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  Subjects -> DISABILITY (Total: 103 journals)
Showing 1 - 200 of 310 Journals sorted alphabetically
Advances in Autism     Hybrid Journal   (Followers: 38)
Advances in Mental Health and Intellectual Disabilities     Hybrid Journal   (Followers: 85)
Advances in Mental Health and Learning Disabilities     Hybrid Journal   (Followers: 30)
Aequitas : Revue de Développement Humain, Handicap et Changement Social     Full-text available via subscription  
African Journal of Disability     Open Access   (Followers: 8)
Ageing & Society     Hybrid Journal   (Followers: 39)
American Annals of the Deaf     Full-text available via subscription   (Followers: 14)
American Journal of Speech-Language Pathology     Full-text available via subscription   (Followers: 54)
Aphasiology     Hybrid Journal   (Followers: 58)
Assistive Technology: The Official Journal of RESNA     Hybrid Journal   (Followers: 17)
Audiology Research     Open Access   (Followers: 9)
Augmentative and Alternative Communication     Hybrid Journal   (Followers: 46)
Autism     Hybrid Journal   (Followers: 157)
Autism & Developmental Language Impairments     Open Access   (Followers: 13)
Autism in Adulthood     Hybrid Journal   (Followers: 11)
Autism Research     Hybrid Journal   (Followers: 44)
Autism's Own     Open Access   (Followers: 11)
British Journal of Learning Disabilities     Hybrid Journal   (Followers: 102)
British Journal of Special Education     Hybrid Journal   (Followers: 43)
British Journal of Visual Impairment     Hybrid Journal   (Followers: 11)
Canadian Journal of Disability Studies     Open Access   (Followers: 35)
Deafness & Education International     Hybrid Journal   (Followers: 7)
Developmental Disabilities Research Reviews     Hybrid Journal   (Followers: 30)
Disability & Rehabilitation     Hybrid Journal   (Followers: 82)
Disability & Society     Hybrid Journal   (Followers: 84)
Disability and Health Journal     Hybrid Journal   (Followers: 18)
Disability and Rehabilitation: Assistive Technology     Hybrid Journal   (Followers: 43)
Disability Compliance for Higher Education     Hybrid Journal   (Followers: 8)
Disability Studies Quarterly     Open Access   (Followers: 38)
Disability, CBR & Inclusive Development     Open Access   (Followers: 17)
Distúrbios da Comunicação     Open Access  
Early Popular Visual Culture     Hybrid Journal   (Followers: 7)
European Review of Aging and Physical Activity     Open Access   (Followers: 10)
Health Expectations     Open Access   (Followers: 16)
Hearing, Balance and Communication     Hybrid Journal   (Followers: 6)
Intellectual Disability Australasia     Full-text available via subscription   (Followers: 12)
International Journal of Audiology     Hybrid Journal   (Followers: 19)
International Journal of Developmental Disabilities     Hybrid Journal   (Followers: 39)
International Journal of Language & Communication Disorders     Hybrid Journal   (Followers: 57)
International Journal of Orthopaedic and Trauma Nursing     Hybrid Journal   (Followers: 11)
International Journal of Technology Assessment in Health Care     Hybrid Journal   (Followers: 16)
Journal for Healthcare Quality     Hybrid Journal   (Followers: 28)
Journal of Accessibility and Design for All     Open Access   (Followers: 12)
Journal of Adult Protection, The     Hybrid Journal   (Followers: 16)
Journal of Aging and Health     Hybrid Journal   (Followers: 28)
Journal of Applied Research in Intellectual Disabilities     Hybrid Journal   (Followers: 53)
Journal of Assistive Technologies     Hybrid Journal   (Followers: 19)
Journal of Autism and Developmental Disorders     Hybrid Journal   (Followers: 82)
Journal of Deaf Studies and Deaf Education     Hybrid Journal   (Followers: 11)
Journal of Disability & Religion     Hybrid Journal   (Followers: 14)
Journal of Disability Policy Studies     Hybrid Journal   (Followers: 29)
Journal of Disability Studies in Education     Open Access  
Journal of Early Hearing Detection and Intervention     Open Access   (Followers: 7)
Journal of Elder Abuse & Neglect     Hybrid Journal   (Followers: 6)
Journal of Enabling Technologies     Hybrid Journal   (Followers: 10)
Journal of Gerontological Social Work     Hybrid Journal   (Followers: 14)
Journal of Integrated Care     Hybrid Journal   (Followers: 18)
Journal of Intellectual & Developmental Disability     Hybrid Journal   (Followers: 63)
Journal of Intellectual Disabilities     Hybrid Journal   (Followers: 40)
Journal of Intellectual Disabilities and Offending Behaviour     Hybrid Journal   (Followers: 56)
Journal of Intellectual Disability - Diagnosis and Treatment     Hybrid Journal   (Followers: 9)
Journal of Intellectual Disability Research     Hybrid Journal   (Followers: 67)
Journal of Learning Disabilities and Offending Behaviour     Hybrid Journal   (Followers: 29)
Journal of Occupational Therapy, Schools, & Early Intervention     Hybrid Journal   (Followers: 48)
Journal of Policy and Practice In Intellectual Disabilities     Hybrid Journal   (Followers: 26)
Journal of Science Education for Students with Disabilities     Open Access   (Followers: 3)
Journal of Social Work in Disability & Rehabilitation     Hybrid Journal   (Followers: 15)
Journal of Speech, Language, and Hearing Research     Full-text available via subscription   (Followers: 92)
Journal of Spinal Cord Medicine     Hybrid Journal   (Followers: 6)
Journal of Visual Impairment & Blindness     Hybrid Journal  
Learning Disabilities : A Multidisciplinary Journal     Full-text available via subscription   (Followers: 11)
Learning Disability Practice     Full-text available via subscription   (Followers: 22)
Mental Health Practice     Full-text available via subscription   (Followers: 21)
Music and Medicine     Hybrid Journal   (Followers: 2)
Physical & Occupational Therapy in Pediatrics     Hybrid Journal   (Followers: 67)
Physical Disabilities : Education and Related Services     Open Access   (Followers: 4)
Public Policy and Aging Report     Hybrid Journal   (Followers: 3)
Quality in Ageing and Older Adults     Hybrid Journal   (Followers: 44)
Research and Practice in Intellectual and Developmental Disabilities     Hybrid Journal   (Followers: 1)
Revista Espaço     Open Access  
Revista Española de Discapacidad     Open Access  
Revista Herediana de Rehabilitacion     Open Access   (Followers: 2)
Revue francophone de la déficience intellectuelle     Full-text available via subscription   (Followers: 1)
Scandinavian Journal of Disability Research     Open Access   (Followers: 26)
Sexuality and Disability     Hybrid Journal   (Followers: 16)
Siglo Cero. Revista Española sobre Discapacidad Intelectual     Open Access  
Sign Language Studies     Full-text available via subscription   (Followers: 3)
Society and Mental Health     Hybrid Journal   (Followers: 14)
Speech Communication     Hybrid Journal   (Followers: 17)
Stigma and Health     Full-text available via subscription   (Followers: 1)
Stress     Hybrid Journal   (Followers: 4)
Technology and Disability     Hybrid Journal   (Followers: 24)
Tizard Learning Disability Review     Hybrid Journal   (Followers: 49)
Topics in Language Disorders     Hybrid Journal   (Followers: 13)
Visual Cognition     Hybrid Journal   (Followers: 10)
Visual Communication     Hybrid Journal   (Followers: 10)
Visual Communication Quarterly     Hybrid Journal   (Followers: 7)
Visual Studies     Hybrid Journal   (Followers: 7)
Working with Older People     Hybrid Journal   (Followers: 40)

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International Journal of Technology Assessment in Health Care
Journal Prestige (SJR): 0.714
Citation Impact (citeScore): 1
Number of Followers: 16  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 0266-4623 - ISSN (Online) 1471-6348
Published by Cambridge University Press Homepage  [353 journals]
  • Consolidated health economic evaluation reporting standards 2022 (CHEERS
           2022) statement: updated reporting guidance for health economic
           evaluations

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      Authors: Husereau; Don, Drummond, Michael, Augustovski, Federico, de Bekker-Grob, Esther, Briggs, Andrew H., Carswell, Chris, Caulley, Lisa, Chaiyakunapruk, Nathorn, Greenberg, Dan, Loder, Elizabeth, Mauskopf, Josephine, Mullins, C. Daniel, Petrou, Stavros, Pwu, Raoh-Fang, Staniszewska, Sophie
      First page: 13
      Abstract: Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals, as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
      PubDate: 2022-01-11
      DOI: 10.1017/S0266462321001732
       
  • Building a model of health technology assessment cooperation: lessons
           learned from EUnetHTA joint action 3

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      Authors: Garrett; Zoe, Imaz-Iglesia, Iñaki, Willemsen, Anne
      First page: 14
      Abstract: ObjectiveThe European Network for Health Technology Assessment (EUnetHTA) was established in 2006. During its final project phase (joint action 3 [JA3]), it undertook an activity to define the scientific and technical principles of a model of health technology assessment (HTA) cooperation in Europe. This policy article presents the key learnings from JA3 partners about developing a model of HTA cooperation.MethodsThere were two phases to the activity: (i) A descriptive phase to describe the elements of HTA cooperation that were already in place in EUnetHTA JA3 and to identify which elements could be improved or were missing. (ii) An analytic phase synthesizing the data collected to identify learnings from the JA3 and to define the scientific and technical principles for a future model of HTA cooperation.ResultsLearnings for developing HTA cooperation were identified in regard to the framework used to support the cooperation, the HTA activities undertaken, the involvement of internal and external actors, managing decision making and the required human resources and support services needed to undertake HTA activities and to coordinate collaboration.ConclusionsThese learnings coming from the experiences of the EUnetHTA JA3 are useful to inform discussions on a European Union regulation for HTA cooperation as well as subsequent work to set up the structures that will be defined in the regulation. The findings also have broader applicability and are relevant to individuals, groups, and organizations setting up HTA programs or establishing their own international collaborations.
      PubDate: 2022-01-28
      DOI: 10.1017/S0266462321001719
       
  • Increasing the impact of budget impact analysis: incorporating uncertainty
           for decision-makers in small markets

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      Authors: Hofmeister; Mark, Clement, Fiona
      First page: 15
      Abstract: For decision-makers considering new medicines for reimbursement and public use, both value for money and affordability are important considerations. Whereas a cost-effectiveness model provides information about value for money, a budget impact assessment (BIA) is customized to a specific context and estimates the total investment needed; one part of affordability. Both analytic approaches have parameter uncertainty within them, yet comparatively little attention is given to parameter uncertainty in BIA. Currently, within BIA, uncertainty exploration is limited to point estimates for plausible scenarios, prompting the question: can a decision-maker be confident in point estimates' Within this paper, our intent is to revitalize the discussion of uncertainty in BIA. In the context of health technology assessments submitted to support reimbursement decision-making, we propose reliance on probabilistic sensitivity analysis conducted in the cost-effectiveness model. If assumptions made in a cost-effectiveness model are valid, probabilistic cost estimates from the model, with the same perspective adopted as the BIA, should also inform BIA. Mean and variance of population outcomes, given parameter uncertainty in model inputs, are estimable from model outputs. As sufficiently large random samples are drawn from a population, the distribution of sample means will follow an approximately normal distribution. Therefore, when drawing samples from the model to inform estimates of budget impact, the assumption of an approximately normal distribution for costs is reasonable. We propose that the variance in mean costs from the cost-effectiveness model also reflects the variance in budget impact estimates and should be used to estimate budget impact confidence intervals.
      PubDate: 2022-01-26
      DOI: 10.1017/S0266462321001707
       
  • Understanding innovation of health technology assessment methods: the
           IHTAM framework

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      Authors: Jiu; Li, Hogervorst, Milou A., Vreman, Rick A., Mantel-Teeuwisse, Aukje K., Goettsch, Wim G.
      First page: 16
      Abstract: Adequate methods are urgently needed to guarantee the good practice of health technology assessment (HTA) for technologies with novel properties. The aim of the study was to construct a conceptual framework to help understand the innovation of HTA methods (IHTAM). The construction of the IHTAM framework was based on two scoping reviews, one on the current practice of innovating methods, that is existing HTA frameworks, and one on theoretical foundations for innovating methods outside the HTA discipline. Both aimed to identify and synthesize concepts of innovation (i.e., innovation processes and roles of stakeholders in innovation). Using these concepts, the framework was developed in iterative brainstorming sessions and subsequent discussions with representatives from various stakeholder groups. The framework was constructed based on twenty documents on innovating HTA frameworks and fourteen guidelines from three scientific disciplines. It includes a generic innovation process consisting of three phases (“Identification,” “Development,” and “Implementation”) and nine subphases. In the framework, three roles that HTA stakeholders can play in innovation (“Developers,” “Practitioners,” and “Beneficiaries”) are defined, and a process on how the stakeholders innovate HTA methods is included. The IHTAM framework visualizes systematically which elements and stakeholders are important to the development and implementation of novel HTA methods. The framework could be used by all stakeholders involved in HTA innovation to learn how to engage dynamically and collaborate effectively throughout the innovation process. HTA stakeholders in practice have welcomed the framework, though additional testing of its applicability and acceptance is essential.
      PubDate: 2022-01-31
      DOI: 10.1017/S0266462322000010
       
  • Addressing uncertainty in relative effectiveness assessments by HTA
           organizations

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      Authors: Vreman; Rick A., Strigkos, George, Leufkens, Hubert G. M., Schünemann, Holger J., Mantel-Teeuwisse, Aukje K., Goettsch, Wim G.
      First page: 17
      Abstract: This study outlines the ways in which different health technology assessment (HTA) organizations deal with uncertainty in relative effectiveness assessments (REAs), using the GRADE framework as a common reference. Guidelines regarding REA and uncertainty assessment methods and three most recent HTA reports (as of April 2020) of seven HTA organizations in Germany, England and Wales, France, the Netherlands, Europe (EUnetHTA), the USA, and Canada were included. First, it was analyzed how each organization addressed uncertainty on the following levels of evidence: (i) individual studies, (ii) body of evidence for one outcome, (iii) body of evidence across all outcomes, and (iv) added net benefit. Second, the extent to which HTA organizations considered the eight domains of certainty of evidence defined by GRADE was assessed. For individual studies, checklists were the most common approach to express uncertainty (4/7 organizations). Uncertainty in the body of evidence for all outcomes and in added benefit was combined in a single conclusion by five organizations. All organizations reported on at least 4/5 downgrading domains of GRADE, while the three upgrading domains were reported less. The operationalization of the assessment of multiple domains was unclear due to vague or absent guidelines. HTA organizations consider most domains of the GRADE framework, but approaches to assess uncertainty within REAs on different levels of evidence differ substantially between organizations. More alignment and guidance on the best methods to deal with uncertainty within HTA could lead to more clarity for stakeholders and to more aligned reimbursement recommendations.
      PubDate: 2022-01-31
      DOI: 10.1017/S026646232100177X
       
  • Analysis of consumer comments into PBAC decision-making (2014–9)

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      Authors: Tjeuw; Emily, Wonder, Michael J.
      First page: 18
      Abstract: ObjectivesThe Pharmaceutical Benefits Advisory Committee (PBAC) is an independent expert body that recommends new technologies for listing on the Pharmaceutical Benefits Scheme. Its decision-making process is evidence-based and considers a technology's clinical effectiveness, safety, and cost-effectiveness compared with other technologies. Since 2014, the PBAC has formally taken into account input from those impacted by the technology via an online consumer comments portal and has also reported on received comments in the Public Summary Documents (PSDs). Comments are welcomed from those whose health the technology is trying to improve, as well as carers, clinicians, and organizations. Our objective was to analyze and review consumer comments in the PBAC's decision-making process.MethodsWe extracted information about consumer comments from the PBAC PSDs from 2014–9. We conducted simple descriptive analyses.ResultsOur findings reveal that two thirds of all submissions did not receive a single consumer comment. Of the remaining third, eight submissions (less than 1 percent) had a substantial number of consumer comments (>500). For these technologies, multiple submissions were required before a recommendation was issued. Submissions spanned multiple therapeutic areas, the therapeutic areas with the most consumer comments were genetic disease, pediatrics, and oncology.ConclusionsIn the light of our review, we have identified limitations to the current consumer comments process, and after an examination of the processes of other comparable health technology assessment agencies, we have identified a number of improvements that could be made to the PBAC's process to increase consumer engagement.
      PubDate: 2022-02-04
      DOI: 10.1017/S0266462321001744
       
  • Topic selection process in health technology assessment agencies around
           the world: a systematic review

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      Authors: Qiu; Yingpeng, Thokala, Praveen, Dixon, Simon, Marchand, Robert, Xiao, Yue
      First page: 19
      Abstract: ObjectiveThe purpose of this study was to systematically review the process for topic selection by health technology assessment (HTA) agencies around the world to provide the knowledge base for the improvement of topic selection frameworks in HTA agencies.MethodsA systematic search was conducted in PubMed and EMBASE to identify papers up to February 2019. Gray literature was identified by screening the Web sites of HTA agencies on the nonprofit member list of the International Network of Agencies for Health Technology Assessment (INAHTA). Data were extracted for each HTA agency and synthesized, with issues including general contextual information about each agency and the process of topic selection.ResultsOut of forty-nine nonprofit members of INAHTA, a total of seventeen HTA agencies with a framework for topic selection were identified from twenty-two included papers/documents. Multiple criteria were used for topic selection in all frameworks and agencies undertook multiple steps, which could include the specification of criteria for topic selection, identification of topics, short listing of potential topics, scoping of potential topics, scoring and ranking of potential topics, and deliberation and decision on final topics for HTA. Shortcomings were found in relation to methods of scoring and ranking as well as lack of monitoring and the evaluation of the process.ConclusionsOur study provides insights into the current practice of topic selection in HTA agencies. Multiple criteria decision analysis methodology appears highly relevant to these processes. A consensus approach for the development of methods of topic selection would be valuable for the HTA community.
      PubDate: 2022-02-07
      DOI: 10.1017/S0266462321001690
       
  • Synthesizing quantitative and qualitative information on multiple
           comparisons of health interventions to facilitate knowledge transfer: an
           example from an EUnetHTA multi-HTA

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      Authors: Formoso; Giulio, Jeroncic, Ana, Bonvicini, Laura, Djuric, Olivera, Erdos, Judit, Pezzarossi, Annamaria, Ballini, Luciana
      First page: 20
      Abstract: ObjectivePresenting an approach to synthesize quantitative and qualitative information from systematic reviews of multiple health interventions.MethodsWithin the context of an EUnetHTA multi-health technology assessment of twenty-three surgical techniques, we developed synthetic single tables, using color gradients and abbreviations, with information on which technologies had been compared, estimates of the size of differences for available comparisons, their clinical relevance, and certainty of the related evidence.ResultsThe proposed methodology provided, through a single depiction, information normally included in multiple figures/tables such as network plots, league tables, and summary of findings tables.ConclusionTransferring information on benefits, risks, and certainty of the available evidence on health interventions may be challenging, especially when assessing multiple treatments: more pieces of information need to be integrated in order to show an overall picture for each of the chosen outcomes, and usual reporting tools may be targeted to researchers more than to different kinds of decision makers. While more in-depth layers of information can always be added to satisfy needs of different audiences, the proposed tools could favor a quick interpretation of articulated scientific data by both decision makers and researchers.
      PubDate: 2022-02-09
      DOI: 10.1017/S0266462322000046
       
  • Eliciting uncertainty for complex parameters in model-based economic
           evaluations: quantifying a temporal change in the treatment effect

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      Authors: Jankovic; Dina, Payne, Katherine, Kanaan, Mona, Bojke, Laura
      First page: 21
      Abstract: BackgroundIn model-based economic evaluations, the effectiveness parameter is often informed by studies with a limited duration of follow-up, requiring extrapolation of the treatment effect over a longer time horizon. Extrapolation from short-term data alone may not adequately capture uncertainty in that extrapolation. This study aimed to use structured expert elicitation to quantify uncertainty associated with extrapolation of the treatment effect observed in a clinical trial.MethodsA structured expert elicitation exercise was conducted for an applied study of a podiatry intervention designed to reduce the rate of falls and fractures in the elderly. A bespoke web application was used to elicit experts’ beliefs about two outcomes (rate of falls and odds of fracture) as probability distributions (priors), for two treatment options (intervention and treatment as usual) at multiple time points. These priors were used to derive the temporal change in the treatment effect of the intervention, to extrapolate outcomes observed in a trial. The results were compared with extrapolation without experts’ priors.ResultsThe study recruited thirty-eight experts (geriatricians, general practitioners, physiotherapists, nurses, and academics) from England and Wales. The majority of experts (32/38) believed that the treatment effect would depreciate over time and expressed greater uncertainty than that extrapolated from a trial-based outcome alone. The between-expert variation in predicted outcomes was relatively small.ConclusionsThis study suggests that uncertainty in extrapolation can be informed using structured expert elicitation methods. Using structured elicitation to attach values to complex parameters requires key assumptions and simplifications to be considered.
      PubDate: 2022-02-18
      DOI: 10.1017/S0266462322000022
       
  • European Network for Health Technology Assessment’s Response to
           COVID-19: Rapid Collaborative Reviews on Diagnostic Tests and Rolling and
           Rapid Collaborative Reviews on Therapeutics

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      Authors: Ballini; Luciana, Wild, Claudia, Djuric, Olivera, Mayer-Ferbas, Julia, Willemsen, Anne, Huic, Mirjana
      First page: 22
      Abstract: ObjectivesIn spring 2020, The European network for Health Technology Assessment (EUnetHTA) decided to join forces to produce best evidence to inform health policy in the COVID-19 pandemic. The objective of this paper is to describe the process and output of the coordinated and collaborative activities of EUnetHTA.MethodsRelevant published and internal documents were retrieved for a descriptive analysis of EUnetHTA processes, methods, and outputs related to EUnetHTA’s response to the pandemic.ResultsProcess: In April 2020, a COVID-19 task force was set up and a survey collected pressing health policy questions across Europe. Two coordinating agencies for diagnostic tests and therapeutics were assigned. A process for prioritization and selection was set up for therapeutics, as well as explicit starting and stopping rules. Methodology: To increase a timely response, it was agreed that the rapid collaborative reviews (rapid CRs) would not require the consultation of manufacturers and the involvement of external experts, but would not differ in the methods and conduct of the systematic search, review, and synthesis of all available evidence, nor in the requirement for reviewing by EUnetHTA partners. Final reports: The joint effort resulted in the production of two rapid CRs on diagnostic tests, nineteen collaborative rolling reviews on therapeutics, three of which later moved to rapid CRs.ConclusionsDuring COVID-19 pandemic, the EUnetHTA partners proved capable of prompt collaboration, which allowed speeding up the production and release of high-quality EUnetHTA outputs, while the relationships with the other European institutions facilitated their quick dissemination.
      PubDate: 2022-03-08
      DOI: 10.1017/S0266462322000071
       
  • Faciliating More Efficient Negotiations for Innovative Therapies: A
           Value-Based Negotiation Framework

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      Authors: Whittal; Amanda, Jommi, Claudio, De Pouvourville, Gérard, Taylor, David, Annemans, Lieven, Schoonaert, Lies, Vermeersch, Sebastian, Hutchings, Adam, Patris, Julien
      First page: 23
      Abstract: ObjectivesAn increasing number of innovative therapies (e.g., gene- and cell-based treatments) have been developed in the past 20 years. Despite the significant clinical potential of these therapies, access delays may arise because of differing perspectives of manufacturers and payers regarding issues such as the value of the product, clinical and financial uncertainties, and sustainability.Managed entry agreements (MEAs) can enable access to treatments that would not be reimbursed by conventional methods because of such concerns. However, although MEA typologies exist, there is currently no structured process to come to agreements on MEAs, which can be difficult to decide upon and implement.To facilitate more structured MEA negotiations, we propose a conceptual “value-based negotiation framework” with corresponding application tools.MethodsThe framework was developed based on an iterative process of scientific literature review and expert input.ResultsThe framework aims to (i) systematically identify and prioritize manufacturer and payer concerns about a new treatment, and (ii) select a mutually acceptable combination of MEA terms that can best address priority concerns, with the lowest possible implementation burden.ConclusionsThe proposed framework will be tested in practice, and is a step toward supporting payers and manufacturers to engage in more structured, transparent negotiations to balance the needs of both sides, and enabling quicker, more transparent MEA negotiations and patient access to innovative products.
      PubDate: 2022-03-11
      DOI: 10.1017/S0266462322000095
       
  • Evidence-Informed Update of Argentina’s Health Benefit Package:
           Application of a Rapid Review Methodology

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      Authors: Alcaraz; Andrea, Alfie, Verónica, Gonzalez, Lucas, Virgilio, Sacha, Garcia-Marti, Sebastián, Augustovski, Federico, Pichon-Riviere, Andrés
      First page: 24
      Abstract: ObjectivesArgentina has a fragmented healthcare system with social security covering almost two thirds of the population. Its benefit package—called compulsory medical program (PMO; by its Spanish acronym Programa Médico Obligatorio)—has not been formally and widely updated since 2005. However, laws, clinical practice guidelines (CPGs), and a high-cost technology reimbursement fund complement it. Our objective was to comprehensively review such a PMO and propose an update considering the corresponding complementary sources.MethodsWe followed four steps: (i) identification of health technologies from the current PMO and complementary sources, (ii) prioritization, (iii) assessment through rapid health technology assessment (HTA), and (iv) appraisal and recommendations. We evaluated three value domains: quality of evidence, net benefit, and economics, which were summarized in a five-category recommendation traffic-light scale ranging from a strong recommendation in favor of inclusion to a strong recommendation for exclusion.ResultsEight hundred fifty technologies were identified; 164 of those, considered as high priority, were assessed through rapid HTAs. Those technologies mentioned in laws and CPGs were mostly outpatient essential medicines, whereas those from the reimbursement system were mostly high-cost drugs; of these 101 technologies, 50 percent were recommended to be kept in the PMO. The other 63 (identified by the Superintendence of Health Services, technology producers, and patients) were mostly medical procedures and high-cost drugs; only 25 percent of those resulted in a favorable recommendation.ConclusionsA methodology based on four clearly identified steps was used to carry out a comprehensive review of an outdated and fragmented benefit package. The use of rapid HTAs and a traffic-light recommendation framework facilitated the deliberative evidence-based update.
      PubDate: 2022-03-11
      DOI: 10.1017/S0266462322000034
       
  • Acceptability of Manufacturer-Proposed Utility Values for NICE Cancer
           Medicine Appraisals: Analysis of Manufacturers’ Information Sources

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      Authors: Takada; Shunsuke, Narukawa, Mamoru
      First page: 25
      Abstract: ObjectivesThe National Institute for Health and Care Excellence’s (NICE) method guide for technology appraisals (TAs) encourages medicine manufacturers to use the EuroQol 5 Dimensions (EQ-5D) in relevant clinical trials to obtain utility values; however, the EQ-5D may have low sensitivity when compared to disease-specific measures. This study investigated whether the NICE TA committee’s acceptance of manufacturer-proposed utility values is dependent on the manufacturers’ sources of the utility values.MethodsUsing publicly available data for 2011–2020, we identified 136 single TAs of cancer medicines, the health-related quality-of-life-measures used in relevant clinical trials, manufacturers’ sources of utility values, and the NICE TA committee’s acceptance of these values. Fisher’s exact tests were performed to compare the acceptability of different value sources and reasons for non-acceptance.ResultsThe number of appraisals for which the EQ-5D in the relevant clinical trials was the source of the manufacturer-proposed utility values increased continuously over time. The TA committee’s acceptance of values was not dependent on the information source. In cases where a submission for which the information source was the EQ-5D was rejected, the reason was generally related to inappropriate values for the UK population or inappropriate data adjustment, not data reliability.ConclusionsOur results demonstrated that according with the NICE’s method guide regarding utility values does not guarantee acceptance by the TA committee. Manufacturers must consider in advance possible differences between their clinical trials and clinical practice in the UK and refine plans for EQ-5D measurement in order to obtain convincing evidence.
      PubDate: 2022-03-17
      DOI: 10.1017/S0266462322000149
       
  • Developing and piloting a context-specified ethics framework for health
           technology assessment: the South African Values and Ethics for Universal
           Health Coverage approach

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      Authors: Krubiner; Carleigh B., Barsdorf, Nicola W., Goldstein, Susan J., Mosam, Atiya, Potgieter, Sunita, DiStefano, Michael J., Tugendhaft, Aviva, Merritt, Maria W., Li, Ryan, Chalkidou, Kalipso, Faden, Ruth R., Hofman, Karen J.
      First page: 26
      Abstract: ObjectivesWhile ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The “South African Values and Ethics for Universal Health Coverage” (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts.MethodsThe SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five.ResultsThe methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context.ConclusionsThe SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.
      PubDate: 2022-03-08
      DOI: 10.1017/S0266462322000113
       
  • The transcatheter aortic valve implantation: an assessment of the
           generalizability of the economic evidences following a systematic review

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      Authors: Ruggeri; Matteo, Donatella, Mandolini, Federica, Campisi, Salvatore, Danese, Costanza, Santori, Marta, Chiappetta, Paolo, Roazzi, Marco, Marchetti
      First page: 27
      Abstract: ObjectivesScientific literature debates on the economic affordability of transcatheter aortic valve implantation (TAVI) in order to give a useful support to decision makers aiming at establishing a reimbursement scheme for TAVI. For this reason, it is important to assess the quality and the generalizability of the existing economic evidences.MethodsThe first step was to run a literature search according to a predefined population, intervention, comparator, and outcome on the cost and effectiveness of the TAVI procedure in comparison to medical therapy and traditional surgery. Second, a manual search was carried out on the Web sites of the main HTA agencies. Third, the checklist developed by Augustovski et al. was applied in order to assess the quality and the generalizability of the articles resulting from the selection process.ResultsOverall, 106 articles were obtained. Of these, sixty-five articles were excluded since the title was not consistent with the objective. Further selection took place after abstract and full-text reading. In the end, thirty-one documents were included for the review. According to the checklist, none of the articles was considered generalizable and only one was considered transferable which compares the TAVI procedure with Medical Management in inoperable patients.ConclusionsDespite the overall quality of the selected studies was considered good, there is still a lack of evidence on whether evidences generated in different contexts can be considered generalizable. Further research on resource consumption and preferences is needed in order to provide decision makers with more robust evidences.
      PubDate: 2022-03-24
      DOI: 10.1017/S0266462321001720
       
  • A Review of Overall Survival Extrapolations of Immune-Checkpoint
           Inhibitors Used in Health Technology Assessments by the French Health
           Authorities

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      Authors: Grumberg; Valentine, Roze, Stéphane, Chevalier, Julie, Borrill, John, Gaudin, Anne-Françoise, Branchoux, Sébastien
      First page: 28
      Abstract: ObjectivesExtrapolation is often required to inform cost-effectiveness (CE) evaluations of immune-checkpoint inhibitors (ICIs) since survival data from pivotal clinical trials are seldom complete. The objectives of this study were to evaluate the accuracy of estimates of long-term overall survival (OS) predicted in French CE assessment reports of ICIs, and to identify models presenting the best fit to the observed long-term survival data.MethodsA systematic review of French assessment reports of ICIs in the metastatic setting since inception until May 2020 was performed. A targeted literature review was conducted to collect associated extended follow-up of randomized controlled trials (RCTs) used in the CE assessment reports. Difference between projected and observed OS was calculated. A range of standard parametric and spline-based models were applied to the extended follow-up data from the RCT to determine the best-fitting survival models.ResultsOf the 121 CE assessment reports published, 11 reports met the inclusion criteria. OS was underestimated in 73 percent of the CE assessment reports. The mean relative difference between each source was −13 percent (median: −15 percent; IQR: −0.4 to 26 percent). Models providing the best fit were those that could reflect nonmonotonic hazards.ConclusionsBased on the available data at the time of submission, longer-term survival of ICIs was not fully captured by the extrapolation models used in CE assessments. Standard and flexible parametric models which can capture nonmonotonic hazard functions provided the best fit to the extended follow-up data. However, these models may still have performed poorly if fitted to survival data available at the time of submission to the French National Authority for Health.
      PubDate: 2022-03-25
      DOI: 10.1017/S0266462322000125
       
  • A Technical Review of the ISPOR Presentations Database Identified Issues
           in the Search Interface and Areas for Future Development

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      Authors: Cooper; Chris, Brown, Anna, Court, Rachel, Schauberger, Ute
      First page: 29
      Abstract: ObjectiveTo undertake a technical review of the search interface of the ISPOR Presentations Database. By technical review, we mean an evaluation of the technical aspects of the search interface and functionality, which a user must navigate to complete a search.MethodsA validated checklist (Bethel and Rogers, 2014, Health Info Libr J, 31, 43-53) was used to identify where the interface performed well, where the interface was adequate, where the interface performed poorly, where functionality available in core biomedical bibliographic databases does not exist in the ISPOR database, and to establish a list of any issues arising during the review. Two researchers independently undertook the technical review in October 2021.ResultsThe ISPOR database scored 35 of a possible 165 (27/111 essential criteria and 8/54 desirable criteria). Two issues arising were identified, both of which will cause searchers to miss potentially eligible abstracts: (i) that search terms, which include * or ' as truncation or wildcard symbols should not be capitalized (e.g., cost* not Cost*; organi'ation not Organi'ation) and (ii) that quotation marks should be straight sided in phrase searching (e.g., “cost analyses” not “cost analyses”).ConclusionsThe ISPOR database is a promising and free database to identify abstracts/posters presented at ISPOR. We summarize two key issues arising, and we set out proposed changes to the search interface, including: adding the ability to export abstracts to a bibliographic tool, exporting search strategies, adding a researcher account, and updating the help guide. All suggestions will further improve this helpful database.
      PubDate: 2022-03-08
      DOI: 10.1017/S0266462322000137
       
  • Early Dialogues for Pharmaceutical Products in European Network for Health
           Technology Assessment Joint Action 3: What Was Done and Where to Go in the
           Future

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      Authors: Galbraith; Margaret, Guilhaume, Chantal, Bélorgey, Chantal
      First page: 30
      Abstract: ObjectivesThe aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3’s (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes.MethodsA descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics.ResultsIn JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat. From June 2017 to May 2021, 113 requests for pharmaceutical EDs were received and 38 conducted. The process was continuously optimized, and different approaches for involving patients were tested. Finally, a centralized procedure was chosen with the key documents produced by two responsible agencies and reviewed by the EDWP. Patient involvement was primarily done by interviewing a national patient representative to obtain general feedback on the disease and the planned study design.ConclusionsDuring JA3, EDs were established as an efficient, successful product. Pharmaceutical companies benefited not only from the positions of the individual agencies for the national HTA, but also from the recommendations that were common to all HTA authorities. In addition, regarding the European HTA Regulation, it will be important to conduct Joint Scientific Consultations with a view toward future Joint Clinical Assessments and to further develop processes aligned with the high demand for consultation.
      PubDate: 2022-03-24
      DOI: 10.1017/S0266462322000083
       
  • Should We Pay for Scientific Knowledge Spillovers' The
           Underappreciated Value of “Failed” R&D Efforts

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      Authors: Xie; Richard Z., Towse, Adrian, Garrison, Louis P.
      First page: 31
      Abstract: Recent experience with COVID-19 has reminded us of the importance of scientific progress in enabling pharmaceutical innovation. Developing novel therapies is a highly risky but rewarding process: it not only produces innovative drugs, but also valuable scientific knowledge that benefits the community of innovators. This paper examines whether the existing reward system for pharmaceutical research and development (R&D) leads to socially optimal levels of scientific knowledge generation and sharing, with a particular focus on the value of failures in the pharmaceutical R&D efforts. We first outline a conceptual approach based on the idea that pharmaceutical R&D efforts produce both medicines and scientific knowledge, and illustrate this with some examples of how failures may generate information beneficial to concurrent and subsequent R&D efforts. We then summarize the relatively small literature on failures in pharmaceutical R&D and their impact on R&D decision making. Lastly, we discuss several market-based and nonmarket-based policy approaches that can address potential shortcomings in the current reward system which may lead to suboptimal R&D and knowledge sharing.
      PubDate: 2022-03-17
      DOI: 10.1017/S0266462322000150
       
  • Key learnings from Institute for Clinical and Economic Review’s
           real-world evidence reassessment pilot

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      Authors: Jaksa; Ashley, Bloudek, Lisa, Carlson, Josh J., Shah, Kanya, Chen, Yilin, Patrick, Amanda R., McKenna, Avery, Campbell, Jon D.
      First page: 32
      Abstract: Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and economic value of therapies in a dynamic clinical landscape. For reassessments of therapies post launch, HTA agencies are looking to real-world evidence (RWE) to enhance the clinical and economic evidence base, though challenges and concerns in using RWE in decision-making exists. Stakeholders are embarking on demonstration projects to address the challenges and concerns and to further define when and how RWE can be used in HTA decision making. The Institute for Clinical and Economic Review piloted a 24-month observational RWE reassessment. Key learnings from this pilot include identifying the benefits and challenges with using RWE in reassessments and considerations on prioritizing and selecting topics relevant for RWE updates.
      PubDate: 2022-03-14
      DOI: 10.1017/S0266462322000162
       
  • Postlaunch evidence generation practices among health technology
           assessment bodies in Europe

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      Authors: Puñal-Riobóo; Janet, Varela-Lema, Leonor, Guilhaume, Chantal, Galbraith, Margaret, Bélorgey, Chantal, Faraldo, Maria José, Meillassoux, Amélie
      First page: 33
      Abstract: ObjectivesThe term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities.MethodsIn December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners.ResultsTwelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission.ConclusionsMost agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.
      PubDate: 2022-04-19
      DOI: 10.1017/S0266462322000174
       
  • European collaboration on health technology assessment: looking backward
           and forward

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      Authors: Ruether; Alric, Imaz-Iglesia, Iñaki, Bélorgey, Chantal, Lo Scalzo, Alessandra, Garrett, Zoe, Guardian, Marcus
      First page: 34
      Abstract: The establishment of health technology assessment (HTA) has been an important topic in Europe for many years. There have been a series of activities starting with first projects in 1994 leading to joint actions from the European Network of HTA (EUnetHTA) ending in 2021. This long interval of engagement with HTA structures, methodology, and processes by all member states led to a reliable basis for European collaboration in HTA. This article shows milestones and developments from EUR-ASSESS in 1994 through the progress of EUnetHTA and the accompanying EU-HTA-Network up to the recent elaboration of the EU-HTA-Regulation. With the EU-HTA-Regulation HTA collaboration is taken out of the trial phase of more than 15 years. Through the previous EU HTA collaboration, the appreciation and understanding of the differences and complexities behind the HTA processes in the EU healthcare systems have improved. It is now necessary to make the final steps toward a sustainable European Network for HTA.
      PubDate: 2022-04-19
      DOI: 10.1017/S026646232200006X
       
  • The development process of economic evaluation guidelines in low- and
           middle-income countries: a systematic review

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      Authors: Daccache; Caroline, Karam, Rita, Rizk, Rana, Evers, Silvia M. A. A., Hiligsmann, Mickaël
      First page: 35
      Abstract: ObjectivesTo review the development of economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs), with the goal of assisting those developing EEGs in LMICs.MethodsWe conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature until March 2021. We extracted data on the methods used in the EEG development process, the responsible party engaged, and the development team’s composition. We conducted a quality assessment, using the Appraisal of Guidelines for Research and Evaluation-Health Systems tool, and then carried out a relative comparison.ResultsFourteen EEGs and nine studies were identified. In ten countries, the Ministry of Health was responsible for handling the development process. The majority of LMICs who developed EEGs did not explicitly report the discipline of those involved in the process. The developers of EEGs followed four main steps: conducting a review on national guidelines, organizing workshops, and getting support from international experts or from organizations. One-third of the identified EEGs failed to engage multisectoral or multidisciplinary developers, and approximately 14 percent did not follow or report any recommended step.ConclusionsThis study identified a scarcity of published information related to the development process and the suboptimal quality of included studies. It provides relevant material to support international organizations and developers of guidelines in LMICs in developing EEGs that fit their national context. In addition, this paper recommends a transparent approach to the design of guidelines and to reporting on the methods for developing them.
      PubDate: 2022-04-22
      DOI: 10.1017/S0266462322000186
       
  • A systematic literature review of revealed preferences of decision-makers
           for recommendations of cancer drugs in health technology assessment

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      Authors: Wang; Yitong, Qiu, Tingting, Nikodem, Mateusz, Francois, Clément, Toumi, Mondher
      First page: 36
      Abstract: ObjectivesThis review intends to provide an overview of revealed preferences of decision-makers for recommendations of cancer drugs in health technology assessment (HTA) among the different agencies.MethodsA systematic literature search was performed in MEDLINE and EMBASE databases from inception to July 2020. The studies were eligible for inclusion if they conducted a quantitative analysis of HTA’s previous decisions for cancer drugs. The factors with p-values below the significance level of .05 were considered as the statistically significant factors for HTA decisions.ResultsA total of nine studies for six agencies in Australia, Belgium, France, South Korea, the UK, and Canada were eligible to be included. From the univariable analysis, improvements in clinical outcomes and cost-effectiveness were found as significant factors for the agencies in Belgium, South Korea, and Canada. From the multivariable analysis, cost-effectiveness was found as a positive factor for the agencies in the UK, South Korea, and Canada. Few factors related to characteristics of disease and technology were found to be significant among the included agencies.ConclusionsDespite the different drug reimbursement systems and the socioeconomic situations, cost-effectiveness and/or improvement on clinical outcomes seemed to be the most important factors for recommendations of cancer drugs among the agencies.
      PubDate: 2022-04-06
      DOI: 10.1017/S0266462322000216
       
  • A Review of Overall Survival Extrapolations of Immune-Checkpoint
           Inhibitors Used in Health Technology Assessments by the French Health
           Authorities – Erratum

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      Authors: Grumberg; Valentine, Roze, Stéphane, Chevalier, Julie, Borrill, John, Gaudin, Anne-Françoise, Branchoux, Sébastien
      First page: 38
      PubDate: 2022-05-17
      DOI: 10.1017/S0266462322000228
       
  • Is value portable' An examination of contextual and practical
           considerations that affect the transferability of value assessments
           between settings

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      Authors: Synnott; Patricia G., Lin, Pei-Jung, Hickson, Stacey S., Glaetzer, Christoph, Ollendorf, Daniel A.
      First page: 39
      Abstract: ObjectivesThe extent to which value assessments are uniquely deployed in any given geographic setting is variable. Increasingly, markets are seeking insights from external health technology assessments (HTAs) to assist with decisions surrounding the adoption of new technologies. We reviewed the environment, infrastructure, and practice of value assessment in six countries, with a focus on how these elements influence the transferability of value assessments between settings.MethodsWe reviewed the diverse settings in which six organizations conducting HTA operate, and explored how differences might affect the transferability of value assessment. We focused attention on Australia’s Pharmaceutical Benefits Advisory Committee, China’s National Center for Medicine and HTA, Germany’s Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Japan’s Center for Outcomes Research and Economic Evaluation for Health (Core 2 Health), the National Institute for Health and Care Excellence in England and Wales, and the Institute for Clinical and Economic Review in the United States.ResultsHTA is adopted to address unique objectives for a given health system and is tailored to support local standards and preferences. Some elements of a value assessment, such as evidence on clinical effectiveness, may be more transferable than others. It is challenging to appropriately adjust external assessments to the local context.ConclusionsContextual differences influence both the role and application of HTA. These differences limit the transferability of value assessments from one setting to another. De novo appraisals, customized to the local decision context, are the ideal approach to determinations about value.
      PubDate: 2022-04-21
      DOI: 10.1017/S026646232200023X
       
  • In Memoriam: H. David Banta

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      Authors: Oortwijn; Wija
      First page: 40
      PubDate: 2022-05-04
      DOI: 10.1017/S0266462322000253
       
  • Transferability of a EUnetHTA relative effectiveness assessment to low-
           and middle-income countries setting

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      Authors: Padmasawitri; T. I. Armina, Fuady, Ahmad
      First page: 42
      Abstract: In 2020, European Network for Health Technology Assessment (EUnetHTA) published a relative effectiveness analysis (REA) of Pretomanid in combination with Bedaquiline and Linezolid for the treatment of extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) (REA PTJA14). This REA may have a significant value for low- and middle-income countries (LMICs) outside Europe, particularly those with a high burden of drug-resistant TB. This commentary focuses on whether the REA PTJA14 can be transferred and to what extent a REA can be translated to LMICs context outside Europe. We found that the assessments on the clinical effectiveness and risks of bias reported in REA PTJA14 are useful for LMICs outside Europe. The highly standardized management of TB will support the applicability of the REA to LMICs outside of Europe. Transferring this REA can reduce workload and efficiently use limited resources to conduct health technology assessment (HTA). However, the transfer should consider several critical issues, including variations in health system delivery and clinical practice and setting-specific constraints. In the TB context, the differences in the current standard treatment for XDR or nonresponsive MDR TB, resources availability for drug-resistant TB management, and how healthcare is delivered in the countries can complicate the applicability of the REA PTJA14. Given that LMICs have limitations in doing HTA, it is now critical to develop standard guidelines for transferring REA or other HTA results from high-income countries or other LMICs to maximize the benefits of the REA for LMICs outside Europe.
      PubDate: 2022-04-28
      DOI: 10.1017/S0266462322000241
       
  • Economic evaluation guidelines in low- and middle-income countries: a
           systematic review

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      Authors: Daccache; Caroline, Rizk, Rana, Dahham, Jalal, Evers, Silvia M. A. A., Hiligsmann, Mickael, Karam, Rita
      First page: 1
      Abstract: ObjectivesTo systematically identify the latest versions of official economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs) and explore similarities and differences in their content.MethodsWe conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature. Using a predefined checklist, we extracted the key features of economic evaluation and the general characteristics of EEGs. We conducted a comparative analysis, including a summary of similarities and differences across EEGs.ResultsThirteen EEGs were identified, three pertaining to lower-middle-income countries (Bhutan, Egypt, and Indonesia), nine to upper-middle-income countries (Brazil, China, Colombia, Cuba, Malaysia, Mexico, Russian Federation, South Africa, and Thailand), in addition to Mercosur, and none to low-income countries. The majority (n = 12) considered cost–utility analysis and health-related quality-of-life outcome. Half of the EEGs recommended the societal perspective, whereas the other half recommended the healthcare perspective. Equity considerations were required in ten EEGs. Most EEGs (n = 11) required the incremental cost-effectiveness ratio and recommended sensitivity analysis, as well as the presentation of a budget impact analysis (n = 10). Seven of the identified EEGs were mandatory for pharmacoeconomics submission. Methodological gaps, contradictions, and heterogeneity in terminologies used were identified within the guidelines.ConclusionAs the importance of health technology assessment is increasing in LMICs, this systematic review could help researchers explore key aspects of existing EEGs in LMICs and explore differences among them. It could also support international organizations in guiding LMICs to develop their own EEGs and improve the methodological framework of existing ones.
      PubDate: 2021-12-21
      DOI: 10.1017/S0266462321000659
       
  • A review of audiovisual telemedicine utilization and satisfaction
           assessment during the COVID-19 pandemic

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      Authors: Agbali; Raphael, Balas, Andrew E., Beltrame, Francesco, De Leo, Gianluca
      First page: 2
      Abstract: IntroductionThe use of telemedicine has broadened as technology that both restores continuity of care during disruptions in healthcare delivery and routinely provides primary care alone or in combination with in-person care. During the Covid-19 outbreak, the use of telemedicine as a routine care modality further accelerated.MethodsA review of scientific studies that used telemedicine to provide care from December 2019 to December 2020 is presented. From an initial set of 2,191 articles, 36 studies are analyzed. Evidence is organized and evaluated according to the country of study, the clinical specialty, the technology platform used, and satisfaction and utilization outcomes.ResultsThirty-one studies reported high patient satisfaction scores. Eight studies reported satisfaction from both providers and patients with no uniformly accepted assessment instrument. Eight studies conducted a descriptive analysis of telemedicine use and patient adoption patterns. Less than one-third of studies were controlled before/after studies. Most studies were conducted in the USA followed by Europe.ConclusionsReported satisfaction rates are high, consistent with previously documented research, whereas utilization rates increased significantly compared with the prepandemic period. Future work in developing standardized uniform assessment instruments, embedded with each telemedicine system, would increase versatility and agility in the assessment, boosting statistical power and the interpretation of results.
      PubDate: 2021-12-20
      DOI: 10.1017/S026646232100060X
       
  • Mentoring as a potential means to assist consumer representatives
           contribute effectively to the assessment of health technologies in
           Australia: a pragmatic review

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      Authors: Walker; Christine, Donovan, Jan, Watson, Jo
      First page: 3
      Abstract: ObjectivesThis project was implemented on behalf of the Health Technology Assessment (HTA) Consumer Consultative Committee (CCC) to explore training to support and retain new consumer representatives to participate effectively in HTA committees. These committees are key parts of the Australian Government's health system. Currently, there is no training available to them, specific to their roles in HTA committees. Hypothesizing that mentoring is appropriate, the project team undertook a literature review to identify definitions of mentoring, its benefits, skills requirements, resources, examples of best practice, and how mentoring might support consumer representatives in formal health technology assessment committee structures.MethodsA rapid review was commenced by the project team and fifty-seven articles were identified and read independently. Following discussion, the team revised its approach as there was little evidence to assess and drew upon thirty-five articles where elements of mentoring were described. Discussion was followed by a thematic qualitative analysis exploring mentoring models.ResultsThe project team agreed that features of mentoring programs were necessary to design a mentoring program under the headings of definitions, mentors’ qualities, benefits of training, resources, other considerations, and evaluation. These assist the design of a pilot project to test mentoring's effectiveness.ConclusionMentoring may assist consumers working in the health technology area to develop their skills and competencies and contribute to representing the needs of health consumers in the approval of applications. A pilot mentoring program is currently being designed and will run with one mentor and one mentee in an HTA committee.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321000611
       
  • Opportunities to improve reporting of rapid response in health technology
           assessment

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      Authors: de Almeida; Matheus O., Montezuma, Thais, de Oliveira Júnior, Haliton A., Ferri, Cleusa Pinheiro
      First page: 4
      Abstract: IntroductionMini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil.MethodsAn electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports.ResultsWe included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence.ConclusionThe quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321000635
       
  • Exploring facilitators and barriers to introducing health technology
           assessment: a systematic review

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      Authors: Suharlim; Christian, Kumar, Ritu, Salim, Julian, Mehra, Meenakshi, Gilmartin, Colin, Amaris Caruso, Ana, Castro, Hector
      First page: 5
      Abstract: ObjectiveThis study aims to identify and codify the facilitators and barriers to help implementing partners institutionalize health technology assessment (HTA) successfully and navigate complex systems for health-related policy making.MethodsWe searched for peer-reviewed and gray literature articles examining HTA programs globally using six databases. Keywords used as a guide for capturing articles included “health technology assessment,” “barrier,” and “facilitator” and their synonyms. Search results were scrutinized for duplicates and screened through a review of titles and abstracts. A full-text review was conducted exploring articles’ coverage of twenty-seven evaluation criteria across four primary areas of interest: barriers/facilitators, motivations, guidelines, and institutional frameworks.ResultsA total of 18,599 records were identified for duplication check, title, and abstract review. A total of 1,594 articles underwent full-text review, leading to a final synthesis of 262 studies. We found that ninety-seven articles discussed barriers/facilitators, with fifty-three of those discussing local capacity and unavailable human resources. Out of the sixty-six articles discussing motivations, forty-two cited the interest in supporting the decision-making process for, and promoting, appropriate resource allocation. Of the sixty-one articles that discussed guidelines and institutional framework, twenty-one articles described HTA as an independent national unit, and sixteen described their HTA unit as a unit within the Ministry of Health (MOH).ConclusionsThis systematic review unpacks the dynamic and relevant contexts for understanding the HTA institutionalization process to help policy makers and practitioners achieve tangible progress in confronting the most critical issues facing priority setting and HTA institutionalization.
      PubDate: 2021-12-21
      DOI: 10.1017/S0266462321000623
       
  • Bridging health technology assessment and healthcare quality improvement
           using international consortium of health outcomes measurement standard
           sets

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      Authors: Kalf; Rachel R. J., Zuidgeest, Marloes, Delnoij, Diana M. J., Bouvy, Marcel L., Goettsch, Wim G.
      First page: 6
      Abstract: ObjectiveAlthough health technology assessment (HTA) and healthcare quality improvement are distinct processes, a greater level of alignment in outcome measures used may increase the quality and efficiency of data collection. This study evaluates the agreement in outcome measures used in oncology for healthcare quality improvement and HTAs, and how these align to the International Consortium for Health Outcomes Measurement (ICHOM) standard sets.MethodsWe conducted a cross-sectional comparative analysis of ICHOM sets focusing on oncological indications and publicly available measures for healthcare quality and HTA reports published by the National Health Care Institute from the Netherlands and the National Institute for Health and Care Excellence from the United Kingdom.ResultsAll ICHOM sets and HTAs used overall survival, whereas quality improvement used different survival estimates. Different progression estimates for cancer were used in HTAs, ICHOM sets, and quality improvement. Data on health-related quality of life (HRQoL) was recommended in all ICHOM sets and all HTAs, but selectively for quality improvement. In HTAs, generic HRQoL questionnaires were preferred, whereas, in quality improvement and ICHOM sets, disease-specific questionnaires were recommended. Unfavorable outcomes were included in all HTAs and all ICHOM sets, but not always for quality improvement.ConclusionsAlthough HTA and quality improvement use outcome measures from the same domains, a greater level of alignment seems possible. ICHOM may provide input on standardized outcome measures to support this alignment. However, residual discrepancies will remain due to the different objectives of HTA and quality improvement.
      PubDate: 2021-12-21
      DOI: 10.1017/S0266462321000520
       
  • Toward a broader concept of societal value: family spillovers in
           Alzheimer's disease

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      Authors: Park; Jenny Yeonhee, Marcum, Zachary A., Garrison, Louis P.
      First page: 7
      Abstract: Recognizing that the “healthcare sector perspective” can be too limited in some situations, the National Institute of Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), and the U.S. Second Panel on Cost-Effectiveness in Health and Medicine all recommend a “societal” perspective in “reference case” cost-effectiveness analyses (CEAs). Although costs of informal caregiving are sometimes included in the CEAs of Alzheimer's Disease (AD) drugs, the benefits and disutility to family members, referred to as “family spillovers” by the U.S. Second Panel, are usually omitted. We estimate that the aggregate cost of family spillovers could be substantial in the USA—on the order of USD 57 billion or over 10 percent of the total economic burden of AD in 2020. Incorporation of family spillovers in AD value frameworks and HTAs is important for comprehensively defining, rewarding, and providing high-value care in AD.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321000593
       
  • A framework for action to improve patient and public involvement in health
           technology assessment

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      Authors: Silva; Aline Silveira, Facey, Karen, Bryan, Stirling, Galato, Dayani
      First page: 8
      Abstract: BackgroundPatient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for “social participation.” This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA.MethodsThis work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework.ResultsAccording to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies.ConclusionsSince the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321000647
       
  • Application of a health technology assessment framework to digital health
           technologies that manage chronic disease: a systematic review

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      Authors: von Huben; Amy, Howell, Martin, Carrello, Joseph, Norris, Sarah, Wortley, Sally, Ritchie, Angus, Howard, Kirsten
      First page: 9
      Abstract: BackgroundAs health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown.ObjectivesTo summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA.MethodsMedline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed.ResultsA total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains.ConclusionsAlthough DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321001665
       
  • Optimizing red blood cell transfusion practices in the intensive care
           unit: a multi-phased health technology reassessment

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      Authors: Soril; Lesley J.J., Noseworthy, Tom W., Townsend, Derek R., Bagshaw, Sean M., Stelfox, Henry T., Zygun, David A., Clement, Fiona M.
      First page: 10
      Abstract: BackgroundHealth technology reassessment (HTR) is a process to manage existing health technologies to ensure ongoing optimal use. A model to guide HTR was developed; however, there is limited practical experience. This paper addresses this knowledge gap through the completion of a multi-phase HTR of red blood cell (RBC) transfusion practices in the intensive care unit (ICU).ObjectiveThe HTR consisted of three phases and here we report on the final phase: the development, implementation, and evaluation of behavior change interventions aimed at addressing inappropriate RBC transfusions in an ICU.MethodsThe interventions, comprised of group education and audit and feedback, were co-designed and implemented with clinical leaders. The intervention was evaluated through a controlled before-and-after pilot feasibility study. The primary outcome was the proportion of potentially inappropriate RBC transfusions (i.e., with a pre-transfusion hemoglobin of 70 g/L or more).ResultsThere was marked variability in the monthly proportion of potentially inappropriate RBC transfusions. Relative to the pre-intervention phase, there was no significant difference in the proportion of potentially inappropriate RBC transfusions post-intervention. Lessons from this work include the importance of early and meaningful engagement of clinical leaders; tailoring the intervention modalities; and, efficient access to data through an electronic clinical information system.ConclusionsIt was feasible to design, implement, and evaluate a tailored, multi-modal behavior change intervention in this small-scale pilot study. However, early evaluation of the intervention revealed no change in technology use leading to reflection on the important question of how the HTR model needs to be improved.
      PubDate: 2021-12-20
      DOI: 10.1017/S0266462321001653
       
  • Medicine characteristics affecting the time to guidance publication by
           National Institute for Health and Care Excellence in the single technology
           appraisal process

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      Authors: Takada; Shunsuke, Narukawa, Mamoru
      First page: 11
      Abstract: ObjectiveIn England, the time gap between marketing authorization (MA) and guidance publication by National Institute for Health and Care Excellence (NICE) can limit patients’ access to new medicines. In this study, our aim was to identify medicine characteristics associated with the long time gap between MA and guidance publication and explore the influencing factors.MethodsWe identified 116 single technology appraisals from 2016 to 2020 using publicly available data, and extracted information on the year of appraisal completion, application type, experiences of similar appraisals, orphan medicinal products (OMPs), cancer medicines, and accelerated assessment. Multiple regression analyses were performed to analyze the associations between the medicine characteristics and key time periods related to health technology assessment and MA processes.ResultsOMPs were associated with a long period between MA and guidance publication. Specifically, OMPs and cancer medicines were associated with slow guidance publication after the final scope (FS) development. However, there was no association between OMPs and the period between validation of MA application and FS development. Non-double-blinded randomized clinical trials and the use of comparators not specified in the FS were associated with slow guidance publication after the FS development.ConclusionsOur results demonstrate that OMPs are associated with a longer period between MA and guidance publication by the NICE than non-OMPs; this may be attributed to the slow guidance publication after the FS development. These findings indicate the necessity to shorten the appraisal process for OMPs.
      PubDate: 2021-12-22
      DOI: 10.1017/S0266462321001677
       
  • Glycated hemoglobin as a surrogate for evaluating the effectiveness of
           drugs in diabetes mellitus trials: a systematic review and trial-level
           meta-analysis

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      Authors: Rivera; Paola Andrea, Rodríguez-Zúñiga, Milton J. M., Caballero-Alvarado, José, Fiestas, Fabián
      First page: 12
      Abstract: ObjectiveThe objective of this study was to investigate whether glycated hemoglobin (HbA1c) is a valid surrogate for evaluating the effectiveness of antihyperglycemic drugs in diabetes mellitus (DM) trials.MethodsWe conducted a systematic review of placebo-controlled randomized clinical trials (RCTs) evaluating the effect of a treatment on HbA1c (mean difference between groups) and clinical outcomes (relative risk of mortality, myocardial infarction, stroke, heart failure, and/or kidney injury) in patients with DM. Then, we investigated the association between treatment effects on HbA1c and clinical outcomes using regression analysis at the trial level. Lastly, we interpreted the correlation coefficients (R) using the cut-off points suggested by the Institute for Quality and Efficiency in Healthcare (IQWiG). HbA1c was considered a valid surrogate if it demonstrated a strong association: lower limit of the 95 percent confidence interval (95 percent CI) of R greater than or equal to .85.ResultsNineteen RCTs were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate for any clinical outcome: mortality (R = .34; 95 percent CI −.14 to .69), myocardial infarction (R = .20; −.30 to .61), heart failure (R = .08; −.40 to .53), kidney injury (R = −.04; −.52 to .47), and stroke (R = .81; .54 to .93).ConclusionsThe evidence from multiple placebo-controlled RCTs does not support the use of HbA1c as a surrogate to measure the effectiveness of antihyperglycemic drugs in DM studies.
      PubDate: 2021-12-22
      DOI: 10.1017/S0266462321001689
       
 
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