Subcutaneous Trastuzumab (Herceptin<sup>®</sup>): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer

Abstract

Aim: Firstly, to quantify active healthcare professional (HCP) time and costs associated with subcutaneous (SC) administration of trastuzumab (Herceptin ® ) compared with the standard intravenous infusion (IV) in the treatment of patients with HER2-positive early breast cancer within the adjuvant PrefHer trial setting; secondly, to measure patient time in the care unit and patient infusion chair time for both routes of administration. Methods: A UK multi-centre prospective, observational Time and Motion study was conducted alongside the PrefHer trial (ClinicalTrials.gov id: NCT01401166). Trained observers measured the duration of each SC and IV related task that HCPs undertook and recorded patient time in the chemotherapy unit and infusion chair. The type and quantity of medical consumables used with each route of administration were also collected. Twenty-four patient episodes were recorded (12 SC, 12 IV). Mean total administration time was calculated as the mean sum of task times, both for IV and SC formulations. The mean cost of each route of administration was calculated as the mean cost of HCP time plus the mean cost of consumables used. HCP time was costed using Personal Social Services Research Unit. Consumables were costed using hospital pharmacy data and online sources. Results: Mean active HCP time for IV administration was 92.6 minutes compared with 24.6 minutes for SC administration. The mean cost for IV preparation and administration was £144.96 (£132.05 of HCP time and £12.92 of consumables) versus £33.15 (£31.99 of HCP time and £1.17 of consumables) for SC administration. Mean time spent in the care unit and in the infusion chair was 94.5 minutes and 75 minutes respectively for IV, and 30.3 minutes and 19.8 minutes for SC. SC administration of trastuzumab could translate to a time saving of 68 minutes (versus IV) with a total cost saving of £111.81 per patient episode. This equates to a potential saving of £2012.58 over a full course of adjuvant treatment (18 cycles). Conclusion: Substituting IV infusion with SC administration of trastuzumab may lead to a substantial reduction in active HCP time, patient chair and unit time, consumable use and overall costs. The reduced patient chair and unit time could provide increased capacity within existing resources.

Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study

“…[5] A time-and-motion study within the PrefHer study demonstrated a mean time saving of 55-57 min of patient chair time and 13-17 min of active healthcare professional time per session with H SC compared with H IV, [6] and several countries have reported estimated increased hospital capacity and/or costsavings with H SC. [7][8][9][10][11][12][13][14][15][16][17] These data support a transition to SC delivery.…”

Economic Analysis of Intravenous vs. Subcutaneously Administered Trastuzumab for the Treatment of HER2+ Early Breast Cancer in Malaysia

“…Our findings of the cost savings of SC are consistent with the results of similar CMA studies from Europe comparing IV and SC trastuzumab. CMAs conducted from the perspective of the England and Wales NHS (₤2013), the Greek health system (€1121), and the Scottish NHS (£3454) have all reported cost savings over 1 year of treatment with SC trastuzumab [21] [23] [25]. In addition, an analysis by Samanta et al estimated cost savings of £271,000 and reduction of pharmacists and nurses workload by 5492 hours from switching a cohort of 200 breast cancer patients from IV to SC trastuzumab in the English NHS [22].…”

“…As mentioned, we relied on estimates and opinions of the study investigators to estimate data inputs. Although we had involved four study sites and averaged the time and resource use to limit bias, since the method was based on opinion and recall rather than direct measurement of time expended in each activity as was performed in the study by Burcombe, there could still be potential information bias in the estimation [21]. However, the estimated nurses time for IV drug administration in this study (20 and 13.3 minutes for loading and subsequent doses) was within the range of those reported in other studies which ranged from 2 minutes in Denmark and Spain to 35 minutes in the UK per IV administration, and up to 60 minutes for an IV loading dose in the National University Hospital of Iceland [21] [24] [36].…”

“…Additionally, the PrefHer study has reported patient preference for the SC administration for trastuzumab over IV, and that use of SC reduced the time of health care professionals and resources needed to manage patients [20]. This savings in time and cost relative to the IV formulation has been shown in several European studies [21]- [24]. In a multi-centre prospective, observational time and motion study, Burcombe and colleagues investigated the time used for treatment with IV and SC trastuzumab for 24 patients in four centres in England and Wales.…”

“…The study found that the mean duration for preparation and administration of IV and SC trastuzumab was 94.5 and 24.6 minutes respectively. This would translate into cost savings for the National Health Service (NHS) of ₤2013 per patient over one year of treatment with SC trastuzumab [21]. Lastly, a time-andmotion sub-analysis of the PrefHer trial reported time savings of pharmacy and drug administration time between 30% (in Switzerland) to 51% (in Spain) from the SC trastuzumab in the SID form compared to IV [24].…”