Time Savings With Rituximab Subcutaneous (SC) Injection Vs Rituximab Intravenous (IV) Infusion: Final Analysis From a Time-and-Motion Study In 8 Countries

Abstract

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.

Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

“…Furthermore, the annual amount of chair time saved per center by patients switching to SC rituximab has been estimated to range from 109 to 219 8-hour days, and the potential benefits for patients and health care systems are being investigated further. 36 Together, these findings suggest that SC administration of rituximab will improve the convenience of this drug, although additional investigation will be required to determine whether the SC route provides equivalent efficacy compared with that of IV administration.…”

Rituximab for subcutaneous delivery: Clinical management principles from a nursing perspective

“…There are also benefits in daily nursing practice with use of SC rather than IV formulation, including no requirement for dose calculation or bag preparation, simplified and faster treatment times with reduced workloads and streamlined patient throughput. 27 Taken together, accumulating clinical evidence and experience, including that of the authors, suggests that SC rituximab can help streamline the care of patients with NHL and improve the overall treatment experience for both patients and health-care professionals. (22) AE, adverse event.…”

“…It simplifies the treatment experience for both patients and health-care professionals, reduces the burden on health-care resources and is likely to improve patient quality of life and treatment adherence. 8,21,26,27 One multinational study demonstrated SABRINA trial: NCT01200758…”

“…Patient throughput, waiting list times and hospital efficiency were greatly improved. 26,27 Nurses' experiences to date support the use of the SC formulation of rituximab in routine clinical practice. In a published survey of 65 nurses who had administered SC rituximab to a total of 166 patients at various investigational sites, 72% reported the SC rituximab delivery process as 'easy' or 'very easy'; 95% rated the experience as 'positive' or 'very positive' and 95% of nurses indicated they would recommend SC administration to patients.…”

Critical appraisal of rituximab in the maintenance treatment of advanced follicular lymphoma

“…Rituximab is typically administered by IV infusions over 1.5–6 hours, and thus a SC rituximab administration over 5–6 minutes could increase patient convenience, improve cost-effectiveness, and reduce adverse events. 29 As a result of a lower absorption, the dose of rituximab must be increased when administered by SC injection, and thus larger volumes of drug are needed. Such SC injection is possible by increasing 12-fold concentration of rituximab respecting the IV preparation, and by the addition of the enzyme recombinant human hyaluronidase (rHuPH20).…”