Cost per NNT for upadacitinib in the treatment of patients with moderate-severe atopic dermatitis in Italy

Authors

  • Andrea Chiricozzi UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Roma - Italy https://orcid.org/0000-0002-6739-0387
  • Antonio Costanzo Department of Biomedical Sciences, Humanitas University, Dermatology Unit, Humanitas Research Hospital, Rozzano, Milano - Italy https://orcid.org/0000-0001-9697-2557
  • Anna Levi AbbVie, Roma - Italy https://orcid.org/0009-0005-1980-7669
  • Federica Parretta AbbVie, Roma - Italy
  • Roberto Ravasio HEOR and RWE Lead, PharmaLex Italy S.p.A. formerly MA Provider, Milano - Italy https://orcid.org/0000-0002-5477-1957

DOI:

https://doi.org/10.33393/grhta.2024.2728

Keywords:

Cost per NNT, Upadacitinib, EASI-75, EASI-90, Italian NHS, Atopic dermatitis

Abstract

Background: Targeted systemic therapies, including abrocitinib, baricitinib, dupilumab, tralokinumab and upadacitinib, are new treatments for moderate to severe atopic dermatitis (AD). We evaluated the efficacy and the costs of these targeted systemic therapies in the treatment of adult patients with moderate to severe AD.

Methods: The clinical efficacy was assessed considering the results of a previous network meta-analysis (NMA). The analysis involved five therapies approved in Italy for the treatment of moderate to severe AD: abrocitinib (ABR), baricitinib (BAR), dupilumab (DUP), tralokinumab (TRA) and upadacitinib (UPA). According to the NMA, the cost of the treatment was based on the number of administrations dispensed at 16 weeks and the clinical efficacy was measured by the number needed to treat (NNT) compared to placebo using the improvement ≥ 75% (EASI-75) or ≥ 90 (EASI-90) from baseline of the eczema area and severity index (EASI). Only the ex-factory price of the targeted systemic therapies was considered. The cost per NNT was adopted as a cost-effectiveness indicator.

Results: At 16 weeks, the cost per NNT based on EASI-75 was lower for UPA 15 mg (€ 6,384.00) compared to BAR 4 mg (€ 11,619.73) and 2 mg (€ 14,524.66), ABR 100 mg (€ 16,265.22), DUP 300 mg (€ 16,115.04) and TRA 300 mg (€ 31,710.24). UPA 15 (€ 8,512.00) also showed the lower cost per NNT based on EASI-90 at 16 weeks compared to BAR 4 mg (€ 14,788.75) and 2 mg (€ 20,862.70), ABR 100 mg (€ 25,922.69), DUP 300 mg (€ 25,992.00) and TRA 300 mg (€ 41,067.36).

Conclusions: The findings show that upadacitinib is the most cost-effective option (cost per NNT) for the treatment of moderate to severe atopic dermatitis.

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References

Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345-360. https://doi.org/10.1016/S0140-6736(20)31286-1 PMID:32738956 DOI: https://doi.org/10.1016/S0140-6736(20)31286-1

Drucker AM. Atopic dermatitis: burden of illness, quality of life, and associated complications. Allergy Asthma Proc. 2017;38(1):3-8. https://doi.org/10.2500/aap.2017.38.4005 PMID:28052794 DOI: https://doi.org/10.2500/aap.2017.38.4005

Rønnstad ATM, Halling-Overgaard AS, Hamann CR, Skov L, Egeberg A, Thyssen JP. Association of atopic dermatitis with depression, anxiety, and suicidal ideation in children and adults: A systematic review and meta-analysis. J Am Acad Dermatol. 2018;79(3):448-456.e30. https://doi.org/10.1016/j.jaad.2018.03.017 PMID:30119868 DOI: https://doi.org/10.1016/j.jaad.2018.03.017

Bylund S, Kobyletzki LB, Svalstedt M, Svensson Å. Prevalence and Incidence of Atopic Dermatitis: A Systematic Review. Acta Derm Venereol. 2020;100(12):adv00160. https://doi.org/10.2340/00015555-3510 PMID:32412646 DOI: https://doi.org/10.2340/00015555-3510

Kim JP, Chao LX, Simpson EL, Silverberg JI. Persistence of atopic dermatitis (AD): A systematic review and meta-analysis. J Am Acad Dermatol. 2016;75(4):681-687.e11. https://doi.org/10.1016/j.jaad.2016.05.028 PMID:27544489 DOI: https://doi.org/10.1016/j.jaad.2016.05.028

Lee HH, Patel KR, Singam V, Rastogi S, Silverberg JI. A systematic review and meta-analysis of the prevalence and phenotype of adult-onset atopic dermatitis. J Am Acad Dermatol. 2019;80(6):1526-1532.e7. https://doi.org/10.1016/j.jaad.2018.05.1241 PMID:29864464 DOI: https://doi.org/10.1016/j.jaad.2018.05.1241

Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: results from an international survey. Allergy. 2018;73(6):1284-1293. https://doi.org/10.1111/all.13401 PMID:29319189 DOI: https://doi.org/10.1111/all.13401

Calzavara Pinton P, Cristaudo A, Foti C, et al. Diagnosis and management of moderate to severe adult atopic dermatitis: a Consensus by the Italian Society of Dermatology and Venereology (SIDeMaST), the Italian Association of Hospital Dermatologists (ADOI), the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC), and the Italian Society of Allergological, Environmental and Occupational Dermatology (SIDAPA). G Ital Dermatol Venereol. 2018;153(2):133-145. PMID:29237258 DOI: https://doi.org/10.23736/S0392-0488.17.05892-8

Hajar T, Gontijo JRV, Hanifin JM. New and developing therapies for atopic dermatitis. An Bras Dermatol. 2018;93(1):104-107. https://doi.org/10.1590/abd1806-4841.20187682 PMID:29641707 DOI: https://doi.org/10.1590/abd1806-4841.20187682

Megna M, Napolitano M, Patruno C, et al. Systemic Treatment of Adult Atopic Dermatitis: A Review. Dermatol Ther (Heidelb). 2017;7(1):1-23. https://doi.org/10.1007/s13555-016-0170-1 PMID:28025775 DOI: https://doi.org/10.1007/s13555-016-0170-1

Waljee AK, Rogers MA, Lin P, et al. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017;357:j1415. https://doi.org/10.1136/bmj.j1415 PMID:28404617 DOI: https://doi.org/10.1136/bmj.j1415

Boguniewicz M, Fonacier L, Guttman-Yassky E, Ong PY, Silverberg J, Farrar JR. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.e2. https://doi.org/10.1016/j.anai.2017.10.039 PMID:29273118 DOI: https://doi.org/10.1016/j.anai.2017.10.039

Agenzia Italiana del Farmaco (AIFA). Determina 13 gennaio 2023 Riclassificazione del medicinale per uso umano «Cibinqo», ai sensi dell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537. (Determina n. 36/2023). (23A00343) (GU Serie Generale n.22 del 27-01-2023). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-01-27&atto.codiceRedazionale=23A00343&elenco30giorni=true (Accessed November 2023)

Agenzia Italiana del Farmaco (AIFA). Determina 3 luglio 2023 Regime di rimborsabilita' e prezzo, a seguito di nuove indicazioni terapeutiche, del medicinale per uso umano «Olumiant». (Determina n. 456/2023). (23A03875) (GU Serie Generale n.157 del 07-07-2023). https://www.gazzettaufficiale.it/eli/id/2023/07/07/23A03875/SG (Accessed November 2023)

Agenzia Italiana del Farmaco (AIFA). Determina 24 novembre 2020 Rinegoziazione e riclassificazione del medicinale per uso umano «Dupixent», ai sensi dell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537. (Determina n. DG/1205/2020). (20A06600) (GU Serie Generale n.305 del 09-12-2020). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2020-12-09&atto.codiceRedazionale=20A06601&elenco30giorni=true (Accessed November 2023)

Agenzia Italiana del Farmaco (AIFA). Determina 8 febbraio 2022 Regime di rimborsabilita' e prezzo, a seguito di nuove indicazioni terapeutiche, del medicinale per uso umano «Dupixent». (Determina n. 115/2022). (22A01099) (GU Serie Generale n.42 del 19-02-2022). https://www.aifa.gov.it/documents/20142/961234/Determina_115-2022_Dupixent.pdf (Accessed November 2023)

Agenzia Italiana del Farmaco (AIFA). Determina 26 luglio 2022 Riclassificazione del medicinale per uso umano «Adtralza», ai sensi dell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537. (Determina n. 537/2022). (22A04366) (GU Serie Generale n.181 del 04-08-2022). https://www.gazzettaufficiale.it/eli/id/2022/08/04/22A04366/SG (Accessed November 2023)

Agenzia Italiana del Farmaco (AIFA). Determina 13 gennaio 2023 Regime di rimborsabilita' e prezzo, a seguito di nuove indicazioni terapeutiche, del medicinale per uso umano «Rinvoq». (Determina n. 19/2023). (23A00338) (GU Serie Generale n.22 del 27-01-2023). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2023-01-27&atto.codiceRedazionale=23A00338&elenco30giorni=true. (Accessed November 2023)

Riassunto delle caratteristiche di prodotto Cibinqo. https://www.ema.europa.eu/en/documents/product-information/cibinqo-epar-product-information_it.pdf. (Accessed November 2023)

Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266. https://doi.org/10.1016/S0140-6736(20)30732-7 PMID:32711801 DOI: https://doi.org/10.1016/S0140-6736(20)30732-7

Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020;156(8):863-873. https://doi.org/10.1001/jamadermatol.2020.1406 PMID:32492087 DOI: https://doi.org/10.1001/jamadermatol.2020.1406

Bieber T, Simpson EL, Silverberg JI, et al; JADE COMPARE Investigators. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021;384(12):1101-1112. https://doi.org/10.1056/NEJMoa2019380 PMID:33761207 DOI: https://doi.org/10.1056/NEJMoa2019380

Riassunto delle caratteristiche di prodotto Olumiant. https://www.ema.europa.eu/en/documents/product-information/olumiant-epar-product-information_it.pdf (Accessed November 2023)

Simpson EL, Lacour J-P, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020;183(2):242-255. https://doi.org/10.1111/bjd.18898 PMID:31995838 DOI: https://doi.org/10.1111/bjd.18898

Simpson EL, Forman S, Silverberg JI, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). J Am Acad Dermatol. 2021;85(1):62-70. https://doi.org/10.1016/j.jaad.2021.02.028 PMID:33600915 DOI: https://doi.org/10.1016/j.jaad.2021.02.028

Reich K, Kabashima K, Peris K, et al. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020;156(12):1333-1343. https://doi.org/10.1001/jamadermatol.2020.3260 PMID:33001140 DOI: https://doi.org/10.1001/jamadermatol.2020.3260

Riassunto delle caratteristiche di prodotto Dupixent. https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_it.pdf (Accessed November 2023)

Simpson EL, Bieber T, Guttman-Yassky E, et al; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016;375(24):2335-2348. https://doi.org/10.1056/NEJMoa1610020 PMID:27690741 DOI: https://doi.org/10.1056/NEJMoa1610020

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 (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287-2303. https://doi.org/10.1016/S0140-6736(17)31191-1 PMID:28478972 DOI: https://doi.org/10.1016/S0140-6736(17)31191-1

Riassunto delle caratteristiche di prodotto Adtralza https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_it.pdf (Accessed November 2023)

Wollenberg A, Blauvelt A, Guttman-Yassky E, et al; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021;184(3):437-449. https://doi.org/10.1111/bjd.19574 PMID:33000465 DOI: https://doi.org/10.1111/bjd.19574

Silverberg JI, Adam DN, Zirwas M, et al. Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis. Am J Clin Dermatol. 2022;23(4):547-559. https://doi.org/10.1007/s40257-022-00702-2 PMID:35857179 DOI: https://doi.org/10.1007/s40257-022-00702-2

Riassunto delle caratteristiche di prodotto Rinvoq https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_it.pdf (Accessed November 2023)

Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. https://doi.org/10.1016/S0140-6736(21)00588-2 PMID:34023008 DOI: https://doi.org/10.1016/S0140-6736(21)00588-2

Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397(10290):2169-2181. https://doi.org/10.1016/S0140-6736(21)00589-4 PMID:34023009 DOI: https://doi.org/10.1016/S0140-6736(21)00589-4

Silverberg JI, Hong HC, Thyssen JP, et al. Comparative Efficacy of Targeted Systemic Therapies for Moderate to Severe Atopic Dermatitis without Topical Corticosteroids: Systematic Review and Network Meta-analysis. Dermatol Ther (Heidelb). 2022;12(5):1181-1196. https://doi.org/10.1007/s13555-022-00721-1 PMID:35435637 DOI: https://doi.org/10.1007/s13555-022-00721-1

Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011;64(2):163-171. https://doi.org/10.1016/j.jclinepi.2010.03.016 PMID:20688472 DOI: https://doi.org/10.1016/j.jclinepi.2010.03.016

Elenco dei medicinali di classe a) rimborsabili dal Servizio sanitario nazionale (SSN) ai sensi dell'articolo 48, comma 5, lettera c), del decreto-legge 30 settembre 2003, n. 269, convertito, con modificazioni, nella legge 24 novembre 2006, n. 326. (Prontuario farmaceutico nazionale 2006). (GU Serie Generale n.156 del 07-07-2006 - Suppl. Ordinario n. 161). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2006-07-07&atto.codiceRedazionale=06A06166&elenco30giorni=false (Accessed November 2023)

Gazzetta Ufficiale (G.U.) Serie Generale n° 154 del 30 giugno 2021. https://www.gazzettaufficiale.it/eli/gu/2021/06/30/154/sg/pdf (Accessed November 2023)

Drucker AM, Morra DE, Prieto-Merino D, et al. Systemic Immunomodulatory Treatments for Atopic Dermatitis: Update of a Living Systematic Review and Network Meta-analysis. JAMA Dermatol. 2022;158(5):523-532. https://doi.org/10.1001/jamadermatol.2022.0455 PMID:35293977 DOI: https://doi.org/10.1001/jamadermatol.2022.0455

Wan H, Jia H, Xia T, Zhang D. Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate-to-severe atopic dermatitis: A network meta-analysis. Dermatol Ther. 2022;35(9):e15636. https://doi.org/10.1111/dth.15636 PMID:35703351 DOI: https://doi.org/10.1111/dth.15636

Pereyra-Rodriguez J-J, Alcantara-Luna S, Domínguez-Cruz J, et al. Short-Term Effectiveness and Safety of Biologics and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. Life (Basel). 2021;11(9):927. https://doi.org/10.3390/life11090927 PMID:34575076 DOI: https://doi.org/10.3390/life11090927

Alves C, Penedones A, Mendes D, Batel Marques F. The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta-analysis. Eur J Clin Pharmacol. 2022;78(12):1923-1933. https://doi.org/10.1007/s00228-022-03400-4 PMID:36207461 DOI: https://doi.org/10.1007/s00228-022-03400-4

Published

2024-02-16

How to Cite

Chiricozzi, A., Costanzo, A., Levi, A., Parretta, F., & Ravasio, R. (2024). Cost per NNT for upadacitinib in the treatment of patients with moderate-severe atopic dermatitis in Italy. Global and Regional Health Technology Assessment, 11(1), 38–50. https://doi.org/10.33393/grhta.2024.2728

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Original Research Articles

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Received 2023-11-17
Accepted 2024-01-21
Published 2024-02-16

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