How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009–2014

Marcianò, Ilaria; Ingrasciotta, Ylenia; Giorgianni, Francesco; Bolcato, Jenny; Chinellato, Alessandro; Pirolo, Roberta; Giorgio, Annalisa Di; Manna, Sonia; Ientile, Valentina; Gini, Rosa; Santarpía, Mariacarmela; Genazzani, Armando A.; Uomo, Ilaria; Pastorello, Maurizio; Addario, Sebastiano Walter Pollina; Scondotto, Salvatore; Cananzi, Pasquale; Da, Roberto; Traversa, Giuseppe; Rossi, Mariangela; Sottosanti, Laura; Caputi, Achille P.; Trifirò, Gianluca

doi:10.1007/s40259-016-0175-4

Cited by 30 publications

(37 citation statements)

References 8 publications

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“…While not the focus of the current review, changing from one originator biologic to another is relatively common in clinical practice, most likely because of inefficacy or intolerability issues with the initial treatment [112, 113]. It is important to note, however, that this scenario is very different from switching between an originator biologic and its biosimilar or between different biosimilars of the same biologic: for example, two originator biologics targeting a given molecule may bind different epitopes, whereas a biologic and its biosimilar or two biosimilars of the same biologic should bind the same epitope.…”

Section: Discussionmentioning

confidence: 99%

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

et al. 2018

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Background The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern.Objectives The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps.Methods A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies.ResultsThe systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups.Conclusions There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.Electronic supplementary materialThe online version of this article (10.1007/s40259-017-0256-z) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

et al. 2018

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“…A recent drug-utilization study [20] found that filgrastim biosimilar use reached >60% in 2014 but varied widely between five Italian regions in which different policies were implemented between 2009 and 2014. Moreover, the study highlighted a switch rate of >20% between different G-CSFs during the first year of treatment, mainly across G-CSF originators (involving the filgrastim originator, lenograstim and pegfilgrastim).…”

Section: Discussionmentioning

confidence: 99%

Impact of Guidance on the Prescription Patterns of G-CSFs for the Prevention of Febrile Neutropenia Following Anticancer Chemotherapy: A Population-Based Utilization Study in the Lazio Region

Trotta¹,

Mayer²,

Mecozzi

et al. 2017

BioDrugs

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BackgroundCurrent guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low.ObjectiveOur objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription.MethodsWe conducted an observational drug-utilization study in the Lazio region of Italy using the Electronic Therapeutic Plan Registry, which collects information on G-CSF prescriptions reimbursed by the regional health service. This registry includes information on demographics, tumour, indication for G-CSF use and previous G-CSF exposure. All therapeutic plans (TPs) registered from 1 July 2015 to 30 June 2016 were selected. A pharmaceutical policy intervention was implemented in November 2015. We evaluated temporal trends regarding G-CSF substances and compared the frequency of TPs for each G-CSF substance during the pre- and post-intervention periods.ResultsA total of 7082 TPs were eligible for the analysis, corresponding to 6592 patients. The frequency of TPs prescribed after the intervention indicated a significant increase in the use of a filgrastim biosimilar (% difference: 14.4; p < 0.001) and significant decreases in the use of lenograstim (% difference: –6.0; p < 0.001) and pegfilgrastim (% difference: –7.8; p < 0.001). The temporal trends analysis showed an increase in TPs using a filgrastim biosimilar (from 34.4% in July 2015 to 49.8% in June 2016; p < 0.0001) and a decrease in TPs using lenograstim and pegfilgrastim.ConclusionsThis study shows it is possible to change attitudes towards the prescription of less expensive G-CSFs in the FN setting when the prescriber’s decision-making processes are supported by evidence that includes both regulatory and clinical information and the analysis of clinical practice data.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-017-0214-9) contains supplementary material, which is available to authorized users.

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“…In Italy, several regional provisions related to biosimilars regulate biologic prescription and expenditure targets. For example, (1) in the Campania and Umbria regions, the main objective is to achieve a biosimilar utilization rate at least equal to the number of naïve patients, whereas in the Veneto region, the dispensed packages of biosimilars must constitute at least 60% of all dispensed packages of G-CSF, EPO, or hGH; (2) in Sicily, Veneto, Campania, and Tuscany, drug-naïve patients must be treated with cheaper biosimilars, and when patients are switched, the lower cost medicine should be chosen; any deviations from these rules should be justified by the prescriber [57][58][59][60]. In Sweden, county councils set quotas and target budgets for hospitals, applicable to various therapeutic classes, including biosimilars.…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

“…Germany, Italy [58,59], and Belgium) or potential financial rewards for physicians who meet their targets (e.g. Italy [6], Sweden, some Spanish regions, and the UK [63,64]).…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

“…Various guidelines on biosimilars have been published by national regulatory authorities, regional authorities, or HTA bodies [e.g. the Federal Joint Committee (G-BA) in Germany; French Drug Agency (ANSM); AIFA, and the regional governments of Tuscany, Veneto, Campania, Umbria, and Sicily in Italy [58,59,67]; as well as NICE; and some county councils and the Drug Therapeutic Committee in the Stockholm region, Sweden [68,69]] and various scientific associations (e.g. the Belgian IBD Research & Development Group [70], French National Society of Gastroenterology [71], Spanish Society of Rheumatology [72], and British Society for Rheumatology [73]).…”

Section: Demand-side Policies For Biosimilarsmentioning

confidence: 99%

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Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

Rémuzat

Kapuśniak²,

Caban³

et al. 2016

Value in Health

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Objective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician's responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs. Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake. ARTICLE HISTORY

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How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009–2014

Cited by 30 publications

References 8 publications

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

Impact of Guidance on the Prescription Patterns of G-CSFs for the Prevention of Febrile Neutropenia Following Anticancer Chemotherapy: A Population-Based Utilization Study in the Lazio Region

Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

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