The Role of Patient Experience in the Value Assessment of Complex Technologies – Do HTA Bodies Need to Reconsider How Value is Assessed?

Sarri, Grammati; Freitag, Andreas; Szegvari, Boglarka; Mountian, Irina; Brixner, Diana; Bertelsen, Neil; Kaló, Zoltán; Upadhyaya, Sheela

doi:10.1016/j.healthpol.2021.03.006

Cited by 13 publications

(9 citation statements)

References 35 publications

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“…Several authors have referred to “The 5Ps” as important contextual considerations in HTA, namely, that the perspectives of many stakeholders–patients, practitioners, payers, producers and policymakers–must be part of any CEA ( Phelps and Madhavan, 2017 ; Slejko et al, 2019 ; Hall, 2020 ; van Overbeeke et al, 2021 ). Incorporating patient preference and experience, and their perception of the quality of life amidst their illness, offsets the objective nature of the traditional CEA methods and theoretically allows for a more comprehensive assessment ( Sarri et al, 2021 ). For example, factors important to the patient regarding the impact their diagnosis will have on those around them ( Vrinzen et al, 2022 ) or life satisfaction should be considered in any assessment ( Hall, 2020 ).…”

Section: Discussionmentioning

confidence: 99%

Reconstructing the value puzzle in health technology assessment: a pragmatic review to determine which modelling methods can account for additional value elements

Muir¹,

Radhakrishnan²,

Freitag³

et al. 2023

Front. Pharmacol.

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Health technology assessment (HTA) has traditionally relied on cost-effectiveness analysis (CEA) as a cornerstone of evaluation of new therapies, assessing the clinical validity and utility, the efficacy, and the cost-effectiveness of new interventions. The current format of cost-effectiveness analysis, however, does not allow for inclusion of more holistic aspects of health and, therefore, value elements for new technologies such as the impact on patients and society beyond its pure clinical and economic value. This study aimed to review the recent modelling attempts to expand the traditional cost-effectiveness analysis approach by incorporating additional elements of value in health technology assessment. A pragmatic literature review was conducted for articles published between 2012 and 2022 reporting cost-effectiveness analysis including value aspects beyond the clinical and cost-effectiveness estimates; searches identified 13 articles that were eligible for inclusion. These expanded modelling approaches mainly focused on integrating the impact of societal values and health equity in cost-effectiveness analysis, both of which were championed as important aspects of health technology assessment that should be incorporated into future technology assessments. The reviewed cost-effectiveness analysis methods included modification of the current cost-effectiveness analysis methodology (distributional cost-effectiveness analysis, augmented cost-effectiveness analysis, extended cost-effectiveness analysis) or the use of multi-criteria decision analysis. Of these approaches, augmented cost-effectiveness analysis appears to have the most potential by expanding traditional aspects of value, as it uses techniques already familiar to health technology assessment agencies but also allows space for incorporation of qualitative aspects of a product’s value. This review showcases that methods to unravel additional value elements for technology assessment exist, therefore, patient access to promising technologies can be improved by moving the discussion from “if” to “how” additional value elements can inform decision-making.

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Section: Discussionmentioning

confidence: 99%

Reconstructing the value puzzle in health technology assessment: a pragmatic review to determine which modelling methods can account for additional value elements

Muir¹,

Radhakrishnan²,

Freitag³

et al. 2023

Front. Pharmacol.

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“…There is limited evidence of EMA consideration of patient perspectives in risk-benefit analyses conducted during conventional therapeutic processes, but increasingly there have been calls to elevate patient input into decision-making by Health Technology Assessment (HTA) bodies (Coulter et al, 2008;Sarri et al, 2021), and some moves by the EMA to involve patients in decision-making (Mühlbacher et al, 2016). There is some scope for those developing innovative medicines to apply to follow alternative pathways for approval, some of which provide greater opportunity for early patient dialogue and consultation in relation to regulatory decisions than conventional approval pathways.…”

Section: The European Unionmentioning

confidence: 99%

Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products

et al. 2021

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Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies to raise distinct scientific, ethical, legal and social issues. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an individual’s genome. This article focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Although clinical trials for genome edited products are only just underway, lessons can be drawn from the marketing approvals pathways for related gene therapy products. This article provides a broad overview of the regulatory pathways that have been adopted by the US Food and Drugs Administration, the European Medicines Authority, and the Australian Therapeutic Goods Administration for reviewing gene therapy products for marketing approval. This analysis focuses on the extent to which public participation processes and transparency and accountability of review pathways are incorporated into marketing approval policy and practice. Following this review, the article proposes the application of Sheila Jasanoff’s “technologies of humility” as a foundation for meaningfully incorporating these pillars of good governance into regulatory processes for the review of products of genome editing. We conclude by articulating clear mechanisms for operationalising technologies of humility in the context of public participation, transparency and accountability, providing a blueprint for future policy development.

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“…Digital care refers to technology and data that inform and improve health care provision [ 4 ]. Unfortunately, today, digital care is often not aligned with the needs and values of its users and other stakeholders [ 5 , 6 ]. Not aligning digital care with stakeholders’ needs and values results in low technology uptake.…”

Section: Introductionmentioning

confidence: 99%

Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study

Siebelink,

van Dam,

Lukkien

et al. 2024

JMIR Ment Health

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Background Responsible digital care refers to any intentional systematic effort designed to increase the likelihood of a digital care technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it. Objective We aimed to present examples of action opportunities for (1) designing “technology”; (2) shaping the “context” of use; and (3) adjusting the behavior of “users” to guide responsible digital care for people with intellectual disabilities. Methods Three cases were considered: (1) design of a web application to support the preparation of meals for groups of people with intellectual disabilities, (2) implementation of an app to help people with intellectual disabilities regulate their stress independently, and (3) implementation of a social robot to stimulate interaction and physical activity among people with intellectual disabilities. Overall, 26 stakeholders participated in 3 multistakeholder workshops (case 1: 10/26, 38%; case 2: 10/26, 38%; case 3: 6/26, 23%) based on the “guidance ethics approach.” We identified stakeholders’ values based on bottom-up exploration of experienced and expected effects of using the technology, and we formulated action opportunities for these values in the specific context of use. Qualitative data were analyzed thematically. Results Overall, 232 effects, 33 values, and 156 action opportunities were collected. General and case-specific themes were identified. Important stakeholder values included quality of care, autonomy, efficiency, health, enjoyment, reliability, and privacy. Both positive and negative effects could underlie stakeholders’ values and influence the development of action opportunities. Action opportunities comprised the following: (1) technology: development of the technology (eg, user experience and customization), technology input (eg, recipes for meals, intervention options for reducing stress, and activities), and technology output (eg, storage and use of data); (2) context: guidelines, training and support, policy or agreements, and adjusting the physical environment in which the technology is used; and (3) users: integrating the technology into daily care practice, by diminishing (eg, “letting go” to increase the autonomy of people with intellectual disabilities), retaining (eg, face-to-face contact), and adding (eg, evaluation moments) certain behaviors of care professionals. Conclusions This is the first study to provide insight into responsible digital care for people with intellectual disabilities by means of bottom-up exploration of action opportunities to take account of stakeholders’ values in designing technology, shaping the context of use, and adjusting the behavior of users. Although part of the findings may be generalized, case-specific insights and a complementary top-down approach (eg, predefined ethical frameworks) are essential. The findings represent a part of an ethical discourse that requires follow-up to meet the dynamism of stakeholders’ values and further develop and implement action opportunities to achieve socially desirable, ethically acceptable, and sustainable digital care that improves the lives of people with intellectual disabilities.

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The Role of Patient Experience in the Value Assessment of Complex Technologies – Do HTA Bodies Need to Reconsider How Value is Assessed?

Cited by 13 publications

References 35 publications

Reconstructing the value puzzle in health technology assessment: a pragmatic review to determine which modelling methods can account for additional value elements

Reconstructing the value puzzle in health technology assessment: a pragmatic review to determine which modelling methods can account for additional value elements

Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products

Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study

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