess dose and dose frequency of infliximab maintenance treatment in patients with IBD using patient chart data. METHODS: A retrospective chart review was conducted at 14 community gastroenterology clinics (GI clinics). Patients were aged ≥18 years, diagnosed with Crohn's disease (CD) or ulcerative colitis (UC), and had a first infliximab administration (index date) between January 1, 2005 and September 30, 2007. At least 24 months of continuous data availability were required with dosing data collected for 12 months after initiation of infliximab therapy. Patients with biologic use and/or participation in an IBD clinical trial within 12 months before the index date were excluded. RESULTS: Charts from 182 CD patients and 86 UC patients were analyzed. About half of the patients were female. Over 90% of patients initiated treatment with infliximab 5 mg/kg. Among CD patients and UC patients, respectively, 79% and 61% continued receiving this dose for maintenance therapy at stable intervals. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 GI clinics during the first year of infliximab treatment. Further, non-anti-tumor necrosis factor medication data were intermittently collected in some charts and, therefore, did not allow for analysis. CONCLUSIONS: Weight-based dosing and, presumably, patient response enabled providers to find the effective infliximab dose for IBD patients. The maintenance dose and administration frequency remained stable during the initial year.

Administrative claims analysis of utilization and costs of care in health plan members with atopic dermatitis who had prior use of a topical corticosteroid and who initiate therapy with pimecrolimus or tacrolimus.

BACKGROUND: In the United States, pimecrolimus cream and tacrolimus ointment are approved as second-line therapy for short-term and intermittent noncontinuous long-term treatment of atopic dermatitis (AD) in nonimmunocompromised patients aged 2 years or older who have failed to respond adequately to other topical prescription treatments (e.g., topical corticosteroids), or when those treatments are not advisable; pimecrolimus is indicated for mild to- moderate AD and tacrolimus for moderate-to-severe AD. Comparative data on the effects of pimecrolimus versus tacrolimus on AD-related health care utilization and costs among similar patients seen in typical clinical practice are currently unavailable. OBJECTIVE: To compare utilization and costs of AD-related medical care in health plan members with AD who had prior use of a topical corticosteroid and who subsequently initiate therapy with pimecrolimus cream or tacrolimus ointment. METHODS: This was an observational, retrospective study using an administrative claims database with dates of service from August 1, 2000, through October 31, 2003, and representing approximately 2.5 million members in health maintenance organizations, preferred provider organizations, and Medicare and Medicaid plans mostly located in the cities of Chicago, Kansas City, and Phoenix and in the states of Kentucky, Florida, and Texas. The study sample included all members with 1 or more pharmacy claims for a topical corticosteroid and a diagnosis of AD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 691.XX (excluding 691.0X), or 692.XX (excluding 692.0X-692.8X)] who subsequently had 1 or more pharmacy claims for pimecrolimus or tacrolimus. AD-related utilization and medical care costs (plan payments plus member cost share) over 12 months of follow-up were compared between the pimecrolimus and tacrolimus groups. Because information on disease severity was not available in the administrative claims data, propensity matching was used to control for differences between groups in baseline demographic and clinical characteristics and pretreatment utilization of AD-related medical care services. RESULTS: Before matching, compared with the tacrolimus group (n = 197), members in the pimecrolimus group (n = 197) were older (mean age of 38 vs. 32 years, P = 0.022), had fewer topical corticosteroid pharmacy claims (mean 2.08 vs. 3.01, P = 0.002), and had fewer grams of corticosteroids dispensed (mean 132 vs. 193, P = 0.029) in the 12 months prior to treatment. After matching, there were 157 members in each group with no statistically significant differences in pretreatment characteristics. During the 12-month follow-up period, the mean (median) number of pharmacy claims was 1.8 (1.0) for pimecrolimus versus 2.0 (1.0) for tacrolimus and the mean (median) grams of study medication were 102 (60) and 105 (60), respectively. Members in the pimecrolimus group received a lower average number of prescriptions for any topical corticosteroids (1.37 vs. 2.04, P = 0.021) and for high-potency topical corticosteroids (0.61 vs. 1.04, P = 0.023) and were less likely to initiate alternative therapy (5% vs. 17%, P <0.001) or receive antistaphylococcal antibiotics (16% vs. 27%, P = 0.014). Members in the pimecrolimus group had lower average (median) AD-related expenditures (75% to 78% attributable to AD drug cost) compared with matched tacrolimus members ($263 [$270] vs. $361 [$398], P = 0.012). CONCLUSIONS: In health plan members with AD who had previously received at least 1 topical corticosteroid prescription, the customary use of pimecrolimus or tacrolimus was 1 to 2 prescriptions in 12 months of followup and only a median of 60 grams of topical medication. The difference in AD-related utilization and costs between pimecrolimus and tacrolimus was small, less than $100 per year, but favored pimecrolimus. Further research using validated measures of disease severity to control for potential confounding is needed to confirm the results of this observational study.