Real-World Patient Characteristics, Utilization Patterns, and Outcomes of US Patients with HR+, HER2- Metastatic Breast Cancer Treated with Abemaciclib.

BACKGROUND: Abemaciclib is the most recent oral cyclin-dependent kinase 4 and 6 inhibitor (CDK4 & 6i) to receive US Food and Drug Administration (FDA) approval to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). Administrative claims data were used to describe patient characteristics and select clinical and economic outcomes in US patients treated in routine clinical practice. Prior analyses from electronic health records data indicate approximately 25% of patients received either palbociclib or ribociclib for MBC before initiating abemaciclib treatment; this work further explored these findings and associated outcomes. METHODS: This retrospective study analyzed medical and pharmacy claims from the IBM® MarketScan® Research Databases between 1 January 2007 to 31 January 2020. Patients with HR+, HER2- MBC newly initiating abemaciclib between 1 September 2017 and 31 October 2019 were included and grouped by concomitant therapy (+aromatase inhibitor (AI), +fulvestrant (F), 200 mg abemaciclib monotherapy (Mono), or +other), and outcomes were analyzed by prior CDK4 & 6i use. Patient and treatment characteristics were summarized with descriptive statistics. Kaplan-Meier methods assessed time-to-discontinuation (TTD; i.e., persistency) and time-to-chemotherapy (TTC). Adherence (defined by the medication possession ratio) and drug wastage were determined. RESULTS: This analysis included 454 patients (mean age 57.7 years), with 35.0% (n = 159) in the +F group, 29.3% (n = 133) in the +AI group, 10.4% (n = 47) in the 200 mg Mono group, and 25.3% (n = 115) in the +other group. Prior chemotherapy and CDK 4 & 6i use were present in 23.8% and 49.8% of all patients, respectively. Visceral metastases were present at abemaciclib initiation in 50.4% in the +AI group; 49.7% in the +F group; and 55.3% in the 200 mg Mono group. Liver metastases were present in 33.7% of the overall population. Among patients without prior CDK4 & 6i use, the median TTD for patients receiving abemaciclib + AI was not reached [95% CI 430-not reached (NR) days], abemaciclib + F [531 days (95% CI 281-NR)], and abemaciclib mono [141 days (95% CI 80-NR)]. Median TTC for abemaciclib + AI and abemaciclib + F groups were not reached and the median TTC for abemaciclib mono was 535 days (95% CI 181-NR). Medication adherence was 88.7% and medication wastage costs among those with at least one dose modification were $808.12 and $452.2 per patient per month based on amount paid and wholesale acquisition cost (WAC), respectively. Mean length of follow-up for all patients was 350 days (SD 187). CONCLUSION: These real-world data complement clinical trial results by examining abemaciclib use among patients treated in routine clinical practice. The sizeable number of patients treated with prior CDK4 & 6i, chemotherapy, and/or visceral metastases at abemaciclib initiation suggest that many patients had very advanced disease and/or were in later stages of their treatment. These data confirm a higher percentage of patients treated with previous CDK4 & 6i than reported previously, reinforcing the importance of the ongoing, prospective clinical trials evaluating outcomes following progression on CDK4 & 6i.

Comparative Effectiveness of Rapid-Acting Insulins in Adults with Diabetes.

BACKGROUND: Although there are a variety of insulin products and new delivery modalities available, the absence of direct clinical and economic comparisons can make treatment planning and formulary decision making difficult. Direct comparisons between insulin aspart and insulin lispro from a large heterogeneous population are not available. OBJECTIVE: To assess differences in clinical outcomes, medication adherence, utilization, and total health care costs between aspart and lispro and vial versus pen modalities for administering these short-acting insulin analogs. METHODS: This retrospective cohort study used administrative claims data from the Humana Research Database to identify people with type 1 or type 2 diabetes and Medicare or commercial insurance (with medical and pharmacy benefits) who newly initiated rapid-acting insulin between January 1, 2008, and December 31, 2013, and were continuously enrolled during the 12-month baseline and 12-month follow-up periods. Generalized linear models were used to assess differences in costs and utilization. Logistic regression models measured the likelihood of having a hypoglycemic event, worsening diabetes complications, or a change in glycated hemoglobin (A1c). RESULTS: 8,189 patients included in the study were grouped by rapid-acting insulin product (aspart, n = 5,364, and lispro, n = 2,566) and modality (vial, n = 6,135, and pen, n = 2,054). There were no significant differences in the percentage of patients with a hypoglycemic event, new or worsening diabetes complications, or change in A1c, and there were no significant differences in adjusted total health care, medical and pharmacy costs, or emergency department visits between any of the product or modality comparisons. There was a significant difference in mean annual inpatient stays between lispro and aspart (adjusted mean = 2.24, 95% CI = 0.73-6.69, and adjusted mean = 2.65, 95% CI = 0.86-7.86, respectively; P < 0.001) and pen and vial cohorts (adjusted mean = 1.74, 95% CI = 0.56-4.99, and adjusted mean = 3.05, 95% CI = 1.01-9.08, respectively; P < 0.001). Adherence was similar for the lispro and aspart cohorts. Adherence was higher in the pen cohort (as measured by medication possession ratio ≥80%) compared with the vial cohort (adjusted odds ratio = 1.29, 95% CI = 1.12-1.50). CONCLUSIONS: This study provides a comprehensive assessment of outcomes and costs between 2 commonly used rapid-acting insulin products. Overall, there was little differentiation between products, although adherence improved significantly with pen devices. These findings may simplify decisions related to formulary options and choice of therapy. DISCLOSURES: No outside funding supported this study. Racsa and Ellis are employees of Comprehensive Health Insights, a subsidiary of Humana, and Saverno was employed with Comprehensive Health Insights at the time of this study. Meah is an employee of, and owns stock in, Humana. The authors have no financial disclosures or potential conflicts of interest to report. All authors contributed equally to study concept and design, data interpretation, and manuscript preparation. Racsa collected the data.

Real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer treated with ziv-aflibercept in community oncology practices in the USA.

Routine clinical practice data often differ from clinical trials. This study describes real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer (mCRC) receiving ziv-aflibercept in non-academic, community oncology practices in the USA. De-identified electronic medical records from Vector Oncology and Altos Solutions databases were analysed. We identified 218 patients diagnosed with mCRC who had received prior oxaliplatin therapy and initiated ziv-aflibercept as part of second-line or later-line therapy. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier analysis. Mean age was 62.8 years at ziv-aflibercept initiation. Most patients (91.7%) received bevacizumab before ziv-aflibercept, 95.4% initiated ziv-aflibercept with FOLFIRI or another irinotecan-based regimen, and 59.6% had received prior irinotecan. Overall, 24.8% of patients initiated ziv-aflibercept in second line, 31.7% in third line, 21.6% in fourth line and 22.0% in later lines of therapy. Mean duration of ziv-aflibercept treatment was 5.3 months. For patients initiating ziv-aflibercept in second-, third- and fourth-line therapy, median OS was 11.9 (95% confidence interval 5.1-16.2), 11.1 (6.9-16.7) and 8.1 (5.2-11.4) months, respectively, and median PFS was 4.4 (2.8-6.5), 4.3 (2.9-6.3) and 3.4 (2.2-5.2) months, respectively. Common adverse events (AEs) (any grade) included gastrointestinal disorders (64.7%) and asthenia/fatigue (63.3%). In routine clinical practice, ziv-aflibercept was frequently initiated in third line or later lines of therapy. Although patients receiving ziv-aflibercept were more heavily pretreated and potentially less robust compared with the VELOUR trial, median OS for patients receiving second-line ziv-aflibercept was comparable. AE rates were similar to or lower than the VELOUR trial.

Treatment Patterns and Health Resource Utilization Among Patients Diagnosed With Early Stage Resected Non-Small Cell Lung Cancer at US Community Oncology Practices.

UNLABELLED: Data on adjuvant therapy in resected non-small cell lung cancer (NSCLC) in routine practice are lacking in the United States. This retrospective observational database study included 609 community oncology patients with resected stage IB to IIIA NSCLC. Use of adjuvant therapy was 39.1% at disease stage IB and 64.9% to 68.2% at stage II to IIIA. The most common regimen at all stages was carboplatin and paclitaxel. BACKGROUND: Platin-based adjuvant chemotherapy has extended survival in clinical trials in patients with completely resected non-small cell lung cancer (NSCLC). There are few data on the use of adjuvant therapy in community-based clinical practice in the United States. MATERIALS AND METHODS: This was a retrospective observational study using electronic medical record and billing data collected during routine care at US community oncology sites in the Vector Oncology Data Warehouse between January 2007 and January 2014. Patients aged ≥ 18 years with a primary diagnosis of stage IB to IIIA NSCLC were eligible if they had undergone surgical resection. Treatment patterns, health care resource use, and cost were recorded, stratified by stage at diagnosis. RESULTS: The study included 609 patients (mean age, 64.8 years, 52.9% male), of whom 215 had stage IB disease, 130 stage IIA/II, 110 stage IIB, and 154 stage IIIA. Adjuvant systemic therapy after resection was provided to 345 (56.7%) of 609 patients, with lower use in patients with stage IB disease (39.1%) than stage II to IIIA disease (64.9-68.2%) (P < .0001). The most common adjuvant regimen at all stages was the combination of carboplatin and paclitaxel. There were no statistically significant differences in office visits or incidence of hospitalization by disease stage. During adjuvant treatment, the total monthly median cost per patient was $17,389.75 (interquartile range, $8,815.61 to $23,360.85). CONCLUSION: Adjuvant systemic therapy was used in some patients with stage IB NSCLC and in the majority of patients with stage IIA to IIIA disease. There were few differences in regimen or health care resource use by disease stage.

Evaluation of a wireless handheld medication management device in the prevention of drug-drug interactions in a Medicaid population.

BACKGROUND: With the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act, widespread adoption of certain health information technologies, such as electronic health records (EHRs) and electronic prescribing (e-prescribing), is imminent. Drug-drug interaction (DDI) screening and medication history information are commonly incorporated into health information exchange systems to improve medical decision making, safety, and quality of care, but the value of these features is unclear. OBJECTIVE: To evaluate the effect of providing access to an early generation electronic medication management program with medication history accessible to prescribers via a wireless handheld personal digital assistant (PDA) device on the incidence of potential DDIs (i.e., DDIs that may or may not cause patient harm). METHODS: This study employed a retrospective pre-intervention/post-intervention study design with a comparison group to evaluate the effectiveness of a wireless handheld medication management program in preventing serious potential DDIs. Licensed prescribers in a state Medicaid program who wrote prescriptions during the period from August 2003 through June 2006 were included in this study. The intervention (PDA) group consisted of clinicians who requested and were granted access to the wireless handheld device containing prescription drug history between August 1, 2004, and June 30, 2005. Initially the device contained 100-day patient-specific medication history, but other functionalities were added during the study period including the ability to check for drug-drug interactions and e-prescribing. The comparison group consisted of prescribers who sent a request to obtain, but did not receive, the wireless handheld device during the same time period. Baseline prescribing patterns of 25 previously identified clinically important potential DDIs were assessed over two 12-month periods, one period prior to (baseline) and one period after (follow-up) an index date (date of device deployment for PDA group; date of request for comparison group). A random-effects negative binomial model was used to analyze the primary outcome, the number of potential DDIs per prescriber per 12-month time period. A secondary outcome of interest, the likelihood that a prescriber would prescribe at least 1 potentially interacting medication pair during the baseline and follow-up periods, was analyzed using a random-effects logistic model. RESULTS: A total of 1,615 prescribers constituted the PDA group, and 600 prescribers made up the comparison group. Prescribers in the 2 groups were significantly different in their specialty practice areas (P less than 0.001), number of pharmacy claims at baseline (P less than 0.001), and the likelihood of prescribing at least 1 potential DDI combination during the 1-year baseline period (P=0.003). However, the prescriber groups were similar in their average age (P=0.241) and geographic location (P=0.181). The most widely prescribed potential DDIs included those involving warfarin with nonsteroidal anti-inflammatory drugs (NSAIDs) and thyroid hormones. The median number of patient medication history updates requested per PDA group prescriber during follow-up was 24 (range 0 to 1,073). At baseline, 1,104 (68.4%) of the PDA group and 449 (74.8%) of the comparison group had no potential DDIs. During the next year, 1,131 (70.0%) and 462 (77.0%) of the PDA group and comparison group, respectively, had no DDIs. The incidence rate ratio was 1.01 (95% CI=0.87-1.17) for the PDA group relative to the comparison group for change in number of potential DDIs. In the logistic regression model, the odds of prescribing at least 1 potential DDI did not significantly differ by group (odds ratio=1.26, 95% CI=0.96-1.66). These results indicate that there was no significant difference between the intervention and comparison group with regard to the change in the rate of potential DDIs between the baseline and follow-up periods. CONCLUSION: A stand-alone medication management program in a wireless PDA device was not frequently used by most prescribers to update patient medication histories and was not associated with a reduction in the rate of prescribing potentially clinically important DDIs.