Public health impact of Rotarix vaccination among commercially insured children in the United States.

BACKGROUND: This study (NCT01915888) assessed public health impact of Rotarix, GSK [RV1] vaccination. METHODS: Children born between 2007-2011 were identified from Truven Commercial Claims and Encounters Databases and observed until earlier of plan disenrollment or five years old. Children receiving one or two doses of RV1 during the vaccination window were assigned to incomplete and complete vaccination cohorts, respectively. Children without rotavirus (RV) vaccination (RV1 OR RotaTeq, Merck & Co., Inc. [RV5]) were assigned to the unvaccinated cohort. Claims with International Classification of Disease 9th edition (ICD-9) codes for diarrhea and RV infections were identified. First RV episode incidence, RV-related and diarrhea-related healthcare resource utilization were compared. Multivariate Poisson regression with generalized estimating equations was used to generate 95% confidence intervals (CIs) around incidence rate ratios (IRR) between cohorts while adjusting for gender, age and calendar year. Mean costs for first RV and diarrhea episodes were calculated with adjustment for gender and birth year; bootstrapping was used to determine statistically significant differences between cohorts. RESULTS: Incidence of first RV episodes was significantly reduced in complete and incomplete vaccination cohorts compared to the unvaccinated cohort (IRR=0.17 [95%CI: 0.09-0.30] and IRR=0.19 [95%CI: 0.06-0.58], respectively). RV-related inpatient, outpatient and emergency room (ER) visits were significantly lower for complete vaccination versus unvaccinated cohort. Diarrhea-related inpatient and ER visit rates were significantly lower for complete vaccination versus unvaccinated cohorts; outpatient rates were similar. RV-related and diarrhea-related resource utilization rates were significantly lower or no different for incomplete vaccination versus unvaccinated cohort. Compared with unvaccinated children, adjusted mean cost for first RV episode and first diarrhea episode per 1000 persons was $11,511 (95%CI: $9855-$12,024) and $46,772 (95%CI: $26,268-$66,604) lower, respectively, for completely vaccinated children. CONCLUSIONS: RV1 vaccination confers benefits in reduction of RV incidence, RV- and diarrhea-related healthcare resource utilization, and RV- and diarrhea-related healthcare costs.

Clinical Outcomes Associated with Switching or Discontinuation from Anti-TNF Inhibitors for Nonmedical Reasons.

PURPOSE: This study evaluated clinical outcomes and health care resource utilization associated with nonmedical switching from or discontinuation of anti-tumor necrosis factor (TNF) therapies in US clinical practice. METHODS: Responding physicians extracted data from the medical charts of patients with Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or psoriatic arthritis who achieved response on an anti-TNF therapy. Physicians selected 2 cohorts of patients that were matched on diagnosis: patients who were switched/discontinued, for nonmedical reasons, from the anti-TNF therapy on which they achieved response (switchers/discontinuers), and patients who continued on their anti-TNF (continuers). Switchers/discontinuers were followed up for 12 months from the date of discontinuation (index date); continuers were followed up for 12 months from the date of an office visit within 2 months of the matched switcher/discontinuer׳s index date. Multivariate regression was used to compare disease flares, disease control, and health care resource utilization between cohorts, with adjustment for baseline characteristics. Subgroup analyses compared data from the continuer cohort to those from (1) patients who were switched to another biologic therapy and (2) patients who were switched to conventional therapy or discontinued from all therapy. FINDINGS: A total of 377 matched pairs of continuers and switchers/discontinuers were analyzed (N = 754), with the latter cohort comprising 284 patients (73.3%) who were and 93 (24.7%) who did not switch to another treatment (biologic or conventional treatment) immediately after discontinuation. Switchers/discontinuers had more frequent flares than did continuers, across severity levels (adjusted incidence rate ratios = 1.67, 2.36, and 3.48 for mild, moderate, and severe flares, respectively; all, P < 0.05). Switchers/discontinuers had a lower rate of well-controlled disease symptoms (46.9% vs 88.1%; adjusted odds ratio = 0.11; P < 0.001). Switchers/discontinuers also had more frequent inpatient hospitalizations, emergency department visits, and outpatient visits (adjusted incidence rate ratios = 3.58, 5.73, and 1.12, respectively; all, P < 0.001). Findings from the subgroup analyses of data from the 183 patients who switched to a biologic therapy and 194 who switched to conventional therapy or discontinued from all therapy were largely consistent with the overall analysis. IMPLICATIONS: In this study, switching/discontinuation from an anti-TNF therapy for nonmedical reasons was associated with significantly worse clinical outcomes and increased health care resource utilization-factors that should be considered when developing treatment algorithms.

Characteristics and outcomes of ALK+ non-small cell lung cancer patients in Korea.

AIM: This study aimed to describe characteristics, treatment patterns and survival among Korean patients diagnosed with locally advanced or metastatic anaplastic lymphoma kinase (ALK)+ non-small cell lung cancer (NSCLC). METHODS: A retrospective patient chart review was conducted in major cancer centers in Korea in 2014-2015. Participating physicians reviewed patient charts and reported characteristics, treatment patterns, clinician-defined progression-free survival (PFS) and overall survival (OS) of ALK+ locally advanced or metastatic NSCLC patients. PFS and OS were estimated using Kaplan-Meier analysis. RESULTS: Physicians reported on 55 ALK+ NSCLC patients. Median age at locally advanced or metastatic NSCLC diagnosis was 60 years. Most patients (82%) received initial chemotherapy; 13% received an ALK inhibitor in the first line; 62% received an ALK inhibitor by the end of follow-up. Of the 30 patients who received crizotinib, 83% discontinued and 13% died during crizotinib therapy. Median PFS on crizotinib was 6.7 months. Of those who discontinued, 32% switched to chemotherapy, 16% switched to a different ALK inhibitor and 52% received no further therapy. After discontinuing crizotinib, median OS was 6.0 months overall, and 3.4 months among patients who did not receive a second-generation ALK inhibitor. CONCLUSION: In this study of locally advanced or metastatic ALK+ NSCLC patients in Korea, roughly one-third did not receive an ALK inhibitor. Among patients who discontinued crizotinib, over half received no further antineoplastic therapy and OS was poor, particularly among patients without second-generation ALK inhibitor use. These findings suggest a need for greater access to effective treatments following crizotinib discontinuation for ALK+ NSCLC patients in Korea.

Out-of-pocket medical costs and third-party healthcare costs for children with Down syndrome.

Prior analyses have estimated the lifetime total societal costs of a person with Down syndrome (DS); however, no studies capture the expected medical costs that patients with DS can expect to incur during childhood. The study utilized the OptumHealth Reporting and Insights administrative claims database from 1999 to 2013. Children with a diagnosis of DS were identified, and their time was divided into clinically relevant age categories. Patients with DS in each age category were matched to controls without chromosomal conditions. Out-of-pocket medical costs and third-party expenditures were compared between the patient-age cohorts with DS and matched controls. Patients with DS had significantly higher mean annual out-of-pocket costs than their matched controls within each age and cost category. Total annual incremental out-of-pocket costs associated with DS were highest among individuals from birth to age 1 ($1,907, P < 0.001). The main drivers of the incremental out-of-pocket costs associated with DS were inpatient costs in the 1st year of life ($925, P < 0.001) and outpatient costs in later years (ranging $183-$623, all P < 0.001). Overall, patients with DS incurred incremental out-of-pocket medical costs of $18,248 between birth and age 18 years; third-party payers incurred incremental costs of $230,043 during the same period. Across all age categories, mean total out-of-pocket annual costs were greater for individuals with DS than those of matched controls. On average, parents of children with DS pay an additional $84 per month for out-of-pocket medical expenses when costs are amortized over 18 years. © 2016 Wiley Periodicals, Inc.

Impact of Paliperidone Palmitate Versus Oral Atypical Antipsychotics on Health Care Resource Use and Costs in Veterans with Schizophrenia.

OBJECTIVE: To compare health care resource utilization and costs in veterans with schizophrenia treated with paliperidone palmitate (PP) versus oral atypical antipsychotics (OAAs). METHODS: A retrospective longitudinal study was conducted using electronic health record data from the Veterans Health Administration. Veterans with schizophrenia (identified using ICD-9-CM 295.x) initiating PP or OAAs between January 2010 and October 2014, with ≥ 12 months of benefits enrollment prior to treatment initiation and ≥ 6 months of enrollment after treatment initiation, and with ≥ 1 Global Assessment of Functioning measurement at baseline were included. Inverse probability of treatment weighted regression models were used to estimate incidence rate ratios (IRRs) and cost differences (CDs) for the impact of PP versus OAAs on health care resource utilization and costs. RESULTS: Among 10,290 eligible veterans, 2,285 and 8,005 were initiated on PP and OAAs, respectively. After adjustment, PP was associated with less frequent all-cause inpatient hospitalizations (IRR = 0.89, P < .001) and more frequent mental health intensive case management visits (IRR = 1.81, P < .001) compared to OAAs. PP treatment was associated with higher likelihood of increased income (odds ratio [OR] = 1.20, P = .027) and lower likelihood of homelessness (OR = 0.82, P < .001). While mean annual pharmacy and outpatient costs were higher among PP users (CD = $3,417 pharmacy, $2,527 outpatient, P < .001), mean annual inpatient costs were lower (CD = -$14,456, P < .001), resulting in average annual total health care (medical and pharmacy) cost savings associated with PP (CD = -$8,511, P = .012) relative to OAAs. CONCLUSIONS: PP treatment was associated with significantly lower total health care costs attributable to reduced inpatient admissions compared to OAAs. Higher mental health intensive case management participation among PP users may have contributed to the differences observed.

Characteristics, treatment patterns, and survival among ALK+ non-small cell lung cancer (NSCLC) patients treated with crizotinib: A chart review study.

OBJECTIVES: Second-generation ALK inhibitors are recently available for ALK+ non-small cell lung cancer (NSCLC) patients previously treated with crizotinib. This study described characteristics, treatment sequencing, and outcomes among locally advanced/metastatic crizotinib-experienced ALK+ NSCLC patients. MATERIALS AND METHODS: From July 2014 to June 2015, a retrospective patient chart review was conducted among physicians from the US, EU, Korea, and Latin America. Participating clinicians identified their ALK+ NSCLC patients who received crizotinib and reported on their clinical characteristics, treatments, and survival using a pre-defined case report form. Kaplan-Meier analyses were used to describe overall survival (OS) and clinician-defined progression-free survival (PFS). RESULTS: Participating clinicians reviewed charts of 158 ALK+ NSCLC patients treated with crizotinib during the study period. Crizotinib was most commonly received in the second-line setting (41% of patients), though this varied across geographical regions. Roughly half (53%) of the patients who discontinued crizotinib received further antineoplastic therapy; second-generation ALK inhibitors (44%) and chemotherapy (42%) regimens were used most frequently. Following crizotinib discontinuation, median OS was 8.2 months. Among patients who did not initiate a second-generation ALK inhibitor following crizotinib, median OS was 4.9 months; among those who did, median OS was not reached. Among patients who received chemotherapy immediately following crizotinib discontinuation, time to clinician-defined PFS from post-crizotinib chemotherapy initiation was 3.6 months. CONCLUSION: Following crizotinib discontinuation, many patients received no further antineoplastic therapy, and OS was poor among patients who did not receive a second-generation ALK inhibitor. Recently available second-generation ALK inhibitors may provide important treatment options for ALK+ NSCLC patients.

Real-World Analysis of Medical Costs and Healthcare Resource Utilization in Elderly Women with HR+/HER2- Metastatic Breast Cancer Receiving Everolimus-Based Therapy or Chemotherapy.

INTRODUCTION: The objective of this study was to analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among elderly women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC). METHODS: Elderly women (≥65 years) with HR+/HER2- mBC who failed a non-steroidal-aromatase-inhibitor and subsequently began a new line of treatment with everolimus-based therapy or chemotherapy for mBC (index therapy) during July 20, 2012 to March 31, 2014 were identified from two large commercial claims databases. All-cause, BC-, and adverse event (AE)-related medical costs (2014 USD), and all-cause and AE-related HRU per patient per month (PPPM) were compared between patients treated with everolimus-based therapy and chemotherapy across their first four lines of therapy for mBC. Adjusted costs and HRU differences were estimated by pooling all lines and using multivariable models adjusted for differences in patient characteristics. RESULTS: In total, 925 elderly patients (mean age approximately 73 years) with HR+/HER2- mBC met the inclusion criteria; 230 received everolimus-based therapy (240 lines) and 737 received chemotherapy (939 lines). Compared with chemotherapy, everolimus-based therapy was associated with significantly lower total all-cause PPPM medical services costs (adjusted mean difference: $4007), driven by lower inpatient ($1994) and outpatient ($1402) costs; lower BC-related medical services costs ($3129), driven by both BC-related inpatient ($1883) and outpatient costs ($913); and lower AE-related medical services costs ($1873; all P < 0.01). Additionally, compared to patients treated with chemotherapy, patients treated with everolimus-based therapy had fewer all-cause outpatient visits (adjusted incidence rate ratio = 0.69), BC-related outpatient visits (0.66), other-medical-service visits (0.65), and AE-related HRU (0.59), which was driven by significantly fewer AE-related outpatient visits (0.56; all P < 0.01). Subgroup analyses comparing medical costs of everolimus-based therapy with capecitabine monotherapy showed consistent results overall. CONCLUSION: This retrospective claims database analysis of elderly women with HR+/HER2- mBC in the United States showed that everolimus-based therapy was associated with significantly lower all-cause, BC-related, and AE-related medical services costs and less use of healthcare resources compared with chemotherapy. FUNDING: Novartis.

Treatment patterns and factors associated with the use of everolimus among post-menopausal women with HR+/HER2- metastatic breast cancer: a retrospective US claims study.

OBJECTIVE: To assess the real-world use of everolimus in the treatment of hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic-breast-cancer (mBC). METHODS: Postmenopausal women with HR+/HER2- mBC who initiated a new therapy for mBC between 20 July 2012 and 31 March 2014 after a non-steroidal-aromatase-inhibitor were identified from two commercial claims databases. Multivariate logistic regressions were used to identify factors associated with everolimus use versus endocrine-monotherapy or chemotherapy. Dosing patterns and adherence to everolimus were summarized. RESULTS: A total of 940 everolimus, 6,134 endocrine-monotherapy, and 3,410 chemotherapy regimens were included across patients' first four lines of therapy. Patients with bone and visceral metastases were more likely to use everolimus versus endocrine-monotherapy. Patients with more comorbidities, visceral or central-nervous-system metastases, and prior chemotherapy use for mBC were less likely to use everolimus versus chemotherapy. Approximately 80% of patients initiated everolimus at label-recommended-dose of 10 mg daily; 60-70% of patients had a medical possession ratio >0.8 to everolimus, and consistently high adherence was observed across lines of therapy. CONCLUSIONS: For HR+/HER2- mBC, patients treated with everolimus had more severe disease than patients treated with endocrine-monotherapy but less severe disease than patients treated with chemotherapy. Most patients used everolimus according to label-recommended dose and adherence was high across lines of therapy.

Comparison of medical costs and healthcare resource utilization of post-menopausal women with HR+/HER2- metastatic breast cancer receiving everolimus-based therapy or chemotherapy: a retrospective claims database analysis.

OBJECTIVE: To analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among post-menopausal women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC). METHODS: Patients with HR+/HER2- mBC who discontinued a non-steroidal aromatase inhibitor and began a new line of treatment with everolimus-based therapy or chemotherapy (index therapy/index date) between July 20, 2012 and April 30, 2014 were identified from two large claims databases. All-cause, BC-related, and adverse event (AE)-related medical costs (in 2014 USD) and all-cause HRU per patient per month (PPPM) were analyzed for both treatment groups across patients' first four lines of therapies for mBC. Adjusted differences in costs and HRU between the everolimus and chemotherapy treatment group were estimated pooling all lines and using multivariable generalized linear models, accounting for difference in patient characteristics. RESULTS: A total of 3298 patients were included: 902 everolimus-treated patients and 2636 chemotherapy-treated patients. Compared to chemotherapy, everolimus was associated with significantly lower all-cause (adjusted mean difference = $3455, p < 0.01) and BC-related ($2510, p < 0.01) total medical costs, with inpatient ($1344, p < 0.01) and outpatient costs ($1048, p < 0.01) as the main drivers for cost differences. Everolimus was also associated with significantly lower AE-related medical costs ($1730, p < 0.01), as well as significantly lower HRU (emergency room incidence rate ratio [IRR] = 0.83; inpatient IRR = 0.74; inpatient days IRR = 0.65; outpatient IRR = 0.71; BC-related outpatient IRR = 0.57; all p < 0.01). CONCLUSIONS: This retrospective claims database analysis of commercially-insured patients with HR+/HER2- mBC in the US showed that everolimus was associated with substantial all-cause, BC-related, and AE-related medical cost savings and less utilization of healthcare resources relative to chemotherapy.

Time on treatment of everolimus and chemotherapy among postmenopausal women with hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative metastatic breast cancer: a retrospective claims study in the US.

OBJECTIVE: This study aimed to compare time on treatment (TOT) among patients treated with everolimus and chemotherapy, two commonly used treatments for hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC). METHODS: Postmenopausal women with HR+/HER2- mBC who initiated ≥1 new line of therapy for mBC during 20 July 2012-31 March 2014 after a non-steroidal aromatase inhibitor were identified from MarketScan and PharMetrics databases (2002Q1-2014Q2) using a claims-based algorithm. Patients were classified into treatment groups by regimen and line of therapy, and were followed until discontinuation of therapy, end of insurance eligibility, or data cut-off (30 June 2014). Discontinuation was defined as a treatment gap of ≥60 days; patients who did not discontinue were censored at the end of follow-up. TOT was compared between everolimus, chemotherapy, and capecitabine monotherapy using Kaplan-Meier analyses and multivariable Cox models adjusting for line of therapy, age, insurance, de novo mBC diagnosis, prior use of chemotherapy for mBC, sites of metastases, and Charlson comorbidity index. RESULTS: Across the first four lines of therapies for mBC, a total of 940 everolimus, 3410 chemotherapy, and 721 capecitabine monotherapy regimens were included. Based on the different lines of therapies, the median TOT ranged from 5.5 to 7.2 months for everolimus, 4.3 to 4.7 months for chemotherapy, and 3.5 to 6.0 months for capecitabine monotherapy. Pooling all lines of therapies, everolimus was associated with significantly longer TOT compared to chemotherapy (multivariable-adjusted hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.62-0.76) or capecitabine monotherapy (multivariable-adjusted HR = 0.73, 95% CI: 0.64-0.83). Longer TOT was consistently observed for everolimus for each line of therapy. LIMITATIONS: Proxies used for identifying HR + /HER2- mBC and treatment line, lack of certain clinical factors in claims data, generalizability limited to commercially insured patients in the US. CONCLUSIONS: This study found that HR+/HER2- mBC patients receiving everolimus experienced significantly longer TOT than those receiving chemotherapy overall or capecitabine monotherapy.

ALK rearrangement testing and treatment patterns for patients with ALK-positive non-small cell lung cancer.

INTRODUCTION: Approximately 2-8% of non-small cell lung cancer (NSCLC) patients have rearrangements in the anaplastic lymphoma kinase gene (ALK). ALK-targeted therapy is available to patients with tumors known to be ALK+. This chart review study described characteristics of patients with ALK+ NSCLC, patterns of ALK testing and subsequent treatments, and oncologists' experience with ALK testing in the US. METHODS: US oncologists provided information in September and October of 2013 on patients from their practice diagnosed with ALK+ locally advanced or metastatic NSCLC, including the timing of ALK testing and treatment received after testing. Participating oncologists were also surveyed about their experience with ALK testing. RESULTS: 27 oncologists provided data on 273 ALK+ NSCLC patients. Patients' median age was 67 years upon NSCLC diagnosis. Smoking history varied, with 33% nonsmokers, 33% light smokers, and 33% heavy smokers. Patients were racially diverse: 59% White, 18% Black, 13% Asian, and 10% other. Upon diagnosis of advanced/metastatic NSCLC, patients who were either not tested (19%) or initially tested negative/inconclusive (1%) all received first-line chemotherapy; the other 219 patients (80%) tested positive, with 133 (61%) receiving an ALK inhibitor and 78 (29%) receiving chemotherapy as first-line treatment. Many oncologists stated being more likely to test for ALK rearrangements among Asians, nonsmokers, and light smokers. CONCLUSIONS: In this sample, ALK+ NSCLC patients were racially diverse with mixed smoking history. One in five patients were not tested before first-line therapy. Oncologists reported being more likely to consider ALK testing for patients with particular smoking and race characteristics.

The epidemiology and targeted therapies for relapsed and refractory CD30+ lymphomas.

BACKGROUND: Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL) both have consistent expression of CD30, a cytokine receptor that is expressed by activated T and B cells but is largely absent from normal tissue. METHODS: A literature search was conducted via PubMed, Google Scholar, and UpToDate to identify relevant peer-reviewed original research or review articles on HL, sALCL, and CD30 targeted therapies. RESULTS: These lymphomas are both more common among males, young adults and the elderly. Although many patients with HL and sALCL can achieve long-term remission after standard first-line therapy, up to a third of these patients are refractory to or relapse after initial therapy. Among these relapsed/refractory patients, many experience disease progression and/or death despite subsequent treatment, and treatment-related adverse events and mortality are not uncommon. To address the need for safer and more effective therapies for these relapsed/refractory patients, researchers have developed therapies that specifically target CD30-expressing cells. Brentuximab vedotin, an antibody-drug conjugate that selectively delivers a toxic microtubule-disrupting agent to malignant cells with CD30 expression, is the first such therapy to be approved in the US and Europe. In clinical trials, brentuximab vedotin has demonstrated efficacy and safety in patients with HL after failure of autologous stem cell transplantation (ASCT), or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and in patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. CONCLUSION: HL and sALCL are both CD30+ lymphomas, and therapies like brentuximab vedotin that target cells expressing CD30 hold promise for the treatment of these diseases.

Cost of adverse events during treatment with everolimus plus exemestane or single-agent chemotherapy in patients with advanced breast cancer in Western Europe.

OBJECTIVE: Treatment options for recurrent or progressive hormone receptor-positive (HR+) advanced breast cancer include chemotherapy and everolimus plus exemestane (EVE + EXE). This study estimates the costs of managing adverse events (AEs) during EVE + EXE therapy and single-agent chemotherapy in Western Europe. METHODS: An economic model was developed to estimate the per patient cost of managing grade 3/4 AEs for patients who were treated with EVE + EXE or chemotherapies. AE rates for patients receiving EVE + EXE were collected from the phase III BOLERO-2 trial. AE rates for single-agent chemotherapy, capecitabine, docetaxel, or doxorubicin were collected from published clinical trial data. AEs with at least 2% prevalence for any of the treatments were included in the model. A literature search was conducted to obtain costs of managing each AE, which were then averaged across Western European countries (when available). Per patient costs for managing AEs among patients receiving different therapies were reported in 2012 euros (€). RESULTS: The EVE + EXE combination had the lowest average per patient cost of managing AEs (€730) compared to all chemotherapies during the first year of treatment (doxorubicin: €1230; capecitabine: €1721; docetaxel: €2390). The most costly adverse event among all patients treated with EVE + EXE was anemia (on average €152 per patient). The most costly adverse event among all patients treated with capecitabine, docetaxel, or doxorubicin was lymphocytopenia (€861 per patient), neutropenia (€821 per patient), and leukopenia (€382 per patient), respectively. CONCLUSIONS: The current model estimates that AE management during the treatment of HR+ advanced breast cancer will cost one-half to one-third less for EVE + EXE patients than for chemotherapy patients. The consideration of AE costs could have important implications in the context of healthcare spending for advanced breast cancer treatment.

Real-world patterns of endocrine therapy for metastatic hormone-receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) breast cancer patients in the United States: 2002-2012.

OBJECTIVE: Clinical guidelines recommend that patients with HR+/HER2- metastatic breast cancer (mBC), the most prevalent mBC subtype, receive three lines of endocrine therapy (ET) prior to transitioning to chemotherapy (CT) in the absence of need for rapid response, symptomatic visceral disease, or suspected endocrine resistance. Little is known about real-world ET treatment patterns among HR+/HER2- mBC patients. RESEARCH DESIGN AND METHODS: Post-menopausal women with HR+/HER2- mBC were identified in the MarketScan databases (2002Q3-2012Q2). Patients were classified as receiving either ET or CT as their first therapy post-mBC diagnosis. Those receiving ET were studied further and stratified into three subgroups based on which of the following events occurred first: transition to CT, discontinuation of ET (90 days without evidence of ET), or end of data or insurance eligibility. MAIN OUTCOME MEASURES: Mean numbers of lines of ET and median durations of each line were summarized for the overall sample and subgroups. RESULTS: Among a total of 19,120 HR+/HER2- mBC patients, 11,545 (60%) initiated an ET; median follow-up time for these patients was 17 months. Seventy-four percent did not receive a second ET. The average patient received 1.36 lines of ET. Among patients with 2+ lines of ET, the duration of each subsequent line was significantly shorter than the previous line. RESULTS were similar in all subgroups. LIMITATIONS: Clinical characteristics and reasons for treatment choices are unavailable in claims data. CONCLUSIONS: Fewer than two thirds of patients initiated treatment for HR+/HER2- mBC with ET. Among those who did, most received only one line of ET before discontinuation or transition to CT. Patients who received multiple lines of ET experienced shorter durations of therapy with each line. Real-world treatment with ET falls short of the targets recommended by guidelines, representing unmet need for treatment options that improve the effectiveness of endocrine therapy.

State-level unemployment and the utilization of preventive medical services.

OBJECTIVE: To study the association between macroeconomic conditions and preventive medical service utilization. DATA SOURCES/STUDY SETTING: Secondary data collection of a survey of the civilian, non-institutionalized population of adults (age 18 and older) in the United States between 1987 and 2010. STUDY DESIGN: Regression analyses that adjust for individual-level demographic and socioeconomic determinants, state and time-fixed effects, and state-specific time trends. DATA COLLECTION/EXTRACTION METHODS: State health departments, with technological and methodological assistance from the Centers for Disease Control and Prevention, conducted a cross-sectional yearly telephone survey using a standardized questionnaire. PRINCIPAL FINDINGS: The use of preventive medical services is procyclical: a 1 percentage point increase in the state-level unemployment rate is associated with a 1.58 percent decrease in the quantity of distinct preventive care services utilized. Women and economically disadvantaged populations are shown to be especially sensitive to macroeconomic fluctuations. CONCLUSIONS: Policy makers should be aware of cyclical changes in preventive care use, particularly among disadvantaged populations, when making challenging budgetary decisions during economic downturns. As physician recommendations can have a strong impact on patients' use, health care providers could increase efforts to persuade patients to seek screening exams and necessary vaccinations during periods of high unemployment.