ICER’s guideline on the acceptance and use of “in-confidence” data from manufacturers of pharmaceuticals, devices, and other health care interventions


22 December 2017 - ICER takes its obligations to transparency and fairness seriously. 

It is our belief that all stakeholders should have access to the broadest set of information possible on a new intervention.

ICER welcomes discussions with stakeholders regarding information that may be viewed as confidential. Discussions should ideally commence during the scoping phase for each topic, near the beginning of the review process.

Two types of in-confidence data will be considered. “Academic-in-confidence” data relates to information that is typically awaiting publication or public presentation (e.g., at a clinical conference). Importantly, ICER considers all confidential clinical data to be academic-in-confidence, regardless of whether the manufacturer has active plans to publish or present such data.“Commercial-in-confidence” data relates to commercially-sensitive information regarding price, market conditions (e.g., uptake projections), terms of reimbursement arrangements with payers, and other information not considered to be academic-in-confidence.

Read ICER Guideline

Michael Wonder

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Michael Wonder