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.

Table 1

*Time Savings with Rituximab SC Injection

Country Active HCP time† (mean) Expected HCP time reduction for yr 1 of treatment, hrs Patient chair time (mean) Expected annual chair time savings for 50 pts,
8-hr days 
Difference, min (IV vs SC) % reduction % time savings achieved in treatment room Difference, min (IV vs SC) % reduction  
AU 6.8 (22.9 vs 16.1) 30 51 0.9 146.3 (197.5 vs 51.3) 74 121.9 
BR 15.6 (31.2 vs 15.6) 50 87 2.1 204.7 (268.2 vs 63.5) 76 170.6 
FR 17.6 (41.4 vs 23.8) 42 88 2.3 182 (278.3 vs 96.4) 65 151.7 
IT 16.1 (38.3 vs 22.2) 42 85 2.1 280.1 (326.3 vs 46.2) 86 233.4 
RU 17.1 (30.0 vs 12.9) 57 79 2.3 244.5 (269.6 vs 25.2) 91 203.7 
SL 8.9 (18.3 vs 9.4) 49 76 1.2 126.1 (196.4 vs 70.3) 64 105.1 
SP 7.0 (26.3 vs 19.3) 27 0.9 252.9 (300.3 vs 47.4) 84 210.7 
UK 38.4 (88.7 vs 50.3) 43 66 5.1 200.3 (238.8 vs 38.5) 84 166.9 
Country Active HCP time† (mean) Expected HCP time reduction for yr 1 of treatment, hrs Patient chair time (mean) Expected annual chair time savings for 50 pts,
8-hr days 
Difference, min (IV vs SC) % reduction % time savings achieved in treatment room Difference, min (IV vs SC) % reduction  
AU 6.8 (22.9 vs 16.1) 30 51 0.9 146.3 (197.5 vs 51.3) 74 121.9 
BR 15.6 (31.2 vs 15.6) 50 87 2.1 204.7 (268.2 vs 63.5) 76 170.6 
FR 17.6 (41.4 vs 23.8) 42 88 2.3 182 (278.3 vs 96.4) 65 151.7 
IT 16.1 (38.3 vs 22.2) 42 85 2.1 280.1 (326.3 vs 46.2) 86 233.4 
RU 17.1 (30.0 vs 12.9) 57 79 2.3 244.5 (269.6 vs 25.2) 91 203.7 
SL 8.9 (18.3 vs 9.4) 49 76 1.2 126.1 (196.4 vs 70.3) 64 105.1 
SP 7.0 (26.3 vs 19.3) 27 0.9 252.9 (300.3 vs 47.4) 84 210.7 
UK 38.4 (88.7 vs 50.3) 43 66 5.1 200.3 (238.8 vs 38.5) 84 166.9 
*

95% confidence intervals will be presented at the conference.

Treatment room + drug preparation area

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.

Author notes

*

Asterisk with author names denotes non-ASH members.