Real-World Treatment Patterns for Lung Neuroendocrine Tumors: A Claims Database Analysis.

OBJECTIVE: The aim of this study was to describe real-world lung neuroendocrine tumor (NET) treatment patterns. METHODS: This study examined cytotoxic chemotherapy (CC), somatostatin analogues (SSA), targeted therapy (TT), interferon, and liver-directed therapies in 2 US claims databases. Patients ≥18 years with ≥1 inpatient or ≥2 outpatient claims for lung NET, initiating pharmacologic treatment between July 1, 2009, and June 30, 2014, were identified and followed until the end of enrollment or study end, whichever occurred first. RESULTS: A total of 785 newly pharmacologically treated lung NET patients were identified: mean (SD) age was 58.6 (9.1) years; 54.0% were female; 78.2% started first-line therapy with CC, 18.1% with SSA, and 1.1% with TT. Mean duration of first-line treatment was 397 days for SSA, 142 days for CC, and 135 days for TT. 74.1% of patients received no pharmacological treatment beyond first-line. The most common second-line treatment was SSA. CONCLUSIONS: Most patients received CC as first-line treatment, with SSA being less common. SSA-treated patients remained on therapy for > 1 year, compared to < 5 months for CC. The high proportion of patients using chemotherapy and the low proportion receiving second-line treatment seems consistent with treatment guidelines for small cell lung cancer rather than for NET. Future studies are warranted to describe reasons for treatment choice, discontinuation, and switching.

Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users: analysis of patient electronic medical record data.

Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for treatment of HIV-1 infection. Despite concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events, some observational studies have shown high rates of EFV continuation at one year and low rates of CNS-related EFV substitution. The objective of this study was to further examine the real-world rate of CNS-related EFV discontinuation in antiretroviral therapy naïve HIV-1 patients. This retrospective cohort study used a nationally representative electronic medical records database to identify HIV-1 patients ≥12 years old, treated with a 1st-line EFV-based regimen (single or combination antiretroviral tablet) from 1 January 2009 to 30 June 2013. Patients without prior record of EFV use during 6-month baseline (i.e., antiretroviral therapy naïve) were followed 12 months post-medication initiation. CNS-related EFV discontinuation was defined as evidence of a switch to a replacement antiretroviral coupled with record of a CNS symptom within 30 days prior, absent lab evidence of virologic failure. We identified 1742 1st-line EFV patients. Mean age was 48 years, 22.7% were female, and 8.1% had a prior report of CNS symptoms. The first year, overall discontinuation rate among new users of EFV was 16.2%. Ten percent of patients (n = 174) reported a CNS symptom and 1.1% (n = 19) discontinued EFV due to CNS symptoms: insomnia (n = 12), headache (n = 5), impaired concentration (n = 1), and somnolence (n = 1). The frequency of CNS symptoms was similar for patients who discontinued EFV compared to those who did not (10.3 vs. 9.9%; P = .86). Our study found that EFV discontinuation due to CNS symptoms was low, consistent with prior reports.

Changes in Healthcare Utilization After Etanercept Initiation in Patients with Rheumatoid Arthritis: A Retrospective Claims Analysis.

INTRODUCTION: Effective treatment for rheumatoid arthritis (RA) may lead to lower overall and RA-related healthcare utilization. We evaluated healthcare utilization before and after initiation of the tumor necrosis factor inhibitor etanercept in patients with moderate to severe RA. METHODS: This retrospective cohort study used data from the MarketScan® claims database. Data from adult patients with RA newly exposed to etanercept between January 1, 2010 and December 31, 2013 were analyzed. Patients had at least one inpatient or outpatient claim for RA and at least one claim for etanercept (first claim was index date). Etanercept compliance was determined on the basis of proportion of days covered (PDC). Primary outcome was change in overall and RA-related healthcare utilization in the year before and year after etanercept initiation. McNemar's test and paired t test, respectively, were used to determine statistical significance for dichotomous and continuous variables. RESULTS: Data from 6737 patients were analyzed; mean age was 49.8 years and 77.3% were female. Overall outpatient services, office visits, outpatient hospital services, laboratory visits, and emergency department visits were significantly lower in the post-index period compared to pre-index. RA-related pharmacotherapy use (oral corticosteroids, opioid analgesics, nonsteroidal anti-inflammatory drugs, and nonbiologic disease-modifying antirheumatic drugs) was significantly lower in the post-index period compared to pre-index. Rates of RA-related total joint arthroplasty, joint reconstructions, and soft tissue procedures were similar in pre-index and post-index periods. High etanercept compliance (PDC ≥80%) was associated with significantly lower rates of RA-related outpatient services, office visits, diagnostic imaging studies, and joint reconstructions compared with noncompliance. CONCLUSION: Overall healthcare utilization decreased after etanercept initiation. Patients who were most compliant with etanercept had significantly lower utilization than less compliant patients. FUNDING: Amgen, Inc.

Early treatment initiation in lower-risk myelodysplastic syndromes produces an earlier and higher rate of transfusion independence.

Myelodysplastic syndromes (MDS) are characterized by ineffective hematopoiesis resulting in refractory cytopenias. Red blood cell (RBC) transfusions can improve anemia; however, prolonged transfusion dependence (TD) is associated with increased morbidity and mortality. Disease-modifying therapy (DMT) for MDS can reduce transfusion requirements, although the optimum timing of DMT initiation is unclear. This retrospective study analyzed linked SEER registry and Medicare claims (2006-2012) to estimate the impact of DMT-initiation (azacitidine, decitabine, or lenalidomide) timing (≤ 3 vs.>3months from start of TD) on the likelihood of achieving transfusion independence (TI) among 508 TD patients with MDS. Mean time to DMT was 28days for early initiators (n=351) and 187days for late initiators (n=157). Fewer early initiators used erythropoiesis-stimulating agents before achieving TI versus late initiators (61.5% vs. 73.9%; P=0.007). In multivariate analyses, early DMT initiation predicted TI achievement (HR, 1.69; P<0.001); patients who met minimum active therapy-exposure requirements were more likely to achieve TI (HR, 2.12; P<0.001). Higher rates of TI were associated with reduced time between onset of TD and DMT initiation. Similarly, patients meeting the minimum treatment-exposure threshold had higher TI rates.

Real-world treatment patterns of gastrointestinal neuroendocrine tumors: A claims database analysis.

AIM: To describe real-world treatment patterns of gastrointestinal neuroendocrine tumors (GI NET). METHODS: In this retrospective cohort study, we used 2009-2014 data from 2 United States commercial claims databases to examine newly pharmacologically treated patients using tabular and graphical techniques. Treatments included somatostatin analogues (SSA), cytotoxic chemotherapy (CC), targeted therapy (TT), interferon (IF) and combinations. We identified patients at least 18 years of age, with ≥ 1 inpatient or ≥ 2 outpatient claims for GI NET who initiated pharmacologic treatment from 7/1/09-6/30/14. A 6 mo clean period prior to first treatment ensured patients were newly treated. Patients were followed until end of enrollment or the study end date, whichever was first. RESULTS: We identified 2258 newly treated GI NET patients: mean (SD) age was 55.6 years (SD = 9.7), 47.2% of the patients were between 55 and 64 years, and 48.8% were female. All regions of the United States were represented. 59.6% started first-line therapy with SSA monotherapy (964 with octreotide LAR, 380 with octreotide SA, and 1 with lanreotide), 33.3% CC, 3.6% TT, and 0.5% IF. The remainder received combinations. Mean follow up was 576 d. Overall mean first-line therapy duration was 361 d (449 d for SSA, 215 for CC, 267 for TT). 58.9% of patients had no pharmacological treatment beyond first line. The most common second-line was combination therapy with SSA. In graphical pattern analysis, there was no clear pattern visible after first line therapy. CONCLUSION: In this study, 60% of patients initiated treatment with SSA alone or in combination. The relatively long time to discontinuation suggests possible sustained effectiveness and tolerability.