Switching Between Epoetins: A Practice in Support of Biosimilar Use.
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ABSTRACT: Background
The acceptability of switching between reference drugs and their biosimilars is often disputed. It is unclear whether this concern is specific to the use of biosimilars or is relevant to the practice of switching between any biological drugs.Objective
The objective of this study was to quantify the occurrence of switching between different erythropoiesis-stimulating agents.Methods
A retrospective drug utilization study was conducted in the Umbria region (Italy). The study population included all residents who received their first epoetin prescription between 1 July 2011 and 31 December 2014. The Umbria drug prescription database and the regional archive of residents were used to gather information. Switching was defined as any transition between different epoetins (different substances and/or different products of the same substance) in a series of two prescriptions. The probability of switching was described in relationship to the duration of treatment in a survival analysis.Results
Overall, 3258 subjects received prescriptions of epoetins. Among the 2896 patients with at least two prescriptions, 354 (12.2%) experienced one or more switches. The probability of switching depended on the duration of treatment: approximately 15% of users switched within 12 months of observation and 25% switched within 2 years. Switching was not limited to reference and biosimilar epoetins and it affected patent and off-patent epoetins equally.Conclusions
Switching between different epoetins was related to the duration of use and most episodes of switching involved epoetins that have never been contrasted in a comparability exercise. The present level of switching may provide reassurance to physicians when taken together with other sources of comparative evidence.
SUBMITTER: D'Amore C
PROVIDER: S-EPMC4746226 | biostudies-literature | 2016 Feb
REPOSITORIES: biostudies-literature
Publications
Switching Between Epoetins: A Practice in Support of Biosimilar Use.
D'Amore Carmen C Da Cas Roberto R Rossi Mariangela M Traversa Giuseppe G
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20160201 1
<h4>Background</h4>The acceptability of switching between reference drugs and their biosimilars is often disputed. It is unclear whether this concern is specific to the use of biosimilars or is relevant to the practice of switching between any biological drugs.<h4>Objective</h4>The objective of this study was to quantify the occurrence of switching between different erythropoiesis-stimulating agents.<h4>Methods</h4>A retrospective drug utilization study was conducted in the Umbria region (Italy) ...[more]
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Project description:Background: By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems and patients. In Belgium, biosimilar uptake and competition is limited compared to other European markets. Whereas other countries have initiated structured biosimilar introduction or switching plans, no such framework or guiding principles are yet available in Belgium. Objective: This study aims to develop recommendations that can inform policy action in Belgium on biosimilar use, especially in the context of switch decision-making, and this by drawing from the perspectives of healthcare professionals involved in procuring, prescribing, switching and dispensing biologicals including biosimilars. Methods: This study made use of the consensus-building Nominal Group Technique, consisting of a three-step process 1) individual grading, 2) three structured Focus Group Discussions, 3) final individual grading involving an expert group of Belgian healthcare professionals (physician specialists and hospital pharmacists). Results: Participants (n = 13) voiced challenges with the use of biosimilars and switching in practice, and a lack of incentives to use them. Six concrete areas for policy development to support stakeholders with biosimilar use and switch decision-making were identified: 1) address stakeholder hesitations regarding (multiple) switching, 2) provide meaningful incentives, 3) guide healthcare professionals with product decision-making, 4), align practical product modalities when possible, 5) involve healthcare professionals in policy making, and 6) provide practical switch support and patient information material, particularly in the ambulatory care setting. For each area, specific consensus-based recommendations were developed. Furthermore, a set of switch management and patient communication principles was derived, including amongst others, generating buy-in from involved stakeholders prior to switching and communicating with a one-voice message. Conclusion: Without cohesive actions to reduce hurdles and without tangible benefits or steering mechanisms, changes in biosimilar use are unlikely in Belgium. To overcome this and stimulate market competitiveness, this study advances a set of concrete policy recommendations. At large, policy makers should develop an integrated policy framework, with a pro-active, best-value biological implementation roadmap that provides guidance and compelling measures to incentivize healthcare professionals to use biosimilars. Particular consideration should go to the ambulatory care setting, since drivers for biosimilar use are quasi absent in this context.
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Project description:Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.
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Project description:ImportanceBiosimilars, or highly similar versions of complex biologic drugs, have the potential to slow drug spending growth; however, biosimilar uptake in the United States has been slow. Little is known about barriers to biosimilar uptake following drug launch.ObjectiveTo examine the patient, physician, and practice characteristics associated with biosimilar use in the Medicare population.Design, setting, and participantsThis cross-sectional study used regression analysis to estimate the association between biosimilar use and various characteristics. Medicare fee-for-service beneficiaries who received a filgrastim product or an infliximab product between the launch of a class's first biosimilar (quarter 3 2015 for filgrastim-sndz and quarter 4 2016 for infliximab-dyyb) and December 2018. Data analysis was conducted from March to November 2020.ExposuresPatient demographic characteristics and product clinical indications; physician demographic characteristics, specialty, and volume of filgrastim or infliximab biologic administration; hospital size, ownership, 340B status, academic medical center status, and system affiliation; physician office size and multispecialty status.Main outcomes and measuresAdministration of a filgrastim or infliximab biosimilar.ResultsThe final filgrastim sample included 25 870 patients (11 857 [45.8%] men; 14 224 [55.0%] aged 65-74 years; 22 617 [87.4%] White individuals) who had 259 178 administrations (79 017 [30.5%] biosimilar administrations), and the final infliximab sample included 14 786 patients (4765 [32.2%] men; 8773 [59.3%] aged 65-74 years; 13 467 [91.1%] White individuals) who had 174 973 administrations (9012 [5.2%] biosimilar administrations). In adjusted analyses, no patient demographic characteristics and 2 of 9 clinical indications (22.2%) were associated with biosimilar use (filgrastim, neutropenia: adjusted difference, -2.0 [95% CI, -3.9 to -0.2] percentage points; P = .03; infliximab, Crohn disease: adjusted difference, -1.8 [95% CI, -2.9 to -0.8] percentage points; P = .001). Several physician characteristics were associated with biosimilar administrations, including high filgrastim or infliximab prescribing volume (high vs low volume, filgrastim: adjusted difference, 3.6 [95% CI, 1.5 to 5.8] percentage points; P = .001; infliximab: adjusted difference, 1.2 [95% CI, 0.3 to 2.2] percentage points; P = .007) and specialty (eg, hematologist-oncologists vs primary care, filgrastim: adjusted difference, -3.0 [95% CI, -5.4 to -0.5] percentage points; P = .02). Numerous practice characteristics were associated with biosimilar use, including practice setting (outpatient hospital department vs office practice, filgrastim: adjusted difference, -16.1 [95% CI, -18.1 to -14.1] percentage points; P < .001; infliximab: adjusted difference, 3.0 [95% CI, 2.2 to 3.7] percentage points; P < .001) and hospital outpatient department ownership status (for-profit vs not-for-profit, filgrastim: adjusted difference, -17.4 [95% CI, -21.6 to -13.3] percentage points; P < .001; infliximab: adjusted difference, 10.8 [95% CI, 6.7 to 14.9] percentage points; P < .001).Conclusions and relevanceIn this study, practice setting and hospital ownership status had the largest associations with biosimilar usage, suggesting practices play a role in steering physicians toward certain medications. However, the types of practices with high biosimilar use differed by drug class. Further research is needed to understand the reasons for these differences across drug classes.
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Project description:BackgroundBiosimilar versions of widely prescribed drugs, including the tumour-necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non-inferior to a reference product after multiple switches between products.AimsTo investigate the evidence evaluating the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.MethodsPublished studies presenting data on switching between reference and biosimilar infliximab were identified by searching the MEDLINE database. Congress abstracts were identified by searching the EMBASE database and manually searching abstracts from relevant congresses.ResultsA total of 113 journal articles and 149 abstracts were found. Of these, 70 were considered relevant and included in this analysis. Most of the publications were uncontrolled, observational studies. Data from six randomised, controlled trials were identified. In general, the evidence revealed no clinically important efficacy or safety signals associated with switching.ConclusionsWhile available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.
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Project description:BACKGROUND:Despite the benefits biosimilars offer in terms of cost savings and patient access, healthcare professionals and patients have been reluctant to use them. Next to insufficient understanding of and trust in biosimilars, healthcare professionals and patients have questions about switching and the nocebo effect when using biosimilars in clinical practice. In addition, clear motivation to use biosimilars may be lacking among these stakeholders. OBJECTIVE:This study aims to provide recommendations on how to improve biosimilar use on both a clinical and a practical level based on insights from healthcare professionals (physicians, hospital pharmacists, nurses), patients (or their representatives), and regulators across Europe. METHODS:We conducted 44 semi-structured interviews with experts from five stakeholder groups across Europe: physicians, hospital pharmacists, nurses, regulators, and patients/representatives. Interviews were transcribed ad verbatim and transcripts analysed according to the thematic framework method. RESULTS:Based on the insights and considerations of the experts interviewed, we identified a number of recommendations to improve the use of biosimilars in clinical practice. Regarding switch implementation, the experts voiced support for the following actions: (1) disseminate evidence from and experience with (multiple) switching; (2) provide clear, one-voice regulatory guidance about the interchangeability of biosimilars and their reference product; (3) apply a multi-stakeholder implementation and communication protocol to guide switching in clinical practice; (4) apply a pragmatic approach when taking switch decisions; and (5) avoid mandated switching, allowing stakeholder communication and alignment. When discussing approaches to increase the willingness of stakeholders to use biosimilars, we concluded that actions should be centred on (1) communicating the benefits provided by biosimilars and the introduction of market competition, (2) increasing awareness among stakeholders about medicine prices and their societal responsibility to use medicines in a cost-effective manner, (3) transparent reporting about the allocation of savings, (4) sharing biosimilar usage data among hospitals and prescribers to allow peer-to-peer benchmarking, and (5) applying a balanced combination of tangible and non-tangible incentives that can be tailored to offset the time and effort expended by stakeholders when switching to a biosimilar. CONCLUSIONS:This study proposes a number of strategic, practical, and overarching recommendations to support healthcare professionals and inform decision makers to improve the clinical use of biosimilars and the willingness of stakeholders to use them. The proposed solutions to fully realise the potential of biosimilars for healthcare systems and patients include developing practical switch guidance, being transparent about the gains from biosimilar use (and how savings are allocated), and developing a combination of non-tangible and tangible incentives for involved stakeholders.
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Project description:BackgroundBiological therapy has revolutionized the treatment of inflammatory bowel disease (IBD). After the expiration of patents for biological innovator products, development of biosimilars increased. CT-P13 was the first biosimilar approved for the same indications as the reference product; however, the approval was based on extrapolated data from rheumatoid arthritis and ankylosing spondylitis. Our aim was to review clinical studies about switching from originator infliximab (IFX-O) to biosimilar infliximab (IXF-B) in IBD, focusing on recently published data and the future of biosimilars.MethodsThe PubMed database was searched for original articles published up to 1 December 2018 reporting data on IFX-B in IBD.ResultsA total of 29 studies assessing switching from IFX-O to IFX-B, 14 assessing induction therapy with IFX-B were found. Efficacy, safety and immunogenicity were discussed. Studies confirm that CT-P13 is safe and equally efficient as the reference product for both induction and maintenance therapy; and that switching from the reference product to biosimilar is non-inferior to continuous biosimilar use. However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking.ConclusionSwitching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.
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