METHODS: Simulation of outcomes and costs was undertaken using a 1-Year decision tree followed by a lifetime horizon Markov. The base-case analysis was performed according to Agenzia Italiana del Farmaco (AIFA) guidelines on the overall population of the studies PRIME 1 and PRIME 2, adopting the Italian National Health Service (NHS) perspective. The following costs were considered: treatment acquisition (currently reimbursed cost), disease, adverse events, and complication management. Model robustness was tested through deterministic univariate analysis and probabilistic sensitivity analysis (PSA).

RESULTS: In the base case, at the currently reimbursed cost, dupilumab was more effective than SC (+1,10 quality adjusted life years, QALYs). The introduction of dupilumab led to an increase in treatment costs (+ € 54.888), which are partially offset by a decrease in the costs of disease management and the management of complications of the disease (respectively -€ 16.153 and -€ 183). The incremental cost-effectiveness ratio (ICER) was €34,991 per QALY gained, below the directional willingness-to-pay threshold considered in Italy (€ 40,000 per QALY gained). Both sensitivity analyses confirmed the strength of the results.

CONCLUSIONS: Dupilumab showed to be a cost-effective treatment for adults with uncontrolled moderate to severe PN in Italy, compared with SC, from the NHS perspective at the currently reimbursed cost.