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


  • Claudio Jommi SDA Bocconi School of Management, Università Bocconi, Milano - Italy
  • Filippo Cipriani Sanofi S.p.a. Milano - Italy
  • Francesca Fanelli Sanofi S.p.a. Milano - Italy
  • Maria Paola Pedone Sanofi S.p.a. Milano - Italy
  • Walter Canonica Personalized Medicine Asthma & Allergy, Humanitas University and Research Hospital, Milano - Italy



Avoidable costs, Budget impact, Cross-coverage, Dupilumab


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 National 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 published 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 million euros, (iii) CRSwNP in 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 alternative 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.


Campillo-Artero C, Puig-Junoy J, Segú-Tolsa JL, Trapero-Bertran M. Price Models for Multi-indication Drugs: A Systematic Review. Appl Health Econ Health Policy. 2020;18(1):47-56.

Jommi C, Minghetti P. Pharmaceutical Pricing Policies in Italy, in Zaheer-Ud-Din Babar (ed.), Pharmaceutical Prices in the 21st Century 2015. Springer, London: 131-51. ultima data di accesso 13/3/2020.

de Bruin-Weller M, Thaçi D, Smith CH, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial. J Dermatol. 2018;178(5):1083-101 (CAFÉ).

Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids: a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-303 (CHRONOS).

Pedrini A, Rossi E, Calabria S, et al. Current Management of Severe Refractory Asthma in Italy: Analysis of Real-World Data. GRHTA. 2017;4(1):e216-20.

Regione Emilia Romagna: Doc PTR n. 288. Maggio 2016. Recepito con Determina n. 9658 del 20/06/2016.

Regione Piemonte:, ultima data di accesso 8/6/2020 (aggiornamento al 24/12/2019). Regione Campania: e Schede Prodotti/Farmaci ed Emoderivati/2019, ultima data di accesso 8/6/2020 (aggiornamento al 5/12/2019); Regione Calabria:, ultima data di accesso 8/6/2020 (aggiornamento al 27/2/2020).

Regione Emilia Romagna: Doc PTR n. 304. Novembre 2017. Recepito con Determina n. 20720 del 21 dicembre 2017.

Regione Veneto, Decreto n. 54 del 9 aprile 2018 “Linee di indirizzo regionali per la gestione farmacologica dell’asma grave non controllato”.

Busse WW, Maspero JF, Rabe KF, et al. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018;35(5):737-48.

Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. Engl J Med. 2018;378(26):2475-85.

Heffler E, Blasi F, Latorre M, et al. The Severe Asthma Network in Italy: Findings and Perspectives. J Allergy Clin Immunol Pract. 2019;7(5):1462-8.

Aifa, Monitoraggio della spesa farmaceutica nazionale e regionale. Gennaio-Dicembre 2018 (, data ultimo accesso 17/5/2019).

Decreto del Ministero della Salute 18 ottobre 2012.

Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394(10209):1618.

Studio Stethos – Data on file.

Khan A, Vandeplas G, Huynh TMT, et al. The Global Allergy and Asthma European Network (GALEN) rhinosinusitis cohort: a large European cross-sectional study of chronic rhinosinusitis patients with and without nasal polyps. Rhinology. 2019;57(1):32-42.

Canonica GW, Colombo GL, Bruno GM. Shadow cost of oral corticosteroids-related adverse events: A pharmacoeconomic evaluation applied to real-life data from the Severe Asthma Network in Italy (SANI) registry. WAO Journal. 2019;12:29-35.



How to Cite

Jommi C, Cipriani F, Fanelli F, Pedone MP, Canonica W. The effects of disease cross-coverage by dupilumab on the costs sustained by the Italian National Health Service. Grhta [Internet]. 2020 Jul. 14 [cited 2023 May 31];7(1):33-9. Available from:



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