Background Antipsychotic medications are used to treat schizophrenia and may be associated with a... more Background Antipsychotic medications are used to treat schizophrenia and may be associated with adverse effects, including tardive dyskinesia (TD), following prolonged use or upon changes in dosing regimen. Objective This retrospective analysis evaluated the burden of antipsychotic dose reduction in Medicare patients with schizophrenia. Methods This matched cohort study used Medicare claims data (2006-2017) analyzed for patients with schizophrenia and two or more claims for antipsychotics, with one or more antipsychotic monotherapy period ≥ 90 days. Cohorts were defined for patients with antipsychotic dose reductions ≥ 10% and stable doses. A separate analysis was conducted using patients with dose reductions ≥ 30%. Outcomes included all-cause emergency room (ER) visits, all-cause inpatient visits, schizophrenia relapse, other psychiatric relapse, and TD diagnosis. Covariates included age, disease duration, comorbidities, and medication use. Results The analysis included 276,030 patients with ≥ 10% dose reductions and 211,575 patients with ≥ 30% dose reductions. Patient characteristics were balanced between cohorts. Patients with ≥ 10% or ≥ 30% dose reductions had a shorter time to ER visit, inpatient visit, schizophrenia relapse, other psychiatric relapse, and TD diagnosis versus those receiving stable doses (all p < 0.001). Significance was maintained when unmatched baseline characteristics were adjusted. Conclusions Patients with antipsychotic dose reductions may be at risk for increased ER visits, increased hospitalizations, and significant unfavorable mental health-related clinical outcomes, suggesting that dose reduction may increase overall health care burden in some patients with schizophrenia. This work highlights the need for alternative strategies in the management of patients with TD.
Background Previous studies have assessed the incremental economic burden of treatment-resistant ... more Background Previous studies have assessed the incremental economic burden of treatment-resistant depression (TRD) versus non-treatment-resistant major depressive disorder (i.e., non-TRD MDD) in commercially-insured and Medicaid-insured patients, but none have focused on Medicare-insured patients. Objective To assess healthcare resource utilization (HRU) and costs of patients with TRD versus non-TRD MDD or without major depressive disorder (MDD; i.e., non-MDD) in a Medicareinsured population. Methods Adult patients were retrospectively identified from the Chronic Condition Warehouse deidentified 100% Medicare database (01/2010-12/2016). MDD was defined as �1 MDD diagnosis and �1 claim for an antidepressant. Patients initiated on a third antidepressant following two antidepressant treatment regimens of adequate dose and duration were considered to have TRD. The index date was defined as the date of the first antidepressant claim for the TRD and non-TRD MDD cohorts, and as a randomly imputed date for the non-MDD cohort. Patients with TRD were matched 1:1 to non-TRD MDD patients and randomly selected non-MDD patients based on propensity scores. Analyses were also performed for a subset of patients aged �65. Results Of 29,543 patients with MDD, 3,225 (10.9%) met the study definition of TRD; 157,611 were included in the non-MDD cohort. Matched patients with TRD and non-TRD MDD were, on average, 58.9 and 59.0 years old, respectively. The TRD cohort had higher per-patient-peryear (PPPY) HRU than the non-TRD MDD (e.g., inpatient visits: incidence rate ratio [IRR] =
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, Sep 1, 2018
To understand factors associated with intensification of basal insulin therapy and treatment impa... more To understand factors associated with intensification of basal insulin therapy and treatment impact on clinical outcomes in patients with type 2 diabetes (T2D). In this retrospective, observational study of the Practice Fusion electronic health record database, eligible patients were adults with T2D, ≥1 basal insulin prescription and office visit in the 6 months before a glycated hemoglobin A1c (A1C) test >7.0% (index date), and no other injectable prescriptions in the 12 months before the index date. Patients were categorized to intensifiers with injectables (rapid-acting insulin [RAI], glucagon-like peptide-1 receptor agonist [GLP-1 RA], or other injectables) or nonintensifiers with injectables (including no change, adding an oral antidiabetes drug, or changing basal insulin dose). Principal outcomes were A1C change, hypoglycemia incidence, and change in body weight. Among 14,653 patients, 2,121 (14.5%) and 12,532 (85.5%) were categorized as intensifiers and nonintensifiers wit...
BACKGROUND: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safe... more BACKGROUND: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone (Ld) in relapsed/refractory multiple myeloma (RRMM), and to date, has the longest follow-up of any monoclonal antibody in patients with RRMM. METHODS: In this extended 4-year follow-up of the ELOQUENT-2 trial, the coprimary endpoints of progression-free survival (PFS) and overall response rate as well as the secondary endpoint of overall survival were assessed. In the absence of head-to-head trials comparing Ld-based triplet regimens to guide treatment selection, 4 randomized controlled trials-ELOQUENT-2, ASPIRE, TOURMALINE-MM1, and POLLUXwere indirectly compared to provide insight into the relative efficacy of these regimens in RRMM. RESULTS: Data at 4 years were consistent with 2-and 3-year follow-up data: ELd reduced the risk of disease progression/death by 29% versus Ld (hazard ratio, 0.71) while maintaining safety. The greatest PFS benefit among the assessed subgroups was observed in patients at the median time or further from diagnosis (≥3.5 years) with 1 prior line of therapy, who had a 44% reduction in the risk of progression/death, and in patients in the high-risk category, who had a 36% reduction in favor of ELd. This regimen also showed a relative PFS benefit that was maintained beyond 50 months. CONCLUSIONS: The sustained PFS benefit and long-term safety of ELd at 4 years, similar to those observed at 2 and 3 years, support ELd as a valuable therapeutic option for the long-term treatment of patients with RRMM. Cancer 2018;124:4032-4043.
Journal of managed care & specialty pharmacy, 2018
The median age at renal cell carcinoma (RCC) diagnosis is 64 years. However, few studies have ass... more The median age at renal cell carcinoma (RCC) diagnosis is 64 years. However, few studies have assessed the real-world time on treatment (TOT), health resource utilization (HRU), costs, or treatment compliance associated with targeted therapy use among patients in this age group with RCC. To assess the HRU, costs, and compliance during TOT among Medicare patients aged ≥ 65 years with advanced RCC (aRCC) who initiated first targeted therapy with pazopanib or sunitinib. Patients with aRCC were identified in the 100% Medicare + Part D databases administered by the Centers for Medicare & Medicaid Services. Eligible patients initiated first targeted therapy with sunitinib or pazopanib (index drug) on or after their first diagnosis of secondary neoplasm between October 19, 2009, and January 1, 2014, and were aged ≥ 65 years as of 1 year before first targeted therapy initiation (index date). Included patients were stratified into pazopanib and sunitinib cohorts based on first targeted thera...
To replicate and extend a recently published analysis of the drivers of excess costs of opioid ab... more To replicate and extend a recently published analysis of the drivers of excess costs of opioid abuse. Retrospective data analysis using de-identified claims data from the Truven MarketScan Commercial Claims and Encounter database. Medical and prescription drug claims from beneficiaries covered by large self-insured US companies were used to select patients with incident diagnoses of opioid abuse between 2012 and 2015. Two cohorts, abusers and nonabusers, were matched using propensity score methods. Excess healthcare costs were estimated over a 6-month baseline period and 12-month follow-up period. Cost drivers were assessed by diagnosis (3-digit International Classification of Diseases, Ninth Revision, Clinical Modification groupings) and place of service. The analysis included 73,714 matched pairs of abusers and nonabusers. Relative to nonabusers, abusers had considerably higher annual healthcare costs of $10,989 per patient, or $1.98 per member per month. Excess costs were similar...
Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have exam... more Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have examined real-world outcomes among elderly patients with advanced renal cell carcinoma (RCC). The purpose of this retrospective claims analysis was to assess real-world overall survival (OS), healthcare resource utilization (HRU), and healthcare costs (both all-cause and associated with RCC diagnosis) among elderly advanced RCC patients starting pazopanib or sunitinib treatment. Advanced RCC patients aged 65 years or older who started first-line treatment with pazopanib or sunitinib (index drug; the initiation date was the index date) were identified from the 100% Medicare database plus Part D linkage (January 1, 2006 to December 31, 2014). Patients were stratified by index drug and matched 1:1 with use of propensity scores based on baseline characteristics. OS was assessed from the index date to death and compared by Kaplan-Meier analyses and univariable Cox models; patients were censored a...
475 Background: Evidence on economic outcomes could provide insight on comparative economic benef... more 475 Background: Evidence on economic outcomes could provide insight on comparative economic benefit of TTs. This study assessed all-cause healthcare resource utilization (HRU) and costs among aRCC patients who initiated pazopanib and sunitinib, two commonly-used first TTs. Methods: Pts with aRCC who initiated sunitinib or pazopanib as first TT (index therapy/index date) were identified in this 100% Medicare data + Part D linkage (1/1/2006-12/31/2014). Characteristics were assessed during the 1 year prior to index date (baseline period) and pts were followed until death, end of eligibility, or end of data (study period), whichever was earliest. Pts were stratified by first TT initiated and 1:1 matched using propensity scores based on age, sex, race, year of RCC diagnosis, metastatic sites, comorbidities, and baseline inpatient, outpatient, emergency room, and pharmacy costs. Study period all-cause HRU and costs (2015 USD) were assessed on a per pt per month (PPPM) basis and compared ...
Background Antipsychotic medications are used to treat schizophrenia and may be associated with a... more Background Antipsychotic medications are used to treat schizophrenia and may be associated with adverse effects, including tardive dyskinesia (TD), following prolonged use or upon changes in dosing regimen. Objective This retrospective analysis evaluated the burden of antipsychotic dose reduction in Medicare patients with schizophrenia. Methods This matched cohort study used Medicare claims data (2006-2017) analyzed for patients with schizophrenia and two or more claims for antipsychotics, with one or more antipsychotic monotherapy period ≥ 90 days. Cohorts were defined for patients with antipsychotic dose reductions ≥ 10% and stable doses. A separate analysis was conducted using patients with dose reductions ≥ 30%. Outcomes included all-cause emergency room (ER) visits, all-cause inpatient visits, schizophrenia relapse, other psychiatric relapse, and TD diagnosis. Covariates included age, disease duration, comorbidities, and medication use. Results The analysis included 276,030 patients with ≥ 10% dose reductions and 211,575 patients with ≥ 30% dose reductions. Patient characteristics were balanced between cohorts. Patients with ≥ 10% or ≥ 30% dose reductions had a shorter time to ER visit, inpatient visit, schizophrenia relapse, other psychiatric relapse, and TD diagnosis versus those receiving stable doses (all p < 0.001). Significance was maintained when unmatched baseline characteristics were adjusted. Conclusions Patients with antipsychotic dose reductions may be at risk for increased ER visits, increased hospitalizations, and significant unfavorable mental health-related clinical outcomes, suggesting that dose reduction may increase overall health care burden in some patients with schizophrenia. This work highlights the need for alternative strategies in the management of patients with TD.
Background Previous studies have assessed the incremental economic burden of treatment-resistant ... more Background Previous studies have assessed the incremental economic burden of treatment-resistant depression (TRD) versus non-treatment-resistant major depressive disorder (i.e., non-TRD MDD) in commercially-insured and Medicaid-insured patients, but none have focused on Medicare-insured patients. Objective To assess healthcare resource utilization (HRU) and costs of patients with TRD versus non-TRD MDD or without major depressive disorder (MDD; i.e., non-MDD) in a Medicareinsured population. Methods Adult patients were retrospectively identified from the Chronic Condition Warehouse deidentified 100% Medicare database (01/2010-12/2016). MDD was defined as �1 MDD diagnosis and �1 claim for an antidepressant. Patients initiated on a third antidepressant following two antidepressant treatment regimens of adequate dose and duration were considered to have TRD. The index date was defined as the date of the first antidepressant claim for the TRD and non-TRD MDD cohorts, and as a randomly imputed date for the non-MDD cohort. Patients with TRD were matched 1:1 to non-TRD MDD patients and randomly selected non-MDD patients based on propensity scores. Analyses were also performed for a subset of patients aged �65. Results Of 29,543 patients with MDD, 3,225 (10.9%) met the study definition of TRD; 157,611 were included in the non-MDD cohort. Matched patients with TRD and non-TRD MDD were, on average, 58.9 and 59.0 years old, respectively. The TRD cohort had higher per-patient-peryear (PPPY) HRU than the non-TRD MDD (e.g., inpatient visits: incidence rate ratio [IRR] =
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, Sep 1, 2018
To understand factors associated with intensification of basal insulin therapy and treatment impa... more To understand factors associated with intensification of basal insulin therapy and treatment impact on clinical outcomes in patients with type 2 diabetes (T2D). In this retrospective, observational study of the Practice Fusion electronic health record database, eligible patients were adults with T2D, ≥1 basal insulin prescription and office visit in the 6 months before a glycated hemoglobin A1c (A1C) test >7.0% (index date), and no other injectable prescriptions in the 12 months before the index date. Patients were categorized to intensifiers with injectables (rapid-acting insulin [RAI], glucagon-like peptide-1 receptor agonist [GLP-1 RA], or other injectables) or nonintensifiers with injectables (including no change, adding an oral antidiabetes drug, or changing basal insulin dose). Principal outcomes were A1C change, hypoglycemia incidence, and change in body weight. Among 14,653 patients, 2,121 (14.5%) and 12,532 (85.5%) were categorized as intensifiers and nonintensifiers wit...
BACKGROUND: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safe... more BACKGROUND: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone (Ld) in relapsed/refractory multiple myeloma (RRMM), and to date, has the longest follow-up of any monoclonal antibody in patients with RRMM. METHODS: In this extended 4-year follow-up of the ELOQUENT-2 trial, the coprimary endpoints of progression-free survival (PFS) and overall response rate as well as the secondary endpoint of overall survival were assessed. In the absence of head-to-head trials comparing Ld-based triplet regimens to guide treatment selection, 4 randomized controlled trials-ELOQUENT-2, ASPIRE, TOURMALINE-MM1, and POLLUXwere indirectly compared to provide insight into the relative efficacy of these regimens in RRMM. RESULTS: Data at 4 years were consistent with 2-and 3-year follow-up data: ELd reduced the risk of disease progression/death by 29% versus Ld (hazard ratio, 0.71) while maintaining safety. The greatest PFS benefit among the assessed subgroups was observed in patients at the median time or further from diagnosis (≥3.5 years) with 1 prior line of therapy, who had a 44% reduction in the risk of progression/death, and in patients in the high-risk category, who had a 36% reduction in favor of ELd. This regimen also showed a relative PFS benefit that was maintained beyond 50 months. CONCLUSIONS: The sustained PFS benefit and long-term safety of ELd at 4 years, similar to those observed at 2 and 3 years, support ELd as a valuable therapeutic option for the long-term treatment of patients with RRMM. Cancer 2018;124:4032-4043.
Journal of managed care & specialty pharmacy, 2018
The median age at renal cell carcinoma (RCC) diagnosis is 64 years. However, few studies have ass... more The median age at renal cell carcinoma (RCC) diagnosis is 64 years. However, few studies have assessed the real-world time on treatment (TOT), health resource utilization (HRU), costs, or treatment compliance associated with targeted therapy use among patients in this age group with RCC. To assess the HRU, costs, and compliance during TOT among Medicare patients aged ≥ 65 years with advanced RCC (aRCC) who initiated first targeted therapy with pazopanib or sunitinib. Patients with aRCC were identified in the 100% Medicare + Part D databases administered by the Centers for Medicare & Medicaid Services. Eligible patients initiated first targeted therapy with sunitinib or pazopanib (index drug) on or after their first diagnosis of secondary neoplasm between October 19, 2009, and January 1, 2014, and were aged ≥ 65 years as of 1 year before first targeted therapy initiation (index date). Included patients were stratified into pazopanib and sunitinib cohorts based on first targeted thera...
To replicate and extend a recently published analysis of the drivers of excess costs of opioid ab... more To replicate and extend a recently published analysis of the drivers of excess costs of opioid abuse. Retrospective data analysis using de-identified claims data from the Truven MarketScan Commercial Claims and Encounter database. Medical and prescription drug claims from beneficiaries covered by large self-insured US companies were used to select patients with incident diagnoses of opioid abuse between 2012 and 2015. Two cohorts, abusers and nonabusers, were matched using propensity score methods. Excess healthcare costs were estimated over a 6-month baseline period and 12-month follow-up period. Cost drivers were assessed by diagnosis (3-digit International Classification of Diseases, Ninth Revision, Clinical Modification groupings) and place of service. The analysis included 73,714 matched pairs of abusers and nonabusers. Relative to nonabusers, abusers had considerably higher annual healthcare costs of $10,989 per patient, or $1.98 per member per month. Excess costs were similar...
Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have exam... more Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have examined real-world outcomes among elderly patients with advanced renal cell carcinoma (RCC). The purpose of this retrospective claims analysis was to assess real-world overall survival (OS), healthcare resource utilization (HRU), and healthcare costs (both all-cause and associated with RCC diagnosis) among elderly advanced RCC patients starting pazopanib or sunitinib treatment. Advanced RCC patients aged 65 years or older who started first-line treatment with pazopanib or sunitinib (index drug; the initiation date was the index date) were identified from the 100% Medicare database plus Part D linkage (January 1, 2006 to December 31, 2014). Patients were stratified by index drug and matched 1:1 with use of propensity scores based on baseline characteristics. OS was assessed from the index date to death and compared by Kaplan-Meier analyses and univariable Cox models; patients were censored a...
475 Background: Evidence on economic outcomes could provide insight on comparative economic benef... more 475 Background: Evidence on economic outcomes could provide insight on comparative economic benefit of TTs. This study assessed all-cause healthcare resource utilization (HRU) and costs among aRCC patients who initiated pazopanib and sunitinib, two commonly-used first TTs. Methods: Pts with aRCC who initiated sunitinib or pazopanib as first TT (index therapy/index date) were identified in this 100% Medicare data + Part D linkage (1/1/2006-12/31/2014). Characteristics were assessed during the 1 year prior to index date (baseline period) and pts were followed until death, end of eligibility, or end of data (study period), whichever was earliest. Pts were stratified by first TT initiated and 1:1 matched using propensity scores based on age, sex, race, year of RCC diagnosis, metastatic sites, comorbidities, and baseline inpatient, outpatient, emergency room, and pharmacy costs. Study period all-cause HRU and costs (2015 USD) were assessed on a per pt per month (PPPM) basis and compared ...
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Papers by Miriam Ellis