Patients’ beliefs and behaviours are associated with perceptions of safety and concerns in a hypothetical biosimilar switch

Gasteiger, Chiara; Lobo, Maria; Dalbeth, Nicola; Petrie, Keith J.

doi:10.1007/s00296-020-04576-7

Cited by 28 publications

(26 citation statements)

References 39 publications

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“…Despite this, the use of biosimilars, the costsavings achieved and their market share vary considerably between biosimilar drugs, therapeutic areas, countries and even within the same country [6,12,13]. Those differences can be linked to an overall lack of biosimilar familiarity worldwide accompanied by concerns about biosimilars efficacy, safety, immunogenicity, extrapolation, switching and interchangeability [8,[14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Health technology assessment of biosimilars worldwide: a scoping review

Ascef

Lopes

Soárez

2020

Health Res Policy Sys

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Background: Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices. Main body: A scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed. Conclusion: HTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.

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Section: Introductionmentioning

confidence: 99%

Health technology assessment of biosimilars worldwide: a scoping review

Ascef

Lopes

Soárez

2020

Health Res Policy Sys

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“…It should be borne in mind that patients themselves look for information about biosimilars on the internet, potentially finding incorrect information. The purpose of providing information is to counter such negative reports as well [9,74,75]. Therefore, publicly available information or educational material about biosimilars for patients should address the general definitions of biological and biosimilar medicines in an understandable way.…”

Section: Information Needs Of Patients About Biosimilar Medicinesmentioning

confidence: 99%

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations

et al. 2021

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Biosimilar medicines support the sustainability of national healthcare systems, by reducing costs of biological therapies through increased competition. However, their adoption into clinical practice largely depends on the acceptance of healthcare providers and patients. Patients are different from health care professionals (HCPs), who are informing themselves professionally. For patients, the biosimilar debate only becomes actual when they are confronted with disease and drug choices. This paper provides a literature review on how patients are and should be informed about biosimilars, searching in scientific databases (i.e., Medline, Embase). Several large surveys have shown a lack of knowledge and trust in biosimilars among European patients in recent years. This review identified five main strategies to inform patients about biosimilars: (1) provide understandable information, (2) in a positive and transparent way, (3) tailored to the individual’s needs, (4) with one voice, and (5) supported by audiovisual material. Moreover, the importance of a multistakeholder approach was underlined by describing the role of each stakeholder. Patients are a large and diffuse target group to be reached by educational programs. Therefore, patient associations have become increasingly important in correctly informing patients about biosimilar medicines. This has led to widespread biosimilar information for patients among European patient associations. Therefore, a web-based screening of European Patients’ Forum (EPF) and International Alliance of Patients’ Organizations (IAPO) member organizations on publicly available information about biosimilars was performed. We found that the level of detail, correctness, and the tone of the provided information varied. In conclusion, it is paramount to set up a close collaboration between all stakeholders to communicate, develop, and disseminate factual information about biosimilars for patients.

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“…However, despite the cost-saving potential of biosimilar drugs, there are still diverging perceptions regarding the efficacy, safety, and immunogenicity of these follow-on biologics [16][17][18]. Importantly, the switching and interchangeability between biologic and biosimilar drugs are still topics of great debate in the treatment of RA [16][17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis

et al. 2021

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Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2). Methods We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-part designs to evaluate the consequences of switching from reference biologics to biosimilar drugs (and vice-versa). Electronic searches will be performed through MEDLINE (via PubMed), EMBASE, LILACS, and CENTRAL (from inception to April 2021). Two independent reviewers will screen studies, extract data, and evaluate the risk of bias. The latter will be carried out considering specific domains from equivalence trials and switching studies. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20), and the co-primary outcome will be the Health Assessment Questionnaire—Disability Index (HAQ-DI). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of the evidence will be assessed based on the GRADE system. Discussion The present investigation proposes a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. Our results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic review registration PROSPERO CRD42019137152 and CRD42019137155

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Patients’ beliefs and behaviours are associated with perceptions of safety and concerns in a hypothetical biosimilar switch

Cited by 28 publications

References 39 publications

Health technology assessment of biosimilars worldwide: a scoping review

Health technology assessment of biosimilars worldwide: a scoping review

Informing Patients about Biosimilar Medicines: The Role of European Patient Associations

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis

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