Exploratory, Participatory and Iterative Assessment of Value: A Response to Recent Commentaries

Grutters, Janneke P.C.; Govers, Tim M.; Nijboer, Jorte; Tummers, Marcia; Wilt, Gert Jan van der; Rovers, Maroeska M.

doi:10.34172/ijhpm.2020.76

Cited by 4 publications

(10 citation statements)

References 19 publications

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“…This is interesting, since recent studies argue that modeling is not particularly useful to distinguish favorable from unfavorable innovations in an early stage, as reaching potential cost-effectiveness is a low bar when large uncertainties exist. 3,71,72 Moreover, conducting traditional analyses such as PSA in an early stage could lead to pseudocertainty, since some uncertainties are not yet quantifiable or even unknown. Instead, it seems more useful to determine directions for further research and the conditions under which the innovation could become of added value.…”

Section: Discussionmentioning

confidence: 99%

“…12,15,73 One of these improvements is the iterative use of modeling: the repeated use of early HTA throughout the research and development stages. 5,8,71,74 It seems that iterative modeling is rarely used, as only 4 of the included studies referred to an earlier model for (previous generations of) the innovation under study. The iterative process should start from a clinical problem with possibly an idea for an innovative solution.…”

Section: Discussionmentioning

confidence: 99%

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The Use of Decision Analytic Modeling in the Evaluation of Surgical Innovations: A Scoping Review

Scholte¹,

Rovers²,

Grutters³

2021

Value in Health

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The main objective of this review was to map how decision analytic models are used in surgical innovation (in which research phase, with what aim) and to understand how challenges related to the assessment of surgical interventions are incorporated.Methods: We systematically searched PubMed, Embase, and the Cochrane Library for studies published in 2018. We included original articles using a decision analytic model to compare surgical strategies. We included modeling studies of surgical innovations. General, innovation, and modeling characteristics were extracted, as were outcomes, recommendations, and handling of challenges related to the assessment of surgical interventions (learning curve, incremental innovation, dynamic pricing, quality variation, organizational impact). Results:We included 46 studies. The number of studies increased with each research phase, from 4% (n = 2) in the preclinical phase to 40% (n = 20) in phase 3 studies. Eighty-one studies were excluded because they investigated established surgical procedures, indicating that modeling is predominantly applied after the innovation process. Regardless of the research stage, the aim to determine cost-effectiveness was most frequently identified (n = 40, 87%), whereas exploratory aims (eg, exploring when a strategy becomes cost-effective) were less common (n = 9, 20%). Most challenges related to the assessment of surgical interventions were rarely incorporated in models (eg, learning curve [n = 1, 2%], organizational impact [n = 2, 4%], and incremental innovation [n = 1, 2%]), except for dynamic pricing (n = 10, 22%) and quality variation (n = 6, 13%).Conclusions: In surgical innovation, modeling is predominantly used in later research stages to assess cost-effectiveness. The exploratory use of modeling seems still largely overlooked in surgery; therefore, the opportunity to inform research and development may not be optimally used.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The Use of Decision Analytic Modeling in the Evaluation of Surgical Innovations: A Scoping Review

Scholte¹,

Rovers²,

Grutters³

2021

Value in Health

Self Cite

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“…164,167 Also, there is an important role for value of information. 164,168,169 Value-of-information (VOI) analysis is a method used to estimate the value of collecting more information for the decision-maker. 170 This information can reduce uncertainty and consequently the probability of making the wrong decision.…”

Section: Economic Evaluation -The Earlier the Bettermentioning

confidence: 99%

“…As such, as opposed to late-stage economic evaluations, which are often considered as a 'one-time' assessment, early-stage evaluations are more iterative and can be conducted in parallel with the development of technology. 164,169,[171][172][173] Consequently, economic evaluations during the early stages of development can have a significant influence on the (future) clinical performance of the technology, whereas in late-stage economic evaluations the specifications and performance of the technology are final. 165,169 In order to guide early economic evaluation, several frameworks have been developed.…”

Section: Economic Evaluation -The Earlier the Bettermentioning

confidence: 99%

“…164,169,[171][172][173] Consequently, economic evaluations during the early stages of development can have a significant influence on the (future) clinical performance of the technology, whereas in late-stage economic evaluations the specifications and performance of the technology are final. 165,169 In order to guide early economic evaluation, several frameworks have been developed. 164,168,171,172,174 Frequently, the developer's perspective is adopted in these frameworks.…”

Section: Economic Evaluation -The Earlier the Bettermentioning

confidence: 99%

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Health and economic outcomes in axial spondyloarhthritis

Webers¹

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People interested in the research are advised to contact the author for the final version of the publication, or visit the DOI to the publisher's website.• The final author version and the galley proof are versions of the publication after peer review.• The final published version features the final layout of the paper including the volume, issue and page numbers. Link to publication General rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.• Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal.If the publication is distributed under the terms of Article 25fa of the Dutch Copyright Act, indicated by the "Taverne" license above, please follow below link for the End User Agreement:

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Linked Pharmacometric‐Pharmacoeconomic Modeling and Simulation in Clinical Drug Development

Hill‐McManus

Marshall

Liu

et al. 2020

Clin Pharma and Therapeutics

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Market access and pricing of pharmaceuticals are increasingly contingent on the ability to demonstrate comparative effectiveness and cost‐effectiveness. As such, it is widely recognized that predictions of the economic potential of drug candidates in development could inform decisions across the product life cycle. This may be challenging when safety and efficacy profiles in terms of the relevant clinical outcomes are unknown or highly uncertain early in product development. Linking pharmacometrics and pharmacoeconomics, such that outputs from pharmacometric models serve as inputs to pharmacoeconomic models, may provide a framework for extrapolating from early‐phase studies to predict economic outcomes and characterize decision uncertainty. This article reviews the published studies that have implemented this methodology and used simulation to inform drug development decisions and/or to optimize the use of drug treatments. Some of the key practical issues involved in linking pharmacometrics and pharmacoeconomics, including the choice of final outcome measures, methods of incorporating evidence on comparator treatments, approaches to handling multiple intermediate end points, approaches to quantifying uncertainty, and issues of model validation are also discussed. Finally, we have considered the potential barriers that may have limited the adoption of this methodology and suggest that closer alignment between the disciplines of clinical pharmacology, pharmacometrics, and pharmacoeconomics, may help to realize the potential benefits associated with linked pharmacometric‐pharmacoeconomic modeling and simulation.

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Exploratory, Participatory and Iterative Assessment of Value: A Response to Recent Commentaries

Cited by 4 publications

References 19 publications

The Use of Decision Analytic Modeling in the Evaluation of Surgical Innovations: A Scoping Review

The Use of Decision Analytic Modeling in the Evaluation of Surgical Innovations: A Scoping Review

Health and economic outcomes in axial spondyloarhthritis

Linked Pharmacometric‐Pharmacoeconomic Modeling and Simulation in Clinical Drug Development

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