Reducing the expert halo effect on Pharmacy and Therapeutics Committees

JAMA

18 January 2019 - At a recent pharmacy and therapeutics committee meeting, a highly respected specialist presented a novel haemostatic drug for addition to the formulary. The drug had been shown in a phase 2 trial to significantly reduce anti–factor-Xa activity in healthy volunteers, and a subsequent uncontrolled, open-label trial showed evidence of haemostasis. 

The cost of the drug was approximately $25 000 to $50 000 per treatment course. Additionally, due to a potential increase in thrombotic risk, a boxed warning was required by the US FDA. The specialist acknowledged the shortcomings of the trials and potential risks but advocated for the addition of the drug to the formulary based on the argument that few other options existed. Discussions about the merits of the drug ensued, and after 15 minutes, the committee was asked to vote.

This scenario plays out at pharmacy and therapeutics committees across the country; an expensive medication is requested to be added to the formulary by a topic expert based on mechanistic explanations, sometimes limited evidence, and perhaps surrogate outcome data.

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Michael Wonder

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Michael Wonder