Last Updated : April 24, 2023
The position statement is a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies
CADTH, Canada’s drug and health technology agency, in collaboration with the Institute for Clinical and Economic Review (ICER) in the US and the National Institute for Health and Care Excellence (NICE) in England, is announcing a position statement entitled Confidentiality of Clinical Evidence Informing Health Technology Assessment Decision-Making.
The statement describes how the 3 health technology assessment (HTA) bodies are changing how they handle some confidential clinical evidence that is submitted through their respective review processes to streamline processes and increase transparency.
Health technology reviews must strike a critical balance between ensuring transparency of the evidence and decision-making and protecting confidential information. While the 3 organizations operate in different health systems, they share a common goal of maximizing transparency in an effort to put evidence at the heart of decision making. Given these similarities, CADTH, ICER and NICE have been working together to create a more consistent approach to handling clinical data. The position statement published today is a tangible result from this ongoing collaboration.
Beginning in May 2023, CADTH and NICE will not routinely redact clinical data that are awaiting publication when they publish their respective recommendations, guidance, or decisions. Respecting the different contexts in which the HTA agencies operate, CADTH commits to engaging with the pharmaceutical industry to identify a reasonable approach to implementation that does not impede existing global publication plans and/or timelines for application filing.
Enhancing a culture of transparency
Key factors driving this change include a desire to respond to evolving global expectations about transparency among regulators and HTA bodies, and the need to focus resources on activities that deliver the greatest benefit for those who use our advice.
Further, enhancing and maturing its culture of transparency is one of CADTH’s key strategic ambitions and is crucial to remaining a trusted source of evidence and advice for pan-Canadian health systems. Transparency is also 1 of the 5 principles that guide CADTH’s approach to assessing evidence and, more broadly, the organization’s approach to all its activities.
Next Steps
CADTH commits to engaging with the pharmaceutical industry to identify a reasonable approach to implementation that does not impede existing global publication plans and/or timelines for application filing. Following this consultation, updates to the Procedures for CADTH Reimbursement Reviews will be outlined in CADTH’s Pharmaceutical Reviews Update, a digest of program updates and news. To receive the Pharmaceutical Reviews Update by email, please subscribe.
Quick Facts
- CADTH is Canada’s drug and health technology agency. It is a not-for-profit organization funded by Canada’s federal, provincial, and territorial governments (except Quebec) to provide independent information and advice about the drugs, devices, and services used in Canada’s publicly funded health care systems.
- Founded in 2006 and nonprofit incorporated in 2013, ICER has become the nation’s nonpartisan, independent, go-to-resource for objective evidence about the value of health care in the US.
- NICE balances the best care with value for money across the NHS and social care in England, to deliver for both individuals and society as a whole.
- In 2022 the International Committee of Medical Journal Editors updated its recommendation on Overlapping Publications to state that scientific journals may publish scientific data, even if they were previously published by regulatory agencies or HTA bodies.
Related Links
Read ICER’s announcement
Read NICE’s announcement
Last Updated : April 24, 2023