Exploring Uncertainty in Economic Evaluations of Drugs and Medical Devices: Lessons from the First Review of Manufacturers' Submissions to the French National Authority for Health

PharmacoEconomics
S GhabriJ Josselin

Abstract

The objective of this paper was to evaluate how uncertainty has been accounted for in the cost-effectiveness analyses (CEAs) submitted by manufacturers to the French National Authority for Health (HAS) and to identify recurring concerns in these submissions. We used a cross-sectional design to evaluate manufacturers' submissions from the beginning of the evaluation process in October 2013 to the end of May 2015 (n = 28). The sources of uncertainty attached to these CEAs were categorized and assessed. Relevant data were extracted independently by two assessors. Adherence to the HAS reference case was generally considered to be acceptable. Methodological uncertainty and parameter uncertainty were the sources of uncertainty that were most frequently explored by manufacturers. The quality of reporting of deterministic sensitivity analysis and probabilistic sensitivity analysis varied substantially across submissions, with a frequent lack of justification of the plausible range of parameter point estimates in 12 submissions (43 %). Structural uncertainty was explored much less frequently. Concerns related to omission of either important clinical events or relevant health states or extrapolation of the effects of the technology beyon...Continue Reading

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Citations

Jul 6, 2016·PharmacoEconomics·William C N DunlopLouise Heron
Jan 31, 2017·Expert Review of Pharmacoeconomics & Outcomes Research·Françoise F HamersCatherine Le Gales
Oct 1, 2019·PharmacoEconomics·Salah GhabriBenoît Le Maux
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Jul 11, 2021·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Svenja PetersohnManuela A Joore

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