OBJECTIVES: To calculate non-pharmacological cost associated with the use of fixed-dose combination of pertuzumab and trastuzumab for subcutaneous (SC) injection (PH-FDC-SC) versus separate administration of intravenous (IV) pertuzumab (P) and IV or SC trastuzumab (T) (P-IV+T-IV or P-IV+T-SC) in patients with HER2-positive breast cancer (BC) in Spain.

METHODS: A cost-minimization model was developed to estimate non-pharmacological costs derived from the treatment of early (neoadjuvant and adjuvant) and metastatic HER2-positive BC patients with each of the three therapeutic options. Direct and indirect costs were estimated and expressed in euros 2023 from the results (active time savings for healthcare professionals, reduction in the use of healthcare consumables, venous access devices and patient treatment room time) of a multicentre, interventional, randomized Phase IIIb time and motion study (PHATIMA-study). All inputs included in the model were validated by an experts’ panel. Furthermore, a quantification of the impact on hospitals' healthcare capacity was conducted based on the optimized processes with the use of SC formulations identified in the H-EXCELENCIA-study and the reduction of preparation and administration times with PH-FDC-SC obtained from the PHATIMA-study. Sensitivity analyses were performed to assess uncertainty and verify the robustness of the results.

RESULTS: The use of PH-FDC-SC versus P-IV+T-IV and P-IV+T-SC reduces non-pharmacological costs by up to 16.9% and 11.9%, respectively in the neoadjuvant treatment, up to 84.1% and 81.9%, respectively in the adjuvant treatment of early BC and up to 50.8% and 40.7%, respectively in the treatment of patients with metastatic BC. In addition, total conversion of P-IV+T-IV and P-IV+T-SC to PH-FDC-SC would increase the treatment capacity of HER2-positive BC patients by up to 27.87% and 22.75%, respectively.

CONCLUSIONS: The use of PH-FDC-SC for the treatment of patients with HER2-positive BC improves the efficiency of the Spanish hospitals by saving non-pharmacological costs and allowing an increase in hospital capacity.