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Early assessment of medical technologies : addressing uncertainty to inform good decisions
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Federici, Carlo Baldassarre (2021) Early assessment of medical technologies : addressing uncertainty to inform good decisions. PhD thesis, University of Warwick.
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Official URL: http://webcat.warwick.ac.uk/record=b3856165
Abstract
Innovation in medical technologies has the potential to strongly improve the quantity and quality of life of sick people suffering from a broad range of conditions. However, the true value of medical technologies at the time of taking adoption and reimbursement decisions is often highly uncertain due to limited clinical and economic evidence.
The overarching objective of this thesis was to explore methods and policy tools to characterize, quantify and address the uncertainty over the effectiveness and cost-effectiveness of medical technologies early on in their life cycle. The problem of uncertainty was addressed both under a methodological aspect and a policy aspect.
Two early cost-effectiveness models were built and used as case-studies to apply a series of methodological approaches. In a model on electrochemotherapy in patients with skin melanoma a probabilistic headroom approach was applied to estimate the maximum achievable price for a technology given the existing early evidence on its effectiveness. A model on a novel total artificial heart was then used to explore the use of Probability Bound Analysis (PBA), a new method which was recently proposed as an alternative way to characterize uncertainty when the lack of evidence hampers the use of more established methods such as probabilistic sensitivity analysis. The same case study was used to explore the potential misalignments which may exist about the most appropriate level of evidence between manufacturers and payers. By defining different utility functions and decisions rules for payers and technology developers respectively, value of information analysis was used to quantify the value of further evidence from both perspectives and the potential gains of reducing it through further research. From a policy perspective, this thesis explored the use of coverage with evidence development schemes as a policy tool for medical devices in Europe. Particularly, through a review of the available evidence and the collection of interviews to European decision-makers the main characteristics and challenges of such schemes were identified.
Uncertainty is an unavoidable fact of life and particularly in healthcare decision making. The recently enforced medical device regulation (MDR) and the approved proposal for a regulation on cooperation in HTA among member states seem to go in the direction of a lifecycle approach for the evaluation of healthcare technologies. According to this new regulatory approach, Technologies will likely be assessed moreiteratively (and differently) as new evidence accumulates over their life cycle. Greater interaction between the stakeholders involved, and in particular technology developers and payers is also envisaged.This paradigm shift will require the development of shared methods to assess the uncertainty surrounding a technology. This thesis aimed to contribute to filling this need, so to allow more appropriate, fair and transparent policy decisions in everyone’s interest.
| Item Type: | Thesis (PhD) | ||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) |
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| Library of Congress Subject Headings (LCSH): | Medical innovations, Medical innovations -- Cost effectiveness, Skin -- Cancer -- Chemotherapy, Evidence-based medicine, Medical care -- Decision making, Uncertainty -- Health aspects | ||||
| Official Date: | December 2021 | ||||
| Dates: |
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| Institution: | University of Warwick | ||||
| Theses Department: | School of Engineering | ||||
| Thesis Type: | PhD | ||||
| Publication Status: | Unpublished | ||||
| Supervisor(s)/Advisor: | Pecchia, Leandro | ||||
| Format of File: | |||||
| Extent: | xiv, 248 leaves : illustrations | ||||
| Language: | eng |
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