Clinical and economic impact of infliximab one-hour infusion protocol in patients with inflammatory bowel diseases:A multicenter study
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摘要
AIM To assess the impact of short infliximab(IFX) infusion on hospital resource utilization and costs.METHODS All inflammatory bowel diseases(IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated.RESULTS One hundred and twenty-five patients were recruited(64 with ulcerative colitis and 61 with Crohn's disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years(SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501(30.5% short infusions). In the analyzed cohort, 1143 h were saved(762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving(-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled(infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase(observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient(average-€17.300 on the whole cohort).CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital's perspective, as it contributes to increase infusion units capacity, and the patients' perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity.
AIM To assess the impact of short infliximab(IFX) infusion on hospital resource utilization and costs.METHODS All inflammatory bowel diseases(IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated.RESULTS One hundred and twenty-five patients were recruited(64 with ulcerative colitis and 61 with Crohn's disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years(SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501(30.5% short infusions). In the analyzed cohort, 1143 h were saved(762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving(-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled(infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase(observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient(average-€17.300 on the whole cohort).CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital's perspective, as it contributes to increase infusion units capacity, and the patients' perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity.
AIM To assess the impact of short infliximab(IFX) infusion on hospital resource utilization and costs.METHODS All inflammatory bowel diseases(IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated.RESULTS One hundred and twenty-five patients were recruited(64 with ulcerative colitis and 61 with Crohn's disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years(SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501(30.5% short infusions). In the analyzed cohort, 1143 h were saved(762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving(-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled(infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase(observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient(average-€17.300 on the whole cohort).CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital's perspective, as it contributes to increase infusion units capacity, and the patients' perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity.
引文
1 Hanauer SB,Feagan BG,Lichtenstein GR,Mayer LF,Schreiber SColombel JF,Rachmilewitz D,Wolf DC,Olson A,Bao W,Rutgeerts P;ACCENT I Study Group.Maintenance infliximab for Crohn’s disease:the ACCENT I randomised trial.Lancet 2002;359:1541-1549[PMID:12047962 DOI:10.1016/S0140-6736(02)08512-4]
2 Sands BE,Anderson FH,Bernstein CN,Chey WY,Feagan BG,Fedorak RN,Kamm MA,Korzenik JR,Lashner BA,Onken JE,Rachmilewitz D,Rutgeerts P,Wild G,Wolf DC,Marsters PA,Travers SB,Blank MA,van Deventer SJ.Infliximab maintenance therapy for fistulizing Crohn’s disease.N Engl J Med 2004;350:876-885[PMID:14985485 DOI:10.1056/NEJMoa030815]
3 Rutgeerts P,Sandborn WJ,Feagan BG,Reinisch W,Olson A,Johanns J,Travers S,Rachmilewitz D,Hanauer SB,Lichtenstein GR,de Villiers WJ,Present D,Sands BE,Colombel JF.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med 2005;353:2462-2476[PMID:16339095 DOI:10.1056/NEJMoa050516]
4 Maini R,St Clair EW,Breedveld F,Furst D,Kalden J,Weisman M,Smolen J,Emery P,Harriman G,Feldmann M,Lipsky P.Infliximab(chimeric anti-tumour necrosis factor alpha monoclonal antibody)versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:a randomised phase III trial.ATTRACT Study Group.Lancet 1999;354:1932-1939[PMID:10622295 DOI:10.1016/S0140-6736(99)05246-05]
5 Reich K,Nestle FO,Papp K,Ortonne JP,Evans R,Guzzo C,Li S,Dooley LT,Griffiths CE;EXPRESS study investigators.Infliximab induction and maintenance therapy for moderate-to-severe psoriasis:a phase III,multicentre,double-blind trial.Lancet 2005;366:1367-1374[PMID:16226614 DOI:10.1016/S0140-6736(05)67566-6]
6 Targan SR,Hanauer SB,van Deventer SJ,Mayer L,Present DH,Braakman T,De Woody KL,Schaible TF,Rutgeerts PJ.A short-term study of chimeric monoclonal antibody c A2 to tumor necrosis factor alpha for Crohn’s disease.Crohn’s Disease c A2 Study Group.NEngl J Med 1997;337:1029-1035[PMID:9321530 DOI:10.1056/NEJM199710093371502]
7 Sands BE,Blank MA,Patel K,van Deventer SJ.Long-term treatment of rectovaginal fistulas in Crohn’s disease:response to infliximab in the ACCENT II Study.Clin Gastroenterol Hepatol 2004;2:912-920[PMID:15476155]
8 Present DH,Rutgeerts P,Targan S,Hanauer SB,Mayer L,van Hogezand RA,Podolsky DK,Sands BE,Braakman T,De Woody KL,Schaible TF,van Deventer SJ.Infliximab for the treatment of fistulas in patients with Crohn’s disease.N Engl J Med 1999;340:1398-1405[PMID:10228190 DOI:10.1056/NEJM199905063401804]
9 Cheifetz A,Smedley M,Martin S,Reiter M,Leone G,Mayer L,Plevy S.The incidence and management of infusion reactions to infliximab:a large center experience.Am J Gastroenterol 2003;98:1315-1324[PMID:12818276 DOI:10.1111/j.1572-0241.2003.07457.x]
10 Buch MH,Bryer D,Lindsay S,Rees-Evans B,Fairclough A,Emery P.Shortening infusion times for infliximab administration.Rheumatology(Oxford)2006;45:485-486[PMID:16352636 DOI:10.1093/rheumatology/kei273]
11 Breynaert C,Ferrante M,Fidder H,Van Steen K,Noman M,Ballet V,Vermeire S,Rutgeerts P,Van Assche G.Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases:a single-center cohort study.Am J Gastroenterol 2011;106:778-785[PMID:21407184 DOI:10.1038/ajg.2011.61]
12 Van Assche G,Vermeire S,Noman M,Amant C,Weyts E,Vleminckx A,Vermeyen MJ,Rutgeerts P.Infliximab administered with shortened infusion times in a specialized IBD infusion unit:a prospective cohort study.J Crohns Colitis 2010;4:329-333[PMID:21122522 DOI:10.1016/j.crohns.2009.12.012]
13 Babouri A,Roblin X,Filippi J,Hébuterne X,Bigard MA,PeyrinBiroulet L.Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases:a prospective multicenter cohort study.J Crohns Colitis 2014;8:161-165[PMID:23994253 DOI:10.1016/j.crohns.2013.08.004]
14 Principi M,Losurdo G,La Fortezza RF,Lopolito P,Lovero R,Grillo S,Bringiotti R,Ierardi E,Di Leo A.Does infliximab short infusion have a beneficial impact on the quality of life in patients with inflammatory bowel diseases?A single centre prospective evaluation.J Gastrointestin Liver Dis 2015;24:165-170[PMID:26114175 DOI:10.15403/jgld.2014.1121.242.tezz]
15 Cappello M,Mazza M,Costantino G,Privitera AC,Bossa F,Lauria A,Grossi L,Principi MB,Della Valle N,Almasio PL.Safety of infliximab(ifx)one-hour infusion in inflammatory bowel disease(IBD):a multicenter study from southern Italy.DLD 2015;47(S 2):e131
16 Marcellusi A,Viti R,Capone A,Mennini FS.Cost of illness probabilistic methodology to assess direct and indirect costs of HCV-related diseases in Italy.Pharmaco Econ Ital Res Artic 2014;16:23[DOI:10.1007/s40276-014-0023-9]
17 Rutgeerts P,Vermeire S,Van Assche G.Mucosal healing in inflammatory bowel disease:impossible ideal or therapeutic target?Gut 2007;56:453-455[PMID:17369375 DOI:10.1136/gut.2005.088732]
18 Rutgeerts P,Feagan BG,Lichtenstein GR,Mayer LF,Schreiber S,Colombel JF,Rachmilewitz D,Wolf DC,Olson A,Bao W,Hanauer SB.Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease.Gastroenterology 2004;126:402-413[PMID:14762776 DOI:10.1053/j.gastro.2003.11.014]
19 van Vollenhoven RF,Gullstr?m E,Klareskog L.Feasibility of 1 hour infliximab infusions.Ann Rheum Dis 2005;64:654[PMID:15769930DOI:10.1136/ard.2003.017590]
20 Neef HC,Riebschleger MP,Adler J.Meta-analysis:rapid infliximab infusions are safe.Aliment Pharmacol Ther 2013;38:365-376[PMID:23815183 DOI:10.1111/apt.12389]
21 Bhat S,Sharma D,Doherty P,Tham TC,Caddy GR.Are accelerated infliximab infusions safe in patients with inflammatory bowel disease?Inflamm Bowel Dis 2010;16:1922-1925[PMID:20848465 DOI:10.1002/ibd.21279]
22 Mc Connell J,Parvulescu-Codrea S,Behm B,Hill B,Dunkle E,Finke K,Snyder K,Tuskey A,Cox D,Woodward B.Accelerated infliximab infusions for inflammatory bowel disease improve effectiveness.World J Gastrointest Pharmacol Ther 2012;3:74-82[PMID:23515325 DOI:10.4292/wjgpt.v3.i5.74]
23 Kuin S,Stolte SB,van den Brink GR,Ponsioen CY,Fockens P,D’Haens GR,L?wenberg M.Short article:Remicade infusions at home:an alternative setting of infliximab therapy for patients with Crohn’s disease.Eur J Gastroenterol Hepatol 2016;28:222-225[PMID:26566062DOI:10.1097/MEG.0000000000000530]
24 Condino AA,Fidanza S,Hoffenberg EJ.A home infliximab infusion program.J Pediatr Gastroenterol Nutr 2005;40:67-69[PMID:15625429 DOI:10.1097/00005176-200501000-00012]
2 Sands BE,Anderson FH,Bernstein CN,Chey WY,Feagan BG,Fedorak RN,Kamm MA,Korzenik JR,Lashner BA,Onken JE,Rachmilewitz D,Rutgeerts P,Wild G,Wolf DC,Marsters PA,Travers SB,Blank MA,van Deventer SJ.Infliximab maintenance therapy for fistulizing Crohn’s disease.N Engl J Med 2004;350:876-885[PMID:14985485 DOI:10.1056/NEJMoa030815]
3 Rutgeerts P,Sandborn WJ,Feagan BG,Reinisch W,Olson A,Johanns J,Travers S,Rachmilewitz D,Hanauer SB,Lichtenstein GR,de Villiers WJ,Present D,Sands BE,Colombel JF.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med 2005;353:2462-2476[PMID:16339095 DOI:10.1056/NEJMoa050516]
4 Maini R,St Clair EW,Breedveld F,Furst D,Kalden J,Weisman M,Smolen J,Emery P,Harriman G,Feldmann M,Lipsky P.Infliximab(chimeric anti-tumour necrosis factor alpha monoclonal antibody)versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:a randomised phase III trial.ATTRACT Study Group.Lancet 1999;354:1932-1939[PMID:10622295 DOI:10.1016/S0140-6736(99)05246-05]
5 Reich K,Nestle FO,Papp K,Ortonne JP,Evans R,Guzzo C,Li S,Dooley LT,Griffiths CE;EXPRESS study investigators.Infliximab induction and maintenance therapy for moderate-to-severe psoriasis:a phase III,multicentre,double-blind trial.Lancet 2005;366:1367-1374[PMID:16226614 DOI:10.1016/S0140-6736(05)67566-6]
6 Targan SR,Hanauer SB,van Deventer SJ,Mayer L,Present DH,Braakman T,De Woody KL,Schaible TF,Rutgeerts PJ.A short-term study of chimeric monoclonal antibody c A2 to tumor necrosis factor alpha for Crohn’s disease.Crohn’s Disease c A2 Study Group.NEngl J Med 1997;337:1029-1035[PMID:9321530 DOI:10.1056/NEJM199710093371502]
7 Sands BE,Blank MA,Patel K,van Deventer SJ.Long-term treatment of rectovaginal fistulas in Crohn’s disease:response to infliximab in the ACCENT II Study.Clin Gastroenterol Hepatol 2004;2:912-920[PMID:15476155]
8 Present DH,Rutgeerts P,Targan S,Hanauer SB,Mayer L,van Hogezand RA,Podolsky DK,Sands BE,Braakman T,De Woody KL,Schaible TF,van Deventer SJ.Infliximab for the treatment of fistulas in patients with Crohn’s disease.N Engl J Med 1999;340:1398-1405[PMID:10228190 DOI:10.1056/NEJM199905063401804]
9 Cheifetz A,Smedley M,Martin S,Reiter M,Leone G,Mayer L,Plevy S.The incidence and management of infusion reactions to infliximab:a large center experience.Am J Gastroenterol 2003;98:1315-1324[PMID:12818276 DOI:10.1111/j.1572-0241.2003.07457.x]
10 Buch MH,Bryer D,Lindsay S,Rees-Evans B,Fairclough A,Emery P.Shortening infusion times for infliximab administration.Rheumatology(Oxford)2006;45:485-486[PMID:16352636 DOI:10.1093/rheumatology/kei273]
11 Breynaert C,Ferrante M,Fidder H,Van Steen K,Noman M,Ballet V,Vermeire S,Rutgeerts P,Van Assche G.Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases:a single-center cohort study.Am J Gastroenterol 2011;106:778-785[PMID:21407184 DOI:10.1038/ajg.2011.61]
12 Van Assche G,Vermeire S,Noman M,Amant C,Weyts E,Vleminckx A,Vermeyen MJ,Rutgeerts P.Infliximab administered with shortened infusion times in a specialized IBD infusion unit:a prospective cohort study.J Crohns Colitis 2010;4:329-333[PMID:21122522 DOI:10.1016/j.crohns.2009.12.012]
13 Babouri A,Roblin X,Filippi J,Hébuterne X,Bigard MA,PeyrinBiroulet L.Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases:a prospective multicenter cohort study.J Crohns Colitis 2014;8:161-165[PMID:23994253 DOI:10.1016/j.crohns.2013.08.004]
14 Principi M,Losurdo G,La Fortezza RF,Lopolito P,Lovero R,Grillo S,Bringiotti R,Ierardi E,Di Leo A.Does infliximab short infusion have a beneficial impact on the quality of life in patients with inflammatory bowel diseases?A single centre prospective evaluation.J Gastrointestin Liver Dis 2015;24:165-170[PMID:26114175 DOI:10.15403/jgld.2014.1121.242.tezz]
15 Cappello M,Mazza M,Costantino G,Privitera AC,Bossa F,Lauria A,Grossi L,Principi MB,Della Valle N,Almasio PL.Safety of infliximab(ifx)one-hour infusion in inflammatory bowel disease(IBD):a multicenter study from southern Italy.DLD 2015;47(S 2):e131
16 Marcellusi A,Viti R,Capone A,Mennini FS.Cost of illness probabilistic methodology to assess direct and indirect costs of HCV-related diseases in Italy.Pharmaco Econ Ital Res Artic 2014;16:23[DOI:10.1007/s40276-014-0023-9]
17 Rutgeerts P,Vermeire S,Van Assche G.Mucosal healing in inflammatory bowel disease:impossible ideal or therapeutic target?Gut 2007;56:453-455[PMID:17369375 DOI:10.1136/gut.2005.088732]
18 Rutgeerts P,Feagan BG,Lichtenstein GR,Mayer LF,Schreiber S,Colombel JF,Rachmilewitz D,Wolf DC,Olson A,Bao W,Hanauer SB.Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease.Gastroenterology 2004;126:402-413[PMID:14762776 DOI:10.1053/j.gastro.2003.11.014]
19 van Vollenhoven RF,Gullstr?m E,Klareskog L.Feasibility of 1 hour infliximab infusions.Ann Rheum Dis 2005;64:654[PMID:15769930DOI:10.1136/ard.2003.017590]
20 Neef HC,Riebschleger MP,Adler J.Meta-analysis:rapid infliximab infusions are safe.Aliment Pharmacol Ther 2013;38:365-376[PMID:23815183 DOI:10.1111/apt.12389]
21 Bhat S,Sharma D,Doherty P,Tham TC,Caddy GR.Are accelerated infliximab infusions safe in patients with inflammatory bowel disease?Inflamm Bowel Dis 2010;16:1922-1925[PMID:20848465 DOI:10.1002/ibd.21279]
22 Mc Connell J,Parvulescu-Codrea S,Behm B,Hill B,Dunkle E,Finke K,Snyder K,Tuskey A,Cox D,Woodward B.Accelerated infliximab infusions for inflammatory bowel disease improve effectiveness.World J Gastrointest Pharmacol Ther 2012;3:74-82[PMID:23515325 DOI:10.4292/wjgpt.v3.i5.74]
23 Kuin S,Stolte SB,van den Brink GR,Ponsioen CY,Fockens P,D’Haens GR,L?wenberg M.Short article:Remicade infusions at home:an alternative setting of infliximab therapy for patients with Crohn’s disease.Eur J Gastroenterol Hepatol 2016;28:222-225[PMID:26566062DOI:10.1097/MEG.0000000000000530]
24 Condino AA,Fidanza S,Hoffenberg EJ.A home infliximab infusion program.J Pediatr Gastroenterol Nutr 2005;40:67-69[PMID:15625429 DOI:10.1097/00005176-200501000-00012]