The effects of disease cross-coverage by dupilumab on the costs sustained by the Italian National Health Service

Background and research question: Label extension for treatments and the relevant disease cross-coverage may produce an economic benefit. This paper assesses this benefit for dupilumab in the perspective of the Italian Na-tional Health Service. Dupilumab was approved for reimbursement for severe atopic dermatitis (AD), severe and refractory asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The analysis focused on the crowding-out effect of dupilumab on alternative treatments. Methods: The research relied on a simplified budget impact model. The model was populated by data from pub-lished evidence and relied on three alternative scenarios for market penetration (15%-30%-100%).Results: Avoidable direct health annual costs due to cross-coverage for (i) asthma in patients treated for AD ranged from 0.46 to 3.43 million euros, (ii) asthma in patients treated for CRSwNP ranged from 0.08 to 0.88 mil-lion euros, (iii) CRSwNPin patients treated for asthma ranged from 0.41 to 4.05 million euros respectively. The total economic benefit ranges from 0.95 to 8.36 million euros. Discussion: The research estimated the crowding-out effect of dupilumab on alternative treatments. It did not incorporate avoided/incremental events due to a possible better/worse risk-benefit profile of dupilumab vs al-ternative treatments and the economic benefit of cross-coverage on lower diseases severity (for example mild asthma). Nonetheless, the analysis relies on the best available evidence for Italy to shed light on a topic which has not been sufficiently investigated, and provides data that will be potentially very important for policy-makers, payers and those who manage new treatments