Introduction: Rituximab and trastuzumab subcutaneous (sc) formulations can offer substantial patient and resource benefits compared with those delivered intravenously (iv). At the national level, the negotiation of the price of the two sc formulations had the objective of guaranteeing the same price/administration compared to iv formulations. The different routes of administration and dosages made it impossible to set an equivalent price per mg. The parity-price was therefore defined taking into account the average values of the reference weight and body surface area of the population enrolled in the pivotal studies of sc formulations. It was therefore necessary to conduct a budget impact analysis (BIA) on data relating to patients at the hospital Careggi, to verify the sustainability of the decision to include trastuzumab and rituximab sc in the Careggi hospital formulary. Then, a survey to verify the real expenditure after one year from the use of the sc drugs was performed.
Methods: Through clinical databases “Oncosys” and “Log 80”, all patients who received rituximab and trastuzumab for the same indications approved for their respective sc formulations, in the year 2014, were selected. Subsequently the total number of patients were observed and also their anthropometric reference characteristics. Considering the cost/mg of iv formulations, for the year 2014, the average dose/administration, cost/administration has been calculated and then the difference between the expenditure using the iv formulation and the sc counting, performed directly by health care workers involved with the preparation of cancer therapies.
Results: According to our analysis, the simultaneous adoption of the two sc drug would determine an annual incremental cost of € 70,496. The survey with real data, after one year from the use of the sc drugs, resulted in an increase of expenditure of € 111,822.
Discussion: The average cost of sc formulations of rituximab and trastuzumab is not consistent with that of the corresponding iv formulations. The parameters used at the moment of national negotiating of the price by AIFA were found to be quite different from those estimated at the time of impact of budget from those actually encountered in clinical practice. Finally, clinical-database for the management of anti-cancer drug unit can effectively be used to conduct budget impact analysis at hospital level.

​

​

Key words: Rituximab, trastuzumab, subcutaneous, budget impact analysis, hospital, clinical database