Rituximab in the treatment of rheumatoid arthritis patients in Italy: a budget impact analysis.

ABSTRACT

OBJECTIVES: The objective of this Budget Impact Analysis is to evaluate the financial implications of a rituximab-based sequencing strategy in the treatment of rheumatoid arthritis in the perspective of the Italian National Health Service. METHODS: Yearly patients who were eligible for a second-line biological DMARD in Italy were entered into a 5-year model. A Markov chain reproduced the course of this cohort under a number of alternative strategies, including anti-TNF-α cycling and rituximab or abatacept as second and third line agents. The dynamic of the simulation was given by first biological drug failure data, mortality rates, and survival-on-treatment data from published literature. Drug acquisition, administration and monitoring costs were assessed. RESULTS: Italian patients refractory to a first anti-TNF-α therapy resulted to be about 650 per year, giving a cumulative number of treated patients in five years of 3,240. The anti-TNF-α cycling had a total direct cost which rose from €8.2 million in the first year to €33.8 million in the fifth. The cost per patient of rituximab was lower than the average cost of the anti-TNF-α therapies; the annual difference was around € 4,300. The savings gained from lower individual costs with rituximab were partially offset by the increasing number of patients receiving active medication, resulting in a substantial cost equivalence between third line rituximab and anti-TNF-α cycling scenarios; rituximab, as a second line therapy, produced a savings in total costs of -31.8%. Strategies including abatacept shared the same dynamics, but with higher costs. CONCLUSIONS: The introduction of rituximab in clinical practice could allow an increase in the number of patients receiving an active rheumatoid arthritis treatment without inflating therapy costs.