Cost per responder for vedolizumab and ustekinumab in Crohn’s disease patients after failure of TNF-α inhibitors in Italy
Keywords:Cost per responder, Crohn’s disease, Italian NHS, TNF-α inhibitors, Ustekinumab, Vedolizumab
Background: The aim of this economic evaluation was to compare the cost per responder between vedolizumab and ustekinumab in patients with Crohn’s disease (CD) after failure of tumor necrosis factor-α inhibitors in Italy.
Methods: Clinical efficacy was assessed using the results of an Italian large multicentre observational retrospective cohort study. The aim of the study was to compare the effectiveness of ustekinumab and vedolizumab as second line therapy in Crohn’s disease patients in which tumour necrosis factor-α inhibitors failed. Clinical efficacy of vedolizumab and ustekinumab was measured by clinical response and clinical remission. Treatment costs were based on the number of administrations at 26 or 52 weeks. Cost per responder, based on clinical efficacy and clinical response, was used as a cost-effectiveness indicator.
Results: Regardless of the clinical efficacy measure used and the treatment duration considered, the cost per responder was consistently lower for vedolizumab compared with ustekinumab on all clinical measures. Considering the clinical response, the cost per responder at 26 weeks was € 15,640 for vedolizumab and € 23,667 for ustekinumab and at 52 weeks was € 23,927 for vedolizumab and € 30,820 for ustekinumab. Considering the clinical remission, the cost per responder at 26 weeks was € 22,832 for vedolizumab and € 33,786 for ustekinumab and at 52 weeks was € 29,488 for vedolizumab and € 46,847 for ustekinumab. Sensitivity analysis confirmed the validity of results.
Conclusion: These results suggest that vedolizumab is a cost-effective option compared with ustekinumab from the perspective of the Italian health service in patients with CD after failure of TNF-α inhibitors.
Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn’s disease. Lancet. 2017;389(10080):1741-1755. https://doi.org/10.1016/S0140-6736(16)31711-1 PMID:27914655 DOI: https://doi.org/10.1016/S0140-6736(16)31711-1
de Souza HS, Fiocchi C. Immunopathogenesis of IBD: current state of the art. Nat Rev Gastroenterol Hepatol. 2016;13(1):13-27. https://doi.org/10.1038/nrgastro.2015.186PMID:26627550 DOI: https://doi.org/10.1038/nrgastro.2015.186
Holko P, Kawalec P, Pilc A. Cost-Effectiveness Analysis of Crohn’s Disease Treatment with Vedolizumab and Ustekinumab After Failure of Tumor Necrosis Factor-α Antagonist. PharmacoEconomics. 2018;36(7):853-865. https://doi.org/10.1007/s40273-018-0653-2PMID:29667146 DOI: https://doi.org/10.1007/s40273-018-0653-2
Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol. 2015;110(9):1324-1338. https://doi.org/10.1038/ajg.2015.233 PMID:26303131 DOI: https://doi.org/10.1038/ajg.2015.233
Turner D, Ricciuto A, Lewis A, et al; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583. https://doi.org/10.1053/j.gastro.2020.12.031 PMID:33359090 DOI: https://doi.org/10.1053/j.gastro.2020.12.031
Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: medical Treatment. J Crohn’s Colitis. 2020;14(1):4-22. https://doi.org/10.1093/ecco-jcc/jjz180PMID:31711158
Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease: a systematic review. Am J Gastroenterol. 2011;106(4):674-684. https://doi.org/10.1038/ajg.2011.60 PMID:21407178 DOI: https://doi.org/10.1038/ajg.2011.60
Gisbert JP, Panés J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. Am J Gastroenterol. 2009;104(3):760-767. https://doi.org/10.1038/ajg.2008.88 PMID:19174781 DOI: https://doi.org/10.1038/ajg.2008.88
Sandborn WJ, Feagan BG, Rutgeerts P, et al; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711-721. https://doi.org/10.1056/NEJMoa1215739 PMID:23964933 DOI: https://doi.org/10.1056/NEJMoa1215739
Sandborn WJ, Gasink C, Gao LL, et al; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn’s disease. N Engl J Med. 2012;367(16):1519-1528. https://doi.org/10.1056/NEJMoa1203572 PMID:23075178 DOI: https://doi.org/10.1056/NEJMoa1203572
Vedolizumab. Riassunto delle caratteristiche del prodotto. Disponibile a: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_it.pdf
Ustekinumab. Riassunto delle caratteristiche del prodotto. Disponibile a: https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_it.pdf
Onali S, Pugliese D, Caprioli FA, et al; IG-IBD. An objective comparison of vedolizumab and ustekinumab effectiveness in Crohn’s disease patients’ failure to TNF-alpha inhibitors. Am J Gastroenterol. 2022;117(8):1279-1287. https://doi.org/10.14309/ajg.0000000000001773 PMID:35467558 DOI: https://doi.org/10.14309/ajg.0000000000001773
Remunerazione delle prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza post acuzie e di assistenza specialistica ambulatoriale. Supplemento ordinario alla “Gazzetta Ufficiale” n. 23 del 28 gennaio 2013 - Serie generale. Online https://www.gazzettaufficiale.it/eli/gu/2013/01/28/23/so/8/sg/pdf (Accessed October 2022)
Erim DO, Mahendraratnam N, Okafor PN, Wheeler SB. The value of vedolizumab as rescue therapy in moderate-severe Crohn’s disease patients with adalimumab non-response in the USA. J Crohn’s Colitis. 2015;9(8):669-675. https://doi.org/10.1093/ecco-jcc/jjv090 PMID:25987351 DOI: https://doi.org/10.1093/ecco-jcc/jjv090
Zhou T, Sheng Y, Guan H. Cost-Effectiveness of Vedolizumab in the Treatment of Moderate-to-Severe Crohn’s Disease in China. Adv Ther. 2021;38(8):4233-4245. https://doi.org/10.1007/s12325-021-01806-7 PMID:34089502 DOI: https://doi.org/10.1007/s12325-021-01806-7
How to Cite
Copyright (c) 2023 Roberto Ravasio, Raffaella Viti, Antonio Saverio Roscini
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors contributing to AboutOpen agree to publish their articles under the Creative Commons NonCommercial 4.0 International License (CC BY-NC 4.0), which allows third parties to copy and redistribute the material providing appropriate credit and a link to the license but does not allow to use the material for commercial purposes and to use the material if it has been remixed, transformed or built upon.