A Novel Approach to the Implementation of Biosimilar Infliximab CT-P13 for the Treatment of IBD Utilising Therapeutic Drug Monitoring: The Edinburgh Experience

Plevris, Nikolas; Deekae, A.; Jones, Gareth; Manship, Thomas; Noble, Colin; Satsangi, Jack; Shand, Alan G.; Arnott, Ian; Lees, Charlie W.

doi:10.1016/s0016-5085(17)31528-7

Cited by 3 publications

(1 citation statement)

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“…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]. In addition, semi-structured one-on-one interviews among staff members involved in an NMS of the originator etanercept to its biosimilar at four rheumatology centers in the UK reported that providers spent 320–1076 additional hours on the NMS process for 149–180 patients per center [38].…”

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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Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies

Numan

Faccin

2018

Adv Ther

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Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical switching remain largely unknown, as much of the evidence comes from poorly or uncontrolled real-world evidence (RWE) studies that often have an element of bias and nonstandardized outcome measures. To appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its biosimilar, we propose that seven key study design elements should be considered when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes. This systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF inhibitors. A comprehensive literature search (January 2012–February 2018) identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 RWE studies) describing non-medical switching from a TNF inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Furthermore, discontinuation rates varied widely among studies (0–87%), suggesting heterogeneity and inconclusiveness of the current efficacy, safety, and immunogenicity evidence, particularly at an individual patient level. Therefore, patients should not be indiscriminately switched from an originator TNF inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence.Funding: AbbVie.Plain Language Summary: Plain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0742-9) contains supplementary material, which is available to authorized users.

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CT-P13: a review on a biosimilar to infliximab in the treatment of inflammatory bowel disease

Albshesh

Ben‐Horin

2019

Expert Opinion on Biological Therapy

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A Novel Approach to the Implementation of Biosimilar Infliximab CT-P13 for the Treatment of IBD Utilising Therapeutic Drug Monitoring: The Edinburgh Experience

Cited by 3 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

Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies

CT-P13: a review on a biosimilar to infliximab in the treatment of inflammatory bowel disease

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