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European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.

ABSTRACT: BACKGROUND:Despite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching. OBJECTIVE:This study aims to provide recommendations on how to improve biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe. METHOD:The study consists of a structured literature review gathering original research data on stakeholder knowledge about biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe. RESULTS:Although improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards biosimilars among healthcare professionals and patients are identified in literature (N studies = 106). Based on the provided insights from interviews with European experts (N = 44), a number of challenges regarding biosimilar stakeholder understanding are identified, including a lack of practical information about biosimilars and their use, a lack of understanding about biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical biosimilar (switch) data, (5) share biosimilar experiences by key opinion leaders and among peers, (6) provide practical biosimilar product information, (7) provide guidance about biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards. CONCLUSIONS:This study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by biosimilar competition.

SUBMITTER: Barbier L

PROVIDER: S-EPMC7669769 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.

Barbier Liese L Simoens Steven S Vulto Arnold G AG Huys Isabelle I

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20201201 6

<h4>Background</h4>Despite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as swi ...[more]

PMID: 33141421

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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.

Project description:Background: Anticholinergic burden (ACB), is defined as the cumulative effect of anticholinergic medication which are widely prescribed to older adults despite increasing ACB being associated with adverse effects such as: falls, dementia and increased mortality. This research explores the views of health care professionals (HCPs) and patients on a planned trial to reduce ACB by stopping or switching anticholinergic medications. The objectives were to explore the views of key stakeholders (patients, the public, and HCPs) regarding the potential acceptability, design and conduct of an ACB reduction trial. Materials and Methods: We conducted qualitative interviews and focus groups with 25 HCPs involved in prescribing medication with anticholinergic properties and with 22 members of the public and patients who were prescribed with the medication. Topic guides for the interviews and focus groups explored aspects of feasibility including: 1) views of a trial of de-prescribing/medication switching; 2) how to best communicate information about such a trial; 3) views on who would be best placed and preferred to undertake such medication changes, e.g., pharmacists or General Practitioners (GPs)? 4) perceived barriers and facilitators to trial participation and the smooth conduct of such a trial; 5) HCP views on the future implementability of this approach to reducing ACB and 6) patients' willingness to be contacted for participation in a future trial. Qualitative data analysis was underpinned by Normalization Process Theory. Results: The public, patients and HCPs were supportive of an ACB reduction trial. There was consensus among the different groups that key points to consider with such a trial included: 1) ensuring patient engagement throughout to enable concerns/potential pitfalls to be addressed from the beginning; 2) ensuring clear communication to minimise potential misconceptions about the reasons for ACB reduction; and 3) provision of access to a point of contact for patients throughout the life of a trial to address concerns; The HCPs in particular suggested two more key points: 4) minimise the workload implications of any trial; and 5) pharmacists may be best placed to carry out ACB reviews, though overall responsibility for patient medication should remain with GPs. Conclusion: Patients, the public and HCPs are supportive of trials to reduce ACB. Good communication and patient engagement during design and delivery of a trial are essential as well as safety netting and minimising workload.

Project description:BACKGROUND:There are various complex reasons that influence sustainable adoption of innovations in health care systems. Low adoption can be caused by a lack of support from one or more stakeholders because their needs and expectations are not always considered or aligned. OBJECTIVE:This study aimed to identify stakeholders' perceptions of barriers and facilitators toward the sustainable adoption of digital health innovations. METHODS:A stakeholder workshop was attended by 12 participants with a range of backgrounds on August 25, 2017, including people representing the views from patients, carers, local hospitals, pharmacy retailers, health insurers, health services researchers, engineers, and technology and pharmaceutical companies in Switzerland. On the basis of adoption of innovation frameworks, we asked participants to interview each other about 3 factors influencing the adoption of digitally delivered health interventions: (1) Facilitators and barriers in the external system, (2) Needs and expectations of stakeholders, and (3) Safety, quality, and usability of innovations. The worksheets and videos generated from the workshop were qualitatively analyzed and summarized. RESULTS:Facilitators for adoption mentioned were high levels of income and education, and digital health is a high priority to stakeholders. Main common interests of different stakeholders were patient satisfaction and job protection. Health care spending was a misaligned interest: although some stakeholders were keen on spending more to obtain or provide the highest quality of care, others were focused on reducing health care spending to provide cost-effective services. Switzerland's diversity and complexity, in terms of its organization with 26 cantons (administrative divisions), were barriers as these made it harder to ensure interoperability of interventions. A culture of innovation was considered a push factor, but adoption was inhibited by persistent paper-based systems, a fear of change, and unwillingness to share data. The sustainability of interventions can be promoted by making them patient-centered, meaning that patients should be involved throughout their development. CONCLUSIONS:Promoting sustainable adoption of digital health remains challenging despite various push factors being in place. Barriers related to fragmentation, patient-centeredness, data security, privacy, trust, and job security need to be addressed. A strength is that people from a wide range of backgrounds attended the workshop. A limitation is that the findings are focused on the macro level. In-depth case studies of specific issues need to be conducted in different settings.

Project description:ObjectiveTo understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients' willingness to try a biosimilar.MethodsAn international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups. Interviews were conducted in adults categorized as: 1) diagnosed: patients with inflammatory bowel disease including Crohn's disease and ulcerative colitis, rheumatoid arthritis, psoriasis, breast cancer, lung cancer, colorectal cancer, or non-Hodgkin's lymphoma; 2) diagnosed advocacy: individuals with these diseases who participated in patient support groups; 3) caregiver: has a loved one with these conditions and is involved in medical decisions; 4) general population: aged 18-64 years, without these conditions. Statistical analyses among groups within a region (US or EU) used column proportions test with a 95% confidence interval.ResultsIn all, 3,198 individuals responded. Awareness about biologic therapies was significantly higher in diagnosed, diagnosed advocacy, and caregiver groups (45%-78%) versus general population (27%; P<0.05). Across all groups, awareness of biosimilars was low; only 6% of the general population reported at least a general impression of biosimilars. Awareness was significantly higher in the diagnosed advocacy group (20%-30%; P<0.05). Gaps in knowledge about biosimilars included safety, efficacy, and access to these agents. Respondents had generally positive perceptions of clinical trials, although barriers to participation were identified.ConclusionAn immediate need exists for patient education about biosimilars and clinical trials to ensure educated and informed decisions are made about biosimilar use.

Dataset Information

European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.

Publications

European Stakeholder Learnings Regarding Biosimilars: Part I-Improving Biosimilar Understanding and Adoption.

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