Stephen Stemkowski

Patterns of Care in Patients with Metastatic Renal Cell Carcinoma Among a U.S. Payer Population with Commercial or Medicare Advantage Membership

BACKGROUND Several systemic therapies are now approved for first- and second-line treatment of metastatic renal cell carcinoma (mRCC). Although the National Comprehensive Cancer Network (NCCN) guidelines offer physicians evidence-based recommendations for therapy, there are few real-world studies to help inform the utilization of these agents in clinical practice. OBJECTIVES To (a) describe the patterns of use associated with systemic therapies for mRCC among Humana members in the United States diagnosed with mRCC, (b) assess consistency with the NCCN guidelines for treatment, and (c) to describe the initial first-line therapy regimen by prescriber specialty and site of care. METHODS This was a retrospective study using Humanas claims database of commercially insured patients and patients insured by the Medicare Advantage Prescription Drug plan. The study period was from January 1, 2007, to December 31, 2013. Patients with mRCC were identified by ICD-9-CM codes 189.0/189.1 and 196.xx to 199.xx; all patients were between 18 and 89 years of age, had received systemic therapy for their disease, and were followed up for 180 days. Outcome measures included choice of initial systemic therapy, starting and ending doses, first-line treatment persistence and compliance, and choice of second-line therapy. Persistence was measured using time to discontinuation of first-line therapy and proportion of days covered (PDC; the ratio of [total days of drug available minus days of supply of last prescription] to [last prescription date minus first prescription date]). Compliance was measured using the medication possession ratio (MPR; the ratio of [total days supply minus days supply of last prescription] to [last prescription date minus first prescription date]). RESULTS A total of 649 patients met all inclusion criteria; 109 were insured by commercial plans and 540 were insured by Medicare. The mean ± SD age of patients was 68.6 ± 9.4 years, and 68.6% were male; Medicare patients were older than commercial patients (71.7 ± 7.4 vs. 56.6 ± 9.1 years, respectively; P < 0.001). The most common comorbidities among the patient population were hypertension, hyperlipidemia, diabetes, and heart disease. The majority of patients (68.6%) received an oral tyrosine kinase inhibitor (TKI) as their first line of therapy: 43.9% received sunitinib, 14.0% received sorafenib, 10.0% received pazopanib, and 0.6% received axitinib. Mean ± SD time to discontinuation of first-line TKI treatment was 169.1 ± 29.5 days with sunitinib, 160.3 ± 41.1 days with pazopanib, and 160.1 ± 41.4 days with sorafenib. Other first-line therapies included inhibitors of mammalian target of rapamycin (mTOR) (19.7%) and the antivascular endothelial growth factor agent bevacizumab (9.4%). Among patients receiving mTOR inhibitors, 14.8% were started on temsirolimus and 4.9% were started on everolimus. The median starting and ending doses were the same for each drug except for sunitinib. Mean ± SD times to discontinuation of temsirolimus, everolimus, and bevacizumab were 171.8 ± 26.2, 137.0 ± 62.2, and 150.8 ± 56.0 days, respectively. Persistence on first-line regimen as measured by PDC was high (PDC ≥ 80%) for 89% of oral therapies and 77% of injectable therapies; first-line compliance was high (MPR ≥ 80%) for 77% of oral therapies and 68% of injectables. Among patients who received second-line therapy, the most common regimen was everolimus (29.2%), followed by bevacizumab (19.8%), temsirolimus (15.6%), and sunitinib (13.6%). Specialty codes obtained from the database provider identified internal medicine specialists and oncologists as the most common prescribers of TKIs and mTOR inhibitors. CONCLUSIONS Patterns of use were similar for each of the prescribed systemic treatments for mRCC, and the majority of patients were highly persistent and compliant with first-line therapies. Time to treatment discontinuation was slightly longer with oral agents compared with injectable drugs.

Healthcare resource utilization and costs for patients with pulmonary arterial hypertension: real-world documentation of functional class

Abstract Background and aims: Pulmonary arterial hypertension (PAH) is a rare medical disease in which patients experience increased pulmonary vascular resistance (PVR) and pulmonary arterial pressure that can result in remodeling of the pulmonary vasculature and heart, and eventually lead to right heart failure and death. As PAH progresses, patients become unable to perform even routine daily tasks without severe shortness of breath (dyspnea), fatigue, dizziness, and fainting (syncope). Treatment strategies largely depend on assessment of an individual patient’s WHO Functional Class. The aim of the present study was to determine whether PAH functional decline, as described by the WHO Functional class (FC), is associated with increased healthcare costs for patients. Methods: Patients with a prescription for a FDA-approved treatment for PAH and a medical claim indicating chronic pulmonary heart disease or right heart catheterization were identified from an administrative claims database. Provider-reported data from prior authorization forms required for advanced PAH therapies and medical charts were examined for reported FC. Healthcare resource utilization and costs were the primary outcomes of interest. Costs were accounted in 2014 US dollars (

Does site-of-care for oncology infusion therapy influence treatment patterns, cost, and quality in the United States?

) from a healthcare payer perspective. Results: Patients with a reported FC-IV were observed to have the worst outcomes; averaging significantly more inpatient admissions, longer average lengths of stay, and more emergency department visits than the other FC sub-groups, resulting in higher medical costs. Conclusions: Using administrative data to document disease severity, this study replicates and expands on findings obtained from the registry study; disease severity was associated with higher healthcare resource utilization and costs. Stakeholders’ implications for patient management are discussed.

The Relationship Between Guideline-Recommended Initiation of Therapy, Outcomes, and Cost for Patients with Metastatic Non-Small Cell Lung Cancer

Abstract Background: The increase in hospital acquisition of community oncology clinics in the US has led to a shift in the site-of-care (SOC) for infusion therapy from the physician office (PO) to the hospital outpatient (HO) setting. Objective: To investigate differences by SOC in treatment patterns, quality, and cost among patients with cancer undergoing first-line infusion therapy. Research design and methods: This retrospective analysis identified adult patients from Humana medical claims who initiated infusion therapy from 2008–2012 for five common cancer types in which infusion therapy is likely, including early stage breast cancer; metastatic breast, lung, and colorectal cancers; and non-Hodgkin’s lymphoma or chronic lymphocytic leukemia. Differences by SOC in first-line treatment patterns and quality of care at end-of-life, defined as infusions or hospitalizations 30 days prior to death, were evaluated using Wilcoxon-Rank Sum and Chi-square tests where appropriate. Differences in cost by SOC were evaluated using risk-adjusted generalized linear models. Main outcome measures: Treatment patterns, quality of care at end of life, healthcare costs. Results: There were differences in duration of therapy and number of infusions for some therapy regimens by SOC, in which patients in the HO had shorter duration of therapy and fewer infusions. There were no differences in quality of care at end-of-life by SOC. Total healthcare costs were 15% higher among patients in HO (

Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study

55,965) compared with PO (

Pharmacotherapy Choice Is Associated with 2-Year Mortality for Patients with Heart Failure and Reduced Ejection Fraction

48,439), p < .0001. Limitations: Analyses was restricted to a claims-based population of cancer patients within a health plan. Conclusion: This study, in an older, predominantly Medicare Advantage oncology cohort, found differences by SOC in treatment patterns and cost, but not quality. Where differences were found, patients receiving care in the HO had shorter duration of therapy and fewer infusions for specific treatment regimens, but higher healthcare costs than those treated in a PO.

An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction

BACKGROUND Guideline-recommended therapy for metastatic non-small cell lung cancer (mNSCLC) encourages evidence-based treatment; however, there is a knowledge gap regarding the influence of guideline-recommended initiation of therapy on outcomes and cost. OBJECTIVE To investigate if lack of guideline-recommended initiation of first-line systemic therapy was associated with worse patient outcomes and increased costs for patients with mNSCLC. METHODS In this retrospective analysis, 1,344 Medicare patients with mNSCLC were identified from Humana data. Performance status (PS) was imputed using procedure, diagnosis, and durable medical equipment codes pre-index. Guideline-recommended initiation of therapy was defined as ≥1 cycle of National Comprehensive Cancer Network-recommended first-line therapy based on age and PS or targeted therapies regardless of age and PS. Demographics and clinical characteristics were compared by guideline-recommended initiation of therapy. A Cox model assessed factors associated with 6-month mortality. End-of-life quality of care indicators included hospital admission and oncology infusions 30 days preceding death and were evaluated using logistic regression models. A generalized linear model assessed the relationship between guideline-recommended initiation of therapy and total health care costs in the 6 months post-index controlling for clinical, demographic, and treatment characteristics. Logistic models for inpatient stays and emergency department visits were also evaluated. RESULTS Guideline-recommended therapy initiation was observed in 75.5% of patients. Patients not initiating guideline-recommended therapy were older, with a mean (SD) age of 72.5 (6.7) versus 71.2 (6.2) years (P = 0.001), and more frequently identified as having a low-income subsidy (30.0% vs. 16.4%; P < 0.001). Among the 24.6% of patients who died ≤ 6 months post-index, a greater percentage had not initiated guideline-recommended therapy (28.8% vs. 23.2%; P = 0.040). In adjusted models, PS (not initiation of guideline-recommended therapy) was predictive of mortality (patients with poor PS had an 84% higher probability of death [P = 0.014]). Among decedents, 64.2% were hospitalized, and 33.9% had an oncology-related infusion within 30 days of death, with no differences by guideline-recommended initiation of therapy. These end-of-life quality indicators were not associated with guideline-recommended initiation of therapy in adjusted models. Overall, 47.5% of patients who initiated guideline-recommended therapy were hospitalized compared with 55.0% of patients who did not (P = 0.026). Patients initiating guideline-recommended therapy had higher post-index total and oncology-related health care costs and fewer hospitalizations. In models, these differences in costs and hospitalizations were not associated with initiation of guideline-recommended therapy. CONCLUSIONS Most patients initiated guideline-recommended therapy, with no differences in mortality and quality of care at the end of life by guideline-recommended initiation of therapy, though adherence beyond treatment initiation was not assessed. Unadjusted hospitalization rates were lower and costs were higher for patients who initiated guideline-recommended therapy. These differences were no longer observed after risk adjustment, suggesting that they may have been influenced by patient characteristics, disease progression, and subsequent treatment decisions. DISCLOSURES This study was sponsored by Genentech. Khoury, Michael, Parikh, and Bunce are employed by Genentech. Casebeer, Drzayich Antol, DeClue, Hopson, Li, and Stemkowski are employed by Comprehensive Health Insights, Humana, which was contracted by Genentech to conduct this study. Sehman is employed by Humana. Based on this research, 2 posters were presented at the Academy of Managed Care Pharmacy Nexus 2017 on October 16-19, 2017, in Dallas, Texas. Another poster was also presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress on October 29-November 2, 2016, in Vienna, Austria.

Pulmonary Arterial Hypertension (Pah): Real-World Treatment Patterns, Outcomes And Costs Based On World Health Organization (Who) Functional Class (Fc)

BACKGROUND Evidence suggests that real-world treatment patterns of chronic obstructive pulmonary disease (COPD) do not always follow evidence-based treatment recommendations such as those of the Global Initiative for Chronic Obstructive Lung Disease, which recommends treatment escalation based on disease progression. This U.S. database study evaluated treatment patterns in patients with COPD, focusing on time to initiation of triple therapy using multiple inhalers. OBJECTIVES To (a) estimate time from diagnosis to initiation of long-acting muscarinic antagonist (LAMA) monotherapy, inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) dual therapy, or LAMA/LABA dual therapy; (b) estimate time to initiation of triple therapy from LAMA monotherapy and ICS/LABA or LAMA/LABA dual therapies; and (c) estimate the likelihood of patient progression to triple therapy. METHODS This study was a retrospective analysis of patients with COPD newly started on LAMA monotherapy, ICS/LABA, or LAMA/LABA therapy between July 1, 2010, and March 31, 2013, as identified in Humanas research database. Patients who were fully insured with commercial or Medicare Advantage insurance plans and were aged ≥ 40 years at index with at least 1 hospitalization, 1 emergency department, or 1 medical office visit claim with a COPD diagnosis in the pre-index year were included in the analysis. Time from diagnosis to initiation of index therapy and time to triple therapy after index therapy were assessed. Multivariable logistic regression models were used to estimate the likelihood of progression to triple therapy. RESULTS Of 13,541 patients with a confirmed diagnosis of COPD, 4,000 received LAMA monotherapy; 8,207 received ICS/LABA therapy; and 77 received LAMA/LABA therapy at index; mean time (± SD) from COPD diagnosis to initiation of triple therapy was 178 (± 134) days, 185 (± 130) days, and 252 (± 124) days, respectively. During the study, 28% (n = 1,130) of patients receiving LAMA monotherapy and 20% (n = 1,647) of patients receiving dual therapy (ICS/LABA, n = 1,615; LAMA/LABA, n = 32) progressed to triple therapy. Of the patients who progressed to triple therapy, 63% and 57% of patients receiving monotherapy and dual therapy, respectively, progressed in the 12 months after the index date. In the 12 months before initiation of triple therapy, approximately 50% of patients in the LAMA monotherapy, ICS/LABA, and LAMA/LABA therapy groups had an exacerbation. In the multivariable analysis, discontinuation of therapy, smoking history, and concomitant use of xanthenes and short-acting beta2-agonists were significant predictors of progression from index therapy to triple therapy. CONCLUSIONS Approximately 25% of patients with COPD progressed to triple therapy within 12 months of initiating treatment with monotherapy or dual therapy. Exacerbations were reported in only 50% of these patients, indicating that the other 50% may have escalated to triple therapy for other reasons. Treatment discontinuation, smoking history, the use of a LAMA, and concomitant medication use were significant predictors of progression to triple therapy. DISCLOSURES This study was a GlaxoSmithKline-sponsored collaborative research study (HO-14-16145). GlaxoSmithKline funded this study and had a role in study design, data analysis, data interpretation, and writing of this report. Stemkowski is a paid employee of Comprehensive Health Insights, which is a wholly owned subsidiary of Humana and was contracted to conduct the study. No funding was provided to Comprehensive Health Insights for manuscript development. At the time of the study, Lane and Tao were paid employees of Comprehensive Health Insights. Stanford is an employee of and stockholder in GlaxoSmithKline.