Recognizing that Evidence is Made, not Born

Lim, Robyn; Lee, David K.; Sabourin, Pierre; Ferguson, John; Metcalf, Marilyn; Smith, Meredith Y.; Corriol‐Rohou, Solange; Eichler, Hans‐Georg; Hirsch, Gigi; Chen, Inhua Muijrers; O’Rourke, Brian; Schiel, Anja; Crabb, Nick; Aronson, Naomi; Pezalla, Edmund J.; Boutin, Marc; Binder, Louise; Wilhelm, Linda

doi:10.1002/cpt.1317

Cited by 3 publications

(2 citation statements)

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“…149 Evolved clinical and HEOR solutions such as enrichment studies and evolution of RWE and indirect treatment comparisons are already being implemented. 150,151 Integration of next-generation diagnostics with smart decision analysis (eg, AI and machine learning) will also further refine patient management approaches and move us toward iterative decision models. Applications may include therapy switching, comparative value and access tiering, sequencing, or integration with performance metrics.…”

Section: Next-generation Diagnostics and Machine Learning Influence On Precision Medicine And Patient Management Decision Makingmentioning

confidence: 99%

Are Global Health Systems Ready for Transformative Therapies?

Faulkner

Spinner²,

Ringo³

et al. 2019

Value in Health

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Background: We have seen significant advancement in a range of health technologies, some with transformative or curative potential. Nevertheless, it is often unclear how global health systems recognize or reward innovation. Objectives:To consider what is transformative, challenges for transformative therapies, and downstream health ecosystem effects.Methods: A systematic review of publications in English between 2012 and 2018 was conducted with a focus on value assessment processes and health system effects of a range of breakthrough health technology categories. After screening 9012 records, 222 unique studies were identified. The study also included an analysis of 100 health technology assessments (HTAs) from 5 markets to consider how and in what ways global HTA bodies evaluate transformative therapies. Global sales and technology/procedure utilization data were also evaluated to gain insights into patient access and commercial impact.Results: This article evaluated uncertainties around evidence of efficacy, safety, and duration of effect, as well as underlying study quality and methodological considerations in the target categories. Although many HTA evaluations had similar approaches to assessing parameters such as safety, there were significant differences across technology categories. Technologydriven trends also surfaced where global HTA and payer systems may not yet be prepared to recognize and reward emerging technology impacts, including use of next-generation diagnostic results to guide care, considering novel impacts on therapy sequencing and clinical pathway management, and changes in payment and health delivery models.Conclusions: Some trends stemming from rapid evolution of breakthrough therapies will prompt reconsideration of our conventional value assessment and reward models, because health system measurement and management processes have not fully anticipated their effects.

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Section: Next-generation Diagnostics and Machine Learning Influence On Precision Medicine And Patient Management Decision Makingmentioning

confidence: 99%

Are Global Health Systems Ready for Transformative Therapies?

Faulkner

Spinner²,

Ringo³

et al. 2019

Value in Health

View full text Add to dashboard Cite

show abstract

“…Regulatory science has different meanings to different audiences but for the purposes of this issue is defined as science and research intended to inform decision making in a regulatory framework. In putting this issue together, we have attempted to cover the very large waterfront of regulatory science, ranging from biomarker validation to novel approaches and acceptability of generation of clinical evidence and regulatory licensure frameworks that now include patient‐focused drug development . We also include regulatory science topics that can improve the effectiveness and efficiency of postmarketing pharmacovigilance, generic drug approval, and strategies to facilitate demonstration of value to support reimbursement .…”

Section: Regulatory Science Advances Regulatory Policymentioning

confidence: 99%

Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

Honig¹,

Zhang

2019

Clin Pharma and Therapeutics

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Regulatory science is defined as science and research intended to inform decision making in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the papers herein deal with the expansive topic of regulatory science and its role in fostering innovation and accelerating access to medicines. Regulatory health authorities, industry, and multiple stakeholders have a shared objective in advancing regulatory science to keep up with the ever‐increasing pace of biomedical science.

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Healthcare can’t stop evolving: innovation as the catalyst for unleashing the managerial potential of value-based healthcare by stimulating intangible assets and enhancing organizational resilience

Gaspary,

Gerhardt,

de Freitas Michelin

et al. 2024

Front. Psychol.

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BackgroundWith increasing healthcare service utilization and the introduction of costly therapies, healthcare organizations are pressured to deliver cost-effective services within constrained budgets. Rising costs and the need for efficient healthcare delivery are major concerns for governments, insurers, and health plans.ObjectivesIt aims to understand the impact of these intangible assets on creating value and organizational resilience in healthcare, informing better practices and strategies for VBHC implementation.MethodsAn applied research approach using the Work Breakdown Structure (WBS) methodology was adopted. The research was divided into seven interconnected Work Packages (WPs), each designed to investigate different aspects of the integration between VBHC and intangible assets, with a focus on enhancing organizational resilience through innovative health processes. Key methodologies included literature reviews and qualitative analyses, employing Open Innovation and Design Thinking.ResultsThe study revealed a dynamic interplay between VBHC, organizational resilience, and intangible assets. It showed that managerial effectiveness is influenced by direct patient outcomes and elements like intellectual capital and organizational reputation. Data integration from various Work Packages provided new insights into how intangible assets underpin VBHC strategies, proposing novel management approaches. Findings highlight the essential role of intangible assets in enhancing service delivery and fostering sustainable healthcare practices.DiscussionThe study highlights a significant oversight in the integration of intangible assets within healthcare organizations, despite their crucial role in optimizing VBHC. It supports literature emphasizing the importance of intellectual capital and organizational culture in enhancing healthcare management efficiency and resilience. A paradigm shift in VBHC to include these assets is needed for building a more adaptable and sustainable healthcare system. This integration can lead to better clinical outcomes, patient satisfaction, and overall healthcare efficiency, aligning more closely with VBHC goals.ConclusionRecognizing and effectively managing intangible assets are paramount for the successful implementation of VBHC and enhanced organizational resilience. Strategic integration of these assets into healthcare management practices can significantly improve patient outcomes and create a more sustainable, patient-centered, and resilient healthcare system. Future studies should develop methodologies for robust measurement and integration of these assets to fully realize the potential of VBHC.

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Recognizing that Evidence is Made, not Born

Cited by 3 publications

References 50 publications

Are Global Health Systems Ready for Transformative Therapies?

Are Global Health Systems Ready for Transformative Therapies?

Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

Healthcare can’t stop evolving: innovation as the catalyst for unleashing the managerial potential of value-based healthcare by stimulating intangible assets and enhancing organizational resilience

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