Economic evaluation of two therapeutic sequences in the first-line treatment of moderate to severe active ulcerative rectocolitis in Italy
DOI:
https://doi.org/10.33393/ao.2024.2893Keywords:
Cost-Consequence Analysis, Inflammatory Bowel Disease, Infliximab, Ulcerative Colitis, Ulcerative Rectocolitis, VedolizumabAbstract
Background: Vedolizumab (VDZ) and infliximab are used to treat moderate to severe ulcerative colitis (UC). The choice of the drug to use at first-line is often based on a combination of clinical and economic factors. The cost of treatment pathway is rarely considered. Therefore, this cost-consequence analysis (CCA) investigated the overall costs of treatment pathway for vedolizumab followed by infliximab (VDZ → IFX) compared to infliximab followed by vedolizumab (IFX → VDZ).
Methods: We used a published cost-consequence model (CCM), based on a targeted literature search reporting the time-on-treatment data for vedolizumab or infliximab in UC in first and second-line of treatment. CCM time horizon was defined by the length of treatment sequences. Considering the Italian hospital perspective, the CCA evaluated the biologic drugs acquisition costs, drug administration costs, hospitalization costs, switch costs, colectomy costs and third-line treatment costs. Third-line options included colectomy, tofacitinib, ustekinumab or dose escalation of second-line biologic.
Results: Over the 5.2-year time horizon (duration of the longer VDZ → IFX pathway), the mean cost per patient of VDZ → IFX pathway was slightly lower than the mean cost per patient of IFX → VDZ pathway (€ 86,339 vs 89,636). The CCM predicted that using VDZ as first-line treatment delayed the time to costly third-line therapies compared to first-line using IFX (VDZ-first-line median time-on-treatment 3.6-years and IFX-second-line 1.6-years; IFX-first-line 1.4-years and VDZ-second-line 2.3-years and third-line 1.5-years).
Conclusion: The CCA showed that a biologic treatment pathway that begins with first-line vedolizumab is not more expensive than one beginning with first-line infliximab and delayed the time to costly third-line.
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References
Kobayashi T, Siegmund B, Le Berre C, et al. Ulcerative colitis. Nat Rev Dis Primers. 2020;6(1):74. https://doi.org/10.1038/s41572-020-0205-x PMID:32913180 DOI: https://doi.org/10.1038/s41572-020-0205-x
Nakase H, Uchino M, Shinzaki S, et al. Evidence-based clinical practice guidelines for inflammatory bowel disease 2020. J Gastroenterol. 2021;56(6):489-526. https://doi.org/10.1007/s00535-021-01784-1 PMID:33885977 DOI: https://doi.org/10.1007/s00535-021-01784-1
Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel J-F. Ulcerative colitis. Lancet. 2017;389(10080):1756-1770. https://doi.org/10.1016/S0140-6736(16)32126-2 PMID:27914657 DOI: https://doi.org/10.1016/S0140-6736(16)32126-2
Cohen RD, Yu AP, Wu EQ, Xie J, Mulani PM, Chao J. Systematic review: the costs of ulcerative colitis in Western countries. Aliment Pharmacol Ther. 2010;31(7):693-707. https://doi.org/10.1111/j.1365-2036.2010.04234.x PMID:20064142 DOI: https://doi.org/10.1111/j.1365-2036.2010.04234.x
Paschos P, Katsoula A, Salanti G, Giouleme O, Athanasiadou E, Tsapas A. Systematic review with network meta-analysis: the impact of medical interventions for moderate-to-severe ulcerative colitis on health-related quality of life. Aliment Pharmacol Ther. 2018;48(11-12):1174-1185. https://doi.org/10.1111/apt.15005 PMID:30378141 DOI: https://doi.org/10.1111/apt.15005
Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; 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 Apr;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
Gray JR, Leung E, Scales J. Treatment of ulcerative colitis from the patient’s perspective: a survey of preferences and satisfaction with therapy. Aliment Pharmacol Ther. 2009;29(10):1114-1120. https://doi.org/10.1111/j.1365-2036.2009.03972.x PMID:19222412 DOI: https://doi.org/10.1111/j.1365-2036.2009.03972.x
Peyrin-Biroulet L, Van Assche G, Sturm A, et al. Treatment satisfaction, preferences and perception gaps between patients and physicians in the ulcerative colitis CARES study: A real world-based study. Dig Liver Dis. 2016;48(6):601-607. https://doi.org/10.1016/j.dld.2016.01.013 PMID:27012447 DOI: https://doi.org/10.1016/j.dld.2016.01.013
Chao YS, Loshak H. Biologics versus Immunomodulators for the Treatment of Ulcerative Colitis: A Review of Comparative Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019. https://www.ncbi.nlm.nih.gov/books/NBK549363/ (Accessed December 2023)
Arora Z, Shen B. Biological therapy for ulcerative colitis. Gastroenterol Rep (Oxf). 2015;3(2):103-109. https://doi.org/10.1093/gastro/gou070 PMID:25344680 DOI: https://doi.org/10.1093/gastro/gou070
Bhattacharya A, Osterman MT. Biologic Therapy for Ulcerative Colitis. Gastroenterol Clin North Am. 2020 Dec;49(4):717-729. https://doi.org/10.1016/j.gtc.2020.08.002 PMID: 33121691 DOI: https://doi.org/10.1016/j.gtc.2020.08.002
Breton J, Kastl A, Conrad MA, Baldassano RN. Positioning biologic therapies in the management of pediatric inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2020;16(8):400-414. PMID:34035746
Dhar A, Wilson A, Reid V, et al. Choice of first biologic in moderate to severe ulcerative colitis – a decision analysis using time-on-treatment and UK costs. Presented at the 2023 ECCO Congress 3rd March 2023. https://doi.org/10.1093/ecco-jcc/jjac190.0763 DOI: https://doi.org/10.1093/ecco-jcc/jjac190.0763
Gov.Uk Guidance. Cost consequence analysis: health economic studies https://www.gov.uk/guidance/cost-consequence-analysis-health-economic-studies (Accessed December 2023)
European Medicines Agency (EMA). Riassunto delle caratteristiche di prodotto. Entyvio. https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_it.pdf (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). DETERMINA 7 luglio 2021 Riclassificazione del medicinale per uso umano «Entyvio», ai sensi dell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537. (Determina n. DG/807/2021). (21A04297) (GU Serie Generale n.174 del 22-07-2021). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2021-07-22&atto.codiceRedazionale=21A04297&elenco30giorni=true ((Accessed December 2023)
European Medicines Agency (EMA). Riassunto delle caratteristiche di prodotto. Remicade. https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_it.pdf (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). DETERMINA 31 luglio 2014 Regime di rimborsabilita' e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano «Remicade (infliximab)». (Determina n. 823/2014). (14A06444) (GU Serie Generale n.190 del 18-08-2014). https://www.gazzettaufficiale.it/eli/id/2014/08/18/14A06444/sg (Accessed December 2023)
European Medicines Agency (EMA). Riassunto delle caratteristiche di prodotto. Remsima. https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_it.pdf. (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). DETERMINA 9 dicembre 2014 Regime di rimborsabilita' e prezzo del medicinale per uso umano «Remsima» (infliximab), autorizzata con procedura centralizzata europea dalla Commissione Europea. (Determina n. 1471/2014). (14A09840) (GU Serie Generale n.302 del 31-12-2014). https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2014-12-31&atto.codiceRedazionale=14A09840&elenco30giorni=true (Accessed December 2023)
European Medicines Agency (EMA). Riassunto delle caratteristiche di prodotto. Adalimumab. https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_it.pdf. (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). DETERMINA 10 aprile 2014 Regime di rimborsabilita' e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano Humira (adalimumab). (Determina n. 350/2014). (14A03306) (GU Serie Generale n.98 del 29-04-2014). https://www.gazzettaufficiale.it/eli/gu/2014/04/29/98/sg/pdf (Accessed December 2023)
European Medicines Agency (EMA). Riassunto delle caratteristiche di prodotto. Golimumab. https://www.ema.europa.eu/en/documents/product-information/simponi-epar-product-information_it.pdf. (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). DETERMINA 19 gennaio 2015 Regime di rimborsabilita' e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano «Simponi» (golimumab). (Determina n. 19/2015). (15A00523) (GU Serie Generale n.22 del 28-01-2015). https://www.aifa.gov.it/documents/20142/241028/determina_Simponi_CU_19-2015.pdf (Accessed December 2023)
Technical Report. Tavolo di Discussione Multidisciplinare: Le sequenze di trattamento nella Colite Ulcerosa. Takeda. Data on file.
Chaparro M, Hermida S, Acosta D, et al. Real world evidence of ustekinumab in ulcerative colitis: short and longterm effectiveness and safety: the ULISES study. United European Gastroenterology Journal 2023, Vol 11 (S8). Oral Presentations. Sunday, October 15, 2023. Unsolved issues in IBD outcome 14:30-15:30 / D4. ISSN 2050- 6414 (Online) onlinelibrary.wiley.com/toc/20506414/2023/11/S8
Macaluso FS, Ventimiglia M, Orlando A. Effectiveness and Safety of Vedolizumab in Inflammatory Bowel Disease: A Comprehensive Meta-analysis of Observational Studies. J Crohns Colitis. 2023;17(8):1217-1227. https://doi.org/10.1093/ecco-jcc/jjad043 PMID:36913311 DOI: https://doi.org/10.1093/ecco-jcc/jjad043
Agenzia Italiana Del Farmaco (AIFA). Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale ai sensi del D.M. 2 agosto 2019. https://www.aifa.gov.it/documents/20142/1283800/Linee_guida_dossier_domanda_rimborsabilita.pdf (Accessed December 2023)
Ministero della Salute. Decreto 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. https://www.gazzettaufficiale.it/eli/gu/2013/01/28/23/so/8/sg/pdf (Accessed December 2023)
Dovizio M, Perrone V, Veronesi C, et al. La gestione terapeutica ed i costi sanitari associati in pazienti con malattie infiammatorie croniche intestinali (MICI): dati di real-world della regione Lazio. Clinico Economics Italian Articles On Outcomes Research. Vol 18 anno 2023 pag 41-48 https://clinicoeconomics.eu/la-gestione-terapeutica-ed-i-costi-sanitari-associati-in-pazienti-con-malattie-infiammatorie-croniche-intestinali-mici-clinico-economics-vol18-2023-pag41-48/ (Accessed December 2023)
Agenzia Italiana Del Farmaco (AIFA). Biosimilari: Analisi della variabilità regionale. Analisi grafica della variabilità regionale dei consumi e del costo dei medicinali biologici a brevetto scaduto nel canale acquisti diretti. (Dato NSIS/Tracciabilità del farmaco aggiornato a dic-2022) https://www.aifa.gov.it/documents/20142/2237305/2_AnalisiVariabilitàRegionale_set-2023.pdf
Macaluso FS, Orlando A, Papi C, et al; Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD); Working panel; Review panel. Use of biologics and small molecule drugs for the management of moderate to severe ulcerative colitis: IG-IBD clinical guidelines based on the GRADE methodology. Dig Liver Dis. 2022;54(4):440-451. https://doi.org/10.1016/j.dld.2022.01.127 PMID:35184989 DOI: https://doi.org/10.1016/j.dld.2022.01.123
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Copyright (c) 2024 Patrizio Armeni, Elena Compagnucci , Gionata Fiorino, Vincenzo Lolli, Grazia Mazzone , Ambrogio Orlando, Mariabeatrice Principi, Roberto Ravasio, Fernando Rizzello, Edoardo Vincenzo Savarino, Francesca Tombari
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Accepted 2024-02-08
Published 2024-03-02
