ispor recommends disclaimer for pharmacoeconomic models
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Current Issues in Pharmacoeconomics 2 __________________________________________ --____ __
ISPOR recommends disclaimer for pharmacoeconomic models
An advisory panel for the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has recommended that pharmacoeconomic models incorporate an appropriate disclaimer. A suggested disclaimer is as follows: 'This economic analysis is based on assumptions and simulations concerning the efficacy of [drug name 1 that meet/do not meet the FDA criteria for claims of efficacy,'
The advisory panel believes that any pharmaco-economic model which uses efficacy assumptions that are not based on the results of randomised controlled trials must prominently disclose such limitations in any promotion of its findings in any publication. The panel also recommends peer review of the underlying assumptions of a pharmacoeconomic model. A final white paper on these recommendations will be released at ISPOR's annual meeting in May.
'If the models can be presented with these disclaimers, it is a step . .. in the right direction' towards moving models 'more into the mainstream', said panel member, Dr Joel Hay from the University of Southern California.
The US FDA is considering iii(.orpuldling ~Ul:h a disclaimer in the guidance for pharmacoeconomic infonnation that it is currently developing. Pharmacoeconomic modeling disclaimer proposed by ISPOR panel. FOe Reports - Pink Sheet - Prescription Pharmaceutical, and Biotechnology 60:
8. 2 Mar 1998 '''''''''''
PharmacoEconomics & Outcomes Naws28 Mar 1998 No. 155 1173-5503198/0155-00021$01.00 Adis International Limited 1998. All rights reserved