Cost-effectiveness Analysis of Dupilumab for the Treatment of Adult Patients with Severe Prurigo Nodularis in Italy
DOI:
https://doi.org/10.2340/actadv.v105.43590Keywords:
prurigo, cost-effectiveness analysis, skin diseases, dupilumab, Quality-Adjusted Life YearsAbstract
Prurigo nodularis is characterized by intensely pruritic nodules that significantly impact patients’ quality of life. This study aims to evaluate the cost-effectiveness of dupilumab compared with the best supportive care for the treatment of severe prurigo nodularis from the perspective of the Italian National Health Service. A cost-effectiveness model was developed using a decision tree followed by a Markov approach with a lifetime horizon (30 years). Baseline characteristics, efficacy, and utility data were derived from the pooled analysis of PRIME and PRIME2 trials. Direct healthcare costs based on drug acquisition, adverse event and complications management, and disease-related healthcare resource utilization were considered. Dupilumab improved health outcomes, with an incremental gain of 1.481 quality-adjusted life-years compared with best supportive care. The total cost of dupilumab treatment was €148,964, compared with €70,957 for the best supportive care arm, thus resulting in an incremental cost-effectiveness ratio of €52,661 per quality-adjusted life-year. Scenario analyses indicated that at a discount ≥ 20%, the incremental cost-effectiveness ratio was lower than €40,000/quality-adjusted life-year. Deterministic and probabilistic sensitivity analyses confirmed the robustness of the results. Dupilumab is likely to be a cost-effective treatment for severe prurigo nodularis patients eligible for systemic therapy in Italy, as it reduces disease burden and healthcare costs associated with uncontrolled prurigo nodularis.
Downloads
References
Ständer S, Pereira MP, Berger T, Zeidler C, Augustin M, Bobko S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch 2020; 5: e42. DOI: https://doi.org/10.1097/itx.0000000000000042
Pereira MP, Steinke S, Zeidler C, Forner C, Riepe C, Augustin M, et al. European Academy of Dermatology and Venereology European Prurigo Project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol 2018; 32: 1059–1065. DOI: https://doi.org/10.1111/jdv.14570
Patruno C, Pelucchi C, Galeone C, Emmi M, Amerio P. Epidemiology and severity of prurigo nodularis in Europe: a literature review with an application to Italian data [In press]. Dermatol Pract Concept 2025; 2: 4716. DOI: https://doi.org/10.5826/dpc.1502a4716
Bahloul D, Ronci G, Isaman DL, Pedone MP, Degli Esposti L, Giacomini E, et al. Healthcare resource utilization and related cost among hospitalized patients with prurigo nodularis: a retrospective cohort study using Italian health claims data. Ital J Dermatol Venereol 2024; 159: 475–483. DOI: https://doi.org/10.23736/S2784-8671.24.07970-2
McCann MR, Kosloski MP, Xu C, Davis JD, Kamal MA. Dupilumab: mechanism of action, clinical, and translational science. Clin Transl Sci 2024; 17: e13899. DOI: https://doi.org/10.1111/cts.13899
Yosipovitch G, Mollanazar N, Ständer S, Kwatra SG, Kim BS, Laws E, et al. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med 2023; 29: 1180–1190. DOI: https://doi.org/10.1038/s41591-023-02320-9
Cao P, Xu W, Jiang S, Zhang L. Dupilumab for the treatment of prurigo nodularis: a systematic review. Front Immunol 2023; 14: 1092685. DOI: https://doi.org/10.3389/fimmu.2023.1092685
AIFA. Evaluation of innovativeness. 2023. Available from https://www.aifa.gov.it/documents/20142/2625301/10_Dupixent_PN_innovativita_GRADE.pdf
EMA. EPAR Dupixent – Summary of product characteristics. 2024 [cited 2025 Jun 10]. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
Kolkhir P, Akdis CA, Akdis M, Bachert C, Bieber T, Canonica GW, et al. Type 2 chronic inflammatory diseases: targets, therapies and unmet needs. Nat Rev Drug Discov 2023; 22: 743–767. DOI: https://doi.org/10.1038/s41573-023-00750-1
Yosipovitch G, Kim BS, Kwatra SG, Mollanazar NK, Ständer S, Satoh T, et al. Dupilumab improves pruritus and skin lesions in patients with prurigo nodularis: pooled results from 2 phase 3 trials (LIBERTY-PN PRIME and PRIME2). JAAD Int 2024; 16: 163–174. DOI: https://doi.org/10.1016/j.jdin.2024.03.025
AIFA. Guidelines for the preparation of the dossier supporting the application for reimbursement and pricing of a medicinal product. 2020.
Sanofi. Study Results. Study of dupilumab for the treatment of patients with prurigo nodularis, inadequately controlled on topical prescription therapies or when those therapies are not advisable (LIBERTY-PN PRIME). ClinicalTrials.gov. 2022 [cited 2025 Jun 10]. Available from: https://clinicaltrials.gov/study/NCT04183335?cond=Prurigo%20Nodularis&intr=NCT04183335&rank=1&tab=results
Sanofi. Study results. Study of dupilumab for the treatment of patients with prurigo nodularis, inadequately controlled on topical prescription therapies or when those therapies are not advisable (PRIME2). ClinicalTrials.gov. 2022 [cited 2025 Jun 10]. Available from: https://clinicaltrials.gov/study/NCT04202679?cond=Prurigo%20Nodularis&intr=NCT04202679&rank=1&tab=results
Costanzo A, Furneri G, Bitonti R, Pedone MP, Fanelli F, Turi RD. Cost-effectiveness analysis of dupilumab for the treatment of severe atopic dermatitis in adults in Italy. Glob Reg Health Technol Assess 2020; 7: 57–65. DOI: https://doi.org/10.33393/grhta.2020.710
ISTAT. Mortality tables. 2024 [cited 2025 Jun 10]. Available from: http://dati.istat.it/Index.aspx?DataSetCode=DCIS_MORTALITA1
NICE. NICE health technology evaluations: the manual. 2023 [cited 2025 Jun 10]. Available from: https://www.nice.org.uk/process/pmg36
van Hout B, Janssen MF, Feng Y-S, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health 2012; 15: 708–715. DOI: https://doi.org/10.1016/j.jval.2012.02.008
Scalone L, Cortesi PA, Ciampichini R, Cesana G, Mantovani LG. Health related quality of life norm data of the Italian general population: results using the EQ-5D-3L and EQ-5D-5L instruments. Epidemiol Biostat Public Health 2015; 12. DOI: https://doi.org/10.2427/11457
Ministry of Health. Decree of 25 November 2024. Remuneration for the provision of outpatient specialist services. (Official Gazette – General Series No. 302 of 27 December 2024). 2024 [cited 2025 Jun 10]; Available from: https://www.gazzettaufficiale.it/eli/id/2024/12/27/24A06929/SG
Codifa – L’Informatore Farmaceutico. 2024 [cited 2025 Jun 10]. Available from: https://www.codifa.it/
Fattore G. A proposal for guidelines for the economic evaluation of health interventions in Italy. PharmacoEconomics Ital Res Artic 2009; 11: 83–93. DOI: https://doi.org/10.1007/BF03320660
Espiñeira Sicre J, Docampo Simón A, Silvestre Salvador JF. Chronic nodular prurigo: a retrospective study of 74 Cases. Actas Dermosifiliogr 2022; 113: 866–873. DOI: https://doi.org/10.1016/j.ad.2022.08.012
Lanza G, Cosentino FII, Ferri R, Lanuzza B, Siragusa M, Tripodi M, et al. Cognitive impairment in inpatients with prurigo nodularis and psychiatric comorbidities. Int J Environ Res Public Health 2021; 18: 6265. DOI: https://doi.org/10.3390/ijerph18126265
Jørgensen KM, Egeberg A, Gislason GH, Skov L, Thyssen JP. Anxiety, depression and suicide in patients with prurigo nodularis. J Eur Acad Dermatol Venereol 2017; 31: e106–e107. DOI: https://doi.org/10.1111/jdv.13827
Pereira MP, Weisshaar E, Halvorsen JA, Wallengren J, Legat FJ, Garcovich S, et al. Chronic prurigo: insufficient disease control in spite of high healthcare usage. J Eur Acad Dermatol Venereol 2023; 37: e808–e812. DOI: https://doi.org/10.1111/jdv.18903
Kambala A, Taylor M, Cornman H, Oladipo O, Gabriel S, Kwatra S. 44469 Risk of suicidal ideation and suicide attempt in patients with prurigo nodularis. J Am Acad Dermatol 2023; 89: AB220. DOI: https://doi.org/10.1016/j.jaad.2023.07.880
Olbrich H, Kridin K, Hernández G, Zirpel H, Sadik CD, Terheyden P, et al. Increased cardiovascular risks and mortality in prurigo nodularis: a global cohort study. EBioMedicine 2024; 103: 105123. DOI: https://doi.org/10.1016/j.ebiom.2024.105123
NICE. Dupilumab for treating moderate to severe atopic dermatitis. Technology appraisal guidance. 2018 [cited 2025 Jun 10]. Available from: https://www.nice.org.uk/guidance/ta534
HAS. Transparency Committee Opinion 11 March 2020. Dupilumab. 2020 [cited 2025 Jun 10]. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2020-07/dupixent_summary_ct18138.pdf
TLV. Dupixent included in Sweden’s high-cost protection scheme with restrictions. 2018 [cited 2025 Jun 10]. Available from: https://www.tlv.se/beslut/beslut-lakemedel/begransad-subvention/arkiv/2018-05-24-dupixent-ingar-i-hogkostnadsskyddet-med-begransning.html?query=dupixent
ICER. Dupilumab and crisaborole for atopic dermatitis: effectiveness and value final evidence report and meeting summary. 2017 [cited 2025 Jun 10]. Available from: https://icer.org/wp-content/uploads/2020/10/MWCEPAC_ATOPIC_FINAL_EVIDENCE_REPORT_060717.pdf
Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389: 2287–2303. DOI: https://doi.org/10.1016/S0140-6736(17)31191-1
Gael M, Schoeffler A, Bursztejn A-C. Efficacy of dupilumab in chronic prurigo: a multicentre retrospective study. Ann Dermatol Venereol 2025; 152: 103336. DOI: https://doi.org/10.1016/j.annder.2024.103336
Paganini C, Talamonti M, Maffei V, Di Raimondo C, Bianchi L, Galluzzo M. Dupilumab for treatment of prurigo nodularis: real-life effectiveness for up to 84 weeks. J Clin Med 2024; 13: 878. DOI: https://doi.org/10.3390/jcm13030878
Allali N, Vataire AL, Sutour L, Bahloul D, Payan M, Thomas RB, et al. EE804 Cost-effectiveness of dupilumab in the treatment of moderate-to-severe prurigo nodularis in France. Value Health 2024; 27: S213 DOI: https://doi.org/10.1016/j.jval.2024.10.1084
Tavi J, Bahloul D, Kuznik A, Thomas RB, Knight C, Manga N, et al. Economic evaluation of dupilumab versus standard of care for the treatment of adult patients with moderate-to-severe prurigo nodularis in the United States. Value Health 2024; 27: S104. DOI: https://doi.org/10.1016/j.jval.2024.10.543
NICE. Dupilumab for treating moderate to severe prurigo nodularis. Technology appraisal guidance.. 2024 [cited 2025 Jun 10]. Available from: https://www.nice.org.uk/guidance/ta955
Additional Files
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2025 Cataldo Patruno, Massimiliano Povero, Andrea Tassone, Maria Paola Pedone, Donia Bahloul, Jules Tavi, Paolo Amerio
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All digitalized ActaDV contents is available freely online. The Society for Publication of Acta Dermato-Venereologica owns the copyright for all material published until volume 88 (2008) and as from volume 89 (2009) the journal has been published fully Open Access, meaning the authors retain copyright to their work.
Unless otherwise specified, all Open Access articles are published under CC-BY-NC licences, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for non-commercial purposes, provided proper attribution to the original work.
