Multiple Criteria Decision Analysis (MCDA) has emerged as a methodology for Health Technology Assessment (HTA). However, limited empirical evidence is available on its use by decision-makers; where ...available, it only comes from single-setting exercises, while cross-country comparative studies are unavailable. This study applies the Advance Value Framework (AVF), an MCDA methodology for HTA based on multi-attribute value theory, through a series of case studies with decision-makers in four countries, to explore its feasibility and compare decision-makers' value preferences and results.
The AVF was applied in the evaluation of three drugs for metastatic, castrate resistant, prostate cancer (abiraterone, cabazitaxel and enzalutamide) in the post-chemotherapy indication. Decision conferences were organised in four European countries in collaboration with their HTA or health insurance organisations by involving relevant assessors and experts: Sweden (TLV), Andalusia/Spain (AETSA), Poland (AOTMiT) and Belgium (INAMI-RIZIV). Participants' value preferences, including performance scoring and criteria weighting, were elicited through a facilitated decision-analysis modelling approach using the MACBETH technique.
Between 6 and 11 criteria were included in each jurisdiction's value model, allocated across four criteria domains; Therapeutic Benefit criteria consistently ranked first in relative importance across all countries. Consistent drug rankings were observed in all settings, with enzalutamide generating the highest overall weighted preference value (WPV) score, followed by abiraterone and cabazitaxel. Dividing drugs' overall WPV scores by their costs produced the lowest “cost per unit of value” for enzalutamide, followed by abiraterone and cabazitaxel. These results come in contrast with the actual country HTA recommendations and pricing decisions.
Overall, although some differences in value preferences were observed between countries, drug rankings remained the same. The MCDA methodology employed could act as a decision support tool in HTA, due to the transparency in the construction of value preferences in a collaborative manner.
•An MCDA value framework was piloted with HTA decision-makers in four EU countries.•The value drivers of three prostate cancer drugs and their importance were analysed.•Decision-maker value preferences were elicited during four decision conferences.•Value rankings of treatment options were similar and consistent across countries.•The proposed MCDA methodology has prospects to act as a decision support tool.
PurposeThis study examines the collaborative value practices of cause-based social entrepreneurship alliances. We investigate key drivers of value creation in such ...alliances.Design/methodology/approachThe study utilizes a longitudinal case study design approach involving four northern Italian businesses for investigating the cause-based social alliances.FindingsThe study findings suggest that cause-based alliance differ from other business relationships due to social mission of the alliance and orientation of partners to a specific social cause. However, over time involved firm may pursue commercial interests.Research limitations/implicationsThe study utilizes a qualitative case study approach to examine the issues. This may have implications on generalizability of study findings. Further, the sample is limited to small firms, which limit its relevance for large firms.Practical implicationsManagers can utilize the study findings to guide the organizing process of a successful cause-based alliance and can implement it with positive outcomes for their firm.Originality/valueThis is one of the first study on the emerging phenomenon of cause-based social alliance. It contributes to the literature on social entrepreneurship. It informs and guides practitioners about motivations and drivers of such alliances.
The Innovative Medicines Initiative–funded, multistakeholders project Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in hematologY (HARMONY) created a task force involving ...patient organizations, medical associations, pharmaceutical companies, and health technology assessment/regulator agencies’ representatives to evaluate the suitability of previously established value frameworks (VFs) for assessing the clinical and societal impact of new interventions for hematologic malignancies (HMs).
Since the HARMONY stakeholders identified the inclusion of patients’ points of view on evaluating VFs as a priority, surveys were conducted with the patient organizations active in HMs and part of the HARMONY network, together with key opinion leaders, pharmaceutical companies, and regulators, to establish which outcomes were important for each HM. Next, to evaluate VFs against the sources of information taken into account (randomized clinical trials, registries, real-world data), structured questionnaires were created and filled by HARMONY health professionals to specify preferred data sources per malignancy. Finally, a framework evaluation module was built to analyze existing clinical VFs (American Society of Clinical Oncology, European Society of Medical Oncology, Magnitude of Clinical Benefit Scale, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Institute for Clinical and Economic Review, National Comprehensive Cancer Network Evidence Blocks, and patient-perspective VF).
The comparative analysis describes challenges and opportunities for the use of each framework in the context of HMs and drafts possible lines of action for creating or integrating a more specific, patient-focused clinical VF for HMs.
None of the frameworks meets the HARMONY goals for a tool that applies to HMs and assesses in a transparent, reproducible, and systematic way the therapeutic value of innovative health technologies versus available alternatives, taking a patient-centered approach and using real-world evidence.
In 2020, a group of 30 stakeholders from Latin America established 15 criteria for a diagnostic technologies value framework (D-VF) to help assess and inform decisions on diagnostic technologies. ...This article aims to present the operationalization, piloting, and initial validation of the framework for its implementation.
This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) operationalization of the D-VF through a literature search for conceptual definitions and assessment tools, (2) piloting of the D-VF through a rapid health technology assessment document applying the methodology of the framework, and (3) a face validation process conducted through a virtual workshop, where usefulness and implementation aspects of the framework were assessed.
The operationalization of the framework was conducted, and a methodological user guide was published. The D-VF criteria were applied in a health technology assessment document on human papilloma virus testing in cervical cancer screening. Also, an open-access training program was developed. Stakeholders agreed on the usefulness of the D-VF for assessment and decision-making stages of diagnostic technologies. However, they highlighted the need to improve technical capacities and the potential for added complexity when applying a D-VF with many criteria. The absence of an established value framework for diagnostic technologies in Latin America and the potential for strengthening technical capacities made the project valuable to those involved.
The diagnostic technologies value framework was shown to be fit for implementation in real-life decision-making settings after the operationalization, piloting, and initial validation phases. Further experiences are important to support its implementation.
To comprehensively identify and map an exhaustive list of value criteria for the assessment of next-generation sequencing/comprehensive genomic profiling (NGS/CGP), to be used as an aid in decision ...making.
We conducted a systematic review to identify existing value frameworks (VFs) applicable to any type of healthcare technology. VFs and criteria were mapped to a previously published Latin American (LA) VF to harmonize definitions and identify additional criteria and or subcriteria. Based on this analysis, we extracted a comprehensive, evidence-based list of criteria and subcriteria to be considered in the design of a NGS/CGP VF.
A total of 42 additional VFs were compared with the LA VF, 88% were developed in high-income countries, 30% targeted genomic testing, and 16% specifically targeted oncology. A total of 242 criteria and subcriteria were extracted; 227 (94%) were fully/partially included in the LA VF; and 15 (6%) were new. Clinical benefit and economic aspects were the most common criteria. VFs oriented to genomic testing showed significant overlap with other VFs. Considering all criteria and subcriteria, a total of 18 criteria and 36 individual subcriteria were identified.
Our study provides an evidence-based set of criteria and subcriteria for healthcare decision making useful for NGS/CGP as well as other health technologies. The resulting list can be beneficial to inform decision making and will serve as a foundation to co-create a multistakeholder NGS/CGP VF that is aligned with the needs and values of health systems and could help to improve patient access to high-value technologies.
•Value frameworks play a crucial role in enhancing transparency and facilitating informed decision making within the healthcare system. They serve as valuable guides, highlighting key dimensions that need evaluation when assessing various healthcare technologies.•Institute for Clinical Effectiveness and Health Policy recently developed a value framework for diagnostic technologies, based on a targeted systematic review and a participatory process with health technology assessment stakeholders in Latin America.•In this article, we report a systematic review to update the previous framework and develop a comprehensive evidence-based list of criteria and subcriteria that could be considered for creation of a next-generation sequencing/comprehensive genomic profiling-targeted value framework, as well as a starting point for value frameworks targeted to other health technologies.
Background: Leber congenital amaurosis is the first form of inherited retinal dystrophy (IRD) treated with a gene therapy approach using voretigene neparvovec (VN). To date, 42 patients have been ...treated, 25 of whom, treated at Clinica Oculistica Vanvitelli (Naples), have shown – after 45 days of treatment – a significant increase in dim-light visual function, a widening of the visual field, and an increase in central visual acuity. Objective: A workshop has been organized to foster rapid access, investigate the current organizational scenario, and identify a value framework suitable for making gene therapy delivery efficient in terms of efficacy, safety, and sustainability. Methods: The workshop involved 14 experts in clinical genetics, ophthalmology, and vitreoretinal surgery. All experts were subjected to questions related to three topics: diagnostic-therapeutic pathway of IRD patients, essential requirements for gene therapy delivery centres, and standardized model for therapy delivery. All contributions were judged to be of equal value. Results: The panel identified: the steps of the diagnostic pathway to achieve early diagnosis; the essential criteria that delivery centres must possess in terms of experience, multidisciplinary team, and technical equipment; a standardized model for VN administration. A network of few centres was identified as the best organizational model for VN delivery since it would ensure the gaining of experience and clinical excellence. Conclusion: This paper provides a perspective that can be used as a starting point to standardize the diagnostic-therapeutic pathway of IRD patients and define the essential requirements that centres must meet for VN administration.
Introduction
Emergence of new therapies are anticipated to improve clinical outcomes and quality of life of persons with haemophilia. Challenges in conducting randomized clinical trials in rare ...diseases have resulted in a lack of direct head‐to‐head comparisons to support value‐based decision‐making between different treatments.
Methods
We conducted a literature review for new and emerging haemophilia A and B therapies (extended half‐life EHL replacement factor, non‐replacement therapies NRT, and gene therapies GT) to identify differentiating patient‐centred outcomes defined previously in a haemophilia value framework. Since the literature included all publication types (e.g., surveys, modelling studies, commentaries/reviews), collected data were assigned level of evidence scores.
Results
Across different classes of therapies, bleeding was determined as the most frequently reported differentiating outcome, with EHL, NRT, and GT each demonstrating an advantage over comparator replacement therapies. EHL therapies for haemophilia A and B and NRT for haemophilia A showed good representation across Tier 1 outcomes (health status achieved/retained), while more publications were identified with Tier 2 (process of recovery) outcomes for NRT than EHL or GT. In Tier 3 (sustainability of health), frequency of breakthrough bleeds represented a differentiating outcome for EHL (both haemophilia A and B), NRT (haemophilia A only), and GT (haemophilia B only), whereas sustained good health was differentiating for most comparisons.
Conclusions
We demonstrate the utility of the haemophilia value framework as a common core outcome set for effectively comparing therapies. Application of this framework will serve as a useful decision‐making tool for patients, clinicians, and within health technology assessments.
KEY POINTS OF CONSIDERATION
With the emergence of high‐cost, paradigm changing treatments across multiple areas of medicine, we, the haemophilia community, need to be equipped to meet the growing demands for more rigorous evidence‐based value assessments using the tools expected by assessors.
The traditional access toolbox needs to evolve to meet the paradigm shift in treatment options. Value can no longer be defined by annualized bleed rates alone. To realize the full impact of new therapies, we need to utilize tools, such as a value framework, to organize evidence, identify data gaps, and assess patient‐defined, meaningful outcomes across a multi‐faceted dimension.
The haemophilia value framework is an effective tool for organizing the available evidence and identifying gaps in the evidence. This can be used for assessing the value of emerging therapies in haemophilia utilizing data generated through randomized clinical trials and real world evidence generation.
This is a call for incorporating the Value Framework into official submissions to authorities, as it captures a broader range of outcomes, including patient meaningful outcomes, in ways that better assess the potential benefits of new therapies.
BACKGROUNDAs the role of immunotherapies and personalized medicine grow, cancer patients have faced many choices in treatments and have suffered financial toxicity. These challenges brought the need ...for the value framework (VF) to guide treatment decision making. METHODSA survey was taken to 102 oncologists about perception for VF. They were asked about priorities among several considerations when they prescribe cancer drugs. Their views on the need for development and potential implications of VF in Korea were assessed, also. RESULTSThe survey shows that 90% of the respondents choose clinical efficacy as the most important value in cancer drugs selection, and the cost of drug was more weighted value in immune checkpoint inhibitors (13.7%). Approximately half (53.9%) answered that they were aware of the existing VFs. Over 90% of respondents agreed with the need for development of a VF for cancer drugs based on Korean healthcare system and further usefulness for decisions about reimbursement issues. Seventy-one percent answered that two representative VFs (American Society Clinical Oncology-VF and European Society for Medical Oncology-Magnitude of Clinical Benefit Scale) should be reflected in value measurement of cancer drugs in Korea. CONCLUSIONThe Korean oncologists recognized the necessity for the clinical application of VF. Further discussion between the stakeholders should be followed to alleviate the financial burden through the value-based decision making of cancer drugs.
Corporate culture and banking Barth, Andreas; Mansouri, Sasan
Journal of economic behavior & organization,
06/2021, Letnik:
186
Journal Article
Recenzirano
This paper empirically analyzes the role of corporate culture in banking. We define culture based on the Competing Value Framework (Quinn and Rohrbaugh, 1983) and find that banks with a more ...pronounced competition-oriented culture have stronger bonus-focused compensation schemes. Banks with a strong focus on growth show higher stock returns and banks with a focus on stability show lower bankruptcy risk. These findings support various theories on bank culture (Thakor, 2012; Song and Thakor, 2019) and highlight the importance of corporate culture as a ‘softer’ aspects of governance to enhance banking stability.
Purpose
Founded on the concept of organizational ambidexterity and the competing value model, the purpose of this paper is to develop an information technology (IT) ambidexterity framework to ...underscore the importance of a balanced and harmonious IT environment in enterprise cloud adoption.
Design/methodology/approach
With survey responses from 165 IT executives in a managerial position who are in charge of cloud computing implementation, partial least square method is used to test the research model.
Findings
Cloud absorptive capacity plays an important role for firms to secure a competitive advantage. The synergy of the two capabilities (flexibility and control), which have conflicting characteristics, contributes to the enhancement of cloud absorptive capacity and leads to a firm’s knowledge accumulation and performance.
Research limitations/implications
This study is the very first attempt that empirically establishes the relationship between a firm’s competitiveness and cloud computing absorptive capacity. This study provides a comprehensive framework that integrates ambidexterity theory with the competing value framework (CVF) with extending the concept of absorptive capacity that is bounded within an organizational perspective into a cloud computing context.
Practical implications
Firms should treat cloud computing as a strategic consideration to secure a competitive advantage in the contemporary business environment. For a firm’s performance, a dual governance structure, that encompasses flexibility and control, is required to achieve competitive advantage from cloud computing adoption.
Originality/value
To facilitate organizational effort in achieving a harmonious cloud environment, the authors propose a comprehensive ambidexterity framework integrating the CVF approach. This framework maps IT ambidexterity onto the CVF. As CVF considers internal and external factors that ambidexterity theory does not cover, integrating two theories can provide more comprehensive implications and discussions regarding cloud computing adoption.
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