OBJECTIVES : A new fixed-dose combination (FDC) of pertuzumab and trastuzumab (PH) administered by a single subcutaneous (SC) injection was recently approved by the EMA for HER2+ BC treatment as an alternative to the conventional intravenous (IV) combination of PH, prepared and administered sequentially. Relative to the IV combination of PH, the SC formulation has comparable safety and efficacy, is preferred by patients and healthcare professionals (HCPs), and could result in cost savings to healthcare systems. This research aims to estimate the budget impact of implementing PH FDC SC for the adjuvant and first-line metastatic treatment of HER2+ BC patients over three years in Italy from both a hospital and societal perspective.

METHODS : The study uses an incidence- and market-based budget impact model to estimate costs with and without the adoption of PH FDC SC. Direct costs include HCP costs for drug preparation and administration activities, costs of non-drug consumables, central access catheter-related costs, adverse event management costs, and drug acquisition costs. Indirect costs include the cost of lost productivity of patients and caregivers. All costs are estimated by multiplying resource use by the unit cost of each resource. Evidence on resource use and unit costs were retrieved from scientific literature and standard Italian tariffs. Number of eligible patients were estimated from published Italian epidemiological data and projected market shares.

RESULTS : Base-case results indicate that the adoption of PH FDC SC would result in net cost savings to both hospitals and the society. Total net budget savings to the society over the first three years are estimated at EUR 1.7 million and EUR 8.0 million in the adjuvant and first-line metastatic treatment settings, respectively.

CONCLUSIONS : This budget impact analysis suggests that PH FDC SC is a cost-saving alternative to the IV combination of PH when treating HER2+ BC patients in Italy.