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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:IntroductionIn healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.Method and analysisThis protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted.Ethics and disseminationThis scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

Project description:BackgroundPrivacy has always been a concern, especially in the health domain. The proliferation of mobile health (mHealth) apps has led to a large amount of sensitive data being generated. Some authors have performed privacy assessments of mHealth apps. They have evaluated diverse privacy components; however, different authors have used different criteria for their assessments.ObjectiveThis scoping review aims to understand how privacy is assessed for mHealth apps, focusing on the components, scales, criteria, and scoring methods used. A simple taxonomy to categorize the privacy assessments of mHealth apps based on component evaluation is also proposed.MethodsWe followed the methodology defined by Arksey and O'Malley to conduct a scoping review. Included studies were categorized based on the privacy component, which was assessed using the proposed taxonomy.ResultsThe database searches retrieved a total of 710 citations-24 of them met the defined selection criteria, and data were extracted from them. Even though the inclusion criteria considered articles published since 2009, all the studies that were ultimately included were published from 2014 onward. Although 12 papers out of 24 (50%) analyzed only privacy, 8 (33%) analyzed both privacy and security. Moreover, 4 papers (17%) analyzed full apps, with privacy being just part of the assessment. The evaluation criteria used by authors were heterogeneous and were based on their experience, the literature, and/or existing legal frameworks. Regarding the set of items used for the assessments, each article defined a different one. Items included app permissions, analysis of the destination, analysis of the content of communications, study of the privacy policy, use of remote storage, and existence of a password to access the app, among many others. Most of the included studies provided a scoring method that enables the comparison of privacy among apps.ConclusionsThe privacy assessment of mHealth apps is a complex task, as the criteria used by different authors for their evaluations are very heterogeneous. Although some studies about privacy assessment have been conducted, a very large set of items to evaluate privacy has been used up until now. In-app information and privacy policies are primarily utilized by the scientific community to extract privacy information from mHealth apps. The creation of a scale based on more objective criteria is a desirable step forward for privacy assessment in the future.

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.

Project description:BACKGROUND:Mental health issues among farmers are identified population health concerns. While one systematic review focused on suicide in farming populations in the United States, there have been no scoping studies examining mental health in farming communities worldwide. The objectives of this scoping review were to: provide a descriptive analysis of the literature pertaining to mental health outcomes in farming populations; describe the international scope of the research; and highlight published mental health services and interventions that have been evaluated. METHODS:Following Arksey and O'Malley's scoping review framework, five major health and science platforms were used to identify studies examining mental health outcomes in farming populations, worldwide. Studies that met a priori inclusion criteria that were published prior to December 31, 2017 were included in this review. Data synthesis and descriptive statistics were conducted using STATA 15® software; proportions were calculated by country. RESULTS:The initial literature search yielded 9,906 records. After title and abstract screening, 676 articles were reviewed in-full. Of these, 341 met a priori inclusion criteria. Studies included were conducted between 1979 and 2017; the majority (265; 77.7%) were published between 2002-2017. The most frequently measured outcomes were stress (41.9%), suicide (33.1%), and depression (32.6%). Over 70% of studies that examined stress described using quantitative research methods, most predominantly, cross-sectional designs (42.7%). Approximately 64% of studies that measured suicide reported using a quantitative approach; the largest proportion of included suicide studies (33.6%) described using cohort designs. Approximately 84% of studies that measured depression described using quantitative approaches; sixty percent of these studies reported using a cross-sectional study design. Twenty included studies described a mental health service or intervention (5.9%). CONCLUSIONS:This scoping review provides a critical overview of the literature examining mental health outcomes in farming populations worldwide. Given the importance of farming and agriculture, this review can be used to ensure future research complements existing work, avoids unnecessary overlap, and begins to tackle the less-studied mental health outcomes amongst farmers. These results can guide researchers to identified gaps in research and services, leading to a more informed approach to future work, and ultimately, a more comprehensive understanding of mental health among farmers worldwide.

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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