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Health technology assessment of biosimilars worldwide: a scoping review.

ABSTRACT: 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.

SUBMITTER: Ascef BO

PROVIDER: S-EPMC7448328 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Health technology assessment of biosimilars worldwide: a scoping review.

Ascef Bruna de Oliveira BO Lopes Ana Carolina de Freitas ACF de Soárez Patrícia Coelho PC

Health research policy and systems 20200826 1

<h4>Background</h4>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 e ...[more]

PMID: 32843051

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Project description:BackgroundMitochondrial diseases are a large group of genetically heterogeneous and clinically diverse disorders. Diagnosis often takes many years for which treatment may not exist. Registries are often used to conduct research, establish natural disease progression, engage the patient community, and develop best disease management practices. In Canada, there are limited centralized registries for mitochondrial disease patients, presenting a challenge for patients and professionals.ObjectiveTo support the creation of such a registry, a systematic scoping review was conducted to map the landscape of mitochondrial disease patient registries worldwide, with a focus on registry design and challenges. Furthermore, it addresses a knowledge gap by providing a narrative synthesis of published literature that describes these registries.MethodsArksey and O'Malley's methodological framework was followed to systematically search English-language literature in PubMed and CINAHL describing the designs of mitochondrial disease patient registries, supplemented by a grey literature search. Data were extracted in Microsoft Excel. Stakeholder consultations were also performed with patient caregivers, advocates, and researchers to provide perspectives beyond those found in the literature. These data were thematically analyzed and were reported in accordance with the PRISMA-ScR reporting guidelines.ResultsA total of 17 articles were identified describing 13 unique registries located in North America, Europe, Australia, and West Asia. These papers described the registries' designs, their strengths, and weaknesses, as well as their tangible outcomes such as facilitating recruitment for research and supporting epidemiological studies.ConclusionBased on our findings in this review, recommendations were formulated. These include establishing registry objectives, respecting patients and their roles in the registry, adopting international data standards, data evaluations, and considerations to privacy legislation, among others. These recommendations could be used to support designing a future Canadian mitochondrial disease patient registry, and to further research directly engaging these registries worldwide.

Project description:BACKGROUND:Addiction is one of the most rapidly growing epidemics that currently plagues nations around the world. In the United States, it has cost the government more than US $700 billion a year in terms of health care and other associated costs and is also associated with serious social, physical, and mental consequences. Increasing efforts have been made to tackle this issue at different levels, from primary prevention to rehabilitation across the globe. With the use of digital technology rapidly increasing, an effort to leverage the consumer health information technologies (CHITs) to combat the rising substance abuse epidemic has been underway. CHITs are identified as patient-focused technological platforms aimed to improve patient engagement in health care and aid them in navigating the complex health care system. OBJECTIVE:This review aimed to provide a holistic and overarching view of the breadth of research on primary prevention of substance abuse using CHIT conducted over nearly past five decades. It also aimed to map out the changing landscape of CHIT over this period. METHODS:We conducted a scoping review using the Arksey and O'Malley's modified methodological framework. We searched 4 electronic databases (PubMed, Cochrane, Scopus, and EMBASE). Papers were included if the studies addressed the use of CHIT for primary prevention of substance abuse and were published in English between 1809 and 2018. Studies that did not focus solely on primary prevention or assessed additional comorbid conditions were eliminated. RESULTS:Forty-two papers that met our inclusion criteria were included in the review. These studies were published between 1970 and 2018 and were not restricted by geography, age, race, or sex. The review mapped studies using the most commonly used CHIT platforms for substance abuse prevention from mass media in the 1970s to mobile and social media in 2018. Moreover, 191 studies that were exclusively focused on alcohol prevention were excluded and will be addressed in a separate paper. The studies included had diverse research designs although the majority were randomized controlled trials (RCT) or review papers. Many of the RCTs used interventions based on different behavioral theories such as family interactions, social cognitive theories, and harm-minimization framework. CONCLUSIONS:This review found CHIT platforms to be efficacious and cost-effective in the real-world settings. We also observed a gradual shift in the types and use of CHIT platforms over the past few decades and mapped out their progression. In addition, the review detected a shift in consumer preferences and behaviors from face-to-face interactions to technology-based platforms. However, the studies included in this review only focused on the aspect of primary prevention. Future reviews could assess the effectiveness of platforms for secondary prevention and for prevention of substance abuse among comorbid populations.

Dataset Information

Health technology assessment of biosimilars worldwide: a scoping review.

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Health technology assessment of biosimilars worldwide: a scoping review.

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