P629 Efficacy, safety and economic impact of the switch to biosimilar of infliximab in inflammatory bowel disease patients in clinical practice: results of one year

Glez, G.E. Rodríguez; Hernández, Laura Díaz; Barrios, Joaquin Alberto; González, M. Vela; Marín, C.A. Tardillo; Romero, María Micaela Viña; Díaz, Cristóbal Espinoza; Hernández, L; Camba, Alejandro Hernández; Alonso, Francisco Javier Merino; Hernández, Faustino Pérez

doi:10.1093/ecco-jcc/jjx002.753

Cited by 7 publications

(4 citation statements)

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“…Thirteen medical center-based cohort studies reported post-NMS treatment costs or medical services (Table 2). Specifically, these studies reported more NMS consultations and outpatient visits [17, 19–23], post-NMS visits or phone consultations for patients experiencing injection-site pain [24], post-NMS medication usage [17, 25, 26], post-NMS loss of response and emergency department visit [27], post-NMS surgery rate (11%) [28], post-NMS steroid use (13%) [28] and post-NMS biosimilar dose escalation (6–35.4%) [26, 29–32]. Nine reported patients discontinued the biosimilar and switched back to the originator [24, 27, 29, 31, 33–37].…”

Section: Post-nms Hru and Hru-related Costsmentioning

confidence: 99%

Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review

et al. 2019

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IntroductionA systematic literature review was conducted to review and summarize the economic impact of non-medical switching (NMS) from biologic originators to their biosimilars (i.e., switching a patient’s medication for reasons irrelevant to the patient’s health).MethodsEnglish publications reporting healthcare resource utilization (HRU) or costs associated with biosimilar NMS were searched in PubMed and EMBASE over the past 10 years and from selected scientific conferences over the past 3 years, along with gray literature for all biologics with an approved biosimilar (e.g., tumor-necrosis factor inhibitors, erythropoiesis-stimulating agents, insulin and hormone therapies).ResultsA total of 1311 publications were retrieved, where 54 studies met the selection criteria. Seventeen studies reported increased real-world HRU or costs related to biosimilar NMS, e.g., higher rates of surgery (11%), steroid use (13%) and biosimilar dose escalating (6–35.4%). Among the studies that the estimated cost impact associated with NMS, 33 reported drug costs reduction, 12 reported healthcare costs post-NMS without a detailed breakdown, and 5 reported NMS setup and managing costs. Cost estimation/simulation studies demonstrated the cost reduction associated with NMS. However, variation across studies was substantial because of heterogeneity in study designs and assumptions (e.g., disease areas, scenarios of drug price discount rates, cost components, population size, study period, etc.).ConclusionReal-world studies reporting the economic impact of biosimilar NMS separately from drug costs are emerging, and those that reported such results found increased HRU in patients with biosimilar NMS. Studies of cost estimation have been largely limited to drug prices. Comprehensive evaluation of the economic impact of NMS should incorporate all important elements of healthcare service needs such as drug price, biologic rebates, HRU, NMS program setup, administration and monitoring costs.FundingAbbVie.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-00998-3) contains supplementary material, which is available to authorized users.

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Section: Post-nms Hru and Hru-related Costsmentioning

confidence: 99%

Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review

et al. 2019

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“…Moreover, LOR may be addressed through dose escalation prior to discontinuation. For the studies that reported dose escalation, the rates ranged from 2.1% to 48.5% [8,39,45,51,54,56,[58][59][60][61][62]74]; however, dose reductions were also reported at a frequency of 8-21.5% [8,39,51,59]. In this study, switching and discontinuation rates for biologic originators by disease area were not captured.…”

Section: Discussionmentioning

confidence: 99%

The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review

Hillhouse¹,

Mathurin

Parison

et al. 2021

Adv Ther

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Introduction To save costs to the healthcare system, forced non-medical switch (NMS) policies that cut drug coverage for originator biologics and fund only less expensive biosimilars are being implemented. However, costs related to the impact of NMS on healthcare resource utilization (HCRU) must also be considered. This study aims to summarize the evidence on the economic impact of an originator-to-biosimilar NMS. Methods A systematic literature review (SLR) was conducted. Publications reporting on HCRU or costs associated with originator-to-biosimilar NMS in the real-world setting were searched in MEDLINE and EMBASE from January 2008 to February 2020. In addition to hand searching the reference lists of relevant publications and SLRs, key conference websites, PubMed, and various government sites were also searched for the 2 years preceding the search (2018–2020). Results A total of 1845 citations were identified, of which 49 were retained for data extraction. Most studies reporting on the HCRU associated with NMS reported on post-NMS HCRU alone without a comparison pre-NMS. However, four studies described a difference in HCRU (i.e., investigations pre- vs post-switch or between non-switchers vs switchers), all of which reported a relative increase in HCRU, including laboratory testing, imaging, medical visits, and hospitalizations, amongst patients who underwent an originator-to-biosimilar NMS. Most studies reporting on the costs associated with NMS reported significant savings following NMS on the basis of drug costs alone. However, four studies specifically reporting on the difference of costs following originator-to-biosimilar NMS all demonstrated an increase in HCRU-related costs associated with NMS (increase in HCRU-related costs of 4–37% or 148–2234 2020 Canadian dollars). Conclusion Amongst the studies that reported on the difference in HCRU pre- vs post-switch or between non-switchers and switchers, all showed an increase in HCRU and related costs associated with NMS, suggesting that the expected overall savings due to less costly drug prices may be reduced as a result of an increase in HCRU and its associated costs post-switch. Nevertheless, more real-world studies that include NMS-related healthcare costs in addition to drug costs are needed. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01951-z.

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“…Results demonstrated high variability in effectiveness, immunogenicity, and safety, with no studies utilizing an infliximab maintenance control arm. Loss of effectiveness for the combined IBD switch population was specifically highlighted in just 6 out of 23 studies, ranging from 4.2 to 25.0% [40,43,44,46,52,54,57]. Suk et al was the only study to clearly specify loss of response in the CD and UC switch populations, at 14% and 33%, respectively [58].…”

Section: Evidence From Observational Studies In Conference Abstractsmentioning

confidence: 99%

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

2020

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Background and Aims Biosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13. Methods A literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance. Results A total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects. Conclusions The majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.

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P629 Efficacy, safety and economic impact of the switch to biosimilar of infliximab in inflammatory bowel disease patients in clinical practice: results of one year

Cited by 7 publications

References 0 publications

Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review

Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review

The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

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