Evidence Required by Health Technology Assessment and Reimbursement Bodies Evaluating Diagnostic or Prognostic Algorithms That Include Omics Data

Barna, Alexandre; Cruz-Sanchez, Teresita M; Brigham, Karen Berg; Thuong, Cong-Tri; Kristensen, Finn Børlum; Durand‐Zaleski, Isabelle

doi:10.1017/s026646231800048x

Cited by 10 publications

(9 citation statements)

References 16 publications

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“…Clinical utility is broadly defined as a measurable improvement in patient outcomes based on patient management changes that are directed by the result of the test [23]. It represents the final and most important of three key parameters from the ACCE model, which takes its name from the criteria for evaluating a genetic test—analytic validity, clinical validity, clinical utility, and associated ethical, legal, and social implications.…”

Section: Precision Oncology Trials—the Quest For Evidencementioning

confidence: 99%

Precision Oncology—The Quest for Evidence

Soldatos¹,

Kaduthanam²,

Jackson³

2019

JPM

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The molecular characterization of patient tumors provides a rational and highly promising approach for guiding oncologists in treatment decision-making. Notwithstanding, genomic medicine still remains in its infancy, with innovators and early adopters continuing to carry a significant portion of the clinical and financial risk. Numerous innovative precision oncology trials have emerged globally to address the associated need for evidence of clinical utility. These studies seek to capitalize on the power of predictive biomarkers and/or treatment decision support analytics, to expeditiously and cost-effectively demonstrate the positive impact of these technologies on drug resistance/response, patient survival, and/or quality of life. Here, we discuss the molecular foundations of these approaches and highlight the diversity of innovative trial strategies that are capitalizing on this emergent knowledge. We conclude that, as increasing volumes of clinico-molecular outcomes data become available, in future, we will begin to transition away from expert systems for treatment decision support (TDS), towards the power of AI-assisted TDS—an evolution that may truly revolutionize the nature and success of cancer patient care.

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Section: Precision Oncology Trials—the Quest For Evidencementioning

confidence: 99%

Precision Oncology—The Quest for Evidence

Soldatos¹,

Kaduthanam²,

Jackson³

2019

JPM

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“…Clinical utility has been de ned as something that improves patient outcomes and adds value to the clinical decision-making process [16]. Clinical utility is viewed as a key standard for reimbursement decision-making, but a lack of evidence and ambiguity regarding standards for the clinical utility of genomic tests has been identi ed in the literature [7,14,[17][18][19]. As decision impact studies report on the impact of a test on decision making, these studies appear to position themselves as a form of evidence to assess clinical utility.…”

Section: Introductionmentioning

confidence: 99%

The Role of Decision Impact Studies in Genomic Medicine in Cancer Care: A Scoping Review and Bibliometric Analysis Protocol

Parker

Miller

2021

Preprint

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BackgroundDecision impact studies have become increasingly prevalent in oncology in recent years, particularly in breast cancer prognostic research. Such studies, which aim to evaluate the impact of a test on clinical decision-making, appear to be a new form of knowledge with the potential to impact clinical practice and regulatory decision-making in genomic medicine. Yet their origins, intended purpose and usage have not yet been explored. The objectives of this review are to identify and characterize decision impact studies in genomic medicine in cancer care. This review is comprised of two parts. First, we will conduct a scoping review to catalogue the characteristics of decision impact studies. The scoping review will be followed by a bibliometric analysis to understand the role of actors and institutions in the production and dissemination of this new knowledge, by identifying influential articles, authors, global research trends and collaboration networks. MethodsWe will conduct a scoping review and a bibliometric analysis of the scoping review results. The search will include four databases, Medline, Embase, Scopus and Web of Science, using a comprehensive search strategy developed through a preliminary review of the literature. Arksey & O’Malley’s scoping review methodology, with updates by Levac et al. will be used, and the review will be reported following the PRISMA-ScR checklist. The FT Model will be used to collect and analyze data on clinical utility of decision impact studies. Our bibliometric analysis, using Bibliometrix software, will elucidate the evolution of these studies and provide data on the trends, influences and networks emerging in the field.DiscussionThis review will be a first step in understanding the evolution and uses of these studies and their potential influence on the integration of emerging genomic technologies into clinical practice. By exploring their origin and evolution across space and time, this study will equip future research to investigate the role of these studies in decision-making for regulatory processes, including market access and public and private coverage decision-making. Systematic review registration: Open Science Framework osf.io/hm3jr

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“…They rely on "omics" technologies such as next-generation sequencing and microarray analysis [4,5]. Health technology assessment (HTA) agencies have taken an interest in these technologies, which already offer a significant value to patients and healthcare systems [6]. In particular, applications of "omic" technologies, as the two commercial diagnostic aiding tools specified above, have shown to provide prognostic utility to physicians for better therapy selection in early breast cancer [4,5].…”

Section: Introductionmentioning

confidence: 99%

“…Commercial diagnostic tests in other indications, including rheumatoid arthritis, diabetes, heart transplantation rejection and other cancerous malignancies, have seen their implementation in the clinic as well. Due to this, the application of these novel "omics" technologies and their added value have been studied and published by different HTA reports [6]. However, as promising as these new technologies are, their assessment seemingly proves to be challenging due to surrounding uncertainty on the clinical utility they provide and their effect on patient outcomes [7].…”

Section: Introductionmentioning

confidence: 99%

A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies

Hoxhaj

Govaerts

Simoens

et al. 2020

IJERPH

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Background: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. Methods: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies’ repositories, we retrieved the published reports on the practical use of these frameworks. Results: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. Conclusions: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects.

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Evidence Required by Health Technology Assessment and Reimbursement Bodies Evaluating Diagnostic or Prognostic Algorithms That Include Omics Data

Cited by 10 publications

References 16 publications

Precision Oncology—The Quest for Evidence

Precision Oncology—The Quest for Evidence

The Role of Decision Impact Studies in Genomic Medicine in Cancer Care: A Scoping Review and Bibliometric Analysis Protocol

A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies

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