BackgroundRapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns.MethodsThis was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR.ResultsThere were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively.ConclusionsReal-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that studied in the clinical trials with more than half of the patients receiving palbociclib plus letrozole in later lines of therapy. CBC testing rates suggested good provider compliance with monitoring guidelines in the USA prescribing information. The occurrence of grade 3 and 4 neutropenia (based on laboratory results) was consistent with the rates of grade 3 and 4 neutropenia in two phase-III studies (PALOMA-2, 56% and 10%; PALOMA-3, 55% and 11%, respectively). Understanding palbociclib utilization in real-world patients and how drug dosing and monitoring are performed aids in the understanding of safe and effective use of the drug.Electronic supplementary materialThe online version of this article (10.1186/s13058-018-0958-2) contains supplementary material, which is available to authorized users.

Although there were no differences in adherence, hospitalizations, or emergency room visits among patients initiating a second- versus first-generation TKI, total all-cause costs and outpatient visits were higher for 2GTKI initiators. With the impending release of generic imatinib, these comparative data will become germane in the selection of a first-line TKI therapy. Because this study used claims from a single health plan, it may not be generalizable to the general population.

BACKGROUND: Few studies have examined oral anticancer treatment utilization patterns among Medicare beneficiaries. OBJECTIVE:To assess treatment utilization patterns of newly initiated oral anticancer agents across national samples of Medicare beneficiaries for 5 cancer types: chronic myeloid leukemia (CML), multiple myeloma (MM), metastatic prostate cancer (mPC), metastatic renal cell carcinoma (mRCC), and metastatic breast cancer (mBC). METHODS:This retrospective claims analysis used 100% Medicare Chronic Condition Data Warehouse (CCW) Parts A, B, and D files from 2011 to 2014 (for CML, MM, mPC, and mRCC patients) and a 5% random fee-for-service sample from 2011 to 2013 (for mBC patients).Outcomes of interest were the number of 30-day supply prescriptions, adherence, and discontinuation of newly initiated (ie, index) oral anticancer agents indicated for each of the cancers. Adherence was calculated with both the "traditional" proportion of days covered (PDC) approach, measured over a fixed

BACKGROUND: Health plans and pharmacy benefit managers have implemented utilization management strategies for newer type 2 diabetes mellitus (T2DM) medications to control pharmacy expenditures. Little is known about the impact of utilization management strategies on overall health care costs and subsequent use of T2DM medications among members who request, but do not receive, a T2DM medication requiring prior authorization (PA).

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