ISSUE:

The development of new treatments has the potential to improve patient outcomes. To support this innovation, safety and efficacy data are often kept confidential during development. However, health technology assessment (HTA) agencies have a responsibility to ensure their evaluations are open and transparent. How can the global healthcare community find a balance between protecting commercially sensitive information and providing transparent information for stakeholders?

OVERVIEW:

Many HTA agencies have processes to protect confidential data that is academically- and/or commercially-sensitive. This allows companies and data owners to provide evidence to HTA agencies without jeopardising future publications or commercial agreements, because the data are redacted from published HTA documents. In 2022, the International Committee of Medical Journal Editors (ICMJE) announced it no longer considers data published by HTA agencies to be duplicate publication. This prompted HTA agencies to reconsider their policies on confidential information in their evaluations, particularly “academic-in-confidence”. Pharmaceutical companies highlighted that current policy allows for provision of clinical data in confidence earlier than public presentation or publication, and that policy changes may affect patient access. In response to this, HTA agencies have been working together to explore how best to address the issue. This is an opportunity for healthcare decision makers alongside industry to consider and debate transparency and data protection.

Dan Ollendorf will present a 5-minute overview of the issue. Each panel member will then have 10 minutes to present their perspective. After the presentations, Dan will summarise and pull out the key themes before a 20-minute panel discussion with audience participation. It’s expected that all stakeholders in the HTA process would benefit from this discussion.