BackgroundRituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.MethodsThis non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient’s first year of treatment (11 rituximab sessions).ResultsMean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27–58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1–5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53–91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1–5.5 eight-hour days.ConclusionsCompared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.Trial RegistrationClinicalTrials.gov NCT01200758

Within PrefHer (NCT01401166), patients and healthcare professionals (HCPs) preferred subcutaneous (SC) over intravenous (IV) trastuzumab. We undertook a prospective, observational time and motion study to quantify patients’ time in infusion chairs and active HCP time in PrefHer. Patients with HER2‐positive early breast cancer received four adjuvant cycles of SC trastuzumab (600 mg fixed dose via SC single‐use injection device [SID, Cohort 1] or SC handheld syringe [HHS, Cohort 2]) then four cycles of standard IV trastuzumab or the reverse sequence. Generic case report forms for IV and SC management, both in the treatment room and the drug preparation area, were tailored to reflect center practices. Patient chair time and active HCP time were recorded. We compared pooled Cohort 1 + 2 IV with Cohort 1 SC SID and Cohort 2 SC HHS mean times across eight countries and individually within them utilizing a random intercept generalized linear mixed‐effects model. Per session, the SC SID saved a mean of 57 min of patient chair time versus IV (range across countries: 47–86; P < 0.0001); the SC HHS saved 55 min (40–81; P < 0.0001). Active HCP time was reduced by a mean of 13 min per session with the SC SID (range across countries: 4–16; P < 0.0001) and 17 min with the SC HHS (5–28; P < 0.0001) versus IV. SC trastuzumab, delivered via SID or HHS, saved patient chair and active HCP times versus IV infusion, supporting a transition to either SC method.

The results suggest that rFVIIIFc may be a cost-effective option for hemophilia A prophylaxis, generating greater quality of life and reduced costs for the Swedish payer compared to more frequently administered rFVIII alternatives.

Misallocation of oncology-specific resources creates "two-tier" cancer patients based on ability to pay for traveling/accommodation. The severity and the consequences of the disease necessitate a bold approach to resource allocation and the establishment of integrated patient support networks that ensure all cancer patients are offered equal opportunities to effective treatment.

Background Rituximab (MabThera®; Rituxan®) is the standard treatment for indolent non-Hodgkin's lymphoma (iNHL). Results from the phase 3 SABRINA study (NCT01200758) showed that a fixed-dose subcutaneous (SC) formulation of rituximab shortened administration time without compromising efficacy or safety compared with intravenous (IV) infusion of rituximab. A switch to the SC formulation is expected to offer healthcare professionals (HCP) time and cost savings. Aims This study aims to quantify resource utilization in terms of active HCP time (ie, time actively dedicated to a patient) and chair time related to rituximab SC vs rituximab IV in the treatment of patients with iNHL and to estimate potential time and cost savings for the conversion from IV to SC (per administration session and for the first year of treatment). Methods This is a multinational, multicenter, prospective, observational time and motion study. Data for rituximab SC injections were collected alongside the MABCUTE (MO25455; NCT01461928) trial, while data for rituximab IV infusions were collected in a real-world setting in the same data collection period and in 23 centers in Italy (IT), Russia (RU), Slovenia (SL), United Kingdom (UK), Spain (SP), France (FR), Austria (AU), and Brazil (BR). Following interviews with a nurse and pharmacy member in each center, generic case report forms for IV, SC, and drug preparation area (including pharmacy) processes were tailored to reflect local site practices. Trained observers recorded both the time that HCPs were actively completing prespecified tasks (using a stopwatch), and patient chair time (based on length of time between patients entering and exiting chairs). This is a descriptive study with convenience-based sample sizes. A random effects regression model was run for each task (pooled sample by country) to generate task mean and 95% confidence interval (CI) using appropriate distributions. IV vs SC process time per patient was calculated as the sum of the mean task times. Results The difference in mean active HCP time saved by switching from rituximab IV to rituximab SC ranged from 6.8 min in AU to 38.4 min in the UK (Table 1). The proportionate reduction in mean HCP time ranged from 27% in SP to 57% in RU. The mean time saved (% reduction) in the treatment room ranged from 0.3 min (2%) in SP to 25.4 min (63%) in the UK. Over the course of the first-year of treatment (6 induction and 3 maintenance sessions), the estimated reduction in total HCP time associated with the switch ranged from 0.9 hr in AU to 5.1 hr in the UK. The differences in mean chair time saved with SC over IV administration ranged from 126.1 min in SL (64%) to 280.1 min (86%) in IT. Simulating these findings for a hypothetical center treating 50 patients for 9 sessions annually indicated that the amount of chair time freed would range from 105.1 (SL) to 233.4 (IT) 8-hour days. Staff opportunity cost estimates will be presented at the conference. Conclusions The current analysis indicates that a switch from rituximab IV to rituximab SC leads to a substantial reduction in administration chair time and in active HCP time. These time savings could allow more time to be used for other patient care activities, increasing the number of patients who could be treated and thus increasing the overall efficiency of treatment centers. Disclosures: De Cock: F. Hoffman-La Roche Ltd: Consultancy, Research Funding. Kritikou:F. Hoffmann-La Roche Ltd: Consultancy, Research Funding. Tao:F. Hoffmann-La Roche Ltd: Consultancy, Research Funding. Wiesner:Genentech: Employment. Off Label Use: Rituximab, administered as an IV infusion, is approved for use in a number of hematologic indications. The data presented here assess a subcutaneous approach to rituximab administration in patients with indolent Non-Hodgkin’s Lymphoma.