Guidelines on ICER’s Acceptance and Use of “In-Confidence” Data from Manufacturers of Pharmaceuticals, Devices, and other Health Interventions
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 holds an equally strong belief that the rights of the owners of confidential and proprietary data should be protected.
ICER reviews are frequently timed to concur with the date of U.S. regulatory approval for drugs and devices, a period in which potentially useful information may not yet have been published in peer-reviewed journals, presented at clinical conferences, or submitted in briefing documents to regulators.
ICER has had need, on occasion, to request such “in-confidence” data from manufacturers to support its evidence synthesis and economic modeling efforts.
Manufacturers or other stakeholders also may have evidence that they would like to share with ICER to help ensure that ICER reviews contain the best possible information, but sometimes this information may need to be treated as confidential, either for business or academic reasons.
ICER’s In-Confidence Policy
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. Specific process steps regarding these two types of data are described in further detail below.
ICER will not accept any in-confidence data that will conceivably lead to the identification of an individual patient or group of patients.
The amount of in-confidence data shared should be kept to a minimum. It is generally considered unacceptable to mark entire documents, or even entire sections of documents, as confidential. Only specific elements, such as analytic results or equations, should be marked confidential.
Manufacturers who provide academic- or commercial-in-confidence data should be aware that these data may be used in ICER’s economic model, which may be shared with other stakeholders involved in the review through ICER’s model transparency program. While all confidential data will be redacted from the shared model, manufacturers who provide confidential data should be aware that it may be possible in some cases for model recipients to “back-calculate” these inputs. To mitigate this risk, ICER and its economic modeling collaborators will include language in all licensing agreements that expressly prohibits the back-calculation of model inputs through “what-if” queries or other methods, and that restricts the ability of model recipients to save or reproduce the model itself. Licensing agreements will also stipulate that organizations receiving the model must agree to keep any proprietary information included in the model confidential, including the model and any non-public data it contains.
Stakeholders should keep ICER updated on whether the information shared remains confidential, or has been introduced to the public domain at some point during the project timeline.
The final decision to submit in-confidence data, subject to the terms outlined in the sections below, remains with the data owner alone.
As described above, regardless of whether publication or presentation is planned, ICER considers all confidential clinical data to be academic-in-confidence and therefore subject to the process described below.
Academic-in-confidence data will be redacted from all external and public ICER documents until the earlier of: (a) publication or presentation of such data by the data owner or study investigators; (b) 18 months following the date of the public ICER meeting; (c) for reports that are not subject to a public meeting, 18 months following report publication. Following any of these dates, ICER will unmask all redacted information from reports, presentations, and other public documents.
Organizations that provide academic in confidence data should be aware of the potential for back-calculation of these data when they are used as inputs for a network meta-analysis (NMA). To mitigate this risk, ICER may choose to redact specific NMA outputs if they clearly reflect the academic-in-confidence inputs used in their generation (e.g., when the sole NMA input for an agent is its efficacy versus placebo, ICER may redact the NMA output for this comparison, but may not for the indirect comparisons against other agents in the network).
When academic-in-confidence data are not yet publicly-available by the time of ICER’s scheduled meeting on the relevant topic, the information will be redacted from reports, presentations, and other publicly-available ICER material. However, a printout of the slides summarizing the evidence review and/or economic evaluation will be made available to the public panel deliberating on the evidence (i.e., CTAF, Midwest CEPAC, or New England CEPAC) that unmasks any redacted data, so that the panel can view all relevant information in an open and transparent manner. Panel members will be instructed not to share the unmasked data or their source beyond the confines of their deliberations.
ICER will consider accepting submission of business-sensitive “commercial-in-confidence” data as part of its review process. As noted above, only non-clinical data will be considered to be potentially commercial-in-confidence information.
Commercial-in-confidence data will generally involve information on pricing, discounting/rebates, market conditions (e.g., uptake projections), and the terms of coverage or reimbursement agreements with specific payers, including any outcomes- or risk-based contracts. Other non-clinical data will be considered by ICER on a case-by-case basis.
Data determined to be commercial-in-confidence will be redacted in all ICER documents in perpetuity, without exception.