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

Abstract

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.

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…Furthermore, there was no clinically meaningful difference in the proportion of ADA-positive patients between groups; the proportion of neutralizing antibody-positive patients was also similar [34]. However, data regarding the economic impact and healthcare resource use of nonmedical switching are limited, as highlighted in a recent systematic literature review that identified few studies using real-world estimations and methodological shortcomings in others [161]. Any increase in direct financial or healthcare professional (HCP) time costs related to switching patients could present an obstacle to biosimilar uptake.…”

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“…33 Indeed, higher healthcare resource utilization and costs have been reported in studies of realworld switches from originator biologics to biosimilars. 27,34 In contrast to the previously mentioned studies showing negative effects associated with switching, other, non-US studies have demonstrated well-tolerated switching to IFX biosimilars and limited effects on long-term clinical outcomes. [35][36][37] Given the diverse evidence regarding biologic treatment switching in the literature, further research is warranted to examine the reasons for treatment switching and discontinuations using real-world data.…”

A health economic guide to market access of biosimilars

“…when a patient is switched from a reference biologic to its biosimilar, is switched back, or is switched between biosimilars out of an, for example, economic rationale [40]. Whether non-medical switching from reference biologics to biosimilars is associated with costs is not (yet) clear: a recent systematic literature review found limited evidence on this topic and pointed to methodological limitations of existing studies [41]. Nevertheless, NHS Scotland, for example, recommends to implement 'invest to save' arrangements to pay for managed switching programs now with a view to generate savings from biosimilar competition later [42].…”