OBJECTIVES: Trastuzumab, the standard treatment for HER2+ breast cancer, is associated with access restrictions in Central-Eastern European (CEE) countries. The aim of this research was to compare the intravenous (IV) and subcutaneous (SC) forms of trastuzumab, and explore the transferability of findings to CEE countries.

METHODS: A systematic literature review of English-language articles was performed by two independent reviewers using PubMed and Web of Science. Data on safety, clinician- and patient reported outcomes (PRO), costs and resource use were extracted.

RESULTS: Out of the 376 abstracts retrieved by the search syntax, 42 full text articles were included in the review. Although SC form was preferred both by patients and health care professionals (HCPs) over the IV form, standard PRO measures were not applied in the published studies and feasibility of self/home administration of SC trastuzumab, especially in case of concomitant IV chemotherapies, was not considered. Time savings for both patients and HCPs due to SC administration demonstrated in controlled clinical trials may not be realized in real-world setting, as in CEE countries waiting time of patients for their treatment is significant and HCPs supervise the therapy of multiple patients parallelly. Savings due to reduced patient and HCP time and reduced productivity loss were valued by Western European salary levels. Feasibility of collecting health care savings in prospective financing diagnosis related group (DRG) schemes was not considered. Productivity gain was overestimated as metastatic patients are usually on sick leave during the treatment period. Economic evaluations did not consider the upcoming patent expiry of IV form.

CONCLUSIONS: Potential benefits of the SC form were not supported by relevant scientific evidence in CEE countries. As patient access to biological treatments is of utmost importance in CEE, the utilization of more affordable multi-source trastuzumab products should be facilitated by policymakers.